SUPPORTING STATEMENT FOR
AN INFORMATION COLLECTION REQUEST (ICR)
1. IDENTIFICATION OF THE INFORMATION COLLECTION
1(a). Title of the Information Collection
Compliance Requirement for Child-Resistant Packaging
OMB No. 2070-0052; EPA No. 0616.09
1(b). Short Characterization/Abstract
This information collection program is designed to provide the Environmental Protection Agency (EPA) with assurances that the packaging of pesticide products sold and distributed to the general public in the United States meets standards set forth by the Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants must certify to the Agency that the packaging or device meets these standards. There are no forms associated with this information collection activity.
2. NEED FOR AND USE OF THE COLLECTION
2(a). Need/Authority for the Collection
Section 25(c)(3) of FIFRA authorizes EPA to establish standards for packaging of pesticide products and pesticidal devices to protect children and adults from serious illness or injury resulting from accidental ingestion or contact (see Attachment A). The law requires that these standards are designed to be consistent with those under the Poison Prevention Packaging Act, administered by the Consumer Product Safety Commission (CPSC). Unless a pesticide product qualifies for an exemption, if the product meets certain criteria regarding toxicity and use, it must be sold and distributed in child-resistant packaging. The authority for this information collection is pursuant to Section 25(c)(3) of the FIFRA. Compliance regulations are contained in 40 Code of Federal Regulations (CFR) Part 157 (Attachment B).
2(b). Practical Utility/Users of the Data
EPA reviews a registrant's child-resistant packaging (CRP) certification to determine if there are human safety/health risk concerns. Exemption requests are reviewed to ascertain if there is a health risk, and if CRP is technically feasible, practicable, and appropriate.
NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
3(a). Non duplication
To avoid duplicative testing of packages for pesticidal and non-pesticidal purposes, EPA's CRP regulations reference the CPSC packaging standards and protocol testing procedures. This is the only information collection activity of its kind and the information collected under this activity is collected only once per event (e.g., once per certification of CRP compliance).
3(b). Public Notice Required Prior to ICR Submission to OMB
In preparing to renew this ICR, EPA published a notice in the Federal Register which provided a 60-day public notice and comment period on the draft ICR (see 72 FR 13274; March 21, 2007). EPA received one public comment in response to this notice which is available in the docket for this ICR and can be accessed at http://www.regulations.gov using the docket indentifier EPA-HQ-OPP-2006-0861. That comment was general in nature about the risk of pesticides, and did not address the burden, cost, or purpose of this information collection.
3(c). Consultations
EPA consults with the CPSC on general packaging issues, products under joint jurisdiction (e.g. bleaches and pine oil products), and the regulatory aspect of implementing consumer (child) safety measures in a way that keeps them consistent with those under the Poison Prevention Packaging Act.
The Agency also discusses specific packaging issues (for example, determining what can reasonably be required or expected in terms of technical and/or economic feasibility) with the CPSC and the packaging industry itself. These consultations occur on an informal "as needed" basis during the process of evaluating exemption requests and certifying to the use of CRP. In the past, when any sort of problem (technical, administrative, or other) arose, or there were suggestions for improvement in the program, the respondent is given ample opportunity to inform the agency and vice versa. This communication between both parties may take place either in a telephone conversation or in a meeting setting, but not necessarily by a prescribed schedule.
During the preparation of this ICR renewal, EPA staff contacted the following representatives of pesticide registrants by telephone and e-mail and asked them for their feedback on the burden and cost estimates in the ICR:
Mark Jernigan Federal Registration Manager Bio-Lab, Inc. P.O. Box 300002 Lawrenceville, GA 30049 (678) 502-4149 |
Amy Plato Roberts Technology Sciences Group Inc. 1150 18th Street, NW, Suite 1000 Washington, DC 20036 Direct Dial: (202) 828-8964 E-Mail: aroberts@tsgusa.com |
Stuart McArthur Sr. Registration Spec. S. C. Johnson & Son, Inc. Howe St., Racine, WI, 53402 Tel. No. (262) 260-2405 |
|
Although Mr. Jernigan, Ms. Roberts, and Mr. McArthur all agreed that preparation times can differ widely, they also agreed that on the average, EPA’s burden hour estimates accurately reflected the time needed to prepare the various types of CRP submissions (see Attachment C).
3(d). Effects of Less Frequent Collection
The information collection occurs once for each product-package combination subject by law to the CRP provisions. In the absence of this information collection activity, the burden of proof would be shifted from the registrant to the EPA. Based on enforcement case precedents involving CRP, EPA would need to have specific evidence to make the product-package case. Consequently, on the basis of the time and cost involved, EPA would find it difficult to fulfill its statutory responsibilities to ensure that pesticides are equipped with protective packages adequate to protect children from accidental illness or injury.
3(e). General Guidelines
The only PRA-imposed guideline in 5 CFR 1320.6 that is exceeded in this collection is the recordkeeping retention period. Registrants or applicants of pesticides for which CRP is required must retain the records required under 40 CFR 157.36 for as long as the registration is valid.
Registrations are valid unless or until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration due to an adverse finding by EPA. Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA-imposed guideline indicating that data, other than health, medical, or tax records need not be retained for more than three years may often be exceeded in this program.
The Agency solicits packaging manufacturers to voluntarily submit samples of CRPs that have passed CRP testing, identify the packaging, its manufacturer, and list the package's classification according to the ASTM International Standard D3475, "Standard Classification of Child-Resistant Packages." The Agency will compile and update the information on an ongoing basis on its CRP Website (www.epa.gov/opprd001/crp/). The Website includes descriptions and photographs of the package, with each package classified according to the ASTM International D3475 Standard.
The CRP Website provides a service to CRP manufacturers and pesticide registrants by displaying the various types of CRP in the marketplace which, in turn, should facilitate compliance with the CRP regulations. An Agency request for, and the public’s submission of, these packaging samples is not a collection of information for the purposes of the Office of Management and Budget (OMB) Paperwork Reduction Act regulations. OMB’s regulations define “information” such that it excludes “samples of products or of any other physical objects” (see 5 CFR 1320.3(h)(2)). Therefore, EPA is not required to estimate the burden associated with submitting these packaging samples.
3(f). Confidentiality
Although submission of confidential information is not required as a part of this information collection, there has been at least one instance where confidential data have been submitted voluntarily as supporting material for an exemption request from CRP compliance requirements.
When any trade secret or Confidential Business Information (CBI) is provided to EPA, such information is protected from disclosure under section 10 of FIFRA. Data submitted to EPA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Manual.
This manual contains instructions relative to all contact with confidential documents, including responsibilities of EPA employees, physical security measures, CBI copying and destruction procedures, transfer of CBI materials within the EPA, to contractors or other government offices, computer security, CBI typing procedures (documents to be typed internally or on contract), and division internal procedures.
The manual dictates that all CBI must be marked or flagged as such, only authorized EPA personnel may be permitted access to CBI, and CBI must be kept in secure (double locked) areas. Additionally, CBI for destruction must be cleared by a Document Control Officer and placed in the Office of Prevention, Pesticides and Toxic Substances paper shredder.
3(g). Sensitive Questions
No information of a sensitive or private nature is requested in this information collection activity.
4. THE RESPONDENTS AND THE INFORMATION REQUESTED
4(a). Respondents/NAICS Codes
The North American Industrial Classification System (NAICS) code for respondents under this ICR is 325320 (Pesticide and other Agricultural Chemical Manufacturing). EPA estimates that 703 registrants will be required to respond to this information collection activity annually. The number of respondents is based on the number of registrants in FY2006 that had active registrations for pesticides meeting the use criteria which trigger Child-Resistant Packaging (CRP) requirements. In FY2006, these registrants held 5,307 pesticide registrations with 40% (2109 pesticide registrations) triggering the CRP requirements. On average, a CRP response will be submitted once every three years for each of these 2109 affected registered products.
4(b). Information Requested
Pesticide registrants subject to the regulations are required to certify to the Agency that the packaging for the pesticide product meets the standards of 40 CFR 157, or request an exemption to the requirement.
(i) Data items, including record keeping requirements
The respondent certification letter must exercise one of the following information options in this section or in section (i)(a) to comply with 40 CFR Part 157:
Certify to CRP by letter to Agency |
The name, and EPA registration number of the product to which the certification applies, the Certification statement, the registrant’s name and address, the date, and the name, title and signature of the company officer making the certification. The Certification statement must contain a statement that the pesticide product complies with 40 CFR 157.32. A description of the packaging used and the ASTM International Standard D3475, "Standard Classification of Child-Resistant Packages," designation is requested (not required). |
Product does not meet Toxicity Criteria |
Submit toxicity data that indicate a specific product's minimal toxicity, or reformulate to a less toxic product and assert that the CRP regulations do not apply. Approximately 2 percent of pesticide registrants choose this option for complying with the CRP program. |
Product is not for Residential Use |
Revise product labeling so that CRP regulations do not apply, i.e., specifying non-residential use areas, or eliminate residential use. The registrant is required to send EPA a copy of the revised labeling. Approximately 2 percent of pesticide registrants use this option. |
Approximately 92 percent of pesticide registrants choose to certify that their pesticide product packaging meets the effectiveness, compatibility, and durability standards at 40 CFR 157.32. Registrants who certify are required to maintain data to corroborate the certification for the duration of the pesticide's registration as required by 40 CFR 157.36. Of those registrants who do certify, approximately 35 percent must submit data because of human safety/health risk concerns. If data is needed, EPA requests that registrants submit data electronically to expedite data analysis. Pesticide Regulation (PR) Notice 97-9 describes the benefits and requirements of electronic data submission (see Attachment D).
(i)(a) Exemptions from CRP
Currently, registrants have several options by which they may be exempted from CRP requirements. These options include:
(1) Package the product in a large size so that CRP regulations do not apply. Exercising this option effectively eliminates sales to the general public. It is based on the concept that certain bulk size pesticide packages are intended for commercial use even in residential areas (i.e., exterminator-use insecticides and contract lawn care products). These package sizes are specified in 40 CFR 157.24 (a)(2). The pesticide registrant is not required to seek a formal exemption for this option, and approximately 4 percent of registrants use this option. However, CRP may be required for products packaged in a size exceeding those outlined in exemption criteria at 40 CFR 157.24(a)(2) if it is determined by the EPA that the product is distributed or sold to the general public. As such, EPA expects that some of these registrants will no longer meet the criteria for the exemption.
(2) Registrants may also assert that an exemption to CRP is warranted because the hazards indicated by the toxicity criteria are not indicative of risk to humans, or that CRP is not technically feasible, practicable, or appropriate. Each request for an exemption is unique, and the data necessary to support an exemption are unique. Less than 1 percent of pesticide registrants choose this option with the CRP program.
(ii) Respondent Activities
In order to comply with the CRP regulations, registrants must engage in the following activities:
Read instructions |
Review requirements of FIFRA section 25 (c)(3) and 40 CFR Part 157, including its reference to 16 CFR 1700.15(b) and 16 CFR 1700.20; |
Plan activities |
Decide under which option to comply with CRP compliance requirements or whether an exemption will be requested; |
Create information |
Compile necessary data regarding compliance or exemption from CRP requirements; |
Review data for reliability and appropriateness |
Review performance testing data to ensure that it will support CRP certification and identify the ASTM International Standard D3475, “Standard Classification of Child-Resistant Packages,” for the package.
|
Prepare and submit certification statement. |
Draft a certification statement citing compliance with CRP requirements and include a description of the package, or explain why the product is not subject to CRP, or request an exemption from CRP compliance requirements and compile/cite any supporting data as necessary. Submit information to EPA. |
Store, file, and maintain data |
Maintain any data and information sent to EPA to certify CRP compliance, support a determination as to why product is not subject to CRP, or justify an exemption from CRP. |
5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
5(a). Agency Activities
Upon receipt of a certification letter, EPA performs the following activities:
Review correspondence |
Review correspondence for completeness. Incomplete/incorrect certifications are returned to registrants; |
Evaluate data and advise registrant |
Evaluate data submitted and determine whether the registrant has met the CRP requirements, has sufficiently substantiated reasons for not being subject to CRP (e.g. reformulate to a less toxic product) or decide whether or not to grant an exemption. Advise registrant of decision; |
Store, file, and maintain data |
All CRP data submitted to the Agency are referenced by an MRID number in the registration file jacket for the pesticide product. The Agency maintains a record of all CRP certifications in its generic database. |
5(b). Collection Methodology and Management
Respondents to this ICR submit the information as part of their larger package for registration of a pesticide product. Although EPA is working to allow electronic submission of registration packages, they are currently submitted by mail. The Agency has no objection to submission of the CRP information on CD ROM as part of the registration package.
For CRP certifications with data, EPA requests that responses are submitted electronically to expedite data analysis. See Attachment D for guidance on electronic data submission. CRP certifications with data are the most burdensome of the four response types under this ICR, comprising about 35 percent of all responses and nearly 80 percent of the total estimated burden.
EPA only collects data in support of a CRP certification when there are human safety/health risk concerns. EPA requires that registrants maintain data in support of their certifications of the child-resistance of the product's packaging or devices. At the time of CRP certification we are requesting that the registrant identify the type of packaging used. This data is a part of their recordkeeping requirements (under 40 CFR 157.36). This additional piece of data may enable the Agency to contact all pesticide registrants using a particular type of CRP should a generic problem with the CRP become evident (e.g. trigger sprayers that are no longer considered CRP). It will also facilitate the review of CRP exemption requests because the Agency can ascertain how similar pesticide formulations are packaged.
The generic database system continually tracks all registration actions from the registration-pending stage through to full registration and until a product is canceled. A generic database maintains information on both currently registered products and previously registered products, thereby acting as a registration action historical file. Additionally, the CRP compliance certification hard copy correspondence letters are filed in the pesticide product registration jacket.
5(c). Small Entity Flexibility
The incorporation of alternative methods to verify that the package meets the requirements of 40 CFR 157.32 have allowed manufacturers to use extrapolation schemes, available child-resistant protocol test data, and supporting documentation without spending the time and money to develop the data on their exact package. The burden and cost to industry also is minimized by: the reference of the CPSC effectiveness standards and protocol test procedures that preclude duplicative testing for pesticidal and non-pesticidal purposes, and also allow for the use of CRP developed for non-pesticidal purposes; the use of packaging manufacturer's data rather than product-specific data; discretion and innovation with regard to product packaging compatibility and package selection; and the granting of the size exemptions without requiring an application from the registrant or approval by EPA.
5(d). Collection Schedule
CRP certification is usually conducted only when a registrant notifies EPA by application of their intention to either change packaging, enter the residential market, or otherwise become subject to CRP regulations. Therefore, for each registered pesticide product, this is a one-time submission unless labeled product use or package design changes.
6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION
6(a). Estimating Respondent Burden
EPA estimates that the average burden associated with this information collection activity is approximately 4.9 hours per response.1 This estimate is based on an average response time across all response types (i.e. submit CRP certifications, submit CRP certifications with data, submit CRP exemption explanation based on large package size, submit CRP exemption explanation based on a lack of toxicity, packaging issues, eliminating residential use, lower product toxicity). The number of respondents expected for each of the various response types is based on the number of each type of CRP submission received annually.
EPA’s estimates of respondent burden do not include any burden at management levels. Responses to this information collection activity are generally handled, without management time, by the technical personnel such as the regulatory affairs person and packaging personnel with some clerical support. These CRP actions require an estimated average of 3.5 hours technical time and 1.4 hours clerical time, which is broken down as follows:
25 technical minutes to ascertain whether the product is subject to the CRP regulations (meets toxicity criteria, residential use) and to decide whether to submit a CRP certification, data, be exempt from regulations due to large size or other criteria;
86 technical minutes to create/prepare the information;
73 technical minutes to review submission for accuracy and appropriateness (process, compile, complete document);
61 clerical minutes to format submission and prepare information;
25 technical minutes to review and sign the appropriate documents; and,
25 clerical minutes to mail the submission, file the respondent copy and CRP documentation
Type of Response |
Number of Responses |
Percent of Total |
CRP certification |
401 |
57 |
CRP certification with data |
246 |
35 |
Exempt – large package size |
28 |
4 |
Exempt – lack of toxicity, packaging, no residential use, lower product toxicity |
28 |
4 |
Respondents submitting CRP certifications without data require 1 hour of technical labor time in order to determine whether the product is subject to the CRP regulations (meets toxicity criteria, residential use), identify the type of CRP used, and prepare the CRP certification. An additional 30 minutes clerical time is required to complete the CRP certification submission to the Agency and file the supporting CRP information.
Respondents submitting CRP certifications with data require 8 hours of technical labor time in order to determine the product is subject to the CRP regulations (meets toxicity criteria, residential use); identify the type of CRP used; prepare the CRP certification; gather the supporting CRP data; and 3 hours of clerical time to prepare the CRP data package, complete the CRP certification submission to the Agency, and file the supporting CRP data.
Respondents that are exempt from CRP requirements based on large package size require no time because the CRP regulations require no action on their part. Respondents that are exempt from CRP requirements for the reasons described in Section 4(b) of this ICR require 4 technical hours and 1.9 clerical hours to prepare their submission indicating why CRP is not required and/or CRP is not possible. These burden estimates by response type are summarized in Table 1.
The total estimated respondent burden to comply with this information collection activity is 3,473 burden hours/year (4.94 hours per respondent x 703 respondents) at a cost of $193,567. This cost estimate is illustrated in Table 2.
Table 1. ANNUAL RESPONDENT BURDEN BY RESPONSE TYPE
Type of Response |
No. of Responses |
Technical Burden |
Clerical Burden |
Aggregate Burden |
||
Hours Per Event |
Total |
Hours Per Event |
Total |
|||
CRP certification |
401 |
1 |
401 |
0.5 |
200.5 |
601.5 |
CRP certification with data |
246 |
8 |
1968 |
3 |
738 |
2706 |
Exempt from CRP due to large package size |
28 |
0 |
0 |
0 |
0 |
0 |
Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity |
28 |
4 |
112 |
1.9 |
53.2 |
165.2 |
TOTAL |
703 |
n/a |
2481 |
n/a |
991.7 |
3,473 |
6(b). Estimating Respondent Costs
For a period of some years, when estimating labor rates for most OPP program ICR renewals, the Agency adjusted the ICR renewal labor rates by using methods such as the NASA Gross Domestic Product (GDP) Deflator Inflation Calculator to index the labor cost for a particular year. However, in July 2006, Agency economists completely re-estimated wages, benefits, and overhead for all labor categories for the pesticide industry, state government and Agency employees. The Agency analysis uses currently available information on labor rates and other benefits from publicly available websites. A copy of the methodology used to re-estimate the labor rates and formulas used to derive the fully loaded rates and overhead costs is in Attachment E.
To derive the labor rates for this ICR, Agency economists estimated the wages for the technical and clerical labor categories using the methodology cited above. The respondent costs for this renewal for technical and clerical rates are estimated at $64.80 and $33.05 per hour, respectively. These labor rates are fully loaded and include benefits and overhead costs.
The total average cost of the estimated burden per respondent to comply with the CRP is approximately $275 per response. Using the Agency’s burden estimate and the fully-loaded labor rates, the Agency estimates total applicant costs to be approximately $193,567 per year. There are no capital expenditures associated with this information collection activity.
Table 2. ANNUAL RESPONDENT BURDEN/COST ESTIMATES
COLLECTION ACTIVITIES |
Burden Hours |
TOTAL |
||
Tech. $64.80/hr. |
Clerical $33.05/hr. |
Burden Hours |
Costs (in USD) |
|
Read instructions |
0.20 |
0 |
0.20 |
12.96 |
Plan activities |
0.21 |
0 |
0.21 |
13.61 |
Create information including electronic format of data |
1.43 |
0 |
1.43 |
92.66 |
Process, compile, and complete written compliance document |
1.24 |
1.04 |
2.28 |
114.72 |
Review submission |
0.41 |
0 |
0.41 |
26.57 |
Store, submit, file, or maintain data |
0 |
0.41 |
0.41 |
13.55 |
TOTAL |
3.5 |
1.4 |
4.94 |
274 |
ANNUAL BURDEN: 4.94 Total Hours x 703 Respondents = 3,473 Burden Hours
ANNUAL COSTS:
(a) Technical: 3.53 hours x $64.80 x 703 respondents = $160,807
(b) Clerical: 1.41 hours x $33.05 x 703 respondents = $ 32,760
Total = $193,567
6(c). Estimating Agency Burden and Cost
The Agency burden hours for the entire CRP process will decrease from 19.8 hours to18.9 hours per response. There has been a significant decrease in the number of exemption requests from CRP due to lack of toxicity or packaging, which is the most resource intensive activity for EPA, which results in an overall decrease in the average Agency burden per response.
Annual burden to the Agency is estimated at 13,296.5 burden hours at a cost of $869,311. The main portion of the burden hours is expected to result from the evaluation of data related to human safety/health risk concerns associated with CRP certification, and assessing some of the more complex options for compliance (e.g. requesting an exemption).
Table 3. ANNUAL AGENCY BURDEN BY RESPONSE TYPE
Action |
No. of Respondents |
Technical Burden |
Clerical Burden |
||
Hrs Per Event |
Total |
Hrs Per Event |
Total |
||
CRP certification |
401 |
2.3 |
922.3 |
1 |
401 |
CRP certification with data |
246 |
40 |
9840 |
1 |
246 |
Exempt from CRP due to large package size (registrant meets size requirement, no action needed) |
28 |
0 |
0 |
0 |
0 |
Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity |
28 |
66.5 |
1862 |
0.9 |
25.2 |
TOTAL |
703 |
n/a |
12,624.3 |
n/a |
672.2 |
Agency Burden = 12,624.3 (technical burden) + 672.2 (clerical burden) = 13,296.5
Total hrs/Agency Action = 13,296.5 ÷ 703 = 18.9 hrs
The average Agency burden per CRP response is estimated to be approximately 18.9 hours, costing $1,236.57 per response ($869,310.82 ÷ 703).
Table 4. ANNUAL AGENCY BURDEN/COST ESTIMATES
COLLECTION ACTIVITIES |
BURDEN HOURS (per respondent) |
TOTAL |
|||
Mgmt. $93.07/hr |
Tech. $66.34/hr |
Clerical $47.17/hr. |
Burden Hours |
Costs (in USD) |
|
Read correspondence |
0 |
1 |
0 |
1 |
$66.34 |
Execute activities including data review and certifications for large size nonliquid pool chemicals |
0 |
17 |
0 |
17 |
$1127.78 |
Store, file, or maintain data |
0 |
0 |
0.9 |
0.9 |
$42.45 |
TOTAL |
0 |
18 |
0.9 |
18.9 |
$1236.57 |
ANNUAL BURDEN: 18.9 Total Hours x 703 Responses = 13,296.5 Hours
ANNUAL COSTS:
(a) Technical: 18 hours x $66.34 x 703 responses = $839,466.36
(b) Clerical: 0.9 hours x $47.17 x 703 responses = $ 29,844.46
Total $869,310.82
6(d). Bottom Line Burden Hours and Cost Table
|
Hours |
Costs |
Respondent Burden/Cost Estimates |
3,473 |
$193,567 |
Agency Burden/Cost Estimates |
13,297 |
$869,311 |
6(e). Reasons for Change In Burden
The number of responses remains the same at 703 from the last ICR approval. The total burden hours per respondent for compliance with the CRP requirements increased from 3 hours to 4.9 hours at a total cost of about $275 per response. The estimated annual burden under the last ICR approval was 2,109 hours. Under this renewal ICR, the annual burden is estimated to be 3,473 hours. The estimated burden increase represents an adjustment. Neither the number of responses nor the average burden estimate for each response type has changed. However, the distribution of those responses among the four response types has changed, with a net shift from less-burdensome to more-burdensome type responses (e.g., increased percentage of registrants electing to certify to the CRP requirements with data).
A number of registrants who have traditionally marketed their products in CRP have selected new packaging designs, thereby triggering the CRP requirements with data to insure human safety/health risk concerns. Additionally, increased burden may be attributed to increased complexity of CRP testing for more complex new CRP (e.g. 2 closures on 1 bottle), increased use of CRP outside necessitating additional information (e.g. outdoor ant baits). Some respondents may opt to certify to CRP due to changes in the cost of packaging, recycling, and safety factors. Some registrants voluntarily use CRP to avoid having to stock multiple packaging inventories for different products and/or an increased environmental conscience. Some respondents may be electing to certify to CRP because it is less time consuming than electing to submit toxicity data, reformulate to a less toxic product, or request an exemption.
6(f). Burden Statement
The total annual respondent burden for the collection of information contained in this ICR is estimated to be 3,473 hours. The average "respondent" (certifier) burden for the Compliance Requirement for the CRP regulations is estimated to be 4.9 hours per submission of data necessary to support a claim that product is not subject to CRP, should be exempt from CRP, or CRP certification, including time for: reading relevant federal legislation and regulations; conducting performance testing on closures and/or devices; reviewing test data; prepare submission or CRP certification; and recordkeeping regarding the CRP certification or submission.
As defined by the PRA and 5 CFR 1320.3(b), “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
To facilitate public comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2006-0861. All documents in the docket are listed in the docket index. Although listed in the index, some information may not be publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID No. EPA-HQ-OPP-2006-0861 and OMB Control No. 2070-0052 in any correspondence.
Attachments to the Supporting Statement
Attachment A: Section 25 (c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - available at http://www.epa.gov/opprd001/crp/ or in the docket to this ICR at EPA-HQ-2006-0861
Attachment B: 40 CFR Part 157 - PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES – available at http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr157_03.html or in the docket to this ICR at EPA-HQ-2006-0861
Attachment C: Record of Consultations Between the U.S. Environmental Protection Agency and Respondents to the Information Collection Request: “Compliance Requirement for Child-Resistant Packaging” - available in the docket to this ICR at EPA-HQ-2006-0861
Attachment D: Pesticide Registration Notice 97-9 - Electronic Submission of Child-resistant Packaging Test Data for All Pesticides and Child-resistant Testing of Prefilled, Nonrefillable Insecticide Bait Stations Not Designed or Intended To Be Opened or Activated in a Manner That Exposes the Contents to Human Contact - available at http://www.epa.gov/opppmsd1/PR_Notices/pr97-9.html or in the docket to this ICR at EPA-HQ-2006-0861
Attachment E: Methodology For Estimating OPP ICR Wage Rates for Industry, State and EPA Labor Costs: Memo From Richard Keigwin, Director Biological and Economic Analysis Division, July 25 , 2006. – available in the docket to this ICR at EPA-HQ-2006-0861
Attachment F: Display Related to OMB Control #2070-0052 - Listings of
Related Regulations in 40 CFR 9.1 - available in the docket to this ICR at EPA-HQ-2006-0861
1 1 Based on Table 1, the avg. technical burden across all response types is approx. 3.53 hrs. per response (2481 ÷ 703) and the avg. clerical burden across all response types is approx. 1.41 hrs. per response (991.7 ÷ 703). For the purposes of estimating respondent burden and cost (see Table 2), EPA assumes that the average burden is 4.94 hrs. per response (3.53 technical hrs. + 1.41 clerical hrs.).
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File Type | application/msword |
File Title | SUPPORTING STATEMENT FOR |
Author | rosalind |
Last Modified By | OPPT |
File Modified | 2007-07-10 |
File Created | 2007-07-09 |