[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Rules and Regulations]
[Pages 102773-102800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28870]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 68, 372, 703, 720, 721, 723, 725, and 761
[EPA-HQ-OPPT-2022-0902; FRL-7906-02-OCSPP]
RIN 2070-AK65
Updates to New Chemicals Regulations Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
amending the new chemicals procedural regulations under the Toxic
Substances Control Act (TSCA). These amendments align the regulatory
text with the amendments to TSCA's new chemicals review provisions
contained in the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, enacted on June 22, 2016, will improve the efficiency of
EPA's review processes, and update the regulations based on existing
policies and experience implementing the New Chemicals Program. This
final rule includes amendments that will increase the quality of
information initially submitted in new chemicals notices and improve
the Agency's processes for timely, effective completion of individual
risk assessments and the new chemicals review process overall. EPA is
also finalizing several amendments to the regulations for low volume
exemptions (LVEs) and low release and exposure exemptions (LoREXs),
which will require EPA approval of an exemption notice prior to
commencement of manufacture, make per- and polyfluoroalkyl substances
(PFAS) categorically ineligible for these exemptions, and provide that
certain persistent, bioaccumulative, toxic (PBT) chemical substances
are ineligible for these exemptions.
DATES: This final rule is effective January 17, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2022-0902, is available online
at https://www.regulations.gov. Additional instructions for visiting
the docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Tyler Lloyd, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4016; e-mail address: lloyd.tyler@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you intend to
manufacture a new chemical substance, or manufacture or process a
chemical substance for a significant new use. The following list of
North American Industrial Classification System (NAICS) codes is not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this document applies to them. Potentially affected
entities may include:
Chemical Manufacturers (NAICS code 325).
Petroleum and Coal Products (NAICS code 324).
Merchant Wholesalers, Nondurable Goods (NAICS code 424).
This list details the types of entities that EPA is aware could
potentially be regulated by this action. Other types of entities not
listed could also be regulated. To determine whether your entity is
regulated by this action, you should carefully examine the
applicability criteria found in 40 CFR 720.22, 721.5, 723.50, and
725.1. If you have questions regarding the applicability of this
action, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
EPA is promulgating this rule pursuant to its authority in TSCA
section 5 (15 U.S.C. 2604). Section 5(a)(1) of the Toxic Substances
Control Act (TSCA), 15 U.S.C. 2604(a)(1), as amended by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act of 2016 (Pub. L.
114-182) (herein referred to as the ``2016 Lautenberg
[[Page 102774]]
Amendments''), provides that no person, as defined at 40 CFR 720.3, may
manufacture (which includes import under TSCA) a new chemical substance
or manufacture or process a chemical substance for a use which EPA has
determined is a significant new use, unless at least 90 days prior to
such manufacture or processing that person submits a notice to EPA
containing the information required by TSCA section 5(d). EPA must
conduct a review of the notice, make one of five possible
determinations pertaining to the likelihood of unreasonable risk of
injury to health or the environment, and take any actions required as a
result of that determination, all within the applicable review period.
The submitted notice must include the information described in TSCA
section 5(d)(1): insofar as known to the submitter or reasonably
ascertainable, information described in certain provisions of TSCA
section 8(a)(2) (e.g., chemical identity, use, and exposure
information); in the form and manner prescribed by EPA, information in
the possession or control of the submitter related to the health or
environmental effects of the chemical substance; and a description of
any other information concerning the environmental and health effects
of the chemical substance, insofar as known to the submitter or
reasonably ascertainable.
C. What action is the Agency taking?
EPA is promulgating amendments to the procedural regulations at 40
CFR parts 720, 721, and 725 to align with the requirements in TSCA
section 5, as amended by the 2016 Lautenberg Amendments, and to make
additional updates. EPA is amending the regulations to specify that EPA
must make a determination on each Pre-Manufacture Notice (PMN),
Significant New Use Notice (SNUN), and Microbial Commercial Activity
Notice (MCAN) received before the submitter may commence manufacturing
or processing of the chemical substance that is the subject of the
notice, and to list the five possible determinations and the actions
required in association with those determinations. In addition, EPA is
finalizing amendments that will clarify the level of detail expected
for the information that a submitter is required to include in a PMN,
SNUN, or exemption notice in order for the notice to be considered
complete. EPA is also finalizing amendments to the procedures for
reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs
and SNUNs that have errors or are incomplete or that are amended during
the applicable review period. Additionally, EPA is finalizing several
amendments to the regulations at 40 CFR 723.50 for LVEs and LoREXs.
These amendments would require EPA approval of an exemption notice
before the submitter may commence manufacture, allow EPA to inform an
LVE or LoREX holder when the chemical substance that is the subject of
the exemption becomes subject to a significant new use rule (SNUR)
under TSCA and the chemical identity is confidential, make PFAS
categorically ineligible for these exemptions, and make certain PBTs
ineligible for these exemptions. Finally, EPA is amending the
regulations pertaining to suspensions for all TSCA section 5 notices to
allow submitters to request suspensions for up to 30 days via oral or
e-mail request. This final rule takes into consideration comments
received on the proposed rule (88 FR 34100, May 26, 2023 (FRL-7906-01-
OCSPP)). Details on the final rule requirements, including
modifications from the proposal, are explained in Unit III.
D. Why is the Agency taking this action?
Under amended TSCA, EPA must review all notices submitted under
TSCA section 5(a)(1) and make a determination pertaining to the risks
of new chemical substances or significant new uses of chemical
substances described in such notices before they can proceed to the
marketplace. Before the 2016 Lautenberg Amendments, TSCA allowed the
PMN or SNUN submitter to commence manufacturing or processing upon
expiration of the review period unless EPA made an affirmative finding
of unreasonable risk. Under amended TSCA, EPA must review all notices
submitted under TSCA section 5(a)(1) and make a determination
pertaining to the risks of every new chemical substance or significant
new use of a chemical substance described in such notices before they
can proceed to the marketplace. To reflect and better meet these
requirements, EPA is amending the procedural regulations codified at 40
CFR parts 720, 721, and 725 and making additional updates based on
existing policies or lessons learned from administering the New
Chemicals Program since TSCA was amended in 2016.
EPA is also finalizing amendments that will clarify the information
that is required to be included in PMNs, SNUNs, and exemption notices
to reduce the need to redo all or part of the risk assessment
(``rework'') due to late submissions of information. This action is
expected to reduce rework of risk assessments by minimizing requests
from submitters to amend their PMNs, SNUNs, or exemption notices with
additional information after the review period has commenced. The
Agency is also finalizing amendments to make clear the procedures that
will be employed if submitters amend their PMNs or SNUNs during the
applicable review period.
EPA is amending the regulations for LVEs and LoREXs so that
submitters may not commence manufacture until EPA has issued a decision
for the exemption notice, to better ensure that manufacture under LVEs
and LoREXs will not present an unreasonable risk. Additionally, EPA is
promulgating amendments that allow the Agency to notify submitters if a
chemical substance for which they hold an LVE or LoREX is or becomes
subject to a proposed or final SNUR and the chemical identity is
confidential, so that chemical manufacturers are made aware that they
may be subject to additional TSCA requirements. EPA is also finalizing
amendments to make PFAS categorically ineligible for an LVE or LoREX,
which would ensure that all new PFAS are reviewed through the full PMN
process. In addition, EPA is making certain PBTs ineligible for these
exemptions, to better manage risks associated with PBT chemical
substances that have anticipated environmental releases and potentially
unreasonable exposures to humans or environmental organisms.
Lastly, EPA is promulgating amendments that will allow informal
(oral or e-mail) requests for review period suspensions of up to 30
days to reduce the number of repeated requests for 15-day suspensions,
because EPA believes that e-mail may be more expedient than oral
communication for many submitters.
E. What are the estimated incremental impacts of this action?
EPA has evaluated the costs and benefits of this rulemaking and
provided an Economic Analysis (EA) of the potential impacts associated
with this rule, titled ``Economic Analysis for the Final Rule: Updates
to New Chemicals Regulations under the Toxic Substances Control Act''
(Ref. 1), which is available in the docket and briefly summarized here.
The benefits of the rule include increased efficiency in both the
submission and review processes for notices submitted through the PMN
form. The changes under this rule would clarify the information
requirements on the PMN form in the Agency's Central Data Exchange
(CDX) to make more transparent the level of detail that EPA needs in
order to make
[[Page 102775]]
a reasoned evaluation. As submitters provide more complete information
in their initial submissions, the changes under this rule are expected
to reduce the frequency with which PMNs, SNUNs, and exemption notices
are amended with additional information and the amount of rework of
risk assessments that the Agency conducts following such amendments.
In addition, the more detailed and comprehensive 90-day review
afforded to PMNs allows EPA to make a more informed hazard
determination for PFAS, leading to improvement in the expected outcome
of these decisions. More informed decision making about a PFAS's
potential risks is likely to result in a reduction in the cost of risk-
based decision making about the PFAS, and an improvement in the
expected outcome of the decisions.
As a result of the changes presented in this rule, the total annual
burden to industry is expected to decrease by approximately 4,528
hours, while total annual costs to industry submitters are expected to
have a net increase of approximately $203,150. The Agency is expected
to experience an annual cost savings of approximately $1,117,132.
II. Background
A. What did EPA propose?
On May 26, 2023 (88 FR 34100; FRL-7906-01-OCSPP), EPA proposed
amendments intended to align the regulatory text with the amendments to
TSCA's new chemicals review provisions contained in the 2016 Lautenberg
Amendments, to improve the efficiency of EPA's review processes, and
update the regulations based on existing policies and experience
implementing the New Chemicals Program. Additionally, the proposal
included amendments that would reduce the need to redo all or part of a
risk assessment by improving information initially submitted in new
chemicals notices, which should also help reduce the length of time
that new chemicals notices are under review. EPA also proposed several
amendments to the regulations for LVEs and LoREXs, which included
requiring EPA approval of an exemption notice prior to commencement of
manufacture, making PFAS categorically ineligible for these exemptions,
and providing that certain PBT chemical substances would be made
ineligible for these exemptions, consistent with EPA's 1999 PBT policy.
Lastly, the proposal included amendments related to the suspension of
the review period.
B. How did the 2016 Lautenberg Amendments change TSCA section 5?
As enacted in 1976, TSCA provided EPA with authority to require
reporting, recordkeeping, and testing, and to issue restrictions
relating to chemical substances and/or mixtures. TSCA section 5(a)(1)
required that a person submit to EPA a notice at least 90 days before
commencing manufacture of a new chemical substance or manufacture or
processing of a chemical substance for a use which EPA determined to be
a significant new use. Under the 1976 law, EPA was not obligated to
make a determination or finding regarding unreasonable risk for each
notice submitted under TSCA section 5(a)(1). EPA's obligations with
respect to making determinations on notices submitted under TSCA
section 5(a)(1) fundamentally changed with the passage of the 2016
Lautenberg Amendments. The 2016 Lautenberg Amendments added a new
paragraph to TSCA at section 5(a)(3) titled ``Review and
Determination,'' under which EPA must review and make one of five
determinations pertaining to the likelihood of risk on all notices
received under TSCA section 5(a)(1), which include PMNs, SNUNs and
MCANs, within the applicable review period. EPA's obligation to take
action after making a determination on a notice submitted under TSCA
section 5(a)(1) also changed with the passage of the 2016 Lautenberg
Amendments.
The 2016 Lautenberg Amendments require EPA to review each notice
submitted under TSCA section 5(a)(1), make a determination on that
notice, and take the action required in association with that
determination within the applicable review period. Under TSCA section
5(i)(3), the ``applicable review period'' means 90 days from the date
EPA receives a notice under TSCA section 5(a)(1), or up to 180 days
from that date if EPA extends the applicable review period according to
the provisions in TSCA section 5(c). The 2016 Lautenberg Amendments
also added a new paragraph at TSCA section 5(a)(4) explaining that a
failure by EPA to render a determination within the applicable review
period would not relieve EPA of any requirement to make such
determination, but would, with certain exceptions, result in a fee
refund to the notice submitter.
TSCA section 5(h) was not significantly amended by the 2016
Lautenberg Amendments. TSCA section 5(h) provides EPA the authority to
exempt a person from certain TSCA section 5 requirements under certain
situations. EPA developed the current LVE and LoREX regulations in 1995
pursuant to TSCA section 5(h)(4) (60 FR 16336, March 29, 1995). See
Unit II. of the May 26, 2023, proposed rule (88 FR 34100) for further
discussion of the 2016 Lautenberg Amendments.
C. How are the new chemicals regulations structured?
EPA's regulations related to TSCA section 5 are codified in Title
40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR).
They include:
Regulations pertaining to PMNs, which are codified at 40
CFR part 720;
Regulations pertaining to SNUNs, which are codified at 40
CFR part 721;
Regulations pertaining to certain exemptions, which are
codified at 40 CFR part 723; and
Regulations pertaining to MCANs and microorganism-related
exemptions, which are codified at 40 CFR part 725.
The information requirements codified for PMNs in 40 CFR 720.45
generally also apply to SNUNs under 40 CFR part 721 (see 40 CFR
721.1(c) and 721.25(a), which cross-reference 40 CFR part 720) and to
LVEs and LoREXs submitted under 40 CFR 723.50 (see 40 CFR 723.50(e)(2),
which cross-references 40 CFR 720.45). As a result, the amendments to
the requirements in 40 CFR 720.45 apply to PMNs and also to SNUNs,
LVEs, and LoREXs. The review procedures for PMNs codified in 40 CFR
part 720 generally also apply to SNUNs under 40 CFR part 721 (see 40
CFR 721.25(c)) but not to exemptions under 40 CFR part 723, so the
amendments to the part 720 review procedures promulgated by this action
apply to PMNs and SNUNs but not to such exemptions. Neither the
information requirements nor the review procedures in 40 CFR part 720
apply to MCANs or microorganism-related exemptions under 40 CFR part
725, so EPA is also finalizing certain amendments to the MCAN and
microorganism-related exemption regulations at 40 CFR part 725.
D. Did EPA receive public comments on the proposed rule?
EPA received 51 public comments on the proposed rule. Commenters
included potentially affected businesses, trade associations,
environmental and public health advocacy groups, unions, and other
Federal agencies. In this preamble, EPA has responded to many of the
significant comments on the proposed rule; however, the more
comprehensive version of EPA's response to comments for this rulemaking
can be found in the Response to Comments document (Ref.
[[Page 102776]]
2). The Response to Comments document summarizes all the comments
relevant to the proposal and EPA's response to those comments. In the
Response to Comments document, EPA also discusses any changes to and
clarifications from the proposed rule made in this final rule.
III. Overview of the Final Rule
This final rule is based on the May 26, 2023, proposed rule (88 FR
34100) and in consideration of the public comments received on the
proposed rule.
A. Amendments To Conform Regulations to 2016 Lautenberg Amendments
EPA is amending the PMN procedural regulations at 40 CFR part 720
to align them with the notice review and determination requirements in
TSCA section 5, as amended by the 2016 Lautenberg Amendments. These
procedural regulations also generally apply to SNUNs under 40 CFR part
721 (see 40 CFR 721.1(c) and 721.25(c)). EPA is also promulgating
similar changes to the MCAN procedural regulations at 40 CFR part 725
to align them with the same notice review and determination
requirements added by the 2016 Lautenberg Amendments. EPA has been
implementing the amended statutory requirements but, prior to this
rulemaking, had not yet codified these updates into the new chemicals
procedural regulations. The amendments specify that EPA must make a
determination on each PMN, SNUN, and MCAN received before the submitter
may commence manufacturing (which includes importing) or processing and
lists the five possible determinations and the actions required in
association with those determinations. EPA is also adding definitions
for new terms and to update existing terminology introduced by the 2016
Lautenberg Amendments.
1. Commencement of Manufacture or Processing
As proposed, EPA is finalizing amendments at 40 CFR 720.75(d) by
removing outdated language allowing the submitter to commence
manufacture of a chemical substance when the review period expires and
adding new language specifying that EPA must issue a determination and
take any required action on each PMN before manufacture may commence.
EPA is also finalizing an amendment to 40 CFR 721.25(d) to state that
any person submitting a SNUN shall not manufacture or process a
chemical substance for a significant new use until EPA has issued a
determination with respect to the significant new use and taken the
actions required in association with that determination. Likewise, EPA
is finalizing an amendment at 40 CFR 725.170(b) and (c) by removing
similar outdated language allowing the submitter to commence
manufacture of a new microorganism or manufacture or processing of a
microorganism for a significant new use when the review period expires
and adding new language specifying that EPA must issue a determination
and take any required action on each MCAN before manufacture or
processing may commence.
Some comments on the proposal challenged the EPA's description of
how the New Chemicals Program operated prior to the passage of the 2016
Lautenberg Amendments and suggested that the 2016 Lautenberg Amendments
had only minor impacts on the Program. EPA disagrees with these
comments, as prior to the 2016 Lautenberg Amendments, EPA was not
required to conduct a review of and issue a determination for every
notice. Following the 2016 Lautenberg Amendments, EPA must review all
notices submitted under TSCA section 5(a)(1) and make a determination
pertaining to the risks of a new chemical or significant new use of an
existing chemical before it is allowed into the marketplace. For a
detailed response to these and other comments, please see the Response
to Comments document (Ref. 2).
2. Required Determinations and Associated Actions
As proposed, EPA is finalizing amendments at 40 CFR 720.75(d) and
725.170 by listing the five possible determinations that EPA must make
for each PMN, SNUN, or MCAN it receives. EPA is also finalizing
amendments to 40 CFR 720.75(d) and 725.170(b) to describe the actions
that EPA must take in association with its determination for a PMN,
SNUN, or MCAN. EPA is codifying those actions, which EPA has been
implementing, as applicable, for every PMN, SNUN, and MCAN since the
2016 Lautenberg Amendments, to be clear about EPA's review process to
the public.
After EPA issues an order under TSCA section 5(e) or (f) and the
applicable review period concludes, the submitter may submit studies,
tests, reports, or other additional information. If EPA concludes from
an assessment of the additional information that one or more of the
prohibitions or limitations contained in the order are no longer
necessary to protect against an unreasonable risk of injury to health
or the environment, EPA may modify or revoke the prohibitions or
limitations of the order. If EPA determines that none of the order
terms are warranted after assessment of the additional information, EPA
may revoke all the requirements of the order.
Several comments on the proposed rule asserted that EPA not only
has the authority to revoke or lessen restrictions in an order after it
has been issued, but also can and must strengthen protections in an
order based on new information received on a chemical substance that
demonstrates the order is insufficient to protect against unreasonable
risk. The commenters further urged EPA to clarify that an order may be
modified based on new information obtained from any source, not solely
the submitter. EPA agrees with these commenters and a detailed response
is available in the Response to Comments document (Ref. 2). Upon
consideration of these comments, EPA is modifying the proposed
amendments at 40 CFR 720.75(d)(3) and 725.170(b)(3) to clarify that new
information may be received from any source, and to add that where such
information demonstrates that the prohibitions or limitations of the
order are not sufficient to protect against an unreasonable risk of
injury to health or the environment, EPA may modify the order or take
other action, as appropriate, to the extent necessary to protect
against such risk.
3. Other Updates
As proposed, EPA is finalizing amendments to the regulation that
will replace the undefined terms ``notice period,'' ``notification
period,'' ``statutory review period,'' and ``notice review period''
with the term ``applicable review period'' throughout 40 CFR part 720
to conform to the new terminology in TSCA section 5 added by the 2016
Lautenberg Amendments. EPA is also finalizing an amendment to add, as
proposed, a definition for ``applicable review period'' to 40 CFR
720.3, which EPA would define as the period starting on the date EPA
receives a complete notice under section 5(a)(1) of the Act and ending
90 days after that date or on such date as is provided for in sections
5(b)(1) or 5(c) of the Act. In response to the proposed amendment
adding a definition for ``applicable review period,'' commenters
expressed difficulty in determining what EPA considers to be a complete
notice and requested that the Agency clearly define what constitutes a
notice that is ``complete.'' EPA considers a complete notice to be a
notice that meets all the procedural requirements indicated in
720.65(c)(1) (e.g. a notice that includes
[[Page 102777]]
a company signature, is submitted via CDX, includes a second copy of
the submission with all confidential information deleted, includes the
payment identity number, etc.) and includes all required information
that is known to or reasonably ascertainable by the submitter, as
described in 720.45 and 720.50. A submission that fails to meet the
statutory information requirements is incomplete, and EPA is justified
in refusing to review the notice until the information is received. In
the Response to Comments document (Ref. 2), EPA discusses in more
detail the longstanding definition of ``known to or reasonably
ascertainable by'' and its application in specific contexts.
After considering the comments, EPA is finalizing an amendment to
add a definition for ``potentially exposed or susceptible
subpopulation'' (PESS) to 40 CFR 720.3. For this rule, EPA is defining
``potentially exposed or susceptible subpopulation'' as proposed and
using the same definition that was proposed and finalized as part of
the rulemaking entitled ``Procedures for Chemical Risk Evaluation under
the Toxic Substances Control Act (TSCA)'' (89 FR 37028, May 3, 2024
(FRL-8529-02-OCSPP)).
As a primary matter, the inclusion of ``overburdened communities''
in the list of example subpopulations in this definition is not itself
a determination. Rather, it is an example of a subpopulation that EPA
may identify as a PESS in future risk assessments, and it is reflective
of the reality that, in addition to groups like children and pregnant
women, there are communities of people that may experience
disproportionate environmental risks from chemicals due to greater
exposure or susceptibility to environmental and health harms.
EPA proposed to add a regulatory definition of PESS that includes
the term ``overburdened communities'' in the list of example
subpopulations. This term, which is an addition to the examples
provided in the statutory definition of PESS at TSCA section 3(12),
reflects the Agency's understanding and acknowledgment that a chemical
substance may disproportionately expose and/or may disproportionately
impact communities already experiencing disproportionate and adverse
human health or environmental burdens. Such disproportionality can be
as a result of greater exposure or vulnerability to environmental
hazards, lack of opportunity for public participation, or other
factors. Increased exposure or vulnerability may be attributable to an
accumulation of negative or lack of positive environmental, health,
economic, or social conditions within these populations or places. The
term describes situations where multiple factors, including both
environmental and socio-economic stressors, may act cumulatively to
impact health and the environment and contribute to persistent
environmental health disparities. These situations may apply to
communities with environmental justice concerns.
While some commenters on the proposed rule objected to the
inclusion of ``overburdened communities,'' EPA believes that it is
appropriate to include ``overburdened communities'' as an example
subpopulation in the definition of PESS. Congress' inclusion of ``such
as'' in the statutory definition provides EPA with clear discretion to
go beyond the statute's list of examples. EPA further disagrees that
this addition is substantively changing the criteria for identification
of PESS (i.e., greater exposure or susceptibility and greater risk than
general population).
EPA does not believe it is necessary to define ``overburdened
communities'' as part of this rule. In the same way that EPA considers
whether children or workers or the elderly are a PESS in the context of
a specific risk assessment, EPA will look to whether ``overburdened
communities'' may become subject to exposure or could be more
susceptible than the general population. EPA does not intend for this
term to be confined to a location or geographic proximity but would use
reasonably available information for each new chemical substance or
significant new use to determine the inclusion of specific communities.
Those who could potentially experience ``greater exposure'' could
include individuals or communities that would experience higher levels
of exposure to a chemical substance due to geography (e.g., fenceline
communities in close proximity to facilities that could emit air
pollutants or living near potential effluent releases to water), unique
exposure pathways that differ from those of the general population
(e.g., Tribal communities where reliance on subsistence fishing may
result in increased exposure via ingestion), and/or aggregate exposure
via multiple conditions of use (e.g., a worker potentially exposed to
the chemical substance who also lives in close proximity to the
facility that may also release the chemical substance through air
emissions).
In making these additions to 40 CFR 720.3, EPA is also revising the
overall format used to list the definitions in 40 CFR 720.3, by
removing the designations for each definition and adopting the
alphabetical listing approach consistent with the recommendation of the
Office of the Federal Register (OFR). See page 2-27 of the OFR's
Document Drafting Handbook, August 2018 Edition (Revision 2.1, dated
October 2023), https://www.archives.gov/federal-register/write/ddh/.
Specifically, EPA is using the revise and republish instructions in the
regulatory text of this final rule to reflect the addition of the two
definitions and the adoption of the recommended undesignated
alphabetical listing format for this definition section. This change
also requires corresponding technical corrections to the citation in
several other regulations. The existing definitions and these other
regulations are otherwise unchanged. Conforming edits to remove the
designations for the definitions in 40 CFR 720.3 are being made to 40
CFR 68.115, 372.38, 703.3, and 761.3.
EPA is also promulgating an update to 40 CFR 720.70(b) by revising
paragraph (b)(3). Some commenters opposed EPA's proposal to remove the
regulatory-only requirement in 40 CFR 720.70(b)(3) to publish a list of
test data submitted in accordance with 40 CFR 720.50(a) in the TSCA
section 5(d)(2) notice of receipt. EPA disagrees with these comments.
As EPA explained in the preamble to the proposed rule (88 FR 34100, May
26, 2023), the Agency believes that its objective of providing such
information to the public is now better achieved through ChemView than
through publication in the Federal Register. Through ChemView, the
Agency currently makes the section 5 notice, including test data
submitted with it, publicly available generally within 5 business days
of receipt, subject to confidentiality protections. EPA is finalizing
the change to 720.70(b)(3) as proposed. For additional response to the
comments received on the amendments to 40 CFR 720.70(b)(3), see the
Response to Comments document (Ref. 2).
B. Amendments Related to Notice Information Requirements
EPA is promulgating amendments to the notice information
requirements at 40 CFR 720.45, as well as corresponding changes to the
PMN form in CDX, to clarify the level of detail expected for
information that must be submitted to EPA in PMN, SNUN, and certain
exemption notices. EPA is finalizing these amendments largely as
proposed, with most changes representing minor clarifications to the
proposed regulatory text in response to the comments.
[[Page 102778]]
1. Background
A notice submitted under TSCA section 5(a)(1) must include the
information described in TSCA section 5(d)(1): (1) insofar as known to
the submitter or reasonably ascertainable, information described in
certain provisions of TSCA section 8(a)(2); (2) in the form and manner
prescribed by EPA, information in the possession or control of the
submitter related to the health or environmental effects of any
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance or any article containing such substance; and
(3) a description of any other information concerning the environmental
and health effects of the chemical substance, insofar as known to the
submitter or reasonably ascertainable. EPA has promulgated regulations
detailing these information requirements in 40 CFR 720.45 and 720.50.
EPA has developed an application form in CDX to collect such
information from submitters. The user guide for CDX is listed in the
references section of this final rule and can be found in the docket
(Ref. 3). This form is prescribed by EPA for submission of PMNs, SNUNs,
LVEs, LoREXs, and test marketing exemption (TME) applications. In this
preamble, EPA refers to the form as the ``PMN form'' for simplicity,
but the changes outlined in this section would impact the other types
of notices that use the same form (i.e., PMNs, SNUNs, LVEs, LoREXs, and
TMEs).
EPA has observed that most section 5 notices do not contain all
required information at the level of detail that EPA needs to perform
refined risk assessments. As described in the preamble of the proposed
rule, these deficiencies frequently result in EPA using conservative
assumptions in its risk assessments due to lack of available data,
which can create delays in the timeline for case completion,
particularly when submitters provide information to EPA late in a
case's review in response to risk estimates stemming from the lack of
available data. In recent years, EPA has issued guidance documents
(Ref. 3 and 4), established pre-screen processes for incoming cases,
and conducted outreach efforts (Ref. 5) to make clearer to submitters
the level of detail necessary for timely review of their chemicals, as
well as to minimize the need for costly rework of case assessment
materials. EPA believes that amending the notice information
requirements at 40 CFR 720.45 to specify the level of detail needed, as
well as building that additional detail into the CDX user interface,
will help submitters provide more detailed section 5 notices and help
to minimize the need for EPA to use default values and conservative
assumptions in its risk assessments due to the lack of available data.
Therefore, EPA is finalizing the amendments to the notice information
requirements at 40 CFR 720.45 as well as the corresponding changes to
the PMN form in CDX largely as described in the proposed rule.
2. Changes to 40 CFR 720.45, 40 CFR 720.50, and the PMN Form
EPA is amending 40 CFR 720.45 and the PMN form in CDX to clarify
the information requirements for a notice. Specifically, EPA is adding
details to certain information requirements already contained in 40 CFR
720.45. EPA is also adding additional reporting fields to the PMN form
to reflect these details. In this action, EPA is adding these details
as separate, unique information requirements in 40 CFR 720.45 and
making corresponding changes to the PMN form to clarify the level of
detail needed for EPA's review of section 5 notices and to ensure that
the fields in the PMN form are consistent with the regulations. In some
cases, information requested in the PMN form is not clearly required in
the 720.45 regulations, so EPA is adding those details to 40 CFR 720.45
to ensure that the regulations and PMN form are as consistent as
possible. Although EPA is finalizing these amendments largely as they
were described in the proposed rule, changes, mostly to improve
clarity, have been made to some amendments in response to comments
received by EPA. In response to comments, EPA is also finalizing
additional amendments to the regulations at 720.45 and 720.50, as well
as to the PMN form in CDX, that further add clarity and better align
the PMN form with the regulations. See Ref. 6, which includes tables
that detail the changes that are being made to 40 CFR 720.45, 720.50,
and the CDX interface per this final rule. Additionally, EPA has
amended 40 CFR 723.50(e) to update a cross-reference to 40 CFR 720.45
based on the amendments made in this rule.
Consistent with TSCA section 5(d)(1), for all information
requirements under 40 CFR 720.45, submitters are only required to
provide information to the extent that it is known to or reasonably
ascertainable by the submitter, as defined at 40 CFR 720.3. Under the
amendments to 40 CFR 720.45, a submitter is required to include in the
PMN form the detailed information finalized in this action, along with
all other information already required, to the extent the information
is known to or reasonably ascertainable by the submitter. This is an
important point because a submitter may not know or be able to
reasonably ascertain certain details about the chemical substance that
is the subject of the notice, such as details about manufacturing,
processing, or use sites not controlled by the submitter. In those
situations, EPA will make conservative assumptions and use default
values for any information that is not known to or reasonably
ascertainable by the submitter and therefore not provided in the PMN
form.
Based on a public comment, EPA is adding language to 720.50(c) to
clarify that submitters can submit additional information not otherwise
required by 720.50(a)-(b) to facilitate EPA's review of the notice.
a. Physical and Chemical Properties and Environmental Fate
Characteristics
The first set of detailed information requirements that EPA is
adding to 40 CFR 720.45 concerns the physical and chemical properties
and environmental fate characteristics of the chemical substance (see
Table 1 in Ref. 6). Currently, if submitters have physical-chemical or
environmental fate test data, they must provide the test data or a
standard literature citation in accordance with 720.50(a)(2)-(3). EPA
collects physical and chemical properties test data required by 40 CFR
720.50, ``Submission of test data and other data concerning the health
and environmental effects of a substance,'' in two ways. First, the CDX
user interface prompts the submitter to attach relevant documents, such
as test data, to the PMN form using an attachment function. Second, the
PMN form includes a CDX user interface screen with form fields for
physical and chemical properties available for completion via a pick
list. Data provided in the PMN form via CDX may be pulled from the test
data provided by submitters per 720.50(a)(2)-(3), or the data can be
submitted as standalone information for which submitters do not have
underlying test data. EPA believes that the information requirements in
40 CFR 720.45 should reflect the PMN form fields. EPA is therefore
adding relevant physical and chemical properties information
requirements in a new provision at 40 CFR 720.45(j)(1) that are already
specified within the PMN form. Submitters must submit physical-chemical
and environmental fate information in the corresponding PMN form fields
in accordance with new paragraph 720.45(j), which is added as described
in the proposed rule.
[[Page 102779]]
EPA is also adding several information requirements to 40 CFR
720.45(j)(1) that are not already specified within the PMN form for
physical and chemical properties. Specifically, EPA is requiring that
data on surface tension and ultraviolet-visible (UV-VIS) absorption, as
well as any particle size distribution analysis, be submitted as part
of the PMN form, to the extent it is known to or reasonably
ascertainable by the submitter. One commenter requested that EPA
clarify the language outlined in the proposed rule for the particle
size distribution analysis data requirement to make it clear that it
includes both the analysis method as well as any data used to develop
the particle size distribution value, a suggestion that EPA is
incorporating in this final rule. Two commenters requested that EPA
include several amendments to the nanomaterial morphology requirements
outlined in the proposed rule, recommendations that EPA considers to be
overly prescriptive and as such is declining to finalize. Additionally,
after considering these comments, EPA anticipates that the proposed
requirements at 40 CFR 720.45(j)(1) for information on aspect ratio,
thickness, and number of layers or walls for nanomaterials are likely
to be applicable only to a narrow subset of nanomaterials. Because this
information would not be relevant to most nanomaterials, EPA will not
include the proposed nanomaterial data requirements in the final
regulations. For all other amendments to 40 CFR 720.45(j), as was
proposed in the May 2023 proposed rule, EPA will also add fields for
attaching associated data on the physical and chemical properties
screen of the PMN form.
As proposed, EPA is also adding information requirements for the
environmental fate characteristics of the chemical substance (see Table
1 in Ref. 6) to 40 CFR 720.45(j)(2). Environmental fate characteristics
test data are already required by 40 CFR 720.50; however, this
provision does not describe in detail what these relevant
characteristics include. In addition, this information is already
collected by EPA as attachments to the PMN form; however, fields for
environmental fate characteristics are not yet included on the CDX user
interface screen pick list. EPA is thus adding the relevant
environmental fate characteristics to the information requirements at
40 CFR 720.45(j)(2) and form fields to the PMN form by expanding the
pick list.
b. Categories of Use
The next set of changes that EPA is finalizing at 40 CFR 720.45
relates to the categories of use of the chemical substance (see Table 2
in Ref. 6). The requirements being finalized include detailed
information on commercial and consumer uses, which already have form
fields in the PMN form in CDX. Although the regulations at 40 CFR
720.45(f) previously required a description of intended categories of
use by function and application, the estimated percent of production
volume devoted to each category of use, and the percent of the new
substance in the formulation for each commercial or consumer use,
certain details on commercial and consumer uses were not specified. The
added information requirements include the types of products or
articles that would incorporate the new chemical substance (e.g.,
household cleaners, plastic articles), how and where a product or
article incorporating the new chemical substance would be used (e.g.,
spray applied indoors, brushed on outdoor surfaces), consumption rates
and frequency and duration of use for products or articles containing
the new chemical substance, and information related to the use of
products or articles containing the new chemical substance by
potentially exposed or susceptible subpopulations. Additionally, EPA is
finalizing at 40 CFR 720.45(f) a requirement to designate applicable
consumer and commercial product categories using Organization for
Economic Co-operation and Development (OECD)-based functional use
codes, which would create consistency with TSCA section 8(a) Chemical
Data Reporting (CDR) requirements in 40 CFR part 711. EPA is finalizing
corresponding changes to the PMN form fields in CDX for this data
element. EPA is also finalizing amendments to 40 CFR 721.25 to ensure
that submitters of SNUNs include in their notice both a description of
the intended categories of use, as required by 40 CFR 720.45(f)(1), and
of all known categories of use, to the extent known to or reasonably
ascertainable by the submitter. Such categories of use may include uses
that are ongoing and not subject to a significant new use rule (SNUR).
Such information is valuable for EPA in determining necessary
regulatory action should potential risks be identified during review of
a SNUN. In the final rule, this provision appears in a new paragraph
(e) of 40 CFR 721.25 rather than as an addition to paragraph (c), and
the text was rephrased slightly for clarification. One commenter
requested that EPA include a provision at 40 CFR 720.45(f) that would
require submitters with chemicals having more than 10 intended uses to
designate codes only for the 10 uses that represent the largest
proportion of the anticipated production volume of the chemical, a
suggestion that EPA is finalizing. EPA, however, will still require
submitters to identify in the free form text field of the PMN form all
intended or known uses of the chemical substance.
c. Details Concerning Manufacture, Processing, and Use
The third set of information requirements that EPA is finalizing at
40 CFR 720.45 is information related to where and how the chemical
substance will be manufactured, processed, or used. These requirements
apply to sites controlled by submitters as well as sites controlled by
others, and although the information requirements that EPA is
finalizing are similar for both, different types of activities often
occur at submitter-controlled sites versus those at sites controlled by
others (e.g., manufacturing versus processing). Moreover, activities at
sites controlled by others are typically not as well characterized by
submitters compared to descriptions of the submitters' own activities,
since in many cases the identity and number of sites controlled by
others is unknown to and not reasonably ascertainable by the submitters
when a notice is submitted. As such, some slight differences exist in
the requirements EPA is finalizing for information related to sites
controlled by submitters versus sites controlled by others. See Ref. 6
for more details.
Both for sites controlled by submitters and for sites controlled by
others, EPA is adding information requirements for site addresses (see
Table 3 and Table 5 in Ref. 6). For submitter-controlled sites, EPA is
also adding requirements for a description of whether a particular
chemical substance is manufactured or processed via batch or continuous
production, as well as the amount of the chemical substance
manufactured or processed in each batch and/or timeframe (see Tables 3,
4, and 5 in Ref. 6). These information requirements already have a
corresponding form field in the PMN form in CDX because they are each
covered by the existing information requirements in 40 CFR 720.45(g)(1)
and (2) and (h) for a process description of operations at such sites.
Since these information requirements were not specified in the
regulations, EPA is finalizing them at 40 CFR 720.45(g)(1) and (2) for
sites controlled by the submitter and 40 CFR
[[Page 102780]]
720.45(h)(1) and (2) for sites not controlled by the submitter.
EPA is also adding requirements for detailed information about the
process diagram or description for each site controlled by the
submitter (see Table 4 in Ref. 6) and for each site not controlled by
the submitter (see Table 5 in Ref. 6). These data elements were
previously required but not expressly included in the list of required
data elements in 40 CFR 720.45. They include descriptions of the
identity, approximate weight per batch or per day for continuous
production, and entry point of all starting materials and feedstocks;
the identity, approximate weight per batch or per day for continuous
production, and entry point of all products, recycle streams, and
wastes, including frequency of any equipment cleaning; the type of
containers used for interim storage and transport of the chemical
substance; and identification, by number, of any points of release. EPA
is finalizing requirements for this information at 40 CFR 720.45(g)(2)
and (h)(2) and in new fields in the PMN form to clarify the level of
detail needed and to ensure that the regulations and PMN form are
consistent.
One commenter noted that an existing data requirement related to
manufacturing, processing, use, and disposal of chemical substances
subject to section 5 notification is ambiguous in its scope. 40 CFR
720.45(d) requires submitters to describe any byproducts resulting from
the manufacture, processing, use, and disposal of a chemical substance,
and the commenter requested that EPA clarify whether its definition of
byproduct includes ``degradation products''. In the Response to
Comments document (Ref. 2), EPA notes that byproducts are distinct from
degradants and that information on degradants is required under the
information requirements outlined in 720.45(j)(2).
d. Worker Exposure
EPA is also finalizing requirements for details about the possible
worker exposures at each site controlled by the submitter (see Table 6
in Ref. 6), and at each site not controlled by the submitter (see Table
7 in Ref. 6). These requirements include types of potential worker
exposure (e.g., dermal, inhalation), descriptions of any protective
equipment and engineering controls in place, the moisture content of
the chemical substance (if a solid), and the percentage of the chemical
substance in the formulation at the time of exposure. In addition, for
sites controlled by others, these requirements also include worker
activities and descriptions of the physical form of the chemical
substance (consistent with information requirements for sites
controlled by the submitter). Although these details are already
covered by the existing information requirements in 40 CFR 720.45(g)(3)
and (h) regarding worker exposure information, and some already have a
corresponding form field in the PMN form in CDX, EPA is finalizing them
as separate, unique information requirements at 40 CFR 720.45(g)(3) and
(h)(3) and in new fields in the PMN form to clarify the level of detail
needed and to ensure that the regulations and PMN form are consistent.
One commenter requested that EPA revise the proposed text at 40 CFR
720.45(g)(3) and (h)(3) to clarify that the worker exposure information
required in 40 CFR 720.45(g)(3)(ii)-(viii) and (h)(3)(ii)-(viii)
pertains to each worker activity occurring during the manufacturing,
processing, and use of the chemical substance, as identified pursuant
to 720.45(g)(3)(i) and 720.45(h)(3)(i). EPA has incorporated this
suggestion in the final rule because it provides additional clarity to
submitters.
Several commenters made requests related to worker exposure that,
if accepted by EPA, would affect the structure of and level of detail
contained in the PMN form in CDX. For example, one commenter requested
that EPA allow submitters to assign a ``Letter of Activity'' (a field
in CDX to link specific worker activities to operations described in
the corresponding manufacturing diagram) to activities at submitter-
controlled sites; the option to assign a Letter of Activity already
exists for activities at sites controlled by others. Another commenter
requested that EPA include in the PMN form dropdown options for
``Worker Activity'' and ``Worker Category'' for sites controlled by
others--dropdown options that currently exist for submitter-controlled
sites in the PMN form. EPA is finalizing all of the aforementioned
suggestions by making corresponding changes to the CDX interface. EPA,
however, also received several additional suggestions related to worker
exposures that EPA is choosing not to adopt. More information on the
comments received relating to worker exposure and EPA's responses can
be found in the Response to Comments document (Ref. 2).
Additionally, EPA is finalizing proposed amendments to 40 CFR
720.45(g)(3) and (h)(3) to ensure that submitters include worker
exposure information from exempt manufacture or related use of the
chemical substance under 40 CFR 720.30 (e.g., manufacture of the
chemical substance under the byproduct or impurity exemptions) at each
site where the chemical substance will be manufactured, processed, or
used, if known or reasonably ascertainable. However, to avoid any
confusion occasioned by the abbreviated, non-exhaustive list of
exemption examples that appeared in a parenthetical in the proposed
regulatory text, the final rule does not include the proposed
parenthetical and streamlines the text by simply cross-referencing 40
CFR 720.30.
e. Environmental Releases
EPA is finalizing information requirements concerning the potential
environmental releases at each site controlled by the submitter (see
Table 8 in Ref. 6) and at each site not controlled by the submitter
(see Table 9 in Ref. 6). EPA is requiring descriptions of the type of
release (e.g., transport, interim storage, disposal, equipment
cleaning), as well as the amount of the chemical substance released
directly to the environment or into a control technology. EPA is
finalizing an amendment to require a description of the amount of the
chemical substance released to the environment after use of a control
technology. EPA is also requiring for equipment cleaning releases a
description of the frequency of equipment cleaning and what is used to
clean equipment. EPA is also requiring for transport and storage
releases a description of how the chemical substance or the product
containing the chemical substance is transported from the site and
stored, as well as information about the containers used. For releases
into air, EPA is requiring Clean Air Act operating permit numbers and a
description of any Leak Detection and Repair program the site has
implemented; one commenter requested that EPA amend the language for
this data element to require a description of the type of control
technology used to treat stack air releases, which EPA is finalizing.
For releases into water, EPA is requiring National Pollutant Discharge
Elimination System (NPDES) permit numbers and information on the
waterbodies and other destinations into which the release occurs; one
commenter requested that EPA also require a description of any outfall
numbers associated with the known points of release associated with the
NPDES permit number(s), a suggestion that EPA is finalizing. For
releases into wastewater treatment plants, EPA is requiring information
on the publicly owned treatment works (POTW) into which the release
occurs. For the
[[Page 102781]]
requirement concerning information on POTW, one commenter requested
that EPA amend this data requirement to also specifically request
information concerning privately owned treatment works to which
releases might occur, the type of wastewater technology employed at any
treatment facilities, and the known or estimated treatment efficiency
at these facilities--all of which are suggestions that EPA is
finalizing. In addition, for sites controlled by others, these
requirements also include a description of the media of release
consistent with the requirement for sites controlled by the submitter.
Although each of these detailed data elements are already covered
by the existing information requirements in 40 CFR 720.45(g)(4) and (h)
regarding environmental releases, and some already have a corresponding
form field in the PMN form in CDX, EPA is finalizing them as separate,
unique information requirements at 40 CFR 720.45(g)(4) and (h)(4) and
in new fields in the PMN form to clarify the level of detail needed and
to ensure that the regulations and PMN form are consistent.
EPA is finalizing amendments to 40 CFR 720.45(g) and (h) to make
their formatting and the information required in both consistent. EPA
recognizes that a submitter may not possess such information about
sites not controlled by the submitter. As mentioned elsewhere in this
preamble and in the Response to Comments document (Ref. 2), submitters
are only required to supply information that is known to or reasonably
ascertainable by them, as defined at 40 CFR 720.3.
Additionally, EPA is finalizing amendments to 40 CFR 720.45(g)(4)
and 720.45(h)(4) to ensure that submitters include environmental
release information from exempt manufacture or related use of the
chemical substances under 40 CFR 720.30 (e.g., manufacture of the
chemical substance under the byproduct or impurity exemptions) at each
site where the chemical substance will be manufactured, processed, or
used, if known or reasonably ascertainable. However, to avoid any
confusion occasioned by the abbreviated, non-exhaustive list of
exemption examples that appeared in a parenthetical in the proposed
regulatory text, the final rule does not include the proposed
parenthetical and streamlines the text by simply cross-referencing 40
CFR 720.30.
f. Pollution Prevention Information
Lastly, EPA is adding optional pollution prevention information at
40 CFR 720.45(k) as proposed. The PMN form in CDX currently includes an
optional text field and attachment function for submitters who wish to
provide pollution prevention information about the chemical substance,
such as information about using alternative fuel sources, reducing the
use of water and chemical inputs, modifying a production process to
produce less waste, implementing water and energy conservation
practices, or substituting for riskier existing products.
3. Other Modifications to the PMN Form in CDX
In addition to the amendments intended to clarify the information
requirements for a notice and the corresponding changes to the PMN form
in CDX outlined in Unit III.B.1. and 2., EPA is also adding statements
with accompanying check boxes to certain screens of the PMN form (such
as when transitioning between the various worksheets completed by the
submitter) that indicate that information fields can only be left blank
if such information is not known to or reasonably ascertainable by the
submitter. Additionally, a statement would warn the submitter of the
potential consequences of leaving the field blank and later amending
the field. If a field is left blank, EPA generally follows the
scientifically informed approach to make conservative assumptions and
use appropriate default values when assessing risk, which could result
in more stringent risk management requirements than might be directed
if data were provided showing such assumptions or default values were
not necessary to use. If a field that has been left blank is later
amended during the review process, EPA may declare the original
submission incomplete (see Unit III.C.3. for a more detailed discussion
on notice amendments indicating that the original submission was
incomplete). Several commenters expressed concerns about the potential
burden posed by the inclusion of these check boxes in the CDX workflow,
concerns with which EPA disagrees. While the inclusion of check boxes
might require submitters to spend slightly more time preparing the PMN
form for their section 5 notices, EPA believes that the improved
quality of submissions resulting from this, and the other changes being
finalized to the CDX environment, will save submitters, as well as EPA,
more time, and resources in the long run. This check box approach does
not have a corresponding regulatory change, as it is consistent with
the existing requirements to provide all information that is known to
or reasonably ascertainable by the submitter and EPA's longstanding
practice to use conservative assumptions and default values in the
absence of information. The ICR document accompanying this final rule
describes the potential modifications to each screen of the PMN form
(Ref. 7).
Some commenters made requests related to the CDX enhancements
outlined in the proposed rule that EPA is addressing in this final
rule. First, two commenters requested that EPA include in the
enhancements to the CDX interface an option for submitters to, if data
are not provided for a particular data element, explain why this
information is not known or reasonably ascertainable, a suggestion that
EPA will incorporate. Another commenter requested that EPA allow
submitters to access a ``beta version'' of the enhanced CDX environment
before rolling out the changes to the broader CDX environment. EPA will
make efforts to do so and plans to share more information with
stakeholders via outreach once this final rule is published. The CDX
enhancements described in this rulemaking will not be finalized upon
publication or effective date of the final rule. The enhancements will
take time to develop, and EPA will make the updated CDX interface
reflecting these changes publicly available as soon as resources allow.
However, submitters are currently able to include all information for
the newly specified data elements described in this preamble and the
amended regulatory text as generic attachments in the current CDX
workflow. EPA will share additional guidance and conduct outreach with
stakeholders prior to the rollout of the changes to CDX and will work
to extend flexibility to submitters in the event that issues arise
related to discrepancies between the regulations and the PMN form
before the CDX enhancements can be implemented.
C. Amendments Related To Pre-Screen, Incomplete Submissions, Correcting
Errors, and New Information
EPA is finalizing amendments to the regulations regarding how EPA
acknowledges the receipt of a notice to account for EPA's pre-screen
process and to clarify the start of the applicable review period,
particularly when a notice contains errors or is incomplete. EPA is
also finalizing amendments to align the process for correcting errors
in
[[Page 102782]]
the notice with the existing process for incomplete submissions. EPA is
further clarifying that an initial notice submission may later be
deemed incomplete if the submitter submits additional information at
any time during the review period that was known to or reasonably
ascertainable by the submitter at the time of initial notice
submission. Finally, EPA is promulgating amendments that clarify that
new information about a chemical substance under EPA review must be
submitted electronically via CDX and that certain notification to EPA
of new information may be made by e-mail.
1. Pre-Screening Procedures
EPA is finalizing amendments to 40 CFR 720.65(a) to codify the pre-
screen process that EPA conducts prior to moving forward to the risk
assessment process. The new language would clarify, for purposes of
transparency, EPA's current pre-screen practice as described in Unit
III.C.1 of the proposed rule preamble. EPA is also finalizing an
amendment to 40 CFR 720.70 to clarify that a notice of receipt will be
published in the Federal Register after EPA receives a complete notice,
rather than merely receiving the notice, to accommodate the pre-
screening procedures. Additionally, based on public comments, EPA is
amending 40 CFR 723.50(e)(3) to add a description of current pre-screen
procedures and update/clarify the process for completing an incomplete
LVE or LoREX notice, which will better align with similar changes made
to 40 CFR 720.65 and with existing electronic submission requirements.
One comment on the proposal asserted that EPA should include in
section 5 prescreen a review of all CBI claims for consistency with
sections 14(b) and (c) of TSCA and treat any submission that includes a
CBI claim that appears to be inconsistent with the requirements of
these sections as ``erroneous or incomplete.'' EPA disagrees with these
comments as assuring that every CBI claim is consistent with section
14(b) and (c) of TSCA would require a substantive review of each claim,
which is well beyond the CBI review requirements described in TSCA
section 14(g). For a more detailed response regarding CBI review during
pre-screen, please see the Response to Comments document (Ref. 2).
2. Correcting Errors in Notices
As proposed, EPA is finalizing amendments at 40 CFR 720.65(a) and
(b) to state that if EPA receives a notice with errors and EPA requests
(as part of the pre-screen process or, at latest, within 30 days of
receipt of the notice) that the submitter remedy such errors, the
applicable review period will not begin until EPA receives a corrected
notice. This will align the process for correcting errors with the
current process in 40 CFR 720.65 for correcting an incomplete notice.
3. Notice Amendments Indicating Original Notice was Incomplete
EPA is finalizing amendments at 40 CFR 720.65(c)(2) and to 40 CFR
720.65(c)(5)(iii) (moved to 720.65(d)(5)(iii)), to clearly communicate
and clarify that EPA may deem an original notice incomplete, and
restart the review period at Day 1, if a submitter provides required
information during the applicable review period without demonstrating
that it was not known to or reasonably ascertainable by the submitter
at the time of the initial notice submission. Additionally, EPA is
updating the reference to 40 CFR 720.80(b)(2) at 40 CFR 720.65(c)(vii)
to instead point to 40 CFR 703.5(c) because the 2023 CBI rule (88 FR
37155, June 7, 2023) moved the language that was previously at
720.80(b)(2) to a new section at 40 CFR 703.5.
As stated in the proposal for this rule (88 FR 34100, May 26,
2023), EPA is changing the longstanding practice of accepting
amendments that contain required information that was known or
reasonably ascertainable at the time of the original submission and
then accepting a request to suspend the review period under 40 CFR
720.75(b).
As explained in Unit II.B., the 2016 Lautenberg Amendments impose
additional obligations on EPA. EPA believes that exercising its
discretionary authority under the existing regulations to declare an
original submission incomplete and restart the applicable review period
upon submission of the complete notice (e.g., when an amendment is
submitted that makes a notice complete) is appropriate in order for EPA
to efficiently meet current statutory requirements. Several comments on
the proposed rule objected to these amendments, stating that submitters
often are prompted to generate new or additional information during the
review period to rebut unforeseen or conservative assumptions made by
EPA. To address this comment and assist with efficient review, EPA is
also amending the notice information requirements at 40 CFR 720.45 to
specify the level of detail needed to perform refined risk assessments,
as well as building that additional detail into the CDX user interface,
which is detailed in Unit III.B of both the proposed rule (88 FR 34100,
May 26, 2023) and this final rule. By specifying more detailed
information requirements in 40 CFR 720.45 and data fields in the CDX
user interface, EPA should receive more complete submissions upfront
and help to minimize the need for EPA to use default values and
conservative assumptions in its risk assessment due to a lack of
available data. The Agency, however, reiterates that the submitter is
required to provide all required information that is known or
reasonably ascertainable at the time of the initial submission and not
in reaction to risk assessment findings. Submitters must provide all
information required by 40 CFR 720.45 and 720.50 upfront to satisfy the
requirement of submitting a complete notice.
In response to the proposal, EPA received a comment asking that the
Agency provide submitters with an opportunity to explain why
information submitted as part of an amendment should not result in
restarting the applicable review period. Under the amendment to 40 CFR
720.65(c)(2) being finalized in this action, the submitter of
additional or revised information during the review period must
demonstrate to EPA's satisfaction that the information was not known to
or reasonably ascertainable by the submitter at the time of the
original submission to preclude an EPA determination that the original
notice was incomplete. Amendments to a notice that will not be
considered as amendments indicating that the original notice was
incomplete are: (1) Amendments based on new data (as described at 40
CFR 720.40(f) and 720.50(a)(4)); (2) Administrative, non-substantive
amendments (e.g., submitter contact information); and (3) Amendments
made at the request of EPA. EPA, however, will take case-by-case facts
into consideration when determining whether a late submission of
information indicates that a notice was incomplete when originally
submitted. If a submitter disagrees with EPA's determination that the
original notice submission was incomplete, the submitter may object
according to the existing procedures at 40 CFR 720.65(c)(4) and (5), as
amended in this final rule, which updates and moves these provisions to
40 CFR 720.65(d)(4) and (5).
As explained in the proposed rule, a notice submitted under TSCA
section 5(a)(1) is statutorily required to include the information
described in TSCA section 5(d)(1) insofar as it is known to the
submitter or reasonably ascertainable. In response to various
procedural amendments proposed in
[[Page 102783]]
this rulemaking, EPA received comments asking the Agency to further
define ``known to or reasonably ascertainable by'' beyond the current
definition at 40 CFR 720.3. While EPA understands and recognizes the
desire to have a more explicitly defined list of criteria or more
detailed definition of ``known to or reasonably ascertainable by,'' EPA
believes that it is not possible to define ``known to or reasonably
ascertainable by'' more explicitly--as was stated in the 1983 final
rule entitled ``Premanufacture Notification; Premanufacture Notice
Requirements and Review Procedures'' (Ref. 8) and restated in the May
2023 proposed rule (88 FR 34100). EPA has not, in this rulemaking,
proposed or finalized any amendment to or undertaken any substantive
reconsideration, reexamination, or reinterpretation of the existing
definition at 40 CFR 720.3. That said, to assist submitters, EPA has
provided additional discussion and examples as to what is meant by
``known to or reasonably ascertainable by'' in the Response to Comments
document (Ref. 2).
4. Notifying EPA of the Receipt of New Information on a Chemical
Substance Under Review
EPA is finalizing amendments to 40 CFR 720.40(f), 40 CFR
720.50(a)(4)(ii), and 40 CFR 723.50(i) to clarify that new information
about a chemical substance under EPA review must be submitted
electronically via CDX, consistent with the general electronic
submission requirements in 40 CFR 720.40(a). In addition, when
submitters receive new information within five days of the end of the
review period, EPA is amending the regulations to allow submitters to
notify EPA by e-mail of the receipt of new information. Although the
regulatory text in 40 CFR 720.40(f) and 40 CFR 723.50(i) are similar,
the regulatory text provided along with the proposed rule erroneously
showed only the proposed changes to 40 CFR 720.40(f) and did not show
proposed changes to 40 CFR 723.50(i). This was an oversight and the
regulatory text accompanying this final rule consistently amends both
40 CFR 720.40(f) and 40 CFR 723.50(i).
D. Amendments to Low Volume Exemptions and Low Release and Exposure
Exemptions
EPA is promulgating several amendments to the current LVE and LoREX
regulations. Specifically, EPA is finalizing amendments so that: (1)
submitters may not commence manufacture until EPA has approved the LVE
or LoREX notice; (2) EPA may proactively inform LVE and LoREX holders
if the chemical substance that is the subject of the LVE or LoREX
becomes subject to a SNUR and the chemical identity is CBI, or if it is
listed on the confidential portion of the TSCA Inventory; (3) PFAS are
categorically ineligible for these exemptions; and (4) certain PBT
chemical substances are ineligible for these exemptions.
LVE and LoREX regulations are promulgated under the statutory
authority of TSCA section 5(h)(4), 15 U.S.C. 2604(h)(4), which provides
that EPA may, upon application and by rule, exempt the manufacturer of
any new chemical substance from all or part of the requirements of TSCA
section 5 if EPA determines that the manufacture, processing,
distribution in commerce, use, or disposal of such chemical substance,
or that any combination of such activities, ``will not present an
unreasonable risk of injury to health or the environment, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified by [EPA] under the conditions of use.''
1. Amendments to Expiration of LVE and LoREX Review Period
EPA is finalizing, as proposed, amendments to the LVE and LoREX
regulations at 40 CFR 723.50(g) to require a notification of approval
of an LVE or LoREX from EPA prior to commencement of manufacture of the
chemical substance under the exemption. Prior to the promulgation of
this amendment, 40 CFR 723.50(g)(2) provided that the submitter may
begin manufacture of a chemical substance under an LVE or LoREX upon
expiration of the 30-day review period if EPA had taken no action. As
described in Unit III.A., EPA is also amending the regulations that
allow submitters to begin manufacture or processing of chemical
substances for which a PMN, MCAN, or SNUN was submitted upon expiration
of the review period, so that those regulations would require a
determination from EPA prior to commencement of manufacture or
processing of such substances. As discussed in Unit III.A., these
changes to 40 CFR 720.75, 721.25(d), and 725.170 are being made to
conform those regulations to the 2016 Lautenberg Amendments. EPA is
finalizing similar amendments to the LVE and LoREX regulations at 40
CFR 723.50 to align with the amendments to the PMN, SNUN, and MCAN
regulations and with the statutory framework and to better ensure that
chemical substances manufactured under LVEs and LoREXs will not present
an unreasonable risk.
2. Notification of LVE and LoREX Holders if the Chemical Substance is
Subject to a SNUR or Listed on the Confidential Portion of the TSCA
Inventory
EPA is finalizing amendments to 40 CFR 723.50 to allow EPA to
inform an LVE or LoREX holder whenever the chemical substance that is
the subject of that LVE or LoREX becomes subject to a proposed or final
SNUR that describes the chemical substance by a generic chemical name
due to a confidentiality claim for its specific chemical identity. This
amendment would, as a courtesy, help inform LVE and LoREX holders of
regulatory requirements that they may have otherwise been unable to
determine on their own without submitting an inquiry to EPA (also known
as a bona fide notice) pursuant to 40 CFR 721.11. In the proposed rule
(88 FR 34100, May 26, 2023), EPA stated that the Agency did not intend
to proactively inform current LVE and LoREX holders about SNURs that
predate this rule and that EPA would only start the practice of
notifying LVE and LoREX holders subject to this amendment after the
date of the final rule. However, upon consideration of public comments
in support of notifying current exemption holders of preexisting SNURs,
EPA intends, subject to availability of resources, to notify current
LVE and LoREX holders about preexisting SNURs that describe the
chemical substance by a generic chemical name. Given current resource
constraints, however, EPA is unable to provide a timeline for when it
will begin and complete this notification effort. A lack of receipt of
this courtesy notice that a chemical substance is subject to a SNUR
does not excuse chemical manufactures and processors from complying
with any existing regulations. LVE and LoREX holders who wish to
determine whether their chemical substance is subject to a SNUR may
always submit an inquiry to EPA (also known as a bona fide notice)
pursuant to 40 CFR 721.11.
In response to public comments, in addition to notifying LVE and
LoREX holders when they are subject to a SNUR, EPA also intends,
subject to availability of resources, to begin notifying LVE or LoREX
submitters if a substance is added to the confidential portion of the
TSCA Inventory as a result of filings by a different submitter that
claimed the specific chemical identity of the substance as
confidential. As of February 7, 2024, more than 460 LVEs and LoREXs
that were granted by EPA pertain to chemical substances that are now
listed on the TSCA Inventory.
[[Page 102784]]
Once on the Inventory, a chemical substance may be subject to
additional requirements under TSCA. Of the more than 390 chemical
substances covered by these LVE and LoREX, approximately 125 are on the
confidential portion of the TSCA Inventory. Without notice by EPA or by
submitting a bona fide notice, a submitter is unlikely to know their
substance is listed on the confidential portion of the Inventory,
unless they also submitted the PMN and subsequent Notice of
Commencement that led to the Inventory listing of the substance. While
EPA intends to begin providing notice to exemption holders whose
chemical substance now appears on the confidential portion of the TSCA
Inventory, EPA does not intend to provide notice to those who hold
granted LVEs or LoREXs pertaining to chemical substances whose specific
chemical identities are added to the public portion of the TSCA
Inventory due to the additional resources this would require and to the
fact this information is publicly available.
In response to public comment, EPA affirms that once a chemical
substance is added to the Inventory, an LVE or LoREX (or any other
exemption from PMN requirements) is no longer necessary to manufacture
the chemical substance and thus any approved LVE or LoREX is no longer
binding on the manufacturer. The premanufacture notice requirements of
TSCA section 5(a)(1), the relevant statutory exemption authority at
TSCA section 5(h)(4), and the LVE/LoREX regulations at 40 CFR 723.50
all apply to manufacturers of new chemical substances, yet a chemical
substance is no longer a ``new chemical substance'' as defined in TSCA
section 3(11) once it is added to the Inventory. While EPA intends to
begin providing notice to LVE and LoREX submitters once their substance
is listed on the confidential portion of the Inventory, EPA does not
intend to formally revoke these exemptions under the process described
in 40 CFR 723.50(h)(2), as that process pertains to new chemical
substances for which manufacture is not otherwise permitted in the
absence of a PMN or applicable exemption.
The amendments to the regulations at 40 CFR 723.50 establish that a
granted LVE or LoREX notice demonstrates a bona fide intent to
manufacture the substance, such that a disclosure to an LVE or LoREX
holder that the substance is the subject of a proposed or final rule
under Part 721 or similarly that the substance is on the confidential
portion of the TSCA Inventory will not be considered public disclosure
of confidential business information under section 14 of the Act. EPA
is not amending the procedures in 40 CFR 723.50(l) for asserting and
protecting confidential business information.
3. Making PFAS Categorically Ineligible for LVEs and LoREXs
EPA is finalizing amendments to limit the scope of the LVE and
LoREX exemptions that were first promulgated in accordance with TSCA
5(h)(4) in 1985 and 1995 respectively (50 FR 16477 (April 26, 1985) and
60 FR 16346 (March 29, 1995)). TSCA 5(h)(4) allows, but does not
require, the Administrator to exempt the manufacturer of any new
chemical substance from all or part of the requirements of TSCA section
5 in certain circumstances. The statute does not specify any
circumstances under which the Administrator would be required to
provide an exemption and EPA's action here is consistent with its
authority under 5(h)(4) to create and/or define the scope of
exemptions. These amendments make PFAS categorically ineligible for
LVEs and LoREXs going forward, using a structural definition of PFAS
for purposes of the LVE and LoREX regulations. Upon the effective date
of this rule, any LVE or LoREX notice for a PFAS that is submitted to
the Agency will be denied upon receipt without substantive review. This
includes any chemical substance where any of the reasonably anticipated
metabolites, environmental transformation products, byproducts, or
reasonably anticipated impurities are a PFAS. Persons who wish to
manufacture a PFAS not on the TSCA Inventory will be required to submit
a PMN at least 90 days prior to commencing manufacture for a non-exempt
commercial purpose. The definition for PFAS that EPA is finalizing is
aligned with the recently finalized TSCA section 8(a)(7) rule (88 FR
70516, October 11, 2023) and the Inactive PFAS SNUR (89 FR 1822,
January 11, 2024). Although PFAS would no longer be eligible for LVE or
LoREX, there may be case-specific circumstances where a use of a new
PFAS or a new use of an existing PFAS may be needed by a federal agency
to meet its mission or is required in order to meet another critical
need. EPA will work with other federal agencies to expedite review of
such cases. Furthermore, EPA recognizes the critical role that many new
chemicals play, including some PFAS, in the manufacture of
semiconductors. The new chemicals program now prioritizes notices for
chemicals used in sectors supported by the Creating Helpful Incentives
to Produce Semiconductors (CHIPS) and Science Act and the Inflation
Reduction Act's (IRA) climate goals. Since beginning the process of
prioritizing CHIPS and Science Act and IRA related chemicals, EPA now
reviews these new chemicals in a third of the time compared to other
sectors. The Agency believes these key sectors are important to growing
new jobs as part of the Biden-Harris Administration's domestic
manufacturing initiatives. For some new chemicals needed by the
semiconductor sector, such as photo-acid generators, EPA's multi-year
collaborative effort with the sector has resulted in a regulatory
pathway for dozens of these chemicals, and recent submittals have had
review timeframes of under 90 days.
As noted in the proposed rule, EPA's New Chemicals Program began
implementing a new policy for reviewing and managing LVE notices for
PFAS in April 2021. In an April 27, 2021, press release announcing the
new PFAS LVE policy (Ref. 9), the Agency stated that ``[g]iven the
complexity of PFAS chemistry, potential health effects, and their
longevity and persistence in the environment, an LVE notice for a PFAS
is unlikely to be eligible for this kind of exemption under the
regulations.'' Since 2021, EPA has reviewed 8 LVE notices for PFAS,
which were each reviewed on a case-by-case basis. Each of the 8 PFAS
were determined to be ineligible for an LVE due to the risks identified
and/or an inability to complete the review in 30 days as a result of
the complexities of the review or uncertainties in the assessment. EPA
has never received or approved any PFAS LoREX notices.
Each of the 8 PFAS that were the subject of LVE notices reviewed
since 2021, or the reasonably anticipated metabolites and environmental
transformation products of those PFAS, was determined to be a PBT
chemical substance. In 5 of the 8 cases, however, the PBT designation
included noted uncertainties for each of the substances reviewed. If
EPA is unable to score a characteristic (e.g., B ``unknown'' for
bioaccumulation), the characteristic is still considered to be
potentially a 2 or higher for the purposes of identifying potential
PBTs (Ref. 10). In many cases, additional uncertainties were identified
for the potential routes of exposure, which included exposures to
workers, the general population, a potentially exposed or susceptible
subpopulation (e.g., consumers, infants), or the environment. PFAS
present a challenge for EPA to evaluate because there is often
insufficient information to quantify the risk they may pose and
consequently make effective decisions
[[Page 102785]]
about how to regulate them (Ref. 11). As currently described in the
regulations, EPA may determine that a new chemical substance is
ineligible for an LVE or LoREX if there are issues concerning toxicity
or exposure that require further review which cannot be accomplished
within the 30-day review period. EPA notes that the shortened 30-day
review period for LVEs and LoREX is one of the major benefits of these
exemptions as it allows companies to introduce new chemical substances
more quickly into commerce. The 30-day review period provides a screen
for EPA to identify any new chemical substances with issues that
require more detailed and comprehensive review and analysis, such as
that available in a full PMN review. See 60 FR 16336. Given the
shortened 30-day review of an LVE along with the inability to require
testing or impose additional restrictions under a section 5(e) or 5(f)
order, EPA was unable to address those uncertainties which would be
necessary to conclude that the substance would not present an
unreasonable risk. Since all of the 8 PFAS that were the subject of LVE
notices were deemed ineligible for the exemption, the submitters were
required to submit a PMN if they wanted to move forward with the
manufacture of the new chemical substances.
For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA
is defining ``PFAS'' using a structural definition. In this rule, EPA
defines PFAS to mean a chemical substance that contains at least one of
these three structures:
(1) R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are
saturated carbons;
(2) R-CF2OCF2-R', where R and R' can either be F, O, or saturated
carbons; or
(3) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated
carbons.
Manufacturers of substances that do not meet this structural
definition and of substances where any of the reasonably anticipated
metabolites, environmental transformation products, byproducts, or
reasonably anticipated impurities do not meet this structural
definition remain eligible to submit an LVE or LoREX notice.
In opposition to these amendments, EPA received comments asserting
that because PFAS are a broad category of chemicals, any proposed
regulatory action on PFAS should not group PFAS into a single category.
Comments also asserted that there was no scientific basis or risk-based
evidence for making PFAS ineligible for LVEs and LoREXs. EPA agrees
with the comments that PFAS are a broad category of chemical substances
with common toxicological properties, exposures, or uses, and notes
that the assessment and management of these substances for regulatory
purposes should generally be done on a case-by-case basis or as groups
of substances with common toxicological properties, exposures, or uses.
Furthermore, EPA believes that any assessment of PFAS should be done in
line with the scientific standards, weight of scientific evidence, and
consideration of any reasonably available information as outlined in
section 26 of TSCA. The amendment to make PFAS ineligible for LVEs and
LoREXs, however, is not based on an assessment of all PFAS or any PFAS
and does not impose risk management restrictions on any PFAS substance.
The decision to make PFAS ineligible for LVEs and LoREXs is not a
determination of risk for all or any PFAS. While the current state of
science and EPA's understanding of PFAS has motivated the decision to
make all PFAS ineligible for LVEs and LoREXs, these amendments are not
based on EPA findings that particular PFAS chemicals, or all chemicals
qualifying as PFAS under this rule, may present unreasonable risks of
injury to human health or the environment under the conditions of use
due to levels of hazards and exposures identified and evaluated by EPA.
Rather, due to the scientific complexities or uncertainties associated
with assessing PFAS and the lack of data on most PFAS with regards to
toxicity and exposure to human health and the environment, EPA expects
in most cases to be unable to determine pursuant to TSCA section
5(h)(4) that a PFAS ``will not present an unreasonable risk'' under the
conditions of use within the 30-day review period provided for LVE and
LoREX notices. This action is a procedural action based on EPA's
experience administering TSCA and reviewing LVEs for PFAS.
Additionally, making PFAS ineligible for the LVE and LoREX
exemptions may in fact reduce burden in many instances by avoiding the
submission and review of LVEs that are ultimately denied and required
to be resubmitted and reviewed anew through the PMN review process.
Furthermore, the New Chemicals Program developed the PFAS Framework to
help ensure that the Program effectively and efficiently reviews and
makes appropriate decisions on new PFAS or significant new uses of
existing PFAS reviewed through PMNs and SNUNs. The PFAS Framework will
guide EPA's review of PFAS under TSCA section 5, ensuring consistency
and efficiency in its review of incoming submissions while advancing
the Agency's goals to ensure protection of public health and the
environment. Please see the Response to Comments document that
accompanies this rule for a more detailed discussion of and response to
the comments received on the amendments to make PFAS categorically
ineligible for LVEs and LoREXs (Ref. 2).
The definition for PFAS promulgated at 40 CFR 723.50 does not
include substances that only have a single fluorinated carbon or
unsaturated fluorinated moieties (e.g., fluorinated aromatic rings and
olefins), which are more susceptible to chemical transformation than
their saturated counterparts, and therefore less likely to persist in
the environment. These potentially degradable substances, if submitted
to EPA in a LVE or LoREX notice, would still be evaluated by EPA and a
decision made to either deny or grant the exemption.
The three-part structural definition for PFAS includes
fluoropolymers. Fluoropolymers are made using fluorinated monomers, and
often fluorinated processing aides, which contributes to the release of
PFAS. In addition, the disposal of fluoropolymers may also result in
PFAS releases. EPA has been concerned about potential risks of
fluoropolymers for more than a decade. On January 27, 2010 (75 FR 4295,
1/27/2010), EPA amended the `polymer exemption rule,' to exclude from
eligibility polymers containing as an integral part of their
composition, except as impurities, certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length. EPA issued this amendment
because, based on information at the time, EPA could no longer conclude
that these polymers will not present an unreasonable risk to human
health or the environment under the terms of the polymer exemption
rule, which is the determination necessary to support an exemption
under section 5(h)(4) of TSCA. While some comments stated that
fluoropolymers are safe, there remains debate on the toxicity of
fluoropolymers especially when considering their entire life cycle
(Ref. 12). EPA's decision to include fluoropolymers as part of the
amendment to make PFAS ineligible for LVEs and LoREXs, however, was not
based on hazard, exposure, or risk. Fluoropolymers are no less
complicated to review than nonpolymeric PFAS, and the Agency expects it
would need the longer 90-day review for a PMN.
At the time of finalizing this rulemaking, EPA is not revoking
previously granted LVEs for PFAS. EPA, however, may take future action
on a case-by-case basis to revoke previously
[[Page 102786]]
granted LVEs for PFAS, which would be done in accordance with the
existing regulations at 40 CFR 723.50(h)(2). EPA believes that the
revocation of any existing LVE should be done on a case-by-case basis.
While there are well identified hazards for many PFAS and PFAS studies
have repeatedly found harm to human health, EPA has not determined that
PFAS as an entire category of chemical substances do not meet the
``will not present unreasonable risk of injury to health or the
environment'' standard of TSCA section 5(h)(4). As noted previously,
EPA's decision to make future PFAS ineligible for LVEs is not based on
hazard or risk but is instead based on EPA's experience administering
TSCA and reviewing LVEs for PFAS (please see the Response to Comments
document for a more detailed discussion (Ref. 2)).
As EPA continues to consider previously granted PFAS LVEs, EPA will
take into consideration the concerns raised about the potential impacts
to domestic semiconductor and electric vehicle industry, national
defense, or other critical applications. The Biden-Harris
Administration is committed to restoring U.S. leadership in
semiconductor and electric vehicle manufacturing, supporting good-
paying jobs across those supply chains, and advancing U.S. economic and
national security. EPA's Framework for Addressing New PFAS and New Uses
of PFAS (PFAS Framework) (Ref. 10) outlines EPA's planned approach when
reviewing new PFAS and new uses of existing PFAS. The application of
the PFAS Framework will help ensure that new PFAS won't harm human
health and the environment and allows that certain PFAS be used when
exposures and releases can be mitigated, which is critical for
important sectors like semiconductors. Under the framework, EPA expects
that some PBT PFAS will not result in worker, general population or
consumer exposure and are not expected to result in releases to the
environment, such as when PFAS are used in a closed system with
occupational protections as is generally the practice in the
manufacture of some semiconductors and other electronic components.
Additionally, EPA continues to work cooperatively with companies who
wish to voluntarily withdraw previously granted LVEs for PFAS. As of
April 1, 2024, 56 LVEs have been withdrawn through EPA's PFAS Low
Volume Exemption Stewardship Program.
4. Codifying EPA's Policy Concerning PBT Chemicals and LVEs and LoREXs
EPA is finalizing amendments to 40 CFR 723.50(d) that would codify
EPA's long-standing practice that, whenever EPA identifies a chemical
substance under LVE or LoREX review (or any reasonably anticipated
metabolites, environmental transformation products, or byproducts of
the substance, or any reasonably anticipated impurities in the
substance) as PBT with anticipated environmental releases and
potentially unreasonable exposures to humans or environmental
organisms, that substance would be ineligible for the LVE or LoREX. As
noted in Unit III.D.3., the LVE and LoREX exemptions were first
promulgated in accordance with TSCA section 5(h)(4) in 1985 and 1995
respectively (50 FR 16477, April 26, 1985 (FRL-2742-1) and 60 FR 16346,
March 29, 1995 (FRL-4923-1)). TSCA section 5(h)(4) allows, but does not
require, the Administrator to exempt the manufacturer of any new
chemical substance from all or part of the requirements of TSCA section
5 in certain circumstances. The statute does not specify any
circumstances under which the Administrator would be required to
provide an exemption and EPA's action here is consistent with both its
long-standing practice and with its authority under TSCA section
5(h)(4) to create and/or define the scope of exemptions.
On November 4, 1999, EPA issued its policy statement identifying a
category for PBT new chemical substances (Ref. 13). The 1999 policy
statement formally acknowledged PBT chemical substances as a category
based on shared characteristics to facilitate premanufacture assessment
and regulation. In response to the proposed amendment to the LVE and
LoREX regulations, EPA received comment asserting that the Agency
cannot categorically make all PBT chemicals ineligible for LVEs and
LoREXs. EPA did not propose to categorically make all PBT chemicals
ineligible for LVEs and LoREXs and is not doing so in this final rule.
Rather, EPA proposed and is finalizing amendments to 40 CFR 723.50(d)
to codify that whenever EPA identifies a chemical substance under LVE
or LoREX review (or any reasonably anticipated metabolites,
environmental transformation products, or byproducts of the substance,
or any reasonably anticipated impurities in the substance) as PBT with
anticipated environmental releases and potentially unreasonable
exposures to humans or environmental organisms, that substance would be
ineligible for the LVE or LoREX. In order to effectuate these
amendments for individual exemption notices, EPA would first need to
review the exemption notice to determine if the substance is a PBT and
then review the environmental releases and exposures to humans or
environmental organisms to determine if releases and exposures are
expected. Only after EPA has reviewed the hazards and exposures, will
EPA make a decision to either grant or deny an LVE or LoREX for a PBT
chemical substance.
Based on EPA's experience administering LVEs and LoREXs, EPA
expects that most exemptions for PBT chemical substances will not be
granted. However, EPA agrees that there are instances where PBT
chemical substances can be managed under an exemption. EPA may receive
an exemption notice for a PBT chemical substance that will not result
in worker, general population, or consumer exposure and that is not
expected to result in releases to the environment, such as chemical
substances used in a closed system to make semiconductors or other
electronic components. In such a negligible exposure and environmental
release scenario where worker exposure is fully mitigated and general
population exposures are not expected, if EPA has sufficient
information on the substance and the conditions of use to ensure that
such PBT chemical substances can be disposed of properly and no
consumer exposure is expected, EPA generally expects to grant the
exemption.
EPA is defining ``PBT chemical substance'' for purposes of 40 CFR
723.50 as ``a chemical substance possessing characteristics of
persistence (P) in the environment, accumulation in biological
organisms (bioaccumulation (B)), and toxicity (T) resulting in
potential risks to humans and ecosystems. For more information on EPA's
Policy on new chemical substances that are PBT, see EPA's 1999 policy
statement (64 FR 60194; November 4, 1999).''
E. Amendments Related to Suspensions of the Review Period
As proposed, EPA is finalizing amendments to 40 CFR 720.75(b)(2) to
allow PMN, SNUN, LVE, and LoREX submitters to request a suspension of
the notice review period for up to 30 days orally or in writing,
including by e-mail, without the need for a formal, written request
submitted to EPA via CDX using e-PMN software. EPA is similarly
finalizing amendments to 40 CFR 725.54(c) to permit MCAN submitters to
request suspensions for up
[[Page 102787]]
to 30 days orally or in writing, including by e-mail, without the need
for a formal, written request submitted to EPA via CDX using e-PMN
software. Some comments to the proposal took issue with increasing the
number of suspension days made through oral or e-mail communication
from 15 to 30 days. These comments suggested such an amendment would
result in less frequent communication from EPA regarding the status of
a new chemical review. EPA disagrees with these comments, as the
amendments would allow the submitter to request up to a 30-day
suspension through oral or e-mail communication; however, submitters
will still be allowed to suspend the review period for a shorter amount
of time if preferred. For a more detailed response to the comments
regarding the amendments relating to suspensions of the review period,
please see the Response to Comments document (Ref. 2).
F. Severability
As explained in this preamble, EPA is finalizing several different
types of amendments in this rule, including amendments related to:
commencement of manufacture or processing; required determinations and
associated actions; terminology and definitions; notice information
requirements; pre-screening procedures; correcting errors in notices;
incomplete notices; notification of the receipt of new information;
expiration of the LVE and LoREX review period; notification of LVE and
LoREX holders regarding certain other actions involving their chemical
substance; PFAS ineligibility for LVE and LoREX exemptions; certain PBT
ineligibility for LVE and LoREX exemptions; and suspensions of the
review period. Each type of amendment functions independently, serves a
discrete purpose, and is intended to be severable from the other
amendments. In the event of litigation staying, remanding, or
invalidating a portion of EPA's amendments in this rule, EPA intends to
preserve all other amendments in this rule to the fullest extent
possible. For example, the amendment to the LVE and LoREX regulations
making PFAS ineligible for such exemptions functions independently from
the amendment to those regulations making certain PBTs ineligible for
the exemptions, such that if either ineligibility provision were stayed
or invalidated, it would have no effect on the other, and EPA intends
that the other would remain effective. Similarly, any stay or
invalidation of the amendment making PFAS ineligible for the LVE and
LoREX exemptions would have no effect on amendments related to
incomplete notices, and vice versa. These specific examples are not
intended to be exhaustive, but rather illustrative of scenarios that
reflect EPA's overarching intent that each type of amendment be
severable.
Furthermore, within the broader category of amendments to notice
information requirements, the rule includes a number of discrete
amendments pertaining to different types of information. Each of these
specific amendments to notice information requirements functions
independently and is intended to be severable from the others. As an
example, if amended information requirements regarding the categories
of use of the chemical substance were to be stayed or invalidated, it
would have no effect on amended information requirements regarding
worker exposure, and vice versa.
The limited circumstance in which severability is not intended is
where a single type of amendment involved changes to multiple
paragraphs or sections of the regulations. For example, in cases where
EPA is finalizing the same or similar amendment in multiple parts of
the CFR for conformity (e.g., where an amendment to part 721, 723, or
725 is intended merely to conform to the same or similar amendment in
part 720), severability is not intended between those provisions. In
addition, were the amendment making PFAS ineligible for LVE and LoREX
exemptions to be invalidated, the related amendment defining PFAS for
purposes of that ineligibility provision would no longer be necessary
or helpful. However, EPA does intend severability in the inverse
scenario: if the definition of PFAS were stayed or invalidated, EPA
intends severability of all other amendments, including the amendment
making PFAS ineligible for LVEs and LoREX.
IV. References
The following is a listing of the documents that are specifically
referenced in this Federal Register notice. The docket includes these
documents and other information considered by EPA, including documents
that are referenced within the documents that are included in the
docket, even if the referenced document is not physically located in
the docket. For assistance in locating these other documents, please
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
1. EPA. Economic Analysis for the Final Rule: Updates to New
Chemicals Regulations under the Toxic Substances Control Act.
December 2024.
2. EPA. Response to Comments on the Proposed Rule Updates to New
Chemicals Regulations Under the Toxic Substances Control Act (TSCA).
December 2024.
3. EPA. Central Data Exchange Online User Guide. Accessible at:
https://cdx.epa.gov/About/UserGuide.
4. EPA. Points to Consider When Preparing TSCA New Chemical
Notification. OMB Control No.: 2070-0012. June 2018. Accessible at:
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca.
5. EPA. TSCA New Chemical Engineering Initiative to Increase
Transparency and Reduce Rework. Accessible at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering.
6. EPA. Tables Detailing the Final Amendments to Add Details to 40
CFR 720.45 Reporting Requirements and Enhancements to the CDX
Reporting Form. December 2024.
7. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA); TSCA Section 5
Premanufacture Review of New Chemical Substances and Significant New
Use Rules for New and Existing Chemical Substances (Revision); EPA
ICR No. 1188.15; OMB Control No. 2070-0038]. December 2024.
8. EPA. Premanufacture Notification; Premanufacture Notice
Requirements and Review Procedures; Final Rule. Federal Register. 48
FR 21722; May 13, 1983 (TSH-FRL 2998-5).
9. EPA. Press Release: EPA Announces Changes to Prevent Unsafe New
PFAS from Entering the Market. April 27, 2021.
10. EPA. Framework for TSCA New Chemicals Review of PFAS
Premanufacture Notices (PMNs) and Significant New Use Notices
(SNUNs). June 2023.
11. Executive Office of the President of the United States. Per- and
Polyfluoroalkyl Substances Report. March 2023.
12. Lohmann, Rainer, et al. Are fluoropolymers really of low concern
for human and environmental health and separate from other PFAS?
Environmental science & technology 54.20 (2020): 12820-12828.
13. EPA. Policy Statement on Category for Persistent,
Bioaccumulative, and Toxic New Chemical Substances. Federal
Register. (64 FR 60194, November 4, 1999) (FRL-6097-7).
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order
[[Page 102788]]
12866, as amended by Executive Order 14094 (88 FR 21879, April 11,
2023). Accordingly, EPA submitted this action to the Office of
Management and Budget (OMB) for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. The EPA prepared an economic
analysis of the potential impacts associated with this action. This
analysis, ``Economic Analysis for the Final Rule: Updates to New
Chemicals Regulations under the Toxic Substances Control Act'' (Ref.
1), is also available in the docket.
B. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
submitted to OMB for review and approval under the PRA (44 U.S.C. 3501
et seq.). The Information Collection Request (ICR) document that EPA
prepared has been assigned EPA ICR No. 1188.15 (Ref. 7). This ICR
represents a revision to the currently approved ICR that covers the
information collection activities contained in the existing
regulations. The Economic Analysis covers the incremental changes from
this action. You can find copies of the Economic Analysis and ICR in
the docket, and the ICR is briefly summarized here.
Respondents/affected entities: Certain chemical manufacturers
(including importers) and processors (see Unit I.A.).
Respondent's obligation to respond: Mandatory under TSCA section 5.
Estimated number of respondents: 560.
Frequency of response: On occasion.
Total estimated incremental burden: Estimates show that this rule
will decrease existing approved ICR burden by 4,528 hours per year.
Burden is defined at 5 CFR 1320.3(b).
Total estimated incremental cost: Estimates show that this rule
will increase existing approved ICR costs by $203,150 per year. This
includes $0 annualized capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
EPA did not receive any comments on the ICR revision that was
posted with the proposed rule. EPA prepared a Response to Comments
document (Ref. 2) that summarizes all the comments relevant to the
proposal, including comments affecting the Agency's burden estimates
related to the rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The Agency's basis is briefly summarized here and is
detailed in the Economic Analysis (Ref. 1).
The majority of firms that submit a TSCA section 5 notice will
realize either no change or a decrease in costs associated with form
submission. However, EPA expects that firms that submit LVE notices for
PFAS will incur an estimated cost of approximately $61,049 per notice
due to the greater burden and non-labor costs associated with
submitting a PMN form. EPA estimates that 98 percent of small firms
(184 firms) will have cost impacts of less than 1 percent of revenues,
less than 1 percent (1 firm) will have cost impacts between 1 and 3
percent of revenues, and 1 percent (2 firms) will have cost impacts
greater than 3 percent of revenues.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(adjusted annually for inflation) or more as described in UMRA, 2
U.S.C. 1531-1538, and does not significantly or uniquely affect small
governments. EPA has concluded that this action imposes no enforceable
duty on any state, local or Tribal governments because, based on EPA's
experience with reviewing TSCA section 5 actions, state, local and
Tribal governments have not been impacted and EPA does not have any
reasons to believe that any state, local, or Tribal government would
engage in the activities such that they would be impacted by this
rulemaking.
In addition, given that the estimated incremental cost on the
private sector is expected to be less than $50,000 (Ref. 1), EPA has
concluded that this rulemaking is not expected to result in
expenditures by the private sector of $183 million or more in any one
year ($100 million in 1995$ adjusted for inflation using the CDP
implicit price deflator).
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-201 of the Executive Order. Therefore,
this action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk. Since this action
does not concern human health risks, EPA's Policy on Children's Health
also does not apply. This procedural rule would align the implementing
regulations codified at 40 CFR parts 720, 721, and 725 with amended
TSCA and make additional updates based on existing policies or lessons
learned from administering the New Chemicals Program since TSCA was
amended in 2016.
Although this procedural rule itself would not directly affect the
level of protection provided to human health or the environment, EPA
expects that the rule would improve the Agency's consideration of risks
to children--in furtherance of EPA's Policy on Children's Health--and
other PESS. In turn, EPA anticipates that the amendments would help
better inform the Agency's determinations for each new chemical
substance or significant new use for which it received a notice under
TSCA section 5(a)(1), pertaining to the likelihood of unreasonable risk
to human health or the environment under known, intended or reasonably
foreseen conditions of use. EPA uses an integrated approach that draws
on knowledge and experience across disciplinary and organizational
lines to
[[Page 102789]]
identify and evaluate concerns regarding health and environmental
effects, and exposure and release.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards under the
NTTAA section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that this type of action does not concern human health
or environmental conditions and therefore cannot be evaluated with
respect to potentially disproportionate and adverse effects on
communities with environmental justice concerns in accordance with
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023). This action is procedural in nature. Therefore,
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on communities with
environmental justice concerns. Although this action does not concern
human health or environmental conditions, EPA identifies and addresses
environmental justice concerns by finalizing, among other things, the
regulatory definition of PESS to include overburdened communities, the
Agency believes that this action would assist EPA and others in
determining the potential exposures, hazards and risks to overburdened
communities associated with the manufacture, processing, distribution
in commerce, use, or disposal of the new chemical substances and
significant new uses of chemical substances subject to this rulemaking.
EPA anticipates that the inclusion of overburdened communities among
the PESS considered in the Agency's review of a TSCA section 5
submission would also enable the Agency, if necessary, to design
appropriate future risk management actions to address an unreasonable
risk that the Agency may determine is presented by that chemical
substance and to consider how such risk management actions would affect
communities with environmental justice concerns.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
EPA will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 68
Administrative practice and procedure, Air pollution control,
Chemicals, Environmental protection, Hazardous substances.
40 CFR Part 372
Environmental protection, Reporting and recordkeeping requirements,
Toxic substances.
40 CFR Part 703
Chemicals, Confidential business information, Environmental
protection, Exports, Hazardous substances, Imports, Reporting and
recordkeeping requirements.
40 CFR Parts 720, 721, 723, and 725
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements.
Dated: December 3, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons set forth in the preamble, 40 CFR
chapter I is amended as follows:
PART 68--CHEMICAL ACCIDENT PREVENTION PROVISIONS
0
1. The authority citation for part 68 continues to read as follows:
Authority: 42 U.S.C. 7412(r), 7601(a)(1), 7661-7661f.
Sec. 68.115 Threshold determination.
0
2. Amend Sec. 68.115(b)(5) by revising the citation ``Sec.
720.3(ee)'' to read ``Sec. 720.3.''
PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW
0
3. The authority citation for part 372 continues to read as follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.38 Exemptions.
0
4. Amend Sec. 372.38(d) by revising the citation ``Sec. 720.3(ee)''
to read ``Sec. 720.3.''
PART 703--CONFIDENTIALITY CLAIMS
0
5. The authority citation for part 703 continues to read as follows:
Authority: 15 U.S.C. 2613.
Sec. 703.3 Definitions.
0
6. Amend Sec. 703.3 by:
0
a. Revising in the introductory text the citation ``Sec. 720.3(ff)''
to read ``Sec. 720.3;''
0
b. Revising in the definition for ``Health and safety study'' the
citation ``Sec. 720.3(k)'' to read ``Sec. 720.3.''
PART 720--PREMANUFACTURE NOTIFICATION
0
7. The authority citation for part 720 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
Sec. 720.1 Scope.
0
8. Amend Sec. 720.1 by removing the phrase ``The rule'' and adding in
its place the phrase ``This part'' wherever it appears.
0
9. Revise and republish Sec. 720.3 to read as follows:
Sec. 720.3 Definitions.
In addition to the definitions under section 3 of the Act, 15
U.S.C. 2602, the following definitions apply to this part.
Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Applicable review period means the period starting on the date EPA
receives a complete notice under section 5(a)(1) of the Act and ending
90 days after that date or on such date as is provided for in sections
5(b)(1) or 5(c) of the Act.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture;
(2) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use; and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in Sec. 720.30(h)(5), except that fluids and particles are
not considered articles regardless of shape or design.
Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance or mixture.
Byproduct material, source material, and special nuclear material
have the
[[Page 102790]]
meanings contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014 et
seq. and the regulations issued under it.
Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
Chemical substance means any organic or inorganic substance of a
particular molecular identity, including any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and any chemical element or uncombined
radical, except that ``chemical substance'' does not include:
(1) Any mixture;
(2) Any pesticide when manufactured, processed, or distributed in
commerce for use as a pesticide;
(3) Tobacco or any tobacco product;
(4) Any source material, special nuclear material, or byproduct
material;
(5) Any pistol, firearm, revolver, shells, or cartridges; or
(6) Any food, food additive, drug, cosmetic, or device, when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State;
or
(2) Which affects trade, traffic, transportation, or commerce
between a place in a State and any place outside of such State.
Cosmetic, device, drug, food, and food additive have the meanings
contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et
seq., and the regulations issued under it. In addition, the term
``food'' includes poultry and poultry products, as defined in the
Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and meat
food products, as defined in the Federal Meat Inspection Act, 21 U.S.C.
60 et seq.; and eggs and egg products, as defined in the Egg Products
Inspection Act, 21 U.S.C. 1033 et seq.
Customs territory of the United States means the 50 States, Puerto
Rico, and the District of Columbia.
Director means the Director of the EPA Office of Pollution
Prevention and Toxics (OPPT).
Distribute in commerce means to sell in commerce, to introduce or
deliver for introduction into commerce, or to hold after introduction
into commerce.
EPA means the U.S. Environmental Protection Agency.
e-PMN software means electronic-PMN software created by EPA for use
in preparing and submitting Premanufacture Notices (PMNs) and other
TSCA section 5 notices and support documents electronically to the
Agency.
Health and safety study or study means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture,
toxicological, clinical, and ecological, or other studies of a chemical
substance or mixture, and any test performed under the Act. Chemical
identity is always part of a health and safety study.
(1) Not only is information which arises as a result of a formal,
disciplined study included, but other information relating to the
effects of a chemical substance or mixture on health or the environment
is also included. Any data that bear on the effects of a chemical
substance on health or the environment would be included.
(2) Examples include:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution,
metabolism, and excretion; cumulative, additive, and synergistic
effects; acute, subchronic, and chronic effects; and structure/activity
analyses.
(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including acute
toxicity tests, chronic toxicity tests, critical life stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture on the environment, including surveys, tests, and studies of:
Biological, photochemical, and chemical degradation; air, water, and
soil transport; biomagnification and bioconcentration; and chemical and
physical properties, e.g., boiling point, vapor pressure, evaporation
rates from soil and water, octanol/water partition coefficient, and
water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed
to measure the exposure of humans or the environment to a chemical
substance or mixture.
(v) Any assessments of risk to health and the environment resulting
from the manufacture, processing, distribution in commerce, use, or
disposal of the chemical substance.
Importer means any person who imports a chemical substance,
including a chemical substance as part of a mixture or article, into
the customs territory of the United States. ``Importer'' includes the
person primarily liable for the payment of any duties on the
merchandise or an authorized agent acting on his or her behalf. The
term also includes, as appropriate:
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and
superseding bond has been filed in accordance with 19 CFR 141.20; or
(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with 19 CFR part 144,
subpart C. (See ``principal importer.'')
Impurity means a chemical substance which is unintentionally
present with another chemical substance.
Intermediate means any chemical substance that is consumed, in
whole or in part, in chemical reactions used for the intentional
manufacture of another chemical substance(s) or mixture(s), or that is
intentionally present for the purpose of altering the rates of such
chemical reactions.
Inventory means the list of chemical substances manufactured or
processed in the United States that EPA compiled and keeps current
under section 8(b) of the Act.
Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.
Manufacture means to produce or manufacture in the United States or
import into the customs territory of the United States.
Manufacture for commercial purposes means:
(1) To manufacture with the purpose of obtaining an immediate or
eventual commercial advantage for the manufacturer, and includes, among
other things, ``manufacture'' of any amount of a chemical substance or
mixture.
(2) The term also applies to substances that are produced
coincidentally during the manufacture, processing, use, or disposal of
another substance or mixture, including byproducts that are separated
from that other substance or mixture and impurities that remain in that
substance or mixture. Byproducts and impurities without separate
commercial value are nonetheless produced for the purpose of obtaining
a commercial advantage, since
[[Page 102791]]
they are part of the manufacture of a chemical substance for commercial
purposes.
Manufacture solely for export means to manufacture for commercial
purposes a chemical substance solely for export from the United States
under the following restrictions on activities in the United States:
(1) Distribution in commerce is limited to purposes of export or
processing solely for export as defined in Sec. 721.3 of this chapter.
(2) The manufacturer and any person to whom the substance is
distributed for purposes of export or processing solely for export (as
defined in Sec. 721.3 of this chapter), may not use the substance
except in small quantities solely for research and development in
accordance with Sec. 720.36.
Manufacturer means a person who imports, produces, or manufactures
a chemical substance. A person who extracts a component chemical
substance from a previously existing chemical substance or a complex
combination of substances is a manufacturer of that component chemical
substance. A person who contracts with a manufacturer to manufacture or
produce a chemical substance is also a manufacturer if:
(1) The manufacturer manufactures or produces the substance
exclusively for that person; and
(2) That person specifies the identity of the substance and
controls the total amount produced and the basic technology for the
plant process.
Mixture means any combination of two or more chemical substances if
the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except ``mixture'' does
include:
(1) Any combination which occurs, in whole or in part, as a result
of a chemical reaction if the combination could have been manufactured
for commercial purposes without a chemical reaction at the time the
chemical substances comprising the combination were combined, and if
all of the chemical substances comprising the combination are not new
chemical substances; and
(2) Hydrates of a chemical substance or hydrated ions formed by
association of a chemical substance with water, so long as the
nonhydrated form is itself not a new chemical substance.
New chemical substance means any chemical substance which is not
included on the Inventory.
Nonisolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the chemical substance passes during a continuous flow process,
but not including tanks or other vessels in which the substance is
stored after its manufacture.
Person means any natural person, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other
business entity, any State or political subdivision thereof, any
municipality, any interstate body, and any department, agency or
instrumentality of the Federal Government.
Pesticide has the meaning contained in the Federal Insecticide,
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the
regulations issued under it.
Possession or control means in possession or control of the
submitter, or of any subsidiary, partnership in which the submitter is
a general partner, parent company, or any company or partnership which
the parent company owns or controls, if the subsidiary, parent company,
or other company or partnership is associated with the submitter in the
research, development, test marketing, or commercial marketing of the
chemical substance in question. (A parent company owns or controls
another company if the parent owns or controls 50 percent or more of
the other company's voting stock. A parent company owns or controls any
partnership in which it is a general partner). Information is included
within this definition if it is:
(1) In files maintained by submitter's employees who are:
(i) Associated with research, development, test marketing, or
commercial marketing of the chemical substance in question.
(ii) Reasonably likely to have such data.
(2) Maintained in the files of other agents of the submitter who
are associated with research, development, test marketing, or
commercial marketing of the chemical substance in question in the
course of their employment as such agents.
Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by EPA who, due to
either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, the elderly, or overburdened communities.
Principal importer means the first importer who, knowing that a new
chemical substance will be imported rather than manufactured
domestically, specifies the identity of the chemical substance and the
total amount to be imported. Only persons who are incorporated,
licensed, or doing business in the United States may be principal
importers.
Process means the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce:
(1) In the same form or physical state as, or in a different form
or physical state from, that in which it was received by the person so
preparing such substance or mixture, or
(2) As part of a mixture or article containing the chemical
substance or mixture.
Processor means any person who processes a chemical substance or
mixture.
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such substance or
another substance, including such research or analysis for the
development of a product'') means quantities of a chemical substance
manufactured or processed or proposed to be manufactured or processed
solely for research and development that are not greater than
reasonably necessary for such purposes.
State means any State of the United States and the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam,
the Canal Zone, American Samoa, the Northern Mariana Islands, and any
other territory or possession of the United States.
Support documents means material and information submitted to EPA
in support of a TSCA section 5 notice, including but not limited to,
correspondence, amendments (if notices for these amendments were
submitted prior to January 19, 2016), and test data. The term ``support
documents'' does not include orders under TSCA section 5(e) (either
consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).
Technically qualified individual means a person or persons:
(1) Who, because of education, training, or experience, or a
combination of these factors, is capable of understanding the health
and environmental risks associated with the chemical substance which is
used under his or her supervision;
(2) Who is responsible for enforcing appropriate methods of
conducting scientific experimentation, analysis, or chemical research
to minimize such risks; and
[[Page 102792]]
(3) Who is responsible for the safety assessments and clearances
related to the procurement, storage, use, and disposal of the chemical
substance as may be appropriate or required within the scope of
conducting a research and development activity.
Test data means data from a formal or informal test or experiment,
including information concerning the objectives, experimental methods
and materials, protocols, results, data analyses, recorded
observations, monitoring data, measurements, and conclusions from a
test or experiment.
Test marketing means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, or article
containing that chemical substance or mixture, by a manufacturer or
processor, to no more than a defined number of potential customers to
explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that
chemical substance, mixture, or article in commerce.
United States, when used in the geographic sense, means all of the
States.
Sec. 720.30 [Amended]
0
10. Amend Sec. 720.30 by revising the citations ``Sec. 720.3(e)'' in
paragraph (a) and ``720.3(u)'' in paragraph (b) to both read ``Sec.
720.3.''
0
11. Amend Sec. 720.40 by revising paragraph (f) to read as follows:
Sec. 720.40 General.
* * * * *
(f) New information. During the applicable review period, if the
submitter possesses, controls, or knows of new information that
materially adds to or changes the information included in the notice,
the submitter must submit that information to EPA within ten days of
receiving the new information, but no later than five days before the
end of the applicable review period. The new information must be
submitted electronically to EPA via CDX and must clearly identify the
submitter and the notice to which the new information is related. If
the new information becomes available during the last five days of the
applicable review period, the submitter must immediately inform its EPA
contact for that notice by telephone or e-mail and submit the new
information electronically to EPA via CDX.
* * * * *
0
12. Amend Sec. 720.45 by:
0
a. Revising paragraphs (a)(4) and (5), and (f) through (h); and
0
b. Adding paragraphs (j) and (k).
The revisions and additions read as follows:
Sec. 720.45 Information that must be included in the notice form.
* * * * *
(a) * * *
(4) If an importer submitting the notice cannot provide all the
information specified in paragraphs (a)(1) and (2) of this section
because it is claimed as confidential by the foreign supplier of the
substance, the importer must have the foreign supplier follow the
procedures in paragraph (a)(3) of this section and provide the correct
chemical identity information specified in paragraphs (a)(1) and (2) of
this section directly to EPA in a joint submission or as a letter of
support to the notice, which clearly references the importer's notice
and PMN User Fee Identification Number. The applicable review period
will commence upon receipt of both the notice and the complete, correct
information, in accordance with Sec. 720.65.
(5) If a manufacturer cannot provide all the information specified
in paragraphs (a)(1) and (2) of this section because the new chemical
substance is manufactured using a reactant having a specific chemical
identity claimed as confidential by its supplier, the manufacturer must
submit a notice directly to EPA containing all the information known by
the manufacturer about the chemical identity of the reported substance
and its proprietary reactant. In addition, the manufacturer must ensure
that the supplier of the confidential reactant submit a letter of
support directly to EPA providing the specific chemical identity of the
confidential reactant, including the CASRN, if available, and the
appropriate PMN or exemption number, if applicable. The letter of
support must reference the manufacturer's name and PMN Fee
Identification Number. The applicable review period will commence upon
receipt of the notice, the letter of support, and the complete, correct
information, in accordance with Sec. 720.65.
* * * * *
(f)(1) A description of the intended category or categories of
consumer or commercial use by function and application, which includes
a description of the following:
(i) The estimated percent of production volume devoted to each
category of use.
(ii) The percent of the new chemical substance in the formulation
for each commercial or consumer use.
(iii) The types of products or articles that would incorporate the
new chemical substance (e.g., household cleaners, plastic articles).
(iv) Information related to the use of products or articles
containing the new chemical substance by potentially exposed or
susceptible subpopulations.
(v) How and where a product or article containing the new chemical
substance would be used (e.g., spray applied indoors, brushed on
outdoor surfaces).
(vi) Consumption rates and frequency and duration of use of
products or articles containing the new chemical substance.
(2) Using the applicable codes listed in Table 1 to paragraph
(f)(2), submitters must designate the consumer and commercial product
category or categories that best describe the consumer and commercial
products in which the new chemical substance is intended or known to be
used. When more than 10 codes apply to the consumer or commercial
products in which the new chemical substance is intended or known to be
used, submitters should only designate the 10 product categories that
represent the highest proportion of the anticipated production volume.
Table 1 to Paragraph (f)(2)--Codes for Reporting Consumer and Commercial
Product Categories
------------------------------------------------------------------------
Code Category
------------------------------------------------------------------------
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101.................... Construction and building materials covering
large surface areas including stone,
plaster, cement, glass and ceramic articles;
fabrics, textiles, and apparel.
CC102.................... Furniture & furnishings including plastic
articles (soft); leather articles.
CC103.................... Furniture & furnishings including stone,
plaster, cement, glass, and ceramic
articles; metal articles; or rubber
articles.
CC104.................... Leather conditioner.
CC105.................... Leather tanning, dye, finishing,
impregnation, and care products.
[[Page 102793]]
CC106.................... Textile (fabric) dyes.
CC107.................... Textile finishing and impregnating/surface
treatment products.
CC108.................... All-purpose foam spray cleaner.
CC109.................... All-purpose liquid cleaner/polish.
CC110.................... All-purpose liquid spray cleaner.
CC111.................... All-purpose waxes and polishes.
CC112.................... Appliance cleaners.
CC113.................... Drain and toilet cleaners (liquid).
CC114.................... Powder cleaners (floors).
CC115.................... Powder cleaners (porcelain).
CC116.................... Dishwashing detergent (liquid/gel).
CC117.................... Dishwashing detergent (unit dose/granule).
CC118.................... Dishwashing detergent liquid (hand-wash).
CC119.................... Dry cleaning and associated products.
CC120.................... Fabric enhancers.
CC121.................... Laundry detergent (unit-dose/granule).
CC122.................... Laundry detergent (liquid).
CC123.................... Stain removers.
CC124.................... Ion exchangers.
CC125.................... Liquid water treatment products.
CC126.................... Solid/Powder water treatment products.
CC127.................... Liquid body soap.
CC128.................... Liquid hand soap.
CC129.................... Solid bar soap.
CC130.................... Air fresheners for motor vehicles.
CC131.................... Continuous action air fresheners.
CC132.................... Instant action air fresheners.
CC133.................... Anti-static spray.
CC134.................... Apparel finishing, and impregnating/surface
treatment products.
CC135.................... Insect repellent treatment.
CC136.................... Pre-market waxes, stains, and polishes
applied to footwear.
CC137.................... Post-market waxes, and polishes applied to
footwear (shoe polish).
CC138.................... Waterproofing and water-resistant sprays.
------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal
Products
------------------------------------------------------------------------
CC201.................... Fillers and putties.
CC202.................... Hot-melt adhesives.
CC203.................... One-component caulks.
CC204.................... Solder.
CC205.................... Single-component glues and adhesives.
CC206.................... Two-component caulks.
CC207.................... Two-component glues and adhesives.
CC208.................... Adhesive/Caulk removers.
CC209.................... Aerosol spray paints.
CC210.................... Lacquers, stains, varnishes, and floor
finishes.
CC211.................... Paint strippers/removers.
CC212.................... Powder coatings.
CC213.................... Radiation curable coatings.
CC214.................... Solvent-based paint.
CC215.................... Thinners.
CC216.................... Water-based paint.
CC217.................... Construction and building materials covering
large surface areas, including wood
articles.
CC218.................... Construction and building materials covering
large surface areas, including paper
articles; metal articles; stone, plaster,
cement, glass, and ceramic articles.
CC219.................... Machinery, mechanical appliances, electrical/
electronic articles.
CC220.................... Other machinery, mechanical appliances,
electronic/electronic articles.
CC221.................... Construction and building materials covering
large surface areas, including metal
articles.
CC222.................... Electrical batteries and accumulators.
------------------------------------------------------------------------
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC301.................... Packaging (excluding food packaging),
including paper articles.
CC302.................... Other articles with routine direct contact
during normal use, including paper articles.
CC303.................... Packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles (soft).
CC304.................... Other articles with routine direct contact
during normal use including rubber articles;
plastic articles (hard).
CC305.................... Toys intended for children's use (and child
dedicated articles), including fabrics,
textiles, and apparel; or plastic articles
(hard).
CC306.................... Adhesives applied at elevated temperatures.
CC307.................... Cement/concrete.
CC308.................... Crafting glue.
CC309.................... Crafting paint (applied to body).
[[Page 102794]]
CC310.................... Crafting paint (applied to craft).
CC311.................... Fixatives and finishing spray coatings.
CC312.................... Modelling clay.
CC313.................... Correction fluid/tape.
CC314.................... Inks in writing equipment (liquid).
CC315.................... Inks used for stamps.
CC316.................... Toner/Printer cartridge.
CC317.................... Liquid photographic processing solutions.
------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
Products
------------------------------------------------------------------------
CC401.................... Exterior car washes and soaps.
CC402.................... Exterior car waxes, polishes, and coatings.
CC403.................... Interior car care.
CC404.................... Touch up auto paint.
CC405.................... Degreasers.
CC406.................... Liquid lubricants and greases.
CC407.................... Paste lubricants and greases.
CC408.................... Spray lubricants and greases.
CC409.................... Anti-freeze liquids.
CC410.................... De-icing liquids.
CC411.................... De-icing solids.
CC412.................... Lock deicers/releasers.
CC413.................... Cooking and heating fuels.
CC414.................... Fuel additives.
CC415.................... Vehicular or appliance fuels.
CC416.................... Explosive materials.
CC417.................... Agricultural non-pesticidal products.
CC418.................... Lawn and garden care products.
------------------------------------------------------------------------
Chemical Substances in Products not Described by Other Codes
------------------------------------------------------------------------
CC980.................... Other (specify).
CC990.................... Non-TSCA use.
------------------------------------------------------------------------
(g) For sites controlled by the submitter:
(1) The identity and address of each site where the new chemical
substance will be manufactured, processed, or used.
(2) A process description of each manufacture, processing, and use
operation which includes a diagram of the major unit operations and
chemical conversions; indication of whether batch or continuous
manufacturing or processing occurs at the site, and the amount
manufactured or processed per batch or per day if continuous and per
year; the identity, approximate weight per batch or per day for
continuous production, and entry point of all starting materials and
feedstocks (including reactants, solvents, catalysts, etc.); the
identity, approximate weight per batch or per day for continuous
production, and entry point of all products, recycle streams, and
wastes, including frequency of any equipment cleaning; the type of
interim storage and transport containers used; and the points of
release of the new chemical substance numbered. If the new chemical
substance is released to two media at the same step in the process,
assign a second number for the second medium.
(3) Worker exposure information for each worker activity
anticipated or known to occur during manufacture, processing, or use of
the new chemical substance, including worker exposure information from
exempt manufacture or related use of the new chemical substance under
Sec. 720.30. This information includes:
(i) A description of each worker activity.
(ii) Type of potential worker exposure (e.g., dermal, inhalation).
(iii) Protective equipment in place, if any, including a
description of the kind of gloves, protective clothing, goggles, or
respirator that limit worker exposure.
(iv) Engineering controls in place, if any.
(v) Physical form of the new chemical substance to which workers
may be exposed and moisture content if physical form is solid.
(vi) The percent of new chemical substance in formulation at time
of worker exposure.
(vii) The number of workers reasonably likely to be exposed.
(viii) The duration of activities.
(4) Information on known or anticipated release of the new chemical
substance to the environment, including releases from the exempt
manufacture or related use of the new chemical substance under Sec.
720.30. This information includes the type of release (e.g., transport,
interim storage, disposal, equipment cleaning), the quantity of the new
chemical substance released directly to the environment, the quantity
of the new chemical substance released into control technology, the
quantity of the new chemical substance released to the environment
after control technology, the media of release, the type of control
technology used, and the following additional information based on the
type of release:
(i) For equipment cleaning releases, frequency of equipment
cleaning and what is used to clean the equipment.
(ii) For transport and storage releases, how the new chemical
substance or product containing the new chemical substance is
transported from the site and stored, whether dedicated containers are
used, whether the cleaning and disposal of the containers is under the
submitter's control, the container cleaning method, the
[[Page 102795]]
frequency of container cleaning, and the amount of release per
container cleaning.
(iii) For releases into air, Clean Air Act operating permit
numbers, a description of any Leak Detection and Repair program in
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the
monitoring and management of fugitive releases) the site has
implemented, and the type of air pollution control technologies used at
the site to treat the stack releases that will contain the new chemical
substance.
(iv) For releases into water, the National Pollutant Discharge
Elimination System (NPDES) permit number(s), outfall numbers, the
name(s) of the waterbody into which the release occurs, and other
destination(s) into which the release occurs.
(v) For releases into wastewater treatment plants, the name(s) of
the publicly owned treatment works (POTW) or privately owned treatment
works into which the release occurs and the corresponding NPDES permit
number(s), the type of wastewater treatment technology or technologies
employed, and a description of the known or expected treatment
efficiency.
(h) For sites not controlled by the submitter:
(1) The identity and address of each site where the new chemical
substance will be manufactured, processed, or used.
(2) A description of each type of processing and use operation
involving the new chemical substance, including identification of the
estimated number of processing or use sites; a process description of
each operation which includes a diagram of the major unit operations
and chemical conversions; the identity, approximate weight per batch or
per day for continuous production, and entry point of all starting
materials and feedstocks (including reactants, solvents, catalysts,
etc.); the identity, approximate weight per batch or per day for
continuous production, and entry point of all products, recycle
streams, and wastes, including frequency of any equipment cleaning; the
type of interim storage and transport containers used; and the points
of release of the new chemical substance numbered. If the new chemical
substance is released to two media at the same step in the process,
assign a second number for the second medium.
(3) Worker exposure information for each worker activity
anticipated or known to occur during manufacture, processing, or use of
the new chemical substance, including worker exposure information from
exempt manufacture or related use of the new chemical substance under
Sec. 720.30. This information includes:
(i) A description of each worker activity.
(ii) Type of potential worker exposure (e.g., dermal, inhalation).
(iii) Protective equipment in place, if any, including a
description of the kind of gloves, protective clothing, goggles, or
respirator that limit worker exposure, if any.
(iv) Engineering controls in place if any.
(v) Physical form of the new chemical substance to which workers
may be exposed and moisture content if physical form is solid.
(vi) The percent of the new chemical substance in formulation at
time of worker exposure.
(vii) The number of workers reasonably likely to be exposed.
(viii) The duration of activities.
(4) Information on known or anticipated release of the new chemical
substance to the environment, including releases from the exempt
manufacture or related use of the new chemical substance under Sec.
720.30. This information includes the type of release (e.g., transport,
interim storage, disposal, equipment cleaning), the quantity of the new
chemical substance released directly to the environment, the quantity
of the new chemical substance released into control technology, the
quantity of the new chemical substance released to the environment
after control technology, the media of release, the type of control
technology used, and the following additional information based on the
type of release:
(i) For equipment cleaning releases, frequency of equipment
cleaning and what is used to clean the equipment.
(ii) For transport and storage releases, how the new chemical
substance or product containing the new chemical substance will be
transported from the site and stored, whether dedicated containers are
used, whether the cleaning and disposal of the containers is under the
submitter's control, the container cleaning method, the frequency of
container cleaning, and the amount of release of the new chemical
substance per container cleaning.
(iii) For releases into air, Clean Air Act operating permit
numbers, a description of any Leak Detection and Repair program in
accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the
monitoring and management of fugitive releases) the site has
implemented, and the type of air pollution control technologies used at
the site to treat the stack releases that will contain the new chemical
substance.
(iv) For releases into water, the National Pollutant Discharge
Elimination System (NPDES) permit number(s), outfall numbers, the
name(s) of the waterbody into which the release occurs, and other
destination(s) into which the release occurs.
(v) For releases into wastewater treatment plants, the name(s) of
the publicly owned treatment works (POTW) or privately owned treatment
works into which the release occurs and the corresponding NPDES permit
number(s), the type of wastewater treatment technology or technologies
employed, and a description of the known or expected treatment
efficiency.
* * * * *
(j) The physical and chemical properties and environmental fate
characteristics of the new chemical substance, which include the
following:
(1) For physical and chemical properties, such information includes
boiling point, sublimation, density/relative density, dissociation
constant, explodability, flammability, melting point, octanol/water
partition coefficient, particle size distribution, particle size
distribution analysis (i.e., analysis method and data used to develop
the particle size distribution), the physical state of the neat
substance, pH, solubility, vapor pressure, volatilization from water,
volatilization from soil, spectra, UV-VIS absorption data, and surface
tension.
(2) For environmental fate characteristics, such information
includes hydrolysis, photolysis, aerobic and anaerobic biodegradation,
atmospheric oxidation half-lives, Henry's law constant, adsorption/
desorption coefficient, bioaccumulation or bioconcentration factor,
Incineration Removal Efficiency (Destruction and Removal Efficiencies
or DREs), and Sewage Treatment (WWTP) Removals.
(k) Information about pollution prevention efforts, such as using
alternative fuel sources, reducing the use of water and chemical
inputs, modifying a production process to produce less waste, or
implementing water and energy conservation practices, or substituting
for riskier existing products. Inclusion of this information is
optional.
0
13. Amend Sec. 720.50 by revising paragraphs (a)(4)(ii) and adding
paragraph (c) to read as follows:
Sec. 720.50 Submission of test data and other data concerning the
health and environmental effects of a substance.
(a) * * *
(4) * * *
[[Page 102796]]
(ii) If a test or experiment is completed before the applicable
review period ends, the person must submit the study, report, or test
data electronically to EPA via CDX, as specified in paragraph (a)(3)(i)
of this section, within ten days of receiving it, but no later than
five days before the end of the review period. If the test or
experiment is completed during the last five days of the review period,
the submitter must inform its EPA contact for that notice by telephone
or e-mail prior to the end of the review period and submit the study,
report, or test data electronically to EPA via CDX.
* * * * *
(c) Other information. A person may submit other information, not
otherwise required in this section, to facilitate EPA's review of the
notice.
* * * * *
0
14. Revise Sec. 720.65 to read as follows:
Sec. 720.65 Acknowledgement of receipt of a notice; errors in the
notice; incomplete submissions; and false and misleading statements.
(a) Notification to the submitter. (1) EPA will acknowledge receipt
of each notice by sending a letter via CDX or U.S. mail to the
submitter that identifies the premanufacture notice number assigned to
the new chemical substance and date on which the applicable review
period begins as described in paragraph (a)(2) of this section.
(2) Before EPA sends an acknowledgement of receipt of a notice
pursuant to paragraph (a)(1) of this section, EPA will conduct a pre-
screen of the notice, typically taking 2-3 days and according to the
criteria under paragraphs (b)(1) and (c)(1) of this section.
(i) If EPA concludes that the notice contains errors warranting
remedy or is incomplete, EPA will notify the submitter according to
paragraph (d)(3) of this section. The applicable review period will not
begin. Once the submitter corrects the errors or incomplete submission
according to the requirements provided by EPA and re-submits the notice
to EPA, EPA will follow the procedures of paragraph (a)(2) of this
section.
(ii) If EPA does not identify errors or determine the notice to be
incomplete during screening, EPA will notify the submitter according to
paragraph (a)(1) of this section. The applicable review period will
begin on the date EPA received the complete notice.
(b) Errors in the notice. (1) Within 30 days of receipt of the
notice, EPA may request that the submitter remedy errors in the notice.
The following are examples of such errors:
(i) Typographical errors that cause data to be misleading or
answers to any questions to be unclear.
(ii) Contradictory information.
(iii) Ambiguous statements or information.
(2) The applicable review period does not begin for notices
containing errors that EPA asks the submitter to remedy until
corrections are made following the procedures of paragraph (d) of this
section.
(c) Incomplete submissions. (1) A submission is not complete, and
the applicable review period does not begin, if:
(i) The wrong person submits the notice form.
(ii) The submitter does not sign the notice form.
(iii) Some or all of the information in the notice or the
attachments are not in English, except for published scientific
literature.
(iv) The submitter does not submit the notice in the manner set
forth in Sec. 720.40(a)(2).
(v) The submitter does not provide information that is required by
section 5(d)(1)(B) and (C) of the Act and Sec. 720.50.
(vi) The submitter does not provide information required by Sec.
720.45 or indicate that it is not known to or reasonably ascertainable
by the submitter.
(vii) The submitter does not submit a second copy of the submission
with all confidential information deleted for the public file, as
required by Sec. 703.5(c).
(viii) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by Sec. 720.40(g).
(ix) The submitter does not submit data which the submitter
believes show that the chemical substance will not present an
unreasonable risk of injury to health or the environment, if EPA has
listed the chemical substance under section 5(b)(4) of the Act, as
required in Sec. 720.40(h).
(x) The submitter does not include an identifying number and a
payment identity number as required by Sec. 700.45(e)(3).
(2) The submission may be declared incomplete if at any time during
the applicable review period the submitter submits additional or
revised information without demonstrating to EPA's satisfaction that
the additional or revised information in the amended notice was not
known to or reasonably ascertainable by the submitter at the time of
initial notice submission (e.g., new information as described in Sec.
720.40(f) or information from testing in progress at the time of the
original submission, as described in Sec. 720.50(a)(4)), unless it
relates to administrative or non-substantive amendments (e.g., changing
the technical point of contact) or amendments made at the request of
EPA.
(d) Corrections to errors in the notice or incomplete submissions.
(1) If EPA receives an incomplete submission or seeks remedy of errors
identified in a notice, EPA will notify the submitter within 30 days of
receipt that the submission contains errors or is incomplete and that
the applicable review period will not begin until EPA receives a
correct and complete notice.
(2) If EPA obtains additional information during the applicable
review period that indicates the original submission was incomplete,
EPA may declare the submission incomplete within 30 days after EPA
obtains the additional information and so notify the submitter.
(3) The notification that a submission contains errors or is
incomplete under paragraph (d)(1) or (2) of this section will include:
(i) A statement of the basis of EPA's determination that the
submission contains errors or is incomplete.
(ii) The requirements for correcting the errors or incomplete
submission.
(iii) Information on procedures under paragraph (d)(4) of this
section for filing objections to the determination or requesting
modification of the requirements for completing the submission.
(4) Within ten days after receipt of notification by EPA that a
submission contains errors or is incomplete, the submitter may file
written objections requesting that EPA accept the submission as a
complete notice or modify the requirements necessary to complete the
submission.
(5) EPA will consider the objections filed by the submitter and
determine:
(i) Whether the submission was complete or incomplete, or whether
to modify the requirements for completing the submission. EPA will
notify the submitter in writing of EPA's response within ten days of
receiving the objections.
(ii) If EPA determines, in response to the objection, that the
submission was complete, the applicable review period will be deemed
suspended on the date EPA declared the notice incomplete and will
resume on the date that the notice is declared complete. The submitter
need not correct the notice as EPA originally requested. If EPA can
complete its review within 90 days from the date of the original
submission, EPA
[[Page 102797]]
may inform the submitter that the running of the review period will
resume on the date EPA originally declared it incomplete.
(iii) If EPA modifies the requirements for completing the
submission or affirms its original determination that the submission
contains errors or is incomplete, or if no objections are filed, the
applicable review period will begin (or if previously begun, will
restart at Day 1) when EPA receives a complete notice.
(e) Materially false or misleading statements. If EPA discovers at
any time that a person submitted materially false or misleading
statements in the notice, EPA may find that the notice was incomplete
from the date it was submitted and take any other appropriate action.
0
15. Amend Sec. 720.70 by revising paragraphs (a) and (b)(3) to read as
follows:
Sec. 720.70 Notice in the Federal Register.
(a) Filing notice of receipt. In accordance with section 5(d)(2) of
the Act, after EPA has received a complete notice, EPA will file a
notice of receipt with the Office of the Federal Register including the
information specified in paragraph (b) of this section.
(b) * * *
(3) For test data submitted in accordance with Sec. 720.40(g), a
summary of the data received will be published.
* * * * *
0
16. Amend Sec. 720.75 by:
0
a. Revising the section heading;
0
b. Removing the phrase ``notice review period'' and adding in its place
the phrase ``applicable review period,'' wherever it appears; and
0
c. Revising paragraphs (a), (b), (c)(4) introductory text, (c)(4)(iii),
and (d).
The revisions read as follows:
Sec. 720.75 Applicable review period and determination.
(a) Length of applicable review period. The applicable review
period specified in section 5(a) of the Act runs for 90 days from the
date EPA receives a complete notice, or the date EPA determines the
notice is complete under Sec. 720.65(d), unless the Agency extends the
applicable review period under section 5(c) of the Act and paragraph
(c) of this section.
(b) Suspension of the running of the applicable review period. (1)
A submitter may voluntarily suspend the running of the applicable
review period if EPA agrees. If EPA does not agree, the review period
will continue to run, and EPA will notify the submitter. A submitter
may request a suspension at any time during the applicable review
period. The suspension must be for a specified period of time.
(2) Requests for suspensions. (i) A request for a suspension of 30
days or less may be made orally, including by telephone, or in writing,
including by e-mail, to the submitter's EPA contact for that notice.
Any request for a suspension exceeding 30 days must be submitted in the
manner set forth in paragraph (b)(2)(ii) of this section. The running
of the applicable review period will be suspended upon approval of the
oral or written request by EPA.
(ii) Requests for suspensions exceeding 30 days must be submitted
electronically to EPA via CDX using e-PMN software. Requests for
suspensions of 30 days or less may also be submitted electronically to
EPA via CDX using e-PMN software. See Sec. 720.40(a)(2)(ii) for
information on how to access the e-PMN software. The running of the
applicable review period will be suspended upon approval of the request
submitted electronically to EPA via CDX using e-PMN software by EPA.
(c) * * *
(4) The following are examples of situations in which EPA may find
that good cause exists for extending the applicable review period:
* * * * *
(iii) EPA has received significant additional information during
the applicable review period, which was not known to or reasonably
ascertainable by the submitter at the time of initial notice
submission.
(d) Determinations. (1) Within the applicable review period, EPA
will make one of the following five determinations, as set forth in
section 5(a)(3) of the Act:
(i) The chemical substance presents an unreasonable risk of injury
to health or the environment, as set forth in section 5(a)(3)(A) of the
Act.
(ii) Information available to EPA is insufficient to permit a
reasoned evaluation of the health and the environmental effects of the
relevant chemical substance, as set forth in section 5(a)(3)(B)(i) of
the Act.
(iii) In the absence of sufficient information to permit EPA to
make such an evaluation, the chemical substance may present an
unreasonable risk of injury to health or the environment, as set forth
in section 5(a)(3)(B)(ii)(I) of the Act.
(iv) The chemical substance is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or substantial human exposure to the
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
(v) The chemical substance is not likely to present an unreasonable
risk of injury to health or the environment, as set forth in section
5(a)(3)(C) of the Act.
(2) EPA will take the following actions required in association
with the determination:
(i) For determinations described in paragraph (d)(1)(i) of this
section, EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the chemical substance, or any combination of such activities, to the
extent necessary to protect against an unreasonable risk of injury to
health or the environment, as set forth in section 5(f) of the Act, or
will issue a proposed rule under section 6(a) of the Act, as set forth
in section 5(f) of the Act.
(ii) For determinations described in paragraphs (d)(1)(ii), (iii),
or (iv) of this section, EPA will issue the submitter an order to
prohibit or limit the manufacture, processing, distribution in
commerce, use, or disposal of the chemical substance, or any
combination of such activities, to the extent necessary to protect
against an unreasonable risk of injury to health or the environment, as
set forth in section 5(e) of the Act. EPA may issue an order under
section 5(e) of the Act that requires certain testing to be conducted
and presented to EPA after the applicable review period has concluded.
(iii) For determinations described in paragraph (d)(1)(v) of this
section, EPA will issue the submitter a document containing EPA's final
determination and will submit for publication in the Federal Register a
statement of the finding, as set forth in section 5(g) of the Act. Upon
EPA's issuance of the determination document, the submitter may
commence the manufacture of the chemical substance without waiting for
the end of the applicable review period.
(3) EPA may modify or revoke the prohibitions and limitations in an
order issued under paragraph (d)(2)(i) or (ii) of this section after
the applicable review period has ended if EPA receives additional
testing, studies, reports, or other information that EPA determines,
upon review, demonstrate that such prohibitions or limitations are no
longer necessary to protect against an unreasonable risk of injury to
health or the environment. Where such information demonstrates that the
prohibitions or limitations of the order are not sufficient to protect
against an unreasonable risk of injury to health or the environment,
EPA may modify the order or take other action, as
[[Page 102798]]
appropriate, to the extent necessary to protect against such risk.
(4) No person submitting a notice in response to the requirements
of this part may manufacture a chemical substance subject to this part
until EPA has issued a determination in accordance with paragraph
(d)(1) of this section and taken the associated action required under
paragraph (d)(2) of this section.
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
17. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
18. Amend Sec. 721.25 by:
0
a. Revising paragraph (d); and
0
b. Adding paragraph (e).
The revisions and additions read as follows:
Sec. 721.25 Notice requirements and procedures.
* * * * *
(d) Any person submitting a significant new use notice in response
to the requirements of this part shall not manufacture or process a
chemical substance identified in subpart E of this part for a
significant new use until EPA has issued a determination with respect
to the significant new use and taken the actions required in
association with that determination in accordance with the procedures
for new chemical substances at Sec. 720.75(d) of this chapter.
(e) When submitting a significant new use notice, in addition to
providing a description of the intended categories of consumer or
commercial use by function and application as required by Sec.
720.45(f)(1) of this chapter, the submitter must also provide, to the
extent known to or reasonably ascertainable by the submitter, a
description of known categories of consumer or commercial use by
function and application.
0
19. Amend Sec. Sec. 721.10647(a)(1), 721.10844(a)(1), 721.10929(a)(1),
721.11149(a)(1), 721.11179(a)(1), 721.11361(a)(1)(iii), and
721.11712(a)(1) by revising the citation ``720.3(c)'' to read
``720.3.''
0
20. Amend Sec. 721.11777(b) by revising the citations ``720.3(w)'' and
``720.3(d)'' to read ``720.3.''
PART 723-PREMANUFACTURE NOTIFICATION EXEMPTIONS
0
21. The authority citation for part 723 continues to read as follows:
Authority: 15 U.S.C. 2604.
0
22. Amend Sec. 723.50 by:
0
a. Revising paragraphs (a)(1);
0
b. Adding paragraphs (b)(11) and (12);
0
c. Revising paragraphs (d);
0
d. Adding paragraphs (e)(2)(xiv);
0
e. Revising paragraphs (e)(3), (g), (h)(2)(v), and (i); and
0
f. Adding paragraph and (p).
The revisions and additions read as follows:
Sec. 723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
(a) * * *
(1) This section grants an exemption from the premanufacture notice
requirements of section 5(a)(1)(A)(i) of the Toxic Substances Control
Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
* * * * *
(b) * * *
(11) PFAS or per- and poly-fluoroalkyl substance means a chemical
substance that contains at least one of these three structures:
(i) R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are
saturated carbons;
(ii) R-CF2OCF2-R', where R and R' can either be F, O, or saturated
carbons; or
(iii) CF3C(CF3)R'R'', where R' and R'' can either be F or saturated
carbons.
(12) PBT chemical substance means a chemical substance possessing
characteristics of persistence (P) in the environment, accumulation in
biological organisms (bioaccumulation (B)), and toxicity (T) resulting
in potential risks to humans and ecosystems. For more information on
EPA's Policy on new chemical substances that are PBTs, see EPA's 1999
policy statement (64 FR 60194, November 4, 1999 (FRL-6097-7)).
* * * * *
(d) Chemical substances that cannot be manufactured under this
exemption. A new chemical substance cannot be manufactured under this
section, notwithstanding satisfaction of the criterion of paragraph
(c)(1) or (2) of this section, if EPA determines, in accordance with
paragraph (g) of this section, that the substance, any reasonably
anticipated metabolites, environmental transformation products, or
byproducts of the substance, or any reasonably anticipated impurities
in the substance, under anticipated conditions of manufacture,
processing, distribution in commerce, use, or disposal of the new
chemical substance:
(1) May cause:
(i) Serious acute (lethal or sublethal) effects;
(ii) Serious chronic (including carcinogenic and teratogenic)
effects; or
(ii) Significant environmental effects.
(2) Or is:
(i) A PFAS.
(ii) A PBT chemical substance with anticipated environmental
releases and potentially unreasonable exposures to humans or
environmental organisms.
* * * * *
(e) * * *
(2) * * *
(xiv) Physical and chemical properties and environmental fate
characteristics (Sec. 720.45(j)).
(3) Incomplete notices. EPA will conduct a pre-screen of the
notice, typically taking 2-3 days and according to the criteria under
paragraph (e)(2) of this section. If EPA concludes that the notice is
incomplete, EPA will notify the submitter and the review period will
not begin. Once the submitter corrects the errors or incomplete
submission according to the requirements provided by EPA and re-submits
the notice to EPA, the review period will begin. If EPA does not
identify errors or determine the notice to be incomplete during
screening, the review period will begin on the date EPA received the
complete notice.
* * * * *
(g) Review period. (1) EPA will review the notice submitted under
paragraph (e) of this section to determine whether manufacture of the
new chemical substance is eligible for the exemption. The review period
will run for 30 days from the date EPA receives a complete notice. To
provide additional time to address any unresolved issues concerning an
exemption application, the exemption applicant may, at any time during
the review period, request a suspension of the review period pursuant
to the provisions of Sec. 720.75(b) of this chapter.
(2) No person submitting a notice under paragraph (e) of this
section may manufacture the new chemical substance until EPA notifies
the submitter that the new chemical substance meets the terms of this
section.
(h) * * *
(2) * * *
(v) If the Agency determines that manufacture of the new chemical
substance does not meet the terms of this section and that the
manufacturer did not act with due diligence and in good faith to meet
the terms of this section, the manufacturer must cease any continuing
manufacture, processing, distribution in commerce, and use of the new
chemical substance within 7 days of the written notification
[[Page 102799]]
under paragraph (h)(2)(iii) of this section. The manufacturer may not
resume manufacture, processing, distribution in commerce, and use of
the new chemical substance until it submits a notice under section
5(a)(1) of the Act and part 720 of this chapter and EPA has made one of
the five determinations as set forth in section 5(a)(3) of the Act and
taken the action required in association with that determination.
* * * * *
(i) Additional information. If the manufacturer of a new chemical
substance under the terms of this exemption obtains test data or other
information indicating that the new chemical substance may not qualify
under terms of this section, the manufacturer must submit these data or
information to EPA within 15 working days of receipt of the
information. If, during the notice review period specified in paragraph
(g) of this section, the submitter obtains possession, control, or
knowledge of new information that materially adds to, changes, or
otherwise makes significantly more complete the information included in
the notice, the submitter must submit that information to EPA within
ten days of receiving the new information, but no later than five days
before the end of the applicable review period. The new information
must be submitted electronically to EPA via CDX and must clearly
identify the submitter and the exemption notice to which the new
information is related. If the new information becomes available during
the last 5 days of the notice review period, the submitter must
immediately inform its EPA contact for that notice by telephone or e-
mail and submit the new information electronically to EPA via CDX.
* * * * *
(p) Subject to a significant new use rule or listed on TSCA
Inventory. If a significant new use rule is proposed or finalized in
part 721 of this chapter for a chemical substance described by a
generic chemical name or if the specific chemical identity of a
chemical substance is listed on the confidential portion of the TSCA
Inventory, EPA may make reasonable efforts to notify any persons who
may also manufacture the same chemical substance under the terms of
this section. A disclosure to a person with an approved exemption under
this section that the chemical substance is subject to a proposed or
final rule in part 721 of this chapter or is listed on the confidential
portion of the TSCA Inventory will not be considered public disclosure
of confidential business information under section 14 of the Act. The
notification will inform manufacturers subject to the terms of this
section that the chemical substance is subject to a proposed or final
significant new use rule under section 5(a)(2) of the Act or is listed
on the TSCA Inventory, and identify the proposed or final section in
subpart E of part 721 of this chapter that pertains to the chemical
substance or the generic name for that substance listed on the public
portion of the TSCA Inventory, as applicable.
PART 725-REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS
0
23. The authority citation for part 725 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
0
24. Amend Sec. 725.8(c)(1) by revising the citation ``720.3(e)'' to
read ``720.3.''
0
25. Amend Sec. 725.54 by revising paragraphs (b)(1), (c) and (d) to
read as follows:
Sec. 725.54 Suspension of the review period.
* * * * *
(b)(1) Request for suspension. A request for suspension may only be
submitted in a manner set forth in this paragraph. The request for
suspension also may be made orally, including by telephone, or in
writing, including by e-mail, to the submitter's EPA contact for that
notice, subject to paragraph (c) of this section.
* * * * *
(c) An oral or written request for suspension may be granted by EPA
for a maximum of 30 days only. Requests for longer suspension must only
be submitted in the manner set forth in paragraph (b)(2) of this
section.
(d) If the submitter has not made a previous oral or written
request, the running of the applicable review period is suspended as of
the date of receipt of the CDX submission by EPA.
0
26. Amend Sec. 725.60 by revising paragraph (a)(1) to read as follows:
Sec. 725.60 Withdrawal of submission by the submitter.
(a)(1) Withdrawal of notice by the submitter. A submitter may
withdraw a notice during the applicable review period by submitting a
statement of withdrawal in a manner set forth in this paragraph. The
withdrawal is effective upon receipt of the CDX submission by EPA.
* * * * *
0
27. Amend Sec. 725.170 by:
0
a. Revising paragraphs (a) and (b); and
0
b. Removing paragraph (c).
The revisions read as follows.
Sec. 725.170 EPA review of the MCAN.
* * * * *
(a) Length of the review period. The MCAN review period specified
in section 5(a) of the Act runs for 90 days from the date EPA receives
a complete MCAN, or the date EPA determines the MCAN is complete under
Sec. 725.33, unless the Agency extends the period under section 5(c)
of the Act and Sec. 725.56.
(b) Determinations. (1) Within the applicable review period, EPA
will make one of the following five determinations on the
microorganism, as set forth in section 5(a)(3) of the Act:
(i) The microorganism presents an unreasonable risk of injury to
health or the environment, as set forth in section 5(a)(3)(A) of the
Act.
(ii) Information available to EPA is insufficient to permit a
reasoned evaluation of the health and the environmental effects of the
microorganism, as set forth in section 5(a)(3)(B)(i) of the Act.
(iii) In the absence of sufficient information to permit EPA to
make such an evaluation, the microorganism may present an unreasonable
risk of injury to health or the environment, as set forth in section
5(a)(3)(B)(ii)(I) of the Act.
(iv) The microorganism is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or substantial human exposure to the
substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.
(v) The microorganism is not likely to present an unreasonable risk
of injury to health or the environment, as set forth in section
5(a)(3)(C) of the Act.
(2) EPA will take the following actions required in association
with the determination.
(i) For determinations described in paragraph (b)(1)(i) of this
section, EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the microorganism, or any combination of such activities, to the extent
necessary to protect against an unreasonable risk of injury to health
or the environment, as set forth in section 5(f) of the Act, or will
issue a proposed rule under section 6(a) of the Act, as set forth in
section 5(f) of the Act.
(ii) For determinations described in paragraphs (b)(1)(ii), (iii),
or (iv), EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce,
[[Page 102800]]
use, or disposal of the microorganism, or any combination of such
activities, to the extent necessary to protect against an unreasonable
risk of injury to health or the environment, as set forth in section
5(e) of the Act. EPA may issue an order under section 5(e) of the Act
that requires certain testing to be conducted and presented to EPA
after the applicable review period has concluded.
(iii) Following determinations described in paragraph (b)(1)(v) of
this section, EPA will issue the submitter a document containing EPA's
final determination and will submit for publication in the Federal
Register a statement of the finding, as set forth in section 5(g) of
the Act. Upon EPA's issuance of the determination document, the
submitter may commence the manufacture of the microorganism without
waiting for the end of the applicable review period.
(3) EPA may modify or revoke the prohibitions and limitations in an
order issued under paragraph (b)(2)(i) or (ii) of this section after
the applicable review period has ended if EPA receives additional
information, testing, studies, or reports that EPA determines, upon
review, demonstrate that such prohibitions or limitations are no longer
necessary to protect against an unreasonable risk of injury to health
or the environment. Where such information demonstrates that the
prohibitions or limitations of the order are not sufficient to protect
against an unreasonable risk of injury to health or the environment,
EPA may modify the order or take other action, as appropriate, to the
extent necessary to protect against such risk.
(4) No person submitting an MCAN in response to the requirements of
this subpart may manufacture a microorganism subject to this subpart
until EPA has issued a determination in accordance with paragraph
(b)(1) of this section and taken the associated action required under
paragraph (b)(2) of this section.
* * * * *
PART 761--POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING,
PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS
0
28. The authority citation for part 761 continues to read as follows:
Authority: 15 U.S.C. 2605, 2607, 2611, 2614, and 2616.
0
29. In Sec. 761.3 amend the definition for ``Importer'' by removing
the citation ``Sec. 720.3(l)'' and adding in its place ``Sec.
720.3.''
* * * * *
[FR Doc. 2024-28870 Filed 12-17-24; 8:45 am]
BILLING CODE 6560-50-P