Proposed Rule2023-01156
Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2023
Issuing agencies
Environmental Protection Agency
Abstract
Under the Toxic Substances Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for those per- and poly- fluoroalkyl substances (PFAS) that have not been manufactured (including imported) or processed for many years and are consequently 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 SNUR would be 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 use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the PFAS subject to this SNUR.
Full Text
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<title>Federal Register, Volume 88 Issue 17 (Thursday, January 26, 2023)</title>
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[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Proposed Rules]
[Pages 4937-4945]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01156]
[[Page 4937]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2022-0867; FRL 9655-01-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: Proposed rule.
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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
proposing a significant new use rule (SNUR) for those per- and poly-
fluoroalkyl substances (PFAS) that have not been manufactured
(including imported) or processed for many years and are consequently
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 SNUR would be 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 use may present
unreasonable risk to health or the environment and ensure that EPA can
prevent future unsafe environmental releases of the PFAS subject to
this SNUR.
DATES: Comments must be received on or before March 27, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0867, using the Federal eRulemaking Portal
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#7b2f28383a242b3d3a283b1e0b1a551c140d"><span class="__cf_email__" data-cfemail="8dd9dececcd2ddcbccdecde8fdeca3eae2fb">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#782c2b3b395530170c1411161d381d0819561f170e"><span class="__cf_email__" data-cfemail="feaaadbdbfd3b6918a9297909bbe9b8e9fd0999188">[email protected]</span></a>.
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:
<bullet> NAICS 324--Petroleum and Coal Product Manufacturing;
<bullet> NAICS 221210--Natural Gas Distribution;
<bullet> NAICS 236220--Commercial and Institutional Building
Construction;
<bullet> NAICS 324--Petroleum and Coal Product Manufacturing;
<bullet> NAICS 32419--Petroleum Lubricating Oil and Grease
Manufacturing;
<bullet> NAICS 325--Chemical Manufacturing;
<bullet> NAICS 325120--Industrial Gas Manufacturing;
<bullet> NAICS 325180--Other Basic Inorganic Chemical
Manufacturing;
<bullet> NAICS 325199--All Other Basic Organic Chemical
Manufacturing;
<bullet> NAICS 325211--Plastics Material and Resin Manufacturing;
<bullet> NAICS 325212--Synthetic Rubber Manufacturing;
<bullet> NAICS 325220--Artificial and Synthetic Fibers and
Filaments Manufacturing;
<bullet> NAICS 325320--Pesticide and Other Agricultural Chemical
Manufacturing;
<bullet> NAICS 325411--Medicinal and Botanical Manufacturing;
<bullet> NAICS 325412--Pharmaceutical Preparation Manufacturing;
<bullet> NAICS 325612--Polish and Other Sanitation Good
Manufacturing;
<bullet> NAICS 325613--Surface Active Agent Manufacturing;
<bullet> NAICS 325998--All Other Miscellaneous Chemical Product and
Preparation Manufacturing;
<bullet> NAICS 326113--Unlaminated Plastics Film and Sheet (except
Packaging) Manufacturing;
<bullet> NAICS 327910--Abrasive Product Manufacturing;
<bullet> NAICS 333999--All Other Miscellaneous General Purpose
Machinery Manufacturing;
<bullet> NAICS 334511--Search, Detection, Navigation, Guidance,
Aeronautical, and Nautical System and Instrument Manufacturing;
<bullet> NAICS 336111--Automobile Manufacturing;
<bullet> NAICS 423120--Motor Vehicle Supplies and New Parts
Merchant Wholesalers;
<bullet> NAICS 423420--Office Equipment Merchant Wholesalers;
<bullet> NAICS 423510--Metal Service Centers and Other Metal
Merchant Wholesalers;
<bullet> NAICS 423740--Refrigeration Equipment and Supplies
Merchant Wholesalers;
<bullet> NAICS 423990--Other Miscellaneous Durable Goods Merchant
Wholesalers;
<bullet> NAICS 424690--Other Chemical and Allied Products Merchant
Wholesalers;
<bullet> NAICS 424720--Petroleum and Petroleum Products Merchant
Wholesalers (except Bulk Stations and Terminals);
<bullet> NAICS 424950--Paint, Varnish, and Supplies Merchant
Wholesalers;
<bullet> NAICS 441110--New Car Dealers;
<bullet> NAICS 447190--Other Gasoline Stations;
<bullet> NAICS 551112--Offices of Other Holding Companies; and
<bullet> NAICS 562--Waste Management and Remediation Services.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations 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
[[Page 4938]]
at 40 CFR part 707, subpart B. In addition, any persons who export or
intend to export a chemical substance that is the subject of a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)); (see also 40 CFR part 707, subpart D
and 40 CFR 721.20).
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
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) (see
Unit IV). 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?
To protect health and the environment and ensure EPA review of
significant new uses of certain PFAS, EPA is proposing a SNUR for those
PFAS that are currently on the TSCA Inventory but which have not been
actively manufactured (including imported) or processed in the U.S.
since 2006 and are consequently designated as inactive on the TSCA
Chemical Substance Inventory. PFAS are a group of synthetic chemicals
that have been in use since the 1940s and are still used in a wide
range of consumer products and industrial applications. This proposed
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. 1).
If a chemical is on the TSCA Chemical Substance Inventory (``TSCA
Inventory''), that chemical substance is considered an ``existing''
chemical substance in U.S. commerce. In some instances, the chemicals
listed on the TSCA Inventory have not been actively manufactured for
many years and are designated as ``inactive'' on the TSCA Inventory.
The chemical substances for which EPA is proposing a SNUR are those
PFAS that are both currently designated as inactive on the TSCA
Inventory and not subject to an existing SNUR, including the existing
SNURs cited at 40 CFR 721.9582 and 721.10536. This category of PFAS
chemical substances (``inactive PFAS'') is described further in Unit
II.A. There are 330 inactive PFAS that are not subject to an existing
SNUR. The specific chemical identities for 30 of these substances that
have been claimed as CBI have generic names (the nonconfidential
substitute for the specific chemical name) that do not contain
``fluor'' or ``fluorine.''
The proposed significant new uses are manufacture (including
import) or processing for any use. The proposed significant new uses
EPA has identified in this unit are based on reasonably available
information that indicates that these uses are not ongoing at the time
of this proposed rule; according to the TSCA Inventory they are
inactive, meaning that those chemicals have not been manufactured
(including imported) or processed in the United States since June 21,
2006. EPA is requesting public comment on this proposal, and
specifically on the Agency's description of the significant new uses
for the chemicals identified, including specific documentation of
ongoing uses, if any.
This proposed SNUR would require persons that intend to manufacture
(including import) or process any of these chemicals for a significant
new use, consistent with the requirements at 40 CFR 721.25, to notify
EPA at least 90 days before commencing such manufacture (including
import) or processing. Once EPA receives a notification, EPA must
either determine that the significant new use is not likely to present
an unreasonable risk of injury to health or the environment, or take
such regulatory action as is associated with an alternative
determination, before the manufacture or processing for the significant
new use could commence.
D. Why is the Agency taking this action?
As noted previously, 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. 1). When TSCA was first passed,
thousands of chemicals, including some PFAS, were grandfathered in
under the statute and allowed to remain in commerce without additional
EPA review. Before TSCA was amended in 2016, EPA completed formal
reviews on only about 20% of new chemicals and had no authority to
address new chemicals about which the Agency lacked sufficient
information, which is part of the reason why many chemicals, including
PFAS, were allowed into commerce without a complete review. Under the
new law, the agency has to formally review the safety of 100% of new
chemicals before they are allowed into commerce. 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.
This proposed 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, and to ensure that an appropriate
determination (relevant to the risks associated with such manufacturing
(including import), processing, distribution in commerce, use and
disposal) has been issued prior to the commencement of such
manufacturing (including import) or processing. The proposed action is
necessary to ensure that manufacturing (including importing) or
processing for the significant new use cannot proceed in the event that
EPA determines that: (1) The significant new use presents an
unreasonable risk under the conditions of use (without consideration of
costs or other nonrisk factors, and including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
by EPA); (2) The information available to EPA is insufficient to permit
a reasoned evaluation of the health and environmental effects of the
significant new use; (3) In the absence of sufficient information, the
manufacture (including import), processing, distribution in commerce,
use, or disposal of the substance, or any combination of such
[[Page 4939]]
activities, may present an unreasonable risk (without consideration of
costs or other nonrisk factors, and including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
by EPA), or (4) There is sufficient potential for environmental release
or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)). In
order for manufacturing (including importing) or processing for the
significant new use to proceed after EPA has made one of the 4
determinations described above, EPA must take actions under TSCA
sections 5(e) or 5(f) to protect health and the environment.
With respect to the chemical substances listed in the proposed
regulatory text, all manufacturing (including importing) and processing
ceased on or before June 21, 2006, as discussed in Unit II.A. Any new
manufacturing (including importing) or processing for any use following
that date would thus significantly change the volume of production,
which is believed to be negligible.
EPA is proposing to exempt from the notice requirement PFAS present
as impurities, certain byproducts, and the importing or processing of
inactive PFAS-containing articles defined at 40 CFR 721.45(d) through
(f) 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)).
The rationale and objectives for this proposed 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
proposed rule. This analysis (Ref. 2), 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 $26,737 per SNUN submission for large business submitters
and $11,047 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 $106 per
notification.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. Clearly mark the part or all the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI, and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov//commenting-epa-dockets">https://www.epa.gov//commenting-epa-dockets</a>.
3. Comments about ongoing uses of inactive PFAS. EPA welcomes
comment on all aspects of this proposed rule. In providing comments on
an ongoing use of inactive PFAS, it would be helpful if you provide
sufficient information for EPA to substantiate any assertions of an
ongoing use.
II. Chemical Substances Subject to This Proposed Rule
A. What chemicals substances are subject to this proposed SNUR?
This proposed SNUR would apply to chemical substances designated as
inactive on the TSCA Inventory that are also PFAS. However, EPA is
proposing 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 section to avoid potential redundancies or
conflicts between the SNURs. Inactive chemical substances on the TSCA
Inventory are those chemical substances that have not been manufactured
(including imported) or processed since June 21, 2006.
TSCA section 8(b) requires EPA to compile, keep current and publish
a list of each chemical substance that is manufactured (including
imported) or processed in the United States for uses under TSCA. Also
called the ``TSCA Inventory'' or simply ``the Inventory,'' it plays a
central role in the regulation of most industrial chemicals in the
United States. TSCA also requires EPA to designate each chemical
substance on the TSCA Inventory as either ``active'' or ``inactive'' in
U.S. commerce (15 U.S.C. 2607(b)(4)(A)). To accomplish that, EPA
finalized a rule requiring industry to notify the Agency of each
chemical substance manufactured (including imported) or processed in
the U.S. over a 10-year period ending on June 21, 2016 (with certain
exemptions from reporting at 40 CFR 710.27(a)) (Ref. 3). This reporting
was completed on October 5, 2018 and, combined with data received under
the Chemical Data Reporting (CDR) rule in 2012 and 2016, was used to
designate each chemical substance on the TSCA Inventory as active or
inactive in U.S. commerce. Starting August 5, 2019, manufacturers
(including importers) and processors have been required to notify EPA
before reintroducing inactive substances into U.S. commerce. Moving a
chemical substance from an inactive designation to an active
designation on the TSCA Inventory does not require review by EPA, only
that EPA be notified via a Notice of Activity form.
EPA has published several SNURs covering certain perfluoroalkyl
sulfonates (67 FR 11007, March 11, 2002 (FRL-6823-6); 67 FR 72854,
December 9, 2002 (FRL-7279-1); 72 FR 57222, October. 9, 2007 (FRL-8150-
4); 78 FR 62443, October 22, 2013 (FRL-9397-1)) and long-chain
perfluoroalkyl carboxylate chemical substances (85 FR 45124, July 27,
2020 (FRL-10010-44)), that use a structural definition, as opposed to a
discrete list, for the PFAS covered in the SNURs. Additionally, other
SNURs (85 FR 45124, July 27, 2020 (FRL-10010-44; 58 FR 27944, May 12,
1993 (FRL-4077-7), as amended at 58 FR 34204, June 23, 1993 (FRL-4587-
1)) and the polymer exemption rule for pre-manufacture notices (PMNs)
(60 FR 16316-16336, March 29, 1995 (FRL-4929-8)) define covered PFAS
polymers using structural definitions (40 CFR 723.250)). Other
scientific and regulatory bodies such as the Organization of Economic
Cooperation and Development (OECD) (Ref. 4) have defined PFAS using
various structural definitions. Thus, there is precedent for using a
structural definition both for TSCA rules and for actions addressing
PFAS. EPA is proposing to adopt a structural definition for this rule
based, in part, on this history of using structural definitions to
establish the scope of chemical substances covered by a SNUR.
For the purposes of this proposed SNUR, the definition of ``PFAS''
includes chemicals that contain at least one of these three structures:
[[Page 4940]]
<bullet> R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are
saturated carbons;
<bullet> R-CF2OCF2-R', where R and R' can either be F, O, or
saturated carbons; or
<bullet> CF3C(CF3)R'R'', where R' and R'' can either be F or
saturated carbons.
While this proposed definition was developed to focus on substances
most likely to be persistent in the environment while excluding those
substances that are ``lightly'' fluorinated (i.e., the molecule only
contains unconnected CF2 or CF3 moieties), EPA acknowledges that
substances that are not fully fluorinated may still be persistent in
the environment, as the persistence of organofluoro compounds is more
related to the density of C-F bonds within the molecule than to the
existence of fully fluorinated carbons. For this SNUR, the proposed
definition's R group requirements do not include substances that only
have a single fluorinated carbon, or unsaturated fluorinated moieties
(e.g., fluorinated aromatic rings and olefins), which are more
susceptible to chemical transformation than their saturated
counterparts, and therefore, are less likely to persist in the
environment (Ref. 5). As such, EPA has determined that, for the purpose
of this proposed rule, the definition does not include substances that
only have a single fluorinated carbon or unsaturated fluorinated
moieties.
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 term ``PFAS'' has been used broadly
for varying research and/or regulatory needs. Various EPA programs may
have distinct needs or purposes from this proposed SNUR, and therefore,
different definitions of the term ``PFAS'' may be appropriate for other
purposes. EPA does not have one Agency-wide definition of PFAS. For
example, a definition from EPA's Office of Water might focus on PFAS
that have been detected in water, whereas a definition for TSCA might
be one for PFAS that are expected the be manufactured and processed for
uses subject to TSCA. The Agency notes that this perspective, that
different entities may have very different needs and no single PFAS
characterization or definition meets all needs, is shared by other
organizations, including the OECD (Ref. 4). EPA seeks comment on
whether the above definition of PFAS is the most appropriate definition
for this SNUR and acknowledges that there may be other rules or
programs that apply different definitions to meet their own needs.
Chemical substances that fall within the scope of this proposed
definition of PFAS encompass chemical substances that meet the
structural definitions used in existing SNURs covering PFAS. However,
the proposed regulatory text clarifies that PFAS subject to an existing
SNUR would be excluded from this proposed SNUR. The Agency is proposing
to exclude these substances from the scope of this proposed rule to
avoid potential redundancies or conflicts between the SNURs. Such
conflicts may arise because of chemical or use-specific exemptions from
the existing significant new uses or because EPA had a reason to lift
general exemptions from an existing SNUR that would still apply under
this proposed SNUR.
The chemical substances for which EPA is proposing a SNUR are the
330 PFAS that are both currently designated as inactive on the TSCA
Inventory and not subject to an existing SNUR. The specific chemical
identities for 30 of these substances that have been claimed as 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 300 inactive PFAS that do not mask ``fluor'' or
``fluorine'' in the generic name in the public docket for this proposed
rule (Ref. 6). Because EPA is proposing to use a structural definition
of PFAS for this SNUR, EPA need not take additional steps to ensure
that the SNUR lists the 30 inactive PFAS that are not subject to an
existing SNUR and whose generic names do not contain ``fluor'' or
``fluorine''. The specific chemical identities of these substances have
been claimed as CBI, and their generic names are the nonconfidential
substitute for the specific chemical name that is treated as
confidential. TSCA section 14(c)(1)(C) requires that generic names
describe the chemical structure of the chemical substance as
specifically as practicable while protecting those features of the
chemical structure that are claimed as confidential; and the disclosure
of which would be likely to cause substantial competitive harm. Generic
names are intended to reveal information about the chemical identity
while masking those structural elements that are confidential. The lack
of ``fluor'' or ``fluorine'' in a generic name masks that the chemical
substance is a PFAS and information masked by a generic name is
considered to be subject to a CBI claim. Therefore, listing the generic
names of these substances on a list of PFAS would disclose structural
information for these substances that has been claimed CBI. As a
courtesy, EPA is also providing a list of 300 inactive PFAS that do not
mask ``fluor'' or ``fluorine'' in the generic name in the public docket
for this proposed rule (Ref. 6).
EPA seeks comment on whether the Agency should take further 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, including those with generic names that mask that the
chemical substance as PFAS, since this proposed rule covers a specific
list of substances. EPA describes two approaches that it could take to
make such a list available below and seeks public input on each such
approach.
First, EPA could determine that there are no applicable CBI claims
for the generic names of the masked PFAS substances using the process
described in 40 CFR 2.204(c). In other words, EPA could use that
process to determine that the limited structural information that would
be disclosed by identifying substances whose generic names do not
include ``fluor'' or ``fluorine'' as PFAS is not CBI. EPA proposes
making a good faith effort to identify and contact the original
submitters of each such PFAS and/or document that EPA cannot find a
successor entity to a submitter that does not continue to operate, then
determining that the generic names that do not include ``fluor'' or
``fluorine'' are not entitled to confidential treatment under 40 CFR
2.204(c)(3).
Alternatively, EPA could use the process under TSCA section
14(d)(7) and 40 CFR 2.306(i)/2.301(g)(2), whereby the Agency may
disclose information claimed CBI if the Administrator determines that
disclosure is relevant in a proceeding under TSCA and the disclosure
preserves confidentiality to the extent practicable without impairing
the proceeding. Under this alternative, EPA would not disclose the
specific chemical identity as part of the rulemaking. Rather, EPA would
list the generic names that lack fluor or fluorine, disclosing that the
chemical is a PFAS. EPA believes this is a limited form of disclosure
that would be consistent with TSCA section 14(d)(7).
B. What are the uses and production volumes of inactive PFAS?
As discussed previously, the term inactive PFAS refers to PFAS that
EPA designated as ``inactive'' in U.S. commerce on the TSCA Inventory
(15 U.S.C. 2607(b)(4)(A)). Starting August 5, 2019, manufacturers
(including importers) and processors have been required to provide
notice to EPA to
[[Page 4941]]
change the commercial activity designation from inactive to active
before using a chemical substance designated as inactive on the TSCA
Inventory for a nonexempt commercial purpose (Ref. 3). The Agency has
not received such notifications for any of the PFAS currently
designated as inactive on the TSCA Inventory. This indicates that all
such PFAS, which include the PFAS covered by this proposed SNUR, are no
longer being manufactured (including imported) or processed for any
nonexempt uses in the United States. 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, the
import or processing of a chemical substance as part of an article (40
CFR 710.27(a)(2)) and the manufacturing or processing of a chemical
substance in small quantities solely for research and development (40
CFR 710.27(a)(1)). Thus, there may be ongoing uses of inactive PFAS for
these exempt activities. These uses would be exempt from this proposed
inactive SNUR pursuant to the general SNUR exemptions at 40 CFR 721.45.
The Agency solicits comment on any ongoing activities exempt from the
Active-Inactive Rule that entities believe would not be covered by the
general SNUR exemptions. The Agency expects to receive additional
information about any ongoing use of PFAS in processed or imported
articles as part of the separate TSCA section 8(a)(7) PFAS reporting
rule that was proposed on June 28, 2021 (June 28, 2021, 86 FR 33962),
once it is finalized, and EPA may consider making inapplicable the
exemption for articles in the future, as discussed in Unit X.
The Active-Inactive Rule also includes an exemption from
notification for the manufacturing or processing of a chemical
substance as described in 40 CFR 720.30(g) or (h) (40 CFR
710.27(a)(3)). Relevant to this proposed rule, the exemption at 40 CFR
720.30(h) covers ``[a]ny byproduct which is not used for commercial
purposes.'' Thus, there may be inactive PFAS that were not reported
under the Active-Inactive Rule because they were only manufactured or
processed as byproducts that are not used for commercial purposes.
There is no such broad exemption for byproducts in EPA's general SNUR
regulations at 40 CFR 721.45. Rather, EPA has only exempted byproducts
from SNUR notification requirements in the limited circumstances where:
[t]he person manufactures, imports, or processes the substance only
as a byproduct which is used only by public or private organizations
that (1) burn it as a fuel, (2) dispose of it as a waste, including
in a landfill or for enriching soil, or (3) extract component
chemical substances from it for commercial purposes. 40 CFR
721.45(e).
Therefore, without an exemption in the general regulations or in the
proposed regulatory text, manufacturing or processing of the inactive
PFAS as a byproduct would be a significant new use. EPA solicits
comment on any ongoing manufacturing or processing of inactive PFAS
subject to this SNUR as a byproduct and whether to include a broader
exemption for manufacturing or processing as a byproduct in this
inactive PFAS SNUR.
C. What are the potential routes and sources of exposure to inactive
PFAS?
Due to their widespread use and persistence in the environment,
most people in the United States have been exposed to PFAS. Biological
sampling has discovered the presence of certain PFAS in fish and in
fish-eating birds across the United States and in locations in Canada,
Sweden, and the South Pacific. The wide distribution of the chemicals
in high trophic levels is strongly suggestive of the potential for
bioaccumulation and/or bioconcentration. Based on currently available
information, EPA believes that in addition to persistence, the length
of the perfluorinated chain may also have an effect on bioaccumulation
and toxicity, which are characteristics of concern for these chemicals
(Ref. 7). EPA expects that there are likely limited potential routes
and sources of exposure to the inactive PFAS covered by the proposed
SNUR because these substances have not been manufactured or processed
for nonexempt uses in the United States since 2006. However, exposure
may be possible because some PFAS are known to persist in the
environment and have been shown to bioaccumulate in wildlife and humans
(Refs. 7 and 8).
III. Rationale and Objectives
A. What is the rationale?
When TSCA was first passed, thousands of chemicals, including some
PFAS, were grandfathered in under the statute and allowed to remain in
commerce without additional EPA review. Before TSCA was amended in
2016, EPA completed formal reviews on only about 20% of new chemicals
and had no authority to address new chemicals about which the Agency
lacked sufficient information, which is part of the reason why many
chemicals, including PFAS, were allowed into commerce without a
complete review. Under the new law, the agency has to formally review
the safety of 100% of new chemicals before they are allowed into
commerce. On October 18, 2021, EPA issued the ``PFAS Strategic Roadmap:
EPA's Commitments to Action 2021-2024'' (Ref. 1). This proposed 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 Roadmap, EPA committed to
considering how to apply TSCA section 5(a)(2) authority to help address
abandoned uses of PFAS as well as future uses of PFAS designated as
inactive on the TSCA Inventory.
In the absence of a SNUR, manufacturing (including importing) or
processing for the significant new uses proposed in this rule may 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. EPA believes that 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 that are persistent and bioaccumulate. Given the concerns
described in Unit II., EPA believes 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), EPA's decision to propose 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. If a
person decides to begin manufacturing (including importing) or
processing any of these chemicals for the use, the notice to EPA allows
the Agency to evaluate the 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?
Based on the considerations in Unit III.A., EPA wants to achieve
the following objectives with regard to the significant new use(s) of
inactive PFAS that are designated in this proposed rule:
[[Page 4942]]
1. EPA would 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.
2. EPA would 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.
3. 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:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> 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 would constitute 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 section 5(a)(2) of TSCA. Since the manufacture
(including import) and processing of inactive PFAS has been
discontinued in the United States see Unit II., 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. Based on consideration of the
statutory factors discussed herein, EPA has preliminarily determined as
significant new uses: manufacture (including import) or processing of
inactive PFAS for any use.
V. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the proposed rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the proposed 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 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 the 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 the 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 is being proposed on
January 26, 2023. Uses arising after the publication of the proposed
rule are distinguished from uses that exist 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.
Persons who begin commercial manufacturing (including importing) or
processing of the chemical substances for a significant new use
identified as of January 26, 2023 would have to cease any such activity
upon the effective date of the final rule. To resume their activities,
these persons would have to 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. 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 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 40 CFR 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
[[Page 4943]]
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. EPA encourages persons to consult with the Agency before
submitting a SNUN. As part of this optional pre-notice consultation,
EPA would discuss specific information it believes may be useful in
evaluating a significant new use.
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
40 CFR 720.40. E-PMN software is available electronically at <a href="https://www.epa.gov/under-tsca">https://www.epa.gov/under-tsca</a>.
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
proposed rule (Ref. 2). In the event that a SNUN is submitted, costs
are estimated at approximately $26,737 per SNUN submission for large
business submitters and $11,047 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 $3,300 (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 proposed rule (Ref. 2).
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 chemical covered in this
proposed SNUR, as stated in the accompanying economic analysis of this
proposed SNUR, the estimated cost of the export notification
requirement on a per unit basis is approximately $106.
X. Regulatory Alternative Considered
EPA is also requesting public comment on the alternative of lifting
the article exemption at 40 CFR 721.45(f). Under this alternative, the
import and processing of articles containing inactive PFAS would be
designated as a significant new use. EPA is not proposing this
regulatory alternative, at this time, because it cannot currently
determine whether or what types of articles containing PFAS covered by
the definition in this proposed SNUR are ongoing or not. The import or
processing of substances solely as part of articles is exempt from the
notification requirements under the Active-Inactive Rule (Ref. 3).
Consequently, the TSCA Inventory does not list chemical substances that
are solely processed or imported as part of articles. The TSCA
Inventory list of inactive PFAS therefore does not take into account
ongoing importation or processing of PFAS in articles. EPA's SNURs are
often amended, however, as ongoing uses of the chemical substances are
phased out. Therefore, as EPA collects evidence and determines that the
importing or processing of inactive PFAS into articles is no longer
ongoing, EPA may consider whether to make inapplicable the articles
exemption at 40 CFR 721.45(f).
EPA also seeks comment on the potential impact on firms that plan
to import or process articles containing inactive PFAS, because, while
not required by the proposed SNUR, these parties may take additional
steps to determine whether inactive PFAS are part of the articles that
they are considering to import or process.
XI. 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 proposed significant new use rule, in Unit II. and in the
references cited throughout the preamble of this proposed rule. EPA
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
[[Page 4944]]
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.
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. ``PFAS Strategic Roadmap: EPA's Commitment to Action
2021-2024.'' EPA-100-K-21-002, October 2021.
2. U.S. EPA. ``Economic Analysis of the Proposed Significant New Use
Rule Per- and Poly-fluoroalkyl Chemical Substances Designated as
Inactive on the TSCA Inventory.'' January 2022.
3. U.S. EPA. TSCA Inventory Notification (Active-Inactive)
Requirements; Final Rule, 82 FR 37520, August 11, 2017.
4. 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.
5. Buck, R.C., Korzeniowski, S.H., Laganis, E, and Adamsky, F.
(2021). ``Identification and classification of commercially relevant
per[hyphen]and poly[hyphen]fluoroalkyl substances (PFAS).''
Integrated Environmental Assessment and Management, 17, 1045-1055.
6. 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.
7. Agency for Toxic Substances and Disease Registry (ATSDR).
``Toxicological Profile for Perfluoroalkyls.'' May 2021. Available
from: <a href="https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf">https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf</a>.
8. 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. (2022).
Per- and polyfluoroalkyl substances in the environment. Science.
375: 6580, 1-14.
XIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/and-executive-orders</a>.
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 under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not
submitted to the Office of Management and Budget (OMB) for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
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. OMB has previously approved the
information collection activities contained in the existing regulations
and has assigned OMB control numbers 2070-0038 (EPA ICR No. 2702.01)
and the information collection activities associated with export
notifications are already approved under OMB control number 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.
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. In making this determination, EPA concludes that the impact of
concern is any significant adverse economic impact on small entities,
and the Agency is certifying that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the proposed rule as
a ``significant new use.'' By definition of the word ``new'' and based
on all information currently available to EPA, it appears that no small
or large entities presently engage in such activities. Since this SNUR
will require a person who intends to engage in such activity in the
future to first notify EPA by submitting a SNUN, no economic impact
will occur unless someone files a SNUN to pursue a significant new use
in the future or forgoes profits by avoiding or delaying the
significant new use. Although some small entities may decide to conduct
such activities in the future, EPA cannot presently determine how many,
if any, there may be. However, EPA's experience to date is that, in
response to the promulgation of SNURs covering over 1,000 chemical
substances, the Agency receives only a handful of notices per year
(Ref. 2). EPA believes the cost of submitting a SNUN is relatively
small compared to the cost of developing and marketing a chemical new
to a firm or marketing a new use of the chemical and that the
requirement to submit a SNUN generally does not have a significant
economic impact.
Therefore, EPA believes that the potential economic impact of
complying with this proposed SNUR is not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published as a final rule on August 8, 1997 (62 FR 42690), the Agency
presented its general determination that proposed and final SNURs are
not expected to have a significant economic impact on a substantial
number of small entities.
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. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). 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). 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,
[[Page 4945]]
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 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks that the Agency 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
concern an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not otherwise been designated by the
Administrator of the Office of Information and Regulatory Affairs as a
significant energy action.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve any technical standards under
section 12(d) of NTTAA, 15 U.S.C. 272 note.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or Indigenous
peoples) and low-income populations.
EPA believes that the human health and environmental conditions
that exist prior to this action do not result in disproportionate and
adverse effects on people of color, low-income populations, and/or
Indigenous peoples because 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 people of color, low-income populations and/or Indigenous peoples
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.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: January 17, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons set forth in the preamble, it is
proposed that 40 CFR chapter I be amended as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.11777 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 chemical substances identified in paragraphs
(b)(1)(i) through (iii) of this section, designated as inactive on the
TSCA Chemical Substance Inventory as of the date of publication of this
proposed rule, are subject to reporting under this section for the
significant new uses described in paragraph (b)(2) of this section.
(i) R-(CF2)-CF(R')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. 2023-01156 Filed 1-25-23; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on January 26, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.