Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Rules and Regulations 102773 

TABLE 1—EPA-APPROVED NON-REGULATORY AND QUASI-REGULATORY MEASURES—Continued 

[Excluding certain resolutions and statutes, which are listed in tables 2 and 3, respectively] 1

Name of SIP provision 

Applicable geographic 

or nonattainment area 

or title/subject 

State submittal date EPA approval date Explanation 

*******

1Table 1 is divided into three parts: Clean Air Act Section 110(a)(2) State Implementation Plan Elements (excluding Part D Elements and 

Plans), Part D Elements and Plans (other than for the Metropolitan Phoenix or Tucson Areas), and Part D Elements and Plans for the Metropolitan Phoenix and Tucson Areas. 

* * * * * 

■ 3. Section 52.145 is amended by 

adding paragraph (o) to read as follows: 

§ 52.145 Visibility protection. 

* * * * * 

(o) Disapproval. On August 15, 2022, 

the Arizona Department of 

Environmental Quality submitted the 

‘‘State Implementation Plan Revision: 

Regional Haze Program (2018–2028).’’ 

(1) The following portions of the 

‘‘State Implementation Plan Revision: 

Regional Haze Program (2018–2028)’’ 

are disapproved because they do not 

meet the applicable requirements of 

Clean Air Act sections 169A and 169B 

and the Regional Haze Rule in 40 CFR 

51.301 through 51.308. 

(i) Chapters 2, 6.1, 6.2, 6.3, 7, 8, 9, and 

10; 

(ii) Appendices B, C, D, E, F, G, H, I, 

J, and L. 

■ 4. Section 52.147 is amended by 

adding paragraph (f) to read as follows: 

§ 52.147 Interstate transport. 

* * * * * 

(f) Disapproval. The SIPs submitted 

on December 11, 2015 and September 

24, 2018 do not meet the requirements 

of Clean Air Act section 

110(a)(2)(D)(i)(II) (interfere with 

measures in any other state to protect 

visibility, only) for the 2012 PM2.5

NAAQS and the 2015 ozone NAAQS, 

respectively. 

[FR Doc. 2024–29508 Filed 12–17–24; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


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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 PreManufacture 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 


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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 crossreferences 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 microorganismrelated 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. 


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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 


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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/federalregister/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. 


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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 physicalchemical 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 physicalchemical 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. 


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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 


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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 submittercontrolled 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 


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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, nonexhaustive 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 


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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, nonsubstantive amendments (e.g., submitter 

contact information); and (3) 

Amendments made at the request of 

EPA. EPA, however, will take case-bycase 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 


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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. 


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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 nonexempt 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-bycase 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 


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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-bycase 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 


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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 caseby-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 


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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 email 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 email 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-toxicsubstances-control-act-tsca/pointsconsider-when-preparing-tsca. 

5. EPA. TSCA New Chemical Engineering 

Initiative to Increase Transparency and 

Reduce Rework. Accessible at: https://

www.epa.gov/reviewing-new-chemicalsunder-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/lawsregulations/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 


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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 


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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Rules and Regulations 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 

■ 1. The authority citation for part 68 

continues to read as follows: 

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

7661–7661f. 

§ 68.115 Threshold determination. 

■ 2. Amend § 68.115(b)(5) by revising 

the citation ‘‘§ 720.3(ee)’’ to read 

‘‘§ 720.3.’’ 

PART 372—TOXIC CHEMICAL 

RELEASE REPORTING: COMMUNITY 

RIGHT-TO-KNOW 

■ 3. The authority citation for part 372 

continues to read as follows: 

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

§ 372.38 Exemptions. 

■ 4. Amend § 372.38(d) by revising the 

citation ‘‘§ 720.3(ee)’’ to read ‘‘§ 720.3.’’ 

PART 703—CONFIDENTIALITY 

CLAIMS 

■ 5. The authority citation for part 703 

continues to read as follows: 

Authority: 15 U.S.C. 2613. 

§ 703.3 Definitions. 

■ 6. Amend § 703.3 by: 

■ a. Revising in the introductory text the 

citation ‘‘§ 720.3(ff)’’ to read ‘‘§ 720.3;’’ 

■ b. Revising in the definition for 

‘‘Health and safety study’’ the citation 

‘‘§ 720.3(k)’’ to read ‘‘§ 720.3.’’ 

PART 720—PREMANUFACTURE 

NOTIFICATION 

■ 7. The authority citation for part 720 

continues to read as follows: 

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

§ 720.1 Scope. 

■ 8. Amend § 720.1 by removing the 

phrase ‘‘The rule’’ and adding in its 

place the phrase ‘‘This part’’ wherever 

it appears. 

■ 9. Revise and republish § 720.3 to read 

as follows: 

§ 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 

§ 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 


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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 electronicPMN 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 


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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 § 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 § 721.3 of this 

chapter), may not use the substance 

except in small quantities solely for 

research and development in 

accordance with § 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, jointventure, 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 


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(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. 

§ 720.30 [Amended] 

■ 10. Amend § 720.30 by revising the 

citations ‘‘§ 720.3(e)’’ in paragraph (a) 

and ‘‘720.3(u)’’ in paragraph (b) to both 

read ‘‘§ 720.3.’’ 

■ 11. Amend § 720.40 by revising 

paragraph (f) to read as follows: 

§ 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. 

* * * * * 

■ 12. Amend § 720.45 by: 

■ a. Revising paragraphs (a)(4) and (5), 

and (f) through (h); and 

■ b. Adding paragraphs (j) and (k). 

The revisions and additions read as 

follows: 

§ 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 § 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 

§ 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. 


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TABLE 1 TO PARAGRAPH (f)(2)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES— 

Continued 

Code Category 

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). 


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TABLE 1 TO PARAGRAPH (f)(2)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES— 

Continued 

Code Category 

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 § 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 § 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 


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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 § 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 § 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. 

■ 13. Amend § 720.50 by revising 

paragraphs (a)(4)(ii) and adding 

paragraph (c) to read as follows: 

§ 720.50 Submission of test data and other 

data concerning the health and 

environmental effects of a substance. 

(a) * * * 

(4) * * * 


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(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. 

* * * * * 

■ 14. Revise § 720.65 to read as follows: 

§ 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 resubmits 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 

§ 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 

§ 720.50. 

(vi) The submitter does not provide 

information required by § 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 § 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 § 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 

§ 720.40(h). 

(x) The submitter does not include an 

identifying number and a payment 

identity number as required by 

§ 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 

§ 720.40(f) or information from testing 

in progress at the time of the original 

submission, as described in 

§ 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 


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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. 

■ 15. Amend § 720.70 by revising 

paragraphs (a) and (b)(3) to read as 

follows: 

§ 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 § 720.40(g), a summary 

of the data received will be published. 

* * * * * 

■ 16. Amend § 720.75 by: 

■ a. Revising the section heading; 

■ b. Removing the phrase ‘‘notice 

review period’’ and adding in its place 

the phrase ‘‘applicable review period,’’ 

wherever it appears; and 

■ c. Revising paragraphs (a), (b), (c)(4) 

introductory text, (c)(4)(iii), and (d). 

The revisions read as follows: 

§ 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 

§ 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 email, to the submitter’s EPA contact for 

that notice. Any request for a 

suspension exceeding 30 days must be 

submitted in the manner set forth in 

paragraph (b)(2)(ii) of this section. The 

running of the applicable review period 

will be suspended upon approval of the 

oral or written request by EPA. 

(ii) Requests for suspensions 

exceeding 30 days must be submitted 

electronically to EPA via CDX using ePMN software. Requests for suspensions 

of 30 days or less may also be submitted 

electronically to EPA via CDX using ePMN software. See § 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 ePMN 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 


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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 

■ 17. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 18. Amend § 721.25 by: 

■ a. Revising paragraph (d); and 

■ b. Adding paragraph (e). 

The revisions and additions read as 

follows: 

§ 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 § 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 

§ 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. 

■ 19. Amend §§ 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.’’ 

■ 20. Amend § 721.11777(b) by revising 

the citations ‘‘720.3(w)’’ and ‘‘720.3(d)’’ 

to read ‘‘720.3.’’ 

PART 723–PREMANUFACTURE 

NOTIFICATION EXEMPTIONS 

■ 21. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 22. Amend § 723.50 by: 

■ a. Revising paragraphs (a)(1); 

■ b. Adding paragraphs (b)(11) and (12); 

■ c. Revising paragraphs (d); 

■ d. Adding paragraphs (e)(2)(xiv); 

■ e. Revising paragraphs (e)(3), (g), 

(h)(2)(v), and (i); and 

■ f. Adding paragraph and (p). 

The revisions and additions read as 

follows: 

§ 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 

(§ 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 § 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 


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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Rules and Regulations 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 

■ 23. The authority citation for part 725 

continues to read as follows: 

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

2625. 

■ 24. Amend § 725.8(c)(1) by revising 

the citation ‘‘720.3(e)’’ to read ‘‘720.3.’’ 

■ 25. Amend § 725.54 by revising 

paragraphs (b)(1), (c) and (d) to read as 

follows: 

§ 725.54 Suspension of the review period. 

* * * * * 

(b)(1) Request for suspension. A 

request for suspension may only be 

submitted in a manner set forth in this 

paragraph. The request for suspension 

also may be made orally, including by 

telephone, or in writing, including by email, to the submitter’s EPA contact for 

that notice, subject to paragraph (c) of 

this section. 

* * * * * 

(c) An oral or written request for 

suspension may be granted by EPA for 

a maximum of 30 days only. Requests 

for longer suspension must only be 

submitted in the manner set forth in 

paragraph (b)(2) of this section. 

(d) If the submitter has not made a 

previous oral or written request, the 

running of the applicable review period 

is suspended as of the date of receipt of 

the CDX submission by EPA. 

■ 26. Amend § 725.60 by revising 

paragraph (a)(1) to read as follows: 

§ 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. 

* * * * * 

■ 27. Amend § 725.170 by: 

■ a. Revising paragraphs (a) and (b); and 

■ b. Removing paragraph (c). 

The revisions read as follows. 

§ 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 § 725.33, 

unless the Agency extends the period 

under section 5(c) of the Act and 

§ 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, 


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102800 Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Rules and Regulations 

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 

■ 28. The authority citation for part 761 

continues to read as follows: 

Authority: 15 U.S.C. 2605, 2607, 2611, 

2614, and 2616. 

■ 29. In § 761.3 amend the definition for 

‘‘Importer’’ by removing the citation 

‘‘§ 720.3(l)’’ and adding in its place 

‘‘§ 720.3.’’ 

* * * * * 

[FR Doc. 2024–28870 Filed 12–17–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 37 

[Docket No. DOT–OST–2024–0090] 

RIN 2105–AF05 

Transportation for Individuals With 

Disabilities; Adoption of Accessibility 

Standards for Pedestrian Facilities in 

the Public Right-of-Way 

AGENCY: Office of the Secretary (OST), 

U.S. Department of Transportation (DOT 

or the Department). 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation (DOT or the Department) 

is amending its Americans with 

Disabilities Act regulations to adopt, 

without modification, the Architectural 

and Transportation Barriers Compliance 

Board’s Accessibility Guidelines for 

Pedestrian Facilities in the Public Rightof-Way (PROWAG) as DOT’s regulatory 

standards for new construction and 

alterations of transit stops in the public 

right-of-way. 

DATES: This rule is effective January 17, 

2025. 

FOR FURTHER INFORMATION CONTACT: For 

general questions, Holly Ceasar-Fox, 

Office of the General Counsel, U.S. 

Department of Transportation, (202) 

366–7420, holly.ceasarfox@dot.gov. For 

legal questions related to PROWAG, 

James T. Esselman, Office of Chief 

Counsel, Federal Highway 

Administration, (202) 366–6181, 

james.esselman@dot.gov. For legal 

questions related to transit, Diane 

Alexander, Office of Chief Counsel, 

Federal Transit Administration, (202) 

366–3101, diane.alexander@dot.gov. For 

questions related to intercity or highspeed rail, Linda Martin, Federal 

Railroad Administration, Office of Chief 

Counsel, 202–689–9408, Linda.Martin@

dot.gov. 

Electronic Access and Filing: This 

document, the notice of proposed 

rulemaking (NPRM), all comments 

received, and all background material 

may be viewed online at 

www.regulations.gov using the docket 

number listed above. Electronic retrieval 

help and guidelines are available on the 

website. It is available 24 hours each 

day, 365 days each year. An electronic 

copy of this document may also be 

downloaded from the Office of the 

Federal Register’s website at 

www.federalregister.gov and the 

Government Publishing Office’s website 

at www.GovInfo.gov. 

SUPPLEMENTARY INFORMATION: The 

Americans with Disabilities Act (ADA) 

directs the Architectural and 

Transportation Barriers Compliance 

Board (U.S. Access Board, or the Board) 

to issue minimum guidelines for 

accessible design to guide the U.S. 

Department of Justice (DOJ) and the U.S. 

Department of Transportation (DOT) in 

the development of ADA accessibility 

standards. See 42 U.S.C. 12204(a). On 

August 8, 2023, the Board issued its 

final rule on Public Rights-of-Way 

Accessibility Guidelines (PROWAG). 

(88 FR 53604). 

Title II of the ADA sets forth 

accessibility requirements applicable to 

public entities. Under Title II, Part B, 

DOT is authorized to implement the 

ADA relating to nondiscrimination in 

the provision of public transportation 

services. See 42 U.S.C. 12149(a). The 

ADA directs DOT to adopt standards for 

accessible public transportation 

facilities that are ‘‘consistent with’’ final 

minimum accessibility guidelines 

issued by the Board. Id. at section 

12149(b). Similarly, Title III of the ADA 

directs DOT to adopt regulations 

implementing the transportation 

provisions of Title III, applicable to 

private entities that provide specified 

public transportation services and 

provides that any standards adopted 

under such regulations must be 

‘‘consistent with’’ final minimum 

accessibility guidelines adopted by the 

Access Board. Id. at sections 12186(a), 

(c). 

Under these authorities, DOT issued a 

notice of proposed rulemaking (NPRM) 

to adopt the PROWAG into DOT’s ADA 

regulations on August 22, 2024 (89 FR 

67922). The NPRM proposed to adopt 

the entirety of the PROWAG into DOT’s 

ADA regulations but noted that DOT’s 

independent regulatory authority under 

the ADA extends only to the 

accessibility of public transportation 

facilities. See 42 U.S.C. 12149(a), 

12186(a), (c). As a result, the NPRM 

proposed that in adopting the PROWAG 

into DOT’s ADA regulations, DOT will 

apply only those provisions applicable 

to new construction and alterations of 

transit stops in the public right-of-way. 

PROWAG R210 requires transit stops 

and transit shelters to comply with 

technical requirements set forth in 

PROWAG R309. Elements required to be 

accessible under PROWAG R309 

include the boarding and alighting area 


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