Proposed Rule2023-10735
Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)
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
May 26, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The United States Environmental Protection Agency (EPA) is proposing amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The proposal includes amendments that would reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review. EPA is also proposing several amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA's 1999 PBT policy.
Full Text
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<title>Federal Register, Volume 88 Issue 102 (Friday, May 26, 2023)</title>
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Proposed Rules]
[Pages 34100-34125]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10735]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 720, 721, 723, and 725
[EPA-HQ-OPPT-2022-0902; FRL-7906-01-OCSPP]
RIN 2070-AK65
Updates to New Chemicals Regulations Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The United States Environmental Protection Agency (EPA) is
proposing amendments to the new chemicals procedural regulations under
the Toxic Substances Control Act (TSCA). These amendments are intended
to align the regulatory text with the amendments to TSCA's new
chemicals review provisions contained in the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, enacted on June 22, 2016,
improve the efficiency of EPA's review processes, and update the
regulations based on existing policies and experience implementing the
New Chemicals Program. The proposal includes amendments that would
reduce the need to redo all or part of the risk assessment by improving
information initially submitted in new chemicals notices, which should
also help reduce the length of time that new chemicals notices are
under review. EPA is also proposing several amendments to the
regulations for low volume exemptions (LVEs) and low release and
exposure exemptions (LoREXs), which include requiring EPA approval of
an exemption notice prior to commencement of manufacture, making per-
and polyfluoroalkyl substances (PFAS) categorically ineligible for
these exemptions, and providing that certain persistent,
bioaccumulative, toxic (PBT) chemical substances are ineligible for
these exemptions, consistent with EPA's 1999 PBT policy.
DATES: Comments must be received on or before July 25, 2023.
[[Page 34101]]
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0902 through 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:
Tyler Lloyd, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4016; email address: <a href="/cdn-cgi/l/email-protection#b0dcdcdfc9d49ec4c9dcd5c2f0d5c0d19ed7dfc6"><span class="__cf_email__" data-cfemail="e08c8c8f9984ce94998c8592a0859081ce878f96">[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#c296918183ef8aadb6aeabaca782a7b2a3eca5adb4"><span class="__cf_email__" data-cfemail="df8b8c9c9ef297b0abb3b6b1ba9fbaafbef1b8b0a9">[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 intend to
manufacture a new chemical substance, or manufacture or process a
chemical substance for a significant new use. The following list of
North American Industry 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> Chemical Manufacturers (NAICS code 325).
<bullet> Petroleum and Coal Products (NAICS code 324).
<bullet> Merchant Wholesalers, Nondurable Goods (NAICS code 424).
If you have any questions regarding the applicability of this
action, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Section 5(a)(1) of the Toxic Substances Control Act (TSCA), 15
U.S.C. 2604(a)(1), as amended by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act of 2016 (Pub. L. 114-182) (herein
referred to as the ``2016 Lautenberg Amendments''), provides that no
person, as defined at 40 CFR 720.3, may manufacture (which includes
import under TSCA) a new chemical substance or manufacture or process a
chemical substance for a use which EPA has determined is a significant
new use, unless at least 90 days prior to such manufacture or
processing that person submits a notice to EPA containing the
information required by TSCA section 5(d). EPA must conduct a review of
the notice, make one of five possible determinations pertaining to the
likelihood of unreasonable risk of injury to health or the environment,
and take any actions required as a result of that determination, all
within the applicable review period. The submitted notice must include
the information described in TSCA section 5(d)(1): insofar as known to
the submitter or reasonably ascertainable, information described in
certain provisions of TSCA section 8(a)(2) (e.g., chemical identity,
use, and exposure information); in the form and manner prescribed by
EPA, information in the possession or control of the submitter related
to the health or environmental effects of the chemical substance; and a
description of any other information concerning the environmental and
health effects of the chemical substance, insofar as known to the
submitter or reasonably ascertainable. EPA is issuing this proposed
rule under TSCA section 5, 15 U.S.C. 2604.
C. What action is the Agency taking?
When EPA receives a premanufacture notice (PMN), significant new
use notice (SNUN), or microbial commercial activity notice (MCAN), the
Agency is required to assess the risk associated with the new chemical
substance or significant new use that is the subject of the notice
under the conditions of use and make a determination for the chemical
substance pertaining to the likelihood of such risk. Under TSCA, the
term ``chemical substance'' includes microorganisms. To improve the
effectiveness and efficiency of these reviews, EPA is proposing to
amend the procedural regulations at 40 CFR parts 720, 721, and 725 to
align with the requirements in TSCA section 5, as amended by the 2016
Lautenberg Amendments, and to make additional updates. In particular,
EPA is proposing to amend the regulations to specify that EPA must make
a determination on each PMN, SNUN, and MCAN received before the
submitter may commence manufacturing or processing of the chemical
substance that is the subject of the notice, and to list the five
possible determinations and the actions required in association with
those determinations. In addition, EPA is proposing to clarify the
level of detail expected for the information that a submitter is
required to include in a PMN, SNUN, or exemption notice in order for
the notice to be considered complete. EPA is also proposing amendments
to the procedures for reviewing PMNs and SNUNs; specifically,
procedures for addressing PMNs and SNUNs that have errors or are
incomplete or that are amended during the applicable review period.
Additionally, EPA is proposing to make several amendments to the
regulations at 40 CFR 723.50 for low volume exemptions (LVEs) and low
release and exposure exemptions (LoREXs). These amendments would
require EPA approval of an exemption notice before the submitter may
commence manufacture, allow EPA to inform an LVE or LoREX holder when
the chemical substance that is the subject of the exemption becomes
subject to a significant new use rule (SNUR) under TSCA and the
chemical identity is confidential, make perfluoroalkyl and
polyfluoroalkyl substances (PFAS) categorically ineligible for these
exemptions, and codify EPA's use of the 1999 PBT policy for these
exemptions by making certain PBTs ineligible for these exemptions.
Finally, EPA is proposing to amend the regulations pertaining to
suspensions for all TSCA section 5 notices to allow submitters to
request suspensions for up to 30 days via oral or email request.
D. Why is the Agency taking this action?
Under amended TSCA, EPA must review all notices submitted under
TSCA section 5(a)(1) and make a determination pertaining to the risks
of new chemical substances or significant new uses of chemical
substances described in such notices before they can proceed to the
marketplace. Before the 2016 Lautenberg Amendments, TSCA allowed the
PMN submitter to commence manufacturing or processing upon expiration
of the review period, unless EPA made an affirmative finding of
unreasonable risk. Under amended TSCA, EPA must review all notices
submitted under TSCA section 5(a)(1) and make a determination
pertaining to the risks of every new chemical substance or significant
new use of chemical substances described in such notices before they
can proceed to the marketplace. To reflect and better meet these
requirements, EPA is proposing to align the procedural regulations
codified at 40 CFR parts 720 and 725 with amended TSCA and to make
additional updates based on existing policies or lessons learned from
[[Page 34102]]
administering the New Chemicals Program since TSCA was amended in 2016.
EPA is also proposing to clarify the information that is required
to be included in PMNs, SNUNs, and exemption notices and to clarify EPA
review procedures to make the review process more efficient, promote
more complete submissions, and reduce the need to redo all or part of
the risk assessment (``re-work'') due to late submissions of
information that delay EPA review of PMNs, SNUNs, and exemption
notices. In order to continue to meet amended TSCA's requirement for
the Agency to make determinations for all PMNs and SNUNs within an
applicable review period of 90 days from receipt (or up to 180 days
with an extension), EPA needs to identify and implement efficiencies in
the PMN and SNUN review process, ensure notices are complete and reduce
re-work of risk assessments. This action, if finalized, is expected to
reduce re-work of risk assessments by minimizing requests from
submitters to amend their PMNs, SNUNs, or exemption notices with
additional information after the review period has commenced. The
Agency is also proposing to clarify the procedures that will be
employed if submitters amend their PMNs or SNUNs during the applicable
review period.
EPA is also proposing to amend the regulations for LVEs and LoREXs
so that submitters may not commence manufacture until EPA has issued a
decision for the exemption notice, to better ensure that manufacture
under LVEs and LoREXs will not present an unreasonable risk.
Additionally, EPA is proposing amendments that would allow the Agency
to notify submitters if a chemical substance for which they hold an LVE
or LoREX becomes subject to a proposed or final SNUR and the chemical
identity is confidential, so that chemical manufacturers are made aware
that they may be subject to additional TSCA requirements.
EPA is also proposing to make PFAS categorically ineligible for an
LVE or LoREX, which would ensure that all new PFAS are reviewed through
the full PMN process. In addition, EPA is proposing to codify EPA's
1999 PBT policy by making certain PBTs ineligible for these exemptions.
Lastly, EPA is proposing to allow informal (oral or email) requests
for review period suspensions of up to 30 days to reduce the number of
repeated requests for 15-day suspensions, and because EPA believes that
email may be more expedient than oral communication for many
submitters.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential incremental impacts of this
rulemaking in an economic analysis (EA), titled ``Economic Analysis for
the Proposed Rule: Updates to New Chemicals Regulations under the Toxic
Substances Control Act'' (Ref. 1), which is available in the docket,
discussed in Unit IV, and briefly summarized here. The benefits of the
rule include increased efficiency in both the submission and review
processes for notices submitted through the PMN form. The changes under
this proposed rule would clarify the information requirements on the
PMN form in the Agency's Central Data Exchange (CDX) to make more
transparent the level of detail that EPA needs in order to make a
reasoned evaluation. As submitters provide more complete information in
their initial submissions, the changes under this proposed rule are
expected to reduce the frequency with which PMNs, SNUNs, and exemption
notices are amended with additional information and the amount of re-
work of risk assessments that the Agency conducts following such
amendments.
As a result of the changes presented in this proposed rule, the
total annual burden to industry is expected to decrease by
approximately 4,518 hours, while total annual costs to industry
submitters are expected to have a net increase of $45,120. The Agency
is expected to experience an annual cost savings of approximately
$923,280.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the part or all of the information that
you claim to be 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/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
As enacted in 1976, TSCA provided EPA with authority to require
reporting, recordkeeping, and testing, and to issue restrictions
relating to chemical substances and/or mixtures. TSCA section 5(a)(1)
required that a person submit to EPA a notice at least 90 days before
commencing manufacture of a new chemical substance or manufacture or
processing of a chemical substance for a use which EPA determined to be
a significant new use. TSCA section 5(e) provided that EPA could issue
a proposed order to regulate a chemical substance for which a notice
was submitted under TSCA section 5(a)(1) if it determined that: (1) the
information available to EPA is insufficient to permit a reasoned
evaluation of the health and environmental effects of the chemical
substance, and (2) the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance may present an
unreasonable risk of injury to health or the environment in the absence
of sufficient information, or the chemical substance is or will be
produced in substantial quantities and may either enter the environment
in substantial quantities or result in significant or substantial human
exposure. Further, TSCA section 5(f) required EPA to issue a proposed
rule or proposed order to regulate the chemical substance, or to seek
an injunction to prohibit the manufacture, processing, or distribution
in commerce of the chemical substance, if it found that there is a
reasonable basis to conclude that the chemical substance presents or
will present an unreasonable risk of injury to health or the
environment.
Under the 1976 law, EPA was not obligated to make a determination
or finding regarding unreasonable risk for each notice submitted under
TSCA section 5(a)(1). However, if EPA decided to take action under TSCA
section 5(e) or 5(f), TSCA required EPA to do so within 90 days of
receiving the notice (or up to 180 days if EPA extended the notice
period pursuant to TSCA section 5(c)). If EPA did not take action
during that time, manufacturing or processing of the chemical substance
could commence.
EPA's obligations with respect to making determinations on notices
submitted under TSCA section 5(a)(1) fundamentally changed with the
passage of the 2016 Lautenberg Amendments. The 2016 Lautenberg
Amendments added a new paragraph to TSCA at section 5(a)(3) titled
``Review and Determination,'' under which EPA must review and make a
determination
[[Page 34103]]
pertaining to the likelihood of risk on all notices received under TSCA
section 5(a)(1), which include PMNs, SNUNs and MCANs, within the
applicable review period and lists five types of risk determinations
available to EPA.
EPA's obligation to take action after making a determination on a
notice submitted under TSCA section 5(a)(1) also changed with the
passage of the 2016 Lautenberg Amendments. Under amended TSCA, EPA is
required to issue an order pursuant to TSCA section 5(e) when it makes
a determination under TSCA section 5(a)(3)(B) that: (1) the information
available to EPA is insufficient to permit a reasoned evaluation of the
health and environmental effects of the chemical substance or
significant new use; (2) 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 to
health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation (PESS) identified as relevant by EPA; or
(3) the chemical substance is or will be produced in substantial
quantities and may either enter the environment in substantial
quantities or result in significant or substantial human exposure. EPA
must issue an order to prohibit or limit the manufacture, processing,
distribution in commerce, use, or disposal of the chemical substance to
the extent necessary to protect against an unreasonable risk of injury
to health or the environment, without consideration of costs or other
non-risk factors, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by EPA
under the conditions of use.
Furthermore, TSCA section 5(f) requires EPA to issue either an
order or a proposed rule under TSCA section 6(a) when EPA makes a
determination under TSCA section 5(a)(3)(A) that a chemical substance
or significant new use presents an unreasonable risk of injury to
health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant by EPA under the
conditions of use. If EPA issues an order under TSCA sections 5(e) or
5(f), it must do so no later than 45 days before the expiration of the
applicable review period.
Lastly, when EPA makes a determination under TSCA section
5(a)(3)(C) that a chemical substance or significant new use is not
likely to present an unreasonable risk of injury to health or the
environment, without consideration of costs or other non-risk factors,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by EPA under the conditions of
use, EPA must publish a statement of its finding in the Federal
Register according to TSCA section 5(g).
In summary, the 2016 Lautenberg Amendments require EPA to review
each notice submitted under TSCA section 5(a)(1), make a determination
on that notice, and take the action required in association with that
determination within the applicable review period. Under TSCA section
5(i)(3), the ``applicable review period'' means 90 days from the date
EPA receives a notice under TSCA section 5(a)(1), or up to 180 days
from that date if EPA extends the applicable review period according to
the provisions in TSCA section 5(c). TSCA section 5(c) allows EPA to
extend the original 90-day review period by up to another 90 days for
good cause and requires the reasons for the extension to be published
in the Federal Register. The 2016 Lautenberg Amendments also added TSCA
section 5(a)(4) explaining that a failure by EPA to render a
determination within the applicable review period would not relieve EPA
of any requirement to make such determination, but would, with certain
exceptions, result in a fee refund to the notice submitter.
TSCA section 5(h) was not significantly amended by the 2016
Lautenberg Amendments. TSCA section 5(h) provides EPA the authority to
exempt a person from certain TSCA section 5 requirements under certain
situations, such as if the person will manufacture the chemical
substance for test marketing purposes, in small quantities for
scientific experimentation, or under other conditions that will not
present an unreasonable risk of injury to health or the environment,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified by EPA under the conditions of use. EPA
developed the LVE and LoREX regulations in 1995 pursuant to TSCA
section 5(h)(4) (60 FR 16336, March 29, 1995).
EPA's regulations related to TSCA section 5 are codified in Title
40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR).
They include:
<bullet> Regulations related to PMNs, which are codified at 40 CFR
part 720;
<bullet> Regulations pertaining to SNUNs, which are codified at 40
CFR part 721;
<bullet> Regulations pertaining to certain exemptions, which are
codified at 40 CFR part 723; and
<bullet> Regulations pertaining to MCANs and microorganism-related
exemptions, which are codified at 40 CFR part 725.
The information requirements codified for PMNs in 40 CFR 720.45
generally also apply to SNUNs under 40 CFR part 721 (see 40 CFR
721.1(c) and 721.25(a), which cross-references 40 CFR part 720) and to
LVEs and LoREXs submitted under 40 CFR 723.50 (see 40 CFR 723.50(e)(2),
which cross-references 40 CFR 720.45). As a result, the proposed
amendments to the requirements in 40 CFR 720.45 would apply to PMNs and
also to SNUNs, LVEs, and LoREXs. The review procedures for PMNs
codified in 40 CFR part 720 generally also apply to SNUNs under 40 CFR
part 721 (see 40 CFR 721.25(c)) but not to exemptions under 40 CFR part
723, so the amendments to the part 720 review procedures proposed in
this action would apply to PMNs and also to SNUNs but not to such
exemptions. Neither the information requirements nor the review
procedures in 40 CFR part 720 apply to MCANs or microorganism-related
exemptions under 40 CFR part 725, so EPA is also proposing amendments
to the MCAN and microorganism-related exemption regulations at 40 CFR
part 725.
III. Summary of Proposed Rule
A. Amendments To Conform Regulations to 2016 Lautenberg Amendments
EPA is proposing changes to the PMN procedural regulations at 40
CFR part 720 to align them with the notice review and determination
requirements in TSCA section 5, as amended by the 2016 Lautenberg
Amendments. These procedural regulations also generally apply to SNUNs
under 40 CFR part 721 (see 40 CFR 721.1(c) and 721.25(c)). EPA is also
proposing similar changes to the MCAN procedural regulations at 40 CFR
part 725 to align them with the same notice review and determination
requirements added by the 2016 Lautenberg Amendments. EPA has been
implementing the amended statutory requirements but has not yet
codified these updates into the new chemicals procedural regulations.
The Agency is now proposing to amend the regulations to specify that
EPA must make a determination on each PMN, SNUN, and MCAN received
before the submitter may commence manufacturing (which includes
importing) or processing and to list the five possible determinations
and the
[[Page 34104]]
actions required in association with those determinations. EPA is also
proposing to add definitions for new terms and to update existing
terminology introduced by the 2016 Lautenberg Amendments.
1. Commencement of Manufacture or Processing
Prior to the passage of the 2016 Lautenberg Amendments, TSCA did
not require EPA to make a risk determination on each notice submitted
under TSCA section 5(a)(1). Rather, TSCA required the submission of a
notice at least 90 days before manufacturing a new chemical substance,
or manufacturing or processing a chemical substance for a significant
new use. If EPA did not take any regulatory action on a notice, the
submitter could commence the manufacturing or processing after 90 days
(or up to 180 days if EPA extended the notice period pursuant to TSCA
section 5(c)). Promulgated in 1983, the PMN procedural regulation at 40
CFR 720.75(d) reflects that prior statutory provision and states that
``in the absence of regulatory action by EPA under section 5(e), 5(f),
or 6(a) of the Act, the submitter may manufacture or import the
chemical substance even if the submitter has not received notice of
expiration [of the review period].'' A similar provision was
promulgated in the MCAN procedural regulations in 1997 at 40 CFR
725.170(b) and (c).
The 2016 Lautenberg Amendments changed the requirements of TSCA
section 5(a) by adding section 5(a)(1)(B)(ii) and (a)(3), which require
EPA to conduct a review of each notice submitted under TSCA section
5(a)(1), make a determination on the notice, and take the action
required in association with that determination before a submitter can
commence the manufacture of a new chemical substance or the manufacture
or processing of a chemical substance for a significant new use. Since
amended TSCA went into effect, EPA has been implementing the new law by
making a determination and taking any required action on each PMN,
SNUN, and MCAN received. However, the outdated regulatory text at 40
CFR 720.75(d) and 725.170(b) and (c) is still in place, even though it
has been superseded by the amendments to the statute.
Therefore, in this action, EPA is proposing to amend 40 CFR
720.75(d) by removing the outdated language allowing the submitter to
commence manufacture of a chemical substance when the review period
expires and adding new language specifying that EPA must issue a
determination and take any required action on each PMN before
manufacture may commence. EPA is also proposing to amend 40 CFR
721.25(d) to state that any person submitting a SNUN shall not
manufacture or process a chemical substance for a significant new use
until EPA has issued a determination with respect to the significant
new use and taken the actions required in association with that
determination. Likewise, EPA is proposing to amend 40 CFR 725.170(b)
and (c) by removing similar outdated language allowing the submitter to
commence manufacture of a new microorganism or manufacture or
processing of a microorganism for a significant new use when the review
period expires and adding new language specifying that EPA must issue a
determination and take any required action on each MCAN before
manufacture may commence.
2. Required Determinations and Associated Actions
As previously described, the 2016 Lautenberg Amendments added a new
paragraph at TSCA section 5(a)(3) titled ``Review and Determination,''
which lists the five possible determinations that EPA may make on a
notice. To improve clarity and help inform the regulated community
about EPA's statutory obligations under TSCA section 5(a)(3), EPA is
proposing to further amend 40 CFR 720.75(d) and 725.170 by listing the
five possible determinations for each PMN, SNUN, or MCAN.
EPA is also proposing to add language to 40 CFR 720.75(d) and
725.170(b) to describe the actions that EPA must take in association
with its determination for a PMN, SNUN, or MCAN. EPA is proposing to
codify those actions, which EPA has been implementing, as applicable,
for every PMN, SNUN, and MCAN since the 2016 Lautenberg Amendments, to
be clear about EPA's review process to the public. The five possible
determinations and associated actions are as follows:
<bullet> When EPA makes a determination for a PMN, SNUN, or MCAN
according to TSCA section 5(a)(3)(C) that the new chemical substance or
significant new use is not likely to present an unreasonable risk of
injury to health or the environment, without consideration of costs or
other non-risk factors, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by EPA
under the conditions of use, EPA issues a determination document to the
submitter of the PMN, SNUN, or MCAN. The submitter may commence
manufacturing or processing of the chemical substance once they receive
the determination document. As required by TSCA section 5(g), EPA also
submits for publication in the Federal Register a statement of the
``not likely'' finding.
<bullet> When EPA makes a determination for a PMN, SNUN, or MCAN
according to TSCA section 5(a)(3)(B) that (1) the information available
to EPA is insufficient to permit a reasoned evaluation of the health
and environmental effects of the new chemical substance or significant
new use, (2) 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 to health or the
environment, without consideration of costs or other non-risk factors,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by EPA, or (3) the chemical
substance is or will be produced in substantial quantities and may
either enter the environment in substantial quantities or result in
significant or substantial human exposure, EPA must issue an order
pursuant to TSCA section 5(e). The order prohibits or limits the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance to the extent necessary to protect against an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by EPA under the conditions of use. EPA may
issue an order under TSCA section 5(e) that requires testing to be
conducted and presented to EPA after the applicable review period has
concluded.
<bullet> When EPA makes a determination for a PMN, MCAN, or SNUN
according to TSCA section 5(a)(3)(A) that the chemical substance or
significant new use presents an unreasonable risk of injury to health
or the environment, without consideration of costs or other non-risk
factors, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by EPA under the
conditions of use, EPA must take one of the following actions described
in TSCA section 5(f) to the extent necessary to protect against such
risk: (1) issue an immediately effective proposed rule to limit the
amount of such substance that may be manufactured, processed, or
distributed in commerce or to impose other requirements described in
TSCA
[[Page 34105]]
section 6(a), or (2) issue an order to prohibit or limit the
manufacture, processing or distribution in commerce of the substance,
to take effect on the expiration of the applicable review period.
After EPA issues an order under TSCA section 5(e) or (f) and the
applicable review period concludes, the submitter may submit studies,
tests, reports, or other additional information. If EPA concludes from
an assessment of the additional information that one or more of the
prohibitions or limitations contained in the order are no longer
necessary to protect against an unreasonable risk of injury to health
or the environment, EPA may modify or revoke the prohibitions or
limitations of the order. If EPA determines that none of the order
terms are warranted after assessment of the additional information, EPA
may revoke all the requirements of the order. EPA is proposing
amendments to 40 CFR 720.75(d) and 725.170 to state that EPA may modify
or revoke the prohibitions and limitations in an order after the
applicable review period has ended if the submitter submits to EPA
additional testing, studies, reports, or other information that EPA
determines, upon review, demonstrate that such prohibitions or
limitations are no longer necessary to protect against an unreasonable
risk of injury to health or the environment. While the current
regulations do not specify that EPA may modify or revoke the
prohibitions and limitations in an issued order, the proposed
amendments at 40 CFR 720.75(d) and 725.170 would codify current
practices. EPA believes that these existing processes and actions for
modifying or revoking the prohibitions and limitations in an issued
order fulfill the requirements of TSCA section 5, as amended by the
2016 Lautenberg Amendments.
3. Other Updates
EPA is proposing to replace the terms ``notice period,''
``notification period,'' ``statutory review period,'' and ``notice
review period'' with the term ``applicable review period'' throughout
40 CFR part 720 to conform to the new terminology in TSCA section 5
added by the 2016 Lautenberg Amendments. EPA is proposing to add a
definition for ``applicable review period'' to 40 CFR 720.3, which EPA
would define as ``the period starting on the date EPA receives a
complete notice under section 5(a)(1) of the Act and ending 90 days
after that date or on such date as is provided for in sections 5(b)(1)
or 5(c) of the Act.'' This proposed definition is based on the TSCA
section 5(i)(3) definition for ``applicable review period.''
EPA is also proposing to add a definition for ``potentially exposed
or susceptible subpopulation'' to 40 CFR 720.3, a term added to TSCA by
the 2016 Lautenberg Amendments. Based on the definition in TSCA section
3(12), EPA would define ``potentially exposed or susceptible
subpopulation'' as ``a group of individuals within the general
population identified by EPA who, due to either greater susceptibility
or greater exposure, may be at greater risk than the general population
of adverse health effects from exposure to a chemical substance or
mixture, such as infants, children, pregnant women, workers, the
elderly, or overburdened communities.''
EPA is also proposing to update 40 CFR 720.70(b) by revising
paragraph (b)(3). The language in paragraph (b) describes the content
of the document that EPA routinely publishes in the Federal Register
under TSCA section 5(d)(2) to announce the receipt of PMNs submitted to
EPA. Although not required by TSCA section 5(d)(2), the first sentence
in 40 CFR 720.70(b)(3) specifies that the document EPA publishes in the
Federal Register pursuant to TSCA section 5(d)(2) will also include a
list of data submitted with the PMN in accordance with 40 CFR
720.50(a). In proposing to establish this requirement in the original
40 CFR part 720 regulations, EPA described its objective as providing
relevant information to the public in terms of the PMNs submitted and
under review with EPA. See e.g., 44 FR 2242, 2253 (January 10, 1979).
That transparency goal is now better achieved through other more
efficient and effective mechanisms that negate the need to publish that
information in the Federal Register. Specifically, to provide
streamlined access to information EPA receives and develops about
chemicals, EPA has built and is constantly expanding content in an
online searchable data base called ChemView (<a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/introduction-chemview">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/introduction-chemview</a>), and
currently makes the PMN itself, including test data submitted with it,
available on ChemView (subject to confidentiality claims) generally
within 5 workdays of receipt. In addition, EPA is making the list of
new chemical submissions received available in one place on our website
to increase transparency and make information on new chemicals easier
to find (see <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-notices-received-epa">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-notices-received-epa</a>). This
approach was adopted several years ago to provide an alternative to
searching individual Federal Register notices and dockets on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The links below provide a listing of the following
types of new chemical submissions received. The lists on the website
are updated on a regular basis and allow anyone to track the status of
active new chemical cases by visiting our page on statistics for the
new chemicals review program (<a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review</a>).
B. Amendments Related to Notice Information Requirements
EPA is proposing changes to the notice information requirements at
40 CFR 720.45, as well as corresponding changes to the reporting form
in CDX, to clarify the level of detail expected for information that
must be submitted to EPA in the PMN, SNUN, and certain exemption
notices.
1. Background
A notice submitted under TSCA section 5(a)(1) must include the
information described in TSCA section 5(d)(1): (1) insofar as known to
the submitter or reasonably ascertainable, information described in
certain provisions of TSCA section 8(a)(2); (2) in the form and manner
prescribed by EPA, information in the possession or control of the
submitter related to the health or environmental effects of any
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance or any article containing such substance; and
(3) a description of any other information concerning the environmental
and health effects of the chemical substance, insofar as known to the
submitter or reasonably ascertainable. EPA has promulgated regulations
detailing these information requirements in 40 CFR 720.45 and 720.50.
EPA has developed an application form in CDX to collect such
information from submitters. The user guide for CDX is listed in the
references section of this proposed rule and can be found in the docket
(Ref. 2). This form is prescribed by EPA for submission of PMNs, SNUNs,
LVEs, LoREXs, and test marketing exemption (TME) applications. In this
preamble, EPA refers to the form as the ``PMN form'' for simplicity,
but the proposed changes outlined in this section would impact the
other types of notices that use the same form (i.e., PMNs, SNUNs, LVEs,
LoREXs, and TMEs).
EPA has observed that most PMN, SNUN, and exemption notices do not
contain all required information at the
[[Page 34106]]
level of detail that EPA needs to perform refined, quantitative risk
assessments. When a submission is lacking detail, EPA typically uses
conservative assumptions and default values to ensure the assessment is
protective of human health and the environment. The Agency may make
predictions using models concerning physical and chemical properties,
environmental transport and partitioning, environmental fate,
environmental toxicity, human health, engineering releases to the
environment, and environmental concentrations--see the document titled
``Points to Consider When Preparing TSCA New Chemical Notification''
(Ref. 3) for more information on EPA's use of predictive models in the
new chemical review process. EPA has repeatedly observed, however, that
when submitters see the level of risk estimated by EPA using such
conservative assumptions and default values, as well as the risk
mitigation measures developed by EPA as a result, submitters often
amend their initial notices to provide additional detailed information.
In an effort to improve the accuracy of EPA's risk assessment,
submitters often either provide information that was missing in their
initial notice or clarify details about the manufacturing process. When
EPA receives such information during the review process, EPA takes the
information into consideration and may redo its risk assessments (``re-
work'') to factor in the additional information. This longstanding
practice of submitters amending their initial notices to provide
additional information after the beginning of the review period and EPA
having to consider the information late in the review process results
in re-work by EPA and diverts EPA attention from processing new
notices. This creates delays in the review of notices generally.
EPA has previously worked to address the inefficiency of the review
process associated with late submission of information by issuing
several supplemental documents to aid submitters in providing all
relevant information in the initial notice. EPA published a Points to
Consider document in 2018 (Ref. 3) and provides a user guide and
resource tab that are accessible within the CDX application and provide
instructions on how to complete the submission (Ref. 2). To further
address this issue, EPA began implementing a pre-screen process for
notices in April 2020, which is detailed in Unit III.C. of this
document. And in July 2022, the Agency launched the TSCA New Chemical
Engineering Initiative to Increase Transparency and Reduce Re-work that
included a broad outreach effort to describe and discuss with
stakeholders how the Agency evaluates data provided with notices and
common issues that cause EPA to have to re-work risk assessments (Ref.
4).
EPA believes that amending the notice information requirements at
40 CFR 720.45 to specify the level of detail needed, as well as
building that additional detail into the CDX user interface, would help
submitters provide all relevant information in their initial notice
submissions. EPA has observed that many data elements in notice
submissions often lack the level of detail that EPA needs. EPA believes
that specifying more detailed information requirements in 40 CFR 720.45
and data fields in the CDX user interface would promote more complete
submissions upfront and help to minimize the need for EPA to use
default values and conservative assumptions in its risk assessment.
Therefore, EPA is proposing to amend the notice information
requirements at 40 CFR 720.45, as well as implementing corresponding
changes to the PMN form in CDX.
2. Proposed Changes to 40 CFR 720.45 and the PMN Form
EPA is proposing to amend 40 CFR 720.45 and the PMN form in CDX to
clarify the information requirements for a notice. Specifically, EPA is
proposing to add details to certain information requirements already
contained in 40 CFR 720.45 and to add additional reporting fields to
the PMN form to reflect these details. This detailed information is
already required by the broader information requirements contained in
40 CFR 720.45 and 720.50 and is reflected in the CDX user interface. In
this action, EPA is proposing to add these details as separate, unique
information requirements in 40 CFR 720.45 and make corresponding
changes to the PMN form to clarify the level of detail needed for EPA's
review of a notice and to ensure that the fields in the PMN form are
consistent with the regulations. In some cases, reporting fields for
detailed information are already included in the PMN form because they
are covered by broader information requirements contained in 40 CFR
720.45 or 720.50. EPA is proposing to add those details to 40 CFR
720.45 so that the regulations and PMN form are consistent. See Ref. 5,
which provides tables that list the detailed information requirements
proposed to be added to 40 CFR 720.45 and indicate whether reporting
fields for that information are already included in the PMN form.
Consistent with TSCA section 5(d)(1), for all information
requirements under 40 CFR 720.45, submitters are only required to
provide information to the extent that it is known to or reasonably
ascertainable by the submitter, as defined at 40 CFR 720.3(p). Under
the proposed changes to 40 CFR 720.45, a submitter would be required to
include in the PMN form the detailed information proposed in this
action, along with all other information already required, to the
extent the information is known to or reasonably ascertainable by the
submitter. This is an important point because a submitter may not know
or be able to reasonably ascertain certain details about the chemical
substance that is the subject of the notice, such as details about
manufacturing, processing, or use sites out of the submitter's control.
In those situations, EPA would make conservative assumptions and use
conservative default values for any information that is not known to or
reasonably ascertainable by the submitter and therefore not provided in
the PMN form.
Currently, if submitters have physical-chemical or environmental
fate test data, they must provide the test data or a standard
literature citation in accordance with 720.50(a)(2)-(3). Submitters
must also submit this information in the corresponding PMN form fields
in accordance with the proposed changes to 720.45(j). Data provided in
the PMN form via CDX may be pulled from the test data provided by
submitters per 720.50(a)(2)-(3), or the data can be submitted as
standalone information for which submitters do not have underlying test
data.
a. Physical and Chemical Properties and Environmental Fate
Characteristics
The first set of detailed information requirements that EPA is
proposing to add to 40 CFR 720.45 is about the physical and chemical
properties and environmental fate characteristics of the chemical
substance (see Table 1 in Ref. 5). EPA currently collects physical and
chemical properties test data required by 40 CFR 720.50, ``Submission
of test data and other data concerning the health and environmental
effects of a substance,'' in two ways. First, the CDX user interface
prompts the submitter to attach relevant documents, such as test data,
to the PMN form using an attachment function. Second, the PMN form
includes a CDX user interface screen with form fields for physical and
chemical properties available for completion via a pick list. To ensure
that the regulations are clear about what
[[Page 34107]]
information fields are included in the PMN form itself, EPA believes
that the information requirements in 40 CFR 720.45 should reflect the
PMN form fields. EPA is therefore proposing to add relevant physical
and chemical properties information requirements in a new provision at
40 CFR 720.45(j)(1) that are already specified within the PMN form.
EPA is proposing several information requirements at 40 CFR
720.45(j)(1) that are not already specified within the PMN form for
physical and chemical properties. EPA is proposing to require in 40 CFR
720.45(j)(1) that data on surface tension and ultraviolet-visible (UV-
VIS) absorption, as well as any particle size distribution analysis, be
submitted as part of the PMN form, to the extent it is known to or
reasonably ascertainable by the submitter. Data on surface tension and
UV-VIS absorption are not currently included on the pick list for
physical and chemical properties in CDX, and their inclusion there as
well as in the proposed regulations at 40 CFR 720.45(j)(1) will promote
more complete submissions. The particle size distribution value is
already a physical and chemical property that appears in the pick list
on the CDX user interface screen, but it would improve EPA's ability to
assess risk if the value were accompanied by the analysis data used to
develop the value. Additionally, EPA proposes to require at 40 CFR
720.45(j)(1) information for aspect ratio, thickness, and number of
layers or walls for nanomaterials. Information requirements for
nanomaterial morphology do not currently appear on the pick list for
physical and chemical properties on the CDX user interface screen or in
the regulations. Requiring data for these properties will allow EPA to
offer additional clarity to submitters providing notices for
nanomaterials, since submitters might otherwise omit such data.
Therefore, EPA is proposing to add these requirements to the
regulations at 40 CFR 720.45(j)(1) and to add fields for attaching
associated data on the physical and chemical properties screen of the
PMN form.
EPA also proposes to add information requirements for the
environmental fate characteristics of the chemical substance (see Table
1 in Ref. 5) to 40 CFR 720.45(j)(2). Environmental fate characteristics
test data are already required by 40 CFR 720.50; however, this
provision does not describe in detail what these relevant
characteristics include. In addition, this information is already
collected by EPA as attachments to the PMN form; however, fields for
environmental fate characteristics are not yet included on the CDX user
interface screen pick list. EPA is proposing to add the relevant
environmental fate characteristics to the information requirements at
40 CFR 720.45(j)(2) and to add form fields to the PMN form by expanding
the pick list.
b. Categories of Use
The next set of information requirements that EPA is proposing to
add to 40 CFR 720.45 relates to the categories of use of the chemical
substance (see Table 2 in Ref. 5). The proposed requirements include
detailed information on commercial and consumer uses, which already
have form fields in the PMN form in CDX specifying in greater detail
the broader information requirement in the regulations at 40 CFR
720.45(f) regarding categories of use. Although the regulations at 40
CFR 720.45(f) currently require a description of intended categories of
use by function and application, the estimated percent of production
volume devoted to each category of use, and the percent of the new
substance in the formulation for each commercial or consumer use,
certain specific information requirements for details on commercial and
consumer uses are not yet specified. These information requirements
include the types of products or articles that would incorporate the
new chemical substance (e.g., household cleaners, plastic articles),
how and where a product or article incorporating the new chemical
substance would be used (e.g., spray applied indoors, brushed on
outdoor surfaces), consumption rates and frequency and duration of use
for products or articles containing the new chemical substance, and
information related to the use of products or articles containing the
new chemical substance by potentially exposed or susceptible
subpopulations. EPA is proposing to add these requirements to
720.45(f). Additionally, EPA is proposing to add to 40 CFR 720.45(f) a
requirement to designate applicable consumer and commercial product
categories using Organisation for Economic Co-operation and Development
(OECD)-based functional use codes, which would create consistency with
TSCA section 8(a) Chemical Data Reporting (CDR) requirements in 40 CFR
part 711. EPA is also proposing corresponding changes to the PMN form
fields in CDX.
c. Details Concerning Manufacture, Processing, and Use
The third set of information requirements that EPA is proposing to
add to 40 CFR 720.45 is information related to each site where the
chemical substance will be manufactured, processed, or used. These
requirements apply to sites controlled by submitters as well as sites
controlled by others, and although the information requirements that
EPA is proposing are similar for both, different types of activities
(e.g., manufacturing versus processing) often occur at submitter-
controlled sites versus those at sites controlled by others. Moreover,
activities at sites controlled by others are typically not as well
characterized by submitters compared to descriptions of the submitters'
own activities, since in many cases the identity and number of sites
controlled by others is unknown to the submitters when a notice is
submitted. As such, some slight differences exist in the requirements
EPA is proposing for information related to sites controlled by
submitters versus sites controlled by others.
For both sites controlled by submitters and sites controlled by
others, EPA is proposing to add information requirements for site
addresses (see Table 3 and Table 5 in Ref. 5). For submitter-controlled
sites, EPA is also proposing to add requirements for whether a
particular chemical substance is manufactured or processed via batch or
continuous production, as well as the amount of the chemical substance
manufactured or processed in a given batch and/or timeframe (see Table
5 in Ref. 5). These proposed information requirements already have a
corresponding form field in the PMN form in CDX because they are each
covered by the existing information requirements in 40 CFR 720.45(g)(1)
and (2) and (h) for a process description of operations at such sites.
Since these proposed information requirements are not yet specified in
the regulations, EPA is proposing to add them at 40 CFR 720.45(g)(1)
and (2) for sites controlled by the submitter and 40 CFR 720.45(h)(1)
and (2) for sites not controlled by the submitter.
EPA is also proposing to add requirements for detailed information
about the process diagram or description for each site controlled by
the submitter (see Table 4 in Ref. 5) and for each site not controlled
by the submitter (see Table 5 in Ref. 5). These requirements include
descriptions of the identity, approximate weight per batch or per day
for continuous production, and entry point of all starting materials
and feedstocks; the identity, approximate weight per batch or per day
for continuous production, and entry point of all products, recycle
streams, and wastes, including frequency of any equipment cleaning; the
type of containers used for interim storage and transport of the
chemical substance; and
[[Page 34108]]
identification, by number, of any points of release. Although these
details are already covered by the existing information requirements in
40 CFR 720.45(g)(2) and (h) for a process description of operations at
such sites, EPA is proposing to add them as separate, unique
information requirements at 40 CFR 720.45(g)(2) and (h)(2) and in new
fields in the PMN form to clarify the level of detail needed and to
ensure that the regulations and PMN form are consistent.
d. Worker Exposure
EPA is also proposing to add requirements for detailed information
about the possible worker exposure at each site controlled by the
submitter (see Table 6 in Ref. 5), and at each site not controlled by
the submitter (see Table 7 in Ref. 5). These requirements include types
of potential worker exposure (e.g., dermal, inhalation), descriptions
of any protective equipment and engineering controls in place, the
moisture content of the chemical substance (if a solid), and the
percentage of the chemical substance in the formulation at the time of
exposure. In addition, for sites controlled by others, these
requirements also include worker activities and descriptions of the
physical form of the chemical substance. Although these details are
already covered by the existing information requirements in 40 CFR
720.45(g)(3) and (h) regarding worker exposure information, and some
already have a corresponding form field in the PMN form in CDX, EPA is
proposing to add them as separate, unique information requirements at
40 CFR 720.45(g)(3) and (h)(3) and in new fields in the PMN form to
clarify the level of detail needed and to ensure that the regulations
and PMN form are consistent.
e. Environmental Releases
Finally, EPA is proposing to add detailed information requirements
about the potential environmental releases at each site controlled by
the submitter (see Table 8 in Ref. 5) and at each site not controlled
by the submitter (see Table 9 in Ref. 5). These requirements include
descriptions of the type of release (e.g., transport, interim storage,
disposal, equipment cleaning); the amount of the chemical substance
released directly to the environment or into control technology; the
amount of the chemical substance released to the environment after
control technology; for equipment cleaning releases, frequency of
equipment cleaning and what is used to clean equipment; for transport
and storage releases, how the chemical substance or the product
containing the chemical substance is transported from the site and
stored and information about the containers used; for releases into
air, Clean Air Act operating permit numbers and a description of any
Leak Detection and Repair program the site has implemented; for
releases into water, National Pollutant Discharge Elimination System
(NPDES) permit numbers and information on the navigable waterways and
other destinations into which the release occurs; and for releases into
wastewater treatment plants, information on the publicly owned
treatment works (POTW) into which the release occurs. In addition, for
sites controlled by others, these requirements also include a
description of the media of release. Although each of these details are
already covered by the existing information requirements in 40 CFR
720.45(g)(4) and (h) regarding environmental releases, and some already
have a corresponding form field in the PMN form in CDX, EPA is
proposing to add them as separate, unique information requirements at
40 CFR 720.45(g)(4) and (h)(4) and in new fields in the PMN form to
clarify the level of detail needed and to ensure that the regulations
and PMN form are consistent.
If the information is not known to or reasonably ascertainable by
the submitter for one or more sites, EPA makes conservative assumptions
and uses default values to replace the missing information whether the
site is controlled by the submitter or not. Therefore, EPA believes
that the level of detail in the regulations for process description,
worker exposure, and environmental release information for sites
controlled by the submitter at 40 CFR 720.45(g) should mirror the level
of detail in the regulations for process description, worker exposure,
and environmental release information for sites not controlled by the
submitter at 40 CFR 720.45(h). EPA is proposing to amend 40 CFR
720.45(g) and (h) to make them consistent. EPA recognizes that a
submitter may not possess such information about sites not controlled
by the submitter. Submitters are only required to supply information
that is known to or reasonably ascertainable by them as defined at 40
CFR 720.3(p).
Additionally, EPA is proposing clarifying amendments to 40 CFR
720.45(g)(3) and (4) and 720.45(h)(3) and (4) to ensure that submitters
include worker exposure and environmental release information from
exempt manufacture or related use of the chemical substances under 40
CFR 720.30 (e.g., a chemical substance manufactured under the byproduct
or impurity exemptions) at each site where the chemical substance will
be manufactured, processed, or used, if known or reasonably
ascertainable. EPA is also proposing clarifying amendments to 40 CFR
721.25(c) to ensure that submitters of SNUNs include in their notice
both a description of the significant new use for which they are
submitting a SNUN and of all other known or intended categories of use.
Such categories of use may include uses that are ongoing and not
subject to a significant new use rule (SNUR). Such information is
valuable for EPA in determining necessary regulatory action should
potential risks be identified during review of a SNUN.
f. Pollution Prevention Information
Lastly, EPA is proposing to add optional pollution prevention
information at 40 CFR 720.45(k). The PMN form in CDX currently includes
an optional text field and attachment function for submitters who wish
to provide pollution prevention information about the chemical
substance, such as information about using alternative fuel sources,
reducing the use of water and chemical inputs, modifying a production
process to produce less waste, implementing water and energy
conservation practices, or substituting for riskier existing products.
EPA estimates that the proposed amendments, which are intended to
clarify the level of detail required for existing data requirements
under 40 CFR 720.45 and 720.50, would have a very minor impact on
submitter burden because they are largely reflected in existing fields
in the PMN form in CDX that submitters already are prompted to
complete. Moreover, they are also already included in the Points to
Consider document (Ref. 3) that submitters are encouraged to review
before completing a notice. EPA's estimate of the burden impacts of
these proposed information requirement amendments are presented in an
Information Collection Request (ICR) document (Ref. 6), a copy of which
is in the docket and is summarized in Unit VI.B.
EPA is seeking comment specifically on its burden estimate and on
the general pros and cons of clarifying these information requirements
in the regulations and making corresponding changes to the PMN form.
EPA is also seeking comment from the public, including those who have
submitted a notice to EPA in the past, on any information requirement
details that are
[[Page 34109]]
not clearly explained in the PMN form or the regulations.
3. Other Modifications to the PMN Form in CDX
In addition to the proposed amendments to clarify the information
requirements for a notice and the corresponding changes to the PMN form
in CDX outlined in Unit III.B.1. and 2., EPA is also considering adding
statements with accompanying check boxes to certain screens of the PMN
form (such as when transitioning between the various worksheets
completed by the submitter) that indicate that information fields can
only be left blank if such information is not known to or reasonably
ascertainable by the submitter. In other words, if a submitter leaves
information fields blank, they would have to check a box on the screen
to affirm that the information is not known to or reasonably
ascertainable by the submitter before advancing to the next screen.
Additionally, a statement would warn the submitter of the potential
consequences of leaving the field blank and later amending the field.
If a field is left blank, EPA would make conservative assumptions and
use conservative default values when assessing risk, which could result
in more stringent risk management requirements. If a field that has
been left blank is later amended during the review process, EPA may
declare the original submission incomplete (see Unit III.C.3. for a
more detailed discussion on notice amendments indicating that the
original submission was incomplete). This check box approach would not
have a corresponding regulatory change, as it is consistent with the
existing requirements to provide all information that is known to or
reasonably ascertainable by the submitter and EPA's longstanding
practice to use conservative assumptions and default values in the
absence of information. The ICR document accompanying this proposed
rule describes the potential modifications to each screen of the PMN
form (Ref. 6).
As an alternative to this check box approach, EPA considered adding
automatic checks in CDX to make certain critical fields mandatory such
that the user could not advance to the next screen in the PMN form or
submit the form without entering information into the field. EPA does
not favor this approach because information required on the PMN form is
required to the extent it is known to or reasonably ascertainable by
the submitter, and EPA understands that there may be situations where
such information may not be known to or reasonably ascertainable by the
submitter. EPA also considered adding a statement and check box to
every screen in the PMN form that information in the form is required
if it is known to or reasonably ascertainable by the submitter, and not
just to certain screens as described above. EPA does not favor this
approach because it would require significant resources to program such
statements and check boxes on each screen. Furthermore, the PMN form is
designed to allow users the flexibility of moving back and forth
through the screens, skipping screens, and returning to previous
screens as needed. EPA feels that implementing such check boxes on
every screen may impede this flexibility and unnecessarily increase the
burden of completing a PMN form. EPA seeks comment on these
alternatives, as well as on whether there are other approaches to
modifying the PMN form to encourage complete submission of data.
C. Amendments Related to Pre-Screen, Incomplete Submissions, Correcting
Errors, and New Information
EPA is proposing amendments to the regulations regarding how EPA
acknowledges the receipt of a notice to account for EPA's pre-screen
process and to clarify the start of the applicable review period,
particularly when a notice contains errors or is incomplete. EPA is
also proposing amendments to align the process for correcting errors in
the notice with the existing process for incomplete submissions. EPA is
also clarifying that a notice is not considered complete at the time of
the initial notice submission if the submitter submits additional
information at any time during the review period that was known to or
reasonably ascertainable by the submitter at the time of initial notice
submission. Finally, EPA is proposing amendments to clarify that new
information about a chemical substance under EPA review must be
submitted electronically via CDX and that certain notification to EPA
of new information may be made by email.
1. Background
The first step that EPA takes after the receipt of a new chemicals
notice before the risk assessment begins is to conduct a pre-screen of
the notice, which typically takes 2-3 days. During the pre-screen
process, EPA determines whether a notice is required for the chemical
substance under TSCA. For example, EPA determines whether the chemical
substance is already on the TSCA Chemical Substance Inventory (also
called the ``TSCA Inventory'' or ``Inventory''), not a ``chemical
substance'' as defined in TSCA section 3(2), or will be manufactured
solely for export. If EPA determines that a notice is not required, EPA
notifies the submitter that they are not required to submit a notice
under TSCA in order to proceed commercially. EPA rejects the notice,
and an applicable review period does not begin. See 40 CFR 720.62.
During this pre-screen process, EPA also initiates a chemistry,
engineering, and administrative screen of the notice. EPA chemists
evaluate whether the chemical identity of the new chemical substance is
clear, the starting materials add up to the final chemical substance,
and the chemical structure is consistent with the name. EPA engineers
evaluate whether certain information is contained in the notice, such
as complete site identification information, manufacturing process
descriptions, and information on environmental releases and worker
exposure for each site. EPA also evaluates whether any of the other
conditions for incomplete submissions outlined in 40 CFR 720.65(c)(1)
have been met, such as a failure to properly sanitize for CBI a second
copy of the notice or the failure to submit the notice in English.
Finally, EPA checks for other errors in the notice. See 40 CFR
720.65(b).
If EPA deems the notice complete after the pre-screen process, then
the notice moves forward to the risk assessment process. If EPA does
not deem the notice complete during the pre-screen period, EPA notifies
the submitter that the notice is incomplete and explains the
requirements for correcting the incomplete submission, per 40 CFR
720.65(c)(3). Once the submitter submits a complete notice according to
the requirements previously provided by EPA, the applicable review
period begins.
Currently, after EPA completes its risk assessment of a chemical
substance, EPA reaches out to the submitter to explain the findings of
the risk assessment and any proposed prohibitions or limitations on the
manufacturing, processing, distribution in commerce, use, or disposal
of the chemical substance. If the submitter disagrees with the
potential risks identified in the risk assessment, the submitter may
provide additional information intended to demonstrate that risks are
lower than EPA estimated. The additional information may be detailed
information on worker exposures or environmental releases that was
missing from the initial notice submission, or it may be previously
unsubmitted testing on the chemical substance to better characterize
the
[[Page 34110]]
potential risk that EPA identified in its assessment. These and other
amendments could indicate that the original notice was incomplete if
the additional information was known to or reasonably ascertainable by
the submitter at the time of the original submission. See 40 CFR
720.65(c)(1)(v) and (vi), (c)(2)(ii). If an original notice is later
found to have been incomplete, EPA may restart the review period at Day
1 when additional information is submitted that then makes the notice
complete.
Under its current practice, EPA may consider the additional
information and, if warranted, conduct the risk assessment again to
factor in the additional information. This is in line with EPA's
longstanding objective to take into consideration reasonably available
information and account for real-world conditions during manufacturing,
processing, distribution, use, or disposal of a chemical substance.
While this practice has the benefit of refining the risk assessments,
it uses EPA resources inefficiently and adds significant time to the
review process.
2. Pre-Screening Procedures
EPA is proposing to amend 40 CFR 720.65(a) to codify the pre-screen
process that EPA conducts prior to moving forward to the risk
assessment process. The new language would clarify, for purposes of
transparency, EPA's current pre-screen practice as described in Unit
III.C.1. If through the pre-screen process EPA finds that the initial
notice submission is complete, Day 1 of the applicable review period is
the day the notice was received by EPA via CDX, consistent with the
existing regulations at 40 CFR 720.75(a). If the pre-screen process
finds that the initial submission is incomplete, the applicable review
period will not begin until EPA receives a complete notice, consistent
with the existing regulation at 40 CFR 720.65(c)(2)(i). After the pre-
screen, EPA may still determine within 30 days of receipt of the
submission, once the risk assessment is underway and the information
submitted more thoroughly evaluated, that the notice is incomplete, as
currently described at 40 CFR 720.65(c)(2)(i). However, it has been
EPA's experience that the pre-screen process helps minimize the number
of submissions identified as incomplete or containing errors later in
the review period. EPA is also proposing an amendment to 40 CFR 720.70
to clarify that a notice of receipt will be published in the Federal
Register after EPA receives a complete notice, rather than merely
receiving the notice, to accommodate the pre-screening procedures.
3. Correcting Errors in Notices
EPA is proposing amendments to 40 CFR 720.65(a) and (b) to state
that if EPA receives a notice with errors and EPA requests (as part of
the pre-screen process or, at latest, within 30 days of receipt of the
notice) that the submitter remedy such errors, the applicable review
period will not begin until EPA receives a corrected notice. This
proposed amendment will align the process for correcting errors with
the current process for correcting an incomplete notice at 40 CFR
720.65(c)(2) through (5). The 1983 final rule that established the
current process for correcting errors stated that ``the submitter is
under no obligation to make the correction, but failure to do so may
cause EPA to extend the review period under section 5(c) of the Act.''
((Ref. 7) (48 FR 21735, May 13, 1983). While the current regulations
and the proposed amendment give EPA discretion to request remedy of
errors, EPA now believes that if the Agency exercises that discretion
to request that the submitter remedy an error, review of the notice
should not move forward until the error is corrected. EPA does
recognize that some errors may be minor and not require correction
prior to EPA initiating review of the notice, such as easily recognized
spelling errors or an incorrectly numbered list--EPA does not intend to
request correction of such errors. EPA's notification to the submitter
that a submission contains errors would include (i) a statement of the
basis of EPA's determination that the submission contains errors, (ii)
the requirements for correcting the errors, and (iii) information on
procedures for filing objections to the determination or requesting
modification of the requirements for completing the submission.
Additionally, EPA is proposing an amendment to remove ``failure to date
the notice form'' as an example of an error because the electronic PMN
form submitted through CDX automatically dates the notice upon
submission and this error is no longer possible.
4. Notice Amendments Indicating Original Notice Was Incomplete
If information required under 40 CFR 720.45 and 720.50 and
specified in the PMN form is known to or reasonably ascertainable by a
submitter, the submitter must report the information in the notice. EPA
defines ``known to or reasonably ascertainable by'' at 40 CFR 720.3(p)
to mean ``all information in a person's possession or control, plus all
information that a reasonable person similarly situated might be
expected to possess, control, or know.'' This definition is not overly
prescriptive and is based on a concept of reasonableness that is fact
specific. Furthermore, the existing regulation at 40 CFR
720.65(c)(2)(ii) states that if EPA obtains additional information
during the review period that indicates the original submission was
incomplete, EPA may declare the submission incomplete. Accordingly, if
a submitter amends their notice during the applicable review period to
add information required under 40 CFR 720.45 or 720.50 that was known
to or reasonably ascertainable by the submitter at the time of the
original submission, EPA would have cause to declare that the original
submission was incomplete. Because the applicable review period does
not begin until a submission is complete, EPA can restart the
applicable review period to Day 1 if a submission is later amended
during the review period and such amendment demonstrates that the
original submission was incomplete.
To date, EPA has generally not exercised its discretionary
authority under section 720.65(c)(2)(ii) to declare original
submissions incomplete when the Agency has received late submissions of
information required by 40 CFR 720.45 or 720.50 that may have been
known to or reasonably ascertainable by the submitter at the time of
the original notice submission. Instead, EPA has considered the
additional information and if applicable, conducted re-work on its risk
assessments. To accomplish this re-work during the applicable review
period, EPA has generally granted a submitter's request for a
suspension of the review period, per 40 CFR 720.75(b).
EPA intends to change this longstanding practice of accepting
amendments that contain information that was known or reasonably
ascertainable at the time of the original submission and then accepting
a request to suspend the review period under 40 CFR 720.75(b). As
explained in Unit II.B., the 2016 Lautenberg Amendments impose
additional obligations on EPA, and EPA believes that exercising its
discretionary authority under the existing regulations to declare an
original submission incomplete and restart the applicable review period
upon submission of the complete notice is appropriate in order for EPA
to efficiently meet current statutory requirements. Overall, amendments
and re-work often lead to an inefficient use of EPA resources and a
review timeline that is not predictable and/or reliable for all
stakeholders. EPA would continue to
[[Page 34111]]
accept amendments and, as necessary, refine risk assessments based on
these amendments, but believes that the shift to restart the applicable
review period would create a more transparent and predictable review
process for submitters.
To clearly communicate this intended change in longstanding
practice, EPA is proposing to amend 40 CFR 720.65(c) by adding a
paragraph (2), which would state that a notice submission may be
declared incomplete if the submitter submits additional or revised
information at any time during the review period without demonstrating
to EPA's satisfaction that such information was not known to or
reasonably ascertainable by the submitter at the time of initial notice
submission. Additionally, EPA is proposing an amendment at 40 CFR
720.65(d)(5)(iii) to clarify that if EPA obtains additional information
during the review period that leads EPA to declare the initial notice
submission incomplete, in accordance with 40 CFR 720.65(d)(2) (proposed
to be redesignated from current 40 CFR 720.65(c)(2)(ii)), the
applicable review period would restart at Day 1 upon receipt of the
complete notice.
It is EPA's view that information on basic physical and chemical
properties and on anticipated environmental releases or worker
exposures at any sites controlled by the submitter, as required at 40
CFR 720.45, would be known to or reasonably ascertainable by the
submitter at the time of the original submission. Furthermore, EPA
believes that it is extremely unlikely that a submitter would neither
know nor be able to reasonably ascertain such information at the time
of the original submission, but could know or ascertain it 20 or 40 or
60 days after the original submission or at other times during the
review period. In this action and with the amendment proposed at 40 CFR
720.65(c)(2), EPA is communicating to stakeholders that they must
provide all information required by 40 CFR 720.45 and 720.50 upfront
and submit a complete notice.
Based on its experience reviewing thousands of notices and
amendments, EPA believes that it should be very uncommon for a
submitter to amend their notice during the review period by adding
information that they could not have known or reasonably ascertained at
the time of the original submission, such as for new information as
described at 40 CFR 720.40(f) or information from testing in progress
at the time of the original submission, as described at 40 CFR
720.50(a)(4). Under the proposed amendment at 40 CFR 720.65(c)(2), the
submitter of additional or revised information during the review period
would have to demonstrate to EPA's satisfaction that the information
was not known to or reasonably ascertainable by the submitter at the
time of the original submission to preclude an EPA determination that
the original notice was incomplete. As a matter of policy, EPA believes
that the only amendments to a notice that would not indicate that the
original notice was incomplete are: (1) amendments based on new data
(as described at 40 CFR 720.40(f) and 720.50(a)(4)); (2)
administrative, non-substantive amendments (e.g., submitter contact
information); and (3) amendments made at the request of EPA. EPA,
however, would take case-by-case facts into consideration when
determining whether a late submission of information indicates that a
notice was incomplete when originally submitted. If a submitter
disagrees with EPA's determination that the original notice submission
was incomplete, the submitter may object according to the existing
procedures at 40 CFR 720.65(c)(4) and (5) (proposed to be redesignated
as 40 CFR 720.65(d)(4) and (5)). Amendments based on new data,
administrative or non-substantive amendments, and amendments made at
the request of EPA would not impact the completeness of a submission.
EPA offers the following example to illustrate the intended change
to its longstanding practice: If a submitter leaves blank a field in
the PMN form for information required under 40 CFR 720.45 to the extent
it is known to or reasonably ascertainable by the submitter, EPA may
use a conservative assumption or default factors in place of that
information for the risk assessment and conclude that certain
prohibitions or limitations on the chemical substance may be warranted.
If after learning the findings of EPA's risk assessment, the submitter
then amends its original notice in CDX by providing information in the
field previously left blank, EPA would notify the submitter, according
to the existing regulation at 40 CFR 720.65(c)(2)(ii) and (c)(3)
(proposed to be redesignated as 40 CFR 720.65(d)(2) and (3)), that the
original submission was incomplete. The submitter may then file an
objection to the determination that the original notice was incomplete,
at which time they may seek to demonstrate that the additional or
revised information was not known to or reasonably ascertainable by
them at the time of initial notice submission. If in response to the
objection, EPA determines the original notice was complete, the
applicable review period will be deemed suspended on the date EPA
declared the notice incomplete and will resume on the date that the
notice is declared complete. However, if EPA considers the objections
and still determines that the original notice was incomplete, or if no
objections are filed, EPA will restart the applicable review period and
the new Day 1 will be the date the additional information that
completed the notice was submitted to EPA.
EPA believes that the meaning of ``known to or reasonable
ascertainable by'' described in this preamble is generally consistent
with EPA's original interpretation laid out in the 1983 final rule
entitled ``Premanufacture Notification; Premanufacture Notice
Requirements and Review Procedures'' (Ref. 7). That final rule states
that ``EPA believes that it is not possible to define `known to or
reasonably ascertainable' more explicitly''; ``EPA believes that
`reasonably ascertainable' can be defined only on a case-by-case
basis''; and ``EPA generally can judge from the notice itself whether
it includes information that is known to or reasonably ascertainable by
the submitter'' (Ref. 7 at page 21730). Further, that final rule
provides an example of what would not be reasonably ascertainable to
illustrate a rather high bar for information to qualify as not
reasonably ascertainable: ``Certainly, in most instances, data-
gathering that is so costly as to preclude commercialization is not
reasonable.'' (Ref. 7 at page 21730)
EPA is seeking comment on the proposed new provision at 40 CFR
720.65(c)(2) and proposed amendment to 40 CFR 720.65(c)(5)(iii)
(proposed to be redesignated as 720.65(d)(5)(iii)), which clarify that
EPA may deem an original notice incomplete, and restart the review
period at Day 1 upon completion of the notice, if a submitter provides
required information during the applicable review period without
demonstrating that it was not known to or reasonably ascertainable by
the submitter at the time of the initial notice submission. EPA is
seeking comment on situations when this interpretation may not be
appropriate.
5. Notifying EPA of the Receipt of New Information on a Chemical
Substance Under Review
EPA acknowledges that in some cases new information can become
available about a chemical substance during the course of its review.
When this occurs, submitters are required to inform EPA in writing and
provide the new information within ten days of receiving
[[Page 34112]]
the new information, but no later than five days before the end of the
notice review period. 40 CFR 720.40(f) and 40 CFR 720.50(a)(4)(ii)
address the requirements for informing EPA of receipt of new
information (including a study, report, or test that is completed
during the notice review period), which require submitters to
communicate receipt of new information to EPA via mail correspondence,
or via telephone if the new information is received within five days of
the end of the notice review period. EPA is proposing to amend 40 CFR
720.40(f) and 40 CFR 720.50(a)(4)(ii) to clarify that new information
about a chemical substance under EPA review must be submitted
electronically via CDX, consistent with the general electronic
submission requirements in 40 CFR 720.40(a). In addition, when
submitters receive new information within five days of the end of the
review period, EPA is proposing to allow them to notify EPA by email of
the receipt of new information. Email communication would provide an
alternative means of notifying EPA of the receipt of new information in
the event that an EPA contact is unavailable to receive a phone call.
While the submitter could use phone or email to notify EPA of the
receipt of new information, all new information would be submitted
electronically to EPA via CDX. Additionally, emails should not contain
CBI.
D. Amendments to Low Volume Exemptions and Low Release and Exposure
Exemptions
EPA is proposing several amendments to the current LVE and LoREX
regulations. Specifically, EPA is proposing that: (1) submitters may
not commence manufacture until EPA has approved the LVE or LoREX
notice; (2) EPA may proactively inform LVE and LoREX holders if the
chemical substance that is the subject of the LVE or LoREX becomes
subject to a SNUR and the chemical identity is CBI, (3) PFAS be
categorically ineligible for these exemptions; and (4) the regulations
codify the ineligibility for exemptions of certain PBTs as described in
EPA's 1999 PBT policy (Ref. 8).
1. Amendments to Expiration of LVE and LoREX Review Period
By way of background, 40 CFR 723.50(a)(2)(i) currently requires
that LVE and LoREX applicants submit a notice of intent to manufacture
a chemical substance under an LVE or LoREX 30 days before commencing
manufacture. 40 CFR 723.50(g)(1) provides that EPA will review the LVE
or LoREX notice to determine whether manufacture of the chemical
substance is eligible for the exemption. LVE and LoREX regulations are
promulgated under the statutory authority of TSCA section 5(h)(4), 15
U.S.C. 2604(h)(4), which provides that EPA may, upon application and by
rule, exempt the manufacturer of any new chemical substance from all or
part of the requirements of TSCA section 5 if EPA determines that the
manufacture, processing, distribution in commerce, use, or disposal of
such chemical substance, or that any combination of such activities,
``will not present an unreasonable risk of injury to health or the
environment, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified by [EPA] under the conditions of
use.'' At present, 40 CFR 723.50(g)(2) provides that the submitter may
begin manufacture of a chemical substance under an LVE or LoREX upon
expiration of the 30-day review period if EPA has taken no action. In
practice, EPA would move to deny an LVE or LoREX notice at the end of
the review period if it were not able to conclude by that time that the
substance will not present unreasonable risk on the basis that there
are issues concerning toxicity or exposure that require further review
which cannot be accomplished within the 30-day review period. EPA's
current practice when other delays occur during the review of an LVE is
to agree to submitter requests to suspend the running of the review
period while EPA completes its review and determines whether to approve
or deny the exemption notice. See 40 CFR 723.50(g)(1).
Elsewhere in this rulemaking, EPA is proposing to amend the
regulations that allow submitters to begin manufacture or processing of
chemical substances for which a PMN, MCAN, or SNUN was submitted upon
expiration of the review period, so that those regulations would
require a determination from EPA prior to commencement of manufacture
or processing of such substances. As discussed in Unit III.A., these
proposed changes to 40 CFR 720.75, 721.25(d), and 725.170 are intended
to conform those regulations to the 2016 Lautenberg Amendments. EPA is
proposing similar amendments to the LVE and LoREX regulations at 40 CFR
723.50 to align with the proposed amendments to the PMN, SNUN, and MCAN
regulations and with the statutory framework and to better ensure that
chemical substances manufactured under LVEs and LoREXs will not present
an unreasonable risk. Specifically, EPA is proposing to amend the LVE
and LoREX regulations at 40 CFR 723.50(g) to require a notification of
approval of an LVE or LoREX from EPA prior to commencement of
manufacture of the chemical substance under the exemption.
2. Notification of LVE and LoREX Holders if the Chemical Substance Is
Subject to a SNUR
At present, when a chemical substance is reviewed via a PMN and
becomes subject to a SNUR, confidentiality claims for the specific
chemical identity in the PMN and reflected in the associated SNUR may,
in the absence of submitting a bona fide, prevent holders of current
LVEs and LoREXs for that same substance from being informed that the
chemical substance is now subject to a SNUR. EPA is proposing to add
language to 40 CFR 723.50 to allow EPA to inform an LVE or LoREX holder
whenever the chemical substance that is the subject of that LVE or
LoREX becomes subject to a proposed or final SNUR that describes the
chemical substance by a generic chemical name due to a confidentiality
claim for its specific chemical identity. This proposed amendment
would, as a courtesy, help inform LVE and LoREX holders of regulatory
requirements that they may have otherwise been unable to determine on
their own without submitting an inquiry to EPA (also known as a bona
fide) pursuant to 40 CFR 721.11. EPA is proposing to amend the
regulations at 40 CFR 723.50 to establish that a granted LVE or LoREX
notice demonstrates a bona fide intent to manufacture the substance,
such that a disclosure to an LVE or LoREX holder that the substance is
the subject of a proposed or final rule under Part 721 will not be
considered public disclosure of confidential business information under
section 14 of the Act. EPA is not proposing in this rulemaking any
revisions to the procedures in 40 CFR 723.50(l) for asserting and
protecting confidential business information.
This amendment would also help inform certain LVE and LoREX holders
that they may now or in the future become subject to chemical data
reporting (CDR) requirements. The CDR requirements described at 40 CFR
711.8 differ for chemical substances subject to certain TSCA actions
(e.g., SNURs). The annual production volume threshold at which
reporting is ordinarily required is 25,000 pounds, and as such LVE
holders are generally exempt, and LoREX holders may be exempt, from
such reporting even if their chemical substance has been added to the
Inventory. However, if a chemical substance previously approved as an
LVE or LoREX is later reviewed as a
[[Page 34113]]
PMN and becomes subject to certain new actions under TSCA (such as a
SNUR) as well as being added to the Inventory, the threshold for
reporting is lowered to 2,500 pounds annually. This creates the
potential for inadvertent non-compliance with CDR requirements by those
LVE and LoREX holders.
EPA does not intend to proactively inform current LVE and LoREX
holders about SNURs that predate this rule. EPA is seeking comment on
its proposal to allow EPA to proactively inform an LVE or LoREX holder
whenever the chemical substance that is the subject of that LVE or
LoREX becomes subject to a proposed or final SNUR that describes the
chemical substance by a generic chemical name. EPA would only start the
practice of notifying LVE and LoREX holders subject to this proposed
amendment after the date of the final rule.
3. Making PFAS Categorically Ineligible for LVEs and LoREXs
EPA is proposing amendments to make PFAS categorically ineligible
for LVEs and LoREXs going forward and proposing a structural definition
of PFAS for purposes of the LVE and LoREX regulations. The Agency is
proposing the same chemical structure definition for PFAS as the
definition proposed in the recent rule entitled ``Per- and Poly-
fluoroalkyl Chemical Substances Designated as Inactive on the TSCA
Inventory; Significant New Use Rule'' (known as the ``Inactive PFAS
SNUR'') (88 FR 4937, January 26, 2023 (FRL-9655-01-OCSPP)).
In April 2021, EPA's New Chemicals Program began implementing a new
policy for reviewing and managing LVE notices for PFAS. In the April
27, 2021 press release announcing the new PFAS LVE policy (Ref. 9), the
Agency stated that ``[g]iven the complexity of PFAS chemistry,
potential health effects, and their longevity and persistence in the
environment, an LVE notice for a PFAS is unlikely to be eligible for
this kind of exemption under the regulations.'' Prior to the new
policy, EPA had approved more than 600 LVE notices for PFAS--many of
which were granted prior to the 2016 Lautenberg Amendments and were
often intended to be substitutes for longer chain PFAS, i.e.,
substances having a fluorinated carbon chain length of C8 or longer.
(In the past, long-chain PFAS were generally thought to present greater
risks to humans and the environment than shorter-chain PFAS). In June
2021, EPA launched the ``PFAS LVE Stewardship Program'' to encourage
the voluntary withdrawal of the more than 600 previously granted PFAS
LVEs. Under that program, an eligible company that wishes to
participate is asked to submit a voluntary withdrawal of their LVE. As
of April 2023, there are 45 PFAS LVEs that have been voluntarily
withdrawn under the PFAS LVE Stewardship Program. EPA has not granted
an LVE for a PFAS since May 2020. EPA has not ever received or approved
any PFAS LoREX notices.
Under the current policy, manufacturers may still submit LVE and
LoREX notices for PFAS, which EPA must review individually. The
proposed amendments to the LVE and LoREX regulations would make PFAS
categorically ineligible to be considered for these exemptions. Under
the proposal, any LVE or LoREX notice for a PFAS that is submitted to
the Agency would be denied upon receipt without substantive review.
This includes any chemical substance where any of the reasonably
anticipated metabolites, environmental transformation products,
byproducts, or reasonably anticipated impurities are a PFAS. Persons
who wish to manufacture a PFAS not on the TSCA Inventory would instead
be required to submit a PMN at least 90 days prior to commencing
manufacture for a non-exempt commercial purpose.
The LVE and LoREX are predicated on strict production volume or
release/exposure limits, respectively, and notices are subject to an
abbreviated 30-day review by EPA designed to serve as a procedural
safeguard to screen out substances that pose potential risks, rather
than the more detailed and comprehensive 90-day review afforded to
PMNs. See 60 FR 16336, March 29, 1995 (FRL-4923-1). The existing LVE
and LoREX regulations at 40 CFR 723.50(h)(1) provide that if EPA
determines during the review period that manufacture of the new
chemical substance does not meet the terms of the LVE or LoREX
requirements or that there are issues concerning toxicity or exposure
that require further review which cannot be accomplished within the 30-
day review period, EPA will notify the manufacturer that the substance
is not eligible for the exemption.
When EPA initially proposed and then finalized the LVE
requirements, EPA considered compiling a list of chemical categories,
based on structure, that would not be eligible for the exemption. See
the proposed rule entitled ``Premanufacture Notification; Proposed
Exemption for Site-Limited Intermediate Chemical Substances and
Chemical Substances Manufactured in Quantities of 10,000 Kg or Less Per
Year'' (47 FR 33896, 33907, August 4, 1982 (FRL-2105-1)); and the final
rule entitled ``Premanufacture Notification Exemption; Exemption for
Chemical Substances Manufactured in Quantities of 1,000 Kg or Less Per
Year'' (50 FR 16477, 16483, April 26, 1985 (FRL-2742-1)). EPA did not
adopt categorical exclusions at the time because EPA believed that
identifying such categories upfront would be unnecessarily resource-
consuming and would provide no more protection than that already
provided by EPA's LVE notice review requirements (50 FR at 16483).
Neither reason, however, is currently persuasive for chemical
substances that meet the proposed structural definition of PFAS. Under
TSCA section 26(c), any action taken by EPA on a single chemical
substance may also be taken with respect to a category of chemical
substances, ``the members of which are similar in molecular
structure.'' Here, it is not difficult or resource-consuming to
identify a category to exclude, as the substances that meet the PFAS
structural definition share a similar structure and are appropriately
addressed as a category in this action. EPA has also committed to
``[b]uild the evidence base on individual PFAS'' and ``use its
authorities to impose appropriate limitations on the introduction of
new unsafe PFAS into commerce and will, as appropriate, use all
available regulatory and permitting authorities to limit emissions and
discharges from industrial facilities.'' (Ref. 10). Additionally, due
to the scientific complexities associated with assessing PFAS and the
lack of data on most PFAS with regards to toxicity and exposure to
human health and the environment, EPA expects in most cases to be
unable to determine pursuant to TSCA section 5(h)(4) that a PFAS ``will
not present an unreasonable risk'' under the conditions of use within
the 30-day review period provided for LVE and LoREX notices. Reviewing
all new PFAS as PMNs also will preserve EPA's authority to address
information gaps when there is insufficient information on the chemical
substance and further support the Agency's PFAS Strategic Roadmap,
which lays out a whole-of-agency approach to addressing PFAS (see
<a href="https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024">https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024</a>).
Under the existing regulations at 40 CFR 723.50(h)(2), at any time
after EPA approves an LVE or LoREX notice, EPA can determine that
manufacture of the new chemical substance does not meet the exemption
criteria. If the Agency does so, it would notify the manufacturer by
certified letter that EPA believes that the new chemical substance does
not meet the
[[Page 34114]]
terms for the exemption. With these considerations in mind, EPA
solicits comment on revoking previously granted LVEs for PFAS pursuant
to the process set forth in 40 CFR 723.50(h)(2) and requiring those who
wish to continue manufacture to submit a PMN.
For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA
is proposing to define ``PFAS'' using a structural definition. EPA is
proposing to define PFAS as a chemical substance that contains at least
one of these three structures:
(1) R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are
saturated carbons
(2) R-CF2OCF2-R', where R and R' can either be F, O, or saturated
carbons
(3) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated
carbons.
Manufacturers of substances that do not meet this structural
definition would remain eligible to submit an LVE or LoREX notice. The
proposed chemical structure definition for PFAS is the same definition
used for the Inactive PFAS SNUR (88 FR 4937, January 26, 2023).
EPA determined that a structural definition was most appropriate
for this rulemaking rather than developing a list of specifically
identified substances. Since the substances that would be submitted in
LVE or LoREX notices are new chemical substances, it is impractical to
generate a comprehensive list of PFAS not on the TSCA Inventory that
may be submitted in the future. Additionally, other TSCA requirements
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 from PMN requirements defines covered PFAS polymers
using structural definitions (40 CFR 723.250)). Furthermore, other
scientific and regulatory bodies such as the OECD (Ref. 11) have
defined PFAS using various structural definitions. Thus, there is clear
precedent for using a structural definition for TSCA rules and other
actions addressing PFAS.
The proposed definition for PFAS does 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 less likely to persist in the environment.
These potentially degradable substances, if submitted to EPA in a LVE
or LoREX notice, would still be evaluated by EPA and a decision made to
either deny or grant the exemption. The proposed three-part structural
definition for PFAS includes fluoropolymers.
The first sub-structure (R-(CF2)-C(F)(R')R''), where both the CF2
and CF moieties are saturated carbons and none of the R groups (R, R'
or R'') can be hydrogen, has been the working definition of PFAS used
by EPA's Office of Pollution Prevention and Toxics when identifying
PFAS on the TSCA Inventory. For this rulemaking, EPA has decided to
expand the working definition to include two additional sub-structures.
The second sub-structure (R-CF2OCF2-R', where R and R' can either
be F, O, or saturated carbons) aims to capture certain fluorinated
ethers. Examples of substances that meet this sub-structure include,
PFMOAA (CASRN 674-13-5) and other chemicals, with properties similar to
hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt
(known as ``GenX chemicals''), that have been found in the Cape Fear
River.
Finally, the third sub-structure (CF3C(CF3)R'R'', where R' and R''
can either be F or saturated carbons) aims to capture fluorinated
substances that are more branched and would not otherwise meet the
first or second sub-structure definitions due to their non-adjacent
carbons. Although these substances have carbons that are not fully
fluorinated and that may be more susceptible to degradation and
metabolism, highly fluorinated moieties of the substance are still
likely to be persistent.
This proposed definition may not be identical to other definitions
of PFAS used within EPA or by other organizations. The term ``PFAS''
has been used varyingly by many organizations for their distinct
research and/or regulatory needs, and different definitions of the term
``PFAS'' may be appropriate for such purposes. The Agency notes that
this perspective, that different users may have distinct needs and that
no single PFAS characterization or definition meets all needs, is
shared by many other organizations, including OECD (see page 29, Ref.
11). EPA proposes that the above definition of ``PFAS'' is the most
appropriate definition for the proposal to make PFAS ineligible for
future LVEs and LoREXs and acknowledges that there may be other rules
or programs that apply different definitions to meet their own needs.
4. PBT Chemicals and LVEs and LoREXs
a. Background
Currently, 40 CFR 723.50(d) describes certain criteria that EPA
uses to determine the eligibility of chemical substances for
manufacture under an LVE and LoREX. These criteria include the
potential of a chemical substance to cause serious acute or chronic
effects or significant environmental effects under anticipated
conditions of manufacture, processing, distribution in commerce, use,
or disposal. These criteria also extend to any reasonably anticipated
metabolites, environmental transformation products, or byproducts of
the chemical substance, as well as any reasonably anticipated
impurities in the substance.
Although numerous factors can contribute to the potential of a
particular chemical substance to cause serious acute or chronic effects
or significant environmental effects as described in 40 CFR 723.50(d),
chemical substances that are persistent, bioaccumulative, and toxic
(PBT) are of special concern because: (1) their persistence in the
environment increases the likelihood of exposure of biological systems
to those chemicals; (2) their bioaccumulative potential increases the
probability that they will move vertically through and become embedded
in trophic chains; and (3) their persistence and bioaccumulation
potential, coupled with toxicity concerns, can result in risk to
biological systems. Once PBT chemicals are released into the
environment, they are often difficult or impossible to remediate.
On November 4, 1999, EPA issued its policy statement (64 FR 60194)
(Ref. 8) identifying a category for PBT new chemical substances. The
1999 policy statement formally acknowledged PBT chemical substances as
a category based on shared characteristics to facilitate premanufacture
assessment and regulation. Furthermore, the PBT policy statement
established EPA's current criteria for identifying PBT chemical
substances for the New Chemicals Program, which involves using
physical-chemical properties, as well as structural activity alerts,
analogue data, and test data to quantify on a scale of 1 to 3 the
potential for persistence (P), bioaccumulation (B), and toxicity (T)
for a given new chemical substance. If a substance scores a 2 or above
for all three characteristics, EPA considers the substance to be PBT.
EPA emphasized in responses to comments received on the October 1998
draft policy released for public comment that the decision to identify
and assess a new chemical
[[Page 34115]]
substance as PBT would be based on the available data and would be made
on a case-by-case basis.
b. Codifying EPA's Policy Concerning PBT Chemicals and LVEs and LoREXs
At present, the exemption regulations at 40 CFR 723.50 do not
expressly disqualify PBT chemical substances from eligibility for the
LVE or LoREX. However, under TSCA section 5(h)(4), EPA may exempt a
chemical substance from section 5 requirements upon application and by
rule only if EPA determines the manufacture, processing, distribution
in commerce, use, or disposal of the substance will not present an
unreasonable risk. And as explained above, the regulations at 40 CFR
723.50(d) provide that chemical substances that may cause serious acute
or chronic effects or significant environmental effects are not
eligible for the LVE or LoREX. When exposure of the environment or
biological organisms (including humans) to a PBT chemical is expected,
one or more of the conditions above (i.e., serious acute or chronic
effects or significant environmental effects) is generally likely to
occur, often making the PBT chemical ineligible for the exemptions.
Whenever the potential for unreasonable exposures to a PBT chemical is
identified during the review of an LVE or LoREX notice, EPA's
longstanding policy has been to deny the exemption notice. However,
EPA's specific concerns for PBT chemicals as they relate to LVEs and
LoREXs are not separately codified in the existing regulations at 40
CFR 723.50.
EPA is therefore proposing amendments to 40 CFR 723.50(d) that
would codify EPA's long-standing practice that, whenever EPA identifies
a chemical substance under LVE or LoREX review (or any reasonably
anticipated metabolites, environmental transformation products, or
byproducts of the substance, or any reasonably anticipated impurities
in the substance) as PBT with anticipated environmental releases and
potentially unreasonable exposures to humans or environmental
organisms, that substance would be ineligible for the LVE or LoREX. The
proposed amendments clarify that PBT chemicals with anticipated
environmental releases and potentially unreasonable human or
environmental organism exposures would be ineligible for the LVE or
LoREX but would not prevent companies from submitting an exemption
notice for a given substance. The finding that a substance is PBT would
be made by EPA during the review of the notice. While EPA has offered
generic guidance regarding how it determines the PBT status of chemical
substances, the policies and science used to ascribe discrete scores
(i.e., 1-3) to the persistence, bioaccumulative potential, and toxicity
of a particular chemical substance are based on the available data and
made on a case-by-case basis. As such, a submitter may not be able to
determine in advance of submitting an exemption notice if EPA would
find the substance to be PBT. Although EPA is ultimately responsible
for assessing whether chemical substances are potentially PBT,
submitters who possess data indicating that their new chemical
substances could be PBT and could be handled in such a way as to result
in anticipated or unreasonable exposures may be less likely to expend
the time and resources to submit an LVE or LoREX notice for EPA review
of those substances if the outcome of the review would almost certainly
be denial of the notice.
EPA is further proposing to define ``PBT chemical substance'' for
purposes of 40 CFR 723.50 as ``a chemical substance possessing
characteristics of persistence (P) in the environment, accumulation in
biological organisms (bioaccumulation (B)), and toxicity (T) resulting
in potential risks to humans and ecosystems. For more information on
EPA's Policy on new chemical substances that are PBT, see EPA's 1999
policy statement (64 FR 60194; November 4, 1999).''
E. Amendments Related to Suspensions of the Review Period
EPA is proposing to amend 40 CFR 720.75(b)(2) to allow PMN, SNUN,
LVE, and LoREX submitters to request a suspension of the notice review
period for up to 30 days orally or in writing, including by email,
without the need for a formal, written request submitted to EPA via CDX
using e-PMN software. EPA is similarly proposing to amend 40 CFR
725.54(c) to permit MCAN submitters to request suspensions for up to 30
days orally or in writing, including by email, without the need for a
formal, written request submitted to EPA via CDX using e-PMN software.
EPA would continue to require that all requests for suspensions
exceeding 30 days be submitted electronically to EPA via CDX using e-
PMN software.
When the notice or exemption review period for a PMN, SNUN, LVE, or
LoREX approaches its end, submitters may request that EPA suspend the
running of the notice review period so that the review period does not
expire (40 CFR 720.75(b); see also 40 CFR 721.25(c) and 723.50(g)(1),
applying the 720.75(b) suspension procedures to SNUNs, LVEs, and
LoREXs). The existing regulations at 720.75(b) specify that such
requests can be made orally to EPA, so long as the length of the
suspension does not exceed 15 days; suspensions exceeding 15 days must
be submitted to EPA in writing via CDX using EPA's e-PMN software. At
the submitter's request, EPA can suspend a notice review period until
the review is complete and a decision has been made for the notice.
Once a final decision is made, any remaining suspension days are
rescinded.
Currently, the regulations at 40 CFR 725.54, which pertain to the
suspension of the review period for MCANs and exemptions related to
microorganisms (e.g., TSCA Environmental Release Applications (TERA)
and Tier II submissions) mirror those at 720.75(b) for PMNs, SNUNs,
LVEs, and LoREXs. As in 40 CFR 720.75(b), the language at 40 CFR 725.54
indicates that submitters may suspend a notice or exemption review
period for up to 15 days via oral request, or for greater than 15 days
via a formal, written request submitted to EPA via CDX using EPA's e-
PMN software. Although suspensions occur less frequently during the
reviews of notices and exemptions for microorganisms than during
reviews for PMNs, SNUNs, LVEs, and LoREXs, submitters do occasionally
request suspensions in order to develop additional information.
Given the relative ease and value of suspending a notice review
period via informal oral request, most submitters who seek suspensions
opt to suspend for 15 days whenever their case is nearing expiration of
its review period to allow EPA to finalize its review. If a case is
suspended, it is often suspended more than once, and submitters
typically informally request multiple 15-day suspensions rather than
requesting a longer suspension in writing via CDX. As such, EPA is
proposing to allow for informal suspensions up to 30 days to reduce the
number of repeated informal requests. Additionally, EPA believes that
email may be more expedient than oral communication for many
submitters. Therefore, EPA is proposing amendments to allow submitters
to request suspensions for up to 30 days either orally or via email.
EPA is seeking comment on its proposal to increase the number of
days permissible for suspensions not requiring a formal, written
request submitted to EPA via CDX using e-PMN software. Specifically,
EPA requests comment on its proposal to permit requests for suspensions
up to 30 days to be communicated orally or via email, and to update the
relevant regulations
[[Page 34116]]
pertaining to suspension of microorganism-related submissions under 40
CFR 725.54 to mirror the proposed changes for suspension of PMNs,
SNUNs, LVEs, and LoREXs. EPA is not considering, proposing, or
requesting comment on any additional changes to the regulations
regarding suspensions at this time.
IV. Economic Analysis
The estimated incremental impacts of this rulemaking are briefly
summarized in this unit and the complete Economic Analysis (Ref. 1) is
available in the docket. The proposed rule is expected primarily to
affect two types of firms:
(1) Manufacturers of PFAS who would have submitted an LVE or LoREX
in the baseline but would need to submit a PMN under the proposed rule
due to the proposed amendment to make PFAS ineligible for the
exemptions; and
(2) Firms submitting any TSCA section 5 notices through the PMN
form (PMNs, SNUNs, LVEs, LoREXs, TMEs) that are expected to submit
fewer amendments to their original submissions due to the amended
procedural requirements of the proposed rule.
While the proposed rule includes additional amendments to the new
chemicals regulations under TSCA, EPA expects that these additional
amendments will not result in incremental burden or savings because
they are largely already performed in the baseline.
As a result of this proposed rule, EPA expects that the average
number of amendments per notice will decrease from 1.81 to 0.9, with a
decrease in burden to EPA of 12 hours per avoided amendment. In
addition, EPA expects that the 12 annual average of LVE submissions for
PFAS will instead be submitted as PMNs. It is expected that individual
submitters of PMNs will experience an overall decrease in burden of 13
hours with an associated decrease in cost of approximately $1,120 per
notice.
Additionally, improvements in the submission process are expected
to reduce inefficiency in the Agency's review process. As a result of
the changes under the proposed rule, it is expected that the cost to
the Agency associated with reviewing PMNs, SNUNs, and exemption notices
will decrease by ten percent. Therefore, it is expected that the Agency
will experience an annual cost savings of approximately $923,280.
V. 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. EPA. Economic Analysis for Proposed Updates to New Chemicals
Regulations under the Toxic Substances Control Act (TSCA). May 2023.
2. EPA. Central Data Exchange Online User Guide. Accessible at:
<a href="https://cdx.epa.gov/About/UserGuide">https://cdx.epa.gov/About/UserGuide</a>.
3. EPA. Points to Consider When Preparing TSCA New Chemical
Notification. OMB Control No.: 2070-0012. June 2018. Accessible at:
<a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca</a>.
4. EPA. TSCA New Chemical Engineering Initiative to Increase
Transparency and Reduce Re-work. Accessible at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering</a>.
5. EPA. Tables Detailing the Proposed Amendments to Add Details to
40 CFR part 720.45 Reporting Requirements and Enhancements to the
CDX Reporting Form. May 2023.
6. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); Updates to New
Chemicals Regulations under the Toxic Substances Control Act;
Proposed Rule (RIN 2070-AK65); EPA ICR No. 2749.01; OMB Control No.
2070-[NEW]. May 2023.
7. EPA. Premanufacture Notification; Premanufacture Notice
Requirements and Review Procedures; Final Rule. Federal Register. 48
FR 21722; May 13, 1983 (TSH-FRL 2998-5).
8. EPA. Policy Statement on Category for Persistent,
Bioaccumulative, and Toxic New Chemical Substances. Federal
Register. (64 FR 60194, November 4, 1999) (FRL-6097-7).
9. EPA. Press Release: EPA Announces Changes to Prevent Unsafe New
PFAS from Entering the Market. April 27, 2021.
10. EPA. PFAS Strategic Roadmap: EPA's Commitments to Action 2021-
2024. October 18, 2021. Accessed at: <a href="https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf">https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf</a>.
11. OECD. Reconciling Terminology of the Universe of Per- and
Polyfluoroalkyl Substances: Recommendations and Practical Guidance.
July 9, 2021. Accessed at: <a href="https://one.oecd.org/document/ENV/CBC/MONO">https://one.oecd.org/document/ENV/CBC/MONO</a>(2021)25/En/pdf.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is not a significant regulatory action as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore
not subject to review under Executive Order 12866.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted to OMB for review and approval under the PRA (44 U.S.C.
3501 et seq.). The Information Collection Request (ICR) document that
EPA prepared has been assigned EPA ICR No. 2749.01 (Ref. 6). This ICR
represents an amendment to the currently approved ICR that covers the
information collection activities contained in the existing
regulations, which are approved under OMB control number 2070-0012 (EPA
ICR No. 574.15). Estimates presented in the ICR below reflect the minor
incremental changes associated with the rule that are presented in the
Economic Analysis (Ref. 1). EPA is proposing amendments to the new
chemicals procedural regulations under TSCA. These amendments are
intended to align the regulatory text with the amendments to TSCA's new
chemicals review provisions and improve the efficiency of EPA's review
processes and update the regulations based on existing policies and
experience implementing the New Chemicals Program. You can find copies
of the Economic Analysis and ICR in the docket, and the ICR is briefly
summarized here.
Respondents/affected entities: Certain manufacturers (including
importers) and processors (see Unit I.A.).
Respondent's obligation to respond: Mandatory under TSCA section 5.
Estimated number of respondents: 560.
Frequency of response: On occasion, i.e., upon submission of a PMN,
SNUN, LVE, LoREX, or MCAN.
Total estimated incremental burden: Estimates show that this
proposed rule will decrease existing approved burden by 4,518 hours per
year. Burden is defined at 5 CFR 1320.3(b).
Total estimated incremental cost: Estimates show that this proposed
rule
[[Page 34117]]
will increase existing approved costs by $45,120 per year. This
includes $0 annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to EPA using the docket identified at the
beginning of this rulemaking. EPA will respond to any ICR-related
comments in the final rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. OMB must receive comments
no later than July 25, 2023.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The Agency's basis is briefly summarized here and is
detailed in the Economic Analysis (Ref. 1).
The majority of firms that submit a TSCA section 5 notice will
realize either no change or a decrease in costs associated with form
submission. However, EPA expects that firms that submit LVE notices for
PFAS will incur an estimated cost of approximately $45,863 per notice
due to the greater burden and non-labor costs associated with
submitting a PMN form. EPA estimates that 99 percent of small firms
(185 firms) will have cost impacts of less than 1 percent of revenues,
less than 1 percent (1 firms) will have cost impacts between 1 and 3
percent of revenues, and 1 percent (2 firms) will have cost impacts
greater than 3 percent of revenues.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more 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 and the
incremental cost on the private sector is estimated to be less than
$50,000. Based on EPA's experience with reviewing actions under TSCA
section 5, 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 would engage in the activities
such that they would be impacted by this rulemaking. In addition, based
on the Economic Analysis prepared for this proposed rule (Ref. 1), EPA
concludes that this rulemaking is not expected to result in
expenditures by the private sector of $100 million or more (when
adjusted annually for inflation) in any one year. Accordingly, this
rulemaking is not subject to the requirements of UMRA sections 202,
203, or 205. The Economic Analysis (Ref. 1) for this action is
summarized in Unit IV. and is available in the docket.
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.
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 EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-201 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 risks, EPA's Policy on Children's Health
also does not apply. This procedural rule would align the procedural
regulations codified at 40 CFR parts 720 and 725 with amended TSCA and
make additional updates based on existing policies or lessons learned
from administering the New Chemicals Program since TSCA was amended in
2016.
Although this procedural rule itself would not directly affect the
level of protection provided to human health or the environment, EPA
expects that the rule would improve the Agency's consideration of risks
to children--in furtherance of EPA's Policy on Children's Health--and
other PESS. In turn, EPA anticipates that the proposed amendments would
help better inform the Agency's determinations for each new chemical
substance or significant new use for which it received a notice under
TSCA section 5(a)(1), pertaining to the likelihood of unreasonable risk
to human health or the environment under known, intended or reasonably
foreseen conditions of use. EPA uses an integrated approach that draws
on knowledge and experience across disciplinary and organizational
lines to identify and evaluate concerns regarding health and
environmental effects, and exposure and release.
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 as a significant
energy action by the Administrator of the Office of Information and
Regulatory Affairs.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve 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
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
[[Page 34118]]
populations. This action is procedural in nature. Therefore, 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 people of color, low-income
populations and/or Indigenous peoples. By proposing, among other
things, to include overburdened communities in the regulatory
definition of PESS.
The Agency believes that this action would assist EPA and others in
determining the potential exposures, hazards and risks to overburdened
communities associated with the manufacture, processing, distribution
in commerce, use, or disposal of the new chemical substances and
significant new uses of chemical substances subject to this rulemaking.
EPA anticipates that the inclusion of overburdened communities among
the PESS considered in the Agency's review of a TSCA section 5
submission would also enable the Agency, if necessary, to design
appropriate future risk management actions to address an unreasonable
risk that the Agency may determine is presented by that chemical
substance and to consider how such risk management actions would affect
communities with environmental justice concerns.
List of Subjects in 40 CFR Parts 720, 721, 723, and 725
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements.
Dated: May 16, 2023.
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 720--PREMANUFACTURE NOTIFICATION
0
1. The authority citation for part 720 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
Sec. 720.1 [Amended]
0
2. Amend Sec. 720.1 by removing the phrase ``The rule'' and adding in
its place the phrase ``This part'' wherever it appears.
0
3. Amend Sec. 720.3 by adding new paragraphs (ll) and (mm) to read as
follows:
Sec. 720.3 Definitions.
* * * * *
(ll) Applicable review period means the period starting on the date
EPA receives a complete notice under section 5(a)(1) of the Act and
ending 90 days after that date or on such date as is provided for in
sections 5(b)(1) or 5(c) of the Act.
(mm) Potentially exposed or susceptible subpopulation means a group
of individuals within the general population identified by EPA who, due
to either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, the elderly, or overburdened communities.
* * * * *
0
4. Amend Sec. 720.40 by revising paragraph (f) to read as follows:
Sec. 720.40 General.
* * * * *
(f) New information. During the applicable review period, if the
submitter possesses, controls, or knows of new information that
materially adds to or changes the information included in the notice,
the submitter must submit that information to EPA within ten days of
receiving the new information, but no later than five days before the
end of the applicable review period. The new information must be
submitted electronically to EPA via CDX and must clearly identify the
submitter and the notice to which the new information is related. If
the new information becomes available during the last five days of the
applicable review period, the submitter must immediately inform its EPA
contact for that notice by telephone or email and submit the new
information electronically to EPA via CDX.
* * * * *
0
5. Amend Sec. 720.45 by:
0
a. Revising paragraphs (a)(4) and (5);
0
b. Revising paragraphs (f) through (h); and
0
c. Adding paragraphs (j) and (k).
The revisions and additions read as follows:
Sec. 720.45 Information that must be included in the notice form.
(a) * * *
(4) If an importer submitting the notice cannot provide all the
information specified in paragraphs (a)(1) and (2) of this section
because it is claimed as confidential by the foreign supplier of the
substance, the importer must have the foreign supplier follow the
procedures in paragraph (a)(3) of this section and provide the correct
chemical identity information specified in paragraphs (a)(1) and (2) of
this section directly to EPA in a joint submission or as a letter of
support to the notice, which clearly references the importer's notice
and PMN User Fee Identification Number. The statutory review period
will commence upon receipt of both the notice and the complete, correct
information, in accordance with Sec. 720.65.
(5) If a manufacturer cannot provide all the information specified
in paragraphs (a)(1) and (2) of this section because the new chemical
substance is manufactured using a reactant having a specific chemical
identity claimed as confidential by its supplier, the manufacturer must
submit a notice directly to EPA containing all the information known by
the manufacturer about the chemical identity of the reported substance
and its proprietary reactant. In addition, the manufacturer must ensure
that the supplier of the confidential reactant submit a letter of
support directly to EPA providing the specific chemical identity of the
confidential reactant, including the CAS number, if available, and the
appropriate PMN or exemption number, if applicable. The letter of
support must reference the manufacturer's name and PMN Fee
Identification Number. The statutory review period will commence upon
receipt of the notice, the letter of support, and the complete, correct
information in accordance with Sec. 720.65.
* * * * *
(f)(1) A description of the intended category or categories of
consumer or commercial use by function and application, which includes
a description of the following:
(i) The estimated percent of production volume devoted to each
category of use.
(ii) The percent of the new chemical substance in the formulation
for each commercial or consumer use.
(iii) The types of products or articles that would incorporate the
new chemical substance (e.g., household cleaners, plastic articles).
(iv) Information related to the use of products or articles
containing the new chemical substance by potentially exposed or
susceptible subpopulations.
(v) How and where a product or article incorporating the new
chemical substance would be used (e.g., spray applied indoors, brushed
on outdoor surfaces).
(vi) Consumption rates and frequency and duration of use of
products or articles incorporating the new chemical substance.
(2) Using the applicable codes listed in table 1 to paragraph
(f)(2), submitters must designate the consumer and commercial product
category or categories that best describe the
[[Page 34119]]
consumer and commercial products in which the new chemical substance is
intended or known to be used.
Table 1 to Paragraph (f)(2)--Codes for Reporting Consumer and Commercial
Product Categories
------------------------------------------------------------------------
Code Category
------------------------------------------------------------------------
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101.................... Construction and building materials covering
large surface areas including stone,
plaster, cement, glass and ceramic articles;
fabrics, textiles, and apparel.
CC102.................... Furniture & furnishings including plastic
articles (soft); leather articles.
CC103.................... Furniture & furnishings including stone,
plaster, cement, glass and ceramic articles;
metal articles; or rubber articles.
CC104.................... Leather conditioner.
CC105.................... Leather tanning, dye, finishing, impregnation
and care products.
CC106.................... Textile (fabric) dyes.
CC107.................... Textile finishing and impregnating/surface
treatment products.
CC108.................... All-purpose foam spray cleaner.
CC109.................... All-purpose liquid cleaner/polish.
CC110.................... All-purpose liquid spray cleaner.
CC111.................... All-purpose waxes and polishes.
CC112.................... Appliance cleaners.
CC113.................... Drain and toilet cleaners (liquid).
CC114.................... Powder cleaners (floors).
CC115.................... Powder cleaners (porcelain).
CC116.................... Dishwashing detergent (liquid/gel).
CC117.................... Dishwashing detergent (unit dose/granule).
CC118.................... Dishwashing detergent liquid (hand-wash).
CC119.................... Dry cleaning and associated products.
CC120.................... Fabric enhancers.
CC121.................... Laundry detergent (unit-dose/granule).
CC122.................... Laundry detergent (liquid).
CC123.................... Stain removers.
CC124.................... Ion exchangers.
CC125.................... Liquid water treatment products.
CC126.................... Solid/Powder water treatment products.
CC127.................... Liquid body soap.
CC128.................... Liquid hand soap.
CC129.................... Solid bar soap.
CC130.................... Air fresheners for motor vehicles.
CC131.................... Continuous action air fresheners.
CC132.................... Instant action air fresheners.
CC133.................... Anti-static spray.
CC134.................... Apparel finishing, and impregnating/surface
treatment products.
CC135.................... Insect repellent treatment.
CC136.................... Pre-market waxes, stains, and polishes
applied to footwear.
CC137.................... Post-market waxes, and polishes applied to
footwear (shoe polish).
CC138.................... Waterproofing and water-resistant sprays.
------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal
Products
------------------------------------------------------------------------
CC201.................... Fillers and putties.
CC202.................... Hot-melt adhesives.
CC203.................... One-component caulks.
CC204.................... Solder.
CC205.................... Single-component glues and adhesives.
CC206.................... Two-component caulks.
CC207.................... Two-component glues and adhesives.
CC208.................... Adhesive/Caulk removers.
CC209.................... Aerosol spray paints.
CC210.................... Lacquers, stains, varnishes and floor
finishes.
CC211.................... Paint strippers/removers.
CC212.................... Powder coatings.
CC213.................... Radiation curable coatings.
CC214.................... Solvent-based paint.
CC215.................... Thinners.
CC216.................... Water-based paint.
CC217.................... Construction and building materials covering
large surface areas, including wood
articles.
CC218.................... Construction and building materials covering
large surface areas, including paper
articles; metal articles; stone, plaster,
cement, glass and ceramic articles.
CC219.................... Machinery, mechanical appliances, electrical/
electronic articles.
CC220.................... Other machinery, mechanical appliances,
electronic/electronic articles.
CC221.................... Construction and building materials covering
large surface areas, including metal
articles.
CC222.................... Electrical batteries and accumulators.
------------------------------------------------------------------------
[[Page 34120]]
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC301.................... Packaging (excluding food packaging),
including paper articles.
CC302.................... Other articles with routine direct contact
during normal use, including paper articles.
CC303.................... Packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles (soft).
CC304.................... Other articles with routine direct contact
during normal use including rubber articles;
plastic articles (hard).
CC305.................... Toys intended for children's use (and child
dedicated articles), including fabrics,
textiles, and apparel; or plastic articles
(hard).
CC306.................... Adhesives applied at elevated temperatures.
CC307.................... Cement/concrete.
CC308.................... Crafting glue.
CC309.................... Crafting paint (applied to body).
CC310.................... Crafting paint (applied to craft).
CC311.................... Fixatives and finishing spray coatings.
CC312.................... Modelling clay.
CC313.................... Correction fluid/tape.
CC314.................... Inks in writing equipment (liquid).
CC315.................... Inks used for stamps.
CC316.................... Toner/Printer cartridge.
CC317.................... Liquid photographic processing solutions.
------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
Products
------------------------------------------------------------------------
CC401.................... Exterior car washes and soaps.
CC402.................... Exterior car waxes, polishes, and coatings.
CC403.................... Interior car care.
CC404.................... Touch up auto paint.
CC405.................... Degreasers.
CC406.................... Liquid lubricants and greases.
CC407.................... Paste lubricants and greases.
CC408.................... Spray lubricants and greases.
CC409.................... Anti-freeze liquids.
CC410.................... De-icing liquids.
CC411.................... De-icing solids.
CC412.................... Lock de-icers/releasers.
CC413.................... Cooking and heating fuels.
CC414.................... Fuel additives.
CC415.................... Vehicular or appliance fuels.
CC416.................... Explosive materials.
CC417.................... Agricultural non-pesticidal products.
CC418.................... Lawn and garden care products.
------------------------------------------------------------------------
Chemical Substances in Products Not Described by Other Codes
------------------------------------------------------------------------
CC980.................... Other (specify).
CC990.................... Non-TSCA use.
------------------------------------------------------------------------
(g) For sites controlled by the submitter:
(1) The identity and address of each site where the new chemical
substance will be manufactured, processed, or used.
(2) A process description of each manufacture, processing, and use
operation which includes a diagram of the major unit operations and
chemical conversions; indication of whether batch or continuous
manufacturing or processing occurs at the site, and the amount
manufactured or processed per batch or per day if continuous and per
year; the identity, approximate weight per batch or per day for
continuous production, and entry point of all starting materials and
feedstocks (including reactants, solvents, catalysts, etc.); the
identity, approximate weight per batch or per day for continuous
production, and entry point of all products, recycle streams, and
wastes, including frequency of any equipment cleaning; the type of
interim storage and transport containers used; and the points of
release of the new chemical substance numbered. If the new chemical
substance is released to two media at the same step in the process,
assign a second number for the second medium.
(3) Worker exposure information, including worker exposure
information from exempt manufacture or related use of the new chemical
substance under Sec. 720.30 (e.g., byproduct, impurity). This
information includes:
(i) Worker activities.
(ii) Type of potential worker exposure (e.g., dermal, inhalation).
(iii) Protective equipment in place, if any, including a
description of the kind of gloves, protective clothing, goggles, or
respirator that limit worker exposure, if any.
(iv) Engineering controls in place, if any.
(v) Physical form of the new chemical substance to which workers
may be exposed and moisture content if physical form is solid.
(vi) The percent of new chemical substance in formulation at time
of worker exposure.
(vii) The number of workers reasonably likely to be exposed.
(viii) The duration of activities.
(4) Information on release of the new chemical substance to the
environment, including releases from the exempt manufacture or related
use of the new
[[Page 34121]]
chemical substance under Sec. 720.30 (e.g., byproduct, impurity). This
information includes the type of release (e.g., transport, interim
storage, disposal, equipment cleaning), the quantity of the new
chemical substance released directly to the environment, the quantity
of the new chemical substance released into control technology, the
quantity of the new chemical substance released to the environment
after control technology, the media of release, the type of control
technology used, and the following additional information based on the
type of release:
(i) For equipment cleaning releases, frequency of equipment
cleaning and what is used to clean the equipment.
(ii) For transport and storage releases, how the new chemical
substance or product containing the new chemical substance is
transported from the site and stored, whether dedicated containers are
used, whether the cleaning and disposal of the containers is under the
submitter's control, the container cleaning method, the frequency of
container cleaning, and the amount of release per container cleaning.
(iii) For releases into air, Clean Air Act operating permit numbers
and a description of any Leak Detection and Repair program in
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the
monitoring and management of fugitive releases) the site has
implemented.
(iv) For releases into water, the National Pollutant Discharge
Elimination System (NPDES) permit number(s), the name(s) of the
navigable waterway(s) into which the release occurs, and other
destination(s) into which the release occurs.
(v) For releases into wastewater treatment plants, the name(s) of
the publicly owned treatment work(s) (POTW) into which the release
occurs and the corresponding NPDES permit number(s).
(h) For sites not controlled by the submitter:
(1) The identity and address of each site where the new chemical
substance will be manufactured, processed, or used.
(2) A description of each type of processing and use operation
involving the new chemical substance, including identification of the
estimated number of processing or use sites; a process description of
each operation which includes a diagram of the major unit operations
and chemical conversions; the identity, approximate weight per batch or
per day for continuous production, and entry point of all starting
materials and feedstocks (including reactants, solvents, catalysts,
etc.); the identity, approximate weight per batch or per day for
continuous production, and entry point of all products, recycle
streams, and wastes, including frequency of any equipment cleaning; the
type of interim storage and transport containers used; and the points
of release of the new chemical substance numbered. If the new chemical
substance is released to two media at the same step in the process,
assign a second number for the second medium.
(3) Worker exposure information, including worker exposure
information from exempt manufacture or related use of the new chemical
substance under Sec. 720.30 (e.g., byproduct, impurity). This
information includes:
(i) Worker activities.
(ii) Type of potential worker exposure (e.g., dermal, inhalation).
(iii) Protective equipment in place, if any, including a
description of the kind of gloves, protective clothing, goggles, or
respirator that limit worker exposure, if any.
(iv) Engineering controls in place if any.
(v) Physical form of the new chemical substance to which workers
may be exposed and moisture content if physical form is solid.
(vi) The percent of new chemical substance in formulation at time
of worker exposure.
(vii) The number of workers reasonably likely to be exposed.
(viii) The duration of activities.
(4) Information on release of the new chemical substance to the
environment, including releases from the exempt manufacture or related
use of the new chemical substance under Sec. 720.30 (e.g., byproduct,
impurity). This information includes the type of release (e.g.,
transport, interim storage, disposal, equipment cleaning), the quantity
of the new chemical substance released directly to the environment, the
quantity of the new chemical substance released into control
technology, the quantity of the new chemical substance released to the
environment after control technology, the media of release, the type of
control technology used, and the following additional information based
on the type of release:
(i) For equipment cleaning releases, frequency of equipment
cleaning and what is used to clean the equipment.
(ii) For transport and storage releases, how the new chemical
substance or product containing the new chemical substance is
transported from the site and stored, whether dedicated containers are
used, whether the cleaning and disposal of the containers is under the
submitter's control, the container cleaning method, the frequency of
container cleaning, and the amount of release of the new chemical
substance per container cleaning.
(iii) For releases into air, Clean Air Act operating permit numbers
and a description of any Leak Detection and Repair program in
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the
monitoring and management of fugitive releases) the site has
implemented.
(iv) For releases into water, the National Pollutant Discharge
Elimination System (NPDES) permit number(s), the name(s) of the
navigable waterway(s) into which the release occurs, and other
destination(s) into which the release occurs.
(v) For releases into wastewater treatment plants, the name(s) of
the publicly owned treatment work(s) (POTW) into which the release
occurs and the corresponding NPDES permit number(s).
* * * * *
(j) The physical and chemical properties and environmental fate
characteristics of the new chemical substance, which includes the
following:
(1) For physical and chemical properties, such information includes
boiling/sublimation temperature, density/relative density, dissociation
constant, explodability, flammability, melting temperature, octanol/
water partition coefficient, particle size distribution, particle size
distribution analysis, the physical state of the neat substance, pH,
solubility, vapor pressure, volatilization from water, volatilization
from soil, spectra, UV-VIS absorption data, and surface tension. For
nanomaterials, such information also includes aspect ratio, thickness,
and number of layers or walls.
(2) For environmental fate characteristics, such information
includes hydrolysis, photolysis, aerobic and anaerobic biodegradation,
atmospheric oxidation half-lives, Henry's law constant, adsorption/
desorption coefficient, bioaccumulation or bioconcentration factor,
Incineration Removal Efficiency (Destruction and Removal Efficiencies
or DREs), and Sewage Treatment (WWTP) Removals.
(k) Information about pollution prevention efforts, such as using
alternative fuel sources, reducing the use of water and chemical
inputs, modifying a production process to produce less waste, or
implementing water and energy conservation practices, or substituting
for riskier existing products. Inclusion of this information is
optional.
[[Page 34122]]
0
6. Amend Sec. 720.50 by revising paragraph (a)(4)(ii) to read as
follows:
Sec. 720.50 Submission of test data and other data concerning the
health and environmental effects of a substance.
(a) * * *
(4) * * *
(ii) If a test or experiment is completed before the applicable
review period ends, the person must submit the study, report, or test
electronically to EPA via CDX, as specified in paragraph (a)(3)(i) of
this section, within ten days of receiving it, but no later than five
days before the end of the review period. If the test or experiment is
completed during the last five days of the review period, the submitter
must inform its EPA contact for that notice by telephone or email prior
to the end of the review period and submit the study, report, or test
electronically to EPA via CDX.
* * * * *
0
7. Amend Sec. 720.65 by:
0
a. Revising paragraphs (a) through (c);
0
b. Redesignating paragraph (d) as paragraph (e);
0
c. Adding a new paragraph (d); and
0
d. Revising newly redesignated paragraph (e).
The revisions and addition read as follows:
Sec. 720.65 Acknowledgement of receipt of a notice; errors in the
notice; incomplete submissions; and false and misleading statements.
(a) Notification to the submitter. (1) EPA will acknowledge receipt
of each notice by sending a letter via CDX or U.S. mail to the
submitter that identifies the premanufacture notice number assigned to
the new chemical substance and date on which the applicable review
period begins as described in paragraph (a)(2) of this section.
(2) Before EPA sends an acknowledgement of receipt of a notice
pursuant to paragraph (a)(1) of this section, EPA will conduct a pre-
screen of the notice, typically taking 2-3 days and according to the
criteria under paragraphs (b)(1) and (c)(1) of this section.
(i) If EPA concludes that the notice contains errors warranting
remedy or is incomplete, EPA will notify the submitter according to
paragraph (d)(3) of this section. The applicable review period will not
begin. Once the submitter corrects the errors or incomplete submission
according to the requirements provided by EPA and re-submits it to EPA,
EPA will follow the procedures of paragraph (a)(2) of this section.
(ii) If EPA does not identify errors or determine the notice to be
incomplete during screening, EPA will notify the submitter according to
paragraph (a)(1) of this section. The applicable review period will
begin on the date EPA received the complete notice.
(b) Errors in the notice. (1) Within 30 days of receipt of the
notice, EPA may request that the submitter remedy errors in the notice.
The following are examples of such errors:
(i) Typographical errors that cause data to be misleading or
answers to any questions to be unclear.
(ii) Contradictory information.
(iii) Ambiguous statements or information.
(2) The applicable review period does not begin for notices
containing errors that EPA asks the submitter to remedy until
corrections are made following the procedures of paragraph (d) of this
section.
(c) Incomplete submissions. (1) A submission is not complete, and
the applicable review period does not begin, if:
(i) The wrong person submits the notice form.
(ii) The submitter does not sign the notice form.
(iii) Some or all of the information in the notice or the
attachments are not in English, except for published scientific
literature.
(iv) The submitter does not submit the notice in the manner set
forth in Sec. 720.40(a)(2).
(v) The submitter does not provide information that is required by
section 5(d)(1)(B) and (C) of the Act and Sec. 720.50.
(vi) The submitter does not provide information required by Sec.
720.45 or indicate that it is not known to or reasonably ascertainable
by the submitter.
(vii) The submitter does not submit a second copy of the submission
with all confidential information deleted for the public file, as
required by Sec. 720.80(b)(2).
(viii) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by Sec. 720.40(g).
(ix) The submitter does not submit data which the submitter
believes show that the chemical substance will not present an
unreasonable risk of injury to health or the environment, if EPA has
listed the chemical substance under section 5(b)(4) of the Act, as
required in Sec. 720.40(h).
(x) The submitter does not include an identifying number and a
payment identity number as required by 40 CFR 700.45(e)(3).
(2) The submission may be declared incomplete if at any time during
the applicable review period the submitter submits additional or
revised information without demonstrating to EPA's satisfaction that
the additional or revised information in the amended notice was not
known to or reasonably ascertainable by the submitter at the time of
initial notice submission (e.g., new information as described in Sec.
720.40(f) or information from testing in progress at the time of the
original submission, as described in Sec. 720.50(a)(4)), unless it
relates to administrative or non-substantive amendments (e.g., changing
the technical point of contact) or amendments made at the request of
EPA.
(d) Corrections to errors in the notice or incomplete submissions.
(1) If EPA receives an incomplete submission or seeks remedy of errors
identified in a notice, EPA will notify the submitter within 30 days of
receipt that the submission contains errors or is incomplete and that
the applicable review period will not begin until EPA receives a
correct and complete notice.
(2) If EPA obtains additional information during the applicable
review period that indicates the original submission was incomplete,
EPA may declare the submission incomplete within 30 days after EPA
obtains the additional information and so notify the submitter.
(3) The notification that a submission contains errors or is
incomplete under paragraph (d)(1) or (2) of this section will include:
(i) A statement of the basis of EPA's determination that the
submission contains errors or is incomplete.
(ii) The requirements for correcting the errors or incomplete
submission.
(iii) Information on procedures under paragraph (d)(4) of this
section for filing objections to the determination or requesting
modification of the requirements for completing the submission.
(4) Within ten days after receipt of notification by EPA that a
submission contains errors or is incomplete, the submitter may file
written objections requesting that EPA accept the submission as a
complete notice or modify the requirements necessary to complete the
submission.
(5)(i) EPA will consider the objections filed by the submitter. EPA
will determine whether the submission was complete or incomplete, or
whether to modify the requirements for completing the submission. EPA
will notify the submitter in writing of EPA's response within ten days
of receiving the objections.
[[Page 34123]]
(ii) If EPA determines, in response to the objection, that the
submission was complete, the applicable review period will be deemed
suspended on the date EPA declared the notice incomplete, and will
resume on the date that the notice is declared complete. The submitter
need not correct the notice as EPA originally requested. If EPA can
complete its review within 90 days from the date of the original
submission, EPA may inform the submitter that the running of the review
period will resume on the date EPA originally declared it incomplete.
(iii) If EPA modifies the requirements for completing the
submission or affirms its original determination that the submission
contains errors or is incomplete, or if no objections are filed, the
applicable review period will begin (or if previously begun, will
restart at Day 1) when EPA receives a complete notice.
(e) Materially false or misleading statements. If EPA discovers at
any time that a person submitted materially false or misleading
statements in the notice, EPA may find that the notice was incomplete
from the date it was submitted and take any other appropriate action.
0
8. Amend Sec. 720.70 by revising paragraphs (a) and (b)(3) to read as
follows:
Sec. 720.70 Notice in the Federal Register.
(a) Filing notice of receipt. In accordance with section 5(d)(2) of
the Act, after EPA has received a complete notice, EPA will file a
notice of receipt with the Office of the Federal Register including the
information specified in paragraph (b) of this section.
(b) * * *
(3) For test data submitted in accordance with Sec. 720.40(g), a
summary of the data received.
* * * * *
0
9. Amend Sec. 720.75 by:
0
a. Revising the section heading;
0
b. Removing the phrase ``notice review period'' and adding in its place
the phrase ``applicable review period;'' wherever it appears; and
0
c. Revising paragraphs (a), (b), (c)(4) and (d) to read as follows:
Sec. 720.75 Applicable review period and determination.
(a) Length of applicable review period. The applicable review
period specified in section 5(a) of the Act runs for 90 days from the
date EPA receives a complete notice, or the date EPA determines the
notice is complete under Sec. 720.65(d), unless the Agency extends the
applicable review period under section 5(c) of the Act and paragraph
(c) of this section.
(b) Suspension of the running of the applicable review period. (1)
A submitter may voluntarily suspend the running of the applicable
review period if EPA agrees. If EPA does not agree, the review period
will continue to run, and EPA will notify the submitter. A submitter
may request a suspension at any time during the applicable review
period. The suspension must be for a specified period of time.
(2)(i) Requests for suspension 30 days or less. A request for a
suspension of 30 days or less may be made orally, including by
telephone, or in writing, including by email, to the submitter's EPA
contact for that notice. Any request for a suspension exceeding 30 days
must be submitted in the manner set forth in paragraph (b)(2)(ii) of
this section. The running of the applicable review period will be
suspended upon approval of the oral or written request by EPA.
(ii) Requests for suspensions greater than 30 days. Requests for
suspensions exceeding 30 days must be submitted electronically to EPA
via CDX using e-PMN software. Requests for suspensions of 30 days or
less may also be submitted electronically to EPA via CDX using e-PMN
software. See Sec. 720.40(a)(2)(ii) for information on how to access
the e-PMN software. The running of the applicable review period will be
suspended upon approval of the request submitted electronically to EPA
via CDX using e-PMN software by EPA.
(c) * * *
(4) The following are examples of situations in which EPA may find
that good cause exists for extending the applicable review period:
(i) EPA has reviewed the notice and determined that there is a
significant possibility that the chemical substance will be regulated
under sections 5(e) or 5(f) of the Act, but EPA is unable to initiate
regulatory action within the initial 90-day period.
(ii) EPA has reviewed the submission and is seeking additional
information.
(iii) EPA has received significant additional information during
the applicable review period, which was not known to or reasonably
ascertainable by the submitter at the time of initial notice
submission.
(d) Determinations. (1) Within the applicable review period, EPA
will make one of the following five determinations, as set forth in
section 5(a)(3) of the Act:
(i) The chemical substance presents an unreasonable risk of injury
to health or the environment, as set forth in section 5(a)(3)(A) of the
Act.
(ii) Information available to EPA is insufficient to permit a
reasoned evaluation of the health and the environmental effects of the
relevant chemical substance, as set forth in section 5(a)(3)(B)(i) of
the Act.
(iii) In the absence of sufficient information to permit EPA to
make such an evaluation, the chemical substance may present an
unreasonable risk of injury to health or the environment, as set forth
in section 5(a)(3)(B)(ii)(I) of the Act.
(iv) The chemical substance is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or substantial human exposure to the
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
(v) The chemical substance is not likely to present an unreasonable
risk of injury to health or the environment, as set forth in section
5(a)(3)(C) of the Act.
(2) EPA will take the following actions required in association
with the determination:
(i) For determinations described in paragraph (d)(1)(i) of this
section, EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance, or any combination of such activities, to the
extent necessary to protect against an unreasonable risk of injury to
health or the environment, as set forth in section 5(f) of the Act, or
will issue a proposed rule under section 6(a) of the Act, as set forth
in section 5(f) of the Act.
(ii) For determinations described in paragraphs (d)(1)(ii), (iii),
or (iv) of this section, EPA will issue the submitter an order to
prohibit or limit the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance, or any
combination of such activities, to the extent necessary to protect
against an unreasonable risk of injury to health or the environment, as
set forth in section 5(e) of the Act. EPA may issue an order under
section 5(e) of the Act that requires certain testing to be conducted
and presented to EPA after the applicable review period has concluded.
(iii) Following a determination described in paragraph (d)(1)(v) of
this section, EPA will issue the submitter a document describing that
determination and will submit for publication in the Federal Register a
statement of the finding, as set forth in section 5(g) of the Act. Upon
EPA's issuance of the determination, the submitter may commence the
manufacture of the
[[Page 34124]]
chemical substance without waiting for the end of the applicable review
period.
(3) EPA may modify or revoke the prohibitions and limitations in an
order issued under paragraph (d)(2)(i) or (ii) of this section after
the applicable review period has ended if the submitter submits to EPA
additional testing, studies, reports, or other information that EPA
determines, upon review, demonstrate that such prohibitions or
limitations are no longer necessary to protect against an unreasonable
risk of injury to health or the environment.
(4) No person submitting a notice in response to the requirements
of this part may manufacture a chemical substance subject to this part
until EPA has issued a determination in accordance with paragraph
(d)(1) of this section and taken the associated action required under
paragraph (d)(2) of this section.
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
10. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
11. Amend Sec. 721.25 by revising paragraphs (c) and (d) to read as
follows:
Sec. 721.25 Notice requirements and procedures.
* * * * *
(c) EPA will process the notice in accordance with the procedures
of part 720 of this chapter, except to the extent they are inconsistent
with this part. When submitting a SNUN the provision at Sec.
720.45(f)(1) of this chapter is modified to require a description of
both known and intended categories of consumer or commercial use by
function and application.
(d) Any person submitting a significant new use notice in response
to the requirements of this part shall not manufacture or process a
chemical substance identified in subpart E of this part for a
significant new use until EPA has issued a determination with respect
to the significant new use and taken the actions required in
association with that determination in accordance with the procedures
for new chemical substances at Sec. 720.75(d) of this chapter.
PART 723--PREMANUFACTURE NOTIFICATION EXEMPTIONS
0
12. The authority citation for part 723 continues to read as follows:
Authority: 15 U.S.C. 2604.
0
13. Amend Sec. 723.50 by:
0
a. Revising paragraph (a)(1);
0
b. Adding paragraphs (b)(11) and (12);
0
c. Revising paragraphs (d), (g), and (h)(2)(v); and
0
d. Adding paragraph (p).
The revisions and additions read as follows:
Sec. 723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
(a) * * *
(1) This section grants an exemption from the premanufacture notice
requirements of section 5(a)(1)(A)(i) of the Toxic Substances Control
Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
* * * * *
(b) * * *
(11) PFAS or per- and poly-fluoroalkyl substance means a chemical
substance that contains at least one of these three structures:
(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; or
(iii) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated
carbons.
(12) PBT chemical substance means a chemical substance possessing
characteristics of persistence (P) in the environment, accumulation in
biological organisms (bioaccumulation (B)), and toxicity (T) resulting
in potential risks to humans and ecosystems. For more information on
EPA's Policy on new chemical substances that are PBTs, see EPA's 1999
policy statement (64 FR 60194, November 4, 1999 (FRL-6097-7)).
* * * * *
(d) Chemical substances that cannot be manufactured under this
exemption. A new chemical substance cannot be manufactured under this
section, notwithstanding satisfaction of the criterion of paragraph
(c)(1) or (2) of this section, if EPA determines, in accordance with
paragraph (g) of this section, that the substance, any reasonably
anticipated metabolites, environmental transformation products, or
byproducts of the substance, or any reasonably anticipated impurities
in the substance, under anticipated conditions of manufacture,
processing, distribution in commerce, use, or disposal of the new
chemical substance:
(1) May cause:
(i) Serious acute (lethal or sublethal) effects;
(ii) Serious chronic (including carcinogenic and teratogenic)
effects; or
(ii) Significant environmental effects.
(2) Or is:
(i) A PFAS.
(ii) A PBT chemical substance with anticipated environmental
releases and potentially unreasonable exposures to humans or
environmental organisms.
* * * * *
(g) Review period. (1) EPA will review the notice submitted under
paragraph (e) of this section to determine whether manufacture of the
new chemical substance is eligible for the exemption. The review period
will run for 30 days from the date EPA receives a complete notice. To
provide additional time to address any unresolved issues concerning an
exemption application, the exemption applicant may, at any time during
the review period, request a suspension of the review period pursuant
to the provisions of Sec. 720.75(b) of this chapter.
(2) No person submitting a notice under paragraph (e) of this
section may manufacture the new chemical substance until EPA notifies
the submitter that the new chemical substance meets the terms of this
section.
(h) * * *
(2) * * *
(v) If the Assistant Administrator determines that manufacture of
the new chemical substance does not meet the terms of this section and
that the manufacturer did not act with due diligence and in good faith
to meet the terms of this section, the manufacturer must cease any
continuing manufacture, processing, distribution in commerce, and use
of the new chemical substance within 7 days of the written notification
under paragraph (h)(2)(iii) of this section. The manufacturer may not
resume manufacture, processing, distribution in commerce, and use of
the new chemical substance until it submits a notice under section
5(a)(1) of the Act and part 720 of this chapter and EPA has made one of
the five determinations as set forth in section 5(a)(3) of the Act and
taken the action required in association with that determination.
* * * * *
(p) Subject to a significant new use rule. If a significant new use
rule is proposed or finalized in part 721 of this chapter for a
chemical substance described by a generic chemical name, EPA may make
reasonable efforts to notify any persons who may also manufacture the
same chemical substance under the terms of this section. A disclosure
to a person with an approved exemption under this section that the
chemical substance is subject to a proposed or final rule in part 721
of this chapter will not be considered public disclosure of
[[Page 34125]]
confidential business information under section 14 of the Act. The
notification will inform manufacturers subject to the terms of this
section that the chemical substance is subject to a proposed or final
significant new use rule under section 5(a)(2) of the Act, and identify
the proposed or final section in subpart E of part 721 of this chapter
that pertains to the chemical substance.
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
14. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
15. Amend Sec. 725.54 by revising paragraphs (b)(1), (c) and (d) to
read as follows:
Sec. 725.54 Suspension of the review period.
* * * * *
(b)(1) Request for suspension. A request for suspension may only be
submitted in a manner set forth in this paragraph. The request for
suspension also may be made orally, including by telephone, or in
writing, including by email, to the submitter's EPA contact for that
notice, subject to paragraph (c) of this section.
* * * * *
(c) An oral or written request for suspension may be granted by EPA
for a maximum of 30 days only. Requests for longer suspension must only
be submitted in the manner set forth in paragraph (b)(2) of this
section.
(d) If the submitter has not made a previous oral or written
request, the running of the applicable review period is suspended as of
the date of receipt of the CDX submission by EPA.
0
16. Amend Sec. 725.60 by revising paragraph (a)(1) to read as follows:
Sec. 725.60 Withdrawal of submission by the submitter.
(a)(1) Withdrawal of notice by the submitter. A submitter may
withdraw a notice during the applicable review period by submitting a
statement of withdrawal in a manner set forth in this paragraph. The
withdrawal is effective upon receipt of the CDX submission by EPA.
* * * * *
0
17. Amend Sec. 725.170 by:
0
a. Revising paragraphs (a) and (b); and
0
b. Removing paragraph (c).
The revisions read as follows.
Sec. 725.170 EPA review of the MCAN.
* * * * *
(a) Length of the review period. The MCAN review period specified
in section 5(a) of the Act runs for 90 days from the date EPA receives
a complete MCAN, or the date EPA determines the MCAN is complete under
Sec. 725.33, unless the Agency extends the period under section 5(c)
of the Act and Sec. 725.56.
(b) Determinations. (1) Within the applicable review period, EPA
will make one of the following five determinations on the
microorganism, as set forth in section 5(a)(3) of the Act:
(i) The microorganism presents an unreasonable risk of injury to
health or the environment, as set forth in section 5(a)(3)(A) of the
Act.
(ii) Information available to EPA is insufficient to permit a
reasoned evaluation of the health and the environmental effects of the
microorganism, as set forth in section 5(a)(3)(B)(i) of the Act.
(iii) In the absence of sufficient information to permit EPA to
make such an evaluation, the microorganism may present an unreasonable
risk of injury to health or the environment, as set forth in section
5(a)(3)(B)(ii)(I) of the Act.
(iv) The microorganism is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or substantial human exposure to the
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
(v) The microorganism is not likely to present an unreasonable risk
of injury to health or the environment, as set forth in section
5(a)(3)(C) of the Act.
(2) EPA will take the following actions required in association
with the determination.
(i) For determinations described in paragraph (b)(1)(i) of this
section, EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the microorganism, or any combination of such activities, to the extent
necessary to protect against an unreasonable risk of injury to health
or the environment, as set forth in section 5(f) of the Act, or will
issue a proposed rule under section 6(a) of the Act, as set forth in
section 5(f) of the Act.
(ii) For determinations described in paragraph (b)(1)(ii), (iii),
or (iv), EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the microorganism, or any combination of such activities, to the extent
necessary to protect against an unreasonable risk of injury to health
or the environment, as set forth in section 5(e) of the Act. EPA may
issue an order under section 5(e) of the Act that requires certain
testing to be conducted and presented to EPA after the applicable
review period has concluded.
(iii) For determinations described in paragraph (b)(1)(v) of this
section, EPA will issue the submitter a document describing that
determination and will submit for publication in the Federal Register a
statement of the finding, as set forth in section 5(g) of the Act. Upon
EPA's issuance of the determination, the submitter may commence the
manufacture of the microorganism without waiting for the end of the
applicable review period.
(3) EPA may modify or revoke the prohibitions and limitations in an
order issued under paragraph (b)(2)(i) or (ii) of this section after
the applicable review period has closed if the submitter submits to EPA
additional information, testing, studies, or reports that EPA
determines, upon review, demonstrate that such prohibitions or
limitations are no longer necessary to protect against an unreasonable
risk of injury to health or the environment.
(4) No person submitting a MCAN in response to the requirements of
this subpart may manufacture a microorganism subject to this subpart
until EPA has issued a determination in accordance with paragraph
(b)(1) of this section and taken any action as required under paragraph
(b)(2) of this section.
[FR Doc. 2023-10735 Filed 5-25-23; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on May 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.