[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Proposed Rules]
[Pages 72439-72441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25583]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 705

[EPA-HQ-OPPT-2020-0549; FRL-7902-04-OCSPP]
RIN 2070-AK67


TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for 
Perfluoroalkyl and Polyfluoroalkyl Substances; Notice of Data 
Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of data availability.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting comment on an Initial Regulatory 
Flexibility Analysis (IRFA) and Updated Economic Analysis following the 
completion of a Small Business Advocacy Review (SBAR) Panel for the 
Toxic Substances Control Act (TSCA) proposed rule for reporting and 
recordkeeping requirements for per- and polyfluoroalkyl substances 
(PFAS). The EPA seeks public comment on all aspects of the IRFA and 
Updated Economic Analysis, including underlying data and assumptions in 
developing its estimates, as well as on certain items presented in the 
IRFA for public comment and related to the protection of Confidential 
Business Information.

DATES: Comments must be received on or before December 27, 2022. 
December 27, 2022

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0549, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Stephanie Griffin, Data 
Gathering and

[[Page 72440]]

Analysis Division (7406M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-1463; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 28, 2021 (86 FR 33926 (FRL-10017-
78)), EPA proposed a rule pursuant to section 8(a)(7) of the Toxic 
Substances Control Act (TSCA). Section 7351 of the FY2020 National 
Defense Authorization Act (NDAA) amended TSCA by adding section 
8(a)(7), which obligates EPA to promulgate a rule by January 1, 2023, 
that requires each person who has manufactured a chemical substance 
that is a PFAS in any year since January 1, 2011, to report and 
maintain records, for each year, information described in TSCA section 
8(a)(2)(A) through (G).
    EPA's proposed rule would require all manufacturers of a chemical 
substance or a mixture containing a chemical substance that is a PFAS 
(including article manufacturers (including import)) in any year since 
2011 to report certain information to EPA related to chemical identity, 
categories of use, volumes manufactured and processed, byproducts, 
environmental and health effects, worker exposure, and disposal (i.e., 
the section 8(a)(2) requirements). EPA also proposed a five-year 
retention period for all relevant records following the submission 
period. Based on information available to EPA at the time of the 
proposed rule's publication, EPA certified that the proposed rule did 
not have significant impact on a substantial number of small entities 
under the Regulatory Flexibility Act (RFA).
    After being extended 30 days (86 FR 41802, August 3, 2021 (FRL-
7902-03-OCSPP)), the comment period for the proposed rule closed on 
September 27, 2021. EPA received 110 unique comments on the proposed 
rule representing a wide range of views. Many commenters asserted that 
the proposed rule lacked sufficient data to support its estimates of 
burden and cost, including those of small entities and article 
importers, such that EPA could not certify its final rule will not have 
a significant impact on a substantial number of small entities under 
the RFA. Based on public comments and additional data sources on PFAS-
containing article importers, EPA convened an SBAR Panel for the 
proposed rule and has prepared an IRFA under the RFA, 5 U.S.C. 601 et 
seq., and evaluated the economic impact of the proposed TSCA section 
8(a)(7) rule on small entities, as well as any significant alternatives 
to the proposed rule that may minimize significant economic impacts on 
small entities while accomplishing the Agency's objectives.
    EPA has updated its estimate of costs for the proposed rule as 
proposed from approximately $10.8M to $875M in social costs, as well as 
from $948,078 to $1.5M in agency costs. As discussed further in the 
IRFA, the affected small businesses subject to the rule are expected to 
incur $863,483,965 in costs for this one-time reporting. EPA is 
considering changes to the final rule from the regulatory proposal 
based on updates to the economic analysis, small business impact 
analysis, and significant regulatory alternatives presented in the 
IRFA, as well as regarding the treatment of confidential business 
information (CBI) for PFAS.
    Since publishing the draft Economic Analysis, EPA has also updated 
the discussion of the benefits of the proposed rule. The IRFA details 
the many activities in the Office of Pollution Prevention and Toxics 
and in other offices across the Agency that will use and benefit from 
the data collected under this proposed rule. The proposed rule will 
provide information on PFAS to which the Agency (or the public) does 
not currently have access. By increasing the data supplied to Agency 
programs, including risk-screening programs across different media, EPA 
expects to more effectively and expeditiously evaluate any potential 
risks posed by PFAS. Ultimately, enhancing the risk screening process 
will have positive consequences for human and environmental health and 
may enable a more efficient allocation of EPA's and society's 
resources. The IRFA also details the potential benefits of the proposed 
rule to external stakeholders, such as tribal, state, and local 
governments, non-governmental organizations, and private-sector 
organizations, based on comments submitted during the proposed rule's 
public comment period. The proposed rule is an information-collecting 
rule and does not attempt to reduce risks related to PFAS. The IRFA's 
benefits analysis does not seek to quantitatively measure the 
associated benefits and does not formally identify or define the 
universe of recipients of those benefits.

II. Request for Public Comments

    EPA welcomes public comment on all aspects of the IRFA and Updated 
Economic Analysis, including underlying data and assumptions in 
developing its estimates, as well as on certain items identified in the 
IRFA and Updated Economic Analysis for public comment:
     The number of potential small article manufacturers 
(including import) that may be subject to the proposed rule;
     The number of PFAS for which small entities may submit 
reports under this rule, including information related to potential 
outliers of the industry-wide average estimate and the estimated 
distribution of PFAS per firm;
     The number of hours small entities will spend on 
understanding the structural definition of PFAS proposed for this rule;
     The number of entities that would be affected by 
implementing a reporting threshold for this proposed rule of either 
2,500 lbs or 25,000 lbs manufactured per year.
    Additionally, EPA welcomes public comment on items in the IRFA that 
were not available for public comment during the proposed rule's 
comment period:
     Regulatory flexibility alternatives, such as exemptions 
for businesses with less than $12 million or $6 million in revenue, 
exemptions for article importers with less than $6 million in revenue, 
limiting the scope of PFAS to a finite list, establishing reporting 
thresholds, simplified reporting forms for certain entities (i.e., 
article importers and manufacturers of research and development (R&D) 
substances in volumes less than 10 kg per year) (see alternatives in 
the IRFA (Ref. 1)).
     Reporting exemptions common to other chemical reporting 
programs, such as for research and development substances, byproducts, 
impurities, recyclers, and intermediates. EPA particularly seeks 
information on the potential impacts of such exemptions, which it did 
not quantify in the IRFA.
     Potentially duplicative or overlapping reporting 
requirements with this proposed rule (see ``Other Federal Rules that 
may Duplicate, Overlap, or Conflict with the Rule'' in the IRFA (Ref. 
1)). EPA specifically requests comment on potential duplication with 
any reporting requirements that have been implemented since the 
publication of the proposed rule.
    EPA also welcomes comments on whether any of the significant 
regulatory alternatives considered in the IRFA, such as de minimis or 
research and development exemptions, would be

[[Page 72441]]

appropriate to extend to more broadly to each person who has 
manufactured a chemical substance that is a perfluoroalkyl or 
polyfluoroalkyl substance in any year since January 1, 2011.
    Lastly, EPA also welcomes public comment on the following items 
pertaining to confidential business information (CBI) that are not in 
the IRFA and Updated Economic Analysis:
     Treatment of chemical identity claims. EPA seeks to 
clarify and add to language included in the PFAS proposed rule based on 
comments received in response to the TSCA CBI Procedures proposed rule 
about an entity's knowledge of a specific chemical identity. PFAS 
proposed rule Section 705.30(a)(2)(iii) indicates that confidentiality 
claims cannot be asserted when a response is left blank or designated 
as ``not known or reasonably ascertainable.'' EPA seeks to explain how 
it will handle such a response in the context of a specific chemical 
identity. If any entity reports a PFAS substance by specific chemical 
identity and does not claim the specific chemical identity as CBI, EPA 
expects to determine that the specific chemical identity is no longer 
entitled to confidential treatment. However, EPA would not make this 
determination where an entity attests that it does not have knowledge 
of the specific chemical identity. Instead, an entity that does not 
have knowledge of a specific chemical identity must initiate a joint 
submission with its supplier or other manufacturer. In these cases, the 
secondary submitter would be responsible for providing the specific 
chemical identity and for asserting and substantiating any CBI claims 
concerning the specific chemical identity. See, e.g., 40 CFR 
711.15(b)(3); 711.30(c). If an entity (likely an article importer) 
attests that it lacks knowledge of the specific chemical identity and 
also that it lacks knowledge of the identity of the manufacturer of the 
substance, the joint submission provisions would not apply, and the 
entity would not be able to make or waive a CBI claim for the specific 
chemical identity.
     Notice prior to publication on the public Inventory. The 
Agency seeks to further clarify and add to language in the PFAS 
proposed rule at 40 CFR 705.30 to explain which entities, if any, 
should expect to receive notice before a chemical identity is moved to 
the public portion of the TSCA inventory. In PFAS proposed rule 40 CFR 
705.30(g), EPA indicated that information not claimed as confidential 
may be made public without further notice to the submitter. EPA seeks 
to clarify that if a submitter reports a PFAS substance by specific 
chemical identity, but does not assert a CBI claim on that specific 
chemical identity, then EPA will move that chemical identity to the 
public portion of the TSCA Inventory without further notice to the 
submitter. EPA is also requesting comment on aligning this provision in 
the final PFAS rule with language in the proposed TSCA CBI Procedures 
rule, by indicating that persons who previously made a CBI claim for 
the same specific chemical identity will also not receive prior notice 
before the specific chemical identity is moved to the public portion of 
the Inventory. See 87 FR 29078, 29081 and proposed 40 CFR 703.5; rule 
docket including comments available at https://www.regulations.gov 
(docket ID EPA-HQ-OPPT-2021-0419).
     Generic names without ``fluor.'' Generic names must be 
sufficiently detailed to identify the reported chemical as a PFAS. 
Specifically, any generic name reported for a PFAS that does not 
contain ``fluor'' in the name would be rejected by EPA as insufficient 
under TSCA section 14(c)(1)(C). Additionally, any previously existing 
generic names from earlier TSCA section 5 submissions for PFAS without 
``fluor'' are insufficient. Further, even if a generic name reported 
under the TSCA 8(a)(7) rule lacks the structural unit ``fluor,'' the 
Agency will identify the chemical substance as a PFAS.

III. References

    The following is a listing of the documents that are specifically 
referenced in this document. For assistance in locating these other 
documents, please consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

1. US EPA. (2022). Initial Regulatory Flexibility Analysis and 
Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and 
Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl 
Substances.

List of Subjects in 40 CFR Part 705

    Environmental protection, Chemicals, Hazardous materials, 
Recordkeeping, and Reporting requirements.

    Dated: November 18, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-25583 Filed 11-23-22; 8:45 am]
BILLING CODE 6560-50-P