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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Proposed Rules including importers of PFAS that are covered as a chemical substance under TSCA section 32. This rule does not require reporting on substances that are excluded from the definition of chemical substance in TSCA section 32B. Those exclusions include, but are not limited to: Any pesticide as defined by the Federal Insecticide, Fungicide, and Rodenticide Act when manufactured, processed, or distributed in commerce for use as a pesticide; any food, food additive, drug, cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device;
tobacco or any tobacco product; any source material, special nuclear material, or byproduct material as such terms are defined in the Atomic Energy Act of 1954; and, any article the sale of which is subject to the tax imposed by Section 4181 of the Internal Revenue Code of 1954. Substances which have been manufactured or imported for intended use as any food, food additive, drug, cosmetic, or device, regulated by the Food and Drug Administration, are not chemical substances under TSCA.
The manufacture of PFAS as a byproduct is not exempt for the purpose of this proposed rule. Unlike TSCA
section 8a1, which specifically provides an exemption for small manufacturers and processors, TSCA
section 8a7 provides no such exemption. Therefore, this proposed rule under TSCA section 8a7 does not exempt small manufacturers from reporting and recordkeeping requirements. See the discussion under Unit II.D. for further discussion of the inclusion of small manufacturers in this proposed rule. The Agencys previous experience with TSCA section 8a1
collections, as well as the Agencys understanding of disposal and other waste management methods involving PFAS, suggests that most respondents affected by this collection activity may be from the following North American Industrial Classification System NAICS code categories:
NAICS 324Petroleum and Coal Product Manufacturing;
NAICS 325Chemical Manufacturing;
NAICS 326113Unlaminated Plastics Film and Sheet except Packaging Manufacturing;
NAICS 327910Abrasive Product Manufacturing;
NAICS 333999All Other Miscellaneous General Purpose Machinery Manufacturing;
NAICS 334511Search, Detection, Navigation, Guidance, Aeronautical,
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and Nautical System and Instrument Manufacturing;
NAICS 336111Automobile Manufacturing;
NAICS 423510Metal Service Centers and Other Metal Merchant Wholesalers;
NAICS 424690Other Chemical and Allied Products Merchant Wholesalers;
NAICS 447190Other Gasoline Stations;
NAICS 551112Offices of Other Holding Companies;
NAICS 562Waste Management and Remediation Services.
Since other entities may also be affected, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action, but rather has provided a guide to help readers determine whether this document applies to them. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER
INFORMATION CONTACT.
In addition, please note that any use of the term manufacture in this document will encompass import and the term manufacturer will encompass importer.
B. What is the Agencys authority for taking this action?
EPA is proposing this rule pursuant to its authority in TSCA section 8a7 15
U.S.C. 2607a7. The National Defense Authorization Act for Fiscal Year 2020
Pub. L. 11692, section 7351 amended TSCA section 8a in December 2019, adding section 8a7, titled PFAS Data.
TSCA section 8a7 requires EPA to promulgate a rule requiring each person who has manufactured a chemical substance that is a PFAS in any year since January 1, 2011 to report information described in TSCA
section 8a2A through G. This includes a broad range of information, such as information related to chemical identity and structure, production, use, exposure, disposal, and health and environmental effects.
TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential also known as confidential business information CBI.
C. What action is the Agency taking?
EPA is proposing reporting and recordkeeping requirements under TSCA section 8a7 for PFAS
manufactured in any year since January 1, 2011. EPA is providing a comment
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period during which the public will have the opportunity to comment on this proposed action and its proposed requirements. Commenters are encouraged to provide comments and feedback related to the proposed reporting and recordkeeping requirements presented in this Notification of Proposed Rulemaking NPRM, including the scope of PFAS
covered by the rule see Unit V. for more discussion on specific items for which the Agency is requesting comments.
EPA is providing a comment period of 60 days from the publication date of this NPRM.
D. Why is the Agency taking this action?
The Agency is proposing this action pursuant to TSCA section 8a7 to obtain certain information known to or reasonably ascertainable by manufacturers of PFAS. TSCA section 8a7 requires the Agency to publish a final rule not later than January 1, 2023.
E. What are the incremental economic impacts?
EPA has prepared an economic analysis of the potential impacts associated with this proposed rule Ref.
13. The primary purpose of this proposed rule is the collection of detailed data on PFAS, as required under TSCA section 8a7. One potential benefit of this action is the information collected may serve as a basis to better understand potential routes of exposure to PFAS and potential human health and environmental impacts of certain PFAS, among other research needs listed in the Agencys PFAS Action Plan.
The industry is expected to incur onetime burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities.
Under the proposed rule, EPA estimates a total industry burden of approximately 122,104 hours, with a cost of approximately $9.8 million. The affected small businesses subject to the proposed rule are expected to incur $1,788,506 in costs for this one-time reporting, with per-firm costs estimated to range from $16,864 to $92,390. The Agency is expected to incur a burden of approximately 7,361 hours and a cost of $948,078. The total social burden and cost are therefore estimated to be approximately 129,465 hours and $10.8
million, respectively Ref. 13.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email see the above
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