Document ID: EPA-HQ-OPPT-2022-0902-0001
Agency: epa
Document Type: Proposed Rule
Title: New Chemicals Regulations under the Toxic Substances Control Act
Posted Date: 2023-05-26T04:00Z

[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Proposed Rules]
[Pages 34100-34125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10735]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 720, 721, 723, and 725

[EPA-HQ-OPPT-2022-0902; FRL-7906-01-OCSPP]
RIN 2070-AK65

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The United States Environmental Protection Agency (EPA) is 
proposing amendments to the new chemicals procedural regulations under 
the Toxic Substances Control Act (TSCA). These amendments are intended 
to align the regulatory text with the amendments to TSCA's new 
chemicals review provisions contained in the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act, enacted on June 22, 2016, 
improve the efficiency of EPA's review processes, and update the 
regulations based on existing policies and experience implementing the 
New Chemicals Program. The proposal includes amendments that would 
reduce the need to redo all or part of the risk assessment by improving 
information initially submitted in new chemicals notices, which should 
also help reduce the length of time that new chemicals notices are 
under review. EPA is also proposing several amendments to the 
regulations for low volume exemptions (LVEs) and low release and 
exposure exemptions (LoREXs), which include requiring EPA approval of 
an exemption notice prior to commencement of manufacture, making per- 
and polyfluoroalkyl substances (PFAS) categorically ineligible for 
these exemptions, and providing that certain persistent, 
bioaccumulative, toxic (PBT) chemical substances are ineligible for 
these exemptions, consistent with EPA's 1999 PBT policy.

DATES: Comments must be received on or before July 25, 2023.

[[Page 34101]]

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2022-0902 through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Tyler Lloyd, New Chemicals Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-4016; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you intend to 
manufacture a new chemical substance, or manufacture or process a 
chemical substance for a significant new use. The following list of 
North American Industry Classification System (NAICS) codes is not 
intended to be exhaustive, but rather provides a guide to help readers 
determine whether this document applies to them. Potentially affected 
entities may include:
     Chemical Manufacturers (NAICS code 325).
     Petroleum and Coal Products (NAICS code 324).
     Merchant Wholesalers, Nondurable Goods (NAICS code 424).
    If you have any questions regarding the applicability of this 
action, please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Section 5(a)(1) of the Toxic Substances Control Act (TSCA), 15 
U.S.C. 2604(a)(1), as amended by the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act of 2016 (Pub. L. 114-182) (herein 
referred to as the ``2016 Lautenberg Amendments''), provides that no 
person, as defined at 40 CFR 720.3, may manufacture (which includes 
import under TSCA) a new chemical substance or manufacture or process a 
chemical substance for a use which EPA has determined is a significant 
new use, unless at least 90 days prior to such manufacture or 
processing that person submits a notice to EPA containing the 
information required by TSCA section 5(d). EPA must conduct a review of 
the notice, make one of five possible determinations pertaining to the 
likelihood of unreasonable risk of injury to health or the environment, 
and take any actions required as a result of that determination, all 
within the applicable review period. The submitted notice must include 
the information described in TSCA section 5(d)(1): insofar as known to 
the submitter or reasonably ascertainable, information described in 
certain provisions of TSCA section 8(a)(2) (e.g., chemical identity, 
use, and exposure information); in the form and manner prescribed by 
EPA, information in the possession or control of the submitter related 
to the health or environmental effects of the chemical substance; and a 
description of any other information concerning the environmental and 
health effects of the chemical substance, insofar as known to the 
submitter or reasonably ascertainable. EPA is issuing this proposed 
rule under TSCA section 5, 15 U.S.C. 2604.

C. What action is the Agency taking?

    When EPA receives a premanufacture notice (PMN), significant new 
use notice (SNUN), or microbial commercial activity notice (MCAN), the 
Agency is required to assess the risk associated with the new chemical 
substance or significant new use that is the subject of the notice 
under the conditions of use and make a determination for the chemical 
substance pertaining to the likelihood of such risk. Under TSCA, the 
term ``chemical substance'' includes microorganisms. To improve the 
effectiveness and efficiency of these reviews, EPA is proposing to 
amend the procedural regulations at 40 CFR parts 720, 721, and 725 to 
align with the requirements in TSCA section 5, as amended by the 2016 
Lautenberg Amendments, and to make additional updates. In particular, 
EPA is proposing to amend the regulations to specify that EPA must make 
a determination on each PMN, SNUN, and MCAN received before the 
submitter may commence manufacturing or processing of the chemical 
substance that is the subject of the notice, and to list the five 
possible determinations and the actions required in association with 
those determinations. In addition, EPA is proposing to clarify the 
level of detail expected for the information that a submitter is 
required to include in a PMN, SNUN, or exemption notice in order for 
the notice to be considered complete. EPA is also proposing amendments 
to the procedures for reviewing PMNs and SNUNs; specifically, 
procedures for addressing PMNs and SNUNs that have errors or are 
incomplete or that are amended during the applicable review period. 
Additionally, EPA is proposing to make several amendments to the 
regulations at 40 CFR 723.50 for low volume exemptions (LVEs) and low 
release and exposure exemptions (LoREXs). These amendments would 
require EPA approval of an exemption notice before the submitter may 
commence manufacture, allow EPA to inform an LVE or LoREX holder when 
the chemical substance that is the subject of the exemption becomes 
subject to a significant new use rule (SNUR) under TSCA and the 
chemical identity is confidential, make perfluoroalkyl and 
polyfluoroalkyl substances (PFAS) categorically ineligible for these 
exemptions, and codify EPA's use of the 1999 PBT policy for these 
exemptions by making certain PBTs ineligible for these exemptions. 
Finally, EPA is proposing to amend the regulations pertaining to 
suspensions for all TSCA section 5 notices to allow submitters to 
request suspensions for up to 30 days via oral or email request.

D. Why is the Agency taking this action?

    Under amended TSCA, EPA must review all notices submitted under 
TSCA section 5(a)(1) and make a determination pertaining to the risks 
of new chemical substances or significant new uses of chemical 
substances described in such notices before they can proceed to the 
marketplace. Before the 2016 Lautenberg Amendments, TSCA allowed the 
PMN submitter to commence manufacturing or processing upon expiration 
of the review period, unless EPA made an affirmative finding of 
unreasonable risk. Under amended TSCA, EPA must review all notices 
submitted under TSCA section 5(a)(1) and make a determination 
pertaining to the risks of every new chemical substance or significant 
new use of chemical substances described in such notices before they 
can proceed to the marketplace. To reflect and better meet these 
requirements, EPA is proposing to align the procedural regulations 
codified at 40 CFR parts 720 and 725 with amended TSCA and to make 
additional updates based on existing policies or lessons learned from

[[Page 34102]]

administering the New Chemicals Program since TSCA was amended in 2016.
    EPA is also proposing to clarify the information that is required 
to be included in PMNs, SNUNs, and exemption notices and to clarify EPA 
review procedures to make the review process more efficient, promote 
more complete submissions, and reduce the need to redo all or part of 
the risk assessment (``re-work'') due to late submissions of 
information that delay EPA review of PMNs, SNUNs, and exemption 
notices. In order to continue to meet amended TSCA's requirement for 
the Agency to make determinations for all PMNs and SNUNs within an 
applicable review period of 90 days from receipt (or up to 180 days 
with an extension), EPA needs to identify and implement efficiencies in 
the PMN and SNUN review process, ensure notices are complete and reduce 
re-work of risk assessments. This action, if finalized, is expected to 
reduce re-work of risk assessments by minimizing requests from 
submitters to amend their PMNs, SNUNs, or exemption notices with 
additional information after the review period has commenced. The 
Agency is also proposing to clarify the procedures that will be 
employed if submitters amend their PMNs or SNUNs during the applicable 
review period.
    EPA is also proposing to amend the regulations for LVEs and LoREXs 
so that submitters may not commence manufacture until EPA has issued a 
decision for the exemption notice, to better ensure that manufacture 
under LVEs and LoREXs will not present an unreasonable risk. 
Additionally, EPA is proposing amendments that would allow the Agency 
to notify submitters if a chemical substance for which they hold an LVE 
or LoREX becomes subject to a proposed or final SNUR and the chemical 
identity is confidential, so that chemical manufacturers are made aware 
that they may be subject to additional TSCA requirements.
    EPA is also proposing to make PFAS categorically ineligible for an 
LVE or LoREX, which would ensure that all new PFAS are reviewed through 
the full PMN process. In addition, EPA is proposing to codify EPA's 
1999 PBT policy by making certain PBTs ineligible for these exemptions.
    Lastly, EPA is proposing to allow informal (oral or email) requests 
for review period suspensions of up to 30 days to reduce the number of 
repeated requests for 15-day suspensions, and because EPA believes that 
email may be more expedient than oral communication for many 
submitters.

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

    EPA has evaluated the potential incremental impacts of this 
rulemaking in an economic analysis (EA), titled ``Economic Analysis for 
the Proposed Rule: Updates to New Chemicals Regulations under the Toxic 
Substances Control Act'' (Ref. 1), which is available in the docket, 
discussed in Unit IV, and briefly summarized here. The benefits of the 
rule include increased efficiency in both the submission and review 
processes for notices submitted through the PMN form. The changes under 
this proposed rule would clarify the information requirements on the 
PMN form in the Agency's Central Data Exchange (CDX) to make more 
transparent the level of detail that EPA needs in order to make a 
reasoned evaluation. As submitters provide more complete information in 
their initial submissions, the changes under this proposed rule are 
expected to reduce the frequency with which PMNs, SNUNs, and exemption 
notices are amended with additional information and the amount of re-
work of risk assessments that the Agency conducts following such 
amendments.
    As a result of the changes presented in this proposed rule, the 
total annual burden to industry is expected to decrease by 
approximately 4,518 hours, while total annual costs to industry 
submitters are expected to have a net increase of $45,120. The Agency 
is expected to experience an annual cost savings of approximately 
$923,280.

F. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that 
you claim to be CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    As enacted in 1976, TSCA provided EPA with authority to require 
reporting, recordkeeping, and testing, and to issue restrictions 
relating to chemical substances and/or mixtures. TSCA section 5(a)(1) 
required that a person submit to EPA a notice at least 90 days before 
commencing manufacture of a new chemical substance or manufacture or 
processing of a chemical substance for a use which EPA determined to be 
a significant new use. TSCA section 5(e) provided that EPA could issue 
a proposed order to regulate a chemical substance for which a notice 
was submitted under TSCA section 5(a)(1) if it determined that: (1) the 
information available to EPA is insufficient to permit a reasoned 
evaluation of the health and environmental effects of the chemical 
substance, and (2) the manufacture, processing, distribution in 
commerce, use, or disposal of the chemical substance may present an 
unreasonable risk of injury to health or the environment in the absence 
of sufficient information, or the chemical substance is or will be 
produced in substantial quantities and may either enter the environment 
in substantial quantities or result in significant or substantial human 
exposure. Further, TSCA section 5(f) required EPA to issue a proposed 
rule or proposed order to regulate the chemical substance, or to seek 
an injunction to prohibit the manufacture, processing, or distribution 
in commerce of the chemical substance, if it found that there is a 
reasonable basis to conclude that the chemical substance presents or 
will present an unreasonable risk of injury to health or the 
environment.
    Under the 1976 law, EPA was not obligated to make a determination 
or finding regarding unreasonable risk for each notice submitted under 
TSCA section 5(a)(1). However, if EPA decided to take action under TSCA 
section 5(e) or 5(f), TSCA required EPA to do so within 90 days of 
receiving the notice (or up to 180 days if EPA extended the notice 
period pursuant to TSCA section 5(c)). If EPA did not take action 
during that time, manufacturing or processing of the chemical substance 
could commence.
    EPA's obligations with respect to making determinations on notices 
submitted under TSCA section 5(a)(1) fundamentally changed with the 
passage of the 2016 Lautenberg Amendments. The 2016 Lautenberg 
Amendments added a new paragraph to TSCA at section 5(a)(3) titled 
``Review and Determination,'' under which EPA must review and make a 
determination

[[Page 34103]]

pertaining to the likelihood of risk on all notices received under TSCA 
section 5(a)(1), which include PMNs, SNUNs and MCANs, within the 
applicable review period and lists five types of risk determinations 
available to EPA.
    EPA's obligation to take action after making a determination on a 
notice submitted under TSCA section 5(a)(1) also changed with the 
passage of the 2016 Lautenberg Amendments. Under amended TSCA, EPA is 
required to issue an order pursuant to TSCA section 5(e) when it makes 
a determination under TSCA section 5(a)(3)(B) that: (1) the information 
available to EPA is insufficient to permit a reasoned evaluation of the 
health and environmental effects of the chemical substance or 
significant new use; (2) in the absence of sufficient information, the 
manufacture, processing, distribution in commerce, use, or disposal of 
the chemical substance may present an unreasonable risk of injury to 
health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed 
or susceptible subpopulation (PESS) identified as relevant by EPA; or 
(3) the chemical substance is or will be produced in substantial 
quantities and may either enter the environment in substantial 
quantities or result in significant or substantial human exposure. EPA 
must issue an order to prohibit or limit the manufacture, processing, 
distribution in commerce, use, or disposal of the chemical substance to 
the extent necessary to protect against an unreasonable risk of injury 
to health or the environment, without consideration of costs or other 
non-risk factors, including an unreasonable risk to a potentially 
exposed or susceptible subpopulation identified as relevant by EPA 
under the conditions of use.
    Furthermore, TSCA section 5(f) requires EPA to issue either an 
order or a proposed rule under TSCA section 6(a) when EPA makes a 
determination under TSCA section 5(a)(3)(A) that a chemical substance 
or significant new use presents an unreasonable risk of injury to 
health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed 
or susceptible subpopulation identified as relevant by EPA under the 
conditions of use. If EPA issues an order under TSCA sections 5(e) or 
5(f), it must do so no later than 45 days before the expiration of the 
applicable review period.
    Lastly, when EPA makes a determination under TSCA section 
5(a)(3)(C) that a chemical substance or significant new use is not 
likely to present an unreasonable risk of injury to health or the 
environment, without consideration of costs or other non-risk factors, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by EPA under the conditions of 
use, EPA must publish a statement of its finding in the Federal 
Register according to TSCA section 5(g).
    In summary, the 2016 Lautenberg Amendments require EPA to review 
each notice submitted under TSCA section 5(a)(1), make a determination 
on that notice, and take the action required in association with that 
determination within the applicable review period. Under TSCA section 
5(i)(3), the ``applicable review period'' means 90 days from the date 
EPA receives a notice under TSCA section 5(a)(1), or up to 180 days 
from that date if EPA extends the applicable review period according to 
the provisions in TSCA section 5(c). TSCA section 5(c) allows EPA to 
extend the original 90-day review period by up to another 90 days for 
good cause and requires the reasons for the extension to be published 
in the Federal Register. The 2016 Lautenberg Amendments also added TSCA 
section 5(a)(4) explaining that a failure by EPA to render a 
determination within the applicable review period would not relieve EPA 
of any requirement to make such determination, but would, with certain 
exceptions, result in a fee refund to the notice submitter.
    TSCA section 5(h) was not significantly amended by the 2016 
Lautenberg Amendments. TSCA section 5(h) provides EPA the authority to 
exempt a person from certain TSCA section 5 requirements under certain 
situations, such as if the person will manufacture the chemical 
substance for test marketing purposes, in small quantities for 
scientific experimentation, or under other conditions that will not 
present an unreasonable risk of injury to health or the environment, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified by EPA under the conditions of use. EPA 
developed the LVE and LoREX regulations in 1995 pursuant to TSCA 
section 5(h)(4) (60 FR 16336, March 29, 1995).
    EPA's regulations related to TSCA section 5 are codified in Title 
40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR). 
They include:
     Regulations related 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-references 40 CFR part 720) and to 
LVEs and LoREXs submitted under 40 CFR 723.50 (see 40 CFR 723.50(e)(2), 
which cross-references 40 CFR 720.45). As a result, the proposed 
amendments to the requirements in 40 CFR 720.45 would apply to PMNs and 
also to SNUNs, LVEs, and LoREXs. The review procedures for PMNs 
codified in 40 CFR part 720 generally also apply to SNUNs under 40 CFR 
part 721 (see 40 CFR 721.25(c)) but not to exemptions under 40 CFR part 
723, so the amendments to the part 720 review procedures proposed in 
this action would apply to PMNs and also to SNUNs but not to such 
exemptions. Neither the information requirements nor the review 
procedures in 40 CFR part 720 apply to MCANs or microorganism-related 
exemptions under 40 CFR part 725, so EPA is also proposing amendments 
to the MCAN and microorganism-related exemption regulations at 40 CFR 
part 725.

III. Summary of Proposed Rule

A. Amendments To Conform Regulations to 2016 Lautenberg Amendments

    EPA is proposing changes to the PMN procedural regulations at 40 
CFR part 720 to align them with the notice review and determination 
requirements in TSCA section 5, as amended by the 2016 Lautenberg 
Amendments. These procedural regulations also generally apply to SNUNs 
under 40 CFR part 721 (see 40 CFR 721.1(c) and 721.25(c)). EPA is also 
proposing similar changes to the MCAN procedural regulations at 40 CFR 
part 725 to align them with the same notice review and determination 
requirements added by the 2016 Lautenberg Amendments. EPA has been 
implementing the amended statutory requirements but has not yet 
codified these updates into the new chemicals procedural regulations. 
The Agency is now proposing to amend the regulations to specify that 
EPA must make a determination on each PMN, SNUN, and MCAN received 
before the submitter may commence manufacturing (which includes 
importing) or processing and to list the five possible determinations 
and the

[[Page 34104]]

actions required in association with those determinations. EPA is also 
proposing to add definitions for new terms and to update existing 
terminology introduced by the 2016 Lautenberg Amendments.
1. Commencement of Manufacture or Processing
    Prior to the passage of the 2016 Lautenberg Amendments, TSCA did 
not require EPA to make a risk determination on each notice submitted 
under TSCA section 5(a)(1). Rather, TSCA required the submission of a 
notice at least 90 days before manufacturing a new chemical substance, 
or manufacturing or processing a chemical substance for a significant 
new use. If EPA did not take any regulatory action on a notice, the 
submitter could commence the manufacturing or processing after 90 days 
(or up to 180 days if EPA extended the notice period pursuant to TSCA 
section 5(c)). Promulgated in 1983, the PMN procedural regulation at 40 
CFR 720.75(d) reflects that prior statutory provision and states that 
``in the absence of regulatory action by EPA under section 5(e), 5(f), 
or 6(a) of the Act, the submitter may manufacture or import the 
chemical substance even if the submitter has not received notice of 
expiration [of the review period].'' A similar provision was 
promulgated in the MCAN procedural regulations in 1997 at 40 CFR 
725.170(b) and (c).
    The 2016 Lautenberg Amendments changed the requirements of TSCA 
section 5(a) by adding section 5(a)(1)(B)(ii) and (a)(3), which require 
EPA to conduct a review of each notice submitted under TSCA section 
5(a)(1), make a determination on the notice, and take the action 
required in association with that determination before a submitter can 
commence the manufacture of a new chemical substance or the manufacture 
or processing of a chemical substance for a significant new use. Since 
amended TSCA went into effect, EPA has been implementing the new law by 
making a determination and taking any required action on each PMN, 
SNUN, and MCAN received. However, the outdated regulatory text at 40 
CFR 720.75(d) and 725.170(b) and (c) is still in place, even though it 
has been superseded by the amendments to the statute.
    Therefore, in this action, EPA is proposing to amend 40 CFR 
720.75(d) by removing the outdated language allowing the submitter to 
commence manufacture of a chemical substance when the review period 
expires and adding new language specifying that EPA must issue a 
determination and take any required action on each PMN before 
manufacture may commence. EPA is also proposing to amend 40 CFR 
721.25(d) to state that any person submitting a SNUN shall not 
manufacture or process a chemical substance for a significant new use 
until EPA has issued a determination with respect to the significant 
new use and taken the actions required in association with that 
determination. Likewise, EPA is proposing to amend 40 CFR 725.170(b) 
and (c) by removing similar outdated language allowing the submitter to 
commence manufacture of a new microorganism or manufacture or 
processing of a microorganism for a significant new use when the review 
period expires and adding new language specifying that EPA must issue a 
determination and take any required action on each MCAN before 
manufacture may commence.
2. Required Determinations and Associated Actions
    As previously described, the 2016 Lautenberg Amendments added a new 
paragraph at TSCA section 5(a)(3) titled ``Review and Determination,'' 
which lists the five possible determinations that EPA may make on a 
notice. To improve clarity and help inform the regulated community 
about EPA's statutory obligations under TSCA section 5(a)(3), EPA is 
proposing to further amend 40 CFR 720.75(d) and 725.170 by listing the 
five possible determinations for each PMN, SNUN, or MCAN.
    EPA is also proposing to add language to 40 CFR 720.75(d) and 
725.170(b) to describe the actions that EPA must take in association 
with its determination for a PMN, SNUN, or MCAN. EPA is proposing to 
codify those actions, which EPA has been implementing, as applicable, 
for every PMN, SNUN, and MCAN since the 2016 Lautenberg Amendments, to 
be clear about EPA's review process to the public. The five possible 
determinations and associated actions are as follows:
     When EPA makes a determination for a PMN, SNUN, or MCAN 
according to TSCA section 5(a)(3)(C) that the new chemical substance or 
significant new use is not likely to present an unreasonable risk of 
injury to health or the environment, without consideration of costs or 
other non-risk factors, including an unreasonable risk to a potentially 
exposed or susceptible subpopulation identified as relevant by EPA 
under the conditions of use, EPA issues a determination document to the 
submitter of the PMN, SNUN, or MCAN. The submitter may commence 
manufacturing or processing of the chemical substance once they receive 
the determination document. As required by TSCA section 5(g), EPA also 
submits for publication in the Federal Register a statement of the 
``not likely'' finding.
     When EPA makes a determination for a PMN, SNUN, or MCAN 
according to TSCA section 5(a)(3)(B) that (1) the information available 
to EPA is insufficient to permit a reasoned evaluation of the health 
and environmental effects of the new chemical substance or significant 
new use, (2) in the absence of sufficient information, the manufacture, 
processing, distribution in commerce, use, or disposal of the chemical 
substance may present an unreasonable risk of injury to health or the 
environment, without consideration of costs or other non-risk factors, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by EPA, or (3) the chemical 
substance is or will be produced in substantial quantities and may 
either enter the environment in substantial quantities or result in 
significant or substantial human exposure, EPA must issue an order 
pursuant to TSCA section 5(e). The order prohibits or limits the 
manufacture, processing, distribution in commerce, use, or disposal of 
the chemical substance to the extent necessary to protect against an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant by EPA under the conditions of use. EPA may 
issue an order under TSCA section 5(e) that requires testing to be 
conducted and presented to EPA after the applicable review period has 
concluded.
     When EPA makes a determination for a PMN, MCAN, or SNUN 
according to TSCA section 5(a)(3)(A) that the chemical substance or 
significant new use presents an unreasonable risk of injury to health 
or the environment, without consideration of costs or other non-risk 
factors, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by EPA under the 
conditions of use, EPA must take one of the following actions described 
in TSCA section 5(f) to the extent necessary to protect against such 
risk: (1) issue an immediately effective proposed rule to limit the 
amount of such substance that may be manufactured, processed, or 
distributed in commerce or to impose other requirements described in 
TSCA

[[Page 34105]]

section 6(a), or (2) issue an order to prohibit or limit the 
manufacture, processing or distribution in commerce of the substance, 
to take effect on the expiration of the applicable review period.
    After EPA issues an order under TSCA section 5(e) or (f) and the 
applicable review period concludes, the submitter may submit studies, 
tests, reports, or other additional information. If EPA concludes from 
an assessment of the additional information that one or more of the 
prohibitions or limitations contained in the order are no longer 
necessary to protect against an unreasonable risk of injury to health 
or the environment, EPA may modify or revoke the prohibitions or 
limitations of the order. If EPA determines that none of the order 
terms are warranted after assessment of the additional information, EPA 
may revoke all the requirements of the order. EPA is proposing 
amendments to 40 CFR 720.75(d) and 725.170 to state that EPA may modify 
or revoke the prohibitions and limitations in an order after the 
applicable review period has ended if the submitter submits to EPA 
additional testing, studies, reports, or other information that EPA 
determines, upon review, demonstrate that such prohibitions or 
limitations are no longer necessary to protect against an unreasonable 
risk of injury to health or the environment. While the current 
regulations do not specify that EPA may modify or revoke the 
prohibitions and limitations in an issued order, the proposed 
amendments at 40 CFR 720.75(d) and 725.170 would codify current 
practices. EPA believes that these existing processes and actions for 
modifying or revoking the prohibitions and limitations in an issued 
order fulfill the requirements of TSCA section 5, as amended by the 
2016 Lautenberg Amendments.
3. Other Updates
    EPA is proposing to replace the terms ``notice period,'' 
``notification period,'' ``statutory review period,'' and ``notice 
review period'' with the term ``applicable review period'' throughout 
40 CFR part 720 to conform to the new terminology in TSCA section 5 
added by the 2016 Lautenberg Amendments. EPA is proposing to add a 
definition for ``applicable review period'' to 40 CFR 720.3, which EPA 
would define as ``the period starting on the date EPA receives a 
complete notice under section 5(a)(1) of the Act and ending 90 days 
after that date or on such date as is provided for in sections 5(b)(1) 
or 5(c) of the Act.'' This proposed definition is based on the TSCA 
section 5(i)(3) definition for ``applicable review period.''
    EPA is also proposing to add a definition for ``potentially exposed 
or susceptible subpopulation'' to 40 CFR 720.3, a term added to TSCA by 
the 2016 Lautenberg Amendments. Based on the definition in TSCA section 
3(12), EPA would define ``potentially exposed or susceptible 
subpopulation'' as ``a group of individuals within the general 
population identified by EPA who, due to either greater susceptibility 
or greater exposure, may be at greater risk than the general population 
of adverse health effects from exposure to a chemical substance or 
mixture, such as infants, children, pregnant women, workers, the 
elderly, or overburdened communities.''
    EPA is also proposing to update 40 CFR 720.70(b) by revising 
paragraph (b)(3). The language in paragraph (b) describes the content 
of the document that EPA routinely publishes in the Federal Register 
under TSCA section 5(d)(2) to announce the receipt of PMNs submitted to 
EPA. Although not required by TSCA section 5(d)(2), the first sentence 
in 40 CFR 720.70(b)(3) specifies that the document EPA publishes in the 
Federal Register pursuant to TSCA section 5(d)(2) will also include a 
list of data submitted with the PMN in accordance with 40 CFR 
720.50(a). In proposing to establish this requirement in the original 
40 CFR part 720 regulations, EPA described its objective as providing 
relevant information to the public in terms of the PMNs submitted and 
under review with EPA. See e.g., 44 FR 2242, 2253 (January 10, 1979). 
That transparency goal is now better achieved through other more 
efficient and effective mechanisms that negate the need to publish that 
information in the Federal Register. Specifically, to provide 
streamlined access to information EPA receives and develops about 
chemicals, EPA has built and is constantly expanding content in an 
online searchable data base called ChemView (https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/introduction-chemview), and 
currently makes the PMN itself, including test data submitted with it, 
available on ChemView (subject to confidentiality claims) generally 
within 5 workdays of receipt. In addition, EPA is making the list of 
new chemical submissions received available in one place on our website 
to increase transparency and make information on new chemicals easier 
to find (see https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-notices-received-epa). This 
approach was adopted several years ago to provide an alternative to 
searching individual Federal Register notices and dockets on https://www.regulations.gov. The links below provide a listing of the following 
types of new chemical submissions received. The lists on the website 
are updated on a regular basis and allow anyone to track the status of 
active new chemical cases by visiting our page on statistics for the 
new chemicals review program (https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review).

B. Amendments Related to Notice Information Requirements

    EPA is proposing changes to the notice information requirements at 
40 CFR 720.45, as well as corresponding changes to the reporting form 
in CDX, to clarify the level of detail expected for information that 
must be submitted to EPA in the PMN, SNUN, and certain exemption 
notices.
1. Background
    A notice submitted under TSCA section 5(a)(1) must include the 
information described in TSCA section 5(d)(1): (1) insofar as known to 
the submitter or reasonably ascertainable, information described in 
certain provisions of TSCA section 8(a)(2); (2) in the form and manner 
prescribed by EPA, information in the possession or control of the 
submitter related to the health or environmental effects of any 
manufacture, processing, distribution in commerce, use, or disposal of 
the chemical substance or any article containing such substance; and 
(3) a description of any other information concerning the environmental 
and health effects of the chemical substance, insofar as known to the 
submitter or reasonably ascertainable. EPA has promulgated regulations 
detailing these information requirements in 40 CFR 720.45 and 720.50.
    EPA has developed an application form in CDX to collect such 
information from submitters. The user guide for CDX is listed in the 
references section of this proposed rule and can be found in the docket 
(Ref. 2). This form is prescribed by EPA for submission of PMNs, SNUNs, 
LVEs, LoREXs, and test marketing exemption (TME) applications. In this 
preamble, EPA refers to the form as the ``PMN form'' for simplicity, 
but the proposed changes outlined in this section would impact the 
other types of notices that use the same form (i.e., PMNs, SNUNs, LVEs, 
LoREXs, and TMEs).
    EPA has observed that most PMN, SNUN, and exemption notices do not 
contain all required information at the

[[Page 34106]]

level of detail that EPA needs to perform refined, quantitative risk 
assessments. When a submission is lacking detail, EPA typically uses 
conservative assumptions and default values to ensure the assessment is 
protective of human health and the environment. The Agency may make 
predictions using models concerning physical and chemical properties, 
environmental transport and partitioning, environmental fate, 
environmental toxicity, human health, engineering releases to the 
environment, and environmental concentrations--see the document titled 
``Points to Consider When Preparing TSCA New Chemical Notification'' 
(Ref. 3) for more information on EPA's use of predictive models in the 
new chemical review process. EPA has repeatedly observed, however, that 
when submitters see the level of risk estimated by EPA using such 
conservative assumptions and default values, as well as the risk 
mitigation measures developed by EPA as a result, submitters often 
amend their initial notices to provide additional detailed information. 
In an effort to improve the accuracy of EPA's risk assessment, 
submitters often either provide information that was missing in their 
initial notice or clarify details about the manufacturing process. When 
EPA receives such information during the review process, EPA takes the 
information into consideration and may redo its risk assessments (``re-
work'') to factor in the additional information. This longstanding 
practice of submitters amending their initial notices to provide 
additional information after the beginning of the review period and EPA 
having to consider the information late in the review process results 
in re-work by EPA and diverts EPA attention from processing new 
notices. This creates delays in the review of notices generally.
    EPA has previously worked to address the inefficiency of the review 
process associated with late submission of information by issuing 
several supplemental documents to aid submitters in providing all 
relevant information in the initial notice. EPA published a Points to 
Consider document in 2018 (Ref. 3) and provides a user guide and 
resource tab that are accessible within the CDX application and provide 
instructions on how to complete the submission (Ref. 2). To further 
address this issue, EPA began implementing a pre-screen process for 
notices in April 2020, which is detailed in Unit III.C. of this 
document. And in July 2022, the Agency launched the TSCA New Chemical 
Engineering Initiative to Increase Transparency and Reduce Re-work that 
included a broad outreach effort to describe and discuss with 
stakeholders how the Agency evaluates data provided with notices and 
common issues that cause EPA to have to re-work risk assessments (Ref. 
4).
    EPA believes that amending the notice information requirements at 
40 CFR 720.45 to specify the level of detail needed, as well as 
building that additional detail into the CDX user interface, would help 
submitters provide all relevant information in their initial notice 
submissions. EPA has observed that many data elements in notice 
submissions often lack the level of detail that EPA needs. EPA believes 
that specifying more detailed information requirements in 40 CFR 720.45 
and data fields in the CDX user interface would promote more complete 
submissions upfront and help to minimize the need for EPA to use 
default values and conservative assumptions in its risk assessment. 
Therefore, EPA is proposing to amend the notice information 
requirements at 40 CFR 720.45, as well as implementing corresponding 
changes to the PMN form in CDX.
2. Proposed Changes to 40 CFR 720.45 and the PMN Form
    EPA is proposing to amend 40 CFR 720.45 and the PMN form in CDX to 
clarify the information requirements for a notice. Specifically, EPA is 
proposing to add details to certain information requirements already 
contained in 40 CFR 720.45 and to add additional reporting fields to 
the PMN form to reflect these details. This detailed information is 
already required by the broader information requirements contained in 
40 CFR 720.45 and 720.50 and is reflected in the CDX user interface. In 
this action, EPA is proposing to add these details as separate, unique 
information requirements in 40 CFR 720.45 and make corresponding 
changes to the PMN form to clarify the level of detail needed for EPA's 
review of a notice and to ensure that the fields in the PMN form are 
consistent with the regulations. In some cases, reporting fields for 
detailed information are already included in the PMN form because they 
are covered by broader information requirements contained in 40 CFR 
720.45 or 720.50. EPA is proposing to add those details to 40 CFR 
720.45 so that the regulations and PMN form are consistent. See Ref. 5, 
which provides tables that list the detailed information requirements 
proposed to be added to 40 CFR 720.45 and indicate whether reporting 
fields for that information are already included in the PMN form.
    Consistent with TSCA section 5(d)(1), for all information 
requirements under 40 CFR 720.45, submitters are only required to 
provide information to the extent that it is known to or reasonably 
ascertainable by the submitter, as defined at 40 CFR 720.3(p). Under 
the proposed changes to 40 CFR 720.45, a submitter would be required to 
include in the PMN form the detailed information proposed in this 
action, along with all other information already required, to the 
extent the information is known to or reasonably ascertainable by the 
submitter. This is an important point because a submitter may not know 
or be able to reasonably ascertain certain details about the chemical 
substance that is the subject of the notice, such as details about 
manufacturing, processing, or use sites out of the submitter's control. 
In those situations, EPA would make conservative assumptions and use 
conservative default values for any information that is not known to or 
reasonably ascertainable by the submitter and therefore not provided in 
the PMN form.
    Currently, if submitters have physical-chemical or environmental 
fate test data, they must provide the test data or a standard 
literature citation in accordance with 720.50(a)(2)-(3). Submitters 
must also submit this information in the corresponding PMN form fields 
in accordance with the proposed changes to 720.45(j). Data provided in 
the PMN form via CDX may be pulled from the test data provided by 
submitters per 720.50(a)(2)-(3), or the data can be submitted as 
standalone information for which submitters do not have underlying test 
data.
a. Physical and Chemical Properties and Environmental Fate 
Characteristics
    The first set of detailed information requirements that EPA is 
proposing to add to 40 CFR 720.45 is about the physical and chemical 
properties and environmental fate characteristics of the chemical 
substance (see Table 1 in Ref. 5). EPA currently collects physical and 
chemical properties test data required by 40 CFR 720.50, ``Submission 
of test data and other data concerning the health and environmental 
effects of a substance,'' in two ways. First, the CDX user interface 
prompts the submitter to attach relevant documents, such as test data, 
to the PMN form using an attachment function. Second, the PMN form 
includes a CDX user interface screen with form fields for physical and 
chemical properties available for completion via a pick list. To ensure 
that the regulations are clear about what

[[Page 34107]]

information fields are included in the PMN form itself, EPA believes 
that the information requirements in 40 CFR 720.45 should reflect the 
PMN form fields. EPA is therefore proposing to add relevant physical 
and chemical properties information requirements in a new provision at 
40 CFR 720.45(j)(1) that are already specified within the PMN form.
    EPA is proposing several information requirements at 40 CFR 
720.45(j)(1) that are not already specified within the PMN form for 
physical and chemical properties. EPA is proposing to require in 40 CFR 
720.45(j)(1) that data on surface tension and ultraviolet-visible (UV-
VIS) absorption, as well as any particle size distribution analysis, be 
submitted as part of the PMN form, to the extent it is known to or 
reasonably ascertainable by the submitter. Data on surface tension and 
UV-VIS absorption are not currently included on the pick list for 
physical and chemical properties in CDX, and their inclusion there as 
well as in the proposed regulations at 40 CFR 720.45(j)(1) will promote 
more complete submissions. The particle size distribution value is 
already a physical and chemical property that appears in the pick list 
on the CDX user interface screen, but it would improve EPA's ability to 
assess risk if the value were accompanied by the analysis data used to 
develop the value. Additionally, EPA proposes to require at 40 CFR 
720.45(j)(1) information for aspect ratio, thickness, and number of 
layers or walls for nanomaterials. Information requirements for 
nanomaterial morphology do not currently appear on the pick list for 
physical and chemical properties on the CDX user interface screen or in 
the regulations. Requiring data for these properties will allow EPA to 
offer additional clarity to submitters providing notices for 
nanomaterials, since submitters might otherwise omit such data. 
Therefore, EPA is proposing to add these requirements to the 
regulations at 40 CFR 720.45(j)(1) and to add fields for attaching 
associated data on the physical and chemical properties screen of the 
PMN form.
    EPA also proposes to add information requirements for the 
environmental fate characteristics of the chemical substance (see Table 
1 in Ref. 5) to 40 CFR 720.45(j)(2). Environmental fate characteristics 
test data are already required by 40 CFR 720.50; however, this 
provision does not describe in detail what these relevant 
characteristics include. In addition, this information is already 
collected by EPA as attachments to the PMN form; however, fields for 
environmental fate characteristics are not yet included on the CDX user 
interface screen pick list. EPA is proposing to add the relevant 
environmental fate characteristics to the information requirements at 
40 CFR 720.45(j)(2) and to add form fields to the PMN form by expanding 
the pick list.
b. Categories of Use
    The next set of information requirements that EPA is proposing to 
add to 40 CFR 720.45 relates to the categories of use of the chemical 
substance (see Table 2 in Ref. 5). The proposed requirements include 
detailed information on commercial and consumer uses, which already 
have form fields in the PMN form in CDX specifying in greater detail 
the broader information requirement in the regulations at 40 CFR 
720.45(f) regarding categories of use. Although the regulations at 40 
CFR 720.45(f) currently require a description of intended categories of 
use by function and application, the estimated percent of production 
volume devoted to each category of use, and the percent of the new 
substance in the formulation for each commercial or consumer use, 
certain specific information requirements for details on commercial and 
consumer uses are not yet specified. These information requirements 
include the types of products or articles that would incorporate the 
new chemical substance (e.g., household cleaners, plastic articles), 
how and where a product or article incorporating the new chemical 
substance would be used (e.g., spray applied indoors, brushed on 
outdoor surfaces), consumption rates and frequency and duration of use 
for products or articles containing the new chemical substance, and 
information related to the use of products or articles containing the 
new chemical substance by potentially exposed or susceptible 
subpopulations. EPA is proposing to add these requirements to 
720.45(f). Additionally, EPA is proposing to add to 40 CFR 720.45(f) a 
requirement to designate applicable consumer and commercial product 
categories using Organisation for Economic Co-operation and Development 
(OECD)-based functional use codes, which would create consistency with 
TSCA section 8(a) Chemical Data Reporting (CDR) requirements in 40 CFR 
part 711. EPA is also proposing corresponding changes to the PMN form 
fields in CDX.
c. Details Concerning Manufacture, Processing, and Use
    The third set of information requirements that EPA is proposing to 
add to 40 CFR 720.45 is information related to each site where the 
chemical substance will be manufactured, processed, or used. These 
requirements apply to sites controlled by submitters as well as sites 
controlled by others, and although the information requirements that 
EPA is proposing are similar for both, different types of activities 
(e.g., manufacturing versus processing) often occur at submitter-
controlled sites versus those at sites controlled by others. Moreover, 
activities at sites controlled by others are typically not as well 
characterized by submitters compared to descriptions of the submitters' 
own activities, since in many cases the identity and number of sites 
controlled by others is unknown to the submitters when a notice is 
submitted. As such, some slight differences exist in the requirements 
EPA is proposing for information related to sites controlled by 
submitters versus sites controlled by others.
    For both sites controlled by submitters and sites controlled by 
others, EPA is proposing to add information requirements for site 
addresses (see Table 3 and Table 5 in Ref. 5). For submitter-controlled 
sites, EPA is also proposing to add requirements for whether a 
particular chemical substance is manufactured or processed via batch or 
continuous production, as well as the amount of the chemical substance 
manufactured or processed in a given batch and/or timeframe (see Table 
5 in Ref. 5). These proposed information requirements already have a 
corresponding form field in the PMN form in CDX because they are each 
covered by the existing information requirements in 40 CFR 720.45(g)(1) 
and (2) and (h) for a process description of operations at such sites. 
Since these proposed information requirements are not yet specified in 
the regulations, EPA is proposing to add them at 40 CFR 720.45(g)(1) 
and (2) for sites controlled by the submitter and 40 CFR 720.45(h)(1) 
and (2) for sites not controlled by the submitter.
    EPA is also proposing to add requirements for detailed information 
about the process diagram or description for each site controlled by 
the submitter (see Table 4 in Ref. 5) and for each site not controlled 
by the submitter (see Table 5 in Ref. 5). These requirements include 
descriptions of the identity, approximate weight per batch or per day 
for continuous production, and entry point of all starting materials 
and feedstocks; the identity, approximate weight per batch or per day 
for continuous production, and entry point of all products, recycle 
streams, and wastes, including frequency of any equipment cleaning; the 
type of containers used for interim storage and transport of the 
chemical substance; and

[[Page 34108]]

identification, by number, of any points of release. Although these 
details are already covered by the existing information requirements in 
40 CFR 720.45(g)(2) and (h) for a process description of operations at 
such sites, EPA is proposing to add them as separate, unique 
information requirements at 40 CFR 720.45(g)(2) and (h)(2) and in new 
fields in the PMN form to clarify the level of detail needed and to 
ensure that the regulations and PMN form are consistent.
d. Worker Exposure
    EPA is also proposing to add requirements for detailed information 
about the possible worker exposure at each site controlled by the 
submitter (see Table 6 in Ref. 5), and at each site not controlled by 
the submitter (see Table 7 in Ref. 5). These requirements include types 
of potential worker exposure (e.g., dermal, inhalation), descriptions 
of any protective equipment and engineering controls in place, the 
moisture content of the chemical substance (if a solid), and the 
percentage of the chemical substance in the formulation at the time of 
exposure. In addition, for sites controlled by others, these 
requirements also include worker activities and descriptions of the 
physical form of the chemical substance. Although these details are 
already covered by the existing information requirements in 40 CFR 
720.45(g)(3) and (h) regarding worker exposure information, and some 
already have a corresponding form field in the PMN form in CDX, EPA is 
proposing to add them as separate, unique information requirements at 
40 CFR 720.45(g)(3) and (h)(3) and in new fields in the PMN form to 
clarify the level of detail needed and to ensure that the regulations 
and PMN form are consistent.
e. Environmental Releases
    Finally, EPA is proposing to add detailed information requirements 
about the potential environmental releases at each site controlled by 
the submitter (see Table 8 in Ref. 5) and at each site not controlled 
by the submitter (see Table 9 in Ref. 5). These requirements include 
descriptions of the type of release (e.g., transport, interim storage, 
disposal, equipment cleaning); the amount of the chemical substance 
released directly to the environment or into control technology; the 
amount of the chemical substance released to the environment after 
control technology; for equipment cleaning releases, frequency of 
equipment cleaning and what is used to clean equipment; for transport 
and storage releases, how the chemical substance or the product 
containing the chemical substance is transported from the site and 
stored and information about the containers used; for releases into 
air, Clean Air Act operating permit numbers and a description of any 
Leak Detection and Repair program the site has implemented; for 
releases into water, National Pollutant Discharge Elimination System 
(NPDES) permit numbers and information on the navigable waterways and 
other destinations into which the release occurs; and for releases into 
wastewater treatment plants, information on the publicly owned 
treatment works (POTW) into which the release occurs. In addition, for 
sites controlled by others, these requirements also include a 
description of the media of release. Although each of these details are 
already covered by the existing information requirements in 40 CFR 
720.45(g)(4) and (h) regarding environmental releases, and some already 
have a corresponding form field in the PMN form in CDX, EPA is 
proposing to add them as separate, unique information requirements at 
40 CFR 720.45(g)(4) and (h)(4) and in new fields in the PMN form to 
clarify the level of detail needed and to ensure that the regulations 
and PMN form are consistent.
    If the information is not known to or reasonably ascertainable by 
the submitter for one or more sites, EPA makes conservative assumptions 
and uses default values to replace the missing information whether the 
site is controlled by the submitter or not. Therefore, EPA believes 
that the level of detail in the regulations for process description, 
worker exposure, and environmental release information for sites 
controlled by the submitter at 40 CFR 720.45(g) should mirror the level 
of detail in the regulations for process description, worker exposure, 
and environmental release information for sites not controlled by the 
submitter at 40 CFR 720.45(h). EPA is proposing to amend 40 CFR 
720.45(g) and (h) to make them consistent. EPA recognizes that a 
submitter may not possess such information about sites not controlled 
by the submitter. Submitters are only required to supply information 
that is known to or reasonably ascertainable by them as defined at 40 
CFR 720.3(p).
    Additionally, EPA is proposing clarifying amendments to 40 CFR 
720.45(g)(3) and (4) and 720.45(h)(3) and (4) to ensure that submitters 
include worker exposure and environmental release information from 
exempt manufacture or related use of the chemical substances under 40 
CFR 720.30 (e.g., a chemical substance manufactured under the byproduct 
or impurity exemptions) at each site where the chemical substance will 
be manufactured, processed, or used, if known or reasonably 
ascertainable. EPA is also proposing clarifying amendments to 40 CFR 
721.25(c) to ensure that submitters of SNUNs include in their notice 
both a description of the significant new use for which they are 
submitting a SNUN and of all other known or intended categories of use. 
Such categories of use may include uses that are ongoing and not 
subject to a significant new use rule (SNUR). Such information is 
valuable for EPA in determining necessary regulatory action should 
potential risks be identified during review of a SNUN.
f. Pollution Prevention Information
    Lastly, EPA is proposing to add optional pollution prevention 
information at 40 CFR 720.45(k). The PMN form in CDX currently includes 
an optional text field and attachment function for submitters who wish 
to provide pollution prevention information about the chemical 
substance, such as information about using alternative fuel sources, 
reducing the use of water and chemical inputs, modifying a production 
process to produce less waste, implementing water and energy 
conservation practices, or substituting for riskier existing products.
    EPA estimates that the proposed amendments, which are intended to 
clarify the level of detail required for existing data requirements 
under 40 CFR 720.45 and 720.50, would have a very minor impact on 
submitter burden because they are largely reflected in existing fields 
in the PMN form in CDX that submitters already are prompted to 
complete. Moreover, they are also already included in the Points to 
Consider document (Ref. 3) that submitters are encouraged to review 
before completing a notice. EPA's estimate of the burden impacts of 
these proposed information requirement amendments are presented in an 
Information Collection Request (ICR) document (Ref. 6), a copy of which 
is in the docket and is summarized in Unit VI.B.
    EPA is seeking comment specifically on its burden estimate and on 
the general pros and cons of clarifying these information requirements 
in the regulations and making corresponding changes to the PMN form. 
EPA is also seeking comment from the public, including those who have 
submitted a notice to EPA in the past, on any information requirement 
details that are

[[Page 34109]]

not clearly explained in the PMN form or the regulations.
3. Other Modifications to the PMN Form in CDX
    In addition to the proposed amendments to clarify the information 
requirements for a notice and the corresponding changes to the PMN form 
in CDX outlined in Unit III.B.1. and 2., EPA is also considering adding 
statements with accompanying check boxes to certain screens of the PMN 
form (such as when transitioning between the various worksheets 
completed by the submitter) that indicate that information fields can 
only be left blank if such information is not known to or reasonably 
ascertainable by the submitter. In other words, if a submitter leaves 
information fields blank, they would have to check a box on the screen 
to affirm that the information is not known to or reasonably 
ascertainable by the submitter before advancing to the next screen. 
Additionally, a statement would warn the submitter of the potential 
consequences of leaving the field blank and later amending the field. 
If a field is left blank, EPA would make conservative assumptions and 
use conservative default values when assessing risk, which could result 
in more stringent risk management requirements. If a field that has 
been left blank is later amended during the review process, EPA may 
declare the original submission incomplete (see Unit III.C.3. for a 
more detailed discussion on notice amendments indicating that the 
original submission was incomplete). This check box approach would not 
have a corresponding regulatory change, as it is consistent with the 
existing requirements to provide all information that is known to or 
reasonably ascertainable by the submitter and EPA's longstanding 
practice to use conservative assumptions and default values in the 
absence of information. The ICR document accompanying this proposed 
rule describes the potential modifications to each screen of the PMN 
form (Ref. 6).
    As an alternative to this check box approach, EPA considered adding 
automatic checks in CDX to make certain critical fields mandatory such 
that the user could not advance to the next screen in the PMN form or 
submit the form without entering information into the field. EPA does 
not favor this approach because information required on the PMN form is 
required to the extent it is known to or reasonably ascertainable by 
the submitter, and EPA understands that there may be situations where 
such information may not be known to or reasonably ascertainable by the 
submitter. EPA also considered adding a statement and check box to 
every screen in the PMN form that information in the form is required 
if it is known to or reasonably ascertainable by the submitter, and not 
just to certain screens as described above. EPA does not favor this 
approach because it would require significant resources to program such 
statements and check boxes on each screen. Furthermore, the PMN form is 
designed to allow users the flexibility of moving back and forth 
through the screens, skipping screens, and returning to previous 
screens as needed. EPA feels that implementing such check boxes on 
every screen may impede this flexibility and unnecessarily increase the 
burden of completing a PMN form. EPA seeks comment on these 
alternatives, as well as on whether there are other approaches to 
modifying the PMN form to encourage complete submission of data.

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

    EPA is proposing amendments to the regulations regarding how EPA 
acknowledges the receipt of a notice to account for EPA's pre-screen 
process and to clarify the start of the applicable review period, 
particularly when a notice contains errors or is incomplete. EPA is 
also proposing amendments to align the process for correcting errors in 
the notice with the existing process for incomplete submissions. EPA is 
also clarifying that a notice is not considered complete at the time of 
the initial notice submission if the submitter submits additional 
information at any time during the review period that was known to or 
reasonably ascertainable by the submitter at the time of initial notice 
submission. Finally, EPA is proposing amendments to clarify that new 
information about a chemical substance under EPA review must be 
submitted electronically via CDX and that certain notification to EPA 
of new information may be made by email.
1. Background
    The first step that EPA takes after the receipt of a new chemicals 
notice before the risk assessment begins is to conduct a pre-screen of 
the notice, which typically takes 2-3 days. During the pre-screen 
process, EPA determines whether a notice is required for the chemical 
substance under TSCA. For example, EPA determines whether the chemical 
substance is already on the TSCA Chemical Substance Inventory (also 
called the ``TSCA Inventory'' or ``Inventory''), not a ``chemical 
substance'' as defined in TSCA section 3(2), or will be manufactured 
solely for export. If EPA determines that a notice is not required, EPA 
notifies the submitter that they are not required to submit a notice 
under TSCA in order to proceed commercially. EPA rejects the notice, 
and an applicable review period does not begin. See 40 CFR 720.62.
    During this pre-screen process, EPA also initiates a chemistry, 
engineering, and administrative screen of the notice. EPA chemists 
evaluate whether the chemical identity of the new chemical substance is 
clear, the starting materials add up to the final chemical substance, 
and the chemical structure is consistent with the name. EPA engineers 
evaluate whether certain information is contained in the notice, such 
as complete site identification information, manufacturing process 
descriptions, and information on environmental releases and worker 
exposure for each site. EPA also evaluates whether any of the other 
conditions for incomplete submissions outlined in 40 CFR 720.65(c)(1) 
have been met, such as a failure to properly sanitize for CBI a second 
copy of the notice or the failure to submit the notice in English. 
Finally, EPA checks for other errors in the notice. See 40 CFR 
720.65(b).
    If EPA deems the notice complete after the pre-screen process, then 
the notice moves forward to the risk assessment process. If EPA does 
not deem the notice complete during the pre-screen period, EPA notifies 
the submitter that the notice is incomplete and explains the 
requirements for correcting the incomplete submission, per 40 CFR 
720.65(c)(3). Once the submitter submits a complete notice according to 
the requirements previously provided by EPA, the applicable review 
period begins.
    Currently, after EPA completes its risk assessment of a chemical 
substance, EPA reaches out to the submitter to explain the findings of 
the risk assessment and any proposed prohibitions or limitations on the 
manufacturing, processing, distribution in commerce, use, or disposal 
of the chemical substance. If the submitter disagrees with the 
potential risks identified in the risk assessment, the submitter may 
provide additional information intended to demonstrate that risks are 
lower than EPA estimated. The additional information may be detailed 
information on worker exposures or environmental releases that was 
missing from the initial notice submission, or it may be previously 
unsubmitted testing on the chemical substance to better characterize 
the

[[Page 34110]]

potential risk that EPA identified in its assessment. These and other 
amendments could indicate that the original notice was incomplete if 
the additional information was known to or reasonably ascertainable by 
the submitter at the time of the original submission. See 40 CFR 
720.65(c)(1)(v) and (vi), (c)(2)(ii). If an original notice is later 
found to have been incomplete, EPA may restart the review period at Day 
1 when additional information is submitted that then makes the notice 
complete.
    Under its current practice, EPA may consider the additional 
information and, if warranted, conduct the risk assessment again to 
factor in the additional information. This is in line with EPA's 
longstanding objective to take into consideration reasonably available 
information and account for real-world conditions during manufacturing, 
processing, distribution, use, or disposal of a chemical substance. 
While this practice has the benefit of refining the risk assessments, 
it uses EPA resources inefficiently and adds significant time to the 
review process.
2. Pre-Screening Procedures
    EPA is proposing to amend 40 CFR 720.65(a) to codify the pre-screen 
process that EPA conducts prior to moving forward to the risk 
assessment process. The new language would clarify, for purposes of 
transparency, EPA's current pre-screen practice as described in Unit 
III.C.1. If through the pre-screen process EPA finds that the initial 
notice submission is complete, Day 1 of the applicable review period is 
the day the notice was received by EPA via CDX, consistent with the 
existing regulations at 40 CFR 720.75(a). If the pre-screen process 
finds that the initial submission is incomplete, the applicable review 
period will not begin until EPA receives a complete notice, consistent 
with the existing regulation at 40 CFR 720.65(c)(2)(i). After the pre-
screen, EPA may still determine within 30 days of receipt of the 
submission, once the risk assessment is underway and the information 
submitted more thoroughly evaluated, that the notice is incomplete, as 
currently described at 40 CFR 720.65(c)(2)(i). However, it has been 
EPA's experience that the pre-screen process helps minimize the number 
of submissions identified as incomplete or containing errors later in 
the review period. EPA is also proposing an amendment to 40 CFR 720.70 
to clarify that a notice of receipt will be published in the Federal 
Register after EPA receives a complete notice, rather than merely 
receiving the notice, to accommodate the pre-screening procedures.
3. Correcting Errors in Notices
    EPA is proposing amendments to 40 CFR 720.65(a) and (b) to state 
that if EPA receives a notice with errors and EPA requests (as part of 
the pre-screen process or, at latest, within 30 days of receipt of the 
notice) that the submitter remedy such errors, the applicable review 
period will not begin until EPA receives a corrected notice. This 
proposed amendment will align the process for correcting errors with 
the current process for correcting an incomplete notice at 40 CFR 
720.65(c)(2) through (5). The 1983 final rule that established the 
current process for correcting errors stated that ``the submitter is 
under no obligation to make the correction, but failure to do so may 
cause EPA to extend the review period under section 5(c) of the Act.'' 
((Ref. 7) (48 FR 21735, May 13, 1983). While the current regulations 
and the proposed amendment give EPA discretion to request remedy of 
errors, EPA now believes that if the Agency exercises that discretion 
to request that the submitter remedy an error, review of the notice 
should not move forward until the error is corrected. EPA does 
recognize that some errors may be minor and not require correction 
prior to EPA initiating review of the notice, such as easily recognized 
spelling errors or an incorrectly numbered list--EPA does not intend to 
request correction of such errors. EPA's notification to the submitter 
that a submission contains errors would include (i) a statement of the 
basis of EPA's determination that the submission contains errors, (ii) 
the requirements for correcting the errors, and (iii) information on 
procedures for filing objections to the determination or requesting 
modification of the requirements for completing the submission. 
Additionally, EPA is proposing an amendment to remove ``failure to date 
the notice form'' as an example of an error because the electronic PMN 
form submitted through CDX automatically dates the notice upon 
submission and this error is no longer possible.
4. Notice Amendments Indicating Original Notice Was Incomplete
    If information required under 40 CFR 720.45 and 720.50 and 
specified in the PMN form is known to or reasonably ascertainable by a 
submitter, the submitter must report the information in the notice. EPA 
defines ``known to or reasonably ascertainable by'' at 40 CFR 720.3(p) 
to mean ``all information in a person's possession or control, plus all 
information that a reasonable person similarly situated might be 
expected to possess, control, or know.'' This definition is not overly 
prescriptive and is based on a concept of reasonableness that is fact 
specific. Furthermore, the existing regulation at 40 CFR 
720.65(c)(2)(ii) states that if EPA obtains additional information 
during the review period that indicates the original submission was 
incomplete, EPA may declare the submission incomplete. Accordingly, if 
a submitter amends their notice during the applicable review period to 
add information required under 40 CFR 720.45 or 720.50 that was known 
to or reasonably ascertainable by the submitter at the time of the 
original submission, EPA would have cause to declare that the original 
submission was incomplete. Because the applicable review period does 
not begin until a submission is complete, EPA can restart the 
applicable review period to Day 1 if a submission is later amended 
during the review period and such amendment demonstrates that the 
original submission was incomplete.
    To date, EPA has generally not exercised its discretionary 
authority under section 720.65(c)(2)(ii) to declare original 
submissions incomplete when the Agency has received late submissions of 
information required by 40 CFR 720.45 or 720.50 that may have been 
known to or reasonably ascertainable by the submitter at the time of 
the original notice submission. Instead, EPA has considered the 
additional information and if applicable, conducted re-work on its risk 
assessments. To accomplish this re-work during the applicable review 
period, EPA has generally granted a submitter's request for a 
suspension of the review period, per 40 CFR 720.75(b).
    EPA intends to change this longstanding practice of accepting 
amendments that contain information that was known or reasonably 
ascertainable at the time of the original submission and then accepting 
a request to suspend the review period under 40 CFR 720.75(b). As 
explained in Unit II.B., the 2016 Lautenberg Amendments impose 
additional obligations on EPA, and EPA believes that exercising its 
discretionary authority under the existing regulations to declare an 
original submission incomplete and restart the applicable review period 
upon submission of the complete notice is appropriate in order for EPA 
to efficiently meet current statutory requirements. Overall, amendments 
and re-work often lead to an inefficient use of EPA resources and a 
review timeline that is not predictable and/or reliable for all 
stakeholders. EPA would continue to

[[Page 34111]]

accept amendments and, as necessary, refine risk assessments based on 
these amendments, but believes that the shift to restart the applicable 
review period would create a more transparent and predictable review 
process for submitters.
    To clearly communicate this intended change in longstanding 
practice, EPA is proposing to amend 40 CFR 720.65(c) by adding a 
paragraph (2), which would state that a notice submission may be 
declared incomplete if the submitter submits additional or revised 
information at any time during the review period without demonstrating 
to EPA's satisfaction that such information was not known to or 
reasonably ascertainable by the submitter at the time of initial notice 
submission. Additionally, EPA is proposing an amendment at 40 CFR 
720.65(d)(5)(iii) to clarify that if EPA obtains additional information 
during the review period that leads EPA to declare the initial notice 
submission incomplete, in accordance with 40 CFR 720.65(d)(2) (proposed 
to be redesignated from current 40 CFR 720.65(c)(2)(ii)), the 
applicable review period would restart at Day 1 upon receipt of the 
complete notice.
    It is EPA's view that information on basic physical and chemical 
properties and on anticipated environmental releases or worker 
exposures at any sites controlled by the submitter, as required at 40 
CFR 720.45, would be known to or reasonably ascertainable by the 
submitter at the time of the original submission. Furthermore, EPA 
believes that it is extremely unlikely that a submitter would neither 
know nor be able to reasonably ascertain such information at the time 
of the original submission, but could know or ascertain it 20 or 40 or 
60 days after the original submission or at other times during the 
review period. In this action and with the amendment proposed at 40 CFR 
720.65(c)(2), EPA is communicating to stakeholders that they must 
provide all information required by 40 CFR 720.45 and 720.50 upfront 
and submit a complete notice.
    Based on its experience reviewing thousands of notices and 
amendments, EPA believes that it should be very uncommon for a 
submitter to amend their notice during the review period by adding 
information that they could not have known or reasonably ascertained at 
the time of the original submission, such as for new information as 
described at 40 CFR 720.40(f) or information from testing in progress 
at the time of the original submission, as described at 40 CFR 
720.50(a)(4). Under the proposed amendment at 40 CFR 720.65(c)(2), the 
submitter of additional or revised information during the review period 
would have to demonstrate to EPA's satisfaction that the information 
was not known to or reasonably ascertainable by the submitter at the 
time of the original submission to preclude an EPA determination that 
the original notice was incomplete. As a matter of policy, EPA believes 
that the only amendments to a notice that would not indicate that the 
original notice was incomplete are: (1) amendments based on new data 
(as described at 40 CFR 720.40(f) and 720.50(a)(4)); (2) 
administrative, non-substantive amendments (e.g., submitter contact 
information); and (3) amendments made at the request of EPA. EPA, 
however, would take case-by-case facts into consideration when 
determining whether a late submission of information indicates that a 
notice was incomplete when originally submitted. If a submitter 
disagrees with EPA's determination that the original notice submission 
was incomplete, the submitter may object according to the existing 
procedures at 40 CFR 720.65(c)(4) and (5) (proposed to be redesignated 
as 40 CFR 720.65(d)(4) and (5)). Amendments based on new data, 
administrative or non-substantive amendments, and amendments made at 
the request of EPA would not impact the completeness of a submission.
    EPA offers the following example to illustrate the intended change 
to its longstanding practice: If a submitter leaves blank a field in 
the PMN form for information required under 40 CFR 720.45 to the extent 
it is known to or reasonably ascertainable by the submitter, EPA may 
use a conservative assumption or default factors in place of that 
information for the risk assessment and conclude that certain 
prohibitions or limitations on the chemical substance may be warranted. 
If after learning the findings of EPA's risk assessment, the submitter 
then amends its original notice in CDX by providing information in the 
field previously left blank, EPA would notify the submitter, according 
to the existing regulation at 40 CFR 720.65(c)(2)(ii) and (c)(3) 
(proposed to be redesignated as 40 CFR 720.65(d)(2) and (3)), that the 
original submission was incomplete. The submitter may then file an 
objection to the determination that the original notice was incomplete, 
at which time they may seek to demonstrate that the additional or 
revised information was not known to or reasonably ascertainable by 
them at the time of initial notice submission. If in response to the 
objection, EPA determines the original notice was complete, the 
applicable review period will be deemed suspended on the date EPA 
declared the notice incomplete and will resume on the date that the 
notice is declared complete. However, if EPA considers the objections 
and still determines that the original notice was incomplete, or if no 
objections are filed, EPA will restart the applicable review period and 
the new Day 1 will be the date the additional information that 
completed the notice was submitted to EPA.
    EPA believes that the meaning of ``known to or reasonable 
ascertainable by'' described in this preamble is generally consistent 
with EPA's original interpretation laid out in the 1983 final rule 
entitled ``Premanufacture Notification; Premanufacture Notice 
Requirements and Review Procedures'' (Ref. 7). That final rule states 
that ``EPA believes that it is not possible to define `known to or 
reasonably ascertainable' more explicitly''; ``EPA believes that 
`reasonably ascertainable' can be defined only on a case-by-case 
basis''; and ``EPA generally can judge from the notice itself whether 
it includes information that is known to or reasonably ascertainable by 
the submitter'' (Ref. 7 at page 21730). Further, that final rule 
provides an example of what would not be reasonably ascertainable to 
illustrate a rather high bar for information to qualify as not 
reasonably ascertainable: ``Certainly, in most instances, data-
gathering that is so costly as to preclude commercialization is not 
reasonable.'' (Ref. 7 at page 21730)
    EPA is seeking comment on the proposed new provision at 40 CFR 
720.65(c)(2) and proposed amendment to 40 CFR 720.65(c)(5)(iii) 
(proposed to be redesignated as 720.65(d)(5)(iii)), which clarify that 
EPA may deem an original notice incomplete, and restart the review 
period at Day 1 upon completion of the notice, if a submitter provides 
required information during the applicable review period without 
demonstrating that it was not known to or reasonably ascertainable by 
the submitter at the time of the initial notice submission. EPA is 
seeking comment on situations when this interpretation may not be 
appropriate.
5. Notifying EPA of the Receipt of New Information on a Chemical 
Substance Under Review
    EPA acknowledges that in some cases new information can become 
available about a chemical substance during the course of its review. 
When this occurs, submitters are required to inform EPA in writing and 
provide the new information within ten days of receiving

[[Page 34112]]

the new information, but no later than five days before the end of the 
notice review period. 40 CFR 720.40(f) and 40 CFR 720.50(a)(4)(ii) 
address the requirements for informing EPA of receipt of new 
information (including a study, report, or test that is completed 
during the notice review period), which require submitters to 
communicate receipt of new information to EPA via mail correspondence, 
or via telephone if the new information is received within five days of 
the end of the notice review period. EPA is proposing to amend 40 CFR 
720.40(f) and 40 CFR 720.50(a)(4)(ii) to clarify that new information 
about a chemical substance under EPA review must be submitted 
electronically via CDX, consistent with the general electronic 
submission requirements in 40 CFR 720.40(a). In addition, when 
submitters receive new information within five days of the end of the 
review period, EPA is proposing to allow them to notify EPA by email of 
the receipt of new information. Email communication would provide an 
alternative means of notifying EPA of the receipt of new information in 
the event that an EPA contact is unavailable to receive a phone call. 
While the submitter could use phone or email to notify EPA of the 
receipt of new information, all new information would be submitted 
electronically to EPA via CDX. Additionally, emails should not contain 
CBI.

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

    EPA is proposing several amendments to the current LVE and LoREX 
regulations. Specifically, EPA is proposing that: (1) submitters may 
not commence manufacture until EPA has approved the LVE or LoREX 
notice; (2) EPA may proactively inform LVE and LoREX holders if the 
chemical substance that is the subject of the LVE or LoREX becomes 
subject to a SNUR and the chemical identity is CBI, (3) PFAS be 
categorically ineligible for these exemptions; and (4) the regulations 
codify the ineligibility for exemptions of certain PBTs as described in 
EPA's 1999 PBT policy (Ref. 8).
1. Amendments to Expiration of LVE and LoREX Review Period
    By way of background, 40 CFR 723.50(a)(2)(i) currently requires 
that LVE and LoREX applicants submit a notice of intent to manufacture 
a chemical substance under an LVE or LoREX 30 days before commencing 
manufacture. 40 CFR 723.50(g)(1) provides that EPA will review the LVE 
or LoREX notice to determine whether manufacture of the chemical 
substance is eligible for the exemption. LVE and LoREX regulations are 
promulgated under the statutory authority of TSCA section 5(h)(4), 15 
U.S.C. 2604(h)(4), which provides that EPA may, upon application and by 
rule, exempt the manufacturer of any new chemical substance from all or 
part of the requirements of TSCA section 5 if EPA determines that the 
manufacture, processing, distribution in commerce, use, or disposal of 
such chemical substance, or that any combination of such activities, 
``will not present an unreasonable risk of injury to health or the 
environment, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified by [EPA] under the conditions of 
use.'' At present, 40 CFR 723.50(g)(2) provides that the submitter may 
begin manufacture of a chemical substance under an LVE or LoREX upon 
expiration of the 30-day review period if EPA has taken no action. In 
practice, EPA would move to deny an LVE or LoREX notice at the end of 
the review period if it were not able to conclude by that time that the 
substance will not present unreasonable risk on the basis that there 
are issues concerning toxicity or exposure that require further review 
which cannot be accomplished within the 30-day review period. EPA's 
current practice when other delays occur during the review of an LVE is 
to agree to submitter requests to suspend the running of the review 
period while EPA completes its review and determines whether to approve 
or deny the exemption notice. See 40 CFR 723.50(g)(1).
    Elsewhere in this rulemaking, EPA is proposing to amend the 
regulations that allow submitters to begin manufacture or processing of 
chemical substances for which a PMN, MCAN, or SNUN was submitted upon 
expiration of the review period, so that those regulations would 
require a determination from EPA prior to commencement of manufacture 
or processing of such substances. As discussed in Unit III.A., these 
proposed changes to 40 CFR 720.75, 721.25(d), and 725.170 are intended 
to conform those regulations to the 2016 Lautenberg Amendments. EPA is 
proposing similar amendments to the LVE and LoREX regulations at 40 CFR 
723.50 to align with the proposed amendments to the PMN, SNUN, and MCAN 
regulations and with the statutory framework and to better ensure that 
chemical substances manufactured under LVEs and LoREXs will not present 
an unreasonable risk. Specifically, EPA is proposing to amend the LVE 
and LoREX regulations at 40 CFR 723.50(g) to require a notification of 
approval of an LVE or LoREX from EPA prior to commencement of 
manufacture of the chemical substance under the exemption.
2. Notification of LVE and LoREX Holders if the Chemical Substance Is 
Subject to a SNUR
    At present, when a chemical substance is reviewed via a PMN and 
becomes subject to a SNUR, confidentiality claims for the specific 
chemical identity in the PMN and reflected in the associated SNUR may, 
in the absence of submitting a bona fide, prevent holders of current 
LVEs and LoREXs for that same substance from being informed that the 
chemical substance is now subject to a SNUR. EPA is proposing to add 
language to 40 CFR 723.50 to allow EPA to inform an LVE or LoREX holder 
whenever the chemical substance that is the subject of that LVE or 
LoREX becomes subject to a proposed or final SNUR that describes the 
chemical substance by a generic chemical name due to a confidentiality 
claim for its specific chemical identity. This proposed amendment 
would, as a courtesy, help inform LVE and LoREX holders of regulatory 
requirements that they may have otherwise been unable to determine on 
their own without submitting an inquiry to EPA (also known as a bona 
fide) pursuant to 40 CFR 721.11. EPA is proposing to amend the 
regulations at 40 CFR 723.50 to establish that a granted LVE or LoREX 
notice demonstrates a bona fide intent to manufacture the substance, 
such that a disclosure to an LVE or LoREX holder that the substance is 
the subject of a proposed or final rule under Part 721 will not be 
considered public disclosure of confidential business information under 
section 14 of the Act. EPA is not proposing in this rulemaking any 
revisions to the procedures in 40 CFR 723.50(l) for asserting and 
protecting confidential business information.
    This amendment would also help inform certain LVE and LoREX holders 
that they may now or in the future become subject to chemical data 
reporting (CDR) requirements. The CDR requirements described at 40 CFR 
711.8 differ for chemical substances subject to certain TSCA actions 
(e.g., SNURs). The annual production volume threshold at which 
reporting is ordinarily required is 25,000 pounds, and as such LVE 
holders are generally exempt, and LoREX holders may be exempt, from 
such reporting even if their chemical substance has been added to the 
Inventory. However, if a chemical substance previously approved as an 
LVE or LoREX is later reviewed as a

[[Page 34113]]

PMN and becomes subject to certain new actions under TSCA (such as a 
SNUR) as well as being added to the Inventory, the threshold for 
reporting is lowered to 2,500 pounds annually. This creates the 
potential for inadvertent non-compliance with CDR requirements by those 
LVE and LoREX holders.
    EPA does not intend to proactively inform current LVE and LoREX 
holders about SNURs that predate this rule. EPA is seeking comment on 
its proposal to allow EPA to proactively inform an LVE or LoREX holder 
whenever the chemical substance that is the subject of that LVE or 
LoREX becomes subject to a proposed or final SNUR that describes the 
chemical substance by a generic chemical name. EPA would only start the 
practice of notifying LVE and LoREX holders subject to this proposed 
amendment after the date of the final rule.
3. Making PFAS Categorically Ineligible for LVEs and LoREXs
    EPA is proposing amendments to make PFAS categorically ineligible 
for LVEs and LoREXs going forward and proposing a structural definition 
of PFAS for purposes of the LVE and LoREX regulations. The Agency is 
proposing the same chemical structure definition for PFAS as the 
definition proposed in the recent rule entitled ``Per- and Poly-
fluoroalkyl Chemical Substances Designated as Inactive on the TSCA 
Inventory; Significant New Use Rule'' (known as the ``Inactive PFAS 
SNUR'') (88 FR 4937, January 26, 2023 (FRL-9655-01-OCSPP)).
    In April 2021, EPA's New Chemicals Program began implementing a new 
policy for reviewing and managing LVE notices for PFAS. In the April 
27, 2021 press release announcing the new PFAS LVE policy (Ref. 9), the 
Agency stated that ``[g]iven the complexity of PFAS chemistry, 
potential health effects, and their longevity and persistence in the 
environment, an LVE notice for a PFAS is unlikely to be eligible for 
this kind of exemption under the regulations.'' Prior to the new 
policy, EPA had approved more than 600 LVE notices for PFAS--many of 
which were granted prior to the 2016 Lautenberg Amendments and were 
often intended to be substitutes for longer chain PFAS, i.e., 
substances having a fluorinated carbon chain length of C8 or longer. 
(In the past, long-chain PFAS were generally thought to present greater 
risks to humans and the environment than shorter-chain PFAS). In June 
2021, EPA launched the ``PFAS LVE Stewardship Program'' to encourage 
the voluntary withdrawal of the more than 600 previously granted PFAS 
LVEs. Under that program, an eligible company that wishes to 
participate is asked to submit a voluntary withdrawal of their LVE. As 
of April 2023, there are 45 PFAS LVEs that have been voluntarily 
withdrawn under the PFAS LVE Stewardship Program. EPA has not granted 
an LVE for a PFAS since May 2020. EPA has not ever received or approved 
any PFAS LoREX notices.
    Under the current policy, manufacturers may still submit LVE and 
LoREX notices for PFAS, which EPA must review individually. The 
proposed amendments to the LVE and LoREX regulations would make PFAS 
categorically ineligible to be considered for these exemptions. Under 
the proposal, any LVE or LoREX notice for a PFAS that is submitted to 
the Agency would be denied upon receipt without substantive review. 
This includes any chemical substance where any of the reasonably 
anticipated metabolites, environmental transformation products, 
byproducts, or reasonably anticipated impurities are a PFAS. Persons 
who wish to manufacture a PFAS not on the TSCA Inventory would instead 
be required to submit a PMN at least 90 days prior to commencing 
manufacture for a non-exempt commercial purpose.
    The LVE and LoREX are predicated on strict production volume or 
release/exposure limits, respectively, and notices are subject to an 
abbreviated 30-day review by EPA designed to serve as a procedural 
safeguard to screen out substances that pose potential risks, rather 
than the more detailed and comprehensive 90-day review afforded to 
PMNs. See 60 FR 16336, March 29, 1995 (FRL-4923-1). The existing LVE 
and LoREX regulations at 40 CFR 723.50(h)(1) provide that if EPA 
determines during the review period that manufacture of the new 
chemical substance does not meet the terms of the LVE or LoREX 
requirements or that there are issues concerning toxicity or exposure 
that require further review which cannot be accomplished within the 30-
day review period, EPA will notify the manufacturer that the substance 
is not eligible for the exemption.
    When EPA initially proposed and then finalized the LVE 
requirements, EPA considered compiling a list of chemical categories, 
based on structure, that would not be eligible for the exemption. See 
the proposed rule entitled ``Premanufacture Notification; Proposed 
Exemption for Site-Limited Intermediate Chemical Substances and 
Chemical Substances Manufactured in Quantities of 10,000 Kg or Less Per 
Year'' (47 FR 33896, 33907, August 4, 1982 (FRL-2105-1)); and the final 
rule entitled ``Premanufacture Notification Exemption; Exemption for 
Chemical Substances Manufactured in Quantities of 1,000 Kg or Less Per 
Year'' (50 FR 16477, 16483, April 26, 1985 (FRL-2742-1)). EPA did not 
adopt categorical exclusions at the time because EPA believed that 
identifying such categories upfront would be unnecessarily resource-
consuming and would provide no more protection than that already 
provided by EPA's LVE notice review requirements (50 FR at 16483). 
Neither reason, however, is currently persuasive for chemical 
substances that meet the proposed structural definition of PFAS. Under 
TSCA section 26(c), any action taken by EPA on a single chemical 
substance may also be taken with respect to a category of chemical 
substances, ``the members of which are similar in molecular 
structure.'' Here, it is not difficult or resource-consuming to 
identify a category to exclude, as the substances that meet the PFAS 
structural definition share a similar structure and are appropriately 
addressed as a category in this action. EPA has also committed to 
``[b]uild the evidence base on individual PFAS'' and ``use its 
authorities to impose appropriate limitations on the introduction of 
new unsafe PFAS into commerce and will, as appropriate, use all 
available regulatory and permitting authorities to limit emissions and 
discharges from industrial facilities.'' (Ref. 10). Additionally, due 
to the scientific complexities associated with assessing PFAS and the 
lack of data on most PFAS with regards to toxicity and exposure to 
human health and the environment, EPA expects in most cases to be 
unable to determine pursuant to TSCA section 5(h)(4) that a PFAS ``will 
not present an unreasonable risk'' under the conditions of use within 
the 30-day review period provided for LVE and LoREX notices. Reviewing 
all new PFAS as PMNs also will preserve EPA's authority to address 
information gaps when there is insufficient information on the chemical 
substance and further support the Agency's PFAS Strategic Roadmap, 
which lays out a whole-of-agency approach to addressing PFAS (see 
https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024).
    Under the existing regulations at 40 CFR 723.50(h)(2), at any time 
after EPA approves an LVE or LoREX notice, EPA can determine that 
manufacture of the new chemical substance does not meet the exemption 
criteria. If the Agency does so, it would notify the manufacturer by 
certified letter that EPA believes that the new chemical substance does 
not meet the

[[Page 34114]]

terms for the exemption. With these considerations in mind, EPA 
solicits comment on revoking previously granted LVEs for PFAS pursuant 
to the process set forth in 40 CFR 723.50(h)(2) and requiring those who 
wish to continue manufacture to submit a PMN.
    For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA 
is proposing to define ``PFAS'' using a structural definition. EPA is 
proposing to define PFAS as a chemical substance that contains at least 
one of these three structures:
    (1) R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are 
saturated carbons
    (2) R-CF2OCF2-R', where R and R' can either be F, O, or saturated 
carbons
    (3) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated 
carbons.
    Manufacturers of substances that do not meet this structural 
definition would remain eligible to submit an LVE or LoREX notice. The 
proposed chemical structure definition for PFAS is the same definition 
used for the Inactive PFAS SNUR (88 FR 4937, January 26, 2023).
    EPA determined that a structural definition was most appropriate 
for this rulemaking rather than developing a list of specifically 
identified substances. Since the substances that would be submitted in 
LVE or LoREX notices are new chemical substances, it is impractical to 
generate a comprehensive list of PFAS not on the TSCA Inventory that 
may be submitted in the future. Additionally, other TSCA requirements 
have relied on a structural definition when appropriate (e.g., the 
long-chain perfluoroalkyl carboxylate (LCPFAC) SNUR defines covered 
substances using a structural definition (40 CFR 721.10536), and the 
polymer exemption from PMN requirements defines covered PFAS polymers 
using structural definitions (40 CFR 723.250)). Furthermore, other 
scientific and regulatory bodies such as the OECD (Ref. 11) have 
defined PFAS using various structural definitions. Thus, there is clear 
precedent for using a structural definition for TSCA rules and other 
actions addressing PFAS.
    The proposed definition for PFAS does not include substances that 
only have a single fluorinated carbon or unsaturated fluorinated 
moieties (e.g., fluorinated aromatic rings and olefins), which are more 
susceptible to chemical transformation than their saturated 
counterparts, and therefore less likely to persist in the environment. 
These potentially degradable substances, if submitted to EPA in a LVE 
or LoREX notice, would still be evaluated by EPA and a decision made to 
either deny or grant the exemption. The proposed three-part structural 
definition for PFAS includes fluoropolymers.
    The first sub-structure (R-(CF2)-C(F)(R')R''), where both the CF2 
and CF moieties are saturated carbons and none of the R groups (R, R' 
or R'') can be hydrogen, has been the working definition of PFAS used 
by EPA's Office of Pollution Prevention and Toxics when identifying 
PFAS on the TSCA Inventory. For this rulemaking, EPA has decided to 
expand the working definition to include two additional sub-structures.
    The second sub-structure (R-CF2OCF2-R', where R and R' can either 
be F, O, or saturated carbons) aims to capture certain fluorinated 
ethers. Examples of substances that meet this sub-structure include, 
PFMOAA (CASRN 674-13-5) and other chemicals, with properties similar to 
hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt 
(known as ``GenX chemicals''), that have been found in the Cape Fear 
River.
    Finally, the third sub-structure (CF3C(CF3)R'R'', where R' and R'' 
can either be F or saturated carbons) aims to capture fluorinated 
substances that are more branched and would not otherwise meet the 
first or second sub-structure definitions due to their non-adjacent 
carbons. Although these substances have carbons that are not fully 
fluorinated and that may be more susceptible to degradation and 
metabolism, highly fluorinated moieties of the substance are still 
likely to be persistent.
    This proposed definition may not be identical to other definitions 
of PFAS used within EPA or by other organizations. The term ``PFAS'' 
has been used varyingly by many organizations for their distinct 
research and/or regulatory needs, and different definitions of the term 
``PFAS'' may be appropriate for such purposes. The Agency notes that 
this perspective, that different users may have distinct needs and that 
no single PFAS characterization or definition meets all needs, is 
shared by many other organizations, including OECD (see page 29, Ref. 
11). EPA proposes that the above definition of ``PFAS'' is the most 
appropriate definition for the proposal to make PFAS ineligible for 
future LVEs and LoREXs and acknowledges that there may be other rules 
or programs that apply different definitions to meet their own needs.
4. PBT Chemicals and LVEs and LoREXs
a. Background
    Currently, 40 CFR 723.50(d) describes certain criteria that EPA 
uses to determine the eligibility of chemical substances for 
manufacture under an LVE and LoREX. These criteria include the 
potential of a chemical substance to cause serious acute or chronic 
effects or significant environmental effects under anticipated 
conditions of manufacture, processing, distribution in commerce, use, 
or disposal. These criteria also extend to any reasonably anticipated 
metabolites, environmental transformation products, or byproducts of 
the chemical substance, as well as any reasonably anticipated 
impurities in the substance.
    Although numerous factors can contribute to the potential of a 
particular chemical substance to cause serious acute or chronic effects 
or significant environmental effects as described in 40 CFR 723.50(d), 
chemical substances that are persistent, bioaccumulative, and toxic 
(PBT) are of special concern because: (1) their persistence in the 
environment increases the likelihood of exposure of biological systems 
to those chemicals; (2) their bioaccumulative potential increases the 
probability that they will move vertically through and become embedded 
in trophic chains; and (3) their persistence and bioaccumulation 
potential, coupled with toxicity concerns, can result in risk to 
biological systems. Once PBT chemicals are released into the 
environment, they are often difficult or impossible to remediate.
    On November 4, 1999, EPA issued its policy statement (64 FR 60194) 
(Ref. 8) identifying a category for PBT new chemical substances. The 
1999 policy statement formally acknowledged PBT chemical substances as 
a category based on shared characteristics to facilitate premanufacture 
assessment and regulation. Furthermore, the PBT policy statement 
established EPA's current criteria for identifying PBT chemical 
substances for the New Chemicals Program, which involves using 
physical-chemical properties, as well as structural activity alerts, 
analogue data, and test data to quantify on a scale of 1 to 3 the 
potential for persistence (P), bioaccumulation (B), and toxicity (T) 
for a given new chemical substance. If a substance scores a 2 or above 
for all three characteristics, EPA considers the substance to be PBT. 
EPA emphasized in responses to comments received on the October 1998 
draft policy released for public comment that the decision to identify 
and assess a new chemical

[[Page 34115]]

substance as PBT would be based on the available data and would be made 
on a case-by-case basis.
b. Codifying EPA's Policy Concerning PBT Chemicals and LVEs and LoREXs
    At present, the exemption regulations at 40 CFR 723.50 do not 
expressly disqualify PBT chemical substances from eligibility for the 
LVE or LoREX. However, under TSCA section 5(h)(4), EPA may exempt a 
chemical substance from section 5 requirements upon application and by 
rule only if EPA determines the manufacture, processing, distribution 
in commerce, use, or disposal of the substance will not present an 
unreasonable risk. And as explained above, the regulations at 40 CFR 
723.50(d) provide that chemical substances that may cause serious acute 
or chronic effects or significant environmental effects are not 
eligible for the LVE or LoREX. When exposure of the environment or 
biological organisms (including humans) to a PBT chemical is expected, 
one or more of the conditions above (i.e., serious acute or chronic 
effects or significant environmental effects) is generally likely to 
occur, often making the PBT chemical ineligible for the exemptions. 
Whenever the potential for unreasonable exposures to a PBT chemical is 
identified during the review of an LVE or LoREX notice, EPA's 
longstanding policy has been to deny the exemption notice. However, 
EPA's specific concerns for PBT chemicals as they relate to LVEs and 
LoREXs are not separately codified in the existing regulations at 40 
CFR 723.50.
    EPA is therefore proposing amendments to 40 CFR 723.50(d) that 
would codify EPA's long-standing practice that, whenever EPA identifies 
a chemical substance under LVE or LoREX review (or any reasonably 
anticipated metabolites, environmental transformation products, or 
byproducts of the substance, or any reasonably anticipated impurities 
in the substance) as PBT with anticipated environmental releases and 
potentially unreasonable exposures to humans or environmental 
organisms, that substance would be ineligible for the LVE or LoREX. The 
proposed amendments clarify that PBT chemicals with anticipated 
environmental releases and potentially unreasonable human or 
environmental organism exposures would be ineligible for the LVE or 
LoREX but would not prevent companies from submitting an exemption 
notice for a given substance. The finding that a substance is PBT would 
be made by EPA during the review of the notice. While EPA has offered 
generic guidance regarding how it determines the PBT status of chemical 
substances, the policies and science used to ascribe discrete scores 
(i.e., 1-3) to the persistence, bioaccumulative potential, and toxicity 
of a particular chemical substance are based on the available data and 
made on a case-by-case basis. As such, a submitter may not be able to 
determine in advance of submitting an exemption notice if EPA would 
find the substance to be PBT. Although EPA is ultimately responsible 
for assessing whether chemical substances are potentially PBT, 
submitters who possess data indicating that their new chemical 
substances could be PBT and could be handled in such a way as to result 
in anticipated or unreasonable exposures may be less likely to expend 
the time and resources to submit an LVE or LoREX notice for EPA review 
of those substances if the outcome of the review would almost certainly 
be denial of the notice.
    EPA is further proposing to define ``PBT chemical substance'' for 
purposes of 40 CFR 723.50 as ``a chemical substance possessing 
characteristics of persistence (P) in the environment, accumulation in 
biological organisms (bioaccumulation (B)), and toxicity (T) resulting 
in potential risks to humans and ecosystems. For more information on 
EPA's Policy on new chemical substances that are PBT, see EPA's 1999 
policy statement (64 FR 60194; November 4, 1999).''

E. Amendments Related to Suspensions of the Review Period

    EPA is proposing to amend 40 CFR 720.75(b)(2) to allow PMN, SNUN, 
LVE, and LoREX submitters to request a suspension of the notice review 
period for up to 30 days orally or in writing, including by email, 
without the need for a formal, written request submitted to EPA via CDX 
using e-PMN software. EPA is similarly proposing to amend 40 CFR 
725.54(c) to permit MCAN submitters to request suspensions for up to 30 
days orally or in writing, including by email, without the need for a 
formal, written request submitted to EPA via CDX using e-PMN software. 
EPA would continue to require that all requests for suspensions 
exceeding 30 days be submitted electronically to EPA via CDX using e-
PMN software.
    When the notice or exemption review period for a PMN, SNUN, LVE, or 
LoREX approaches its end, submitters may request that EPA suspend the 
running of the notice review period so that the review period does not 
expire (40 CFR 720.75(b); see also 40 CFR 721.25(c) and 723.50(g)(1), 
applying the 720.75(b) suspension procedures to SNUNs, LVEs, and 
LoREXs). The existing regulations at 720.75(b) specify that such 
requests can be made orally to EPA, so long as the length of the 
suspension does not exceed 15 days; suspensions exceeding 15 days must 
be submitted to EPA in writing via CDX using EPA's e-PMN software. At 
the submitter's request, EPA can suspend a notice review period until 
the review is complete and a decision has been made for the notice. 
Once a final decision is made, any remaining suspension days are 
rescinded.
    Currently, the regulations at 40 CFR 725.54, which pertain to the 
suspension of the review period for MCANs and exemptions related to 
microorganisms (e.g., TSCA Environmental Release Applications (TERA) 
and Tier II submissions) mirror those at 720.75(b) for PMNs, SNUNs, 
LVEs, and LoREXs. As in 40 CFR 720.75(b), the language at 40 CFR 725.54 
indicates that submitters may suspend a notice or exemption review 
period for up to 15 days via oral request, or for greater than 15 days 
via a formal, written request submitted to EPA via CDX using EPA's e-
PMN software. Although suspensions occur less frequently during the 
reviews of notices and exemptions for microorganisms than during 
reviews for PMNs, SNUNs, LVEs, and LoREXs, submitters do occasionally 
request suspensions in order to develop additional information.
    Given the relative ease and value of suspending a notice review 
period via informal oral request, most submitters who seek suspensions 
opt to suspend for 15 days whenever their case is nearing expiration of 
its review period to allow EPA to finalize its review. If a case is 
suspended, it is often suspended more than once, and submitters 
typically informally request multiple 15-day suspensions rather than 
requesting a longer suspension in writing via CDX. As such, EPA is 
proposing to allow for informal suspensions up to 30 days to reduce the 
number of repeated informal requests. Additionally, EPA believes that 
email may be more expedient than oral communication for many 
submitters. Therefore, EPA is proposing amendments to allow submitters 
to request suspensions for up to 30 days either orally or via email.
    EPA is seeking comment on its proposal to increase the number of 
days permissible for suspensions not requiring a formal, written 
request submitted to EPA via CDX using e-PMN software. Specifically, 
EPA requests comment on its proposal to permit requests for suspensions 
up to 30 days to be communicated orally or via email, and to update the 
relevant regulations

[[Page 34116]]

pertaining to suspension of microorganism-related submissions under 40 
CFR 725.54 to mirror the proposed changes for suspension of PMNs, 
SNUNs, LVEs, and LoREXs. EPA is not considering, proposing, or 
requesting comment on any additional changes to the regulations 
regarding suspensions at this time.

IV. Economic Analysis

    The estimated incremental impacts of this rulemaking are briefly 
summarized in this unit and the complete Economic Analysis (Ref. 1) is 
available in the docket. The proposed rule is expected primarily to 
affect two types of firms:
    (1) Manufacturers of PFAS who would have submitted an LVE or LoREX 
in the baseline but would need to submit a PMN under the proposed rule 
due to the proposed amendment to make PFAS ineligible for the 
exemptions; and
    (2) Firms submitting any TSCA section 5 notices through the PMN 
form (PMNs, SNUNs, LVEs, LoREXs, TMEs) that are expected to submit 
fewer amendments to their original submissions due to the amended 
procedural requirements of the proposed rule.
    While the proposed rule includes additional amendments to the new 
chemicals regulations under TSCA, EPA expects that these additional 
amendments will not result in incremental burden or savings because 
they are largely already performed in the baseline.
    As a result of this proposed rule, EPA expects that the average 
number of amendments per notice will decrease from 1.81 to 0.9, with a 
decrease in burden to EPA of 12 hours per avoided amendment. In 
addition, EPA expects that the 12 annual average of LVE submissions for 
PFAS will instead be submitted as PMNs. It is expected that individual 
submitters of PMNs will experience an overall decrease in burden of 13 
hours with an associated decrease in cost of approximately $1,120 per 
notice.
    Additionally, improvements in the submission process are expected 
to reduce inefficiency in the Agency's review process. As a result of 
the changes under the proposed rule, it is expected that the cost to 
the Agency associated with reviewing PMNs, SNUNs, and exemption notices 
will decrease by ten percent. Therefore, it is expected that the Agency 
will experience an annual cost savings of approximately $923,280.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Economic Analysis for Proposed Updates to New Chemicals 
Regulations under the Toxic Substances Control Act (TSCA). May 2023.
2. EPA. Central Data Exchange Online User Guide. Accessible at: 
https://cdx.epa.gov/About/UserGuide.
3. 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.
4. EPA. TSCA New Chemical Engineering Initiative to Increase 
Transparency and Reduce Re-work. Accessible at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering.
5. EPA. Tables Detailing the Proposed Amendments to Add Details to 
40 CFR part 720.45 Reporting Requirements and Enhancements to the 
CDX Reporting Form. May 2023.
6. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA); Updates to New 
Chemicals Regulations under the Toxic Substances Control Act; 
Proposed Rule (RIN 2070-AK65); EPA ICR No. 2749.01; OMB Control No. 
2070-[NEW]. May 2023.
7. EPA. Premanufacture Notification; Premanufacture Notice 
Requirements and Review Procedures; Final Rule. Federal Register. 48 
FR 21722; May 13, 1983 (TSH-FRL 2998-5).
8. EPA. Policy Statement on Category for Persistent, 
Bioaccumulative, and Toxic New Chemical Substances. Federal 
Register. (64 FR 60194, November 4, 1999) (FRL-6097-7).
9. EPA. Press Release: EPA Announces Changes to Prevent Unsafe New 
PFAS from Entering the Market. April 27, 2021.
10. EPA. PFAS Strategic Roadmap: EPA's Commitments to Action 2021-
2024. October 18, 2021. Accessed at: https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
11. OECD. Reconciling Terminology of the Universe of Per- and 
Polyfluoroalkyl Substances: Recommendations and Practical Guidance. 
July 9, 2021. Accessed at: https://one.oecd.org/document/ENV/CBC/MONO(2021)25/En/pdf.

VI. 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 not a significant regulatory action as defined in 
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by 
Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore 
not subject to review under Executive Order 12866.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have 
been submitted to OMB for review and approval under the PRA (44 U.S.C. 
3501 et seq.). The Information Collection Request (ICR) document that 
EPA prepared has been assigned EPA ICR No. 2749.01 (Ref. 6). This ICR 
represents an amendment to the currently approved ICR that covers the 
information collection activities contained in the existing 
regulations, which are approved under OMB control number 2070-0012 (EPA 
ICR No. 574.15). Estimates presented in the ICR below reflect the minor 
incremental changes associated with the rule that are presented in the 
Economic Analysis (Ref. 1). EPA is proposing amendments to the new 
chemicals procedural regulations under TSCA. These amendments are 
intended to align the regulatory text with the amendments to TSCA's new 
chemicals review provisions and improve the efficiency of EPA's review 
processes and update the regulations based on existing policies and 
experience implementing the New Chemicals Program. You can find copies 
of the Economic Analysis and ICR in the docket, and the ICR is briefly 
summarized here.
    Respondents/affected entities: Certain manufacturers (including 
importers) and processors (see Unit I.A.).
    Respondent's obligation to respond: Mandatory under TSCA section 5.
    Estimated number of respondents: 560.
    Frequency of response: On occasion, i.e., upon submission of a PMN, 
SNUN, LVE, LoREX, or MCAN.
    Total estimated incremental burden: Estimates show that this 
proposed rule will decrease existing approved burden by 4,518 hours per 
year. Burden is defined at 5 CFR 1320.3(b).
    Total estimated incremental cost: Estimates show that this proposed 
rule

[[Page 34117]]

will increase existing approved costs by $45,120 per year. This 
includes $0 annualized capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates and any suggested methods for 
minimizing respondent burden to EPA using the docket identified at the 
beginning of this rulemaking. EPA will respond to any ICR-related 
comments in the final rule. You may also send your ICR-related comments 
to OMB's Office of Information and Regulatory Affairs using the 
interface at https://www.reginfo.gov/public/do/PRAMain. Find this 
particular ICR by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. OMB must receive comments 
no later than July 25, 2023.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The Agency's basis is briefly summarized here and is 
detailed in the Economic Analysis (Ref. 1).
    The majority of firms that submit a TSCA section 5 notice will 
realize either no change or a decrease in costs associated with form 
submission. However, EPA expects that firms that submit LVE notices for 
PFAS will incur an estimated cost of approximately $45,863 per notice 
due to the greater burden and non-labor costs associated with 
submitting a PMN form. EPA estimates that 99 percent of small firms 
(185 firms) will have cost impacts of less than 1 percent of revenues, 
less than 1 percent (1 firms) will have cost impacts between 1 and 3 
percent of revenues, and 1 percent (2 firms) will have cost impacts 
greater than 3 percent of revenues.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The action imposes 
no enforceable duty on any state, local or tribal governments and the 
incremental cost on the private sector is estimated to be less than 
$50,000. Based on EPA's experience with reviewing actions under TSCA 
section 5, state, local, and tribal governments have not been impacted 
by these rulemakings, and EPA does not have any reasons to believe that 
any state, local, or tribal government would engage in the activities 
such that they would be impacted by this rulemaking. In addition, based 
on the Economic Analysis prepared for this proposed rule (Ref. 1), EPA 
concludes that this rulemaking is not expected to result in 
expenditures by the private sector of $100 million or more (when 
adjusted annually for inflation) in any one year. Accordingly, this 
rulemaking is not subject to the requirements of UMRA sections 202, 
203, or 205. The Economic Analysis (Ref. 1) for this action is 
summarized in Unit IV. and is available in the docket.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have substantial direct effects on the states, on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-201 of the Executive Order. Therefore, 
this action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk. Since this action 
does not concern human health risks, EPA's Policy on Children's Health 
also does not apply. This procedural rule would align the procedural 
regulations codified at 40 CFR parts 720 and 725 with amended TSCA and 
make additional updates based on existing policies or lessons learned 
from administering the New Chemicals Program since TSCA was amended in 
2016.
    Although this procedural rule itself would not directly affect the 
level of protection provided to human health or the environment, EPA 
expects that the rule would improve the Agency's consideration of risks 
to children--in furtherance of EPA's Policy on Children's Health--and 
other PESS. In turn, EPA anticipates that the proposed amendments would 
help better inform the Agency's determinations for each new chemical 
substance or significant new use for which it received a notice under 
TSCA section 5(a)(1), pertaining to the likelihood of unreasonable risk 
to human health or the environment under known, intended or reasonably 
foreseen conditions of use. EPA uses an integrated approach that draws 
on knowledge and experience across disciplinary and organizational 
lines to identify and evaluate concerns regarding health and 
environmental effects, and exposure and release.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, distribution 
or use of energy and has not otherwise been designated as a significant 
energy action by the Administrator of the Office of Information and 
Regulatory Affairs.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards under the 
NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
Federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or Indigenous 
peoples) and low-income

[[Page 34118]]

populations. This action is procedural in nature. Therefore, EPA 
believes that it is not practicable to assess whether the human health 
or environmental conditions that exist prior to this action result in 
disproportionate and adverse effects on people of color, low-income 
populations and/or Indigenous peoples. By proposing, among other 
things, to include overburdened communities in the regulatory 
definition of PESS.
    The Agency believes that this action would assist EPA and others in 
determining the potential exposures, hazards and risks to overburdened 
communities associated with the manufacture, processing, distribution 
in commerce, use, or disposal of the new chemical substances and 
significant new uses of chemical substances subject to this rulemaking. 
EPA anticipates that the inclusion of overburdened communities among 
the PESS considered in the Agency's review of a TSCA section 5 
submission would also enable the Agency, if necessary, to design 
appropriate future risk management actions to address an unreasonable 
risk that the Agency may determine is presented by that chemical 
substance and to consider how such risk management actions would affect 
communities with environmental justice concerns.

List of Subjects in 40 CFR Parts 720, 721, 723, and 725

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

    Dated: May 16, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

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

PART 720--PREMANUFACTURE NOTIFICATION

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

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

Sec.  720.1  [Amended]

0
2. Amend Sec.  720.1 by removing the phrase ``The rule'' and adding in 
its place the phrase ``This part'' wherever it appears.
0
3. Amend Sec.  720.3 by adding new paragraphs (ll) and (mm) to read as 
follows:

Sec.  720.3  Definitions.

* * * * *
    (ll) Applicable review period means the period starting on the date 
EPA receives a complete notice under section 5(a)(1) of the Act and 
ending 90 days after that date or on such date as is provided for in 
sections 5(b)(1) or 5(c) of the Act.
    (mm) Potentially exposed or susceptible subpopulation means a group 
of individuals within the general population identified by EPA who, due 
to either greater susceptibility or greater exposure, may be at greater 
risk than the general population of adverse health effects from 
exposure to a chemical substance or mixture, such as infants, children, 
pregnant women, workers, the elderly, or overburdened communities.
* * * * *
0
4. Amend Sec.  720.40 by revising paragraph (f) to read as follows:

Sec.  720.40  General.

* * * * *
    (f) New information. During the applicable review period, if the 
submitter possesses, controls, or knows of new information that 
materially adds to or changes the information included in the notice, 
the submitter must submit that information to EPA within ten days of 
receiving the new information, but no later than five days before the 
end of the applicable review period. The new information must be 
submitted electronically to EPA via CDX and must clearly identify the 
submitter and the notice to which the new information is related. If 
the new information becomes available during the last five days of the 
applicable review period, the submitter must immediately inform its EPA 
contact for that notice by telephone or email and submit the new 
information electronically to EPA via CDX.
* * * * *
0
5. Amend Sec.  720.45 by:
0
a. Revising paragraphs (a)(4) and (5);
0
b. Revising paragraphs (f) through (h); and
0
c. Adding paragraphs (j) and (k).
    The revisions and additions read as follows:

Sec.  720.45  Information that must be included in the notice form.

    (a) * * *
    (4) If an importer submitting the notice cannot provide all the 
information specified in paragraphs (a)(1) and (2) of this section 
because it is claimed as confidential by the foreign supplier of the 
substance, the importer must have the foreign supplier follow the 
procedures in paragraph (a)(3) of this section and provide the correct 
chemical identity information specified in paragraphs (a)(1) and (2) of 
this section directly to EPA in a joint submission or as a letter of 
support to the notice, which clearly references the importer's notice 
and PMN User Fee Identification Number. The statutory review period 
will commence upon receipt of both the notice and the complete, correct 
information, in accordance with Sec.  720.65.
    (5) If a manufacturer cannot provide all the information specified 
in paragraphs (a)(1) and (2) of this section because the new chemical 
substance is manufactured using a reactant having a specific chemical 
identity claimed as confidential by its supplier, the manufacturer must 
submit a notice directly to EPA containing all the information known by 
the manufacturer about the chemical identity of the reported substance 
and its proprietary reactant. In addition, the manufacturer must ensure 
that the supplier of the confidential reactant submit a letter of 
support directly to EPA providing the specific chemical identity of the 
confidential reactant, including the CAS number, if available, and the 
appropriate PMN or exemption number, if applicable. The letter of 
support must reference the manufacturer's name and PMN Fee 
Identification Number. The statutory review period will commence upon 
receipt of the notice, the letter of support, and the complete, correct 
information in accordance with Sec.  720.65.
* * * * *
    (f)(1) A description of the intended category or categories of 
consumer or commercial use by function and application, which includes 
a description of the following:
    (i) The estimated percent of production volume devoted to each 
category of use.
    (ii) The percent of the new chemical substance in the formulation 
for each commercial or consumer use.
    (iii) The types of products or articles that would incorporate the 
new chemical substance (e.g., household cleaners, plastic articles).
    (iv) Information related to the use of products or articles 
containing the new chemical substance by potentially exposed or 
susceptible subpopulations.
    (v) How and where a product or article incorporating the new 
chemical substance would be used (e.g., spray applied indoors, brushed 
on outdoor surfaces).
    (vi) Consumption rates and frequency and duration of use of 
products or articles incorporating the new chemical substance.
    (2) Using the applicable codes listed in table 1 to paragraph 
(f)(2), submitters must designate the consumer and commercial product 
category or categories that best describe the

[[Page 34119]]

consumer and commercial products in which the new chemical substance is 
intended or known to be used.

Table 1 to Paragraph (f)(2)--Codes for Reporting Consumer and Commercial
                           Product Categories
------------------------------------------------------------------------
           Code                               Category
------------------------------------------------------------------------
  Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101....................  Construction and building materials covering
                            large surface areas including stone,
                            plaster, cement, glass and ceramic articles;
                            fabrics, textiles, and apparel.
CC102....................  Furniture & furnishings including plastic
                            articles (soft); leather articles.
CC103....................  Furniture & furnishings including stone,
                            plaster, cement, glass and ceramic articles;
                            metal articles; or rubber articles.
CC104....................  Leather conditioner.
CC105....................  Leather tanning, dye, finishing, impregnation
                            and care products.
CC106....................  Textile (fabric) dyes.
CC107....................  Textile finishing and impregnating/surface
                            treatment products.
CC108....................  All-purpose foam spray cleaner.
CC109....................  All-purpose liquid cleaner/polish.
CC110....................  All-purpose liquid spray cleaner.
CC111....................  All-purpose waxes and polishes.
CC112....................  Appliance cleaners.
CC113....................  Drain and toilet cleaners (liquid).
CC114....................  Powder cleaners (floors).
CC115....................  Powder cleaners (porcelain).
CC116....................  Dishwashing detergent (liquid/gel).
CC117....................  Dishwashing detergent (unit dose/granule).
CC118....................  Dishwashing detergent liquid (hand-wash).
CC119....................  Dry cleaning and associated products.
CC120....................  Fabric enhancers.
CC121....................  Laundry detergent (unit-dose/granule).
CC122....................  Laundry detergent (liquid).
CC123....................  Stain removers.
CC124....................  Ion exchangers.
CC125....................  Liquid water treatment products.
CC126....................  Solid/Powder water treatment products.
CC127....................  Liquid body soap.
CC128....................  Liquid hand soap.
CC129....................  Solid bar soap.
CC130....................  Air fresheners for motor vehicles.
CC131....................  Continuous action air fresheners.
CC132....................  Instant action air fresheners.
CC133....................  Anti-static spray.
CC134....................  Apparel finishing, and impregnating/surface
                            treatment products.
CC135....................  Insect repellent treatment.
CC136....................  Pre-market waxes, stains, and polishes
                            applied to footwear.
CC137....................  Post-market waxes, and polishes applied to
                            footwear (shoe polish).
CC138....................  Waterproofing and water-resistant sprays.
------------------------------------------------------------------------
    Chemical Substances in Construction, Paint, Electrical, and Metal
                                Products
------------------------------------------------------------------------
CC201....................  Fillers and putties.
CC202....................  Hot-melt adhesives.
CC203....................  One-component caulks.
CC204....................  Solder.
CC205....................  Single-component glues and adhesives.
CC206....................  Two-component caulks.
CC207....................  Two-component glues and adhesives.
CC208....................  Adhesive/Caulk removers.
CC209....................  Aerosol spray paints.
CC210....................  Lacquers, stains, varnishes and floor
                            finishes.
CC211....................  Paint strippers/removers.
CC212....................  Powder coatings.
CC213....................  Radiation curable coatings.
CC214....................  Solvent-based paint.
CC215....................  Thinners.
CC216....................  Water-based paint.
CC217....................  Construction and building materials covering
                            large surface areas, including wood
                            articles.
CC218....................  Construction and building materials covering
                            large surface areas, including paper
                            articles; metal articles; stone, plaster,
                            cement, glass and ceramic articles.
CC219....................  Machinery, mechanical appliances, electrical/
                            electronic articles.
CC220....................  Other machinery, mechanical appliances,
                            electronic/electronic articles.
CC221....................  Construction and building materials covering
                            large surface areas, including metal
                            articles.
CC222....................  Electrical batteries and accumulators.
------------------------------------------------------------------------

[[Page 34120]]

 
 Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC301....................  Packaging (excluding food packaging),
                            including paper articles.
CC302....................  Other articles with routine direct contact
                            during normal use, including paper articles.
CC303....................  Packaging (excluding food packaging),
                            including rubber articles; plastic articles
                            (hard); plastic articles (soft).
CC304....................  Other articles with routine direct contact
                            during normal use including rubber articles;
                            plastic articles (hard).
CC305....................  Toys intended for children's use (and child
                            dedicated articles), including fabrics,
                            textiles, and apparel; or plastic articles
                            (hard).
CC306....................  Adhesives applied at elevated temperatures.
CC307....................  Cement/concrete.
CC308....................  Crafting glue.
CC309....................  Crafting paint (applied to body).
CC310....................  Crafting paint (applied to craft).
CC311....................  Fixatives and finishing spray coatings.
CC312....................  Modelling clay.
CC313....................  Correction fluid/tape.
CC314....................  Inks in writing equipment (liquid).
CC315....................  Inks used for stamps.
CC316....................  Toner/Printer cartridge.
CC317....................  Liquid photographic processing solutions.
------------------------------------------------------------------------
    Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
                                Products
------------------------------------------------------------------------
CC401....................  Exterior car washes and soaps.
CC402....................  Exterior car waxes, polishes, and coatings.
CC403....................  Interior car care.
CC404....................  Touch up auto paint.
CC405....................  Degreasers.
CC406....................  Liquid lubricants and greases.
CC407....................  Paste lubricants and greases.
CC408....................  Spray lubricants and greases.
CC409....................  Anti-freeze liquids.
CC410....................  De-icing liquids.
CC411....................  De-icing solids.
CC412....................  Lock de-icers/releasers.
CC413....................  Cooking and heating fuels.
CC414....................  Fuel additives.
CC415....................  Vehicular or appliance fuels.
CC416....................  Explosive materials.
CC417....................  Agricultural non-pesticidal products.
CC418....................  Lawn and garden care products.
------------------------------------------------------------------------
      Chemical Substances in Products Not Described by Other Codes
------------------------------------------------------------------------
CC980....................  Other (specify).
CC990....................  Non-TSCA use.
------------------------------------------------------------------------

    (g) For sites controlled by the submitter:
    (1) The identity and address of each site where the new chemical 
substance will be manufactured, processed, or used.
    (2) A process description of each manufacture, processing, and use 
operation which includes a diagram of the major unit operations and 
chemical conversions; indication of whether batch or continuous 
manufacturing or processing occurs at the site, and the amount 
manufactured or processed per batch or per day if continuous and per 
year; the identity, approximate weight per batch or per day for 
continuous production, and entry point of all starting materials and 
feedstocks (including reactants, solvents, catalysts, etc.); the 
identity, approximate weight per batch or per day for continuous 
production, and entry point of all products, recycle streams, and 
wastes, including frequency of any equipment cleaning; the type of 
interim storage and transport containers used; and the points of 
release of the new chemical substance numbered. If the new chemical 
substance is released to two media at the same step in the process, 
assign a second number for the second medium.
    (3) Worker exposure information, including worker exposure 
information from exempt manufacture or related use of the new chemical 
substance under Sec.  720.30 (e.g., byproduct, impurity). This 
information includes:
    (i) Worker activities.
    (ii) Type of potential worker exposure (e.g., dermal, inhalation).
    (iii) Protective equipment in place, if any, including a 
description of the kind of gloves, protective clothing, goggles, or 
respirator that limit worker exposure, if any.
    (iv) Engineering controls in place, if any.
    (v) Physical form of the new chemical substance to which workers 
may be exposed and moisture content if physical form is solid.
    (vi) The percent of new chemical substance in formulation at time 
of worker exposure.
    (vii) The number of workers reasonably likely to be exposed.
    (viii) The duration of activities.
    (4) Information on release of the new chemical substance to the 
environment, including releases from the exempt manufacture or related 
use of the new

[[Page 34121]]

chemical substance under Sec.  720.30 (e.g., byproduct, impurity). This 
information includes the type of release (e.g., transport, interim 
storage, disposal, equipment cleaning), the quantity of the new 
chemical substance released directly to the environment, the quantity 
of the new chemical substance released into control technology, the 
quantity of the new chemical substance released to the environment 
after control technology, the media of release, the type of control 
technology used, and the following additional information based on the 
type of release:
    (i) For equipment cleaning releases, frequency of equipment 
cleaning and what is used to clean the equipment.
    (ii) For transport and storage releases, how the new chemical 
substance or product containing the new chemical substance is 
transported from the site and stored, whether dedicated containers are 
used, whether the cleaning and disposal of the containers is under the 
submitter's control, the container cleaning method, the frequency of 
container cleaning, and the amount of release per container cleaning.
    (iii) For releases into air, Clean Air Act operating permit numbers 
and a description of any Leak Detection and Repair program in 
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the 
monitoring and management of fugitive releases) the site has 
implemented.
    (iv) For releases into water, the National Pollutant Discharge 
Elimination System (NPDES) permit number(s), the name(s) of the 
navigable waterway(s) into which the release occurs, and other 
destination(s) into which the release occurs.
    (v) For releases into wastewater treatment plants, the name(s) of 
the publicly owned treatment work(s) (POTW) into which the release 
occurs and the corresponding NPDES permit number(s).
    (h) For sites not controlled by the submitter:
    (1) The identity and address of each site where the new chemical 
substance will be manufactured, processed, or used.
    (2) A description of each type of processing and use operation 
involving the new chemical substance, including identification of the 
estimated number of processing or use sites; a process description of 
each operation which includes a diagram of the major unit operations 
and chemical conversions; the identity, approximate weight per batch or 
per day for continuous production, and entry point of all starting 
materials and feedstocks (including reactants, solvents, catalysts, 
etc.); the identity, approximate weight per batch or per day for 
continuous production, and entry point of all products, recycle 
streams, and wastes, including frequency of any equipment cleaning; the 
type of interim storage and transport containers used; and the points 
of release of the new chemical substance numbered. If the new chemical 
substance is released to two media at the same step in the process, 
assign a second number for the second medium.
    (3) Worker exposure information, including worker exposure 
information from exempt manufacture or related use of the new chemical 
substance under Sec.  720.30 (e.g., byproduct, impurity). This 
information includes:
    (i) Worker activities.
    (ii) Type of potential worker exposure (e.g., dermal, inhalation).
    (iii) Protective equipment in place, if any, including a 
description of the kind of gloves, protective clothing, goggles, or 
respirator that limit worker exposure, if any.
    (iv) Engineering controls in place if any.
    (v) Physical form of the new chemical substance to which workers 
may be exposed and moisture content if physical form is solid.
    (vi) The percent of new chemical substance in formulation at time 
of worker exposure.
    (vii) The number of workers reasonably likely to be exposed.
    (viii) The duration of activities.
    (4) Information on release of the new chemical substance to the 
environment, including releases from the exempt manufacture or related 
use of the new chemical substance under Sec.  720.30 (e.g., byproduct, 
impurity). This information includes the type of release (e.g., 
transport, interim storage, disposal, equipment cleaning), the quantity 
of the new chemical substance released directly to the environment, the 
quantity of the new chemical substance released into control 
technology, the quantity of the new chemical substance released to the 
environment after control technology, the media of release, the type of 
control technology used, and the following additional information based 
on the type of release:
    (i) For equipment cleaning releases, frequency of equipment 
cleaning and what is used to clean the equipment.
    (ii) For transport and storage releases, how the new chemical 
substance or product containing the new chemical substance is 
transported from the site and stored, whether dedicated containers are 
used, whether the cleaning and disposal of the containers is under the 
submitter's control, the container cleaning method, the frequency of 
container cleaning, and the amount of release of the new chemical 
substance per container cleaning.
    (iii) For releases into air, Clean Air Act operating permit numbers 
and a description of any Leak Detection and Repair program in 
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the 
monitoring and management of fugitive releases) the site has 
implemented.
    (iv) For releases into water, the National Pollutant Discharge 
Elimination System (NPDES) permit number(s), the name(s) of the 
navigable waterway(s) into which the release occurs, and other 
destination(s) into which the release occurs.
    (v) For releases into wastewater treatment plants, the name(s) of 
the publicly owned treatment work(s) (POTW) into which the release 
occurs and the corresponding NPDES permit number(s).
* * * * *
    (j) The physical and chemical properties and environmental fate 
characteristics of the new chemical substance, which includes the 
following:
    (1) For physical and chemical properties, such information includes 
boiling/sublimation temperature, density/relative density, dissociation 
constant, explodability, flammability, melting temperature, octanol/
water partition coefficient, particle size distribution, particle size 
distribution analysis, the physical state of the neat substance, pH, 
solubility, vapor pressure, volatilization from water, volatilization 
from soil, spectra, UV-VIS absorption data, and surface tension. For 
nanomaterials, such information also includes aspect ratio, thickness, 
and number of layers or walls.
    (2) For environmental fate characteristics, such information 
includes hydrolysis, photolysis, aerobic and anaerobic biodegradation, 
atmospheric oxidation half-lives, Henry's law constant, adsorption/
desorption coefficient, bioaccumulation or bioconcentration factor, 
Incineration Removal Efficiency (Destruction and Removal Efficiencies 
or DREs), and Sewage Treatment (WWTP) Removals.
    (k) Information about pollution prevention efforts, such as using 
alternative fuel sources, reducing the use of water and chemical 
inputs, modifying a production process to produce less waste, or 
implementing water and energy conservation practices, or substituting 
for riskier existing products. Inclusion of this information is 
optional.

[[Page 34122]]

0
6. Amend Sec.  720.50 by revising paragraph (a)(4)(ii) to read as 
follows:

Sec.  720.50  Submission of test data and other data concerning the 
health and environmental effects of a substance.

    (a) * * *
    (4) * * *
    (ii) If a test or experiment is completed before the applicable 
review period ends, the person must submit the study, report, or test 
electronically to EPA via CDX, as specified in paragraph (a)(3)(i) of 
this section, within ten days of receiving it, but no later than five 
days before the end of the review period. If the test or experiment is 
completed during the last five days of the review period, the submitter 
must inform its EPA contact for that notice by telephone or email prior 
to the end of the review period and submit the study, report, or test 
electronically to EPA via CDX.
* * * * *
0
7. Amend Sec.  720.65 by:
0
a. Revising paragraphs (a) through (c);
0
b. Redesignating paragraph (d) as paragraph (e);
0
c. Adding a new paragraph (d); and
0
d. Revising newly redesignated paragraph (e).
    The revisions and addition read as follows:

Sec.  720.65  Acknowledgement of receipt of a notice; errors in the 
notice; incomplete submissions; and false and misleading statements.

    (a) Notification to the submitter. (1) EPA will acknowledge receipt 
of each notice by sending a letter via CDX or U.S. mail to the 
submitter that identifies the premanufacture notice number assigned to 
the new chemical substance and date on which the applicable review 
period begins as described in paragraph (a)(2) of this section.
    (2) Before EPA sends an acknowledgement of receipt of a notice 
pursuant to paragraph (a)(1) of this section, EPA will conduct a pre-
screen of the notice, typically taking 2-3 days and according to the 
criteria under paragraphs (b)(1) and (c)(1) of this section.
    (i) If EPA concludes that the notice contains errors warranting 
remedy or is incomplete, EPA will notify the submitter according to 
paragraph (d)(3) of this section. The applicable review period will not 
begin. Once the submitter corrects the errors or incomplete submission 
according to the requirements provided by EPA and re-submits it to EPA, 
EPA will follow the procedures of paragraph (a)(2) of this section.
    (ii) If EPA does not identify errors or determine the notice to be 
incomplete during screening, EPA will notify the submitter according to 
paragraph (a)(1) of this section. The applicable review period will 
begin on the date EPA received the complete notice.
    (b) Errors in the notice. (1) Within 30 days of receipt of the 
notice, EPA may request that the submitter remedy errors in the notice. 
The following are examples of such errors:
    (i) Typographical errors that cause data to be misleading or 
answers to any questions to be unclear.
    (ii) Contradictory information.
    (iii) Ambiguous statements or information.
    (2) The applicable review period does not begin for notices 
containing errors that EPA asks the submitter to remedy until 
corrections are made following the procedures of paragraph (d) of this 
section.
    (c) Incomplete submissions. (1) A submission is not complete, and 
the applicable review period does not begin, if:
    (i) The wrong person submits the notice form.
    (ii) The submitter does not sign the notice form.
    (iii) Some or all of the information in the notice or the 
attachments are not in English, except for published scientific 
literature.
    (iv) The submitter does not submit the notice in the manner set 
forth in Sec.  720.40(a)(2).
    (v) The submitter does not provide information that is required by 
section 5(d)(1)(B) and (C) of the Act and Sec.  720.50.
    (vi) The submitter does not provide information required by Sec.  
720.45 or indicate that it is not known to or reasonably ascertainable 
by the submitter.
    (vii) The submitter does not submit a second copy of the submission 
with all confidential information deleted for the public file, as 
required by Sec.  720.80(b)(2).
    (viii) The submitter does not include any information required by 
section 5(b)(1) of the Act and pursuant to a rule promulgated under 
section 4 of the Act, as required by Sec.  720.40(g).
    (ix) The submitter does not submit data which the submitter 
believes show that the chemical substance will not present an 
unreasonable risk of injury to health or the environment, if EPA has 
listed the chemical substance under section 5(b)(4) of the Act, as 
required in Sec.  720.40(h).
    (x) The submitter does not include an identifying number and a 
payment identity number as required by 40 CFR 700.45(e)(3).
    (2) The submission may be declared incomplete if at any time during 
the applicable review period the submitter submits additional or 
revised information without demonstrating to EPA's satisfaction that 
the additional or revised information in the amended notice was not 
known to or reasonably ascertainable by the submitter at the time of 
initial notice submission (e.g., new information as described in Sec.  
720.40(f) or information from testing in progress at the time of the 
original submission, as described in Sec.  720.50(a)(4)), unless it 
relates to administrative or non-substantive amendments (e.g., changing 
the technical point of contact) or amendments made at the request of 
EPA.
    (d) Corrections to errors in the notice or incomplete submissions. 
(1) If EPA receives an incomplete submission or seeks remedy of errors 
identified in a notice, EPA will notify the submitter within 30 days of 
receipt that the submission contains errors or is incomplete and that 
the applicable review period will not begin until EPA receives a 
correct and complete notice.
    (2) If EPA obtains additional information during the applicable 
review period that indicates the original submission was incomplete, 
EPA may declare the submission incomplete within 30 days after EPA 
obtains the additional information and so notify the submitter.
    (3) The notification that a submission contains errors or is 
incomplete under paragraph (d)(1) or (2) of this section will include:
    (i) A statement of the basis of EPA's determination that the 
submission contains errors or is incomplete.
    (ii) The requirements for correcting the errors or incomplete 
submission.
    (iii) Information on procedures under paragraph (d)(4) of this 
section for filing objections to the determination or requesting 
modification of the requirements for completing the submission.
    (4) Within ten days after receipt of notification by EPA that a 
submission contains errors or is incomplete, the submitter may file 
written objections requesting that EPA accept the submission as a 
complete notice or modify the requirements necessary to complete the 
submission.
    (5)(i) EPA will consider the objections filed by the submitter. EPA 
will determine whether the submission was complete or incomplete, or 
whether to modify the requirements for completing the submission. EPA 
will notify the submitter in writing of EPA's response within ten days 
of receiving the objections.

[[Page 34123]]

    (ii) If EPA determines, in response to the objection, that the 
submission was complete, the applicable review period will be deemed 
suspended on the date EPA declared the notice incomplete, and will 
resume on the date that the notice is declared complete. The submitter 
need not correct the notice as EPA originally requested. If EPA can 
complete its review within 90 days from the date of the original 
submission, EPA may inform the submitter that the running of the review 
period will resume on the date EPA originally declared it incomplete.
    (iii) If EPA modifies the requirements for completing the 
submission or affirms its original determination that the submission 
contains errors or is incomplete, or if no objections are filed, the 
applicable review period will begin (or if previously begun, will 
restart at Day 1) when EPA receives a complete notice.
    (e) Materially false or misleading statements. If EPA discovers at 
any time that a person submitted materially false or misleading 
statements in the notice, EPA may find that the notice was incomplete 
from the date it was submitted and take any other appropriate action.
0
8. Amend Sec.  720.70 by revising paragraphs (a) and (b)(3) to read as 
follows:

Sec.  720.70  Notice in the Federal Register.

    (a) Filing notice of receipt. In accordance with section 5(d)(2) of 
the Act, after EPA has received a complete notice, EPA will file a 
notice of receipt with the Office of the Federal Register including the 
information specified in paragraph (b) of this section.
    (b) * * *
    (3) For test data submitted in accordance with Sec.  720.40(g), a 
summary of the data received.
* * * * *
0
9. Amend Sec.  720.75 by:
0
a. Revising the section heading;
0
b. Removing the phrase ``notice review period'' and adding in its place 
the phrase ``applicable review period;'' wherever it appears; and
0
c. Revising paragraphs (a), (b), (c)(4) and (d) to read as follows:

Sec.  720.75  Applicable review period and determination.

    (a) Length of applicable review period. The applicable review 
period specified in section 5(a) of the Act runs for 90 days from the 
date EPA receives a complete notice, or the date EPA determines the 
notice is complete under Sec.  720.65(d), unless the Agency extends the 
applicable review period under section 5(c) of the Act and paragraph 
(c) of this section.
    (b) Suspension of the running of the applicable review period. (1) 
A submitter may voluntarily suspend the running of the applicable 
review period if EPA agrees. If EPA does not agree, the review period 
will continue to run, and EPA will notify the submitter. A submitter 
may request a suspension at any time during the applicable review 
period. The suspension must be for a specified period of time.
    (2)(i) Requests for suspension 30 days or less. A request for a 
suspension of 30 days or less may be made orally, including by 
telephone, or in writing, including by email, to the submitter's EPA 
contact for that notice. Any request for a suspension exceeding 30 days 
must be submitted in the manner set forth in paragraph (b)(2)(ii) of 
this section. The running of the applicable review period will be 
suspended upon approval of the oral or written request by EPA.
    (ii) Requests for suspensions greater than 30 days. Requests for 
suspensions exceeding 30 days must be submitted electronically to EPA 
via CDX using e-PMN software. Requests for suspensions of 30 days or 
less may also be submitted electronically to EPA via CDX using e-PMN 
software. See Sec.  720.40(a)(2)(ii) for information on how to access 
the e-PMN software. The running of the applicable review period will be 
suspended upon approval of the request submitted electronically to EPA 
via CDX using e-PMN software by EPA.
    (c) * * *
    (4) The following are examples of situations in which EPA may find 
that good cause exists for extending the applicable review period:
    (i) EPA has reviewed the notice and determined that there is a 
significant possibility that the chemical substance will be regulated 
under sections 5(e) or 5(f) of the Act, but EPA is unable to initiate 
regulatory action within the initial 90-day period.
    (ii) EPA has reviewed the submission and is seeking additional 
information.
    (iii) EPA has received significant additional information during 
the applicable review period, which was not known to or reasonably 
ascertainable by the submitter at the time of initial notice 
submission.
    (d) Determinations. (1) Within the applicable review period, EPA 
will make one of the following five determinations, as set forth in 
section 5(a)(3) of the Act:
    (i) The chemical substance presents an unreasonable risk of injury 
to health or the environment, as set forth in section 5(a)(3)(A) of the 
Act.
    (ii) Information available to EPA is insufficient to permit a 
reasoned evaluation of the health and the environmental effects of the 
relevant chemical substance, as set forth in section 5(a)(3)(B)(i) of 
the Act.
    (iii) In the absence of sufficient information to permit EPA to 
make such an evaluation, the chemical substance may present an 
unreasonable risk of injury to health or the environment, as set forth 
in section 5(a)(3)(B)(ii)(I) of the Act.
    (iv) The chemical substance is or will be produced in substantial 
quantities, and such substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities or there 
is or may be significant or substantial human exposure to the 
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
    (v) The chemical substance is not likely to present an unreasonable 
risk of injury to health or the environment, as set forth in section 
5(a)(3)(C) of the Act.
    (2) EPA will take the following actions required in association 
with the determination:
    (i) For determinations described in paragraph (d)(1)(i) of this 
section, EPA will issue the submitter an order to prohibit or limit the 
manufacture, processing, distribution in commerce, use, or disposal of 
the chemical substance, or any combination of such activities, to the 
extent necessary to protect against an unreasonable risk of injury to 
health or the environment, as set forth in section 5(f) of the Act, or 
will issue a proposed rule under section 6(a) of the Act, as set forth 
in section 5(f) of the Act.
    (ii) For determinations described in paragraphs (d)(1)(ii), (iii), 
or (iv) of this section, EPA will issue the submitter an order to 
prohibit or limit the manufacture, processing, distribution in 
commerce, use, or disposal of the chemical substance, or any 
combination of such activities, to the extent necessary to protect 
against an unreasonable risk of injury to health or the environment, as 
set forth in section 5(e) of the Act. EPA may issue an order under 
section 5(e) of the Act that requires certain testing to be conducted 
and presented to EPA after the applicable review period has concluded.
    (iii) Following a determination described in paragraph (d)(1)(v) of 
this section, EPA will issue the submitter a document describing that 
determination and will submit for publication in the Federal Register a 
statement of the finding, as set forth in section 5(g) of the Act. Upon 
EPA's issuance of the determination, the submitter may commence the 
manufacture of the

[[Page 34124]]

chemical substance without waiting for the end of the applicable review 
period.
    (3) EPA may modify or revoke the prohibitions and limitations in an 
order issued under paragraph (d)(2)(i) or (ii) of this section after 
the applicable review period has ended if the submitter submits to EPA 
additional testing, studies, reports, or other information that EPA 
determines, upon review, demonstrate that such prohibitions or 
limitations are no longer necessary to protect against an unreasonable 
risk of injury to health or the environment.
    (4) No person submitting a notice in response to the requirements 
of this part may manufacture a chemical substance subject to this part 
until EPA has issued a determination in accordance with paragraph 
(d)(1) of this section and taken the associated action required under 
paragraph (d)(2) of this section.

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
10. The authority citation for part 721 continues to read as follows:

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

0
11. Amend Sec.  721.25 by revising paragraphs (c) and (d) to read as 
follows:

Sec.  721.25  Notice requirements and procedures.

* * * * *
    (c) EPA will process the notice in accordance with the procedures 
of part 720 of this chapter, except to the extent they are inconsistent 
with this part. When submitting a SNUN the provision at Sec.  
720.45(f)(1) of this chapter is modified to require a description of 
both known and intended categories of consumer or commercial use by 
function and application.
    (d) Any person submitting a significant new use notice in response 
to the requirements of this part shall not manufacture or process a 
chemical substance identified in subpart E of this part for a 
significant new use until EPA has issued a determination with respect 
to the significant new use and taken the actions required in 
association with that determination in accordance with the procedures 
for new chemical substances at Sec.  720.75(d) of this chapter.

PART 723--PREMANUFACTURE NOTIFICATION EXEMPTIONS

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

    Authority:  15 U.S.C. 2604.

0
13. Amend Sec.  723.50 by:
0
a. Revising paragraph (a)(1);
0
b. Adding paragraphs (b)(11) and (12);
0
c. Revising paragraphs (d), (g), and (h)(2)(v); and
0
d. Adding paragraph (p).
    The revisions and additions read as follows:

Sec.  723.50  Chemical substances manufactured in quantities of 10,000 
kilograms or less per year, and chemical substances with low 
environmental releases and human exposures.

    (a) * * *
    (1) This section grants an exemption from the premanufacture notice 
requirements of section 5(a)(1)(A)(i) of the Toxic Substances Control 
Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
* * * * *
    (b) * * *
    (11) PFAS or per- and poly-fluoroalkyl substance means a chemical 
substance that contains at least one of these three structures:
    (i) R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are 
saturated carbons;
    (ii) R-CF2OCF2-R', where R and R' can either be F, O, or saturated 
carbons; or
    (iii) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated 
carbons.
    (12) PBT chemical substance means a chemical substance possessing 
characteristics of persistence (P) in the environment, accumulation in 
biological organisms (bioaccumulation (B)), and toxicity (T) resulting 
in potential risks to humans and ecosystems. For more information on 
EPA's Policy on new chemical substances that are PBTs, see EPA's 1999 
policy statement (64 FR 60194, November 4, 1999 (FRL-6097-7)).
* * * * *
    (d) Chemical substances that cannot be manufactured under this 
exemption. A new chemical substance cannot be manufactured under this 
section, notwithstanding satisfaction of the criterion of paragraph 
(c)(1) or (2) of this section, if EPA determines, in accordance with 
paragraph (g) of this section, that the substance, any reasonably 
anticipated metabolites, environmental transformation products, or 
byproducts of the substance, or any reasonably anticipated impurities 
in the substance, under anticipated conditions of manufacture, 
processing, distribution in commerce, use, or disposal of the new 
chemical substance:
    (1) May cause:
    (i) Serious acute (lethal or sublethal) effects;
    (ii) Serious chronic (including carcinogenic and teratogenic) 
effects; or
    (ii) Significant environmental effects.
    (2) Or is:
    (i) A PFAS.
    (ii) A PBT chemical substance with anticipated environmental 
releases and potentially unreasonable exposures to humans or 
environmental organisms.
* * * * *
    (g) Review period. (1) EPA will review the notice submitted under 
paragraph (e) of this section to determine whether manufacture of the 
new chemical substance is eligible for the exemption. The review period 
will run for 30 days from the date EPA receives a complete notice. To 
provide additional time to address any unresolved issues concerning an 
exemption application, the exemption applicant may, at any time during 
the review period, request a suspension of the review period pursuant 
to the provisions of Sec.  720.75(b) of this chapter.
    (2) No person submitting a notice under paragraph (e) of this 
section may manufacture the new chemical substance until EPA notifies 
the submitter that the new chemical substance meets the terms of this 
section.
    (h) * * *
    (2) * * *
    (v) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer did not act with due diligence and in good faith 
to meet the terms of this section, the manufacturer must cease any 
continuing manufacture, processing, distribution in commerce, and use 
of the new chemical substance within 7 days of the written notification 
under paragraph (h)(2)(iii) of this section. The manufacturer may not 
resume manufacture, processing, distribution in commerce, and use of 
the new chemical substance until it submits a notice under section 
5(a)(1) of the Act and part 720 of this chapter and EPA has made one of 
the five determinations as set forth in section 5(a)(3) of the Act and 
taken the action required in association with that determination.
* * * * *
    (p) Subject to a significant new use rule. If a significant new use 
rule is proposed or finalized in part 721 of this chapter for a 
chemical substance described by a generic chemical name, EPA may make 
reasonable efforts to notify any persons who may also manufacture the 
same chemical substance under the terms of this section. A disclosure 
to a person with an approved exemption under this section that the 
chemical substance is subject to a proposed or final rule in part 721 
of this chapter will not be considered public disclosure of

[[Page 34125]]

confidential business information under section 14 of the Act. The 
notification will inform manufacturers subject to the terms of this 
section that the chemical substance is subject to a proposed or final 
significant new use rule under section 5(a)(2) of the Act, and identify 
the proposed or final section in subpart E of part 721 of this chapter 
that pertains to the chemical substance.

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

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

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

0
15. Amend Sec.  725.54 by revising paragraphs (b)(1), (c) and (d) to 
read as follows:

Sec.  725.54  Suspension of the review period.

* * * * *
    (b)(1) Request for suspension. A request for suspension may only be 
submitted in a manner set forth in this paragraph. The request for 
suspension also may be made orally, including by telephone, or in 
writing, including by email, to the submitter's EPA contact for that 
notice, subject to paragraph (c) of this section.
* * * * *
    (c) An oral or written request for suspension may be granted by EPA 
for a maximum of 30 days only. Requests for longer suspension must only 
be submitted in the manner set forth in paragraph (b)(2) of this 
section.
    (d) If the submitter has not made a previous oral or written 
request, the running of the applicable review period is suspended as of 
the date of receipt of the CDX submission by EPA.
0
16. Amend Sec.  725.60 by revising paragraph (a)(1) to read as follows:

Sec.  725.60  Withdrawal of submission by the submitter.

    (a)(1) Withdrawal of notice by the submitter. A submitter may 
withdraw a notice during the applicable review period by submitting a 
statement of withdrawal in a manner set forth in this paragraph. The 
withdrawal is effective upon receipt of the CDX submission by EPA.
* * * * *
0
17. Amend Sec.  725.170 by:
0
a. Revising paragraphs (a) and (b); and
0
b. Removing paragraph (c).
    The revisions read as follows.

Sec.  725.170  EPA review of the MCAN.

* * * * *
    (a) Length of the review period. The MCAN review period specified 
in section 5(a) of the Act runs for 90 days from the date EPA receives 
a complete MCAN, or the date EPA determines the MCAN is complete under 
Sec.  725.33, unless the Agency extends the period under section 5(c) 
of the Act and Sec.  725.56.
    (b) Determinations. (1) Within the applicable review period, EPA 
will make one of the following five determinations on the 
microorganism, as set forth in section 5(a)(3) of the Act:
    (i) The microorganism presents an unreasonable risk of injury to 
health or the environment, as set forth in section 5(a)(3)(A) of the 
Act.
    (ii) Information available to EPA is insufficient to permit a 
reasoned evaluation of the health and the environmental effects of the 
microorganism, as set forth in section 5(a)(3)(B)(i) of the Act.
    (iii) In the absence of sufficient information to permit EPA to 
make such an evaluation, the microorganism may present an unreasonable 
risk of injury to health or the environment, as set forth in section 
5(a)(3)(B)(ii)(I) of the Act.
    (iv) The microorganism is or will be produced in substantial 
quantities, and such substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities or there 
is or may be significant or substantial human exposure to the 
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
    (v) The microorganism is not likely to present an unreasonable risk 
of injury to health or the environment, as set forth in section 
5(a)(3)(C) of the Act.
    (2) EPA will take the following actions required in association 
with the determination.
    (i) For determinations described in paragraph (b)(1)(i) of this 
section, EPA will issue the submitter an order to prohibit or limit the 
manufacture, processing, distribution in commerce, use, or disposal of 
the microorganism, or any combination of such activities, to the extent 
necessary to protect against an unreasonable risk of injury to health 
or the environment, as set forth in section 5(f) of the Act, or will 
issue a proposed rule under section 6(a) of the Act, as set forth in 
section 5(f) of the Act.
    (ii) For determinations described in paragraph (b)(1)(ii), (iii), 
or (iv), EPA will issue the submitter an order to prohibit or limit the 
manufacture, processing, distribution in commerce, use, or disposal of 
the microorganism, or any combination of such activities, to the extent 
necessary to protect against an unreasonable risk of injury to health 
or the environment, as set forth in section 5(e) of the Act. EPA may 
issue an order under section 5(e) of the Act that requires certain 
testing to be conducted and presented to EPA after the applicable 
review period has concluded.
    (iii) For determinations described in paragraph (b)(1)(v) of this 
section, EPA will issue the submitter a document describing that 
determination and will submit for publication in the Federal Register a 
statement of the finding, as set forth in section 5(g) of the Act. Upon 
EPA's issuance of the determination, the submitter may commence the 
manufacture of the microorganism without waiting for the end of the 
applicable review period.
    (3) EPA may modify or revoke the prohibitions and limitations in an 
order issued under paragraph (b)(2)(i) or (ii) of this section after 
the applicable review period has closed if the submitter submits to EPA 
additional information, testing, studies, or reports that EPA 
determines, upon review, demonstrate that such prohibitions or 
limitations are no longer necessary to protect against an unreasonable 
risk of injury to health or the environment.
    (4) No person submitting a MCAN in response to the requirements of 
this subpart may manufacture a microorganism subject to this subpart 
until EPA has issued a determination in accordance with paragraph 
(b)(1) of this section and taken any action as required under paragraph 
(b)(2) of this section.

[FR Doc. 2023-10735 Filed 5-25-23; 8:45 am]
BILLING CODE 6560-50-P