`[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Rules and Regulations]
[Pages 102773-102800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28870]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 68, 372, 703, 720, 721, 723, 725, and 761

[EPA-HQ-OPPT-2022-0902; FRL-7906-02-OCSPP]
RIN 2070-AK65


Updates to New Chemicals Regulations Under the Toxic Substances 
Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
amending the new chemicals procedural regulations under the Toxic 
Substances Control Act (TSCA). These amendments 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, will improve the efficiency of 
EPA's review processes, and update the regulations based on existing 
policies and experience implementing the New Chemicals Program. This 
final rule includes amendments that will increase the quality of 
information initially submitted in new chemicals notices and improve 
the Agency's processes for timely, effective completion of individual 
risk assessments and the new chemicals review process overall. EPA is 
also finalizing several amendments to the regulations for low volume 
exemptions (LVEs) and low release and exposure exemptions (LoREXs), 
which will require EPA approval of an exemption notice prior to 
commencement of manufacture, make per- and polyfluoroalkyl substances 
(PFAS) categorically ineligible for these exemptions, and provide that 
certain persistent, bioaccumulative, toxic (PBT) chemical substances 
are ineligible for these exemptions.

DATES: This final rule is effective January 17, 2025.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2022-0902, is available online 
at https://www.regulations.gov. Additional instructions for visiting 
the docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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; e-mail address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you 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 Industrial Classification System (NAICS) codes is not 
intended to be exhaustive, but rather provides a guide to help readers 
determine whether this document applies to them. Potentially affected 
entities may include:
     Chemical Manufacturers (NAICS code 325).
     Petroleum and Coal Products (NAICS code 324).
     Merchant Wholesalers, Nondurable Goods (NAICS code 424).
    This list details the types of entities that EPA is aware could 
potentially be regulated by this action. Other types of entities not 
listed could also be regulated. To determine whether your entity is 
regulated by this action, you should carefully examine the 
applicability criteria found in 40 CFR 720.22, 721.5, 723.50, and 
725.1. If you have 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?

    EPA is promulgating this rule pursuant to its authority in TSCA 
section 5 (15 U.S.C. 2604). 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

[[Page 102774]]

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.

C. What action is the Agency taking?

    EPA is promulgating amendments to 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. EPA is amending the regulations to specify that EPA 
must make a determination on each Pre-Manufacture Notice (PMN), 
Significant New Use Notice (SNUN), and Microbial Commercial Activity 
Notice (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 
finalizing amendments that will 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 finalizing 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 finalizing several 
amendments to the regulations at 40 CFR 723.50 for LVEs and 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 PFAS 
categorically ineligible for these exemptions, and make certain PBTs 
ineligible for these exemptions. Finally, EPA is amending 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 
e-mail request. This final rule takes into consideration comments 
received on the proposed rule (88 FR 34100, May 26, 2023 (FRL-7906-01-
OCSPP)). Details on the final rule requirements, including 
modifications from the proposal, are explained in Unit III.

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 or SNUN 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 a chemical substance described in such notices before they 
can proceed to the marketplace. To reflect and better meet these 
requirements, EPA is amending the procedural regulations codified at 40 
CFR parts 720, 721, and 725 and making additional updates based on 
existing policies or lessons learned from administering the New 
Chemicals Program since TSCA was amended in 2016.
    EPA is also finalizing amendments that will clarify the information 
that is required to be included in PMNs, SNUNs, and exemption notices 
to reduce the need to redo all or part of the risk assessment 
(``rework'') due to late submissions of information. This action is 
expected to reduce rework 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 finalizing amendments to make clear the procedures that 
will be employed if submitters amend their PMNs or SNUNs during the 
applicable review period.
    EPA is amending 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 
promulgating amendments that allow the Agency to notify submitters if a 
chemical substance for which they hold an LVE or LoREX is or 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 finalizing 
amendments 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 making certain PBTs ineligible for these 
exemptions, to better manage risks associated with PBT chemical 
substances that have anticipated environmental releases and potentially 
unreasonable exposures to humans or environmental organisms.
    Lastly, EPA is promulgating amendments that will allow informal 
(oral or e-mail) requests for review period suspensions of up to 30 
days to reduce the number of repeated requests for 15-day suspensions, 
because EPA believes that e-mail may be more expedient than oral 
communication for many submitters.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the costs and benefits of this rulemaking and 
provided an Economic Analysis (EA) of the potential impacts associated 
with this rule, titled ``Economic Analysis for the Final Rule: Updates 
to New Chemicals Regulations under the Toxic Substances Control Act'' 
(Ref. 1), which is available in the docket 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 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

[[Page 102775]]

a reasoned evaluation. As submitters provide more complete information 
in their initial submissions, the changes under this rule are expected 
to reduce the frequency with which PMNs, SNUNs, and exemption notices 
are amended with additional information and the amount of rework of 
risk assessments that the Agency conducts following such amendments.
    In addition, the more detailed and comprehensive 90-day review 
afforded to PMNs allows EPA to make a more informed hazard 
determination for PFAS, leading to improvement in the expected outcome 
of these decisions. More informed decision making about a PFAS's 
potential risks is likely to result in a reduction in the cost of risk-
based decision making about the PFAS, and an improvement in the 
expected outcome of the decisions.
    As a result of the changes presented in this rule, the total annual 
burden to industry is expected to decrease by approximately 4,528 
hours, while total annual costs to industry submitters are expected to 
have a net increase of approximately $203,150. The Agency is expected 
to experience an annual cost savings of approximately $1,117,132.

II. Background

A. What did EPA propose?

    On May 26, 2023 (88 FR 34100; FRL-7906-01-OCSPP), EPA proposed 
amendments intended to align the regulatory text with the amendments to 
TSCA's new chemicals review provisions contained in the 2016 Lautenberg 
Amendments, to improve the efficiency of EPA's review processes, and 
update the regulations based on existing policies and experience 
implementing the New Chemicals Program. Additionally, the proposal 
included amendments that would reduce the need to redo all or part of a 
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 also proposed several 
amendments to the regulations for LVEs and LoREXs, which included 
requiring EPA approval of an exemption notice prior to commencement of 
manufacture, making PFAS categorically ineligible for these exemptions, 
and providing that certain PBT chemical substances would be made 
ineligible for these exemptions, consistent with EPA's 1999 PBT policy. 
Lastly, the proposal included amendments related to the suspension of 
the review period.

B. How did the 2016 Lautenberg Amendments change TSCA section 5?

    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. 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). 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 one of five 
determinations 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. 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.
    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). The 2016 Lautenberg Amendments 
also added a new paragraph at 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. EPA developed the current LVE and LoREX regulations in 1995 
pursuant to TSCA section 5(h)(4) (60 FR 16336, March 29, 1995). See 
Unit II. of the May 26, 2023, proposed rule (88 FR 34100) for further 
discussion of the 2016 Lautenberg Amendments.

C. How are the new chemicals regulations structured?

    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:
     Regulations pertaining to PMNs, which are codified at 40 
CFR part 720;
     Regulations pertaining to SNUNs, which are codified at 40 
CFR part 721;
     Regulations pertaining to certain exemptions, which are 
codified at 40 CFR part 723; and
     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-reference 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 amendments to 
the requirements in 40 CFR 720.45 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 promulgated by this action 
apply to PMNs and 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 finalizing certain amendments to the MCAN and 
microorganism-related exemption regulations at 40 CFR part 725.

D. Did EPA receive public comments on the proposed rule?

    EPA received 51 public comments on the proposed rule. Commenters 
included potentially affected businesses, trade associations, 
environmental and public health advocacy groups, unions, and other 
Federal agencies. In this preamble, EPA has responded to many of the 
significant comments on the proposed rule; however, the more 
comprehensive version of EPA's response to comments for this rulemaking 
can be found in the Response to Comments document (Ref.

[[Page 102776]]

2). The Response to Comments document summarizes all the comments 
relevant to the proposal and EPA's response to those comments. In the 
Response to Comments document, EPA also discusses any changes to and 
clarifications from the proposed rule made in this final rule.

III. Overview of the Final Rule

    This final rule is based on the May 26, 2023, proposed rule (88 FR 
34100) and in consideration of the public comments received on the 
proposed rule.

A. Amendments To Conform Regulations to 2016 Lautenberg Amendments

    EPA is amending 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 promulgating 
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, prior to this 
rulemaking, had not yet codified these updates into the new chemicals 
procedural regulations. The amendments 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 
lists the five possible determinations and the actions required in 
association with those determinations. EPA is also adding definitions 
for new terms and to update existing terminology introduced by the 2016 
Lautenberg Amendments.
1. Commencement of Manufacture or Processing
    As proposed, EPA is finalizing amendments at 40 CFR 720.75(d) by 
removing 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 finalizing an amendment to 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 finalizing an amendment at 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 or 
processing may commence.
    Some comments on the proposal challenged the EPA's description of 
how the New Chemicals Program operated prior to the passage of the 2016 
Lautenberg Amendments and suggested that the 2016 Lautenberg Amendments 
had only minor impacts on the Program. EPA disagrees with these 
comments, as prior to the 2016 Lautenberg Amendments, EPA was not 
required to conduct a review of and issue a determination for every 
notice. Following the 2016 Lautenberg Amendments, EPA must review all 
notices submitted under TSCA section 5(a)(1) and make a determination 
pertaining to the risks of a new chemical or significant new use of an 
existing chemical before it is allowed into the marketplace. For a 
detailed response to these and other comments, please see the Response 
to Comments document (Ref. 2).
2. Required Determinations and Associated Actions
    As proposed, EPA is finalizing amendments at 40 CFR 720.75(d) and 
725.170 by listing the five possible determinations that EPA must make 
for each PMN, SNUN, or MCAN it receives. EPA is also finalizing 
amendments 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 codifying 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.
    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.
    Several comments on the proposed rule asserted that EPA not only 
has the authority to revoke or lessen restrictions in an order after it 
has been issued, but also can and must strengthen protections in an 
order based on new information received on a chemical substance that 
demonstrates the order is insufficient to protect against unreasonable 
risk. The commenters further urged EPA to clarify that an order may be 
modified based on new information obtained from any source, not solely 
the submitter. EPA agrees with these commenters and a detailed response 
is available in the Response to Comments document (Ref. 2). Upon 
consideration of these comments, EPA is modifying the proposed 
amendments at 40 CFR 720.75(d)(3) and 725.170(b)(3) to clarify that new 
information may be received from any source, and to add that where such 
information demonstrates that the prohibitions or limitations of the 
order are not sufficient to protect against an unreasonable risk of 
injury to health or the environment, EPA may modify the order or take 
other action, as appropriate, to the extent necessary to protect 
against such risk.
3. Other Updates
    As proposed, EPA is finalizing amendments to the regulation that 
will replace the undefined 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 also finalizing an amendment to add, as 
proposed, 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. In response to the proposed amendment 
adding a definition for ``applicable review period,'' commenters 
expressed difficulty in determining what EPA considers to be a complete 
notice and requested that the Agency clearly define what constitutes a 
notice that is ``complete.'' EPA considers a complete notice to be a 
notice that meets all the procedural requirements indicated in 
720.65(c)(1) (e.g. a notice that includes

[[Page 102777]]

a company signature, is submitted via CDX, includes a second copy of 
the submission with all confidential information deleted, includes the 
payment identity number, etc.) and includes all required information 
that is known to or reasonably ascertainable by the submitter, as 
described in 720.45 and 720.50. A submission that fails to meet the 
statutory information requirements is incomplete, and EPA is justified 
in refusing to review the notice until the information is received. In 
the Response to Comments document (Ref. 2), EPA discusses in more 
detail the longstanding definition of ``known to or reasonably 
ascertainable by'' and its application in specific contexts.
    After considering the comments, EPA is finalizing an amendment to 
add a definition for ``potentially exposed or susceptible 
subpopulation'' (PESS) to 40 CFR 720.3. For this rule, EPA is defining 
``potentially exposed or susceptible subpopulation'' as proposed and 
using the same definition that was proposed and finalized as part of 
the rulemaking entitled ``Procedures for Chemical Risk Evaluation under 
the Toxic Substances Control Act (TSCA)'' (89 FR 37028, May 3, 2024 
(FRL-8529-02-OCSPP)).
    As a primary matter, the inclusion of ``overburdened communities'' 
in the list of example subpopulations in this definition is not itself 
a determination. Rather, it is an example of a subpopulation that EPA 
may identify as a PESS in future risk assessments, and it is reflective 
of the reality that, in addition to groups like children and pregnant 
women, there are communities of people that may experience 
disproportionate environmental risks from chemicals due to greater 
exposure or susceptibility to environmental and health harms.
    EPA proposed to add a regulatory definition of PESS that includes 
the term ``overburdened communities'' in the list of example 
subpopulations. This term, which is an addition to the examples 
provided in the statutory definition of PESS at TSCA section 3(12), 
reflects the Agency's understanding and acknowledgment that a chemical 
substance may disproportionately expose and/or may disproportionately 
impact communities already experiencing disproportionate and adverse 
human health or environmental burdens. Such disproportionality can be 
as a result of greater exposure or vulnerability to environmental 
hazards, lack of opportunity for public participation, or other 
factors. Increased exposure or vulnerability may be attributable to an 
accumulation of negative or lack of positive environmental, health, 
economic, or social conditions within these populations or places. The 
term describes situations where multiple factors, including both 
environmental and socio-economic stressors, may act cumulatively to 
impact health and the environment and contribute to persistent 
environmental health disparities. These situations may apply to 
communities with environmental justice concerns.
    While some commenters on the proposed rule objected to the 
inclusion of ``overburdened communities,'' EPA believes that it is 
appropriate to include ``overburdened communities'' as an example 
subpopulation in the definition of PESS. Congress' inclusion of ``such 
as'' in the statutory definition provides EPA with clear discretion to 
go beyond the statute's list of examples. EPA further disagrees that 
this addition is substantively changing the criteria for identification 
of PESS (i.e., greater exposure or susceptibility and greater risk than 
general population).
    EPA does not believe it is necessary to define ``overburdened 
communities'' as part of this rule. In the same way that EPA considers 
whether children or workers or the elderly are a PESS in the context of 
a specific risk assessment, EPA will look to whether ``overburdened 
communities'' may become subject to exposure or could be more 
susceptible than the general population. EPA does not intend for this 
term to be confined to a location or geographic proximity but would use 
reasonably available information for each new chemical substance or 
significant new use to determine the inclusion of specific communities. 
Those who could potentially experience ``greater exposure'' could 
include individuals or communities that would experience higher levels 
of exposure to a chemical substance due to geography (e.g., fenceline 
communities in close proximity to facilities that could emit air 
pollutants or living near potential effluent releases to water), unique 
exposure pathways that differ from those of the general population 
(e.g., Tribal communities where reliance on subsistence fishing may 
result in increased exposure via ingestion), and/or aggregate exposure 
via multiple conditions of use (e.g., a worker potentially exposed to 
the chemical substance who also lives in close proximity to the 
facility that may also release the chemical substance through air 
emissions).
    In making these additions to 40 CFR 720.3, EPA is also revising the 
overall format used to list the definitions in 40 CFR 720.3, by 
removing the designations for each definition and adopting the 
alphabetical listing approach consistent with the recommendation of the 
Office of the Federal Register (OFR). See page 2-27 of the OFR's 
Document Drafting Handbook, August 2018 Edition (Revision 2.1, dated 
October 2023), https://www.archives.gov/federal-register/write/ddh/. 
Specifically, EPA is using the revise and republish instructions in the 
regulatory text of this final rule to reflect the addition of the two 
definitions and the adoption of the recommended undesignated 
alphabetical listing format for this definition section. This change 
also requires corresponding technical corrections to the citation in 
several other regulations. The existing definitions and these other 
regulations are otherwise unchanged. Conforming edits to remove the 
designations for the definitions in 40 CFR 720.3 are being made to 40 
CFR 68.115, 372.38, 703.3, and 761.3.
    EPA is also promulgating an update to 40 CFR 720.70(b) by revising 
paragraph (b)(3). Some commenters opposed EPA's proposal to remove the 
regulatory-only requirement in 40 CFR 720.70(b)(3) to publish a list of 
test data submitted in accordance with 40 CFR 720.50(a) in the TSCA 
section 5(d)(2) notice of receipt. EPA disagrees with these comments. 
As EPA explained in the preamble to the proposed rule (88 FR 34100, May 
26, 2023), the Agency believes that its objective of providing such 
information to the public is now better achieved through ChemView than 
through publication in the Federal Register. Through ChemView, the 
Agency currently makes the section 5 notice, including test data 
submitted with it, publicly available generally within 5 business days 
of receipt, subject to confidentiality protections. EPA is finalizing 
the change to 720.70(b)(3) as proposed. For additional response to the 
comments received on the amendments to 40 CFR 720.70(b)(3), see the 
Response to Comments document (Ref. 2).

B. Amendments Related to Notice Information Requirements

    EPA is promulgating amendments to the notice information 
requirements at 40 CFR 720.45, as well as corresponding changes to the 
PMN form in CDX, to clarify the level of detail expected for 
information that must be submitted to EPA in PMN, SNUN, and certain 
exemption notices. EPA is finalizing these amendments largely as 
proposed, with most changes representing minor clarifications to the 
proposed regulatory text in response to the comments.

[[Page 102778]]

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 final rule and can be found in the docket 
(Ref. 3). 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 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 section 5 notices do not contain all 
required information at the level of detail that EPA needs to perform 
refined risk assessments. As described in the preamble of the proposed 
rule, these deficiencies frequently result in EPA using conservative 
assumptions in its risk assessments due to lack of available data, 
which can create delays in the timeline for case completion, 
particularly when submitters provide information to EPA late in a 
case's review in response to risk estimates stemming from the lack of 
available data. In recent years, EPA has issued guidance documents 
(Ref. 3 and 4), established pre-screen processes for incoming cases, 
and conducted outreach efforts (Ref. 5) to make clearer to submitters 
the level of detail necessary for timely review of their chemicals, as 
well as to minimize the need for costly rework of case assessment 
materials. 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, 
will help submitters provide more detailed section 5 notices and help 
to minimize the need for EPA to use default values and conservative 
assumptions in its risk assessments due to the lack of available data. 
Therefore, EPA is finalizing the amendments to the notice information 
requirements at 40 CFR 720.45 as well as the corresponding changes to 
the PMN form in CDX largely as described in the proposed rule.
2. Changes to 40 CFR 720.45, 40 CFR 720.50, and the PMN Form
    EPA is amending 40 CFR 720.45 and the PMN form in CDX to clarify 
the information requirements for a notice. Specifically, EPA is adding 
details to certain information requirements already contained in 40 CFR 
720.45. EPA is also adding additional reporting fields to the PMN form 
to reflect these details. In this action, EPA is adding these details 
as separate, unique information requirements in 40 CFR 720.45 and 
making corresponding changes to the PMN form to clarify the level of 
detail needed for EPA's review of section 5 notices and to ensure that 
the fields in the PMN form are consistent with the regulations. In some 
cases, information requested in the PMN form is not clearly required in 
the 720.45 regulations, so EPA is adding those details to 40 CFR 720.45 
to ensure that the regulations and PMN form are as consistent as 
possible. Although EPA is finalizing these amendments largely as they 
were described in the proposed rule, changes, mostly to improve 
clarity, have been made to some amendments in response to comments 
received by EPA. In response to comments, EPA is also finalizing 
additional amendments to the regulations at 720.45 and 720.50, as well 
as to the PMN form in CDX, that further add clarity and better align 
the PMN form with the regulations. See Ref. 6, which includes tables 
that detail the changes that are being made to 40 CFR 720.45, 720.50, 
and the CDX interface per this final rule. Additionally, EPA has 
amended 40 CFR 723.50(e) to update a cross-reference to 40 CFR 720.45 
based on the amendments made in this rule.
    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. Under the 
amendments to 40 CFR 720.45, a submitter is required to include in the 
PMN form the detailed information finalized 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 not controlled by the submitter. In those 
situations, EPA will make conservative assumptions and use default 
values for any information that is not known to or reasonably 
ascertainable by the submitter and therefore not provided in the PMN 
form.
    Based on a public comment, EPA is adding language to 720.50(c) to 
clarify that submitters can submit additional information not otherwise 
required by 720.50(a)-(b) to facilitate EPA's review of the notice.
a. Physical and Chemical Properties and Environmental Fate 
Characteristics
    The first set of detailed information requirements that EPA is 
adding to 40 CFR 720.45 concerns the physical and chemical properties 
and environmental fate characteristics of the chemical substance (see 
Table 1 in Ref. 6). 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). EPA 
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. 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. EPA believes that the information requirements in 
40 CFR 720.45 should reflect the PMN form fields. EPA is therefore 
adding 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. Submitters must submit physical-chemical 
and environmental fate information in the corresponding PMN form fields 
in accordance with new paragraph 720.45(j), which is added as described 
in the proposed rule.

[[Page 102779]]

    EPA is also adding several information requirements to 40 CFR 
720.45(j)(1) that are not already specified within the PMN form for 
physical and chemical properties. Specifically, EPA is requiring 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. One commenter requested that EPA 
clarify the language outlined in the proposed rule for the particle 
size distribution analysis data requirement to make it clear that it 
includes both the analysis method as well as any data used to develop 
the particle size distribution value, a suggestion that EPA is 
incorporating in this final rule. Two commenters requested that EPA 
include several amendments to the nanomaterial morphology requirements 
outlined in the proposed rule, recommendations that EPA considers to be 
overly prescriptive and as such is declining to finalize. Additionally, 
after considering these comments, EPA anticipates that the proposed 
requirements at 40 CFR 720.45(j)(1) for information on aspect ratio, 
thickness, and number of layers or walls for nanomaterials are likely 
to be applicable only to a narrow subset of nanomaterials. Because this 
information would not be relevant to most nanomaterials, EPA will not 
include the proposed nanomaterial data requirements in the final 
regulations. For all other amendments to 40 CFR 720.45(j), as was 
proposed in the May 2023 proposed rule, EPA will also add fields for 
attaching associated data on the physical and chemical properties 
screen of the PMN form.
    As proposed, EPA is also adding information requirements for the 
environmental fate characteristics of the chemical substance (see Table 
1 in Ref. 6) 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 thus adding the relevant 
environmental fate characteristics to the information requirements at 
40 CFR 720.45(j)(2) and form fields to the PMN form by expanding the 
pick list.
b. Categories of Use
    The next set of changes that EPA is finalizing at 40 CFR 720.45 
relates to the categories of use of the chemical substance (see Table 2 
in Ref. 6). The requirements being finalized include detailed 
information on commercial and consumer uses, which already have form 
fields in the PMN form in CDX. Although the regulations at 40 CFR 
720.45(f) previously required 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 details on commercial and consumer uses were not specified. The 
added 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. Additionally, EPA is 
finalizing at 40 CFR 720.45(f) a requirement to designate applicable 
consumer and commercial product categories using Organization 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 finalizing 
corresponding changes to the PMN form fields in CDX for this data 
element. EPA is also finalizing amendments to 40 CFR 721.25 to ensure 
that submitters of SNUNs include in their notice both a description of 
the intended categories of use, as required by 40 CFR 720.45(f)(1), and 
of all known categories of use, to the extent known to or reasonably 
ascertainable by the submitter. 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. In the final rule, this provision appears in a new paragraph 
(e) of 40 CFR 721.25 rather than as an addition to paragraph (c), and 
the text was rephrased slightly for clarification. One commenter 
requested that EPA include a provision at 40 CFR 720.45(f) that would 
require submitters with chemicals having more than 10 intended uses to 
designate codes only for the 10 uses that represent the largest 
proportion of the anticipated production volume of the chemical, a 
suggestion that EPA is finalizing. EPA, however, will still require 
submitters to identify in the free form text field of the PMN form all 
intended or known uses of the chemical substance.
c. Details Concerning Manufacture, Processing, and Use
    The third set of information requirements that EPA is finalizing at 
40 CFR 720.45 is information related to where and how 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 
finalizing are similar for both, different types of activities often 
occur at submitter-controlled sites versus those at sites controlled by 
others (e.g., manufacturing versus processing). 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 and not reasonably ascertainable by the submitters 
when a notice is submitted. As such, some slight differences exist in 
the requirements EPA is finalizing for information related to sites 
controlled by submitters versus sites controlled by others. See Ref. 6 
for more details.
    Both for sites controlled by submitters and for sites controlled by 
others, EPA is adding information requirements for site addresses (see 
Table 3 and Table 5 in Ref. 6). For submitter-controlled sites, EPA is 
also adding requirements for a description of 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 each batch and/or timeframe (see Tables 3, 
4, and 5 in Ref. 6). These 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 information requirements were not specified in the 
regulations, EPA is finalizing them at 40 CFR 720.45(g)(1) and (2) for 
sites controlled by the submitter and 40 CFR

[[Page 102780]]

720.45(h)(1) and (2) for sites not controlled by the submitter.
    EPA is also adding requirements for detailed information about the 
process diagram or description for each site controlled by the 
submitter (see Table 4 in Ref. 6) and for each site not controlled by 
the submitter (see Table 5 in Ref. 6). These data elements were 
previously required but not expressly included in the list of required 
data elements in 40 CFR 720.45. They 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 identification, by number, of any points of release. EPA 
is finalizing requirements for this information 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.
    One commenter noted that an existing data requirement related to 
manufacturing, processing, use, and disposal of chemical substances 
subject to section 5 notification is ambiguous in its scope. 40 CFR 
720.45(d) requires submitters to describe any byproducts resulting from 
the manufacture, processing, use, and disposal of a chemical substance, 
and the commenter requested that EPA clarify whether its definition of 
byproduct includes ``degradation products''. In the Response to 
Comments document (Ref. 2), EPA notes that byproducts are distinct from 
degradants and that information on degradants is required under the 
information requirements outlined in 720.45(j)(2).
d. Worker Exposure
    EPA is also finalizing requirements for details about the possible 
worker exposures at each site controlled by the submitter (see Table 6 
in Ref. 6), and at each site not controlled by the submitter (see Table 
7 in Ref. 6). 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 (consistent with information requirements for sites 
controlled by the submitter). 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 finalizing 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. 
One commenter requested that EPA revise the proposed text at 40 CFR 
720.45(g)(3) and (h)(3) to clarify that the worker exposure information 
required in 40 CFR 720.45(g)(3)(ii)-(viii) and (h)(3)(ii)-(viii) 
pertains to each worker activity occurring during the manufacturing, 
processing, and use of the chemical substance, as identified pursuant 
to 720.45(g)(3)(i) and 720.45(h)(3)(i). EPA has incorporated this 
suggestion in the final rule because it provides additional clarity to 
submitters.
    Several commenters made requests related to worker exposure that, 
if accepted by EPA, would affect the structure of and level of detail 
contained in the PMN form in CDX. For example, one commenter requested 
that EPA allow submitters to assign a ``Letter of Activity'' (a field 
in CDX to link specific worker activities to operations described in 
the corresponding manufacturing diagram) to activities at submitter-
controlled sites; the option to assign a Letter of Activity already 
exists for activities at sites controlled by others. Another commenter 
requested that EPA include in the PMN form dropdown options for 
``Worker Activity'' and ``Worker Category'' for sites controlled by 
others--dropdown options that currently exist for submitter-controlled 
sites in the PMN form. EPA is finalizing all of the aforementioned 
suggestions by making corresponding changes to the CDX interface. EPA, 
however, also received several additional suggestions related to worker 
exposures that EPA is choosing not to adopt. More information on the 
comments received relating to worker exposure and EPA's responses can 
be found in the Response to Comments document (Ref. 2).
    Additionally, EPA is finalizing proposed amendments to 40 CFR 
720.45(g)(3) and (h)(3) to ensure that submitters include worker 
exposure information from exempt manufacture or related use of the 
chemical substance under 40 CFR 720.30 (e.g., manufacture of the 
chemical substance under the byproduct or impurity exemptions) at each 
site where the chemical substance will be manufactured, processed, or 
used, if known or reasonably ascertainable. However, to avoid any 
confusion occasioned by the abbreviated, non-exhaustive list of 
exemption examples that appeared in a parenthetical in the proposed 
regulatory text, the final rule does not include the proposed 
parenthetical and streamlines the text by simply cross-referencing 40 
CFR 720.30.
e. Environmental Releases
    EPA is finalizing information requirements concerning the potential 
environmental releases at each site controlled by the submitter (see 
Table 8 in Ref. 6) and at each site not controlled by the submitter 
(see Table 9 in Ref. 6). EPA is requiring descriptions of the type of 
release (e.g., transport, interim storage, disposal, equipment 
cleaning), as well as the amount of the chemical substance released 
directly to the environment or into a control technology. EPA is 
finalizing an amendment to require a description of the amount of the 
chemical substance released to the environment after use of a control 
technology. EPA is also requiring for equipment cleaning releases a 
description of the frequency of equipment cleaning and what is used to 
clean equipment. EPA is also requiring for transport and storage 
releases a description of how the chemical substance or the product 
containing the chemical substance is transported from the site and 
stored, as well as information about the containers used. For releases 
into air, EPA is requiring Clean Air Act operating permit numbers and a 
description of any Leak Detection and Repair program the site has 
implemented; one commenter requested that EPA amend the language for 
this data element to require a description of the type of control 
technology used to treat stack air releases, which EPA is finalizing. 
For releases into water, EPA is requiring National Pollutant Discharge 
Elimination System (NPDES) permit numbers and information on the 
waterbodies and other destinations into which the release occurs; one 
commenter requested that EPA also require a description of any outfall 
numbers associated with the known points of release associated with the 
NPDES permit number(s), a suggestion that EPA is finalizing. For 
releases into wastewater treatment plants, EPA is requiring information 
on the publicly owned treatment works (POTW) into which the release 
occurs. For the

[[Page 102781]]

requirement concerning information on POTW, one commenter requested 
that EPA amend this data requirement to also specifically request 
information concerning privately owned treatment works to which 
releases might occur, the type of wastewater technology employed at any 
treatment facilities, and the known or estimated treatment efficiency 
at these facilities--all of which are suggestions that EPA is 
finalizing. In addition, for sites controlled by others, these 
requirements also include a description of the media of release 
consistent with the requirement for sites controlled by the submitter.
    Although each of these detailed data elements 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 finalizing 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.
    EPA is finalizing amendments to 40 CFR 720.45(g) and (h) to make 
their formatting and the information required in both consistent. EPA 
recognizes that a submitter may not possess such information about 
sites not controlled by the submitter. As mentioned elsewhere in this 
preamble and in the Response to Comments document (Ref. 2), submitters 
are only required to supply information that is known to or reasonably 
ascertainable by them, as defined at 40 CFR 720.3.
    Additionally, EPA is finalizing amendments to 40 CFR 720.45(g)(4) 
and 720.45(h)(4) to ensure that submitters include environmental 
release information from exempt manufacture or related use of the 
chemical substances under 40 CFR 720.30 (e.g., manufacture of the 
chemical substance under the byproduct or impurity exemptions) at each 
site where the chemical substance will be manufactured, processed, or 
used, if known or reasonably ascertainable. However, to avoid any 
confusion occasioned by the abbreviated, non-exhaustive list of 
exemption examples that appeared in a parenthetical in the proposed 
regulatory text, the final rule does not include the proposed 
parenthetical and streamlines the text by simply cross-referencing 40 
CFR 720.30.
f. Pollution Prevention Information
    Lastly, EPA is adding optional pollution prevention information at 
40 CFR 720.45(k) as proposed. 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.
3. Other Modifications to the PMN Form in CDX
    In addition to the amendments intended 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 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. 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 generally follows the 
scientifically informed approach to make conservative assumptions and 
use appropriate default values when assessing risk, which could result 
in more stringent risk management requirements than might be directed 
if data were provided showing such assumptions or default values were 
not necessary to use. 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). Several commenters expressed concerns about the potential 
burden posed by the inclusion of these check boxes in the CDX workflow, 
concerns with which EPA disagrees. While the inclusion of check boxes 
might require submitters to spend slightly more time preparing the PMN 
form for their section 5 notices, EPA believes that the improved 
quality of submissions resulting from this, and the other changes being 
finalized to the CDX environment, will save submitters, as well as EPA, 
more time, and resources in the long run. This check box approach does 
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 final rule 
describes the potential modifications to each screen of the PMN form 
(Ref. 7).
    Some commenters made requests related to the CDX enhancements 
outlined in the proposed rule that EPA is addressing in this final 
rule. First, two commenters requested that EPA include in the 
enhancements to the CDX interface an option for submitters to, if data 
are not provided for a particular data element, explain why this 
information is not known or reasonably ascertainable, a suggestion that 
EPA will incorporate. Another commenter requested that EPA allow 
submitters to access a ``beta version'' of the enhanced CDX environment 
before rolling out the changes to the broader CDX environment. EPA will 
make efforts to do so and plans to share more information with 
stakeholders via outreach once this final rule is published. The CDX 
enhancements described in this rulemaking will not be finalized upon 
publication or effective date of the final rule. The enhancements will 
take time to develop, and EPA will make the updated CDX interface 
reflecting these changes publicly available as soon as resources allow. 
However, submitters are currently able to include all information for 
the newly specified data elements described in this preamble and the 
amended regulatory text as generic attachments in the current CDX 
workflow. EPA will share additional guidance and conduct outreach with 
stakeholders prior to the rollout of the changes to CDX and will work 
to extend flexibility to submitters in the event that issues arise 
related to discrepancies between the regulations and the PMN form 
before the CDX enhancements can be implemented.

C. Amendments Related To Pre-Screen, Incomplete Submissions, Correcting 
Errors, and New Information

    EPA is finalizing 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 finalizing amendments to align the process for correcting errors 
in

[[Page 102782]]

the notice with the existing process for incomplete submissions. EPA is 
further clarifying that an initial notice submission may later be 
deemed incomplete 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 promulgating amendments that 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 e-mail.
1. Pre-Screening Procedures
    EPA is finalizing amendments to 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 of the proposed rule preamble. EPA is also finalizing 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. Additionally, based on public comments, EPA is 
amending 40 CFR 723.50(e)(3) to add a description of current pre-screen 
procedures and update/clarify the process for completing an incomplete 
LVE or LoREX notice, which will better align with similar changes made 
to 40 CFR 720.65 and with existing electronic submission requirements.
    One comment on the proposal asserted that EPA should include in 
section 5 prescreen a review of all CBI claims for consistency with 
sections 14(b) and (c) of TSCA and treat any submission that includes a 
CBI claim that appears to be inconsistent with the requirements of 
these sections as ``erroneous or incomplete.'' EPA disagrees with these 
comments as assuring that every CBI claim is consistent with section 
14(b) and (c) of TSCA would require a substantive review of each claim, 
which is well beyond the CBI review requirements described in TSCA 
section 14(g). For a more detailed response regarding CBI review during 
pre-screen, please see the Response to Comments document (Ref. 2).
2. Correcting Errors in Notices
    As proposed, EPA is finalizing amendments at 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 will align the process for correcting errors with the 
current process in 40 CFR 720.65 for correcting an incomplete notice.
3. Notice Amendments Indicating Original Notice was Incomplete
    EPA is finalizing amendments at 40 CFR 720.65(c)(2) and to 40 CFR 
720.65(c)(5)(iii) (moved to 720.65(d)(5)(iii)), to clearly communicate 
and clarify that EPA may deem an original notice incomplete, and 
restart the review period at Day 1, 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. Additionally, EPA is 
updating the reference to 40 CFR 720.80(b)(2) at 40 CFR 720.65(c)(vii) 
to instead point to 40 CFR 703.5(c) because the 2023 CBI rule (88 FR 
37155, June 7, 2023) moved the language that was previously at 
720.80(b)(2) to a new section at 40 CFR 703.5.
    As stated in the proposal for this rule (88 FR 34100, May 26, 
2023), EPA is changing the longstanding practice of accepting 
amendments that contain required 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. 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 (e.g., when an amendment is 
submitted that makes a notice complete) is appropriate in order for EPA 
to efficiently meet current statutory requirements. Several comments on 
the proposed rule objected to these amendments, stating that submitters 
often are prompted to generate new or additional information during the 
review period to rebut unforeseen or conservative assumptions made by 
EPA. To address this comment and assist with efficient review, EPA is 
also amending the notice information requirements at 40 CFR 720.45 to 
specify the level of detail needed to perform refined risk assessments, 
as well as building that additional detail into the CDX user interface, 
which is detailed in Unit III.B of both the proposed rule (88 FR 34100, 
May 26, 2023) and this final rule. By specifying more detailed 
information requirements in 40 CFR 720.45 and data fields in the CDX 
user interface, EPA should receive more complete submissions upfront 
and help to minimize the need for EPA to use default values and 
conservative assumptions in its risk assessment due to a lack of 
available data. The Agency, however, reiterates that the submitter is 
required to provide all required information that is known or 
reasonably ascertainable at the time of the initial submission and not 
in reaction to risk assessment findings. Submitters must provide all 
information required by 40 CFR 720.45 and 720.50 upfront to satisfy the 
requirement of submitting a complete notice.
    In response to the proposal, EPA received a comment asking that the 
Agency provide submitters with an opportunity to explain why 
information submitted as part of an amendment should not result in 
restarting the applicable review period. Under the amendment to 40 CFR 
720.65(c)(2) being finalized in this action, the submitter of 
additional or revised information during the review period must 
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. Amendments to a notice that will not be 
considered as amendments indicating 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, will 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), as 
amended in this final rule, which updates and moves these provisions to 
40 CFR 720.65(d)(4) and (5).
    As explained in the proposed rule, a notice submitted under TSCA 
section 5(a)(1) is statutorily required to include the information 
described in TSCA section 5(d)(1) insofar as it is known to the 
submitter or reasonably ascertainable. In response to various 
procedural amendments proposed in

[[Page 102783]]

this rulemaking, EPA received comments asking the Agency to further 
define ``known to or reasonably ascertainable by'' beyond the current 
definition at 40 CFR 720.3. While EPA understands and recognizes the 
desire to have a more explicitly defined list of criteria or more 
detailed definition of ``known to or reasonably ascertainable by,'' EPA 
believes that it is not possible to define ``known to or reasonably 
ascertainable by'' more explicitly--as was stated in the 1983 final 
rule entitled ``Premanufacture Notification; Premanufacture Notice 
Requirements and Review Procedures'' (Ref. 8) and restated in the May 
2023 proposed rule (88 FR 34100). EPA has not, in this rulemaking, 
proposed or finalized any amendment to or undertaken any substantive 
reconsideration, reexamination, or reinterpretation of the existing 
definition at 40 CFR 720.3. That said, to assist submitters, EPA has 
provided additional discussion and examples as to what is meant by 
``known to or reasonably ascertainable by'' in the Response to Comments 
document (Ref. 2).
4. Notifying EPA of the Receipt of New Information on a Chemical 
Substance Under Review
    EPA is finalizing amendments to 40 CFR 720.40(f), 40 CFR 
720.50(a)(4)(ii), and 40 CFR 723.50(i) 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 amending the regulations to allow submitters to 
notify EPA by e-mail of the receipt of new information. Although the 
regulatory text in 40 CFR 720.40(f) and 40 CFR 723.50(i) are similar, 
the regulatory text provided along with the proposed rule erroneously 
showed only the proposed changes to 40 CFR 720.40(f) and did not show 
proposed changes to 40 CFR 723.50(i). This was an oversight and the 
regulatory text accompanying this final rule consistently amends both 
40 CFR 720.40(f) and 40 CFR 723.50(i).

D. Amendments to Low Volume Exemptions and Low Release and Exposure 
Exemptions

    EPA is promulgating several amendments to the current LVE and LoREX 
regulations. Specifically, EPA is finalizing amendments so 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, or if it is 
listed on the confidential portion of the TSCA Inventory; (3) PFAS are 
categorically ineligible for these exemptions; and (4) certain PBT 
chemical substances are ineligible for these exemptions.
    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.''
1. Amendments to Expiration of LVE and LoREX Review Period
    EPA is finalizing, as proposed, amendments to 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. Prior to the promulgation of 
this amendment, 40 CFR 723.50(g)(2) provided 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 had taken no action. As 
described in Unit III.A., EPA is also amending 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 
changes to 40 CFR 720.75, 721.25(d), and 725.170 are being made to 
conform those regulations to the 2016 Lautenberg Amendments. EPA is 
finalizing similar amendments to the LVE and LoREX regulations at 40 
CFR 723.50 to align with the 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.
2. Notification of LVE and LoREX Holders if the Chemical Substance is 
Subject to a SNUR or Listed on the Confidential Portion of the TSCA 
Inventory
    EPA is finalizing amendments 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 
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 notice) pursuant to 40 CFR 721.11. In the proposed rule 
(88 FR 34100, May 26, 2023), EPA stated that the Agency did not intend 
to proactively inform current LVE and LoREX holders about SNURs that 
predate this rule and that EPA would only start the practice of 
notifying LVE and LoREX holders subject to this amendment after the 
date of the final rule. However, upon consideration of public comments 
in support of notifying current exemption holders of preexisting SNURs, 
EPA intends, subject to availability of resources, to notify current 
LVE and LoREX holders about preexisting SNURs that describe the 
chemical substance by a generic chemical name. Given current resource 
constraints, however, EPA is unable to provide a timeline for when it 
will begin and complete this notification effort. A lack of receipt of 
this courtesy notice that a chemical substance is subject to a SNUR 
does not excuse chemical manufactures and processors from complying 
with any existing regulations. LVE and LoREX holders who wish to 
determine whether their chemical substance is subject to a SNUR may 
always submit an inquiry to EPA (also known as a bona fide notice) 
pursuant to 40 CFR 721.11.
    In response to public comments, in addition to notifying LVE and 
LoREX holders when they are subject to a SNUR, EPA also intends, 
subject to availability of resources, to begin notifying LVE or LoREX 
submitters if a substance is added to the confidential portion of the 
TSCA Inventory as a result of filings by a different submitter that 
claimed the specific chemical identity of the substance as 
confidential. As of February 7, 2024, more than 460 LVEs and LoREXs 
that were granted by EPA pertain to chemical substances that are now 
listed on the TSCA Inventory.

[[Page 102784]]

Once on the Inventory, a chemical substance may be subject to 
additional requirements under TSCA. Of the more than 390 chemical 
substances covered by these LVE and LoREX, approximately 125 are on the 
confidential portion of the TSCA Inventory. Without notice by EPA or by 
submitting a bona fide notice, a submitter is unlikely to know their 
substance is listed on the confidential portion of the Inventory, 
unless they also submitted the PMN and subsequent Notice of 
Commencement that led to the Inventory listing of the substance. While 
EPA intends to begin providing notice to exemption holders whose 
chemical substance now appears on the confidential portion of the TSCA 
Inventory, EPA does not intend to provide notice to those who hold 
granted LVEs or LoREXs pertaining to chemical substances whose specific 
chemical identities are added to the public portion of the TSCA 
Inventory due to the additional resources this would require and to the 
fact this information is publicly available.
    In response to public comment, EPA affirms that once a chemical 
substance is added to the Inventory, an LVE or LoREX (or any other 
exemption from PMN requirements) is no longer necessary to manufacture 
the chemical substance and thus any approved LVE or LoREX is no longer 
binding on the manufacturer. The premanufacture notice requirements of 
TSCA section 5(a)(1), the relevant statutory exemption authority at 
TSCA section 5(h)(4), and the LVE/LoREX regulations at 40 CFR 723.50 
all apply to manufacturers of new chemical substances, yet a chemical 
substance is no longer a ``new chemical substance'' as defined in TSCA 
section 3(11) once it is added to the Inventory. While EPA intends to 
begin providing notice to LVE and LoREX submitters once their substance 
is listed on the confidential portion of the Inventory, EPA does not 
intend to formally revoke these exemptions under the process described 
in 40 CFR 723.50(h)(2), as that process pertains to new chemical 
substances for which manufacture is not otherwise permitted in the 
absence of a PMN or applicable exemption.
    The amendments to the regulations at 40 CFR 723.50 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 or similarly that the substance is on the confidential 
portion of the TSCA Inventory will not be considered public disclosure 
of confidential business information under section 14 of the Act. EPA 
is not amending the procedures in 40 CFR 723.50(l) for asserting and 
protecting confidential business information.
3. Making PFAS Categorically Ineligible for LVEs and LoREXs
    EPA is finalizing amendments to limit the scope of the LVE and 
LoREX exemptions that were first promulgated in accordance with TSCA 
5(h)(4) in 1985 and 1995 respectively (50 FR 16477 (April 26, 1985) and 
60 FR 16346 (March 29, 1995)). TSCA 5(h)(4) allows, but does not 
require, the Administrator to exempt the manufacturer of any new 
chemical substance from all or part of the requirements of TSCA section 
5 in certain circumstances. The statute does not specify any 
circumstances under which the Administrator would be required to 
provide an exemption and EPA's action here is consistent with its 
authority under 5(h)(4) to create and/or define the scope of 
exemptions. These amendments make PFAS categorically ineligible for 
LVEs and LoREXs going forward, using a structural definition of PFAS 
for purposes of the LVE and LoREX regulations. Upon the effective date 
of this rule, any LVE or LoREX notice for a PFAS that is submitted to 
the Agency will 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 will be required to submit 
a PMN at least 90 days prior to commencing manufacture for a non-exempt 
commercial purpose. The definition for PFAS that EPA is finalizing is 
aligned with the recently finalized TSCA section 8(a)(7) rule (88 FR 
70516, October 11, 2023) and the Inactive PFAS SNUR (89 FR 1822, 
January 11, 2024). Although PFAS would no longer be eligible for LVE or 
LoREX, there may be case-specific circumstances where a use of a new 
PFAS or a new use of an existing PFAS may be needed by a federal agency 
to meet its mission or is required in order to meet another critical 
need. EPA will work with other federal agencies to expedite review of 
such cases. Furthermore, EPA recognizes the critical role that many new 
chemicals play, including some PFAS, in the manufacture of 
semiconductors. The new chemicals program now prioritizes notices for 
chemicals used in sectors supported by the Creating Helpful Incentives 
to Produce Semiconductors (CHIPS) and Science Act and the Inflation 
Reduction Act's (IRA) climate goals. Since beginning the process of 
prioritizing CHIPS and Science Act and IRA related chemicals, EPA now 
reviews these new chemicals in a third of the time compared to other 
sectors. The Agency believes these key sectors are important to growing 
new jobs as part of the Biden-Harris Administration's domestic 
manufacturing initiatives. For some new chemicals needed by the 
semiconductor sector, such as photo-acid generators, EPA's multi-year 
collaborative effort with the sector has resulted in a regulatory 
pathway for dozens of these chemicals, and recent submittals have had 
review timeframes of under 90 days.
    As noted in the proposed rule, EPA's New Chemicals Program began 
implementing a new policy for reviewing and managing LVE notices for 
PFAS in April 2021. In an 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.'' Since 2021, EPA has reviewed 8 LVE notices for PFAS, 
which were each reviewed on a case-by-case basis. Each of the 8 PFAS 
were determined to be ineligible for an LVE due to the risks identified 
and/or an inability to complete the review in 30 days as a result of 
the complexities of the review or uncertainties in the assessment. EPA 
has never received or approved any PFAS LoREX notices.
    Each of the 8 PFAS that were the subject of LVE notices reviewed 
since 2021, or the reasonably anticipated metabolites and environmental 
transformation products of those PFAS, was determined to be a PBT 
chemical substance. In 5 of the 8 cases, however, the PBT designation 
included noted uncertainties for each of the substances reviewed. If 
EPA is unable to score a characteristic (e.g., B ``unknown'' for 
bioaccumulation), the characteristic is still considered to be 
potentially a 2 or higher for the purposes of identifying potential 
PBTs (Ref. 10). In many cases, additional uncertainties were identified 
for the potential routes of exposure, which included exposures to 
workers, the general population, a potentially exposed or susceptible 
subpopulation (e.g., consumers, infants), or the environment. PFAS 
present a challenge for EPA to evaluate because there is often 
insufficient information to quantify the risk they may pose and 
consequently make effective decisions

[[Page 102785]]

about how to regulate them (Ref. 11). As currently described in the 
regulations, EPA may determine that a new chemical substance is 
ineligible for an LVE or LoREX if there are issues concerning toxicity 
or exposure that require further review which cannot be accomplished 
within the 30-day review period. EPA notes that the shortened 30-day 
review period for LVEs and LoREX is one of the major benefits of these 
exemptions as it allows companies to introduce new chemical substances 
more quickly into commerce. The 30-day review period provides a screen 
for EPA to identify any new chemical substances with issues that 
require more detailed and comprehensive review and analysis, such as 
that available in a full PMN review. See 60 FR 16336. Given the 
shortened 30-day review of an LVE along with the inability to require 
testing or impose additional restrictions under a section 5(e) or 5(f) 
order, EPA was unable to address those uncertainties which would be 
necessary to conclude that the substance would not present an 
unreasonable risk. Since all of the 8 PFAS that were the subject of LVE 
notices were deemed ineligible for the exemption, the submitters were 
required to submit a PMN if they wanted to move forward with the 
manufacture of the new chemical substances.
    For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA 
is defining ``PFAS'' using a structural definition. In this rule, EPA 
defines PFAS to mean 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; or
    (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 and of substances where any of the reasonably anticipated 
metabolites, environmental transformation products, byproducts, or 
reasonably anticipated impurities do not meet this structural 
definition remain eligible to submit an LVE or LoREX notice.
    In opposition to these amendments, EPA received comments asserting 
that because PFAS are a broad category of chemicals, any proposed 
regulatory action on PFAS should not group PFAS into a single category. 
Comments also asserted that there was no scientific basis or risk-based 
evidence for making PFAS ineligible for LVEs and LoREXs. EPA agrees 
with the comments that PFAS are a broad category of chemical substances 
with common toxicological properties, exposures, or uses, and notes 
that the assessment and management of these substances for regulatory 
purposes should generally be done on a case-by-case basis or as groups 
of substances with common toxicological properties, exposures, or uses. 
Furthermore, EPA believes that any assessment of PFAS should be done in 
line with the scientific standards, weight of scientific evidence, and 
consideration of any reasonably available information as outlined in 
section 26 of TSCA. The amendment to make PFAS ineligible for LVEs and 
LoREXs, however, is not based on an assessment of all PFAS or any PFAS 
and does not impose risk management restrictions on any PFAS substance. 
The decision to make PFAS ineligible for LVEs and LoREXs is not a 
determination of risk for all or any PFAS. While the current state of 
science and EPA's understanding of PFAS has motivated the decision to 
make all PFAS ineligible for LVEs and LoREXs, these amendments are not 
based on EPA findings that particular PFAS chemicals, or all chemicals 
qualifying as PFAS under this rule, may present unreasonable risks of 
injury to human health or the environment under the conditions of use 
due to levels of hazards and exposures identified and evaluated by EPA. 
Rather, due to the scientific complexities or uncertainties 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. This action is a procedural action based on EPA's 
experience administering TSCA and reviewing LVEs for PFAS.
    Additionally, making PFAS ineligible for the LVE and LoREX 
exemptions may in fact reduce burden in many instances by avoiding the 
submission and review of LVEs that are ultimately denied and required 
to be resubmitted and reviewed anew through the PMN review process. 
Furthermore, the New Chemicals Program developed the PFAS Framework to 
help ensure that the Program effectively and efficiently reviews and 
makes appropriate decisions on new PFAS or significant new uses of 
existing PFAS reviewed through PMNs and SNUNs. The PFAS Framework will 
guide EPA's review of PFAS under TSCA section 5, ensuring consistency 
and efficiency in its review of incoming submissions while advancing 
the Agency's goals to ensure protection of public health and the 
environment. Please see the Response to Comments document that 
accompanies this rule for a more detailed discussion of and response to 
the comments received on the amendments to make PFAS categorically 
ineligible for LVEs and LoREXs (Ref. 2).
    The definition for PFAS promulgated at 40 CFR 723.50 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 three-part structural definition for PFAS includes 
fluoropolymers. Fluoropolymers are made using fluorinated monomers, and 
often fluorinated processing aides, which contributes to the release of 
PFAS. In addition, the disposal of fluoropolymers may also result in 
PFAS releases. EPA has been concerned about potential risks of 
fluoropolymers for more than a decade. On January 27, 2010 (75 FR 4295, 
1/27/2010), EPA amended the `polymer exemption rule,' to exclude from 
eligibility polymers containing as an integral part of their 
composition, except as impurities, certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length. EPA issued this amendment 
because, based on information at the time, EPA could no longer conclude 
that these polymers will not present an unreasonable risk to human 
health or the environment under the terms of the polymer exemption 
rule, which is the determination necessary to support an exemption 
under section 5(h)(4) of TSCA. While some comments stated that 
fluoropolymers are safe, there remains debate on the toxicity of 
fluoropolymers especially when considering their entire life cycle 
(Ref. 12). EPA's decision to include fluoropolymers as part of the 
amendment to make PFAS ineligible for LVEs and LoREXs, however, was not 
based on hazard, exposure, or risk. Fluoropolymers are no less 
complicated to review than nonpolymeric PFAS, and the Agency expects it 
would need the longer 90-day review for a PMN.
    At the time of finalizing this rulemaking, EPA is not revoking 
previously granted LVEs for PFAS. EPA, however, may take future action 
on a case-by-case basis to revoke previously

[[Page 102786]]

granted LVEs for PFAS, which would be done in accordance with the 
existing regulations at 40 CFR 723.50(h)(2). EPA believes that the 
revocation of any existing LVE should be done on a case-by-case basis. 
While there are well identified hazards for many PFAS and PFAS studies 
have repeatedly found harm to human health, EPA has not determined that 
PFAS as an entire category of chemical substances do not meet the 
``will not present unreasonable risk of injury to health or the 
environment'' standard of TSCA section 5(h)(4). As noted previously, 
EPA's decision to make future PFAS ineligible for LVEs is not based on 
hazard or risk but is instead based on EPA's experience administering 
TSCA and reviewing LVEs for PFAS (please see the Response to Comments 
document for a more detailed discussion (Ref. 2)).
    As EPA continues to consider previously granted PFAS LVEs, EPA will 
take into consideration the concerns raised about the potential impacts 
to domestic semiconductor and electric vehicle industry, national 
defense, or other critical applications. The Biden-Harris 
Administration is committed to restoring U.S. leadership in 
semiconductor and electric vehicle manufacturing, supporting good-
paying jobs across those supply chains, and advancing U.S. economic and 
national security. EPA's Framework for Addressing New PFAS and New Uses 
of PFAS (PFAS Framework) (Ref. 10) outlines EPA's planned approach when 
reviewing new PFAS and new uses of existing PFAS. The application of 
the PFAS Framework will help ensure that new PFAS won't harm human 
health and the environment and allows that certain PFAS be used when 
exposures and releases can be mitigated, which is critical for 
important sectors like semiconductors. Under the framework, EPA expects 
that some PBT PFAS will not result in worker, general population or 
consumer exposure and are not expected to result in releases to the 
environment, such as when PFAS are used in a closed system with 
occupational protections as is generally the practice in the 
manufacture of some semiconductors and other electronic components. 
Additionally, EPA continues to work cooperatively with companies who 
wish to voluntarily withdraw previously granted LVEs for PFAS. As of 
April 1, 2024, 56 LVEs have been withdrawn through EPA's PFAS Low 
Volume Exemption Stewardship Program.
4. Codifying EPA's Policy Concerning PBT Chemicals and LVEs and LoREXs
    EPA is finalizing 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. As 
noted in Unit III.D.3., the LVE and LoREX exemptions were first 
promulgated in accordance with TSCA section 5(h)(4) in 1985 and 1995 
respectively (50 FR 16477, April 26, 1985 (FRL-2742-1) and 60 FR 16346, 
March 29, 1995 (FRL-4923-1)). TSCA section 5(h)(4) allows, but does not 
require, the Administrator to exempt the manufacturer of any new 
chemical substance from all or part of the requirements of TSCA section 
5 in certain circumstances. The statute does not specify any 
circumstances under which the Administrator would be required to 
provide an exemption and EPA's action here is consistent with both its 
long-standing practice and with its authority under TSCA section 
5(h)(4) to create and/or define the scope of exemptions.
    On November 4, 1999, EPA issued its policy statement identifying a 
category for PBT new chemical substances (Ref. 13). The 1999 policy 
statement formally acknowledged PBT chemical substances as a category 
based on shared characteristics to facilitate premanufacture assessment 
and regulation. In response to the proposed amendment to the LVE and 
LoREX regulations, EPA received comment asserting that the Agency 
cannot categorically make all PBT chemicals ineligible for LVEs and 
LoREXs. EPA did not propose to categorically make all PBT chemicals 
ineligible for LVEs and LoREXs and is not doing so in this final rule. 
Rather, EPA proposed and is finalizing amendments to 40 CFR 723.50(d) 
to codify 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. In order to effectuate these 
amendments for individual exemption notices, EPA would first need to 
review the exemption notice to determine if the substance is a PBT and 
then review the environmental releases and exposures to humans or 
environmental organisms to determine if releases and exposures are 
expected. Only after EPA has reviewed the hazards and exposures, will 
EPA make a decision to either grant or deny an LVE or LoREX for a PBT 
chemical substance.
    Based on EPA's experience administering LVEs and LoREXs, EPA 
expects that most exemptions for PBT chemical substances will not be 
granted. However, EPA agrees that there are instances where PBT 
chemical substances can be managed under an exemption. EPA may receive 
an exemption notice for a PBT chemical substance that will not result 
in worker, general population, or consumer exposure and that is not 
expected to result in releases to the environment, such as chemical 
substances used in a closed system to make semiconductors or other 
electronic components. In such a negligible exposure and environmental 
release scenario where worker exposure is fully mitigated and general 
population exposures are not expected, if EPA has sufficient 
information on the substance and the conditions of use to ensure that 
such PBT chemical substances can be disposed of properly and no 
consumer exposure is expected, EPA generally expects to grant the 
exemption.
    EPA is defining ``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

    As proposed, EPA is finalizing amendments to 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 e-mail, without the need for a formal, written request 
submitted to EPA via CDX using e-PMN software. EPA is similarly 
finalizing amendments to 40 CFR 725.54(c) to permit MCAN submitters to 
request suspensions for up

[[Page 102787]]

to 30 days orally or in writing, including by e-mail, without the need 
for a formal, written request submitted to EPA via CDX using e-PMN 
software. Some comments to the proposal took issue with increasing the 
number of suspension days made through oral or e-mail communication 
from 15 to 30 days. These comments suggested such an amendment would 
result in less frequent communication from EPA regarding the status of 
a new chemical review. EPA disagrees with these comments, as the 
amendments would allow the submitter to request up to a 30-day 
suspension through oral or e-mail communication; however, submitters 
will still be allowed to suspend the review period for a shorter amount 
of time if preferred. For a more detailed response to the comments 
regarding the amendments relating to suspensions of the review period, 
please see the Response to Comments document (Ref. 2).

F. Severability

    As explained in this preamble, EPA is finalizing several different 
types of amendments in this rule, including amendments related to: 
commencement of manufacture or processing; required determinations and 
associated actions; terminology and definitions; notice information 
requirements; pre-screening procedures; correcting errors in notices; 
incomplete notices; notification of the receipt of new information; 
expiration of the LVE and LoREX review period; notification of LVE and 
LoREX holders regarding certain other actions involving their chemical 
substance; PFAS ineligibility for LVE and LoREX exemptions; certain PBT 
ineligibility for LVE and LoREX exemptions; and suspensions of the 
review period. Each type of amendment functions independently, serves a 
discrete purpose, and is intended to be severable from the other 
amendments. In the event of litigation staying, remanding, or 
invalidating a portion of EPA's amendments in this rule, EPA intends to 
preserve all other amendments in this rule to the fullest extent 
possible. For example, the amendment to the LVE and LoREX regulations 
making PFAS ineligible for such exemptions functions independently from 
the amendment to those regulations making certain PBTs ineligible for 
the exemptions, such that if either ineligibility provision were stayed 
or invalidated, it would have no effect on the other, and EPA intends 
that the other would remain effective. Similarly, any stay or 
invalidation of the amendment making PFAS ineligible for the LVE and 
LoREX exemptions would have no effect on amendments related to 
incomplete notices, and vice versa. These specific examples are not 
intended to be exhaustive, but rather illustrative of scenarios that 
reflect EPA's overarching intent that each type of amendment be 
severable.
    Furthermore, within the broader category of amendments to notice 
information requirements, the rule includes a number of discrete 
amendments pertaining to different types of information. Each of these 
specific amendments to notice information requirements functions 
independently and is intended to be severable from the others. As an 
example, if amended information requirements regarding the categories 
of use of the chemical substance were to be stayed or invalidated, it 
would have no effect on amended information requirements regarding 
worker exposure, and vice versa.
    The limited circumstance in which severability is not intended is 
where a single type of amendment involved changes to multiple 
paragraphs or sections of the regulations. For example, in cases where 
EPA is finalizing the same or similar amendment in multiple parts of 
the CFR for conformity (e.g., where an amendment to part 721, 723, or 
725 is intended merely to conform to the same or similar amendment in 
part 720), severability is not intended between those provisions. In 
addition, were the amendment making PFAS ineligible for LVE and LoREX 
exemptions to be invalidated, the related amendment defining PFAS for 
purposes of that ineligibility provision would no longer be necessary 
or helpful. However, EPA does intend severability in the inverse 
scenario: if the definition of PFAS were stayed or invalidated, EPA 
intends severability of all other amendments, including the amendment 
making PFAS ineligible for LVEs and LoREX.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this Federal Register notice. 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 the Final Rule: Updates to New 
Chemicals Regulations under the Toxic Substances Control Act. 
December 2024.
2. EPA. Response to Comments on the Proposed Rule Updates to New 
Chemicals Regulations Under the Toxic Substances Control Act (TSCA). 
December 2024.
3. EPA. Central Data Exchange Online User Guide. Accessible at: 
https://cdx.epa.gov/About/UserGuide.
4. EPA. Points to Consider When Preparing TSCA New Chemical 
Notification. OMB Control No.: 2070-0012. June 2018. Accessible at: 
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca.
5. EPA. TSCA New Chemical Engineering Initiative to Increase 
Transparency and Reduce Rework. Accessible at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering.
6. EPA. Tables Detailing the Final Amendments to Add Details to 40 
CFR 720.45 Reporting Requirements and Enhancements to the CDX 
Reporting Form. December 2024.
7. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA); TSCA Section 5 
Premanufacture Review of New Chemical Substances and Significant New 
Use Rules for New and Existing Chemical Substances (Revision); EPA 
ICR No. 1188.15; OMB Control No. 2070-0038]. December 2024.
8. EPA. Premanufacture Notification; Premanufacture Notice 
Requirements and Review Procedures; Final Rule. Federal Register. 48 
FR 21722; May 13, 1983 (TSH-FRL 2998-5).
9. EPA. Press Release: EPA Announces Changes to Prevent Unsafe New 
PFAS from Entering the Market. April 27, 2021.
10. EPA. Framework for TSCA New Chemicals Review of PFAS 
Premanufacture Notices (PMNs) and Significant New Use Notices 
(SNUNs). June 2023.
11. Executive Office of the President of the United States. Per- and 
Polyfluoroalkyl Substances Report. March 2023.
12. Lohmann, Rainer, et al. Are fluoropolymers really of low concern 
for human and environmental health and separate from other PFAS? 
Environmental science & technology 54.20 (2020): 12820-12828.
13. EPA. Policy Statement on Category for Persistent, 
Bioaccumulative, and Toxic New Chemical Substances. Federal 
Register. (64 FR 60194, November 4, 1999) (FRL-6097-7).

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 14094: 
Modernizing Regulatory Review

    This action is a ``significant regulatory action'' as defined in 
Executive Order

[[Page 102788]]

12866, as amended by Executive Order 14094 (88 FR 21879, April 11, 
2023). Accordingly, EPA submitted this action to the Office of 
Management and Budget (OMB) for Executive Order 12866 review. 
Documentation of any changes made in response to the Executive Order 
12866 review is available in the docket. The EPA prepared an economic 
analysis of the potential impacts associated with this action. This 
analysis, ``Economic Analysis for the Final Rule: Updates to New 
Chemicals Regulations under the Toxic Substances Control Act'' (Ref. 
1), is also available in the docket.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this 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. 1188.15 (Ref. 7). This ICR 
represents a revision to the currently approved ICR that covers the 
information collection activities contained in the existing 
regulations. The Economic Analysis covers the incremental changes from 
this action. You can find copies of the Economic Analysis and ICR in 
the docket, and the ICR is briefly summarized here.
    Respondents/affected entities: Certain chemical 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.
    Total estimated incremental burden: Estimates show that this rule 
will decrease existing approved ICR burden by 4,528 hours per year. 
Burden is defined at 5 CFR 1320.3(b).
    Total estimated incremental cost: Estimates show that this rule 
will increase existing approved ICR costs by $203,150 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 title 40 of the CFR are listed in 40 CFR part 9. When 
OMB approves this ICR, the Agency will announce that approval in the 
Federal Register and publish a technical amendment to 40 CFR part 9 to 
display the OMB control number for the approved information collection 
activities contained in this final rule.
    EPA did not receive any comments on the ICR revision that was 
posted with the proposed rule. EPA prepared a Response to Comments 
document (Ref. 2) that summarizes all the comments relevant to the 
proposal, including comments affecting the Agency's burden estimates 
related to the rule.

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 $61,049 per notice 
due to the greater burden and non-labor costs associated with 
submitting a PMN form. EPA estimates that 98 percent of small firms 
(184 firms) will have cost impacts of less than 1 percent of revenues, 
less than 1 percent (1 firm) 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 
(adjusted annually for inflation) or more as described in UMRA, 2 
U.S.C. 1531-1538, and does not significantly or uniquely affect small 
governments. EPA has concluded that this action imposes no enforceable 
duty on any state, local or Tribal governments because, based on EPA's 
experience with reviewing TSCA section 5 actions, state, local and 
Tribal governments have not been impacted 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, given that the estimated incremental cost on the 
private sector is expected to be less than $50,000 (Ref. 1), EPA has 
concluded that this rulemaking is not expected to result in 
expenditures by the private sector of $183 million or more in any one 
year ($100 million in 1995$ adjusted for inflation using the CDP 
implicit price deflator).

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 implementing 
regulations codified at 40 CFR parts 720, 721, 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 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

[[Page 102789]]

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.

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 and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    EPA believes that this type of action does not concern human health 
or environmental conditions and therefore cannot be evaluated with 
respect to potentially disproportionate and adverse effects on 
communities with environmental justice concerns in accordance with 
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 
25251, April 26, 2023). 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 communities with 
environmental justice concerns. Although this action does not concern 
human health or environmental conditions, EPA identifies and addresses 
environmental justice concerns by finalizing, among other things, the 
regulatory definition of PESS to include overburdened communities, 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.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and the 
EPA will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 68

    Administrative practice and procedure, Air pollution control, 
Chemicals, Environmental protection, Hazardous substances.

40 CFR Part 372

    Environmental protection, Reporting and recordkeeping requirements, 
Toxic substances.

40 CFR Part 703

    Chemicals, Confidential business information, Environmental 
protection, Exports, Hazardous substances, Imports, Reporting and 
recordkeeping requirements.

40 CFR Parts 720, 721, 723, and 725

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

    Dated: December 3, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons set forth in the preamble, 40 CFR 
chapter I is amended as follows:

PART 68--CHEMICAL ACCIDENT PREVENTION PROVISIONS

0
1. The authority citation for part 68 continues to read as follows:

    Authority:  42 U.S.C. 7412(r), 7601(a)(1), 7661-7661f.


Sec.  68.115  Threshold determination.

0
2. Amend Sec.  68.115(b)(5) by revising the citation ``Sec.  
720.3(ee)'' to read ``Sec.  720.3.''

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW

0
3. The authority citation for part 372 continues to read as follows:

    Authority:  42 U.S.C. 11023 and 11048.


Sec.  372.38  Exemptions.

0
4. Amend Sec.  372.38(d) by revising the citation ``Sec.  720.3(ee)'' 
to read ``Sec.  720.3.''

PART 703--CONFIDENTIALITY CLAIMS

0
5. The authority citation for part 703 continues to read as follows:

    Authority:  15 U.S.C. 2613.


Sec.  703.3  Definitions.

0
6. Amend Sec.  703.3 by:
0
a. Revising in the introductory text the citation ``Sec.  720.3(ff)'' 
to read ``Sec.  720.3;''
0
b. Revising in the definition for ``Health and safety study'' the 
citation ``Sec.  720.3(k)'' to read ``Sec.  720.3.''

PART 720--PREMANUFACTURE NOTIFICATION

0
7. The authority citation for part 720 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2613.


Sec.  720.1  Scope.

0
8. Amend Sec.  720.1 by removing the phrase ``The rule'' and adding in 
its place the phrase ``This part'' wherever it appears.

0
9. Revise and republish Sec.  720.3 to read as follows:


Sec.  720.3  Definitions.

    In addition to the definitions under section 3 of the Act, 15 
U.S.C. 2602, the following definitions apply to this part.
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    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.
    Article means a manufactured item:
    (1) Which is formed to a specific shape or design during 
manufacture;
    (2) Which has end use function(s) dependent in whole or in part 
upon its shape or design during end use; and
    (3) Which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article and that may occur as 
described in Sec.  720.30(h)(5), except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance or mixture.
    Byproduct material, source material, and special nuclear material 
have the

[[Page 102790]]

meanings contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014 et 
seq. and the regulations issued under it.
    Central Data Exchange or CDX means EPA's centralized electronic 
document receiving system, or its successors.
    Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical, except that ``chemical substance'' does not include:
    (1) Any mixture;
    (2) Any pesticide when manufactured, processed, or distributed in 
commerce for use as a pesticide;
    (3) Tobacco or any tobacco product;
    (4) Any source material, special nuclear material, or byproduct 
material;
    (5) Any pistol, firearm, revolver, shells, or cartridges; or
    (6) Any food, food additive, drug, cosmetic, or device, when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    Commerce means trade, traffic, transportation, or other commerce:
    (1) Between a place in a State and any place outside of such State; 
or
    (2) Which affects trade, traffic, transportation, or commerce 
between a place in a State and any place outside of such State.
    Cosmetic, device, drug, food, and food additive have the meanings 
contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et 
seq., and the regulations issued under it. In addition, the term 
``food'' includes poultry and poultry products, as defined in the 
Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and meat 
food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 
60 et seq.; and eggs and egg products, as defined in the Egg Products 
Inspection Act, 21 U.S.C. 1033 et seq.
    Customs territory of the United States means the 50 States, Puerto 
Rico, and the District of Columbia.
    Director means the Director of the EPA Office of Pollution 
Prevention and Toxics (OPPT).
    Distribute in commerce means to sell in commerce, to introduce or 
deliver for introduction into commerce, or to hold after introduction 
into commerce.
    EPA means the U.S. Environmental Protection Agency.
    e-PMN software means electronic-PMN software created by EPA for use 
in preparing and submitting Premanufacture Notices (PMNs) and other 
TSCA section 5 notices and support documents electronically to the 
Agency.
    Health and safety study or study means any study of any effect of a 
chemical substance or mixture on health or the environment or on both, 
including underlying data and epidemiological studies, studies of 
occupational exposure to a chemical substance or mixture, 
toxicological, clinical, and ecological, or other studies of a chemical 
substance or mixture, and any test performed under the Act. Chemical 
identity is always part of a health and safety study.
    (1) Not only is information which arises as a result of a formal, 
disciplined study included, but other information relating to the 
effects of a chemical substance or mixture on health or the environment 
is also included. Any data that bear on the effects of a chemical 
substance on health or the environment would be included.
    (2) Examples include:
    (i) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; data on behavioral disorders; dermatoxicity; 
pharmacological effects; mammalian absorption, distribution, 
metabolism, and excretion; cumulative, additive, and synergistic 
effects; acute, subchronic, and chronic effects; and structure/activity 
analyses.
    (ii) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including acute 
toxicity tests, chronic toxicity tests, critical life stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular chemical substance or 
mixture on the environment, including surveys, tests, and studies of: 
Biological, photochemical, and chemical degradation; air, water, and 
soil transport; biomagnification and bioconcentration; and chemical and 
physical properties, e.g., boiling point, vapor pressure, evaporation 
rates from soil and water, octanol/water partition coefficient, and 
water solubility.
    (iv) Monitoring data, when they have been aggregated and analyzed 
to measure the exposure of humans or the environment to a chemical 
substance or mixture.
    (v) Any assessments of risk to health and the environment resulting 
from the manufacture, processing, distribution in commerce, use, or 
disposal of the chemical substance.
    Importer means any person who imports a chemical substance, 
including a chemical substance as part of a mixture or article, into 
the customs territory of the United States. ``Importer'' includes the 
person primarily liable for the payment of any duties on the 
merchandise or an authorized agent acting on his or her behalf. The 
term also includes, as appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20; or
    (4) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with 19 CFR part 144, 
subpart C. (See ``principal importer.'')
    Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    Intermediate means any chemical substance that is consumed, in 
whole or in part, in chemical reactions used for the intentional 
manufacture of another chemical substance(s) or mixture(s), or that is 
intentionally present for the purpose of altering the rates of such 
chemical reactions.
    Inventory means the list of chemical substances manufactured or 
processed in the United States that EPA compiled and keeps current 
under section 8(b) of the Act.
    Known to or reasonably ascertainable by means 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.
    Manufacture means to produce or manufacture in the United States or 
import into the customs territory of the United States.
    Manufacture for commercial purposes means:
    (1) To manufacture with the purpose of obtaining an immediate or 
eventual commercial advantage for the manufacturer, and includes, among 
other things, ``manufacture'' of any amount of a chemical substance or 
mixture.
    (2) The term also applies to substances that are produced 
coincidentally during the manufacture, processing, use, or disposal of 
another substance or mixture, including byproducts that are separated 
from that other substance or mixture and impurities that remain in that 
substance or mixture. Byproducts and impurities without separate 
commercial value are nonetheless produced for the purpose of obtaining 
a commercial advantage, since

[[Page 102791]]

they are part of the manufacture of a chemical substance for commercial 
purposes.
    Manufacture solely for export means to manufacture for commercial 
purposes a chemical substance solely for export from the United States 
under the following restrictions on activities in the United States:
    (1) Distribution in commerce is limited to purposes of export or 
processing solely for export as defined in Sec.  721.3 of this chapter.
    (2) The manufacturer and any person to whom the substance is 
distributed for purposes of export or processing solely for export (as 
defined in Sec.  721.3 of this chapter), may not use the substance 
except in small quantities solely for research and development in 
accordance with Sec.  720.36.
    Manufacturer means a person who imports, produces, or manufactures 
a chemical substance. A person who extracts a component chemical 
substance from a previously existing chemical substance or a complex 
combination of substances is a manufacturer of that component chemical 
substance. A person who contracts with a manufacturer to manufacture or 
produce a chemical substance is also a manufacturer if:
    (1) The manufacturer manufactures or produces the substance 
exclusively for that person; and
    (2) That person specifies the identity of the substance and 
controls the total amount produced and the basic technology for the 
plant process.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except ``mixture'' does 
include:
    (1) Any combination which occurs, in whole or in part, as a result 
of a chemical reaction if the combination could have been manufactured 
for commercial purposes without a chemical reaction at the time the 
chemical substances comprising the combination were combined, and if 
all of the chemical substances comprising the combination are not new 
chemical substances; and
    (2) Hydrates of a chemical substance or hydrated ions formed by 
association of a chemical substance with water, so long as the 
nonhydrated form is itself not a new chemical substance.
    New chemical substance means any chemical substance which is not 
included on the Inventory.
    Nonisolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the chemical substance passes during a continuous flow process, 
but not including tanks or other vessels in which the substance is 
stored after its manufacture.
    Person means any natural person, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity, any State or political subdivision thereof, any 
municipality, any interstate body, and any department, agency or 
instrumentality of the Federal Government.
    Pesticide has the meaning contained in the Federal Insecticide, 
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the 
regulations issued under it.
    Possession or control means in possession or control of the 
submitter, or of any subsidiary, partnership in which the submitter is 
a general partner, parent company, or any company or partnership which 
the parent company owns or controls, if the subsidiary, parent company, 
or other company or partnership is associated with the submitter in the 
research, development, test marketing, or commercial marketing of the 
chemical substance in question. (A parent company owns or controls 
another company if the parent owns or controls 50 percent or more of 
the other company's voting stock. A parent company owns or controls any 
partnership in which it is a general partner). Information is included 
within this definition if it is:
    (1) In files maintained by submitter's employees who are:
    (i) Associated with research, development, test marketing, or 
commercial marketing of the chemical substance in question.
    (ii) Reasonably likely to have such data.
    (2) Maintained in the files of other agents of the submitter who 
are associated with research, development, test marketing, or 
commercial marketing of the chemical substance in question in the 
course of their employment as such agents.
    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.
    Principal importer means the first importer who, knowing that a new 
chemical substance will be imported rather than manufactured 
domestically, specifies the identity of the chemical substance and the 
total amount to be imported. Only persons who are incorporated, 
licensed, or doing business in the United States may be principal 
importers.
    Process means the preparation of a chemical substance or mixture, 
after its manufacture, for distribution in commerce:
    (1) In the same form or physical state as, or in a different form 
or physical state from, that in which it was received by the person so 
preparing such substance or mixture, or
    (2) As part of a mixture or article containing the chemical 
substance or mixture.
    Processor means any person who processes a chemical substance or 
mixture.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including such research or analysis for the 
development of a product'') means quantities of a chemical substance 
manufactured or processed or proposed to be manufactured or processed 
solely for research and development that are not greater than 
reasonably necessary for such purposes.
    State means any State of the United States and the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
the Canal Zone, American Samoa, the Northern Mariana Islands, and any 
other territory or possession of the United States.
    Support documents means material and information submitted to EPA 
in support of a TSCA section 5 notice, including but not limited to, 
correspondence, amendments (if notices for these amendments were 
submitted prior to January 19, 2016), and test data. The term ``support 
documents'' does not include orders under TSCA section 5(e) (either 
consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).
    Technically qualified individual means a person or persons:
    (1) Who, because of education, training, or experience, or a 
combination of these factors, is capable of understanding the health 
and environmental risks associated with the chemical substance which is 
used under his or her supervision;
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or chemical research 
to minimize such risks; and

[[Page 102792]]

    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the chemical 
substance as may be appropriate or required within the scope of 
conducting a research and development activity.
    Test data means data from a formal or informal test or experiment, 
including information concerning the objectives, experimental methods 
and materials, protocols, results, data analyses, recorded 
observations, monitoring data, measurements, and conclusions from a 
test or experiment.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor, to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture, or article in commerce.
    United States, when used in the geographic sense, means all of the 
States.


Sec.  720.30  [Amended]

0
10. Amend Sec.  720.30 by revising the citations ``Sec.  720.3(e)'' in 
paragraph (a) and ``720.3(u)'' in paragraph (b) to both read ``Sec.  
720.3.''

0
11. 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 e-mail and submit the new 
information electronically to EPA via CDX.
* * * * *

0
12. Amend Sec.  720.45 by:
0
a. Revising paragraphs (a)(4) and (5), and (f) through (h); and
0
b. 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 applicable 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 CASRN, 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 applicable 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 containing 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 containing 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 consumer and commercial 
products in which the new chemical substance is intended or known to be 
used. When more than 10 codes apply to the consumer or commercial 
products in which the new chemical substance is intended or known to be 
used, submitters should only designate the 10 product categories that 
represent the highest proportion of the anticipated production volume.

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.

[[Page 102793]]

 
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.
------------------------------------------------------------------------
 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).

[[Page 102794]]

 
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 deicers/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 for each worker activity 
anticipated or known to occur during manufacture, processing, or use of 
the new chemical substance, including worker exposure information from 
exempt manufacture or related use of the new chemical substance under 
Sec.  720.30. This information includes:
    (i) A description of each worker activity.
    (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.
    (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 known or anticipated 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. 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

[[Page 102795]]

frequency of container cleaning, and the amount of release per 
container cleaning.
    (iii) For releases into air, Clean Air Act operating permit 
numbers, 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, and the type of air pollution control technologies used at 
the site to treat the stack releases that will contain the new chemical 
substance.
    (iv) For releases into water, the National Pollutant Discharge 
Elimination System (NPDES) permit number(s), outfall numbers, the 
name(s) of the waterbody 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 works (POTW) or privately owned treatment 
works into which the release occurs and the corresponding NPDES permit 
number(s), the type of wastewater treatment technology or technologies 
employed, and a description of the known or expected treatment 
efficiency.
    (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 for each worker activity 
anticipated or known to occur during manufacture, processing, or use of 
the new chemical substance, including worker exposure information from 
exempt manufacture or related use of the new chemical substance under 
Sec.  720.30. This information includes:
    (i) A description of each worker activity.
    (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 the 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 known or anticipated 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. 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 will be 
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, 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, and the type of air pollution control technologies used at 
the site to treat the stack releases that will contain the new chemical 
substance.
    (iv) For releases into water, the National Pollutant Discharge 
Elimination System (NPDES) permit number(s), outfall numbers, the 
name(s) of the waterbody 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 works (POTW) or privately owned treatment 
works into which the release occurs and the corresponding NPDES permit 
number(s), the type of wastewater treatment technology or technologies 
employed, and a description of the known or expected treatment 
efficiency.
* * * * *
    (j) The physical and chemical properties and environmental fate 
characteristics of the new chemical substance, which include the 
following:
    (1) For physical and chemical properties, such information includes 
boiling point, sublimation, density/relative density, dissociation 
constant, explodability, flammability, melting point, octanol/water 
partition coefficient, particle size distribution, particle size 
distribution analysis (i.e., analysis method and data used to develop 
the particle size distribution), 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.
    (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.

0
13. Amend Sec.  720.50 by revising paragraphs (a)(4)(ii) and adding 
paragraph (c) 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) * * *

[[Page 102796]]

    (ii) If a test or experiment is completed before the applicable 
review period ends, the person must submit the study, report, or test 
data 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 e-mail prior to the end of the review period and submit the study, 
report, or test data electronically to EPA via CDX.
* * * * *
    (c) Other information. A person may submit other information, not 
otherwise required in this section, to facilitate EPA's review of the 
notice.
* * * * *

0
14. Revise Sec.  720.65 to 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 the notice 
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.  703.5(c).
    (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 Sec.  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) EPA will consider the objections filed by the submitter and 
determine:
    (i) 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.
    (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

[[Page 102797]]

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
15. 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 will be published.
* * * * *

0
16. 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) introductory text, (c)(4)(iii), 
and (d).
    The revisions 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) Requests for suspensions. (i) A request for a suspension of 30 
days or less may be made orally, including by telephone, or in writing, 
including by e-mail, 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 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:
* * * * *
    (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) For determinations described in paragraph (d)(1)(v) of this 
section, EPA will issue the submitter a document containing EPA's final 
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 document, the submitter may 
commence the manufacture of the 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 EPA receives 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. Where such information demonstrates that the 
prohibitions or limitations of the order are not sufficient to protect 
against an unreasonable risk of injury to health or the environment, 
EPA may modify the order or take other action, as

[[Page 102798]]

appropriate, to the extent necessary to protect against such risk.
    (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
17. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
18. Amend Sec.  721.25 by:
0
a. Revising paragraph (d); and
0
b. Adding paragraph (e).
    The revisions and additions read as follows:


Sec.  721.25  Notice requirements and procedures.

* * * * *
    (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.
    (e) When submitting a significant new use notice, in addition to 
providing a description of the intended categories of consumer or 
commercial use by function and application as required by Sec.  
720.45(f)(1) of this chapter, the submitter must also provide, to the 
extent known to or reasonably ascertainable by the submitter, a 
description of known categories of consumer or commercial use by 
function and application.

0
19. Amend Sec. Sec.  721.10647(a)(1), 721.10844(a)(1), 721.10929(a)(1), 
721.11149(a)(1), 721.11179(a)(1), 721.11361(a)(1)(iii), and 
721.11712(a)(1) by revising the citation ``720.3(c)'' to read 
``720.3.''

0
20. Amend Sec.  721.11777(b) by revising the citations ``720.3(w)'' and 
``720.3(d)'' to read ``720.3.''

PART 723-PREMANUFACTURE NOTIFICATION EXEMPTIONS

0
21. The authority citation for part 723 continues to read as follows:

    Authority:  15 U.S.C. 2604.


0
22. Amend Sec.  723.50 by:
0
a. Revising paragraphs (a)(1);
0
b. Adding paragraphs (b)(11) and (12);
0
c. Revising paragraphs (d);
0
d. Adding paragraphs (e)(2)(xiv);
0
e. Revising paragraphs (e)(3), (g), (h)(2)(v), and (i); and
0
f. Adding paragraph and (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.
* * * * *
    (e) * * *
    (2) * * *
    (xiv) Physical and chemical properties and environmental fate 
characteristics (Sec.  720.45(j)).
    (3) Incomplete notices. EPA will conduct a pre-screen of the 
notice, typically taking 2-3 days and according to the criteria under 
paragraph (e)(2) of this section. If EPA concludes that the notice is 
incomplete, EPA will notify the submitter and the review period will 
not begin. Once the submitter corrects the errors or incomplete 
submission according to the requirements provided by EPA and re-submits 
the notice to EPA, the review period will begin. If EPA does not 
identify errors or determine the notice to be incomplete during 
screening, the review period will begin on the date EPA received the 
complete notice.
* * * * *
    (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 Agency 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

[[Page 102799]]

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.
* * * * *
    (i) Additional information. If the manufacturer of a new chemical 
substance under the terms of this exemption obtains test data or other 
information indicating that the new chemical substance may not qualify 
under terms of this section, the manufacturer must submit these data or 
information to EPA within 15 working days of receipt of the 
information. If, during the notice review period specified in paragraph 
(g) of this section, the submitter obtains possession, control, or 
knowledge of new information that materially adds to, changes, or 
otherwise makes significantly more complete 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 exemption notice to which the new 
information is related. If the new information becomes available during 
the last 5 days of the notice review period, the submitter must 
immediately inform its EPA contact for that notice by telephone or e-
mail and submit the new information electronically to EPA via CDX.
* * * * *
    (p) Subject to a significant new use rule or listed on TSCA 
Inventory. 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 or if the specific chemical identity of a 
chemical substance is listed on the confidential portion of the TSCA 
Inventory, 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 or is listed on the confidential 
portion of the TSCA Inventory will not be considered public disclosure 
of 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 or is listed 
on the TSCA Inventory, and identify the proposed or final section in 
subpart E of part 721 of this chapter that pertains to the chemical 
substance or the generic name for that substance listed on the public 
portion of the TSCA Inventory, as applicable.

PART 725-REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

0
23. The authority citation for part 725 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, 2613, and 2625.


0
24. Amend Sec.  725.8(c)(1) by revising the citation ``720.3(e)'' to 
read ``720.3.''

0
25. 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 e-mail, 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
26. 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
27. 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 paragraphs (b)(1)(ii), (iii), 
or (iv), EPA will issue the submitter an order to prohibit or limit the 
manufacture, processing, distribution in commerce,

[[Page 102800]]

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) Following determinations described in paragraph (b)(1)(v) of 
this section, EPA will issue the submitter a document containing EPA's 
final 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 document, 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 ended if EPA receives 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. Where such information demonstrates that the 
prohibitions or limitations of the order are not sufficient to protect 
against an unreasonable risk of injury to health or the environment, 
EPA may modify the order or take other action, as appropriate, to the 
extent necessary to protect against such risk.
    (4) No person submitting an 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 the associated action required under 
paragraph (b)(2) of this section.
* * * * *

PART 761--POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, 
PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS

0
28. The authority citation for part 761 continues to read as follows:

    Authority:  15 U.S.C. 2605, 2607, 2611, 2614, and 2616.


0
29. In Sec.  761.3 amend the definition for ``Importer'' by removing 
the citation ``Sec.  720.3(l)'' and adding in its place ``Sec.  
720.3.''
* * * * *
[FR Doc. 2024-28870 Filed 12-17-24; 8:45 am]
 BILLING CODE 6560-50-P`