[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Rules and Regulations]
[Pages 1822-1831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00412]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2022-0867; FRL 9655-02-OCSPP]
RIN 2070-AL10
Per- and Poly-Fluoroalkyl Chemical Substances Designated as
Inactive on the TSCA Inventory; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
finalizing a significant new use rule (SNUR) for 329 per- and poly-
fluoroalkyl substances (PFAS) that are designated as inactive on the
TSCA Chemical Substance Inventory. PFAS are a group of chemicals that
have been used in industry and consumer products since the 1940s
because of their useful properties, such as water and stain resistance.
Many PFAS break down very slowly and can build up in people, animals,
and the environment over time. Exposure at certain levels to specific
PFAS can adversely impact human health and other living things. Persons
subject to the final SNUR are required to notify EPA at least 90 days
before commencing any manufacture (including import) or processing of
the chemical substance for a significant new use. Once EPA receives a
notification, EPA must review and make an affirmative determination on
the notification, and take such action as is required by any such
determination before the manufacture (including import) or processing
for the significant new use can commence. Such a review will assess
whether the new use may present unreasonable risk to health or the
environment and ensure that EPA takes appropriate action as required to
protect health or the environment.
DATES: This final rule is effective March 11, 2024. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (EST) on
January 25, 2024.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0867, is available online
at https://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket) in the Environmental
Protection Agency Docket Center (EPA/DC) in Washington, DC. Please
review the visitor instructions and additional information about the
docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Bethany Masten, Existing
Chemicals Risk Management Division (7404M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8803; 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. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, or distribute in commerce chemical
substances and mixtures. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
NAICS 221210--Natural Gas Distribution;
NAICS 236220--Commercial and Institutional Building
Construction;
[[Page 1823]]
NAICS 324--Petroleum and Coal Product Manufacturing;
NAICS 324--Petroleum and Coal Product Manufacturing;
NAICS 32419--Petroleum Lubricating Oil and Grease
Manufacturing;
NAICS 325--Chemical Manufacturing;
NAICS 325120--Industrial Gas Manufacturing;
NAICS 325180--Other Basic Inorganic Chemical
Manufacturing;
NAICS 325199--All Other Basic Organic Chemical
Manufacturing;
NAICS 325211--Plastics Material and Resin Manufacturing;
NAICS 325212--Synthetic Rubber Manufacturing;
NAICS 325220--Artificial and Synthetic Fibers and
Filaments Manufacturing;
NAICS 325320--Pesticide and Other Agricultural Chemical
Manufacturing;
NAICS 325411--Medicinal and Botanical Manufacturing;
NAICS 325412--Pharmaceutical Preparation Manufacturing;
NAICS 325612--Polish and Other Sanitation Good
Manufacturing;
NAICS 325613--Surface Active Agent Manufacturing;
NAICS 325998--All Other Miscellaneous Chemical Product and
Preparation Manufacturing;
NAICS 326113--Unlaminated Plastics Film and Sheet (except
Packaging) Manufacturing;
NAICS 327910--Abrasive Product Manufacturing;
NAICS 333999--All Other Miscellaneous General Purpose
Machinery Manufacturing;
NAICS 334511--Search, Detection, Navigation, Guidance,
Aeronautical, and Nautical System and Instrument Manufacturing;
NAICS 336111--Automobile Manufacturing;
NAICS 423120--Motor Vehicle Supplies and New Parts
Merchant Wholesalers;
NAICS 423420--Office Equipment Merchant Wholesalers;
NAICS 423510--Metal Service Centers and Other Metal
Merchant Wholesalers;
NAICS 423740--Refrigeration Equipment and Supplies
Merchant Wholesalers;
NAICS 423990--Other Miscellaneous Durable Goods Merchant
Wholesalers;
NAICS 424690--Other Chemical and Allied Products Merchant
Wholesalers;
NAICS 424720--Petroleum and Petroleum Products Merchant
Wholesalers (except Bulk Stations and Terminals);
NAICS 424950--Paint, Varnish, and Supplies Merchant
Wholesalers;
NAICS 441110--New Car Dealers;
NAICS 447190--Other Gasoline Stations;
NAICS 551112--Offices of Other Holding Companies; and
NAICS 562--Waste Management and Remediation Services.
This action may also affect certain entities through pre-existing
import, including import certification, and export notification rules
under TSCA. Chemical importers are subject to the import provision of
TSCA section 13 (15 U.S.C. 2612), which requires that the Secretary of
the Treasury ``refuse entry into the customs territory of the United
States'' of any substance, mixture, or article containing a chemical
substance or mixture that fails to comply with any rule issued under
TSCA or that ``is offered for entry in violation'' of TSCA or certain
rules or orders issued under TSCA, including rules issued under TSCA
section 5. Persons who import any chemical substance in bulk form, as
part of a mixture, or as part of an article (if required by rule) are
also subject to TSCA section 13 import certification requirements and
the corresponding regulations promulgated at 19 CFR 12.118 through
12.127 (see also 19 CFR 127.28). Chemical importers of the chemical
substances in bulk form, as part of a mixture, or as part of an article
(if required by rule) must certify that the shipment of the chemical
substance complies with all applicable rules and orders under TSCA,
including regulations issued under TSCA sections 5, 6, 7 and Title IV.
The EPA policy in support of import certification appears at 40 CFR
part 707, subpart B.
In addition, pursuant to 40 CFR 721.20, any persons who export or
intend to export a chemical substance that is the subject of this final
rule are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1) requires persons to submit a significant new
use notice (SNUN) to EPA at least 90 days before they manufacture
(including import) or process the chemical substance for that use (15
U.S.C. 2604(a)(1)(B)(i)). TSCA further provides that such manufacturing
(including import) or processing may not commence until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and taken such actions as are required in association with
that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit
V., the general SNUR provisions are found at 40 CFR part 721, subpart
A.
TSCA section 26(c) (15 U.S.C. 2625(c)) authorizes EPA to take
action under other sections of TSCA with respect to categories of
chemical substances.
C. What action is the Agency taking?
This final SNUR will require persons to notify EPA at least 90 days
before commencing any manufacture (including import) or processing of
those 329 PFAS described in Unit II. that are designated as inactive on
the TSCA Chemical Substance Inventory (TSCA Inventory) and that are not
subject to an existing SNUR, including the existing SNURs cited at 40
CFR 721.9582 and 721.10536, for any use. EPA is providing a list of the
299 inactive PFAS that do not mask ``fluor'' or ``fluorine'' in the
generic name in the public docket for this rule (Ref. 1). This category
of PFAS chemical substances (``inactive PFAS'') is described further in
Unit II.
EPA is exempting from the notice requirement PFAS present as
impurities, any byproducts which are not used for commercial purposes,
and the importing or processing of inactive PFAS-containing articles
because notification for the commercial activity designation (as active
or inactive) on the TSCA Inventory is not required for such substances
(see 40 CFR 710.27(a)). Similarly, EPA is exempting from the notice
requirement PFAS manufactured or processed: in small quantities solely
for research and development, for test marketing purposes, as a non-
isolated intermediate, or solely for export from the United States as
described in 40 CFR 720.30(e) or 721.3, except where the Administrator
has made a finding described in TSCA section 12(a)(2).
The SNUR was proposed in the Federal Register on January 26, 2023
(88 FR 4937 (FRL 9655-01-OCSPP)). EPA received a total of 20 public
comment submissions in response to the notice. EPA received one ongoing
use claim in Unit V. of the Response to Comments document (Ref. 2). EPA
[[Page 1824]]
reviewed the ongoing use claim, requested additional information, and
has determined that the use is not ongoing, as described in Unit XI.D.
D. Why is the Agency taking this action?
As noted in the January 26, 2023, proposed rule (88 FR 4937 (FRL
9655-01-OCSPP)), this action is part of the comprehensive approach
outlined in the Agency's ``PFAS Strategic Roadmap: EPA's Commitments to
Action 2021-2024'' to proactively prevent PFAS from entering air, land,
and water at levels that can adversely impact human health and the
environment (Ref. 3). This SNUR is necessary to ensure that EPA
receives timely advance notice of any future manufacturing (including
import) or processing of inactive PFAS for new uses that may produce
changes in human or environmental exposures.
The rationale and objectives for this SNUR are further explained in
Unit III.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances included in this
rule. This analysis (Ref. 4), which is available in the docket, is
discussed in Unit IX., and is briefly summarized here.
In the event that a SNUN is submitted, costs are estimated to be
approximately $26,894 per SNUN submission for large business submitters
and $11,204 for small business submitters. In addition, for persons
exporting a substance that is the subject of a SNUR, a one-time notice
to EPA must be provided for the first export or intended export to a
particular country, which is estimated to be approximately $43 per
notification.
II. Chemical Substances Subject to This Rule
As discussed in Units II. and III. of the proposed rule (88 FR
4937, January 26, 2023 (FRL 9655-01-OCSPP)), this SNUR applies to
chemical substances designated as inactive on the TSCA Inventory that
are also PFAS, except that inactive PFAS already subject to a
significant new use rule, including but not limited to the significant
new use rules cited at 40 CFR 721.9582 and 721.10536, are not subject
to notice requirements under this action to avoid potential
redundancies or conflicts between the SNURs.
For the purposes of this SNUR, the definition of ``PFAS'' includes
chemicals that contain at least one of these three structures:
R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are
saturated carbons;
R-CF2OCF2-R', where R and R' can either be F, O, or
saturated carbons; or
CF3C(CF3)R'R'', where R' and R'' can either be F or
saturated carbons.
As described in Unit II. of the January 26, 2023, proposed rule (88
FR 4937 (FRL-9655-01-OCSPP)), this definition was developed to focus on
substances most likely to be persistent in the environment and EPA
notes that this definition may not be identical to other definitions of
PFAS used within EPA or by other domestic or international
organizations.
The chemical substances for which EPA is finalizing a SNUR are the
329 PFAS that are both currently designated as inactive on the TSCA
Inventory and that are not subject to an existing SNUR. The specific
chemical identities for 30 of these substances that have been claimed
as Confidential Business Information (CBI) have generic names (the
nonconfidential substitute for the specific chemical name) that do not
contain ``fluor'' or ``fluorine.'' EPA is providing a list of the 299
inactive PFAS that do not mask ``fluor'' or ``fluorine'' in the generic
name in the public docket for this rule (Ref. 1). Because EPA is
finalizing a structural definition of PFAS for this SNUR, EPA need not
take additional steps to list the 30 inactive PFAS that are not subject
to an existing SNUR and whose generic names do not contain ``fluor'' or
``fluorine''.
On October 14, 2022, prior to the publication of the proposed SNUR,
EPA received a Notice of Activity for CASRN 306-92-3. This substance
was erroneously included in the initial count and list of the 300
inactive PFAS that do not mask ``fluor'' or ``fluorine'' in the
supplemental document, ``List of Select Chemicals Subject to the
Proposed Significant New Use Rule Per- and Poly-fluoroalkyl Chemical
Substances Designated as Inactive on the TSCA Inventory'' (Ref. 5). The
designation of this substance was ``active'' at the time of the
proposed rule and, as such, it is not subject to this final rule and
the correct number of chemical substances for which EPA is finalizing a
SNUR is 329.
EPA received one Notice of Activity for CASRN 35101-47-7 on March
2, 2023, after the publication of the proposed rule. As described in
Unit IV of the proposed rule, uses arising after January 26, 2023, are
significant new uses, and persons who began commercial manufacturing
(including importing) or processing for a significant new use have to
cease upon the effective date of the final rule. To resume their
activities, these persons must first comply with all applicable SNUR
notification requirements and wait until all TSCA prerequisites for the
commencement of manufacturing (including importing) or processing have
been satisfied.
III. Rationale and Objectives
A. What is the rationale for this action?
As discussed in Units II. and III. of the proposed rule (88 FR
4937, January 26, 2023 (FRL-9655-01-OCSPP)), PFAS can adversely impact
human health and the environment. This final action is part of a
comprehensive approach to proactively prevent PFAS from entering air,
land, and water at levels that can adversely impact human health and
the environment.
In the absence of this final SNUR, manufacturing (including
importing) or processing for the significant new uses in this rule
could begin at any time after a manufacturer submits a Notice of
Activity under section 8 of TSCA and the substance becomes ``active''
on the TSCA Inventory; EPA would not be provided prior notice under
section 5 or an opportunity to review and address potential risks
associated with the proposed new use. The manufacture (including
import) or processing for any use of inactive PFAS would increase the
magnitude and duration of exposure to humans and the environment to
these chemicals. Given the concerns described in Units II. and III. of
the proposed rule (88 FR 4937, January 26, 2023 (FRL-9655-01-OCSPP)),
EPA has determined that notification and EPA's required review are
warranted for these chemicals prior to their potential reintroduction
into commerce.
Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), as described in Unit IV. of the proposed rule (88 FR
4937, January 26, 2023 (FRL-9655-01-OCSPP)), EPA's decision to issue a
SNUR for a particular chemical use follows an analysis of the relevant
factors listed in section 5(a)(2) and need not be based on an extensive
evaluation of the hazard, exposure, or potential risk associated with
that use. If a person decides to begin manufacturing (including
importing) or processing any of these chemicals for the significant new
use, the notice to EPA allows the Agency to evaluate the new use
according to the specific parameters and circumstances surrounding the
conditions of use at the time it receives such a notification.
B. What are the objectives of this action?
Based on the considerations in Unit III.A., EPA will achieve the
following
[[Page 1825]]
objectives with regard to the significant new use(s) of inactive PFAS
that are designated in this rule:
EPA will receive notice of any person's intent to
manufacture (including import) or process the chemical substances for
the described significant new use before that activity begins.
EPA will have an opportunity to review and evaluate
information submitted in a SNUN before the notice submitter begins
manufacturing (including importing) or processing the chemical
substances for the described significant new use.
EPA must either determine that the significant new use is
not likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
under TSCA section 5 before the manufacture or processing for the
significant new use could commence.
IV. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing (including importing), processing, distribution in
commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what constitutes a significant new use of an inactive
PFAS, EPA considered relevant information about the toxicity or
expected toxicity of these substances, likely human exposures and
environmental releases associated with possible uses, and the four
factors listed in TSCA section 5(a)(2). Since the manufacture
(including import) and processing of inactive PFAS has been
discontinued in the United States, exposure will decrease over time. As
such, EPA expects their presence in humans and the environment to
decline over time. If any new uses of inactive PFAS were to resume
after having been phased out, EPA believes that such uses could both
change the type and form and increase the magnitude and duration of
human and environmental exposure to the substances, constituting a
significant new use.
EPA acknowledges that the reporting of commercial activity under
the TSCA Inventory Notification (Active-Inactive) Requirements Rule
(``Active-Inactive rule'') was not required for several activities,
including, but not limited to, importing or processing of inactive
PFAS-containing articles, and manufacturing (including importing) or
processing of inactive PFAS as impurities, byproducts not used for
commercial purposes, small quantities solely for research and
development, for test marketing purposes, as a non-isolated
intermediate, or solely for export from the United States (Ref. 6).
Thus, EPA has determined that the designation of these PFAS as inactive
does not provide a sufficient basis to conclude that there are not
ongoing uses of inactive PFAS for these activities, and because this
SNUR is based on information obtained from the Active-Inactive rule,
EPA is not at this time designating uses for these activities as
significant new uses. Based on consideration of the statutory factors
discussed herein, EPA has determined as significant new uses:
manufacture (including import) or processing of inactive PFAS for any
use except:
(1) Importing or processing of inactive PFAS-containing
articles; and/or
(2) Manufacture (including import) or processing of inactive
PFAS:
As impurities,
As byproducts not used for commercial purposes,
In small quantities solely for research and
development,
For test marketing purposes,
For use as a non-isolated intermediate, or
Solely for export from the United States.
V. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Pre-manufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the significant new use is not
likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
under TSCA section 5 before the manufacturing (including importing) or
processing for the significant new use could commence. If EPA
determines that the significant new use is not likely to present an
unreasonable risk, EPA is required under TSCA section 5(g) to make
public, and submit for publication in the Federal Register, a statement
of EPA's finding.
Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to TSCA section 13, which requires that the Secretary of the
Treasury ``refuse entry into the customs territory of the United
States'' of any substance, mixture, or article containing a chemical
substance or mixture that fails to comply with any rule issued under
TSCA or that ``is offered for entry in violation'' of TSCA or certain
rules or orders issued under TSCA, including SNURs issued under TSCA
section 5. Persons who import any chemical substance in bulk form, as
part of a mixture, or as part of an article (if required by rule) are
also subject to TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.
VI. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
As discussed in the Federal Register of April 24, 1990 (55 FR 17376
(FRL-3658-5)), EPA has decided that the intent of TSCA section
5(a)(1)(B) is best served by designating a use as a significant new use
as of the date of publication of the proposed rule, rather than as of
the effective date of the final rule. This rule was proposed on January
26, 2023 (88 FR 4937 (FRL-9655-01-OCSPP)). Uses arising after the
publication of the proposed rule are
[[Page 1826]]
distinguished from uses that existed at publication of the proposed
rule. The former would be new uses, the latter ongoing uses, except
that uses that are ongoing as of the publication of the proposed rule
would not be considered ongoing uses if they have ceased by the date of
issuance of a final rule. EPA solicited public comment to identify any
ongoing manufacturing or processing of inactive PFAS subject to the
proposed SNUR. EPA received one ongoing use claim captured in the
Response to Comments in Unit V. (Ref. 2). EPA reviewed the ongoing use
claim, requested additional information, and has determined that the
use is not ongoing, as described in Unit XI.D.
Persons who began commercial manufacturing (including importing) or
processing of the chemical substances for a significant new use
identified as of January 26, 2023, must cease any such activity upon
the effective date of this final rule. To resume their activities,
these persons first have to comply with all applicable SNUR
notification requirements and wait until all TSCA prerequisites for the
commencement of manufacturing (including importing) or processing have
been satisfied. Consult the Federal Register document of April 24, 1990
(55 FR 17376 (FRL-3658-5)) for a more detailed discussion of the cutoff
date for ongoing uses.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not usually require
developing new information (e.g., generating test data) before
submission of a SNUN. There is an exception: development of information
is required where the chemical substance subject to the SNUR is also
subject to a rule, order, or consent agreement under TSCA section 4
(see TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule or order covering the
chemical substance, persons are required to submit only information in
their possession or control and to describe any other information known
to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR
721.25 and 720.50). However, as a general matter, EPA recommends that
SNUN submitters include information that would permit a reasoned
evaluation of risks posed by the chemical substance during its
manufacture (including import), processing, distribution in commerce,
use, or disposal. Potentially useful information includes physical-
chemical property data and any information related to persistence,
bioaccumulation, toxicity, and other characteristics that may help
predict the impact of a chemical substance on health or the
environment.
Submitting a SNUN that does not include information sufficient to
permit a reasoned evaluation may increase the likelihood that EPA will
either respond with a determination that the information available to
the Agency is insufficient to permit a reasoned evaluation of the
health and environmental effects of the significant new use or,
alternatively, that in the absence of sufficient information, the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance may present an unreasonable risk of injury.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs and define the terms of any potentially necessary
controls if the submitter provides detailed information on human
exposure and environmental releases that may result from the
significant new use of the chemical substances.
VIII. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what information may be useful in
evaluating a significant new use notice. Discussions with the Agency
prior to submission can afford ample time to conduct any tests that
might be helpful in evaluating risks posed by the substance. According
to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same
notice requirements and EPA regulatory procedures as persons submitting
a PMN, including submission of test data on health and environmental
effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA
Form No. 7710-25, generated using e-PMN software, and submitted to the
Agency in accordance with the procedures set forth in 40 CFR 721.25 and
720.40. E-PMN software is available electronically at https://www.epa.gov/chemicals-under-tsca.
IX. Economic Analysis
A. What is the analysis for SNUNs?
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers (including
importers) and processors of the chemical substances included in this
rule (Ref. 4). In the event that a SNUN is submitted, costs are
estimated at approximately $26,894 per SNUN submission for large
business submitters and $11,204 for small business submitters. These
estimates include the cost to prepare and submit the SNUN, and the
payment of a user fee. Businesses that submit a SNUN would be subject
to either a $19,020 user fee required by 40 CFR 700.45(b)(2)(iii), or,
if they are a small business as defined at 13 CFR 121.201, a reduced
user fee of $3,330 (40 CFR 700.45(b)(1)). Additionally, these estimates
reflect the costs and fees as they are known at the time this rule is
promulgated. EPA's complete economic analysis is available in the
public docket for this rule (Ref. 4).
B. What is the analysis for export notifications?
Under TSCA section 12(b) and the implementing regulations at 40 CFR
part 707, subpart D, exporters must notify EPA if they export or intend
to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under TSCA section 5.
For persons exporting a substance that is the subject of a SNUR, a one-
time notice to EPA must be provided for the first export or intended
export to a particular country. The total costs of export notification
will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical is
exported). While EPA is unable to make any estimate of the likely
number of export notifications for the chemicals covered in this SNUR,
as stated in the accompanying economic analysis of this SNUR, the
estimated cost of the export notification requirement on a per unit
basis is approximately $43.
X. Scientific Standards, Evidence, and Available Information
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science, as applicable. These information sources
supply information relevant to whether a particular use would be a
significant new use, based on relevant factors including those listed
under TSCA section 5(a)(2). As noted in Unit III., EPA's decision to
promulgate a SNUR for a particular chemical use need not be based on an
extensive evaluation of the hazard, exposure, or potential risk
associated with that use.
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this SNUR, in Unit II. of the January 26, 2023, proposed rule (88 FR
4937 (FRL-9655-01-OCSPP)), and in the references cited throughout the
preamble of the proposed rule. EPA
[[Page 1827]]
recognizes, based on the available information, that there is
variability and uncertainty in whether any particular significant new
use would actually present an unreasonable risk. For precisely this
reason, it is appropriate to secure a future notice and review process
for these uses, at such time as they are known more definitely. The
extent to which the various information, procedures, measures, methods,
protocols, methodologies or models used in EPA's decision have been
subject to independent verification or peer review is adequate to
justify their use, collectively, in the record for a significant new
use rule.
XI. Response to Public Comment
The Agency reviewed and considered all comments received related to
the January 26, 2023, proposed rule (88 FR 4937 (FRL-9655-01-OCSPP)).
Copies of all comments are available in the docket for this action
(EPA-HQ-OPPT-2022-0867), and EPA responses are in the Response to
Comments document (Ref. 2), which is also available in the docket.
Several primary comment topics included: the Agency's statutory
authority; the definition of PFAS; significant new uses; ongoing
manufacturing and processing; chemical identity claimed as CBI;
byproducts, impurities, and non-isolated intermediates; and costs and
fees of SNUN submissions which are summarized in this unit, along with
EPA responses.
1. Comment: Several commenters stated that EPA is acting within its
authority under TSCA with the proposed SNUR. Other commenters commented
that EPA is acting outside of its statutory authority and one commenter
claimed that the inactive status of a chemical or chemicals on the TSCA
Inventory should not be used as the sole basis for a SNUR and that the
proposal appears to undercut the simple notification procedure for
changing the status of a chemical substance from inactive to active
that Congress included when TSCA was amended. One commenter stated that
Congress did not include in the 2016 amendments a provision that
requires any form of substantive review of substances prior to change
of status from inactive to active. The same commenter stated that EPA
appears not to have undertaken a chemical-by-chemical review for the
three hundred substances subject to this SNUR, and findings on a
chemical-specific basis have not been provided.
Response: EPA disagrees that this SNUR, issued pursuant to TSCA
section 5(a) undercuts the notification procedure established under
TSCA section 8(b). TSCA section 8(b)(5)(B)(i) requires that ``[a]ny
person that intends to manufacture or process for a nonexempt
commercial purpose a chemical substance that is designated as an
inactive substance shall notify the Administrator before the date on
which the inactive substance is manufactured or processed.'' This
Notice of Activity reporting requirement applies to all chemical
substances designated as inactive, including those subject to this
SNUR. EPA separately has authority under TSCA section 5(a) to determine
that uses of a chemical substance (or category of chemical substances)
are ``significant new uses'' for which notification to EPA is required
before manufacture (including import) or processing for the significant
new use can commence. EPA has authority under TSCA section 5(a) to
promulgate SNURs for ``any chemical substance,'' without regard to
whether the chemical substance is designated as active or inactive.
There is also no requirement that EPA need undertake a chemical-by-
chemical review as the commenter suggests. One common characteristic of
concern of PFAS is that many break down very slowly and can build up in
people, animals, and the environment over time (Ref. 7). As described
in Unit IV. of the January 26, 2023, proposed rule (88 FR 4639 (FRL-
9655-01-OCSPP)), the baseline projected volume for these 329 inactive
PFAS is presumed to be minimal based on their inactive TSCA Inventory
designation. As such, any new manufacturing or processing of any of
these chemical substances would significantly change the production
volume and produce changes in human or environmental exposures to these
chemical substances. Thus, EPA has determined it is necessary to review
and make an affirmative determination on potential risks of the
chemical substances under section 5 before the manufacture (including
import) or processing of the chemical substances for the described
significant new use could begin.
2. Comment: Many commenters discussed the proposed definition of
PFAS for this rule. Several commenters suggested that EPA identify
covered PFAS by specific identification rather than through a
structural definition. One commenter stated that structural definitions
are difficult to use as they require an extensive understanding of the
often-complex chemistry of PFAS, and structural definitions may also be
ambiguous and over-inclusive. Other commenters stated that should EPA
move ahead with a broad definition and stated that the definition
should be consistent with the definition of PFAS the Agency uses in
other regulations, or that EPA should work with Federal partners to
ensure a consistent Federal definition of PFAS. Two commenters stated
that EPA should adopt a definition of PFAS that more closely aligns
with the Organization for Economic Co-operation and Development's
(OECD) broad definition (Ref. 8).
Response: EPA believes it has been chemically precise in the
proposed structural definition and appreciates that there are
differences between the definition of PFAS used for this rule, for
other actions in the Agency, and by other Federal agencies. The Agency
considered adopting various definitions, including some of those
suggested by commenters, but ultimately determined those definitions
were not appropriate for this rule because they were not developed to
focus on substances most likely to be persistent in the environment
while excluding those substances that are ``lightly'' fluorinated. In
reaching this decision, EPA considered that OECD also stipulates that
there may be different definitions of ``PFAS'' for different entities
or for different purposes, and that it may be appropriate for there to
be different definitions or interpretations depending on the specific
scenario. The proposed definition focused on substances with greater
potential for exposures to people and/or the environment and by
extension more potential to present risks. Adopting the OECD definition
of PFAS for this rule would have included many substances whose only
fluorine molecule is in a terminal -CF3 and that do not share a
structure that is likely to result in the substance's persistence in
the environment, or which would degrade to a substance that shares
toxicological or physiochemical properties with perfluorooctanoic acid
(PFOA), perfluorooctanesulfonic acid (PFOS), or GenX (Ref. 9).
EPA disagrees that the scope of substances subject to notification
requirements should be a discrete list and not a structural definition.
EPA points out that other regulations promulgated pursuant to TSCA have
relied on a structural definition when appropriate (e.g., the long-
chain perfluoroalkyl carboxylate (LCPFAC) SNUR defines covered
substances using a structural definition (40 CFR 721.10536), and the
polymer exemption rule for new chemical PMNs defines covered PFAS
polymers using structural definitions (40 CFR 723.250)).
Additionally, there are PFAS on the TSCA Inventory whose generic
names
[[Page 1828]]
do not clearly state the substance is fluorinated (i.e., no ``fluor''
included in the generic name). The inclusion of those chemicals on a
discrete list for reporting under this rule would disclose structural
information for these substances that has been claimed as CBI. EPA is
finalizing the rule as proposed and is providing the list of the 299
inactive PFAS that do not mask ``fluor'' or ``fluorine'' in the generic
name in the public docket for this rule. EPA believes that providing a
list of the 299 PFAS should eliminate most ambiguity, and notes that an
entity with a valid commercial need for EPA to verify if a substance is
on the inventory can submit a Bona Fide Intent to Manufacture or Import
Notice (``bona fide notice''). EPA will consider the information
submitted in a bona fide notice and, if the Agency believes that the
submitter has demonstrated a genuine intent to manufacture or import,
search the full TSCA Inventory master file and provide a written
determination to the submitter on the TSCA Inventory status (including
SNUR status) for the requested chemical substance.
3. Comment: Several commenters stated that SNURs are intended to
address truly new uses. The commenters state that the dormant status of
a substance on the TSCA Inventory does not mean that a previous use
should be considered new when reintroduced into commerce. Two
commenters stated that under TSCA, EPA is required to evaluate a
substance prior to promulgating a SNUR. One commenter suggested that
EPA specifically exclude from the notification requirements any uses
that were identified to EPA in previously submitted PMNs. Another
commenter said that addressing the discontinued use of an existing
chemical with a SNUR is only administratively efficient where other
requirements of TSCA section 5 have been met and where (1) stakeholder
groups are broadly aware of the proposal and (2) agree with EPA that
the use is permanently discontinued or being phased out; the commenter
stated that these elements have not been met.
Response: EPA disagrees that the previous use of a chemical
substance listed as inactive on the TSCA Inventory should not be
considered new when such use is restarted. TSCA section 5 gives EPA the
authority to designate uses of a chemical as Significant New Uses,
including but not limited to uses that were ongoing in the past but are
not longer in process. Part of EPA's rationale for promulgating this
SNUR is that the chemical substances subject to this SNUR are
considered to be PFAS. Certain PFAS are associated with risk to human
health and the environment, and one common characteristic of concern of
PFAS is that many break down very slowly and can build up in people,
animals, and the environment over time. Therefore, EPA has determined
that any use of these PFAS would produce changes in human or
environmental exposures and should trigger a SNUN and accompanying EPA
review and action as necessary. EPA also disagrees in part with the
commenter who suggested that EPA specifically exclude from the SNUN
requirements any uses that were identified to EPA in previously
submitted PMNs. However, uses of chemical substances for which a PMN
has been submitted (and for which EPA has reasonably available
information that such uses are ongoing) are considered ongoing uses for
which the SNUR does not apply. If production of a chemical has ceased,
the use of the chemical substance is not considered to be ongoing and
such use is covered by this SNUR.
EPA required reporting (with certain exemptions from reporting at
40 CFR 710.27(a)) under the Active-Inactive reporting rule of each
chemical substance manufactured (including imported) or processed in
the U.S. over a 10-year period ending on June 21, 2016, and there was
no manufacturing (including import), or processing reported for these
inactive PFAS (Ref. 6). EPA believes the comment period for the
proposed SNUR allowed for stakeholder groups to be broadly aware of the
proposal notice and provided an additional opportunity for industry to
provide specific documentation of the status of each chemical. EPA
received one ongoing use claim and has determined that the use is not
ongoing, as described in Unit XI.D.
4. Comment: An anonymous submitter notified EPA that it intends to
manufacture a PFAS covered by the proposed SNUR. The commenter stated
that since EPA is not authorized under TSCA to adopt a SNUR for an
ongoing use, it should exclude this substance from the final SNUR.
Response: EPA investigated the confidentially submitted information
and determined that the manufacture of this substance is not ongoing.
EPA is therefore not excluding the manufacture of this substance from
the final SNUR.
5. Comment: Several commenters provided feedback on the options
described in the proposed rule for potential further agency action to
list out in the regulation either the specific chemical identity or
generic name of all of the chemicals that fall within the scope of the
proposed SNUR. Some commenters stated that EPA must identify all
substances for which the chemical identity has been claimed as CBI,
regardless as to whether ``fluor'' or ``fluorine'' appears in the name.
Another commenter stated that TSCA section 14(d)(3) allows information
claimed as CBI to be disclosed if the Agency determines that disclosure
is ``necessary to protect health or the environment against an
unreasonable risk of injury to health or the environment.'' Thus, the
commenter stated that EPA should override CBI claims in the context of
this proposed SNUR and identify those PFAS whose generic names do not
include ``fluor'' or ``fluorine''. The commenter concluded that since
these PFAS are inactive, any business interest in their confidentiality
is minimal and overridden by the need of states and the public for the
information. Another commenter stated that although EPA must maintain
substantiated CBI claims for these substances, EPA can include the
generic names and PMN and accession numbers, which are not CBI, which
will minimize the potential for confusion about whether certain
substances are subject to this proposal. Another commenter stated that
EPA should use its authority under TSCA section 14(f) to require re-
substantiation of and review the chemical identity CBI claims for these
PFAS. Additionally, the commenter stated that EPA should initiate
review of the remaining specific chemical identity CBI claims to ensure
they comply with TSCA section 14. Another commenter relinquished its
CBI claims for the specific chemical identities for twelve substances
listed in the confidential portion of the TSCA Inventory that EPA has
identified as being subject to the proposed SNUR and requested that EPA
move them to the public portion of the TSCA Inventory.
Response: EPA disagrees that all substances for which the chemical
identity has been claimed as CBI must be identified. Under section
14(c) of TSCA, submitters may claim information submitted to EPA under
TSCA as CBI. The listing of a chemical substance as ``inactive'' on the
TSCA inventory does not itself impact CBI claims relating to such
chemical substance, including CBI claims relating to the structure or
chemical identity of a chemical substance. Further, as explained
previously, EPA is finalizing a structural definition of the chemical
substances subject to this SNUR, and EPA believes that persons will be
able to identify PFAS subject to this SNUR based on that structural
definition, regardless of whether there is a universally known unique
identifier.
[[Page 1829]]
For additional convenience, EPA is providing a list of the inactive
PFAS that do not mask ``fluor'' or ``fluorine'' in the generic name in
the public docket for this rule.
EPA disagrees that its conclusions pursuant to section 5 of TSCA
supporting the proposed SNUR for these substances meet the very
different conclusions that would prompt mandatory CBI review in
accordance with section 14(f). The fact that the substances are
currently designated as inactive following reporting under section 8(b)
of TSCA does not mean that the substance identities are no longer
treated as confidential by the original CBI claimant or by subsequent
or prospective manufacturers, and therefore EPA has not determined that
the status of a substance as inactive on the TSCA inventory is a
``reasonable basis to believe'' that chemical identity information
about such substance ``does not qualify'' for CBI protection, as is
required by TSCA section 14(f)(2)(B). Further, CBI claims asserted
prior to the enactment of the Lautenberg amendments to TSCA in 2016 do
not automatically expire as do most post-Lautenberg CBI claims.
However, if a SNUN on any of these substances is submitted, EPA would
review any renewed CBI claim for chemical identity at that time, in
accordance with the requirements of TSCA section 14(g). Submitters of
such SNUNs that assert a CBI claim for chemical identity should expect
that if the generic name submitted with such a claim does not identify
the substance as a PFAS, EPA expects to require revision of the generic
name to meet the generic name requirements in TSCA section 14(c).
Finally, the request that EPA initiate review of the remaining specific
chemical identity CBI claims to ensure they comply with TSCA section 14
is outside the scope of this rulemaking.
EPA acknowledges the commenter who relinquished its CBI claims for
the specific chemical identities and plans to move the twelve
substances into the public portion of the TSCA Inventory.
6. Comment: Many commenters stated that requiring reporting on the
manufacture of any substances that were exempt under the Active-
Inactive Rule would not be appropriate, including substances
manufactured and processed solely for export or test marketing, non-
isolated intermediates, and all other exemptions from PMN requirements
listed at 40 CFR 720.30(h) (Ref. 6). Other commenters expressed
opposition to the proposed exemptions. One commenter stated that
exposure to minuscule amounts of PFAS is a threat to human health and
safety, and the reintroduction of inactive PFAS, in even the smallest
quantities, should therefore be subject to the same intense health and
safety review as other quantities of PFAS. One commenter urged EPA to
finalize the rule without regulatory exemptions and extend the proposed
SNUR to byproducts because they are significant sources of PFAS
exposure and environmental releases.
Response: EPA acknowledges that the standard SNUR exemptions do not
fully align with the Active-Inactive reporting exemptions. In the final
rule, EPA is adding an exemption for non-isolated intermediates and
expanding the exemption for byproducts for consistency with the PMN
exemptions at 40 CFR 720.30(g) and (h)(2) and believes that these
exemptions are now consistent with the exemptions from Active-Inactive
reporting. As EPA collects evidence of the use of PFAS, potentially
including inactive PFAS, EPA may consider making certain exemptions
inapplicable in the future. The Agency expects to receive additional
information about any ongoing use of PFAS as part of the separate TSCA
section 8(a)(7) PFAS reporting rule that was proposed on June 28, 2021
(86 FR 33962 (FRL-7902-01-OCSPP)) and finalized on October 11, 2023 (88
FR 70516 (FRL 7902-02-OCSPP)).
7. Comment: One commenter stated that the proposal incorrectly
estimated the costs related to the submission of a SNUN. The commenter
said that the estimated cost of $26,737 is inconsistent with the
Agency's latest proposal for increasing TSCA fees. Another commenter
stated that while the user fee may discourage a manufacturer from using
PFAS in a significant way, it is likely that the user fee will deter
users from submitting a SNUN altogether.
Response: EPA disagrees that the proposal incorrectly estimated the
costs related to the submission of a SNUN, and notes that the latest
proposal for TSCA fees referenced by the commenter has not been
finalized. EPA disagrees with the commenter that a user fee would
encourage a manufacturer to circumvent the SNUR. EPA has enforcement
mechanisms in place to ensure compliance with EPA regulations.
XII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. U.S. EPA. ``List of Select Chemicals Subject to the Proposed
Significant New Use Rule Per- and Poly-fluoroalkyl Chemical
Substances Designated as Inactive on the TSCA Inventory.'' October
2022.
2. U.S. EPA. ``Response to Comments on the Final Per- and Poly-
fluoroalkyl Chemical Substances Designated as Inactive on the TSCA
Inventory Significant New Use Rule (SNUR).'' October 2023.
3. U.S. EPA. ``PFAS Strategic Roadmap: EPA's Commitment to Action
2021-2024.'' EPA-100-K-21-002, October 2021.
4. U.S. EPA. ``Economic Analysis of the Final Significant New Use
Rule Per- and Poly-fluoroalkyl Chemical Substances Designated as
Inactive on the TSCA Inventory.'' October 2023.
5. U.S. EPA. ``List of Select Chemicals Subject to the Proposed
Significant New Use Rule Per- and Poly-fluoroalkyl Chemical
Substances Designated as Inactive on the TSCA Inventory.'' January
2022.
6. U.S. EPA. TSCA Inventory Notification (Active-Inactive)
Requirements; Final Rule, 82 FR 37520 (FRL-9964-22), August 11,
2017.
7. Evich, Marina G., Davis, Mary J.B., McCord, James P., Acrey,
Brad, Awkerman, Jill A., Knappe, Detlef R.U., Lindstrom, Andrew B.,
Speth, Thomas F., Tebes-Stevens, Caroline, Strynar, Mark J., Wang,
Zhanyun, Weber, Eric J., Henderson, Matthew W., Washington, John W.
Per- and polyfluoroalkyl substances in the environment. Science.
375: 6580, 1-14. February 4, 2022
8. Organisation for Economic Co-operation and Development (OECD).
``Reconciling Terminology of the Universe of Per- and
Polyfluoroalkyl Substances: Recommendations and Practical
Guidance.'' July 9, 2021.
9. United Nations Environment Programme. Sources, Fates, Toxicity,
and Risks of Trifluoroacetic Acid and Its Salts: Relevance to
Substances Regulated Under the Montreal and Kyoto Protocols. Report
No. 2016-01. February 2016. https://ozone.unep.org/sites/default/files/2019-08/TFA2016.pdf.
XIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/regulations/and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is not a significant regulatory action under Executive
Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive
Order 14094
[[Page 1830]]
(88 FR 21879, April 11, 2023), and was therefore not subject to
Executive Order 12866 review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. The Office of Management and
Budget (OMB) has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control numbers 2070-0038 (EPA ICR No. 1188.13) and 2070-0030 (EPA ICR
No. 0795.16). If an entity were to submit a SNUN to the Agency, the
annual burden is estimated to be less than 100 hours per response, and
the estimated burden for export notifications is less than 1.5 hours
per notification. In both cases, burden is estimated to be reduced for
submitters who have already registered to use the electronic submission
system. This burden estimate includes the time needed to review
instructions, search existing data sources, gather and maintain the
data needed, and complete, review and submit the required SNUN.
EPA is amending the table in 40 CFR part 9 to list the SNURs and
OMB approval number for the information collection activities contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. The
Information Collection Request (ICR) covering the SNUR activities was
previously subject to public notice and comment prior to OMB approval,
and given the technical nature of the table, EPA finds that further
notice and comment to amend it is unnecessary. As a result, EPA finds
that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this
table without further notice and comment.
EPA always welcomes your feedback on the burden estimate. Send any
comments about the accuracy of the burden estimate, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
I certify this action will not have a significant economic impact
on a substantial number of small entities under the RFA, 5 U.S.C. 601
et seq. The small entities subject to the requirements of this action
are potential future manufacturers (defined by statute to include
importers), processors, and exporters of one or more subject chemical
substances for a significant new use designated in the SNUR. The
requirement to submit a SNUN applies to any person (including small or
large entities) who intends to engage in any activity described in the
final rule as a ``significant new use.'' Because these uses are
``new,'' based on all information currently available to EPA, the
Agency has determined that no small or large entities presently engage
in such activities. A SNUR requires that any person who intends to
engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was 10 in Federal fiscal year (FY) FY2016, 14
in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in
FY2021, and only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $19,020 to $3,330.
This lower fee reduces the total reporting and recordkeeping cost of
submitting a SNUN to about $11,204 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684 (FRL-5597-1)), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandates as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. Based on EPA's experience with proposing and
finalizing SNURs, state, local, and tribal governments have not been
impacted by these rulemakings, and EPA does not have any reasons to
believe that any state, local, or tribal government will be impacted by
this action. As such, EPA has determined that this final rule will not
impose any enforceable duty, contain any unfunded mandate, or the
otherwise have any effect on small governments subject to the
requirements of UMRA section 202, 203, 204, or 205 (2 U.S.C. 1501 et
seq.).
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999) because 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: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive order. Therefore, this action is not subject to Executive
Order 13045 because it does not concern an environmental health risk or
safety risk. Since this action does not concern human health, EPA's
Policy on Children's Health also does not apply.
Although this action does not concern an environmental health or
safety risk, the designation of certain uses of PFAS as significant new
uses ensures the Agency has an opportunity to review and address
potential risks associated with such uses before an entity begins
commencing any manufacture (including import) or processing of PFAS for
that use. Once EPA receives a notification, EPA must review and make
[[Page 1831]]
an affirmative determination on the notification, and take such action
as is required by any such determination before the manufacture
(including import) or processing for the significant new use can
commence. Such a review will assess whether the use identified in the
SNUN may present unreasonable risk to health or the environment and
ensure that EPA can prevent future unsafe environmental releases of
PFAS subject to the SNUR. As discussed previously, EPA is concerned
about the potential for adverse health effects from PFAS for children
and will evaluate the risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a ``significant regulatory action''
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards under the
NTTAA section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
The EPA believes that it is not practicable to assess whether the
human health or environmental conditions that exist prior to this
action result in disproportionate and adverse effects on communities
with environmental justice concerns.
The Agency believes that the inactive PFAS included in this action
are no longer being manufactured (including imported) or processed for
any uses in the United States. EPA believes that it is not practicable
to assess whether this action is likely to result in new
disproportionate and adverse effects on environmental justice
communities because the Agency is not able anticipate which chemical
substances and uses, if any, will be submitted for a significant new
use notice under this action.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 8, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons set forth in the preamble, 40 CFR
chapter I is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. Amend Sec. 9.1 in the table by adding an entry for Sec. 721.11777
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
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721.11777............................................... 2070-0038
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PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
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4. Add Sec. 721.11777 in numerical order to subpart E to read as
follows:
Sec. 721.11777 Per- and poly-fluoroalkyl chemical substances
designated as inactive on the TSCA Inventory.
(a) Definitions. The definitions in Sec. 721.3 apply to this
section.
(b) Chemical substances and significant new uses subject to
reporting. (1) The 329 chemical substances identified in paragraphs
(b)(1)(i) through (iii) of this section, designated as inactive on the
TSCA Chemical Substance Inventory as of January 26, 2023, are subject
to reporting under this section for the significant new uses described
in paragraph (b)(2) of this section. The requirements of this section
do not apply to quantities of the substance that are manufactured or
processed as nonisolated intermediates, as defined at 40 CFR 720.3(w),
or to quantities of the substance that are manufactured or processed as
a byproduct, as defined in 40 CFR 720.3(d), which are not used for
commercial purposes.
(i) R-(CF2)-CF(R')'', where both the CF2 and CF moieties are
saturated carbons;
(ii) R-CF2OCF2-R', where R and R' can either be F, O, or saturated
carbons; and
(iii) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated
carbons.
(2) The significant new uses for the chemical substances identified
in paragraph (b)(1) of this section are: manufacture (including import)
or processing for any use.
(c) Chemical substances not subject to reporting. The chemical
substances already subject to a rule under this part, including Sec.
721.9582, and Sec. 721.10536, are not subject to reporting under this
section.
(d) Specific requirements. The provisions of subpart A of this part
apply to this section.
[FR Doc. 2024-00412 Filed 1-10-24; 8:45 am]
BILLING CODE 6560-50-P