Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
Title: |
Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate (3:1); Revision to the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals under the Toxic Substances Control Act (TSCA); Final Rule (RIN 2070-AL02) |
EPA ICR No.: |
2779.02 |
OMB Control No.: |
2070-0230 |
Docket ID No.: |
EPA-HQ-OPPT-2023-0376 |
In January 2021, the U.S. Environmental Protection Agency (EPA) finalized five rules under section 6(h) of the Toxic Substances Control Act (TSCA) regarding prohibitions and restrictions on the following five chemical substances: decabromodiphenyl ether (decaBDE) (Chemical Abstract Services Number (CASRN) 1163-19-5), phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7), 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (CASRN 732-26-3), pentachlorothiophenol (PCTP) (CASRN 133-49-3), and hexachlorobutadiene (HCBD) (CASRN 87-68-3). Based on information submitted by regulated entities since the publication of the 2021 decaBDE and PIP (3:1) final rules, the Agency has determined that amendments to both rules are necessary to address implementation issues and to further reduce the potential for exposures. Thus, EPA is finalizing revisions to the 2021 decaBDE and PIP (3:1) final rules under TSCA. EPA has developed this Information Collection Request (ICR) that includes the total burden for these two chemicals under the Paperwork Reduction Act (PRA) and, once approved by the Office of Management and Budget (OMB), EPA will merge these activities and estimates with the existing ICR (EPA ICR No. 2599.03; OMB Control No 2070-0213), which includes all the PBT chemicals from the previous rulemakings.
This ICR addresses the following information collection activities contained in EPA’s revisions to the 2021 final rules for decaBDE and PIP (3:1) under TSCA section 6(h).
For decaBDE:
Third-party disclosure for export notification for decaBDE-containing wire and cable for nuclear power generation facilities.
Worker protection information generation, recordkeeping, and notification requirements, including:
Development of documentation of respiratory protection program and selection of personal protective equipment (PPE), and related recordkeeping;
Development of documentation for designated areas and related recordkeeping; and
Development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control, exposure monitoring records, PPE program implementation documentation, and respirator program documentation.
For PIP (3:1):
Downstream notification requirements through Safety Data Sheets (SDS) or label,
Worker protection information generation, recordkeeping, and notification requirements, including:
Development of documentation of respiratory protection program and selection of PPE, and related recordkeeping;
Development of documentation for designated areas and related recordkeeping; and
Development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control, exposure monitoring records, PPE program implementation documentation, and respirator program documentation.
The final rule also requires that records be retained for 5 years from the date of generation.
Table 1: Summary Total Burden
Activity IC |
Number of Respondents |
Annual Number of Responses |
Average Annual Responses per Respondent |
Annual Burden (Hours) |
Annual O&M Costs (Dollars) |
Agency |
N/A |
N/A |
N/A |
N/A |
- |
Reporting for Decabromodiphenyl ether (DecaBDE) (CASRN 1163-19-5) |
2 |
2 |
1 |
8 |
- |
Reporting for Phenol, isopropylated phosphate (3:1) (PIP (3:1)) (CASRN 68937-41-7) |
26,803 |
26,803 |
1 |
42,293 |
- |
Total: |
26,805 |
26,805 |
1 |
42,300 |
- |
1Totals may not sum due to rounding |
TSCA – Section 6(h) of TSCA (15 U.S.C. § 2605(h) directs EPA to take action under section 6(a) on certain PBT chemical substances. Under section 6(h), EPA must address risks and reduce exposure to these PBT chemicals to the extent practicable. With regard to the PBT chemicals, section 6(a) authorizes EPA to:
Prohibit or limit manufacture, processing, or distribution in commerce;
Prohibit or limit the manufacture, processing, or distribution in commerce above a specified concentration of the chemical substance;
Require minimum warnings and instructions with respect to use, distribution, or disposal;
Require manufacturers or processors to make and retain records;
Prohibit or regulate any manner of commercial use;
Prohibit or regulate any manner of disposal; and/or
Require manufacturers or processors to give notice of the unreasonable risk of injury, and to recall products if required.
Additionally, with the obligation to promulgate these rules, EPA also has the authority to amend them (e.g., if circumstances change, including in relation to the receipt of new information). It is well settled that the Agency has inherent authority to reconsider, revise, or repeal past decisions to the extent permitted by law so long as the Agency provides a reasoned explanation. See F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).
For decaBDE, EPA is finalizing revisions to the 2021 final rule to require the use of personal PPE during certain activities involving decaBDE. EPA is also finalizing: a prohibition on releases to water during the manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products; an extension for the compliance date for the phase-out of processing and distribution in commerce of decaBDE-containing wire and cable insulation for nuclear power generation facilities; an export notification requirement for decaBDE-containing wire and cable for nuclear power generation facilities; an exclusion to allow for distribution in commerce of new and replacement parts containing decaBDE; and a regulatory threshold level for unintentional decaBDE present in products and articles at less than 0.1% by weight.
For PIP (3:1), EPA is finalizing revisions to the 2021 final rule to require the use of PPE for the domestic manufacturing and processing of PIP (3:1) and certain PIP (3:1)-containing products and articles. EPA is also finalizing: phase-outs on processing and distribution for certain uses; new exclusions from the prohibitions on processing and distribution in commerce of PIP (3:1) for use in wire harnesses and electric circuit boards and for the processing and distribution in commerce of such PIP (3:1)-containing harnesses and circuit boards; an exclusion to allow for distribution in commerce of new and replacement parts containing PIP (3:1); and an regulatory threshold level for unintentional decaBDE and PIP (3:1) present in products and articles at less than 0.1% by weight.
The information collection activities covered by this ICR are necessary to enhance the exposure reductions as directed by TSCA section 6(h).
Export notification: The required TSCA section 12(b) export notifications for decaBDE-containing wire and cable for nuclear power generation facilities are received by EPA’s Planning, Management, and Operations Division (PMOD) in OPPT. This action would extend the section 12(b) export notification to a narrow subset of articles containing decaBDE. For more information about the paperwork burdens associated with export notification, see OMB Control No. 2070-0030.
Downstream Notification: Without the downstream notification requirement, there is a greater likelihood that non-prohibited uses of PIP (3:1) could be diverted to prohibited uses, or that users would buy or use materials that they do not realize are subject to the restrictions in the final rule. Downstream notification would be carried out by updates to the relevant SDS or label and is necessary for effective implementation and enforcement of the rule as it provides a record of notification on use restrictions throughout the supply chain. Downstream notification is required for manufacturers, processors, and distributors in commerce of PIP (3:1) and PIP (3:1)-containing products, who would notify companies downstream upon shipment of PIP (3:1) about the prohibitions. The information submitted to downstream companies through the SDS would provide knowledge and awareness of the restrictions to these companies.
Worker
protection information, recordkeeping, and notification requirements:
EPA has authority under section 6 of TSCA to require recordkeeping
related to the regulatory requirements imposed by EPA. This is
especially important where, as here, such records are needed for
effective implementation and enforcement of the TSCA section 6(h)
rule to reduce exposures to the extent practicable. Information
collection activities for such records required for worker protection
measures would provide potentially exposed persons in a workplace
with clear and necessary information and would provide EPA with a
necessary evidential mechanism for effective enforcement. The
regulated entities would develop, compile, and retain records that
are necessary for implementing worker protection requirements,
provide workplace notification to potentially exposed persons, and
serve as a reference for EPA or authorized entities. These records
include records for implementing regulated areas, exposure monitoring
records, if required, and selection of PPE. These records demonstrate
that regulated entities are in compliance with the requirements in
this rule. Compliance with the rule is required to reduce exposures
to extent practicable to reduce risk to human health identified by
EPA for decaBDE and PIP (3:1). These recordkeeping requirements are
also necessary to permit the EPA to conduct its enforcement
activities and to ensure compliance within the regulated community.
This additional regulation should not substantially increase the
burden on these companies since PPE is already in use and being
codified under this rule in most cases.
The
Administrator will use the information collected under this ICR to
furnish the proposed notice to the government of the importing
country. The importing country typically uses the information
provided to ensure that chemicals imported into their country comply
with their applicable laws and regulations.
The
required TSCA section 12(b) export notifications for
decaBDE-containing wire and cable for nuclear power generation
facilities are received by EPA’s Program Management and
Operations Division (PMOD) in OPPT. This action would extend the TSCA
section 12(b) export notification to a narrow subset of articles
containing decaBDE. For more information about the paperwork burdens
associated with export notification, see OMB Control No. 2070-0030.
EPA’s collection pursuant to the TSCA section 6(a) regulations do not duplicate any other collection. EPA is requiring information to ensure the reduction of exposure to the extent practicable to decaBDE and PIP (3:1). While this collection activity required by EPA is similar to those of other Federal agencies such as OSHA, some entities who were not previously required to maintain certain records under the OSHA standard may be subject to recordkeeping requirements in order to demonstrate they have addressed risks by reducing exposures to the extent practicable under TSCA section 6(h). The requirements of this final rule also include regulated entities where OSHA requirements are not applicable (e.g., public sector workers not covered by an OSHA State plan, and self-employed workers). Thus, these are EPA-specific collection activity guidelines for the regulation of decaBDE and PIP (3:1) under TSCA section 6(h) and therefore has no duplicative requirements. An exporter of decaBDE-containing wire and cable for nuclear power generation facilities, by this rule, will be required to submit one annual notice to EPA. There are no viable alternate sources for the Agency to obtain the information necessary to provide the necessary information to the governments of importing countries.
Under section 6(h) of TSCA (15 U.S.C. § 2605(h)), EPA must address the risks of injury to health or the environment that the Agency determines are presented by decaBDE and PIP (3:1) and must reduce exposure to the substances to the extent practicable by applying one or more requirements under TSCA section 6(a), (see #1 above). EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is important where, as here, such records and reports are necessary for effective implementation and enforcement of the section 6(h) rule.
Regarding the worker protection related requirements, due to the nature of the triggering events that initiate information collection activities under the final rule (i.e., the exposure of workers, and potentially exposed persons) a shorter timeframe for record retention is not feasible. The information collection activities covered by this ICR are necessary in order to ensure the effective reduction of exposures to address risks from decaBDE and PIP (3:1), thus any associated burdens to the regulated entities are necessary for the implementation of this TSCA section 6(h) rule. Should the records in this information collection activity not be maintained nor be made accessible in accordance with the fine rule, effective implementation of the worker protection measures would be compromised and EPA would not be able to determine if exposure is reduced to the extent practicable to address risk presented by the chemical substances, and will hinder investigative efforts by the regulated entity and by EPA.
Due to the nature of the triggering events that initiate information collection activities for export notification, less frequent collection is not feasible. The rules only include reporting information to third parties as needed via Safety Data Sheet and to EPA via export notification requirements as described below.
Consistent with EPA regulations at 40 CFR 707.65(a)(1)(i), and pursuant to this proposed rule, an exporter will be required to submit, on an annual basis, one TSCA section 12(b) notice for each country to which decaBDE-containing wire and cable for nuclear power generation facilities is exported. Further, pursuant to 40 CFR 707.65(a)(2), such TSCA section 12(b) notice must be submitted to EPA “within seven days of forming the intent to export or on the date of export, whichever is earlier. A notice of intent to export must be based on a definite contractual obligation, or an equivalent intra-company agreement, to export the regulated chemical.” Once EPA receives this information, it will inform the importing country’s national focal point under the Stockholm Convention to ensure that the government of the country to which the chemical is imported may consider any applicable obligations under the Stockholm Convention.
EPA believes this action will not have a significant economic impact on a substantial number of small entities. Of the 26,805 firms impacted by the rule, 24,865 are considered small. All of small firms subject to this requirement have a cost-revenue impact of less than 3 percent, and 6% of small firms have an impact under 1 percent.
a) requiring respondents to report information to the agency more often than quarterly;
b) requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
c) requiring respondents to submit more than an original and two copies of any document;
d) requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
e) in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
f) requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
g) that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
h) requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
This final rule and information collection activity will require that regulated entities subject to workplace protection regulations retain records for a duration of 5 years from the date of its inception. EPA is proposing to increase the recordkeeping requirement from three to five years and to remove the 30-day timeframe to make records available for decaBDE and PIP (3:1). Due to the additional requirements in this final rule, specifically those pertaining to worker safety, EPA believes that the five-year timeframe regarding recordkeeping is more appropriate. Furthermore, this is consistent with the timeframe associated with other TSCA section 6(a) rulemakings which include worker protection requirements. EPA expects that 5-year retention of records for workplace protection is necessary for effective implementation and enforcement of this final rule.
EPA developed the proposed rule title “Decabromodiphenyl Ether and Phenol, Isopropylated Phosphate (3:1); Revision to the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals under the Toxic Substances Control Act (TSCA)” published in the Federal Register for public comment (88 FR 82287, November 3, 2023). The proposed rule served as the public notice for this ICR amendment, which is available in the public docket. Interested parties were directed to submit comments referencing Docket ID No. EPA-HQ-OPPT-2023-0376. The final rule, Economic Analysis, and ICR were developed with consideration of comments received from the public in response to the notice of proposed rulemaking.
EPA has developed a Response to Comments document that summarizes the comments received and EPA’s responses that were not included and responded to in the preamble. This document is available in the docket for the rulemaking (EPA-HQ-OPPT-2023-0376).
This question is not applicable to this ICR.
EPA will
disclose information that is covered by a claim of confidentiality
only to the extent permitted by, and in accordance with, the
procedures in TSCA and 40 CFR part 2. Information submitted under
specific reporting requirements of TSCA, or in support of TSCA, is
subject to the provisions of section 14 of TSCA and to EPA's
Regulations on the Confidentiality of Business Information (see 40
CFR part 2). Failure to follow these procedures fully at the time of
document submission to EPA is interpreted by the Agency as a waiver
of confidentiality claims. Submitters may claim confidentiality for
proprietary information. However, notwithstanding any claim of
confidentiality, the foreign government of the importing country will
be notified of the export of the substance(s) in question.
No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108, as amended, “Responsibilities for the Maintenance of Records about Individuals by Federal Agencies.”
Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under ‘Annual Cost to Federal Government’
This ICR specifies two chemical-specific information collections (ICs) for the paperwork requirements on persons who manufacture, process, or distribute in commerce decaBDE or PIP (3:1). For each respondent category, the ICR describes the respondents, the information collection activities and related estimates for burden and costs associated with those activities. The general activities and methodology for estimating the burden and cost of the paperwork requirements for these rules is as follows, as does a chemical-specific IC discussion which specifies the instances in which the paperwork requirements apply and presents chemical-specific burden and labor cost estimates.
Costs
EPA assumes no direct costs are associated with this collection. Labor costs are based on fully loaded wage rates and are shown in Table 2.
Table 2: Technical Wage Rates
Labor Category |
Data Series 1 |
Period |
Wage ($/hour) |
Fringe Benefit |
Total Comp. |
Overhead as % of Total Comp.2 |
Overhead |
Hourly Loaded Wages3 |
(a) |
(b) |
(c) =(b)+(a) |
(d) |
(e)=(c)*(d) |
(f)=(c)+(e) |
|||
Managerial |
BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial” |
2022 Q04 |
$54.29 |
$24.66 |
$78.95 |
20% |
$15.79 |
$94.74 |
Professional / Technical |
BLS ECEC, Private Manufacturing industries, “Professional and related“ |
2022 Q04 |
$46.01 |
$23.27 |
$69.28 |
20% |
$13.86 |
$83.14 |
Production Worker / Clerical |
BLS ECEC, Private Manufacturing industries, “Office and Administrative Support” |
2022 Q04 |
$23.11 |
$10.33 |
$33.44 |
20% |
$6.69 |
$40.13 |
Industrial Hygienist |
Wage: BLS OES Occupat. Employ. and Wages, Occup. Health and Safety Specialists (SOC 19-5011); Fringes (as percent): BLS ECEC, Private Manufacturing industries, “Professional and related" |
May 21 |
$37.86 |
$19.15 |
$57.01 |
20% |
$11.40 |
$68.41 |
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Based on the rule’s compliance dates and exemptions in the CFR, the following activities involving the use of decaBDE may permissibly be ongoing:
Until 2036, or the end of the vehicles’ service lives, manufacturing, processing, and distribution in commerce of decaBDE for use in replacement parts for motor vehicles and the decaBDE-containing replacement parts.
After the end of the service life for aerospace vehicles manufactured before January 8, 2024, import, processing, and distribution in commerce of such vehicles that contain decaBDE in any part. After the end of the service life for aerospace vehicles manufactured after January 8, 2024, manufacture, processing, and distribution in commerce of decaBDE for use in replacement parts for such vehicles, and the replacement parts to which decaBDE has been added for such vehicles.
After the end of their service life, for processing and distribution in commerce of plastic shipping pallets that contain decaBDE and were manufactured prior to the publication date of the rule.
Processing and distribution in commerce for recycling of decaBDE-containing plastic products and articles (i.e., the plastic to be recycled is from articles and products that were originally made with decaBDE), and for decaBDE-containing products or articles made from such recycled plastic, in which no new decaBDE is added during the recycling or production process.
Companies identified with these uses of decaBDE, and thus most likely affected by the paperwork requirements for decaBDE, are associated with the North American Industrial Classification System (NAICS) codes:
Plastics Product Manufacturing (NAICS Code 3261)
Custom Compounding of Purchased Resins (NAICS Code 325991)
Nuclear Electric Power Generation (NAICS Code 221113)
Materials Recovery Facilities (NAICS Code 562920)
Aircraft Engine and Engine Parts Manufacturing (NAICS Code 336412)
Other Aircraft Part and Auxiliary Equipment Manufacturing (NAICS Code 336413)
Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing (NAICS Code 336415)
Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS Code 336419)
Motor Vehicle Body Manufacturing (NAICS Code 336211)
Motor Vehicle Gasoline Engine and Engine Parts Manufacturing (NAICS Code 336310)
Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS Code 336320)
Other Motor Vehicle Parts Manufacturing (NAICS Code 336390)
Motorcycle, Bicycle and Parts Manufacturing (NAICS Code 336991)
All Other Transportation Equipment Manufacturing (NAICS Code 336999)
Estimated Number of Potential Respondents
Based on EPA’s Public 2020 Chemical Data Reporting (CDR) data (EPA 2019) and the activities prohibited for decaBDE, EPA estimates that 2 respondents are subject to the paperwork requirements of the final rule for decaBDE.
Activities and Data Items
Rule Familiarization Burden
EPA assumes that each manufacturer (including importers), processor, and distributor of products or articles that contain the regulated chemicals will spend three hours in the first year of the rule for those subject to PPE requirements and one hour for those not subject to PPE requirements for becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to comply with the rule’s requirements.
Export Notification Burden
EPA is requiring that all persons intending to export decaBDE or decaBDE-containing wire and cable for nuclear power generation facilities be required to notify EPA under TSCA section 12(b). EPA estimates export notification will take approximately 13 hours in the first year of the rule for the one company estimated to be subject to this requirement.
Downstream Notification Burden
There are no downstream notification requirements for firms using decaBDE.
Recordkeeping Burden
Manufacturers (including importers), processors, and distributors of the chemicals are required by the final rule to maintain, for a period of five years from the date the record is generated, ordinary business records, such as bills of lading, invoices, or comparable documents related to compliance with this rule.
Under some conditions of use, this rule requires that companies provide respiratory and dermal PPE to workers. There are recordkeeping costs associated with PPE requirements, listed below. EPA estimates that PPE documentation will take small firms (less than 20 employees) 1 hour, medium firms (20-499 employees) 4 hours, and large firms (more than 500 employees) 16 hours in the first year of the rule.
The following must be documented according to the rule:
(A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle the chemical (decaBDE) or handle equipment or materials on which the chemical may present, and the type of PPE selected to be worn by each of these persons;
(B) The basis for PPE selection (e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area);
(C) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE;
(D) The basis for the regulated area, including monitoring data and documentation of any controls or combination of controls that have reduced exposure to where airborne concentrations of PIP (3:1) can no longer reasonably be expected resulting in a smaller or no regulated area being established; and
(E) Procedures to notify potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation.
Estimated Annual IC Burden and Cost
EPA estimates that paperwork burden associated with rule requirements for decaBDE is 8 hours per year, as shown in Table 3.
IC Calculation: |
EPA’s Estimates:a |
|
1. Responses: |
||
Total Number of Respondents |
2 |
|
Number of Responses (chemicals) per Respondent |
1 |
|
Time Period for Each Response |
On occasion |
|
Annual Frequency (times per year, per respondent) |
1 |
|
Annual Number of Responsesb |
2 |
|
2. Burden Hours: |
||
Activities |
Hour per Responseb |
Annual Hour Burden |
Reporting (Rule Familiarization) |
1.0 |
2 |
Third-Party Disclosure (Export Notification) |
4.2 |
4 |
Recordkeeping (PPE Documentation, Small Manufacturer) |
1.0 |
0 |
Recordkeeping (PPE Documentation, Medium Manufacturer) |
4.0 |
1 |
Recordkeeping (PPE Documentation, Large Manufacturer) |
16.0 |
0 |
Total Burden Hours: |
- |
8 |
3. Capital and O&M Costs (this does NOT include labor costs): |
||
Activities |
Cost per Response |
Annual Cost |
Reporting (Rule Familiarization) |
$0.00 |
$0.00 |
Third-Party Disclosure (Export Notification) |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Small Manufacturer) c |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Medium Manufacturer) c |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Large Manufacturer) c |
$0.00 |
$0.00 |
Total Capital and O&M Costs: |
$0.00 |
$0.00 |
4. Annual Responses and Burdens: |
||
Annual Totals |
Total Requested |
|
Annual Responses |
2 |
|
Annual Hour Burden (rounded to nearest hour) |
8 |
|
Annual Cost (Non-Labor) |
$0.00 |
|
a Based on details provided in the Tables presented earlier in this section. b This number is used as a multiplier to calculate the Annual Burden hours and costs. c Burden incurred in first year only. Average 3-year burdens are 0.3, 1.3, and 5.3 hour for small, medium, and large manufacturers, respectively. Note: Totals may not sum due to rounding. |
Based on the rule’s compliance dates and exemptions, the following activities involving the use of PIP (3:1) may still be ongoing:
Processing and distribution in commerce for use in hydraulic fluids either for the aviation industry or to meet military specifications for safety and performance where no alternative chemical is available that meets U.S. Department of Defense specification requirements;
Processing and distribution in commerce for use in lubricants and greases for turbine and aviation use;
Processing and distribution in commerce for use in new and replacement parts for the automotive and aerospace industry, and the distribution in commerce of the parts to which PIP (3:1) has been added;
Processing and distribution in commerce for use as an intermediate in a closed system to produce cyanoacrylate adhesives;
Processing and distribution in commerce for use as an adhesive and sealant until four years after January 6, 2025;
Processing and distribution in commerce for use in specialized engine filters for locomotive and marine applications;
Processing for recycling and distribution in commerce for the recycling of PIP (3:1) containing plastic that has no new PIP (3:1) added during the recycling process;
Processing and distribution in commerce of articles and products made from recycled PIP (3:1) containing plastic that has no new PIP (3:1) added during the recycling process or to the articles and products made from the recycled plastic; and
Processing and distribution in commerce of PIP (3:1) for use in articles and PIP (3:1)-containing articles after October 31, 2024.
Companies identified with these uses of PIP (3:1), and thus most likely affected by the paperwork requirements for PIP (3:1) are associated with the North American Industrial Classification System codes associated with the following industries:
Adhesive Manufacturing (NAICS Code 325520);
Air and Gas Compressor Manufacturing (NAICS Code 333912);
Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS Code 333415);
Aircraft Engine and Engine Parts Manufacturing (NAICS Code 336412);
Aircraft Manufacturing (NAICS Code 336411);
All Other Basic Organic Chemical Manufacturing (NAICS Code 325199);
All Other Industrial Machinery Manufacturing (NAICS Code 333248);
All Other Miscellaneous Electrical Equipment and Component Manufacturing (NAICS Code 335999);
All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS Code 333998);
All Other Plastics Product Manufacturing (NAICS Code 326199);
All Other Transportation Equipment Manufacturing (NAICS Code 336999);
Analytical Laboratory Instrument Manufacturing (NAICS Code 334516);
Appliance Repair and Maintenance (NAICS Code 811412);
Audio and Video Equipment Manufacturing (NAICS Code 334310);
Automobile and Light Duty Motor Vehicle Manufacturing (NAICS Code 336110);
Automobile and Other Motor Vehicle Merchant Wholesalers (NAICS Code 423110);
Bare Printed Circuit Board Manufacturing (NAICS Code 334412);
Boat Building (NAICS Code 336612);
Broadwoven Fabric Mills (NAICS Code 313210);
Computer and Computer Peripheral Equipment and Software Merchant Wholesalers (NAICS Code 432430);
Computer Storage Device Manufacturing (NAICS Code 334112);
Computer Terminal and Other Computer Peripheral Equipment Manufacturing (NAICS Code 334118);
Construction Machinery Manufacturing (NAICS Code 333120);
Current-Carrying Wiring Device Manufacturing (NAICS Code 335931);
Custom Compounding of Purchased Resins (NAICS Code 325991);
Electronic Computer Manufacturing (NAICS Code 334111);
Electronic Connector Manufacturing (NAICS Code 334417);
Farm and Garden Machinery and Equipment Merchant Wholesalers (NAICS Code 423820);
Farm Machinery and Equipment Manufacturing (NAICS Code 333111);
Guided Missile and Space Vehicle Manufacturing (NAICS Code 336414);
Guided Missile and Space Vehicle Propulsion Unit Parts Manufacturing (NAICS Code 336415);
Heating Equipment (except Warm Air Furnaces) Manufacturing (NAICS Code 333414);
Heavy Duty Truck Manufacturing (NAICS Code 336120);
Household Appliances, Electric Housewares, and Consumer Electronics Merchant Wholesalers (NAICS Code 423620);
Industrial Machinery and Equipment Merchant Wholesalers (NAICS Code 423830);
Industrial Supplies Merchant Wholesalers (NAICS Code 423840);
Industrial Truck, Tractor, Trailer and Stacker Machinery Manufacturing (NAICS Code 333924);
Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing (NAICS Code 333413);
Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS 334513);
Lawn and Garden Tractor and Home Lawn and Garden Equipment Manufacturing (NAICS Code 333112);
Major Household Appliance Manufacturing (NAICS Code 335220);
Manufacturing and Reproducing Magnetic and Optical Media (NAICS Code 334610);
Mechanical Power Transmission Equipment Manufacturing (NAICS Code 333613);
Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (NAICS Code 423450);
Mining Machinery and Equipment Manufacturing (NAICS Code 333131);
Miscellaneous Intermediation (NAICS Code 523910);
Motor and Generator Manufacturing (NAICS Code 335312);
Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS Code 336320);
Motor Vehicle Gasoline Engine and Engine Parts Manufacturing (NAICS Code 336310);
Motor Vehicle Supplies and New Parts Merchant Wholesalers (NAICS Code 423120);
Motorcycle, Bicycle and Parts Manufacturing (NAICS Code 336991);
New Car Dealers (NAICS Code 441110);
Other Aircraft Part and Auxiliary Equipment Manufacturing (NAICS Code 336413);
Other Basic Inorganic Chemical Manufacturing (NAICS Code 325180);
Other Chemical and Allied Products Merchant Wholesalers (NAICS Code 424690);
Other Commercial and Industrial Machinery and Equipment Rental and Leasing (NAICS Code 532490);
Other Communications and Energy Wire Manufacturing (NAICS Code 335929);
Other Communications Equipment Manufacturing (NAICS Code 334290);
Other Electronic Component Manufacturing (NAICS Code 334419);
Other Electronic Parts and Equipment Merchant Wholesalers (NAICS Code 432690);
Other Engine Equipment Manufacturing (NAICS Code 333618);
Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS Code 336419);
Other Motor Vehicle Parts Manufacturing (NAICS Code 336390);
Paint and Coating Manufacturing (NAICS Code 325510);
Petroleum Lubricating Oil and Grease Manufacturing (324191);
Petroleum Refineries (NAICS Code 324110);
Plastics Material and Resin Manufacturing (NAICS Code 325211);
Plastics Product Manufacturing (NAICS Code 3261);
Printed Circuit Assembly (Electronic Assembly) Manufacturing (NAICS Code 334418);
Plumbing, Heating, and Air-Conditioning Contractors (NAICS Code 238220);
Relay and Industrial Control Manufacturing (NAICS Code 335314);
Semiconductor and Related Device Manufacturing (NAICS Code 334413);
Semiconductor Machinery Manufacturing (NAICS Code 333242);
Ship Building and Repairing (NAICS Code 336611);
Small Electrical Appliance Manufacturing (NAICS Code 335210);
Sporting and Athletic Goods Manufacturing (NAICS Code 339920);
Surface Active Agency Manufacturing (NAICS Code 325613);
Surgical Appliance and Supplies Manufacturing (NAICS Code 339113);
Switchgear and Switchboard Apparatus Manufacturing (NAICS Code 335313); and
Travel Trailer and Camper Manufacturing (NAICS Code 336214).
Estimated Number of Potential Respondents
Based on EPA’s Public 2020 Chemical Data Reporting (CDR) data (EPA 2019) and the activities prohibited for PIP (3:1), EPA estimates that 26,803 respondents are subject to the paperwork requirements of the final rule for PIP (3:1).
Activities and Data Items
Rule Familiarization Burden
EPA assumes that each manufacturer (including importers), processor, and distributor of products or articles that contain the regulated chemicals will spend three hours in the first year of the rule for those subject to PPE requirements and one hour for those not subject to PPE requirements for becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to comply with the rule’s requirements.
Export Notification Burden
There are no export notification requirements for firms using PIP (3:1).
Downstream Notification Burden
EPA is also amending the downstream notification statement that must accompany shipments of PIP (3:1) or PIP (3:1) containing products to conform to the terms of the prohibitions in the final rule. Since downstream notification was required in the 2021 PIP (3:1) PBT rule, EPA generally assumes that firms have updated their product’s Safety Data Sheets (SDS) in the baseline. EPA believes that the costs of making any minor adjustments to the SDS text needed as a result of this final rule would be minimal, but since the exact number of firms modifying their SDS is unknown, incremental downstream notification costs are not quantified.
Recordkeeping Burden
Manufacturers (including importers), processors, and distributors of the chemicals are required by the final rule to maintain, for a period of five years from the date the record is generated, ordinary business records, such as bills of lading, invoices, or comparable documents related to compliance with this rule.
However, under some conditions of use, this current rule requires that companies provide respiratory and dermal PPE to workers. There are recordkeeping costs associated with PPE requirements, listed below. EPA estimates that PPE documentation will take small firms (less than 20 employees) 1 hour, medium firms (20-499 employees) 4 hours, and large firms (more than 500 employees) 16 hours in the first year of the rule.
The following must be documented according to the rule:
(A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle the chemical (PIP (3:1)) or handle equipment or materials on which the chemical may present, and the type of PPE selected to be worn by each of these persons;
(B) The basis for PPE selection (e.g., demonstration based on permeation testing or manufacturer specifications that each item of PPE selected provides an impervious barrier to prevent exposure during expected duration and conditions of exposure, including the likely combinations of chemical substances to which the PPE may be exposed in the work area);
(C) Appropriately sized PPE and training on proper application, wear, and removal of PPE, and proper care/disposal of PPE;
(D) The basis for the regulated area, including monitoring data and documentation of any controls or combination of controls that have reduced exposure to where airborne concentrations of PIP (3:1) can no longer reasonably be expected resulting in a smaller or no regulated area being established; and
(E) Procedures to notify potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation.
Estimated Annual IC Burden and Cost
EPA estimates that paperwork burden associated with rule requirements for PIP (3:1) is about 42,300 hours per year, as shown in Table 4.
Table 4: IC Estimates for PIP (3:1) |
||
IC Calculation: |
EPA’s Estimates: a |
|
1. Responses: |
||
Total Number of Respondents |
26,803 |
|
Number of Responses (chemicals) per Respondent |
1 |
|
Time Period for Each Response |
On occasion |
|
Annual Frequency (times per year, per respondent) |
1 |
|
Annual Number of Responses |
26,803 |
|
2. Burden Hours: |
||
Activities |
Hour per Responseb |
Annual Hour Burden |
Reporting (Rule Familiarization) |
1.0 |
26,803 |
Third-Party Disclosure (Export Notification) |
0.0 |
0 |
Recordkeeping (PPE Documentation, Small Manufacturer) |
1.0 |
2,524 |
Recordkeeping (PPE Documentation, Medium Manufacturer) |
4.0 |
6,304 |
Recordkeeping (PPE Documentation, Large Manufacturer) |
16.0 |
6,661 |
Total Burden Hours: |
- |
42,293 |
3. Capital and O&M Costs (this does NOT include labor costs): |
||
Activities |
Cost per Response |
Annual Cost |
Reporting (Rule Familiarization) |
$0.00 |
$0.00 |
Third-Party Disclosure (Export Notification) |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Small Manufacturer)c |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Medium Manufacturer))c |
$0.00 |
$0.00 |
Recordkeeping (PPE Documentation, Large Manufacturer))c |
$0.00 |
$0.00 |
Total Capital and O&M Costs: |
$0.00 |
$0.00 |
4. Annual Responses and Burdens: |
||
Annual Totals |
Total Requested |
|
Annual Responses |
26,803 |
|
Annual Hour Burden (rounded to nearest hour) |
42,300 |
|
Annual Cost (Non-Labor) |
$0 |
|
a Based on details provided in the Tables presented earlier in this section. b This number is used as a multiplier to calculate the Annual Burden hours and costs. c Burden incurred in first year only. Average 3-year burdens are 0.3, 1.3, and 5.3 hour for small, medium, and large manufacturers, respectively. Note: Totals may not sum due to rounding. |
The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
There are no operational and/or maintenance costs.
The rules include reporting information to third parties as needed via Safety Data Sheet, recordkeeping requirements, and reporting to EPA via export notification requirements as described below.
For the economic analyses for the 2021 final PBT rules (EPA 2021a) and (EPA 2021b), EPA estimated that it would need one FTE employee for implementation (e.g., compliance assistance and enforcement) activities under both the decaBDE and PIP (3:1) rules (two FTEs total). This final rule would modify the existing rules. EPA does not expect that it will require any additional (incremental) Agency staff time to implement the rules under the proposed revisions (proposed or primary alternative options). The additional one company subject to the export notification requirement under the proposed rule does not change the 2021 estimate of 1 FTE and therefore EPA expects no additional Federal government cost for this ICR.
EPA
will not receive or process any information as a result of the
collection. Therefore, EPA estimates that it costs the Agency
approximately $0 to carry out the activities associated with the
information collection activities covered by this ICR.
The change in the total estimated respondent burden is an increase of 42,259 from the 2024 renewal of the 2021 rule ICR. This increase in burden reflects the addition of programmatic changes from the final rule. The baseline burden estimate is from the 2024 ICR renewal of the existing ICR prior to the final rule, with adjustments to the burden estimates, including changes in the number of respondents and the number of responses provided by those respondents, to capture changes and updates since the existing ICR was published. These regulatory changes include additional rule familiarization, export notification, and PPE documentation requirements.
This question is not applicable to this ICR.
This question is not applicable to this ICR.
EPA does not request an exception to the certification of this information collection.
This collection of information is approved by OMB under the PRA, 44 U.S.C. 3501 et seq. OMB Control No. 2070-0230. Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR 751.401-413. 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 public reporting and recordkeeping burden for this collection of information is estimated to be 10 hours per year (17 hours for decaBDE and 65,435 hours for PIP (3:1)). Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Information Engagement Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave. NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function.
All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
U.S. Bureau of Labor Statistics (BLS). (2023). Employer Costs for Employee
Compensation (ECEC) Supplemental Tables. Retrieved from https://www.bls.gov/web/ecec.supp.toc.htm
U.S. Environmental Protection Agency (EPA). (2020a). CDR Data 2016-2019.
U.S. Environmental Protection Agency (EPA). (2020b). Handbook on Valuing Changes
in Time Use Induced by Regulatory Requirements and Other EPA Actions. EPA-236-B-15-001.
In National Center for Environmental Economics (Ed.).
U.S. Environmental Protection Agency (EPA). (2021a). Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), (2021a).
U.S. Environmental Protection Agency (EPA). (2021a). Phenol, Isopropylated Phosphate
(3:1) (PIP 3:1); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA
Section 6(h), (2021b).
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File Modified | 0000-00-00 |
File Created | 2024-11-20 |