TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Notice of Data Availability and Request for Comment, 72439-72441 [2022-25583]
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Federal Register / Vol. 87, No. 226 / Friday, November 25, 2022 / Proposed Rules
section of this
preamble for more information).
INFORMATION CONTACT
IV. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a significant
regulatory action and was therefore not
submitted to the Office of Management
and Budget (OMB) for review.
B. Paperwork Reduction Act (PRA)
This action does not impose an
information collection burden under the
PRA because this action does not
impose additional requirements beyond
those imposed by state law.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. This action will not
impose any requirements on small
entities beyond those imposed by state
law.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. This action does not
impose additional requirements beyond
those imposed by state law.
Accordingly, no additional costs to
state, local, or tribal governments, or to
the private sector, will result from this
action.
E. Executive Order 13132: Federalism
khammond on DSKJM1Z7X2PROD with PROPOSALS
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Coordination
With Indian Tribal Governments
This action does not have tribal
implications, as specified in Executive
Order 13175, because the SIP is not
approved to apply on any Indian
reservation land or in any other area
where the EPA or an Indian tribe has
demonstrated that a tribe has
jurisdiction, and will not impose
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17:08 Nov 23, 2022
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substantial direct costs on tribal
governments or preempt tribal law.
Thus, Executive Order 13175 does not
apply to this action.
Dated: November 4, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
BILLING CODE 6560–50–P
The EPA interprets Executive Order
13045 as applying only to those
regulatory actions that concern
environmental health or safety risks that
the EPA has reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it does not impose additional
requirements beyond those imposed by
state law.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
Section 12(d) of the NTTAA directs
the EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. The EPA believes that this
action is not subject to the requirements
of section 12(d) of the NTTAA because
application of those requirements would
be inconsistent with the CAA.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The state did not evaluate
environmental justice considerations as
part of its SIP submittal. There is no
information in the record inconsistent
with the stated goals of E.O. 12898 of
achieving environmental justice for
people of color, low-income
populations, and indigenous peoples.
List of Subjects in 40 CFR Part 52
Environmental protection,
Administrative practice and procedure,
Air pollution control, Carbon oxides,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen oxides, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
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[FR Doc. 2022–25382 Filed 11–23–22; 8:45 am]
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
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; notice of data
availability.
AGENCY:
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
SUMMARY:
E:\FR\FM\25NOP1.SGM
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Federal Register / Vol. 87, No. 226 / Friday, November 25, 2022 / Proposed Rules
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:
griffin.stephanie@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with PROPOSALS
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
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additional data sources on PFAScontaining 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.
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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 industrywide 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
E:\FR\FM\25NOP1.SGM
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Federal Register / Vol. 87, No. 226 / Friday, November 25, 2022 / Proposed Rules
khammond on DSKJM1Z7X2PROD with PROPOSALS
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
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17:08 Nov 23, 2022
Jkt 259001
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
PO 00000
Frm 00028
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72441
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
E:\FR\FM\25NOP1.SGM
25NOP1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
