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pdfEconomic Analysis of the
Bulk Pesticide Container
Design and Residue
Removal Standards
June 1, 2006
Executive Summary of the Economic Analysis of the Final Pesticide Container Design and
Residue Removal Standards
The Environmental Protection Agency (EPA) is finalizing the standards for pesticide container
design and residue removal as required under Section 19 of the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA). The final standards include design and labeling requirements for
non-refillable and refillable pesticide containers to ensure that
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containers are strong and durable;
minimize human and environmental exposure during container handling;
facilitate container disposal and recycling;
minimize cross-contamination of pesticides distributed in refillable containers;
codify safe refilling management practices;
encourage the us e of refillable containers to reduce container disposal problems; and
provide instructions for proper cleaning of pesticide containers.
The improvements made in the design of pesticide containers and the removal of residues from
containers prior to disposal as a result of the final pesticide container standards are expected to
benefit pesticide users, non-users and the environment through a reduction in exposure to
pesticides from unintended pesticide container spills and leaks.
The total annual cost of compliance with the final standards to the regulated industries (i.e.,
pesticide registrants, agricultural pesticide refillers, and swimming pool applicators) is estimated
at $8.4 million. This estimate is based on an examination of the current level of compliance of
pesticide containers with the final standards, and the cost of moving from the current level of
compliance to the final standards. The cost to pesticide registrants is estimated at $5.6 million
per year. None of the more than 1,800 pesticide registrant companies (including 1,658 small
businesses as defined by SBA) subject to the final standards are estimated to be significantly
impacted by compliance with the final standards (the ratio of the cost of compliance to current
industry average revenues for all businesses is estimated to be less than 0.02 percent). Pesticide
registrants are responsible for ensuring that pesticide containers are designed in accordance with
the final container design and labeling standards, and for following the pesticide container
refilling requirements for pesticide containers in the agricultural and
industrial/commercial/government pesticide markets.
Agricultural pesticide refillers and swimming pool applicators are responsible for following the
pesticide container refilling requirements for containers in the agricultural pesticide market and
pool chemicals market, respectively. The estimated annual cost of compliance with the final
pesticide container standards for pesticide refillers is $2.6 million. For swimming pool
applicators, the estimated annual cost of compliance is $0.2 million. As is the case with
pesticide registrants, none of the estimated 16,795 agricultural pesticide refilling businesses (of
which16,642 are small businesses as defined by SBA) and 322 swimming pool supply
companies (of which 305 are small businesses as defined by SBA) are estimated to be
significantly impacted by compliance with the final standards (the ratio of the cost of compliance
to current industry average revenues for all businesses in each industry is estimated to be less
than 0.01 percent)
The human health-related benefits expected as a result of the final pesticide container standards
include a reduction in the estimated number of unintentional container-related pesticide human
exposures of an estimated 610 to 768 incidents per year. This amounts to an estimated $264,051
to $332,311 in avoided costs of illness per year. The non-human health-related benefits expected
as a result of the final rule include a cost savings of $4.5 million from the disposal of
nonrefillable containers as nonhazardous rather than hazardous material, because of compliance
with the container standards. We are unable to quantify other non-health related benefits of the
final rule, but they include a reduction in the number of unintentional pesticide exposures to
terrestrial and aquatic wildlife, and avoided costs of property damage/spill cleanup costs from
pesticide container-related spills.
The pesticide container design and residue removal standards were proposed in 1994. In
response to public comments submitted on the proposed standards, a number of changes were
made to the proposed pesticide container design and residue removal standards, and these
changes are reflected in the final rule. The changes result in a reduction in the total estimated
cost of compliance with the pesticide container standards by as much as 80 percent from the
proposed rule (which was originally estimated at $40.1 million to $55.5 million per year for
compliance with the proposed standards (EPA preferred option), compared to $8.4 million for
the current final standards). The lower estimated costs are due in part to the exemption in the
final rule of household pesticide product labels from containing language requiring triple rinsing
of nonrefillable pesticide containers prior to disposal. As a result of this change, no end user
impacts are estimated in the final rule, which were estimated at more than $8 million in the
proposed rule impact analysis. Other significant changes in the regulations for the final rule,
which led to decreased costs for the industries impacted by the rule include reference to and the
adoption of existing Department of Transportation (DOT) standards in the regulations, and the
relaxation of the residue removal standard for nonrefillable containers from 99.9999 percent to
99.99 percent.
In general, the expected benefits of the pesticide container standards are similar between the
proposed and final rule. Due to the availability of more detailed data on pesticide containerrelated human exposures, the estimated number of pesticide container-related human exposure
incidents avoided as a result of the pesticide container standards declined from an estimated
1,650 to 2,250 incidents avoided per year as a result of the proposed standards, to an estimated
610 to 768 incidents avoided per year as a result of the final standards. And, due to the change in
the scope of the pesticide container standards, which resulted in fewer nonrefillable containers
affected by the final rule, the nonrefillable container disposal benefits (from reduced hazardous
waste) declined by more than 30 percent from the proposed to the final rule.
Contents
1.0 Introduction.............................................................................................................................. 1
1.1 Need for Regulation........................................................................................................ 2
1.2 Regulatory Background of the Final Rule...................................................................... 3
1.3 Scope of the Economic Analysis for the Final Pesticide Rule ....................................... 5
1.4 Estimated Costs and Benefits of the Final Rule ............................................................. 5
1.4.1 Costs Summary................................................................................................... 6
1.4.2 Benefits Summary ............................................................................................ 11
1.5 Limitations of the Final Rule Economic Analysis........................................................ 11
2.0 Final Rule Standards and Comparison of the Costs and Benefits of the Final and the
Proposed Rule Standards ....................................................................................................... 13
2.1 Final Rule Standards..................................................................................................... 13
2.2 Changes in Pesticide Container Design and Residue Removal Standards from the
Proposed to the Final Rule............................................................................................ 16
2.3 Response to Comments to the Proposed Standards...................................................... 18
2.4 Comparison of the Estimated Costs and Benefits of the Final and Proposed Standards
...................................................................................................................................... 19
3.0 Pesticide Container Compliance Profile................................................................................ 23
3.1 Introduction .................................................................................................................. 23
3.2 Pesticide Container Universe........................................................................................ 28
3.3 The Implications of the Scope of the Regulations on the Container Estimates ........... 33
3.3.1 Manufacturing Use Products and Plant-Incorporated Protectants.................... 35
3.3.2 Antimicrobial Pesticide Products ..................................................................... 35
3.3.3 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Toxicity Categories I and II.............................................................................. 37
3.3.4 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Restricted Use Products.................................................................................... 38
3.3.5 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Toxicity Categories III and IV That Are Not Restricted Use Products............ 39
3.3.6 Summary of Pesticide Container Scope Criteria .............................................. 39
3.4 Regulatory Compliance Baseline ................................................................................. 44
3.4.1 Regulatory Compliance Rates for Non-Refillable Containers ......................... 44
3.4.2 Regulatory Compliance Rates for Refillable Containers ................................. 50
3.4.3 Regulatory Compliance Rates for Refilling Activities..................................... 55
4.0 Pesticide Container Standards Cost Analysis ........................................................................ 58
4.1 Introduction .................................................................................................................. 58
4.2 The Basic Framework of the Cost Analysis ................................................................. 59
4.3 Characteristics of the Regulated Entities That Are Inputs to the Cost Analysis .......... 62
4.4 Estimating the Costs of Complying with the Final Regulations .................................. 64
4.4.1 Estimate the Number of Pesticide Containers in Each Market Sector ............. 65
4.4.2 Estimate the Number of Pesticide Containers in Each Market Sector That Fall
Within the Scope of the Container Rule........................................................... 65
4.4.3 Allocate Containers That Fall Within the Scope of the Rule in Each Market
Sector to Each of the Size Classes.................................................................... 66
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4.4.4
For Each Regulation Under the Pesticide Container Rule, Estimate the Number
of Containers That Fall Within the Scope of the Rule That Are Out of
Compliance with That Regulation.................................................................... 67
4.4.5 For Each Regulation Under the Container Rule, Estimate the Number of
Containers That Fall Within the Scope of the Rule That Are Out of Compliance
with That Regulation – for the Average Registrant in Each Combination of
Market Sector and Size Class ........................................................................... 70
4.4.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Containers
into Compliance................................................................................................ 70
4.4.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs........ 74
4.4.8 Calculate the Annualized Cost of Complying with Each Regulation .............. 75
4.4.9 Estimate the Annualized Cost of Complying with All Regulations per Average
Regulated Entity in Each Combination of Market Sector and Size Class –
Assuming No Waivers...................................................................................... 81
4.4.10 Estimate the Annual Cost of Complying with All Regulations per Average
Regulated Entity in Each Combination of Market Sector and Size Class –
Allowing for Waivers ....................................................................................... 83
4.5 Estimating the Costs of Compliance with Refilling-Related Regulations ................... 86
4.5.1 Allocate Refillable Containers That Fall Within the Scope of the Rule in Each
of the Relevant Market Sectors to Each of the Regulated Refilling Entity
Categories Within the Market Sector ............................................................... 87
4.5.2 Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule for Each Category of Regulated Entity for Each Refillable Container Type
88
4.5.3 Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule for Pesticide Refillers in Each Size Class Within Each Refiller Category
88
4.5.4 For Each Refilling-Related Regulation Under the Pesticide Container Rule,
Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule That Are Out of Compliance with That Regulation................................. 89
4.5.5 For Each Refilling-Related Regulation Under the Pesticide Container Rule,
Estimate the Number of Refillings That Fall Within the Scope of the Rule That
Are Out of Compliance with That Regulation – for the Average Regulated
Entity in Each Combination of Refiller and Size Class.................................... 90
4.5.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Refillings
into Compliance................................................................................................ 91
4.5.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs........ 93
4.5.8 Calculate the Annualized Cost of Complying with the Refilling Regulations. 94
4.6 The Total Annual Costs of the Rule ............................................................................. 95
4.7 Impact Analysis .......................................................................................................... 102
4.8 Sensitivity Analysis .................................................................................................... 105
5.0 The Human and Non-Human Health Benefits of the Final Standards ................................ 116
5.1 Introduction ................................................................................................................ 116
5.2 Human Health-Related Benefits: Estimated Annual National Cases and Valuation of
Pesticide Product-Related Illnesses and Injuries Potentially Avoided by the Standards
.................................................................................................................................... 117
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5.2.1 Summary of Approach.................................................................................... 118
5.2.2 Derivation of the Annual Percentage of Pesticide Illnesses Potentially Avoided
as a Result of the Container Design and Residue Removal Regulations ....... 118
5.2.3 Profile of Annual National Pesticide Exposure Cases.................................... 123
5.2.4 Extrapolation to Estimate of Nationwide Cases Potentially Avoided from the
Container Design and Residue Removal Standards ....................................... 128
5.2.5 Valuing Avoided Pesticide Product-Related Illnesses as a Result of the
Container Regulations .................................................................................... 131
5.3 Non-Human Health-Related Benefits of the Pesticide Container Regulations .......... 143
5.3.1 Non-Refillable Container Disposal Benefits .................................................. 143
5.3.2 Environmental Effects Avoided Due to Container-Related Pesticide Exposures
153
5.3.3 Property Damage/Spill Cleanup Costs Avoided ............................................ 154
5.4 Summary of the Benefits of the Final Standards........................................................ 157
References................................................................................................................................... 158
Appendixes
Appendix A. Compliance Costs for the Pesticide Container Standards .................................... 162
A.1 Non-Refillable Container Costs.................................................................................. 164
A.1.1 Residue Removal Standard............................................................................. 164
A.1.2 Administrative Requirements - Recordkeeping ............................................. 171
A.2 Refillable Container Costs.......................................................................................... 174
A.2.1 Administrative Requirements ......................................................................... 174
A.2.2 Standard for Container Marking..................................................................... 177
A.2.3 Standards for Openings .................................................................................. 181
A.2.4 Bulk Container Standards............................................................................... 184
A.3 Refilling Compliance Costs........................................................................................ 185
A.4 Cost of Label Requirements ....................................................................................... 188
A.5 Waiver Costs............................................................................................................... 192
Appendix B. Compliance Profile Estimation Details ................................................................ 193
B.1 Assumptions and Procedure for Converting Pesticide Volume and Weight into
Number of Refillable Containers in Use .................................................................... 193
B.2 Number of Refillables in Use by the Pool Industry: A Separate Discussion and
Consideration.............................................................................................................. 195
Appendix C. Regulation-Specific Cost Schedules..................................................................... 196
Appendix D. Profile of Industries Regulated by the Pesticide Container Regulations ............. 210
D.1 Pesticide Registrants................................................................................................... 211
D.1.1 Pesticide Registrants’ NAICS Codes ............................................................. 212
D.1.2 Analysis of Large Pesticide Registrants ......................................................... 213
D.1.3 Analysis of Small Pesticide Registrants ......................................................... 214
D.1.4 Container Profile for Registrants by Market Sector and Size Category......... 216
D.2 Agricultural Pesticide Refillers .................................................................................. 218
D.3 Swimming Pool Market.............................................................................................. 220
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Appendix E. 1994 Proposed Rule Container Standards Costs and Benefits ............................. 223
E.1 Estimated Cost of Proposed Rule Container Standards.............................................. 223
E.2 Estimated Benefits of the Proposed Rule Container Standards.................................. 226
Appendix F. Nationwide and State Regulations and Standards for Pesticide Containers ......... 228
F.1 Department of Transportation Hazardous Materials Regulations .............................. 228
F.2 United Nations Recommendations on the Transport of Dangerous Goods................ 229
F.3 Mid America CropLife Association (MACPA): MACA-75 Manufacturer Specification
and User Guidelines for Portable Agrichemical Tanks .............................................. 231
F.4 Container Population Affected by the container regulations and the Three Major
National Regulations/Standards ................................................................................. 232
F.5 Detailed Comparison of the Pesticide Container Regulations and the Three Major
Regulations/Standards ................................................................................................ 236
F.5.1 Design Standards ............................................................................................ 236
F.5.2 Permanent Markings....................................................................................... 236
F.5.3 Dispensing Capability..................................................................................... 237
F.5.4 Closures .......................................................................................................... 237
F.5.5 Residue Removal Design Standard ................................................................ 237
F.5.6 Production Testing.......................................................................................... 237
F.5.7 Production Retesting....................................................................................... 238
F.5.8 Reconditioning................................................................................................ 238
F.5.9 Waiver ............................................................................................................ 238
F.5.10 Recordkeeping ................................................................................................ 239
F.5.11 Refilling .......................................................................................................... 239
F.5.12 Labeling .......................................................................................................... 240
F.6 Existing EPA Policy Applicable to Pesticide Containers........................................... 260
F.6.1 Child-Resistant Packaging (40 CFR Part 157) ............................................... 260
F.6.2 Consumer Labeling Initiative ......................................................................... 260
F.6.3 Bulk Pesticide Enforcement Policy ................................................................ 261
F.7 State Regulations and Standards................................................................................. 265
F.7.1 Container Design and Performance Standards ............................................... 265
F.7.2 Refilling Requirements................................................................................... 265
F.7.3 Transfer of Pesticides Between Containers .................................................... 266
F.7.4 Residue Removal Procedures ......................................................................... 266
F.7.5 Container Collection and Disposal Procedures .............................................. 266
F.7.6 Pesticide Storage Guidelines .......................................................................... 267
Appendix G. Comparison of the Final Container Regulations with the 1994 Proposed Container
Regulations .......................................................................................................................... 273
G.1 Scope .......................................................................................................................... 273
G.2 Design Standards ........................................................................................................ 274
G.3 Permanent Markings................................................................................................... 275
G.4 Dispensing Capability................................................................................................. 275
G.5 Closures ...................................................................................................................... 275
G.6 Residue Removal Design Standard ............................................................................ 275
G.7 Design Qualification Testing...................................................................................... 276
G.8 Production Testing and Periodic Retesting ................................................................ 276
G.9 Reconditioning............................................................................................................ 277
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G.10 Waiver ........................................................................................................................ 277
G.11 Certification ................................................................................................................ 277
G.12 Recordkeeping ............................................................................................................ 277
G.13 Refilling ...................................................................................................................... 278
G.14 Labeling ...................................................................................................................... 278
Appendix H. Characterization of Unintentional Human Pesticide and Antimicrobial Exposures
and Health Effects in the TESS Database............................................................................ 287
H.1 General Characterization of Unintentional Human Pesticide and Antimicrobial
Exposures.................................................................................................................... 287
H.2 Characterization of Health Effects Associated with Unintentional Human Pesticide and
Antimicrobial Exposure Cases ................................................................................... 288
Appendix I. Benchmark Costs for Physician Office Visits by Current Procedural Terminology,
Fourth Edition (CPT-4) Code .............................................................................................. 293
Appendix J. Case Summaries of 1999 California Incidents That Would Have Been Prevented by
the Container Regulations.................................................................................................... 294
Appendix K. Pesticide Container and Refilling Requirements Cost Analysis Tables ............... 307
Page v
Tables and Figures
Table 1.1. The Types of Expected Benefits from the Container Design and Residue Removal
Regulations and Their Sources ................................................................................................ 3
Table 1.2. Overview of the Rule Requirements............................................................................. 6
Table 1.3. Quantified Costs and Benefits of the Rule Requirements (2005$)............................... 7
Table 1.4. Estimated Annual Cost of Compliance a with the Final Container Design and Residue
Removal Standards for the Average Regulated Entity (2005$) .............................................. 9
Table 1.5. Estimated Annual Cost of Compliance with the Pesticide Container Design and
Residue Removal Standards by Standard a ............................................................................ 10
Table 1.6. Estimated Benefits Associated with the Final Pesticide Container Design and Residue
Removal Regulations (2005$) a ............................................................................................. 11
Table 2.1. Annual Compliance Cost Comparison Between the Final and Proposed
Pesticide Container Standards (2005$).................................................................................. 19
Table 2.2. Comparison of Human Health-Related and Non-Human Health-Related Benefits for
the Proposed and Final Container Standards (2005$) ........................................................... 20
Table 3.1. Market Sector Equivalent Between the Current Analysis and the
1993 EPA Proposed Container Rule RIA.............................................................................. 25
Table 3.2. Generalization of Impacts of Pesticide Container Regulations on Regulated Entities26
Table 3.3. SBA and EPA Alternative Definitions of Small and Large Businesses Affected by the
Pesticide Container Regulations ............................................................................................ 27
Table 3.4. Estimated Number of Non-Refillable Pesticide Containers in Use by Major Market
Sectors.................................................................................................................................... 30
Table 3.5. Estimated Number of Refillable Pesticide Containers in Use by Major Market Sectors
32
Table 3.6. Estimated Number of Swimming Pool Chemical Refillable Containers Affected by
the Pesticide Container Regulations ...................................................................................... 33
Table 3.7. Summary of Regulatory Scope ................................................................................... 34
Table 3.8. Percentage of Pesticide Containers Affected by the Final Rule Scope Criteria ......... 38
Table 3.9. Estimated Number of Non-Refillable Pesticide Containers Affected by the Pesticide
Container Regulations a.......................................................................................................... 41
Table 3.10. Estimated Number of Refillable Pesticide Containers Affected by the
Pesticide Container Regulations a .......................................................................................... 43
Table 3.11. Overview of the Container Regulations.................................................................... 44
Table 3.12. Regulatory Compliance Rates for Non-Refillable Containers a ............................... 45
Table 3.13. Regulatory Compliance Rates for Refillable Containers.......................................... 53
Table 3.14. Repackaging/Refilling Requirements and Responsibility ........................................ 56
Table 4.1. Types of Regulated Entities by Market Sector ........................................................... 59
Table 4.2. Overview of Regulated Entities and Types of Regulations with Which They Must
Comply .................................................................................................................................. 60
Table 4.3. Intersection of the Pesticide Container Regulations and Regulated Entities.............. 61
Page vi
Table 4.4. Types of Containers Considered in the Analysis........................................................ 62
Table 4.5. Estimated Numbers of Regulated Entities by Market Sector and Size Class............. 64
Table 4.6. Percentages of Total Revenue in Each Size Class...................................................... 64
Table 4.7. Number of Containers by Market Sector, and Number and Percentages that Fall
Within the Scope of the Container-Related Regulations Under the Container Rule............. 66
Table 4.8a. Estimated Numbers of Non-Refillable Containers Out of Compliance with the
Container-Related Regulations a ............................................................................................ 68
Table 4.8b. Estimated Numbers of Refillable Containers Out of Compliance with the ContainerRelated Regulations a ............................................................................................................. 69
Table 4.9a. Total (Undiscounted) Costs a of Complying with All Regulations for Non-Refillables
Under the Container Rule (2005$)b ....................................................................................... 73
Table 4.9b. Total (Undiscounted) Costs a of Complying with All Regulations for Refillables
Under the Container Rule (2005$)b ....................................................................................... 74
Table 4.10a. Estimated Annual Cost of Complying with Each Container Regulation for NonRefillable Containers for the Average Registrant by Market Sector and Size Class (Interest
Rate = 3 percent) (2005$)a ..................................................................................................... 77
Table 4.10b. Estimated Annual Cost of Complying with Each Container Regulation for
Refillable Containers for the Average Registrant by Market Sector and Size Class (Interest
Rate = 3 percent) (2005$) a .................................................................................................... 78
Table 4.10c. Estimated Annual Cost of Complying with Each Container Regulation for NonRefillable Containers for the Average Registrant by Market Sector and Size Class (Interest
Rate = 7 percent) (2005$)a ..................................................................................................... 79
Table 4.10d. Estimated Annual Cost of Complying with Each Container Regulation for
Refillable Containers for the Average Registrant by Market Sector and Size Class (Interest
Rate = 7 percent) (2005$)a ..................................................................................................... 80
Table 4.11a. Total Annualized Costs Over a 20-Year Period of the Pesticide Container Rule for
the Average Registrant: Total Without a Waiver (Interest =3 percent)................................. 82
Table 4.11b. Total Annualized Costs Over a 20-Year Period of the Pesticide Container Rule for
the Average Registrant: Total Without a Waiver (Interest =7 percent)................................. 82
Table 4.11c. Total Annualized Costs Over a 20 Year Period of the Pesticide Container Rule for
the Average Registrant: Total With a Waiver (Interest Rate = 3 percent) ............................ 84
Table 4.11d. Total Annualized Costs Over a 20 Year Period of the Pesticide Container Rule for
the Average Registrant: Total With a Waiver (Interest Rate = 7 percent) ............................ 84
Table 4.12. Container-Related Standards and Waivers ............................................................... 85
Table 4.13. Estimated Annual Pesticide Container Refilling Rates ............................................ 89
Table 4.14. Estimated Numbers of Refilling Steps (or Requirements) per Year Out of
Compliance with Refilling-Related Requirements (2005$) .................................................. 90
Table 4.15. Total Compliance Costs a Related to Refilling Requirements for
Refillable Containers (2005$)b .............................................................................................. 93
Table 4.16a. Estimated Annual Cost of Complying with the Refilling-Related Container
Regulations for the Average Refiller by Refiller Category and Size Class
(Interest = 3 percent) (2005$)a ............................................................................................... 94
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Table 4.16b. Estimated Annual Cost of Complying with the Refilling-Related Container
Regulations for the Average Refiller by Refiller Category and Size Class
(Interest = 7 percent) (2005$)a ............................................................................................... 95
Table 4.17a. Total Annual Costs of the Pesticide Container Rule for Regulated Entities (Interest
Rate = 3 percent) (2005$) ...................................................................................................... 97
Table 4.17b. Total Annual Costs of the Pesticide Container Rule for Regulated Entities (Interest
Rate = 7 percent) (2005$) ...................................................................................................... 99
Table 4.18a. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule
(Interest Rate = 3 percent) (2005$)...................................................................................... 101
Table 4.18b. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule
(Interest Rate = 7 percent) (2005$)...................................................................................... 102
Table 4.19a. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated
Entity (Interest Rate = 3 percent) (2005$)........................................................................... 103
Table 4.19b. Ratio of Annual Compliance Cost to Annual Revenue for the Average Regulated
Entity (Interest Rate = 7 percent) (2005$)........................................................................... 104
Table 4.20. Annual National Cost of Regulation Under the Pesticide Container Rule (2005$) 106
Table 4.21. “Low-End” and “High-End” Assumptions for Sensitivity Analysis ...................... 108
Table 4.22. Total Annual Costs of the Pesticide Container Rule for Regulated Entities: Using
“Low End” Assumptions (Interest Rate = 3 percent) (2005$) ............................................ 110
Table 4.23. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule:
Using “Low End” Assumptions (Interest Rate = 3 percent) (2005$).................................. 112
Table 4.24. Total Annual Costs of the Pesticide Container Rule for Regulated Entities: Using
“High End” Assumptions (Interest Rate = 3 percent) (2005$)............................................ 113
Table 4.25. Total Annual National Cost of Each Regulation Under the Pesticide Container Rule:
Using “High End” Assumptions (Interest Rate = 3 percent) (2005$) ................................. 115
Table 5.1. The Types of Expected Benefits from the Container Design and Residue Removal
Regulations and Their Sources ............................................................................................ 117
Table 5.2. Number of Reported Total, Intentional, and Pine Oil-Related Illnesses a in
California’s Pesticide Illness Surveillance Program in 1999 .............................................. 120
Figure 5.1. Flow Chart of 1999 California Department of Pesticide Regulation (CDPR)
Pesticide-Related Incidents.................................................................................................. 122
Table 5.3. Profile of Unintentional Pesticide Exposures by Reason of Exposure..................... 125
Table 5.4. Guidelines for Field Definition of Clinical Effect Relationships to Exposure ......... 126
Table 5.5. Frequency of Clinical Effects “Related” to Unintentional Pesticide Product Exposures
127
Table 5.6. Detailed Distribution of Clinical Effects “Related” to Unintentional Pesticide Product
Exposures Among Patients Experiencing With Concomitant” Pesticide Exposures .......... 127
Table 5.7. Percent Distribution of Clinical Effects Among Patients Experiencing Effects
“Related” to Unintentional Pesticide Product Exposures.................................................... 128
Table 5.8. Estimated Frequency of Clinical Effects for Avoidable Cases as a Result of the
Container Regulations ......................................................................................................... 130
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Table 5.9. Estimated National Number of Avoidable Clinical Effects as a Result of the
Container Regulations ......................................................................................................... 131
Table 5.10. Expected Number of Avoidable Illnesses as a Result of Container Regulation by
Severity of Clinical Effect ................................................................................................... 132
Figure 5.2. Components of the Health Benefits Valuation for the Container Design and Residue
Removal Regulations........................................................................................................... 134
Table 5.11. Medical Outcome by Management Site for Pesticide Product-Related Unintentional
Exposures, TESS, 2001 a ..................................................................................................... 135
Table 5.12. Duration of Clinical Effect by Medical Outcome for Pesticide Product-Related
Unintentional Exposures, TESS, 2001 a .............................................................................. 136
Table 5.13. Benchmark Evaluation and Management Costs for Physician Office Visit for an
Established Patient Requiring an Expanded, Problem-Focused Evaluation, Adjusted to 2005
Dollars a ................................................................................................................................ 137
Table 5.14. Outpatient Physician Unit Costs by Medical Outcome .......................................... 137
Table 5.15. Mean Hospitalization Charges and Length of Stay for Injuries/Poisonings from
HCUP 1994, Adjusted to 2005 Dollars a ............................................................................. 138
Table 5.16. Inpatient Hospitalization Unit Costs....................................................................... 138
Table 5.17. Socioeconomic Data Used to Calculate Indirect Cost of Illness ............................ 139
Table 5.18. Value of a Day of Full Productivity........................................................................ 140
Table 5.19. Average Clinical Effect Duration and Indirect Cost of Illness by Medical Outcome
141
Table 5.20. Value of Annual Avoided Pesticide-Related Cases as a Result of the Container
Regulations (2005 dollars) a ................................................................................................. 142
Table 5.21. Non-Refillable Containers Subject to the Labeling Requirements and Their
Associated Weights ............................................................................................................. 145
Table 5.22. Non-Refillable Containers Included in the Scope of the Non-Health Benefits
Analysis ............................................................................................................................... 147
Table 5.23. Number of Non-Refillable Containers Diverted from the Hazardous Waste Stream
to the Non-Hazardous Waste Stream After the Promulgation of the Labeling Requirements
150
Table 5.24. Non-Discounted Benefits Associated with the Diversion of Non-Refillable
Containers from the Hazardous Waste Stream to the Non-Hazardous Waste Stream (2005$)
152
Table 5.25. Characteristics of Potential Pesticide-Related Chemical Spills Recorded in the ARIP
156
Table K-2b. Number of Containers Out of Compliance for the Average Registrant, by
Requirement, Market Sector, and Entity Size (Refillable Containers)................................ 313
Appendix Tables
Table A-1. Compliance Costs Associated with the Container Standards.................................. 164
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Table A-2. Estimated Number of Active Registrations (Formulations) per Registrant by Size
Category: Current Versus Proposed Rule............................................................................ 165
Table A-3. Estimated Number of Active Registrations per Registrant Size Category.............. 166
Table A-4. Estimated Number of Active Products Subject to the Residue Removal Standard. 167
Table A-5. Estimated Number of Active Products Subject to the Residue Removal Standard by
Registrant Size Category ..................................................................................................... 168
Table A-6. Comparison of the Estimated Number of Active Registrations (Formulations) per
Average Registrant by Size Category.................................................................................. 168
Table A-7. Non-Refillable Container Residue Removal Compliance Cost Inputs
and Assumptions.................................................................................................................. 169
Table A-8. Non-Refillable Container Residue Removal Compliance Costs (2005$) ............... 171
Table A-9. Non-Refillable Container Recordkeeping Cost Inputs and Assumptions ............... 173
Table A-10. Non-Refillable Container Recordkeeping Costs ................................................... 174
Table A-11. Refillable Container Administrative Cost Inputs and Assumptions...................... 176
Table A-12. Refillable Container Administrative Costs (2005$) .............................................. 177
Table A-13. Refillable Container Marking Cost Inputs and Assumptions (2005$) .................. 179
Table A-14. Refillable Container Marking Costs (2005$) ........................................................ 180
Table A-15. Cost Inputs and Assumptions for Refillable Container Openings (2005$) ........... 183
Table A-16. Refillable Container Openings Costs (2005$)....................................................... 184
Table A-17. Bulk Container Standards Compliance Costs........................................................ 185
Table A-18. Refilling Requirement Cost Inputs and Assumptions (2005$).............................. 187
Table A-19. Refilling Requirement Costs (2005$).................................................................... 188
Table A-20. Labeling Requirement Cost Inputs and Assumptions (2005$).............................. 191
Table A-21. Labeling Requirement Costs (2005$).................................................................... 192
Table C-1. Undiscounted Cost of Complying with the Residue Removal Standards for
Nonrefillable Containers Under the Current Rule ............................................................... 196
Table C-2. Undiscounted Costs of Complying with Recordkeeping Requirements for
Nonrefillable Containers Under the Container Rule ........................................................... 198
Table C-3. Undiscounted Costs of Complying with the Container Marking Standards for
Refillable Containers Under the Container Rule ................................................................. 200
Table C-4. Undiscounted Costs of Complying with the Standards of Openings (for LiquidMinibulk Containers Only) for Refillable Containers Under the Container Rule............... 202
Table C-5. Undiscounted Costs of Complying with the Bulk Container Standards for Refillable
Containers Under the Container Rule.................................................................................. 204
Table C-6. Undiscounted Costs of Complying with Administrative Requirements for Refillable
Containers Under the Containment Rule............................................................................. 206
Table C-7. Undiscounted Costs of Complying with the Labeling Requirements for All
Containers Under the Container Rule.................................................................................. 208
Table D-1. Estimated Number of Pesticide Registrants Affected by the Pesticide Container
Regulations .......................................................................................................................... 212
Page x
Table D-2. Most Common NAICS Codes Associated with Sample of 804 Pesticide Registrants
213
Table D-3. Economic Profile of Pesticide Registrants by Entity Size....................................... 215
Table D-4. Procedure Used to Establish Market-Specific Regulated Entities........................... 217
Table D-5. Economic Profile of Agricultural Pesticide Refillers by Entity Size ...................... 219
Table D-6. Economic Profile of Swimming Pool Supply Companies by Entity Size ............... 222
Table E-1. Summary of Annual Revenue Requirements (ARR) and ARRs as a Percentage of
Sales for Representative Formulating Facilities in Each Market Sector Under Regulatory
Options 1, 2, and 3 and Scenarios 1 and 2 for the Proposed Pesticide Container Standards
(2005$)................................................................................................................................. 224
Table E-2. Summary of Annual Revenue Requirements (ARR) and ARRs as a Percentage of
Sales for Representative Agricultural Refilling Facilities in Regulatory Options 1, 2, and 3
for the Proposed Pesticide Container Standards (2005$) .................................................... 225
Table E-3. Total Cost (Annual Revenue Requirement or ARR) of the Proposed Pesticide
Container and Labeling Standards....................................................................................... 226
Table E-4. Estimated Benefits of the Proposed Container and Labeling Standards.................. 227
Table F-1. Grouping Criteria for Administration Through Oral Ingestion, Dermal Contact, and
Inhalation of Dusts and Mists .............................................................................................. 230
Table F-2. Scope of Container Regulations Versus Scope of Other National Regulations and
Standards.............................................................................................................................. 233
Table F-3. Comparison of Container Regulations with Other National Regulations and
Standards.............................................................................................................................. 242
Table F-4. Comparison of Container Regulations with Other EPA Policies.............................. 263
Table F-5. Eight-State Analysis of Pesticide Container Guidelines .......................................... 268
Table G-1. Comparison of Final Container Regulations with Proposed Container Regulations
280
Table H-1. Percent Distribution of Age of Exposure Case by Reason of Exposure ................. 287
Table H-2. Percent Distribution of Exposure Chronicity to Reason of Exposure ..................... 288
Table H-3. Profile of Unintentional Pesticide and Antimicrobial Exposures by Medical Outcome
289
Table H-4. Percent Distribution of Age of Exposure Patient by Symptom Severity of Medical
Outcome Among “With Concomitants” Exposure Cases ................................................... 290
Table H-5. Duration of Clinical Effects by Symptom Severity Among Those “With
Concomitant” Cases Exhibiting Minor, Moderate or Major Medical Outcomes ................ 291
Table H-6. Percent Distribution of Symptom Severity of Medical Outcome by Management Site
Among “With Concomitant” Exposure Cases..................................................................... 291
Table H-7. Percent Distribution of Management Site by Age of “With Concomitant” Exposure
Patient .................................................................................................................................. 292
Table I-1. Benchmark Costs for Physician Office Visits by Current Procedural Terminology,
Fourth Edition (CPT-4) Code .............................................................................................. 293
Page xi
Table J-1. Number of Cases in California in 1999 Considered by EPA as “Very Likely” or
“Possibly” Preventable by the Container Regulations......................................................... 294
Table J-2. Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been
“Very Likely” or “Possibly” Prevented by the Container Regulations ............................... 296
Table K-1a. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,
and Market Sector: Nonrefillable Liquid Pesticide Containers........................................... 307
Table K-1b. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,
and Market Sector: Nonrefillable Solid Pesticide Containers ............................................. 308
Table K-1c. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,
and Market Sector: Refillable Liquid Pesticide Containers ................................................ 310
Table K-1d. Number of Containers Within the Scope of the Rule by Container Type, Entity Size,
and Market Sector: Refillable Solid Pesticide Containers................................................... 311
Table K-2. Number of Containers Out of Compliance for the Average Registrant, by
Requirement, Market Sector, and Entity Size ..................................................................... 312
Table K-3. Number of Refillable Containers by Type of Refilling Entity ................................. 314
Table K-4a. Annual Refillings per Refiller Currently Not in Compliance with Inspection
Requirement by Container Type, Entity Size, and Market Sector ...................................... 315
Table K-4b. Annual Refillings per Refiller Currently Not in Compliance with Container
Cleaning Requirement by Container Type, Entity Size, and Market Sector ....................... 316
Table K-4c. Annual Refillings per Refiller Currently Not in Compliance with Container
Tracking (Recordkeeping) Requirement by Container Type, Entity Size, and Market Sector
317
Table K-5a. Present Discounted Value of Container Rule Compliance Costs, 3% Discount Rate
318
Table K-5b. Present Discounted Value of Container Rule Compliance Costs, 7% Discount Rate
319
Page xii
Economic Analysis of the Final Container Rule
1.0 Introduction
The U.S. Environmental Protection Agency (EPA) is imposing requirements under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) for pesticide container design. EPA is also
establishing procedures, standards, and label language to facilitate removal of pesticides from
containers prior to disposal. Additionally, EPA is imposing requirements for bulk pesticide
containment and procedures for container refilling operations. These regulations are necessary
to implement statutory authority requiring EPA to develop regulations for the safe storage and
disposal of pesticides as a means of protecting human health and the environment.
Sections 19(e) and (f) of FIFRA grant EPA broad authority to establish standards and procedures
to assure the safe use, reuse, storage, and disposal of pesticide containers. FIFRA Section 19(e)
requires EPA to promulgate regulations for “the design of pesticide containers that will promote
the safe storage and disposal of pesticides.” The regulations must ensure, to the fullest extent
practicable, that the containers:
(1) Accommodate procedures used for removal of pesticides from the containers and rinsing of
the containers.
(2) Facilitate safe use of the containers, including elimination of splash and leakage.
(3) Facilitate safe disposal of the containers.
(4) Facilitate safe refill and reuse of the containers.
FIFRA Section 19(f) requires EPA to promulgate regulations “prescribing procedures and
standards for the removal of pesticides from containers prior to disposal.” The statute states that
the regulations may:
(1) Specify, for each major type of pesticide container, procedures and standards for, at a
minimum, triple rinsing or the equivalent degree of pesticide removal.
(2) Specify procedures that can be implemented promptly and easily in various circumstances
and conditions.
(3) Provide for reuse, whenever practicable, or disposal of rinse water and residue.
(4) Be coordinated with requirements imposed under the Resource Conservation and Recovery
Act (RCRA) for rinsing containers.
Section 19(f) also provides that EPA, in its discretion, may exempt products intended solely for
household use.
Section 19(h), titled “Relationship to Solid Waste Disposal Act,” specifies that nothing in
Section 19 shall diminish the authorities or requirements of RCRA. Also, the Food Quality
Protection Act (FQPA) of 1996 amended Section 19(h) of FIFRA to add an exemption for
certain antimicrobial pesticides.
The following economic analysis (EA) is one of two economic analyses that estimate the costs
and benefits of compliance with the regulations for the safe storage and disposal of pesticides. It
estimates the costs and benefits of compliance with the pesticide container design and residue
removal requirements of the final rule, including the container refilling requirements and the
Page 1
label language requirements for pesticide container residue removal. The second EA provides
estimates of the costs and benefits of compliance with the bulk pesticide containment
requirements of the final rule.1
The EA for pesticide container design and residue removal is organized into five chapters. The
first two chapters present the regulatory background of the final rule, a description of the final
pesticide container standards, and a summary of the results of the EA. Chapter 3 presents an
analysis of pesticide container compliance with the final container standards. Chapter 4 presents
the analysis of the estimated costs of compliance with the final container standards. And
Chapter 5 presents the estimated benefits of compliance with the final container standards. A
detailed description of the scope of the EA is presented in Section 1.2.
1.1 Need for Regulation
The container design and residue removal standards are largely pollution prevention regulations
that will safeguard workers, such as loaders, mixers, and applicators, and the environment by
reducing the risk of exposure to concentrated pesticides. The improvements in pesticide
container designs will enhance the safe handling, dispensing, use, and residue removal efficiency
of pesticide containers. The improvement in procedures and/or container designs will also help
facilitate the “clean rinsing” of emptied containers either prior to disposal or recycling, or prior
to reuse. There are numerous types of human health-related benefits and non-human healthrelated (environment-related) benefits that will stem from such improvements because of
relatively fewer expected spills, leaks, and other risks associated with exposure (e.g., handling by
workers during disposal, discharges to the environment, and potential public exposures).
Table 1.1 summarizes the various types of expected benefits (i.e., improved worker safety,
improved public health, reduced environmental risk, and other effects) resulting from the
proposed container design/residue removal regulations. It also characterizes the sources of the
expected benefits. Other than human health-related and environment-related benefits, the
regulation will have other effects such as property damage, personal liability effects, and
insurance costs. In addition, there are likely to be cost savings from the disposal of rigid nonrefillable containers as non-hazardous rather than hazardous waste as a result of the regulations,
and a reduction in the number of environmental effects and property damage/spill cleanup costs
as a result of the container regulations.
1
Two separate economic analyses are conducted for the rule primarily because the standards for pesticide containers
and the standards for containment of bulk pesticides are different, and, as a result, require two distinct economic
analyses. That is, because the standards regulate different structures (containers versus bulk containment), and
different industries (registrants, agricultural refillers, and swimming pool supply companies for the container
standards; agricultural refillers and commercial pesticide applicators for the bulk containment standards), different
assumptions and inputs will be used in the EA for each set of standards. Rather than creating a single, lengthy
document containing two different economic analyses, the Agency chose to write a separate document for each EA.
Page 2
Table 1.1. The Types of Expected Benefits from the Container Design and Residue
Removal Regulations and Their Sources
Expected Benefit
Source of Expected Benefit
Human Health-Related Benefits
Improved Worker Safety
•
•
•
•
•
•
Improved Public Health
•
•
•
Reduced accidental spills
Fewer leaks
Less dripping
Less frequent container stress failure (durability,
formulation/container degradation)
Reduced personal sickness and injury
Improved worker productivity
Less risk of exposure to spills and leaking/dripping
Less contamination of surface water and groundwater sources
Less personal injury from accidental spills and chronic contamination
sources
Non-Human Health-Related Benefits
Reduced Environmental Risk
•
•
•
Reduced accidental spills
Fewer chronic accumulations of chemicals in
loading/mixing/cleaning areas
Reduced risk of harm from pesticide residues to terrestrial and
aquatic wildlife including sensitive and critical habitats
Less disposal of hazardous containers in landfills
•
•
•
•
•
Reduced property damage
Reduced risk of personal injury and liability
Lower costs for personal liability insurance
Reduced disposal costs for cleaner containers
Reduced loss of product from spills and leaks
•
Other Effects
1.2 Regulatory Background of the Final Rule
In a Notice of Proposed Rulemaking (NPRM) issued on February 11, 1994 (59 FR 6712), EPA
proposed standards for pesticide containers and containment structures. The proposal included
requirements for non-refillable and refillable containers that would ensure the safe use, refill,
reuse, and disposal of the containers. The proposal also included standards for containment
structures, which would promote safe storage of pesticides in bulk containers. Additionally, the
proposed rule contained amendments to the labeling regulations in 40 CFR Part 156 to ensure
adequate levels of residue removal from containers.
The public comment period for the NPRM closed on July 11, 1994. EPA received about 1,900
pages of comments from more than 200 commenters, including many trade associations and
individual companies from the pesticide manufacturing, pesticide retail, and container
manufacturing industries as well as many state regulatory agencies.
EPA received many comments during the public comment period on a few issues. In particular,
comments addressed the scope of the container standards and the relationship between the 1994
proposed rule and the Department of Transportation (DOT) standards for hazardous materials
packaging. A third issue arose from the 1996 passage of the FQPA, which amended Section
19(h) of FIFRA to add an exemption for certain antimicrobial pesticides. To solicit comment on
Page 3
EPA’s interpretation of the new statutory language on exempting antimicrobial pesticides and to
reopen comment on the scope of the container regulations and an approach for incorporating
DOT’s standards, EPA published a supplemental notice in the Federal Register on October 21,
1999 (64 FR 56917, EPA 1999). The notice also provided an alternative definition of small
business for certain sectors of the pesticide industry. The purpose of the alternative definition
was for use in analyzing the potential impacts to small businesses that were presented as part of
the economic analysis.2
The public comment period for the supplemental notice closed on March 20, 2000. EPA
received comments from about 70 respondents, including many trade associations and individual
companies from the pesticide manufacturing, pesticide retail, and container manufacturing
industries as well as many state regulatory agencies.
On June 30, 2004, EPA reopened the comment period for 45 days to solicit public input on any
policies, market practices, technology, or other issues relating to this rule’s requirements that
would not have been available, or could not have been addressed at the time of either the
proposed rule in 1994 or the supplemental notice in 1999. While EPA has attempted to stay
current on developments in pesticide container and containment structure policies, regulations,
technology, and practices, the Agency believed that it was appropriate to solicit input from the
regulated community, state regulators, and others to ensure that we are fully aware of the current
state of the pesticide container and containment universe before finalizing the pesticide container
and containment regulations. The comment period generated 50 comments mainly from
pesticide manufacturers, state regulatory agencies, and agricultural pesticide dealers. (See the
preamble to the proposed rule and Section 2.3 of this document for a more complete discussion
of comments received by EPA.)
Prior to 1995, recommendations regarding procedures for storage and disposal of pesticides and
pesticide containers were listed under 40 CFR Part 165. On June 19, 1995, as part of the federal
government’s initiative to streamline regulations, Part 165 was deleted as unnecessary (60 FR
32094) because it contained recommendations rather than requirements. Subpart A of Part 165
covered the scope and definitions in the recommendations. Subpart B dealt with EPA’s disposal
of suspended and canceled pesticides, and EPA has completed disposal of all pesticides for
which it was responsible under those regulations. Subparts C and D contained recommended
procedures for storage and disposal of pesticide containers. Subparts A, B, C, and D were
superseded by the passage of the Resource Conservation and Recovery Act in 1976. FIFRA
Section 19, as revised in 1988 and 1996, contains authority for EPA in the area of pesticide
storage and disposal, and the final pesticide container and containment regulations promulgated
are being inserted into a newly established Part 165.
2
As discussed by EPA in the 1999 Supplemental Notice on Standards for Pesticide Containers and Containment
(EPA, 1999b), the alternative definition disaggregates small businesses as defined by the Small Business
Administration (SBA) into three size categories: small-small, medium-small, and large-small businesses. EPA is
concerned that using an overly broad definition of small business in the economic analysis of the regulations may
result in significant economic impacts on smaller entities that will be camouflaged when combined with information
about potential impacts on facilities that meet the SBA size standard for small business but are not typical of a small
business in that industry sector. (See Chapter 3 for industry-specific small business definitions.)
Page 4
1.3 Scope of the Economic Analysis for the Final Pesticide Rule
The EA conducted for the final pesticide container standards estimates the costs and benefits of
compliance with four sets of standards, including: (1) container design standards for nonrefillable containers; (2) container design standards for refillable containers; (3) repackaging
(refilling) standards for refillable containers; and (4) standards for container labeling for all
containers. The components of the final pesticide container standards EA include:
(1) A profile of the regulated community. This includes specific economic characteristics of
each industry regulated under the container regulations—such as North American Industry
Classification System (NAICS) codes, the average company size, revenues for the average
company, total industry revenues, the distribution of firms between small and large—to be
used to estimate the costs and impacts of the container standards. (See Chapter 3.)
(2) A profile of the containers not in compliance with the final pesticide container design and
residue removal requirements. The profile contains the estimates and analysis of the baseline
estimated number of containers, the number of containers covered under the scope of the
regulations, and the number of containers not in compliance with the regulations. (See
Chapter 3.)
(3) An analysis of the cost of compliance with the final pesticide container design and residue
removal requirements. The analysis includes the methodology for calculating the costs of
compliance and the estimates of the costs for standards related to:
(a) refillable and non-refillable containers—how containers must be constructed,
permanently marked, and labeled to ensure safety;
(b) refilling—what activities (i.e., container inspection, rinsing, and recordkeeping) are
required to ensure that the act of refilling containers does not pose safety or health problems.
The estimated costs are presented at different levels of aggregation for all regulated
industries, each industry, a representative facility in each industry, and for each standard.
(See Chapter 4.)
(4) An analysis of the small business impacts of compliance with the final pesticide container
standards for each regulated industry. These impacts are presented using both the Small
Business Administration (SBA) definition of a small business, and the alternative definition
of a small business adopted specifically for this rule.3 Impacts are estimated as the
proportion of increased facility costs to current facility revenues. (See Chapter 4.)
(5) An analysis of the human and non-human health-related benefits of compliance with the final
pesticide container standards. The quantified human health-related benefits are estimated as
the cost savings from eliminating container-related human exposure incidents. The
quantified non-human health-related benefits are estimated as the cost savings from
disposing of non-refillable containers as non-hazardous rather than hazardous material. (See
Chapter 5.)
1.4 Estimated Costs and Benefits of the Final Rule
The pesticide container regulations specify a number of standards that create costs to the
regulated community of bringing containers into compliance with the container standards, as
well as benefits to humans and the environment. Improvements in the design and removal of
3
See footnote 2.
Page 5
residues from containers will benefit humans and the environment by reducing exposures to
pesticides from pesticide containers. Table 1.2 provides a summary of the final pesticide
container design and residue removal standards, which will be described in more detail in
Chapter 2.
As is evident from the table, there are a number of requirements common to both non-refillable
and refillable containers (i.e., DOT standards and some labeling), and a number of requirements
specific to non-refillable containers (i.e., container dispensing capability, standardized closures,
residue removal, and some labeling) and refillable containers (i.e., serial number marking, oneway valves/tamper-evident devices, bulk container requirements, refilling requirements, and
some labeling). The EA addresses each standard separately in regards to pesticide container
compliance and the estimated cost of compliance.
Table 1.2. Overview of the Rule Requirements
Non-Refillable
Containers
Refillable Containers
1. DOT container design,
construction, and marking
standards
2. Container dispensing
capability
3. Standardized closures
4. Residue removal
5. Recordkeeping
1. DOT container design,
construction, and marking
standards
2. Serial number marking
3. One-way valves or
tamper-evident devices
4. Bulk container
requirements
Refilling Pesticide
Products
1. Pesticide registrants (see
Section 3.1) develop
information
2. Registrants and others
comply with specified
conditions
3. Refillers (registrants and
others) obtain and follow
registrant information, and
clean, inspect, and label
containers before refilling
them
Labels
1. Identify container as nonrefillable or refillable (all
labels)
2. Statements to prohibit
reuse and offer for
recycling; batch code (all
non-refillable containers)
3. Cleaning instructions
(some non-refillable
containers)
4. Cleaning instructions
before final disposal (all
refillable containers)
5. Leave blank spaces for
net contents and
establishment number
(some refillable containers)
Source: Final Container Rule.
The following two subsections summarize the estimated costs (including small business impacts)
and benefits, respectively, of compliance with the final pesticide container standards. Chapters 4
and 5 present the analysis of the estimated costs and benefits of compliance with the final
pesticide container standards.
1.4.1 Costs Summary
The total annualized costs of the pesticide container design and residue removal requirements are
estimated to be approximately $8.4 million and $8.5 million at 3 percent and 7 percent discount
rate respectively,4 while the total estimated annualized benefits range from $4.7 million to $4.8
4
The total estimated costs are nearly the same at both 3 percent and 7 percent because the majority of the costs of
compliance (as discussed in Chapter 4) are attributed to the container-related standards (i.e., standards for residue
removal, recordkeeping, container markings, closures, bulk containers, certification, and labeling), which incur most
Page 6
million (depending on the discount rate used)5 (see Table 1.3). The estimated non-human healthrelated benefits account for more than 90 percent of the quantified total benefits of compliance
with the requirements of the rule.
Assuming 610–768 human health-related illness and injuries potentially avoided as a result of
the container regulations (see Chapter 5), the total cost per avoided case ranges from $10,896 to
$13,718 (Table 1.3).
Table 1.3. Quantified Costs and Benefits of the Rule Requirements (2005$)
Cost/Benefit Category
Annualized Cost/Benefit at a
3% Discount Rate
Annualized Cost/Benefit at a
7% Discount Rate
$8,367,385
$8,449,929
$4,735,981–$4,804,240
$4,235,280–$4,296,452
$264,051–$332,311
$236,635–$297,807
$4,471,929
$3,998,645
610–768 Cases
610–768 Cases
$10,896–$13,718
$11,003–$13,852
Total Cost
Total Benefits
Human Health-Related Benefits
Non-Human Health-Related Benefits
Total Cost Per Avoided Human Health-Related Case
Number of Cases Avoided
Total Cost Per Avoided Case
Table 1.4 provides a summary of the estimated annualized cost of compliance with the final
container design and residue removal standards (at a 3 percent discount rate) for the average
entity and totaled for each of the regulated industries (i.e., pesticide registrants, agricultural
pesticide refillers, and swimming pool supply companies), across all market sectors6 for each
entity size category (i.e., large, large-small, medium-small, and small-small). The costs include
the estimated cost of compliance with the standards for residue removal, recordkeeping,
container markings, container openings, bulk containers, labeling, and repackaging. The other
standards (i.e., DOT packaging, container closures, and container dispensing) do not have any
costs associated with them due to the availability of containers compliant with these standards as
discussed in Chapter 3.
The estimated costs are highest for pesticide registrants, accounting for more than 70 percent of
the total cost of compliance. Pesticide registrants are primarily responsible for the pesticide
container-related standards (i.e., residue removal, recordkeeping, container markings, container
openings, bulk containers, and labeling), although they do have some repackaging
responsibilities (i.e., inspection, cleaning, and recordkeeping) in both the agricultural and
industrial/commercial/ government markets. The estimated costs for agricultural pesticide
refillers and swimming pool supply companies, which are responsible for the pesticide container
refilling requirements in their associated markets, are significantly less (Table 1.4).
of their costs in the first year of compliance. The refilling-related requirements (container inspection, cleaning, and
recordkeeping before each refill), which represent a smaller proportion of total costs, are estimated to be nearly the
same each year.
5
For ease of presentation, the estimates using only the 3 percent discount rate will be presented in the text of the
document. Chapters 4 and 5 present in tabular format the estimated costs and benefits of compliance with the final
container standards, respectively, at both the 3 percent and 7 percent rates.
6
The market sectors analyzed include the agricultural, industrial/commercial/government (I/C/G), and home and
garden (H&G) market sectors. See Chapter 3 for a description of each market sector.
Page 7
Table 1.5 provides a summary of the total estimated annual cost of compliance by final pesticide
container standard. As a result of assumed pesticide container compliance, no costs of
compliance are estimated for meeting the DOT packaging standards, closure standards, and
standards for container dispensing capability for non-refillable containers, and the DOT
packaging standards for refillable containers. Approximately 16 percent of the cost of
compliance is attributed to compliance with the residue removal standards. The refilling-related
standards and labeling standards account for 38 percent and 27 percent of the total cost of
compliance, respectively.
Page 8
Table 1.4. Estimated Annual Cost of Compliance a with the Final Container Design and
Residue Removal Standards for the Average Regulated Entity (2005$)
Cost for the Average Regulated
Entity b
Regulated Entity
Number of
Entities
Interest Rate =
3%
Cost over All Regulated
Entities b, c
Interest Rate = Interest Rate =
7%
3%
Interest Rate =
7%
Pesticide Registrants
Small
$1,806
$1,936
$2,993,825
$3,209,477
Large-Small
166
$5,434
$5,975
$903,024
$992,891
Medium-Small
495
$2,613
$2,854
$1,293,158
$1,412,186
Small-Small
997
$800
$807
$797,642
$804,400
146
$17,967
$19,078
$2,623,114
$2,785,386
$5,616,939
$5,994,863
Large
Total
d
Agricultural Pesticide Refillers
Small
Large-Small
Medium-Small
Small-Small
Large
Total
$88
$80
$1,464,350
$1,330,876
251
$871
$764
$218,684
$191,692
2395
$267
$237
$640,191
$566,418
13996
$43
$41
$605,474
$572,767
153
$7,255
$6,336
$1,110,296
$969,709
$2,574,646
$2,300,585
d
Swimming Pool Supply Companies
Small
$19
$20
$5,808
$6,034
14
$34
$33
$474
$458
Medium-Small
117
$23
$24
$2,732
$2,755
Small-Small
174
$15
$16
$2,602
$2,821
17
$10,000
$8,732
$169,993
$148,448
$175,800
$154,481
$8,367,385
$8,449,929
Large-Small
Large
Total
d
Total Cost Across All Regulated Industries
e
a
See Chapter 4 for information on calculations and estimated costs.
For pesticide registrants, average entity costs and costs for all entities by entity size are averaged across all market
sectors (see Chapter 4).
c
For each industry, costs across all entities are found by multiplying the average entity cost by the number of
entities of that size. May not be equal to the multiplication of the numbers in the table due to rounding.
d
Total equals the sum of the cost over all regulated entities for each industry.
e
Total Cost Across All Regulated Industries equals the sum of Total for each industry.
b
Page 9
Table 1.5. Estimated Annual Cost of Compliance with the Pesticide Container Design and
Residue Removal Standards by Standard a
Annual National Cost
(3% Interest Rate)
Standard
Interest Rate = 3 percent
Interest Rate = 7 percent
For Non-Refillable Containers
DOT Packaging Standards - hazardous material
$0
$0
DOT Packaging Standards - non-hazardous
material
$0
$0
Closure Standards
$0
$0
Standards for Container Dispensing Capability
$0
$0
$1,465,967
$1,343,068
$202,617
$210,575
For Refillable Containers
DOT Packaging Standards - hazardous material
$0
$0
DOT Packaging Standards - non-hazardous
material
$0
$0
$241,402
$227,685
$261,018
$291,648
Residue Removal Standards
Other Administrative Requirements recordkeeping
Standards for Container Markings
Standards for Openings (for liquid minibulks
only)
7
Bulk Container Standards
$574,504
$641,923
Other Administrative requirements - recordkeeping
$138,849
$136,753
For Refilling
$3,198,256
$2,849,969
For Labeling
$2,252,148
$2,715,685
Cost of Waivers
Total National Annual Cost
a
See Chapter 4 for information on calculations and estimated costs.
$32,624
$32,624
$8,367,385
$8,449,929
As discussed later in Chapter 4, small businesses are not estimated to be significantly impacted
by compliance with the final container design and residue removal requirements. The estimated
costs of compliance for small businesses in each of the regulated industries, as a proportion of
their current revenues, are estimated to be less than 1 percent. Using the Small Business
Administration (SBA) definition of small businesses, the costs of compliance for small
businesses are estimated to be less than 0.02 percent of the current average entity revenues.
According to the alternative small business definition used in this analysis (which further divides
small businesses into large-small, medium-small, and small-small business),8 no small business
is estimated to incur costs that account for more than 0.04 percent of current average entity
revenues.
7
Minibulks are bulk containers of liquid pesticide greater than 55 gallons but less than 500 gallons and dry pesticide
containers greater than 100 pounds and less than 400 pounds in capacity.
8
See footnote 2.
Page 10
1.4.2 Benefits Summary
Table 1.6 presents the human and non-human health-related benefits of the final pesticide
container standards as discussed in Chapter 5. The estimated annual human health-related
benefits of compliance with the final container standards are estimated to range from $264,051 to
$332,311 due to the cost savings from avoiding 610–768 container-related incidents as a result of
the final container standards. The estimated annual non-human health-related benefits of
compliance with the final container standards are estimated to range from $4.0 million to $4.5
million. These benefits are estimated as the cost savings from disposal of non-refillable pesticide
containers as non-hazardous material, rather than hazardous material, as a result of the final
pesticide container regulations. Additional, non-quantified benefits include the reduction in the
number of environment-related incidents of exposure, and avoided property damage/spill
cleanup costs, which suggest that the social value of the benefits is higher than the quantified
amount (see Chapter 5 for a more detailed discussion).
Table 1.6. Estimated Benefits Associated with the Final Pesticide Container Design and
Residue Removal Regulations (2005$) a
Benefit
Category
Human HealthRelated
Benefits
Non-Human
Health-Related
Benefits
Type of Benefit
Avoided cases
Estimated Benefits
•
•
610–768 cases annually (= $264,051–$332,311 in annualized
health benefits)
Additional 1,945 to 2,449 cases annually with “possible”
cases (= an additional $841,644 million to $1,059,240 in
annualized health benefits)
Improved worker safety
•
Possible health benefit; lost productivity valued as part of
health benefits from avoided cases
Improved public health
•
Possible health benefit; continued benefit of avoided cases
throughout the compliance schedule
Tipping fee cost savings for •
non-refillable containers
$4,471,929 (3% discount rate)–$3,998,645 (7% discount rate)
in annualized cost savings
Environment-related effects •
Damage reduction from fewer exposures of terrestrial and
aquatic wildlife, including those in sensitive and critical
habitats, to pesticides and residues
Avoided property
damage/spill cleanup costs
•
Pesticide container rules will prevent property damage and/or
reduce the costs associated with unintended, container-related
pesticide releases
a
See Chapter 5 for the discussion of human health-related and non-human health-related benefits.
1.5 Limitations of the Final Rule Economic Analysis
Conducting the EA for the final pesticide container standards required extensive information.
For example, in determining the baseline level of pesticide container compliance with the final
standards, information had to be obtained on: (1) the number of existing refillable and nonrefillable containers, by container type, size, and end-use market; (2) the number of existing
refillable and non-refillable containers that fall under the scope of the container rule; and (3) the
number of refillable and non-refillable containers that fall under the scope of the container rule
and that are in compliance with each container design and residue removal standard. To obtain
the information necessary to complete the analysis, EPA relied on the regulatory impact analysis
(RIA) conducted for the proposed container design and residue removal standards (EPA, 1993).
Page 11
Contacts with industry experts and various state and federal agency personnel (including EPA
personnel), as well as a review of the literature, were used to estimate, verify, and update the data
throughout the report to the extent possible.9 We make every attempt to clearly state the
assumptions throughout the analysis, and we present a sensitivity analysis in Chapter 4. The
sensitivity analysis presents the costs of compliance with the container standards using lower and
upper bounds on the assumptions used in the EA.
In summary, Chapter 1 has presented the statutory basis for the promulgation of the pesticide
container standards final rule, a summary of the regulatory history of the standards, and a
summary of the results of the EA. The next chapter continues with the introduction to the final
pesticide container standards; presenting the final pesticide container design and residue removal
standards, the changes in the standards from the proposed to the final standards, the response to
comments to the proposed standards, and the economic impacts (i.e., the change in the costs and
benefits of compliance) of the changes from the proposed to the final standards. The final three
chapters (Chapters 3, 4, and 5) present the analysis of the costs and benefits of compliance with
the final pesticide container standards.
9
The RIA for the proposed standards for pesticide container design and residue removal was a major source of the
data used in the EA for the final standards. EPA verified and updated the majority of the data used. However, it
was infeasible to reconstruct some of the data, and EPA therefore used the data as presented in the RIA for the
proposed container standards.
Page 12
2.0 Final Rule Standards and Comparison of the Costs and Benefits of the
Final and the Proposed Rule Standards
Chapter 1 presented the regulatory history of the pesticide container and bulk containment rule,
an analysis of the scope of the EA, and a summary of the results of the EA. In Chapter 2, the
final pesticide container design and residue removal standards are presented. These are the
standards for which pesticide container compliance is determined in Chapter 3, and for which we
estimate the costs and benefits of compliance in Chapters 4 and 5, respectively. Chapter 2 also
presents a description of the changes made in the pesticide container standards from proposed to
final, and presents a comparison of the costs and benefits of compliance estimated for the final
and proposed container standards.
2.1 Final Rule Standards
Until now, the design of containers holding pesticides has been guided only by an interrelated
combination of nationwide recommendations,10 federal regulations,11 and state regulations and
standards. (See Appendix F for complete discussion of these standards.) These
recommendations, regulations, and standards form the basis for the final rule for pesticide
container design and residue removal. Given the large set of standards already in existence, this
rule is primarily a harmonizing and consolidation exercise, and EPA estimates that most
containers are in compliance with many aspects of the rule because containers are already
meeting a variety of other standards, as discussed in more detail in the pesticide container
compliance profile presented in Chapter 3.
The pesticide container standards as described below are the end result of revisions made to the
1994 proposed standards for pesticide containers, based on the public comments submitted and
discussions with a number of interested parties, including other EPA offices, government
agencies, and the regulated community (see Section 2.2 for a discussion of the changes in the
standards from proposed to final and Appendix G for a comparison of the proposed and final
pesticide container standards.) The first seven standards presented apply to certain non-refillable
and refillable containers (as specified for each standard), while the eighth standard (the
repackaging standard) applies only to refillable containers, and the final labeling standard applies
to all containers. The final pesticide container design and residue removal standards are as
follows:
(1) Pesticide Container Design Standards
The final container standards adopt a subset of the Department of Transportation Hazardous
Materials Regulations (DOT HMR) packaging standards at the Packing Group III level for
pesticides not classified as DOT hazardous materials. Pesticides that are classified as DOT
hazardous materials must comply with all applicable DOT regulations. For the purpose of
enforcing the pesticide container regulations, the final rule identifies the DOT requirements for
all three packing groups that are “equivalent” to the Packing Group III requirements applicable
to products that are not DOT hazardous materials. Under the regulations, sale or distribution of
10
11
United Nations (1999); Mid America Crop Protection Association (MACA, 1999 and 1986).
Department of Transportation Hazardous Materials Regulations (DOT HMR) (49 CFR Parts 107-179).
Page 13
pesticides in containers not meeting all of the standards (the specifically listed ones in the
pesticide regulations and the adopted DOT packaging standards) is prohibited. Both nonrefillable and refillable pesticide containers must meet these standards.
(2) Pesticide Container Permanent Markings
The regulations for non-refillable pesticide containers and refillable pesticide containers refer to
and adopt the DOT standards, which include marking requirements. Additionally, the
regulations require a serial number or other identifying code for each refillable container.
(3) Pesticide Container Dispensing Capability
The regulations stipulate that liquid pesticide non-refillable containers with a capacity greater
than 20 liters (5.3 gallons) be designed to eliminate splash and leakage during normal pouring of
the contents. No dispensing capability requirements are specified for refillable pesticide
containers.
(4) Pesticide Container Closures
Four closures are specified for non-refillable rigid containers having a capacity greater than
3.0 liters for liquid agricultural pesticides, and the final standard should not overlap with the
Child-Resistant Packaging requirements. Liquid minibulk refillable containers (refillables)
require a one-way valve, tamper-evident device, or both on each opening. Liquid bulk refillables
must be equipped with a pressure-relieving device and locking shutoff valve, and cannot have
external sight gauges.
(5) Pesticide Container Residue Removal Design Standard and Procedures
With regard to non-refillable containers, the regulations specify that every registrant test three
containers from each rigid container/dilutable formulation combination to determine that the
containers are capable of achieving a “four-9s” laboratory performance standard (a reduction of
the original active ingredient concentrate to 0.01 percent in a fourth rinse, equivalent to
99.99 percent removal). Percent removal represents the percentage of the original concentration
of the active ingredient in the pesticide product when compared to the concentration of that
active ingredient in the fourth rinse according to a formula.
(6) Pesticide Container Standards Waiver
The regulations include procedures for allowing a compliance waiver from adopting the
specified DOT requirements for both non-refillable and refillable containers. In addition, for
non-refillable containers, the regulations provide for waivers from the standard closure, container
dispensing, and residue removal standards.
(7) Pesticide Container Recordkeeping
The regulations require several types of recordkeeping. The first addresses the documentation
that the container used meets each aspect of the non-refillable container design standards. For
non-refillables, the period extends for as long as the container design type is used with the
registered pesticide product, plus 3 years.
Page 14
The second type of recordkeeping requirement involves records kept by the registrants regarding
repackaging. The registrants are required to keep copies of the contracts or authorizations,
residue removal procedures for refilling, and list of acceptable containers for the current
operating year and for 3 years thereafter.
The third type of recordkeeping involves refillers keeping copies of the documents identified in
the previous paragraph for the registrants for the current operating year and for 3 years thereafter
(as with the registrant recordkeeping).
The fourth type of recordkeeping involves information the refillers have to record when they
repackage and when they receive refillable containers. Refillers must record three pieces of
information when a pesticide is repackaged. No recordkeeping is required when a refillable
container is received. These records must be kept for 3 years.
(8) Pesticide Container Refilling
Registrants who directly sell or distribute pesticide products in refillables or sell or distribute
pesticide products to refillers for repackaging are held responsible for providing instructions and
documentation for refilling. Refillers who repackage pesticide products into refillable containers
for distribution or sale must comply with the refilling residue removal procedure developed by
registrants and can repackage any quantity of a pesticide product into a refillable container up to
the rated capacity of the container. In addition, refillers must inspect the exteriors and interiors
of the containers to ensure that the containers meet the necessary criteria for container integrity,
required markings, and openings. Refillers must also clean each refillable container according to
the residue removal procedure for pesticide product refilling (supplied by the registrant) before
repackaging the product, unless certain criteria are met.
(9) Pesticide Container Labeling
The scope of the labeling requirement includes all labels for all pesticide products, not just those
that fall within the scope of the non-refillable container, refillable container, and repackaging
(refilling) regulations. However, the final regulations exempt household products from the
residue removal instructions. Labels may include blank areas to allow a refiller to put any
amount of product into a refillable and designate on the label the amount and to add its EPAdesignated number for the refilling establishment. Other information to be included on the label
is a description of the container type giving its intended purpose (such as a refillable or nonrefillable statement) and detailed residue removal instructions. The regulations state that
household products are exempt from requiring residue removal instructions on their labels and
that durable permanent marking (versus permanent marking) is acceptable.
The level of required compliance for a pesticide product to these standards is not the same for all
products. While the labeling standards apply to all pesticide products, there is a subset of
pesticide products that are not subject to the pesticide non-refillable and refillable container
design standards and refilling standards. The level of compliance with these requirements
depends on a number of factors, such as the type of product (e.g., end-use, manufacturing,
antimicrobial), toxicity of the product, and use of the product. Chapter 3 provides a complete
description of the scope of the pesticide container requirements.
Page 15
2.2 Changes in Pesticide Container Design and Residue Removal Standards from the
Proposed to the Final Rule
The final pesticide container design and residue removal standards differ significantly from the
1994 proposed standards. The final standards are narrower in scope than the proposed
regulations, exempt certain antimicrobial pesticides, require less stringent container design and
residue removal requirements, and adopt some of the Department of Transportation (DOT)
hazardous materials regulations. As a result, the estimated economic impacts on the regulated
community under the final standards are different from the estimated economic impacts under
the proposed standards.
EPA received approximately 1,900 pages of comments from more than 200 commenters (e.g.,
trade associations, pesticide manufacturers, pesticide retailers, and many state regulatory
agencies) on the proposed rule. In response, two significant issues were readdressed, and the
comment period was reopened in 1999. The two issues were: (1) the scope of the container
standards; and (2) the relationship between the 1994 proposed rule and the DOT standards for
hazardous materials packaging. In the final rule (as discussed below), EPA has revised the scope
of the container standards to be risk-based with exemptions, and has adopted many of the design
and construction standards that would apply to DOT Packing Group III materials. These and
other changes made to each standard are as follows. (See Appendix G for additional information
on the changes from the proposed to the final rule.)
(1) Scope of the Pesticide Container Design and Residue Removal Standards
Regarding the scope of the pesticide container design and residue removal regulations, the
proposed regulations generally affected all containers used to package pesticide products,
without regard to industry, use, risk, or container type and size. Only manufacturing use
products were exempt from the proposed regulations. The final rule exempts manufacturing use
products, plant-incorporated protectants, and certain antimicrobial products from the nonrefillable container, refillable container, and repackaging (refilling) regulations. All other
products are subject to the container-related regulations, although the number of non-refillable
container standards is greatly reduced for some products. As proposed, all pesticide products
(except household products) are subject to the container labeling requirements in the final rule.
(2) Pesticide Container Design Standards
The proposed regulations included some very general design standards, but also included some
specific tests, such as a drop test for minibulk containers. The final standards specify some DOT
HMR packaging standards for pesticides classified as DOT hazardous materials. Pesticides that
are not classified as DOT hazardous materials are required to be packaged in accordance with the
specified design and construction standards that would apply to a DOT Packing Group III
material.
(3) Pesticide Container Permanent Markings
The proposed standards required many more specific permanent markings for non-refillable and
refillable containers. For example, non-refillables required the EPA registration number and
name and a symbol or code of materials used to make the container, and refillables required the
statement, “Meets EPA standards for refillable containers.” The final regulations, as described
Page 16
above, refer to and adopt the DOT standards for non-refillables and refillables (which specify
certain markings), and require a serial number or other identifying code for each refillable
container.
(4) Pesticide Container Dispensing Capability
The proposed regulations stipulated that liquid containers be designed to eliminate the splash and
leakage during normal pouring of the contents, closing or resealing the container, and during
storage and cleaning of the container. The final regulations regarding pouring are the same
except that they apply only to non-refillables liquid containers with a capacity greater than 20
liters (5.3 gallons). The proposed requirement to reseal completely was not finalized because an
equivalent requirement is included in the adopted DOT standards.
(5) Pesticide Container Closures
The proposed and final standards for container closures are the same.
(6) Pesticide Container Residue Removal Design Standard
With regard to non-refillable containers, the proposed regulations specified that registrants must
demonstrate that each rigid/dilutable container/formulation combination achieved a “six-9s”
laboratory performance standard (a reduction of the original active ingredient concentrate to
0.0001 percent in a fourth rinse, equivalent to 99.9999 percent removal). The final regulations
require that every registrant test three containers from each rigid container/dilutable formulation
combination to determine that the containers are capable of attaining at least 99.99 percent
removal of each active ingredient in the fourth rinsate after a triple rinse.
(7) Pesticide Container Design and Residue Removal Standard Waiver
The proposed regulations permitted a waiver for standard closures and the residue removal
standard only (non-refillable containers), while the final regulations include provisions for both
non-refillable and refillable containers to waive adoption of the subset of DOT standards, and,
for non-refillables, the standard closure, container dispensing, and residue removal requirements.
(8) Pesticide Container Certification
The proposed rule required registrants to certify that the non-refillable and refillable containers
used for the distribution or sale of pesticides meet the container design standards. The final rule
does not require certification.
(9) Pesticide Container Recordkeeping
The proposed and final regulations require similar types of recordkeeping, although the final rule
requires fewer records and decreases the length of time that many of the records must be kept.
(10) Pesticide Container Refilling
The proposed and final regulations contain nearly the same requirements for the refilling of
pesticide containers, including specific guidelines for registrants and refillers. However, the
final rule changes two of the conditions to: (1) require a contract between the parties (rather than
Page 17
a contract or an authorization as proposed); and (2) allow repackaging at an end user location
under certain circumstances (rather than requiring the repackaging to be conducted at a
registered establishment as proposed).
(11) Pesticide Container Labeling
The proposed and final regulations for container labeling are similar, but the final regulations are
generally more flexible because they provide a range of specific statements. While the proposed
regulations required the residue removal instructions on all rigid non-refillable containers with
dilutable products, the final regulations exempt household containers and allow for durable
container markings (rather than only permanent as proposed).
2.3 Response to Comments to the Proposed Standards
As previously mentioned, EPA received approximately 1,900 pages of comments from more
than 200 commenters in response to the proposed pesticide container standards. The majority of
the comments received were directed toward the proposed container standards and their effect on
the regulated industries, resulting, in part, in the changes to the proposed standards as described
in the previous section. Only a relatively small portion of the comments submitted in response to
the proposed container standards were directed toward the regulatory impact analysis (RIA)
conducted for the proposed container standards. As a result, there were few changes made in the
assumptions used to calculate the costs of compliance from the proposed to the final container
standards based on the comments submitted. Rather, the differences between the proposed and
final rule economic analyses (EAs) primarily reflect changes made in the scope and requirements
of the container standards.
There are two exceptions. The first is the consideration of the swimming pool industry in the
final EA. This industry was not considered separately in the RIA for the proposed container
standards. As a result of comments submitted by the swimming pool industry, which provided a
reasonable justification for being considered separately,12 the EA for the final standards
considers swimming pool supply companies relative to the refilling standards. The other
exception is the calculation of the indirect, non-health benefits in the RIA associated with the
movement from non-refillable to refillable containers. In the proposed rule, these indirect
benefits (see Section 2.4) were estimated, and, in response, a number of comments were
submitted by the regulated industry questioning the magnitude of these benefits. Although EPA
still maintains that there could be a shift from non-refillables to refillable containers as a result of
the final pesticide container standards, EPA acknowledges that there is more uncertainty in the
assumptions made in the analysis of indirect benefits and the magnitude of these benefits than is
made evident in the proposed rule RIA. As a result, the EA for the final pesticide container
standards does not attempt to quantify these indirect benefits.
12
The swimming pool industry, which includes pool, spas, hot tubs, and whirlpools, successfully argued that it is
unique because it uses and refills a large number of small refillables (an estimated 1 million 1- or 2.5-gallon
containers).
Page 18
2.4 Comparison of the Estimated Costs and Benefits of the Final and Proposed
Standards
As described in Section 2.2, EPA made a number of significant changes to the pesticide
container standards from the proposed to the final standards. As a result, there are differences in
the level of compliance with these standards for existing containers, leading to differences in the
estimated costs and benefits of compliance with the pesticide container standards between the
proposed and final rule. Tables 2.1 and 2.2 present the estimated costs and benefits of
compliance for the final and proposed pesticide container standards.
Table 2.1. Annual Compliance Cost Comparison Between the Final and Proposed
Pesticide Container Standards (2005$)
Compliance Cost for Final
Container Standards a
Cost Item
Compliance Cost for Proposed
Container Standards b
$8.4 million
$40.1 to $55.5 million
Total Cost of Compliance by Regulated Industry
Pesticide Registrants
$5.6 million
$27.3 to $37.3 million
Total Cost of Compliance
Agricultural Pesticide Refillers
$2.6 million
$4.7 million
End Users
No Analysis Completed
$8.2 to $13.6 million
Swimming Pool Supply Companies
$0.2 million
No Analysis Completed
$2.9 million
$22.2 to $32.2 million
$3.2 million
$4.7 million
Total Cost of Compliance by Standard
Container-Related Standards c
Refilling-Related Standards
d
Labeling Standards
$2.3 million
$13.3 to 18.7 million
a
See Chapter 4 for the cost analysis of the pesticide container regulations. Figures presented here are calculated
using a 3% discount rate. Figures for both 3% and 7% discount rates are presented in Chapter 4.
b
Based on the costs estimated for Regulatory Option 2 in the proposed rule RIA for pesticide containers, which was
EPA’s preferred option in the proposed rule. The range of cost estimates results from the consideration of two
scenarios under each regulatory option (see Appendix E).
c
The container-related standards include DOT packaging standards and recordkeeping standards for refillable and
non-refillable containers; closure standards, standards for container dispensing, and residue removal standards for
non-refillables; and standards for container marking, openings, and bulk containers for refillable containers.
d
The refilling-related standards include the inspection, cleaning, and recordkeeping of refillable containers.
Page 19
Table 2.2. Comparison of Human Health-Related and Non-Human Health-Related
Benefits for the Proposed and Final Container Standards (2005$)
Benefit Category
Final Container Standards a
Proposed Container Standards b
Human Health-Related Benefits
Avoided Cases
• 610 to 768 cases annually (=
• 1,650 to 2,250 acute illnesses
$264,051 to $332,311 in annualized
annually
health benefits per year)
• Additional 1,945 to 2,449 cases
annually with “possible” cases (= an
additional $841,644 to $1,059,240
in annualized health benefits)
Improved Worker Safety
• Possible health benefit; lost
• Reduced personal sickness and
productivity valued as part of health
injury
benefits from avoided cases
• Improved worker productivity
Improved Public Health
• Possible health benefit; continued
• Less personal injury from
benefit of avoided cases throughout
accidental spills and chronic
the compliance schedule
contamination sources
Non-Human Health-Related Benefits
Non-Refillable Container
• $4.5 million per year
• $5.6 to $6.9 million per year
Disposal Benefit (2005$)
Non-Refillable to Refillable • Not quantified
• $36 to $109 million per year
Container Benefit
a
See Chapter 5 for the pesticide container regulations human health related and non-human health related benefits
analysis. Figures presented here are calculated using a 3% discount rate. Figures for both 3% and 7% discount rates
are presented in Chapter 5.
b
Proposed container rule RIA (EPA, 1993, pg. XIV-3). See Appendix E.
The total cost of compliance with the final standards is estimated to be significantly lower than
the estimated total cost of compliance with the proposed standards (see Table 2.1). This is
primarily the result of the changes in the container standards from the proposed to final rule.
One of the significant changes between the proposed and final pesticide container rule is the
elimination of the labeling standard requiring household users to triple rinse non-refillable
containers prior to disposal. The estimated cost of this requirement accounts for a significant
portion of the difference between the final and proposed container standards in terms of
estimated total cost and estimated labeling standards cost, and all of the difference between the
end user costs (which are not expected in the final rule without the labeling requirement for
household users to triple rinse containers prior to disposal).
The difference in costs between the final and proposed rule for pesticide registrants (and the
container-related standards, for which the pesticide registrants are responsible) is attributed
primarily to the changes in the container standards from the proposed to final rule. Change in
residue removal standards, which are now applicable to only flowable concentrate products, has
significantly reduced the total cost of the rule. In addition, reduction in the estimated time to
inspect, clean, and record information for refillable containers and the elimination of certification
requirements also account for the difference between the total estimated costs for pesticide
refillers (and the refilling-related standards) to comply with the final container standards versus
the proposed container standards. Swimming pool supply companies face similar costs for
refilling; however, this industry was not addressed in the proposed rule RIA. The proposed rule
RIA for pesticide containers estimated costs to refill containers for agricultural refillers only,
ignoring not only the swimming pool industry, but also some agricultural and
Page 20
industrial/commercial/government product refilling responsibilities (and therefore increased
costs of compliance) for pesticide registrants.
Table 2.2 presents the estimated human health-related and non-human health-related benefits of
compliance with the final and proposed container standards. Both analyses estimate the number
of potentially avoided illnesses. In addition, there were other human health-related benefits
discussed qualitatively in the proposed regulations, such as improved worker safety and
improved public health, which remain relevant to the final regulations. In the RIA for the
proposed container standards, the avoided cases were estimated by extrapolating 1988–1989
California incident data to the national level. For that analysis, the number of cases per year
found to be attributable to container-related problems in California was assumed to represent
approximately 10 percent of the nation’s total, resulting in a total annual estimate of 1,650 to
2,250 potentially avoided cases. In the EA for the final standards, it is similarly assumed that the
percentage of illnesses related to pesticide products occurring in California in 1999 would not
differ significantly from the United States as a whole. However, unlike the proposed regulations,
this ratio is applied to national data on pesticide exposures, rather than extrapolating it to a
national estimate. The EA for the final container standards also estimates dollar benefits for the
potentially avoided cases as a result of the final container standards, which was not done in the
RIA for the proposed container standards. The total human health-related benefits calculated in
the final rule EA ($264,051 to $332,311 per year) are estimates of the costs avoided as a result of
estimated avoided cases of pesticide illness. The analysis considers costs including outpatient
costs, inpatient costs, the value of lost productivity, and the value of premature mortality.
The only quantified non-human health-related benefits calculated in the EA for the final
pesticide container standards is the annual cost-saving benefit associated with the diversion of
non-refillable containers from the hazardous waste management stream to the solid (nonhazardous) waste stream. This annual benefit was also calculated in the RIA for the proposed
pesticide container standards. The differences between the results of the two analyses stems
from the changes in the scope criteria in the final rule, leading to a smaller number of containers
estimated to be diverted from the hazardous to non-hazardous waste stream in the final rule EA,
and, as a result, lower estimated dollar benefits.
In addition to the non-refillable container disposal benefits, the RIA for the proposed container
standards estimated indirect benefits associated with the switch from use of non-refillable
containers to refillable containers, which was expected (not required) as a result of the container
standards. The types of indirect cost savings estimated as a result of the switch to refillable
containers include: (1) container cost savings, (2) container disposal cost savings, and
(3) substantial labor savings associated with triple rinsing of used non-refillable pesticide
containers. The sum of indirect benefits was estimated to range from $36 million to $109
million. These benefits are not quantified in the final container standards EA.
In summary, this chapter presented (1) the final standards for pesticide containers and the
changes that have been made to the standards from the proposed to the final rule, and (2) a
summary of the estimated costs and benefits of compliance with the final and with the proposed
pesticide container standards. The remaining three chapters present the analysis of the costs and
benefits of compliance with the final pesticide container standards. The first step in this analysis
Page 21
(Chapter 3) involves determining the level of compliance of pesticide containers with the final
container standards. This information feeds into the second step of the analysis (Chapter 4),
which estimates the cost of compliance with the final standards. The final step (Chapter 5)
estimates the benefits to humans and the environment expected to result from compliance with
the final pesticide container standards.
Page 22
3.0 Pesticide Container Compliance Profile
3.1 Introduction
This chapter presents a baseline regulatory compliance profile of pesticide containers that will be
affected by the container regulations. In general, the container regulations address four
categories, which include:
•
•
•
•
Non-refillable container standards;
Refillable container standards;
Repackaging of pesticide products; and
Container labeling.
The container regulations compliance affects several types of entities across multiple pesticide
market sectors. The three entities that are potentially affected by the container regulations are
pesticide registrants, agricultural pesticide refillers, and swimming pool supply companies. The
following is a description of each of these entities as well as a description of how these entities
are affected by the container rule. For a more detailed description of each entity type see
Appendix D.
•
Pesticide registrants include all establishments engaged in the formulation and preparation
of all types of pesticides (e.g., insecticides, fungicides, and herbicides). This regulated entity
includes both pesticide manufacturers and independent formulators who hold one or more
pesticide registrations. Registrants include those who distribute or sell pesticides in nonrefillable containers or refillable containers directly, those who distribute or sell pesticides to
independent formulators or refillers, and in some cases direct refiller establishments.
Pesticide registrants are basically required to ensure that all non-refillable and refillable
containers meet the container rule construction and design standards, develop and provide
information to refillers, and ensure that labels include the specified information. Pesticide
registrants are responsible for procedural and handling activities for approximately 10
percent of the refillables in the agricultural market (Paulson, 2002) and all of the refillables in
the industrial/commercial/government (I/C/G) market.13 The primary NAICS code
designation for pesticide registrants is 325320 – Pesticide and Other Agricultural Chemical
Manufacturing.14 The Dun & Bradstreet (D&B) database of company information and
financial data provides NAICS codes with company information where available.
Registrants may serve one or more of the pesticide use market sectors (i.e., agricultural,
13
Don Paulson recently retired from Ciba/Novartis and is currently a consultant to Syngenta and CropLife America,
formerly the American Crop Protection Association (ACPA). Mr. Paulson was very active in the ACPA packaging
task force in the 1990s and co-surveyed the number of agricultural pesticide containers for ACPA with Tom Gilding
between 1989 and 1996.
14
Other NAICS codes associated with pesticide registrants include: (1) 422690 – 1997 NAICS - Otr Chem & Allyd
Prdct Whlslrs, (2) 422910 1997 NAICS – Farm Supplies Wholesalers, (3) 325612 – Polish and Other Sanitation
Good Manufacturing, (4) 325998 – All Other Miscellaneous Chemical Product and Preparation Manufacturing,
(5) 325188 – All Other Basic Inorganic Chemical Manufacturing, (6) 453998 – All Other Miscellaneous Store
Retailers (except Tobacco Stores), and (7) 325412 – Pharmaceutical Preparation Manufacturing. (See Appendix D.)
Page 23
industrial/commercial/government, and/or home and garden). (See below for a discussion of
each market sector.)
•
Agricultural pesticide refillers include only independent agricultural market sector refillers.
The agricultural pesticide refiller entity is generally an agricultural chemical dealer (or
retailer) who supplies pesticide products to farmers or other end users in refillable containers
for large-scale application, although it could also be a distributor. Agricultural pesticide
refillers are subject to container refilling requirements each time a refillable container is
repackaged. Generally, this regulated entity is responsible for inspecting, rinsing, relabeling
containers prior to reuse, and maintaining appropriate records. It is estimated that 90 percent
of agricultural pesticide product is distributed or sold by agricultural pesticide refillers, and
the remaining 10 percent is distributed or sold directly by registrants (Paulson, 2002).
Agricultural pesticide refillers are generally represented under NAICS 422910 – Farm
Supplies and Wholesale Sector, which consists of “establishments primarily engaged in
wholesaling farm supplies, such as animal feeds, fertilizers, agricultural chemicals,
pesticides, plant seeds and plant bulbs” (U.S. Department of Commerce, 1997).
•
Swimming pool supply companies include registrants and other companies that repackage
sodium hypochlorite, an antimicrobial used in pools and spas. Swimming pool supply
companies are affected by certain requirements in the final rule for repackaging (refilling)
sodium hypochlorite. These companies must meet certain refilling requirements, but not all.
Refillables are required to be inspected, cleaned, and properly labeled. Swimming pool
repackagers must maintain certain records, but not all. Copies of the residue removal
procedures for refilling and description of acceptable containers must be on file, but a record
of certain information recorded each time a container is refilled (e.g., product, amount) is not
required. A primary NAICS code for swimming pool supply companies is 453998 – All
Other Miscellaneous Store Retailers (except Tobacco Stores).
Other entities handle pesticide containers but are not regulated under the final rule. For example,
agricultural commercial applicators and self-applicators (farmers) routinely use combinations of
non-refillable and refillable containers. These entities typically do not redistribute or resell
refillable containers or provide refilling services other than for self-application or self-use;
therefore, these entities will not be subject to the final refilling requirements. As a result, these
entities are not included in this industry profile.
It is difficult to estimate the impact of the container regulations on end users or consumers of
pesticide containers. The container regulations do not include specific requirements for end
users or consumers. However, the labeling requirements for pesticide registrants require that
certain information, including proper residue removal procedures prior to disposal, be included
on pesticide labels. The impact of these labeling requirements on end users and consumers is
uncertain. Information on the current residue removal practices of end users and consumers is
not readily available; thus, estimating the change in behavior associated with the container rule
labeling requirements is also unavailable. We assume the labeling requirement impact on end
users or consumers is indirect and negligible.
Page 24
The container regulations are associated with three major market sectors of pesticide use:
agricultural, I/C/G, and home and garden (H&G). The market sectors used in the compliance
profile are consistent with EPA’s Pesticides Industry Sales and Usage: 2000-2001 Market
Estimates report (EPA, 2002b) and the Economic Profile of the U.S. Pesticide Industry (EPA,
2000a). The agricultural sector forms the largest market for conventional pesticides, with
herbicides used most commonly, followed by insecticides and fungicides. The I/C/G sector
includes use of pesticide products by professional applicators at I/C/G facilities, on military
bases, in hospitals, for janitorial use, and in homes and gardens. The H&G sector represents
pesticide products formulated for household use in and around the home.
The market sectors considered in this analysis differ slightly from the market sectors considered
in the proposed container rule RIA (EPA, 1993). Table 3.1 illustrates how the market sectors
considered in this analysis compare with the market sectors used previously.
Table 3.1. Market Sector Equivalent Between the Current Analysis and the
1993 EPA Proposed Container Rule RIA
Current Analysis
Proposed Container Rule RIA
Agricultural
Agricultural
Industrial/Commercial/Government
Industrial
Institutional
Swimming Pool Supply Companies a
Not considered separately
Home & Garden
Household
a
Swimming pool supply companies are subject to a subset of the refilling requirements. Swimming pool supply
companies must meet certain refilling requirements, but not all. Refillables are required to be inspected, cleaned
(unless specified conditions in §165.170 are met), and properly labeled. Swimming pool supply companies must
maintain certain records, but not all. Copies of the residue removal procedures for refilling and description of
acceptable containers must be on file (§165.218(a)), but a record of certain information recorded each time a
container is refilled (e.g., product, amount) is not required (§165.218(b)). Swimming pool supply companies could
be considered part of both the I/C/G and H&G markets. For the purposes of this analysis, however, swimming pool
supply companies were considered separately for the refillable container and repackaging requirements. For nonrefillable containers, the containers holding sodium hypochlorite for swimming pool use are included with the
estimates of containers in the I/C/G and H&G markets.
Table 3.2 illustrates which regulated entities are responsible for which container regulations.
Table 3.2 is not intended to be comprehensive; rather, it is designed to provide a brief overview
showing how each of the regulated entities identified and characterized in this chapter will be
affected by the container rule.
Table 3.3 illustrates the SBA and EPA alternative small business definitions for entities affected
by the container regulations. A small entity is defined as:
• A small business according to the Small Business Administration (SBA) regulations at 13
CFR 121.201. The SBA defines small businesses by category of business using NAICS
codes. Not all companies within a given regulated entity have registered under the same
NAICS code. The SBA definition is based on the primary NAICS code or codes that best
represent(s) the regulated entity.
Page 25
Table 3.2. Generalization of Impacts of Pesticide Container Regulations on Regulated Entities
Pesticide
Registrants
Container Rule Activities
Agricultural
Pesticide
Refillers
Swimming Pool
Supply
Companies
9
9
Non-Refillable Containers
Ensure that all containers meet a subset of DOT packaging standards
9
Ensure that liquid product containers dispense properly and have standard closures
9
Ensure that containers meet the residue removal standard for dilutable pesticides in rigid containers
9
Refillable Containers
Ensure that containers meet a subset of DOT packaging standards
9
Mark containers with a serial number
9
Ensure that a one-way valve and/or tamper-evident device is in place for liquid minibulks
9
Ensure that a vent, gauge, and shutoff valve are in place for liquid bulk containers
9
Meet repackaging conditions
9a
a
Develop cleaning procedures for repackaging
9
Inspect, clean, and ensure proper labeling of containers
9a
9
9b
Maintain records
9a
9
9c
Labeling Standards
Ensure that labels include specified information
9
a
Refilling requirements affect pesticide registrants for 10 percent of the total refillable containers in the agricultural market sector and all of the containers in
the I/C/G market sector. Available data are insufficient to differentiate pesticide registrants that also repackage I/C/G market pesticide products from those that
do not. Therefore, pesticide registrants are held accountable.
b
Swimming pool supply companies must meet certain refilling requirements, but not all. Refillables are required to be inspected, cleaned (unless specified
conditions in §165.170 are met), and properly labeled.
c
Swimming pool supply companies must maintain certain records, but not all. Copies of the residue removal procedures for refilling and a description of
acceptable containers must be on file (§165.218(a)), but a record of certain information recorded each time a container is refilled (e.g., product, amount) is not
required (§165.218(b)).
Page 26
Table 3.3. SBA and EPA Alternative Definitions of Small and Large Businesses Affected by the
Pesticide Container Regulations
Regulated Entity
Pesticide Registrants
Agricultural
Pesticide Refillers
Swimming Pool
Supply Companies
SBA Definitions
Primary NAICS Code(s)
Size
325320 – Pesticide and Other
Agricultural Chemical
Manufacturing
Small
422910 – Farm Supply
Wholesalers
453998 – All Other
Miscellaneous Store Retailers
(except Tobacco Stores)
EPA Alternative Definitions
Definition
(13 CFR Part 121)
500 or fewer employees
Size
Small-Small
1 to 19 employees
Medium-Small
20 to 99 employees
Large-Small
Large
501 or more employees
Large
Small
100 or fewer employees
Small-Small
Large
101 or more employees
Small
Maximum revenues of $6.0
million a
Revenues greater than $6.0
million a
a
100 to 500 employees
501 or more employees
1 to 9 employees
Medium-Small
10 to 49 employees
Large-Small
50 to 100 employees
Large
Small-Small
Medium-Small
Large-Small
Large
Definition
Large
101 or more employees
1 to 9 employees
10 to 49 employees
50 or more employees
Revenues greater than $6.0
million a
The SBA small business size standard is no more than $6 million in revenue for NAICS 453998. The analysis divided the SBA small businesses into the
three EPA alternative small business size categories regardless of employee or revenue totals once the regulated entity passed the SBA-defined small business
screening.
Page 27
•
•
A small governmental jurisdiction that is a government of a city, county, town, school
district, or special district with a population of less than 50,000.
Any small, not-for-profit enterprise that is independently owned and operated and is not
dominant in its field.
This economic analysis (EA) evaluates an alternative definition of small entities or businesses
potentially affected by the container regulations. As discussed by EPA in the 1999 Standards for
Pesticide Containers and Containment Proposed Rule Supplemental Notice (EPA, 1999), the
alternative definition disaggregates the SBA-defined small businesses into three size categories:
small-small, medium-small, and large-small businesses. EPA is concerned that using an overly
broad definition of small business in the EA of the container regulations may result in significant
economic impacts on smaller entities that will be camouflaged when combined with information
about potential impacts on facilities that meet the SBA size standard for small business but are
not typical of a small business in that industry sector. Table 3.3 represents each affected industry
by the SBA definition of small business and the alternative definition used in this analysis.
Two industry sectors considered in the 1999 Supplemental Notice were pesticide formulators and
agrichemical dealers. These regulated entities correspond with pesticide registrants and
agricultural pesticide refillers, respectively, in this EA. We have also developed an alternative
small business definition that disaggregates the SBA-define small businesses into small-small,
medium-small and large-small businesses for the swimming pool supply companies.
The remainder of this chapter is divided into three sections. Section 3.2 describes how we
estimated the total universe of pesticide containers in use for the three market sectors
(agricultural, I/C/G, and H&G). Section 3.3 illustrates how we applied the scope criteria to the
total universe of pesticide containers to estimate how many containers are ultimately affected by
the container regulations. Section 3.4 examines the extent to which pesticide containers are
already in compliance with various components of the container regulations.
3.2 Pesticide Container Universe
An estimate of the current number of non-refillable and refillable containers in the agricultural,
I/C/G, and H&G markets is based on data from the following sources:
•
•
•
•
1996 agricultural pesticide container survey by the American Crop Protection Association
(ACPA, 1997).
Container number estimates derived from a 1989 pesticide container survey conducted by the
pesticide industry. The groups that participated include the National Agricultural Chemicals
Association (NACA), the Mid America CropLife Association (MACA), the International
Sanitary Supply Association (ISSA), and the Chemical Specialties Manufacturers
Association (CSMA).
Non-refillable container numbers from 2001 and 1991 surveys conducted by the American
Chemistry Council (formerly the Chemical Manufacturers Association).
Information and best professional judgment from industry and association representatives
(EPA, 2005, and Paulson, 2002).
Page 28
Because of the pesticide use diversity among the major pesticide markets, the number of
containers is estimated separately for each market. The general approach we took was to
summarize the number of containers by type from the appropriate source(s) and adjust container
numbers as appropriate to reflect current use levels based on 2001 information and best
professional judgment (EPA, 2005). Tables 3.4 and 3.5 illustrate the estimated number of nonrefillable and refillable containers, respectively, that are currently in use. Table 3.6 gives
estimates of the number of swimming pool chemical containers affected by the container
regulations. A more detailed discussion of how the estimates were derived for refillable
containers can be found in Appendix B.
Page 29
Table 3.4. Estimated Number of Non-Refillable Pesticide Containers in Use by
Major Market Sectors
Container Size Category
Industrial/
Commercial/
Government b
Agricultural a
Home &
Garden c
Total
Liquid Pesticide Products
30-55 Gallons
Plastic
309,100
1,600,000
0
1,909,100
Steel
115,500
2,320,000
0
2,435,500
Plastic
58,100
14,048,000
0
14,106,100
Steel
28,800
960,000
0
988,800
27,877,500
21,072,000
28,000,000
76,949,500
0
1,440,000
8,000,000
9,440,000
1,007,000
20,560,000
104,000,000
125,567,000
Steel
0
160,000
12,000,000
12,160,000
Glass
0
240,000
8,000,000
8,240,000
544,600
0
0
544,600
Barrier
82,200
0
0
82,200
Bag-In-Box
500
260,000
0
260,500
0
23,200,000
200,000,000
223,200,000
5 Gallons
1 To < 5 Gallons
Plastic
Steel
< 1 Gallon
Plastic
Water Soluble Packets
PVA
Aerosol Cans
Other Sizes
0
0
0
0
30,023,300
85,860,000
360,000,000
475,883,300
429,500
0
0
429,500
0
0
0
0
Plastic
1,849,200
0
0
1,849,200
Paper
8,161,000
0
0
8,161,000
0
1,120,000
39,500,000
40,620,000
Subtotal
Dry Pesticide Products
> 100 lb Bulk
56-100 lb Bags
45-55 lb Bags
11-44 lb Bags
Plastic
3,764,900
0
0
44,384,900
Paper
2,216,600
0
0
2,216,600
328,900
0
0
328,900
5,730,200
0
0
5,730,200
26,400
0
0
26,400
2,273,000
370,000
500,000
3,143,000
1-10 lb Bags
Plastic
Paper
Jugs
2.5 gallons
1 quart to < 2.5 gallons
Page 30
Table 3.4 (Continued). Estimated Number of Non-Refillable Pesticide Containers in Use by
Major Market Sectors
Container Size Category
Agricultural a
Industrial/
Commercial/
Government b
Home &
Garden c
Total
PVA
44,070,700
1,300,000
0
45,370,700
Barrier
11,879,100
430,000
0
12,309,100
> 30 pounds
12,300
1,280,000
0
1,292,300
< 30 pounds
129,600
0
0
129,600
3,442,200
0
0
3,442,200
84,313,600
4,500,000
40,000,000
128,813,600
114,336,900
90,360,000
400,000,000
604,696,900
18.91%
14.94%
66.15%
Fiber Drums
Other Sizes
Subtotal
Total - Non-Refillables
Percentage of Non-Refillables
a
Current estimates of the number of non-refillable containers in the agricultural market were taken from the most
recent (1996) ACPA Container Survey (ACPA, 1997). Number of containers has been rounded to the nearest
hundred for purposes of this table. Actual container estimates surveyed are used throughout the pesticide container
compliance profile (Chapter 3) and cost analysis (Chapter 4). EPA (2005) determined that the 1996 ACPA
Container Survey results were reasonable and should be used based on correspondence with Tom Gilding of
CropLife America (formerly ACPA).
b
Current estimates of the number of non-refillable containers in the I/C/G market were based on the combined total
number of containers for the industrial and institutional market sectors used in the proposed container rule RIA
(EPA, 1993). EPA solicited comments from the American Chemistry Council (ACC) and ISSA in May 2001 to aid
in updating the I/C/G non-refillable container estimates. The ACC received information on the number of
containers used by 11 out of 40 member companies. This information was used to modify the current estimated
number of containers in the I/C/G market sector. As a result, EPA made the following changes in the estimated
number of non-refillable container estimates for the I/C/G market sector (EPA, 2005):
• Bag-in-box: Two companies reported 133,162 bag-in-box containers. Since only a small number of companies
reported using these containers, this estimate was doubled and rounded down to 260,000.
• One quart to < 2.5 gallon plastic: Two companies reported 184,617 containers in this category. This estimate
was doubled and rounded to 370,000.
• Water soluble PVA packets and barrier packs: Three companies reported 653,305 water soluble PVA packets.
This estimate was doubled and rounded to 1,300,000. The number of barrier packs was calculated based on a
ratio of three PVA packets to one barrier pack, resulting in an estimated 430,000 barrier packs.
c
Current estimates of the number of non-refillable containers in the H&G market were based on the total number of
containers in the household market sector used in the proposed container rule RIA (EPA, 1993). EPA received the
following qualitative feedback from John DiFazio of Consumer Specialty Products Association (CSPA) with regard
to the current number of H&G non-refillable containers in use versus the 1993 estimates:
• Liquid non-refillables: (1) 1 to <5 gallon plastic - about the same; (2) <1 gallon plastic - about the same; (3) <1
gallon steel - much less; and (4) aerosol cans - about the same.
• Dry non-refillables: (1) 11 to 44 pound plastic bags - a bit less; (2) 1 to 10 pound paper bags - a bit more; (3) 1
quart to <2.5 gallon plastic - a bit less; and (4) subtotal for dry non-refillables - more, possibly much more.
As a result, the following non-refillable container estimate modifications were made:
• <1 gallon steel: Assumed that “much less” reduced the estimate for this category from 24,000,000 to
12,000,000.
• Flexible bags (see note “d” below): Assumed that “a bit less” 11 to 44 pound plastic bags combined with “a bit
more” 1 to 10 pound paper bags increased the estimate for this category from 28,000,000 to 40,000,000, with
500,000 of this total allocated to the “1 quart to <2.5 gallon plastic” size category specifically and the
remaining 39,500,000 allocated to flexible bags with no size criteria specified.
d
As with the proposed container rule RIA (EPA, 1993), no size criteria are specified for flexible bags. For the
purposes of this analysis, all of the flexible bags for the market sector were allocated to the “11 to 44 pound
paper/plastic bags” category.
Page 31
Table 3.5. Estimated Number of Refillable Pesticide Containers in Use
by Major Market Sectors
Container Size Category
Agricultural a
Home &
Garden c
I/C/G b
Total
Liquid Pesticide Products
Retail Bulk Tanks (>500 Gal)
Plastic
Steel
12,060
7,200
0
19,260
1,340
800
0
2,140
1,170
8,400
0
9,570
130
2,800
0
2,930
34,800
9,000
0
43,800
6,700
1,000
0
7,700
172,600
9,000
0
181,600
57,600
1,000
0
58,600
48,800
2,920
0
51,720
4,000
4,380
0
8,380
Large Tanks (251-500 Gal)
Plastic
Steel
126-250 Gallons
Plastic
Steel
61-125 Gallons
Plastic
Steel
26-60 Gallons
Plastic
Steel
5-25 Gallons
Plastic
Steel
Other Sizes
Subtotal
127,900
0
0
127,900
99,800
0
0
99,800
0
0
0
0
566,900
46,500
0
613,400
Dry Pesticide Products
Retail Bulk Tanks (> 4,000 lbs)
Large Tanks (2,501-4,000 lbs)
101-2,500 lb Bags
< 100 lb Bags
Other Sizes
Subtotal
Total - Refillables
Percentage of Refillables
175
0
0
175
5,425
0
0
5,425
13,300
0
0
13,300
677,800
0
0
677,800
0
0
0
0
696,700
0
0
696,700
1,263,600
46,500
0
1,310,100
96.45%
3.55%
0.00%
Note: See Table 3.6 for estimates of the number of swimming pool chemical containers in use.
a
Current estimates of the number of refillable containers in the agricultural market were based on converting the
formulated volume (gal) and formulated weight (lbs) of pesticides reported in the 1996 ACPA Container Survey
(ACPA, 1997) to the number of refillable containers in use. The non-bulk container estimates were rounded to the
nearest hundred, and the bulk container estimates were rounded to nearest multiple of five. See Appendix B.
b
Current estimates of the number of refillable containers in the I/C/G market were based on the combined total
number of containers for the industrial and institutional market sectors used in the proposed container rule RIA
(EPA, 1993). EPA solicited comments from the ACC and ISSA in May 2001 to aid in updating the I/C/G refillable
container estimates. No changes to the estimated number of refillable containers were warranted, based on
responses from the ACC and ISSA.
c
The analysis assumes that there are no refillable containers in the H&G market.
Page 32
Table 3.6. Estimated Number of Swimming Pool Chemical Refillable
Containers Affected by the Pesticide Container Regulations
Number of Containers a
Container Size Category
Liquid Pesticide Products
Retail Bulk Tanks (>500 Gal)
Plastic
1,620
Steel
180
Bulk Tanks (251-500 Gal)
Plastic
4,680
Steel
520
126-250 Gallons
Plastic
0
Steel
0
61-125 Gallons
Plastic
0
Steel
0
26-60 Gallons
Plastic
140,000
Steel
0
5-25 Gallons
Plastic
70,000
Steel
0
Other Sizes b
1,000,000
Total – Refillables
1,217,000
a
Estimates are based on comments to the 1999 Supplemental Notice submitted by
relevant trade associations (i.e., the Chlorine Institute, National Spa and Pool Institute,
and Swimming Pool Chemical Manufacturers Association) that provide the average
number of refillings and volume. Based on the comments, the number of refillings
was assumed to be 8. A smaller refilling rate of 4 was assumed for larger containers.
This refilling rate was used with the data on volume from the comments (38 million
gallons of sodium hypochlorite in use for pools in spas annually) to arrive at the total
number of containers.
b
Other sizes include relatively smaller, 1- or 2.5-gallon plastic containers known to be
in use.
3.3 The Implications of the Scope of the Regulations on the Container Estimates
The regulations specify which pesticide products are and are not subject to the regulations
(40 CFR Part 165 Subparts C, D, and E). The container scope criteria are relatively complex, but
some of the key points are briefly summarized here and in Table 3.7:
Page 33
Table 3.7. Summary of Regulatory Scope
Pesticide Products NOT Subject to the Pesticide Container Regulations
Non-Refillable and Refillable Containers
The following three categories of pesticide products are not subject to the non-refillable container, refillable
container, and repackaging regulations:
(1) Manufacturing use products (MUPs);
(2) Plant-incorporated protectants (PIPs); and
(3) Antimicrobial pesticide products that satisfy all four of these criteria:
• It is an antimicrobial pesticide, as defined in FIFRA Section 2(mm), or it has antimicrobial properties, as
defined in FIFRA Section 2(mm)(1)(A), and is subject to a tolerance or a food additive regulation.
• Its label includes directions for use on a site in at least one of the 10 antimicrobial product use categories
identified as “household, industrial, or institutional.” a
• It is not a hazardous waste when it is intended to be disposed, as defined in 40 CFR Part 261.
• EPA has not specifically found that the product must be subject to the container provisions to prevent an
unreasonable adverse effect on the environment.
Pesticide Products Subject to the Pesticide Container Regulations
Non-Refillable Containers
Other than MUPs, PIPs, and exempt antimicrobial products, a pesticide product sold or distributed in a nonrefillable container is subject to all of the non-refillable container regulations if it satisfies at least one of the
following criteria: b
(1) It meets the criteria of Toxicity Category I;
(2) It meets the criteria of Toxicity Category II; or
(3) It is classified for restricted use (as set out in 40 CFR parts 152.160–152.175).
If a product (other than MUPs, PIPs, and exempt antimicrobials) does not meet any of these criteria, the product is
subject to only the basic DOT requirements in 49 CFR 173.24.
Refillable Containers and Repackaging
Other than MUPs, PIPs, and exempt antimicrobial products, a pesticide product sold or distributed in a refillable
container is subject to the refillable container and repackaging regulations.
Pesticide Products Subject to the Pesticide Container Labeling Standards
All pesticide products are subject to the new labeling standards.
a
The “household, industrial, or institutional” antimicrobial product use categories are: (1) food handling/storage
establishments premises and equipment; (2) commercial, institutional, and industrial premises and equipment;
(3) residential and public access premises; (4) medical premises and equipment; (5) human drinking water
systems; (6) materials preservatives; (7) industrial processes and water systems; (8) antifouling coatings; (9) wood
preservatives; and (10) swimming pools.
b
The residue removal standard affects a smaller subset of Toxicity Category I , II, and restricted use products
because it is applicable to only flowable concentrate products.
(1) The non-refillable container, refillable container, and repackaging regulations do not apply
to the same subset of pesticide products, although the structure of the non-refillable container
regulations is different.
(2) For the non-refillable container regulations, only “higher-risk” products are subject to all of
the non-refillable container requirements. The “lower-risk” products are subject only to the
basic DOT requirements. In particular:
Page 34
(a) A product is subject to all non-refillable container requirements if it is classified in at
least one of the following categories: (1) Toxicity Category I, (2) Toxicity Category II, or
(3) Restricted Use Product.15
(b) All other products (those in Toxicity Category III or IV that are not restricted use
products) must comply only with the basic DOT requirements in 49 CFR 173.24.
(3) For the refillable container and repackaging regulations, antimicrobial products that are used
only in swimming pools (and closely related sites such as hot tubs, spas, or whirlpools) are
exempt from some of the standards.
(4) The new labeling standards apply to all pesticide products.
The remainder of this section discusses how the container regulations’ scope affects the estimate
of the number of containers affected by the regulation.
3.3.1 Manufacturing Use Products and Plant-Incorporated Protectants
Manufacturing use products (MUPs) and plant-incorporated protectants (PIPs) are explicitly
exempt from the pesticide container regulations. MUPs are any products intended (labeled) for
formulation or repackaging into other pesticide products and therefore assumed to be excluded
from estimates of the pesticide container universe. PIPs are substances that plants produce for
protection against pests. These substances and the genetic material necessary to produce them
are pesticides under FIFRA if humans intend these substances to prevent, repel, or mitigate any
pest. Bags of seed or other containers containing PIPs are assumed to be excluded from the
estimates of the pesticide container universe based on the scope of the data sources used. In
particular, the 1996 ACPA Container Survey (ACPA, 1997) used as the basis for the agricultural
market container estimates did not assess containers containing PIPs. Therefore, it is assumed
that none of the containers considered in this analysis will be affected by the MUP or PIP
exemptions.
3.3.2 Antimicrobial Pesticide Products
The container rule’s antimicrobial exemption applies only to containers in the I/C/G and H&G
markets. EPA (2005) determined that 27.7 percent of the total number of containers in each of
the two markets (and distributed by container type) would be antimicrobial product containers.16
Additionally, EPA (2005) identified the number of antimicrobial products subject to the
container regulations (1,350 products or 29.8 percent of the total number of antimicrobial
products [4,528]), and the number of antimicrobial products that are exempt from the regulations
(3,178 products, or 70.2 percent of the total number of antimicrobial products). As a result, it is
15
The residue removal standard affects a smaller subset of Toxicity Category I, II, and restricted use products
because it is applicable to only flowable concentrate products.
16
The estimate of the total number of antimicrobial product containers is based on the estimated usage of
antimicrobial pesticides in the H&G and I/C/G markets. The estimate of 27.7 percent assumes that the total number
of antimicrobial product containers is in the same proportion as the number of antimicrobial products subject to the
regulations. The estimate is calculated by multiplying 29.8 percent, the percentage of antimicrobial products subject
to container regulations (EPA, 2005), by the total amount of antimicrobial usage, and dividing this value by the total
usage of pesticides: antimicrobial, conventional (e.g., herbicides, insecticides), and other (e.g., petroleum oil).
Page 35
assumed that approximately 8.25 percent (.277 * .298) of all I/C/G and H&G non-refillable and
refillable containers are antimicrobial products subject to all the container regulations.
EPA’s attempt in the 1999 Supplemental Notice (EPA, 1999) to partially exempt antimicrobials
used in swimming pools from some refillable container requirements was drafted to apply to
products that were eligible for exemption. EPA acknowledges that some of the products that
were intended to be partially exempted from the refillable container standards are hazardous
wastes when they are disposed. They are therefore not eligible for the antimicrobial exemption
from the container rule. In other words, the partial exemption from the refillable container
standards as described in the Supplemental Notice would not have applied to the products for
which it was intended to provide relief. Antimicrobial products that were not eligible for
exemption would have had to comply with the full set of container regulations.
As stated in the Supplemental Notice, EPA acknowledges that applying some of the refillable
container standards (specifically, the serial number marking, one-way valves or tamper-evident
devices, and recordkeeping) to sodium hypochlorite used in swimming pools would disrupt the
current refillable container system for these products and would probably cause the refillables to
be replaced by millions of single-use, non-refillable containers. EPA believes that adding
millions of pounds of these non-refillable containers to the waste stream is inconsistent with the
goals of Section 19(e) of FIFRA, particularly the goal that the regulations facilitate the safe refill
and reuse of containers. Therefore, in the Supplemental Notice, EPA attempted to create a
partial exemption from the refillable container standards for these products.
Based on comments and an analysis of which antimicrobial pesticides may be hazardous waste
when they are disposed, EPA is revising the partial exemption in the final rule so that it
accomplishes EPA’s intended goal. The partial exemption will apply to “antimicrobial” products
that are:
•
•
•
Distributed in refillable containers;
Subject to the container regulations; and
Used in swimming pools, spas, hot tubs, and whirlpools.
EPA is limiting the scope of the reduced set of refillable container standards to products used
only in swimming pools, spas, hot tubs, and whirlpools because commenters on the proposed
container rule and the Supplemental Notice made a convincing case that applying the full set of
refillable container regulations to the refillable containers servicing these sites would be
burdensome. A significant factor was the large amount of detail about the refillable containers
used for distributing pool chemicals (generally 1- or 2.5-gallon plastic containers), the large
amount of product distributed in these containers, and the system that the pesticide registrants
had in place for managing these containers.
The estimated number of refillable containers in the swimming pool industry is not readily
available. Comments to the 1999 Supplemental Notice submitted by relevant trade associations
(i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical
Manufacturers Association) were considered in the process of determining a reasonable number
of refillable containers of various sizes used by the estimated 305 small and 17 large swimming
Page 36
pool supply companies (or companies that routinely refill containers for distributing sodium
hypochlorite for pool disinfection). Table 3.6 illustrates the estimated number of swimming pool
chemical refillable containers subject to the container regulations.
3.3.3 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Toxicity Categories I and II
The scope criteria for the container standards limit the universe of non-refillable containers that
are affected by all of the non-refillable container requirements. Pesticide products classified in
Toxicity Category I or II are subject to all of the non-refillable container regulations.
Based on an analysis of pesticide registration data in an Office of Pesticide Programs database
and literature searching, we estimated the percentage of pesticide active ingredients (PAIs) in
Toxicity Categories I and II used in the agricultural, I/C/G, and H&G markets. The pounds of
PAIs applied in each market sector was based on 1999 information compiled for the “Pesticide
Industry Sales and Usage: 1998 and 1999 Market Estimates” report (EPA, 2002b). We crosschecked all PAIs comprising 0.05 percent or greater of the pounds applied in the agricultural
market, and all I/C/G and H&G PAIs, to determine their toxicity category and whether the PAI
was also classified for restricted use. In the agricultural market, it is estimated that Toxicity
Category I and Toxicity Category II PAIs account for 28.7 percent and 22.9 percent of the total
pounds applied, respectively. In the I/C/G market, Toxicity Category I and II PAIs account for
an estimated 28.4 percent each of the pounds applied. In the H&G market, Toxicity Category I
and II PAIs account for an estimated 18.5 percent and 45.7 percent of the total pounds applied,
respectively. It is assumed that the relative percentage of the pounds applied for PAIs
categorized as Toxicity Category I or II is applicable to the number of pesticide containers
affected by the container regulations according to the toxicity scope criteria (see Table 3.8).
Page 37
Table 3.8. Percentage of Pesticide Containers Affected by the Final Rule Scope Criteria
Pesticide Container
Final Rule Scope Criteria
Agricultural
(%)
Industrial/Commercial/
Government (%)
Home & Garden
(%)
Pesticide Products NOT Subject to the Pesticide Container Regulations
Manufacturing Use Products
0
0
0
Plant-Incorporated Protectants
0
0
0
0
8.25
8.25
Antimicrobials
a
Pesticide Products Sold or Distributed in Non-Refillable Containers Subject to All of the Non-Refillable
Container Regulations b
Toxicity Category I
28.7
28.4
18.5
Toxicity Category II
22.9
28.4
45.7
Restricted Use Products
12.9
5.2
3.0
The antimicrobial exemption only applies to containers in the I/C/G and H&G markets. EPA (2005) determined
that 27.7 percent of the total number of containers in each of the two markets (and distributed by container type)
would be antimicrobial product containers. Additionally, EPA (2005) identified the number of antimicrobial
products subject to the container regulations (1,350 products or 29.8 percent of the total number of antimicrobial
products [4,528]), and the number of antimicrobial products that are exempt from the regulations (3,178 products, or
70.2 percent of the total number of antimicrobial products). As a result, approximately 8.25 percent (.277 * .298) of
all I/C/G and H&G non-refillable and refillable containers were assumed to be antimicrobial products subject to all
the container regulations.
b
The container rule scope criteria limit compliance with all of the non-refillable container regulations to non-exempt
products that meet the Toxicity Category I, Toxicity Category II, and/or restricted use criteria. Other non-exempt
products sold in non-refillable containers (those in Toxicity Categories III and IV that are not restricted use
products) must comply only with the basic DOT packaging standards in 49 CFR 173.24. These products are
considered separately because they are not subject to the full set of non-refillable container requirements.
a
3.3.4 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Restricted Use Products
Pesticide products classified for restricted use are also subject to all of the non-refillable
container regulations. The same data set and assumptions used to evaluate PAI toxicity were
used to develop the percentage of pesticide containers affected by the restricted use nonrefillable container scope criteria. PAIs and/or pesticide products ranging in toxicity (i.e.,
Toxicity Categories I through IV) may be classified for restricted use. Those PAIs that did not
meet the scope criteria based on toxicity (Toxicity Categories III and IV) were separated from
those that were affected by the container regulations (Toxicity Categories I and II). Each of the
PAIs in the Toxicity Categories III and IV were evaluated to determine if they were classified for
restricted use. In the agricultural market, Toxicity Category III and Toxicity Category IV
restricted use products account for an estimated 12.9 percent of the total pounds applied. In the
I/C/G and H&G markets, Toxicity Category III and Toxicity Category IV restricted use products
account for an estimated 5.2 percent and 3.0 percent of the pounds applied in each of these
markets, respectively.17 It is assumed that the relative percentage of PAIs categorized as
Toxicity Category III or IV substances and classified for restricted use were applicable to the
number of pesticide containers affected by the container regulations according to the restricted
use scope criteria (see Table 3.8).
17
Pesticide usage in the H&G market includes some applications by lawn care professionals and pest control
operators, who may be certified pesticide applicators and can, therefore, apply restricted use pesticides.
Page 38
3.3.5 Non-Exempt Products Sold or Distributed in Non-Refillable Containers:
Toxicity Categories III and IV That Are Not Restricted Use Products
Pesticide products classified in Toxicity Categories III and IV that are not restricted use
products are not subject to the full set of non-refillable container requirements. Instead, these
products are subject only to the basic DOT requirements in 49 CFR 173.24. These products are
not subject to the other non-refillable container requirements, such as the container closure,
container dispensing, and residue removal standards. Also, these products are not subject to the
other DOT requirements that are adopted by the pesticide container regulations.
3.3.6 Summary of Pesticide Container Scope Criteria
Table 3.8 summarizes the percentage of non-refillable and refillable containers affected by the
container scope criteria. As stated in Sections 3.3.1–3.3.4, the percentage of pesticide products
subject to the container scope criteria was applied to the estimated number of containers for each
size category.
We estimated the number of containers that are affected by the container regulations out of the
total universe of pesticide containers based on the percentage of containers affected by the scope
criteria listed in Table 3.8. For example, for “1 to <5 gallons” plastic non-refillables in the
agricultural sector, we estimated the number of containers affected by the container rule as:
(0.287 + 0.229 + 0.129) * 27,877,500 = 17,980,988 containers
where:
•
•
“27,877,500” is the total number of containers in use in this size category (see Table 3.4.);
“(0.287 + 0.229 + 0.129)” represents the percentage of containers subject to the container
regulations based on the Toxicity Category I, Toxicity Category II, and restricted use product
classifications, respectively.
For the I/C/G and H&G markets, the same considerations as for the agricultural market sector
applied for determining the number of containers subject to the container regulations with one
exception. In these market sectors, we considered antimicrobial pesticide containers separately
from non-antimicrobial pesticide containers. Therefore, the number of containers containing
antimicrobials subject to the container regulations was added to the number of non-antimicrobial
pesticide containers that met the container rule scope criteria based on Toxicity Category I,
Toxicity Category II, and restricted use product classifications. For example, for I/C/G “30 to 55
gallon” plastic non-refillables, we estimated the number of containers affected by container rule
as:
(1,600,000 * 0.277 * 0.298) + {(0.284 + 0.284 + 0.052) * [1,600,000 * (1 - 0.277)]} =
848,711 containers
Page 39
where:
•
•
•
•
“1,600,000” is the total number of 30 to 55 gallon plastic non-refillable containers in use in
the I/C/G market (see Table 3.4);
“0.277” is the percentage of containers that hold antimicrobials;
“0.298” is the percentage of antimicrobials that are subject to the container regulations; and
“(0.284 + 0.284 + 0.052)” represents the percentage of containers subject to the container
regulations based on the Toxicity Category I, Toxicity Category II, and restricted use product
classifications, respectively.
We calculated the number of pesticide containers affected by the scope criteria for each nonrefillable and refillable container size category. Tables 3.9 and 3.10 detail the number of nonrefillables and refillables, respectively, that are within the scope of the container regulations and
are potentially affected by the regulations.
As mentioned earlier, all products are subject to the refillable container and repackaging
regulations. As a result of this requirement, the number of refillable containers in the
agricultural market sector affected by the container regulations as displayed in Table 3.10 is the
same as in Table 3.5, which establishes the baseline number of refillable pesticide containers in
use. However, certain antimicrobial products in the I/C/G market sector (in fact, 70.2 percent of
antimicrobial products, as previously discussed) are exempt from the container regulations. As a
result of this exemption, the number of refillable containers in the I/C/G market is less than the
baseline for I/C/G refillable containers as described in Table 3.5. For example, in the baseline,
there are an estimated 7,200 refillable liquid plastic retail bulk tanks in the I/C/G market sector.
Due to the antimicrobial exemption, an estimated 5,800 containers of this type fall under the
scope of the regulations. The calculation is as follows:
(7,200 * 0.277 * 0.298) + [7,200 * (1-0.277)] = 5,800.
Page 40
Table 3.9. Estimated Number of Non-Refillable Pesticide Containers Affected by the
Pesticide Container Regulations a
Size Category
Industrial/
Commercial/
Government
Agricultural
Home &
Garden
Total
Liquid Pesticide Products
30-55 Gallons
Plastic
199,434
848,711
0
1,048,145
74,518
1,230,631
0
1,305,149
Plastic
37,496
7,451,684
0
7,489,181
Steel
18,594
509,227
0
527,821
17,986,536
11,177,527
15,909,183
45,073,245
0
763,840
4,545,481
5,309,321
649,731
10,905,939
59,091,250
70,646,921
Steel
0
84,871
6,818,221
6,903,092
Glass
0
127,307
4,545,481
4,672,787
351,374
0
0
351,374
Barrier
53,012
0
0
53,012
Bag-In-Box
303
137,916
0
138,219
0
12,306,312
113,637,020
125,943,332
Steel
5 Gallons
1 to < 5 GALLONS
Plastic
Steel
< 1 Gallon
Plastic
Water Soluble Packets
PVA
Aerosol Cans
Other Sizes
0
0
0
0
19,370,998
45,543,965
204,546,636
269,461,599
277,097
0
0
277,097
0
0
0
0
Plastic
1,193,113
0
0
1,193,113
Paper
5,265,477
0
0
5,265,477
0
1,120,000
39,500,000
0
Plastic
2,429,134
594,098
22,443,311
25,466,543
Paper
1,430,124
0
0
1,430,124
212,196
0
0
212,196
3,697,147
0
0
3,697,147
17,020
0
0
17,020
1,466,578
196,264
284,093
1,946,935
Subtotal
Dry Pesticide Products
> 100 lb Bulk
56-100 lb Bags
45-55 lb Bags
11-44 lb Bags
1-10 lb Bags
Plastic
Paper
Jugs
2.5 gallons
1 quart to < 2.5 gallons
Page 41
Table 3.9 (Continued). Estimated Number of Non-Refillable Pesticide Containers Affected
by the Pesticide Container Regulations a
Size Category
Agricultural
Industrial/
Commercial/
Government
Home &
Garden
Total
Water Soluble Packets
PVA
28,434,409
689,578
0
29,123,987
7,664,424
228,091
0
7,892,515
> 30 pounds
7,925
678,969
0
686,894
< 30 pounds
83,628
0
0
83,628
2,220,893
0
0
2,220,893
Barrier
Fiber Drums
Other Sizes
Subtotal
Total - Non-Refillables
Percentage of Non-Refillables
54,399,166
2,387,000
22,727,404
79,513,570
73,770,164
47,930,965
227,274,040
348,975,169
21.14%
13.73%
65.13%
a
Estimates based on the container rule scope criteria (see Section 2.3) applied to the total universe of non-refillable
containers (see Section 2.2).
Page 42
Table 3.10. Estimated Number of Refillable Pesticide Containers Affected by the
Pesticide Container Regulations a
Container Size Category
Agricultural
Industrial/
Commercial/
Government
Swimming
Pool
Industry b
Home &
Garden
Total
Liquid Pesticide Products
Retail Bulk Tanks (>500 Gal)
Plastic
Steel
12,060
5,800
1,620
0
19,480
1,340
644
180
0
2,164
1,170
6,767
4,680
0
12,617
130
2,256
520
0
2,906
34,800
7,250
0
0
42,050
6,700
806
0
0
7,506
172,600
7,250
0
0
179,850
57,600
806
0
0
58,406
48,800
2,352
140,000
0
191,152
4,000
3,528
0
0
7,528
127,900
0
70,000
0
197,900
99,800
0
0
0
99,800
Large Tanks (251-500 Gal)
Plastic
Steel
126-250 Gallons
Plastic
Steel
61-125 Gallons
Plastic
Steel
26-60 Gallons
Plastic
Steel
5-25 Gallons
Plastic
Steel
Other Sizes
c
0
0
1,000,000
0
1,000,000
566,900
37,458
1,217,000
0
1,821,358
Retail Bulk Tanks (>4,000 lbs)
175
0
0
0
175
Large Tanks (2,501-4,000 lbs)
5,425
0
0
0
5,425
Subtotal
Dry Pesticide Products
101-2,500 lb Bags
Fiber Drums
Other Sizes
Subtotal
Total – Refillables
Percentage of Refillables
13,300
0
0
0
13,300
677,800
0
0
0
677,800
0
0
0
0
0
696,700
0
0
0
696,700
1,263,600
37,458
1,217,000
0
2,518,058
50.18%
1.49%
48.33%
0.00%
a
Estimates based on the container regulations scope criteria (see Section 2.3) applied to the total universe of
refillable containers (see Section 2.2 and Table 3.5).
b
Assumed estimates based on comments to the 1999 Supplemental Notice submitted by relevant trade associations
(i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical Manufacturers
Association).
c
Other sizes include relatively smaller, 1- or 2.5-gallon plastic containers.
Page 43
3.4 Regulatory Compliance Baseline
Table 3.11 provides an overview of the pesticide container regulatory requirements broken down
by various components of the rule.
Table 3.11. Overview of the Container Regulations
Non-Refillable
Containers
All Non-Exempt
Products
(1) Basic DOT packaging
standards (49 CFR 173.24)
All Non-Exempt
Products Meeting Scope
Criteria
(1) DOT container design,
construction, and marking
standards
(2) Container dispensing
capability
(3) Standardized closures
(4) Residue removal
(5) Recordkeeping
Refillable Containers
Non-Exempt Products
(1) DOT container design,
construction, and marking
standards
(2) Serial number
marking*
(3) One-way valves or
tamper-evident devices*
(4) Bulk container
requirements
* Swimming pool
antimicrobial products are
not subject to these
requirements.
Repackaging Pesticide
Products
All Non-Exempt
Products
(1) Pesticide registrants
develop information
(2) Registrants and others
comply with specified
conditions
(3) Refillers (registrants
and others) obtain and
follow registrant
information, and clean,
inspect, and label
containers before refilling
them*
*Swimming pool
antimicrobial products are
not subject to several of
these requirements.
Labels
All Products
(1) Identify container as
non-refillable or refillable
All Products in NonRefillable Containers
(1) Statements to prohibit
reuse and offer for
recycling; batch code
Some Products in NonRefillable Containers
(1) Cleaning instructions
All Products in Refillable
Containers
(1) Cleaning instructions
before final disposal
Some Products in
Refillable Containers
(1) Leave blank spaces for
net contents and
establishment number
3.4.1 Regulatory Compliance Rates for Non-Refillable Containers
The regulatory components and compliance rates affecting non-refillable containers are
discussed below. The regulatory components affect three different sets of non-refillable
containers; all non-exempt products (Section 3.4.1.1), all non-exempt products meeting the scope
criteria (Section 3.4.1.2), and all products (Section 3.4.1.3). Table 3.12 summarizes the
container rule regulation compliance rates for non-refillable containers.
3.4.1.1 All Non-Exempt Products
All non-exempt products sold or distributed in non-refillable containers must comply with the
basic DOT packaging requirements in 49 CFR 173.24. It is assumed that all containers comply
with these requirements, which establish minimum standards for container integrity,
compatibility, and filling limits.
Page 44
Table 3.12. Regulatory Compliance Rates for Non-Refillable Containers a
DOT
DOT
Packaging Packaging
Standards Standards –
nonhazardous
Other
materials b hazardous
Labeling
administrative
Standards for container dispensing
(§165.60materials c
requirements
requirements
64)
(§165.60-64) Closure Standards d, e (§165.66)
capability f, g, h (§165.68)
(recordkeeping)
(Sec.156)
Small-Small Establishments
Agriculture
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
100.0%
95.0%
90.0%
I/C/G
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Home & Garden 100.0%
100.0%
100.0% 80.5%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Medium-Small Establishments
Agriculture
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
100.0%
95.0%
90.0%
I/C/G
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Home & Garden 100.0%
100.0%
100.0% 80.5%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Large-Small Establishments
Agriculture
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
100.0%
95.0%
90.0%
I/C/G
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Home & Garden 100.0%
100.0%
100.0% 80.5%
50.0%
0.0%
0.0%
N/A
N/A
N/A
Large Establishments
Agriculture
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
100.0%
95.0%
90.0%
100.0%
100.0%
100.0% 81.5%
35.0%
50.0%
0.0%
0.0%
I/C/G
N/A
N/A
N/A
100.0%
100.0% 80.5%
50.0%
0.0%
0.0%
Home & Garden 100.0%
N/A
N/A
N/A
a
In many cases, a regulation is not applicable to particular types of containers in a particular market sector. For example, the closure standards for non-refillables
are applicable only to containers that hold at least 1 gallon and that hold liquid products in the agricultural market sector.
b
Under the container rule, both containers for hazardous materials and non-hazardous materials must comply with the DOT standards for containers for hazardous
materials. The costs of complying with the DOT standards for containers holding hazardous materials are therefore attributed to the DOT standards and not the
container rule.
c
For non-hazardous materials, we assume that DOT-compliant containers can be purchased on the market at prices comparable to non-compliant containers. We
also assume that within the compliance period, regulated entities will exhaust their inventory of non-compliant containers and replace them with compliant
containers at no extra cost. This assumption was based on inputs from container manufactures that indicated that only DOT-compliant containers are sold.
Accordingly, we assume that all non-compliant containers will be out of use by the time the rule goes into effect.
d
The closure standards are not applicable to I/C/G and H&G establishments. They are also not applicable to liquid containers less than 1 gallon in capacity, watersoluble packets, bag in boxes, and aerosol cans. They are also not applicable to dry product containers.
Page 45
e
Table 3.12 (Continued). Regulatory Compliance Rates for Non-Refillable Containers a
The first percentage represents the compliance rate for liquid containers 30 to 55 gallons. The second percentage represents the compliance rate for liquid
containers of 5 gallons, and liquid containers in the “other sizes” category. The third percentage represents the compliance rate for liquid containers 1 to <5
gallons.
f
The standards for container dispensing capability are not applicable to liquid containers 30 to 55 gallons, water soluble packets, bag in boxes, and aerosol cans.
They are also not applicable to dry product containers.
g
For agricultural and I/C/G establishments: The first percentage represents the compliance rate for liquid containers of 5 gallons. The second percentage
represents the compliance rate for liquid containers 1 to less than 5 gallons. The third percentage represents the compliance rate for liquid containers less than 1
gallon. The fourth percentage represents the compliance rate for liquid containers in the “other sizes” category.
h
For H&G establishments: The first percentage represents the compliance rate for liquid containers of 5 gallons. The second percentage represents the
compliance rate for liquid containers less than 5 gallons. The third percentage represents the compliance rate for liquid containers in the “other sizes” category.
Page 46
3.4.1.2 All Non-Exempt Products Meeting Scope Criteria
Non-exempt products are subject to all of the following non-refillable container regulations if the
product is classified as Toxicity Category I, Toxicity Category II, or restricted use.
Department of Transportation (DOT) Standards
Products sold or distributed in non-refillable containers must meet a subset of the DOT
Hazardous Materials Regulations (HMR), which establish standards for container design,
construction, and marking. Pesticide products that are not DOT hazardous materials must
comply with some of the general packaging requirements and the non-bulk and bulk packaging
standards for Packing Group III (the least stringent requirements). Pesticide products that are
DOT hazardous materials must comply with all of DOT’s regulations. For purposes of the
container regulations, EPA is specifically adopting the same kind of DOT requirements as for the
non-DOT hazardous materials, but for the product’s packing group.
EPA estimates that approximately 35 percent of pesticide products in use fall under the DOT
definition of a hazardous material and therefore meet the DOT requirements (EPA, 1999). We
assume that 35 percent of all pesticide containers in the three major markets and for each size
category are DOT hazardous materials. Therefore, these containers are already in compliance
with the container regulations.
It is assumed that the remaining 65 percent products sold or distributed in non-refillable
containers contain DOT non-hazardous material. It is assumed that these containers are also
already in compliance with the Packing Group III requirements. This assumption is consistent
with the proposed EPA container rule RIA which assumed that most of the containers in use
were DOT-compliant and that nearly all containers in production were also DOT-compliant.
This assumption was also validated for the final EPA container rule EA through additional
discussions with pesticide registrants, refillers and industry experts. Compliance with the DOTrelated standards was high for the proposed rule, and, given the increasing availability and use of
DOT-compliant containers, it is assumed in the final rule that those containers that were out of
compliance have either been replaced or will be replaced with compliant containers within the
compliance period.
Container Closures for Liquid Pesticide Products
To further allow for the safe use of pesticide containers, the container rule requires that rigid
non-refillable containers that have a capacity of at least 3.0 liters (0.79 gallons) and are used to
hold liquid agricultural pesticides have one of four standardized closures. Container closure
requirements are not required for rigid non-refillables in the I/C/G or H&G markets. The
container closure compliance rate for affected agricultural non-refillables is based upon an
assumption that EPA made for the proposed container rule RIA (EPA, 1993):
•
•
•
100.0 percent compliance for “30 to 55 gallon” containers;
95.0 percent compliance for “5 gallon” and “other” size containers; and
90.0 percent compliance for “1 to <5 gallon” containers.
Page 47
Container Dispensing Capability
The container regulations state that non-refillable containers of 20 liters (5.3 gallons) or smaller
for liquid products must allow the contents to be poured without glugging and with minimal
dripping. The major factors that reportedly affect pesticide dispensing are the design of the
container opening, and the design and placement of the container handle. The container
dispensing capability compliance rate for affected non-refillables is based upon assumptions that
EPA made for the proposed container rule RIA.18 Since there are no new data with which to
update these assumptions, the assumptions are left in place. Therefore, the following compliance
rates are assumed for all of the affected liquid non-refillables:
Agricultural Market
• 100.0 percent compliance for “5 gallon” containers;
• 81.5 percent compliance for “1 to <5 gallons” containers;
• 35.0 percent compliance for “<1 gallon” containers; and
• 50.0 percent compliance for “other” size containers.
I/C/G Market
• 100.0 percent compliance for “5 gallon” containers;
• 81.5 percent compliance for “1 to <5 gallons” containers;
• 35.0 percent compliance for “<1 gallon” containers; and
• 50.0 percent compliance for “other” size containers.
H&G Market
• 100.0 percent compliance for “5 gallon” containers;
• 80.5 percent compliance for “1 to <5 gallons” and “< 1 gallon” size containers; and
• 50.0 percent compliance for “other” containers.
Residue Removal Standards
The container regulations specify a residue removal standard for rigid containers for flowable
concentrate products that meets the Toxic Category I or II criteria and/or are classified for
restricted use. The regulations specify a test protocol that requires every registrant to test three
containers from each rigid container/dilutable formulation combination to determine that the
containers are capable of attaining at least 99.99 percent removal of each active ingredient in the
fourth rinsate after a triple rinse.
It is assumed that the average establishment, regardless of size or market sector, uses three rigid
container types per formulation, based on an assumption EPA made in its Container Rule RIA.
The residue removal standards, however, are applicable to only flowable concentrate products.
The representative number of existing and new formulations is assumed to vary by registrant
size. It is assumed that there are 0.25 existing and new formulations for the large registrants, 0.20
existing and formulations for the large-small registrants, 0.10 existing and new formulations for
18
Refer to the Proposed Container Rule RIA (EPA, 1993), Table G-7, Non-refillable rigid containers: Compliance
with container dispensing requirements for all three regulatory options, except as noted otherwise, “percent of
plastic containers in market that meet requirement” and the table footnotes for information to substantiate the
assumptions used in this analysis.
Page 48
the medium-small registrants and 0.05 existing and new formulations for the small-small
registrants that will be subject to the residue removal standards (see Appendix A).
Not all existing container/formulations will be tested because test data conforming to the residue
removal protocol on a different non-refillable container/formulation may be used to demonstrate
that a non-refillable container meets the residue removal standard (“me-too” scenario). In the
proposed container rule RIA, EPA assumed that a lower range of 50 percent of all the container
formulation combinations will be tested and an upper range of 100 percent of all such
combinations will be tested. In the final economic analysis, the midpoint of this range, 75
percent, is used since the extent to which “me-toos” will apply is not known.
It is also assumed that a certain number of container/formulation combinations will fail the initial
residue removal test, requiring a second test using a container carefully selected from the open
market and expected to rinse more readily. Based on a study conducted for EPA, EPA assumed
in the proposed container rule RIA that 13 percent of small, medium, and large agricultural
containers and 3 percent of small and medium industrial/institutional/household containers
would not pass a triple-rinse test where 99.999 percent (“five-9s”) of a given formulation would
be removed after rinsing (EPA, 1993 and 1992b). The 99.99 percent (“four-9s”) standard in the
final rule is expected to have a much lower initial failure rate. Testing data summarized in the
final rule preamble show that one out of the 79 container/formulation combinations tested did not
reach the four-9s level. However, since the residue removal standards apply to only flowable
concentrate products, in the final economic analysis, a higher (30 percent) failure rate is
assumed. This is based on the failure rate of flowable concentrate container/formulation
combinations in the study of 79 container/formulation combinations tested (see Appendix A).
For all other container/formulation combinations, the final economic analysis assumes a 2
percent failure rate for all containers (all markets and all sizes of facilities).
Recordkeeping
For each pesticide product that is distributed or sold in non-refillable containers that meet the
scope criteria, pesticide registrants must maintain certain records to show compliance with the
non-refillable container standards. It is assumed that none of the pesticide registrants are
currently maintaining these records.
3.4.1.3 All Products
Labeling
The new labeling standards apply to all pesticide products. Therefore, the labeling compliance
rates are applicable to all pesticide registrants selling or distributing pesticide products in nonrefillable containers. The pesticide container regulations modify the label requirements in 40
CFR Part 156. The new standards require statements that:
•
•
•
Identify a container as non-refillable;
Prohibit the reuse or refilling of a non-refillable container;
Provide a recycling statement for non-refillable containers;
Page 49
•
•
Provide a lot number or other identification code on non-refillable containers; and
Provide residue removal instructions on some containers.19
All of these statements are to be grouped and appear under the heading, “Storage and Disposal.”
It is assumed that no non-refillable containers are labeled with all of the required statements at
this time.
3.4.2 Regulatory Compliance Rates for Refillable Containers
Each of the regulatory components and compliance rates affecting refillable containers is
discussed below. The regulatory components affect all non-exempt products sold or distributed
in refillable containers, except for labeling requirements, which affect all refillable containers.
Antimicrobial pesticides used in swimming pools are subject to a reduced set of these
requirements. The H&G market does not include refillable containers and is not affected by the
refillable container regulations.
DOT Standards
All non-exempt products sold or distributed in refillable containers must meet a subset of the
DOT Hazardous Materials Regulations (HMR), which establish standards for container design,
construction, and marking. Pesticide products that are not DOT hazardous materials must
comply with some of the general packaging requirements and the non-bulk and bulk packaging
standards for Packing Group III (the least stringent requirements). Pesticide products that are
DOT hazardous materials must comply with all of DOT’s regulations. For the purpose of the
container regulations, EPA is specifically adopting the same kinds of DOT requirements as for
the non-DOT hazard materials, but for the product’s packing group.
EPA estimates that approximately 35 percent of non-exempt pesticide products in use meet the
DOT definition of a hazardous material and are therefore in compliance with the DOT
requirements (EPA, 1999b). It is assumed that 35 percent of all pesticide containers in the three
major markets and for each size category are DOT hazardous materials.
The remaining 65 percent of non-exempt products sold or distributed in refillable containers are
not DOT hazardous materials. However, it is assumed that containers used for the DOT nonhazardous materials are in compliance with the Packing Group III requirements. This
assumption is consistent with the proposed EPA container rule RIA which assumed that most of
the containers in use were DOT-compliant and that nearly all containers in production were also
DOT-compliant. This assumption was also validated for the final EPA container rule EA
through additional discussions with pesticide registrants, refillers and industry experts.
Compliance with the DOT-related standards was high for the proposed rule, and, given the
increasing availability and use of DOT-compliant containers, the final rule assumed that those
containers that were out of compliance have either been replaced or will be replaced with
compliant containers within the compliance period.
19
Residue removal instructions are required on the labels of all refillable containers and on the labels of rigid nonrefillable containers holding dilutable products that are not for residential use.
Page 50
Standards for Container Markings
The container regulations require that non-exempt pesticide products that are sold or distributed
in refillable containers be durably marked with a serial number or other identifying code (using
techniques including stamping, embossing, burning, or printing). The information must be
visibly located on the outside part of the container. We assume that none of the pesticide
registrants are durably marking refillable containers with a serial number at this time.
Standards for Openings
The container regulations limit access to the interior of liquid minibulk containers by requiring
that each opening of a liquid minibulk container other than a vent have a one-way valve, a
tamper-evident device, or both. EPA believes that one-way valves and tamper-evident devices
will give repackagers reasonable assurance of the previous contents of the containers. Most
agricultural minibulks and small volume returnable containers supplied by or purchased from
registrants are equipped with either a one-way valve or a tamper-evident device (EPA, 1992b)
and are therefore expected to be in compliance in the baseline. Agricultural minibulks obtained
on the open market, rather than from registrants, usually lack tamper-evident devices or one-way
valves, so refillers must add them (or something similar). The standards for openings are not
applicable to bulk tanks.
The standards for the openings compliance rate for affected refillables is based on assumptions
that EPA made for the proposed container rule RIA (EPA, 1993)20:
•
•
65.0 percent compliance for minibulk containers in the agricultural market; and
10.0 percent compliance for minibulk containers in the I/C/G market (assumes that tote bins
are minibulks, but small volume returnables in the I/C/G market are not minibulks).
Bulk Container Standards
The container regulations include a general integrity standard for all bulk containers and, for
liquid bulk containers, require vents and lockable valves and prohibit external sight gauges. The
bulk container standards compliance rate is based upon assumptions that EPA made for the
proposed container rule RIA (EPA, 1993):
•
•
•
•
100.0 percent compliance for dry bulk containers;
75.0 percent compliance for liquid plastic bulk containers in the agricultural market;
20.0 percent compliance for liquid steel bulk containers in the agricultural market; and
5.0 percent compliance for I/C/G liquid bulk containers.
Labeling
The new labeling standards apply to all pesticide products. Therefore, the labeling compliance
rates are applicable to registrants selling or distributing pesticide products in refillable
containers. The pesticide container regulations modify the labeling requirements in 40 CFR Part
156. The new standards for refillables require statements that:
20
Refer to the Proposed Container Rule RIA (EPA, 1993) Tables VII-8 and VII-9 and the table footnotes for
information to substantiate the assumptions used in this analysis.
Page 51
•
•
Prohibit users of refillable containers from refilling such containers with substances other
than pesticides; and
Provide residue removal instructions.
All of these statements are to be grouped and appear under the heading, “Storage and Disposal.”
It is assumed that none of the refillable containers are labeled with all of the container rule’s
required statements at this time.
Other Administrative Requirements
For each non-exempt pesticide product that is distributed or sold in refillable containers,
pesticide registrants must prepare and keep records of the repackaging-related documents. It is
assumed that none of the pesticide registrants are currently keeping these records.
The regulatory compliance rates for refillable containers are summarized in Table 3.13.21 The
compliance rates affect pesticide registrants selling or distributing refillable containers
containing non-exempt pesticide products. It is assumed that the container standards for
refillables in the swimming pool industry are unaffected by the container regulations because
they are either partially exempt from or already in compliance with the applicable standards
(EPA, 2002c). This assumption is based on comments received from pool supply companies,
industry associations, and an antimicrobial manufacturer, who pointed out many positive aspects
of the refillable containers they currently use, including: they are durable and appropriately
sized; they meet applicable DOT standards; there is a deposit system that leads to nearly
100 percent return of the containers; the company inspects and, if necessary, reconditions the
containers before refilling them; an applicator can tell if the container has been tampered with
when removing the cap; and their one-gallon containers are of the “no-glug” design. It is
assumed that swimming pool chemicals are not in compliance with the new labeling
requirements in 40 CFR Part 156.
21
We used the compliance rates presented in this table to calculate the total number of containers not in compliance
by regulation, which we then multiplied by the unit cost of regulation to develop total cost.
Page 52
Table 3.13. Regulatory Compliance Rates for Refillable Containers
DOT Packaging DOT Packaging
Standards –
Standards
non-hazardous
hazardous
materials b
materials a
(§165.110-114) (§165.110-114)
Small-Small Establishments
Standards
for
container
marking c
(§165.116)
Standards for
openings (for
liquid
minibulks
only)d, e
(§165.118)
Labeling
Bulk container standards e, f requirements
(§165.120)
(§156)
Agricultural
100.0%
I/C/G
100.0%
Swimming Pool
100.0%
Supply Companies
Home & Garden
N/A
Medium-Small Establishments
100.0%
100.0%
0.0%
0.0%
65.0%
10.0%
100.0%
100.0%
100.0%
100.0%
100.0%
N/A
N/A
N/A
N/A
100.0%
Agricultural
100.0%
I/C/G
100.0%
Swimming Pool
100.0%
Supply Companies
Home & Garden
N/A
Large-Small Establishments
100.0%
100.0%
0.0%
0.0%
65.0%
10.0%
100.0%
100.0%
100.0%
100.0%
100.0%
N/A
N/A
N/A
N/A
100.0%
Agricultural
I/C/G
Swimming Pool
Supply Companies
Home & Garden
100.0%
100.0%
100.0%
100.0%
0.0%
0.0%
65.0%
10.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
N/A
N/A
N/A
N/A
N/A
100.0%
Agricultural
100.0%
100.0%
0.0%
65.0%
100.0%
I/C/G
100.0%
100.0%
0.0%
10.0%
100.0%
Swimming Pool
Supply Companies
100.0%
100.0%
100.0%
100.0%
N/A
75.0% 20.0%
5.0%
N/A
N/A
N/A
75.0% 20.0%
5.0%
N/A
N/A
N/A
75.0% 20.0%
5.0%
N/A
N/A
N/A
Other
administrative
requirements –
refilling
documents
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
N/A
N/A
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
N/A
N/A
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
N/A
N/A
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
Large Establishments
75.0%
20.0%
5.0%
N/A
N/A
Home & Garden
N/A
N/A
N/A
N/A
100.0%
N/A
N/A
N/A
a
Under the container regulations, both containers for hazardous and non-hazardous materials must comply with the DOT standards for containers for
hazardous materials. The costs of complying with the DOT standards for containers holding hazardous materials are therefore attributed to the DOT standards
and not to the container regulations.
Page 53
b
Table 3.13 (Continued). Regulatory Compliance Rates for Refillable Containers
For non-hazardous materials, we assume that DOT-compliant containers can be purchased on the market at prices comparable to non-compliant containers.
We also assume that within the compliance period, regulated entities will exhaust their inventory of non-compliant containers and replace them with compliant
containers at no extra cost.
c
The standards for container markings are not applicable to I/C/G plastic containers from 5 to 25 gallons and to I/C/G liquid containers under the “other sizes”
category.
d
The standards for openings (for liquid minibulks only) are not applicable to retail bulk tanks, and to dry product containers. These standards are also not
applicable to I/C/G liquid containers under the “other sizes” category.
e
The bulk container standards are only applicable to retail bulk tanks.
f
For bulk containers in the all markets, the first percentage represents the compliance rate for dry bulk containers. For the agricultural market, the second
percentage refers to liquid plastic bulk containers and the third percentage refers to liquid steel bulk containers. For the I/C/G market the percentage refers to
all liquid bulk containers.
Page 54
3.4.3 Regulatory Compliance Rates for Refilling Activities
The container regulations establish procedural and handling standards to ensure that containers
are refilled legally and safely. Registrants have certain responsibilities to develop information,
and, if a different company (such as a retailer) repackages their product into refillable containers,
to ensure that certain conditions are met. The person who is actually doing the refilling—
regardless of whether it is the registrant or another company—must obtain the registrant’s
information; comply with certain conditions; and clean, inspect, and ensure proper labeling of
the refillable containers.
It is assumed that the refilling requirements for 90 percent of the total number of agricultural
refillables under the scope of the container rule are attributed to agricultural pesticide refillers
and the remaining 10 percent are attributed to pesticide registrants (Paulson, 2002).22 All
refilling requirements in the I/C/G market are attributed to pesticide registrants because there is
no readily available information to differentiate an industry sector that repackages pesticide
products in the I/C/G market that is also not a registrant for products in that sector. All refilling
requirements in the swimming pool industry are attributed to registrants and swimming pool
supply companies.
The standards for establishments that repackage pesticide products into refillable containers
(refillers) require that these entities inspect, clean, and keep certain records about the refillable
containers that they refill (§165.198–§165.218). Using professional judgment based on
consultations with pesticide registrants, refillers, and industry experts, we estimated that 60
percent of establishments inspect refillables before refilling, 92 percent properly clean the
container before refilling, and none of the establishments currently implements recordkeeping
that meets the standards.
Based on comments from pool supply companies, industry associations, and an antimicrobial
manufacturer, EPA has determined that swimming pool supply companies in general inspect
containers before refilling (EPA, 2002c). For this analysis, we assumed that 95 percent of
refillable containers in the swimming pool industry are properly inspected prior to refill. EPA
has also determined that refillables in the swimming pool industry will probably not have to be
cleaned prior to refilling because specified conditions (§165.170) will be met and certain
recordkeeping requirements do not apply (§165.178(b)) (EPA, 2002c). We assumed that all of
the refillables in the swimming pool industry are already in compliance with the applicable
cleaning and recordkeeping requirements.
Table 3.14 summarizes the container rule refilling requirements for entities handling pesticide
products that are repackaged into refillable containers for sale or distribution.
22
We used these assumptions to allocate the total number of containers in each size and type category to the
different markets (e.g., pesticide registrants, agricultural pesticide refillers). For example, out of the estimated
12,060 plastic bulk containers in the agricultural market, 10,854 (90 percent) are attributed to agricultural pesticide
refillers. We then used these numbers to develop estimates of number of containers in not in compliance and finally
to estimate the cost of compliance by registrants.
Page 55
Table 3.14. Repackaging/Refilling Requirements and Responsibility
Registrants Who Distribute
or Sell in Refillable
Containers
Registrants Who Distribute
or Sell to Outside Refillers
for Repackaging
Refillers Who Are
Not the Registrants of the Product
(Outside Refillers)
Ensure product integrity
Yes
Yes
Yes
Develop written documents describing: (1) how to clean
containers and (2) acceptable containers
Yes
Yes
No
Comply with conditions to allow an outside refiller to
repackage your product (e.g., provide contract or
authorization) a
No
Yes
No
Comply with conditions to allow you to repackage a
registrant’s product (e.g., obtain contract or authorization) a
No
No
Yes
Have documents available at refilling establishment b
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Yes
No
Yes
Identify product previously in container to determine the
appropriate cleaning procedure b
Yes
No
Yes
Clean container b,c
Yes
No
Yes
Visually inspect container b,c
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
5 years
5 years
5 years
Requirement
Be a registered producing establishment
b
Repackage product only into acceptable container
b
Repackage up to rated capacity of container b
No limits on size of container
Label container
Recordkeeping
b
c
Compliance period
b
a
The conditions for a registrant to allow a refiller that is not part of the registrant’s company to repackage a product include (a) the repackaging results in no change
in the pesticide formulation; (b) the refiller is a registered producing establishment; (c) the registrant and refiller enter into a written contract for the refiller to
repackage the pesticide product and to use the product’s label; (d) the product is repackaged only into refillable containers that comply with the regulations; and
(e) there are no changes to the pesticide label (other than adding the appropriate net contents and EPA establishment number).
b
The repackaging regulations do not specifically apply these standards to registrants who distribute or sell to refillers that are not part of their company for
repackaging. In this case, the registrant is not actually repackaging the product into refillable containers, which is the activity that these requirements are intended to
address. The table therefore indicates “no” for these registrants. However, some of these requirements apply because of other regulations. For example, these
registrants are required to be registered producing establishments by 40 CFR Part 167. In addition, a registrant may also repackage product directly into refillable
containers as described in the previous column, and those requirements would thus apply.
c
Antimicrobial products that are used only in swimming pools (and closely related sites such as hot tubs, spas, or whirlpools) are exempt from the portions of the
cleaning and inspecting requirements that relate to serial numbers and one-way valves/tamper-evident devices and from some of the recordkeeping.
Page 56
In summary, this chapter presented the level of compliance of pesticide containers with the final
container standards. We calculated the number of pesticide containers affected by the scope
criteria for each non-refillable and refillable container size category for all the market sectorsAgriculture, I/CG and H&G. We also described the regulatory compliance baseline that presents
the percentage of containers expected to be in compliance with the requirements of the container
rule. This provides an estimate of the number of containers not in compliance, which we use in
the cost analysis presented in the next chapter (Chapter 4).
Page 57
4.0 Pesticide Container Standards Cost Analysis
4.1 Introduction
This chapter describes the methods and the results of the analysis of the costs of the container
regulations. Section 4.2 defines the basic framework of the analysis: the categories of regulated
entities considered, the market sectors examined, the container types included, the specific
regulations covered, and the broad assumptions that underlie the analysis.23 Section 4.3
describes those characteristics of the regulated entities that are inputs to the cost analysis: the
number of regulated entities and, for each category of regulated entity, the percentage of total
annual revenue in each size class. Section 4.4 describes the method for estimating the costs
incurred by pesticide registrants of complying with the container-related regulations. Section 4.5
describes the method for estimating the costs incurred by pesticide refillers (a broad category that
includes several categories of regulated entities, described in Section 4.2 below) of complying
with the refilling-related regulations.
The estimates of total annualized compliance cost, both by regulated entity and by regulation, are
presented in Section 4.6. The total annualized costs of the pesticide container rule are calculated
across all regulations contained within it, for:
•
•
•
•
•
•
•
The average regulated entity – in each combination of entity type, market sector, and
company size class;
All regulated entities – in each combination of entity type, market sector, and company size
class;
The average pesticide registrant with a “representative share” in each market sector;24
All pesticide registrants (across all market sectors) in each company size class;
All pesticide registrants across all market sectors and company size classes;
All regulated entities within each category complying with refilling-related regulations; and
All regulated entities.
These results are shown in Tables 4.17a and 4.17b in Section 4.6. Regulated entities in this
analysis are companies rather than individual facilities. In addition to costs per regulated entity,
costs are calculated by regulation, as shown in Tables 4.18a and 4.18b.
The impact of the container regulation on the average regulated entity in each regulated entity
type is measured as the ratio of its annual compliance cost to its annual revenue. The results of
the impact analysis, for each combination of market sector and size class, are presented in
Section 4.7. The subcategories of the “small” size category are aggregated for the Small
Business Regulatory Enforcement Fairness Act (SBREFA) analysis of impact. Finally, in
23
Specific assumptions made at different points in the analysis are detailed in the appropriate sections.
The cost analysis estimates the compliance costs of an average pesticide registrant in each market sector, as well
as the compliance costs of an average pesticide registrant that works in all three market sectors. The average
pesticide registrant that works in all three market sectors is assumed to have the same distribution of containers
across market sectors as the distribution of pesticides (by volume) across market sectors. That is, if the distribution
of pesticide usage by volume is 40 percent, 30 percent and 30 percent in the agricultural, I/C/G, and H&G markets,
respectively, then the distribution of containers by an average pesticide registrant who for example has 100
containers will be 40, 30, and 30 for the three markets, respectively.
24
Page 58
Section 4.8 the results of two sensitivity analyses are presented—one that uses a set of “low-end”
input values (i.e., input values that will result in lower-cost estimates) and one that uses a set of
“high-end” input values (i.e., input values that will result in higher-cost estimates).
4.2 The Basic Framework of the Cost Analysis
There are two broad sets of regulations under the pesticide container rule. One set of regulations
pertains to pesticide containers themselves—how they must be constructed, marked, and labeled
to ensure safety. The regulated entities that must comply with these regulations are the pesticide
registrants. The other set of regulations concerns the refilling (or repackaging) of (refillable)
pesticide containers, specifying what must be done to ensure that the act of refilling a pesticide
container does not pose safety or health problems. The regulated entities (broadly termed
“pesticide refillers”) that must comply with this set of regulations are agricultural pesticide
refillers, swimming pool supply companies, and some pesticide registrants (in particular,
pesticide registrants in two of the three market sectors plus the swimming pool industry).
Descriptions of each of these categories of regulated entities can be found in Section 3.1 and
Appendix D.
To the extent possible, we estimated costs for regulated entities separately by the market sectors
in which they operate. The categorization of regulated entities by market sector is shown in
Table 4.1.
Table 4.1. Types of Regulated Entities by Market Sector
Agricultural
Sector
Industrial/
Commercial/
Government
(I/C/G) Sector
Swimming
Pool
Industry
Home & Garden
(H&G) Sector
(Households)
Pesticide Registrants
9
9
9
9
Agricultural Pesticide Refillers
9
Swimming Pool Supply Companies
9a
a
Swimming pool supply companies could be considered part of both the I/C/G and H&G markets. However, for the
purposes of this analysis, we considered swimming pool supply companies separately.
The types of containers covered under the container regulation are broadly categorized as nonrefillable and refillable containers. Because the set of regulations pertaining to the activity of
refilling obviously involves only refillable containers, only regulated entities that engage in
refilling must comply with them. A broad overview of the regulated entities and the sets of
regulations with which they must comply is provided in Table 4.2. A more detailed overview,
identifying the pesticide container standards with which the different regulated entities must
comply, is given in Table 4.3.25
25
See Chapter 2, Chapter 3, and Appendix G for a more detailed description of the final pesticide container
standards.
Page 59
Table 4.2. Overview of Regulated Entities and Types of Regulations with
Which They Must Comply
Regulation of Pesticide
Containers
(Non-Refillables and
Refillables)
Regulation of Refilling
(Refillables)
In the Agricultural Sector
9
9
In the I/C/G Sector
9
9
In the Home & Garden Sector
9
In the Swimming Pool Industry
9
Regulated Entity
Pesticide Registrants:
9
9
Agricultural Pesticide Refillers
a
9
Swimming Pool Supply Companies
a
Swimming pool supply companies are subject to a subset of the refilling requirements. Swimming pool supply
companies must maintain certain records, but not all. Swimming pool supply companies must meet certain refilling
requirements, but not all. Refillables are required to be inspected and cleaned (unless specified conditions in
§165.170 are met) but not do not need to be relabeled. Copies of the residue removal procedures for refilling and
description of acceptable containers must be on file (§165.218(a)), but a record of certain information recorded each
time a container is refilled (e.g., product, amount) is not required (§165.218(b)). Swimming pool supply companies
could be considered part of both the I/C/G and H&G markets. For the purposes of this analysis, however, we
considered swimming pool supply companies separately.
Page 60
Table 4.3. Intersection of the Pesticide Container Regulations and Regulated Entities
Pesticide Container Regulations
Pesticide Registrants
Agricultural
Pesticide Refillers
Swimming Pool
Supply Companies
9
9b
Non-Refillable Containers
Ensure that containers meet a subset of DOT packaging standards
9
Ensure that liquid product containers dispense properly and have standard closures
9
Develop residue removal procedures for dilutable pesticides in rigid containers
9
Refillable Containers
Ensure that containers meet a subset of DOT packaging standards
9
Mark containers with a serial number
9
Ensure that a one-way valve and/or tamper-evident device is in place for liquid
minibulks
9
Ensure that a vent, gauge, and shutoff valve are in place for liquid bulk containers
9
Meet repackaging conditions
9a
Develop cleaning procedures for repackaging
9a
Inspect, clean, and properly label containers
9a
9
9b
Maintain records
9a
9
9b
Labeling Standards
Ensure that labels include specified information
9
a
Refilling requirements affect pesticide registrants for 10 percent of the total refillable containers in the agricultural market sector and all of the containers in
the I/C/G market sector. Available data are insufficient to differentiate pesticide registrants that also repackage I/C/G market pesticide products from those that
do not. Therefore, pesticide registrants are held accountable.
b
Swimming pool supply companies must meet certain refilling requirements, but not all. Refillables are required to be inspected and cleaned (unless specified
conditions in §165.170 are met) but not do not need to be relabeled. Swimming pool supply companies must maintain certain records, but not all. Copies of
the residue removal procedures for refilling and description of acceptable containers must be on file (§165.218(a)), but a record of certain information recorded
each time a container is refilled (e.g., product, amount) is not required (§165.218(b)).
Page 61
Containers within the broad categories of non-refillable and refillable containers are further
subdivided by size and material type, as shown in Table 4.4.
Table 4.4. Types of Containers Considered in the Analysis
Containers for Liquid Products
Containers for Dry Products
Non-Refillables
30 - 55 gallons, plastic
56 - 100 lb. bags, paper/plastic
30 - 55 gallons, steel
45 - 55 lb. bags, plastic
5 gallons, plastic
45 - 55 lb. bags, paper
5 gallons, steel
11 - 44 lb. bags, plastic
1 - <5 gallons, plastic
11 - 44 lb. bags, paper
1 - <5 gallons, steel
1 - 10 lb. bags, plastic
< 1 gallon, plastic
1 - 10 lb. bags, paper
< 1 gallon, steel
2.5 gallon jugs
< 1 gallon, glass
1 qt. - < 2.5 gallon jugs
Water soluble packets – PVA packets
Water soluble packets – PVA packets
Water soluble packets – barrier packs
Water soluble packets – barrier packs
Bag in box
> 101 lb. bulk containers
Aerosol can
> 30 lb. fiber drums
< 30 lb. fiber drums
Other
Refillables
Bulk Tanks (> 500 gallons), plastic
Bulk (> 4,000 lbs.), paper/plastic
Bulk Tanks (> 500 gallons), steel
Large (2,501 - 4,000 lbs.), paper/plastic
Large Tanks (251 - 500 gallons), plastic
101 - 2,500 lbs., paper/plastic
Large Tanks (251 - 500 gallons), steel
Fiber drums
126 - 250 gallons, plastic
Other sizes
126 - 250 gallons, steel
61 - 125 gallons, plastic
61 - 125 gallons, steel
26 - 60 gallons, plastic
26 - 60 gallons, steel
5 - 25 gallons, plastic
5 - 25 gallons, steel
Other sizes
4.3 Characteristics of the Regulated Entities That Are Inputs to the Cost Analysis
Regulated entities are divided into two size classes: small and large. As discussed in Chapter 3,
for this analysis, the “small” category is further sub-divided into “small-small,” “medium-small,”
and “large-small.”26 We estimated costs for several of the cost categories listed above (e.g.,
26
This analysis considers an alternative definition to the Small Business Administration’s (SBA’s) definition of
small business for the industries potentially affected by the final pesticide container regulations. The analysis
Page 62
costs for the average regulated entity in each combination of entity type, market sector, and size
class) using the following two characteristics of regulated entities as inputs:
•
•
The number of entities in each combination of market sector and size class; and
The breakdown of total revenue by size class (i.e., the percentage of total revenue attributed
to large establishments and to small-small, medium-small, and large-small establishments).
We used the number of entities in a combination of market sector and company size class to
calculate the number of containers out of compliance with each regulation under the container
rule per average regulated entity in that combination of market sector and size class. For
example, there are estimated to be 26,703 1 to <5 gallon plastic non-refillable containers out of
compliance with the standards for container dispensing capability among “large-small” pesticide
registrants in the agricultural sector.27 There are 66 such pesticide registrants, so the average
number of containers out of compliance with that regulation per “large-small” registrant in the
agricultural sector is 402 (=26,703/66).28
We used the percentage of total revenue attributed to regulated entities in a given size class to
allocate the number of containers that fall within the scope of the container rule within each
market sector to the different size classes (see Section 4.4.3). For example, 0.8 percent of
revenue among pesticide registrants is associated with “large-small” establishments. Using this
as a proxy for the distribution of containers that fall under the scope of the rule, the analysis
assumed that 0.8 percent of all such containers were registered by “large-small” establishments
in each market sector.
Appendix D describes the data sources and procedures we used to characterize representative
regulated entities for each market sector and size category. In general, Dun & Bradstreet
financial data were matched to the representative list of companies for each regulated entity type,
and the companies were profiled based on the SBA definition of small and large businesses and
EPA’s alternative definitions of small businesses (see Appendix D).
disaggregates the SBA-defined small businesses into three categories: small-small, medium-small, and large-small.
EPA is concerned that using an overly broad definition of small business in the economic analysis of the container
regulations may result in significant economic impacts on smaller entities that will be camouflaged when combined
with information about potential impacts on facilities that meet the SBA size standard for small business but are not
typical of a small business in that industry sector.
27
We calculated the number of plastic non-refillable containers out of compliance for the container dispensing
capability among “large-small” pesticide registrants in the agricultural sector by multiplying the total number of
non-refillable containers affected by the container regulations (17,986,536, see Table 3.9) and multiplying it by the
percentage of containers among the “large-small” containers (0.8%), which was obtained from the distribution of
total revenues across the pesticide registrant company size categories. Out of the 144,339 (17,986,536*0.08)
containers, 81.5% are expected to be in compliance with the container dispensing standards (see Table 3.12) which
gives 26,703 containers not in compliance (144,339*0.185).
28
Discrepancy is due to rounding. The inputs to the calculation shown here (26,703 and 66) are rounded. The
output, 402, is based on the unrounded numbers.
Page 63
Table 4.5 presents the estimated numbers of regulated entities by market sector and size
category.29 The percentages of total revenue in each size class within a regulated entity type are
given in Table 4.6.30
Table 4.5. Estimated Numbers of Regulated Entities by Market Sector and Size Class
Size Classes
Market Sector
Small-Small
Medium-Small
Large-Small
Large
All Size Classes
Pesticide Registrants
Agricultural
399
198
66
58
722
I/C/G
299
148
50
44
541
Home & Garden
299
148
50
44
541
Total
997
495
166
146
1,804
Agricultural Pesticide Refillers
Agricultural
13,996
2,395
251
153
16,795
Total
2,395
251
153
16,795
117
14
17
322
13,996
Swimming Pool Supply Companies
Total
174
Table 4.6. Percentages of Total Revenue in Each Size Class
Regulated Entity Type
Pesticide registrants
Agricultural pesticide refillers
Swimming pool supply companies
Small-Small
0.2%
18.0%
0.2%
Size Classes
Medium-Small Large-Small
0.4%
25.8%
0.7%
0.8%
9.1%
0.2%
Large
98.6%
47.0%
98.9%
4.4 Estimating the Costs of Complying with the Final Regulations
This section describes the method of estimating the costs of complying with the set of containerrelated regulations incurred by the average pesticide registrant. For a given combination of
market sector and size class, the analysis proceeds through the following series of steps to a final
estimate of the cost to the average pesticide registrant in that market sector/size class per
container-related regulation:
•
•
•
Estimate the number of containers in the market sector;
Estimate the number of those containers that fall within the scope of the container rule;
Estimate the number of those containers that are associated with pesticide registrants in the
size class;
29
The number of regulated entities in each size category is distributed across the market sector based on the amount
of pesticide product used in each market sector (see Appendix D for details). The 2001 pesticide use estimates that
the agricultural, I/C/G, and H&G sectors used 40 percent, 30 percent, and 30 percent of pesticides, respectively.
Based on these percentages, the number of registrants in the large size category (146) that are in the agricultural
sector is calculated as 0.40*146 = 58.
30
The revenue ratio for each pesticide registrant size category is based on the per size category total revenue
compared to the revenue for the total universe of registrants based on the PPIS sample data set (see Appendix D for
details).
Page 64
•
•
•
•
For each regulation under the container rule, estimate the number of those containers that are
out of compliance with the regulation;
Estimate the number of containers out of compliance with each regulation per average
registrant in the market sector/size class;
Estimate the cost, in each year of a 20-year period, of bringing those containers into
compliance, and the present discounted value of that 20-year stream of costs, using a
3 percent discount rate and a 7 percent discount rate; and
Annualize this present discounted value, using a 3 percent interest rate and a 7 percent
interest rate.
The steps are described below in the order in which they were carried out in the analysis.
4.4.1 Estimate the Number of Pesticide Containers in Each Market Sector
The cost analysis begins by using the number of pesticide containers of each type within each
market sector, separately for non-refillable and refillable containers, as described in Chapter 3.
4.4.2 Estimate the Number of Pesticide Containers in Each Market Sector That Fall
Within the Scope of the Container Rule
As discussed in Chapter 3, not all containers fall within the scope of the full set of container
regulations.31 For the next step in the cost analysis, we estimate the number of containers, within
each combination of container type and market sector, that fall within the scope of the rule. The
process of estimating the number of containers that fall within the scope of the container rule in
each market sector is described in Chapter 3. The estimated numbers of containers (across all
container types) in each market sector, and the estimated numbers and percentages that fall
within the scope of the container rule, are presented, separately for non-refillables and refillables,
in Table 4.7.
31
The scope criteria apply the full set of non-refillable container regulations to non-exempt products that meet the
Toxicity Category I, Toxicity Category II, and/or restricted use criteria. The basic DOT packaging standards in 49
CFR 173.24 apply to all non-exempt products that are distributed/sold in non-refillable containers.
Page 65
Table 4.7. Number of Containers by Market Sector, and Number and Percentages that
Fall Within the Scope of the Container-Related Regulations Under the Container Rule
Agricultural
Sector
Non-Refillables
Number of containers c
Number of containers within the
scope of the container rule
Percentage of containers within
the scope of the container rule
Refillables
Total number of containers
Number of containers within the
scope of the container rule b
I/C/G Sector
Home &
Garden
Sector
Swimming
Pool
Industry a
Total
114,336,894
90,360,000
400,000,000
0
604,696,894
73,770,164
47,930,965
227,274,040
0
348,975,169
64.5%
53.0%
56.8%
0
57.7%
1,263,600
46,500
0
1,217,000
2,527,100
1,263,600
37,458
0
1,217,000
2,518,058
Percentage of containers within
100.0%
80.6%
--100.0%
99.6%
the scope of the container rule
a
The swimming pool industry is part of the I/C/G and H&G sectors, but is analyzed separately for the refillable
container analysis. Most refillables are in compliance with the regulations, except the labeling and other
administrative requirements, because these containers store DOT hazardous materials.
b
Swimming pool refillers are subject to a subset of the refilling requirements. Swimming pool refillers must meet
certain refilling requirements, but not all. See Table 3.1 footnote for more detail.
c
See Tables 3.4 and 3.9 for non-refillables and Tables 3.5 and 3.10 for refillables.
4.4.3 Allocate Containers That Fall Within the Scope of the Rule in Each Market Sector
to Each of the Size Classes
To allocate those containers that fall within the scope of the container rule to pesticide registrants
within each of the different size classes, it is assumed that the percentage of total revenue
(among all pesticide registrants) associated with establishments in a given size class is a
reasonable proxy for the percentage of containers registered by registrants in that size class. This
allocation of containers to size classes by percentage revenue was applied to each of the market
sectors, and within each market sector, to each container type. For example, of the 73,770,164
non-refillable containers in the agricultural sector that fall within the scope of the container rule
(see Table 4.7), 0.8 percent (see Table 4.6), or 591,993, are assumed to be registered by largesmall pesticide registrants.32 Of the 73,770,164 non-refillable containers in the agricultural
sector that fall with the scope of the container rule, 199,434 are 30–55 gallon plastic containers
for holding liquid products. Of those, it is assumed that 0.8 percent, or 1,600 containers, are
registered by large-small pesticide registrants (see Table K-1).33 By the end of this step in the
analysis, all containers that fall within the scope of the container rule are allocated to pesticide
registrants in each combination of market sector and size class.
32
Percentages given here are rounded. The numbers are based on the unrounded percentages, and are therefore
slightly different from what would be obtained if the rounded percentages had been used.
33
Table K-1 contains estimates of the number of containers by container type for each container and facility size
category.
Page 66
4.4.4 For Each Regulation Under the Pesticide Container Rule, Estimate the Number of
Containers That Fall Within the Scope of the Rule That Are Out of Compliance
with That Regulation
Many containers are already in compliance with one or more of the regulations under the
pesticide container rule and therefore do not need to be brought into compliance. For this step of
the cost analysis, the compliance rates estimated for each type of container in each combination
of market sector and size class are used. The estimation of compliance rates is described in
Chapter 3.
The number of containers of a given type within a given combination of market sector and size
class that are out of compliance is just the number of containers of that type in that combination
of market sector and size class that fall within the scope of the rule multiplied by one minus the
corresponding compliance rate. For example, it is estimated that 35 percent of non-refillable
plastic containers for holding liquid products smaller than one gallon registered by large-small
establishments in the agricultural sector are in compliance with the dispensing capability
requirement (§165.68 of the rule). It is estimated that 5,214 containers of that type in large-small
establishments in the agricultural sector fall within the scope of the rule. The estimated number
of containers of that type in that combination of market sector and size class that are out of
compliance with the dispensing capability requirement is (1 - 0.35)*5,214 = 3,389.
The rates of compliance with the final pesticide container regulations by container type are
described in Chapter 3. Tables 4.8a (for non-refillables) and 4.8b (for refillables) give the
numbers of containers (over all types) estimated to be out of compliance with each of the
container-related regulations under the pesticide container rule.
Page 67
Table 4.8a. Estimated Numbers of Non-Refillable Containers Out of Compliance with the Container-Related Regulations a
DOT Packaging
Standards –
hazardous
materials b
(§165.60-64)
Small-Small Establishments
Agriculture
I/C/G
Home & Garden
Medium-Small Establishments
Agriculture
I/C/G
Home & Garden
Large-Small Establishments
Agriculture
I/C/G
Home & Garden
Large Establishments
Agriculture
I/C/G
Home & Garden
DOT Packaging
Standards – nonhazardous
materials c
(§165.60-64)
Closure
Standards
(§165.66)
Standards for
container
dispensing
capability
(§165.68)
Labeling
requirements
Other administrative
requirements –
recordkeeping
0
0
0
0
0
0
3,418
0
0
7,115
17,904
33,636
139,972
90,944
431,230
139,972
90,944
431,230
0
0
0
0
0
0
7,975
0
0
16,600
41,771
78,476
326,568
212,183
1,006,105
326,568
212,183
1,006,105
0
0
0
0
0
0
14,456
0
0
30,092
75,722
142,259
591,993
384,638
1,823,837
591,993
384,638
1,823,837
0
0
0
0
0
0
1,775,609
0
0
3,696,028
9,300,532
17,473,004
72,711,631
47,243,200
224,012,868
72,711,631
47,243,200
224,012,868
Total Number of Containers
Agriculture
0
0
1,801,458
3,749,834
73,770,164
73,770,164
0
0
0
9,435,929
47,930,965
47,930,965
I/C/G
0
0
0
17,727,375
227,274,040
227,274,040
Home & Garden
0
0
1,801,458
30,913,138
348,975,169
348,975,169
Total Containers
a
In many cases, a regulation is not applicable to particular types of containers in a particular market sector. For example, the closure standards for non-refillables
are applicable only to containers that hold at least 1 gallon and that hold liquid products in the agriculture sector. In all cases in which a regulation was not
applicable, a compliance rate of 100% was used, so that there would be 0% “out of compliance.”
b
Under the container rule, both containers for hazardous materials and non-hazardous materials must comply with the DOT standards for containers for
hazardous materials. The costs of complying with the DOT standards for containers holding hazardous materials are therefore attributed to the DOT standards
and not the container rule.
c
For non-hazardous materials, we assume that DOT-compliant containers can be purchased on the market at prices comparable to non-compliant containers. We
also assume that within the compliance period, regulated entities will exhaust their inventory of non-compliant containers and replace them with compliant
containers at no extra cost.
Page 68
Table 4.8b. Estimated Numbers of Refillable Containers Out of Compliance with the Container-Related Regulations a
Standards for
DOT Packaging DOT Packaging
Standards –
Standards for openings (for
Standards –
non-hazardous
container
liquid
hazardous
materials c
minibulks only)
materials b
marking
(§165.110-114) (§165.110-114)
(§165.116)
(§165.118)
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Bulk
container
standards
(§165.120)
Labeling
requirements
Other
administrative
requirements –
refilling
documents d
0
0
0
0
0
0
2,398
72
0
367
396
0
8
15
0
2,398
2,380
0
2,398
2,380
0
0
0
0
0
0
0
5,594
168
0
856
924
0
18
35
0
5,594
5,553
0
5,594
5,553
0
0
0
0
0
0
0
10,140
304
0
1,551
1,676
0
33
63
0
10,140
10,067
0
10,140
10,067
0
0
0
0
0
0
0
1,245,469
37,374
0
190,497
205,796
0
4,028
7,720
0
1,245,469
1,236,458
0
1,245,469
1,236,458
0
Total Number of Containers
Agriculture
0
0
1,263,600
193,270
4,087
1,263,600
1,263,600
0
0
37,919
208,792
7,832
1,254,458
1,254,458
I/C/G
0
0
0
0
0
0
0
Home & Garden
0
0
1,301,519
402,062
11,919
2,518,058
2,518,058
Total Containers
a
In many cases, a regulation is not applicable to particular types of containers in a particular market sector. In all cases in which a regulation was not applicable, a
compliance rate of 100% was used, so that there would be 0% “out of compliance.”
b
Under the container rule, both containers for hazardous materials and non-hazardous materials must comply with the DOT standards for containers for
hazardous materials. The costs of complying with the DOT standards for containers holding hazardous materials are therefore attributed to the DOT standards
and not the container rule.
c
For non-hazardous materials, we assume that DOT-compliant containers can be purchased on the market at prices comparable to non-compliant containers. We
also assume that within the compliance period, regulated entities will exhaust their inventory of non-compliant containers and replace them with compliant
containers at no extra cost.
d
Other administrative requirements relate to preparing and keeping records of the repackaging-related documents. The costs related to these requirements are
included here (rather than the repackaging regulation) because these costs are solely the registrant’s costs —not refillers’ costs.
Page 69
4.4.5 For Each Regulation Under the Container Rule, Estimate the Number of
Containers That Fall Within the Scope of the Rule That Are Out of Compliance
with That Regulation – for the Average Registrant in Each Combination of
Market Sector and Size Class
For each combination of container type, market sector, and size class, the number of containers
out of compliance with each container regulation is divided by the number of pesticide
registrants in that combination of market sector and size class (see Table 4.5). This yields an
estimate of the number of containers of each type that are out of compliance with each regulation
for an “average registrant” in each market sector-size class combination.34 For example, there
are an estimated 836,533 plastic 30–55 gallon non-refillable containers for liquid products
registered by large establishments in the I/C/G sector that are out of compliance with the labeling
requirements (see Table K-2).35 There are estimated to be 44 large establishments in the I/C/G
sector. It is therefore estimated that the number of plastic 30–55 gallon non-refillable containers
for liquid products that are out of compliance with the labeling requirements for the average
large pesticide registrant in the I/C/G sector is 836,533/44 = 19,099.36
4.4.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Containers into
Compliance
There are two dimensions to the cost calculations. First, compliance costs may be fixed or
variable.37 (See Table A-1 of Appendix A for a description of the type of cost associated with
each container standard.) Fixed costs do not depend on the number of containers that must be
brought into compliance with the regulation, whereas variable costs do. Fixed costs include, for
example, the cost of a filing cabinet or the cost of initial testing of each combination of container
type and pesticide formulation. A fixed cost was estimated for each regulation, as described in
detail in Appendix A.
Total variable cost increases with each container brought into compliance. The marginal
variable cost curve was assumed to be horizontal; that is, there was assumed to be a constant unit
variable cost, so that the variable cost incurred by bringing N containers into compliance is N
times the variable cost of bringing one container into compliance. A unit variable cost was
estimated for each regulation, as described in detail in Appendix A.
The second dimension of the cost calculations is the time dimension. Some costs are incurred
only once (e.g., at the beginning of the period of time over which costs may be incurred),
whereas other costs are incurred in each year of the period. The distinction between fixed costs
and variable costs is not the same as the distinction between one-time costs and annual costs.
Some fixed costs may occur year after year, whereas some variable costs may occur only once, at
the beginning of the cost period. For example, the cost of testing combinations of non-refillable
34
An “average registrant” in a market sector-size class combination is assumed to have the same combination of
container types as the market sector-size class combination as a whole.
35
Table K-2 presents estimates of the number of containers by container type for each container and facility size
category.
36
Discrepancy is due to rounding. The inputs to the calculation shown here (836,533 and 44) are rounded. The
output, 19,099, is based on the unrounded numbers.
37
For some regulations there are only fixed costs (e.g., all container-related regulations for non-refillables have only
fixed costs); for some, there are only variable costs; and for some there are both (see Appendix A).
Page 70
containers and pesticide formulations is a fixed cost (it does not depend on the number of nonrefillable containers subject to the regulations), but it is assumed to be incurred in each year, as
new formulations are introduced. The cost of bringing liquid minibulk containers into
compliance with the standards for openings is a variable cost (it increases as the number of liquid
minibulk containers increases), but it occurs only once, at the beginning of the cost period.
Unless a pesticide registrant is able to obtain a waiver releasing it from the responsibility to
comply with a given container regulation, the annual cost of complying with the regulation is
found by:
•
•
•
Calculating the cost in each year of the 20-year period;
Calculating the presented discounted value of the resulting stream of costs; and
Annualizing this present discounted value.
Pesticide registrants will have 3 years in which to bring their non-refillable containers into
compliance with regulations under the rule. It is assumed that the compliance costs associated
with non-refillables will be incurred beginning at the end of the third year. Pesticide registrants
will have 5 years in which to bring their refillable containers into compliance with regulations
under the rule. It is assumed that the compliance costs associated with refillables will be
incurred beginning at the end of the fifth year. In calculating the present discounted value of the
costs of a regulation, all costs are discounted back to the beginning of the first year of the 20year period.
The costs incurred in a single year are the fixed costs (if any in that year) plus the variable costs
(if any in that year). If:
•
•
•
Fn denotes the fixed cost of complying with the regulation in the nth year (n=1, ..., 20);
UVCn denotes the unit variable cost of complying with the regulation in the nth year; and
N denotes the number of containers out of compliance with the regulation annually,38
then the cost of complying with the regulation in the nth year is:
Fn + UVCn*N.
Both fixed and unit variable costs, however, may differ for pesticide registrants in different
market sectors and/or different size classes, and the cost analysis attempted to capture those
differences whenever possible. For example, cost of testing to ensure compliance with the
residue removal standard depends on the number of formulations, which tends to vary with the
size of the establishment. The number of existing formulations for the average large
establishment, for example, is estimated to be 0.25, whereas the number of existing formulations
for the average small-small establishment is only 0.05 (see Appendix A, Table A.6). This results
in greater testing costs for the average large pesticide registrant than the average small-small one.
38
The number of containers to which the unit variable cost must be applied, if variable costs are annual, is assumed
not to change over the 20-year period.
Page 71
In addition, the type of container could affect the unit variable cost of compliance. The simple
formula above is therefore made more specific as follows: The cost of complying with the ith
regulation for the average pesticide registrant in the jth market sector and the kth size class in the
nth year of the 20-year period is
M
CCijkn = Fijkn + ∑ (UVCijkmn ∗ N ijkmn ) ,
m =1
where:
•
•
•
•
•
CCijkn denotes the cost of complying with the ith regulation for the average pesticide
registrant in the jth market sector and the kth size class in the nth year;
Fijkn denotes the fixed cost of complying with the ith regulation for the average pesticide
registrant in the jth market sector and the kth size class in the nth year;
M denotes the number of container types;
UVCijkmn denotes the unit variable cost, specific to the mth container type, of complying with
the ith regulation for the average pesticide registrant in the jth market sector and the kth size
class in the nth year; and
Nijkmn denotes the number of containers of the mth type that are out of compliance with the ith
regulation for the average pesticide registrant in the jth market sector and the kth size class in
the nth year (assumed not to change over the n years).
For example, the unit (per-container) variable cost of meeting the bulk container standards for
refillable containers is estimated to be $856 (regardless of container type or market sector).
There is no fixed cost. The average large establishment in the agricultural sector has 51 plastic
“large” bulk tanks and 18 steel “large” bulk tanks out of compliance with the bulk container
standards. The cost to the average large establishment in the agricultural sector of complying
with this regulation in year 3 is, then,39
$0 + (51)*($856) + (18)*($856) = $43,571 + $15,492 = $59,063
The 20-year schedules of costs associated with non-refillables and refillables, for the average
pesticide registrant in each combination of market sector and size class, is shown in Tables 4.9a
and 4.9b, respectively. Regulation-specific cost schedules for the average pesticide registrant in
each combination of market sector and size class are shown in Appendix C. (Note: There are no
costs for those regulations not shown in the tables in Appendix C due to assumed 100 percent
compliance. In other words, for non-refillable containers no costs are associated with the DOT
packaging standards, container closure standards, and standards for container dispensing
capability. For refillable containers, no costs are associated with the DOT packaging standards.)
39
Discrepancy is due to rounding. The inputs to the calculation shown here (51 and 18) are rounded. The output,
$59,063, is based on the unrounded numbers.
Page 72
Table 4.9a. Total (Undiscounted) Costs a of Complying with All Regulations for
Non-Refillables Under the Container Rule (2005$)b
Year c
Establishment
3
4 - 20
Large-Small Establishments
Agricultural
$58,808
$2,274
I/C/G
$58,808
$2,274
Home & Garden
$58,808
$2,274
Medium-Small Establishments
Agricultural
$27,096
$1,166
I/C/G
$27,096
$1,166
Home & Garden
$27,096
$1,166
Small-Small Establishments
Agricultural
$4,424
$598
I/C/G
$4,424
$598
Home & Garden
$4,424
$598
Large Establishments
Agricultural
$92,638
$2,814
I/C/G
$92,638
$2,814
Home & Garden
$92,638
$2,814
a
Costs are rounded to the nearest dollar.
Costs for the following regulations are included: residue removal standards, recordkeeping
requirements, and labeling requirements.
c
The compliance period for non-refillables is 3 years. The analysis assumes that costs are incurred
beginning at the end of the third year.
b
Page 73
Table 4.9b. Total (Undiscounted) Costs a of Complying with All Regulations for Refillables
Under the Container Rule (2005$)b
Year c
Establishment
3
4 - 20
Large-Small Establishments
Agricultural
$2,153
$126
I/C/G
$2,194
$102
Home & Garden
N/A
N/A
Medium-Small Establishments
Agricultural
$988
$63
I/C/G
$996
$59
Home & Garden
N/A
N/A
Small-Small Establishments
Agricultural
$565
$45
I/C/G
$566
$44
Home & Garden
N/A
N/A
Large Establishments
Agricultural
$155,894
$3,819
I/C/G
$161,637
$455
Home & Garden
N/A
N/A
a
Costs are rounded to the nearest dollar.
b
Costs for the following regulations are included: container marking standards, standards for openings, bulk
container standards, and recordkeeping requirements.
c
The compliance period for refillables is 5 years. The analysis assumes that costs are incurred beginning at the
end of the fifth year.
4.4.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs
In order to determine the total cost of complying with a regulation over the period of analysis, in
this case 20 years, we could simply sum all the costs incurred regardless of the year in which
they were incurred. However, when costs are incurred is very important. Economic theory holds
that given a choice, people would rather consume goods and services now rather then in the
future. All else being equal, regulatory options that create benefits now and incur costs later are
preferred to options that incur costs now and create benefits later. Therefore, we must take this
into account when comparing the costs and benefits of alternative regulatory options.
We accomplish this by discounting any costs that will be incurred in the future. The amount by
which we discount future expenditures is known as the social discount rate. We conducted our
analysis using both a 3 percent and 7 percent social discount rate.
Page 74
The present discounted value (pdv) of the 20-year stream of compliance costs associated with the
ith regulation for the average pesticide registrant in the jth market sector and the kth size class is
20
CCijkpdv = ∑
n =1
CCijkn
(1 + d ) n
where d is the discount rate.
For example, costs to meet the residue removal standard begin in year 3 and go through year 20.
In year 3, there are fixed costs associated with the existing containers; in subsequent years there
are fixed costs associated with containers for new products. The compliance cost associated with
existing containers for a small-small pesticide registrant in the agricultural sector, for example, in
year 3 is $494. The compliance cost associated with new containers in each subsequent year
(years 4–20) is $479. Using a 3 percent discount rate, and discounting back to the beginning of
year 1, the present discounted value of the stream of costs associated with the residue removal
standard for a small-small pesticide registrant in the agricultural sector is $6,993. Since all costs
are discounted back to year 1, this $$6,993 is the cost to society as if all costs were incurred in
year 1.40
4.4.8 Calculate the Annualized Cost of Complying with Each Regulation
As mentioned above, the present discounted value of the costs of a regulation tells us how much
it would cost to comply with a regulation if all costs were incurred in the first year of
implementation. In order to discuss the cost per year of complying with a regulation, we must
annualize the present discounted value of costs over the period of analysis, in this case 20 years.
If the present discounted value is like paying cash upfront for a house in year 1, then the
annualized cost is the mortgage payment that would be required to pay off a mortgage equal to
the present discounted value at a rate of interest equal to the discount rate. Annualization
provides a “per year” cost for each regulatory option so that we can compare costs across
regulatory options that require expenditures at different times. Also, later on we will be able to
compare the annualized costs and benefits of each regulatory option.
The present discounted value of the costs of complying with a regulatory option is annualized
over the 20-year period, using the same discount rate used to obtain present discounted values.
The annualized (ann.) cost of complying with the ith regulation for the average pesticide
registrant in the jth market sector and the kth size class is calculated using discount rate r, as:41
⎛
⎞
r
CCijkann. = ⎜⎜
⎟ ∗ CCijkpdv
− 20 ⎟
⎝ [1 + r ] ∗ [1 − (1 + r ) ] ⎠
The estimated annual cost of complying with each regulation for the average registrant in each
combination of market sector and size class is shown in Tables 4.10a (for non-refillables) and
40
See Table K-5 for presented discounted cost by market and by type of cost –fixed and variable.
The procedure for annualization is based on the guidelines for economic analyses that are published by EPA
(EPA, 2000b).
41
Page 75
4.10b (for refillables) assuming a discount rate of 3 percent, and Tables 4.10c and 4.10d
assuming a discount rate of 7 percent.42 As displayed in the tables, the highest cost of
compliance is associated with the residue removal because of the testing procedure, and the
labeling standards because all the containers are assumed to be not in compliance.
42
When compared to residue removal standards, much of the other administrative costs and labeling costs are
incurred in the initial year. Therefore, the annualized costs for labeling and administrative requirements are higher
at the 7 percent discount rate. The medium-small registrants and small-small registrants have low upfront year 1-5
costs (relative to ongoing year 6-20 costs) associated with residual removal requirements. Therefore, the annualized
costs for these registrants are higher at the 3 percent discount rate than at the 7 percent discount rate.
Page 76
Table 4.10a. Estimated Annual Cost of Complying with Each Container Regulation for Non-Refillable Containers for the
Average Registrant by Market Sector and Size Class (Interest Rate = 3 percent) (2005$)a
DOT Packaging DOT Packaging
Standards
Standards –
Standards – nonfor container
Closure
hazardous
hazardous
dispensing
materials
Standards capability
materials
(§165.60-64)
(§165.66)
(§165.60-64)
(§165.68)
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Residue
removal
standards
(§165.70)
Other
administrative
requirements –
recordkeeping
Labeling
requirements b
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$456
$456
$456
$88
$88
$88
$190
$190
$190
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$913
$913
$913
$131
$131
$131
$1,491
$1,491
$1,491
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$1,825
$1,825
$1,825
$161
$161
$161
$3,314
$3,314
$3,314
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$2,282
$2,282
$2,282
$161
$161
$161
$5,302
$5,302
$5,302
a
Rounded to the nearest dollar.
Unlike the other requirements, the labeling requirement is assumed to result in one fixed cost (and no variable costs) that covers labeling of both nonrefillable and refillable containers. Therefore, although the costs given in this table are listed under “non-refillables,” they actually include the (fixed) costs
of labeling templates for all containers.
b
Page 77
Table 4.10b. Estimated Annual Cost of Complying with Each Container Regulation for Refillable Containers for the Average
Registrant by Market Sector and Size Class (Interest Rate = 3 percent) (2005$) a
DOT Packaging
Standards –
hazardous
materials
(§165.110-114)
DOT Packaging
Standards – nonhazardous
materials
(§165.110-114)
Standards for
container
marking
(§165.116)
Standards for
openings (for
liquid minibulks
only) (§165.118)
Other
Bulk container administrative
standards
requirements –
(§165.120)
recordkeeping
Labeling
requirements b
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$2
N/A
$59
$59
N/A
-------
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$5
$0
N/A
$5
$1
N/A
$4
$11
N/A
$83
$83
N/A
-------
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$27
$3
N/A
$29
$3
N/A
$24
$61
N/A
$125
$125
N/A
-------
Large Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$3,807
$356
N/A
$4,084
$428
N/A
$3,325
$8,495
N/A
$125
$125
N/A
-------
Medium-Small Establishments
a
Rounded to the nearest dollar.
The costs resulting from the labeling requirement are listed in Table 4.10a since, unlike the other requirements, these are assumed to result in one fixed
cost (and no variable costs) that covers labeling of both non-refillable and refillable containers.
b
Page 78
Table 4.10c. Estimated Annual Cost of Complying with Each Container Regulation for Non-Refillable Containers for the
Average Registrant by Market Sector and Size Class (Interest Rate = 7 percent) (2005$)a
DOT Packaging DOT Packaging
Standards –
Standards –
hazardous
non-hazardous
materials
materials
(§165.60-64)
(§165.60-64)
Closure
Standards
(§165.66)
Standards for
container
dispensing
capability
(§165.68)
Residue
removal
standards
(§165.70)
Other
administrative
requirements –
recordkeeping
Labeling
requirements b
Small-Small Establishments
Agricultural
$0
$0
$0
$0
$418
$91
$229
I/C/G
$0
$0
$0
$0
$418
$91
$229
Home & Garden
$0
$0
$0
$0
$418
$91
$229
Medium-Small Establishments
Agricultural
$0
$0
$0
$0
$836
$137
$1,798
I/C/G
$0
$0
$0
$0
$836
$137
$1,798
Home & Garden
$0
$0
$0
$0
$836
$137
$1,798
Large-Small Establishments
Agricultural
$0
$0
$0
$0
$1,672
$166
$3,996
I/C/G
$0
$0
$0
$0
$1,672
$166
$3,996
Home & Garden
$0
$0
$0
$0
$1,672
$166
$3,996
Large Establishments
Agricultural
$0
$0
$0
$0
$2,091
$166
$6,393
I/C/G
$0
$0
$0
$0
$2,091
$166
$6,393
Home & Garden
$0
$0
$0
$0
$2,091
$166
$6,393
a
Rounded to the nearest dollar.
b
Unlike the other requirements, the labeling requirement is assumed to result in one fixed cost (and no variable costs) that covers labeling of both nonrefillable and refillable containers. Therefore, although the costs given in this table are listed under “non-refillables,” they actually include the (fixed)
costs of labeling templates for all containers.
Page 79
Table 4.10d. Estimated Annual Cost of Complying with Each Container Regulation for Refillable Containers for the Average
Registrant by Market Sector and Size Class (Interest Rate = 7 percent) (2005$)a
DOT Packaging
Standards –
hazardous
materials
(§165.110-114)
DOT
Standards for
Packaging
openings (for
Standards –
Standards for
liquid
Bulk container
non-hazardous
container
minibulks
materials
marking
only)
standards
(§165.120)
(§165.110-114)
(§165.116)
(§165.118)
Other
administrative
requirements –
recordkeeping
Labeling
requirements b
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$3
N/A
$58
$58
N/A
-------
$0
$0
N/A
$0
$0
N/A
$5
$0
N/A
$6
$1
N/A
$5
$13
N/A
$83
$83
N/A
-------
$0
$0
N/A
$0
$0
N/A
$26
$2
N/A
$33
$3
N/A
$27
$68
N/A
$122
$122
N/A
-------
Large Establishments
Agricultural
$0
$0
$3,592
$4,564
$3,715
$122
--I/C/G
$0
$0
$334
$478
$9,492
$122
--Home & Garden
N/A
N/A
N/A
N/A
N/A
N/A
--a
Rounded to the nearest dollar.
b
The costs resulting from the labeling requirement are listed in Table 4.10a since, unlike the other requirements, they are assumed to result in one fixed cost (and
no variable costs) that covers labeling of both non-refillable and refillable containers.
Page 80
4.4.9 Estimate the Annualized Cost of Complying with All Regulations per Average
Regulated Entity in Each Combination of Market Sector and Size Class –
Assuming No Waivers
In the absence of any waivers, the total annualized cost of complying with all container-related
regulations for the average pesticide registrant in the jth market sector and the kth size class is
I
ann .
.
CC ann
jk ( w / o waiver ) = ∑ CCijk ,
i =1
where i is the number of such regulations. With one exception, regulations are directed at either
refillable containers or non-refillables. Even for regulations that are essentially the same for
non-refillables and refillables (e.g., administrative requirements – recordkeeping), the cost
analysis assumes that any fixed costs incurred for non-refillables are separate from those
incurred for refillables (e.g., it is assumed that a separate filing cabinet is purchased for each set
of records). The exception is the labeling requirement, which results in only fixed costs that are
not incurred separately for non-refillable and refillable containers.
The total annualized cost of complying with all regulations, in the absence of any waivers, for
the average pesticide registrant in the jth market sector and the kth size class can then be
rewritten as:
N nr
Nr
i =1
i =1
.
ann .
ann .
ann .
CC ann
jk ( w / o waiver ) = ∑ CCijk ( nr ) + ∑ CCijk ( r ) +CC jk ( labeling )
where:
•
•
•
•
•
Nnr denotes the number of container-related regulations for non-refillable containers;
Nr denotes the number of container-related regulations for refillable containers;
CCijkann . ( nr ) denotes the annualized cost of complying with the ith regulation for nonrefillables, for the average registrant in the jth market sector and the kth size class;
CCijkann . ( r ) denotes the annualized cost of complying with the ith regulation for refillables, for
the average registrant in the jth market sector and the kth size class; and
CCijkann . (labeling ) denotes the annualized cost of complying with the labeling requirements for
the average registrant in the jth market sector and the kth size class.
The total annualized compliance cost without waivers, across all regulations, for the average
registrant in the jth market sector and the kth size class is shown in Tables 4.11a and 4.11b. At
3 percent, costs of compliance without a waiver range from as high as $19,807 ($20,642 at
7 percent) for large registrants to $796 ($800 at 7 percent) for small-small registrants. As
described in Tables 4.10a and 4.10b, the majority of the cost is associated with compliance with
the residue removal and labeling requirements.43
43
When compared to large-small and large registrants, small-small and medium-small registrants have low upfront
year 1-5 costs (relative to ongoing year 6-20 costs) associated with the residual removal requirements. Therefore,
the annualized costs for the medium-small and small-small registrants are higher at the 3 percent discount rate than
at the 7 percent discount rate, while the opposite is true for the large-small and large registrants.
Page 81
Table 4.11a. Total Annualized Costs Over a 20-Year Period of the Pesticide Container
Rule for the Average Registrant: Total Without a Waiver (Interest =3 percent)
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Annualized Cost
$5,506
$5,492
$5,426
$2,633
$2,631
$2,618
$796
$795
$793
$19,087
$17,149
$7,870
Table 4.11b. Total Annualized Costs Over a 20-Year Period of the Pesticide Container
Rule for the Average Registrant: Total Without a Waiver (Interest =7 percent)
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Annualized Cost
$6,041
$6,030
$5,956
$2,870
$2,867
$2,854
$800
$799
$797
$20,642
$19,077
$8,772
Page 82
4.4.10 Estimate the Annual Cost of Complying with All Regulations per Average
Regulated Entity in Each Combination of Market Sector and Size Class – Allowing
for Waivers
EPA may modify or waive the requirements for some but not all of the container-related
Regulations. For non-refillables, EPA may:
•
•
•
•
Modify or waive the requirements of the DOT packaging standards for non-hazardous
materials (§165.60) and for hazardous materials (§165.62);
Approve a non-standard closure (i.e., a closure not listed in §165.66);
Modify or waive the container dispensing standards (§165.68); and
Modify or waive the residue removal standard (§165.70).
For refillables, EPA may modify or waive the requirements of the DOT packaging standards for
non-hazardous materials (§165.110) and for hazardous materials (§165.112).
The total annualized compliance cost, across all regulations, for the average registrant in the jth
market sector and the kth size class when a waiver has been obtained is shown in Tables 4.11c
and 4.11d. The standards, and their potential to be waived, are summarized in Table 4.12. As
expected, given the range of standards that can be waived (in particular, the residue removal
standard), costs are lower for the registrant that obtains a waiver compared to the registrant that
does not obtain a waiver (see Tables 4.11a and 4.11b). With a waiver, costs of compliance range
from $17,167 at 3 percent ($18,914at 7 percent) for large registrants, to $698 at 3 percent ($740
at 7 percent) for small-small registrants.
Page 83
Table 4.11c. Total Annualized Costs Over a 20 Year Period of the Pesticide Container
Rule for the Average Registrant: Total With a Waiver (Interest Rate = 3 percent)
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Annualized Cost
$4,042
$4,028
$3,962
$2,082
$2,080
$2,067
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
$701
$701
$698
$17,167
$15,229
$5,950
Table 4.11d. Total Annualized Costs Over a 20 Year Period of the Pesticide Container
Rule for the Average Registrant: Total With a Waiver (Interest Rate = 7 percent)
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Annualized Cost
$4,731
$4,719
$4,646
$2,395
$2,393
$2,379
$744
$743
$740
$18,914
$17,348
$7,043
Page 84
Table 4.12. Container-Related Standards and Waivers
May It Be Modified or
Waived?
Standard
Non-Refillables
DOT packaging (design, construction, and marking) standards – for non-hazardous
materials (§165.60)
Yes
DOT packaging (design, construction, and marking) standards – for hazardous
materials (§165.62)
Yes
Closure standards (§165.66)
Yes
Standards for container dispensing capability (§165.68)
Yes
Residue removal standards (§165.70)
Yes
Recordkeeping (§165.86)
No
Labeling (§156.144(d))
a
Yes
Refillables
DOT packaging (design, construction, and marking) standards – for non-hazardous
materials (§165.110)
Yes
DOT packaging (design, construction, and marking) standards – for hazardous
materials (§165.112)
Yes
Standards for marking (§165.116)
No
Standards for openings (§165.118)
No
Standards for bulk containers (§165.120)
No
a
Labeling (§156.144(d))
Yes
The regulations specify that the label requirements can be modified or waived. For the purposes of the cost
analysis, we assume that the label requirements are more likely to be modified than completely waived, so it is
assumed that registrants still incur the cost of changing the pesticide label. Therefore, label waivers are not included
in the waiver cost analysis.
a
The cost analysis assumes that:
•
•
•
•
•
Pesticide registrants will apply for a waiver only if they are reasonably certain of getting it;
Five percent of registrants will apply for a waiver;
All those who apply will get the waiver;
If a requirement is waived, the cost of meeting the requirement is zero; and
There is a cost to apply for a waiver.
The total annualized cost of complying with the container rule for the average pesticide registrant
in the jth market sector and the kth size class who applies for and gets a waiver can be written as:
.
CC ann
jk ( w / waiver ) =
∑ CC
i∈S nr
ann .
ijk
.
( nr ) + ∑ CCijkann . ( r ) + C jk ( waiver ) + CC ann
jk ( labeling )
m∈S r
where:
•
Snr is the set of container-related regulations for non-refillable containers for which a waiver
cannot be obtained;
Page 85
•
•
•
Sr is the set of container-related regulations for refillable containers for which a waiver
cannot be obtained;
Cjk(waiver) is the cost of applying for a waiver for the average pesticide registrant in the jth
market sector and the kth size class; and
All other components on the right-hand side of the equation are as described above.
The expected annualized cost for the average pesticide registrant in the jth market sector and the
kth size class, given that pjk percent of all pesticide registrants in the jth market sector and the kth
size class apply for and obtain waivers (which relieve them of the responsibility of complying
with some but not all regulations), is:
.
ann .
ann .
E (CC ann
jk ) = p jk ∗ CC jk ( w / waiver ) + (1 − p jk ) ∗ CC jk ( w / o waiver )
As noted above, it is assumed that pjk = 0.05 for all j and k; that is, 5 percent of pesticide
registrants apply for and receive a waiver.44 The cost of the waiver is an estimated $362 (see
Appendix A). The expected cost to a large-small agricultural pesticide registrant, for example,
using the estimates of total annualized costs with and without a waiver at 3 percent found in
Tables 4.11a and 4.11c, respectively, would be:
(0.05)*($4,042) + (1-0.05)*($5,506) = $5,43345
Total expected annualized costs (across all container-related regulations), given that waivers are
available for some regulations, are given in Tables 4.17a and 4.17b in Section 4.6, where total
expected costs for both container-related and refilling-related regulations are summarized.
4.5 Estimating the Costs of Compliance with Refilling-Related Regulations
The method use to estimate the costs of complying with the set of refilling-related regulations
incurred by the average pesticide refiller is basically the same as the method of estimating the
costs of complying with the set of container-related regulations. For a given pesticide refiller
category/size class (e.g., large agricultural pesticide refillers), the analysis proceeds through the
following series of steps to a final estimate of the cost to the average pesticide refiller in that
refiller category/size class per refilling-related regulation:
•
•
•
Estimate the number of refillable containers in the relevant market sector;
Estimate the number of those that fall within the scope of the rule;
Estimate the number of those that are refilled by pesticide refillers in the refiller category
(this is an issue only for the agricultural sector, in which there are two categories of pesticide
refillers – agricultural pesticide refillers and agricultural pesticide registrants);
44
The assumption that the probability of applying for and getting a waiver is the same for all market sectors and size
classes is made in the absence of sufficient information to the contrary.
45
The difference between this estimated cost ($5,433) and the estimate of cost provided in Table 4.17a ($5,477) is
the annual cost of complying with the refilling-related regulations for an average large-small agricultural pesticide
registrant ($44) (see Section 4.5).
Page 86
•
•
•
•
•
•
Using annual refilling rates estimated for each different type of refillable container refilled by
each category of pesticide refiller, estimate the total number of refillings per year in each
refiller category;
Estimate the number of refillings per year in each refiller category/size class;
For each refilling-related regulation under the rule, estimate the number of those refillings
that are out of compliance with the regulation in each refiller category/size class;
Estimate the number out of compliance with each regulation per average refiller in each
refiller category/size class;
Estimate the cost, in each year of a 20-year period, of bringing those refillings into
compliance, and the present discounted value of that 20-year stream of costs, using a
3 percent discount rate and a 7 percent discount rate; and
Annualize this present discounted value, using a 3 percent interest rate and a 7 percent
interest rate.
This section describes the method of estimating the costs of complying with the refilling-related
regulations under the pesticide container rule for the average refilling entity. The steps are
described in the order in which they were carried out in the analysis. The first two steps in the
process (estimating the number of refillable pesticide containers in each market sector and
estimating the number of refillable pesticide containers in each market sector that fall within the
scope of the rule) were already carried out for the analysis of the costs of the container-related
regulations, and are described above in Sections 4.4.1 and 4.4.2. The description of methods
presented here begins at the third step.
4.5.1 Allocate Refillable Containers That Fall Within the Scope of the Rule in Each of
the Relevant Market Sectors to Each of the Regulated Refilling Entity Categories
Within the Market Sector
The agricultural and I/C/G sectors have regulated entities that will have to comply with the set of
refilling-related regulations under the pesticide container rule (see Tables 4.2 and 4.3). H&G
containers, however, are not refilled, so this market sector does not enter into the refilling cost
analysis. In the I/C/G sector, I/C/G pesticide registrants make up the only refiller category.
Therefore, 100 percent of all refillable containers of each type in the I/C/G market sector that fall
within the scope of the rule were allocated to I/C/G pesticide registrants for this part of the cost
analysis.
Although swimming pool supply companies are considered to be in the I/C/G and H&G sectors,
we treat them separately. As described in Chapter 3, refillable containers associated with
swimming pool supply companies were not included in the data used to estimate the number of
containers in the I/C/G market. Therefore, the refillables associated with swimming pool supply
companies were estimated differently and are treated differently in the cost analysis because they
are subject to a portion of the refilling requirements only. That is, the number of refillable
containers of each type, and the number that fall within the scope of the rule, refilled by
swimming pool supply companies were calculated separately. Therefore, the swimming pool
industry is treated as its own market sector, and all of the refillable containers that fall within the
scope of the rule in the swimming pool industry are allocated to swimming pool supply
companies.
Page 87
Within the agricultural sector there are two refiller categories:
•
•
Agricultural pesticide refillers; and
Agricultural pesticide registrants.
It is estimated that 90 percent of the refillable containers that fall within the scope of the rule in
the agricultural sector are refilled by agricultural pesticide refillers, and 10 percent are refilled by
agricultural pesticide registrants (see Table K-3). More details about this assumption are
provided in Chapter 3.
4.5.2 Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule for Each Category of Regulated Entity for Each Refillable Container Type
Table 4.13 lists the estimated annual refilling rates (number of refillings per container per year).
Refilling rates for the agricultural sector are based on information provided by Paulson (2002).
Refilling rates for the I/C/G sector are transferred from assumptions made in the proposed
container rule RIA for small volume refillable containers (EPA, 1993, Appendix G). Refilling
rates for the swimming pool industry (antimicrobial pesticide supply companies) are
approximately twice the rate (eight times per year) used in the proposed container rule RIA.
This is based on professional judgment and comments submitted to EPA. The relative amount of
sodium hypochlorite used and the number of refillable containers needed to meet demand in the
pool treatment industry are considered.
4.5.3 Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule for Pesticide Refillers in Each Size Class Within Each Refiller Category
The same size classes that were applied to pesticide registrants were also applied to the different
refiller categories, as shown in Table 4.5 above. Analogous to the method used to allocate
containers within each market sector to the different size classes, the analysis assumed that the
percentage of total revenue (among all pesticide refillers in a given category, such as agricultural
pesticide refillers) associated with pesticide refillers in a given size class is a reasonable proxy
for the percentage of refillings by pesticide refillers in that size class. This allocation of
refillings to size classes by percentage revenue was applied to each category of pesticide refiller,
and within each refiller category, to each container type. For example, there are assumed to be
54,810 refillings of 126-250 gallon plastic containers for holding liquid products per year by
agricultural pesticide refillers.46 Of those, we assume 9.1 percent (see Table 4.6), or 5,009
refillings, to be refillings by large-small agricultural pesticide refillers.47 Across all sizes and
types of container, there are assumed to be 2,083,500 refillings per year by agricultural pesticide
refillers.48 Of these, 9.1 percent, or 190,397, are attributed to large-small pesticide refillers. By
the end of this step in the analysis, all refillings that fall within the scope of the container rule are
allocated to each combination of pesticide refiller category and size class.
46
The number of refillings in each container type category is the product of the number of containers in that
category and refilling rate per container. For the 126–50 gallon plastic container category for agricultural refillers,
31,320 containers * 1.75 refillings per year per container = 54,810 refillings per year.
47
Percentages given in the text are rounded. The numbers here are based on the unrounded percentages, and are
therefore slightly different from what would be obtained if the rounded percentages had been used.
48
The total number of refillings for each refiller class is the sum of the number of refillings over all container type
categories.
Page 88
Table 4.13. Estimated Annual Pesticide Container Refilling Rates
Estimated Annual Refilling Rate
Refillable Container Type
Agricultural
Pesticide
Refillers a
Agricultural
Pesticide
Registrants a
I/C/G Pesticide
Registrants b
Swimming Pool
Industry –
Antimicrobial
Applicators c
Containers for Holding Liquid Products
5 - 25 gallon, plastic or steel
2.25
2.25
4
8
26 - 60 gallon, plastic or steel
1.75
1.75
4
8
61 - 125 gallon, plastic or steel
1.75
1.75
4
N/A
126 - 250 gallon, plastic or steel
1.75
1.75
4
N/A
Large (251 - 500 gallons)
1.25
1.25
4
4
Bulk (> 500 gallons)
1.25
1.25
4
4
Other
1.75
1.75
4
8
< 100 lbs.
1.75
1.75
4
N/A
101 - 2500 lbs.
1.75
1.75
4
N/A
Large (2501 - 4409 lbs.)
1.25
1.25
4
N/A
Bulk (> 4409 lbs.)
1.25
1.25
4
N/A
Other
1.75
1.75
4
N/A
Containers for Holding Dry Products
a
Agricultural sector refilling rates are based on Paulson (2002).
I/C/G refilling rates based are based on assumptions in the proposed container rule RIA (EPA, 1993,
Appendix G).
c
Estimates are based on comments to the 1999 Supplemental Notice submitted by relevant trade associations (i.e.,
the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool Chemical Manufacturers Association)
that provide the average number of refillings. Based on the comments, the number of refillings was assumed to be
8. A smaller refilling rate of 4 was assumed for larger containers.
b
4.5.4 For Each Refilling-Related Regulation Under the Pesticide Container Rule,
Estimate the Number of Refillings per Year That Fall Within the Scope of the
Rule That Are Out of Compliance with That Regulation
As with the container-related regulations, it is estimated that for each refilling-related regulation,
some percentage of refillings are already in compliance with the regulation and therefore do not
need to be brought into compliance. This step of the cost analysis of refilling-related regulations
relied on compliance rates estimated for refillings of each type of refillable container in each
combination of refiller category and size class. The estimation of compliance rates is described
in Chapter 3.
The number of refillings of a given type of refillable container within a given combination of
pesticide refiller category and size class that are out of compliance with a given regulation is just
the number of refillings of that type of container in that combination of refiller category and size
class that fall within the scope of the rule multiplied by (1 - the corresponding compliance rate).
For example, it is estimated that, among large agricultural pesticide refillers, 60 percent of
refillings of 126–250 gallon plastic refillable containers for holding liquid products are in
compliance with the requirement to inspect the container before refilling. There are estimated to
Page 89
be 25,767 refillings per year of that type of container by large agricultural pesticide refillers that
fall within the scope of the rule. It is estimated that the number of refillings of that type of
container by large agricultural pesticide refillers that are out of compliance with the requirement
to inspect the container before refilling is (1 - 0.6)*25,767 = 10,307.
The numbers of refillings (of all types of refillable containers) estimated to be out of compliance
with each of the refilling-related regulations under the pesticide container rule is given in
Table 4.14.
Table 4.14. Estimated Numbers of Refilling Steps (or Requirements) per Year Out of
Compliance with Refilling-Related Requirements (2005$)
Requirement to
Inspect Container
Before Refilling
Agricultural Pesticide Refillers
Small-Small
Medium-Small
Large-Small
Large
Agricultural Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
I/C/G Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
Swimming Pool Supply Companies
Small-Small
Medium-Small
Large-Small
Large
Requirement to
Clean Container
Before Refilling
Recordkeeping with
Each Refilling
150,077
215,367
76,159
391,797
30,015
43,073
15,232
78,359
375,191
538,418
190,397
979,494
176
410
743
91,271
35
82
149
18,254
439
1,025
1,858
228,178
114
265
481
59,073
23
53
96
11,815
284
663
1,202
147,682
996
3,449
829
480,126
0
0
0
0
0
0
0
0
4.5.5 For Each Refilling-Related Regulation Under the Pesticide Container Rule,
Estimate the Number of Refillings That Fall Within the Scope of the Rule That
Are Out of Compliance with That Regulation – for the Average Regulated Entity
in Each Combination of Refiller and Size Class
For each combination of refillable container type, refiller category, and size class, we divide the
number of refillings out of compliance with each refilling-related regulation (see Table 4.14) by
the number of pesticide refillers in that combination of refiller category and size class (see Table
4.5). This yields an estimate of the number of refillings of each type of refillable container that
is out of compliance with each regulation for an “average pesticide refiller” in each refiller type-
Page 90
size class combination.49 For example, there are an estimated 2,061 refillings of 126–250 gallon
plastic containers for holding liquid products by large agricultural pesticide refillers that are out
of compliance with the requirement to clean the container before refilling. There are estimated
to be 153 large agricultural pesticide refillers. It is therefore estimated that the number of
refillings of 126–250 gallon plastic containers for holding liquid products that are out of
compliance with the requirement to clean the container before refilling for the average large
agricultural pesticide refiller is 2,061/153 = 13.5 (see Table K-4b).50
4.5.6 Estimate the Cost, in Each Year of a 20-Year Period, of Bringing Refillings into
Compliance
The estimation of the costs of bringing refillings into compliance with refilling-related
regulations follows the same pattern as the estimation of costs for container-related regulations.
Compliance costs may be fixed or variable. Fixed costs do not depend on the number of
refillings that must be brought into compliance with the regulation, whereas variable costs do.
The only fixed cost associated with refilling requirements is the cost of a file cabinet, estimated
at $229.65. (See Appendix A for compliance cost figures.)
Total variable cost increases with each refilling brought into compliance. As with the containerrelated variable costs, the marginal variable cost curve was assumed to be horizontal; that is,
there was assumed to be a constant unit variable cost, so that the variable cost incurred by
bringing N refillings into compliance is N times the variable cost of bringing one refilling into
compliance. The variable costs associated with refilling are the costs of inspecting, cleaning, and
recording certain information about refillable containers when refilling. We estimate a unit
variable cost for each regulation, as described in detail in Appendix A.
The second dimension of the cost calculations is the time dimension. Some costs are incurred
only once (e.g., at the beginning of the period of time over which costs may be incurred),
whereas other costs are incurred in each year of the 20-year period.
The cost of complying with a refilling-related regulation is calculated by:
•
•
•
Calculating the cost in each year of the 20-year period;
Calculating the presented discounted value of the resulting stream of costs; and
Annualizing this present discounted value.
Waivers are not available for the refilling-related regulations. Pesticide refillers will have
5 years in which to bring their refillings into compliance with regulations under the rule. The
analysis assumes that refilling-related compliance costs will be incurred beginning at the end of
the fifth year. In calculating the present discounted value of the costs of a regulation, all costs
are discounted back to the beginning of the first year of the 20-year period.
49
An “average refiller” in a refiller category/size class combination is assumed to refill the same combination of
refillable container types as the refiller category/size class combination as a whole.
50
Table K-4 presents information for each combination of container type, container size, market type, and entity
size.
Page 91
The cost of compliance with the three refilling requirements—to inspect, clean, and record
information about refillable containers when refilling—were combined together into a single cost
estimate. The calculation of these costs is carried out in the same way as the cost of complying
with a container-related regulation. The only difference is that the unit is now a refilling rather
than a container. The costs incurred in a single year are the fixed costs (if any in that year) plus
the variable costs (if any in that year). If
•
•
•
Fn denotes the fixed cost of complying with the refilling regulations in the nth year (n=1, ...,
20);
UVCn denotes the unit variable cost of complying with the refilling regulations in the nth
year; and
N denotes the number of refillings out of compliance with the regulation annually;51
then the cost of complying with the refilling regulations in the nth year is:
Fn + UVCn * N.
As with container-related compliance costs, it is possible that both fixed and unit variable costs
differ for pesticide refillers in different refiller categories and/or size classes. There was
insufficient information to capture any such differences in this cost analysis. (Total variable
costs will vary, however, because the numbers of refillings varies across refiller categories and
size classes.) It is also possible that unit variable or fixed costs could differ by refillable
container type, but as with possible differences across refiller categories and/or size classes, there
was insufficient information to capture any such possible differences.
Therefore, although in theory the calculation of the cost of complying with the ith regulation for
the average pesticide refiller in the jth refiller category and the kth size class in the nth year of
the 20-year period would follow the same basic pattern as for container-related compliance costs
(shown in Section 4.4.6),
M
CCijkn = Fijk +
∑ (UVC
m= 1
ijkmn
* N ijkmn ) ,
in practice, a simpler formula is used, in which only the number of refillings varies by refiller
category and/or size class and regulation, and the unit variable cost varies for the regulation.
The cost of complying with the three refilling requirements is just the fixed cost (it was assumed
that a single file cabinet would suffice for all three refilling regulations) plus the three variable
costs. Each unit variable cost was estimated by estimating the time required to meet the
regulation (e.g., the time it takes to clean a refillable container before refilling) and multiplying
by the hourly wage rate. For example, we estimate that it takes one minute, or 0.0167 hour, to
inspect a container before refilling. We estimate the labor cost per hour to be $29.13. The unit
variable cost of inspection is, then, 0.0167 x $29.13 = $0.4865. There are estimated to be 90
refillings out of compliance with the inspection regulation for the average medium-small
51
The number of refillings to which the unit variable cost must be applied, if variable costs are annual, is assumed
not to change over the 20-year period.
Page 92
agricultural pesticide refiller each year. The annual (undiscounted) variable cost of meeting the
inspection regulation for the average medium-small agricultural pesticide refiller is therefore
$0.49 x 90 = $43.78.
The 20-year schedule of costs for the three refilling regulations combined for the average
pesticide refiller in each market sector/refilling category/size class is shown in Table 4.15. Due
to the significantly larger number of containers refilled by the large registrants compared to the
small registrants, costs of compliance are estimated to be significantly higher in each year for the
large registrants.
Table 4.15. Total Compliance Costs a Related to Refilling Requirements for
Refillable Containers (2005$)b
Year c
Establishment
Large-Small Establishments
Agricultural Pesticide Refillers
Agricultural pesticide registrants
I/C/G – Pesticide registrants
Swimming Pool Supply Companies
Medium-Small Establishments
Agricultural Pesticide Refillers
Agricultural pesticide registrants
I/C/G – Pesticide registrants
Swimming Pool Supply Companies
Small-Small Establishments
Agricultural Pesticide Refillers
Agricultural pesticide registrants
I/C/G – Pesticide registrants
Swimming Pool Supply Companies
Large Establishments
Agricultural Pesticide Refillers
Agricultural pesticide registrants
I/C/G – Pesticide registrants
Swimming Pool Supply Companies
5
6-20
$1,408
$273
$267
$258
$1,178
$43
$37
$29
$579
$238
$237
$244
$349
$8
$7
$14
$271
$231
$231
$232
$42
$2
$1
$3
$10,174
$6,300
$5,468
$13,942
$9,944
$6,070
$5,238
$13,712
a
Costs are rounded to the nearest dollar.
Compliance with the refilling requirements involves both fixed and variable costs.
c
The compliance period for non-refillables is 5 years. The analysis assumes that costs are incurred beginning at the
end of the fifth year.
b
4.5.7 Calculate the Present Discounted Value of the 20-Year Stream of Costs
The present discounted value of the 20-year stream of compliance costs associated with the
refilling regulations for the average pesticide refiller in the jth refiller category and the kth size
class is:
20
CC
pdv
jk
=
CC jkn
∑ (1 + d )
n =1
Page 93
n
where d is the discount rate. Two discount rates were considered: 3 percent and 7 percent. Table
K-5 shows the present discounted value of each year’s costs refilling requirement costs for each
the average pesticide refiller in each market sector/refilling category and size class.
4.5.8 Calculate the Annualized Cost of Complying with the Refilling Regulations
The present discounted value of the cost of complying with the refilling regulations was
annualized over the 20-year period, using two interest rates (r) that were assumed to be the same
as the two discount rates used to obtain present discounted values (that is, when the discount rate
was assumed to be 3 percent, the interest rate was also assumed to be 3 percent, and similarly for
7 percent). The annualized cost of complying for the average pesticide refiller in the jth refiller
category and the kth size class is calculated using interest rate r as
⎛
⎞
r
.
pdv
CC ann
=⎜
− 20 ⎟ * CC jk
jk
⎝ [1 + r ]*[1 − (1 + r ) ]⎠
.
The estimated annualized cost of complying with the three refilling-related regulations
(combined) for the average refiller in each combination of refiller category and size class is
shown in Tables 4.16a (at 3 percent interest) and 4.16b (at 7 percent interest). As discussed
earlier, due to the significantly larger number of containers refilled by the large registrants
compared to the small registrants, the estimated annual cost of compliance is estimated to be
significantly higher for large registrants.
Table 4.16a. Estimated Annual Cost of Complying with the Refilling-Related Container
Regulations for the Average Refiller by Refiller Category and Size Class
(Interest = 3 percent) (2005$)a
Cost of Requirements to Inspect, Clean,
and Track Container Before Refilling
Refiller Category / Size Class
Agricultural Pesticide Refillers
Small-Small
Medium-Small
Large-Small
Large
Agricultural Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
I/C/G Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
Swimming Pool Supply Companies
Small-Small
$43
$267
$871
$7,255
$14
$19
$45
$4,434
$14
$18
$40
$3,828
$15
Page 94
Medium-Small
$23
Large-Small
$34
Large
$10,000
a
Costs for all three refilling-related requirements are aggregated. Some costs are higher at the 7 percent
discount rate while the others are higher at the 3 percent discount rate depending on whether the costs incurred
in the initial year is high. If the initial year costs are high then the typically the cost estimate is higher for the 7
percent discount rate and vice versa. For example, the large swimming pool supply companies face a high cost
in the initial year while the small-small agricultural pesticide refiller faces low initial year costs. Accordingly,
the cost at the 7 percent discount rate is higher for the large former, while the opposite is true for the latter.
Table 4.16b. Estimated Annual Cost of Complying with the Refilling-Related Container
Regulations for the Average Refiller by Refiller Category and Size Class
(Interest = 7 percent) (2005$)a
Cost of Requirements to Inspect, Clean,
and Track Container Before Refilling
Refiller Category / Size Class
Agricultural Pesticide Refillers
Small-Small
Medium-Small
Large-Small
Large
Agricultural Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
I/C/G Pesticide Registrants
Small-Small
Medium-Small
Large-Small
Large
Swimming Pool Supply Companies
Small-Small
Medium-Small
Large-Small
Large
a
Costs for all three refilling-related requirements are aggregated.
$41
$237
$764
$6,336
$16
$20
$42
$3,874
$15
$19
$38
$3,345
$16
$24
$33
$8,732
4.6 The Total Annual Costs of the Rule
We calculated the total annual costs of the pesticide container rule, across all regulations
contained within it, for:
•
•
•
•
•
The average regulated entity – in each combination of entity type, market sector, and size
class;
All regulated entities – in each combination of entity type, market sector, and size class;
The average pesticide registrant with a “representative share” in each market sector;
All pesticide registrants (across all market sectors) in each size class;
All pesticide registrants across all market sectors and size classes;
Page 95
•
•
All regulated entities within each category complying with refilling-related regulations; and
All regulated entities.
The cost of complying with each of the container-related and refilling-related regulations under
the rule, for the average regulated entity in each combination of regulated entity category, market
sector, and size class are given above in Tables 4.10a–4.10d and 4.16a and 4.16b, respectively.
The estimation of costs across all regulations for the average regulated entity is described in
Sections 4.4 and 4.5. The sets of regulations to which each regulated entity category is subject
are summarized in Table 4.2. The numbers of regulated entities in each category of regulated
entity for each combination of market sector and size class are given in Table 4.5. The
information in all these tables is synthesized in Tables 4.17a and 4.17b, which summarize the
annualized costs across all regulations for each type of regulated entity and across all regulated
entities, at 3 percent interest and 7 percent interest, respectively. In general, as displayed in
Tables 4.17a and 4.17b (and as discussed earlier), costs are also higher for the average large
entity than for the average small entity, and the costs are higher for large entities when
considered over all entities. The exceptions include the large-small registrants, which have a
similar number of regulated entities to large registrants, making their costs smaller over all
regulated entities; and large agricultural pesticide refillers, which have higher costs over all
entities, despite a relatively small number of entities in this market sector and size. At 3 percent
and 7 percent, the total cost of compliance over all regulated entities is estimated to be
$8.4 million and $8.5 million, respectively. With a 3 percent discount rate, pesticide registrants
account for nearly $5.6 million (or almost 70 percent) of the total cost of compliance, while
agricultural pesticide refillers and swimming pool supply companies account for less than $2.6
million and $180,000 of the total cost of compliance, respectively.
Page 96
Table 4.17a. Total Annual Costs of the Pesticide Container Rule for Regulated Entities
(Interest Rate = 3 percent) (2005$)
For the Average
Regulated
Entity
Number of
Regulated
Entities
Regulated Entities
Pesticide Registrants
Large-Small
Agricultural
$5,477
66
I/C/G
$5,459
50
Home & Garden
$5,352
50
$5,434
Average Across Market
Sectors a
National Total Across Market Sectors
Medium-Small
Agricultural
$2,625
198
I/C/G
$2,621
148
Home & Garden
$2,591
148
$2,613
Average Across Market
Sectors a
National Total Across Market Sectors
Small-Small
Agricultural
$805
399
I/C/G
$805
299
Home & Garden
$788
299
$800
Average Across Market
Sectors a
National Total Across Market Sectors
Large
Agricultural
$23,425
58
I/C/G
$20,881
44
Home & Garden
$7,774
44
$17,967
Average Across Market
Sectors a
National Total Across Market Sectors
National Total Across Market Sectors and Size Categories
Agricultural Pesticide Refillers
Large-Small
$871
251
Medium-Small
$267
2,395
Small-Small
$43
13,996
Large
$7,255
153
National Total Across Size Categories
Page 97
Over All
Regulated
Entities
$364,061
$272,139
$266,825
$903,024
$519,462
$389,096
$384,601
$1,293,158
$321,217
$240,698
$235,727
$797,642
$1,367,998
$914,608
$340,508
$2,623,114
$5,616,939
$218,684
$640,191
$605,474
$1,110,296
$2,574,646
Table 4.17a (Continued). Total Annual Costs of the Pesticide Container Rule for
Regulated Entities (Interest Rate = 3 percent) (2005$)
Swimming Pool Supply Companies – Antimicrobial Applicators
Large-Small
$34
Medium-Small
$23
Small-Small
$15
Large
$10,000
14
117
174
17
$474
$2,732
$2,602
$169,993
National Total Across Size Categories
$175,800
National Total Across All Regulated Entities
$8,367,385
The average pesticide registrant across market sectors is assumed to have the same distribution across market
sectors as the distribution of pesticides across market sectors (by volume of pesticide) in the pesticide industry
as a whole:
Agricultural sector:
40 percent
Industrial/commercial/govt. sector:
30 percent
Home & Garden sector:
30 percent
a
Page 98
Table 4.17b. Total Annual Costs of the Pesticide Container Rule for Regulated Entities
(Interest Rate = 7 percent) (2005$)
Regulated Entities
Pesticide Registrants
Large-Small
Agricultural
I/C/G
Home & Garden
Average Across
Market Sectors a
For the Average
Regulated Entity
Number of
Regulated
Entities
$6,018
$6,003
$5,891
$5,975
Over All
Regulated
Entities
66
50
50
$399,987
$299,243
$293,661
National Total Across Market Sectors
$992,891
$2,865
$2,863
$2,830
$2,854
198
148
148
$567,135
$424,939
$420,112
National Total Across Market Sectors
$1,412,186
Medium-Small
Agricultural
I/C/G
Home & Garden
Average Across
Market Sectors a
Small-Small
Agricultural
I/C/G
Home & Garden
$813
$812
$794
$807
399
299
299
$324,089
$242,890
$237,420
National Total Across Market Sectors
$804,400
Average Across
Market Sectors a
Large
Agricultural
I/C/G
Home & Garden
$24,430
$22,335
$8,685
$19,078
58
44
44
$1,426,696
$978,272
$380,418
Average Across
Market Sectors a
National Total Across Market Sectors
National Total Across Market Sectors and Size Categories
$2,785,386
$5,994,863
Agricultural Pesticide Refillers
Large-Small
Medium-Small
Small-Small
Large
$764
$237
$41
$6,336
National Total Across Size Categories
Page 99
251
2,395
13,996
153
$191,692
$566,418
$572,767
$969,709
$2,300,585
Table 4.17b (Continued). Total Annual Costs of the Pesticide Container Rule for
Regulated Entities (Interest Rate = 7 percent) (2005$)
Swimming Pool Supply Companies – Antimicrobial Applicators
Large-Small
Medium-Small
Small-Small
Large
$33
$24
$16
14
117
174
$8,732
17
$458
$2,755
$2,821
$148,448
National Total Across Size Categories
$154,481
National Total Across All Regulated Entities
$8,449,929
The average pesticide registrant across market sectors is assumed to have the same distribution across market
sectors as the distribution of pesticides across market sectors (by volume of pesticide) in the pesticide industry as
a whole:
Agricultural sector:
40 percent
Industrial/commercial/govt. sector: 30 percent
Home & Garden sector:
30 percent
a
Page 100
Costs are presented by regulation in Tables 4.18a and 4.18b. Approximately 16 percent of the
cost of compliance is attributed to compliance with the residue removal standards. The refillingrelated standards and labeling standards account for 38 percent and 27 percent of the total cost of
compliance, respectively.
Table 4.18a. Total Annual National Cost of Each Regulation Under the Pesticide
Container Rule (Interest Rate = 3 percent) (2005$)
Regulation
Annual National Cost
For Non-Refillable Containers
DOT Packaging Standards - hazardous material a
DOT Packaging Standards - non-hazardous material
Closure Standards
$0
a
a
$0
Standards for container dispensing capability a
Residue Removal standards
$0
a
$1,465,967
$202,617
Other administrative requirements – recordkeeping
For Refillable Containers
DOT Packaging Standards - hazardous material a
DOT Packaging Standards - non-hazardous material
$0
a
Standards for container markings
Standards for openings (for liquid minibulks only)
Bulk container standards
Other administrative requirements – recordkeeping
For Refilling
For Labeling
Cost of Waivers
a
$0
$0
$241,402
$261,018
$574,504
$138,849
$3,198,256
$2,252,148
$32,624
Total National Cost Annually
Incorporates waivers for 5 percent of pesticide registrants.
Page 101
$8,367,385
Table 4.18b. Total Annual National Cost of Each Regulation Under the Pesticide
Container Rule (Interest Rate = 7 percent) (2005$)
Regulation
Annual National Cost
For Non-Refillable Containers
DOT Packaging Standards - hazardous material a
$0
DOT Packaging Standards - non-hazardous material a
$0
Closure Standards a
$0
Standards for container dispensing capability a
Residue Removal standards
$0
a
$1,343,068
Other administrative requirements – recordkeeping
$210,575
For Refillable Containers
DOT Packaging Standards - hazardous material a
$0
DOT Packaging Standards - non-hazardous material a
$0
Standards for container markings
$227,685
Standards for openings (for liquid minibulks only)
$291,648
Bulk container standards
$641,923
Other administrative requirements – recordkeeping
$136,753
For Refilling
$2,849,969
For Labeling
$2,715,685
Cost of Waivers
a
$32,624
Total National Cost Annually
Incorporates waivers for 5 percent of pesticide registrants.
$8,449,929
4.7 Impact Analysis
The impact of the pesticide container rule on a regulated entity is measured as the ratio of that
entity’s annual cost of complying with the rule to its annual revenue. The impacts of the rule are
estimated using both a 3 percent interest rate and a 7 percent interest rate. Estimated impacts are
given for the average regulated entity in each combination of market sector and size class in
Tables 4.19a and 4.19b. For all regulated entities (at both 3 percent and 7 percent) the annual
cost to revenue ratio is less than 0.02 percent. The highest ratios are associated with the small
pesticide registrants. Agricultural pesticide refillers and swimming pool supply companies have
annual cost to revenue ratios very close to zero.
Page 102
Table 4.19a. Ratio of Annual Compliance Cost to Annual Revenue for the Average
Regulated Entity (Interest Rate = 3 percent) (2005$)
Annual Cost For
the Average
Regulated
Entity b
Annual CostAnnual Revenue Revenue Ratio For
For the Average
the Average
Regulated Entity c Regulated Entity
Regulated Entities a
Small Pesticide Registrants
Agricultural
$1,817
$9,439,902
0.02%
I/C/G
$1,813
$9,439,902
0.02%
Home & Garden
$1,784
$9,439,902
0.02%
Large-Small Pesticide Registrants
Agricultural
$5,477
$52,676,100
0.01%
I/C/G
$5,459
$52,676,100
0.01%
Home & Garden
$5,352
$52,676,100
0.01%
Medium-Small Pesticide Registrants
Agricultural
$2,625
$9,758,400
0.03%
I/C/G
$2,621
$9,758,400
0.03%
Home & Garden
$2,591
$9,758,400
0.03%
Small-Small Pesticide Registrants
Agricultural
$805
$2,075,800
0.04%
I/C/G
$805
$2,075,800
0.04%
Home & Garden
$788
$2,075,800
0.04%
Large Pesticide Registrants
Agricultural
$23,425
$7,363,740,000
0.00%
I/C/G
$20,881
$7,363,740,000
0.00%
Home & Garden
$7,774
$7,363,740,000
0.00%
Agricultural Pesticide Refillers
Small
$88
$1,985,935
0.00%
Large-Small
$871
$22,705,400
0.00%
Medium-Small
$267
$6,730,300
0.00%
Small-Small
$43
$802,500
0.01%
Large
$7,255
$191,604,900
0.00%
Swimming Pool (Antimicrobial) Supply
Companies
Small
$19
$1,537,432
0.00%
Large-Small
$34
$5,266,697
0.00%
Medium-Small
$23
$2,620,614
0.00%
Small-Small
$15
$509,031
0.00%
Large
$10,000
$2,511,092,910
0.00%
a
Average cost for the small size category is calculated by adding the cost for the small-small, medium-small, and
large-small categories and dividing the sum by the total number of companies in the small size category. Similarly,
the average revenue for the small size category was calculated by adding the total revenue for each of its component
size categories and dividing the sum by the total number of companies in the small size category.
b
Annual cost of the average regulated entity is calculated by dividing the total cost for the regulated entities by the
total number of entities under the scope of the rule.
c
Annual average revenue for the average regulated entity is calculated by dividing the total revenue by the total
number of entities.
Page 103
Table 4.19b. Ratio of Annual Compliance Cost to Annual Revenue for the Average
Regulated Entity (Interest Rate = 7 percent) (2005$)
Annual Cost For
the Average
Regulated
Entity b
Annual
Revenue For
the Average
Regulated
Entity c
Annual CostRevenue Ratio For
the Average
Regulated Entity
Regulated Entities a
Small Pesticide Registrants
Agricultural
$1,947
$9,439,902
0.02%
I/C/G
$1,944
$9,439,902
0.02%
Home & Garden
$1,912
$9,439,902
0.02%
Large-Small Pesticide Registrants
Agricultural
$6,018
$52,676,100
0.01%
I/C/G
$6,003
$52,676,100
0.01%
Home & Garden
$5,891
$52,676,100
0.01%
Medium-Small Pesticide Registrants
Agricultural
$2,865
$9,758,400
0.03%
I/C/G
$2,863
$9,758,400
0.03%
Home & Garden
$2,830
$9,758,400
0.03%
Small-Small Pesticide Registrants
Agricultural
$813
$2,075,800
0.04%
I/C/G
$812
$2,075,800
0.04%
Home & Garden
$794
$2,075,800
0.04%
Large Pesticide Registrants
Agricultural
$24,430 $7,363,740,000
0.00%
I/C/G
$22,335 $7,363,740,000
0.00%
Home & Garden
$8,685 $7,363,740,000
0.00%
Agricultural Pesticide Refillers
Small ag. pesticide refillers
$80
$1,985,935
0.00%
Large-Small ag. pesticide refillers
$764
$22,705,400
0.00%
Medium-Small ag. pesticide refillers
$237
$6,730,300
0.00%
Small-Small ag. pesticide refillers
$41
$802,500
0.01%
Large ag. pesticide refillers
$6,336
$191,604,900
0.00%
Swimming Pool (Antimicrobial) Supply
Companies
Small swimming pool supply companies
$20
$1,537,432
0.00%
Large-Small swimming pool supply companies
$33
$5,266,697
0.00%
Medium-Small swimming pool supply companies
$24
$2,620,614
0.00%
Small-Small swimming pool supply companies
$16
$509,031
0.00%
Large swimming pool supply companies
$8,732 $2,511,092,910
0.00%
a
Average cost for the small size category is calculated by adding the cost for the small-small, medium-small, and
large-small categories and dividing it by the total number of companies in the small size category. Similarly, the
average revenue for the small size category was calculated by dividing the total revenue for each of its component
size category and dividing it by the total companies in this size category.
b
Annual cost of the average regulated entity is calculated by dividing the total cost for the regulated entities by the
total number of entities under the scope of the rule.
c
Annual average revenue for the average regulated entity is calculated by dividing the total revenue by the total
number of entities.
Page 104
For purposes of the analysis under the Small Business Regulatory Enforcement and Fairness Act
(SBREFA), we combined the three sub-categories of small businesses within the “small” size
class (i.e., large-small, medium-small, and small-small) into a single “small” size class for each
regulated entity type in Tables 4.19a and 4.19b. A threshold for regulations potentially causing
significant impacts to small businesses is an annual cost to revenue ratio of greater than
1 percent. As is evident from these tables, in no case are annual compliance costs for the average
small regulated entity expected to exceed 0.02 percent of annual average revenue. As a result,
significant impacts on small businesses are not expected as a result of the container regulations.
The ratio is highest among small entities for small pesticide registrants, at 0.02 percent. Small
agricultural pesticide refillers and small swimming pool supply companies are estimated to have
annual revenue to cost ratios very close to zero.
We found similar results using the alternative definition of small businesses used in the EA. The
impacts to small businesses using the alternative definition, in terms of the annual revenue to
cost ratio, are estimated to be no more than 0.04 percent. As with the SBA-defined small
entities, the highest ratio is measured for small pesticide registrants—ranging from a ratio of
0.01 percent for large-small registrants to 0.04 percent for small-small registrants. The annual
cost to revenue ratio does not change using the alternative definition of small business (versus
the SBA definition) for small agricultural pesticide refillers and small swimming pool supply
companies. Redefining the small pesticide registrant has provided more information in regards
to the impacts expected across the spectrum of small businesses impacted by the container
regulations, but the impacts still remain below the threshold of causing a significant impact to
small businesses.
4.8 Sensitivity Analysis
Many of the assumptions present in the preceding cost analysis discussion (and presented in
detail in Appendix A) are inherently uncertain, though every effort has been made to use the best
available data to inform our assumptions. Despite efforts to minimize the uncertainty,
uncertainty remains. It is important, therefore, to attempt to characterize the impact that this
uncertainty has on the magnitude of the total regulatory compliance costs we have estimated for
the container regulations.
To test the sensitivity of total cost estimates to the assumptions in the analysis, compliance costs
have been recalculated based on a suite of lower- and upper-bound assumptions that bound the
central cost estimate presented in the primary analysis. The lower-bound suite of assumptions is
composed of adjustments to the primary assumptions that lower the overall container regulations
compliance cost. The upper-bound suite of assumptions is composed of adjustments to the
primary assumptions that increase the overall compliance cost for the container regulations. We
calculated the resulting upper- and lower-bound costs in the same manner as described in the
preceding sections. We used a 3 percent discount rate to calculate the present discounted value
of costs and in the annualization of those costs.
Page 105
Parameters were selected for sensitivity analysis based on the following two criteria:
(1) Total costs appear particularly sensitive to a given assumption; and
(2) We have a reasonable idea regarding what the lower and upper bounds of a given assumption
should be.
The sensitivity analysis is summarized in Table 4.20. As compared to the total cost estimate of
$8.4 million (3 percent discount rate) and $8.5 million (7 percent discount rate), the “low-end”
total cost is $4.9 million, while the “high-end” estimate is $11.0 million.52 The low-end total cost
estimate is 42 percent lower than the total cost under primary assumptions, while the high-end
estimate is 32 percent higher.
Table 4.20. Annual National Cost of Regulation Under the Pesticide Container Rule
(2005$)
Sensitivity Scenario
3% discount rate
7% discount rate
Low (3% discount rate)
Annual Cost Nationally
$8,367,385
$8,449,929
$4,852,818
High (3% discount rate)
$11,043,774
The underlying suites of “low-end” and “high-end” assumptions are given in Table 4.21. The
detailed breakdown of resulting costs are shown in Tables 4.22 and 4.23, based on the “low-end”
suite of assumptions, and in Tables 4.24 and 4.25 based on the “high-end” suite of assumptions.
These tables show the same set of total cost results that were shown for the primary analysis in
Tables 4.17a, 4.17b, 4.18a, and 4.18b.
In order to assess the sensitivity of the cost estimates to the different assumptions, we calculated
the percentage reduction in total costs associated with a change in each assumption for the “lowend” assumption. We find that the largest percentage reduction in cost is because of changes in
the labeling requirements (22 percent). Under the primary cost assumption we assume that 50
percent of the label changes are “routine” and incur only one-third of the label change cost and
50 percent of the label changes are “necessary” and incur all the label change cost, while in the
“low-end” cost assumptions we assume that all label changes are “routine.” Since the labeling
change cost is high, ranging from $205 for a “routine” change small-small establishments to
$5,069 for a “necessary” change for all establishments except the small-small, changes in the
assumptions about the number of entities for which this is a “routine” or a “necessary” change
have a fairly significant implication on the cost.
The assumption about the percentage of container/formulations combinations that will be exempt
from residue removal testing because of similarities to other container/formulations
combinations (“me-toos”) led to a 4 percent reduction in cost. Changing the percentage of
containers that pass the initial residue removal test from 30 percent to 0 percent reduced the cost
by 5 percent. Reducing the labor time assumptions by 25 percent for the refilling compliance
criteria reduces the cost by 9 percent, while for standards for container markings and
52
Both cost estimates are based on a 3 percent discount rate.
Page 106
administrative requirements for both non-refillables and refillables, the reduction in labor time
assumptions by 25 percent reduces the cost by less than 2 percent.
In addition to the above assumption, we also considered the sensitivity of the cost analysis to
changes in the assumption about the time it takes to inspect containers. The analysis assumes
that on average it takes about 1 minute to inspect containers. Given that a relatively larger
number of containers are small, this seems reasonable. When we change the inspection time to 5
minutes, the total cost estimate increases to $10.5 million, which is a significant increase. It is
not clear, however, that 5 minutes is a more reasonable assumption for the amount of time it
takes to inspect containers. Although it is conceivable that in reality large containers take about
5 minutes and smaller containers take less, we did not have data to support different inspection
times for different container sizes.
Page 107
Table 4.21. “Low-End” and “High-End” Assumptions for Sensitivity Analysis
Regulation
“Low-End” Cost
Assumptions
Primary Cost Assumptions
“High-End” Cost
Assumptions
Non-Refillable Sensitivity Tests
Residue Removal
Standard Percent of Containers
Retested a
All containers pass the
initial residue removal
test.
30% of the containers pass the 50% of the containers
initial residue removal test.
pass the residue removal
test.
Residue Removal
Standard “Me-Toos” b
50% of all
container/formulations
combinations exempt
from residue removal
testing.
25% of all
container/formulation
combinations exempt from
residue removal testing.
Administrative
Requirements Recordkeeping c
Reduce labor time
assumptions by 25%.
Increase labor time
Large and Large-Small
Establishments: 40 hours for assumptions by 25%.
existing container/formulation
combinations and 4 hours for
new container/formulation
combinations.
Medium-Small
Establishments:
36 hours for existing
container/formulation
combinations and 3 hours for
new container/formulation
combinations
Small-Small Establishments:
24 hours for existing
container/formulation
combinations and 2 hours for
new container/formulation
combinations
Refillable Sensitivity Tests
Administrative
Reduce labor time
Requirements assumptions by 25%.
Recordkeeping c
No container/formulation
combinations exempt
from residue removal
testing.
Increase labor time
Large and Large-Small
Establishments: 31 hours for assumptions by 25%.
existing container/formulation
combinations and 4.4 hours
for new container/formulation
combinations.
Medium-Small
Establishments:
21 hours for existing
container/formulation
combinations and 2.5 hours
for new container/formulation
combinations
Small-Small Establishments:
11 hours for existing
container/formulation
combinations and 2 hours for
new container/formulation
combinations
Page 108
Table 4.21. “Low-End” and “High-End” Assumptions for Sensitivity Analysis
“Low-End” Cost
Assumptions
Regulation
Primary Cost Assumptions
“High-End” Cost
Assumptions
Standards for Container
Marking c
Reduce labor time
assumptions by 25%.
It takes 5 minutes to mark
each container.
Increase labor time
assumptions by 25%.
Refiller Sensitivity Tests
Refilling Compliance
Criteria d
Reduce labor time
assumptions by 25%.
For each refill, it takes 1
minute to inspect, 10 minutes
to rinse, and 2 minutes to
record information about a
container.
Increase labor time
assumptions by 25%.
Facility-Level Sensitivity Tests
Labeling Requirements e
Assume that all label
changes during the
compliance period are
“routine” changes and
incur only one-third of
the label change cost.
Assume that 50% of label
Assume that all label
changes are “routine” and
changes during the
incur only one-third of the
compliance period are
label change cost, and 50% of “necessary” and incur all
label changes are “necessary” of the label change cost.
and incur all of the label
change cost.
a
Primary cost assumption based on final container regulations that require containers to achieve only a four-9s
standard. It is assumed that all containers will pass the four-9s standard as a lower bound. The high-end assumption
is based on a container’s ability to achieve a six-9s standard. See EPA (1993, p. IX-13).
b
In the proposed container rule RIA, EPA made a lower cost assumption that 50 percent of container/formulation
combinations would be exempt from residue removal testing because of similarities to other container/formulation
combinations (“me-toos”). EPA’s upper cost assumption stated that all container/formulations would be tested.
These high- and low-end cost assumptions are retained here and use the mid-point between the two as the primary
cost assumption. See EPA (1993, p. IX-13).
c
Labor times used in the primary analysis are based on assumptions made by EPA in the proposed container rule
RIA (EPA, 1993, p. IX-13). It is assumed that plus or minus 25 percent of the labor time used in the primary
analysis is a reasonable uncertainty bound.
d
Using professional judgment, based on estimates made by EPA in the proposed container rule RIA as a baseline
(EPA, 1993, p. IX-13), the labor times associated with the primary cost assumptions are estimated.
e
The primary cost assumption is based on assumptions made by EPA in the proposed container rule RIA (EPA,
1993, pp. X-1 through X-7). We believe a reasonable lower cost assumption is that all label changes during the
compliance period are considered “routine” (therefore incurring only one-third the cost of changing a label). A
reasonable high-end cost assumption is that all label changes during the compliance period are considered
“necessary” (therefore incurring the total cost of changing a label). The primary analysis assumes that during the
compliance period 50 percent of label changes are routine and the rest are necessary.
Page 109
Table 4.22. Total Annual Costs of the Pesticide Container Rule for Regulated Entities:
Using “Low End” Assumptions (Interest Rate = 3 percent) (2005$)
For the
Average
Regulated
Entity
Regulated Entities
Pesticide Registrants
Large-Small
Agricultural
I/C/G
Home & Garden
Number of
Regulated
Entities
$1,745
$1,734
$1,635
$1,709
66
50
50
Average
Across Market
Sectors a
National Total Across Market Sectors
Medium-Small
Agricultural
I/C/G
Home & Garden
$884
$882
$850
$873
Home & Garden
198
148
148
$384
399
$153,067
$383
$367
$379
299
299
$114,671
$109,788
$15,778
$14,249
$2,185
$11,242
$377,527
58
44
44
Average
Across Market
Sectors a
National Total Across Market Sectors
National Total Across Market Sectors and Size
Categories
Agricultural Pesticide Refillers
Large-Small ag. pesticide refillers
Medium-Small ag. pesticide refillers
Small-Small ag. pesticide
refillers
Large ag. pesticide refillers
$921,459
$624,126
$95,699
$1,641,283
$2,734,662
$657
$267
251
$204
$164,824
2,395
$36
$5,445
13,996
153
$499,340
$833,217
National Total Across Size Categories
Page 110
$174,928
$130,895
$126,118
$431,941
Average
Across Market
Sectors a
National Total Across Market Sectors
Large
Agricultural
I/C/G
Home & Garden
$115,978
$86,438
$81,496
$283,912
Average
Across Market
Sectors a
National Total Across Market Sectors
Small-Small
Agricultural
I/C/G
Over All
Regulated
Entities
$1,985,265
Table 4.22 (Continued). Total Annual Costs of the Pesticide Container Rule for Regulated
Entities: Using “Low End” Assumptions (Interest Rate = 3 percent) (2005$)
For the
Average
Regulated
Entity
Regulated Entities
Swimming Pool Applicators – Antimicrobial
Applicators
Large-Small swimming pool applicators
Medium-Small swimming pool applicators
Small-Small swimming pool applicators
Large swimming pool applicators
Number of
Regulated
Entities
$29
$21
$14
$7,503
National Total Across Size Categories
14
117
174
17
Over All
Regulated
Entities
$401
$2,427
$2,514
$127,549
$132,891
National Total Across All Regulated Entities
$4,852,818
The average pesticide registrant across market sectors is assumed to have the same distribution across market
sectors as the distribution of pesticides across market sectors (by volume of pesticide) in the pesticide industry as
a whole:
Agriculture sector:
40 percent
Industrial/Commercial/Govt.: 30 percent
Home and Garden:
30 percent
a
Page 111
Table 4.23. Total Annual National Cost of Each Regulation Under the Pesticide Container
Rule: Using “Low End” Assumptions (Interest Rate = 3 percent) (2005$)
Regulation
For Non-Refillable Containers
DOT Packaging Standards - hazardous material a
Annual National Cost
v
DOT Packaging Standards - non-hazardous material a
$0
Closure Standards a
$0
Standards for container dispensing capability a
$0
Residue Removal standards a
Other administrative requirements – recordkeeping
For Refillable Containers
DOT Packaging Standards - hazardous material a
$708,913
$151,963
DOT Packaging Standards - non-hazardous material a
Standards for container markings
Standards for openings (for liquid minibulks only)
Bulk container standards
Other administrative requirements – recordkeeping
$0
$181,065
$261,018
$574,504
$109,480
For Refilling:
For Labeling:
Cost of Waivers:
a
Total National Cost Annually
Incorporates waivers for 5 percent of pesticide registrants.
Page 112
$0
$2,458,094
$393,188
$14,594
$4,852,818
Table 4.24. Total Annual Costs of the Pesticide Container Rule for Regulated Entities:
Using “High End” Assumptions (Interest Rate = 3 percent) (2005$)
Regulated Entities
For the Average
Regulated Entity
Pesticide Registrants:
Large-Small
Agricultural
I/C/G
Home & Garden
Number of
Regulated
Entities
$8,227
$8,201
$8,087
$8,177
66
50
50
Average Across
Market Sectors a
National Total Across Market Sectors:
Medium-Small
Agricultural
I/C/G
Home & Garden
Average Across Market Sectors a
$3,874
$3,869
$3,838
$3,862
I/C/G
Home & Garden
Average Across Market Sectors a
$974
$973
$956
$969
198
148
148
Average Across Market Sectors a
$29,842
$26,285
$12,135
$23,463
399
299
299
$1,086
$331
$51
Large ag. pesticide refillers
$9,066
National Total Across Size Categories:
Page 113
$388,510
$291,083
$286,024
$965,617
58
44
44
National Total Across Market Sectors:
National Total Across Market Sectors and Size Categories:
Agricultural Pesticide Refillers
Large-Small ag. pesticide
refillers
Medium-Small ag. pesticide refillers
Small-Small ag. pesticide refillers
$766,744
$574,358
$569,658
$1,910,760
National Total Across Market Sectors:
Large
Agricultural
I/C/G
Home & Garden
$546,825
$408,850
$403,165
$1,358,840
National Total Across Market Sectors:
Small-Small
Agricultural
Over All
Regulated
Entities
$1,742,799
$1,151,286
$531,518
$3,425,603
$7,660,820
251
$331
$272,544
2,395
$51
153
13,996
$1,387,376
$3,164,027
Table 4.24 (Continued). Total Annual Costs of the Pesticide Container Rule for Regulated
Entities: Using “High End” Assumptions (Interest Rate = 3 percent) (2005$)
Swimming Pool Applicators – Antimicrobial Applicators
Large-Small swimming pool applicators
Medium-Small swimming pool applicators
Small-Small swimming pool applicators
Large swimming pool applicators
$39
$26
$15
$12,496
14
117
174
17
$548
$3,037
$2,690
$212,436
National Total Across Size Categories
$218,710
National Total Across All Regulated Entities
$11,043,557
The average pesticide registrant across market sectors is assumed to have the same distribution across market sectors
as the distribution of pesticides across market sectors (by volume of pesticide) in the pesticide industry as a whole:
Agriculture sector:
40 percent
Industrial/Commercial/Govt.: 30 percent
Home and Garden:
30 percent
a
Page 114
Table 4.25. Total Annual National Cost of Each Regulation Under the Pesticide Container
Rule: Using “High End” Assumptions (Interest Rate = 3 percent) (2005$)
Annual National
Cost
Regulation
For Non-Refillable Containers
DOT Packaging Standards - hazardous material a
$0
DOT Packaging Standards - non-hazardous material
Closure Standards
a
a
$0
Standards for container dispensing capability
a
$0
a
Residue Removal standards
Other administrative requirements – recordkeeping
$1,403,140
$253,271
For Refillable Containers
DOT Packaging Standards - hazardous material a
$0
DOT Packaging Standards - non-hazardous material
Standards for container markings
Standards for openings (for liquid minibulks only)
Bulk container standards
Other administrative requirements – recordkeeping
a
For Refilling
For Labeling
Cost of Waivers
a
$0
Total National Cost Annually
Incorporates waivers for 5 percent of pesticide registrants.
Page 115
$0
$301,743
$261,018
$574,504
$167,730
$3,938,418
$4,111,108
$32,624
$11,043,557
5.0 The Human and Non-Human Health Benefits of the Final Standards
5.1 Introduction
The container design and residue removal standards are largely pollution prevention regulations
that will safeguard workers, such as loaders, mixers, and applicators, and the environment by
reducing the risk of exposure to concentrated pesticides. First, the proposed improvements in
pesticide container designs will enhance the safe handling, dispensing, use, and residue removal
efficiency of pesticide containers. Second, the improvement in procedures and/or container
designs will help facilitate the “clean rinsing” of emptied containers either prior to disposal or
recycling, or prior to reuse. There are numerous types of human health-related benefits and nonhuman health-related (environment-related) benefits that will stem from such improvements
because of relatively fewer expected spills, leaks, and other risks associated with exposure (e.g.,
handling by workers during disposal, discharges to the environment, and potential public
exposures).
Table 5.1 summarizes the various types of expected benefits (i.e., improved worker safety,
improved public health, reduced environmental risk, and other effects) resulting from the
proposed container design/residue removal regulations. It also characterizes the sources of the
expected benefits. Besides human health-related and environment-related benefits, there are
other effects such as property damage, personal liability effects, and insurance costs that
contribute to the overall benefits assessment. Due to limitations in the data available on these
benefits, there is a high degree of uncertainty concerning both the number and average cost
(including unquantifiable components of loss such as pain and suffering) of both container
design and residue removal problems. As a result, the costs of all of the expected benefits cannot
be quantified. However, data do exist to quantify some of the expected benefits of the
regulations. Section 5.2 discusses the method and estimates of the number of pesticide-related
illnesses and injuries potentially avoided as a result of the pesticide container regulations and
presents the estimated value of these avoided illnesses and injuries. Section 5.3 discusses and
estimates the cost savings from the disposal of rigid non-refillable containers as non-hazardous
rather than hazardous waste as a result of the regulations, and discusses the potential for a
reduction in the number of environmental effects and property damage/spill cleanup costs as a
result of the container regulations.
Page 116
Table 5.1. The Types of Expected Benefits from the Container Design and Residue
Removal Regulations and Their Sources
Expected Benefit
Source of Expected Benefit
Human Health-Related Benefits
Improved Worker Safety
•
•
•
•
•
•
Improved Public Health
•
•
•
Reduced accidental spills
Fewer leaks
Less dripping
Less frequent container stress failure (durability,
formulation/container degradation)
Reduced personal sickness and injury
Improved worker productivity
Less risk of exposure to spills and leaking/dripping
Less contamination of surface water and groundwater sources
Less personal injury from accidental spills and chronic contamination
sources
Non-Human Health-Related Benefits
Reduced Environmental Risk
•
•
•
Reduced accidental spills
Fewer chronic accumulations of chemicals in
loading/mixing/cleaning areas
Reduced risk of harm from pesticide residues to terrestrial and
aquatic wildlife including sensitive and critical habitats
Less disposal of hazardous containers in landfills
•
•
•
•
•
Reduced property damage
Reduced risk of personal injury and liability
Lower costs for personal liability insurance
Reduced disposal costs for cleaner containers
Reduced loss of product from spills and leaks
•
Other Effects
5.2 Human Health-Related Benefits: Estimated Annual National Cases and Valuation
of Pesticide Product-Related Illnesses and Injuries Potentially Avoided by the
Standards
In this section, the annual nationwide number and value of pesticide-related illnesses and injuries
potentially avoided as a result of the pesticide container design and residue removal regulations
is estimated. The calculations involved in the results and the underlying methodology used in
the derivation of the national estimate is described. Section 5.2.1 describes the overall
methodological approach used. This is followed in Section 5.2.2 by a discussion of the state data
used to derive the percentage of pesticide illnesses potentially related to the container design and
residue removal standards. Section 5.2.3 describes the annual national number of pesticide
exposures and resulting illnesses to which the state data were applied. Section 5.2.4 discusses
the extrapolation of the state data to estimated pesticide illnesses nationwide and provides a
discussion of these findings. Finally, Section 5.2.5 describes the approach to valuing the avoided
illnesses by estimating the direct and indirect costs for several severity levels of illness. More
detailed information on the general and health-related characteristics of the Toxic Exposure
Surveillance System (TESS) exposure data subset underlying our discussion in Section 5.2.3 can
be found in Appendix H, and additional data on direct costs for physician visits, relevant to
Section 5.2.5, is listed in Appendix I. The detailed case summaries from California in 1999 that
we used in the analysis (Section 5.2.2) to determine the percentage of pesticide illness potentially
related to the container regulations are located in Appendix J.
Page 117
5.2.1 Summary of Approach
The first step in estimating the number of illnesses expected to be avoided as a result of the
container design and residue removal regulations required identifying the available surveillance
data on the number of toxic substance related illnesses. After reviewing the available toxic
substance surveillance systems, we selected TESS for estimating the number of injuries and
illnesses associated with pesticide exposure per year. TESS is a comprehensive surveillance
system developed in 1983 by the American Association of Poison Control Centers (AAPCC) to
track acute illness and injury related to toxic substances. The system contains detailed
toxicological information on poison exposures reported to more than 60 poison centers around
the country, capturing an estimated 98.8 percent of all poison exposures reported to poison
centers in the United States. We requested a detailed report from AAPCC (2002) describing
“unintentional” exposures to fungicides, herbicides, insecticides, rodenticides, non-pine oil
disinfectants, and anti-algae paints to estimate the annual number of unintentional pesticide
illness cases expected per year. For the purposes of this analysis, we will refer to these
conventional and antimicrobial pesticide substance categories as “pesticide products.”
Given the estimated annual national illnesses associated with pesticide products in the TESS
data, we estimated the percentage of those cases that may have resulted from incidents related to
containers and residue removal. The percentage to be applied to the annual number of
unintentionally caused pesticide product illnesses from TESS was based on EPA’s examination
of state-level case history data from California. EPA examined case summaries from the
Pesticide Illness Surveillance Program (PISP) database maintained by the California Department
of Pesticide Regulation (CDPR) for 1999 and estimated the number of cases that are “very
likely,” “possibly,” and “unlikely” to be avoided as a result of the regulations (CDPR, 2001a,b).
The estimates of cases that were “very likely” to be avoided as a result of the regulations were
used to calculate the ratio of pesticide container design/residue-related cases to total pesticide
product incidents in California. We applied this state-level proportion to the United States as a
whole to estimate the annual national number of avoided pesticide product illnesses that are
expected as a result of the container design and residue removal regulations.
We purchased a single report from TESS itemizing the exposures involving the TESS pesticide
product categories described above. We selected the product categories to most closely resemble
the pesticide products covered in the California database. In particular, the active ingredients
considered by CDPR as antimicrobials were determined to be covered by the TESS categories
queried. Therefore, the percentage of pesticide-related illnesses avoided as a result of the
regulations, estimated for California, could be applied to the national number of pesticide-related
illnesses queried from TESS. The potential illnesses avoided from the container design and
residue removal regulations described are therefore attributable to both antimicrobial and
conventional pesticide products.
5.2.2 Derivation of the Annual Percentage of Pesticide Illnesses Potentially Avoided as a
Result of the Container Design and Residue Removal Regulations
CDPR conducts ongoing surveillance of people and the environment to detect the potential for
pesticide exposure as part of its pesticide safety program. CDPR’s PISP has required mandatory
reporting of pesticide illnesses since 1971, making it the most comprehensive monitoring
Page 118
program in the country. Under a California state statute, physicians are required to report any
suspected case of pesticide-related illness or injury to the local health officer within 24 hours of
examining the patient.
In addition, CDPR reviews doctor’s reports for workers’ compensation claims under the
pesticide illness surveillance program. Staff members investigate any claim that mentions
(1) pesticides as a possible cause of illness or injury or (2) unspecified chemicals if the setting is
one in which pesticide use is likely. CDPR also works with the California Poison Control
System to facilitate reporting of pesticide-related illnesses by health care workers.
To estimate the percentage of unintentional pesticide product illnesses potentially avoided as a
result of the container regulations, it is first necessary to determine the number of unintentional
pesticide product-related illnesses in California. In 1999, CDPR reported 1,201 episodes in
which the pesticide exposure was at least a possible contributing factor to illness or injury.53 The
number of intentional cases occurring in California, however, is not readily available in a
summary report.
We examined the case summaries for a subset of the 1,201 CDPR cases in 1999, corresponding
to a query on particular activity patterns.54 Sixteen potential cases of intentional ingestion were
identified among this subset, 15 of which were conventional pesticides and one antimicrobial.
The 1999 CDPR summary table of pesticide-related illnesses summarized by activity and type of
exposure reports that 35 of the 1,201 total incidents occurred as a result of ingestion (CDPR,
2001b). Of the 35 cases, only 10 would have been excluded in the subset examined,
corresponding to “routine indoor” and “routine outdoor” activities.55 Assuming that (1) pesticide
ingestion would be the only means of intentional exposure and (2) none of the ingestion
exposures occurring during “routine indoor” and “routine outdoor” activities were intentional,
the 16 intentional incidents identified from case reports should reflect the total number of
intentional pesticide-related illnesses in the CDPR database. Using these assumptions, it was
estimated that for 1999, 1,185 of the pesticide cases in California were due to unintentional
exposures.
53
1999 incident data is representative of the other years for which data have been analyzed relative to the container
regulations. In 1999 there were 16 container related cases while from 1995-1999 there were on an average 15
container related cases.
54
A total of 489 case summaries resulted from EPA’s query of the 1999 CDPR incident database. The query was for
incidents from the following field “activities,” during which EPA believes container-related illnesses are likely to
occur:
(1) Occupational: Mixer/loader, aerial (code 111); Mixer/loader, ground (112); Mixer/loader, hand (113);
Applicator, hand (123); Applicator, other (124); Repair/maintenance (160); Exposed to concentrate (182);
Emergency response (183); Other (199)
(2) Non-Occupational: Application (220); Other (299).
55
The CDPR incident database defines routine indoor and outdoor activity in the following way:
(1) Routine indoor activity: Conducts activities in an indoor environment with minimal expectation for exposure to
pesticides. This includes people in offices and businesses, residential structures, etc., who are not handling
pesticides.
(2) Routine outdoor activity: Conducts activities in an outdoor environment with minimal expectation for exposure
to pesticides. This excludes field workers in agricultural fields. This includes gardeners who are not handling
pesticides.
Page 119
Furthermore, since pine oil will not be subject to the regulations, and since it was not included in
the revised TESS query, the cases in 1999 that involved pine oil must also be excluded. In the
1999 CDPR summary table of pesticide-related illnesses summarized by pesticide, it is reported
that seven cases involved pine oil (CDPR, 2001a). However, the single antimicrobial intentional
case identified above also involved pine oil; therefore, an additional six cases were ultimately
excluded from the total number of unintentional pesticide product-related illnesses in California.
The breakdown of pesticide product cases is summarized in Table 5.2.
Table 5.2. Number of Reported Total, Intentional, and Pine Oil-Related Illnesses a in
California’s Pesticide Illness Surveillance Program in 1999
Description
Total Cases
Number of Cases
a
1,201
Intentional, antimicrobial pesticide case
1
Intentional, conventional pesticide cases
15
Pine oil cases
6
Total Unintentional Pesticide Product Cases
1,179
Only those cases in which the relationship between pesticide exposure and illness is designated as “possible,”
“probable,” or “definite” are included.
a
To estimate the number of potentially avoided cases as a result of the rule, EPA examined the
full set of 1999 CDPR cases summaries with regards to the container design and residue removal
standards and whether or not an antimicrobial chemical would be subject to the regulations. The
likelihood that an incident would have been prevented by the regulations was categorized into
three groups:
•
•
•
V = very likely the incident would have been prevented by the container regulations;
P = possible the incident would have been prevented by the container regulations; and
U = unlikely the incident would have been prevented by the container regulations.56
EPA estimated that seven conventional pesticide illnesses and nine antimicrobial pesticide
illnesses would be subject to and were “very likely” to be prevented by the regulations. These
cases represent 1.36 percent of the 1,179 incidents in California that were due to unintentional,
non-pine oil exposures. A flow chart showing the distribution of CDPR cases is presented in
Figure 5.1.
In addition to the 16 incidents designated as “very likely” avoided by the rule, 51 incidents were
are designated by EPA as “possibly” avoided: 15 conventional pesticide illnesses “possibly”
56
An example of each category of likelihood (very likely, possibly, and unlikely, respectively) that an incident
would have been prevented by the container regulations:
Case 1999-511 (glyphosate): While preparing to spray weeds, a homeowner pulled up on the plunger of a ready-touse glyphosate container. The plunger handle broke off, allowing glyphosate to spray up into his face. He felt
irritant symptoms, so he showered and sought medical attention.
Case 1999-56 (cypermethrin): A courtesy clerk dropped a can of insecticide as she returned it to the shelf. When
she picked it up, it exploded in her face. She washed but developed symptoms 30 minutes later.
Case 1999-932 (methyl bromide): Two workers tried to remove the custom locking caps from a methyl bromide
cylinder and replace it with a standard cap before returning the cylinder to the dealer. The valve was opened and
released methyl bromide.
Page 120
avoided as a result of the regulations; 30 non-exempt antimicrobial illnesses “possibly” avoided
as a result of the regulations; and six antimicrobial illnesses that would “very likely” be avoided
if subject to the regulations, but for which it is unclear from the information provided if they are
subject to the regulations.
Page 121
Figure 5.1. Flow Chart of 1999 California Department of Pesticide Regulation (CDPR) Pesticide-Related Incidents
1201 total CDPR illness “possibly”
, “probably” or “definitely” related
to pesticide exposure.
385antimicrobial
related illnesses
1 (pine oil) case
from intentional
exposure +
331 cases
“unlikely”
related to
container
design and
residue
removal
30/1179 = 2.54% cases
involving non-exempt
antimicrobials possibly
prevented by the
container regulations
815 nonantimicrobial
related illnesses
379 cases from
unintentional
exposure
39 cases
“possibly”
related to
container
design and
residue
removal
15 cases from
unintentional
exposure
9 cases “very
likely” related
to container
design and
residue
removal
standards
6/1179 = 0.51% cases
involving antimicrobials
but whether subject to
container regulations
and/or insufficient
information
7 cases
“unlikely”
related to
container
design and
residue
removal
16/1179 = 1.36%
pesticide and
antimicrobials-related
illnesses occurring in
CA potentially avoided
by the container design
Page 122
800 cases from
intentional
exposure
15 cases
“unlikely”
related to
container
design and
residue
removal
778 cases
“unlikely”
related to
container
design and
residue
removal
15/1179 = 1.27%
pesticide related
illnesses potentially
avoided by the
container design and
residue removal
These 51 incidents are potentially avoided as a result of the regulations and if included in the
analysis, would increase the percentage of unintentional pesticide product cases by 4.33 percent
(51 of 1,179 cases). For the purposes of extrapolating California data to the national analysis and
valuing the avoided cases, only those cases identified as “very likely” avoided by the regulations
are included (16 of 1,179 cases). It is important to note, however, that additional benefits would
be realized if a portion of these “possible” cases are also avoided as a result of the regulations.
In estimating the percentage of pesticide product-related illnesses potentially avoided, no
adjustment was made for the proportion of pesticide users (e.g., end users, pesticide formulators,
pesticide registrants) already in compliance with the new regulations. Although some percentage
of pesticide users will already be in compliance, it was assumed that any pesticide user already in
compliance should not experience illnesses related to container design and residue removal.
Consequently, any container-related illnesses captured by CDPR’s database should reflect
entities that are not in compliance and, therefore, potentially avoided as a result of the
regulations.
In addition, no adjustment was made based on the percentage of containers covered by the
regulations due to toxicity category. We assumed that those container-related exposures resulting
in illnesses and physician visits would have high enough toxicity levels to be covered by the
regulations. To the extent to which some of the illnesses observed in the CDPR database were
due to pesticide containers excluded by the regulations, the potential benefits could be
overstated.
5.2.3 Profile of Annual National Pesticide Exposure Cases
In the previous section, it was estimated from the California PISP database for 1999 that
approximately 1.36 percent (16 of 1,179 unintentional conventional or antimicrobial pesticide
cases) of illnesses related to pesticide products occurring in California were likely to have been
avoided as a result of the container design and residue removal standards. To estimate the
number of illnesses to which this proportion may translate nationwide, this ratio is applied to the
annual number of unintentional conventional and antimicrobial pesticide-related illnesses
occurring across the country.57 To determine the number of injuries and illnesses related to
pesticide products throughout the United States on an annual basis, an annual detailed report of
2001 TESS data was acquired from the American Association of Poison Control Centers
(AAPCC, 2002). Since TESS is a national surveillance system database in which reports of
human exposures are recorded, the number of exposure cases that resulted in illness was
determined before applying the ratio. This overall methodology is described below in more
detail, including the query of TESS exposure data submitted (Section 5.2.3.1) and the estimated
number of illnesses resulting from pesticide-related unintentional exposures (Section 5.2.3.2).
5.2.3.1 TESS Database Query
After reviewing the format of the findings published in the annual summary, a detailed 2001
TESS report was requested from AAPCC of “unintentional” exposures to the following
57
In using this methodology, it is assumed that the ratio for California would not differ significantly for the United
States as a whole.
Page 123
conventional and antimicrobial pesticide substance categories. As described earlier, for the
purposes of this analysis these substances are referred to as “pesticide products”:
•
•
•
•
•
•
Fungicides;
Herbicides;
Insecticides;
Rodenticides;
Non-pine oil disinfectants; and
Anti-algae paints.
These categories are determined by AAPCC, and more detailed examples of included substances
are identified in the annual summary published in the American Journal of Emergency Medicine
(Litovitz et al., 2002). The illnesses resulting from exposures in which these substances are
implicated were made compatible with those evaluated in CDPR’s PISP by excluding cases
involving pine oil. Similarly, because intentional cases were excluded from the California dataset
in order to estimate the number of potentially avoided cases, the underlying reason for the
exposure was required to be “unintentional.” Therefore, it was requested that these data be
limited only to those resulting from “unintentional” exposures among all other reasons for
poison.58
In 2001, unintentional exposures accounted for 85.2 percent of all reported human poison
exposures (1,931,841 cases out of 2,267,979 reported). Exposures labeled as “intentional” were
involved in 11.6 percent, “other” for 0.7 percent, “adverse reaction” for 2.2 percent, and
“unknown” for 0.4 percent of total overall exposures. The specific definitions associated with
unintentional reasons of exposure are described in Table 5.3.
From the entire TESS database in 2001, of the substances most frequently involved in human
exposures, pesticides59 accounted for 4 percent of the total number of overall toxic exposures.
Among the substances most frequently involved in exposures of children under 6 years of age,
pesticides also represented 4 percent of the total. This was slightly higher, at 4.5 percent of the
total number of exposures, in adults over 19 years old. By limiting the search criteria for the
TESS query, the detailed frequency and distributional information was evaluated just among
accidental pesticide poisonings for the specific categories of pesticide products expected to be
regulated under the rule. The results of the TESS query showed that in 2001, pesticide products
were implicated in 80,978 unintentional exposures. These cases will be referred to as
“unintentional exposures to pesticide products.” The breakdown of these unintentional pesticide
exposure cases by reason is provided in Table 5.3.
58
Other reasons for exposure in TESS were: (1) intentional (e.g., suicidal, abuse, misuse); (2) other (e.g., malicious,
contaminant/tampering); (3) adverse reaction (e.g., drug, food); and (4) unknown.
59
The pesticide group includes fungicides, herbicides, insecticides, repellents, and rodenticides as itemized in
Litovitz, et al. (2002). Repellents were excluded from the query made by EPA.
Page 124
Table 5.3. Profile of Unintentional Pesticide Exposures by Reason of Exposure
Exposure
Reason
With
Concomitants a
Description
Number
General
Any exposure not specifically defined below
Environmental
Percent
Without
Concomitants b
Number
Percent
65,766
81.21%
63,809
82.15%
Any passive, non-occupational exposure that
results from contamination of air, water, or soil
(usually but not always caused by man-made
contaminations)
6,571
8.11%
6,005
7.73%
Occupational
Any exposure that occurs as a direct result of
the person being on the job or in the workplace
2,625
3.24%
2,271
2.92%
Therapeutic
Error
An unintentional deviation from a proper
therapeutic regimen that results in the wrong
dose, incorrect route of administration,
administration to the wrong person, or
administration of the wrong substance (only
exposures to medications or products
substituted for medications are included)
603
0.74%
573
0.74%
Misuse
Improper or incorrect use of a nonpharmaceutical substance (exposure unplanned
or not foreseen by the patient)
5,018
6.20%
4,694
6.04%
Bite/Sting
All animal bites and stings, with or without
envenomation
56
0.07%
21
0.03%
Food Poisoning Suspected or confirmed food poisoning and
ingestion of food contaminated with
microorganisms
42
0.05%
18
0.02%
297
0.37%
281
0.36%
Unknown
Exposure determined to be unintentional but
exact reason is unknown
Total
80,978 100.00%
77,672 100.00%
Source: AAPCC (2002, Report 7 “Reason” and p. 8 “Field Definitions”).
a
“With Concomitants” indicates that a pesticide substance was implicated in the exposure case but could have
involved another substance which may or may not have been another pesticide.
b
“Without Concomitants” indicates that only one pesticide substance was implicated in the exposure.
The majority (77,672 of 80,978 cases or 95.92 percent) of unintentional pesticide exposures in
2001 involved only a single pesticide product substance. These cases of exposure are detailed in
the “Without Concomitants” column in Table 5.3. The remaining fraction (4.08 percent) of
unintentional pesticide exposures in 2001 involved more than a single substance, but at least one
pesticide product. These cases are reflected in the column “With Concomitants” along with the
majority of cases without concomitants, to equal the total number of unintentional exposures to
pesticide products for 2001 (80,978). Therefore, the column “With Concomitants” indicates
exposures in which a pesticide substance was implicated, but another substance, which may or
may not have been another pesticide product, may also have been involved. Since the exposure
cases without concomitants only involve a single pesticide product, we considered restricting the
analysis to those incidents. However, we did not believe that this would be appropriate since a
pesticide product is still implicated in the exposure incident despite the possible co-occurrence of
another substance. Therefore, subsequent estimates are based on the data that included
concomitants.
Page 125
The unintentional reason categories were also reviewed to determine if the corresponding cases
were suitable for this analysis. When we compared the definitions of reason categories, the
“therapeutic error” and “bite/sting” categories initially appeared to be inappropriate for the
objective of this analysis; however, when the data for unintentional exposures were reviewed
without concomitants, the implication of pesticide products in the exposures was not
dramatically altered (e.g., therapeutic error comprises 0.74 percent of all unintentional exposures
to pesticide substances under both scenarios). Therefore, these categories are included in this
analysis. In the discussion below regarding the estimation of annual illnesses related to
conventional and antimicrobial pesticides from reported exposure cases, the overall figure of
80,978 cases of exposure with concomitants is used.
5.2.3.2 Annual National Illnesses Resulting from Unintentional Human Pesticide
Product Exposure Cases
This section describes the number of illnesses used as the national estimate to which the
California-derived proportion of container-related illnesses was applied to total illnesses. As
described above, TESS is a national surveillance database for exposures to toxic substances. In
this section, the evaluation of the proportion of these exposures that resulted in illness is
described. Although the query was limited to pesticide products, not all the observed illnesses
were a result of the pesticide. Three categories are used to describe the relationship between the
clinical effect observed and the exposure in TESS: “related,” “not related,” and “unknown if
related.” For the purposes of this analysis, since we are interested in the number of illnesses that
result from these exposures, we evaluated the cases in which the clinical effects were labeled
“related” to the pesticide exposure as a “low-end” scenario estimate, and the cases in which the
clinical effects were labeled “related” plus those labeled “unknown if related” as a “high-end”
scenario estimate. The guidelines used to assess the relationship between observed clinical
effects and unintentional exposures to pesticide products are summarized in Table 5.4.
Table 5.4. Guidelines for Field Definition of Clinical Effect Relationships to Exposure
Exposure-Clinical Effect
Relationship
Selection Criteria
Related
•
•
•
•
Timing of clinical effect is reasonable for reported exposure;
Severity of effect is consistent with reported exposure;
Effect is consistent with anticipated substance toxicity;
Clinical assessment of relationship was made by a physician.
Not related
•
Effect was pre-existing or began prior to the exposure, and was not
augmented or worsened as a result of the exposure, or
Effect can be ascribed to a documentable alternative etiology.
•
Unknown if Related
•
Relationship between exposure and effect cannot be reasonably
ascertained;
• Effect has never been ascribed to the particular substance, but an
alternative etiology cannot be conclusively established;
• Effect is not expected based on reported exposure;
• Knowledge of patient’s history (e.g., concomitant illnesses, other
medications) is not adequate to allow a determination of the
relationship between the exposure and the effect.
Source: AAPCC (2002, “Field Definitions,” p. 8).
Page 126
Of all the cases presented, 75.93 percent exhibited no clinical effects related to the pesticide
exposure, 14.34 percent of patients exhibited one clinical effect, 6.40 percent showed two
clinical effects, and 3.33 percent sustained three or more clinical effects (Table 5.5). Therefore,
of the 80,978 exposure cases reported, 19,492 victims exhibited clinical effects related to the
pesticide exposure. This estimate represents the “low-end” scenario estimate of the total annual
national cases of pesticide illnesses. To verify the initial assumption to use the number of
unintentional exposures to pesticide products with concomitants as the basis of this analysis, the
frequency distribution for the clinical effects among exposures without concomitants was also
examined. When the frequency of clinical effects is evaluated among exposures without
concomitants, a similar pattern of distribution of clinical effects is present.
Table 5.5. Frequency of Clinical Effects “Related” to
Unintentional Pesticide Product Exposures
Number of
With Concomitants
Without Concomitants
Clinical Effects
Number of Patients
Percentage of
Number of
Percentage of
Observed
Patients
Patients
Patients
0
61,486
75.93%
59,543
76.66%
1
11,614
14.34%
11,024
14.19%
19,492
2
5,181
6.40%
4,790
6.17%
3
1,820
2.25%
1,586
2.04%
4
567
0.70%
488
0.63%
5 or more
310
0.38%
241
0.29%
Total
80,978
100.00%
77,672
100.00%
Source: AAPCC (2002, Report 12 “Frequency of Clinical Effects - Related”).
There were 31,504 clinical effects observed among patients who were determined to have an
illness “related” to the unintentional exposure. In total, these 31,504 clinical effects were
observed for the 19,492 exposure cases that resulted in a related illness. This pattern is a result
of the information highlighted in Table 5.5 and detailed in Table 5.6, where 11,614 patients
sustained a single clinical effect, 5,181 patients had two effects, 1,820 exhibited three effects,
567 suffered four effects, and 310 cases resulted in five or more clinical effects.
Table 5.6. Detailed Distribution of Clinical Effects “Related” to Unintentional Pesticide
Product Exposures Among Patients Experiencing With Concomitant” Pesticide Exposures
Number of Clinical
Effects Observed
With Concomitants
Number of Patients a
Percentage of Patients
Number of Observed
Clinical Effects “Related” to
Exposures b
1
11,614
59.58%
11,614
2
5,181
26.58%
10,362
3
1,820
9.34%
5,460
4
567
2.91%
2,268
5 or more
310
1.59%
1,800
Total
19,492
100.00%
Number of patients with observed clinical effect from Table 5.5.
b
Number of “related” clinical effects corresponding to the number of patients from note (a) above.
a
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31,504
Table 5.7 shows the distribution of the 31,504 clinical effects observed among patients who were
determined to have an illness related to the unintentional pesticide product exposure. Of the
cases in which some clinical effect related to a pesticide exposure was observed (approximately
24 percent of the total exposures overall from Table 5.5 above: 19,492 ÷ 80,978 = 0.24), the
majority of patients suffered ocular (26.95 percent), gastrointestinal (24.06 percent), and dermal
(17.28 percent) health effects.
Table 5.7. Percent Distribution of Clinical Effects Among Patients Experiencing Effects
“Related” to Unintentional Pesticide Product Exposures
Clinical Effect
Cardiovascular
Number of Observed
Clinical Effects
“Related” to
Exposures a
Percent
Number of Observed
Clinical Effects
“Unknown if Related”
to Exposures a
Percent
410
1.30%
185
2.27%
Dermal
5,445
17.28%
995
12.22%
Gastrointestinal
7,581
24.06%
2,700
33.15%
42
0.13%
24
0.29%
Neurological
3,122
9.91%
1,788
21.95%
Ocular
8,491
26.95%
323
3.97%
32
0.10%
21
0.26%
Respiratory
3,735
11.86%
624
7.66%
Miscellaneous
2,646
8.40%
1,484
18.22%
Hematologic/Hepatic
Renal/Genitourinary
Total
31,504
100.00%
8,144
100.00%
Source: AAPCC (2002, Report 13 “Distribution of Clinical Effects”).
a
Number reflects clinical effects and not the number of exposure cases, since a single patient can sustain multiple
clinical effects (frequency distribution for multiple clinical effects is shown in Table 5.5 and detailed in Table 5.6).
Table 5.7 also shows the number of observed clinical effects among patients in which the effect
was “related” or “unknown if related” to the pesticide exposure. It is believed that these
“unknown if related” cases should be considered in the analysis since it is known that a pesticide
product was involved, but it is unclear from the report whether the exposure was responsible for
the illness. However, while the available TESS data showed that 31,504 “related” clinical
effects corresponded to 19,492 exposures cases, similar data are not available for the “unknown
if related” effects. For these clinical effects, only 8,144 effects were “unknown if related” to the
exposure. Below an approach is described for estimating the number of “unknown if related”
illnesses, using the ratio of illnesses to effects from the “related” cases. Including “unknown if
related” cases with the “related” cases could serve as a “high-end” estimate for the annual
number of avoided unintentional pesticide illnesses expected nationwide as a result of the
container design and residue removal regulations, since it is unclear what proportion of these
cases are truly a result of the pesticide exposure.
5.2.4 Extrapolation to Estimate of Nationwide Cases Potentially Avoided from the
Container Design and Residue Removal Standards
This section describes the method for deriving the frequency of cases and number of clinical
effects avoided as a result of the container regulations. The number of cases avoided is
estimated by applying the percentage of pesticide illnesses determined to be container-related
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(1.36 percent as calculated in Section 5.2.2) to the number of cases resulting in illness in TESS
that are (1) known to be “related” to pesticide exposure (“low-end” estimate) and (2) known to
be “related” plus “unknown if related” to the exposure (“high-end” scenario). From Section
5.2.3.2 above, we determined that the number of nationwide illnesses resulting from
unintentional pesticide-related exposures was estimated to be 19,492. Assuming that
1.36 percent of these illnesses are related to container design or residue problems, the number of
potentially avoided cases with clinical effects is 265. In 2001, 64 poison centers participated in
TESS, reporting more than 2 million human exposure cases, which represent an estimated
98.8 percent of all poison exposures reported to poison centers in the United States. If it is
assumed that these cases represent 98.8 percent of the number of illnesses potentially avoided
from the container design and residue removal regulations, then the “low-end” scenario number
would be 268 (265 * 1.012 = 268, where the scaling factor of 1.012 is the inverse of 98.8
percent). The estimated frequency of associated clinical effects for these 268 illnesses (based on
the frequency distribution in TESS for all unintentional, pesticide product-related illnesses) is
provided in Table 5.8.60
As a “high-end” estimate of cases avoided, we included those cases in TESS where some
pesticide exposure was reported but it is unclear if the pesticide was responsible for the illness.
As discussed earlier, the available TESS data for this subset of “unknown if related” cases were
limited to the number of clinical effects, rather than the number of cases. Since one case may
result in more than one clinical effect, the use of this data would overestimate the number of
cases avoided. In order to extrapolate the number of cases from the number of clinical effects for
this subset, we applied the ratio of cases to clinical effects for those illnesses known to be
“related” to pesticide exposure (0.62, calculated as 19,492 related exposures cases to 31,504
clinical effects = 0.62) to the “unknown if related” cases (8,144 “unknown if related” clinical
effects * 0.62 = 5,039 “unknown if related” cases). This was added to the number of “related”
cases to determine an upper bound of 24,531 as the total number of pesticide-related cases in
TESS for the “high-end” scenario:
19,492 “related” cases + 5,039 “unknown if related” cases = 24,531 “high-end” cases
The same percentage (1.36 percent) and scaling factor (1.012) were applied to generate the
“high-end” estimate of 337 (24,531 “high-end” pesticide-related cases * 1.36 percent of these
illnesses are related to container design or residue problems * 1.012 scaling factor = 337 cases)
of the number of cases potentially avoided by the regulations, as shown in Table 5.8.
Table 5.8 also presents the distribution of the estimated number of clinical effects per avoided
case. This estimate was generated by applying the frequency distribution observed in TESS for
illnesses known to be “related” to pesticide exposures (see Table 5.6) to the estimated number of
avoided cases. By doing so, it is assumed that the frequency of clinical effects for pesticide
illnesses resulting from container design/residue issues is the same as for all pesticide-related
illnesses. The assumption is also made that for those cases in which it is unclear that pesticides
are the implicated agent, the same number of clinical effects would be observed per case.
60
If possible container-related cases are included the “low-end” and “high-end” estimate of associated clinical
effects is 853 and 1074 respectively. See Appendix J.
Page 129
Table 5.8. Estimated Frequency of Clinical Effects for Avoidable Cases as a Result of the
Container Regulations
Number of Clinical
Effects per Case
Percent of Cases with
Clinical Effect a
Number of Cases Avoided b
“Low-End” Scenario c
“High-End” Scenario d
1
59.58%
160
201
2
26.58%
71
90
3
9.34%
25
31
4
2.91%
8
10
5 or more
1.59%
4
5
Total
100%
268
337
Notes: Numbers are scaled by a factor of 1.012 to reach 100 percent coverage of the national population. Frequencyspecific estimates may not sum to totals due to rounding.
a
Derived from Table 5.5 and as shown in Table 5.6.
b
Distribution of number of cases avoided (e.g., with 1, 2, 3, 4, 5 or more clinical effects per case) are calculated
from the total number (268 and 337 in “low-end” and “high-end” scenarios, respectively), using the percentage of
cases with different numbers of clinical effects.
c
From cases “related” to exposure.
d
From cases “related” and “unknown if related” to exposure.
Table 5.9 shows the estimated number and type of avoided clinical effects as a result of the
regulations. In order to estimate the number of clinical effects potentially avoided, the number
of cases avoided was scaled by a factor of 1.616. This represents the ratio of clinical effects
“related” to exposures in TESS to the total number of cases resulting in those effects (31,504
“related” clinical effects to 19,492 “related” exposure cases = 1.616). Therefore, on average, a
pesticide product-related illness results in 1.616 clinical effects as defined in TESS. By applying
this ratio to the number of cases avoided as a result of the regulation, it is assumed that the
container-related illnesses, on average, result in the same number of clinical effects per case as
all pesticide-related illnesses. It is also assumed that the relative distribution of types of clinical
effects are the same for container-related cases. The clinical breakdown of the potentially
avoided clinical effects shown in Table 5.9 was derived using the distributions in Table 5.7 for
“related” and “unknown if related” cases, respectively. The number of clinical effects avoided
per year is estimated to be in the range of 433 to 545. These correspond to the estimated range
of 268 to 337 potentially avoidable pesticide product illness cases as a result of the rule.61
The approach to scaling estimates of potentially avoided cases based on the reported population
coverage of TESS is discussed above. In addition, although CDPR takes many steps to ensure
that the data collected are as comprehensive as possible, it is inevitable that some illnesses
related to pesticide products go unreported or undiagnosed. For the purposes of this analysis, if
some cases are overlooked by CDPR, the percentage estimated and applied to the TESS data is
not necessarily biased. As long as the proportion of those unreported or undiagnosed cases that
are related to container design or residue problems is no different from the proportion reported
by CDPR, then an unbiased percentage estimate will be obtained.
61
If possible cases are included the number of clinical effects avoided for “low-end”, “unknown if related” and
“high-end” scenario are 1379, 357 and 1736 respectively. See appendix J.
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Table 5.9. Estimated National Number of Avoidable Clinical Effects as a Result of the
Container Regulations
Clinical Effect
Cardiovascular
Dermal
Gastrointestinal
Hematologic/Hepatic
Neurological
Number of Clinical
Effects Avoided
“Low-End” Scenario a, b
Number of Clinical
Effects Avoided
“Unknown if Related” to
Exposures a, b
Number of Clinical
Effects Avoided
“High-End” Scenario b
6
3
8
75
14
88
104
37
141
1
<1
1
43
25
67
117
4
121
Renal/Genitourinary
<1
<1
<1
Respiratory
51
9
60
Miscellaneous
36
20
57
c
c
Ocular
Total
433
112
545
Note: Clinical effect-specific estimates may not sum to totals due to rounding.
a
Distributions of clinical effects shown here were derived from the total number of clinical effects calculated (see
note (b) below), using the percentages shown in Table 5.7. (e.g., for the “low-end” scenario, 433 cases *
1.30 percent of total “related” effects are cardiovascular = 6 cardiovascular effects; for the “high-end” scenario, 112
cases * 2.27 percent of total “unknown if related” effects are cardiovascular = 3 cardiovascular effects added).
b“
Low-end” scenario clinical effects are represented by those effects “related” to the pesticide exposure, while the
“high-end” scenario includes those “related” and those “unknown if related” to the pesticide exposure. If possible
cases are included the number of clinical effects avoided for “low-end”, “unknown if related” and “high-end”
scenario are 1379, 357 and 1736 respectively.
c
Number of cases avoided from Table 5.8 are scaled by a factor of 1.616 to estimate the number of clinical effects
resulting from those reported cases (e.g., for the “low-end” scenario, 268 cases * 1.616 = 433 clinical effects).
Another point to consider is the mechanism by which the data are collected for the TESS
database. Since case reports are collected through reporting to poison control centers across the
country, it is possible that acute illnesses and injuries are more likely to be reported than chronic
effects resulting from the exposure. Similarly, clinical effects were generally recorded at the
time of the poison report and may have been lost in follow-up and therefore gone unreported if
the victim developed symptoms subsequent to the initial report. Since the estimate of avoidable
cases and related clinical effects was based on these reports, the actual number of related
illnesses may have been higher (see Appendix J for a description of these exposures potentially
lost to follow-up).
5.2.5 Valuing Avoided Pesticide Product-Related Illnesses as a Result of the Container
Regulations
This section describes the approach to the quantitative valuation of the cases of pesticide product
illness that may be potentially avoided as a result of the container design and residue removal
regulations. In order to estimate the potential cost savings from these avoided cases of pesticide
product-related illness, these cases are first characterized into general illness severity categories
for which the average costs for outpatient physician visits, inpatient hospitalizations, lost
productivity, and premature mortality is derived. In using this methodology, we made use of the
additional data available in the TESS report that provide insight into the type or degree of
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outcome/clinical effects observed for exposure cases. A profile of medical outcome severity as
reported in TESS is presented in Appendix H.
5.2.5.1 Avoided Pesticide Product-Related Illnesses by Severity Level
The potentially avoided cases calculated above are classified into the following TESS outcome
categories (see Table 5.10 and Appendix H):
•
•
•
•
Minor effect: patient developed some signs or symptoms as a result of the exposure but they
were minimally bothersome and generally resolved with no residual disability or
disfigurement;
Moderate effect: patient exhibited signs or symptoms as a result of the exposure that were
more pronounced, more prolonged, or more of a systemic nature than minor symptoms
(usually some form of treatment is indicated);
Major effect: patient exhibited signs or symptoms as a result of the exposure that were lifethreatening or resulted in significant residual disability or disfigurement; and
Death: patient died as a result of the exposure or as a direct complication of the exposure.
Table 5.10. Expected Number of Avoidable Illnesses as a Result of Container Regulation
by Severity of Clinical Effect
TESS With Concomitants
Medical
Outcome/Severity
Number of Cases
No Effect
18,385
Minor Effect
12,084
Moderate Effect
Major Effect
Death
Potential Cases Avoided from Regulations
Percentage a, b
56.14%
43.86%
36.90%
“High-End”
Scenario a
“Low-End”
Scenario a
343
268
225
431
337
284
2,164
6.61%
40
51
111
0.34%
2
3
0.01%
c
<1c
2
<1
Total
32,746
100.00%
610 d
768 d
Numbers have been rounded for presentation purposes.
b
Percentages were calculated to equal 100 percent for the five medical outcome categories using their associated
number of cases from Table H-3 (Appendix H), since complete data were known for these five categories.
c
0.04 deaths were estimated for the “Low-End” scenario and 0.05 deaths for the “High-End”.
d
Totals were calculated assuming that the potential illnesses avoided as a result of the container regulations in
Section 5.2.4 (268 for the “low-end” scenario and 337 for the “high-end” scenario) constitute the minor effect,
moderate effect, major effect, and death severity categories: e.g., 268 ÷ 43.86% = 610. The breakdown by severity
category was then calculated using this derived total.
a
In addition, a “no effect” category is included (“no effect” represents a patient who reported an
exposure but developed no signs or symptoms as a result of exposure). In theory, cases that did
not result in any observed clinical effect should not be associated with any potential medical cost
savings. However, TESS data show that, in reality, some proportion of those exhibiting “no
effect” did visit a health care facility and therefore incurred medical costs (shown below). In
addition, there are likely to be costs associated with lost productivity for the time and anxiety
associated with a call to a poison control center.
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Table 5.10 presents the expected number of overall avoided cases as a result of the container
design and residue removal regulations, when cases both with and without any clinical effect are
considered. Note that the “low-end” and “high-end” scenario estimates from Section 5.2.4 of
268 and 337 cases, respectively, correspond to the following four medical outcome categories:
minor effect, moderate effect, major effect, and death.
The “no effect” cases, in which no clinical effect was observed, are not a component of the 268
to 337 cases calculated in Section 5.2.4 above, since the California incident data from CDPR
cover only pesticide exposures that resulted in symptoms. In order to estimate the number of
avoided exposure cases that did not result in clinical effects, the expected number of these cases
is calculated based on the percentage distribution of medical outcome/severity observed across
the entire TESS database of pesticide-related exposures (see Appendix H). This calculation is
based on the information provided in Table H-3, which presents the cases according to the
severity of the medical outcome, evaluating only the categories “No Effect,” “Minor Effect,”
“Moderate Effect,” “Major Effect,” and “Death.” Using the actual number of cases reported to
TESS for these categories, the proportion of cases that each medical outcome category
contributes to the total is recalculated, as presented in Table 5.10.62 As a result of this
recalculated distribution, it is estimated that 43.86 percent of exposures resulted in clinical
effects (including minor, moderate, and major effects, and death), and 56.14 percent of exposures
resulted in “no effect,” as shown in Table 5.10.63 For the “low-end” scenario, we estimated that
268 illnesses would be avoided by the rule. Assuming that the ratio between exposures with
clinical effects and exposures with “no effect” from TESS holds true in this subset, the number
of cases with “no effect” avoided by the rule can be estimated as follows:
268
x
=
⇒ x = 343
43.86% 56.14%
Using this methodology, it is assumed that the distribution of severity of effect (ranging from “no
effect” to “death”) for exposures related to container design and residue removal is no different
than for all exposures to pesticide products resulting in calls to poison control centers
nationwide. Data are not available to suggest that the subset of container-related pesticide
62
After examining the medical outcome descriptions shown in Table H-3, we recalculated the distribution among
only the first 5 categories (no effect, minor effect, moderate effect, major effect, and death) to use in this calculation
of illness severity. We decided not to use the percentage distribution for all the categories shown in Table H-3
because sufficient information on the outcome of the exposure was not available for the remaining categories. For
example, for the category “no follow-up, potentially toxic,” we were not able to assign a reasonable medical
outcome category to value based on the uncertainties presented in its description: “Patient was lost to follow-up,
refused to follow-up or was not followed but the exposure was significant and may have resulted in a moderate,
major, or fatal outcome.” Similarly, for the “unrelated effect” category, we are not concerned with cases for which
the exposure was not responsible for the medical outcome. Since we want to categorize the medical outcome of
exposure in order to value the benefits, we decided that including such cases would not be representative of the
exposure cases. Instead, we assumed that the distribution for those cases in which the medical outcome was known
is representative of the outcomes from all exposures.
63
The “no effect” category shown in Table H-3 differs from the 75.93 percent with zero clinical effects shown in
Table 5.5 because the latter shows the number of clinical effects known at the time of the poisoning incident report.
Alternatively, the medical outcome information presented in Table H-3 describes the known effect resulting from
the incident. However, it is possible that the “no follow-up” categories in Table H-3 may or may not have had
clinical effects, or could have had clinical effects later. This information is not known.
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illnesses typically result in more or less severe illnesses than any other pesticide exposure. If this
assumption is not true, the benefits calculated here could be over- or understated due to an overor underestimate of the severity of health effects avoided.
5.2.5.2 Unit Costs for Morbidity and Mortality by Severity Level
The valuation of health benefits associated with reduced pesticide-related morbidity and
mortality focuses on direct costs for outpatient visits and inpatient hospitalization stays, indirect
costs of lost productivity, and premature mortality based on the “value of a statistical life” (VSL)
approach (see Figure 5.2). The value of reduced morbidity is estimated below using TESS data
on the likelihood of pesticide product-related cases of varying severity levels seeking medical
care. These data are then used to generate unit costs associated with physician visits, hospital
stays, and lost productivity for each level of clinical severity. Subsequently, the total value of
reduced morbidity associated with the container rule is estimated by applying these costs to the
number of avoided cases by level of severity and summing across severity levels. The premature
mortality valuation is performed by first generating a VSL estimate in year 2005 dollars and then
applying the number of premature deaths (or the probability of premature mortality), estimated in
the previous section, to this VSL.
Figure 5.2. Components of the Health Benefits Valuation for the Container Design and
Residue Removal Regulations
Outpatient
Costs
Inpatient
Costs
Value of Lost
Productivity
Value of
Premature
Mortality
Total Health Benefits
Medical Care Utilization
In order to estimate direct costs for medical care utilization, the unit costs per outpatient
physician visit and inpatient hospitalization stay were derived. The unit costs per visit were then
converted to unit costs per pesticide case for each severity level other than death (no effect, mild,
moderate, and major) to reflect the probability of visiting a health care facility. The following
equation presents the method used to generate unit costs by severity level:
UnitCostseverity = UnitCost per visit × P(HCFvisit )
where:
UnitCostseverity = the unit cost per case for a particular severity level;
UnitCostper visit = the unit cost per health care visit; and
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P(HCFvisit)
= the probability of visiting a health care facility for a particular severity level.
TESS provides data on health care facility visits for clinical effects associated with pesticiderelated exposure. Table 5.11 presents the distribution of health care visitation by medical
outcome/severity. In TESS, a health care facility is defined as “any hospital-based ward or
emergency department, free-standing emergency medical clinic (emergicenter), first aid station,
physician’s office, or clinic.” Therefore, it is not possible to distinguish between outpatient
physician visits, emergency room visits, and inpatient hospitalization stays. As would be
expected, as the clinical effect severity level increases, the proportion of cases requiring health
care facility visits increases as well.
Table 5.11. Medical Outcome by Management Site for Pesticide Product-Related
Unintentional Exposures, TESS, 2001 a
Management Site b
Medical Outcome/Severity
Non-Health Care Facility
Health Care Facility
Refused Referral c
No Effect
76.86%
22.58%
0.56%
Minor Effect
67.30%
30.32%
2.38%
Moderate Effect
24.45%
70.65%
4.91%
9.52%
86.67%
3.81%
Major Effect
Death
0%
100%
0%
Source: Adapted from AAPCC (2002, Report 39 “Medical Outcome by Management Site”).
a
Excludes those cases with management site designated as “other” and “unknown.”
b
Represents row percent.
c
Although refused referral cases are those that should have received health care facility treatment, they did not and
therefore did not incur medical care costs. It is not clear whether some of these cases ultimately received treatment
at a later time.
The proportion of cases visiting health care facilities in Table 5.11 were used to adjust outpatient
physician visit unit costs for each level of clinical effect severity. For hospitalization stays, it is
assumed that only cases with major clinical effects require inpatient treatment. Table 5.12
presents TESS data on the duration of clinical effects by medical outcome/severity. For cases
with minor effects, 74 percent lasted less than eight hours and 88 percent less than one day.
Similarly, 43 percent of cases with moderate effects lasted less than eight hours and 63 percent
less than one day. On the contrary, 59 percent of cases with major clinical effects lasted one or
more days and 30 percent lasted three or more days. As a result, it is assumed that only cases
with major effects would incur hospitalization inpatient costs and the unit cost per hospitalization
stay is converted to a unit cost per major effect case in the same way as described for outpatient
visits. Table 5.12 is also used to estimate the indirect cost of lost productivity, described in the
section titled “Lost Productivity” below.
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Table 5.12. Duration of Clinical Effect by Medical Outcome for Pesticide Product-Related
Unintentional Exposures, TESS, 2001 a
Duration of
Clinical Effects
Medical Outcome/Severity b
Minor Effect
Moderate Effect
Major Effect
#2 Hours
53.84%
18.34%
6.82%
2-8 Hours
20.60%
24.19%
9.09%
8-24 Hours
13.70%
20.33%
25.00%
1-3 Days
6.99%
17.94%
29.55%
3-7 Days
3.30%
12.49%
11.36%
1 Week - 1 Month
1.24%
4.66%
6.82%
>1 Month
0.30%
1.70%
5.68%
Anticipated Permanent
0.03%
0.34%
5.68%
Source: Adapted from AAPCC (2002, Report 23 “Duration of Clinical Effects by Medical Outcome”).
a
Excludes those cases with “unknown” duration of clinical effect.
b
Represents column percent.
Outpatient Costs
To estimate outpatient unit costs, we obtained physician visit benchmark fees from the online
division of Intellimed, a private corporation that provides analytical software with inpatient and
outpatient databases to health care-related organizations.64 Evaluation and management costs are
provided by Current Procedural Terminology, Fourth Edition (CPT-4) code, an American
Medical Association classification used for defining outpatient treatment. Costs are available for
new and established patients, based on the type of evaluation and management received. For this
analysis, it is assumed that patients visit their current physician for evaluation and management
based on a focused problem. Appendix I provides a list of benchmark costs for varying levels of
complexity of care for both new and established patients.
Table 5.13 provides the current cost estimate for a physician visit of an established patient for an
expanded, problem-focused evaluation, updated to 2005 dollars. The cost, $39.35, represents
only the evaluation and management costs. Diagnostic and medicinal costs are not included in
this estimate and would be more likely to vary by level of severity. These costs would add to the
estimates of direct medical costs avoided due to the container regulations.
64
Formerly the Medical Cost and Quality Assistance (MECQA) Web site, the Web site can now be accessed at
www.myhealthscore.com.
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Table 5.13. Benchmark Evaluation and Management Costs for Physician Office Visit for
an Established Patient Requiring an Expanded, Problem-Focused Evaluation,
Adjusted to 2005 Dollars a
CPT-4 Code
Cost b
Brief Description
99213
Established patient requiring:
$39.35
1. Expanded, problem-focused history
2. Expanded, problem-focused examination
3. Medical decision-making of low complexity
a
Cost data obtained from online division of Intellimed (Intellimed, 2002)
See Appendix I for benchmark costs for other CPT-4 codes.
b
Cost is updated to year 2005 from year 2000 by scaling based on Medicare Physician Fee Schedule conversion
factors. See AAMC (1999) for the year 2000 conversion factor and AAPMR (2004) for the year 2005 conversion
factor.
Using the health care facility utilization data from TESS, reported in Table 5.11, the outpatient
physician unit costs per case by level of clinical severity are estimated. Table 5.14 presents the
adjusted unit costs for cases with no clinical effect, minor effect, moderate effect, and major
effect. The adjusted unit costs range from $8.89 for “no effect” to $34.11 for “major effect.”
Table 5.14. Outpatient Physician Unit Costs by Medical Outcome
Unit Cost a
Medical Outcome/Severity
No Effect
$8.89
Minor Effect
$11.93
Moderate Effect
$27.80
Major Effect
$34.11
a
Unit costs represent the cost per case and are calculated by multiplying
the benchmark cost in Table 5.13 by the percentage of cases visiting health
care facilities in Table 5.11.
Inpatient Costs
Hospital utilization data were obtained from the Healthcare Cost and Utilization Project (HCUP),
a series of databases compiled by the Agency for Healthcare Research and Quality (AHRQ).65
HCUP contains patient-level health care data on costs and quality of health services, treatment
outcome, and access to health care collected through state data organizations, hospital
associations, private data organizations, and the federal government. Unit cost estimates for
hospital stays were obtained from the HCUP-3 Nationwide Inpatient Sample (NIS) Release 3
(AHRQ, 1994), which contains all 1994 discharge records from a 20-percent sample of U.S.
community hospitals from 17 states.
Table 5.15 presents mean length of stay and mean charges for diagnosis-related group (DRG)
455, “other injury, poisoning, toxic effect diagnosis w/o CC,”66 updated to 2005 dollars using an
65
Formerly called the Agency for Health Care Policy and Research (AHCPR), part of the U.S. Department of
Health and Human Services.
66
CC as defined AHCPR (1994) “(Complications, Comorbidities). Patients who are more seriously ill tend to
require more hospital resources than patients who are less seriously ill, even though they are admitted to the hospital
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adjustment based on the Consumer Price Index (CPI-U) for “medical care services”.67 DRGs
are a classification of hospital case types into groups expected to have similar hospital resource
use. Therefore, DRG 455 should provide a reasonable approximation of the charges associated
with treatment of pesticide-related illness.
Table 5.15. Mean Hospitalization Charges and Length of Stay for Injuries/Poisonings from
HCUP 1994, Adjusted to 2005 Dollars a
Diagnosis-Related
Group (DRG)
DRG Description
Mean Length of Stay
Mean Charges
455
Other injury, poisoning & toxic effect
1.64
$6,856
diagnosis w/o complications or
comorbidities
a
Data obtained from HCUP-3 Nationwide Inpatient Sample (NIS) Release 3 AAPMR (2002) Updated to 2005
dollars using CPI-U for “medical care services” (Bureau of Labor Statistics, 2005).
Using the health care facility utilization data from TESS, reported in Table 5.11, and assuming
that only cases with major effects will have inpatient hospital stays, the inpatient unit costs per
severity level case by severity level are estimated (see Table 5.16). The unit cost for “major
effect” is $5,942, representing the average charge for a hospital stay across all “major effect”
cases, based on the percentage of “major effect” cases that visit a health care facility
(86.67 percent from Table 5.11).
Table 5.16. Inpatient Hospitalization Unit Costs
Medical Outcome/Severity
Unit Cost a
No Effect
$0
Mild Effect
$0
Moderate Effect
$0
Major Effect
$5,942
a
Unit cost for “major effect” is the average cost across all “major
effect” cases. Unit costs represent the cost per case and are
calculated by multiplying the benchmark cost in Table 5.15 by the
percentage of cases visiting health care facilities in Table 5.11.
Lost Productivity
For the purposes of this analysis, a “lower-productivity day” is defined as a day when activity is
restricted and the person may be less productive in the performance of normal activities (i.e.,
work, housekeeping, leisure). In order to calculate the value lost due to a lower-productivity
day, it is first necessary to estimate the value of a day of full productivity and then estimate the
magnitude of reduced productivity associated with each severity level. The socioeconomic data
were collected from the U.S. Bureau of Labor Statistics and U.S. Bureau of the Census to
calculate average number of hours spent on work, housekeeping, leisure, and sleep, as presented
in Table 5.17. Using these data, the value of a day of full productivity can be calculated as
for the same reason. Recognizing this, the DRG grouper splits certain DRGs based on the presence of secondary
diagnoses for specific complications or comorbidities (CC).”
67
CPI-U for Medical Care Services http://data.bls.gov/cgi-bin/surveymost?cu
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presented in Table 5.18. From a review of the pesticide exposure cases in California that were
potentially avoidable as a result of the container standards, the majority of instances occurred
during occupational activities. Therefore, the indirect cost of illness reflects estimated activity
patterns for a typical working adult on any particular day.
Table 5.17. Socioeconomic Data Used to Calculate Indirect Cost of Illness
Data
Value
Average hours an employed person works per week
33.8 a
Average hours housekeeping per week (male)
13.4 b
Average hours housekeeping per week (female)
28.3 b
Number of males aged 16 years and over in the U.S.
111,256,354 c
Number of females aged 16 years and over in the U.S.
117,365,320 c
Average hours people aged 16 years and over spend housekeeping per week
21.0
Median hourly earnings (all workers)
$16.41 d
Median hourly earnings (service, private household female)
$9.62 d
2002 Effective Tax Rate (includes federal, state, and FICA)
29.1% e
Bureau of Labor Statistics (2005).
b
Research Triangle Institute (1994).
c
U.S. Census Bureau (2004).
d
Bureau of Labor Statistics (2004) (adjusted to 2005 using inflation rate): Median hourly earnings (all workers)
calculated as $657 in 2005 median weekly earnings for all workers 16 years and over (inflated from $638 in 2004
median weekly earnings using an inflation rate of 1.029), divided by 40 hours of work per week. Median hourly
earnings (service, private household female) calculated as $385 in 2005 median weekly earnings (inflated from $374
in 2004 median weekly earnings using an inflation rate of 1.029), divided by 40 hours of work per week.
e
Tax Foundation (2005).
a
Economic theory dictates that the gross wage rate is the best indicator of the value of production
associated with an hour of work. As show in Table 5.18, the average gross wage rate in the
United States is $16.41 per hour. Therefore, each hour of lost work due to illness will be valued
at $16.41. Since housekeeping is a non-market activity, no market value exists with which to
value the loss to society when housekeeping activity is lost due to illness; an implicit value must
be determined. Most cost of illness studies use the average after-tax wage for private household
workers as a proxy (see Tolley et al., 1994; Research Triangle Institute, 1994). This value is
calculated as $6.82 per hour, as shown in Table 5.18. Finally, an hour of leisure is valued at the
average after-tax wage rate of $11.64 per hour.
In order to estimate the reduction in productivity resulting from a pesticide exposure potentially
avoidable from the regulations, the TESS data on the duration of illness by medical
outcome/severity were used (see Table 5.12). For each severity level, an average duration of
clinical illness was generated and the proportion of a day spent with the illness was calculated.
This proportion was applied to the value of a day of full productivity to estimate the indirect cost
of illness. Therefore, the loss in productivity is directly proportional to the time spent with the
illness.
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Table 5.18. Value of a Day of Full Productivity
Activity
Hours/Day
Hourly Value
Total Value
4.8 a
$16.41
$79.26
3.0
a
c
$20.50
Leisure
8.2
b
Sleep
8.0
Work
Housekeeping
$6.82
$11.64
$0.00
d
$95.03
$0.00
Total Value of a Day of Full Productivity
$194.80
For work, based on the weekly estimate in Table 5.17 divided by 7 days per week; for housekeeping, based on the
number of hours people aged 16 years and over spend on housekeeping per week (21.0 hrs/wk), divided by 7 days
per week.
b
Leisure time is the time left per day after work, housekeeping, and assuming 8 hours of sleep (24 hours per day 4.8 hours work - 3.0 hours housekeeping - 8.0 hours sleeping = 8.2 hours leisure).
c
Housekeeping rate is based on the median hourly earnings for service, private household female (shown in Table
5.17) less income tax (average of 29.1 percent for 2005).
d
Leisure rate is based on the median hourly earnings for all workers (shown in Table 5.17) less income tax (average
of 29.1 percent for 2005).
a
To determine the average duration of clinical illness for each severity level in TESS, a weighted
average of the exposure durations was calculated based on the frequency distribution of clinical
effect duration. Two scenarios were calculated: a “low-end” scenario based on the midpoint of
the duration category and a “high-end” scenario based on the upper bound of the duration
category. Two clinical effect duration categories (“>1 month” and “anticipated permanent”)
were unbounded, and we assumed that the “>1 month” category stretched from 1 to 3 months
and the “anticipated permanent” category was assumed to last 1 year for the “upper-bound”
estimate and one-half of a year for the “lower bound.”68
In addition, data on duration of clinical effects were not available for “no effect” group.
However, since approximately 25 percent of these cases visited health care facilities (see Table
5.11) it was assumed that these 25 percent experienced reduced productivity for the shortest
clinical effect duration group (<2 hours) and the remaining 75 percent experienced no reduced
productivity. Table 5.19 provides the average clinical effect durations and indirect unit costs
associated with the “low-end” and “high-end” scenarios.
68
Although the “anticipated permanent” category may reflect conditions that last indefinitely, since we do not know
the nature of the permanent clinical effect, it is unclear that this will result in permanent lost productivity.
Page 140
Table 5.19. Average Clinical Effect Duration and Indirect Cost of Illness
by Medical Outcome
Medical
Outcome/Severity
No Effect a
Minor Effect
Moderate Effect
Major Effect
Scenario b
Average Duration of
Clinical Effect (Days) c
Unit Cost for Lost
Productivity Day d
Low-End
0.01
$1.83
High-End
0.02
$3.67
Low-End
0.9
$179.82
High-End
1.4
$279.88
Low-End
3.7
$717.35
High-End
5.9
$1,146.56
Low-End
16.4
$3,192.25
High-End
29.9
$5,817.81
a
Data on duration of clinical effect were not available for “no effect” group. However, since approximately
25 percent of these cases visited health care facilities it was assumed that these 25 percent experienced reduced
productivity for the shortest clinical effect duration group (<2 hours) and the remaining 75 percent experienced no
reduced productivity.
b
The “low-end” scenario uses the midpoint of the range of clinical effect duration to calculate the average duration,
and the “high-end” scenario uses the upper end of the range.
c
Average duration of clinical effect for all except the “No Effect” case is based on a weighted average of the
durations presented in Table 5.12. The category “>1 month” was assumed to be 1-3 months (where the midpoint =
60 days) and the category “anticipated permanent” was assumed to be 1 year (where the midpoint = 182.5 days) for
the low-end estimate and one half year for the high-end estimate. For example, the low-end estimate of average
duration of clinical effect is calculated by multiplying the mid-point of average duration in the first column in Table
5.12 with the corresponding percentage of Minor Effect cases (calculating the sum of products of column 1 and
column 2 in Table 5.12).
d
The unit cost is the indirect cost in terms of lost productivity associated with the average duration of clinical illness
for a particular severity level. For example, the unit cost for lost productivity day was calculated by multiplying the
value of a productive day ($194.80) with the average duration of clinical effect (0.01). The average duration of
clinical effect is rounded off therefore the value for unit cost is less than the simple multiplication of average
duration and value of a productive day.
Premature Mortality
A “value of a statistical life” (VSL) was used to estimate a value of the potential reduction in
fatalities from pesticide-related illnesses. EPA's Office of Air and Radiation’s (OAR) work on
the value of a statistical life has been widely cited throughout the Agency. Recently, OAR
responded to a recent SAB opinion about the previous VSL estimate used ($4.8 million in 1990
dollars) and changed the estimates (EPA,2004):
“The mean value of avoiding one statistical death is assumed to be $5.5 million in
1999 dollars. This represents a central value consistent with the range of values
suggested by recent meta-analyses of the wage-risk VSL literature. The
distribution of VSL is characterized by a confidence interval from $1 to $10
million, based on two meta-analyses of the wage-risk VSL literature. The $1
million lower confidence limit represents the lower end of the interquartile range
from the Mrozek and Taylor (2002) meta-analysis. The $10 million upper
confidence limit represents the upper end of the interquartile range from the
Viscusi and Aldy (2003) meta-analysis (EPA,2004).”
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For this benefits analysis, EPA used the VSL estimate of $5.5 million (in 1999 dollars), updated
to the base year of the analysis (2005). Using CPI data for all items from the Bureau of Labor
Statistics, this estimated VSL was calculated to be $6.42 million in 2005 dollars.69
In this analysis, it is estimated that less than one pesticide-related death (0.04 to 0.05 deaths) will
be avoided as a result of the container regulations each year (see Table 5.10). A reduction in
0.04 deaths can be seen as four deaths avoided over a 100-year period. This can also be viewed
as a reduction in mortality risk for every person in the United States of 1.27 x 10-10, based on the
2004 U.S. Census estimate of 294 million people in the United States. This estimate of avoided
mortality is applied to the year 2005 value of a statistical death to estimate a range of $240,000
to $301,000 for annual avoided premature mortality as a result of the regulations (see Table
5.20).
Table 5.20. Value of Annual Avoided Pesticide-Related Cases as a Result of the Container
Regulations (2005 dollars) a
Medical
Outcome/
Severity
No effect
Scenario
Avoided
Cases c
Outpatient Inpatient
Costs d
Costs e
Lost
Premature
Productivity f, g Mortality
Total h
Low-end
343
$3,045
--
$628
--
$3,674
High-end
431
$3,833
--
$791
--
$4,623
Minor effect Low-end
225
$2,688
--
$40,512
--
$43,200
High-end
284
$3,383
--
$50,984
--
$54,367
Moderate
effect
Low-end
40
$1,122
--
$28,941
--
$30,062
High-end
51
$1,412
--
$36,422
--
$37,834
Major effect Low-end
2
$71
$12,297
$6,606
--
$18,973
High-end
3
$89
$15,479
$8,314
--
$23,878
Low-end
<1
--
--
--
$239,542
$239,542
Death
Total
b
High-end
<1
--
--
--
$301,465
$301,465
Low-end
610
$6,926
$12,297
$76,686
$239,542
$335,451
High-end
768
$8,716
$15,476
$96,510
$301,465
$422,167
All cost estimates are rounded to the nearest dollar.
b
Estimated deaths avoided as a result of the container rule are 0.04 for the lower-bound estimate and 0.05 for the
upper-bound estimate. The value of avoided mortality is the same as the value of a reduction in four deaths or five
deaths over a hundred-year period, respectively.
c
See Table 5.10 for derivations.
d
Outpatient costs are equal to the number of avoided cases times the per case outpatient cost (see Table 5.14). Costs
may not add due to rounding.
e
Inpatient costs are equal to the number of avoided cases times the per case inpatient cost (see Table 5.16). Costs
may not add due to rounding.
f
Lost productivity costs are equal to the number of avoided cases times the per unit cost of lost productivity (see
Table 5.19). Costs may not add due to rounding.
g
Lost productivity estimates are based on the “low-end” estimate of indirect cost of illness, as described in the “Lost
Productivity” subsection of Section 5.2.5.2. The value of the “high-end” estimates for lost productivity are not
shown here, but can be calculated using the unit costs from Table 5.19.
a
69
$5.5 million in 1999 dollars was adjusted using the Consumer Price Index-All Urban Consumers (CPI-U), U.S.
All items, base period 1982-84=100, series ID CUUR0000SA0 from the Bureau of Labor Statistics (2005), as
follows: 194.6 (April 2005 index) ÷ 166.6 (1999 index) * $5.5 million = $6.42 million.
Page 142
h
If possible container-related cases are included the “low-end” and “high-end” benefit estimates are $1,069,249 and
$1,345,657 respectively.
5.2.5.3 Total Value of Avoided Pesticide Product-Related Illnesses
In Section 5.2.5.1 above, the annual number of cases of pesticide-related illnesses avoided as a
result of the container regulations by level of severity was estimated. The value of these avoided
cases are calculated by applying the unit costs by severity level estimated for outpatient
physician visits, inpatient hospitalization stays, and lost productivity to the avoided cases of
morbidity and the value of a statistical life to the avoided premature mortality estimate. Table
5.20 presents the annual health benefits valuation estimates for each of the endpoints and
severity levels described above. The value of avoided pesticide-related illnesses is provided for
the “low-end” and “high-end” estimates of cases avoided, described in Section 5.2.4 above.
It is estimated that 610 to 768 cases could have been avoided as a result of the container design
and residue removal regulations each year, corresponding to approximately $335,451 to
$422,167 in annual health benefits. If the 51 “possible” cases in California are included, which
increases the percentage of total pesticide product-related cases potentially avoided by
4.33 percent, the annual health benefits would be an additional $1.07 million to $1.35 million
annually (corresponding to an additional 1,946 to 2,449 cases).70
Since the compliance period for the rulemaking is either 3 or 5 years depending on the type of
container involved, we assume that 50 percent of average annual benefits will begin to accrue in
year 3 and the remaining 50 percent of average annual benefits will begin to accrue in year 5.
Given the compliance schedule, the annualized benefit over a 20-year period of analysis at a
3 percent discount rate is $264,051 for the low-end scenario and $332,311 for the high-end
scenario. Similarly, the annualized benefit over a 20-year period of analysis at a 7 percent
discount rate ranges from $236,635 (low-end scenario) to $297,807 (high-end scenario). If
possible cases are included the annualized benefit for the low-end and high-end scenario are
$841,664 and $1,059,240 respectively at the 3 percent discount rate, and $754,274 and $949,259
respectively at the 7 percent discount rate.
5.3 Non-Human Health-Related Benefits of the Pesticide Container Regulations
This section describes the inputs and assumptions used to calculate the non-human health-related
benefits associated with the pesticide container regulations. For this analysis, three direct benefit
categories are considered: benefits associated with the disposal of non-refillable containers
(Section 5.3.1), benefits associated with reduced environmental and ecological incidents
(Section 5.3.2), and the benefits associated with avoided cleanup costs and property damage
(Section 5.2.3).
5.3.1 Non-Refillable Container Disposal Benefits
The pesticide container regulations will directly affect the use and disposal practices of rigid
non-refillable containers for two reasons. First, rigid non-refillable pesticide containers that fall
70
See Appendix J for detailed information of the “possible” cases, defined by EPA as cases that may have possibly
been prevented by the container regulations.
Page 143
within the scope of the container regulations will be required to meet residue removal
standards.71 Second, all rigid non-refillable pesticide containers that are not exempt under the
new labeling requirements must have labels that include the applicable instructions for removing
pesticide residues from the container prior to container disposal (§156.146). Benefits therefore
should be related to containers that will meet the residue removal and/or the labeling
requirements that did not do so previously. However, the residue removal standards are
applicable to only certain flowable concentrate formulations and it is not clear how many
containers should be tied to these formulations. Since we cannot accurately estimate the number
of containers associated with reside removal standards we are conservatively not including the
containers diverted from the waste stream as a result of this standard in the benefits estimate.
This implies that the benefits estimate will understate the true estimate of benefits from the rule.
In the regulatory impact analysis (RIA) that EPA conducted for the proposed version of the
pesticide container rule (EPA, 1993), EPA made a number of assumptions regarding nonrefillable containers and their use that we retain in this analysis. It assumed that the number of
non-refillable containers appropriately managed and disposed of will increase after promulgation
of the final rule because of (1) the presence on container labels of specific rinsing information
regarding how and when a triple rinse must be conducted due to the labeling requirements, and
(2) an increased likelihood that landfills once hesitant to accept appropriately managed pesticide
containers as solid waste would now do so instead of treating them as hazardous.
Though appropriate container management and disposal would result in fewer environmental
damages, such as fewer pesticide residues in soil, surface and ground water, and fewer healthrelated damages over time (See Section 5.3.2), due to limitations in the data available, estimates
of all of these potential benefits cannot be made. Instead, the difference in cost between the
disposal of non-refillable pesticide containers that, before the rule, were disposed of as hazardous
waste, and the disposal of non-refillable pesticide containers that, after the rule, would be
disposed of as non-hazardous waste is calculated as a quantified measure of the environmental
benefits of the container regulations. Because hazardous waste treatment is more costly than
non-hazardous, the resulting cost savings is a direct benefit related to the regulations.
The benefits associated with the diversion of non-refillable pesticide containers from the
hazardous waste stream (where waste treatment is more expensive) into the solid waste stream
are calculated in a number of steps. Each step is discussed in the order in which it was carried
out in the analysis.
5.3.1.1 Step 1: Determine Which Container Types Are Subject to the Labeling
Requirements
There are a number of non-refillable container types that are considered in the estimation of costs
associated with the pesticide container regulations. These include containers that hold dry and
71
The residue removal requirements apply to only flowable concentrate products that are non-antimicrobial and
non-exempt antimicrobial that are included under the Toxic Category I or II criteria and/or are classified for
restricted use and that are dilutable and packaged in rigid containers. The final regulations require that every
registrant test three containers from each rigid container/dilutable formulation combination to determine that the
containers are capable for attaining at least 99.99 percent removal of each active ingredient in the fourth rinsate after
the triple rinse (see Chapter 3).
Page 144
liquid pesticides, plastic and steel containers of varying sizes, water-soluble packets, bag-in-box
containers, aerosol cans, paper and plastic bags, glass jugs, fiber drums, and “other” containers.
Not all of these containers are subject to the labeling requirements, however, since only rigid
containers can be triple rinsed. Table 5.21 displays the container types and sizes that are subject
to the labeling requirements.
Table 5.21 also displays the weights associated with the containers. Weights are needed to
calculate the volume of containers that are no longer treated as hazardous waste. Weights for
plastic containers are based on information gathered by the 2001 High-Density Polyethylene
(HDPE) Container Survey, conducted by the Agricultural Container Recycling Council (ACRC,
2001). All other container weights are transferred from the proposed container rule RIA (EPA,
1993).
Table 5.21. Non-Refillable Containers Subject to the Labeling Requirements and Their
Associated Weights
Container Size
Weight - Plastic (lbs.) a
Weight - Steel/Other (lbs.) b
Container Type: Liquid Products
< 1 Gallon
0.15
0.5
1 to < 5 Gallons
0.54
1.38
5 Gallons
3
6
30 - 55 Gallons
23
42.5
Container Type: Dry Products - Jugs
Quart to < 2.5 Gallons
N/A
0.6
2.5 Gallons
N/A
1.5
a
b
Source: ACRC (2001).
Source: proposed container rule RIA (EPA, 1993, Table XIV-5).
5.3.1.2 Step 2: Determine the Number of Containers Included in the Scope of the
Non-Health Benefits Analysis
The residue removal requirements apply to only flowable concentrate products that are nonantimicrobial and non-exempt antimicrobial that are included under the Toxic Category I or II
criteria and/or are classified for restricted use and that are dilutable and packaged in rigid
containers (see Chapter 3 for a complete discussion). As mentioned above, since we are unable
to accurately determine the number of containers associated with the flowable concentrate
products/formulations, we are not including the containers diverted from the waste stream as a
result of this standard in the estimate.
The container labeling requirements apply to all pesticide products except those that are
considered residential/household use pesticide products.72 Non-refillable containers subject to
the labeling requirements must meet the following criteria:
72
The total universe of containers is based on the total number of containers in use from Chapter 3.
Page 145
•
•
Container does not hold a dilutable product that meets the Toxic Category I or II criteria
and/or is classified for restricted use (this includes antimicrobial containers exempt from the
residue removal requirements); and
Container does not hold a residential/household use product.
It is assumed that all containers used in the home and garden (H&G) market sector are for
residential and household purposes only and are therefore exempt from the labeling
requirements. The containers in the H&G market sector are therefore excluded from
consideration under this category. The total number of non-refillables included in the universe
of containers subject to the labeling requirements is presented in Table 5.22.
Page 146
Table 5.22. Non-Refillable Containers Included in the Scope of the Non-Health Benefits Analysis
Container Type:
Dry Products
Container Type: Liquid Products
30-55 Gallons
Plastic
5 Gallons
Steel
Plastic
1 To < 5 Gallons
Steel
Plastic
Number of Containers Subject to the Labeling Requirements
Agriculture
309,104
I/C/G
1,600,000
H&G
0
Total
1,909,104
58,116
28,819
2,320,000 14,048,000
115,496
960,000
0
0
0
2,435,496 14,106,116
988,819
< 1 Gallon
Steel
Plastic
Steel
Jugs
Glass
2.5 Gallons 1qt-2.5 Gal
a
0
1,007,023
0
0
26,379
2,273,060
21,072,000 1,440,000
27,877,458
20,560,000
160,000
240,000
0
370,000
0
0
0
0
0
0
48,949,458 1,440,000
21,567,023
160,000
240,000
26,379
2,643,060
0
a
The container labeling requirements apply to all pesticide products except those that are considered residential/household use (H&G market) pesticide products.
See Table 3.4.
Page 147
5.3.1.3 Step 3: Estimate the Number of Non-Refillable Containers Diverted from the
Hazardous Waste Stream to the Non-Hazardous Waste Stream After
Promulgation of the Labeling Requirements
To calculate this benefit category, the percentage of containers that will be appropriately rinsed
and disposed of under the container rule needs to be estimated, as does the percentage of total
containers that will continue to be inappropriately disposed of (without having been properly
rinsed or with a container design that does not rinse clean). For lack of better data, these
percentage estimates are based on educated extrapolations taken from the proposed container
rule RIA (EPA, 1993). The proposed container rule RIA estimated its pre-regulation rinse rates
based on information from the following sources:
(1) The rinsing behavior observed in a late 1970s study (as reported by Taylor, undated)
and two other surveys (Ozkan, 1991, and EPA, 1992a) related to agricultural pesticide
use. The Taylor study suggested that 35 percent of farmer applicators triple rinse pesticide
containers and only 18 percent of custom applicators triple rinse. The Ozkan study found
that more than 90 percent of farmer-pesticide users in Wayandot County, Ohio, rinsed their
empty pesticide containers at least once, though only 45 percent regularly rinsed three times.
EPA reported that a 1988 South Dakota farmer survey of pesticide applicators in seven
counties indicated that 55 percent of the farmers rinsed their empty containers, although
many of them only once or twice. Across studies, it was therefore observed that between 45
percent and 82 percent of farmer applicators do not triple rinse. Though the rinsing
behaviors were based on observations taken from the agricultural sector, we applied these
rinsing rates to the other markets as well.
(2) The percentage of agricultural and industrial/institutional containers not meeting the
proposed standard (at that time a six-9s standard) after a triple rinse, as observed in a
1992 study (EPA, 1992c). The study tested the percentage of containers not meeting a five9s standard. The study finds that 13 percent of the containers tested at small, medium, and
large agricultural facilities and 3 percent of the containers tested at small and medium
industrial/institutional facilities did not meet a five-9s requirement for residue removal. The
final rule requires containers pass only four-9s standard. Based on the residue removal data
in the preamble to the final rule that shows that only 1 of the 79 container/formulation
combinations failed to meet the four-9s standard, a 2 percent failure rate is applied in this
analysis.
The proposed container rule RIA acknowledged that it was likely that the proportion of farmers
not triple rinsing was less than the upper bound of the observed range of rinsing behaviors
(between 45 percent and 82 percent). The RIA therefore estimated that in the baseline, 50
percent of all containers were rinsed inadequately or not rinsed at all and should be considered
hazardous prior to the labeling and residue removal requirements. The other 50 percent of
containers were therefore rinsed adequately and considered non-hazardous waste. After
promulgation of these requirements, however, the proposed container rule RIA estimated that 20
percent of all containers would remain hazardous (due to improper rinsing or no rinsing at all).
Transferring these assumptions to the current analysis, it is therefore assumed that 30 percent of
those containers listed in Table 5.22 that are subject to the labeling requirements will be rinsed
Page 148
properly after promulgation of the rule. However, non-refillable containers that comply with the
labeling requirements may still be designed in such a way that inappropriate levels of pesticide
residues remain in the containers even after a triple rinse. Based on the EPA
container/formulation residue removal testing study (EPA, 1992c), a two percent failure was
found across all container formulations to achieve the four-9s level. Therefore, an estimated 28
percent of containers listed in Table 4.22 that are subject to the labeling requirements will no
longer be hazardous waste when disposed of [# of containers * 0.28].73
For example, applying this 28 percent factor to the number of eligible 5-gallon plastic containers
used in the agricultural market (58,116) yields 16,272 containers that will no longer be hazardous
waste (see Table 5.23). Table 5.23 presents, by container size and market sector, the number of
non-refillable containers that will be converted from hazardous to non-hazardous waste after the
promulgation of the pesticide container labeling requirements.
73
Based on assumptions made in the proposed container rule RIA (EPA, 1993), we assume that 50 percent of all
containers are considered hazardous prior to the labeling requirements. After promulgation of these requirements,
however, only 20 percent of all containers will remain hazardous (due to improper rinsing, no rinsing, etc.). Because
these containers only have to comply with the labeling requirements, a number of rigid containers holding dilutable
pesticides may be designed in such a way that inappropriate levels of pesticide residues remain in the containers
even after a triple rinse. The cost analysis assumed that 2 percent of container/formulation combinations for all sizes
and all market categories would not pass the residue removal test. That assumption is applied here, subtracting 2
percent from the 30 percent of containers no longer considered hazardous due to the labeling requirements. In other
words, 28 percent of containers listed in Table 5.22 that are subject to only the labeling requirements will no longer
be hazardous waste when disposed of [# of containers * 0.28].
Page 149
Table 5.23. Number of Non-Refillable Containers Diverted from the Hazardous Waste Stream to the Non-Hazardous Waste
Stream After the Promulgation of the Labeling Requirements
Container Type: Liquid Products
30-55 Gallons
Plastic
5 Gallons
Steel
Plastic
Container Type: Dry
Products
1 To < 5 Gallons
Steel
Plastic
< 1 Gallon
Steel
Plastic
Steel
Jugs
Glass
2.5
Gallons
1qt-2.5
Gal
Number of Containers Diverted from the Hazardous Waste Stream After Compliance with Labeling Requirements a
Agriculture
I/C/G
86,549
32,339
16,272
8,069
7,805,688
0
281,966
0
0
7,386
636,457
448,000
649,600
3,933,440
268,800
5,900,160
403,200
5,756,800
44,800
67,200
0
103,600
H&G
0
0
0
0
0
0
0
0
0
0
0
Total
534,549
681,939
3,949,712
276,869
13,705,848
403,200
6,038,766
44,800
67,200
7,386
740,057
a
Based on assumptions made in the proposed container rule RIA (EPA, 1993), we assume that 50 percent of all containers are considered hazardous prior to the
labeling requirements. After promulgation of these requirements, however, only 20 percent of all containers will remain hazardous (due to improper rinsing, no
rinsing, etc.). Because these containers only have to comply with the labeling requirements, a number of rigid containers holding dilutable pesticides may be
designed in such a way that inappropriate levels of pesticide residues remain in the containers even after a triple rinse. The cost analysis assumed that 2 percent
of container/formulation combinations for all sizes and all market categories would not pass the residue removal test. That assumption is applied here,
subtracting 2 percent from the 30 percent of containers no longer considered hazardous due to the labeling requirements. In other words, 28 percent of
containers listed in Table 5.22 that are subject to only the labeling requirements will no longer be hazardous waste when disposed of [# of containers * 0.28].
Page 150
5.3.1.4 Step 4: Calculate the Benefits Associated with the Diversion of
Non-Refillable Containers from the Hazardous Waste Stream to the
Non-Hazardous Waste Stream
Recall that this benefit category is based on the difference in cost between the disposal of nonrefillable pesticide containers that, before the rules, were disposed of as hazardous waste, and the
disposal of non-refillable pesticide containers that, after the rules, would be disposed of as nonhazardous waste. Because hazardous waste disposal is more costly than non-hazardous waste
disposal, the benefit is the resulting cost savings per ton of container waste.
Now that the number of non-refillable containers converted from hazardous to non-hazardous
waste after the promulgation of the labeling requirements has been estimated (Table 5.23), the
number of containers must be converted to a total weight (in pounds) per container category. By
multiplying the total number of containers that are no longer hazardous by each container size’s
listed weight in Table 5.21, the total weight of containers no longer considered hazardous can be
estimated. For example, multiplying the total number of non-hazardous 5-gallon plastic
containers subject to the labeling requirements (3,949,754) by the assumed weight of a
representative 5-gallon plastic container (3 pounds) equals 11,849,137 pounds, or 5,925 tons, of
5-gallon plastic containers that can now be disposed of as non-hazardous waste in sanitary
landfills (see Table 5.24).
The dollar benefits associated with the diversion of waste from hazardous facilities to nonhazardous landfills are based on the difference in per ton tipping fees associated with each type
of waste treatment. We estimated non-hazardous (solid) waste tipping fees based on average
tipping fees in 13 states.74 The average across states was $58/ton (2005$). Hazardous waste
tipping fees of $233/ton (2005$) were taken from the proposed container rule RIA (EPA, 1993)
and adjusted for inflation to 2005 dollars. The cost savings achieved by diverting containers
from the hazardous waste stream to the solid waste stream is therefore $175/ton.
Total non-discounted benefits across all container sizes equal $5,687,420 annually (2005$).
Benefits begin in the fourth year after promulgation, allowing for a 3-year compliance period for
both the labeling and residue removal requirements. Table 5.24 presents the benefits in terms of
tipping fee cost savings for each container type and size as well as the total benefits for this
direct benefit category.
For the 20-year regulatory period we consider in this analysis, direct non-health benefits occur in
each year from years 4 to 20. Discounting this stream of annual benefits, summing across years,
and annualizing over a 20-year period yields a discounted annualized benefit of $4,471,929 using
a 3 percent discount rate and $3,998,645 using a 7 percent discount rate.
74
States included: CA, CT, IA, IL, MA, ME, MN, NH, NY, PA, RI, VT, WI. Sources: IA, IL, MI, MN, WI (Lovell,
2001); CA (CA IWMB, 2002); CT, MA, ME, NH, NY, RI, VT (Watson, 2002); PA (PA DEP, 1997).
Page 151
Table 5.24. Non-Discounted Benefits Associated with the Diversion of Non-Refillable Containers from the
Hazardous Waste Stream to the Non-Hazardous Waste Stream (2005$)
Container Type:
Dry Products
Container Type: Liquid Products
30-55 Gallons
Plastic
5 Gallons
Steel
Plastic
1 To < 5 Gallons
Steel
Plastic
< 1 Gallon
Steel
Plastic
Steel
Jugs
Glass
2.5 Gal
1qt-2.5 Gal
Total Weight of Containers Diverted from the Hazardous Waste Stream
Total (lbs)
Total (tons)
12,294,630
28,982,402
11,849,137
1,661,216
7,401,158
556,416
905,815
22,400
33,600
4,432
1,110,085
6,147
14,491
5,925
831
3,701
278
453
11
17
2
555
$1,965
$2,948
$389
$97,399
a
Tipping Fee Cost Savings (Hazardous Waste Disposal vs. Solid Waste Disposal) of $175/ton (2005$)
Total b
$1,078,731
$2,542,916 $1,039,643 $145,755
$649,378
$48,820
$79,476
Total Non-Discounted Benefits (Summed Across Container Type and Size
Categories)
a
$5,687,420
Solid waste tipping fees based on average tipping fees in 13 states. The average across states was $58/ton (2005$). Hazardous waste tipping fees of $233/ton
(2005$) were taken from the proposed container rule RIA (EPA, 1993) and adjusted for inflation to 2005 dollars. The cost savings achieved by diverting
containers from the hazardous waste stream to the solid waste stream is therefore $175/ton.
b
Totals may not add due to rounding.
Page 152
5.3.2 Environmental Effects Avoided Due to Container-Related Pesticide Exposures
The failure or mishandling of pesticide containers and the resulting exposure to pesticides pose
significant risks to the environment. Once the pesticide container rules are promulgated,
however, the risk of such exposures will decrease due to reduced accidental spills, fewer leaks,
less dripping, less frequent container stress failure, and proper rinsing prior to container disposal.
The direct non-health benefit that results is therefore the damage reduction from fewer exposures
of terrestrial and aquatic wildlife, including those in sensitive and critical habitats, to pesticides
and residues. Unfortunately, a quantitative measure of the avoidance of such environmental
damages related directly to the pesticide container regulations is very difficult to estimate.
The extent to which pesticide-related environmental incidents occur in the United States is not
well documented. The primary clearinghouse for the reporting of such incidents is the
Ecological Incident Information System (EIIS), a database maintained by the Ecological Fate
and Effects Division of the Office of Pesticide Programs at EPA. The two primary sources of
incident reports that are submitted to the EIIS are reports filed by pesticide registrants and
government agencies. The container rule requires that pesticide registrants or manufacturers
report to EPA any information related to known adverse environmental effects due to releases of
their registered pesticides. Many of these ecological incidents are probably not observed or
reported, however.
For example, the California Department of Pesticide Regulations (CDPR) is thought to be at the
forefront of state agencies in terms of pesticide tracking, management, monitoring, and reporting.
However, very few ecological incidents that occur in California are logged into the CDPR’s
database of priority investigations—the only statewide database that tracks such events (EPA,
2005). In California, pesticide-related releases are initially investigated by county agricultural
commissioners. If a particular release is deemed to meet “priority investigation status,” it is
referred to the CDPR and logged into the database of priority investigations. An annual
summary of all priority investigations, if any, is then provided to EPA for input into the EIIS.
For non-health incidents, the current thresholds for categorizing an environmental incident as a
priority investigation in California include:
Animals and Wildlife: Any pesticide incident with associated level of mortality that exceeds
the following:
Non-Target Birds: 50
Non-Target Fish: 500
Listed Endangered or Threatened Species: 1
Domesticated, Game, or Other Non-Target Animals: 5
As one can see from the priority investigation criteria, it is likely that many pesticide-related
incidents occur but never warrant priority investigation status. California maintains no records
of such incidents, and of the records it does maintain and submit to EPA, only three spill-related
environmental incidents were reported between 1968 and the present.
The spill/leak-related incidents are singled out in the EIIS since they are the incidents most likely
to be avoided by the promulgation of the pesticide container regulations. Within the EIIS, there
have been 43 spill/leak-related aquatic and terrestrial environmental incidents reported since its
Page 153
inception in 1992 (with reports dating back to 1968). In total, 15 states have submitted spillrelated environmental incident reports with varying degrees of severity. Incidents have ranged
from an unknown number of species incapacitated to thousands of acute cases of animal
mortality. Species affected include minnow, trout, catfish, largemouth bass, salmon, blue crab,
banded water snake, American alligators, egrets, wood storks, and turkey vultures to name only a
few. Of the spill-related incidents, however, the cause of only a handful can be categorized as
potentially container-related.
In fact, of the 43 spill-related incidents in the EIIS database that had sufficient description in the
incident report, only five could be considered container related. They are summarized as
follows:
•
•
•
•
•
Chlorpyrifos termicide leaked while a technician was repairing a tank. A significant quantity
spilled onto the driveway. The technician washed the spilled chemical into a storm drain,
which ran into a public duck pond resulting in a possible fish kill. The total number of
species affected was not reported (EIIS #I001849-001).
In California, approximately 100,000 carp and trout were killed as the result of endrin
pesticide containers being discarded near an artesian well (EIIS #B0000-225-01).
A 5-gallon can of Hydrothol 191 (endothall) was found dripping in a drain near Richvale,
California. More than 1,000 fish were killed, mostly carp (EIIS #B0000-231-03).
A fish kill occurred on a creek in Sangamon County, Illinois, due to a leaking sight valve on
a 1,000 gallon tank. The type of pesticide was not reported (EIIS #I0000659-001).
A fish kill occurred in a creek in Baton Rouge, Louisiana, due to a leaking 55-gallon drum of
2,4-D and bromacil and a leaking 55-gallon drum of degreaser. Approximately 600 fish were
killed along 1.6 miles of the creek (EIIS #I004668-001).
The extent of national pesticide container-related environmental incidents reported in the EIIS is
likely to be an underestimate of the actual number of container-related incidents. Therefore,
caution should be taken in using EIIS to characterize the number and size of national containerbased pesticide-related incidents that could be avoided once the container rules are in place.
Though this type of benefit is not quantified in the current analysis, it should be noted that such
benefits are likely to exist in association with the pesticide container rule.
5.3.3 Property Damage/Spill Cleanup Costs Avoided
For the same reasons we are unable to estimate the benefits associated with avoided
environmental incidents (a lack of data from which to relate container-related spills to property
damage and the related costs of cleanup), we are unable to draw any conclusions regarding the
extent to which the pesticide container rules will prevent property damage or reduce the costs
associated with unintended, container-related pesticide releases.
Data does exist, however, that tracks hazardous material releases. One primary database is the
Accidental Release Information Program (ARIP) database, maintained by the Chemical
Emergency Preparedness and Prevention Office (CEPPO) within the Office of Solid Waste and
Emergency Response (OSWER), which contains 4,946 incident records from between 1986 and
1999. Most recently, EPA used the ARIP data and findings in support of the development of
regulatory guidance for chemical accident prevention as mandated by the Risk Management
Page 154
Program Rule (written to implement section 112(r) of the amended Clean Air Act). EPA
discontinued the ARIP program in 1999 when EPA completed its regulatory guidance effort.
EPA administered the ARIP to learn about the causes and consequences of accidental releases of
hazardous substances from fixed facilities and the actions that have been or could have been
effective in preventing them from occurring. EPA used select releases collected in the
Emergency Response Notification System database for the ARIP questionnaire, targeting those
accidental releases at fixed facilities that resulted in off-site consequence or environmental
damage. Unfortunately, a search of the database yielded no definitive pesticide container-related
accidental releases.
We queried the database to extract all potential pesticide-related releases. We limited the search
to the following SIC Codes:
2879
2869
2819
2865
2833
5261
5191
2491
2049
Pesticides & Agricultural Chemicals
Industrial Organic Chemicals
Industrial Inorganic Chemicals
Cyclic Organic Crudes & Intermediates
Medicinal Chemicals & Botanical Products
Retail Nurseries & Lawn Supply Stores
Farm Supplies
Wood Preserving
Food Preparations
There were 142 incidents recorded in the ARIP database associated with these SIC codes. Only
27 of these 142, however, were incidents related to “storage vessels” or “valves” that were
caused by “equipment failure” rather than “operational error.”75 Table 5.25 lists characteristics
of these 27 incidents.
75
The cause of release for 5 of the 27 incidents was not identified in the ARIP database. We therefore included
these incidents in the “equipment failure” category.
Page 155
Table 5.25. Characteristics of Potential Pesticide-Related Chemical Spills Recorded
in the ARIP
Spills
6
Vapor Releases
17
Spills and Vapor Releases
4
Total
27
No Environmental Effects Recorded
(Field Left Blank)
15
No Environmental Effects (Field Marked
None)
9
Environmental Effects (Soil
Contamination or Other)
3
Total
27
Injuries Recorded (Facility Employees,
Contractors, General Public, and/or
Responders)
7
No Injuries (Fields Marked Zero)
20
Total
27
8
Number of Facilities that Provided
Cleanup Cost Information
Average Cleanup Cost (2000$)
$22,231
Minimum Cleanup Cost (2000$)
$1,438
Maximum Cleanup Cost (2000$)
$126,432
Primary Product or Service
Pesticides & Chemicals; Organic & Inorganic Chemicals & Pesticides;
Agricultural Chemicals; Agricultural Products; Wood Preservation;
Nursery Items (Fertilizer, Pesticides & Garden Tools); Medicinal
Chemicals and Botanical Products; Manufacturing of Human Health
Products, Pesticides, & Agricultural Chemicals; Industrial Organic
Chemicals; Industrial Inorganic Chemicals
Chemicals Released
Sulfuric Acid, Nitric Acid, Methyl Chloride, Nitrogen Dioxide,
Chlorine, Ammonia, Toluene, Hydrogen Chloride, Carbon
Tetrachloride, Phosphoric Acid, Creosote, Ethylene Oxide,
Ammonium Hydroxide
With the level of detail provided by ARIP, it is difficult to determine if a particular release would
or would not be avoided due to the promulgation of the pesticide container regulations. We
therefore provide the ARIP releases to demonstrate that chemical spills and other unintentional
releases occur and that there is a cost associated with their cleanup. However, we are unable to
draw any conclusions regarding the extent to which pesticide registrants and refillers will avoid
cleanup costs due to the pesticide container regulations. Furthermore, it is impossible to draw
any conclusions regarding the representativeness of the facilities surveyed by ARIP compared to
the universe of all facilities that experience chemical releases. The criteria for selecting incidents
to survey changed over time, and in the last few years of the survey (between 1997 and 1999),
the ARIP survey effort scaled back its data collection efforts to only nine incidents surveyed per
year, due to Paperwork Reduction Act requirements. We therefore cannot extrapolate the ARIP
release information to represent a more broad estimate of potential pesticide container-related
spills throughout the United States.
Page 156
5.4 Summary of the Benefits of the Final Standards
As discussed above, the container design and residue removal standards are largely pollution
prevention regulations that will safeguard workers and the environment by reducing the risk of
exposure to concentrated pesticides. There are numerous types of human health-related benefits
and non-human health-related benefits that will stem from such improvements because of
relatively fewer expected spills, leaks, and other risks associated with exposure (e.g., handling by
workers during disposal, discharges to the environment, and potential public exposures).
The expected benefits resulting from the proposed container design/residue removal regulations
include: reduced pesticide-related illnesses and injuries, the cost savings associated with the
disposal of rigid non-refillable containers as non-hazardous rather than hazardous waste, and the
reduction in the number of accidental pesticide spills. Due to data limitations, we were only able
to monetize the benefits associated with the first two benefit categories.
The largest monetary benefit of the container standards is the decrease in disposal costs of nonrefillable containers. Large numbers of non-refillable containers that are currently disposed of in
hazardous waste landfills will now be able to be disposed of in sanitary landfills at a much
reduced cost ($175/ton). This savings results in an annualized benefit of $4,471,929 using a 3
percent discount rate and $3,998,645 using a 7 percent discount rate.
The new standards will also have a positive effect on human health. It is estimated that 610 to
768 cases of illness will be avoided as a result of the container design and residue removal
regulations each year. Assuming a 3 percent discount rate, this results in an annualized benefit of
$264,051 (“Low-End” scenario) to $332,311 (“High-End” scenario). At a 7 percent discount
rate, the health benefits range from $236,635 to $297,807. If the 51 “possible” cases in
California are included, which increases the percentage of total pesticide product-related cases
potentially avoided by 4.33 percent, the annual health benefits could be at five times this amount.
Therefore, the total monetized benefits of the container design and residue removal standards
range from $4,735,980 to $4,804,240 at a 3 percent discount rate and $4,235,280 to $4,296,452
at a 7% discount rate.
The new container design and residual removal standards will also result in a decrease in the
number of accidental pesticide spills that occur each year. This will have two benefits. First,
large pesticide spills can have a significant effect on the environment. Second, by reducing the
number of pesticide spills, the new standards will decrease response and clean up costs
associated with these spills. We investigated several data sources to document the cause,
environmental effect, and response and clean up costs associated with accidental pesticide spills.
Although we were able to document that the new standards will likely prevent some future
pesticide spills, and that these spills do have negative environmental consequences and result in
clean-up costs, the data do not allow us to estimate the magnitude of these benefits. Though this
type of benefit is not quantified in the current analysis, due to data limitations, these data are
proof that such benefits are likely to result from the new standards.
Page 157
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Page 161
Appendix A. Compliance Costs for the Pesticide Container Standards
The inputs used to estimate fixed and unit variable compliance costs associated with the pesticide
container rule are based upon information taken from four sources:
(3) The Proposed Container Rule Regulatory Impact Analysis (RIA) (EPA, 1993). The
assumptions used in that analysis were based on informal surveys of and consultations with
pesticide registrants, refillers, and industry experts. The proposed container rule RIA also
went through a review and comment period. The cost assumptions from the proposed EPA
container rule are used as the primary source of cost information for the current analysis.
(4) An informal survey of registrants, refillers, and industry experts. Where possible, cost
assumptions transferred from the proposed EPA container rule RIA are updated with up-todate information collected from an informal survey of registrants, refillers, and industry
experts.
(5) Public comments. Public comments to the 1994 proposed rule, 1999 Supplemental Notice
(EPA, 1999), and 2004 comment period provided information and data in support of the
assumptions made and data used in the economic analysis.
(6) Best professional judgment. In cases where new information was not available, but a
revision of the proposed EPA container rule assumptions seemed warranted, we used best
professional judgment to estimate certain cost inputs.
The following section describes the source of each cost input and presents, in tabular form, the
value of each cost assumption organized by the particular container standard, the size of the
establishment, and the establishment’s market sector.
Costs associated with the container standards are characterized in three ways. There are
compliance period costs, capital costs, and recurring costs.
•
Compliance period costs are associated with actions regulated entities must undertake to
come into compliance with a particular regulation. It is assumed that affected entities will
wait until the end of the compliance period to take these actions. The compliance periods for
the various regulation categories are:
- Non-refillable containers: 3 years;
- Refillable containers: 5 years;
- Refilling or repackaging: 5 years; and
- Labeling: 5 years.
•
Capital costs can be thought of as a one-time purchase of equipment and/or materials related
to the compliance of a particular regulation. It is assumed that any capital equipment that
must be acquired is purchased at the end of the compliance period.
•
Recurring costs are those that regulated entities will incur on an annual or intermittent basis
once the regulations are promulgated. Therefore, costs start in the first year after the end of
the compliance period.
Page 162
Not all pesticide container standards have costs associated with them. Table A-1 displays each
of the container standards and lists whether there is a cost associated with compliance. If a cost
is estimated related to the container standards, Table A-1 describes whether that cost is fixed or
variable.
There are two reasons why a particular container standard would not have a cost associated with
compliance. First, the container regulations state that pesticides that are considered Department
of Transportation (DOT) hazardous materials must be packaged in containers that meet the DOT
standards for hazardous materials. Therefore, any costs that regulated entities incur in
complying with this standard for pesticides that are DOT hazardous materials are attributed to
the DOT standards and not the container regulations. In other words, we consider the DOT
standards for hazardous material containers to be in the compliance baseline for DOT hazardous
materials. Second, it is assumed that there are containers available on the market today that
comply with many of the regulations listed in Table A-1. This assumption is consistent with the
proposed EPA container rule RIA which assumed that nearly all containers on the market met
container closure and dispensing standards, and that most of the containers in use were DOTcompliant and that nearly all containers in production were DOT-compliant. These assumptions
were confirmed for the final EPA container rule EA through additional discussions with
pesticide registrants, refillers and industry experts. Compliance with the DOT-related standards
was high for the proposed rule, and, given the increasing availability and use of DOT-compliant
containers, the final rule assumes that those containers that were out of compliance have either
been replaced or will be replaced with compliant containers within the compliance period at no
extra cost.76
For those regulations where costs are associated with compliance, there are two inputs that many
of the regulations share: labor rates and an inflation factor. First, many of the requirements, such
as the administrative requirements (recordkeeping), container inspection, and marking of
containers, involve labor costs. For this analysis, a base hourly wage of $15.54 is used for
administrative labor and $48.22 is used for professional labor. These wages were calculated by
averaging the hourly wage for each labor class across the agricultural chemical, industrial
organic chemical, and miscellaneous chemical product industries. Using these average wages,
we applied a 25 percent fringe adjustment to the hourly rate and a 50 percent overhead
adjustment to the wage plus fringe. This results in an hourly rate of $29.13 for administrative
labor and $90.42 for professional labor. The industry-specific occupational wage estimates are
taken from the Bureau of Labor Statistics’ Occupational Employment Statistics (BLS, 2000).
All costs and cost inputs presented in this report are in 2005$.
76
Two DOT non-hazardous material packing standards had costs associated with them in the proposed EPA
container rule RIA (the nonrefillable container marking and refillable container drop test standards). For the
nonrefillable container marking requirement, the proposed rule estimated costs to mark containers with an EPA
registration number and other statements. For the refillable container drop test requirement, the proposed rule RIA
estimated costs to replace containers that were not in compliance with the drop test standard. The final EPA
container rule EA estimates no compliance costs with these requirements because it is assumed that nearly all
pesticide containers meet the DOT standards.
Page 163
Table A-1. Compliance Costs Associated with the Container Standards
Container Standard
Cost Associated
with Compliance?
Cost Type/
Reason for No Cost
DOT Packaging Standards Hazardous Material
No.
Costs attributed to the DOT
standards, not the container
regulation standards.
DOT Packaging Standards –
Non-Hazardous Material
No.
Containers that meet the
standards are available on the
open market at no extra cost.
Closure Standards
No.
Containers that meet the
standards are available on the
open market at no extra cost.
Standards for Container
Dispensing Capability
No.
Containers that meet the
standards are available on the
open market at no extra cost.
Residue Removal Standards
Yes.
Fixed.
Administrative Requirements Recordkeeping
Yes.
Fixed.
Standards for Container Marking
Yes.
Variable.
Standards for Openings
Yes.
Variable.
Bulk Container Standards
Yes.
Variable.
Inspection and Cleaning Standards
Yes.
Variable.
Language Changes
Yes.
Fixed.
A.1 Non-Refillable Container Costs
A.1.1 Residue Removal Standard
The cost of complying with the final standards for the removal of residues from non-refillable
containers is attributed to the cost of ensuring that each non-refillable container design type and
pesticide formulation combination meets the residue removal standard. The container
regulations propose that every registrant test three containers from each rigid container/dilutable
formulation combination to determine that the containers are capable of attaining at least 99.99
percent removal of each active ingredient in the fourth rinsate after a triple rinse. In the proposed
container rule RIA, EPA estimated that it costs $3,425 to conduct the residue removal test using
three containers, which is transferred to the current analysis.77
In addition to the testing cost, it is necessary to know how many rigid container/dilutable
formulation combinations there are per establishment to calculate the total residue removal
compliance cost. It is assumed that the average establishment, regardless of size or market
sector, uses three rigid container types per formulation, based on an assumption EPA made in its
proposed container rule RIA. In an informal survey of pesticide registrants for the final rule
economic analysis (EA), we determined that this was a reasonable assumption. Of nine
responses across small, medium, and large registrants, four registrants indicated that on average
77
Values quoted from the proposed container rule RIA have been updated to 2005$ to make them comparable with
values in this economic analysis.
Page 164
they used three containers to package each of their formulations (from a range of 1 to 12
container types per formulation).
To develop the representative number of formulations for large and small registrants, the analysis
begins by examining the active registrations for large companies, based on company registration
information from EPA’s Pesticide Product Information System (PPIS) database and Dun &
Bradstreet data for determining company size. We downloaded the necessary container
regulation Section 3 Product Information Files from the PPIS Web site
(http://www.epa.gov/opppmsd1/PPISdata/) and then uploaded the files into a Microsoft Access
database. We removed inactive registrations (and corresponding company data) from the
database, and as a result, identified 1,804 registrants holding 16,407 active registrations (or
formulations).
Based on the large pesticide registrant profile (see Appendix D), we matched approximately
4,600 registrations with the 146 large pesticide registrants identified in the industry profile. As a
result, we calculated that each large registrant had on average 32 active registrations. We
distributed the approximately 11,700 remaining active registrations (approximately 16,400 4,600) among the small registrants using best professional judgment by assigning on average
more registrations to large-small companies (20) than medium-small companies (9) and smallsmall companies (3). Table A-2 summarizes the estimated number of registrations per company
in each size category based on the approach described. The table also lists the assumptions made
on the number of active registrations per registrant size category for the proposed rule, which
was significantly higher due to less specific data available on the number of active registrations.
Table A-2. Estimated Number of Active Registrations (Formulations) per Registrant by
Size Category: Current Versus Proposed Rule
Estimated Number of
Active Registrations
(Formulations) per
Registrant
Proposed Rule Estimate
of the Number of Active
Registrations
(Formulations) per
Registrant a
Large Registrants
32 b
430
Large-Small Registrants
20
430
Medium-Small Registrants
9
60
Small-Small Registrants
3
16
Size Category
a
Estimates taken from the proposed container rule RIA (EPA, 1993).
Calculated by dividing the total number of active registrations (4,575) by the
estimated number of registrants in each size category (146) and rounding the result up
to the nearest integer (31.3 to 32).
b
As shown in Table A-3, by multiplying the number of active registrations per registrant by the
number of registrants in each size category (see Table D-3), the total number of active
registrations (15,438) and the percent of active registrations per size category can be calculated.
This number is less than the actual number of active registrations (16,407) due to rounding in the
per registrant size category.
Page 165
Table A-3. Estimated Number of Active Registrations per Registrant Size Category
Size Category
Estimated Number
Number of
Percentage of
Number of
of Active
Active
Active
Registrants in
Registrations per Size Category b Registrations per Registrations per
Registrant a
Size Category
Size Category
Large Registrants
32
146
4,672
30%
Large-Small Registrants
20
166
3,320
22%
Medium-Small Registrants
9
495
4,455
29%
Small-Small Registrants
3
997
2,991
19%
c
Total (Registrants or Active
NA
1,804
15,438
100%
Registrations)
a
See Table A-2.
b
See Table D-3.
c
May not add due to rounding. The estimated 15,438 products are less than the estimated total number of
registrations based on EPA data due to rounding in per registrant estimates.
However, not all active registrations are subject to the residue removal standard. Only products
that are subject to the full set of non-refillable container standards and that are flowable
concentrate products in rigid containers are subject to the residue removal standard. The
products that are subject to the full set of non-refillable container standards are those products
that are not specifically exempt and that are: (1) classified in Toxicity Category I or II, and/or
(2) are restricted use products (RUPs). Of the products that meet these criteria, only products
that are formulated as flowable concentrates and that are packaged in rigid containers (i.e., not in
bags) are subject to the residue removal standard.
An analysis of total number of products formulated as flowable concentrates that are Toxicity
Category I and II and RUPs provides an estimate of the number of active registrations that are
subject to the residue removal standard. Based on an analysis of EPA product registration data
on the number and type of registered products, an estimated 105 (rounded up to 110) active
registrations (products) are subject to the residue removal standard (Table A-4). The analysis
first identified from EPA product registration data the total number of registered Toxicity
Category I, II, III, and IV products, restricted use products, and antimicrobial products (column
one of Table A-4). The analysis then estimated the percentage of these products that are subject
to the residue removal standard (column two of Table A-4) by selecting from the EPA product
registration data only those products formulated as flowable concentrates (346) and studying
their labels to determine which of these products are Toxicity Category I and II and RUPs.
Based on this analysis, an estimated 3 percent of Toxicity Category I, 3 percent of Toxicity
Category II, and 6 percent of RUPs in Toxicity Category III/IV are subject to the residue
removal standard (Table A-4). None of the identified flowable concentrate products are
antimicrobial products.
Page 166
Table A-4. Estimated Number of Active Products Subject to the
Residue Removal Standard
Number of
Products in
Category a
Percentage of Products
Subject to Residue
Removal Standard b
Number of Products
Subject to Residue
Removal Standard c
Toxicity Category I (non-antimicrobial)
1,434
3%
43
Toxicity Category II (non-antimicrobial)
1,585
3%
48
225
6%
14
1,350
0%
0
Product Category
Restricted Use Product in Toxicity
Category III/IV (non-antimicrobial)
Antimicrobial Products that are subject to
non-refillable container standards d
Total
4,594
NA
105 e
a
Based on information from EPA pesticide product databases.
b
Information on the percentage of active products subject to the residue removal standard was estimated by
identifying all active flowable concentrate registrations and studying their labels to determine which products are
Toxicity Category I and II and/or RUPs. This column represents the estimated percentage of the registered products
that are Toxicity Category I and II and RUP flowable concentrates in rigid containers.
c
The number of products subject to the residue removal standard is calculated by multiplying the number of
products in each category by the corresponding percentage of the sample subject to the residue removal standard.
d
None of the 346 active registered flowable concentrate products are antimicrobial products.
e
The number of products subject to the residue removal standard is rounded to 110 products in the analysis.
Based on this information, Table A-3 can be amended to include the estimated number of active
registrations (formulations) subject to the residue removal standard per registrant (Table A-5).
This information is calculated by distributing the estimated 110 products subject to the residue
removal standard among the four registrant size categories according to the same percentages as
in Table A-3, and dividing the resulting value by the number of registrants in that size category.
The result is a significant reduction in the number of active registrations subject to the residue
removal standard. For example, for the average large registrant, the estimated number of active
registrations subject to the residue removal standard drops from 32 to 0.23 (rounded up to 0.25)
when considering only those products specifically subject to the residue removal standard. This
value suggests that not every large registrant has an existing registration that will be subject to
the residue removal standard. However, on average, across all registrants, each registrant has
one-quarter of an existing registration subject to the residue removal standard. Table A-6
provides a comparison of the different estimates of the number of active registrations,
considering all active registrations (column three of Table A-6), and considering only active
registrations subject to the residue removal standard (column two of Table A-6).
Page 167
Table A-5. Estimated Number of Active Products Subject to the Residue Removal
Standard by Registrant Size Category
Number of Active
Registrations
Number of Active
Percentage of
Subject to Residue
Registrations Subject
Number of
Removal Standard
Active
to Residue Removal
Registrants in
per Average
Registrations per
Standard per Size
Size Category a
Size Category c
Registrant d
Category b
Size Category
Large Registrants
30%
33
146
0.23
Large-Small Registrants
22%
24
166
0.14
Medium-Small Registrants
29%
32
495
0.06
Small-Small Registrants
19%
21
997
0.02
Total (Registrants or
NA
110
1,804
NA
Active Registrations)
a
See Table A-3.
b
Equal to the percent of active registration per size category times the total number of active registrations (110).
This analysis assumes that the number of active registrations subject to the residue removal standard is distributed
by registrant size category in the same proportion as all active registrations.
c
See Table D-3.
d
Equal to the number of active registration subject to the residue removal standard divided by the number of
registrants in each size category.
Table A-6. Comparison of the Estimated Number of Active Registrations (Formulations)
per Average Registrant by Size Category
Size Category
Estimated Number of
Active Registrations
(Formulations)
Estimated Number of
Subject to the Residue Active Registrations
(Formulations) per
Removal Standard
per Registrant a
Registrant c
Large Registrants
0.25
32
Large-Small Registrants
0.20
20
Medium-Small Registrants
0.10
9
Small-Small Registrants
0.05
3
Total Registrants
NA
NA
The proposed container rule RIA assumed that the number of new formulations per registrant per
year that require testing was two for all entity sizes except small-small registrants, for which the
RIA assumed one new formulation that requires testing each year. No new data are available
with which to update the assumption about the number of new products per year. However,
since there are so few existing registrations that are subject to the residue removal standard, this
assumption must be adjusted to reflect the changes in the scope of the requirements from the
proposed to the final rule. In the absence of data, the final rule EA makes the assumption that
the number of new formulations subject to the residue removal standard per registrant per year is
the same as the number of existing formulations subject to the residue removal standard per
registrant. That is, for the final rule, it is assumed that there are 0.25 new formulations per
registrant per year that require testing (or one every 4 years) for the large registrants; 0.20 new
formulations per registrant per year that require testing (or one every 5 years) for the large-small
Page 168
registrants; 0.10 new formulations per registrant per year that require testing (or one every 10
years) for medium-small registrants; and 0.05 new formulations per registrant per year that
require testing (or one every 20 years) for the small-small registrants (Table A-7).
Table A-7. Non-Refillable Container Residue Removal Compliance Cost Inputs
and Assumptions
Percent
Container
Testing
ReNew
Types per
Existing
“Me-Too”
Cost
Establishment Type
(2005$)a Formulation a Formulations b Formulations b tested c Scenario d
Large-Small Establishments
Agriculture
$3,425
3
0.2
0.2
30%
75%
I/C/G
$3,425
3
0.2
0.2
30%
75%
Home & Garden
$3,425
3
0.2
0.2
30%
75%
Medium-Small Establishments
Agriculture
$3,425
3
0.1
0.1
30%
75%
I/C/G
$3,425
3
0.1
0.1
30%
75%
Home & Garden
$3,425
3
0.1
0.1
30%
75%
Small-Small Establishments
Agriculture
$3,425
3
0.05
0.05
30%
75%
I/C/G
$3,425
3
0.05
0.05
30%
75%
Home & Garden
$3,425
3
0.05
0.05
30%
75%
Large Establishments
Agriculture
$3,425
3
0.25
0.25
30%
75%
I/C/G
$3,425
3
0.25
0.25
30%
75%
Home & Garden
$3,425
3
0.25
0.25
30%
75%
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993: pg. IX-13).
Costs were updated to 2005 dollars, and other assumptions were revised based on new data and discussions with
industry experts.
b
Revised number of existing formulations per establishment based on analysis of the PPIS active registration
database. The same value is estimated for new formulations.
c
The percent retested is based on residue removal testing studies of different container/formulation
combinations. The retesting value is equal to the difference between the number of flowable concentrate
container/formulation types failing the four-9s and five-9s standard.
d
The “Me-Too” Scenario refers to the percentage of formulations that will be tested—i.e., 25 percent of the
container/formulation combinations are assumed not to be tested as a result of using test data from different
container/formulation combinations that passed the protocol to demonstrate that these container/formulation
combinations pass as well.
Not all container/formulation combinations subject to the residue removal standard will be
tested, however. In the proposed container rule RIA, EPA made this assumption because test
data conforming to the residue removal protocol on a different non-refillable
container/formulation combination may be used to demonstrate that a non-refillable container
meets the residue removal standard. This is referred to as the “me-too” scenario. Because EPA
did not know the extent to which “me-toos” applied, they assumed a lower range of 50 percent of
all container/formulation combinations will be tested and an upper range of 100 percent of all
such combinations will be tested. For this analysis, the midpoint of the range, 75 percent, is used
since the extent to which “me-toos” will apply is not known.
Page 169
It is also assumed that a certain number of container/formulation combinations will fail the initial
residue removal test, requiring a second test using a container carefully selected from the open
market and expected to rinse more readily. Based on a study conducted for EPA, EPA assumed
in the proposed container rule RIA that 13 percent of small, medium, and large agricultural
containers and 3 percent of small and medium industrial/commercial/government containers
would not pass a triple-rinse test where 99.999 percent (five-9s standard) of a given formulation
would be removed after rinsing (EPA, 1992b). The proposed rule requires containers to pass
only a four-9s standard (99.99 percent removed after rinsing). The preamble to the final rule
summarizes the residue removal data from tests conducted using a standard testing procedure to
test currently used formulations and container designs. The data show that all 26 of the flowable
concentrate container formulations tested met the four-9s standard. However, 7 of the 26
container/formulation combinations tested (or 27 percent) failed to meet the five-9s standard.
Because of the relatively large difference between the number of tests that meet the four-9s and
the five-9s standards, we assume the difference (30 percent, rounded up from the 27 percent
failure rate in the study) as the failure rate in the EA. In other words, the EA for the final rule
assumes a 30 percent retesting rate due to failure in the first test for all registrant company sizes
and market segments. It is assumed that all container/formulation combinations pass the retest.
Table A-7 displays the unit cost inputs and associated assumptions that comprise the residue
removal standard compliance costs in this analysis. Table A-8 presents the compliance and
annual costs associated with the residue removal standard. The costs associated with the testing
of existing container/formulation combinations are considered to be compliance period costs
incurred at the end of the third year (at the end of the compliance period for non-refillable
containers), and the annual testing of new container/formulation combinations are annual costs
incurred in each year after the end of the compliance period (years 4 through 20).
To demonstrate how costs in Table A-8 are calculated from the information in Table A-7, the
cost inputs associated with large-small agricultural establishments are used. Initial testing costs
of the existing formulations, and incurred in the compliance period, are calculated by multiplying
the number of container types per formulation (3) by the number of existing formulations (0.2).
Multiplying the number of existing formulation/container combinations (0.6) by the testing cost
($3,425), and adjusting that result by the “me-too” adjustment factor (75 percent of
container/formulation combinations tested), yields an initial testing cost of $1,541. The retesting
cost for existing container/formulation combinations are calculated by multiplying those
combinations (0.6) by the percent retested factor (30 percent). This result (0.18) is then
multiplied by the testing cost ($3,425). The resulting retest cost incurred by large-small
agricultural establishments in the compliance period is $617. The same calculations apply for
the initial testing and retesting costs for new container/formulation combinations (annual costs).
Page 170
Table A-8. Non-Refillable Container Residue Removal Compliance Costs (2005$)
Initial Test
Re-test Cost - Re-test Cost Initial Test Cost New
Const Existing
Existing
Establishment Type
(Annual)b
New (Annual)a (Compliance)b
(Compliance)a
Large-Small Establishments
Agriculture
$1,541
$1,541
$617
$617
I/C/G
$1,541
$1,541
$617
$617
Home & Garden
$1,541
$1,541
$617
$617
Medium-Small Establishments
Agriculture
$771
$771
$308
$308
I/C/G
$771
$771
$308
$308
Home & Garden
$771
$771
$308
$308
Small-Small Establishments
Agriculture
$385
$385
$154
$154
I/C/G
$385
$385
$154
$154
Home & Garden
$385
$385
$154
$154
Large Establishments
Agriculture
$1,927
$1,927
$771
$771
I/C/G
$1,927
$1,927
$771
$771
Home & Garden
$1,927
$1,927
$771
$771
a
Initial test costs are calculated as follows: (Testing Cost) * (# Containers/Formulation) * (# of
Formulations [Existing or New]) * (% “Me-Toos”).
b
Retest costs are calculated as follows: (Testing Cost) * (# Containers/Formulation) * (# of
Formulations [Existing or New]) * (% Retested).
A.1.2 Administrative Requirements - Recordkeeping
For each pesticide product that a registrant handles, the container standards require the registrant
to generate and maintain a number of records (listed in §165.86 of the container regulations) for
as long as a particular non-refillable container design type is used to distribute or sell the
pesticide product and for 3 years thereafter. Therefore, the costs associated with this
recordkeeping are attributed to the administrative labor costs and the capital cost of acquiring a
file cabinet to store the records. File cabinet costs are based on the average price of a fourdrawer legal file cabinet surveyed across a number of office supply stores ($229.65). The labor
time assumptions are based on estimates used by EPA in the proposed container rule RIA. Since
no new data are available to update these recordkeeping labor time estimates, they are left in
place. It is assumed that these data are reasonable, however, based on the anticipated amount of
recordkeeping required by the container regulations.
Table A-9 displays the cost inputs and assumptions that comprise the labor-related recordkeeping
costs. Hours represent the total amount of time it takes to fulfill the recordkeeping requirements.
For existing container/formulation combinations, the labor time is spent at the end of the
compliance period (3 years for non-refillable container requirements). For new
container/formulation combinations, the labor time is spent in each year (years 4 through 20)
after the end of the compliance period. Note that the labor time assumptions change between
establishment size categories, since the number of formulations handled by each establishment
depends on the size of that establishment (see Table A-6 for the number of formulations by
establishment type). The more container/formulation combinations, the longer it takes to
Page 171
complete the recordkeeping requirements. It is also assumed that administrative personnel will
fill out the required paperwork. Therefore, the administrative cost of labor is applied in this
analysis.
Table A-10 presents the capital, compliance, and annual costs for the residue removal standard.
The cost associated with the acquisition of a file cabinet ($229.65) is considered a capital cost
that establishments incur at the end of the 3-year compliance period for the non-refillable
container regulations. Generating the paperwork necessary for existing container/formulation
combinations is a compliance period cost also incurred at the end of the 3-year compliance
period. The annual generation and maintenance of paperwork for new container/formulation
combinations is an annual cost that establishments incur each year between years 4 through 20.
To demonstrate how recordkeeping costs in Table A-10 are calculated from the information in
Table A-9, the cost inputs associated with large-small agricultural establishments are used.
Multiplying the administrative cost of labor ($29.13) by the number of hours assumed that it will
take a large-small agricultural establishment to fulfill its recordkeeping requirements for existing
container/formulation combinations (40 hours), the compliance period cost for the non-refillable
container requirements is estimated to be $1,165.23 for large-small agricultural establishments.
Using the same procedure to calculate recordkeeping costs for new container/formulation
combinations, the administrative cost of labor ($29.13) is multiplied by the recordkeeping labor
time for new container/formulation combinations (4 hours). It is estimated to cost large-small
agricultural establishments $116.52 annually to fulfill the recordkeeping requirements for new
container/formulation combinations.
Page 172
Table A-9. Non-Refillable Container Recordkeeping Cost Inputs and Assumptions
Recordkeeping Labor Recordkeeping Labor
Time for all
Time for all
Cont./Form. Combs. - Cont./Form. Combs. Establishment Type
Existing (hours)a
New (hours)a
Large-Small Establishments
Labor Cost/Hour Administrative (2005$)b
Agriculture
40c
4
$29.13
I/C/G
Home & Garden
Medium-Small Establishments
Agriculture
I/C/G
Home & Garden
Small-Small Establishments
Agriculture
I/C/G
Home & Garden
Large Establishments
Agriculture
I/C/G
Home & Garden
40
40
4
4
$29.13
$29.13
36
36
36
3
3
3
$29.13
$29.13
$29.13
24
24
24
2
2
2
$29.13
$29.13
$29.13
40
40
40
4
4
4
$29.13
$29.13
$29.13
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg.
IX-13).
b
The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational
Employment statistics available on the BLS Web site, http://www.bls.gov/oes/2000, and updated
from 2002$.
c
Hours represent the time it takes to generate and maintain the records associated with the nonrefillable container recordkeeping regulations in §165.86 of the FIFRA container regulations.
Page 173
Table A-10. Non-Refillable Container Recordkeeping Costs
File Cabinet Cost
(Capital) a
Recordkeeping Cost Existing (Compliance) b
Recordkeeping Cost New (Annual) b
Agricultural
$229.65
$1,165.23
$116.52
I/C/G
$229.65
$1,165.23
$116.52
Home & Garden
$229.65
$1,165.23
$116.52
Agricultural
$229.65
$1,048.71
$87.39
I/C/G
$229.65
$1,048.71
$87.39
Home & Garden
$229.65
$1,048.71
$87.39
Agricultural
$229.65
$699.14
$58.26
I/C/G
$229.65
$699.14
$58.26
Home & Garden
$229.65
$699.14
$58.26
Agricultural
$229.65
$1,165.23
$116.52
I/C/G
$229.65
$1,165.23
$116.52
Home & Garden
$229.65
$1,165.23
$116.52
Establishment Type
Large-Small Establishments
Medium-Small Establishments
Small-Small Establishments
Large Establishments
a
File cabinet costs are based on the average price of a four-drawer legal file cabinet surveyed across a number of
office supply stores.
b
Recordkeeping costs (compliance period or annual) are calculated as follows: Labor Time * Labor Cost. (See
Table A-9.)
A.2 Refillable Container Costs
A.2.1 Administrative Requirements
If a registrant distributes or sells a pesticide product in refillable containers (either directly or to a
refiller for repackaging), the regulations require that the registrant create certain documents and
maintain a number of records. These documents include, for each pesticide product, a
description of acceptable containers and a written residue removal procedure. (See §§165.164
and 165.190.) The registrant must maintain copies of the documents for the current operating
year and 3 years after. (See §§165.176(a) and 165.194.) The registrant must also provide copies
of the documents to independent refillers (§165.192). If the product will be repackaged by an
independent refiller, the registrant must enter into a contract with the refiller and keep a copy of
the contract (§§165.182 and 165.194). This kind of arrangement is currently standard operating
practice because it is specified in EPA’s Bulk Pesticide Enforcement policy. Therefore, the costs
associated with the contract are not included as part of this economic analysis. It is worth noting
that the administrative requirements are actually located in the repackaging regulations, but are
included in the refillable container part of the cost analysis because they are borne by refillers.
The costs associated with the administrative requirements are attributed to administrative labor
costs and the capital cost of acquiring a file cabinet to store the record.78 File cabinet costs are
78
This file cabinet is separate from the one used to store records associated with the non-refillable container
requirements.
Page 174
based on the average price of a four-drawer legal file cabinet surveyed across a number of office
supply stores ($229.65). The labor time assumptions are based on estimates used by EPA in the
proposed container rule RIA. Since no new data are available to update these recordkeeping
labor time estimates, these values are left in place.
Table A-11 displays the cost inputs and assumptions that comprise the labor-related
administrative costs. Hours represent the total amount of time it takes to fulfill the refillable
container administrative requirements. For existing container/formulation combinations, the
labor time is spent at the end of the compliance period (5 years for refillable container and
repackaging requirements). For new container/formulation combinations, the labor time is spent
in each year (years 6 through 20) after the end of the compliance period. Note that the labor time
assumptions change between establishment size categories, since the number of formulations
handled by each establishment depends on the size of that establishment (see Table A-6 for the
number of formulations by establishment type). The more refillable container/formulation
combinations, the longer it takes to complete the administrative requirements. Since no new data
are available to refute or validate these assumptions, they are left in place. It is also assumed that
administrative personnel will fill out the required paperwork. The administrative cost of labor is,
therefore, applied in this analysis.
Table A-12 presents the capital, compliance, and annual costs for the residue removal standard.
We consider the cost associated with the acquisition of a file cabinet ($229.65) a capital cost that
establishments incur at the end of the five-year refillable container regulations compliance
period. Generating the documents necessary for existing refillable container/formulation
combinations is a compliance period cost also incurred at the end of the five-year compliance
period. The annual generation and maintenance of paperwork is annual cost establishments incur
each year between years six through 20.
To demonstrate how administrative costs in Table A-12 are calculated from the information in
Table A-11, the cost inputs associated with large-small agricultural establishments are used.
Multiplying the cost of administrative labor ($29.13) by the number of hours it is assumed that it
will take a large-small agricultural establishment to: (1) develop a description of acceptable
refillable containers for use with each formulation (4 hours), and (2) revise or generate the
written residue removal procedures for existing refillable containers (24 hours), it is estimated
that the compliance period cost for the refillable container recordkeeping requirements will be
$815.66 for large-small agricultural establishments. Using the same procedure to calculate
recordkeeping costs for new refillable container/formulation combinations, the administrative
cost of labor ($29.13) is multiplied by the equivalent recordkeeping labor time categories for
new container/formulation combinations (1 hour + 2.4 hours). It is estimated that it costs largesmall agricultural establishments $99.04 annually to fulfill the recordkeeping requirements for
new refillable container/formulation combinations.
Page 175
Table A-11. Refillable Container Administrative Cost Inputs and Assumptions
Administrative Labor Time (hours)
Establishment Type
List of
Acceptable
Containers Existing a
List of
Acceptable
Containers New a
Written Res.
Rem. Procedure Existing a
Written Res.
Rem.
Procedure New a
Labor Cost/hr –
Administrative b
Large-Small Establishments
Agricultural
4
1
24
2.4
$29.13
I/C/G
4
1
24
2.4
$29.13
Home & Garden
4
1
24
2.4
$29.13
Medium-Small Establishments
Agricultural
3
0.5
16
1.5
$29.13
I/C/G
3
0.5
16
1.5
$29.13
Home & Garden
3
0.5
16
1.5
$29.13
Agricultural
2
0.5
8
1
$29.13
I/C/G
2
0.5
8
1
$29.13
Home & Garden
2
0.5
8
1
$29.13
Large Establishments
Agricultural
4
1
24
2.4
$29.13
I/C/G
4
1
24
2.4
$29.13
Home & Garden
4
1
24
2.4
$29.13
Small-Small Establishments
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).
The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment
statistics (BLS, 2000).
b
Page 176
Table A-12. Refillable Container Administrative Costs (2005$)
Establishment Type
File Cabinet Cost (Capital) a
Recordkeeping Cost
- Existing
(Compliance) b
Recordkeeping Cost - New
(Annual) b
Large-Small Establishments
Agricultural
$229.65
$815.66
$99.04
I/C/G
$229.65
$815.66
$99.04
Home & Garden
$229.65
$815.66
$99.04
Agricultural
$229.65
$553.48
$58.26
I/C/G
$229.65
$553.48
$58.26
Home & Garden
$229.65
$553.48
$58.26
Agricultural
$229.65
$291.31
$43.70
I/C/G
$229.65
$291.31
$43.70
Home & Garden
$229.65
$291.31
$43.70
Agricultural
$229.65
$815.66
$99.04
I/C/G
$229.65
$815.66
$99.04
Home & Garden
$229.65
$815.66
$99.04
Medium-Small Establishments
Small-Small Establishments
Large Establishments
a
File cabinet costs are based on the average price of a four-drawer legal file cabinet surveyed across a number of
office supply stores.
b
Recordkeeping costs (compliance period or annual) are calculated as follows: Labor Time (Design Standard
Documentation + List of Acceptable Containers + Written Residue Removal Procedure) * Labor Cost.
A.2.2 Standard for Container Marking
Section 165.116 of the container regulations states that each refillable container must be durably
marked with a serial number or other identifying code that will distinguish the individual
container from all other containers. It is assumed that ink is the preferred method of applying the
serial number and that all registrants already have the equipment (for example, stencils or
printers) to apply the ink. This assumption is based on information presented in EPA’s proposed
container rule RIA. The RIA quoted a source (Bach, 1992) who stated that
producers/formulators who package pesticides in refillable drums or barrels are already
stenciling information on their containers before shipping and most, if not all, have stenciling
equipment. It is assumed that this is still the case; most refillable containers in the current
analysis are drum or barrel sized and larger. The container marking costs in this analysis,
therefore, are the cost of acquiring the ink, the labor time it takes to apply the serial number to
the container, and the number of containers that the serial number must be applied to. Because
there is no new information to replace the assumptions used in the proposed container rule RIA,
with the exception of the hourly wage of labor, all of the cost inputs and assumptions associated
with this cost category are taken from the proposed container rule RIA.
EPA’s contacts with industry experts and equipment and/or supply vendors determined that the
cost of a gallon of ink was $34.25; one gallon of ink could mark 70,000 containers; it takes
Page 177
approximately five minutes to add a serial number to each refillable container; and that a plastic
refillable container lasts 5 years while a steel refillable container lasts 15 years. These
assumptions are used to determine the two types of costs associated with the marking of
refillable containers: the cost associated with marking existing refillable containers and, because
refillable containers wear out, the cost of marking new containers that will need a serial number
application over the course of the container regulations.
The costs associated with marking existing refillable containers are considered a compliance
period cost, incurred by establishments at the end of the 5-year compliance period for the
refillable container regulations. Though all plastic refillable containers, and one-third of steel
refillable containers, will wear out and need replacement during the compliance period, it is
assumed that the total inventory of refillable containers subject to the container marking
regulations will not change by the end of the compliance period. By the end of the compliance
period, therefore, all refillable containers will be subject to the container marking regulations and
will need a serial number application. Though the marking of these existing containers will be
phased in over the course of the 5-year compliance period, for consistency with other compliance
period costs in the analysis, it is assumed that establishments incur the cost of marking existing
refillable containers at the end of the compliance period in year 5.
The cost of marking new containers that will replace existing containers as they wear out after
the compliance period are considered annual costs that establishments will incur yearly (in years
6 through 20). However, because only one-fifth of plastic containers and one-fifteenth of steel
containers will require replacement each year, the annual unit marking costs are adjusted by the
same factors.
Table A-13 displays the cost inputs and assumptions that comprise the container marking unit
costs. Table A-14 presents the compliance period and annual costs associated with marking
individual containers. To demonstrate how container marking costs in Table A-14 are calculated
from the information in Table A-13, the cost inputs associated with large-small agricultural
establishments are used. The unit cost associated with the ink needed to mark each container is
calculated by dividing the cost of a gallon of ink ($34.25) by the number of containers it is
estimated to mark (70,000), resulting in a cost of $0.00049 per container. The labor cost
associated with the physical act of marking the containers is calculated by multiplying the time it
takes to mark the container (five minutes, or 8.33 percent of an hour) by the administrative rate
of labor ($29.13/hour), which equals $2.43 per container. The full ink and labor unit costs are
applied to the containers subject to marking at the end of the compliance period, one-fifth of
these unit costs are applied to the annual cost of marking plastic refillable containers, and onefifteenth of these unit costs are applied to the annual cost of marking steel refillable containers.
The annual cost per entity range from $1 for small-small agricultural establishments to $3,807
for large agricultural establishments (see Table A-14).
Page 178
Table A-13. Refillable Container Marking Cost Inputs and Assumptions (2005$)
Labor Cost/hr Administrative b
Refillable
Container
Lifespan Plastic a
Refillable
Container
Lifespan Steel a
0.0833
$29.13
5
15
70,000
0.0833
$29.13
5
15
70,000
0.0833
$29.13
5
15
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
Small-Small Establishments
Agricultural
$34.25
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
Large Establishments
Agricultural
$34.25
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
$34.25
70,000
0.0833
$29.13
5
15
Establishment
Type
# Containers
Marked/gal. a
Stencil
Time/
Container
(hour) a
$34.25
70,000
$34.25
$34.25
Ink
($/gal.) a
Large-Small Establishments
Agricultural
I/C/G
c
Home & Garden
Medium-Small Establishments
Agricultural
$34.25
I/C/G
c
Home & Garden
I/C/G
c
Home & Garden
I/C/G
c
Home & Garden
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).
The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment
statistics (BLS, 2000).
c
Container marking is not required for refillable containers used for antimicrobials used in the swimming pool
market, such as sodium hypochlorite. This adjustment is made to the number of refillable containers subject to the
container marking regulations presented in the compliance profile and explained in Chapter 3 by considering the
containers of swimming pool antimicrobials separately.
b
Page 179
Table A-14. Refillable Container Marking Costs (2005$)
Unit Stencil
Labor Cost Plastic
(Compliance/
Annual) a
Unit Stencil
Labor Cost Steel
(Compliance/
Annual) a
$2.43
$2.43
$0.00049
$0.00049
$27
$2.43
$2.43
$0.00049
$0.00049
$3
$2.43
$2.43
$0.00049
$0.00049
$0
Agricultural
$2.43
$2.43
$0.00049
$0.00049
$5
c
$2.43
$2.43
$0.00049
$0.00049
$0
$2.43
$2.43
$0.00049
$0.00049
$0
Agricultural
$2.43
$2.43
$0.00049
$0.00049
$1
c
$2.43
$2.43
$0.00049
$0.00049
$0
$2.43
$2.43
$0.00049
$0.00049
$0
Agricultural
$2.43
$2.43
$0.00049
$0.00049
$3,807
c
$2.43
$2.43
$0.00049
$0.00049
$356
$2.43
$2.43
$0.00049
$0.00049
$0
Establishment Type
Unit Ink Cost Unit Ink
Plastic
Cost – Steel
(Compliance/ (Compliance Annual Cost
Annual) b
/ Annual) b
per Entity d
Large-Small Establishments
Agricultural
I/C/G
c
Home & Garden
Medium-Small Establishments
I/C/G
Home & Garden
Small-Small Establishments
I/C/G
Home & Garden
Large Establishments
I/C/G
Home & Garden
a
Unit labor costs (compliance period costs) associated with refillable container markings are calculated as follows:
Labor Time to Mark Each Container * Labor Cost. To calculate the annual labor cost of marking refillable
containers, we adjust the compliance period unit cost by a factor to account for the life span of each container:
Labor Time to Mark Each Container * Labor Cost b Unit ink costs (compliance period costs) associated with
refillable container markings are calculated as follows: Ink Cost per Gallon ÷ # of Containers Marked per Gallon.
To calculate the annual ink cost of marking refillable containers, we adjust the compliance period unit cost by a
factor to account for the life span of each container: (Ink Cost per Gallon ÷ # of Containers Marked per Gallon)
c
Container marking is not required for refillable containers used for certain antimicrobials, including refillable
containers filled with sodium hypochlorite, a common antimicrobial used in the swimming pool industry. This
adjustment is made to the number of refillable containers subject to the container marking regulations presented in
the compliance profile and explained in Chapter 3.
d
Average annual container marking compliance cost per firm. Annual cost is calculated by calculating the sum of
the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent
discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.
Page 180
A.2.3 Standards for Openings
The container regulations limit access to the interior of liquid minibulk containers by requiring
that each opening of a liquid minibulk container other than a vent have a one-way valve, a
tamper-evident device, or both. EPA believes that one-way valves and tamper-evident devices
will give repackagers reasonable assurance of the previous contents of the containers. Most
agricultural minibulks and small volume returnable containers supplied by or purchased from
registrants are equipped with either a one-way valve or a tamper-evident device (EPA, 1992b)
and are therefore expected to be in compliance in the baseline. Agricultural minibulks obtained
on the open market, rather than from registrants, usually lack tamper-evident devices or one-way
valves, so refillers must add them (or something similar). The standards for openings are not
applicable to bulk tanks.
The compliance rate for the standards for the openings for affected refillables is based on
assumptions that EPA made for the proposed container rule RIA (EPA, 1993)79. It is assumed
that 65 percent minibulk containers are compliant in the agricultural market and 10 percent are
compliant compliance for minibulk containers in the I/C/G market (assumes that tote bins are
minibulks, but small volume returnables in the I/C/G market are not minibulks).
Because the compliance period for this regulation is 5 years, many refillable containers will
reach the end of their life span by the time the rule is implemented. It is assumed that these
containers will be replaced by compliant containers that are available on the open market at no
extra cost. Using the same refillable life span assumption that was used to estimate container
marking costs, it is assumed that plastic refillable containers must be replaced every 5 years and
steel refillable containers every 15 years. As a result, no plastic refillable containers will incur
the cost of modifying their container openings for the express purpose of complying with the
regulation. Further, assuming that containers, which meet Container Rule standards, are
available on the market for no extra cost, there will be no compliance costs associated with
plastic containers.
Only one-third of existing steel refillable containers, however, will be replaced during the
compliance period (5-year compliance period divided by the 15-year life span). To come into
compliance with the regulation, two-thirds of existing steel refillable containers will need to add
tamper-evident devices. It is assumed that all of these containers will require the tamper-evident
modification. EPA estimated that the cost of such a modification, including labor and materials,
was $109.60. Establishments incur this cost at the end of the 5-year compliance period for the
refillable container regulations.
Table A-15 presents the cost inputs and assumptions used to calculate the costs for this
regulation. Table A-16 presents the one-time unit variable compliance cost of this regulation.
To demonstrate how opening standard unit costs in Table A-16 are calculated from the
information in Table A-15, the cost inputs associated with large-small agricultural establishments
are used. There are no unit costs associated with the opening standards for plastic refillable
containers because 100 percent of plastic refillable containers will be replaced by compliant
79
Refer to the Proposed Container Rule RIA (EPA, 1993) Tables VII-8 and VII-9 and the table footnotes for
information to substantiate the assumptions used in this analysis.
Page 181
containers during the compliance period (5-year compliance period/5-year plastic refillable
lifespan = 100% plastic refillable compliance). There are unit costs associated with the opening
standards for steel refillable containers, however. Only 33 percent of steel refillable containers
will be replaced with compliant containers during the compliance period (5-year compliance
period/15-year steel refillable lifespan = 33.33% steel refillable compliance). The unit cost of
complying with the container opening standard for steel refillables is therefore calculated by
multiplying the modification costs for existing containers ($109.60) by the percentage of steel
refillable containers not in compliance with the opening standard (1 - 33.33% = 66.67%). The
resultant unit cost is $73.07. To compute the cost of the opening standard to the average
pesticide refiller in each size category and market sector, the average cost per steel container
($73.07) is multiplied by the number of steel containers the average refiller is assumed to have
for each market sector and size category. The average cost per entity ranges from $1 for smallsmall agricultural establishments to $4,084 for large agricultural establishments. The details of
the calculations are presented in Chapter 4, sections 4.5.6 through 4.5.8.
Page 182
Table A-15. Cost Inputs and Assumptions for Refillable Container Openings (2005$)
Establishment
Type
% of
% of
Containers
Containers
Not Replaced Not Replaced
During
During
Modification
Compliance
Compliance
Costs for
Period Period
Existing
Plastic b
- Steel b
Containers a
Refillable
Container
Lifespan Plastic a
Refillable
Container
Lifespan Steel a
5
5
15
0%
67%
$109.60
5
5
15
0%
67%
$109.60
5
5
15
0%
67%
$109.60
Compliance
Period (yrs)
Large-Small Establishments
Agricultural
I/C/G
c
Home & Garden
Medium-Small Establishments
Agricultural
5
5
15
0%
67%
$109.60
I/C/G c
5
5
15
0%
67%
$109.60
Home & Garden
5
5
15
0%
67%
$109.60
5
15
0%
67%
$109.60
5
5
15
0%
67%
$109.60
5
5
15
0%
67%
$109.60
Agricultural
5
5
15
0%
67%
$109.60
c
5
5
15
0%
67%
$109.60
5
5
15
0%
67%
$109.60
Small-Small Establishments
Agricultural
5
I/C/G
c
Home & Garden
Large Establishments
I/C/G
Home & Garden
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).
b
Calculated by dividing the length of the compliance period (5 years) by the assumed lifespan of a refillable
container (plastic – 5 years, steel – 15 years).
c
Container marking is not required for refillable containers used for certain antimicrobials, including refillable
containers filled with sodium hypochlorite, a common antimicrobial used in the swimming pool industry. This
adjustment is made to the number of refillable containers subject to the container marking regulations presented in
Chapter 3.
Page 183
Table A-16. Refillable Container Openings Costs (2005$)
Establishment Type
Opening Standard Unit
Cost - Plastic
(Compliance) a
Opening Standard
Unit Cost - Steel
(Compliance) b
$0.00
$73.07
$29
$0.00
$73.07
$3
$0.00
$73.07
$0
$0.00
$73.07
$5
$0.00
$73.07
$1
$0.00
$73.07
$0
$0.00
$73.07
$1
$0.00
$73.07
$0
$0.00
$73.07
$0
$0.00
$73.07
$4,084
$0.00
$73.07
$428
$0.00
$73.07
$0
Annual Cost per
Entity d
Large-Small Establishments
Agricultural
Industrial/Commercial/Government
c
Home & Garden
Medium-Small Establishments
Agricultural
Industrial/Commercial/Government
c
Home & Garden
Small-Small Establishments
Agricultural
Industrial/Commercial/Government
c
Home & Garden
Large Establishments
Agricultural
Industrial/Commercial/Government
c
Home & Garden
a
Because it is assumed that all plastic refillable containers will be replaced with compliant containers by the end
of the 5-year compliance period at no extra cost, there are no compliance period unit costs associated with plastic
refillable containers under this regulation.
b
The unit cost of modifying a refillable steel container’s opening is calculated as follows: Modification Cost * (1 % of Containers Replaced During Compliance Period).
c
Container marking is not required for refillable containers used for certain antimicrobials, including refillable
containers filled with sodium hypochlorite, a common antimicrobial used in the swimming pool industry. This
adjustment is made to the number of refillable containers subject to the container marking regulations presented in
the compliance profile and explained in Chapter 3.
d
Average annual container opening compliance cost per firm. Annual cost is calculated by calculating the sum of
the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent
discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.
A.2.4 Bulk Container Standards
The bulk container standards (§165.120) require that bulk containers at independent refillers’
establishments and their appurtenances be designed to resist extreme changes in temperature and
be resistant to corrosion, puncture, or cracking, and that they also be capable of withstanding all
operating stresses. It is assumed that the bulk containers currently used by refillers, and those
that exist on the market today, comply with these basic design requirements. The bulk container
standards also require that liquid bulk containers be equipped with a vent or other similar device,
that external sight gauges be removed from bulk containers and replaced with another type of
gauge, and that the containers be equipped with a shutoff valve that can be locked closed.
After conversations with industry experts, EPA assumed in its proposed container rule RIA that
all dry bulk containers satisfy the bulk container standards and 75 percent of agricultural liquid
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plastic bulk containers, 20 percent of agricultural liquid steel bulk containers and 5 percent of all
liquid bulk containers in the I/C/G market are in compliance with the bulk container standards.
For the current analysis, it is assumed that a float gauge will be chosen to comply with the bulk
container regulations. EPA estimated that the cost of external sight gauge removal was $68.50
per bulk tank and that the cost of float gauge installation was $787.25 (updated to 2005$). These
costs are retained in this analysis. Table A-17 displays these one-time per-container compliance
costs. It is assumed that establishments incur these costs at the end of the 5-year compliance
period for refillable container regulations. The annual cost per entity ranges from $1 for the
small-small agricultural establishment to $8,495 for the large I/C/G establishment. The annual
cost are calculated as the sum of the present value of the costs incurred from year 5 to year 20 ,
annualized using a 3 percent discount rate. The details of the annualization method are presented
in Chapter 4, sections 4.5.6 through 4.5.8. The analysis assumes that all new bulk containers
purchased will be in compliance with the regulations.
Table A-17. Bulk Container Standards Compliance Costs
Cost of External Sight
Gauge Removal
(Compliance) a
Cost of Float
Gauge Installation
(Compliance) a
Agricultural
$68.50
$787.25
Industrial/Commercial/Government
$68.50
$787.25
$61
N/A
N/A
N/A
Medium-Small Establishments
Agricultural
$68.50
$787.25
Industrial/Commercial/Government
$68.50
$787.25
$11
N/A
N/A
N/A
Small-Small Establishments
Agricultural
$68.50
$787.25
$1
Industrial/Commercial/Government
$68.50
$787.25
$2
Establishment Type
Annual Cost per
Entity b
Large-Small Establishments
Home & Garden
Home & Garden
Home & Garden
$24
$4
N/A
N/A
Large Establishments
Agricultural
$68.50
$787.25
$3,325
Industrial/Commercial/Government
$68.50
$787.25
$8,495
N/A
N/A
Home & Garden
N/A
N/A
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pg. IX-13).
Average annual bulk container standards compliance cost per firm. Annual cost is calculated by calculating the
sum of the present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent
discount rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.
b
A.3 Refilling Compliance Costs
The standards for establishments that repackage pesticide products into refillable containers
(refillers) require that these entities inspect, clean, and record information about the refillable
containers that they refill (§§165.160–165.176, and §§165.200–165.218). The cost to do this is
primarily associated with the labor time it takes to conduct the inspections, cleaning, and
Page 185
recordkeeping. Total costs also include the fixed capital cost of acquiring a file cabinet to store
the required paperwork, the costs of which are the same as file cabinets acquired to store records
associated with both the refillable and non-refillable container requirements ($229.65).
Using our best professional judgment, based on estimates made by EPA in the proposed
container rule RIA as a baseline (EPA, 1993, pg. IX-13), we estimated the labor time associated
with inspecting, cleaning, and recordkeeping of a refillable container each time it is refilled. We
estimated that it takes one minute to inspect the refillable container, 10 minutes to clean it, and
two minutes to conduct the recordkeeping.80 This is a reasonable assumption on the median time
take given that small containers are likely to take about one minute for inspection majority of the
containers are small. It is assumed that these are administrative tasks; therefore, the
administrative rate of labor ($29.13/hour) is used to calculate costs. Unlike the majority of costs
calculated in this analysis, the unit costs associated with the refilling regulations are calculated
every time a container is refilled. The refilling rate assumptions, and associated discussion, are
presented in Chapter 4.
Table A-18 presents the labor time assumptions for each of the refilling requirements and the
hourly wage of administrative labor. Table A-19 presents the fixed capital cost of acquiring the
file cabinet and the unit variable costs of complying with the inspection, cleaning, and
recordkeeping requirements. The cost of the file cabinet is a one-time compliance period cost
that refilling establishments will incur at the end of the 5-year compliance period for refiller
regulations. The unit costs of inspection, cleaning, and recordkeeping of the containers that
refilling establishments refill are considered annual costs that are incurred in years 6 through 20.
To demonstrate how refilling compliance costs in Table A-19 are calculated from the
information in Table A-18, the cost inputs associated with large-small agricultural establishments
are used. The unit cost associated with the inspection, cleaning, and recordkeeping of each
container that is refilled is calculated based on the time it takes to complete each task (1, 10, and
2 minutes per refill, respectively) multiplied by the administrative cost of labor ($29.13). The
resulting unit (per refill) costs are therefore $0.49 for container inspection, $4.86 for container
cleaning, and $0.97 for container recordkeeping. The annual cost per entity ranges from $14 for
the small-small agricultural pesticide registrants to $10,000 for the large swimming pool
companies. Annual cost is calculated by calculating the sum of the present discounted value of
costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount rate. The
details of the annualization proceedure are presented in Chapter 4 in sections 4.5.6 through 4.5.8.
80
The recordkeeping involves recording the container’s EPA registration number, amount of the pesticide product
distributed or sold in the refillable container, the date of the repackaging, and the serial number of the refillable
container.
Page 186
Table A-18. Refilling Requirement Cost Inputs and Assumptions (2005$)
Establishment Type
Inspection Time per
Container Refill
(min) a
Cleaning Time per
Container Refill
(min) a
Recordkeeping
Time per Container
Refill (min) a
Labor Cost/hr Administrative b
Agricultural Pesticide Refillers
Large-Small
1
10
2
$29.13
Medium-Small
1
10
2
$29.13
Small-Small
1
10
2
$29.13
Large
1
10
2
$29.13
Agricultural Pesticide Registrants
Large-Small
1
10
2
$29.13
Medium-Small
1
10
2
$29.13
Small-Small
1
10
2
$29.13
Large
1
10
2
$29.13
Industrial/Commercial/Government - Pesticide Registrants
Large-Small
1
10
2
$29.13
Medium-Small
1
10
2
$29.13
Small-Small
1
10
2
$29.13
Large
1
10
2
$29.13
Swimming Pool Supply Companies - Antimicrobial Applicators
Large-Small
1
10
2
$29.13
Medium-Small
1
10
2
$29.13
Small-Small
1
10
2
$29.13
Large
1
10
2
$29.13
a
Using our best professional judgment, based on estimates made by EPA in the proposed container rule RIA as a
baseline (EPA, 1993, pg. IX-13), we estimated the labor time associated with inspecting, cleaning, and
recordkeeping of a refillable container each time it is refilled.
b
The occupational wage estimates are taken from the Bureau of Labor Statistics’ Occupational Employment
statistics (BLS, 2000).
Page 187
Table A-19. Refilling Requirement Costs (2005$)
Establishment Type
Unit Variable
Unit Variable
Cost of
Cost of
File Cabinet
Unit Variable
Inspection (per Cost of Cleaning Recordkeeping
Cost
refill) b
(per refill) b
(Compliance) a
(per refill) b
Annual Cost
per Entity c
Agricultural Pesticide Refillers
Large-Small
$229.65
$0.49
$4.86
$0.97
$871
Medium-Small
$229.65
$0.49
$4.86
$0.97
$267
Small-Small
$229.65
$0.49
$4.86
$0.97
$43
Large
$229.65
$0.49
$4.86
$0.97
$7,255
Agricultural Pesticide Registrants
Large-Small
$229.65
$0.49
$4.86
$0.97
$45
Medium-Small
$229.65
$0.49
$4.86
$0.97
$19
Small-Small
$229.65
$0.49
$4.86
$0.97
$14
Large
$229.65
$0.49
$4.86
$0.97
$4,434
Industrial/Commercial/Government - Pesticide Registrants
Large-Small
$229.65
$0.49
$4.86
$0.97
$40
Medium-Small
$229.65
$0.49
$4.86
$0.97
$18
Small-Small
$229.65
$0.49
$4.86
$0.97
$14
Large
$229.65
$0.49
$4.86
$0.97
$3,828
Swimming Pool Supply Companies - Antimicrobial Applicators
Large-Small
$229.65
$0.49
$4.86
$0.97
$34
Medium-Small
$229.65
$0.49
$4.86
$0.97
$23
Small-Small
$229.65
$0.49
$4.86
$0.97
$15
Large
$229.65
$0.49
$4.86
$0.97
$10,000
a
File cabinet costs are based on the average price of a four-drawer legal file cabinet surveyed across a number of
office supply stores.
b
The unit costs of complying with the refilling requirements are calculated as follows: Labor Time (per refill) *
Labor Cost.
c
Average annual refilling requirement cost per firm. Annual cost is calculated by calculating the sum of the
present discounted value of costs incurred from years 5 to 20, and then annualizing it using a 3 percent discount
rate. The details of the calculations are presented in Chapter 4 in sections 4.5.6 through 4.5.8.
A.4 Cost of Label Requirements
The container regulations, in addition to all of the compliance requirements detailed above, will
also modify the labeling requirements in 40 CFR Part 156 (Labeling Requirements for Pesticides
and Devices) by adding Subpart H, entitled “Container Labeling,” and by modifying §156.10
(Labeling Requirements). The new labeling regulations will require that specific statements be
placed on the label or container of all pesticide products and will also provide detailed residue
removal instructions on the labels of some products. However, the final regulations exempt
household products from the residue removal instructions.
The costs to comply with the labeling requirements are associated with the costs for a label
change on virtually all formulated pesticide products, since much of the required information is
Page 188
not currently found on pesticide labels. Label changes must be made by the end of the 3-year
compliance period for the labeling regulations.
Labeling cost inputs are based on the assumptions made in the proposed container rule RIA. In
that analysis, EPA received label change cost data from a number of independent small, medium,
and large pesticide formulators. Averaging across the responses received, EPA estimated that
the label change costs for small facilities were $1,918 per label change and $5,069 per label
change for medium and large facilities (in 2005$). These costs represent the cost of the artwork
or typesetting, two proof readings, and printing plates. The purchase of the labels themselves
was considered an ordinary cost of doing business and was therefore not included in the label
change costs. Also, the cost of disposing unused, non-compliant labels was not included in the
label change costs because EPA assumed that each facility would be able to use up existing label
inventory during the compliance period. Because there is no information to replace the
assumptions used in the proposed container rule RIA, all of the cost inputs and assumptions
associated with this cost category are taken from the proposed container rule RIA.
In the proposed container rule RIA, EPA assumed that because many pesticide labels routinely
undergo changes every 1 to 3 years, facilities will change 50 percent of all their labels during the
compliance period.81 For labels that undergo a routine change, EPA assumed that the additional
language required by the labeling regulations would be incorporated at the same time. The entire
cost of the label change, therefore, was not associated with the labeling requirements. Instead,
EPA assumed that only one-third of the cost of the artwork changes was attributed to the labeling
requirements (the cost of adding text to an already planned label change). The remaining 50
percent of the labels were assumed by EPA to require changing during the compliance period for
one reason only: to come into compliance with the labeling requirements. Therefore, EPA
attributed the full costs of changing the labels directly to the labeling requirements.
There are two slight differences between the current analysis and the proposed container rule
RIA. First, in the current analysis, the label change costs for small facilities from the proposed
container rule RIA are transferred to the small-small facilities, and the label change costs for
medium and large facilities are transferred to medium-small, large-small, and large
establishments. Second, the compliance period for the final labeling requirements is 3 years as
opposed to the 2-year compliance period assumed in the proposed container rule RIA. Though
the compliance period is now longer, there is not sufficient information to alter the proposed
rule’s assumption that 50 percent of all label changes that occur during the compliance period are
routine (with only one-third of the total label change cost considered a cost of compliance), and
that the other 50 percent are the result of the need to come into compliance with the regulation
(with 100 percent of the total label change cost considered a cost of compliance). This
assumption is therefore retained and applied to the current analysis.
The number of label changes that establishments must make is based on the number of
formulations they package. It is assumed, as in the proposed container rule RIA, that each
formulation requires one label change. The number of existing formulations per facility is the
same as that used throughout the current analysis (see Table A-2). Table A-20 displays the cost
81
The proposed container rule RIA assumed a 2-year compliance period, though the proposed labeling requirements
did not specify a definite compliance schedule or date.
Page 189
inputs and assumptions used to calculate the label change costs, and Table A-21 displays the
total facility-level compliance cost.
It is assumed that facilities incur the label change costs at the end of the compliance period for
the 3-year labeling regulations. It is also assumed that once registrants make all of the labeling
changes to existing labels by the end of the compliance period, establishments will incur no new
labeling costs in the future; the artwork or typesetting and printing plates will have been
modified to meet the labeling language requirements and will not need future modifications as a
result of the labeling regulations. Also, facilities will be able to incorporate this labeling text into
labels of new products at no additional cost.
To demonstrate how certification costs in Table A-21 are calculated from the information in
Table A-20, the cost inputs associated with large-small agricultural establishments are used. The
facility-level cost associated with routine label changes for existing formulations is calculated by
multiplying the number of formulations (20) by the percentage of label changes considered
routine (50 percent). The resulting number of existing formulations (10) is then multiplied by
the cost of a routine label change ($479.50 per label change). Routine label changes therefore
cost large-small agricultural establishments $4,795. The facility-level cost associated with
necessary label changes for existing formulations is calculated similarly; the other half of
existing formulations (10) is multiplied by the cost of a necessary label change ($5,069 per label
change). Necessary label changes therefore cost large-small agricultural establishments $50,690.
Page 190
Table A-20. Labeling Requirement Cost Inputs and Assumptions (2005$)
Establishment Type
Label Cost - Routine
Change a
Label Cost Necessary Change a
% of Label
Changes
Considered
Routine a
Existing
Formulations b
Large-Small Establishments
Agricultural
$479.50
$5,069
50%
20
I/C/G
$479.50
$5,069
50%
20
Home & Garden
$479.50
$5,069
50%
20
Medium-Small Establishments
Agricultural
$479.50
$5,069
50%
9
I/C/G
$479.50
$5,069
50%
9
Home & Garden
$479.50
$5,069
50%
9
Small-Small Establishments
Agricultural
$205.50
$1,918
50%
3
I/C/G
$205.50
$1,918
50%
3
Home & Garden
$205.50
$1,918
50%
3
Large Establishments
Agricultural
$479.50
$5,069
50%
32
I/C/G
$479.50
$5,069
50%
32
Home & Garden
$479.50
$5,069
50%
32
a
Cost inputs based on assumptions made by EPA in the proposed container rule RIA (EPA, 1993, pp. X-1 through
X-7). Only one-third of the total label change cost are considered routine cost of compliance.
b
Revised number of existing formulations per establishment based on analysis of the PPIS active registration
database. See Table A-2.
Page 191
Table A-21. Labeling Requirement Costs (2005$)
Total Cost - Routine Change
(Compliance) a
Total Cost - Necessary Change
(Compliance) b
Agricultural
$4,795
$50,690
I/C/G
$4,795
$50,690
Home & Garden
$4,795
$50,690
Agricultural
$2,175
$22,810.50
I/C/G
$2,175
$22,810.50
Home & Garden
$2,175
$22,810.50
Agricultural
$308.25
$2,877
I/C/G
$308.25
$2,877
Home & Garden
$308.25
$2,877
Agricultural
$7,672
$81,104
I/C/G
$7,672
$81,104
Home & Garden
$7,672
$81,104
Establishment Type
Large-Small Establishments
Medium-Small Establishments
Small-Small Establishments
Large Establishments
a
Facility-level routine labeling costs are calculated as follows: # of Existing Formulations * % of Label Changes
Considered Routine * Routine Label Change Cost.
b
Facility-level necessary labeling costs are calculated as follows: # of Existing Formulations * % of Label
Changes Considered Necessary * Necessary Label Change Cost.
A.5 Waiver Costs
In addition to the costs associated with the container and labeling regulations, there are costs
associated with the waiver applications that registrants may choose to submit to be exempted
from particular regulations. For facilities that do submit a waiver, EPA assumed in the proposed
container rule RIA that it took a facility manager 4 hours to complete the waiver. We assume
this is a reasonable amount of time to compose and submit a waiver for one or all regulations
eligible for exemption. This labor time multiplied by the assumed hourly wage of professional
labor equaled the facility-level cost of completing a waiver. EPA assumed in the proposed
container rule that this cost was the same across all market sectors and facility sizes. These
assumptions are retained in the current analysis, using the updated professional labor wage of
$90.42/hour. The total cost facilities incur when applying for a waiver is therefore labor time
(4 hours) multiplied by labor cost ($90.42/hour), which equals $361.69. It is assumed that
facilities will apply for waivers, and therefore incur waiver costs, in the first year that the
container rules are promulgated.
Page 192
Appendix B. Compliance Profile Estimation Details
B.1 Assumptions and Procedure for Converting Pesticide Volume and Weight into
Number of Refillable Containers in Use
The number of refillable containers in the agricultural market is calculated by converting the
formulated volume (in gallons) and formulated weight (in pounds) of pesticides reported in the
1996 American Crop Protection Association (ACPA) Container Survey (ACPA, 1997) into the
number of refillable containers in use. We assumed the following in order to convert pesticide
volume and weight used into the estimated number of refillable containers in use for the
agricultural market:
Assumed representative non-bulk container sizes per category (Paulson, 2002):
Liquid refillables
• 5–25 gallon plastic/steel: 15 gal;
• 26–60 gallon plastic/steel: 45 gal, based on average between common sizes of 30 and 60
gallons;
• 61–125 gallon plastic/steel: 85 gal, based on mid-point across range of sizes between 60 and
110 gallons;
• 126–250 gallon plastic: 180 gal, based on mid-point across range of sizes between 140 and
220 gallons; and
• 126–250 gallon steel: 225 gal, based on average between common sizes of 200 and 250
gallons.
Dry refillables
• <100 pound non-bulks: 75 lbs, based on mid-point across range of sizes between 50 and 100
pounds; and
• 101–2,500 pound non-bulks: 1,100 lbs, based on mid-point across common range of sizes
between 1,000 and 1,200 pounds.
Assumed refill rates (Paulson, 2002):
• Small and large liquid refillables are estimated to be refilled on average 2–2.5 and 1.5–2
times annually, respectively. As a result, the refill rate for 5–25 gallon containers was 2.25
times annually and for 26–250 gallon container sizes was 1.75 times annually.
• Dry non-bulk refillables are estimated to be refilled on average 1.5–2 times annually, with
1.75 used in the analysis.
• Bulk liquid and dry containers are assumed to be refilled on average 1–1.5 times annually,
with 1.25 used in the analysis.
These estimates include the assumption that not all containers are refilled to capacity.
Assumed representative bulk container sizes (Paulson, 2002):
• Liquid: 2,500 gallons; and
• Dry: 2,501 pounds.
Page 193
We used the following procedure to estimate the number of agricultural refillable containers in
use:
(7) Estimate the number of new, non-bulk containers: Divide the formulated amount in use
based on the 1996 ACPA Container Survey by the assumed average non-bulk container size
for that category and round the estimate to the nearest hundred. For example, there are an
estimated 34,700 new “5–25 gallon plastic” refillables in existence based on a formulated
volume of 519,842 gallons divided by the representative container size of 15 gallons (34,656
rounded to 34,700). New refillables are assumed to be filled initially by a pesticide registrant
at the manufacturing or formulating facility.
(8) Estimate the number of existing non-bulk containers: Refillables repackaged with
pesticide product are assumed to be refilled primarily by agricultural pesticide refillers.
Pesticide product refilled into existing refillables is assumed to pass through the bulk
containers considered in the 1996 ACPA Container Survey. Therefore, the ratio of
formulated volume (or weight) for a given container size category versus the total non-bulk
container formulated volume (or weight) was multiplied by the total liquid (or dry)
formulated volume (or weight) in use and divided by the representative container size times
the annual refill rate. For example, we estimated there are 93,200 existing “5–25 gallon
plastic” refillables in use based on the following equation:
(519,842/7,589,197)*45,923,755/(15*2.25)
(total volume in 5-25 gallon plastic category/total non-bulk volume) *
total liquid volume in use/(representative container size*refill rate)
(9) Sum the new and existing refillables for each size category: For example, the total
number of “5–25 gallon plastic” refillables in use was estimated to be 127,900 (34,700 new
plus 93,200 existing containers).
(10) Estimate the number of bulk containers: There does not appear to be an observable
increasing or decreasing trend in the formulated volume and weight of annual pesticide use
over the 1989 through 1996 ACPA Container Survey period. Therefore, no net change in the
number of bulk containers is assumed to have occurred since the 1996 survey.
The 1996 ACPA Container Survey bulk container formulated amount represents the amount
of pesticides distributed from pesticide manufacturers and formulators to retailers through
stationary bulk containers in 1996.82 The method in which the pesticide is transported from
the manufacturer or formulator to the retailer (i.e., via tank car or tanker truck) is not
important to the analysis. The number of containers taken out of circulation annually is
unknown. Based on this information, we divided the 1996 bulk container formulated amount
by the representative bulk container size (2,500 gallons or 2,501 pounds) multiplied by the
82
The 1996 APCA Container Survey defined bulk containers as containers larger than 250 gallons.
Page 194
refill rate mid-point estimate (1.25 times annually). As a result, the total estimated number of
liquid and dry bulk containers in use was 14,700 and 5,600, respectively.
The estimated numbers of liquid (>500 gallons) and dry (>4,000 pounds) retail bulk tanks (as
defined in this economic analysis) are 13,400 (12,060 plastic and 1,340 steel) and 175,
respectively. These estimates were considered reasonable by EPA and Don Paulson (2002)
and are consistent with the estimates used for the economic analysis of the containment
rule.83 Of the remaining 1,300 liquid minibulk tanks (251-500 gallons), we assume that 90
percent (or 1,170) are plastic and 10 percent (or 130) are steel. There are 5,425 dry minibulk
containers assumed in the analysis (5,600 - 175).
B.2 Number of Refillables in Use by the Pool Industry: A Separate Discussion and
Consideration
Sodium hypochlorite is an antimicrobial that is exempt from certain container requirements (see
Chapter 3). Public commenters on the 1994 proposed container rule (EPA,1994) and 1999
Supplemental Notice (EPA, 1999), including pool supply companies, industry associations, and
an antimicrobial manufacturer, specifically addressed the impact that the container regulations
would have on refillable containers currently used to distribute sodium hypochlorite for
swimming pool/spa use. It is assumed that the estimated number of refillable containers in use in
the industrial/commercial/government (I/C/G) and home and garden (H&G) markets does not
include the refillables used in the swimming pool industry. This assumption is based on the
comments received and EPA’s understanding of the source data used to derive container
estimates for the proposed container rule RIA and subsequent updates to the estimates for this
analysis.
Currently, based on comments to the 1999 Supplemental Notice submitted by relevant trade
associations (i.e., the Chlorine Institute, National Spa and Pool Institute, and Swimming Pool
Chemical Manufacturers Association), we estimate that more than 38 million gallons of sodium
hypochlorite are estimated to be distributed each year in refillable containers ranging in size from
jugs (1 and 2.5 gallons) to drums (30 and 55 gallons) to minibulks (220 and 330 gallons). The
comments also suggest that the average number of refillings and is eight. A smaller refilling rate
of four was assumed for larger containers. This refilling rate was used with the data on volume
from the comments (38 million gallons of sodium hypochlorite in use for pools in spas annually)
to arrive at the total number of containers.
83
A separate economic analysis is written for the requirements for bulk containment structures. The containment
regulations apply only to stationary bulk containers at retail facilities, custom applicators, and custom blenders,
while the bulk container standards apply only to bulk containers at independent refillers.
Page 195
Appendix C. Regulation-Specific Cost Schedules
Table C-1. Undiscounted Costs a of Complying with the Residue Removal Standards for Non-Refillable Containers
Under the Current Rule b
Establishment
3
4
5
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$539
$539
$539
$2,697
$2,697
$2,697
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Year c
6
7
8
9
10
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
Page 196
Table C-1 (Continued). Undiscounted Costs a of Complying with the Residue Removal Standards for Non-Refillable
Containers Under the Current Rule b
Establishment
11
12
13
14
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$539
$539
$539
$539
$539
$539
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Year
15
16
17
18
19
20
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$2,158
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$1,079
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$539
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
$2,697
a
Costs are rounded to the nearest dollar.
b
Compliance with the Residue Removal Standards involves only fixed costs.
c
The compliance period for non-refillables is 3 years. The analysis assumes that costs are incurred beginning at the end of the third year.
Page 197
Table C-2. Undiscounted Costs a of Complying with Recordkeeping Requirements for Non-Refillable Containers Under the
Container Rule b
Establishment
3
4
5
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$1,165
$1,165
$1,165
$117
$117
$117
$117
$117
$117
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$1,049
$1,049
$1,049
$87
$87
$87
$699
$699
$699
$1,165
$1,165
$1,165
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Year c
6
7
8
9
10
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
Page 198
Table C-2 (Continued). Undiscounted Costs a of Complying with Recordkeeping Requirements for Non-Refillable Containers
Under the Container Rule b
Establishment
Year
15
16
11
12
13
14
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$58
$58
$58
$58
$58
$58
$58
$58
$58
$117
$117
$117
$117
$117
$117
$117
$117
$117
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
a
17
18
19
20
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$87
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$58
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
$117
Costs are rounded to the nearest dollar.
Compliance with the Other Administrative Requirements (recordkeeping) involves only fixed costs.
c
The compliance period for non-refillables is 3 years. The analysis assumes that costs are incurred beginning at the end of the third year.
b
Page 199
Table C-3. Undiscounted Costs a of Complying with the Container Marking Standards for Refillable Containers Under the
Container Rule b
Establishment
5
6
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$166
$15
N/A
$27
$3
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$31
$3
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Year c
7
8
9
10
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$7
$1
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$23,231
$2,072
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
Page 200
Table C-3 (Continued). Undiscounted Costs a of Complying with the Container Marking Standards for Refillable Containers
Under the Container Rule b
Establishment
11
12
13
14
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$1
$0
N/A
$1
$0
N/A
$3,720
$356
N/A
$3,720
$356
N/A
Large Establishments
Agricultural
I/C/G
Home & Garden
Year
15
16
17
18
19
20
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$27
$3
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$5
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$1
$0
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
$3,720
$356
N/A
a
Costs are rounded to the nearest dollar.
Compliance with the Container Marking Standards involves only variable costs.
c
The compliance period for refillables is 5 years. The analysis assumes that costs are incurred beginning at the end of the fifth year.
b
Page 201
Table C-4. Undiscounted Costs a of Complying with the Standards of Openings (for Liquid-Minibulk Containers Only) for
Refillable Containers Under the Container Rule b
Establishment
5
6
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$519
$54
N/A
$0
$0
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$96
$10
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Year c
7
8
9
10
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$20
$2
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$72,555
$7,605
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
Page 202
Table C-4 (Continued). Undiscounted Costsa of Complying with the Standards of Openings (for Liquid-Minibulk Containers
Only) for Refillable Containers Under the Container Ruleb
11
12
13
14
Year
15
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
Large Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
$0
$0
N/A
Establishment
a
16
17
18
19
20
Costs are rounded to the nearest dollar.
b
Compliance with the Standards for Openings (for liquid minibulk containers only) involves only variable costs.
c
The compliance period for refillables is 5 years. The analysis assumes that costs are incurred beginning at the end of the fifth year. The analysis also assumes
that compliant containers can be purchased at no extra cost at the end of the compliance period.
Page 203
Table C-5. Undiscounted Costsa of Complying with the Bulk Container Standards for Refillable Containers
Under the Container Ruleb
5
6
Yearc
7
$423
$1,080
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
$78
$200
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
$17
$43
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
$59,063
$150,914
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Gardend
Medium-Small Establishments
Agricultural
I/C/G
Home & Gardend
Small-Small Establishments
Agricultural
I/C/G
Home & Gardend
Large Establishments
Agricultural
I/C/G
Home & Gardend
Page 204
8
9
10
Table C-5 (Continued). Undiscounted Costsa of Complying with the Bulk Container Standards for Refillable Containers
Under the Container Ruleb
Establishment
Large-Small Establishments
Agricultural
I/C/G
Home & Gardend
Medium-Small Establishments
Agricultural
I/C/G
Home & Gardend
Small-Small Establishments
Agricultural
I/C/G
Home & Gardend
Large Establishments
Agricultural
I/C/G
Home & Gardend
a
11
12
13
14
Year
15
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
16
17
18
19
20
Costs are rounded to the nearest dollar.
b
Compliance with the Bulk Container Standards involves only variable costs.
c
The compliance period for refillables is 5 years. The analysis assumes that costs are incurred beginning at the end of the fifth year. The analysis also
assumes that bulk containers purchased after the five-year compliance period will be in compliance at no extra cost.
d
Compliance costs for Home & Garden establishments are not applicable because the number of bulk containers in Home & Garden establishments is zero.
Page 205
Table C-6. Undiscounted Costsa of Complying with Administrative Requirements for Refillable Containers
Under the Containment Ruleb
Establishment
5
6
$1,133
$1,133
N/A
$128
$128
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$841
$841
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Yearc
7
8
9
10
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$550
$550
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$1,133
$1,133
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
Page 206
Table C-6 (Continued). Undiscounted Costsa of Complying with Administrative Requirements for Refillable Containers Under
the Containment Ruleb
Establishment
11
12
13
14
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$58
$58
N/A
$58
$58
N/A
Large Establishments
Agricultural
I/C/G
Home & Garden
$128
$128
N/A
$128
$128
N/A
Year
15
16
17
18
19
20
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$73
$73
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$58
$58
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
$128
$128
N/A
a
Costs are rounded to the nearest dollar.
Compliance with the Other Administrative Requirements (preparing certain documents and recordkeeping) involves only
fixed costs.
c
The compliance period for refillables is 5 years. The analysis assumes that costs are incurred beginning at the end of the fifth year.
b
Page 207
Table C-7. Undiscounted Costsa of Complying with the Labeling Requirements for All Containers Under the Container Ruleb
Yearc
Establishment
3
4
5
6
7
8
9
10
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$55,485
$55,485
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$55,485
$0
$0
$0
$0
$0
$0
$0
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$24,968
$24,968
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$24,968
$0
$0
$0
$0
$0
$0
$0
$3,185
$3,185
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$3,185
$0
$0
$0
$0
$0
$0
$0
$88,776
$88,776
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$88,776
$0
$0
$0
$0
$0
$0
$0
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
Large Establishments
Agricultural
I/C/G
Home & Garden
Page 208
Table C-7 (Continued). Undiscounted Costsa of Complying with the Labeling Requirements for All Containers
Under the Container Ruleb
Establishment
11
12
13
14
Year
15
Large-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
Medium-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
Small-Small Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
Large Establishments
Agricultural
I/C/G
Home & Garden
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
a
16
17
18
19
20
Costs are rounded to the nearest dollar.
Compliance with the Labeling Requirements involves only fixed costs.
c
The compliance period for non-refillables is 3 years. The analysis assumes that labeling costs are incurred beginning at the end of the third year. The
analysis also assumes no costs after the compliance period because existing labels will be in compliance and new labeling text will be incorporated into
the labels of new products at no additional cost.
b
Page 209
Appendix D. Profile of Industries Regulated by the Pesticide Container
Regulations
This appendix provides descriptive and quantitative information about the three regulated entities
estimated to be affected by the current container regulations: (1) registrants, (2) agricultural
pesticide refillers, and (3) swimming pool supply companies. Relevant details on the economic
and financial characteristics associated with all regulated entities are discussed. This information
is necessary to assess the potential impacts of regulatory compliance costs associated with the
container regulations.
Two industry sectors considered in the 1999 Supplemental Notice were pesticide formulators and
agrichemical dealers. These regulated entities correspond with pesticide registrants and
agricultural pesticide refillers, respectively, in this analysis.
Tables 3.3 and 3.4 illustrate which regulated entities are responsible for which pesticide
container regulations, and provide a brief overview showing how each of the regulated entities
identified and characterized in Chapter 3 will be affected by the container rule.
Another purpose of this appendix is to identify the small entities that are potentially affected by
the container regulations. A small entity is defined as:
•
•
•
A small business as defined in the Small Business Administration (SBA) regulations at 13
CFR §121.201—the SBA defines small businesses by category of business using North
American Industry Classification System (NAICS) codes;
A small governmental jurisdiction that is a government of a city, county, town, school
district, or special district with a population of less than 50,000; and
Any small, not-for-profit enterprise that is independently owned and operated and is not
dominant in its field.
This economic analysis evaluates an alternative definition of small entities or businesses
potentially affected by the container regulations. As discussed by EPA in the 1999 Supplemental
Notice on Standards for Pesticide Containers and Containment (EPA, 1999), the alternative
definition disaggregates the SBA-defined small businesses into three size categories: small-small
(SS), medium-small (MS), and large-small (LS) businesses. EPA is concerned that using an
overly broad definition of small business in the economic analysis of the container regulations
may result in significant economic impacts on smaller entities that will be camouflaged when
combined with information about potential impacts on facilities that meet the SBA size standard
for small business but are not typical of a small business in that industry sector.
Page 210
D.1 Pesticide Registrants
According to §165.42, §165.92, and §165.142 of the container regulations, registrants that
distribute or sell a pesticide product in non-refillable or refillable containers, and/or distribute or
sell pesticide products to a refiller (that is not part of the same entity) for repackaging into
refillable containers, constitute a business that must comply with the standards. Pesticide active
ingredient (PAI) manufacturers may or may not be subject to the container regulations because
§165.46, §165.96, and §165.146 of the container regulations indicate that the standards do not
apply to manufacturing use products. However, many PAI manufacturers are vertically
integrated to pesticide formulating facilities through direct ownership or wholesale distribution
of PAIs to independent formulators. Also, registrants are responsible for complying with the
label requirements in 40 CFR Part 156.
Pesticide registrants are basically required to ensure that all non-refillable and refillable
containers meet the container construction and design standards, develop and provide
information to refillers, and ensure that labels include the specified information. Pesticide
registrants are responsible for procedural and handling activities for approximately 10 percent of
the refillables in the agricultural market (Paulson, 2002) and all of the refillables in the I/C/G
market.84 Inadequate data are available to differentiate pesticide registrants that are or are not
engaged directly in pesticide refilling activities.
The total universe of affected pesticide registrants used in this analysis was derived based on the
number of unique companies holding active Section 3 and/or Section 24(c) pesticide
registrations. EPA queried the Pesticide Product Information System (PPIS) database in July
2002 and determined that 1,956 companies with unique EPA company numbers held more than
16,000 Section 3 and 24(c) pesticide registrations. The PPIS database contains information for
all pesticide products registered in the United States, including registrant name and address,
chemical ingredients, toxicity category, product names, distributor brand names, site/pest uses,
pesticidal type, formulation code, and registration status.
The registrant universe was reduced by consolidating companies that have recently merged and
combining companies that are considered subsidiaries or part of a larger “parent” company.
Companies were consolidated in four ways:
•
We matched unique companies with EPA company numbers to company information and
financial data from the Dun & Bradstreet (D&B) database. The D&B data included
information on the company total number of employees; most recent sales and revenue
information; and primary business classifications—NAICS code and Standard Industrial
Classification (SIC) code where possible. In order to link registrants in the PPIS sample data
set with the D&B database, we identified each company’s Data Universal Numbering System
(DUNS) number. The D&B DUNS number is a unique identifier for a single business entity,
which also links together the corporate family structure. Using the corresponding DUNS
84
Don Paulson recently retired from Ciba/Novartis and currently is a consultant to Syngenta and CropLife America,
formerly the American Crop Protection Association (ACPA). Mr. Paulson was very active in the ACPA packaging
task force in the 1990s and co-surveyed the number of agricultural pesticide containers for ACPA with Tom Gilding
between 1989 and 1996.
Page 211
numbers, we “rolled up” or consolidated companies to the Global Ultimate DUNS number or
“parent” level.
•
In some cases company information in D&B did not reflect recent mergers; therefore, we
consolidated the registrant universe manually by adjusting for known company mergers. For
example, Aventis CropScience was acquired by Bayer CropScience in June 2002.
•
We matched and consolidated company names for all EPA company numbers based on the
likelihood that the company numbers actually reflect one company and/or based on EPA
recommendations.
As a result, the set of 1,956 unique company numbers in EPA’s PPIS database was reduced to
1,804 unique companies. These 1,804 companies represent the pesticide registrant universe for
this analysis. Table D-1 illustrates this process numerically.
Table D-1. Estimated Number of Pesticide Registrants Affected by the
Pesticide Container Regulations
Pesticide Registrants
Number of unique companies in EPA’s PPIS database
holding Section 3 and/or Section 24(c) registration(s)
Estimated Number of
Entities
1,956 a
243 b
Total number of duplicate companies
Consolidated number of duplicate companies
Total
91
1,804
a
As of July 2002.
b
Number of all companies with unique EPA company numbers that were consolidated based
on the following criteria: (1) matching of EPA company numbers with Dun & Bradstreet
DUNS and Global Ultimate DUNS numbers; (2) consolidation as a result of recent mergers
and acquisitions; or (3) matching of company names associated with unique EPA company
numbers.
D.1.1 Pesticide Registrants’ NAICS Codes
A company’s total employees and revenue information is required to break down the estimated
total number of affected pesticide registrants into entity size categories according to SBA and
EPA alternative definitions of company size specifications and to determine the impact of the
container regulations on pesticide registrants. The company size specifications are based on the
SBA definition for the primary NAICS code for pesticide registrants.
To confirm the primary NAICS code designation for pesticide registrants, we counted the
number of pesticide registrants associated with each NAICS codes, which were available from
D&B for 804 (out of an estimated 1,804 total) pesticide registrants. The eight most common sixdigit NAICS codes designated in D&B for the set of registrants (399 out of 804) are presented in
Table D-2. A total of 184 six-digit NAICS codes are associated with at least one of the 804
registrants.
Page 212
Table D-2. Most Common NAICS Codes Associated with Sample of 804 Pesticide
Registrants
NAICS
CODE
325320
a
Count of
NAICS
Code
U.S. Industry Title
SBA Threshold
88
Pesticide and Other Agricultural Chemical
Manufacturing
500 employees
422690
84
1997 NAICS - Otr Chem & Allyd Prdct Whlslrs
100 employees
422910
65
1997 NAICS - Farm Supplies Wholesalers
100 employees
325612
62
Polish and Other Sanitation Good Manufacturing
500 employees
325998
30
All Other Miscellaneous Chemical Product and
Preparation Manufacturing
500 employees
325188
27
All Other Basic Inorganic Chemical Manufacturing
1,000 employees
453998
22
All Other Miscellaneous Store Retailers (except
Tobacco Stores)
$6 million in revenue
325412
21
Pharmaceutical Preparation Manufacturing
750 employees
a
NAICS code 325320 was considered the primary NAICS code associated with pesticide registrants in the proposed
container rule RIA (EPA, 1993). The 325- NAICS series is used to designate types of “Chemical Manufacturing”
industries.
D.1.2 Analysis of Large Pesticide Registrants
Company information on some pesticide registrants is unknown or unavailable. However, D&B
data are more likely to be available for large companies than for small companies, based on the
way D&B collects company financial information and on the availability of the required data.
To estimate the total number of large pesticide registrants, we assumed that D&B data are
available for all large firms.85 A total of 146 companies were considered to be large based on the
company’s defined NAICS code and associated SBA definitions. This estimate was derived by
collecting information from the D&B database for companies at the parent company level as of
November 2002. In some cases a company identified with a unique DUNS number is ultimately
part of a larger “parent” company, a corporation that owns more than 50 percent of another
company, at the Global Ultimate DUNS number level. We identified the parent company in
D&B using the Global Ultimate DUNS number associated with each company listing. Global
Ultimate DUNS numbers in the D&B database are the highest parent company level containing
revenue and employee number information.
Additionally, we made modifications to the large pesticide registrant universe based on
knowledge of the industry. For example, at the time of analysis in fall 2002, D&B contained
financial information for both Aventis and Bayer CropScience. Bayer CropScience recently
acquired Aventis, and these companies are now consolidated. This and other modifications
85
D&B data for certain large pesticide registrants may not be readily available, and all parent companies considered
to be large may not have been identified. In addition, mergers and acquisitions may slightly reduce the number of
large registrants considered in the analysis. Given this uncertainly, it is assumed that the estimated number of large
pesticide registrants is reasonable.
Page 213
condensed the number of large pesticide registrants slightly. Table D-3 illustrates the results of
the large pesticide registrant economic profile. The average revenue for a large pesticide
registrant is estimated to be $6,882 million with an average number of employees of
approximately 19,300.
D.1.3 Analysis of Small Pesticide Registrants
We generated a random sample of firms from the PPIS database to determine the breakdown of
the remaining 1,658 firms, which are SBA-defined small firms. A randomly selected set of
1,000 unique companies identified in PPIS as holding one or more Section 3 registrations was
used for determining the number and financial characteristics of small pesticide registrant
entities. Because PPIS data do not contain information on the financial aspects of the registrants,
we matched the 1,000 randomly selected firms with company information and financial data
from D&B.
We identified DUNS numbers for 853 of the 1,000 firms in the PPIS sample data set using firm
name, address, and primary line of business. The additional identifiers, beyond firm name, were
necessary in many cases where D&B listed several companies with the same name. Of the 853
registrants in the PPIS sample data set, only 615 companies had sufficient information on total
revenue and number of employees to be included in this analysis.
We queries the D&B database using the DUNS numbers of the 615 potentially affected entities
to retrieve the ultimate parent company name (i.e., Global Ultimate DUNS number), annual
sales, total employees, and primary NAICS code.86
Based on total employees and financial data from D&B, we determined the entity size and
average sales revenue of pesticide registrants in the PPIS sample data set as illustrated in Table
D-3. We identified a total of 568 unique parent companies, of which 449 or 79 percent were
considered small businesses by SBA definitions. Of the SBA-defined small pesticide registrants,
approximately 60 percent (270) were small-small, 30 percent (134) were medium-small, and 10
percent (45) were large-small, based on EPA’s alternative small business definitions.
86
All financial information in this industry profile is summarized at the global ultimate parent company level. The
global ultimate parent is the highest-level firm within the company’s structure. For example, a major pesticide
manufacturer may be headquartered in Chicago, but have facilities in Memphis and St. Louis. The company
information from PPIS may list the Memphis or St. Louis facility locations, and/or the D&B database may include
company financial information from facility level up to the global ultimate parent company level. D&B data may
make it possible to determine that all three of these locations are owned by the same parent company.
Page 214
Table D-3. Economic Profile of Pesticide Registrants by Entity Size
PPIS Registrant Data a
Entity Size
Category
Definition
Total
Companies
Total Revenue
Percentage of
for All
Small
Companies
Companies
(million)
Pesticide Registrants
Average
Revenue per
Company
(million)
Average
Number of
Employees
per Company
Total Revenue
for All
Percentage of
Entities
Total Entities
(million) b
Total Revenue
SBA-Defined Sizes
Large
501 or more
employees
146
NA
$1,075,106
$7,364
19,266
146
$1,075,106
98.6%
Small
500 or fewer
employees
449 c
NA
$4,239
$9.44
39
1,658
$15,651
1.4%
NA
NA
NA
NA
NA
1,804 d
$1,090,757
100.0%
Total
EPA Alternative Small Business Sizes
e
Large-Small
100 to 500
employees
45
10.0%
$2,370
$52.68
217
166
$8,753
0.8%
Medium-Small
20 to 99
employees
134
29.8%
$1,307
$9.76
44
495
$4,829
0.4%
Small-Small
1 to 19
employees
270
60.1%
$561
$2.08
8
997
$2,070
0.2%
Total
449
NA
$4,239
$9.44
39
1,658
$15,651
1.4%
Sufficient Dun & Bradstreet company information and financial data were assumed to be available for all SBA-defined large pesticide registrants, based on the set of
1,804 unique pesticide registrants identified as having one or more Section 3 or Section 24(c) pesticide registrations. The total number of pesticide registrants that met
this criteria and were considered to be large companies was 146. For SBA-defined small businesses, a random sample of 1,000 unique pesticide registrants was used to
develop the economic profile. A total of 565 unique parent companies were identified as having sufficient financial information at the Global Ultimate DUNS number
level to be included in the analysis, of which 449 or 79 percent were considered small businesses by SBA definitions.
b
Calculated as the average revenue per company multiplied by the total number of entities for the respective size category.
c
SBA-defined small businesses identified out of a random sample of 1,000 unique companies with one or more active Section 3 or Section 24(c) registrations.
d
Number of all companies with unique EPA company numbers that were consolidated based on the following criteria: (1) matching of EPA company numbers with D&B
DUNS and Global Ultimate DUNS numbers; (2) as a result of recent mergers and acquisitions; (3) matching of company names associated with unique EPA company
numbers; or (4) recommended by EPA to be consolidated based on nearly identical name matching and/or prior knowledge.
e
EPA discussed alternative definitions of small businesses for some industry sectors in the 1999 Supplemental Notice on Standards for Pesticide Containers and
Containment (EPA, 1999). EPA is concerned that using an overly broad definition of small business in the economic analysis of container regulations may result in
significant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on those facilities that meet the SBA
size standard for small business but are not typical of a small business in that industry sector.
a
Page 215
The relative percentages for the EPA alternative small business categories from the sample of
449 small pesticide registrants with sufficient D&B data were applied to the total universe of
1,658 small registrants from the PPIS database. As a result, the SBA-defined small pesticide
registrant universe was estimated to include 997 small-small registrants, 495 medium-small
registrants, and 166 large-small registrants, based on the EPA alternative small business
definitions.
The D&B data for the 449 unique small companies with sufficient financial data were used to
determine size (by SBA definition) and to estimate average or typical annual revenue to generate
the economic profile for potentially affected small pesticide registrant entity size categories
(SBA-defined and EPA alternative definitions for small businesses). The data from the random
sample of small pesticide registrants are summarized in Table D-3 and the economic profile is
applied to the total universe of 1,658 small pesticide registrants.
D.1.4 Container Profile for Registrants by Market Sector and Size Category
The procedure for mapping pesticide containers and associated regulatory requirements to
pesticide registrants is shown in Table D-4. To the extent that certain antimicrobials are exempt
from consideration, the number of containers associated with each pesticide registrant size
category and ultimately with individual representative entities will vary. The container profile is
used to estimate the average number of containers for a given size category and type that can be
associated with a given pesticide registrant size (by SBA large and small definitions and by EPA
alternative definitions for small businesses) and market sector (agricultural,
industrial/commercial/government, and home and garden).
The procedure described in steps 3 and 4 of Table D-4 was duplicated for all non-refillable and
refillable container types and sizes. In the pesticide container regulations cost analysis (Chapter
4), the number of containers associated with each representative entity size category of pesticide
registrants is used in combination with the regulation compliance rates (see Chapter 3) to derive
costs of compliance and anticipated SBA small business impacts.
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Table D-4. Procedure Used to Establish Market-Specific Regulated Entities
Step 1. Distribute the pesticide registrants across market sectors (agricultural, I/C/G, and H&G) based
on volume of pesticides used by each sector according to the Pesticide Industry Sales and Usage: 2000 and
2001 Market Estimates (EPA, 2002b).
From EPA’s pesticide use and sales report, we know the
amount of pesticide product used in each market sector. The
total amount of pesticide product considered includes
conventional pesticides, other pesticides, and an EPA estimate
of 29.8 percent of the antimicrobial products (wood
preservatives, chlorine/hypochlorites, and specialty biocides)
subject to the container regulations. The total number of SS,
MS, LS, and large pesticide registrant entities is distributed
among market sectors, based on the relative amount of the
assumed pesticide product subject to the container regulations
used by each sector in 2001.
Example: 2001 total pesticide use is as
follows: 40% agricultural, 30% I/C/G, and
30% H&G. Accordingly, the number of
pesticide registrants by size and market sector
is as follows:
SS
MS
LS
Large
Agricultural
399
198
66
58
I/C/G
299
148
50
44
H&G
299
148
50
44
Total
997
495
166
146
Step 2. Derive total revenue by pesticide registrant size category and determine the revenue ratio for
each pesticide registrant size category by market sector to the total revenue for that market sector.
Sum the total revenue for SS, MS, LS, and large pesticide
Example: Total revenue for SS, MS, LS, and
registrants based on PPIS sample data set analysis results for
large firms in the PPIS sample data set were
average revenue by pesticide registrant size category.
$2,070 million, $4,829 million, $8,753
Multiplying the average revenue by the total number of
million, and $1,075,106 million, respectively.
registrants in each category yields the total.
Determine the revenue ratio for each pesticide registrant size
category based on the total revenue per size category compared
to the revenue for the total universe of registrants. The
SS
revenue ratios for the registrant size categories are applicable
MS
to each market sector.
LS
Total Revenue
(million)
Revenue Ratio
$2,070
0.2%
$4,829
0.4%
$8,753
0.8%
Large
$1,075,106
98.6%
Total
$1,090,757
100.0%
Step 3. Distribute the containers that are affected by the container regulations in each size/type category
into entity size categories for each market sector (agricultural, I/C/G, and H&G).
For each liquid and dry product pesticide container size
category, apply the revenue ratio to allocate the containers to
SS, MS, LS, and large entities for each market sector. Repeat
example procedure to the right for every container category
(size, type, material).
Example: The 199,434 potentially affected
30–55 gallon plastic non-refillable containers
in the agricultural market sector are distributed
as follows:
Agricultural
SS
MS
LS
Large
378
883
1,600
197K
Step 4. Determine the number of containers per representative pesticide registrant by entity size for each
market sector.
Calculate the number of containers for an average (or
representative) pesticide registrant for each size category in
each market sector by dividing the number of each type of
container in each market sector (step 3) by the number of
companies in each market sector (step 1). Repeat example
procedure to the right for every container category (size, type,
material).
Numbers may not add due to rounding.
Page 217
Example: Using the above example, the
number of plastic 30-55 gal. containers for the
Agricultural (market sector) firms is as
follows:
Agricultural
SS
MS
LS
Large
1
4.5
24
3,389
D.2 Agricultural Pesticide Refillers
The agricultural pesticide refiller entity is analogous to agricultural chemical dealers who
generally supply pesticide products to farmers or other end users in refillable containers for
large-scale application. Agricultural pesticide refillers are subject to the repackaging
requirements each time a pesticide is repackaged into a refillable container. Generally, this
regulated entity is responsible for inspecting, rinsing, and properly labeling containers prior to
reuse, and maintaining appropriate records.
Agricultural pesticide refillers repackage and supply the majority of pesticides to farmers and
other agricultural end users. It is estimated that 90 percent of agricultural pesticide product
distributed in refillable containers is distributed or sold by agricultural pesticide refillers, and the
remaining 10 percent is distributed or sold directly by registrants (Paulson, 2002). Agricultural
pesticide refillers are generally represented under NAICS 422910 (Farm Supplies and Wholesale
Sector), which consists of “establishments primarily engaged in wholesaling farm supplies, such
as animal feeds, fertilizers, agricultural chemicals, pesticides, plant seeds and plant bulbs” (U.S.
Department of Commerce, 1997).
This analysis considers only agricultural pesticide refillers, even though the regulations do not
prohibit refilling by companies other than registrants in non-agricultural markets. To represent
current business practices, we assumed that all pesticides in the I/C/G market are repackaged by
the registrants and that there are no refillables used in the H&G market/
We extracted the revenue and employee data directly from the D&B database for all
establishments with NAICS 422910 designations to generate the industry profile for agricultural
pesticide refillers. It is assumed that the financial information extracted from D&B for the
NAICS 422910 market sector is representative of the agricultural pesticide refiller entities
subject to the container regulations. As a result, we pulled 24,360 records from the D&B
database, with 21,599 establishments having sufficient financial data to be included in the
analysis. We consolidated these data by Domestic Ultimate DUNS number in order to aggregate
facilities by parent company designation, resulting in a total of 12,511 unique companies
identified. In a few instances where discrepancies arise in revenue and employee information at
the Domestic Ultimate DUNS level, we used the maximum values for the D&B data fields
“Employees Total” and “Sales Volume (US$)” associated with each Ultimate DUNS number.
We then broke down the D&B sample data set into small and large entity size according to the
SBA small business definition for NAICS 422910 (i.e., SBA defines a small business for NAICS
422910 as having 100 employees or fewer). As illustrated in Table D-5, 99 percent of the 12,511
unique parent companies we identified were considered small by the SBA definition. Based on
the EPA alternative small business definitions presented in Table 3.3, approximately 83 percent
were small-small, 14 percent were medium-small, and 2 percent were large-small (see
Table D-5).87
87
Regulated facilities in this analysis are companies rather than individual facilities.
Page 218
Table D-5. Economic Profile of Agricultural Pesticide Refillers by Entity Size
Agricultural Pesticide
Refillers
D&B Sample Data Set for NAICS 422910
Entity Size
Category
Definition
Total
Companies
Percent of
Total
Companies
Total
Revenue for
All
Companies
(million)
Percent of
Total
Revenue
Average
Revenue per
Company
(million)
Average
Number of
Employees
per Company
Total
Entities a
Total
Revenue for
All Entities
(million) b
SBA-Defined Sizes
Large
101 or more
employees
114
0.9%
$21,842
47.1%
$191.60
448
153
$29,322
Small
100 or fewer
employees
12,397
99.1%
$24,670
52.9%
$1.99
6
16,642
$33,050
Total
12,511
100.0%
$46,416
100.0%
$3.71
10
16,795 c
$62,372
EPA Alternative Small Business Sizes
Large-Small
50 to 100
employees
d
187
1.5%
$4,246
9.2%
$22.71
71
251
$5,700
Medium-Small
10 to 49
employees
1,784
14.3%
$12,006
25.9%
$6.73
19
2,395
$16,118
Small-Small
1 to 9
employees
10,426
83.3%
$8,341
18.0%
$0.80
3
13,996
$11,232
12,397
99.1%
$24,670
52.9%
$1.99
6
16,642
$33,050
Total
a
The percentage of total companies in the D&B sample data set was applied to the estimated number of agricultural pesticide refillers used in the analysis.
The average revenue of agricultural pesticide refillers for each entity size category was multiplied by the total number of entities for the given size category.
c
EPA estimate based on state estimates where available; otherwise, SIC 5191.02 + 5191.14 from the American Business Information Lists of 9 Million Businesses, 1990.
The same total number is estimated as presented in the 1999 Supplemental Notice on Standards for Pesticide Containers and Containment (EPA, 1999).
d
EPA discussed alternative definitions of small businesses for some industry sectors in the 1999 Supplemental Notice on Standards for Pesticide Containers and
Containment (EPA, 1999). EPA is concerned that using an overly broad definition of small business in the economic analysis of the container regulations may result in
significant economic impacts on smaller entities that will be camouflaged when combined with information about potential impacts on those facilities that meet the SBA
size standard for small business but are not typical of a small business in that industry sector.
b
Page 219
Based on information collected by EPA (see footnote c to Table D-5), it was determined that no
one NAICS code was unique to agrichemical dealers or agricultural pesticide refillers.
Therefore, the economic profile for the sample of 12,511 companies was applied to the total
universe of 16,795 agricultural pesticide refillers. The estimated number of agricultural pesticide
refillers potentially affected (16,795 companies) is based on the information presented in the
1999 Supplemental Notice (EPA, 1999) and the proposed container rule RIA. This estimate is
considered to be a reasonable estimate for the current total number of entities potentially
affected.
The number and types of refillable containers associated with agricultural pesticide refillers that
are subject to the repackaging regulations are assumed to be approximately 90 percent of the
total for each container size category (Paulson, 2002). We duplicated the procedure described in
steps 3 and 4 of Table D-4 to determine the number of refillable containers associated with a
representative agricultural pesticide refiller in each SBA and EPA alternative size category. The
total number of containers that fall within the scope of the container regulations is presented by
market sector in Chapter 4 (Table 4.7).
D.3 Swimming Pool Market
EPA has determined that certain antimicrobial products are exempt from the container
regulations (EPA, 2002a). Container requirements for antimicrobial products that are subject to
the rule will primarily affect pesticide registrants. However, applicators of sodium hypochlorite
used to disinfect pool and spa water (i.e., swimming pool supply companies) have been
identified as regulated entities that will be required to comply with some refillable container and
repackaging requirements. Refillable containers for the products must comply with the adopted
DOT standards and bulk container standards (if applicable), but not the marking or one-way
valve/tamper-evident device requirements. Swimming pool supply companies must meet certain
refilling requirements, but not all. Refillables are required to be inspected and cleaned (unless
specified conditions in §165.170 are met) and must be properly labeled. Swimming pool supply
companies must maintain certain records, but not all. Copies of the residue removal procedures
for refilling and description of acceptable containers must be on file, but a record of certain
information recorded each time a container is refilled (e.g., product, amount) is not required.
The partial set of repackaging (refilling) requirements and compliance rates are detailed in
Chapter 3.
A readily available data source that could be used to characterize the swimming pool chemical
industry impacts associated with the container regulations does not exist. There is no current
NAICS code that is specifically devoted to the swimming pool supply industry. Additionally,
the Chlorine Institute, National Spa and Pool Institute, and the Swimming Pool Chemical
Manufacturers Association were unable to provide adequate information. Based on EPA data,
we generated a list of 472 company names associated with registered sodium hypochlorite
products. The primary NAICS code associated with these companies is 453998 (All Other
Miscellaneous Store Retailers [except Tobacco Stores] – 7.6 percent), and 235990 (All Other
Special Trade Contractors – 5.9 percent). To keep SBA small/large business distinctions from
becoming too complex, we used establishment records with the most common NAICS code
designation to characterize the swimming pool chemical industry.
Page 220
We consolidated the establishment records with the same Domestic Ultimate DUNS number to
estimate the number of potentially affected swimming pool supply companies (322) at the parent
company level. All parent companies having sufficient revenue and employee data were divided
into small and large businesses based on the SBA small business size standard for NAICS
453998, which is no more than $6 million in revenue. Once the D&B parent companies were
grouped into small and large SBA defined size categories, we divided the SBA small businesses
into the three EPA alternative small business size categories based on the criteria presented
earlier in Table 3.3.
Table D-6 illustrates the number of affected swimming pool supply companies, by size, and the
financial information associated with the average company for each given entity size category.
The total number of swimming pool supply companies subject to the refilling requirements is
322, with nearly all (94.7 percent) of those entities considered SBA small businesses.
Information is not readily available to estimate which swimming pool chemical companies use
refillable containers for sodium hypochlorite. Therefore, it is assumed that all swimming pool
chemical companies identified will likely be subject to the repackaging requirements. The
number of refillable containers associated with representative swimming pool supply companies
were found for each size category based on steps 3 and 4 described in Table D-4. The total
number of containers that fall within the scope of the container regulations is presented by
market sector in Chapter 4 (Table 4.7).
Page 221
Table D-6. Economic Profile of Swimming Pool Supply Companies a by Entity Size
D&B/InfoUSA Data Set for 472 Selected Companies with Registered Sodium Hypochlorite Products b
Entity Size
Category
Definition
SBA-Defined Sizes
c
Large
Revenues greater than $6.0 million
Small
Revenues up to $6.0 million
Total Companies
Percentage of
Total
Companies
Total Revenue for Percentage
all Companies
of Total
(millions)
Revenue
Average
Revenue per
Company
Average
Number of
Employees
per Company
17
5.3%
$41,445
98.9%
$2,437,954,281
12,119
305
94.7%
$455
1.1%
$1,492,653
13
14
4.4%
$72
0.17%
$5,113,298
70
117
36.3%
$298
0.71%
$2,544,285
20
174
54.0%
$86
0.21%
$494,205
4
322
NA
$41,900
NA
$130,125,720
652
d
EPA Alternative Small Business Sizes
Large-Small
50 or more employees
Medium-Small
10 to 49 employees
Small-Small
1 to 9 employees
Total e
a
Currently, only refillable containers used in the pool chemical industry are considered. These are primarily used for repackaging sodium hypochlorite for commercial
and residential pool servicing.
b
Based on EPA analysis of sodium hypochlorite pesticide registrations.
c
The SBA small business size standard is no more than $6 million in revenue for NAICS 453998. The analysis divided the SBA small businesses into the three EPA
alternative small business size categories regardless of employee or revenue totals once the regulated entity passed the SBA-defined small business screening.
d
EPA has not previously proposed alternative definitions of small businesses for swimming pool supply companies. However, EPA is concerned that using an overly
broad definition of small business in the economic analysis of the container regulations may result in significant economic impacts on smaller entities that will be
camouflaged when combined with information about potential impacts on those facilities that meet the SBA size standard for small business but are not typical of a small
business in that industry sector.
e
No employee or revenue data were available for 140 companies out of the initial 472 companies considered. As a result, these companies have not been included in this
summary table. In addition, 10 companies in the data collected were also removed from consideration because they proved to be duplicates of another record (i.e., they
were found to have the same Domestic Ultimate parent company).
Page 222
Appendix E. 1994 Proposed Rule Container Standards Costs and Benefits
E.1 Estimated Cost of Proposed Rule Container Standards
Three regulatory options are evaluated in the proposed container and labeling standards:
(1) Regulatory Option 1, a low stringency option, (2) Regulatory Option 2, representing EPA’s
proposed minimum standards, and (3) Regulatory Option 3, a more stringent option. Under all
three options, non-refillable containers must meet general integrity standards; must be marked
with the EPA registration number of the pesticide and the name, symbol, or code of the
material(s) from which the container is constructed; must be designed so that the container pours
in a continuous, coherent stream (doesn’t glug), drippage is eliminated, and the container
recloses securely; and must have one of four standardized closures to encourage and expedite the
use of closed handling systems (if the container is used to hold a pesticide labeled for use in the
production of an agricultural commodity). In addition, under Regulatory Option 1, each
container/formulation combination must meet a five-9s (99.999 percent) residue removal
standard following a prescribed protocol for testing and analyzing the rinsate from a fourth rinse.
Under Regulatory Options 2 and 3, a more stringent residue removal standard of six-9s (99.9999
percent) must be met. Under Regulatory Option 3, non-refillable containers with a capacity of
greater than 5 gallons that are used to contain liquid pesticides are prohibited; any such container
must be a refillable container and must meet the standards for refillable containers. And finally,
certain certification and recordkeeping requirements are consistent among all three regulatory
options. We analyzed two different scenarios under all three regulatory options, with Scenario 1
assuming that 50 percent of all non-refillable/dilutable formulation combinations will be tested
for the residue removal standard, whereas Scenario 2 represents a works-case analysis in that 100
percent of all container/formulation combinations are assumed to be tested for the standard.
Additional requirements for refillable containers include, under Regulatory Option 1, no drop
tests; under Regulatory Option 2, all minibulk refillable containers must undergo a drop test of
2.6 feet to 3.9 feet, depending on whether the pesticide contained is dry or liquid; and under
Regulatory Option 3, all minibulk refillable containers refillable containers must undergo drop
tests per DOT standards, as well as a vibration test, lifting device test, stacking device test,
hydrostatic test, and leakage test. Additional requirements for registrants include certification,
recordkeeping requirements, and provision of certain materials to refilling establishments,
including written residue removal procedures and a written list of acceptable refillable containers
for each product. Requirements for refilling establishments relative to refillable containers are
the same under all three regulatory options, including obtaining specified
authorization/information from the registrant(s), container inspection procedures, repackaging
procedures, and recordkeeping/inspection requirements.
Table E-1 and Table E-2 summarize the estimated costs of the proposed container standards for
representative formulator and refiller facilities by market, respectively. Both the annual cost and
annual cost as a proportion of annual sales are summarized for all three regulatory options and
for both scenarios in the Tables. Table E-3 summarizes the total costs of the proposed container
standards. Costs are aggregated by regulatory option and scenario for all facilities for both the
container and labeling standards.
Page 223
Table E-1. Summary of Annual Revenue Requirements (ARR) a and ARRs as a Percentage
of Sales for Representative Formulating Facilities in Each Market Sector Under
Regulatory Options 1, 2, and 3 b and Scenarios 1 and 2 c for the Proposed Pesticide
Container Standards (2005$)
Market/Representative
Formulator Facility Type
Scenario 1
Agricultural Market
Small Agricultural Facility
Medium Agricultural Facility
Large Agricultural Facility 1
Large Agricultural Facility 2
Large Agricultural Facility 3
Large Agricultural Facility 4
Industrial Market
Small Industrial Facility
Medium Industrial Facility
Institutional Market
Small Institutional Facility
Medium Institutional Facility
Household Market
Small Household Facility
Medium Household Facility
Regulatory Option 1
Regulatory Option 2
Regulatory Option 3
ARR
($000)
ARR
($000)
ARR
($000)
ARR/sales
(%)
ARR/sales
(%)
ARR/sales
(%)
$33
$126
$726
$801
$3,331
$822
0.6
0.46
0.19
0.21
0.87
0.21
$35
$135
$796
$871
$3,401
$892
0.64
0.49
0.21
0.23
0.89
0.23
$94
$223
$913
$988
$3,518
$1,009
1.71
0.81
0.24
0.26
0.92
0.26
$45
$184
0.82
0.67
$46
$190
0.84
0.69
$304
$703
5.55
2.56
$40
$133
0.72
0.49
$41
$139
0.75
0.51
$197
$451
3.6
1.65
$37
$128
0.67
0.47
$38
$134
0.7
0.49
$38
$134
0.7
0.49
Scenario 2
Agricultural Market
Small Agricultural Facility
$72
1.3
$77
1.4
$135
2.47
Medium Agricultural Facility
$228
0.83
$248
0.91
$336
1.23
Large Agricultural Facility 1
$1,313
0.34
$1,452
0.38
$1,569
0.41
Large Agricultural Facility 2
$1,389
0.36
$1,528
0.4
$1,645
0.43
Large Agricultural Facility 3
$3,919
1.02
$4,058
1.06
$4,175
1.09
Large Agricultural Facility 4
$1,409
0.37
$1,549
0.4
$1,653
0.43
Industrial Market
Small Industrial Facility
$75
1.37
$79
1.44
$337
6.15
Medium Industrial Facility
$279
1.02
$292
1.07
$805
2.94
Institutional Market
Small Institutional Facility
$70
1.28
$74
1.35
$230
4.19
Medium Institutional Facility
$228
0.83
$241
0.88
$553
2.02
Household Market
Small Household Facility
$67
1.23
$71
1.3
$71
1.3
Medium Household Facility
$223
0.81
$236
0.86
$236
0.86
a
One method for analyzing uneven cost streams is to calculate their equivalent, constant-level cost per year. This
equivalent cost is referred to as the annual revenue requirement (ARR) because the present value of such an annual
revenue stream would just offset or equal the present value of the cost stream.
Page 224
Table E-1 (Continued). Summary of Annual Revenue Requirements (ARR) a and ARRs as
a Percentage of Sales for Representative Formulating Facilities in Each Market Sector
Under Regulatory Options 1, 2, and 3 b and Scenarios 1 and 2 c for the Proposed Pesticide
Container Standards (2005$)
b
Regulatory Option 1:
• Five-9s residue removal standard for non-refillables
• No drop test required for refillables
• Other EPA-proposed requirements.
Regulatory Option 2:
• Six-9s residue removal standard for non-refillables
• Other EPA-proposed requirements.
Regulatory Option 3
• Six-9s residue removal standard for non-refillables
• Non-refillables greater than 5 gallons prohibited for liquid pesticides
• Extensive container integrity tests for container design
• Other EPA-proposed requirements.
c
Scenario 1: 50% of container/formulation combinations tested for residue removal. Scenario 2: 100% of
container/formulation combinations tested for residue removal.
Table E-2. Summary of Annual Revenue Requirements (ARR) a and ARRs as a Percentage
of Sales for Representative Agricultural Refilling Facilities in Regulatory Options 1, 2, and
3 b for the Proposed Pesticide Container Standards (2005$)
Representative Agricultural Refilling
Facility
Regulatory Option 1
ARR ($)
ARR/Sales (%)
Regulatory Option 2 and 3
ARR ($)
ARR/Sales (%)
Small Refilling Facility
$314
0.013
$637
0.026
Medium Refilling Facility
$618
0.008
$1,263
0.016
$1,491
0.005
$2,999
0.01
Large Refilling Facility
a
One method for analyzing uneven cost streams is to calculate their equivalent, constant-level cost per year. This
equivalent cost is referred to as the annual revenue requirement (ARR) because the present value of such an annual
revenue stream would just offset or equal the present value of the cost stream.
b
Regulatory Option 1:
• No drop test required for refillables
• Other EPA-proposed requirements.
Regulatory Option 2: Other EPA-proposed requirements.
Regulatory Option 3:
• Extensive container integrity tests for container design
• Other EPA-proposed requirements.
Page 225
Table E-3. Total Cost (Annual Revenue Requirement or ARR) of the Proposed Pesticide
Container and Labeling Standards
Container Standards
Formulating
Refilling
Industry
Industry
(million $)
(million $)
Labeling Standards
Formulating
End User b
Industry
(million $)
(million $)
Regulatory Option/
Total ARR
Scenario a
(million $)
Regulatory Option 1
Scenario 1
$21.4
$2.6
$5.1
$8.2
$37.3
Scenario 2
$30.4
$2.6
$5.1
$13.6
$51.6
Regulatory Option 2
Scenario 1
$22.2
$4.7
$5.1
$8.2
$40.1
Scenario 2
$32.2
$4.7
$5.1
$13.6
$55.5
Regulatory Option 3
Scenario 1
$87.8
$4.7
$5.1
$8.2
$105.8
Scenario 2
$97.8
$4.7
$5.1
$13.6
$121.1
a
Regulatory Option 1:
• Five-9s residue removal standard for non-refillables
• No drop test required for refillables
• Other EPA-proposed requirements.
Regulatory Option 2:
• Six-9s residue removal standard for non-refillables
• Other EPA-proposed requirements.
Regulatory Option 3:
• Six-9s residue removal standard for non-refillables
• Non-refillables greater than 5 gallons prohibited for liquid pesticides
• Extensive container integrity tests for container design
• Other EPA-proposed requirements.
Scenario 1: 50% of container/formulation combinations tested for residue removal. Scenario 2: 100% of
container/formulation combinations tested for residue removal
b
For end users only, Scenarios 1 and 2 are not defined as in Footnote a. Rather, Scenario 1 assumes a 60%
compliance rate by end users for triple rinsing certain container that have a triple rinse requirement for the first time,
and Scenario 2 assumes a 100% compliance rate for triple rinsing the same universe of containers. Household end
users account for approximately 85% of the total cost under each scenario, and institutional end users account for
approximately 15%.
E.2 Estimated Benefits of the Proposed Rule Container Standards
The RIA for the proposed container and labeling standards estimates both direct and indirect
benefits (See Chapter 5 for details). The direct benefits (see Table E-4) include: (1) health- and
environment-related benefits resulting from a reduction in the incidents of container failure and
the risks posed by accidental spills of pesticide, leaks, dripping, and the residue remaining in
pesticide containers; (2) a quantitative estimate of disposal-related benefits resulting from lower
costs for non-refillable container disposal as non-hazardous waste after triple rinsing (versus
disposal as hazardous waste); and (3) several additional categories of qualitative benefits (e.g.,
increased worker productivity and reduced property damage).
The estimated indirect benefits are associated with the switch from use of non-refillable
containers to refillable containers, which are expected (not required) as a result of the container
standards. The types of indirect cost savings estimated as a result of the switch to refillable
containers include: (1) container cost savings, (2) container disposal cost savings, and
(3) substantial labor savings associated with triple rinsing of used non-refillable pesticide
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containers. The sum of indirect benefits is estimated to range from $36.4 million to $109.1
million with a midpoint of $72.8 million.
Table E-4. Estimated Benefits of the Proposed Container and Labeling Standards
Benefits Estimated in the
Proposed Container Rule
RIA
Direct Benefits
Indirect Benefits
Type of Benefit
Estimated Benefits
Health- and Environment- EPA estimated that 1,650 to 2,250 acute illness
Related Effects
incidents caused by container design/residue removal
problems could potentially be avoided annually
throughout the United States. In addition, a potentially
significant number of unreported acute pesticide
poisoning incidents and environmental incidents may
be avoided.
Non-Refillable Container
Disposal Effects
$5,649,880 to $6,904,800
Other Container
Design/Residue Removal
and Labeling Effects
In addition to these quantitative benefit estimates,
several additional categories of benefits were
qualitatively presented, including potential reductions
in liability/insurance costs, increased worker
productivity, creation of a lower at-risk work
environment, and the potential for reduced property
damage from pesticide accidents and improved
pesticide management.
Refillable Container
Cost-Saving Effects
$29,535,145 to $88,605,435
Refillable Container
Disposal Cost-Saving
Effects
$545,945 - $1,637,835
Refillable Container
Labor-Saving (Rinsing)
Effects
$6,280,765 - $18,842,295
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Appendix F. Nationwide and State Regulations and Standards for Pesticide
Containers
This section will examine the following nationwide regulations or standards:
•
•
•
•
U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR) (i.e.,
49 CFR Parts 107-179);
United Nation (UN) Recommendations on the Transport of Dangerous Goods (UN, 1999);
Mid America CropLife Association: MACA-75 Manufacturer Specifications and User
Guidelines for Liquid Pesticides and Other Agri-Chemicals Not Subject to U.S. DOT
Specification Packaging (MACA, 1992); and
Existing EPA policy applicable to pesticide containers.
UN recommendations and the MACA-75 specifications, which are voluntary, are included
because research has shown that the majority of container manufacturers produce containers
meeting one or both of these standards. These are viewed by major container manufacturers as
necessary rather than optional standards.
Regulations affecting containers and packaging that have been specifically excluded are the
Resource Conservation and Recovery Act (RCRA) regulations (40 CFR §261.7(b)(3)). Because
the container regulations address the usage rather than disposal of containers, there is very little
overlap with the RCRA regulations. The only overlap occurs at the time of container disposal.
It is EPA’s intent that containers that are triple rinsed as provided in the container regulations
will meet the requirements for “empty” under RCRA at 40 CFR §261.7(b)(3). While there is no
specific final residue removal standard for refillable containers, users will likely meet one of the
removal requirements at §261.7(b) if their container holds a hazardous waste and they wish to
avoid regulation under RCRA.
This appendix is organized into seven sections. The first three sections (F.1, F.2, and F.3)
present a brief overview of the three major regulations/standards (DOT HMR, UN
recommendations, and MACA-75 specifications, respectively). Section F.4 describes the
container population affected by each of the three major regulations/standards. Section F.5
presents the requirements of the major regulations/standards as they compare with the container
regulations. Section F.6 presents a summary of existing EPA policies and regulations that affect
the baseline container regulation compliance rate. The final section (F.7) presents a summary of
existing state regulations and standards for pesticide containers.
F.1
Department of Transportation Hazardous Materials Regulations
The DOT HMR apply to the interstate (and in some cases, intrastate) transportation of hazardous
materials in commerce (DOT, 1996). In general, the DOT HMR specify requirements for
packaging, classification, handling, transport, hazard communication, and incident reporting of
hazardous materials. The HMR are enforced by the Federal Highway Administration, the
Federal Aviation Administration, the Federal Railroad Administration, and the U.S. Coast Guard.
The DOT HMR hazard class definitions are generally aligned with nine risk classes used in the
UN recommendations described in the next subsection. Under this classification system,
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pesticides primarily fall under Hazard Class 6, Division 6.1, although some may also meet the
criteria for flammable materials (RTI, 1989). Hazard Class 6 uses a definition related to oral,
dermal, and inhalation toxicity, similar to that for the UN recommendations. The HMR also
contain 20 UN performance-oriented packaging standards for non-bulk containers. These
requirements contain general standards for specific types of packaging such as plywood drums,
plastic drums and jerricans,88 fiber drums, and steel jerricans. In addition, there are testing
standards that apply to all non-bulk packaging types. These requirements follow the UN
recommendations for non-bulk containers and include the following tests: drop, leakproofness,
hydrostatic pressure, and stacking. Non-bulk packaging used for hazardous materials in the
United States must also be capable of withstanding a vibration standard that is not included in the
UN recommendations.
The HMR prescribe various performance levels in packaging hazardous materials based on the
level and nature of hazards posed by the material to be packaged. All packaging, regardless of
type, must be designed so that under normal conditions of transport, no contents will be released.
Also, the containers must be designed so that the effectiveness of the packaging will not be
substantially altered by temperature.
The DOT HMR requirements apply regardless of whether the container is refillable. If a
container is refillable, it must also meet the reuse provisions found at 49 CFR §173.28, which
require inspections before reuse, and the following provisions for non-bulk containers: retesting
of liquid packaging for leakproofness, durable marking, and minimum thickness criteria for
metal and plastic drums and jerricans. The DOT HMR also contain requirements regarding the
reconditioning and remanufacturing of non-bulk packaging.
Portable tanks are subject to 49 CFR §173.32, which addresses “Qualification, maintenance and
use of portable tanks other than Specification IM portable tanks.” These provisions contain
recordkeeping, retesting, and container/material compatibility requirements, some of which are
required by tank specification (e.g., DOT Specifications 56, 57, and 60). There are special
requirements for containers constructed before May 15, 1950, as well as provisions addressing
deteriorated, damaged, and unused tanks. There are also additional requirements for these tanks
at 49 CFR §§173.32a, 173.32b, and 173.32c addressing the approval of Specification IM
portable tanks, the periodic testing and inspection of these tanks, and requirements regarding
their use.
F.2
United Nations Recommendations on the Transport of Dangerous Goods
The UN Recommendations on the Transport of Dangerous Goods were developed by the UN
Committee of Experts on the Transport of Dangerous Goods (1999). While these
recommendations address dangerous goods that are shipped internationally, they also affect
containers shipped domestically. Many packaging manufacturers are beginning to follow
portions of these recommendations for containers shipped domestically. Additionally, some
companies ship both domestically and internationally, and the containers used meet both the UN
recommendations and the DOT HMR discussed in the previous subsection. The DOT design
88
A jerrican, as defined by the DOT HMR, is a metal or plastic “packaging” of rectangular or polygonal crosssection (49 CFR 171.8).
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specification packaging system was accepted in international transport under transitional
provisions which expired on December 31, 1990; after that date, the packaging for most
hazardous materials in international transport were required to conform to the UN standards (55
FR 52404). As of October 1996, UN performance-oriented packaging standards added to the
DOT Hazardous Materials Regulations (HMR) by HM-181 were fully in effect (Deadrick, 1992;
55 FR 52408 and 52473-52474).
The UN recommendations classify dangerous goods into nine risk classes. For each class, there
is a set of criteria; any substance meeting those criteria is considered in that class. Class 6—
Poisonous (toxic) and Infectious Substances—is the class where many pesticides would fall.89 A
material is a Class 6 poison if it is “liable to either cause death or serious injury or to harm
human health if swallowed, inhaled or by skin contact” (UN Committee of Experts on the
Transport of Dangerous Goods, 1999, p. 97). Division 6.1 specifically addresses poisonous
(toxic) substances; Chapter 2.6 in the guidance document on the UN recommendations (UN
Committee of Experts on the Transport of Dangerous Goods, 1999), which addresses Division
6.1, includes a section that allows shippers of pesticides to determine which of three Packing
Groups is appropriate for their material. Many of the pesticides listed are insecticides because
they tend to be more toxic to humans than either herbicides or fungicides. The three Packing
Groups—I, II & III—are based on toxicity classifications: the lethal dose to 50 percent of the
sample population (LD50s) for oral and dermal activity and the lethal concentration to 50 percent
of the population (LC50) for inhalation activity. Packing Group I contains the most toxic
materials. The criteria for these groups are shown in Table F-1.
Table F-1. Grouping Criteria for Administration Through Oral Ingestion,
Dermal Contact, and Inhalation of Dusts and Mists
Packing Group
I
II
III
Oral Toxicity LD50
(mg/kg) a
Dermal Toxicity
LD50 (mg/kg) a
Inhalation Toxicity by
Dusts and Mists
LC50 (mg/l) b
≤5
≤40
≤0.5
>5-50
>40-200
>0.5-2
c
Solids: >50-200
>200-1,000
>2-10
Liquids: >50-500
Source: UN Committee of Experts on the Transport of Dangerous Goods (1999).
a
Lethal dose to 50% of the sample population.
b
Lethal concentration to 50% of the sample population.
c
Tear gas substances should be included in Packing Group II even if their toxicity data correspond to Packing
Group III values.
89
Some may meet the criteria for a flammable substance and be placed in either Class 3 - Flammable liquids or
Class 4 - Flammable solids, or possibly Class 8 - Corrosives (RTI, 1989; EPA, 2005).
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The UN recommendations contain standards for two different container size groups:
•
•
Non-bulk packaging, which has a net mass of 882 lbs (400 kgs) or less, and whose capacity
is 119 gals (450 L) or less, and
Intermediate bulk containers (IBCs), which are rigid or flexible portable packagings with a
capacity of not more than 500 gals and are not included in non-bulk packaging.90
The recommendations for both non-bulk containers and IBCs include permanent marking,
construction standards, and performance testing—including drop, leakproofness, hydraulic
pressure, and stacking tests. IBCs must also meet bottom lift and top lift testing. There are also
special tests that flexible containers (e.g., bags) must meet (UN Committee of Experts on the
Transportation of Dangerous Goods, 1999).
F.3
Mid America CropLife Association (MACPA): MACA-75 Manufacturer
Specification and User Guidelines for Portable Agrichemical Tanks
The Mid America CropLife Association has adopted the MACA-75 standards for the
conglomerate of regional crop protection associations represented at the national level. MACPA
was formerly known as the Midwest Agricultural Chemicals Association (MACA); hence the
MACA-75 standards have retained their title by recognition of the association’s former name.
These specifications were developed by MACA’s Bulk Pesticide Task Force Committee,
because MACA recognized that the majority of pesticides sold were not considered DOT
hazardous material.91 The lack of regulation could result in certain tanks (especially minibulks)
being used to transport pesticides even though the tanks were not of a design or construction that
allowed for safe movement over the highway (MACA, 1986). The eventual consequences of this
lack of regulation could be environmental pollution, severe government regulation, bad publicity,
and potentially large civil liabilities to the pesticide industry. To avoid these consequences,
MACA developed the MACA-75 tank specifications, which apply to containers of 60 to 660
gallons. While MACA is only one of several regional agricultural chemical associations across
the country, its tank specifications and user guidelines have become accepted nationally and are
the standards used by many container manufacturers (MACA, 1992, 1986; Bartenhagen, 1992;
Snyder Industries, 1992).
The MACA-75 specifications include general construction requirements regarding minimum
strength, openings that allow for internal visual inspection, and handling characteristics (tiedown/loading design features). Standards are also included to address appurtenances, closures,
plumbing connected to the tank, and emergency pressure relief devices. Tanks designed under
MACA-75 specifications must meet a series of qualification tests, including vibration,
leakproofness, drop, lifting device, base support structure, stacking, and hydrostatic testing.
90
In the UN Recommendations on the Transport of Dangerous Goods (UN, 1999) no lower limit is given for IBCs,
but the definition of IBCs states “other than those [non-bulk packagings] specified in Chapter 6.1.” Thus, it would
appear that the IBC’s lower capacity limit is 450 L.
91
At the time the MACA standards were developed, DOT used a different classification system from the nine
hazard classes introduced by HM-181. Then, pesticides considered DOT hazardous materials were mostly classified
as Class B poisons, flammable liquids, or combustible liquids. EPA felt that the number of pesticides covered was
20-25 percent of all pesticides; HM-181 has probably increased the number of pesticides included. Herbicides still
comprise a major portion of those pesticides not covered because they tend not to be as toxic to mammals as many
insecticides.
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F.4
Container Population Affected by the container regulations and the Three Major
National Regulations/Standards
To better understand the compliance baseline, we compared the affected pesticides and pesticide
container populations of the three major regulations/standards (i.e., DOT HMR, UN
Recommendations on the Transport of Dangerous Goods, and MACA-75 Guidelines) to the
container regulations. Table F-2 summarizes the affected container population for the three
major sets of regulations/standards.
Both the DOT HMR and UN recommendations cover pesticide containers that (1) are
transported, and (2) hold pesticides that are highly toxic (i.e., LD50 of 200 mg/kg or less for
solids and 500 mg/kg or less for liquids) or meet the DOT HMR/UN criteria for a flammable or
corrosive material. The DOT HMR regulate these containers, either through direct regulation or
exemption, regardless of container size or whether the container is refillable. The MACA-75
specifications primarily affect containers that (1) contain liquid agricultural pesticides of lower
toxicity (e.g., most herbicides, and certain fungicides and insecticides that are not considered
DOT hazardous materials) that are not DOT HMR flammable or corrosive materials, (2) are of
sizes 60 to 660 gallons, and (3) are used in the agricultural market. Thus, based on this
combination of requirements, recommendations, and voluntary standards, those containers that
are currently not subject to marking, construction, or performance standards include:
•
•
•
•
Containers of 60 gallons or less, holding liquid pesticides that are used in the agricultural
market and are not DOT hazardous materials;
Containers holding dry pesticides that are used in the agricultural market and are not DOT
hazardous materials;
Containers of any size holding liquid and dry pesticides that are used in non-agricultural
markets and are not DOT hazardous materials; and
Bulk containers containing any pesticides that are not transported. (Some states have
standards for stationary bulk containers.)
These containers are subject to the full effects of the final container regulations in that they are
effectively starting from a “no standards” baseline and will become subject to the full
requirements of the regulations.
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Table F-2. Scope of Container Regulations Versus Scope of Other National Regulations and Standards
Container Regulations
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
UN Recommendations on the
Transport of Dangerous Goods
MACA-75
Manufacturer
Specification and User
Guidelines
Pesticides
Affected
Other than manufacturing use
products (MUPs), plant-incorporated
protectants, and exempt antimicrobial
products, all pesticide products are
subject to the non-refillable container
regulations. A product is subject to
all non-refillable container
requirements if it satisfies at least one
of the following criteria:
(1) It meets the criteria of Toxicity
Category I.
(2) It meets the criteria of Toxicity
Category II.
(3) It is a restricted use product.
Pesticides that meet the definition of a
hazardous material in 49 CFR §171.8
If it doesn’t meet any of these criteria,
the product is subject to only the basic
DOT requirements in the nonrefillable container regulations.
Other than MUPs, plant-incorporated
protectants, and exempt antimicrobial
products, all pesticide products are
subject to all of the refillable
container and repackaging
regulations.
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Those meeting UN risk class
Agricultural pesticides,
definitions 1–9 (i.e., most in
with exceptions (see
class 6, Division 6.1 Toxic
below).
Substances). Includes pesticides
with oral LD50 <500 mg/kg for
liquids and 200 mg/kg for solids.
DOT Packing Group I and II
pesticides are primarily included.
Some pesticides may also meet
criteria of flammable or
corrosive material.
Table F-2 (Continued). Scope of Container Regulations Versus Scope of Other National Regulations and Standards
Container Regulations
Unaffected
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Pesticides that do not meet the hazardous
The following three categories of
material definition in 49 CFR §171.8.
pesticide products are not subject to
the non-refillable container, refillable
container, and repackaging
regulations:
(1) Manufacturing use products;
(2) Plant-incorporated protectants; and
(3) Antimicrobial pesticide products
that satisfy all four of these criteria:
• The product is an antimicrobial
pesticide, as defined in the
container regulations Section
2(mm), or it has antimicrobial
properties, as defined in the
container regulations Section
2(mm)(1)(A), and is subject to a
tolerance or a food additive
regulation.
• Its label includes directions for
use on a site in at least one of the
10 antimicrobial product use
categories identified as
“household, industrial or
institutional.”
• It is not a hazardous waste when
it is intended to be disposed, as
defined in 40 CFR Part 261.
• It is not specifically included in
the regulations by EPA.
Container Type/Size
Refillable
All containers filled and refilled with
eligible product more than once.
No distinction between refillable and nonrefillable containers with regard to specific
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UN Recommendations on the
Transport of Dangerous Goods
MACA-75
Manufacturer
Specification and User
Guidelines
Those pesticides that do not meet Liquid pesticides and
UN risk class definitions 1-9.
other agrichemicals
subject to DOT
specification packaging.
No distinction between refillable
and non-refillable containers
No distinction between
refillable and non-
Table F-2 (Continued). Scope of Container Regulations Versus Scope of Other National Regulations and Standards
Container Regulations
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
UN Recommendations on the
Transport of Dangerous Goods
MACA-75
Manufacturer
Specification and User
Guidelines
NonRefillable
Containers that are designed and
constructed for one-time filling only
with eligible pesticide.
requirements; however, DOT refers to “reuse” with regard to specific
of containers.
requirements.
refillable containers with
regard to specific
requirements.
Non-Bulk
No regulatory distinction between
non-bulk and bulk with regard to
requirements.
Packaging that has: (1) a maximum capacity
of 450 L (119 gallons) or less as a receptacle
for a liquid; (2) a maximum net mass of 400
kg (882 pounds) or less and a maximum
capacity of 450 L (119 gallons) or less as a
receptacle for a solid; or (3) a water capacity
of 454 kg (1,000 pounds) or less as a
receptacle for a gas as defined in §173.115.
(§171.8)
Net mass ≤400 kg
Capacity ≤450 L
(6.1.1.1)
Does not specify.
Bulk
No regulatory distinction between
non-bulk and bulk with regard to
requirements.
Bulk packaging means a packaging, other
than a vessel or a barge, including a transport
vehicle or freight container, in which
hazardous materials are loaded with no
intermediate form of containment and which
has:
(1) A maximum capacity greater than 450 L
(119 gallons) as a receptacle for a liquid;
(2) A maximum net mass greater than 400 kg
(882 pounds) and a maximum capacity greater
than 450 L (119 gallons) as a receptacle for a
solid; or
(3) A water capacity greater than 454 kg
(1,000 pounds) as a receptacle for a gas as
defined in §173.115.
(§171.8)
IBC defined as rigid or flexible
portable packagings other than
those specified in Division 6.1
that (A) have a capacity of:
(i) Not more than 3,000 L for
solids and liquids of Packing
Groups (PG) II and II;
(ii) Not more than 1.5 m3 for
solids of PG I when packed in
flexible, rigid plastics,
composite, fiberboard, and
wooden IBCs;
(iii) Not more than 3.0 m3 for
solids of PG I when packed in
metal IBCs; and
(iv) Not more than 3.0 m3 for
radioactive material of Class 7.
(1.2.1)
60–660 gallons
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F.5
Detailed Comparison of the Pesticide Container Regulations and the Three Major
Regulations/Standards
The container regulations under consideration include several components. This section details
13 major components of the container regulations and compares them to the relevant
requirements of the DOT HMR, UN recommendations, and MACA-75 specifications. Each
component is discussed separately below.
F.5.1 Design Standards
The container regulations adopt the DOT HMR packaging standards for pesticides classified as
DOT hazardous materials. Pesticides that are not classified as DOT hazardous materials are
required to be packaged in accordance with the specified design and construction standards that
would apply to a DOT Packing Group III material. Under the container regulations, sale or
distribution of pesticides in containers not meeting the DOT standards for design, construction,
and markings is prohibited, and registrants are held responsible for, but are not required to report,
the design standards.
The container regulations incorporate a provision similar to the DOT limited quantity exceptions
that provide exceptions parallel to those in the DOT HMR. The integrity use and compatibility
standards of the DOT HMR are incorporated into the container regulations with the exception of
additional requirements in the container regulations for bulk refillable containers for
appurtenances and listing of compatible containers for pesticide formulations.
The UN recommendations and the MACA-75 specifications are much more specific. The UN
recommendations contain detailed construction requirements by container/material grouping.
These requirements address which construction materials can be used; the design of openings
and closures; seams; and, in some cases, minimum allowable material thickness. MACA-75
specifications are somewhat more general, but the requirements are more detailed than the
container regulations and address minimum strength, handling characteristics, and
draining/cleaning capability.
F.5.2 Permanent Markings
All of the current regulations/standards examined require some form of permanent marking on
each container; however, each regulation/standard varies somewhat in the information required.
The container regulation requirements for non-refillables and refillables refer to and adopt the
DOT standards. Additionally, container regulations require a serial number or other identifying
code for each non-refillable container.
The information requirements that are common between the refillable container requirements
and the regulatory/standards baseline are: manufacturer name or symbol, year of manufacture,
and name or symbol (code) of materials the container is made from. The UN IBC
recommendation calls for a marking that signifies conformity to design type. Serial number and
capacity rating are required only under the EPA requirements and MACA-75 specifications.
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F.5.3 Dispensing Capability
The container regulations stipulate that containers with a capacity greater than 20 liters (5.3
gallons) need to be designed to eliminate the splash and leakage during normal pouring of the
contents, closing or resealing of the container, and storage and cleaning of the container.
The other three regulations/recommendations primarily mention dispensing capability in terms of
cleaning and storing. MACA-75 recommends that tanks be designed so that, when necessary,
they can be totally drained.
F.5.4 Closures
Safe use of pesticide containers extends to closed systems (also known as closed transfer
systems). All four nationwide standards are similar in that they each discuss regulations/
recommendations for proper container closures. Each standard specifies in some fashion that
containers must be equipped with closures that will be secure and leakproof. However, EPA’s
regulations are the most specific about specific closure sizes (see Table F-3 for more details).
F.5.5 Residue Removal Design Standard
Only the MACA-75 guidelines specify a standard for residue removal for non-refillable
containers. The MACA-75 standard applies to bulk tanks and states that containers should be
designed to allow the product to completely drain out of the tank. With regard to non-refillable
containers, the container requirements specify that each rigid/dilutable container/formulation
combination must achieve a certain laboratory performance standard (a reduction of the original
active ingredient concentrate to .01 percent in a fourth rinse or equivalent to 99.99 percent
removal). This specification, of course, does not guarantee that these containers will be rinsed to
this level by the end user in the field before container disposal.
While the UN recommendations, the DOT HMR, and the MACA-75 specifications all address
residue removal from refillable containers, the container regulations are the most specific
regarding how much must be removed and how it should be removed. The UN
recommendations state only that the container should be “purged” of its former contents before
refilling; no procedures are specified. The DOT HMR state that before the container is refilled,
it must “be free from incompatible residue.” The MACA-75 specifications recommend that each
portable tank be kept in dedicated service to one product “in order to reduce contamination and
content-disposal problems.” If the container must be used for another product, the container
must be examined “to determine presence of previous product and then “all of the residue from
the former loading” must be cleaned out.
The container regulations require that the every registrant test three containers from each rigid
container/dilutable formulation combination to determine that the containers are capable of
attaining at least 99.99 percent removal of each active ingredient in the fourth rinsate after a
triple rinse.
F.5.6 Production Testing
The container regulations do not specify production testing requirements. However, by adopting
DOT HMR design standards, the container regulations indirectly include production testing for
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performance of drop, leakproofness, hydrostatic pressure, stacking, and cooperative tests (as
applicable) for each new or different packaging.
For non-bulk containers, DOT HMR (or the container regulations) and UN recommendations
require sampling of 3–6 containers, whereas the MACA-75 guidelines do not specify. For bulk
containers, the container and DOT regulations require representative samples of all design types,
while the UN recommendations and MACA-75 specifications suggest using one container. The
DOT HMR (or container regulations) filling requirements are the same as the UN
recommendations and similar to the MACA-75 specifications. Drop testing requirements for
DOT (or container regulations) are similar to the UN recommendations, while the MACA-75
specifications only state that the standard is two feet.
F.5.7 Production Retesting
Rather than directly specifying, the container regulations adopt DOT HMR standards for an
interval for repeating production testing. The product retesting intervals for DOT HMR bulk is
every year, but varies according to the container specifications. For example, each IBC must be
tested in accordance to the leakproofness test and visually inspected every 2.5 years. Under the
UN recommendations, retesting of a particular container design must be conducted at intervals
established by a “competent authority.” The MACA-75 specifications do not address product
retesting for the container design.
The non-bulk DOT HMR is the only set of requirements requiring a leakproofness test before
reuse of each container. The MACA-75 specifications and the UN recommendations specify
rerunning a leakproofness test on tanks at least every 2 years and 2.5 years, respectively. The
DOT HMR specifications for non-bulks require that each tank must be fully retested every 2
years.
F.5.8 Reconditioning
Only the UN recommendations and the DOT HMR have specific reconditioning standards.
Under the UN recommendations, containers (including non-bulks) must be capable of passing all
appropriate performance tests, and each one must undergo the leakproofness test before it can be
reused for transport. The DOT HMR contain specific requirements for reconditioning metal
drums and require that all other reconditioned containers be capable of meeting all non-bulk
performance standards. A reconditioned container must have a permanent mark representing a
certification that the reconditioned container conforms to the DOT HMR standards for that
container design.
F.5.9 Waiver
None of the nationwide standards except the container regulations specify a procedure for
obtaining a waiver for all or parts of the regulation or standard. The container regulations
include procedures for allowing a waiver of compliance for portions of the regulation based on
the registrant’s capacity to demonstrate that the container meets or exceeds DOT standards for
hazardous materials.
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F.5.10 Recordkeeping
EPA container records requirements are more extensive than those of the baseline. The
regulations require several types of recordkeeping. The first addresses the documentation that
the container used meets each aspect of the non-refillable container design standards. For nonrefillables, the period extends for as long as the container design type is used with the registered
pesticide product, plus 3 years. The second type of recordkeeping requirement involves records
kept by the registrants regarding repackaging. The registrants are required to keep copies of the
contracts or authorizations, residue removal procedures for refilling, and list of acceptable
containers for the current operating year and for 3 years after.
The third type of recordkeeping involves refillers keeping copies of the documents identified in
the previous paragraph for the registrants for the current operating year and for 3 years after (as
with the registrant recordkeeping). The fourth type of recordkeeping involves information the
refillers have to record when they repackage and when they receive refillable containers.
Refillers must record three pieces of information when a pesticide is repackaged. No
recordkeeping is required when a refillable container is received. These records must be kept for
3 years.
The UN recommendations, the DOT HMR, and the MACA-75 specifications have no
requirements analogous to the second type of recordkeeping. Relative to the first type, however,
the UN recommendations for IBCs do include recordkeeping provisions but only to the extent
that a report should be kept of each inspection. This report should be retained at least until the
date of the next inspection. Testing records also are recommended. The MACA-75 standards
are similar, stipulating written records of the annual inspections. The results of the 2-year test
for leakproofness must also be kept by tank serial number. The DOT HMR currently require
records only for non-bulk packaging. These records are limited to information regarding the
design qualification testing, including documenting the types of tests conducted; dates; locations;
packaging specifications; test specifics (e.g., drop heights, hydrostatic pressures); results; and
test operators’ names or name of the person responsible for testing each packaging at each
location where that packaging was manufactured; and at each location where design qualification
tests are conducted. This information must be retained for as long as the packaging is produced
and for at least 2 years thereafter. Similar information must be kept for periodic retesting. This
information must be kept until such tests are performed successfully again and for at least 2 years
from the date of each test.
F.5.11 Refilling
The container regulations contain a great amount of detail regarding refilling, including specific
guidelines for registrants and refillers. For example, registrants who directly sell or distribute
pesticide products in refillables or sell or distribute pesticide products to refillers for repackaging
are held responsible for providing instructions and documentation for refilling. Refillers who
package or repackage pesticide products into refillable containers for distribution or sale must
comply with the residue removal procedure for refilling developed by registrants and repackage
any quantity of a pesticide product into a refillable container up to the rated capacity of the
container. In addition, refillers must inspect the exterior and interiors of the containers to ensure
that the container meets the necessary criteria with respect to container integrity, required
markings, and openings; and clean each refillable container according to the pesticide product’s
Page 239
residue removal procedure for refilling before repackaging the product, unless certain criteria are
met.
With regard to refilling, the UN and DOT regulations are much less detailed than the container
regulations. They both specify that each package must be inspected before reuse. The MACA-75
specifications also refer to refilling recommendations only in terms of inspection. They
recommend that fillers examine the tank to determine the presence of any residue of the previous
product to prevent contamination and clean out residue of the former lading if the tank must be
refilled with another product.
An inspection prior to refilling is required under the container regulations and under each of the
regulations/standards included in the baseline. The container regulations and the MACA-75
standards are the most detailed with regard to how the inspection should be conducted. The
MACA-75 standards also specify a thorough exterior/interior inspection annually (or at the
beginning of each use season), and on a 2-year basis, an inspection that includes retesting for
leakproofness. The UN recommendations for non-bulk containers include inspection before each
filling, and, for certain container types, (e.g., rigid metal and plastic containers) inspections every
2.5 years to the “satisfaction of the competent authority” with regard to external conditions of the
container and proper functioning of service equipment. Every 5 years, these containers are also
inspected to the satisfaction of the competent authority, to determine:
•
•
•
Conformance to design type, including marking;
Internal and external conditions, and
Proper functioning of service equipment.
DOT standards (both the specifications and non-bulk packaging) indicate that on inspection the
container must not show a reduction in integrity (non-bulks) and must be “free from
incompatible residues, rupture or other damage which reduces its [the container’s] structural
integrity.” The container regulations require a tamper-evident device for containers holding
liquids, and the MACA-75 standards specify an anti-backfilling device for such containers.
These devices must be checked before each refilling.
F.5.12 Labeling
Labeling requirements were originally considered under the proposed container and containment
regulations in the 1994 proposed container rule. In this section, labeling requirements are
compared with existing standards as referenced in the 1994 Proposed Rule.
The Proposed Rule adopted PR Notice 83-3 recommendations (EPA, 1983), which provided the
pesticide user certain statements and instructions on the container label for pesticide and
container storage and removal. Additionally, container regulations require container labels to
include the product’s intended use and registration number and container type information.
The DOT HMR require containers to be labeled with general specifications pertaining to the
nature of the hazard of the product. UN recommendations also requires a statement on the label
regarding the primary and secondary risks of the product. The DOT HMR or UN
recommendations do not contain labeling specifications for product or container storage and
Page 240
disposal nor a unique identifier to track the product. MACA-75 specifications do not include
labeling.
Table F-3 presents a side-by-side comparison of the 13 requirement categories and subcategories
between the container regulations and the three major regulations/standards.
Page 241
Table F-3. Comparison of Container Regulations with Other National Regulations and Standards
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Container Requirements
UN Recommendations on the Transport of
Dangerous Goods
MACA-75
Manufacturer
Specification and
User Guidelines
Refillable
Requirement
Design
Standards
Requirements
Non-Refillable
Prohibit
distribution or
sale of pesticide
product in nonrefillable
container unless
the container met
standard.
(§165.42)
Minibulk
Bulk
Prohibit distribution or sale of pesticide
product in refillable container unless
container met standard.
(§165.92)
Container must meet DOT standards
for design, construction, and markings
in accordance with Packing Group III
material as defined by DOT.
(§§165.60–165.64)
Bulk and IBC
Non-Bulk
Specific construction requirements for the 20
packaging types, including seams, opening/closing
sizes and types, compatibility of container and
materials, construction materials (§§173 (e.g.,
173.24) 178, 180)
Container must
meet DOT
standards for
design,
construction, and
markings in
accordance with
Packing Group
III material as
defined by DOT.
(§§165.60–
165.64)
Page 242
Non-Bulk
IBC
Bulk
Specific construction
standards by container
type (e.g., steel drums,
plastic drums, and
jerricans), including:
opening size, seams,
construction materials,
etc.
(6.1.4)
(1) Resistant to or
protected from
deterioration.
(2) Constructed so that
contents can’t escape
under normal conditions.
(3) Gaskets made of
materials not subject to
attack by the contents of
the IBCs.
(4) All service equip.
positioned or protected to
minimize risk of escape
or contents owing to
damage.
(5) Designed to withstand
internal pressure of
contents and stresses of
normal handling and
transport.
(6) Specific construction
requirements by
container type.
(7) Each IBC capable of
passing relevant
performance tests.
(6.5.1.5)
Examples:
(1) Construction
materials (1.2.1)
(2) Minimum strength
requirements (1.3.1)
(3) Inspection
openings (1.3.2)
(4) Fork-liftable
(1.3.3)
(5) Fastening/blocking
for transport (1.3.4)
(6) Pressure release
valve (1.4.4)
(7) Seal to verify
tank/content integrity
(1.4.5)
(8) Appurtenance
protection (1.4.3)
(9) Draining/cleaning
capability
(1.3.6)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Reporting
No reporting
under these
regulations.
Refer to
standards under
the container
regulations
6(a)(2) to
determine if
incidents
involving
containers are
reportable to
EPA. (§165.80)
No reporting under these regulations.
Refer to standards under the container
regulations 6(a)(2) to determine if
incidents involving containers are
reportable to EPA. (§165.130)
Each carrier that transports hazardous materials shall
report in writing to DOT when there has been an
unintentional release of hazardous materials or any
quantity of hazardous materials has been discharged
during transportation. (§171.16)
None.
A report of each
inspection of conformity
to design type kept until
date of next inspection.
(6.5.1.6.4(b))
Not specified.
Responsibility
Registrants.
(§165.42)
Registrants. (§165.92)
Manufacturer or any person who performs a function
prescribed in this part shall perform that function in
accordance with this part.
§178.2(a)(2)
Not specified.
Not specified.
Not specified.
Integrity - Use
Not specified.
Not specified.
Each package used for
the shipment of
hazardous materials shall
be designed, constructed,
maintained, filled, its
contents so limited, and
closed, so that under
conditions normally
incident to transportation:
(1) Except as otherwise
provided, there will be no
identifiable (without the
use of instruments)
release of hazardous
materials to the
environment;
(2) The effectiveness of
the package will not be
substantially reduced; for
example, impact
resistance, strength,
packaging compatibility,
Specific requirements
according to
packaging type
relating to
containers designed so
that they remain
secure and leakproof
under normal
conditions of
transport. (6.1.4)
Resistant to and protected
from deterioration from
external environment.
(6.5.1.5.1)
Minimum strength
requirements and
handling requirements.
(1.3)
Each liquid and dry
bulk container and
its appurtenances
must meet the
following
standards:
(1) Be resistant to
extreme changes in
temperature and
constructed of
materials
adequately thick to
not fail and be
resistant to
corrosion, puncture,
or cracking; and
(2) Capable of
withstanding all
operating stresses.
(§165.120(a))
Each package used for
the shipment of
hazardous materials shall
be designed, constructed,
maintained, filled, its
contents so limited, and
closed, so that under
conditions normally
incident to
transportation(1) Except as otherwise
provided, there will be no
identifiable (without the
use of instruments)
release of hazardous
materials to the
environment;
(2) The effectiveness of
the package will not be
substantially reduced; for
example, impact
resistance, strength,
Page 243
None of the contents can
escape under normal
conditions of transport.
(6.5.1.6.2, 6.5.1.5.6)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
etc. must be maintained
for the minimum and
maximum temperatures
encountered during
transportation;
(3) There will be no
mixture of gases or
vapors in the package
which could, through any
credible spontaneous
increase of heat or
pressure, significantly
reduce the effectiveness
of the packaging.
(§173.24(b))
(4) Additional integrity
requirements for
Intermediate Bulk
Containers (§178.704)
packaging compatibility,
etc. must be maintained
for the minimum and
maximum temperatures
encountered during
transportation;
(3) There will be no
mixture of gases or
vapors in the package
which could, through any
credible spontaneous
increase of heat or
pressure, significantly
reduce the effectiveness
of the packaging.
(§173.24(b))
Page 244
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Integrity Compatibility
Non-Refillable
Not specified.
Refillable
Registrants develop a description of
acceptable containers, which are those
that meet the standards in Subpart D
and are compatible with the pesticide
formulation. (§§165.164(b) and
165.190(b))
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
(1) Even though certain packages are specified in this Construction should
part, it is, nevertheless, the responsibility of the
be appropriate to its
person offering a hazardous material for
intended use (6.1.4)
transportation to ensure that such packages are
compatible with their lading. This particularly applies
to corrosivity, permeability, softening, premature
aging and embrittlement.
(2) Packaging materials and contents must be such
that there will be no significant chemical or galvanic
reaction between the materials and contents of the
package.
(3) Plastic packages and receptacles must be of a type
compatible with the lading and may not be permeable
to an extent that a hazardous condition is likely to
occur during transportation, handling or refilling.
Each plastic packaging or receptacle which is used
for liquid hazardous materials must be capable of
withstanding without failure the procedure specified
in appendix B of this part
Alternative procedures or rates of permeation are
permitted if they yield a level of safety equivalent to
or greater than that provided by paragraph
§173.24(e)(3)(ii) of this section and are specifically
approved by the Associate Administrator for
Hazardous Materials Safety.
(4) Mixed contents. Hazardous materials may not be
packed or mixed together in the same outer
packaging with other hazardous or non-hazardous
materials if such materials are capable of reacting
dangerously with each other and causing combustion
or dangerous evolution of heat;
evolution of flammable, poisonous, or asphyxiant
gases; or
formation of unstable or corrosive materials.
(5) Packagings used for solids, which may become
liquid at temperatures likely to be encountered during
transportation, must be capable of containing the
hazardous material in the liquid state. §173.24(e)
Page 245
MACA-75
Manufacturer
Specification and
User Guidelines
IBC
Bulk
IBCs and closures
constructed with
materials compatible
with their contents so not
liable
(1) to be attacked by
contents so as to make
their use dangerous or
(2) cause contents to
react or decompose, or
form harmful or
dangerous compounds
with IBCs (6.5.1.5.3)
Each tank must be
made of materials
having performance
characteristics suitable
to their application
(1.2.1)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Permanent
Markings
Non-Refillable
Not specified.
Refillable
Serial number or other identifying code
for each container (§165.116)
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
Each packaging represented as manufactured to a
DOT specification or a UN standard must be marked
on a non-removable component of the packaging
with specification markings conforming to the
applicable specification, and with the following:
(1) In an unobstructed area, with letters, and
numerals identifying the standards or specification
(e.g., UN 1A1, DOT 4B240ET, etc.).
(2) Unless otherwise specified in this part, with the
name and address or symbol of the packaging
manufacturer or, where specifically authorized, the
symbol of the approval agency certifying compliance
with a UN standard. Symbols, if used, must be
registered with the Associate Administrator for
Hazardous Materials Safety. Duplicate symbols are
not authorized.
(3) The markings must be stamped, embossed,
burned, printed or otherwise marked on the
packaging to provide adequate accessibility,
permanency, contrast, and legibility so as to be
readily apparent and understood.
Page 246
UN Recommendations on the Transport of
Dangerous Goods
MACA-75
Manufacturer
Specification and
User Guidelines
Non-Bulk
IBC
Bulk
(1) UN packaging
symbol
(2) Code designating
type of packaging
(3) Letter of
designation
(4) Relative density
for which the design
type has been tested.
(5) Either letter “S”
denoting that
packaging intended for
transport of solids or
inner packagings or
for packagings
intended to contain
liquids, hydraulic test
pressure which
packaging has shown
to withstand
(6) Last 2 digits of the
year which packaging
was manufactured.
(7) State authorizing
allocation of the mark
(8) Name of
manufacturer or other
ID of packaging
(9) Specific marking
according to
packaging type
(10) Reconditioning
markings
(6.1.3.1)
(1) UN packaging
symbol.
(2) Code designating
type of IBC
(3) Letter designating the
packing groups for which
the design type has been
approved.
(4) Month and year of
manufacture
(5) State authorizing
allocation of the mark.
(6) Name or symbol of
manufacturer and other
ID of the IBC as
specified by competent
authority
(7) Stacking test load
(8) Maximum
permissible gross mass.
(9) Conformity to design
type
(10) Additional markings
for certain categories of
IBCs (6.5.2.1)
(1) Tank manufacturer
(2) SpecificationMACA 75
(3) Material of
construction
(4) Design pressure
(5) Test pressure
(6) Rated gross weight
(7) Volumetric
capacity
(8) Serial number
(9) Tare weight
(10) Production date
(11) Other
specifications
according to tank type
(2.1.1)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
(4) Unless otherwise specified, letters and numerals
must be at least 12.0 mm (0.47 inches) in height
except that for packagings of less than or equal to 30
L (7.9 gallons) capacity for liquids or 30 kg (66
pounds) capacity for solids the height must be at least
6.0 mm (0.2 inches). For packagings having a
capacity of 5 L (1 gallon) or 5 kg (11 pounds) or less,
letters and numerals must be of an appropriate size.
(5) For packages with a gross mass of more than 30
kg (66 pounds), the markings or a duplicate thereof
must appear on the top or on a side of the packaging.
(6) A UN standard packaging marking or multiple
markings are permitted provided container meets all
applicable standards.
(7) Authorized exemptions allowed.
(§178.3, §178.503(a), §178.703)
Dispensing
Capability
If container has
capacity of 30 L
or less & if
container holds a
liquid pesticide,
container must:
(1) Allow
contents of nonrefillable
container to pour
out in a
continuous,
coherent stream
(2) Minimize
dripping
(§165.68)
Not specified.
Not specified.
Closures on packagings
Must be leakproof (6.1.4) No contents should escape under normal
shall be so designed and
conditions (6.5.1.5.2)
closed that under
conditions normally
incident to transportation:
(1) Except as provided in
paragraph (g) of this
section, there is no
identifiable release of
hazardous materials to
the environment from the
opening to which the
closure is applied; and
(2) The closure is secure
and leakproof.
(§173.24(f))
Page 247
Each tank must be
designed so that, when
necessary, it may be
totally drained (1.3.6)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Closures
Non-Refillable
Four closure
sizes are
specified for
containers that
meet all of these
criteria: (1) rigid
container; (2)
capacity greater
than or equal to
3.0 liters (0.79
gal.); (3) holds
liquid
agricultural
pesticide; (4) is
not an aerosol
container; (5) is
not a pressurized
container.
(§165.66) Final
rule should not
overlap with
child-resistant
packaging
requirements.
Refillable
Each opening of
each liquid
minibulk
container must
have a one-way
valve, a tamperevident device,
or both
(§165.118)
(1) Each liquid bulk
container must A)
be equipped with a
vent or other device
designed to relieve
excess pressure,
prevent losses by
evaporation,
exclude
precipitation.
(2) External sight
gauges are
prohibited.
(3) Container
connections except
for vents must be
equipped with a
shutoff valve which
can be locked
closed
(§165.120(b))
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
(1) Closures on
packagings shall be so
designed and closed that
under conditions
(including the effects of
temperature and
vibration) normally
incident to
transportation(i) Except as provided in
paragraph (g) of this
section, there is no
identifiable release of
hazardous materials to
the environment from the
opening to which the
closure is applied; and
(ii) The closure is secure
and leakproof.
(2) Except as otherwise
provided in this
subchapter, a closure
(including gaskets or
other closure
components, if any) used
on a specification
packaging must conform
to all applicable
requirements of the
specification.
(§173.24 (f))
§178.601(g)(5)
Specific construction
standards according to
type. For example,
closure device must be
designed so it remains
secure and leakproof
under normal conditions
of transport (6.1.4)
Page 248
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
Constructed so that none of the contents can
escape under normal conditions (6.5.1.5)
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Closure must protect
against leakage or
accidental opening
that might be caused
by vibration,
corrosion,
temperature, or other
circumstances
normally encountered
during transportation
or sue. The tank
structure may be used
to provide this
protection. (1.4.1)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Residue
For rigid
Removal
Design Standard containers with
dilutable
pesticide,
container must
be capable of
99.99% removal
of each active
ingredient.
Percent removal
represents the
percent of the
original
concentration of
the active
ingredient in the
pesticide product
when compared
to the
concentration of
that active
ingredient in the
fourth rinse
according to a
formula.
(§165.70)
Design Standard
Responsibility
Registrant
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Each tank must be
designed so that, when
necessary, it may be
totally drained and
thoroughly drained out
(1.3.6)
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not specified.
Page 249
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Container Requirements
Requirement
Bulk and IBC
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
Non-Refillable
Refillable
Procedure
Conduct rinsing
(triple and/or
pressure) on the
label if rigid
container &
dilutable
pesticide.
Registrant develops a written residue
removal procedure for each pesticide
product placed in a refillable container
that is adequate to maintain product
integrity. (§§165.164(a) and
165.190(a)) Before refilling, the
refiller (which could be a registrant)
must clean each refillable container by
conducting the pesticide product’s
residue removal procedure for refilling
unless certain conditions are met.
(§165.170 and 165.210) Before
disposal, conduct the rinsing procedure
on the label.
To be considered empty and not subject to DOT
requirements, packaging must be “sufficiently
cleaned to remove any potential hazard.”
(§173.29(b)(2)(ii))
Must be free from incompatible residue for reuse.
(§§173.28(a))
Not specified.
Not specified.
Examine to determine
presence of previous
product. Each portable
agrichemical tank
should be kept in
dedicated service;
however, if tank must
be refilled with
another product, clean
out all residue of the
former lading. (2.1.2)
Procedure
Responsibility
End user
Before refilling: registrant and refiller
(which could be the registrant). Before
disposal: whoever disposes of
container, could be registrant, refiller,
end user, or someone else.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Production
Testing
No
No
No
Yes
Yes
Yes
Yes
Yes
Sampling
No
No
No
IBC-Samples of all
intermediate bulk
container design types
(§178.810(c))
3-6 containers
(§178.602)
3-6 containers
(6.1.5.3.1)
1 container (says the
same or different IBC
may be used for each
drop (6.5.4.9.3))
1 container (1.7.1)
Filling
Requirements
No
No
No
Filled at least: solids95%, liquid-98%
(§178.602, §178.810)
Filled at least: solids95%, liquid-98%
(§178.602)
Filled to at least:
solids-95%; liquid98% (6.1.5.2.1)
Filled to at least: solids95%; liquid-98%
(6.5.4.9.2)
Filled to rated gross
weight but not over
98% of volume
(1.7.1.2)
Page 250
Non-Bulk
MACA-75
Manufacturer
Specification and
User Guidelines
IBC
Bulk
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Drop Test
Non-Refillable
No
Refillable
No
No
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
The drop test must be
conducted for the
qualification of all
packaging design types
and performed
periodically as specified
in §178.601(e)
Drop heights are
determined according to
the packing group,; for
liquids, if the test is
performed with water,
there are specific
requirements (§178.603,
§178.810)
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
Non-Bulk
IBC
The drop test must be
conducted for the
qualification of all
packaging design types
and performed
periodically as specified
in §178.601(e). Drop
heights, measured as the
vertical distance from the
target to the lowest point
on the package, must be
determined as follows:
(1) For solids and liquids,
if the test is performed
with the solid or liquid to
be transported or with a
non-hazardous material
having essentially the
same physical
characteristic, the drop
height must be
determined according to
packing group and (2)
Specific requirements if
for liquids, the test is
performed with water
(§178.603(e)).
If test performed with
materials to be carried
or with another
substance having
essentially same
physical
characteristics, 0.8 m 1.8 m depending on
packing group. Other
heights will apply
based on relative
density (6.1.5.3.4)
Depends on relative
density: (1) 1.8m, 1.2 m,
0.8m if relative density
1.2 or (2) density *
1.5m/d * 1.0m/d * 0.67m
if relative density > 1.2.
(6.5.4.1.3)
Page 251
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
2 ft. (1.7.1.2)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Production
Retesting
Non-Refillable
Not specified,
however DOT
standards are
referred to and
adopted. (49
CFR Parts 178
and 180)
Refillable
Not specified,
however DOT
standards are
referred to and
adopted. (49
CFR Parts 178
and 180)
Not specified,
however DOT
standards are
referred to and
adopted. (49 CFR
Parts 178 and 180)
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
UN Recommendations on the Transport of
Dangerous Goods
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk and IBC
Non-Bulk
Non-Bulk
IBC
Bulk
Manufacturer-periodic
retesting §178.601(e)
-Each IBC intended to
contain liquids or solids
that are loaded or
discharged under
pressure must be tested in
accordance with the
leakproofness test
prescribed in §178.813 of
this subchapter and
visually inspected every
2.5 years, starting from
the date of manufacture
or the date of a repair
(§180.352b)
The performance of the
drop, leakproofness,
hydrostatic pressure, and
stacking tests.
(§178.601(c)(2)) The
packaging manufacturer
shall achieve successful
test results for the
periodic retesting at
intervals established by
the manufacturer of
sufficient frequency to
ensure that each
packaging produced by
the manufacturer is
capable of passing the
design qualification tests.
Changes in retest
frequency are subject to
the approval of the
Associate Administrator
for Hazardous Materials
Safety. For single or
composite packagings,
the periodic retests must
be conducted at least
once every 12 months.
For combination
packagings, the periodic
retests must be conducted
at least once every 24
months. (§178.601(e))
At intervals
established by
competent authority.
(6.1.5.1.3) Retesting
before reuse every 2.5
years (§173.32(e))
At intervals established
by competent authority.
(6.5.4.1.4) All packages
subject to the
leakproofness test with
air prescribed in
§178.604 must be
checked for
leakproofness before
reuse. (§173.28(b)
(2))
Every 2 years perform
leak test immediately
prior to the use season
for the tank. (2.1.4)
At minimum, check at
two year inspection
fill with nonhazardous liquid and
be sure tank does not
leak. (2.1.4)
Page 252
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Container Requirements
Requirement
Reconditioning
Miscellane
Non-Refillable
Refillable
UN Recommendations on the Transport of
Dangerous Goods
Bulk and IBC
Non-Bulk
Non-Bulk
MACA-75
Manufacturer
Specification and
User Guidelines
IBC
Bulk
No. However,
may be
applicable to
drums.
No
No
Packagings and
receptacles used more
than once must be in
such condition, including
closure devices and
cushioning materials, that
they conform in all
respects to the prescribed
requirements of this
subchapter. Before reuse,
each packaging must be
inspected and may not be
reused unless free from
incompatible residue,
rupture, or other damage
which reduces its
structural integrity.
(§173.28)
(1) Reconditioning of
metal drums is: cleaning,
restoring and inspecting.
Packagings that have
visible signs of
deterioration must be
rejected. (§173.28)
(2) Reconditioning of a
non-bulk packaging other
than a metal drum or a
UN 1H1 plastic drum
includes: removal of
former contents,
cleaning, inspecting,
replacing non-integral
parts with new or
refurbished parts, and
restoring to meet
standards. (§173.28)
(3) A person who
reconditions a packaging
must mark and certify the
package before reuse.
(§178.503(c)(d))d (d)
The marking may
different than the original
but must not identify a
greater container
capacity.
(4) Packagings which
have significant defects
which cannot be repaired
may not be reused.
(§173.28c)
(1) Requires
leakproofness test
(4.1.1.12
(2) Must be able to
pass all tests (4.1.1.9)
(1) Requires
leakproofness test
(4.1.1.12)
(2) Must be able to pass
all tests (6.5.1.6.6)
No
---
---
---
---
---
---
---
Additional guidelines
in leakproofness
(1.8.1), hydrostatic
(1.7.2.2), stacking
(1.7.1.5), vibration
(1.7.1.1), base support
(1.7.1.4), and lifting
device (1.7.1.3).
ous
Page 253
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Waiver
Yes. May be
issued by EPA
for the following
reasons: (1) if
registrant
demonstrates
container safety
standard meets
or exceeds DOT
standards for
hazardous
materials; (2)
necessary or
similarly
protective nonstandard closure;
(3) or other
reasons as
necessary.
Waiver must be
obtained in
writing.
(§§165.72,
165.74)
Yes. May be
issued by EPA if
registrant
demonstrates
container safety
standard meets
or exceeds DOT
standards for
hazardous
materials.
Waiver must be
obtained in
writing.
(§§165.122,
165.124)
Not specified.
Certification
Not required
Not required.
Marking on the packaging with appropriate
DOT or UN markings certifies that:
(1) All requirements of the DOT specification
or UN standard are met.
(2) All functioned performed by or on behalf of
the person whose name or symbol appears as
part o f the marking conform to requirements
specified in this part. (§§178.3(a)(2), 178.2(b))
Not specified.
Non-Bulk
Not specified.
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
Not specified.
A transport certificate and mark shall be issued
attesting that container design meets the standards.
(5.4.1.6)
Page 254
MACA-75
Manufacturer
Specification and
User Guidelines
IBC
Bulk
Not applicable.
A certificate and mark
shall be issued attesting
that design type
including its equipment
meets the standards.
(6.5.1.6.3)
No
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Record
keeping
Non-Refillable
Refillable
For each
pesticide
product,
maintain records
for as long as the
non-refillable
container design
type is used to
distribute or sell
the pesticide
product and for 3
years thereafter.
Must keep the
following
records:
1) Name and
EPA registration
number of the
pesticide product
2) Description of
the design type
of the nonrefillable
container in
which pesticide
product is
distributed or
sold
3) copy of the
certification as
described in
§§165.82 and
165.84
4) Record to
document
compliance with
the requirement
for closures in
§165.66
5) Record to
document
compliance with
dispensing
standards in
§165.68.
(§165.86)
Keep a copy of the certification for as
long as a refillable container is used to
distribute the product and for 3 years
after. (§165.136)
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Yes, relative to testing
for IBCs. (§178.801(l))
Non-Bulk
Yes, relative to testing
for refillables.
(§178.601(1))
Page 255
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
Yes, relative to
testing. (6.1.5.8.9)
IBC
Yes, relative to
inspections and tests.
(6.5.4.14.4, 6.5.1.6.5)
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Yes, relative to
maintenance and
inspection. (2.1.5,
2.2.6)
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
Refilling
Transfer
Not Applicable.
Replaces the Bulk Pesticides
Enforcement Policy with §165.182 and
§165.200. Provides that registrants
may allow a refiller to prepackage the
registrant’s pesticide product into any
size refillable container and distribute
or sell under the registrant’s
registration (provided all conditions of
the rule are met). Require registrants to
submit to EPA acknowledgement that
they have entered into a repackaging
agreement with a refiller and they are
responsible for the integrity of the
repackaged product.
Responsibility Registrant that
distributes or
sells products in
refillable
containers
Not applicable.
(1) Product not adulterated or different
from composition described.
(§165.162)
(2) Registrant would be required to
develop written residue removal
procedure for refilling each pesticide
product. (§165.164)
(3) Registrant required to develop a
written list of acceptable containers for
each registered pesticide. (§165.164)
(4) Refiller at establishment must use
approved container(s) (§165.166), have
required documentation (§165.168),
clean and inspect containers before
refilling (§§165.170–165.174), and
appropriately label the containers
(§165.176).
(5) Keep and make available to EPA
records on pesticide products
distributed or sold and information on
container history and use. (§165.178)
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Page 256
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Non-Refillable
Refillable
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Bulk and IBC
Non-Bulk
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
IBC
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Responsibility Registrant that
distributes or
sells products to
refillers for
repackaging
Not applicable.
(1) Repackaging results in no change to
pesticide formulation and occurs at an
EPA approved location. (§165.182)
(2) Registrant must provide refiller
with a written contract/authorization.
(§165.186)
(3) Registrant responsible for product
integrity (§165.188)
(4) Registrant required to provide
refiller with a written residue removal
procedure for refilling each pesticide
product before or at the time of
distribution or sale. (§§165.190,
165.192)
(5) Registrant required to provide
refiller with a written list of acceptable
containers for each registered pesticide.
(§§165.190, 165.192)
(6) Keep and make available to EPA
records on contracts entered into with
refillers, residue removal procedure,
and list of acceptable containers for the
current operating year and 3 years after
that. (§165.194)
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Responsibility Refiller
Not applicable.
(1) Required to possess necessary
written authorizations. (§165.200)
(2) Product not adulterated or different
from composition described.
(§165.204)
(3) Refiller at establishment must use
approved container(s) (§165.206), have
required documentation (§165.208),
clean and inspect containers before
refilling (§§165.210–165.214), and
appropriately label the containers
(§165.216).
(4) Keep and make available to EPA
records on pesticide products
distributed or sold and information on
container history and use. (§165.218)
Not specified.
Not specified.
Not specified.
Not specified.
Not specified.
Page 257
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Inspection
Non-Refillable
Not applicable.
Refillable
Inspection prior to packaging or
refilling (§§165.174 and 165.214)
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
UN Recommendations on the Transport of
Dangerous Goods
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk and IBC
Non-Bulk
Non-Bulk
IBC
Bulk
Before reuse, each
packaging must be
inspected and may not be
reused unless free from
incompatible residue,
rupture, or other damage
which reduces its
structural integrity.
(§173.28,
§178.601(c)(g))
Refillables-inspection
prior to refill. (§173.28,
§180.352) Before reuse,
each packaging must be
inspected and may not be
reused unless free from
incompatible residue,
rupture, or other damage
which reduces its
structural integrity.
(§173.28,
§178.601(c)(g))
Inspection before each
fill (4.1.1.9)
Before each refill.
(4.1.1.9) For some types
of packaging, inspection
by a competent authority
required, thorough every
5 years and less thorough
every 2.5 years.
(6.5.1.6.4)
Before each refill;
annual and 2 yr.
inspections more
thorough. (2.1.1, 2.1.2,
2.1.4) Before loading
a product into any
tank, the filler should
perform the following:
(1) verify for anti
back-filling device or
other filling control
device on the
discharge opening.
(2) Examine the tank
to determine the
presence of any
residue of the previous
product to prevent
contamination. Clean
out reside of the
former lading if tank
must be refilled with
another product.
(3) Examine tank and
support structure for
any significant
structural
damage(2.1.2)
Page 258
Table F-3 (Continued). Comparison of Container Regulations with Other National Regulations and Standards
Container Requirements
Requirement
Labeling
DOT Hazardous Materials Regulations
(49 CFR Parts 100-199)
Non-Refillable
Refillable
Bulk and IBC
(1)Identify
container type +
recycle
statement
(156.140(a))
(2) Residue
removal
statement
(156.144(d))
(1) Reserve space for net weight of
contents (156.10(d)(7))
(2) Reserve space for EPA
establishment number (156.10(f))
(3) Identify container type (156.140(b))
(4) Residue removal statement
Except as specified in
§172.400a, each person
who offers for
transportation or
transports a hazardous
material in any of the
following packages or
containment devices,
shall label the package or
containment device with
labels specified for the
material in §172.101 and
§172.400
Examples:
(1) general label
specifications
(2) codes indicating the
primary hazard of the
material
(3) codes indicating
subsidiary hazards
(4) specific labels
according to
hazard class or division
(§172.101(g), §172.400)
Non-Bulk
Labels of primary and
subsidiary risk (5.2.2.1)
Page 259
UN Recommendations on the Transport of
Dangerous Goods
Non-Bulk
1. Precautionary
markings (1.1.1)
2. Marked in
accordance with
applicable provisions
of the container
regulations (1.2.1)
3. Tanks designed,
constructed, or tested
under these guidelines
aren’t required to be
labeled or marked as
prescribed by DOT
Haz. Mat. Regs unless
they contain DOT
regulated hazardous
materials (1.1.3)
4. Containers over 119
gallons capacity,
containing
combustible liquids,
must be marked and
placarded as required
to DOT HMR (1.1.4)
IBC
Not specified
MACA-75
Manufacturer
Specification and
User Guidelines
Bulk
Not specified
F.6
Existing EPA Policy Applicable to Pesticide Containers
Existing EPA regulations, recommendations, and programs have an effect on the baseline
compliance rate of the container regulations. Three policies that are examined to estimate this
effect are the child-resistant packaging requirements already specified under container
regulations, the Consumer Labeling Initiative, and the Bulk Pesticide Enforcement Policy. It is
important to estimate the impacts of these policies in order to determine the level of adjustments
and changes that the affected market sectors will make to come into compliance under the
container regulations. Each of these current policies affects some but not all of the components
of the container regulations. Below is a summary of each policy and its relevant impacts on the
container regulations. Following the policy summaries, Table F-4 provides a side-by-side
comparison of the relevant components of the container regulations.
F.6.1 Child-Resistant Packaging (40 CFR Part 157)
Subpart B of 40 CFR Part 157 prescribes requirements for child-resistant packaging (CRP) of
pesticide products and devices under authority of the container regulations Sections 25(a)(1) and
25(c)(3). The purpose of this regulation is to protect children and adults from serious injury or
illness resulting from accidental ingestion or contact with pesticides or devices regulated under
the container regulations. The CRP requirements are targeted toward products that meet toxicity
criteria and are intended for residential use. Table F-4 details the toxicity criteria used to
determine eligibility. Pesticides classified for restricted use or that are packaged in large sizes
are exempt.
The CRP standards are set for effectiveness, compatibility, and durability and must be certified
by EPA. Registrants must keep on record a (1) description of the container, (2) copy of the
certification statement, (3) document verifying the package is child-resistant, (4) written
evidence verifying that the container has been tested, and (5) an explanation of why the container
and closure are compatible in cases where the components are purchased separately.
F.6.2 Consumer Labeling Initiative
EPA’s Consumer Labeling Initiative (CLI) is a voluntary, cooperative partnership effort among
federal, state, and local government agencies, the pesticide and cleaner industry, environmental
groups, and other interested groups. CLI was promulgated by a Pesticide Registration (PR)
Notice posted in the Federal Register (EPA,1996). The purpose of CLI is to make labels easier
to read and understand on indoor insecticides, outdoor pesticides, and household hard surface
cleaners (i.e., floor and basin, tub and tile), some of which are registered
antimicrobials/disinfectants.
CLI has undergone two phases. Phase I began in early 1996 and ended on September 30, 1996. It
was comprised of three components: qualitative consumer research, a literature review of
relevant publications and reports of studies available in the public domain or provided by various
stakeholders, and a review of extensive stakeholder comments solicited through the Federal
Register Notice.
Phase II, which began in October 1996, resulted from this first phase of research. Phase II
addressed issues that Phase I did not complete or include, including conducting in-depth
Page 260
quantitative consumer research, finding ways to improve labels by using clearer wording and
storage and disposal information, and identifying other information about ingredients that
consumers want and need on labels. This phase also included the development of a consumer
education campaign.
Pesticide Regulation Notices are issued by EPA’s Office of Pesticide Programs to inform
pesticide registrants and other interested persons about important policies, procedures, and
regulatory decisions. The labeling recommendations of the Phase I and II reports, some of which
have been included in PR Notices, are as follows:
•
•
•
•
•
•
•
•
Include emergency telephone numbers on product labels;
Use common chemical names, not formal chemical names;
Use the heading “Other Ingredients” instead of the little understood term “Inert Ingredients”;
Use the more readily understood heading “First Aid,” instead of “Statement of Practical
Treatment”;
Include simplified, medically correct First Aid Statements;
List only meaningful ingredient identification;
Provide consistent and clear directions for storage and disposal; and
Specify label recommendations according to pesticide type.
The CLI affects a relatively small portion of the pesticides included in the scope of the container
regulations. This class of products includes outdoor pesticides under Toxicity Categories I or II,
which are not exempt as eligible antimicrobials. It appears unlikely that outdoor pesticides in
Toxicity Categories III and IV, which meet container regulations, were intended for use in the
scope of the CLI. The CLI targets the home and garden sector whereas the container regulations
are intended for eligible containers used by all market sectors. Table F-4 below compares the
requirements of the 1994 Proposed Rule regulations for container labeling with the CLI
recommendations.
F.6.3 Bulk Pesticide Enforcement Policy
The Bulk Pesticide Enforcement Policy was published in July 1977 (41 FR 55932). This policy
was developed to define when bulk shipments and transfer practices were allowable without a
separate registration. The commercial transfer of pesticides in bulk can involve changing the
container at various stages of the distribution process; however, “repackaging” (“transferring a
pesticide formulation from one container to another without a change in the composition of the
formulation or the labeling for sale or distribution,” 40 CFR §165.3) is considered “production”
of a pesticide as defined in 40 CFR §167.3. A registration is needed for distribution or sale of a
repackaged product. The Bulk Policy clarifies that a separate registration is not needed, as long
as “the transfer of a registered product in ‘bulk’ involves only the changing of the product
container with no change:
(1) “to the pesticide formulation,
(2) to the product’s accepted labeling [with exceptions regarding information required by the
policy regarding the repackaging establishment and package content], and
(3) to the identity of the party accountable for the product’s integrity.”
Page 261
If the above three conditions are met, the repackaged product is considered to be encompassed
within the terms of the original product registration. The policy details when a new registration
is needed and how to satisfy the third criterion regarding “accountability” for product integrity.
Primarily, this criterion is met if the repackager has written authorization from the registrant
allowing the repackager to repackage the pesticide at a registered establishment and to use the
registrant’s label.
The Bulk Pesticides Enforcement Policy is often referred to as the “55-gallon” policy because it
defines the term “bulk” to mean any volume of pesticide greater than 55 gallons or 100 pounds
held in an individual container. This policy may have discouraged repackaging smaller amounts
(i.e., it placed a lower limit on the quantity of pesticide that could be introduced into refillable
bulk containers and on the capacity of the containers because such quantities could not be
repackaged without a new registration). On March 4, 1991, this policy was amended to allow
the repackaging of any quantity of pesticides into refillable containers, provided that:
(4) “The container is designed and constructed to accommodate the return and refill of greater
than 55 gallons liquid or 100 lb. dry materials; and
(11) Either: (a) the containers are dedicated to and refilled with one specific active ingredient
in a compatible formulation, or (b) the container is thoroughly cleaned according to written
instructions provided by the registrant to the dealer prior to introducing another chemical to
the container in order to avoid cross-contamination; and
(12) All other conditions of the July 11, 1977 policy are met.”
The Bulk Pesticides Enforcement Policy does not include any container construction or
performance standards. With regard to labeling and marking, the policy indicates that the
registrant’s label must be used for the repackaged material, and this label must reflect the
establishment number of the establishment that repackaged the material and the appropriate net
content statement. Permanent marking is not required.
The refillable container requirements do not change the conditions under which repackaging a
pesticide can occur without requiring a new registration. The safeguards specified in the Bulk
Pesticides Enforcement Policy are incorporated into the final container regulations through the
requirements regarding registrant and refilling establishment repackaging responsibilities. The
Bulk Pesticides Enforcement Policy will be rescinded after the container regulations are final.
The final regulations make the following general changes:
(5) Repackaging is allowed for any quantity of pesticide into any size of container, as long as
that container meets the standards for a refillable container, and
(6) Specific labeling, marking, design, and performance standards are established for refillable
containers.
Page 262
Table F-4. Comparison of Container Regulations with Other EPA Policies
Category
Container Regulations
Child-Resistant Packaging
(49 CFR Part 157)
Consumer Labeling
Initiative
(FR 61:12011)
Bulk Pesticide
Enforcement
Policy
(40 CFR Part 167)
Scope
(1) The product is classified in
Toxicity Category I or II, or
(2) The container capacity is
greater than or equal to the
container size criterion of 5 L (1.3
gallons) or 5 kg (11 lbs), or
(3) The product is intended for
outdoor use and the label includes
at least one of the specified
environmental statements (FR
64:203, Table 5)
Exempt: Antimicrobials eligible
for exemption (FR 64:203,
Table 5)
(1) The product has toxicity of: 1.5 g/kg LD50
oral; 2,000 mg/kg LD50 acute dermal; or 2 mg/l
LC50 acute inhalation; or
(2) The product is corrosive to the eye, causes
corneal irritation persisting 21+ days; or
(3) The product is corrosive to the skin or causes
severe skin irritation at 72 hrs; or
(4) EPA determines packaging could significantly
reduce serious hazard or injury. and
(5) Product intended for residential use.
Exempt: Product classified for restricted use or
packaged in large sizes.
(1) Indoor insecticides
(2) Household surface
cleaners
(3) Outdoor pesticides
Some of these pesticides are
registered antimicrobials.
Separate
registration is not
needed to transfer a
registered product
from one container
to another
(repackaging) as
long as the
composition of the
formulation and
labeling for sale or
distribution remains
the same.
Design
Standards
Major component of regulation
developed for refillable and nonrefillable container standards
(refer to Table F-3 above).
(1) Effectiveness: meets specification in 16 CFR
§170.20.
(2) Compatibility: product does not interfere with
the child-resistant packaging or is detrimental to
the integrity of the container.
(3) Durability: child-resistant packaging meets
standards over lifetime of container.
Not applicable.
The container is
designed and
constructed to
accommodate the
return and refill of
>5 gallon liquid or
100 lb of dry
material. (1991
amendment to the
policy)
Certification
Not required.
Child-resistant packaging device must be certified
by EPA along with compatibility with container.
Not applicable.
None.
Record of CRP and container certifications must
be kept while container is in use.
Not applicable.
None.
Recordkeeping Record of container certifications
must be kept while container is in
use.
Page 263
Table F-4 (Continued). Comparison of Container Regulations with Other EPA Policies
Category
Labeling
Container Regulations
Labeling regulations pertain to:
(1) For refillables, reserve space
for net contents and EPA
establishment number.
(2) Residue removal instructions.
(3) Identification of container
types.
Child-Resistant Packaging
(49 CFR Part 157)
Not specified.
Page 264
Consumer Labeling
Initiative
(FR 61:12011)
Voluntary labeling
recommendations pertain to :
(1) Simplifying and
clarifying language,
ingredient listings, and first
aid statements.
(2) Providing useful storage
and disposal information.
Bulk Pesticide
Enforcement
Policy
(40 CFR Part 167)
The original
registered label
must be attached to
the transferred
product. Also it
must reflect the
establishment
number of the
establishment at
which the product
was transferred.
F.7
State Regulations and Standards
State regulations and standards have an important role in managing pesticide containers. Just as
nationwide regulations/standards affect the baseline compliance rate of container regulations,
state-level regulations/standards also have an impact on the baseline compliance rate. States
have developed container-related regulations varying from no or weak standards to stringent
requirements. This suggests that adjustments to the nationwide compliance rate are necessary to
compensate for variability in state-level container regulations.
While a comprehensive state-level container standards analysis is beyond the scope of this
economic analysis, this section will discuss some of the applicable state regulations and
guidelines that focus on container performance standards and the rinsing, disposal, and storage of
pesticide containers. To obtain information on state pesticide regulations, we conducted a survey
of Internet literature for eight states located in different regions of the United States. The main
source of information used for this section was the National Agricultural Safety Database
(NASD) maintained by the Centers for Disease Control and Prevention (CDC). The NASD
includes pesticide container-related articles and brochures contributed by professionals and
organizations from states across the country. Additional information collected and summarized
in this section comes from state agencies responsible for pesticide container standards and
university extension programs providing recommendations.
The results of the eight-state analysis are summarized in the following sections by requirement
category. Following the summaries is Table F-5, which includes state-by-state details of the
rinsing, disposal, and storage guidelines from the eight states evaluated.
F.7.1 Container Design and Performance Standards
States are prohibited from imposing any requirements for pesticide packaging in addition to, or
different from, those required under the container regulations (Section 14(b)). The container
regulations require pesticides that are considered DOT hazardous materials to be packaged in
containers that meet the DOT hazardous materials regulations, which contain performance,
design, and management standards. Most, if not all, states have adopted the DOT HMR in some
form and, in this way, regulate pesticide containers holding DOT hazardous materials. These
requirements must be at least as stringent as the federal requirements.
F.7.2 Refilling Requirements
Some states have adopted bulk pesticide storage regulations that by definition allow repackaging
and transfer into refillable containers with the assurance that certain standards are being met.
Such standards may address, depending on the state, refillable storage containers and
appurtenances, secondary containment, operational area containment (mixing/loading/refilling
activities), security, inspection and maintenance, open burning of agrichemical containers, and
other issues. Iowa and South Dakota have effectively incorporated EPA’s 1977 Bulk Pesticides
Enforcement Policy.
Applicators can purchase small quantities of pesticides in containers that are refilled by the
registrant. Several registrants market pesticides in these small refillable containers (e.g., 15 or 30
gallons) in compliance with both federal and state law. They do this by having the containers
Page 265
returned to them for refilling, rather than to a dealer. Registrants are able to trace and ensure
return of these containers by numbering each one and requiring a deposit.
F.7.3 Transfer of Pesticides Between Containers
California has regulations requiring the use of closed systems when (1) employees handle any
liquid pesticide or liquid mix or dilution of pesticide displaying the signal word “DANGER” on
the label or (2) employees handle any minimal exposure pesticide. California defines a “closed
system” as “a procedure for removing a pesticide from its original container, rinsing the empty
container and transferring the pesticide product and dilutions and rinse solution through
connecting hoses, pipes, and couplings that are sufficiently tight to prevent exposure of any
person to the pesticide or rinse solution” (CalEPA, 1998). Employees must receive training in
the proper use and safety precautions of closed systems. Employees who only handle up to one
gallon of product per day in original containers of up to one gallon in size are exempted from the
closed system requirement.
California has found its closed-system requirement difficult to implement because of the variety
of container sizes, shapes, and materials. Additionally, not all reusable containers are adaptable
to closed systems. The container regulations do not address the use of closed systems for either
the registrant or the refilling establishment, but the requirement for use of standardized closures
for non-refillable containers should encourage and expedite the use of closed systems. EPA’s
final container regulations do not specify that refillable containers must conform to the use of
standardized closures.
F.7.4 Residue Removal Procedures
A number of states have developed residue removal procedures for users. These are sometimes
part of a regulatory requirement or are published as recommendations in Cooperative Extension
circulars or bulletins. The removal procedures vary by state and typically include triple rinsing
and/or pressure rinsing. Table F-5 contains descriptions of the residue removal procedures,
either required or recommended, for those states that have such procedures.
F.7.5 Container Collection and Disposal Procedures
A number of states have instituted some form of pesticide container disposal program. The
primary function of these programs is to provide pesticide users with a secure and
environmentally controlled site for returning empty containers, so that uncontrolled disposal and
dumping of pesticide containers is reduced. These programs also help to ensure that residues
have been properly removed from empty containers. States commonly recommend that rinsed,
empty pesticide containers be disposed of in approved, sanitary landfills. Pesticide container
collection sites and toxic waste cleanup days are also common. South Dakota, for example,
establishes 19 sites across the state during the summer for pesticide container collection. Some
states, including Florida and Nebraska, allow for some pesticide containers to be disposed of by
open burning. Opening burning of pesticide containers is prohibited by state statute in Michigan.
Florida and Nebraska also permit the burial of properly rinsed pesticide containers in open fields,
with regulations that the burial be a minimum of 18 inches deep and in a location where surface
and groundwater will not be polluted. California prohibits the burial of pesticide containers.
Page 266
F.7.6 Pesticide Storage Guidelines
Pesticide storage guidelines are similar from state to state. Generally, states recommend that
pesticides and pesticide containers should be stored in a clean, dry, well-ventilated, insulated,
fireproof structure that can be locked and monitored by responsible personnel. Storage
guidelines commonly specify that only pesticide and pesticide containers should be stored
together to avoid the contamination of other products. Visible signs on all entrance points with
the words “danger,” “warning,” or “keep out” are also recommended. Michigan has special
storage guidelines for bulk pesticides which specify permissible locations of storage facilities
based on distance from water supplies. The Iowa State University Extension is promoting “Zero
Pesticide Storage” to encourage farmers to inventory and properly dispose of all unneeded or
unusable pesticides in 2 to 3 years.
Page 267
Table F-5. Eight-State Analysis of Pesticide Container Guidelines
Rinsing Guidelines
Disposal Guidelines
Storage Guidelines
Source
FLORIDA
Triple-rinse, or jet-rinse, applicable to
metal, glass, and plastic containers, with
the exception of aerosol cans:
1.
Empty container into spray tank
and drain in vertical position for
30 seconds
2.
Add a measured amount of rinse
water (or other dilutant) so
container is 1/5 to 1/4 full
3.
Rinse container thoroughly, pour
into tank, and drain for 30
seconds.
4.
Repeat step three times
5.
Puncture container before final
drain
6.
Crush pesticide container
immediately; sell as scrap for
recycling or bury
7.
Bury triple-rinsed containers a
minimum of 18 inches deep but
well above the ground water table
(never bury in wetlands or
sinkholes).
Florida state law allows for some pesticide containers to be
disposed of by open burning. Strict regulations apply.
Farmers may bury triple-rinsed containers on their own
property. Containers should be buried at least 18 inches
deep but well above the ground water table, and never in
sinkholes and wetlands. Farmers should receive permission
from the landowner before burying containers on rented
property. Non-farmers who bury empty pesticide containers
on the their own property must notify their local Department
of Environmental Regulation of the burial.
Safe storage rules:
NASD:
1.
Keep pesticides and other poisons locked in a
http://www.cdc.gov/nasd/
cabinet, room, or separate building designated
solely for their storage.
2.
Post the cabinet, room, or building with a sign,
“PESTICIDES—POISONS, KEEP OUT,” or
similar signs
3.
Control access to the facility to one to three
highly trusted, responsible individuals
4.
Never store pesticides where food, feed, seed,
fertilizers, or other products may become
contaminated
5.
Only store pesticides in their original containers
6.
Facility shall be reasonably fireproof and wellventilated; temperatures should be kept between
freezing and 100 degrees F
7.
Concrete block walls, sealed concrete floors with
no floor drains, and metal shelves are
recommended over wooden structures
8.
Store dry pesticides on the top shelves, liquids
on the lower shelves
9.
Electrical fixtures should be dust- and explosionproof.
MICHIGAN
Triple-rinse, or pressure-rinse,
applicable to all empty pesticide
containers. After triple-rinsing,
puncture metal and plaster containers.
Metal and plastic containers should be punctured after they
are properly rinsed. Rinsed glass, metal, and plastic
containers may be buried in approved sanitary landfills.
Safe storage rules:
•
Keep a separate structure for pesticide storage
•
Structure should be locked at all times and
protected from temperature extremes, high
Open burning of pesticide containers is prohibited by state
humidity, and direct sunlight
statute.
•
Structure should be dark, cook, dry, wellventilated, insulated to prevent freezing, and
Michigan has had an agricultural plastic pesticide container
constructed to state and local fire codes for
recycling program in operation since 1992. This program
storing flammable/combustible materials
facilitates grinding and recycling of clean, plastic containers. •
Never store pesticides near feed, seed, food, or
fertilizers.
Storage guidelines for bulk pesticides also exist in
Michigan. The guidelines specify permissible
locations of storage facilities, based on distance from
water supplies.
Page 268
NASD:
http://www.cdc.gov/nasd/
Michigan Department of Agriculture:
http://www.michigan.gov/mda
Table F-5 (Continued). Eight-State Analysis of Pesticide Container Guidelines
Rinsing Guidelines
Disposal Guidelines
Storage Guidelines
Source
IOWA
Triple-rinse, or pressure-rinse,
Empty pesticide containers that have been properly rinsed
applicable to all empty pesticide
may be disposed of in approved landfills.
containers:
1.
Fill container about 20 percent full
of water, replace the cap securely,
and shake the container
2.
Pour rinse water into a spray tank
3.
Drain for at least 30 seconds
4.
Repeat two times
5.
Puncture all containers.
The Iowa State University Extension recommends that
pesticide users try to achieve “Zero Pesticide Storage”
in 2 to 3 years. The following initial steps are
suggested:
•
Determine what pesticides are in storage; banned
pesticides such as DDT or Chlordane should be
disposed of by professionals at the next Toxic
Waste Cleanup Day
•
Set aside all pesticides that are no longer wanted
or that are unusable (unusable pesticides may be
ineffective or dangerous to use due to poor
storage conditions); store them properly until the
next Toxic Waste Cleanup Day.
NASD:
http://www.cdc.gov/nasd/
KANSAS
Triple-rinse applicable to all empty
containers of liquid pesticides.
NASD:
http://www.cdc.gov/nasd/
Wash the inside of the tractor with
detergent and water and change the
cab’s filters when finished applying
pesticides.
MARYLAND
Triple-rinse pesticide containers and
return the rinsate to the spray tank.
Puncture thoroughly rinsed pesticide containers so they
cannot be reused.
Pesticides should be stored in their original containers
in a cool, well-ventilated, locked location away from
pumps and water sources.
Pesticides containers may be disposed of in a licensed
sanitary landfill.
Maryland Cooperative Extension:
httphttp://www.pesticide.u
md.edu/Leaflets.html
Leaflet #9 Protecting
Groundwater from
Pesticides
Page 269
Table F-5 (Continued). Eight-State Analysis of Pesticide Container Guidelines
Rinsing Guidelines
Disposal Guidelines
Storage Guidelines
Source
Reduce the amount of pesticides kept in storage at any
one time, storing it no longer than necessary.:
•
Rotate pesticide supply, using the oldest products
first
•
Store pesticides under proper conditions; most
pesticides require storage temperatures between
40 and 100 degrees F under relatively dry
conditions
•
Store in a location away from occupied areas and
on an impermeable floor, such as concrete, to
allow detection and containment of spills.
South Dakota Department of Agriculture:
http://www.state.sd.us/doa/das/pest_was.h
tm
SOUTH DAKOTA
Containers must be either triple-rinsed
or pressure-rinsed prior to recycling or
disposal.
Triple rinse:
•
Remove cover from container;
empty pesticide into the sprayer
tank; let container drip and drain
for an extra 30 seconds once it is
empty
•
Fill the container 1/5 to 1/4 full
with water
•
Secure the cover on the container
•
Remove cover and empty rinsate
into the sprayer tank; let container
drip and drain for an extra 30
seconds
•
Repeat two more times
•
Leave container open to air dry
•
Inspect container for cleanliness –
pay close attention to threads and
the outside of the container (more
rinsing may be necessary).
Pesticide containers are collected at approximately 19 sites
across South Dakota during the summer. Containers are
inspected before acceptance. Acceptable containers are
recycled, while containers with visible residue are rejected.
Applicators with unacceptable containers are asked to
properly clean and return them.
A person shall not construct a bulk pesticide storage facility,
for the storage of more than 300 gallons, without a
secondary means of containment. Plans and specifications
for the facility must be submitted to the Secretary of
Agriculture for review and approval prior to construction.
http://www.state.sd.us/doa/das/pest_sum.h
tm
NEBRASKA
All empty pesticide containers must be
either triple-rinsed or pressure-rinsed.
Triple-rinsing (applicable for plastic,
non-pressurized metal, and glass
containers):
•
Remove cap from container;
empty remaining pesticide into the
spray tank, allowing container to
drain for 30 seconds
•
Fill container 10% to 20% full of
water or rinse solution
•
Secure the pesticide container cap
•
Swirl liquid within the container
to rinse all inside surfaces
•
Remove cap; add rinsate from
container to spray tank and allow
to drain for at least 30 seconds
•
Repeat two more times
•
Replace cap and dispose of
container properly.
Nebraska has community landfills and other sites that accept
empty plastic agricultural pesticide containers that have been
pressure- or triple-rinsed. All containers are thoroughly
inspected before acceptance.
Pesticide containers are divided into three groups:
•
Group I: combustible containers that held all pesticides
except for heavy metals
•
Group II: noncombustible containers (metal, glass, and
plastic) that held all pesticides except for heavy metals
•
Group III: both combustible and noncombustible
containers used for pesticides containing heavy metals.
Storage Area Guidelines:
•
Store pesticides and pesticide containers in a fireresistant structure with a concrete floor and good
ventilation
•
Post weatherproof signs stating “Danger –
Pesticides, Keep Out!” or a similar warning on
each door of the facility and over all windows
•
Use pesticide storage area ONLY for pesticides
•
Good lighting–both natural and artificial–is
necessary in storage area; some liquid pesticides,
for example, are subject to photodecomposition
and therefore should not be stored in direct
Group I containers may be disposed of by:
sunlight
•
Burning in a special high-temperature pesticide
•
Insulate storage areas to avoid temperature
incinerator
extremes
•
Burial in a specially designated disposal landfill
•
An electrically shielded exhaust-type ventilating
•
Burning small quantities (50 pounds or one day’s
fan may be needed in the storage area to reduce
accumulation, whichever is less) if local ordinances
the temperature and concentrations of toxic
permit
fumes
•
Burial singly in open fields at least 18 inches below the •
For storage of large quantities or pesticides, fire
detector sensors and fire-fighting equipment are
surface, but only in locations where surface and
Page 270
NebGuide, Cooperative Extension,
Institute of Agriculture and Natural
Resources, University of Nebraska–
Lincoln
http://www.ianr.unl.edu/pubs/pesticides
Table F-5 (Continued). Eight-State Analysis of Pesticide Container Guidelines
Rinsing Guidelines
Pressure-rinsing (applicable for plastic
and non-pressurized metal containers):
•
Remove cap from container;
empty pesticide into spray tank,
allowing container to drain for 30
seconds
•
Insert pressure-rinser nozzle by
puncturing through the lower side
of the container
•
Hold container upside down over
the spray tank openings
•
Rinsate will run into the spray
tank
•
Rinse for the length of time
recommended by the manufacturer
(at least 30 seconds); rotate the
nozzle to rinse all inside surfaces
•
Rinse caps in a bucket of water for
more than one minute and pour
this rinse water into spray tank
•
Replace cap and dispose of
container properly.
Disposal Guidelines
Storage Guidelines
subsurface water will not be polluted; containers
should not be buried in locations likely to be used as
future building sites or where animals might uncover
them while rooting or digging.
•
Group II containers may be disposed of by:
•
Burial in a sanitary landfill
•
If group II containers are not properly
•
rinsed, they can only be disposed of by burial in a
specially designated landfill.
Group III containers may be disposed of by:
•
Disposal in a sanitary landfill, if the container has been
triple-rinsed and punctured to facilitate draining
•
Any Group III container that is not or cannot be rinsed
must be sealed in a watertight container and buried in a
specially designated hazardous waste landfill.
Page 271
recommended; provide floor plan and records of
the location and nature of pesticides in storage to
the police or county sheriff, fire department, and
public health department
Provide wooden pallets or metal shelves for
storing granular and dry formulations packaged
in sacks, fiber drums, boxes, or other waterpermeable containers.
Source
Table F-5 (Continued). Eight-State Analysis of Pesticide Container Guidelines
Rinsing Guidelines
Disposal Guidelines
Storage Guidelines
Source
Safe storage guidelines:
•
Keep pesticides and empty containers under
direct personal control at all times
•
Acceptable pesticide storage areas include: (1) a
locked, fenced area, (2) a lockable storage
compartment, (3) a locked truck or trailer with
side racks (the tops of the racks should be at least
six feet above the ground)
•
Keep storage areas clean, dry, ventilated, and
adequately lighted
•
Keep pesticides and fertilizers separate in storage
area
•
Post warning signs on all storage areas
containing pesticides (or empty containers) with
the signal words “DANGER” or “WARNING”
on the label; post signs on all directions of
approach, if possible; sign must be readable from
25 feet away.
Worker Health and Safety Branch,
CalEPA, “Pesticide Safety Information
Series A”
http://www.cdpr.ca.gov/docs/whs/pdf/hs1
743.pdf
CALIFORNIA
Each emptied container that held less
than 28 gallons of a liquid pesticide
diluted for use shall be rinsed by the
user at the time of use. There are two
rinsing procedures:
Procedure 1:
•
For containers smaller than 5
gallons, use enough water to fill
the container 1/4 full; for larger
containers, use enough water to
fill it 1/5 full
•
Close the container securely and
agitate
•
Drain the solution into the mix
tank; allow the container to empty
completely
•
Repeat steps a minimum of 2 more
times.
Dispose of all empty pesticide containers in a manner
approved by the CalEPA, Department of Toxic Substances
Control. Glass, plastic, and metal containers should be
disposed of in an approved disposal site. No pesticide
container should be buried.
Disposal requirements may differ by county. In many
counties, people must possess a permit or certificate issued
by the local agricultural commissioner to dispose of rinsed
containers.
Procedure 2:
•
Turn the empty container over and
place the opening over a nozzle;
this nozzle must be located in the
opening of the mix tank so the
liquid will drain into the tank; the
nozzle must be able to rinse all
inner surfaces of the container
•
Turn the nozzle on and rinse until
the water coming from the
container is clear; use a minimum
of ½ the container volume of
water.
Other rinsing methods may be used, if
approved by the Department of
Pesticide Regulation (DPR).
Page 272
Appendix G. Comparison of the Final Container Regulations with the 1994
Proposed Container Regulations
The final container regulations differ significantly from the 1994 proposed regulations. The final
regulations are narrower in scope than the proposed regulations, exempt certain antimicrobial
pesticides, and adopt some of the Department of Transportation (DOT) hazardous materials
regulations. As a result, the economic impacts on the regulated community will be different
under the final regulations than under the proposed regulations.
EPA received approximately 1,900 pages of comments from more than 200 commenters (e.g.,
trade associations, pesticide manufacturers, pesticide retailers, and many state regulatory
agencies) on the proposed rule. In response, two significant issues were readdressed, and the
comment period was reopened in 1999. The two issues were: (1) the scope of the container
standards; and (2) the relationship between the 1994 proposed rule and the DOT standards for
hazardous materials packaging. In the final rule (as discussed below), EPA has revised the scope
of the container standards to be risk-based with exemptions, and has adopted many of the design
and construction standards that would apply to DOT Packing Group III materials. These and
other changes made to each standard are as follows.
The following is a comparison of the proposed and final container requirements under
consideration by EPA for 11 major sections of the container regulations. Each category is
discussed in a separate section below:
G.1 Scope
The proposed regulations generally affected all containers used to package pesticide products,
without regard to industry, use, risk, or container type and size. Only manufacturing use
products were exempt from the proposed regulations.
The final CONTAINER regulations affect a significant number but not all of the total containers
used in the pesticide industry. The scope criteria of the final regulations are based on the
characteristics and/or human risk associated with the pesticide product contained. All
manufacturing use products, all plant-incorporated protectants, and certain antimicrobial
products are not subject to the final regulations. In particular, antimicrobial pesticide products
that satisfy all four of the following criteria are exempt from the regulations:
•
•
•
•
The product is an antimicrobial pesticide, as defined in the container regulations Section
2(mm), or it has antimicrobial properties, as defined in the container regulations Section
2(mm)(1)(A), and is subject to a tolerance or a food additive regulation.
Its label includes directions for use on a site in at least one of the 10 antimicrobial product
use categories identified as “household, industrial or institutional.”
It is not a hazardous waste when it is intended to be disposed, as defined in 40 CFR Part 261.
EPA has not specifically found that the product must be subject to the regulations to prevent
an unreasonable adverse effect on the environment.
As set out in the last bullet, the final regulations include a provision to require a specific
antimicrobial product or group of products to comply with the container regulations if a problem
Page 273
becomes evident. EPA may consider evidence such as use history, accident data, monitoring
data, or other pertinent evidence in deciding whether the product must comply with the container
standards to prevent an unreasonable adverse effect on the environment.
Other than MUPs, plant-incorporated protectants, and exempt antimicrobial products, all
pesticide products are subject to the non-refillable container, refillable container, repackaging
and labeling regulations.
However, the scope of the non-refillable container regulations is different in that only “higherrisk” products are subject to all of the non-refillable container requirements. The “lower-risk”
products are subject only to the basic DOT requirements. In particular:
•
•
A product is subject to all non-refillable container requirements if it is classified in at least
one of the following categories:
- Toxicity Category I
- Toxicity Category II
- Restricted use product.
All other products (those in Toxicity Category III or IV that are not restricted use products)
must comply only with the basic DOT requirements in 49 CFR §173.24.
For the refillable container and repackaging regulations, all products (that are not specifically
exempt) are subject to the full set of requirements. The only exception is that antimicrobial
products used in swimming pools and closely related sites are subject to a reduced number of
requirements.
To estimate the number of containers affected by the container rule, EPA estimated the
percentage of pesticide products in Toxicity Categories I and II, and the percentage of
antimicrobial pesticides. Based on an analysis of information in an Office of Pesticide Programs
database (EPA, 1998a), EPA estimated the percentage of pesticide products in Toxicity Category
I used on agricultural crops and forestry and ornamental turf/plants to be 20 and 10 percent,
respectively. Toxicity Category II pesticide products were estimated to be 15 percent used on
agricultural crops and forestry and ornamental turf/plants. Fifteen percent of all pesticide
products used for agricultural products and forestry and ornamental turf/plants were in Toxicity
Category II.
For comparison purposes, EPA estimated that 70 percent of antimicrobial pesticides eligible for
exemption are classified in Toxicity Category I and 15 percent in Toxicity Category II. The
antimicrobial pesticide exemption applies only to non-agricultural pesticide use. EPA estimated
that an additional 10 to 20 percent of pesticide products above and beyond those affected by the
toxicity criteria would also be affected by the hazard statement scope criteria and an additional
15 to 25 percent affected by the container size criteria. In the end, approximately 50 to 90
percent of pesticide containers were expected to be affected by the scope criteria.
G.2 Design Standards
Design standards were very general in the proposed regulations. The final container standards
adopt a subset of the Department of Transportation Hazardous Materials Regulations (DOT
Page 274
HMR) packaging standards at the Packing Group III level for pesticides not classified as DOT
hazardous materials. Pesticides that are classified as DOT hazardous materials must comply
with all applicable DOT regulations. For the purpose of enforcing the pesticide container
regulations, the final rule identifies the DOT requirements for all three packing groups that are
“equivalent” to the Packing Group III requirements applicable to products that are not DOT
hazardous materials. Under the regulations, sale or distribution of pesticides in containers not
meeting all of the standards (the specifically listed ones in the pesticide regulations and the
adopted DOT packaging standards) is prohibited. Both non-refillable and refillable pesticide
containers must meet these standards.
G.3 Permanent Markings
Proposed container regulations specified permanent marking requirements for non-refillable and
refillable containers. Non-refillables required the EPA registration number and the name,
symbol, or code of materials used to make the container, and refillables required several pieces
of information including the statement, “Meets EPA standards for refillable containers.” The
final regulations for non-refillables and refillables refer to and adopt the DOT standards, which
include marking requirements. Additionally, the final regulations require a serial number or
other identifying code to be durably marked on each refillable container.
G.4 Dispensing Capability
The proposed regulations stipulated that all non-refillable containers for liquids be designed to
eliminate the splash and leakage during normal pouring of the contents, closing or resealing of
the container, and storage and cleaning of the container. The final regulations apply only to
liquid non-refillable containers with a capacity greater than 20 liters (5.3 gallons) and are the
same except the resealing criterion was replaced by a DOT equivalent. No dispensing capability
requirements are specified in either the proposed or final container regulations for refillable
containers.
G.5 Closures
The final requirements for container closures are essentially the same as the proposed closure
standards. Four closures are specified for non-refillable rigid containers having a capacity
greater than 3.0 liters for liquid agricultural pesticides. The proposed and final regulations
should not overlap with the child-resistant packaging requirements. Liquid minibulk refillables
require a one-way valve, tamper-evident device, or both on each opening. Liquid bulk refillable
containers must be equipped with a pressure-relieving device and locking shutoff valve and
cannot have external sight gauges.
G.6 Residue Removal Design Standard
With regard to non-refillable containers, the proposed regulations specified that registrants must
demonstrate that each rigid/dilutable container/formulation combination achieves a “six-9s”
laboratory performance standard (a reduction of the original active ingredient concentrate to
.0001 percent in a fourth rinse or equivalent to 99.9999 percent removal). The final regulations
require only a “four-9s” standard, where rigid containers with dilutable pesticides must be
capable of 99.99 percent removal of each active ingredient. Percent removal represents the
Page 275
percentage of the original concentration of the active ingredient in the pesticide product when
compared to the concentration of that active ingredient in the fourth rinse according to a formula.
The final regulations require that every registrant test three containers from each rigid
container/dilutable formulation combination to determine that the containers are capable of
attaining at least 99.99 percent removal of each active ingredient in the fourth rinsate after a
triple rinse.
The proposed regulations required that a minimum of 19 randomly selected containers be
sampled for residue removal compliance and required the testing to be done according to the full
GLP rule.
Residue removal procedures for the final and proposed regulations are the same, except that
household products are exempt from the residue removal labeling requirements for nonrefillables. For non-refillable, rigid containers with dilutable pesticides, triple and/or pressure
rinsing is required prior to disposal, and the procedure is specified on the pesticide label.
Additionally, for refillables, registrants are required to develop written residue removal
procedures for each pesticide product, and refillers are required to follow the procedures before
each refill.
G.7 Design Qualification Testing92
The proposed regulations specified several container design qualification testing requirements; in
particular, residue removal testing for non-refillable containers and drop testing for refillable
minibulk containers. The final regulations do not specifically require residue removal testing for
non-refillable containers, although in reality the registrants will have to conduct some testing to
be able to show that their containers meet the residue removal standard. The details of the
testing procedure will be included in an OPP testing guideline. The final regulations do not
provide the specific details of a drop test for minibulks as the proposed regulations did. Instead,
the final rule adopts the DOT HMR design standards for non-refillable and refillable containers,
thereby incorporating DOT’s design qualification testing for drop, leakproofness, hydrostatic
pressure, stacking, and cooperative tests (as applicable) for each new or different packaging.
G.8 Production Testing and Periodic Retesting92
The proposed regulations did not address production testing or periodic retesting, whereas the
final regulations require production testing and periodic retesting by adopting DOT HMR
standards. Depending on the kind of container, the DOT HMR specify the retesting intervals
(e.g., every 12 or 24 months for DOT non-bulk packages). In addition, the DOT HMR specify
92
The titles of Sections G.7 and G.8 are consistent with the DOT definitions of design qualification testing, periodic
retesting, and production testing (49 CFR §178.601(c)). For the sake of completeness:
“Design qualification testing is the performance of the drop, leakproofness, hydrostatic pressure, stacking, and
cooperage tests, as applicable, prescribed in sections..., for each new or different packaging, at the start of
production of that packaging.
Periodic retesting is the performance of the drop, leakproofness, hydrostatic pressure, and stacking tests, as
applicable, prescribed in sections..., at the frequency specified in §178.601(e) of this subpart.
Production testing is the performance of the leakproofness test prescribed in §178.604 of this subpart on each
single or composite packaging intended to contain a liquid.”
Page 276
production testing (testing each and every container for compliance with the leakproofness test)
for some types of containers.
G.9 Reconditioning
The proposed regulations did not address reconditioning of containers. The final rule
incorporates DOT requirements (such as 49 CFR §173.28) that allow and account for
reconditioning.
G.10 Waiver
The proposed rule provided for waivers from the standard closure and residue removal standards
for non-refillable containers. The final rule includes provisions for these two waivers, plus
waivers from the container dispensing requirements (for non-refillable containers) and from the
cross-referenced DOT requirements (for non-refillable and refillable containers.)
G.11 Certification
The proposed regulations required registrants to certify that the non-refillable and refillable
containers used for distribution or sale of pesticides meet the regulatory standards. As proposed,
the certification needed to contain information including the EPA registration number and the
name of company official who certified the container. The final rule does not require
certification.
G.12 Recordkeeping
The proposed and final regulations require several types of recordkeeping. The first addresses
the documentation that the container used meets each aspect of the EPA design standards. In the
proposed rule, the records for non-refillable container design specified six pieces of information
and required the records to be kept for as long as the container design type was used with the
registered pesticide product, plus 3 years. The final recordkeeping requirements are similar,
although only five pieces of information must be kept. In the proposed rule, the records for
refillable containers included documentation of compliance with the drop test and a copy of the
certification and needed to be kept for as long as the registrant allowed the container to be used,
plus 3 additional years. The final rule does not include any refillable container design
recordkeeping because the standards for which records were proposed are not being finalized.
The second type of recordkeeping requirement involves records kept by the registrants regarding
repackaging. The proposed rule required registrants to keep copies of the contracts or
authorizations, residue removal procedure for refilling, and list of acceptable containers for as
long as the registrant distributes or sells a product to a refiller and for 3 years thereafter. The
final rule requires registrants to keep the same records, but changes the time period to the current
operating year and for 3 years thereafter.
The third type of recordkeeping requires refillers to keep copies of the documents identified in
the previous paragraph for the registrants. The same documents are specified in both the
proposed and final regulations, although the time period for maintaining the records in the final
rule was changed to the current operating year and for 3 years after (as for the registrant
recordkeeping).
Page 277
The fourth type of recordkeeping involves information that refillers have to record when they
repackage and when they receive refillable containers. The proposed rule required refillers to
record six pieces of information each time a pesticide was repackaged into a refillable container
and four pieces of information each time a refiller received a refillable container. These records
were to be kept for 3 years. The final rule maintains the same time frame, but significantly
decreases the amount of information that refillers must keep. In the final rule, refillers must
record only three pieces of information when a pesticide is repackaged, and no recordkeeping is
required when a refillable container is received.
G.13 Refilling
The proposed and final regulations contain nearly the same requirements for refilling, including
specific guidelines for registrants and refillers. For example, registrants that directly sell or
distribute pesticide products in refillables or sell or distribute pesticide products to refillers for
repackaging are held responsible for providing instructions and documentation for refilling.
Refillers that repackage pesticide products into refillable containers for distribution or sale must
comply with the residue removal procedure for refilling developed by registrants and can
repackage any quantity of a pesticide product into a refillable container up to the rated capacity
of the container. In addition, refillers must inspect the exterior and interiors of the containers to
ensure that the container meets the necessary criteria with respect to container integrity, required
markings, and openings. Refillers must also clean each refillable container according to the
pesticide product’s residue removal procedure for refilling (supplied by the registrant) before
repackaging the product, unless certain criteria are met. Both the proposed and final regulations
set out conditions for allowing registrants and refillers to engage in repackaging. The final rule
has the same general structure of these conditions, although the final rule changes two of the
conditions to: (1) require a contract between the parties (rather than a contract or an authorization
as proposed); and (2) allow repackaging at an end user location under certain circumstances
(rather than requiring the repackaging to be conducted at a registered establishment as proposed).
G.14 Labeling
Labeling requirements under the final regulations are generally more flexible than the proposed
regulations because they provide a range of specific statements. The scope of the labeling
requirement (proposed and final) includes all labels for all pesticide products, not just those that
fall within the container rule scope. However, the final regulations exempt household products
from the residue removal instructions. Labels may include blank areas, which are more
specifically described in the final regulations, to allow a refiller to put any amount of product
into a refillable, designate on the label the amount, and add its EPA establishment number. This
is an option in the final rule, but was required in the proposal. Other information to be included
on the label is a description of the container type (intended purpose, such as a refillable or nonrefillable statement) and detailed residue removal instructions. Changes between the final and
proposed regulations include clarifying that durable permanent marking is acceptable versus
permanent marking, adding alternatives for the recycling and reuse statements for refillables,
exempting household products from including residue removal instructions, and several minor
changes that offer greater flexibility and clarity.
Page 278
Table G-1 presents a side-by-side comparison of the 14 requirement categories and subcategories
between the final and proposed regulations for the three major container types (non-refillable,
refillable minibulk, and refillable bulk). In the table (as in the previous discussion), only
substantial changes in the requirements are mentioned. For the purposes of this analysis,
substantial changes are modifications that would change the costs and/or the assumptions made
in the proposed container rule RIA. All changes, including those made for clarification
purposes, are described in the preamble of the final rule.
Page 279
Table G-1. Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
1. Scope
2. Design Standards
(general)
Non-Refillable
Minibulks
Refillable
Bulks
The following three categories of pesticide products are not subject to the nonrefillable container, refillable container, and repackaging regulations:
(1) Manufacturing use products (MUPs),
(2) Plant-incorporated protectants, and
(3) Antimicrobial pesticide products that satisfy all four of these criteria:
- The product is an antimicrobial pesticide, as defined in the container regulations
Section 2(mm), or it has antimicrobial properties, as defined in the container
regulations Section 2(mm)(1)(A), and is subject to a tolerance or a food additive
regulation.
- Its label includes directions for use on a site in at least one of the 10 antimicrobial
product use categories identified as “household, industrial or institutional.”
- It is not a hazardous waste when it is intended to be disposed, as defined in 40
CFR Part 261.
- EPA has not specifically found that the product must be subject to the regulations
to prevent an unreasonable adverse effect on the environment.
Other than MUPs, plant-incorporated
protectants, and exempt antimicrobial
products, all pesticide products are
subject to the non-refillable container
regulations. A product is subject to all
non-refillable container requirements if
it satisfies at least one of the following
criteria:
(1) It meets the criteria of Toxicity
Category I.
(2) It meets the criteria of Toxicity
Category II.
(3) It is a restricted use product.
If it does not meet any of these criteria,
the product is subject to only the basic
DOT requirements in 49 CFR §173.24.
Other than MUPs, plant-incorporated
protectants, and exempt antimicrobial
products, all pesticide products are
subject to all of the refillable container
and repackaging regulations.
Prohibit distribution or sale of pesticide
product in non-refillable container
unless the container meets the
standards. (§165.42)
Container must meet certain DOT
standards for design, construction, and
markings in accordance with Packing
Group III material as defined by DOT.
(§§165.60–165.64)
Prohibit distribution or sale of pesticide
product in refillable container unless
container meets the standards. (§165.92)
Container must meet certain DOT
standards for design, construction, and
markings in accordance with Packing
Group III material as defined by DOT.
(§§165.110–165.114)
Same general integrity standards for bulk
containers as proposed. (§164.120)
Page 280
Non-Refillable
Minibulks
Bulks
MUPs are exempt. All other pesticide products affected.
Cannot sell or distribute pesticide in a
non-refillable container unless container
meets the standards. (§165.102(a)(1)).
General integrity requirements.
Can’t sell or distribute pesticide in a
refillable container unless container
meets the standards. (§165.124(a)(1)).
General integrity requirements for
minibulks. Different general integrity
standards for bulk containers.
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
Non-Refillable
Minibulks
Refillable
Bulks
Non-Refillable
Minibulks
Bulks
3. Permanent Markings
Incorporates DOT marking.
Incorporates DOT marking. Also, serial Permanent only: EPA registration number
number or other identifying code marked and the name, symbol, or code of
durably on each container. (§165.116)
material(s) used to make container.
(§165.102(c))
Permanent only: name of container
manufacturer, model number, date of
manufacture, capacity, the name,
symbol or code of material(s) used to
make container, serial number, and the
statement, “Meets EPA standards for
refillable containers.” (§165.124(b))
4. Dispensing Capability
If container has capacity of 20 L or less
and if container holds a liquid pesticide,
container must:
(1) Allow contents to pour out in a
continuous, coherent stream, and
(2) Minimize dripping.
(§165.68)
Not specified.
Require all containers that hold liquid
pesticide to:
(1) Allow contents to pour in continuous,
coherent stream,
(2) Dispense without leaking or dripping,
and
(3) Once container has been resealed, not
allow the pesticide to escape during
storage or agitation.
(§165.102(d))
Not specified.
5. Closures
Similar to proposed rule requirements.
(§165.66)
Same as proposed
rule requirements.
(§165.118)
Four closure sizes are specified for
containers that meet all of these criteria:
(1) rigid container; (2) capacity greater
than or equal to 3.0 liters (0.79 gal.);
(3) holds liquid agricultural pesticide;
(4) is not an aerosol container; (5) is not a
pressurized container. (§165.102(e))
Final rule should not overlap with childresistant packaging requirements.
Each opening of
each liquid
minibulk
container must
have a one-way
valve, a tamperevident device, or
both.
(§165.124(e))
Same as proposed
rule requirements.
(§165.120(b))
Page 281
For liquid bulk
containers:
(1) The container
must be equipped
with a vent or
other device
designed to
relieve excess
pressure, prevent
losses by
evaporation,
exclude
precipitation.
(2) External sight
gauges are
prohibited.
(3) Container
connections
except for vents
must be equipped
with a shutoff
valve that can be
locked closed.
(§165.124(f))
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
6. Residue Removal
Design Standard
Non-Refillable
The final regulations
require only a “four-9s”
standard, where rigid
containers with dilutable
pesticides must be capable
of 99.99 percent removal
of each active ingredient.
Percent removal
represents the percentage
of the original
concentration of the active
ingredient in the pesticide
product when compared to
the concentration of that
active ingredient in the
fourth rinse according to a
formula.
Minibulks
Not specified.
Refillable
Bulks
Not specified.
Non-Refillable
For rigid containers with dilutable
pesticide, registrant must demonstrate that
container achieves 99.9999% removal of
each active ingredient. Testing done
according to full GLP regulations.
(§165.104)
Testing done by sampling of a minimum
19 random containers for residue removal
compliance.
(§165.105(b)(1))
The final regulations
require that every
registrant test three
containers from each rigid
container/dilutable
formulation combination.
Page 282
Minibulks
Not specified.
Bulks
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
Non-Refillable
Minibulks
Refillable
Non-Refillable
Bulks
Minibulks
Bulks
Procedure
Same as proposed rule requirements,
but household products are exempt.
Same as proposed rule requirements.
Conduct rinsing (triple and/or pressure) on
the label if rigid container & dilutable
pesticide.
(156.144(d))
Registrant develops a written residue
removal procedure for each pesticide
product placed in a refillable container
that is adequate to maintain product
integrity. (§§165.164(a) and
165.190(a))
Before refilling, the refiller (which
could be a registrant) must clean each
refillable container by conducting the
pesticide product’s residue removal
procedure for refilling unless certain
conditions are met. (§§165.170 and
165.210)
Before disposal, conduct the rinsing
procedure on the label. (§156.144(e))
Procedure
Responsibility
Same as proposed rule requirements.
Same as proposed rule requirements.
End user.
Before refilling: registrant and refiller
(which could be the registrant). Before
disposal: whoever disposes of
container, could be registrant, refiller,
end user or someone else.
7. Design Qualification
Testing
Residue removal testing not required,
but registrants will have to do some
testing to show they comply with the
standard. Incorporates DOT design
qualification tests.
Incorporates DOT
design
qualification tests.
Incorporates DOT
design
qualification tests.
Yes, required residue removal testing
Yes, required drop No.
test for minibulks
Sampling
Three containers for residue removal
test, as described in OPP test procedure.
Sampling for DOT tests as set out in the
DOT regulations.
As set out in DOT
regulations.
As set out in DOT
regulations.
Nineteen random containers at a minimum One random
(for residue removal). (§165.105(b)(1))
container; drop
testing.
No.
Drop Test
Incorporates drop test (and other tests)
in DOT regulations. (49 CFR Parts 178
and 180)
Incorporates drop
test (and other
tests) in DOT
regulations.
(49 CFR Parts 178
and 180)
Incorporates drop
test (and other
tests) in DOT
regulations.
(49 CFR Parts 178
and 180)
No.
No.
Page 283
Solids - 2.6 ft. and
liquids - 3.9 ft.
(§165.125(c-e))
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
Non-Refillable
Refillable
Non-Refillable
Minibulks
Bulks
8. Production Testing
and Periodic Retesting
Incorporates production testing and
periodic retesting in DOT regulations.
(49 CFR Parts 178 and 180)
Incorporates
production testing
and periodic
retesting in DOT
regulations.
(49 CFR Parts 178
and 180)
Incorporates
production testing
and periodic
retesting in DOT
regulations.
(49 CFR Parts 178
and 180)
No.
No.
No.
9. Reconditioning
Incorporates DOT regulations that
provide for reconditioning.
(49 CFR §173.28)
No.
No.
No. However, may be applicable to
drums.
No.
No.
10. Waiver
Yes. Provisions to waive: (1) adoption
of the subset of DOT standards (new);
(2) standard closure requirement (as
proposed); (3) container dispensing
standards (new); and (4) residue
removal standard (as proposed) if the
specified criteria are met. Waiver must
be obtained in writing. (§§165.72,
165.74)
Yes. There is a provision to waive
adoption of the DOT standards if the
specified criterion is met. (New) waiver
must be obtained in writing. (§§165.122,
165.124)
Yes. May be issued by EPA if registrant
can demonstrate that waiving compliance
with residue removal procedure does not
result in unreasonable risk. (§165.104(c))
There is also the option to request
approval of a non-standard closure, which
is ultimately a waiver (§165.102(e)(2))
Not specified.
11. Certification
No
No
Yes. (§165.111(a))
Yes. (§165.126(a))
12. Recordkeeping
Similar to proposed rule requirements,
but copy of certification is not required.
(§165.86)
No recordkeeping required.
For each pesticide product, maintain
records for as long as the non-refillable
container design type is used to distribute
or sell the pesticide product and for 3
years thereafter. Must keep the following
records:
(1) Name and EPA registration number of
the pesticide product
(2) Description of the design type of the
non-refillable container in which pesticide
product is distributed or sold
(3) Copy of the certification
(4) Record to document compliance with
the requirement for closures
(5) Record to document compliance with
dispensing standards
(6) Record to document compliance with
residue removal standard.
(§165.107)
For each product distributed/sold to a
refiller for repackaging into refillable
containers, maintain records for as long
as a refillable container is used to
distribute the product and for 3 years
thereafter. Must keep the following
records:
(1) Description of the refillable
container(s)
(2) Record to document compliance
with the drop test for minibulks (if
applicable)
(3) Copy of the certification.
(§165.128)
For Container
Design
Requirements
Page 284
Minibulks
Bulks
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
For Repackaging
Requirements
Non-Refillable
Not applicable.
Minibulks
Refillable
Bulks
Registrant records: Must keep the same
records, but for a different time period
(current operating year and for 3 years
thereafter.) (§§165.176(a) and 165.194)
Non-Refillable
Not applicable.
Minibulks
Bulks
Registrant records: For as long as a
registrant distributes or sells a product
to a refiller and for 3 years thereafter,
the registrant must keep copies of: the
contract or authorization, residue
removal procedure for refilling, and list
of acceptable containers. (§165.132)
Refiller “informational” records: Must
keep the same records, but for a different
time period (current operating year and
for 3 years thereafter). (§§165.176(a)
and 165.218(a))
Refiller “informational” records: For as
long as a refiller distributes or sells a
product in refillable containers and for
3 years thereafter, the refiller must keep
copies of the contract or authorization,
residue removal procedure for refilling,
and list of acceptable containers.
(§165.136(a))
Refiller repackaging records: Each time
a refiller repackages into a refillable
container for sale or distribution, must
generate and maintain the following for
3 years: product information; date of
repackaging; serial number of container.
(§§165.176(b) and 165.218(b))
Refiller repackaging records: Each time
a refiller repackages into a refillable
container for sale or distribution, must
generate and maintain the following for
3 years: product information; date of
sale; name & address of consignee;
serial number of container; record of
inspection; record of cleaning.
(§165.136(c))
Refiller container return records: Not
required in final rule.
Refiller container return records: Each
time a refiller receives a refillable
container, must record and maintain the
following for 3 years: name & address
of person providing container; serial
number of container; date the container
was received; product last sold in
container. (§165.136(b))
Page 285
Table G-1 (Continued). Comparison of Final Container Regulations with Proposed Container Regulations
Final Container Requirements
1994 Proposed Container Requirements
Refillable
Requirement
13. Refilling
Transfer
Non-Refillable
Minibulks
Refillable
Bulks
Non-Refillable
Minibulks
Bulks
Not Applicable.
Same general structure as proposed rule
requirements, but the final rule changes
two of the conditions to require a
contract between the parties rather than a
contract or authorization and to allow
repackaging at an end user location if
conducted by a registered establishment.
(§§165.182 and 165.202)
Not applicable.
Replaces the Bulk Pesticides
Enforcement Policy with §165.129.
Provides that registrants may allow a
refiller to repackage the registrant’s
pesticide product into any size
refillable container and distribute or
sell under the registrant’s registration
(provided all conditions of the rule are
met). Also establishes the
responsibilities of registrants and
refillers for various parts of the refilling
process.
Responsibility for
Product Integrity
Not applicable.
Same as proposed rule requirements.
(§165.162, 165.188 and 165.206)
Not applicable.
Both the registrant and refiller held
responsible for integrity of the
repackaged product; different but
related roles regarding label and
repackaging. (§§165.129–165.34)
Inspection
Not applicable.
Same as proposed rule requirements.
(§§165.168 and 165.210)
Not applicable.
Refiller inspects prior to repackaging.
(§165.134(e))
Similar to and more specific and
flexible than proposed requirements.
Additional/amended requirements
include:
(1) Durable markings acceptable
(§156.140)
(2) Non-refillable statement includes
alternatives for recycling and reuse
directions (§156.140(a))
(3) Exempt household products from
requiring residue removal instructions.
(§156.144(c)) (See residue removal
procedures above.)
(4) Rinsing procedure includes “or
equivalent.” (§156.146(a)) (See residue
removal procedures above.)
Similar to and more specific and flexible
than proposed requirements.
Additional/amended requirements
include:
(1) Durable markings acceptable
(§156.140)
(2) More specific description of use of
blank space on labels for net contents
and EPA establishment registration
number, and makes blank spaces
optional (“may include”) (§156.10(d)(f))
(3) Container type requirement includes
an alternative statement. (§156.140(b))
(4) Residue removal statement
(§156.156) (See residue removal
procedures above.)
(1) Identify container type + recycle + do
not reuse statement (§156.140(a))
(2) Residue removal statement
(§156.144(d)) (See residue removal
procedures above.)
(1) Reserve space for net weight of
contents (§156.10(d)(7))
(2) Reserve space for EPA
establishment number (§156.10(f))
(3) Identify container type
(§156.140(b))
(4) Residue removal statement
(§156.144(e)) (See residue removal
procedures above.)
14. Labeling
Page 286
Appendix H. Characterization of Unintentional Human Pesticide and
Antimicrobial Exposures and Health Effects in the TESS Database
H.1 General Characterization of Unintentional Human Pesticide and Antimicrobial
Exposures
One of the strengths of TESS information is that it provides a perspective on the extent of
pesticide exposures occurring throughout the country. For example, we have information on the
distribution of the age of unintentional pesticide exposure victims by the reason of exposure
(Table H-1). Generally, children less than 6 years of age comprised 54 percent of the overall
exposure cases seen. Thirty-seven percent of the incidents involved adults over 19 years old,
followed by young children 6 to 12 years old (6 percent), and young adults 13 to 19 years old (3
percent). Overall, in children under 6 years of age most cases (64.05 percent) were observed as a
result of “general” unintentional exposure causes.
Table H-1. Percent Distribution of Age of Exposure Case by Reason of Exposure
Exposure Reason
≤ 5 Years
Old
6-12 Years
Old
13-19 Years
Old
≥ 20 Years
Old
Unknown
Total a
General
64.05%
5.14%
2.21%
27.83%
0.76%
81.21%
Environmental
17.12%
8.78%
4.92%
67.40%
1.78%
8.11%
Occupational
0.04%
0.04%
6.93%
91.54%
1.45%
3.24%
22.55%
21.72%
8.13%
46.43%
1.16%
0.74%
6.38%
7.87%
5.26%
79.97%
0.52%
6.20%
19.64%
7.14%
3.57%
66.07%
3.57%
0.07%
9.52%
4.76%
47.62%
38.10%
0%
0.05%
29.29%
5.72%
5.39%
58.59%
1.01%
0.37%
Therapeutic Error
Misuse
Bite/sting
Food poisoning
Unknown
Total
54.10%
5.57%
2.85%
36.62%
0.86%
100.00%
Source: AAPCC (2002, Report 31 “Reason by Age (Adults Lumped)”).
a
Represents column percent where total number of cases is 80,978; other percentages represent row percent.
As expected, adults sustained the majority (91.54 percent) of exposures occurring in
occupational environments. Although adults comprised only 36.62 percent of the overall victim
population, they made up the largest proportion of exposures in each specific reason of exposure
category, except for “general.”
Table H-2 below shows a similar breakdown of these unintentional exposures categories by
exposure chronicity. Of all the unintentional pesticide and antimicrobial exposures observed in
2001, the overwhelming majority (97 percent) of them were considered “acute” exposures.
Chronic exposures comprised 1.4 percent of all unintentional pesticide and antimicrobial
exposures, acute-on-chronic exposures represented approximately one percent, and cases in
which the chronicity could not be determined accounted for 0.2 percent of overall unintentional
exposures.
Page 287
Table H-2. Percent Distribution of Exposure Chronicity to Reason of Exposure
Exposure Reason
Acute a
Acute-onchronic b
Chronic c
Unknown d
Total e
General
98.84%
0.52%
0.50%
0.14%
81.27%
Environmental
88.66%
3.12%
7.56%
0.65%
8.11%
Occupational
88.99%
2.70%
7.20%
1.10%
3.24%
Therapeutic Error
90.05%
4.31%
5.47%
0.17%
0.74%
Misuse
95.56%
2.01%
2.21%
0.22%
6.20%
Bite/sting
94.64%
1.79%
3.57%
0%
0.07%
100.00%
0%
0%
0%
0.05%
93.60%
2.36%
2.02%
2.02%
0.37%
Food poisoning
Unknown
TOTAL
97.40%
0.93%
1.44%
0.22%
100.00%
Source: AAPCC (2002, Report 42 “Reason by Exposure Chronicity”).
a
Acute: a single, repeated or continuous exposure occurring over a period of 8 hours or less.
b
Acute-on-chronic: single exposure that was preceded by a continuous, repeated, or intermittent exposure occurring
over a period exceeding 8 hours.
c
Chronic: a continuous, repeated, or intermittent exposure to the same substance lasting longer than 8 hours.
d
Unknown: unable to determine whether the exposure is acute or chronic.
e
Represents column percent where total number of cases is 80,978; other percentages represent row percent.
H.2 Characterization of Health Effects Associated with Unintentional Human Pesticide
and Antimicrobial Exposure Cases
TESS data also offer some insight into the type or degree of outcome or clinical effects and the
location of the activities performed to manage the exposure. We evaluated these data and
determined the appropriate stratification with which to estimate the number of unintentional
pesticide-related illnesses expected per year. This section characterizes the overall patterns seen
among unintentional pesticide exposures.
The general distribution of exposure cases by medical outcome is presented for both the “with
concomitants” and “without concomitants” categories in Table H-3. In this case, the distribution
of medical outcome does not vary significantly between the two categories.
Page 288
Table H-3. Profile of Unintentional Pesticide and Antimicrobial Exposures by
Medical Outcome
Medical
Outcome
With Concomitants a
Description
Without
Concomitants b
Number
Percent
Number
Percent
No effect
Patient developed no signs or symptoms as a
result of exposure
18,385
22.70%
17,888
23.03%
Minor effect
Patient developed some signs or symptoms as a
result of the exposure, but they were minimally
bothersome and generally resolved with no
residual disability or disfigurement
12,084
14.92%
11,295
14.54%
Moderate effect Patient exhibited signs or symptoms as a result
of the exposure that were more pronounced,
more prolonged, or more of a systemic nature
than minor symptoms (usually some form of
treatment is indicated)
2,164
2.67%
1,876
2.42%
111
0.14%
87
0.11%
2
0%
2
0%
Major effect
Patient exhibited signs or symptoms as a result
of the exposure that were life-threatening or
resulted in significant residual disability or
disfigurement
Death
Patient died as a result of the exposure or as a
direct complication of the exposure
No follow-up,
nontoxic
No follow-up calls were made to determine the
patient’s outcome because the substance
implicated was nontoxic, the amount
implicated was insignificant, or the route of
exposure was unlikely to result in a clinical
effect
13,773
17.01%
13,612
17.52%
No follow-up,
minimal
toxicity
No follow-up calls were made to determine the
patient’s outcome because the exposure was
likely to result in only minimal toxicity of a
trivial nature
25,388
31.35%
24,482
31.52%
No follow-up,
potentially
toxic
Patient was lost to follow-up, refused followup, or was not followed, but the exposure was
significant and may have resulted in a
moderate, major, or fatal outcome
2,378
2.94%
2,229
2.87%
Unrelated effect Exposure was probably not responsible for the
effect
6,693
8.27%
6,201
7.98%
Total
80,978 100.00%
77,672 100.00%
Source: AAPCC (2002, Report 22 “Medical Outcome” and p. 6 “Field Definitions”).
a
“With Concomitants” indicates that a pesticide substance was implicated in the exposure case but could have
involved another substance that may or may not have been another pesticide.
b
“Without concomitants” indicates that only one pesticide substance was implicated in the exposure.
We evaluated only the unintentional pesticide and antimicrobial exposures “with concomitants”
to include all the cases in which a pesticide was involved. The majority of cases reported
showed no effect (23 percent) or was an exposure in which minimal toxicity concerns were
involved (31 percent).
Page 289
Table H-4 displays the severity of symptoms associated with exposures distributed by age. As
described earlier, young children account for the majority of the exposed population (54 percent)
in the 80,978 reported cases. However, from Table H-4, we see that they also account for the
majority of the individuals who showed no effect from the reported exposure (75 percent) as well
as of the individuals involved in nontoxic exposures (77 percent). By contrast, adults were
among the majority of victims exhibiting minor, moderate, or major medical effects. More
severe outcomes (“major effect”) also occurred in the adult (over 19 years old) category. Results
for the exposures resulting in death appear to be equally distributed between less-than-6-yearolds and over-19-year-olds, but this is representative of the two deaths reported in 2001.
Table H-4. Percent Distribution of Age of Exposure Patient by Symptom Severity of
Medical Outcome Among “With Concomitants” Exposure Cases
Medical Outcome
No effect
Minor effect
b
Moderate effect
Major effect
b
b
≤ 5 Years
Old
6-12 Years
Old
74.57%
5.32%
24.90%
13-19 Years
Old
≥ 20 Years
Old
Unknown
1.68%
17.97%
0.46%
23.70%
7.15%
4.97%
62.20%
0.78%
14.92%
11.23%
3.51%
4.16%
80.18%
0.93%
2.67%
Total a
27.93%
5.41%
9.01%
55.86%
1.80%
0.14%
Death
50.00%
0%
0%
50.00%
0%
0%
No follow-up, nontoxic
77.02%
4.94%
1.68%
15.72%
0.64%
17.01%
No follow-up, minimal
toxicity
53.39%
5.90%
3.06%
36.64%
1.01%
31.35%
No follow-up,
potentially toxic
43.82%
4.12%
2.86%
45.75%
3.45%
2.94%
Unrelated effect
24.07%
4.62%
3.35%
67.00%
0.97%
8.27%
Total
54.10%
5.57%
2.85%
36.62%
0.86%
100.00%
Source: AAPCC (2002, Report 51a “Medical Outcome by Age (Adults Lumped)”).
a
Represents column percent where total number of cases is 80,978; other percentages represent row percent.
b
The duration of the clinical effects observed in these outcome categories are highlighted in Table H-5 below.
Table H-5 shows the tendency for increasing duration of the clinical effects with more severe
outcomes among those exhibiting minor, moderate, or major medical outcomes. Although these
outcome categories were defined above in Table H-3, some examples of common symptoms
demonstrated in each group may include:
•
•
•
Minor effect: self-limited gastrointestinal symptoms, drowsiness, skin irritation, first-degree
dermal burn, transient cough;
Moderate effect: corneal abrasion, high fever, disorientation, isolated brief seizures that
respond readily to treatment; and
Major effect: repeated seizures, respiratory compromise during intubation, cardiac or
respiratory arrest.
Page 290
Table H-5. Duration of Clinical Effects by Symptom Severity Among Those “With
Concomitant” Cases Exhibiting Minor, Moderate or Major Medical Outcomes
Duration
≤ 2 hours
Minor Effect
Moderate Effect
48.49%
Major Effect
14.93%
Total
5.41%
43.10%
> 2 and 8 hours
18.55%
19.69%
7.21%
18.64%
> 8 and 24 hours
12.34%
16.54%
19.82%
13.03%
> 24 hours and ≤ 3 days
6.30%
14.60%
23.42%
7.68%
> 3 days and ≤ 1 week
2.97%
10.17%
9.01%
4.10%
> 1 week and ≤ 1 month
1.12%
3.79%
5.41%
1.55%
> 1 month
0.27%
1.39%
4.50%
0.47%
Anticipated permanent
0.02%
0.28%
4.50%
0.10%
Unknown
9.93%
18.62%
20.72%
11.32%
a
Total
84.16%
15.07%
0.77%
100.00%
Source: AAPCC (2002, Report 23 “Duration of Clinical Effects by Medical Outcome”).
a
Represents row percent where total number minor, moderate and major effects is 14,359; other percentages
represent column percent.
Most minor effects lasted less than 2 hours, and as expected, victims with major effects tended to
experience more prolonged effects.
Table H-6 gives more insight regarding the severity of reported cases and the medical resources
required to manage them. The majority of all unintentional pesticide exposures (77 percent)
reported to poison centers were managed in a non-health care facility, such as at the site of the
exposure (which could be the patient’s home). Treatment in health care facilities was involved
in 20 percent of the reported cases and was recommended in another 1.27 percent of patients.
Table H-6. Percent Distribution of Symptom Severity of Medical Outcome by
Management Site Among “With Concomitant” Exposure Cases
Medical Outcome
Non-Health
Care
Health Care
Facility
Facility
Other
Refused
Referral
Unknown
Total a
No effect
76.57%
22.49%
0.36%
0.55%
0.03%
22.70%
Minor effect
66.44%
29.93%
1.02%
2.35%
0.26%
14.92%
Moderate effect
23.94%
69.18%
1.57%
4.81%
0.51%
2.67%
9.01%
81.98%
5.41%
3.60%
0%
0.14%
0%
100%
0%
0%
0%
0%
Major effect
Death
No follow-up, nontoxic
93.25%
6.43%
0.25%
0.03%
0.05%
17.01%
No follow-up, minimal
toxicity
88.03%
10.32%
0.81%
0.37%
0.47%
31.35%
No follow-up,
potentially toxic
28.17%
46.01%
3.11%
14.00%
8.70%
2.94%
Unrelated effect
61.09%
34.87%
1.00%
1.51%
1.52%
8.27%
Total
77.29%
20.10%
0.75%
1.27%
0.60%
100.00%
Source: AAPCC (2002, Report 39 “Medical Outcome by Management Site”).
a
Represents column percent where total number of cases is 80,978; other percentages represent row percent.
Page 291
Table H-4 above showed that the majority of victims experiencing minor, moderate, or major
effects were over 19 years old. According to Table H-6, the majority of victims with moderate
and major effects are managed in a health care facility. Table H-7 provides the distribution of
the victims that were treated in health care facilities, where children less than 6 years old and
adults over 19 years of age were most often treated and released when they were evaluated at a
health care facility. However, adults over 19 years of age were also approximately twice as
likely as children less than 6 years old to be admitted to the hospital for their exposure.
Table H-7. Percent Distribution of Management Site by Age of “With Concomitant”
Exposure Patient
Management Site
≤ 5 Years
Old
6-12 Years
13-19
≥ 20 Years
Old
Years Old
Old
Non-health care facility
56.75%
5.99%
2.73%
Health care facility
Unknown
Totala
33.71%
0.81%
77.29%
45.80%
3.75%
3.22%
46.43%
0.79%
21.36%
Treated/released
52.01%
3.98%
2.84%
40.68%
0.48%
16.24%
Admitted, critical care
28.84%
5.03%
4.23%
61.11%
0.79%
0.47%
Admitted, non-critical care
32.50%
2.12%
7.31%
57.88%
0.19%
0.64%
1.85%
1.85%
20.37%
74.07%
1.85%
0.07%
Lost to follow-up/left against
medical advice
25.33%
3.26%
3.59%
65.10%
2.72%
2.69%
Refused Referral
24.98%
2.34%
3.90%
67.90%
0.88%
1.27%
Other
34.26%
13.61%
5.90%
41.48%
4.75%
0.75%
Unknown
32.37%
5.19%
2.28%
56.02%
4.14%
0.60%
Admitted, psychiatry
TOTAL
54.10%
5.57%
2.85%
36.62%
0.86%
100.00%
Source: AAPCC (2002, Report 45a “Management Site by Age - Row %”).
a
Represents column percent where total number of cases is 80,978; other percentages represent row percent.
Page 292
Appendix I. Benchmark Costs for Physician Office Visits by Current
Procedural Terminology, Fourth Edition (CPT-4) Code
Table I-1. Benchmark Costs for Physician Office Visits by Current Procedural
Terminology, Fourth Edition (CPT-4) Code
CPT-4
Code
Brief Description
Cost
(Year 2000$)
Cost
(Year 2005$) a
99201
New patient requiring:
1. Problem focused history
2. Problem focused examination
3. Straightforward medical decision-making
$30.61
$31.68
99202
New patient requiring:
1. Expanded problem focused history
2. Expanded problem focused examination
3. Straightforward medical decision-making
$48.44
$50.14
99203
New patient requiring:
1. Detailed history
2. Detailed examination
3. Medical decision-making of low complexity
$66.95
$69.30
99204
New patient requiring:
1. Comprehensive history
2. Comprehensive examination
3. Medical decision-making of moderate complexity
$99.58
$103.07
99205
New patient requiring:
1. Comprehensive history
2. Comprehensive examination
3. Medical decision-making of high complexity
$125.15
$129.54
99211
Established patient. May not require a physician.
Presenting problems are minimal (5 minutes).
$13.46
$13.93
99212
Established patient requiring 2 of these 3 components:
1. Problem focused history
2. Problem focused examination
3. Straightforward medical decision-making
$26.58
$27.51
99213
Established patient requiring 2 of these 3 components:
1. Expanded problem focused history
2. Expanded problem focused examination
3. Medical decision-making of low complexity
$38.02
$39.35
99214
Established patient requiring 2 of these 3 components:
1. Detailed history
2. Detailed examination
3. Medical decision-making of moderate complexity
$57.53
$59.55
99215
Established patient requiring 2 of these 3 components:
$90.83
$94.01
1. Comprehensive history
2. Comprehensive examination
3. Medical decision-making of high complexity
Source: Online division of Intellimed, accessible at www.myhealthscore.com.
a
Prices provided at www.myhealthscore.com were year 2000 dollars, as of October 23, 2002. These costs were
converted to 2005 dollars by applying the Medicare Physician Fee Schedule conversion factors: [2005 conversion
factor] ÷ [2000 conversion factor] = $37.8975 ÷ $36.6137 = 1.0351.
Page 293
Appendix J. Case Summaries of 1999 California Incidents That Would Have
Been Prevented by the Container Regulations
In Chapter 5, we described the state data used to derive the percentage of pesticide illnesses
potentially related to the container standards. This section provides a more detailed view of the
underlying cases in California in 1999 that were used in the calculation of the percentage. First,
we provide a breakdown of the cases based on the likelihood of prevention by the regulation and
whether the pesticide involved is subject to the regulations. This is followed by individual case
summaries for each of the cases used by EPA to estimate the percentage of potentially avoidable
pesticide illnesses as a result of the regulation.
Table J-1 shows the number of cases associated with the incidents in California in 1999 that were
considered by EPA to have been “very likely” or “possibly” prevented by the container
regulations. Sixteen cases were considered “very likely,” and 51 cases were considered
“possible.” Table J-2 presents the specific case summaries, along with two columns of
information critical to the calculations described in Chapter 5.
Table J-1. Number of Cases in California in 1999 Considered by EPA as “Very Likely” or
“Possibly” Preventable by the Container Regulations
Likelihood of Incident
Prevention
Regulated Pesticide Category
Very Likely
Possibly
Total
Other Pesticide
7
15
22
Antimicrobial
9
30
39
Antimicrobial (unclear whether subject to regulations)
3
3
6
Total
19
48
67
Note: Shaded areas denote the 51 “possible” cases, which if included, would increase the annual health benefits by
an additional 1,950 to 2,451 cases, as described in Section 5.2.5.3. The three unclear antimicrobial cases are
included in the “Possible” incidents
The first column of interest is “Reg Impact,” which designates EPA’s evaluation of the
regulatory impact. In addition to this condition of whether the incident was likely to have been
prevented by the regulations, EPA also considered whether the chemical involved was subject to
the regulations (noted in the column “Product Category”). Here, EPA determined that cases
involving non-antimicrobial agents were subject to the regulations (“Not A”). For the remaining
cases, where the antimicrobial pesticide was known, EPA determined whether it would be
subject to the regulations (“A-in” if subject to regulations, otherwise exempt and omitted from
the table).
However, in six cases antimicrobial pesticides were involved, but it was not clear from the
California Department of Pesticide Regulations (CDPR) information available whether the
pesticide is subject to the container regulations (denoted “A ?” in Table J-2). Three of these
cases were initially categorized as “very likely” and three were “possibly” prevented by the
regulations, as shown in Table J-1. Due to the limited data and the uncertainties surrounding
these cases, we regrouped the three former cases as “possibly” for a conservative approach to
Page 294
deriving the percentage of pesticide illnesses potentially related to the container design and
residue removal standards.
Additional cases avoided if possible cases are included
Similar to calculations described in 5.2.4 and 5.2.5, we estimate the additional cases avoided if
the 51 “possible” cases were also considered. The 51 “possible” cases (from CDPR)
corresponds to 4.33 percent of the total unintentional pesticide product cases in CDPR (i.e., 51 /
1,179 = 4.33 percent). In 2001, 64 poison control centers participated in TESS, reporting more
than 2 million human exposure cases, which represent an estimated 98.8 percent of all poison
exposures reported to poison centers in the U.S. To scale up to 100 percent, we need the inverse
of 98.8 percent, which is 1.012)
Avoided illnesses with clinical effects = 19,492 * 4.33% * 1.012 = 853 cases, where 19,492 is
the number of nationwide illnesses resulting from unintentional pesticide-related exposures
(from TESS); used for “low-end” scenario. To calculate the “high-end” scenario, we go through
the same steps using 24,531 (19,492 related cases + 5039 unknown if related) “high-end” cases
as the basis from TESS, which results in 1,074 cases avoided.
From Table 5.10, we have that 43.86% of exposures resulted in clinical effects (including minor,
moderate, major effects, and death) and 56.14% of exposures resulted in “no effect.” Assuming
these same ratios between exposures with clinical effects and exposures with “no effect,” than
we can estimate the number of cases with “no effect” avoided by the rule would be:
853
x
=
⇒ x = 1,092
43.86% 56.14%
Therefore, the total number of additional cases that could have been avoided if the 51 “possible”
cases were considered from the CDPR data, is 1,945 (853 + 1,092 = 1,945). This number
represents the “low-end” scenario. To calculate the “high-end” scenario, we go through the same
steps using 1,074 “high-end” cases resulting in clinical effects, which results in 2,449 “high-end”
cases avoided.
1,074
x
=
⇒ x = 1,375
43 .86 % 56 .14 %
Page 295
Table J-2. Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly” Prevented by
the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Pesticide(s)
Days
off
Work
Days
in
Hosp
Reg
Impact c
Comments
HANDLING CONTAINER FOR APPLICATION/USE
Opening or closing container (other than drops)
99-44
def
A-in
red, irritated eye
sodium hypochlorite
0
0
P
After removing the cap to a bleach bottle, a restaurant manager
poked a hole in the inside seal causing a drop of bleach to
splash into his eye. He flushed the eye; failed to wear
provided eye protection.
99-121
pro
A-in
red, irritated eyes
sodium hypochlorite
0
0
P
According to the manager, a bus boy splashed sanitizer into his
eyes when he opened a 5-gallon sanitizer container prior to
connecting it to the dishwasher. His eyes felt irritated so a coworker drove him to the hospital.
99-176
def
A-in
red, burning eye,
blurred vision
sodium hypochlorite
0
0
P
Kennel technician flicked a drop of bleach into her eye as she
pulled the inner seal from a new bottle of bleach. She flushed
her eye; failed to wear employer-provided gloves & eye wear.
sodium hypochlorite
1
0
V
As a worker poured pool chlorine into a dispensing barrel, the
container’s handle broke off in his hands. The container fell
into the barrel and splashed liquid chlorine onto his face. The
liquid ran down behind his goggles and into his eyes.
sodium hypochlorite
0
0
P
School food service worker splashed bleach in her eye while
pouring a sanitizer from a gallon container into a small spray
bottle. She acknowledged having been trained to wear rubber
gloves & goggles, but failed to do so.
Handler opens container and then drops it
99-840
def
A-in
severely painful, red
& dry eyes, blurred
vision, sluggishly
reactive pupils
Transfer pesticide from container, unspecified
99-334
def
A-in
red eye, superficial
corneal burn
99-783
def
A-in
scratchy, burning, red sodium hypochlorite
eyes
2
0
P
Liquid pool chlorine sprayed into the faces of a delivery driver
and his assistant when the assistant uncapped a hose
incautiously. They rinsed eyes & were taken to a hospital.
Both recovered fully within 5 days.
99-995
def
A-in
red, burning eye
0
0
P
When a camp maintenance worker poured liquid chorine into a
cistern to treat the camp’s drinking water, some of the liquid
splashed up into his eye. He flushed the eye and sought
medical attention.
sodium hypochlorite
Page 296
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Pesticide(s)
Case No. Relation a Category b Medical Description
99-1121
def
A-in
red, dry and burning sodium hypochlorite
eye, blurred vision
99-1401
def
A-in
burning eye
sodium hypochlorite
Handler is exposed while mixing/loading; exposure involves the container
99-719
pro
A?
burning eye
peroxyacetic acid
Days
off
Work
Days
in
Hosp
0
0
0
0
P
As employee poured disinfectant into a spa, some liquid
contacted his hand. He then touched the contaminated hand to
his eye, which began burning, so he flushed it before seeking
medical attention.
0
0
P
Sterilant failed to completely drain from its packet into a
sterilizer when a medical technician submerged the packet in
water and cut it open. She accidentally splashed a drop of
liquid into her eye. She flushed it with water.
0
P
A pool chlorine delivery driver asked a swimming pool
employee to shut a valve during the transfer process. When
the employee attempted to close the valve, it broke. Liquid
chlorine splashed on his body.
Handler is exposed while mixing/loading; exposure involves the transfer equipment
99-395
pro
A-in
burning, irritated skin sodium hypochlorite
0
on face, neck,
shoulder; headache,
brief transient eye
irritation
Reg
Comments
Impact c
P
When a hurried correctional officer tried to pour bleach from a
5-gallon container into a cup, she splashed some bleach into
her eye. She failed to wear label-required eye protection.
99-613
def
A-in
redness, burning
sensation in eye,
slightly blurred
vision
sodium hypochlorite
0
0
P
Employee attempted to dislodge what he believed was a
blockage in the disinfectant discharge tube when the
disinfectant splashed toward his face and into his eye. He
flushed the eye with water and sought medical attention.
99-715
def
A-in
redness, stinging &
burning pain in eyes
sodium hypochlorite
0
0
P
Mobile home park manager investigated problem with pool
chlorinator. During inspection, a line blew off and sprayed
liquid chlorine in his face. Force of spray lifted his goggles.
He had no pesticide training.
99-854
def
A-in
irritated, burning eye
sodium hypochlorite
1
0
P
As a prison employee attempted to connect a bleach hose to a
water treatment tank, the hose popped off and splashed bleach
into his eye. He flushed it with water and went to the
infirmary, which sent him to a doctor.
Page 297
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Days
off
Work
Pesticide(s)
Days
in
Hosp
Reg
Impact c
Comments
Handler is exposed while mixing/loading; exposure does not involve the container and/or transfer equipment
99-402
def
A-in
burning, irritated eye
sodium hypochlorite
0
0
P
As a housekeeper cleaned the restroom, she poured bleach into
a bucket of water and splashed some in her eye. She
developed symptoms and sought medical attention. She failed
to wear the provided eye protection.
99-635
def
A-in
red & irritated eye
sodium hypochlorite
17
0
P
As a meat packing plant employee filled a machine with
cleaner & disinfectant, some solution splashed into his eye.
He sought medical attention. He failed to wear provided eye
protection.
99-779
pos
Not A
itchy, red, burning
propargite, adjuvant
rash on face and neck
0
0
P
Worker mixed, loaded & applied propargite to a grape
vineyard for 3 or 4 days. He first noticed his neck feeling hot
while loading the propargite in the spray tank. He saw a
doctor the next day when symptoms worsened.
99-819
def
A-in
red, burning eye
0
0
P
When a custodian poured bleach into bucket, some of it
splashed into his eye. He developed symptoms and sought
medical attention. He failed to wear provided eye protection.
99-865
pro
Not A
red, burning, itching not determined,
and papular lesion on metolachlor, trifluralin
penis
0
0
P
After mixing/loading herbicides, an applicator urinated w/o
washing his hands. He developed symptoms and saw a doctor
2 hours later. Grower & worker have conflicting statements
about application dates and protective gear.
99-1005
def
A-in
burning, painful and
slightly red eye
sodium hypochlorite
0
0
P
Veterinary assistant prepared to mop the floor of the clinic. As
she poured bleach into the mop bucket, some splashed up into
her eye. She sought medical attention.
99-1047
def
A?
red, burning eye
unknown
0
0
P
As restaurant employee poured liquid sanitizer into water,
some of it splashed up into his eye. He developed symptoms
and sought medical attention. Restaurant switched to granular
sanitizer.
99-1135
def
A-in
red, burning, painful
eye
sodium hypochlorite
5
0
P
When a shop employee poured bleach into a bucket, she
splashed some into her eye. She flushed it and sought medical
attention. The bucket contained cleaning towels.
sodium hypochlorite
Page 298
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Pesticide(s)
Case No. Relation a Category b Medical Description
99-1146
def
A-in
red, painful eye
sodium hypochlorite
Days
off
Work
Days
in
Hosp
0
0
Reg
Comments
Impact c
P
While preparing a bleach solution to wash walls, a custodian
splashed the liquid into his eye. He flushed the eye with water
and continued work. He sought medical attention the next day.
Use or application
99-120
def
A-in
red, irritated eye
sodium hypochlorite
0
0
P
Amusement park worker splashed sanitizer in his eye as he
poured the liquid into a sink of dishes. The eye remained
irritated after flushing it, so he went to a hospital emergency
room.
99-406
pro
A-in
red, burning eye
sodium hypochlorite
0
0
P
Hospital housekeeper splashed bleach in her eye while
cleaning a toilet. She flushed her eye with water before
seeking medical attention in the hospital emergency room.
99-674
def
Not A
mildly swollen
eyelid, irritated eye
permethrin
5
0
P
SPCO removed safety glasses to examine a plugged nozzle.
While manipulating the nozzle, it unplugged and sprayed
permethrin into his eye. He flushed the eye with water and
saw a doctor the next day.
99-682
def
A-in
red, burning eye,
blurred vision, small
erosions over right
cornea
sodium hypochlorite
1
0
P
As a swimming instructor poured chlorine into the pool, some
liquid splashed up into her eye. She flushed the eye & sought
medical attention. Label instructions were almost illegible.
99-713
pro
A?
water & burning
eyes, irritated throat,
brief wheezing
headache
peroxyacetic acid
0
0
V
As an LVN placed a sterilant container into a sterilizing
machine, the lid broke. She removed the container and poured
sterilizer into an adjacent sink according to instructions. She
exposed herself to fumes & developed symptoms.
99-1128
def
A-in
burning eye
sodium hypochlorite
0
0
P
Pool serviceman ignored explicit company policy by failing to
wear provided PPE. As he poured pool chlorine into a spa,
liquid splashed up into his eye. He flushed it and sought
medical attention.
Page 299
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Pesticide(s)
Days
off
Work
Days
in
Hosp
Reg
Impact c
Comments
Miscellaneous
99-288
pro
Not A
red, irritated eyes
adjuvant
0
0
P
As employee put away a spreader-binder container, he set it
down hard, causing the material to splash up into his eyes.
The cap was not screwed on tight. He rinsed his eyes with
water and went home for the day. He saw a doctor the next
day.
99-320
pos
Not A
red, burning, painful
eye
not determined,
diuron, glyphosate,
oxyfluorfen, simazine
0
0
P
Farm worker felt something in right eye while hand-pouring a
herbicide into a spray tank equipped with a boom sprayer and a
hand wand. He wore safety glasses with brow and temple
protection. He is unsure what got into his eye.
OTHER CONTAINER HANDLING
Handling that seems to be related to use
99-196
def
Not A
red and burning skin
on the palm of the
left hand
not determined, 2,4-D,
diquat, fluazifopbutyl, mecoprop
?
0
V
A herbicide leaked onto a homeowner’s left hand as she
adjusted the nozzle on a ready-to-use product. Her hand began
to burn so she rinsed it with water for 15 minutes before
seeking medical attention. She failed to wear the required
rubber gloves.
99-296
pro
Not A
severe burning &
pain in eyes
glyphosate
0
0
P
While holding a glyphosate container, homeowner
contaminated his hand with residue on the container. He
rubbed his eyes and developed symptoms. He irrigated the
eyes and sought medical attention.
99-689
pro
Not A
headache, nausea,
lightheadedness,
slight difficulty
breathing
glyphosate
4
0
p
As an employee talked to an unhappy customer, he took the lid
off a hand pump sprayer and accidentally splashed some of the
pesticide onto her arms. The sprayer was left in her work area
where she smelled the fumes. She developed symptoms.
red, burning eye
sodium hypochlorite
0
0
P
While cleaning a co-worker’s cart, a janitor reached for a
bottle of bleach with a loosened cap. The cap came off and
spilled bleach into her eye. She flushed it and was taken for
medical evaluation.
Moving containers on a cart
99-1048
pro
A-in
Page 300
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Pesticide(s)
Days
off
Work
Days
in
Hosp
Reg
Impact c
Comments
Miscellaneous
99-340
def
Not A
99-1177
def
A-in
red, irritated eyes
fipronil
0
0
P
Child grabbed flea treatment product from her grandfather’s
hands. She meant to apply it, but squirted it in her eyes while
trying to open it. Her grandparents rinsed her eyes
immediately and took her to the emergency room.
redness, temporary
loss of vision
sodium hypochlorite
3
0
P
As employee changed the disinfectant container for a
dishwasher, some of the liquid splashed up into his eye. He
flushed it & sought medical attention. His employer provided
no eye protection.
STORAGE
Stock management
99-90
def
A-in
red, burning eye
sodium hypochlorite
1
0
V
As a worker stacked liquid pool chlorine cases onto a hand
truck, some liquid from the bottom of a case splashed up into
his eye. He immediately flushed his eye with water and sought
medical attention; failed to wear provided safety glasses.
99-546
def
A?
nausea, headache,
vomiting
unknown
?
0
V
As employee lifted boxes of disinfectant containers, bottom
fell out of one box. Container broke upon impact and contents
splashed up into his face. He developed symptoms and sought
medical attention the next day.
99-1001
def
A-in
red, irritated eye,
blurred vision
sodium hypochlorite
0
0
V
Pool chlorine leaked and wet its carton. When the store
manager moved the carton, it caught on a nail & tore. The
chlorine containers fell out and liquid splashed into his eye.
He flushed it & sought medical attention.
99-1105
def
Not A
2 dime-sized blisters
on the hand between
fingers
not determined,
chloropicrin, methyl
bromide
0
0
P
While prepping empty fumigant cylinders for return to
manufacturer, a grower placed safety cap back on a cylinder.
He noticed wetness on his hand & smelled chloropicrin.
Within a few hours, he noticed blisters on his hand.
sodium hypochlorite
1
0
V
Liquid from a cracked disinfectant container splashed into an
employee’s eyes as he stocked shelves at a retail store. He
developed symptoms & sought medical attention.
Leaking/broken container on shelf causes exposure
99-560
def
A-in
red, burning, itchy
eyes, temporary
blindness
Page 301
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Days
Product
off
CDPR
Pesticide(s)
Work
Case No. Relation a Category b Medical Description
99-580
pro
Not A
nausea, upset
not determined, 2,4-D,
0
stomach
dichlorprop,
mecoprop
99-610
def
Not A
99-1354
pro
A?
Days
in
Hosp
0
Reg
Comments
Impact c
V
When a customer picked up a leaking herbicide bottle from a
shelf, he contaminated his hand. He bought another bottle and
drove home. While driving home, he became nauseous so he
washed his hands upon arriving home. He saw a doctor the
next day.
red, burning eye
metolachlor
0
0
V
Shop foreman splashed a concentrated herbicide in his eye
when he investigated a wet package. He had received
applicator training. After the incident, his employer directed
him to wear PPE in all dealings with chemicals.
rough, dry skin on
fingers, itchy &
burning hands
phenolic disinfectants
0
0
V
Hospital service technician developed skin irritation through
repeated contact with leaking containers, one of which is a
disinfectant. He saw a nurse practitioner who instructed him to
wear protective gloves when handling containers.
Container falls off shelf or is dropped after being taken from a shelf
99-903
pro
Not A
burning eyes, nose,
throat and chest
MSMA
0
0
V
Sales clerk dropped a bottle of herbicide while stocking
shelves. Upon impact, the lid popped off and the herbicide
splashed into his face & eyes. He flushed them & sought
medical attention.
pain & corneal
abrasion in eye
sodium hypochlorite
0
0
P
As employee stocked the grocery shelves with disinfectant, he
accidentally squeezed the trigger nozzle on a bottle and
squirted the disinfectant into his eye. A co-worker
immediately drove him to a medical clinic for treatment.
sodium hypochlorite
1
0
V
When a cashier dropped a bleach bottle, some of the liquid
splashed up into her eyes. She flushed her eyes and saw a
doctor, who noted normal exam except for eyelid opening.
cypermethrin
0
0
P
A courtesy clerk dropped a can of insecticide as she returned it
to the shelf. When she picked it up, it exploded in her face.
She washed but developed symptoms 30 minutes later.
Stocking shelves or displays
99-275
def
A-in
Retail – exposure occurs at cashier/check out stand
99-128
def
A-in
pain, irritation in
eyes
Retail – exposure from handling returns
99-56
pro
Not A
red, watery eyes and
burning sensation of
eyes and face
Page 302
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Pesticide(s)
Case No. Relation a Category b Medical Description
99-510
def
A-in
red, burning, tearing sodium hypochlorite
eye, red eyelids
99-891
Days
off
Work
Days
in
Hosp
0
0
Reg
Comments
Impact c
P
As grocery store employee handled a returned gallon of bleach,
a loose cap allowed some to spill on a roll of tape. When she
picked up the tape, the liquid splashed into her eye. She
flushed her eye with water.
def
Not A
blurred vision, light
sensitivity in the eye
malathion
3
0
P
Dissatisfied customer slammed a plastic bag containing a
broken malathion bottle onto the returns counter causing
malathion to splatter into the cashier’s eye. She flushed her
eye and saw a doctor the next day.
99-720
pro
A-in
mildly red, burning
pain in eye
calcium hypochlorite
0
0
V
When a grocery store clerk picked up a leaking bag of granular
pool chlorine, some of the product blew up into her eye. Her
eye began burning so a co-worker took her to a doctor.
99-786
pro
A-in
itchy, red, burning
sodium hypochlorite
skin on arm, sensitive
to light touch, nausea
0
0
V
Pool sanitizer spilled from a leaking bottle onto a retail clerk’s
arm. She felt her skin immediately begin to burn so she
washed it with soap & water. Her skin reddened and she felt
nauseous.
99-889
pos
A-in
watery, irritated,
bloodshot eye
sodium hypochlorite
0
0
V
Retail clerk handled a wet box of liquid pool chlorine. She
said it did not smell like chlorine. Later, her eye became
irritated. She flushed it with water and was sent to a doctor.
99-1159
pos
A-in
red, burning in eye
copper naphthenate
0
0
V
Retail clerk rubbed his eye after carrying an unopened can of
wood preservative. The eye began to burn and he flushed it
immediately with water.
V
Farm supply company driver picked up a bag of diazinon
powder. Bag split open and powder poofed up into his face.
He washed face, removed shirt, developed symptoms that
night. His family had the flu at the time.
Retail – other
TRANSPORTATION
Exposure while loading or unloading a vehicle
99-133
pos
Not A
nausea,
lightheadedness,
slightly dry mouth,
difficulty breathing,
sluggishness
diazinon
0
Page 303
0
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Pesticide(s)
Days
off
Work
Days
in
Hosp
Reg
Impact c
Comments
Container leaks or spills during transport
99-168
pro
Not A
burning testicle and
abdomen skin, leg
numbness
trifluralin
0
0
P
An unopened box with 2 containers fell off a truck as 2
employees drove to an application site. One employee
contaminated himself with pesticide & developed symptoms.
He saw a doctor 4 hours later.
red, burning eyes,
difficulty breathing,
burning lungs &
facial skin
sodium hypochlorite
0
0
P
Two police officers spent 30 minutes directing traffic at
vehicular accident site involving a pool service company truck.
The chemicals spilled and formed a whitish cloud to which the
officers were exposed.
Repackaging - transferring pesticide from one container to another (not for application or use)
99-1219
pro
A-in
difficulty breathing, calcium hypochlorite
0
0
pain upon deep
breathing
P
As a pool maintenance worker transferred granular pool
chlorine from a large container to a small one, he inhaled the
fumes. He developed symptoms and sought medical attention.
He smokes 4–5 packs of cigarettes per week.
Spill – various causes (not drop, not moving, not falling off shelves)
99-1441
pro
A-in
coughing, breathing not determined,
difficulty, eye
hydrogen chloride,
irritation, dizziness
sodium hypochlorite
Transportation – accident
99-1353
pro
A-in
OTHER
Mix up containers/mistake/mis-labeled containers
99-541
pro
A?
burning in throat,
unknown
chest heaviness,
transient shortness of
breath
15
0
P
Contractor was checking on a nearby tank when he noticed the
cloud of greenish gas and shouted for people to clear the area.
He reported that one of his employees also was present and
experienced similar symptoms.
0
0
P
Someone apparently poured an unknown liquid into a broken
container of granular pool chlorine causing generation of
fumes. Upon investigating an odor complaint, a store manager
discovered the problem, inhaled the fumes & developed
symptoms.
0
0
P
Public works employee developed symptoms after helping to
clean up a herbicide spill. He went home to rest. His
supervisor went to his home and took him for medical care.
Cleanup
99-785
pos
Not A
nausea, sleepiness,
eye irritation
oxyfluorfen
Page 304
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Product
CDPR
Case No. Relation a Category b Medical Description
Pesticide(s)
Days
off
Work
Days
in
Hosp
Reg
Impact c
0
0
P
Comments
Miscellaneous household exposures
99-1055
pos
A-in
red, irritated eye
sodium hypochlorite
When a worker added disinfectant bleach to a load of laundry,
some bleach splashed up into her eye. She rinsed the eye and
continued working. The eye still bothered her 23 days later and
she sought medical attention.
SPECIFIC PESTICIDES OR CONTAINERS
Fogger
99-284
def
Not A
coughing, sore throat, not determined,
burning eyes, rash on methoprene, piperonly
head
butoxide, pyrethrins,
synergist
?
0
V
Homeowner successfully activated 2 insecticide foggers, but
the tab snapped off the third and sprayed the insecticide into
her face. She rinsed her face and eyes with a garden hose and
sought medical attention. Her symptoms resolved within a few
days.
?
0
P
Man developed symptoms after spraying an aerosol insecticide
in his room. He reportedly inhaled some as well as getting
some on his skin.
0
0
V
While preparing to spray weeds, a homeowner pulled up on the
plunger of a ready-to-use glyphosate container. The plunger
handle broke off, allowing glyphosate to spray up into his face.
He felt irritant symptoms, so he showered and sought medical
attention.
0
0
P
Homeowner treated a crape myrtle with an old dormant spray,
thought to contain copper & oil. When the nozzle tip came off
the hand pump sprayer, the wind blew pesticide stream into his
face & eyes. He washed up & saw a doctor.
Aerosol container – exposure occurs during application (use of the container)
99-1411
pos
Not A
nausea, vomiting,
diarrhea, mild
sweating, abdominal
pain, possible mild
tremor
chlorpyrifos
Spray bottle – spray mechanism and bottle separate, causing exposure
99-511
def
Not A
bad taste in mouth,
glyphosate
nauseam eye
irritation
99-1365
pro
Not A
burning eyes, blurred unknown
vision
Page 305
Table J-2 (Continued). Case Summaries of Incidents in California in 1999 Considered by EPA to Have Been “Very Likely” or “Possibly”
Prevented by the Container Regulations
Source: EPA (2005).
a
“CDPR Relation” refers to the California Department of Pesticide Regulation (CDPR) evaluation of the degree of correlation between pesticide exposure and resulting symptoms,
where the term “pesticide-related” refers to cases that fall into one of the three following relationships:
Definite (def): High degree of correlation between pattern of exposure and resulting symptoms. Requires both medical evidence (such as measured cholinesterase inhibition,
positive allergy tests, characteristic signs observed by medical professional) and physical evidence of exposure (environmental and/or biological samples, exposure history) to
support the conclusions.
Probable (pro): Relatively high degree of correlation exists between the pattern of exposure and the resulting symptoms. Either medical or physical evidence is inconclusive or
unavailable.
Possible (pos): Some degree of correlation evident. Medical and physical evidence are inconclusive or unavailable.
b
“Product Category” refers to the following codes, developed and assigned by EPA regarding the type of pesticide involved and whether it is subject to the Container Regulations
given the information provided in the CDPR case summary:
Not A: not an antimicrobial, assumed to be subject to the regulations.
A-in: antimicrobial that is subject to the regulations (i.e., antimicrobial that is “in” the scope of the regulations).
A ?: antimicrobial, but it is unclear whether or not it will be subject to the regulations, either because there is not enough information, or it is not clear how all of the regulatory
criteria would apply to it.
c
“Reg Impact” refers to whether EPA determined the incident to be “very likely” (V) or “possibly” (P) prevented by the container regulations.
Page 306
Appendix K. Pesticide Container and Refilling Requirements Cost Analysis Tables
Table K-1a. Number of Containers Within the Scope of the Rule by Container Type, Entity Size, and Market Sector: NonRefillable Liquid Pesticide Containers
30-55 Gallons
Plastic
5 Gallons
Steel
Plastic
1 to < 5 Gallons
Steel Plastic
Water Soluble
Bag in
Packets
PVA Barrier Box
Packets Packs
< 1 Gallon
Steel
Plastic
Steel
Glass
Subtotal-Liquid
Containers
Aerosol
Cans
Small-Small Establishments
Agricultural
I/C/G
Home &
Garden
378
141
71
35
34,128
0
1,233
0
0
667
101
1
0
36,755
1,610
2,335
14,139
966
21,208
1,449
20,693
161
242
0
0
262
23,350
86,415
0
0
0
0
30,186
8,625
112,120
12,937
8,625
0
0
0
215,615
388,107
Medium-Small Establishments
Agricultural
I/C/G
Home &
Garden
883
330
166
82
79,623
0
2,876
0
0
1,555
235
1
0
85,752
3,757
5,448
32,987
2,254
49,481
3,381
48,279
376
564
0
0
611
54,478
201,616
0
0
0
0
70,427
20,122
261,587
30,183
20,122
0
0
0
503,052
905,494
Large-Small Establishments
Agricultural
1,600
598
301
149
144,339
0
5,214
0
0
2,820
425
2
0
155,449
I/C/G
Home &
Garden
6,811
9,876
59,799
4,086
89,698
6,130
87,518
681
1,022
0
0
1,107
98,756
365,483
0
0
0
0
127,669
36,477
474,198
54,715
36,477
0
0
0
911,918
1,641,453
73,449
36,958
0
640,408
0
0
346,332
52,251
299
0
19,093,042
752,880 10,749,449
83,653
125,480
0
0 135,937
12,129,728
44,890,451
15,680,901 4,480,257 58,243,346 6,720,386 4,480,257
0
0
Large Establishments
Agricultural
196,572
18,327
17,728,446
I/C/G
Home &
Garden
836,533 1,212,973 7,344,760 501,920
11,017,139
0
0
0
0
Page 307
0 112,006,434 201,611,581
Table K-1b. Number of Containers Within the Scope of the Rule by Container Type, Entity Size, and Market Sector: NonRefillable Solid Pesticide Containers
11-44 lb
Bags
45 - 55 lb Bags
Paper/
Plastic
Paper
Plastic
Small-Small Establishments
11 - 44 lb Bags
Plastic
1 - 10 lb Bags
Paper
Plastic
Jugs
2.5
1 qt to
Gallons < 2.5 Gal
Paper
Water Soluble
Packets
PVA
Barrier
Packets
Packs
Bulk
> 101 lb
Agricultural
0
2,264
9,991
4,609
2,714
403
7,015
32
2,783
53,951
14,542
526
I/C/G
Home &
Garden
0
0
0
1,127
0
0
0
0
372
1,308
433
0
0
0
Medium-Small Establishments
0
42,584
0
0
0
0
539
0
0
0
Agricultural
0
5,282
23,309
10,753
6,331
939
16,367
75
6,492
125,874
33,929
1,227
I/C/G
Home &
Garden
0
0
0
2,630
0
0
0
0
869
3,053
1,010
0
0
0
99,353
0
0
0
0
1,258
0
0
0
Agricultural
0
9,575
42,255
19,493
11,477
1,703
29,669
137
11,769
228,181
61,506
2,224
I/C/G
Home &
Garden
0
0
0
4,768
0
0
0
0
1,575
5,534
1,830
0
0
Large Establishments
0
0
180,104
0
0
0
0
2,280
0
0
0
Agricultural
0 1,175,993
5,189,922
209,151 3,644,096
16,776
1,445,534 28,026,402 7,554,447
273,121
I/C/G
Home &
Garden
0
0
0
585,573
0
0
0
0
193,448
679,683
224,818
0
0
0
0 22,121,271
0
0
0
0
280,016
0
0
0
0
Large-Small Establishments
2,394,278 1,409,603
Page 308
Table K-1b (Continued). Number of Containers Within the Scope of the Rule by Container
Type, Entity Size, and Market Sector: Non-Refillable Solid Pesticide Containers
Fiber Drums
> 30 lb
< 30 lb
Other
Subtotal-Dry
Containers
Total
Small-Small Establishments
Agricultural
15
159
4,214
103,217
139,972
I/C/G
1,288
0
0
4,529
90,944
Home & Garden
0
0
0
43,123
431,230
Medium-Small Establishments
Agricultural
35
370
9,832
240,816
326,568
I/C/G
3,006
0
0
10,567
212,183
Home & Garden
0
0
0
100,610
1,006,105
Large-Small Establishments
Agricultural
64
671
17,822
436,544
591,993
I/C/G
5,449
0
0
19,155
384,638
Home & Garden
0
0
0
182,384
1,823,837
Large Establishments
Agricultural
7,811
82,428
2,189,025 53,618,588
72,711,631
I/C/G
669,226
0
0
2,352,749
47,243,200
Home & Garden
0
0
0
22,401,287
224,012,868
Page 309
Table K-1c. Number of Containers Within the Scope of the Rule by Container Type, Entity Size, and Market Sector: Refillable
Liquid Pesticide Containers
“Large” Bulk
Tanks
Plastic Steel
Bulk Tanks
126 - 250
(> 250 Gallons)
Gallons
Plastic Steel Plastic Steel
61 - 125 Gallons
26 - 60 Gallons
5 - 25 Gallons
Plastic
Plastic
Plastic
Steel
Steel
Subtotal-Liquid
Containers
Other
Sizes
Steel
Small-Small Establishments
Agricultural
23
3
2
0
66
13
327
109
93
8
243
189
0
1,076
I/C/G
14
2
22
5
14
2
14
2
270
7
133
0
1,897
2,380
Home & Garden
0
0
Swimming Pool
3
0
Industry
Medium-Small Establishments
0
0
0
0
0
0
0
0
0
0
0
0
10
1
0
0
0
0
287
0
144
0
2,052
2,498
Agricultural
53
6
5
1
154
30
764
255
216
18
566
442
0
2,510
I/C/G
33
4
51
12
32
4
32
4
630
16
310
0
4,427
5,553
0
0
0
0
0
0
0
0
0
0
0
0
0
1
33
4
0
0
0
0
996
0
498
0
7,112
8,655
11
9
1
279
54
1,385
462
392
32
1,026
801
0
4,549
Home & Garden
0
Swimming Pool
12
Industry
Large-Small Establishments
Agricultural
97
I/C/G
60
7
92
22
58
6
58
6
1,142
28
562
0
8,025
10,067
Home & Garden
0
Swimming Pool
3
Industry
Large Establishments
0
0
0
0
0
0
0
0
0
0
0
0
0
0
8
1
0
0
0
0
241
0
120
0
1,718
2,091
1,321
1,153
128 34,301
6,604
170,123 56,773
48,100
3,943
126,065 98,368
0
558,766
Agricultural
I/C/G
Home & Garden
Swimming Pool
Industry
11,887
7,313
2,736
7,146
794
7,146
794
140,310
3,478
68,996
0
985,651
1,236,458
0
813 11,282
0
0
0
0
0
0
0
0
0
0
0
0
0
1,602
178
4,629
514
0
0
0
0
138,476
0
69,238
0
989,117
1,203,756
Page 310
Table K-1d. Number of Containers Within the Scope of the Rule by Container Type, Entity
Size, and Market Sector: Refillable Solid Pesticide Containers
Bulk
101 - 2,500
“Large”
< 100 lb
(> 2,501 lbs)
lbs
Bulk
Tank Paper/Plastic Paper/Plastic Paper/Plastic
Subtotal-Dry
Containers
Other
Total
Small-Small Establishments
Agricultural
0
10
25
1,286
0
1,322
2,398
I/C/G
0
0
0
0
0
0
2,380
Home & Garden
0
0
0
0
0
0
0
Swimming Pool Industry
0
0
0
0
0
0
2,498
Agricultural
1
24
59
3,001
0
3,084
5,594
I/C/G
0
0
0
0
0
0
5,553
Home & Garden
0
0
0
0
0
0
0
Swimming Pool Industry
0
0
0
0
0
0
8,655
Agricultural
1
44
107
5,439
0
5,591
10,140
I/C/G
0
0
0
0
0
0
10,067
Home & Garden
0
0
0
0
0
0
0
Swimming Pool Industry
0
0
0
0
0
0
2,091
172
5,347
13,109
668,074
0
686,703
1,245,469
I/C/G
0
0
0
0
0
0
1,236,458
Home & Garden
0
0
0
0
0
0
0
Swimming Pool Industry
0
0
0
0
0
0
1,203,756
Medium-Small Establishments
Large-Small Establishments
Large Establishments
Agricultural
Page 311
Table K-2a. Number of Containers Out of Compliance for the Average Registrant, by Requirement, Market Sector, and Entity Size
(Nonrefillable Containers)
DOT Packaging
Standards,
Hazardous Material
Small Establishments
Agriculture
Indust./Comm./Govt.
Home & Garden
Total
Small-Small Establishments
Agriculture
Indust./Comm./Govt.
Home & Garden
Total
Medium-Small Establishments
Agriculture
Indust./Comm./Govt.
Home & Garden
Total
Large-Small Establishments
Agriculture
Indust./Comm./Govt.
Home & Garden
Total
Large Establishments
Agriculture
Indust./Comm./Govt.
Home & Garden
Total
DOT Packaging
Standards, Nonhazardous Material
Closure
Standards
Dispensing
Standards
Labeling
Recordkeeping
0
0
0
0
0
0
0
0
39
0
0
39
81
272
511
865
1,596
1,383
6,556
9,535
1,596
1,383
6,556
9,535
0
0
0
0
0
0
0
0
9
0
0
9
18
60
112
190
351
304
1,442
2,097
351
304
1,442
2,097
0
0
0
0
0
0
0
0
40
0
0
40
84
281
529
894
1,650
1,429
6,778
9,857
1,650
1,429
6,778
9,857
0
0
0
0
0
0
0
0
217
0
0
217
453
1,519
2,854
4,825
8,906
7,716
36,586
53,208
8,906
7,716
36,586
53,208
0
0
0
0
0
0
0
0
30,404
0
0
30,404
63,288
212,341
398,927
674,556
1,245,062
1,078,612
5,114,449
7,438,123
1,245,062
1,078,612
5,114,449
7,438,123
Page 312
Table K-2b. Number of Containers Out of Compliance for the Average Registrant, by Requirement, Market Sector, and Entity Size
(Refillable Containers)
DOT Packaging
DOT Packaging
Standards,
Standards, NonHazardous
hazardous Material
Material
Labeling
Recordkeeping
Container
Markings
Minibulk
Container
Openings
Bulk Container
Standards
Small Establishments
Agriculture
0.00
0.00
27.34
27.34
27.34
4.18
0.09
Indust./Comm./Govt.
0.00
0.00
36.19
36.19
1.09
6.02
0.23
Home & Garden
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Total
0.00
0.00
63.53
63.53
28.43
10.20
0.31
Agriculture
0.00
0.00
6.01
6.01
6.01
0.92
0.02
Indust./Comm./Govt.
0.00
0.00
7.96
7.96
0.24
1.32
0.05
Home & Garden
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Total
0.00
0.00
13.97
13.97
6.25
2.24
0.07
Medium-Small Establishments
Agriculture
0.00
0.00
28.26
28.26
28.26
4.32
0.09
Indust./Comm./Govt.
0.00
0.00
37.41
37.41
1.13
6.23
0.23
Home & Garden
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Total
0.00
0.00
65.67
65.67
29.39
10.55
0.32
Large-Small Establishments
Agriculture
0.00
0.00
152.56
152.56
152.56
23.33
0.49
Indust./Comm./Govt.
0.00
0.00
201.94
201.94
6.10
33.61
1.26
Small-Small Establishments
Home & Garden
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Total
0.00
0.00
354.50
354.50
158.66
56.94
1.75
Agriculture
0.00
0.00
21326.52
21326.52
21326.52
3261.93
68.98
Indust./Comm./Govt.
0.00
0.00
28229.63
28229.63
853.30
4698.55
176.25
Large Establishments
Home & Garden
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Total
0.00
0.00
49556.14
49556.14
22179.81
7960.48
245.23
Page 313
Table K-3. Number of Refillable Containers by Type of Refilling Entity
Number of Containers within the Scope
of the Rule
Type of Refilling Entity
Agriculture
Agricultural Pesticide Refillers
Agricultural Pesticide Registrants
I/C/G -- Pesticide registrants
Swimming Pool Industry -- Antimicrobial Applicators
Home & Garden
Total
Page 314
Liquid
566,900
Dry
696,700
Total
1,263,600
510,210
627,030
1,137,240
56,690
69,670
126,360
37,458
0
37,458
1,217,000
0
1,217,000
0
0
0
2,388,258
696,700
2,518,058
Table K-4a. Annual Refillings per Refiller Currently Not in Compliance with Inspection Requirement by Container Type, Entity
Size, and Market Sector
61 - 125 Gallons
Large-Small
2.0
0.2
0.2
0.0
8.0
1.5
Medium-Small
0.6
0.1
0.1
0.0
2.4
0.5
Small-Small
0.1
0.0
0.0
0.0
0.3
0.1
Large
16.7
1.9
1.6
0.2
67.3 13.0
Agricultural Pesticide Registrants
Small
0.0
0.0
0.0
0.0
0.1
0.0
Large-Small
0.1
0.0
0.0
0.0
0.3
0.1
Medium-Small
0.0
0.0
0.0
0.0
0.1
0.0
Small-Small
0.0
0.0
0.0
0.0
0.0
0.0
Large
10.2
1.1
1.0
0.1
41.1
7.9
I/C/G -- Pesticide registrants
Small
0.3
0.0
0.3
0.1
0.3
0.0
Large-Small
1.5
0.2
1.7
0.6
1.9
0.2
Medium-Small
0.3
0.0
0.3
0.1
0.3
0.0
Small-Small
0.1
0.0
0.1
0.0
0.1
0.0
Large
208.8 23.2
243.6
81.2
261.0 29.0
Swimming Pool Supply Companies -- Antimicrobial Applicators
Small
0.0
0.0
0.0
0.0
0.0
0.0
Large-Small
0.0
0.0
0.1
0.0
0.0
0.0
Medium-Small
0.0
0.0
0.1
0.0
0.0
0.0
Small-Small
0.0
0.0
0.0
0.0
0.0
0.0
Large
18.9
2.1
54.5
6.1
0.0
0.0
37.7 29.4
11.2
8.7
1.3
1.0
318.3 248.3
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.2
0.9
0.3
0.0
7.5
3.1
0.9
0.1
25.7
155.4
46.1
5.5
1311.8
0.0
0.0
0.0
0.0
303.4
89.9
10.7
2560.2
0.3
1.5
0.3
0.1
203.9
0.1
0.5
0.1
0.0
68.1
0.1
0.4
0.1
0.0
57.7
0.0
0.0
0.0
0.0
4.7
0.2
0.2
1.4
1.1
0.3
0.2
0.1
0.0
194.3 151.6
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.1
0.0
0.0
0.0
0.0
4.6
0.0
0.1
0.0
0.0
15.7
1.0
5.7
1.1
0.2
800.8
0.0
0.0
0.0
0.0
0.0
2.0
11.2
2.1
0.4
1562.9
0.3
1.9
0.3
0.1
261.0
0.0
0.2
0.0
0.0
29.0
0.1
0.2
0.6
0.9
0.1
0.2
0.0
0.0
84.7 127.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 3258.3
Page 315
2.0
6.9
3.4
0.7
Other
Total
0.9
0.3
0.0
7.7
Plastic Steel Plastic Steel
Other
11.2
3.3
0.4
94.4
Steel
< 100 lb
Paper/Plastic
13.2
3.9
0.5
111.5
26 - 60 Gallons
39.6
11.7
1.4
334.0
Steel Plastic
5 - 25 Gallons
126 - 250 Gallons
Plastic
101 - 2,500 lbs
Paper/Plastic
Steel
Bulk (> 2,501 lbs)
Paper/Plastic
Plastic
Container Type: Dry Products
“Large” Bulk Tank
Plastic Steel
Agricultural Pesticide Refillers
Bulk Tanks
(> 250 Gallons)
“Large” Bulk Tanks
Container Type: Liquid Products
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.7
9.6
1.8
0.4
1348.7
1.0
3.4
1.7
0.3
0.0
0.0
0.0
0.0
14.2
49.1
24.3
4.7
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
17.3
59.6
29.5
5.7
0.0 1629.2
0.0
23274 0.0
0.0
0.0
0.0
0.0
28242.9
0.0
0.0
0.0
0.0
Table K-4b. Annual Refillings per Refiller Currently Not in Compliance with Container Cleaning Requirement by Container
Type, Entity Size, and Market Sector
Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel
Agricultural Pesticide Refillers
Large-Small
0.4
0.0
0.0
0.0
1.6
0.3
7.9
2.6
2.2
0.2
7.5
5.9 0.0 0.0
Medium-Small
0.1
0.0
0.0
0.0
0.5
0.1
2.3
0.8
0.7
0.1
2.2
1.7 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.1
0.0
0.3
0.1
0.1
0.0
0.3
0.2 0.0 0.0
Large
3.3
0.4
0.3
0.0
13.5
2.6
66.8 22.3
18.9
1.5
63.7 49.7 0.0 0.0
Agricultural Pesticide Registrants
Small
0.0
0.0
0.0
0.0
0.0
0.0
0.1
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large-Small
0.0
0.0
0.0
0.0
0.1
0.0
0.3
0.1
0.1
0.0
0.3
0.2 0.0 0.0
Medium-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.1
0.0
0.0
0.0
0.1
0.0 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large
2.0
0.2
0.2
0.0
8.2
1.6
40.8 13.6
11.5
0.9
38.9 30.3 0.0 0.0
I/C/G -- Pesticide registrants
Small
0.1
0.0
0.1
0.0
0.1
0.0
0.1
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large-Small
0.3
0.0
0.3
0.1
0.4
0.0
0.4
0.0
0.1
0.2
0.0
0.0 0.0 0.0
Medium-Small
0.1
0.0
0.1
0.0
0.1
0.0
0.1
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large
41.8
4.6
48.7 16.2
52.2
5.8
52.2
5.8
16.9 25.4
0.0
0.0 0.0 0.0
Swimming Pool Supply Companies -- Antimicrobial Applicators
Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Medium-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Page 316
Total
Other
< 100 lb
Paper/Plastic
101 - 2,500 lbs
Paper/Plastic
Bulk (> 2,501 lbs)
Paper/Plastic
“Large” Bulk Tank
Other
5 - 25 Gallons
Container Type: Dry Products
26 - 60 Gallons
61 - 125 Gallons
126 - 250 Gallons
Bulk Tanks
(> 250 Gallons)
“Large” Bulk
Tanks
Container Type: Liquid Products
0.2
0.1
0.0
1.5
0.6 31.1
0.2
9.2
0.0
1.1
5.1 262.4
0.0
0.0
0.0
0.0
60.7
18.0
2.1
512.0
0.0
0.0
0.0
0.0
0.9
0.0
0.2
0.0
1.1
0.0
0.2
0.0
0.0
3.1 160.2
0.0
0.0
0.0
0.0
0.0
0.4
2.2
0.4
0.1
312.6
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.3
1.9
0.4
0.1
269.7
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Table K-4c. Annual Refillings per Refiller Currently Not in Compliance with Container Tracking (Recordkeeping)
Requirement by Container Type, Entity Size, and Market Sector
Page 317
Total
Other
< 100 lb
Paper/Plastic
101 - 2,500 lbs
Paper/Plastic
Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel Plastic Steel
Agricultural Pesticide Refillers
Large-Small
4.9 0.5
0.5
0.1
20.0
3.8
99.0 33.0
28.0
2.3
94.3 73.6 0.0 0.1
Medium-Small
1.5 0.2
0.1
0.0
5.9 1.1
29.3
9.8
8.3
0.7
27.9 21.8 0.0 0.0
Small-Small
0.2 0.0
0.0
0.0
0.7
0.1
3.5
1.2
1.0
0.1
3.3
2.6 0.0 0.0
Large
41.7 4.6
4.0
0.4 168.4 32.4 835.1 278.7 236.1 19.4 795.6 620.8 0.0 0.6
Agricultural Pesticide Registrants
Small
0.0
0.0
0.0
0.0
0.1 0.0
0.7
0.2
0.2
0.0
0.6
0.5 0.0 0.0
Large-Small
0.2 0.0
0.0
0.0
0.7
0.1
3.6
1.2
1.0
0.1
3.5
2.7 0.0 0.0
Medium-Small
0.0
0.0
0.0
0.0
0.1 0.0
0.7
0.2
0.2
0.0
0.6
0.5 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.0 0.0
0.1
0.0
0.0
0.0
0.1
0.1 0.0 0.0
Large
25.4 2.8
2.5
0.3 102.8 19.8 509.8 170.1 144.1 11.8 485.7 379.0 0.0 0.4
I/C/G -- Pesticide registrants
Small
0.7
0.1
0.8
0.3
0.8 0.1
0.8
0.1
0.3
0.4
0.0
0.0 0.0 0.0
Large-Small
3.7
0.4
4.4
1.5
4.7 0.5
4.7
0.5
1.5
2.3
0.0
0.0 0.0 0.0
Medium-Small
0.7
0.1
0.8
0.3
0.9 0.1
0.9
0.1
0.3
0.4
0.0
0.0 0.0 0.0
Small-Small
0.1
0.0
0.2
0.1
0.2 0.0
0.2
0.0
0.1
0.1
0.0
0.0 0.0 0.0
Large
522.1 58.0 609.1 203.0 652.6 72.5 652.6 72.5 211.7 317.6
0.0
0.0 0.0 0.0
Swimming Pool Supply Companies -- Antimicrobial Applicators
Small
0.0
0.0
0.0
0.0
0.0 0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large-Small
0.0
0.0
0.0
0.0
0.0 0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Medium-Small
0.0
0.0
0.0
0.0
0.0 0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Small-Small
0.0
0.0
0.0
0.0
0.0 0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Large
0.0
0.0
0.0
0.0
0.0 0.0
0.0
0.0
0.0
0.0
0.0
0.0 0.0 0.0
Bulk (> 2,501 lbs)
Paper/Plastic
“Large” Bulk Tank
Other
5 - 25 Gallons
Container Type: Dry Products
26 - 60 Gallons
61 - 125 Gallons
126 - 250 Gallons
Bulk Tanks
(> 250 Gallons)
“Large” Bulk
Tanks
Container Type: Liquid Products
2.2
0.7
0.1
18.7
7.6 388.6
2.3 115.2
0.3
13.7
64.3 3279.4
0.0 758.5
0.0 224.8
0.0
26.8
0.0 6400.4
0.0
0.1
0.0
0.0
11.4
0.1
2.6
0.3
14.3
0.1
2.7
0.0
0.6
39.3 2001.9
0.0
5.0
0.0
27.9
0.0
5.2
0.0
1.1
0.0 3907.2
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
4.3
0.0
24.1
0.0
4.5
0.0
1.0
0.0 3371.7
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Table K-5a. Present Discounted Value of Compliance Costs per Entity for Refilling Requirement, 3% Discount Rate
Year
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
$1215
$987
$958
$930
$903
$877
$851
$826
$802
$779
$756
$734
$713
$692
$672
$652
Medium-Small
499
293
284
276
268
260
252
245
238
231
224
218
211
205
199
193
Small-Small
234
35
34
33
32
31
30
29
28
28
27
26
25
24
24
23
8776
8328
8085
7850
7621
7399
7184
6974
6771
6574
6383
6197
6016
5841
5671
5506
205
7
6
6
6
6
6
5
5
5
5
5
5
5
4
4
Large-Small
236
36
35
34
33
32
31
30
30
29
28
27
26
26
25
24
Medium-Small
205
7
7
6
6
6
6
6
5
5
5
5
5
5
5
4
Agricultural Pesticide Refillers
Large-Small
Large
Agricultural Pesticide Registrants
Small
Small-Small
Large
200
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5434
5084
4936
4792
4652
4517
4385
4258
4134
4013
3896
3783
3673
3566
3462
3361
Industrial/Commercial/Government Pesticide Registrants
Large-Small
230
31
30
30
29
28
27
26
26
25
24
23
23
22
21
21
Medium-Small
204
6
6
5
5
5
5
5
5
5
4
4
4
4
4
4
Small-Small
199
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
4717
4387
4259
4135
4015
3898
3784
3674
3567
3463
3362
3264
3169
3077
2987
2900
Large
Swimming Pool Supply Companies – Antimicrobial Applicators
Large-Small
223
24
24
23
22
22
21
20
20
19
19
18
18
17
16
16
Medium-Small
210
12
12
11
11
11
10
10
10
9
9
9
9
8
8
8
Small-Small
200
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
12026
11484
11149
10825
10509
10203
9906
9618
9337
9065
8801
8545
8296
8055
7820
7592
Large
Page 318
Table K-5b. Present Discounted Value of Compliance Costs per Entity for Refilling Requirement, 7% Discount Rate
Year
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
$1004
$785
$734
$686
$641
$599
$560
$523
$489
$457
$427
$399
$373
$349
$326
$305
Medium-Small
413
233
218
203
190
178
166
155
145
135
127
118
111
103
97
90
Small-Small
193
28
26
24
23
21
20
18
17
16
15
14
13
12
12
11
7254
6626
6193
5787
5409
5055
4724
4415
4126
3856
3604
3368
3148
2942
2750
2570
169
5
5
5
4
4
4
3
3
3
3
3
2
2
2
2
Large-Small
195
29
27
25
24
22
21
19
18
17
16
15
14
13
12
11
Medium-Small
169
5
5
5
4
4
4
4
3
3
3
3
3
2
2
2
Agricultural Pesticide Refillers
Large-Small
Large
Agricultural Pesticide Registrants
Small
Small-Small
Large
165
1
1
1
1
1
1
1
1
1
1
1
1
1
0
0
4492
4045
3780
3533
3302
3086
2884
2695
2519
2354
2200
2056
1922
1796
1678
1569
Industrial/Commercial/Government Pesticide Registrants
Large-Small
190
25
23
22
20
19
18
17
16
15
14
13
12
11
10
10
Medium-Small
169
5
4
4
4
4
3
3
3
3
3
2
2
2
2
2
Small-Small
165
1
1
1
1
1
1
1
1
1
1
1
0
0
0
0
3899
3491
3262
3049
2849
2663
2489
2326
2174
2032
1899
1774
1658
1550
1448
1354
Large
Swimming Pool Supply Companies – Antimicrobial Applicators
Large-Small
184
19
18
17
16
15
14
13
12
11
10
10
9
9
8
7
Medium-Small
174
10
9
8
8
7
7
6
6
6
5
5
5
4
4
4
Small-Small
166
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
9940
9137
8539
7981
7459
6971
6515
6088
5690
5318
4970
4645
4341
4057
3792
3544
Large
Page 319
| File Type | application/pdf |
| File Title | Microsoft Word - container EA 06-01-2006 |
| Author | ahofmann |
| File Modified | 2016-06-22 |
| File Created | 2006-07-13 |