74292 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 702 

[EPA–HQ–OPPT–2023–0496; FRL–8529–01– 

OCSPP] 

RIN 2070–AK90 

Procedures for Chemical Risk 

Evaluation Under the Toxic 

Substances Control Act (TSCA) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA, ‘‘the Agency’’) is 

proposing to amend the procedural 

framework rule for conducting risk 

evaluations under the Toxic Substances 

Control Act (TSCA). The purpose of risk 

evaluations under TSCA is to determine 

whether a chemical substance presents 

an unreasonable risk of injury to health 

or the environment, without 

consideration of costs or non-risk 

factors, including unreasonable risk to 

potentially exposed or susceptible 

subpopulations identified as relevant to 

the risk evaluation by EPA, under the 

conditions of use. EPA has reconsidered 

the procedural framework rule for 

conducting such risk evaluations and 

determined that certain aspects of that 

framework should be revised to better 

align with applicable court decisions 

and the statutory text, to reflect the 

Agency’s experience implementing the 

risk evaluation program following 

enactment of the 2016 TSCA 

amendments, and to allow for 

consideration of future scientific 

advances in the risk evaluation process 

without need to further amend the 

Agency’s procedural rule. 

DATES: Comments must be received on 

or before December 14, 2023. Under the 

Paperwork Reduction Act, comments on 

the information collection provisions 

are best assured of consideration if the 

Office of Management and Budget 

(OMB) receives a copy of your 

comments on or before November 29, 

2023. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2023–0496, 

through the Federal eRulemaking Portal 

at https://www.regulations.gov. Follow 

the online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Additional 

instructions on commenting or visiting 

the docket, along with more information 

about dockets generally, is available at 

https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Susanna W. Blair, Immediate Office, 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 564–4371; email address: 

blair.susanna@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

EPA is primarily proposing to amend 

procedural requirements that apply to 

the Agency’s activities in carrying out 

TSCA risk evaluations. However, EPA is 

also proposing certain amendments to 

the process and requirements that 

manufacturers (including importers) 

would be required to follow when they 

request an Agency-conducted TSCA risk 

evaluation on a particular chemical 

substance. You may be potentially 

affected by this action if you 

manufacture or import chemical 

substances regulated under TSCA. Since 

other entities may also be interested, the 

Agency has not attempted to describe all 

the specific entities and corresponding 

NAICS codes for entities that may be 

interested in or affected by this action. 

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: 

• Petroleum Refineries (NAICS code 

324110); 

• Chemical Manufacturing (NAICS 

code 325); 

• Unlaminated Plastics Film and 

Sheet (except Packaging) Manufacturing 

(NAICS code 326113); 

• Unlaminated Plastics Profile Shape 

Manufacturing (NAICS code 326121); 

• Plastics Pipe and Pipe Fitting 

Manufacturing (NAICS code 326122); 

• Laminated Plastics Plate, Sheet 

(except Packaging), and Shape 

Manufacturing (NAICS code 326130); 

• Polystyrene Foam Product 

Manufacturing (NAICS code 326140); 

• Urethane and Other Foam Product 

(except Polystyrene) Manufacturing 

(NAICS code 326150); 

• Plastics Bottle Manufacturing 

(NAICS code 326160); 

• Plastics Plumbing Fixture 

Manufacturing (NAICS code 326191); 

• All Other Plastics Product 

Manufacturing (NAICS code 326199); 

• Tire Manufacturing (except 

Retreading) (NAICS code 326211); 

• Tire Retreading (NAICS code 

326212); 

• Rubber and Plastics Hoses and 

Belting Manufacturing (NAICS code 

326220); 

• Rubber Product Manufacturing for 

Mechanical Use (NAICS code 326291); 

• All Other Rubber Product 

Manufacturing (NAICS code 326299); 

• Pottery, Ceramics, and Plumbing 

Fixture Manufacturing (NAICS code 

327110); 

• Clay Building Material and 

Refractories Manufacturing (NAICS 

code 327120); 

• Flat Glass Manufacturing (NAICS 

code 327211); 

• Other Pressed and Blown Glass and 

Glassware Manufacturing (NAICS code 

327212); 

• Glass Container Manufacturing 

(NAICS code 327213); 

• Glass Product Manufacturing Made 

of Purchased Glass (NAICS code 

327215); 

• Cement Manufacturing (NAICS 

code 327310); 

• Ready Mix Concrete Manufacturing 

(NAICS code 327320); 

• Concrete Block and Brick 

Manufacturing (NAICS code 327331); 

• Concrete Pipe Manufacturing 

(NAICS code 327332); and 

• Other Concrete Product 

Manufacturing (NAICS code 327390). 

If you have any questions regarding 

the applicability of this proposed action 

to a particular entity, consult the 

technical information contact listed 

under FOR FURTHER INFORMATION

CONTACT. 

B. What is the Agency’s authority for 

taking this action? 

EPA is issuing this Notice of Proposed 

Rulemaking (NPRM) pursuant to the 

authority in TSCA section 6(b)(4) (15 

U.S.C. 2605(b)(4)). EPA has inherent 

authority to reconsider previous 

decisions and to revise, replace, or 

repeal a decision to the extent permitted 

by law and supported by reasoned 

explanation. See FCC v. Fox Television 

Stations, Inc., 556 U.S. 502, 515 (2009); 

see also Motor Vehicle Mfrs. Assn v. 

State Farm Mutual Auto. Ins. Co., 463 

U.S. 29, 42 (1983). See also the 

discussion in Units II.A. and B. 

C. What action is the Agency taking? 

EPA is proposing to amend 

regulations that address how the Agency 

conducts risk evaluations on chemical 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74293 

substances under TSCA. These changes 

include, but are not limited to, targeted 

changes to certain definitions, 

clarifications regarding the required 

scope of risk evaluations, considerations 

related to peer review and the Agency’s 

implementation of the scientific 

standards, the approach for risk 

determinations on chemical substances 

and considerations related to 

unreasonable risk, and the process for 

revisiting a completed risk evaluation. 

EPA is also proposing to amend the 

process and requirements for 

manufacturers making a voluntary 

request for an Agency-conducted risk 

evaluation on a particular chemical 

substance. EPA is requesting public 

comment on all aspects of this proposal. 

D. Why is the Agency taking this action? 

As further explained in Units I., II., 

and III., EPA reexamined the July 20, 

2017, final rule (Ref. 1) (hereinafter 

‘‘2017 final rule’’) that established 

procedures and requirements for 

chemical risk evaluation under TSCA, 

in consideration of: 

• The statutory text and structure and 

Congressional intent. 

• The November 14, 2019, opinion 

issued by U.S. Court of Appeals for the 

Ninth Circuit in response to petitions 

for judicial review, consolidated under 

Safer Chemicals, Healthy Families v. 

USEPA (Ref. 2), of the 2017 final rule 

and related court orders. 

• Executive Order 13990, Protecting 

Public Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis (Ref. 3). 

• Lessons learned from the Agency’s 

implementation of the risk evaluation 

program to date including feedback 

from the National Academies of Science 

Engineering and Medicine and scientific 

peer reviewers. 

As a result of this reexamination, the 

Agency is proposing targeted 

amendments of the 2017 final rule. 

E. What are the estimated incremental 

impacts of this action? 

The incremental impacts of this 

action are associated with procedural 

requirements, as described in Unit III.K., 

which apply to manufacturers when 

manufacturers (including importers) 

elect to request that EPA perform a risk 

evaluation on a particular chemical 

substance. EPA has estimated the 

potential burden and costs associated 

with the proposed requirements for 

submitting a request for an Agencyconducted risk evaluation on a 

particular chemical substance. These 

estimates of burden and costs are 

available in the docket, and are 

discussed in Unit V. and briefly 

summarized here (Ref. 4). 

The total estimated annual burden is 

166 hours and $115,711 (per year), 

which is based on an estimated per 

request burden of 166 hours. 

In addition, EPA’s evaluation of the 

potential costs associated with this 

action is discussed in Unit VI.B. Since 

this rulemaking focuses on the activities 

that a manufacturer must perform, the 

estimated incremental costs to the 

public are expected to be negligible. 

EPA requests specific comment on the 

burden estimate and assumptions 

associated with the calculation 

associated with the burden (e.g., number 

of requests EPA expects). 

F. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI 

Do not submit CBI to EPA through 

https://www.regulations.gov or email. If 

you wish to include CBI in your 

comment, please follow the applicable 

instructions at https://www.epa.gov/ 

dockets/commenting-epa-dockets#rules 

and clearly mark the part or all of the 

information that you claim to be CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. 

Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

2. Tips for Preparing Your Comments 

When preparing and submitting your 

comments, see the commenting tips at 

https://www.epa.gov/dockets/ 

commenting-epa-dockets.html. 

II. Background 

A. Statutory Requirements for Risk 

Evaluation 

TSCA section 6(b)(4) requires EPA to 

establish, by rule, a process to conduct 

risk evaluations. Specifically, EPA is 

directed to use this process to 

‘‘determine whether a chemical 

substance presents an unreasonable risk 

of injury to health or the environment, 

without consideration of costs or other 

non-risk factors, including an 

unreasonable risk to a potentially 

exposed or susceptible subpopulation 

identified as relevant to the risk 

evaluation by the Administrator, under 

the conditions of use.’’ (15 U.S.C. 

2605(b)(4)(A)). TSCA sections 6(b)(4)(A) 

through (H) enumerate the deadlines 

and minimum requirements applicable 

to this process, including provisions 

that direct which chemical substances 

must undergo risk evaluation, the 

development of criteria for 

manufacturer-requested risk 

evaluations, the minimum components 

of an Agency risk evaluation, and the 

timelines for public comment and 

completion of the risk evaluation. The 

law also requires EPA to consider 

reasonably available information and 

operate in a manner that is consistent 

with the best available science and 

make decisions based on the weight of 

the scientific evidence. (15 U.S.C. 

2625(h) and (i)). 

B. Judicial Review of the 2017 Final 

Rule 

In the preamble of the 2017 final rule, 

EPA explained that it interpreted the 

requirements of TSCA section 6 to apply 

to conditions of use for which 

manufacturing, processing, or 

distribution in commerce is intended, 

known to be occurring, or reasonably 

foreseen to occur, rather than to legacy 

uses, which EPA used as a term for 

continuing, in-situ uses of chemicals for 

which manufacturing, processing, or 

distribution in commerce had ceased 

(e.g., certain phased-out flame 

retardants present in textiles or 

furniture that continue to be used, 

asbestos-containing pipe wrap, etc.), or 

associated disposal. In addition, among 

other regulatory provisions, the 2017 

final rule established that the 

submission of inaccurate, incomplete, or 

misleading information pursuant to a 

manufacturer-requested risk evaluation 

is a prohibited act subject to penalties 

under title 18 of the U.S. Code. The 

2017 final rule also established 

requirements for information that must 

be submitted by a manufacturer when 

requesting that EPA conduct a risk 

evaluation (40 CFR 702.37(b)(4)) and 

that the submitted information be held 

to the scientific standards established in 

TSCA section 26(h) (40 CFR 

702.37(b)(6)). 

Several non-governmental 

organizations filed petitions for judicial 

review of the 2017 final rule, which 

were consolidated in the U.S. Court of 

Appeals for the Ninth Circuit (hereafter, 

the ‘‘Ninth Circuit’’) under Safer 

Chemicals, Healthy Families v. USEPA, 

on August 10, 2017 (Ref. 2). The Ninth 

Circuit issued its opinion on November 

14, 2019, holding that the EPA 

unlawfully excluded ‘‘legacy uses and 

associated disposals’’ from the 

conditions of use that the agency would 

consider in any risk evaluation (Ref. 2). 

Also, at the Agency’s request, the Ninth 

Circuit (1) vacated and remanded the 

rule provisions applying criminal 

penalties to the submission of 

inaccurate or incomplete information to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74294 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

EPA pursuant to a manufacturerrequested risk evaluation, and (2) 

remanded without vacatur the rule 

provisions addressing the information 

requirements for, and application of the 

TSCA section 26 scientific standards to, 

a manufacturer-requested risk 

evaluation (Ref. 5). 

The Court declined to rule on several 

other aspects of the challenge, including 

that the rule suggested EPA would make 

risk determinations on individual uses 

of a chemical instead of on the chemical 

itself, and statements in the preamble 

regarding broad discretion to choose to 

exclude conditions of use from the 

scope of the risk evaluations. The Court 

reasoned that petitioners’ claim that 

EPA would make risk determinations on 

individual uses instead of on the 

chemical itself as the law required was 

not justiciable due to ambiguity in the 

2017 final rule text. The Court noted it 

was unclear ‘‘whether the Agency will 

actually conduct risk evaluations in the 

manner [those litigants] fear[ed]’’ and 

that the claim was therefore not 

justiciable (Ref. 2). With regard to 

petitioners’ claim that EPA intended to 

exclude conditions of use out of the 

scope of the risk evaluations, the court 

held that claim not ripe, but noted that 

it did ‘‘not interpret the language in the 

[2017 final rule] to say anything about 

exclusion of conditions of use’’ (Ref. 2). 

C. Review of the 2017 Final Rule Under 

Executive Order 13990 

Executive Order 13990 instructs that 

the Federal Government be guided by 

the best science and be protected by 

processes that ensure the integrity of 

Federal decision-making, and 

established the Administration’s policy 

of, among other concerns, following the 

science, improving public health and 

protecting the environment, limiting 

exposure to dangerous chemicals, 

reducing greenhouse gas emissions, and 

prioritizing environmental justice (EJ) 

when delivering on these concerns. 

Executive Order 13990 also instructs 

agencies to (1) review actions issued 

between January 20, 2017, and January 

20, 2021, that may be inconsistent with 

or present obstacles to implementing the 

policy established in the order and, (2) 

consider suspending, revising, or 

rescinding such actions. Also on 

January 20, 2021, the Biden-Harris 

Administration issued a list of specific 

actions to be reviewed in accordance 

with Executive Order 13990 that 

included the 2017 final rule (Ref. 6). 

EPA announced certain policy 

changes for TSCA risk evaluations on 

June 30, 2021 (Ref. 7) to ensure that risk 

evaluations follow the science and the 

law, including: 

1. Expanded Consideration of Exposure 

Pathways 

Prior to June 30, 2021, the first 10 risk 

evaluations did not consistently assess 

air, water or disposal exposures to the 

general population based on an 

argument that these exposure pathways 

were already regulated, or could be 

regulated, under other statutes 

administered by EPA, such as the Clean 

Air Act, Safe Drinking Water Act, Clean 

Water Act, Resource Conservation and 

Recovery Act, or Comprehensive 

Environmental Response, 

Compensation, and Liability Act. The 

approach to exclude certain exposure 

pathways conflicted with the plain 

language of the law to evaluate chemical 

substances under the known, intended 

or reasonably foreseen circumstances 

associated with the full lifecycle of the 

chemical substance. It prevented 

consideration of relevant exposure 

information (e.g., information indicating 

presence of the chemical in air or water) 

in spite of statutory requirements that 

the Agency base its decisions on the 

best available science. The approach 

also resulted in a failure to consistently 

and comprehensively address potential 

exposures to the general population, as 

well as to certain potentially exposed or 

susceptible subpopulations. EPA 

announced it would no longer exclude 

consideration of such exposure 

pathways from TSCA risk evaluations. 

2. Assumptions About Use of Personal 

Protective Equipment (PPE) 

Prior to June 30, 2021, EPA’s TSCA 

risk evaluations generally assumed that 

workers were always provided and 

appropriately used PPE. However, as 

described in Unit III.G.1., data on 

violations of PPE use suggest that 

assumptions that PPE is always 

provided to workers, worn properly, 

and effective at eliminating exposures 

are not justified. In addition, TSCA 

requires that risk evaluations consider 

the known, intended or reasonably 

foreseen circumstances associated with 

the chemicals substance—including 

circumstances that result or could result 

in exposures to workers. For the reasons 

described further in Unit III.E.1., EPA 

believes that circumstances that result 

in occupational exposures to chemicals 

are reasonable to foresee, and, in many 

cases, known. As such, continued 

application of this general assumption 

could result in risk evaluations that 

underestimate risks, and in turn, 

prevent risk management rules from 

affording necessary protections. EPA 

announced that it would no longer 

assume that PPE is always used in 

occupational settings when making 

unreasonable risk determinations for a 

chemical. 

3. ‘‘Whole Chemical’’ Risk 

Determination Approach 

Prior to June 30, 2021, EPA made 

separate unreasonable risk 

determinations for each condition of use 

identified in the risk evaluation scope. 

EPA announced that, going forward, it 

would make the determination of 

unreasonable risk on ‘‘the chemical 

substance,’’ rather than for each 

individual condition of use in isolation. 

As described further in Unit III.F.1., 

doing so going forward better aligns 

with the statute and Congress’ intent, 

and enables the Agency’s risk 

determinations to better reflect the 

potential for combined exposures across 

multiple conditions of use. 

EPA invites public comment on the 

adoption of these changes in the 

amended procedural rule. 

D. Agency Implementation 

Since the 2017 final rule, EPA has 

finalized ten chemical risk evaluations 

under TSCA and published a draft 

supplement to the risk evaluation for 

1,4-Dioxane. Additionally underway are 

20 more risk evaluations on highpriority substances, a part 2 of the 

asbestos risk evaluation that will cover 

additional fiber types and ‘‘legacy’’ 

conditions of use, and several 

manufacturer-requested risk evaluations 

(Ref. 8). EPA is also developing a 

number of rulemakings to address 

unreasonable risks identified in these 

risk evaluations. The Agency has gained 

valuable experience in carrying out 

these actions and received a wealth of 

feedback on our procedures from public 

commenters and through scientific peer 

review. The proposed rule reflects 

lessons learned, efforts to increase 

efficiencies, and includes improvements 

to the process and requirements for 

manufacturer-requested risk evaluations 

that are more consistent with Agency 

scientific practices and policies. The 

proposed rule also includes some 

structural and substantive revisions for 

greater clarity and readability, and, 

more generally, to enhance the public’s 

understanding of how EPA expects to 

carry out TSCA risk evaluations. 

EPA intends that the provisions of 

this rulemaking be severable. In the 

event that any individual provision or 

part of this rulemaking is invalidated, 

EPA intends that this would not render 

the entire rulemaking invalid, and that 

any individual provisions that can 

continue to operate will be left in place. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74295 

III. Proposed Amendments 

A. Policy Objectives 

The risk evaluation process 

established in 40 CFR part 702, subpart 

B outlines how EPA will determine, 

pursuant to TSCA section 6(b)(4)(A), 

whether a chemical substance presents 

an unreasonable risk of injury to health 

or the environment. EPA’s general 

objectives for the proposed 

amendments, in keeping with the 

considerations addressed in Unit II, are 

to (1) better align the TSCA risk 

evaluation process with the statutory 

text and structure and Congressional 

intent, (2) ensure that the risk 

evaluation process under TSCA is 

consistent with the best available 

science and based on the weight of the 

scientific evidence, maintains the 

integrity of Federal decision-making, 

and upholds the policy in various 

Executive orders, (3) address the 

outcome of the Ninth Circuit litigation 

on the 2017 final rule, (4) apply lessons 

learned to date to improve the Agency’s 

processes moving forward, and (5) 

enhance the public’s understanding of 

how EPA expects to carry out 

subsequent TSCA risk evaluations. 

Through improvements to the risk 

evaluation process in these proposed 

amendments, EPA anticipates that any 

risk management actions following any 

determination that a chemical substance 

presents unreasonable risk will result in 

needed public health and 

environmental protections that limit 

exposure to dangerous chemicals, and, 

where applicable, address the climate 

crisis and advance environmental 

justice. 

To accomplish these objectives, EPA 

is proposing targeted changes and 

clarifying edits to the existing process 

by which the Agency evaluates risk 

from chemical substances for purposes 

of TSCA section 6. Additionally, this 

proposal includes structural changes to 

the regulatory text to accomplish these 

goals. EPA is not proposing to establish 

highly detailed provisions that will 

address every eventuality or possible 

consideration that might arise. Due to 

the rapid advancement of the science of 

risk evaluation and the science and 

technology that inform risk evaluation, 

this proposed rule seeks to ensure that 

the risk evaluation process is 

transparent, without unduly restricting 

the science that will be used to conduct 

the evaluations, allowing the Agency 

flexibility to adapt and keep pace with 

changing science as it conducts TSCA 

risk evaluations into the future. 

B. General Provisions 

1. Applicability of Updated Procedures 

EPA is proposing that the changes to 

the procedures as part of this 

rulemaking would be applied to all risk 

evaluations initiated on or after the date 

of the final rule. For risk evaluations in 

process as of the date of the final rule, 

EPA would expect to apply the 

proposed changes to those risk 

evaluations only to the extent 

practicable, taking into consideration 

the statutory requirements and 

deadlines. Where a change to a risk 

evaluation would prevent the Agency 

from meeting the statutory deadline, for 

example, EPA would generally not view 

that change as practicable. However, 

where applying a proposed change 

would impact timeliness but also ensure 

compliance with other statutory 

obligations (e.g., conducting an 

appropriately scoped risk evaluation), 

EPA would make a judgment on 

practicability by weighing the 

implications for public health and 

environment, defensibility from both a 

scientific and legal perspective, Agency 

priorities and the availability of 

resources. As a general matter, EPA 

believes that most of its ongoing risk 

evaluations, including the ongoing 

supplement to the 1,4-Dioxane risk 

evaluation and part two of the Asbestos 

risk evaluation, will likely conform to 

the changes contemplated in this 

NPRM, and does not anticipate 

significant challenges in this area. 

Finally, EPA does not expect to apply 

these procedures retroactively to risk 

evaluations already completed. 

2. Categories of Chemical Substances 

EPA is proposing to clarify the 

regulations with respect to their 

applicability to risk evaluations on 

categories of chemical substances. 

Pursuant to TSCA section 26(c), 

wherever TSCA requires or authorizes 

EPA to take action on a chemical 

substance, EPA can take that same 

action with respect to a category of 

chemical substances (i.e., groups of 

chemical substances which are, for 

example, similar in molecular structure, 

in physical, chemical, or biological 

properties, in use, or in mode of 

entrance into the human body or into 

the environment). Although the rule’s 

procedural requirements generally refer 

to ‘‘chemicals’’ or ‘‘chemical 

substances,’’ EPA is proposing to clarify 

in the regulatory text at § 702.31(d) that 

those references also apply to categories 

of chemical substances. 

C. Definitions 

EPA is proposing changes to a number 

of definitions codified in the existing 

regulatory text. EPA is proposing to 

eliminate the codified definitions for 

‘‘best available science’’ and ‘‘weight of 

scientific evidence.’’ As described in 

greater detail in Unit III.I., EPA believes 

that defining these concepts in the 

rulemaking is both unnecessary and 

inhibits the Agency’s flexibility to 

quickly adapt to and implement 

changing science. Not codifying 

regulatory definitions of these scientific 

terms is consistent with the approach in 

the 2017 proposed rule (Ref. 9) 

(hereinafter ‘‘2017 proposed rule’’) and 

was supported by public comment. 

Instead, as described in Unit III.I. EPA 

intends to ensure that its risk 

evaluations are consistent with Agency 

guidance and methodologies in 

applying these terms. As TSCA requires, 

at 15 U.S.C. 2625(h), EPA’s risk 

evaluations will continue to use 

scientific information, technical 

procedures, measures, methods, 

protocols, methodologies, or models, 

employed in a manner consistent with 

the best available science. Further, both 

risk evaluation and risk management 

decisions under TSCA section 6 will be 

based on the weight of the scientific 

evidence, as required by 15 U.S.C. 

2625(i). EPA’s expected application of 

these terms is more fully described in 

Unit III.G. regarding Risk Evaluation 

Considerations. 

Second, and as described further in 

Unit III.G.4., EPA is proposing an 

addition to the examples identified in 

the definition of ‘‘potentially exposed or 

susceptible subpopulation’’ which 

currently include ‘‘infants, children, 

pregnant women, workers, or the 

elderly.’’ The Agency proposes to add 

‘‘overburdened communities’’ to better 

reflect the Agency’s intent to consider 

risks to particular communities in the 

United States that potentially 

experience disproportionate 

environmental harms and risks, while 

also ensuring environmental justice— 

the fair treatment and meaningful 

involvement of all people regardless of 

race, color, culture, national origin, 

income, and educational levels with 

respect to the development, 

implementation, and enforcement of 

protective environmental laws, 

regulations, and policies—is considered 

where appropriate, including as part of 

any subsequent risk management action. 

Finally, EPA is proposing minor 

updates to a number of other definitions 

to better align with existing Agency 

guidance. Specifically, the definitions 

for ‘‘pathways’’ and ‘‘routes’’ have been 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74296 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

adjusted for consistency with EPA’s 

Exposure Factors Handbook (Ref. 10). 

Additionally, EPA is also proposing 

clarifying edits to the definitions for 

‘‘aggregate exposure’’ and ‘‘sentinel 

exposure’’ to align with Agency 

guidance, and to make clear that the 

terms can apply not only to individual 

persons, but to the populations and 

environment when doing so is 

consistent with the best available 

science. EPA is not proposing to amend 

the definitions for ‘‘act,’’ ‘‘conditions of 

use,’’ ‘‘reasonably available 

information,’’ ‘‘sentinel exposure,’’ 

‘‘uncertainty,’’ or ‘‘variability.’’ 

D. Technical Corrections and 

Reorganization 

The proposed rule reflects a number 

of minor updates and corrections and 

general organizational restructuring. For 

example, references to 15 U.S.C. 

2605(b)(2)(A) have been removed in 

light of the fact that the law’s one-time 

requirement related to identification of 

the first group of 10 chemicals for risk 

evaluation has been satisfied and is no 

longer applicable for purposes of the 

procedural rule. Additionally, EPA 

made minor updates to the regulatory 

text to correct typos and to ensure 

consistency in use of certain phrases 

(e.g., manufacturer-requested risk 

evaluations). More generally, EPA 

aimed to improve the readability of 

certain provisions, and, ultimately, 

enhance the public’s ability to 

understand how EPA will undertake 

TSCA risk evaluations. As part of this 

effort, EPA is proposing to reorganize 

the sequence and structure of regulatory 

provisions to, for example, establish 

sections that distinguish between the 

components of the risk evaluation, the 

analytic considerations to be applied in 

the risk evaluation, and the associated 

procedural timeframes and actions. EPA 

welcomes comment on these changes to 

enhance clarity and readability. EPA has 

provided a short description of the 

reorganization: 

• Proposed §§ 702.31, 702.33, and 

702.35 have retained the same 

organization. 

• Proposed § 702.37 ‘‘Evaluation 

requirements’’ includes many of the 

components of § 702.41 of the 2017 final 

rule, including statutory requirements of 

a risk evaluation, upholding the science 

requirements of section 26(h), inclusion 

of conditions of use, and clarity 

regarding making an unreasonable risk 

determination on the chemical 

substance. This section also includes 

EPA’s approach to information and 

information sources, much of which is 

moved from § 702.41(b) in the 2017 final 

rule. New proposed language included 

in this proposed section is EPA’s 

approach to conducting a fit-for-purpose 

risk evaluation, addressing information 

gaps, and use of data gathering 

authorities. 

• Proposed § 702.39 is a newly titled 

section ‘‘Components of risk 

evaluation’’ that is composed of 2017 

final rule §§ 702.41, 702.43, 702.45. This 

one section includes the components of 

a risk evaluation (e.g., scope, hazard 

assessment, exposure assessment, risk 

characterization, risk determination) 

and what they must contain. Some of 

the specific requirements of the hazard 

and exposures assessment have been 

streamlined and reconfigured from the 

2017 final rule. 

• Proposed § 702.41 ‘‘Peer review’’ 

was § 702.47 in the 2017 final rule. 

• Proposed § 702.43 contains the 

parts of a risk evaluation (e.g., draft 

scope, final scope, draft risk evaluation 

and final risk evaluation) and the 

process and timelines associated with 

the development and publication of 

these parts. Much of this section was 

moved from the 2017 final rule § 702.41. 

This proposed section now includes 

provisions pertaining to substantive 

revisions to these documents post 

publication. 

• Proposed § 702.45 is the revised 

process for submitting a manufacturer 

requested risk evaluation, moved from 

the 2017 final rule 702.37. 

• Proposed § 702.47 ‘‘Interagency 

collaboration’’ remains unchanged from 

2017 final rule § 702.39. As part of 

EPA’s commitment to identify 

information earlier in the prioritization 

and risk evaluation processes, the 

Agency expects to continue to engage 

and enhance coordination with other 

Federal agencies that may have 

chemical-specific information. Doing so 

will not only serve to inform the 

Agency’s work in the risk evaluation, 

but can also help to proactively identify 

conditions of use that may be essential 

to national security, critical 

infrastructure, and/or mission critical 

uses, identify existing safety measures 

Federal agencies already have in place 

for their uses, and inform any 

subsequent risk management 

approaches. 

• Proposed § 702.49 ‘‘Publicly 

available information’’ remains 

substantively unchanged from § 702.51 

from the 2017 final rule. 

E. Scope of TSCA Risk Evaluations 

1. Inclusion of All Conditions of Use 

EPA is proposing a number of changes 

to the regulatory text to make clear that 

the scope of TSCA risk evaluations will 

not exclude any ‘‘conditions of use’’ 

(i.e., any circumstance, based on 

reasonably available information, under 

which a chemical substance is known, 

intended or reasonably foreseen to be 

manufactured, processed, distributed in 

commerce, used, or disposed of) to 

better align with the statutory text and 

structure, including modification to 

various provisions in the current rule 

that state or imply that EPA has broad 

discretion to choose which conditions 

of use it will or will not evaluate. These 

proposed amendments are intended to 

ensure that the scopes of future risk 

evaluations are determined in 

accordance with the law. 

When TSCA was originally signed 

into law in 1976, there were tens of 

thousands of chemicals in commerce 

and the law imposed no mandate that 

EPA conduct any assessments to 

determine whether those existing 

chemicals present unreasonable risk of 

injury to health or the environment. 

While EPA did conduct some risk 

assessments on a handful of these 

existing chemicals prior to 2016, those 

assessments were focused on a specific 

subset of individual conditions of use of 

chemicals (e.g., paint and coating 

removal, vapor degreasing, etc.). The net 

effect of this use-by-use approach was 

that—even if EPA were to identify risks 

through a risk assessment and 

successfully promulgate a rule under 

TSCA to manage those particular risks— 

the public would still not have certainty 

regarding risks from the full spectrum of 

uses of the chemical substance. This 

uncertainty, in turn, would continue to 

erode public confidence in the safety of 

chemicals pervasive in our households, 

communities and the environment, and 

encourage states to adopt an 

increasingly complex patchwork of 

regulatory measures to address chemical 

risks. 

One of the defining features of the 

2016 amendments to TSCA was the 

mandate for EPA to systematically 

prioritize those thousands of existing 

chemicals for review, and then to 

evaluate their risks, holistically, under 

the chemical’s ‘‘conditions of use’’—a 

phrase that Congress defined to capture 

a chemical’s full lifecycle, i.e., ‘‘the 

circumstances, as determined by the 

Administrator, under which a chemical 

substance is intended, known, or 

reasonably foreseen to be manufactured, 

processed, distributed in commerce, 

used, or disposed of.’’ (15 U.S.C. 

2602(4)). While clearly a significant 

undertaking, Congress recognized that 

comprehensive progress on evaluating 

the universe of thousands of existing 

chemicals would not be made without 

this mandate, coupled with a strong 

risk-based safety standard and deadlines 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74297 

for completing the work (Ref. 11). To 

allow EPA to continue to address only 

a subset of each chemical’s uses as part 

of the new TSCA process would deny 

such comprehensive progress. 

The question of whether the Agency 

has broad discretion under the law to 

exclude conditions of use from the 

scope of risk evaluations was the source 

of much discussion publicly during the 

development of the 2017 proposed and 

final rules. EPA believes the approach 

proposed herein is more consistent with 

congressional intent and reflects 

consensus of technical discussion with 

congressional negotiators leading up to 

the passage of the 2016 amendments. 

See also Ref. 11 at p. S3516 (implying 

the lack of discretion in the ‘‘mandate 

to consider conditions of use’’) and p. 

S3519 (referencing the prior TSCA risk 

assessments that did not consider ‘‘all 

conditions of use’’ and Congress’ desire 

to nonetheless allow EPA to proceed 

with risk management based on those 

select ‘‘partial’’ risk evaluations). 

However, in the preamble to the 2017 

final rule the Agency asserted that it 

retained discretion to exclude 

conditions of use from the scope of 

TSCA risk evaluations. Ref. 1 at p. 

33729. 

In support of this assertion of 

discretionary scoping authority in the 

2017 final rule, EPA pointed to language 

in TSCA section 6(b)(4)(D) that requires 

EPA to identify the conditions of use in 

a scope document that the Agency 

‘‘expects to consider’’ in a risk 

evaluation and the ‘‘as determined by 

the Administrator’’ phrasing in the 

statutory definition of ‘‘conditions of 

use’’ itself (Ref. 1 at p. 33729). EPA 

argued that such language gave the 

Agency discretion to select among the 

conditions of use and, ultimately, to 

exclude conditions of use from the 

scope of TSCA risk evaluations. EPA 

expressed at that time that those 

provisions empowered the Agency to 

exclude, for example, conditions of use 

that the Agency deemed ‘‘de minimis’’ 

in nature, or conditions of use where 

opportunities for exposure were likely 

to be limited (e.g., closed system or 

intermediate) (Ref. 1 at p. 33729). As 

discussed further in Unit III.E.3., EPA 

has also relied on this interpretation to 

exclude consideration of exposure 

pathways in TSCA risk evaluations 

where EPA or another regulatory agency 

had or could assess and regulate the 

same chemical—a policy that excluded 

exposures to the general population 

through air, water and disposal, and left 

potential risks unaccounted for. 

Upon further review, and as described 

in the preamble to the 2017 proposed 

rule and supported by legislative 

history, EPA believes that the better 

reading of TSCA’s statutory text and 

structure is that EPA does not have 

discretionary scoping authority, and 

that risk evaluations are to be conducted 

on the circumstances under which the 

chemical is known, intended and 

reasonably foreseen to be manufactured, 

processed, distributed in commerce, 

used, and disposed of (i.e., activities 

that constitute the ‘‘conditions of use’’ 

within the meaning of TSCA section 

3(4)) (15 U.S.C. 2602(4)). The plain 

language of TSCA section 6(b)(4)(A) 

specifies that EPA must determine in a 

risk evaluation whether ‘‘a chemical 

substance’’ presents an unreasonable 

risk of injury to health or the 

environment ‘‘under the conditions of 

use.’’ Similar language appears 

throughout section 6 of the law. See, for 

example, 15 U.S.C. 2605(b)(4)(G)(i) and 

(ii) stating that the risk evaluation ‘‘for 

a chemical substance’’ must be 

completed within 3 to 3.5 years of 

initiation. As such, while EPA at one 

time interpreted the statue to permit a 

different approach, the statute is better 

interpreted as requiring that the 

evaluation must be on the chemical 

substance—not a subset of individual 

conditions of use of the chemical 

substance. EPA also believes the 

purpose of the requirement to evaluate 

the ‘‘chemical substance’’ was to ensure 

that the Agency, through the risk 

evaluation process, would 

comprehensively determine whether a 

chemical substance, under the known, 

intended, and reasonably foreseen 

circumstances of manufacture, 

processing, distribution in commerce, 

use and disposal, presents an 

unreasonable risk. This reading also 

aligns with the requirements under the 

2016 TSCA amendments to establish a 

constant pipeline of activity on 

assessing chemical substances and 

managing risks, effectively driving 

forward progress on the tens of 

thousands of unreviewed existing 

chemical substances in commerce (15 

U.S.C. 2605(b)(2) and (b)(3)(C)). In the 

absence of comprehensive risk 

evaluations on chemical substances (i.e., 

an approach that considered only a 

subset of a chemical’s uses), the 

unevaluated uses would create 

uncertainty as to whether EPA had fully 

addressed a chemical’s unreasonable 

risk and further delay progress on the 

backlog of existing chemicals. 

Given these considerations, EPA 

believes that the phrase ‘‘as determined 

by the Administrator’’ in the statutory 

definition of ‘‘conditions of use’’ 

requires application of fact and 

professional judgment in determining 

whether or not a particular 

circumstance is known, intended or 

reasonably foreseen—and should not be 

viewed as license to select among those 

circumstances in determining which 

should be included or excluded from 

the scope of a risk evaluation that is to 

be completed on a chemical substance 

(15 U.S.C. 2602(4)). Likewise, the 

instruction in TSCA section 6(b)(4)(D) 

for the Agency to—during the scoping 

phase—identify the conditions of use it 

‘‘expects to consider’’ in a risk 

evaluation, is best read as directing the 

Agency to identify the uses and other 

activities that it has determined 

constitute the conditions of use of the 

chemical substance, while 

acknowledging that the Agency’s 

expectations at the scoping phase may 

not always align perfectly with the 

conditions of use actually considered 

and assessed in draft and final risk 

evaluations. EPA may, for example, 

mistakenly identify a condition of use in 

the scope document, and later remove it 

from analysis in the risk evaluation. 

Alternatively, EPA might be unaware of 

or inadvertently exclude a condition of 

use during the scoping phase, but later 

incorporate it into its risk evaluation. 

While EPA at one time interpreted the 

language differently, EPA no longer 

believes that the ‘‘expects to consider’’ 

language in TSCA section 6(b)(4)(D) 

gives the Agency broad discretion to 

choose among conditions of use that it 

will include in a risk evaluation of a 

chemical substance. The Ninth Circuit 

agreed with this view, noting that the 

phrase ‘‘conditions of use that the EPA 

plans to consider’’ in the 2017 final rule 

and the similar phrase ‘‘expects to 

consider’’ in TSCA section 6(b)(4)(D) 

simply refer to the Agency’s role in 

determining what the conditions of use 

are for a particular substance, and do 

not grant EPA discretion to exclude 

conditions of use from the scope of a 

risk evaluation (Ref. 2). 

Consideration of all conditions of use 

in TSCA risk evaluations is also 

necessary from a scientific perspective 

to ensure development of a technically 

sound determination as to whether a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment. Thus, consideration of 

all conditions of use ensures risk 

evaluations are consistent with the best 

available science and based on the 

weight of scientific evidence (15 U.S.C. 

2625(h) and (i)). As discussed further in 

Unit III.G.2., there may be situations 

where certain conditions of use are 

associated with relatively lower 

exposures, but nonetheless in the 

aggregate those uses may contribute to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74298 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

unreasonable risk. Exclusion of 

conditions of use from risk 

evaluations—irrespective of the 

Agency’s intention in so doing— 

deprives the public of a complete 

picture of the chemical’s risk, and may 

leave significant risk to human health or 

the environment unaccounted for and 

ultimately unaddressed. 

For these reasons, the proposed rule 

clarifies that EPA will not exclude 

conditions of use (i.e., any 

circumstances under which the 

chemical is known, intended or 

reasonably foreseen to be manufactured, 

processed, distributed in commerce, 

used or disposed of) from the scope of 

a risk evaluation by amending the 

regulatory text where it was either 

stated or implied that the Agency had 

broad discretion to exclude certain 

conditions of use from analysis. 

2. Determination of ‘‘Conditions of Use’’ 

Although EPA no longer interprets 

TSCA to allow the Agency to exclude 

any intended, known or reasonably 

foreseen conditions of use from the 

scope of a risk evaluation, EPA 

nonetheless retains authority to exercise 

judgment in making its determination as 

to whether a particular circumstance is 

intended, known, or reasonably 

foreseen, and therefore falls within the 

definition of ‘‘condition of use’’ for a 

particular chemical. As such, for each 

risk evaluation, EPA has and will 

continue to undergo a process to 

determine each chemical’s conditions of 

use, analyzing reasonably available 

information and applying the facts, 

Agency expertise and professional 

judgment on a case-by-case basis. As 

described previously, the phrase ‘‘as 

determined by the Administrator’’ in the 

statutory definition of ‘‘conditions of 

use’’ requires EPA to review the 

reasonably available information and 

exercise judgment in determining 

whether a particular circumstance is 

intended, known or reasonably foreseen. 

For example, when information suggests 

that a circumstance of manufacture, 

processing, distribution in commerce, 

use or disposal is known to be 

occurring, EPA will determine that 

known circumstance to be a condition 

of use and include it within the scope 

of the risk evaluation, irrespective of 

other factors like the likelihood of that 

particular condition of use to be a 

significant contributor to risk. Likewise, 

where, in the Agency’s professional 

judgment, a circumstance is reasonably 

foreseen to occur in the future, EPA will 

determine that circumstance to be a 

condition of use and include it within 

the scope of the risk evaluation, even 

where that condition of use may not 

contribute significantly to the Agency’s 

ultimate conclusions on risk. 

In the preamble to the 2017 final rule 

(Ref. 1) EPA identified legacy disposal 

as falling outside the definition of 

‘‘conditions of use.’’ EPA interpreted the 

TSCA definition for ‘‘conditions of use’’ 

as focusing on circumstances that are 

prospective or on-going, rather than 

reaching back to evaluate risks 

associated with legacy disposal (i.e., 

disposal that has already occurred) (Ref. 

1 at p. 33730). The Ninth Circuit agreed, 

holding that TSCA unambiguously does 

not require legacy disposals to be 

considered as conditions of use (Ref. 2 

at pp. 425–426). The Court reasoned 

that a substance that has already been 

disposed of will not ordinarily be 

intended, known, or reasonably foreseen 

to be prospectively manufactured, 

processed, distributed in commerce, 

used, or disposed of again (Ref. 2). EPA 

is not reconsidering that issue in this 

proposal. However, EPA generally does 

not view any other categorical 

exclusions from the definition of 

condition of use as appropriate. 

With respect to legacy use and 

associated disposal, however, EPA now 

believes that such circumstances are, in 

fact, ‘‘conditions of use’’ and must be 

considered in risk evaluations. (Ref. 2, 

pp. 420–421). An example would be insitu asbestos insulation, a product no 

longer manufactured but nevertheless 

an ongoing downstream use. Future 

disposal of asbestos insulation is clearly 

an example of a chemical substance 

being ‘‘disposed of’’ and to the extent it 

is ‘‘intended’’ that such a substance be 

disposed of, or ‘‘known’’ that it will be, 

or if such disposal is ‘‘reasonably 

foreseen,’’ that circumstance 

unambiguously falls within TSCA’s 

definition of ‘‘conditions of use.’’ (Ref. 

2, pp. 420–421). As such, EPA is already 

developing a ‘‘part 2’’ of the TSCA risk 

evaluation for asbestos in order to 

include analysis of exposures and 

potential risks from legacy uses and 

expects future risk evaluations to also 

consider legacy uses and associated 

disposals as conditions of use (i.e., 

circumstances associated with ‘‘use’’ 

and ‘‘disposal’’). EPA believes that this 

approach is consistent with the 

statutory text and structure, as well as 

Congressional intent. 

There are other categories of 

circumstances that EPA intends to 

consider in future risk evaluations 

associated with conditions of use that 

also bear mention. The known, 

intended, and reasonably foreseen 

production of a chemical as a byproduct 

or the known presence of a chemical as 

an impurity or within an article, for 

example, are squarely ‘‘conditions of 

use’’ that generally must be included 

within the scope of risk evaluations. 

Likewise, where EPA has reasonably 

available information demonstrating 

that certain exposures associated with a 

spill or leak are known or reasonably 

foreseen to occur during a condition of 

use that is part of a risk evaluation (e.g., 

regular or predictable exposures from 

equipment leaks as part of the 

manufacturing process), EPA would 

expect to include that exposure within 

the scope of the risk evaluation. 

However, EPA would not expect to 

include within the scope of the risk 

evaluation exposures from releases of a 

chemical substance that are 

unsubstantiated, speculative or 

otherwise not likely to occur. For 

example, a future one-time accident 

involving the chemical substance that 

could be caused by an atypical one-time 

set of circumstances would generally 

not be assessed as part of a risk 

evaluation. Additionally, EPA would 

generally not include within the scope 

of the risk evaluation exposures 

associated with future extreme weather 

events (e.g., hurricanes and wildfires). 

However, if information reasonably 

available to the Agency indicated that 

factors such as rising sea levels or 

extreme temperatures made worse by 

climate change were leading to regular 

and predictable changes in exposures 

associated with a given condition of use 

of a chemical substance, EPA would 

expect to consider those exposures 

within the scope of the risk evaluation. 

EPA requests comment on alternative 

proposals for considering potential 

climate-related risks. As discussed 

further in Units III.E.4. and III.I.2., EPA 

may adjust the level of refinement for a 

particular exposure assessment by 

conducting a ‘‘fit-for-purpose’’ 

assessment. While EPA will always 

apply the scientific standards required 

under TSCA, the depth or extent of 

analysis will be commensurate with the 

nature and significance of the decision. 

For example, EPA may find that the 

types of exposures described in this 

paragraph warrant consideration as part 

of an exposure assessment, either in a 

qualitative or a quantitative exposure 

assessment. Additionally, the Agency 

will decide the level of analysis 

warranted based on a number of factors, 

including but not limited to: the 

substance’s physical-chemical 

properties; environmental fate and 

transport properties; the likely duration, 

intensity, frequency, and number of 

exposures under the condition of use; 

reasonably available information about 

the release; and other relevant 

considerations. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74299 

Even where a condition of use is not 

expected to be a significant contributor 

to risk from a particular chemical, TSCA 

nonetheless requires EPA to include it 

in the scope of the risk evaluation. 

However, and as described in Unit 

III.E.4., EPA has discretion to conduct 

its evaluations in a fit-for-purpose 

manner, which may justify tailoring the 

level of analyses to focus more 

detailed—and therefore more time and 

resource intensive—quantitative efforts 

on the conditions of use that pose the 

greatest potential for exposure and 

therefore risk. 

3. Inclusion of All Exposure Pathways 

In carrying out the first ten risk 

evaluations under TSCA, EPA narrowed 

the scope of those evaluations by 

excluding analysis of certain exposures 

to the general population from releases 

to air, water and land. The approach, 

which was not contemplated in the 

procedural framework rule but was first 

articulated in ‘‘Problem Formulation’’ 

documents published in 2018 (after the 

Final Scope documents) for each of the 

first ten chemicals undergoing risk 

evaluation, was premised on an 

argument that those pathways were 

already adequately assessed and 

managed—or could theoretically in the 

future be assessed and managed—under 

other EPA statutes and regulatory 

programs (Ref. 12). EPA further stated at 

that time that its intention was to use 

Agency resources efficiently under the 

TSCA program, avoid duplicating efforts 

taken pursuant to other Agency 

programs, maximize scientific and 

analytical efforts, and meet TSCA’s 

statutory deadline for completing risk 

evaluations. In the final risk evaluations 

for the first ten chemicals, EPA 

excluded exposure pathways that could 

be covered by regulatory programs 

under the Clean Air Act (CAA), Clean 

Water Act (CWA), Safe Drinking Water 

Act (SDWA), Resource Conservation 

and Recovery Act (RCRA), and 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) (e.g., drinking water 

pathways covered under the SDWA due 

to the existence of National Primary 

Drinking Water Regulations (NPDWRs) 

with chemical-specific, enforceable 

Maximum Contaminant Levels (MCL), 

or the inclusion of the chemical as an 

unregulated chemical on the Candidate 

Contaminant List (CCL)). EPA further 

asserted that this approach was 

supported by several TSCA authorities, 

including TSCA section 6(b)(4)(D), 

which gives the Agency authority to 

include the conditions of use that the 

Administrator ‘‘expects to consider’’ 

and section 9(b)(1), which allows 

Administrator to use other EPA 

administered statutes, if the 

Administrator determines there is risk 

to health or the environment (Ref. 13). 

This approach was criticized by the 

Science Advisory Committee on 

Chemicals (SACC), public commenters, 

and others (Ref. 14, 15, 16). As 

announced on June 30, 2021, EPA will 

no longer follow the approach and no 

longer intends to apply it to risk 

evaluations. Additionally, the Agency 

applied the Draft TSCA Screening Level 

Approach for Assessing Ambient Air 

and Water Exposures to Fenceline 

Communities Version 1.0 (Ref. 17) and 

additional feedback from peer review 

and public comment in order to 

consider whether its past failure to have 

assessed the risks associated with these 

exposures—along with its application of 

other past policies and interpretations— 

may have resulted in unaccounted 

potential risks. EPA has reconsidered 

the text of the relevant statutory 

provisions, overarching statutory 

structure and context, and legislative 

history, and no longer interprets the law 

to authorize exclusion of exposure 

pathways from the scope of TSCA risk 

evaluations because other EPA offices 

have already or could in the future 

regulate those chemicals. EPA’s prior 

interpretation in support of that 

approach was premised in large part on 

the Agency’s interpretation of TSCA 

section 6(b)(4)(D) as providing the 

discretionary authority to tailor the 

scope of exposures evaluated in TSCA 

risk evaluations. See, e.g., Risk 

Evaluation for Methylene Chloride, sec. 

1.4.2 (Ref. 13). For the reasons 

explained in Unit III.B., EPA no longer 

interprets TSCA section 6(b)(4)(D) to 

provide broad discretionary authority to 

exclude conditions of use or exposure 

pathways from the scope of TSCA risk 

evaluations. 

EPA also cited TSCA section 9(b)(1) 

as support for its approach, asserting 

that the instruction in that provision for 

the Administrator to ‘‘coordinate actions 

taken under [TSCA] with actions taken 

under other Federal laws administered 

[by EPA]’’ provided a broad, 

freestanding authority to exclude from 

the scope of TSCA risk evaluations 

exposure pathways that are addressed or 

could in the future be addressed by 

other EPA-administered statutes and 

regulatory programs. See, e.g., Risk 

Evaluation for Methylene Chloride, 

section 1.4.2 (Ref. 13). EPA asserted that 

such exclusions from TSCA risk 

evaluations were also permitted under 

the remaining text of TSCA section 

9(b)(1), which establishes a process for 

determining whether to use EPAadministered authorities other than 

TSCA to protect against a risk ‘‘[i]f the 

Administrator determines that a risk to 

health or the environment associated 

with a chemical substance or mixture 

could be eliminated or reduced to a 

sufficient extent by actions taken under 

the authorities contained in such other 

Federal laws.’’ But upon 

reconsideration, neither provision in 

TSCA section 9(b)(1) is properly 

interpreted as authorizing exposure 

pathways to be excluded from TSCA 

risk evaluations. 

Intra-agency coordination is integral 

to ensuring that EPA actions are wellinformed, effective, and efficient, but a 

general requirement under TSCA 

section 9(b)(1) to ‘‘coordinate actions’’ 

cannot be read to displace the more 

specific requirements under TSCA 

section 6(b)(4)(F) to conduct a risk 

evaluation that shall ‘‘integrate and 

assess available information on hazards 

and exposures for the conditions of use 

of the chemical substance,’’ and ‘‘take 

into account . . . the likely duration, 

intensity, frequency, and number of 

exposures under the conditions of use of 

the chemical substance.’’ And the 

remaining text of TSCA section 9(b) is 

directed at risk management action, 

which cannot logically take place until 

after EPA has conducted an evaluation 

and determined that a risk is presented. 

If exposure pathways covered by other 

laws are not assessed in TSCA risk 

evaluations, it is unclear how the 

Administrator would have sufficient 

information to determine under TSCA 

section 9(b) that a risk to health or the 

environment associated with a chemical 

substance could be eliminated or 

reduced to a sufficient extent under 

another Federal law, or whether it is in 

the public interest to protect against 

such risk by actions taken under 

TSCA—a finding that must, pursuant to 

TSCA section 9(b)(2), consider ‘‘all 

relevant aspects of the risk.’’ Legislative 

history from TSCA’s original 1976 

enactment supports this understanding 

that TSCA section 9(b)—the text of 

which was at that time split between 

TSCA section 9(b) and TSCA section 

6(c) (pertaining to risk management 

rulemaking procedures)—is properly 

interpreted in the context of risk 

management action rather than any 

preceding evaluation of risk (Ref. 18). 

As explained in the Conference 

Committee’s 1976 report (Ref. 18) ‘‘the 

requirement to examine other EPA laws 

and to make determinations applies 

only when the Administrator takes 

regulatory action to protect against an 

unreasonable risk under this Act.’’ 

EPA recognizes that there may be 

exposure-reducing impacts from 

existing regulations and intends to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74300 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

consider reasonably available 

information when estimating exposures, 

including available monitoring data. 

There may also be circumstances where 

an unreasonable risk identified in the 

risk evaluation may be eliminated or 

reduced to a sufficient extent under the 

authorities contained in other Federal 

laws, such that a referral under TSCA 

section 9 might be appropriate. 

However, the mere existence of 

authority to assess or regulate a 

chemical, exposure pathway, or use 

under a statute other than TSCA does 

not equate to effective risk management 

of that chemical, exposure pathway or 

use, and an assumption that risk will— 

or could be—managed in the future 

cannot be used to satisfy the Agency’s 

statutory obligations to evaluate existing 

chemical substances under TSCA and 

manage identified risks. Wholesale 

exclusion of identified exposure 

pathways for a chemical substance from 

the scope of the TSCA risk evaluation 

for that substance is inconsistent with 

EPA’s obligations under TSCA section 

6(b)(4)(F), as noted, as well as with 

requirements under TSCA section 26(h), 

(i) and (k) to make decisions based on 

science that are consistent with the best 

available science and are based on the 

weight of the scientific evidence, and to 

take into consideration reasonably 

available information relating to a 

chemical substance, ‘‘including . . . 

exposure information,’’ under the 

conditions of use. Furthermore, TSCA 

section 9 already contemplates a time 

and place for determination of whether 

EPA or another Federal agency can 

adequately address chemical risks under 

the authority of another Federal law: 

during the risk management rulemaking 

process after the risk has been identified 

in a risk evaluation. 

Accordingly, EPA is proposing 

changes in the rule to ensure that risk 

evaluations include all relevant 

exposure pathways, thereby providing 

the basis for development of strong, 

scientifically and legally defensible 

regulatory protections. Specifically, EPA 

is proposing to explicitly require that 

each risk evaluation assess all exposure 

routes and pathways relevant to the 

chemical substance under the 

conditions of use, including those that 

are regulated under other Federal 

statutes. 

4. Comprehensive But Fit-For-Purpose 

While the changes described in Unit 

III.E.1. through 3. could all lead to 

future TSCA risk evaluations that are 

more comprehensive in scope, EPA 

recognizes the enormity of the challenge 

to complete these responsibilities 

within the timeframes set forth by 

Congress. The law provides the Agency 

with only 3 to 3.5 years to finalize a 

TSCA risk evaluation. The primary 

purpose of a TSCA risk evaluation is to 

support regulatory decision making— 

either to form the basis of a subsequent 

rulemaking to eliminate identified 

unreasonable risk under TSCA section 

6(a), or to determine that the chemical 

does not present unreasonable risk and 

therefore rulemaking is not necessary. 

Given the tens of thousands of existing 

chemicals, Congress further mandated 

that risk evaluations be completed on an 

ongoing basis and within specified 

timeframes. 

Risk evaluations under TSCA should 

not be so complex or procedurally 

cumbersome that they cannot reliably be 

completed within the timeframes 

required by the statute. At the same 

time, EPA cannot produce partial or 

incomplete TSCA risk evaluations or 

otherwise pursue risk evaluations in a 

manner that is incompatible with the 

statutory framework. Although EPA 

must balance resource expenditure and 

manageability, it must do so within the 

confines of its statutory mandate. As 

such, EPA is proposing some changes to 

the rule to ensure consistency with 

TSCA’s text, structure, and purpose, 

while also clarifying where the statute 

provides flexibilities in how EPA 

conducts TSCA risk evaluations. For 

example, the proposed rule makes clear 

that a risk evaluation must assess the 

full range of conditions of use and all 

exposure routes and pathways, and that 

a single risk determination will be made 

on the chemical substance, but these 

can be accomplished with a fit-forpurpose approach that allows for 

varying types and levels of analysis. 

In order for TSCA implementation 

efforts to be sustainable, risk evaluations 

must be fit-for-purpose such that the 

Agency meets both the substantive 

statutory and regulatory requirements 

for conducting risk evaluations, while 

completing those evaluations within the 

statutory deadlines. (15 U.S.C. 

2605(b)(4)). For example, while risk 

evaluations must consider the full 

spectrum of the chemical’s conditions of 

use, not all of those conditions of use 

will warrant the same level of 

evaluation. As described in the 2017 

final rule, EPA expects it may be able 

to complete its analysis on certain 

conditions of use and/or exposure 

pathways without extensive or 

quantitative evaluations of exposure. 

For example, lower-volume or less 

dispersive uses could receive less 

quantitative evaluations than uses with 

more extensive or complicated exposure 

patterns. In addition, not all identified 

toxicological endpoints may need the 

same level of analysis and 

consideration. Efficiencies may be 

gained in similarly tailoring approaches 

to peer review and/or systematic review. 

EPA can make scientifically sound risk 

determinations, considering reasonably 

available information, consistent with 

the best available science, and based on 

the weight of scientific evidence, 

through a combination of different types 

of information and risk assessment 

approaches. Ultimately, the proposed 

changes—TSCA risk evaluations that are 

both more comprehensive (e.g., that 

consider all exposure pathways) and 

better incorporate fit-for-purpose 

approaches that ensure EPA is meeting 

its statutory deadlines—will lead to 

more scientifically sound and legally 

defensible risk evaluations that support 

robust TSCA section 6(a) risk 

management rules that address any 

unreasonable risks of injury to human 

health or the environment. 

5. Additional Efficiencies 

Based on the Agency’s early 

implementation efforts and experience 

using the data gathering authorities 

afforded under the amended statute, it 

has become clear that EPA should 

identify, obtain, review, and synthesize 

data and information for risk 

evaluations much earlier in the TSCA 

existing chemical risk assessment and 

risk management process. Doing so will 

enable the Agency to finalize risk 

evaluations in the aggressive timeframes 

provided by the law, and as necessary, 

initiate risk management actions in a 

timely manner. EPA believes a more 

sustainable process would involve— 

either during prioritization or before— 

review of reasonably available 

information, identification of data needs 

and gaps, and preliminary efforts to 

scope the potential risk evaluation. 

Prioritization is the statutorily required 

initiating step in the TSCA existing 

chemical risk evaluation and risk 

management process. (15 U.S.C. 

2605(b)). This 9- to 12-month process 

includes a risk-based screening to 

ultimately designate a chemical 

substance as a high-priority substance 

for risk evaluations or low-priority 

substance for which a risk evaluation is 

not warranted at the time. In the interest 

of creating additional efficiencies, EPA 

is proposing a process in which the 

Agency would publish and take 

comment during prioritization on 

preliminary information to inform the 

scope of the potential risk evaluation, 

which may result in the publication of 

the ‘‘draft scope’’ before the initiation of 

the subsequent risk evaluation. 

More specifically, when early 

indications suggest the chemical is 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74301 

likely to meet the criteria for a highpriority designation, EPA expects to 

publish the draft scope for public 

comment, to correspond with one of the 

two statutorily required 90-day 

comment periods associated with 

prioritization. Publishing this 

information early will allow the Agency 

to give an early indication as to the 

conditions of use, hazards, exposures 

and potentially exposed or susceptible 

subpopulations that the Agency expects 

to consider and may provide early 

indications as to how the Agency 

expects to conduct a fit-for-purpose risk 

evaluation. This information will 

accompany the prioritization screening 

review criteria, and EPA will look to 

public comment and submission of 

available relevant data to inform both 

the final priority designation but also, if 

the chemical is then designated as a 

high priority, the information to inform 

the scope. 

As the first statutorily required step of 

the risk evaluation process, TSCA 

requires the Agency to publish the 

scope of the risk evaluation no later 

than 6 months after initiating the risk 

evaluation. (15 U.S.C. 2605(b)(4)(D)). 

This scope must include the hazards, 

exposures, conditions of use, and the 

potentially exposed or susceptible 

subpopulations the Administrator 

expects to consider. Under the 2017 

final rule, however, EPA must publish 

the scope in a ‘‘draft’’ form, followed by 

no less than a 45-day public comment 

period. The 2017 final rule states that 

the Agency generally expects to publish 

this draft no later than 3 months after 

initiation of the risk evaluation. 

Stakeholders supported this provision 

during the development of the 2017 

proposed rule; due to the gravity of the 

‘‘final’’ scope on the risk evaluation 

process and possible state preemption, 

it was important for stakeholders to 

have the ability to comment on the draft 

scope. The proposed rule would 

maintain the requirement to publish a 

draft scope but set forth an expectation 

to publish the information as early as 

the prioritization process (e.g., 

concurrent with the proposed highpriority designation), to allow the 

Agency more time to review and 

effectively use the public input in the 

development of the risk evaluation’s 

scope. EPA requests comment on this 

proposed approach of publishing a draft 

scope during the prioritization process 

when it is clear that the chemical 

undergoing the prioritization process 

will be designated as a high-priority 

chemical. 

F. Risk Determinations 

1. Determinations on the ‘‘Chemical 

Substance’’ 

EPA is proposing to clarify the 

regulations with respect to the way EPA 

makes a risk determination at the 

conclusion of the TSCA risk evaluation 

process. As described earlier, EPA 

believes, as supported by the plain 

language in the law, that the chemical’s 

full spectrum of conditions of use must 

be included and assessed in the risk 

evaluation. EPA fully intends to 

continue to consider exposures 

associated with each condition of use. 

However, following that analysis, and 

for the reasons described in this Unit, 

the Agency no longer intends to make 

separate risk determinations for 

individual conditions of use. Instead, 

EPA is proposing changes to the 

regulations to clarify and codify the 

approach that the Agency originally 

proposed in the 2017 proposed rule (i.e., 

to make a single risk determination on 

the whole chemical substance). EPA 

believes that this approach is consistent 

with the statutory text and structure, as 

well as Congressional intent, and will 

enable the Agency’s risk determinations 

to better reflect the potential for 

combined exposures across multiple 

conditions of use. 

In the 2017 proposed rule, EPA 

proposed that risk determinations be 

made on the ‘‘chemical substance,’’ 

consistent with the plain language of the 

law and Agency’s interpretation of the 

new requirements in TSCA at that time. 

(Ref. 9 at pp. 7572, 7565 through 7566, 

and 7580). As described in the 

preamble, ‘‘TSCA section 6(b)(4)(A) 

specifies that a risk evaluation must 

determine whether ‘a chemical 

substance’ presents an unreasonable risk 

of injury to health or the environment 

‘under the conditions of use.’ The 

evaluation is on the chemical 

substance—not individual conditions of 

use—and it must be based on ‘the 

conditions of use.’ ’’. Thus, in the 2017 

proposed regulatory text, EPA proposed 

to determine whether the chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

under the conditions of use. (Ref. 9 at 

p. 7480). 

The 2017 proposed rule provided an 

exception that would allow EPA to 

make an ‘‘early determination’’ for a 

specific use that was deemed to present 

unreasonable risk. Where such an early 

determination was made, the risk 

management efforts to address that 

specific use could begin more 

expeditiously and not wait until the end 

of the 3 to 3.5 year risk evaluation 

process (Ref. 8 at pp. 7568 and 7578). 

EPA did not propose a similar process 

for use-specific early determinations of 

no unreasonable risk. This exception 

made logical sense, in that, if a specific 

use of a chemical—in isolation— 

presented an unreasonable risk under 

TSCA, that chemical itself would 

necessarily present an unreasonable risk 

irrespective of risks posed by other uses. 

The converse may not be true. Where a 

specific use might not present an 

‘‘unreasonable risk’’ on its own, it may 

nonetheless contribute to an 

unreasonable risk determination when 

considered together with other uses of 

the chemical (e.g., when considering it 

in an aggregate exposure scenario). 

EPA received comment on the 2017 

proposed rule that limiting ‘‘early 

determinations’’ only to uses that 

present unreasonable risk was unfair, 

and encouraged the Agency to extend 

this concept of early, use-specific risk 

determinations to those uses determined 

not to present unreasonable risk. The 

2017 final rule stated that ‘‘EPA will 

determine whether the chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

under each condition of uses [sic] 

within the scope of the risk evaluation, 

either in a single decision document or 

in multiple decision documents’’ (Ref. 

1). There was one particular passage in 

the preamble to the 2017 final rule 

which stated that EPA would make 

individual risk determinations for all 

conditions of use identified in the 

scope. (Ref. 1 at p. 33744). 

Concerns about a use-specific 

approach to risk determinations were 

raised as part of litigation on the final 

rule in Safer Chemicals v. EPA (Ref. 2 

at p. 413), including that such an 

approach ignores the potential risks 

when the same individuals are exposed 

to the same chemical through multiple 

conditions of use (e.g., in the workplace 

and in the home). Those exposures, 

when combined, may present 

unreasonable risk, whereas, when 

viewed in isolation, may not. A panel of 

the Ninth Circuit Court of Appeals 

recognized the ambiguity of the 

regulation on this point, and ultimately 

held that a challenge regarding ‘‘use-byuse risk evaluations [was] not justiciable 

because it is not clear, due to the 

ambiguous text of the Risk Evaluation 

Rule, whether the Agency will actually 

conduct risk evaluations in the manner 

Petitioners fear’’ (Ref. 2 at p. 413). 

Subsequent to the Ninth Circuit’s 

decision, EPA made individual risk 

determinations for each condition of use 

evaluated in the first ten risk 

evaluations (i.e., the condition of usespecific approach to risk 

determinations). That approach was 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74302 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

based on the particular passage in the 

preamble to the 2017 final rule stating 

that EPA would make individual risk 

determinations for all conditions of use 

identified in the scope. (Ref. 1 at p. 

33744). The approach resulted in a mix 

of findings that certain conditions of use 

for a chemical ‘‘present unreasonable 

risk’’ while others ‘‘do not present 

unreasonable risk.’’ 

As announced in June 2021 as the 

path forward for the first ten risk 

evaluations, EPA has revisited this 

decision and determined to revise the 

use-specific risk determinations for 

most of the first ten chemicals to reflect 

a single determination on the chemical 

substance itself (Ref. 7). These revisions 

did not require the Agency to change 

any of its underlying analyses in the risk 

evaluations. In the case of many of these 

first 10 chemicals, EPA had already 

determined that many or most of the 

individual conditions of use presented 

an unreasonable risk. 

In revising the risk determinations for 

the first 10 chemicals, EPA noted that in 

contrast to the portion of the preamble 

of the 2017 final rule that discusses the 

intent of the Agency to make multiple 

risk determinations, the regulatory text 

itself and other statements in the 

preamble reference a risk determination 

for the chemical substance under its 

conditions of use, rather than separate 

risk determinations for each of the 

conditions of use of a chemical 

substance. See for example, the revised 

risk determination for Methylene 

Chloride (Ref. 13). Notwithstanding the 

one preambular statement about 

condition of use-specific risk 

determinations, the preamble to the 

2017 final rule also contains support for 

a risk determination on the chemical 

substance as a whole. 

Although the Agency indicated in its 

June 2021 announcement that it would 

make a single risk determination on a 

chemical when it was ‘‘clear that 

majority of conditions of use warrant 

one determination,’’ EPA now believes 

a better understanding of the statute is 

that a single determination on the 

chemical substance is required in every 

instance, and is proposing to make this 

clear in this procedural rule. TSCA 

section 6(b)(4)(A) specifies that in a risk 

evaluation, EPA must determine 

whether ‘‘a chemical substance’’ 

presents an unreasonable risk of injury 

to health or the environment ‘‘under the 

conditions of use.’’ This language 

clarifies that the risk determination is 

on the chemical substance—not 

individual conditions of use—and it 

must be based on ‘‘the conditions of 

use.’’ 

Although EPA previously found 

ambiguity in TSCA section 6(b)(4)(A), it 

now believes that a better reading of the 

statute in light of its content and 

structure (and other reasons described 

in this paragraph) is that it requires EPA 

to simultaneously evaluate all 

conditions of use of a chemical 

substance. TSCA section 6(a) requires 

EPA to apply risk-management 

requirements ‘‘to the extent necessary so 

that the chemical substance or mixture 

no longer presents such risk.’’ This 

phrasing suggests that the chemical 

substance presents the unreasonable 

risk, and not specific conditions of use. 

Further, TSCA section 6(i)(1) explains 

that ‘‘a determination by the 

Administrator under subsection 

(b)(4)(A) that a chemical substance does 

not present an unreasonable risk of 

injury to health or the environment 

shall be issued by order and considered 

to be a final agency action, effective 

beginning on the date of issuance of the 

order.’’ Similarly, TSCA section 6(i)(2) 

explains that ‘‘a final rule promulgated 

under subsection (a), including the 

associated determination by the 

Administrator under subsection 

(b)(4)(A) that a chemical substance 

presents an unreasonable risk of injury 

to health or the environment, shall be 

. . . a final agency action, effective 

beginning on the date of promulgation 

of the final rule.’’ Both of these 

provisions speak in terms of whether 

the chemical substance presents 

unreasonable risk. Neither provision 

mentions the conditions of use. The 

structure of TSCA section 6(i) also 

implies a binary decision by not 

addressing a scenario in which a 

chemical substance would be subject to 

TSCA section 6(i)(1) and (2). 

EPA’s view that there should be one 

determination on the chemical 

substance is further bolstered by TSCA’s 

preemption provisions at Section 18, 

and its numerous references to 

‘‘chemical substance.’’ In TSCA section 

18(a)(1)(B)—titled ‘‘Chemical substances 

found not to present an unreasonable 

risk or restricted’’—the law states that 

preemption applies, for example, when 

EPA issues ‘‘the determination’’ in 

TSCA section 6(i)(1) (i.e., a 

determination that the chemical 

substance does not present an 

unreasonable risk). EPA notes in 

particular that the word 

‘‘determination’’ in this provision is 

singular, suggesting Congress did not 

envision multiple determinations under 

TSCA section 6(i)(1). Additionally, 

TSCA section 18(a)(1)(B)(ii) states that 

permanent preemption is triggered by a 

final TSCA section 6(a) risk 

management rule for ‘‘the chemical 

substance,’’ suggesting again that 

Congress did not envision that TSCA 

section 6(a) risk management rules 

would address only risks presented by 

individual uses or some subset of a 

chemical’s uses, but rather unreasonable 

risk presented by the chemical as a 

whole. 

Based on its text and structure, EPA 

now reads TSCA as requiring the 

Agency, in each risk evaluation, to make 

a single risk determination of the 

chemical substance. EPA does not 

believe that the statutory text and 

structure permit the Agency to make 

separate risk determinations for each 

condition of use. The legislative history 

also tends to favor this reading, 

including Congressional floor 

statements made on the day of passage 

supporting the risk determination being 

for the chemical substance. ‘‘. . . EPA’s 

understanding of a chemical’s 

conditions of use . . . will be critical to 

EPA’s final determination of whether a 

chemical is safe or presents an 

unreasonable risk that must be 

controlled’’ and S3520 ‘‘A Section 6(i) 

order, determining that a chemical 

substance does not present an 

unreasonable risk under conditions of 

use, is similarly final Agency action 

applicable to all those conditions of use 

that were identified in the scope of 

EPA’s risk evaluation on the chemical 

substance’’).’’ (Ref. 11). 

Although the Agency has previously 

referred to this as a ‘‘whole chemical’’ 

approach, this descriptor may have 

created some confusion regarding the 

Agency’s intent and purpose. EPA 

believes that a more accurate 

description of the approach is simply 

one where the Agency makes its risk 

determination for the chemical 

substance. A determination that a 

chemical substance presents an 

unreasonable risk does not mean that 

the entirety or whole of that chemical’s 

uses—or even a majority of uses— 

presents an unreasonable risk. Rather, 

EPA may determine that a chemical 

substance presents an unreasonable risk 

based on risk associated with even a 

single condition of use. 

Some have criticized this approach in 

public comments on the revised risk 

determinations. They have noted, for 

example, that a singular risk 

determination could create confusion as 

to whether all uses or only certain uses 

of a chemical pose unreasonable risk. 

Fundamentally, EPA believes these 

concerns are risk communication issues 

that the Agency can and intends to 

continue to improve on. EPA will in 

every risk evaluation provide a rationale 

and explanation as to which conditions 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74303 

of use or exposure pathways are 

significant contributors to risk. The 

Agency is committed to clearly 

communicating on the Agency’s 

analysis of particular uses within the 

risk evaluation and will not make 

statements about the risk associated 

with the chemical substance absent 

such explanation. Rather, as indicated 

in the proposed regulatory text at 40 

CFR 702.37(a)(5), and in order to inform 

risk management requirements, EPA 

generally expects every risk 

determination to identify which 

conditions of use are—or are not— 

significant contributors to EPA’s 

determination that the risk presented is 

unreasonable. That said, for those 

chemical substances that EPA 

determines present unreasonable risk, 

the risk evaluation is not the end of the 

TSCA process. The primary purpose of 

a risk evaluation is not to provide the 

public with guidance or suggested 

actions with respect to particular 

chemical uses. Risk evaluations are 

scientific documents intended to inform 

EPA decisions as to whether regulatory 

action is needed to address 

unreasonable risks to human health or 

the environment. Ultimately, when the 

TSCA existing chemicals review 

process—including any TSCA section 

6(a) rulemaking to manage risk—is 

complete, the public should have full 

confidence that the chemical can only 

be manufactured, processed, distributed 

in commerce, used and disposed of in 

accordance with the associated risk 

management requirements, and that the 

chemical substance no longer presents 

an unreasonable risk. 

Likewise, others have expressed 

concern that EPA will use a singular 

risk determination to regulate in an 

overly broad manner. A determination 

of unreasonable risk for a chemical 

substance does not mean that EPA will, 

by default, propose or finalize a section 

6(a) risk management rule requiring all 

manufacture or use of the chemical 

substance to be banned. EPA’s statutory 

authority to regulate chemicals under 

TSCA section 6 is available only ‘‘to the 

extent necessary so that the chemical 

substance or mixture no longer presents 

[unreasonable] risk.’’ (15 U.S.C. 

2605(a)). EPA has a range of authorities 

available under TSCA section 6(a) to 

address unreasonable risk, including— 

but not limited to—requiring additional 

occupational safety measures, product 

labels, or concentration limits. Where 

such measures can eliminate 

unreasonable risk, EPA may propose 

them as part of the risk management 

rulemaking process. EPA’s 

determination of appropriate regulatory 

requirements will be on a case-by-case 

basis, and will not regulate chemical 

substances in a manner that is 

inconsistent with the requirements of 

TSCA sections 6(a) and (c)(2). For 

example, EPA may derive an exposure 

limit in the risk evaluation. Such a limit 

would necessarily be based solely on 

risk-related information, adhering to the 

statutory directive not to consider costs 

or other non-risk factors during the risk 

evaluation. However, because EPA is 

required to consider costs and other 

non-risk factors during the risk 

management phase, including whether 

uses of a substance are critical to 

Federal mission needs, or whether 

alternatives for a use of a substance 

exist, the exposure limit presented in a 

risk evaluation may not always or 

automatically signal the manner in 

which EPA will regulate occupational 

risks during the risk management phase. 

It is important to note, however, in 

exercising EPA’s authority under TSCA 

section 6(a) to ensure that ‘‘the chemical 

substance . . . no longer presents such 

risk,’’ EPA may regulate conditions of 

use that do not themselves contribute to 

unreasonable risk for a given chemical. 

For example, where a risk evaluation’s 

underlying analysis suggests that 

particular use downstream in the supply 

chain is significantly contributing to 

unreasonable risk determination for the 

chemical substance, EPA’s risk 

management actions need not apply 

only to the downstream use. EPA may, 

for example, determine that elimination 

of the unreasonable risk requires 

regulation of the chemical’s upstream 

manufacture, processing or distribution 

in commerce—even where the upstream 

activity itself does not directly result in 

the exposures that present the 

unreasonable risk. 

EPA considered whether to repropose a process for making usespecific early determinations of 

unreasonable risk prior to completing 

the risk evaluation for the remaining 

conditions of use, as contemplated in 

the original 2017 proposed rule. 

However, based on experience in 

conducting risk evaluations on the first 

10 chemicals and implementing the new 

requirements in TSCA section 6, the 

notion of early, use-specific risk 

determinations is not practical or 

realistic within the statutory deadlines. 

The theoretical benefit of such an 

approach—enabling the early start of 

risk management efforts for the subset of 

uses that are clearly of highest risk—is 

outweighed by the burdens of managing 

the completion of multiple risk 

evaluation processes on a single 

chemical followed by potentially 

multiple rulemakings, each of which 

must comply with statutory deadlines. 

In the event that there is a known, 

imminent and unreasonable risk of 

serious or widespread injury to health 

or the environment (i.e., imminent 

hazard) associated with a use or 

chemical that the Agency needs to 

address immediately, TSCA section 7 

provides EPA the authority to take such 

immediate action. 

EPA believes the approach, consistent 

with the 2017 proposed rule, (i.e., to 

make a single risk determination on the 

chemical substance) is aligned with the 

statutory text and structure, and will 

ensure that the Agency is best 

positioned to incorporate reasonably 

available information, make 

determinations consistent with the best 

available science and based on the 

weight of scientific evidence, including, 

where appropriate, risk determinations 

that consider aggregate exposure 

resulting from multiple conditions of 

use. (15 U.S.C. 2625(h), (i), and (k)). As 

such, EPA is proposing that risk 

evaluations will always culminate in a 

single risk determination on the 

‘‘chemical substance’’ instead of 

individual risk determinations on 

individual conditions of use. EPA is 

proposing related conforming changes 

throughout the regulatory text, 

including the proposed addition of 

702.37(a)(5) and the explicit mention of 

a single determination in 702.39(f)(1). 

2. ‘‘Unreasonable Risk’’ Considerations 

TSCA requires that a risk evaluation 

include a determination of whether or 

not a chemical presents unreasonable 

risk, and further requires that this 

determination be independent of cost or 

other non-risk factors. (15 U.S.C. 

2506(b)(4)(A) and (F)(iii)). Neither TSCA 

nor the 2017 final rule define 

‘‘unreasonable risk’’ given the 

inherently unique nature of each risk 

evaluation and the need for EPA to 

make this determination on a case-bycase basis. As described in the preamble 

to the 2017 final rule (Ref. 1 at p. 

33735), EPA may weigh a variety of 

factors in determining unreasonable 

risk. The Administrator will consider 

relevant factors including, but not 

limited to: The effects of the chemical 

substance on health and human 

exposure to such substance under the 

conditions of use (including cancer and 

non-cancer risks); the effects of the 

chemical substance on the environment 

and environmental exposure under the 

conditions of use; the population 

exposed (including any susceptible 

subpopulations), the severity of hazard 

(the nature of the hazard, the 

irreversibility of hazard), and 

uncertainties. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74304 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

The 2016 amendments also required 

that EPA’s determination of 

unreasonable risk consider the risks to 

potentially exposed or susceptible 

subpopulations. Where EPA identifies 

risks as part of the risk evaluation, the 

risks to a potentially exposed or 

susceptible population may be more 

significant or severe than the risks to the 

general population. EPA would more 

explicitly reflect this statutory 

requirement in proposed § 702.39(f), as 

the 2017 final rule did not explicitly 

reference the statutory requirement to 

consider the risk to potentially exposed 

or susceptible subpopulations when 

making the final risk determination. 

Additionally, as discussed more fully in 

Unit III.G.4., the proposed rule clarifies 

that ‘‘overburdened communities’’ are 

one example of a group that may be 

considered as potentially exposed or 

susceptible subpopulations within a 

given risk evaluation. ‘‘Overburdened 

communities’’ may include various 

populations or communities in the 

United States that potentially 

experience disproportionate 

environmental harms and risks or 

multiple burdens from chemical 

exposure. The proposed change clarifies 

that EPA will consider the risk to 

potentially exposed or susceptible 

subpopulations as part of its 

determination of whether or not the 

chemical presents unreasonable risk. 

Likewise, and as discussed further in 

Units III.G.2. and 3., EPA’s 

determination of unreasonable risk from 

the chemical substance will also 

consider, where relevant, the Agency’s 

analyses on aggregate exposures and 

cumulative risk. For example, where a 

single population is exposed to a 

chemical through multiple routes or 

pathways, EPA’s assessment of those 

aggregate exposures may inform the 

determination of whether that chemical 

presents an unreasonable risk. 

Similarly, a cumulative risk assessment 

may be conducted on a category of 

chemicals, where the science supports 

this type of assessment, and the findings 

may inform the unreasonable risk 

determination for the category. 

G. Risk Evaluation Considerations 

1. Occupational Exposure Assumptions 

EPA is proposing some clarifications 

to the assumptions that it will and will 

not apply in risk evaluations related to 

worker exposure. 

In carrying out the first ten TSCA 

chemical risk evaluations, as part of the 

unreasonable risk determinations, EPA 

assumed that workers were provided 

and always used personal protective 

equipment (PPE) in a manner that 

achieves the stated assigned protection 

factor (APF) for respiratory protection, 

or used impervious gloves for dermal 

protection. In support of this 

assumption, EPA relied on public 

comments indicating that some 

employers, particularly in the industrial 

setting, provide PPE to their employees 

and follow established worker 

protection standards (e.g., OSHA 

requirements for protection of workers). 

As EPA noted in prior risk evaluations 

(e.g., Risk Evaluation for Methylene 

Chloride (Dichloromethane, DCM), 126 

(Ref. 13 at p. 126), the consideration of 

assumed use of PPE in a risk 

determination could lead to an 

underestimation of the risk to workers. 

Further, parties in litigation as well as 

public commenters on several TSCA 

risk evaluations argued that making risk 

determinations based on assumptions of 

PPE conflates the risk evaluation and 

risk management phases. In June 2021, 

the Agency announced it would be 

revisiting the risk determinations that 

were based on these assumptions and 

noted its plans to consider information 

on use of PPE and other ways industry 

protects its workers during the risk 

management process (Ref. 7). 

TSCA requires that EPA evaluate the 

chemical substance under the intended, 

known, or reasonably foreseen 

circumstances associated with the 

chemical’s manufacture, processing, 

distribution in commerce, use and 

disposal. EPA believes that the blanket 

occupational exposure assumptions on 

PPE do not reflect the known or 

reasonably foreseen chemical exposures 

that impact workers, and their 

continued application in TSCA risk 

evaluations would result in 

underestimates of risk. For example, 

workers may be highly exposed because 

they are not covered by Occupational 

Safety and Health Administration 

(OSHA) standards, their employers are 

out of compliance with OSHA 

standards, or because the PPE is not 

sufficient to address the risk or their 

PPE does not fit or function properly. 

Further, many of OSHA’s chemicalspecific permissible exposure limits 

were largely adopted in the 1970s and 

have not been updated since they were 

established (Ref. 19). Additionally, 

TSCA risk evaluations are subject to 

statutory science standards, an explicit 

requirement to consider risks to 

potentially exposed or susceptible 

subpopulations, and a prohibition on 

considering costs and other non-risk 

factors when determining whether a 

chemical presents an unreasonable risk 

that warrants regulatory actions—all 

requirements that do not apply to 

development of OSHA regulations. As 

such, EPA may find unreasonable risk 

for purposes of TSCA notwithstanding 

OSHA requirements. Where risk 

evaluations assume fully protective PPE 

use, and therefore little or no exposures 

for workers, the risk evaluations may 

underestimate and/or fail to identify 

unreasonable risk. EPA is requesting 

public comment on how the Agency can 

provide a transparent and detailed basis 

for the proposed unreasonable risk 

determination and existing chemical 

exposure limits derived from the risk 

evaluation process. 

EPA is not suggesting that there is 

widespread non-compliance with 

applicable OSHA standards. In fact, 

EPA has received public comments from 

industry in response to various EPA 

documents associated with TSCA risk 

evaluations about occupational safety 

practices currently in use at their 

facilities, including adherence to OSHA 

standards and non-OSHA industry 

guidelines. EPA also acknowledges that 

other Federal agencies and their 

contractors that use chemicals may 

similarly have well-established 

occupational control measures in place. 

EPA will consider comments received 

during the risk evaluation process, as 

well as other information on use of PPE 

and other ways industry and Federal 

agencies protect their workers, as 

potential ways to address unreasonable 

risk during the risk management 

process. EPA recognizes that in some 

instances and in certain workplace 

locations, particularly advanced 

manufacturing facilities (e.g., those 

involved in the aerospace and defense 

industrial base industrial sectors) there 

could be well-established occupational 

safety protections in place. As EPA 

moves forward with risk management 

rules, the Agency will strive for 

consistency with existing OSHA 

requirements and/or best industry 

practices when those measures would 

address the identified unreasonable risk 

and would adopt a similar approach 

when making decisions about managing 

risks for uses of chemicals that are 

required to meet national security and 

critical infrastructure mission 

imperatives for other Federal agencies. 

EPA will proactively communicate with 

Federal agencies to identify such 

circumstances with an aim to propose 

measures in the risk management 

process to address occupational risk that 

will meet TSCA’s statutory requirement 

to eliminate unreasonable risk of injury 

to health and the environment, while 

also leveraging ongoing interagency 

dialogue and striving to avoid potential 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74305 

impacts to mission and infrastructure 

critical uses. 

EPA is proposing regulatory 

amendments to clarify that, in future 

risk evaluations, EPA’s consideration of 

occupational exposure scenarios in the 

exposure assessments will take into 

account reasonably available 

information, including information 

regarding known and reasonably 

foreseen circumstances where 

subpopulations of workers are exposed 

due to absence or ineffective use of 

personal protective equipment. The EPA 

intends to assess and include in the risk 

evaluation the use of PPE, any 

engineering controls, and other 

industrial hygiene practices at 

industrial, commercial, and Federal 

facilities. Where information is made 

available, the Agency will take into 

account known occupational control 

measures in the exposure assessments. 

However, the Agency will not consider, 

as part of the unreasonable risk 

determination, exposure reduction 

based on assumed use of PPE by 

workers. For purposes of the risk 

determination at § 702.39(f)(2), EPA 

would distinguish between an 

‘‘assumed’’ use of PPE and a use that is 

supported by the reasonably available 

information and therefore known to be 

inherent in the performance of an 

activity. For example, where EPA has 

reasonably available information that 

substantiates use and effectiveness of 

PPE (e.g., information demonstrating 

that performance of a condition of use 

is impossible in the absence of PPE), 

EPA generally expects to take that 

information into account in the risk 

determination. The exposure reduction 

information (e.g., use of PPE) from the 

risk evaluation’s exposure assessment 

would then be considered and 

incorporated in a future risk 

management action, as appropriate and 

as required pursuant to TSCA section 

6(a), and we encourage commenters 

with interests or concerns on this to 

offer comments on this point in 

connection with such a future action. 

2. Aggregate Exposure 

Pursuant to TSCA section 

6(b)(4)(F)(ii), when conducting a risk 

evaluation, EPA must ‘‘describe whether 

aggregate or sentinel exposures to a 

chemical substance under the 

conditions of use were considered, and 

the basis for that consideration.’’ While 

there is no mandate to conduct 

aggregate exposure analyses, EPA may 

conduct aggregate exposure analyses at 

its discretion. In the 2017 final rule EPA 

defined aggregate exposure as ‘‘the 

combined exposures to an individual 

from a single chemical substance across 

multiple routes and across multiple 

pathways.’’ In this proposed rule, EPA 

is proposing slight revisions to the 

definition. Aggregate exposure analysis 

is not only used to assess exposure to 

an individual, but may also be used to 

assess exposure for a population, 

subpopulation or the environment. 

Thus, EPA is proposing to strike ‘‘to an 

individual’’ from the definition, which 

is consistent with the definition used in 

General Principles for Performing 

Aggregate Exposure and Risk 

Assessments (Ref. 20). Additionally, 

EPA is proposing to strike ‘‘single’’ 

chemical, as TSCA allows the Agency to 

conduct risk evaluations on categories 

of chemicals. 

The consideration of an aggregate 

exposure assessment may be 

particularly important for assessing 

chemical risks to overburdened 

communities. If a community is exposed 

to a chemical substance through 

multiple routes and/or pathways (e.g., 

exposure via air, land, and water or 

exposure via drinking water and water 

recreation) and/or from multiple sources 

(e.g., through different conditions of use 

occurring at multiple facilities), the 

Agency has the authority to aggregate 

those exposures, subject to the best 

available science standard, per TSCA 

section 26(h). Not only does the Agency 

have the authority, but in developing a 

comprehensive risk estimate for a 

chemical substance, it is the Agency’s 

responsibility to consider the 

aggregation of what may be lower 

individual exposures from individual 

conditions of use and routes of 

exposure. EPA is committed to 

conducting an aggregate assessment, as 

supported by the science, in future 

TSCA risk evaluations. In an aggregate 

exposure assessment, it may be 

appropriate to also consider potential 

background exposures from non-TSCA 

uses that are not within the scope of the 

risk evaluation. EPA could also consider 

the disproportionate impacts that 

background exposures may have on 

overburdened communities to inform 

the final unreasonable risk 

determination. 

3. Cumulative Risk 

Advancing the science to support 

cumulative risk assessment is a high 

priority for the Agency. Cumulative risk 

assessment is applicable to all lifestages, 

and could inform the Agency’s efforts to 

understand and mitigate those risks to 

potentially exposed or susceptible 

subpopulations, including children and 

overburdened communities. Several 

reports from the National Research 

Council (NRC)—including the 1994 

report Science and Judgment in Risk 

Assessment (Ref. 21) the 2008 report 

Phthalates and Cumulative Risk 

Assessment: The Tasks Ahead (Ref. 22), 

and the 2009 report Science and 

Decisions: Advancing Risk Assessment 

(Ref. 23)—have highlighted the 

importance of understanding the 

combined risk from multiple chemical 

stressors. These reports, as well as 

statutory requirements such as those 

presented in the Food Quality 

Protection Act of 1996 (Ref. 24), have 

helped drive EPA’s evolving work on 

cumulative risk assessment. Because 

individuals are co-exposed to many 

chemicals in their daily lives, some of 

which may have the same health effects, 

EPA believes that in some cases the best 

approach to assess risk to human health 

may be to look at the combined risk to 

health from multiple chemicals. 

Although TSCA does not mandate 

that EPA must conduct cumulative risk 

assessments, TSCA does require that 

EPA, when conducting TSCA risk 

evaluations in 3 to 3.5 years (15 U.S.C. 

2605(b)(4)(G)), consider the reasonably 

available information, consistent with 

the best available science, and make 

decisions based on the weight of the 

scientific evidence (15 U.S.C. 2625(h), 

(i), and (k)). EPA recognizes that for 

some chemical substances undergoing 

risk evaluation, the best available 

science may indicate that the 

development of a cumulative risk 

assessment is appropriate to ensure that 

risk to human health and the 

environment is adequately 

characterized. TSCA also gives the 

Agency the authority to consider the 

combined risk from multiple chemical 

substances or a category of chemical 

substances. (15 U.S.C. 2625(c)). Under 

TSCA section 26(c), EPA may take ‘‘any 

action authorized’’ under any provision 

of TSCA, in accordance with that 

provision with respect to a category of 

chemical substances or mixtures of 

chemical substances. TSCA defines 

‘‘category of chemical substances’’ as a 

group of chemical substances the 

members of which are similar in 

molecular structure, in physical, 

chemical, or biological properties, in 

use, or in mode of entrance into the 

human body or into the environment, or 

the members of which are in some other 

way suitable for the classification as 

such for purposes of [TSCA].’’ (15 

U.S.C. 2625(c)). This definition provides 

EPA with the flexibility to group 

chemical substances for inclusion in a 

risk evaluation and a cumulative risk 

assessment when supported by the best 

available science. 

There are multiple definitions of the 

term ‘‘cumulative risk assessment.’’ For 

TSCA risk evaluations, the Agency is 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74306 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

currently relying on the definition in 

EPA’s Framework for Cumulative Risk 

Assessment that defines cumulative risk 

assessment as ‘‘an analysis, 

characterization, and possible 

quantification of the combined risks to 

health and/or the environment from 

multiple agents and/or stressors’’ (Ref. 

25). This could include evaluation of 

multiple chemical substances that 

jointly exert a common toxic effect. 

Exposures to these chemicals could 

occur through multiple exposure 

pathways and through multiple routes 

of exposure. EPA expects to use 

available EPA (Refs. 26, 27, 28, 29), 

OECD (Ref. 30), and World Health 

Organization/International Programme 

on Chemical Safety (WHO/IPCS) (Ref. 

31) guidances that outline two principal 

considerations for grouping chemicals 

for inclusion in a cumulative risk 

assessment: (1) Toxicologic similarity; 

and (2) Evidence of co-exposure over a 

relevant timeframe. 

A risk evaluation on a single chemical 

may not accurately provide a complete 

understanding of the risks to an exposed 

population, given simultaneous 

exposure to multiple chemicals. In turn, 

without considering the cumulative risk 

of chemicals, the Agency’s risk 

mitigation may not fully be able to 

consider the public-health implications 

of various risk management options for 

reducing exposure. EPA is committed to 

considering applying cumulative risk 

assessment approaches, as appropriate 

and where such analysis, based on 

reasonably available information, 

represents the best available science, for 

future chemicals undergoing risk 

evaluation. The Agency developed and 

released a Draft Proposed Principles of 

Cumulative Risk Assessment Under the 

Toxic Substances Control Act (Ref. 32) 

and Draft Proposed Approach for 

Cumulative Risk Assessment of HighPriority Phthalates and a Manufacturer 

Requested Phthalate Under the Toxic 

Substances Control Act (Ref. 33) for 

public comment and peer review in 

February 2023. The Agency is 

considering feedback from both 

stakeholders and peer reviewers and 

EPA will continue to develop robust 

methodology for the inclusion of 

cumulative risk assessment in TSCA 

risk evaluations. EPA seeks comment on 

how the Agency could incorporate 

provisions for cumulative risk 

assessment into our risk evaluation 

procedures in a way that would 

accommodate future advancements in 

the science of cumulative risk 

assessment as well as ensure that the 

scope and complexity of any such 

assessments is consistent with that 

envisioned by Congress when it 

established deadlines for conducting 

risk evaluations. 

As described in Unit III.G.4., TSCA 

also explicitly requires EPA’s risk 

evaluations to consider unreasonable 

risk to ‘‘potentially exposed or 

susceptible subpopulations,’’ and the 

statute provides authority to consider 

non-chemical as well as chemical 

stressors when identifying these 

subpopulations. Non-chemical stressors 

are factors found in the built, natural, 

and social environments including 

physical factors (e.g., geographic 

location) and psychosocial factors (e.g., 

poor nutrition) (Ref. 34). EPA’s Office of 

Research and Development has defined 

cumulative impacts as the totality of 

exposures to combinations of chemical 

and non-chemical stressors and their 

effects on health, well-being, and 

quality of life outcomes (Ref. 34) and 

may or may not include toxicologically 

defined risk. EPA has not to date 

considered cumulative impacts in TSCA 

risk evaluations, but may in the future 

as appropriate data, methods, and 

guidance are available. 

4. Potentially Exposed or Susceptible 

Subpopulations 

TSCA requires EPA to evaluate risk to 

‘‘potentially exposed or susceptible 

subpopulation[s]’’ identified as relevant 

to the risk evaluation by the 

Administrator, under the conditions of 

use. (15 U.S.C. 2605(b)(4)(A)). TSCA 

defines the term as ‘‘a group of 

individuals within the general 

population identified by the 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, or the elderly.’’ (15 U.S.C. 

2602(12)). TSCA does not further define 

‘‘greater susceptibility’’ or ‘‘greater 

exposure,’’ giving the Agency discretion 

to interpret these terms. Greater 

susceptibility could include increased 

risk of experiencing an adverse effect 

due to one’s lifestage or a pre-existing 

condition or circumstance (e.g., 

immune-compromised conditions, 

lifestyle factors such as smoking status 

or alcohol abuse, age, ethnicity, or sex). 

This is consistent with EPA’s Policy on 

Children’s Health to protect children 

from environmental exposures by 

consistently and explicitly considering 

early life exposures and lifelong health 

in all human health decisions. The 

Agency will use its discretion and 

interpret ‘‘greater exposure’’ to 

potentially include fenceline 

communities (e.g., those communities in 

close proximity to facilities emitting air 

pollutants or living near effluent 

releases to water) or body burden. 

Additionally, Congress’ inclusion of 

‘‘such as’’ allows EPA to potentially 

identify communities who ‘‘may be at 

greater risk than the general 

population.’’ Thus, EPA may evaluate 

any subpopulation that may be at 

greater risk due to greater susceptibility 

or exposure, and identify additional 

subpopulations other than those 

examples listed in the statute, where 

warranted. 

To ensure that the TSCA risk 

evaluations conducted for existing 

chemicals fully consider and evaluate 

the risks to these vulnerable 

communities, EPA is proposing to 

amend the regulatory definition of 

‘‘potentially exposed or susceptible 

subpopulations.’’ Specifically, EPA is 

proposing to add ‘‘overburdened 

communities’’—communities that may 

be disproportionately exposed or 

impacted by environmental harms—to 

the list of example subpopulations. The 

disproportionality can be as a result of 

greater vulnerability to environmental 

hazards, lack of opportunity for public 

participation, or other factors. Increased 

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. 

EPA’s 2017 proposed rule proposed a 

definition of PESS that included more 

examples of PESS than set forth by 

Congress in the statutory definition. 

EPA did not finalize that definition as 

proposed. In response to public 

comments, the Agency explained that 

‘‘it would be difficult for the Agency to 

list all the potential subpopulations that 

the Agency might have reason to 

include in a risk evaluation’’ and that 

EPA did not want to imply exclusion of 

other subpopulations. However, EPA 

now believes that it is appropriate to 

propose the addition of ‘‘overburdened 

communities’’ to the definition of PESS 

because it reflects the Agency’s 

understanding and acknowledgment 

that exposure to a chemical substance 

may disproportionately impact 

communities already experiencing 

disproportionate and adverse human 

health or environmental burdens. 

Nothing in TSCA or this proposed rule 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74307 

would prevent the Agency from 

identifying another group or 

subpopulation as a ‘‘potentially exposed 

or susceptible subpopulation’’ in a given 

TSCA risk evaluation and specifically 

considering those exposures and risks 

within. 

To identify overburdened 

communities when conducting a risk 

evaluation, EPA will engage the public 

throughout the TSCA prioritization and 

risk evaluation processes, work with 

EPA offices such as the Office of 

Environmental Justice and External 

Civil Rights and the Office of Research 

and Development, and may use 

available screening tools, such as 

EJSCREEN (Ref. 35) or EnviroAtlas (Ref. 

36). These and other tools may also 

allow the Agency to capture greater 

susceptibility or greater exposure using 

the data layers for socioeconomic factors 

(e.g., income/poverty, education) or 

location (e.g., housing, employment, 

geography), and for environmental 

indicators (e.g., air toxics cancer risk, 

respiratory hazard index, particulate 

matter levels, ozone, Superfund site 

proximity, hazardous waste proximity, 

proximity to multiple chemical 

manufacturing or processing facilities), 

which may provide information for 

future cumulative assessment. EPA also 

continues to develop approaches for 

assessing the risk to overburdened 

communities. For example, in 2022 EPA 

submitted for peer review the Screening 

Level Approach for Assessing Ambient 

Air and Water Exposures to Fenceline 

Communities (Ref 16). This proposed 

screening level methodology evaluated 

the potential chemical exposures and 

associated potential risks to fenceline 

communities, or communities in close 

proximity, and thus commonly at 

greater exposure, to chemical emission 

sources. The Agency continues to 

develop risk evaluation approaches to 

help determine risk from all relevant 

exposure pathways with an emphasis on 

exposures to these commonly 

overburdened communities. 

H. Science Policy and Scientific 

Standards 

1. Scientific Guidelines and Procedures 

Congress recognized the importance 

of Agency policies, procedures and 

guidance necessary to facilitate 

implementation of the 2016 

amendments to TSCA. (15 U.S.C. 

2625(l)(1)). This proposed rule, as does 

the 2017 final rule, codifies the use of 

appropriate Agency guidance in the 

development of risk evaluations 

(proposed § 702.37(a)(1)). Agency 

guidance and methodology documents, 

which may include publicly available 

handbooks, frameworks, protocols, or 

any other process support documents 

have long provided process and method 

transparency to Agency scientific work 

products. The appropriateness of the 

documents relates to their application in 

the methods, approaches, and science 

policy decisions used in TSCA risk 

evaluations. For example, the Exposure 

Factors Handbook: 2011 Edition (Ref. 

10), provides exposure assessors inside 

the Agency as well as outside, with data 

on standard factors to calculate human 

exposure to environmental agents. Other 

EPA guidance and methodology 

documents provide background for the 

development of the TSCA risk 

evaluations, specifically the EPA 

Guidelines for Carcinogen Risk 

Assessment (Ref. 37), and the EPA 

Supplemental Guidance for Assessing 

Susceptibility from Early-Life Exposure 

to Carcinogens (Ref. 38). EPA will 

continue to use these and other existing 

Agency guidances in the development 

of TSCA risk evaluations. EPA may 

develop and use additional guidance as 

needed using a transparent process. 

2. Peer Review 

Science is the foundation that 

supports the work of EPA, and this is 

equally true for TSCA risk evaluations. 

The quality and integrity of the science 

are vital to the credibility of the 

Agency’s decisions and processes, 

including but not limited to the 

evaluation of risks from chemicals, 

determination of whether a chemical 

presents an unreasonable risk, decisions 

on how best to manage that risk, and 

ultimately the Agency’s effectiveness in 

pursuing its mission to protect human 

health and the environment. One 

important element in ensuring that 

decisions are consistent with the best 

available science and based on the 

weight of scientific evidence is to have 

an open, transparent and independent 

scientific peer review process along 

with opportunities for public comment. 

EPA has a long-standing history of 

peer review and has shown its 

commitment to peer review in the TSCA 

program. TSCA section 26(o) required 

EPA to establish an advisory committee, 

known as the Science Advisory 

Committee on Chemicals (SACC), to 

provide independent advice and expert 

consultation with respect to the 

scientific and technical aspects of issues 

relating to the implementation of TSCA. 

EPA expects to continue to obtain 

scientific advice and peer review from 

the SACC. The 2017 final rule explicitly 

required peer review to be conducted on 

all risk evaluations, which the Agency 

did for each of the first ten risk 

evaluations (Ref. 8). Reports from those 

peer review committees proved 

extremely instructive and resulted in 

more robust and scientifically 

defensible products and improvements 

to EPA methods used in the risk 

evaluation process. 

The Agency remains committed to 

using peer review in the development of 

TSCA risk evaluations and any 

associated methods or approach type 

documents and proposes to retain the 

provision to require peer review in the 

risk evaluation process. However, EPA 

is proposing some modifications to the 

language from the 2017 final rule to 

provide increased clarity on both the 

guidance the Agency will use to 

conduct peer review and on what peer 

review will be conducted. First, the 

Agency proposes removing the reference 

to specific versions of guidance 

documents. The 2017 final rule names 

specifically the EPA Peer Review 

Handbook 4th Edition 2015 (Ref. 39) 

and OMB’s Information Quality Bulletin 

for Peer Review (Ref. 40). While at the 

time of this proposed rule these 

documents were and still are applicable, 

the Agency recognizes that these 

documents may be updated and/or their 

names modified and seeks to avoid 

confusion as to which guidance 

documents will be used. The Agency 

proposes at § 702.41 to refer instead to 

‘‘applicable peer review policies, 

procedures, guidance documents, and 

methods adopted by EPA and the Office 

of Management and Budget (OMB) to 

serve as the guidance for peer review 

activities. EPA interprets ‘‘applicable’’ 

to reference the most current versions 

and believes this change will 

appropriately incorporate any future 

versions of peer review guidance 

documents from both the Agency and 

OMB (i.e., the EPA Peer Review 

Handbook and OMB Final Information 

Quality Bulletin for Peer Review). 

The peer review guidance documents 

discussed in this Unit III.H.2., as well as 

their predecessors, provide guidance on 

all aspects of the peer review process. 

This includes guidance on when to 

conduct peer review and on what 

should be considered in selecting the 

appropriate peer review approach, 

including allowable latitude for the type 

of peer review that EPA can conduct. In 

determining the appropriate type of peer 

review, EPA can consider the 

complexity of the information and any 

prior peer review of underlying 

information. EPA has previously used 

this flexibility in the TSCA program and 

sought a letter peer review, as opposed 

to, for instance, a committee established 

under the Federal Advisory Committee 

Act (FACA) (5 U.S.C. 10), to peer review 

new and updated information used in 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74308 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

the revised draft risk evaluation for 

Pigment Violet 29 (Ref. 41). 

The Agency fully intends to uphold 

the EPA Peer Review Policy Statement, 

which states in part, ‘‘. . . For highly 

influential scientific assessments, 

external peer review is the expected 

procedure. For influential scientific 

information intended to support 

important decisions, or for work 

products that have special importance 

in their own right, external peer review 

is the approach of choice . . .’’ 

However, as discussed in the EPA Peer 

Review Handbook 4th Edition, there are 

circumstances when the additional peer 

review of influential products that have 

had adequate prior peer review may not 

be necessary (Ref. 39). As the Agency 

looks to the future of TSCA risk 

evaluations, it is expected that specific 

approaches may be used repeatedly, 

after due consideration of complexity, 

novelty, and prior peer review. That is, 

there may be situations when repeated 

peer review is not warranted. 

For example, EPA did not peer review 

the 2020 1,4-Dioxane; Supplemental 

Analysis to the Draft TSCA Risk 

Evaluation (Ref. 42). In response to peer 

review of the draft risk evaluation for 

1,4-dioxane, published in September 

2019 (Ref. 43), members of the SACC, as 

well as public commenters, highlighted 

omissions in the draft evaluation, 

specifically 1,4-dioxane exposures as a 

byproduct in products and general 

population exposure from the surface 

water pathway. As a result, those 

conditions of use from the presence of 

1,4-dioxane as a byproduct in consumer 

use were included in the scope of a 

supplemental analysis to the draft risk 

evaluation. In that situation, because the 

analytical approaches to assessing the 

unreasonable risk associated with these 

conditions of use mirrored those 

approaches used for the conditions of 

use evaluated in the peer reviewed 

September 2019 draft risk evaluation 

and there was not new or novel 

scientific information to consider, the 

Agency determined that additional peer 

review was not warranted, but sought 

public comment on the supplemental 

analysis. 

EPA believes that future risk 

evaluations and associated analyses may 

present similar circumstances for EPA’s 

consideration. Rather than peer 

reviewing an entire risk evaluation, in 

adhering to applicable guidance, it may 

be appropriate for EPA to conduct peer 

review on only portions or sections that 

constitute unreviewed influential 

information. EPA also expects that a 

TSCA risk evaluation may use peer 

reviewed products (e.g., risk 

assessments, hazard assessments, 

models), or portions thereof, conducted 

by another EPA office or other 

authoritative body (e.g., state, national, 

or international programs), for which 

both the best available science and 

weight of scientific evidence standards 

were adhered to (see Unit III.I.1.). EPA’s 

Peer Review Handbook specifically 

references circumstances that may not 

necessitate additional peer review 

including ‘‘work that has been 

previously reviewed in a manner 

consistent with the OMB Peer Review 

[Bulletin] and EPA’s Peer Review 

Handbook’’ (Ref. 39). Thus, this portion 

or section of a TSCA assessment may 

not need additional peer review. To this 

end, EPA proposes to add clarity around 

what will be peer reviewed. The 2017 

final rule stated that ‘‘the risk 

evaluation’’ will be peer reviewed. The 

proposed regulatory text at § 702.41 

provides EPA’s expectation that peer 

review activities could be conducted on 

risk evaluations ‘‘or portions thereof.’’ 

EPA believes this provides the needed 

flexibility to conserve Agency resources 

and avoid redundant peer review. EPA 

requests comments on the proposed 

changes with respect to peer review, 

including whether the proposed 

addition of ‘‘or portions thereof’’ is 

consistent with OMB and Agency 

guidance. 

Consistent with the 2017 proposed 

and final rules, EPA will not seek peer 

review of any determination as to 

whether the risk is ‘‘unreasonable,’’ 

which is an Agency policy 

determination. Consistent with OMB 

and EPA guidance, the purpose of peer 

review is the independent review of the 

science underlying the TSCA risk 

assessment not an evaluation of EPA’s 

policy determinations. TSCA expressly 

reserves to the Agency the final 

determination of whether risk posed by 

a chemical substance is ‘‘unreasonable.’’ 

(15 U.S.C. 2605(i)). This is consistent 

with the statutory purpose of the SACC, 

‘‘to provide independent advice and 

expert consultation, at the request of the 

Administrator, with respect to the 

scientific and technical aspects of issues 

relating to the implementation of this 

title’’ (15 U.S.C. 2625(o)(2)). 

I. Scientific Standards 

TSCA section 6(h) and (i) require the 

Agency to make decisions under TSCA 

section 6 in a manner that is consistent 

with the best available science and 

based on the weight of scientific 

evidence. Specifically, TSCA section 

26(h) requires that in carrying out TSCA 

sections 4, 5, and 6, to the extent the 

Agency makes decisions based on 

science, the Agency shall ‘‘use scientific 

information, technical procedures, 

measures, methods, protocols, 

methodologies, or models, employed in 

a manner consistent with the best 

available science.’’ The statute then lists 

considerations: (1) The extent to which 

the scientific information, technical 

procedures, measures, methods, 

protocols, methodologies, or models 

employed to generate the information 

are reasonable for and consistent with 

the intended use of the information; (2) 

The extent to which the information is 

relevant for the Administrator’s use in 

making a decision about a chemical 

substance or mixture; (3) The degree of 

clarity and completeness with which 

the data, assumptions, methods, quality 

assurance, and analyses employed to 

generate the information are 

documented; (4) The extent to which 

the variability and uncertainty in the 

information, or in the procedures, 

measures, methods, protocols, 

methodologies, or models, are evaluated 

and characterized; and (5) The extent of 

independent verification or peer review 

of the information or of the procedures, 

measures, methods, protocols, 

methodologies or models. Section 26(i) 

states ‘‘the Administrator shall make 

decisions under sections 4, 5, and 6 

based on the weight of scientific 

evidence.’’ TSCA does not define either 

‘‘best available science’’ or ‘‘weight of 

scientific evidence’’ and there is no 

requirement in the statute to define 

them by rule. Codification of definitions 

has potentially broader impacts beyond 

TSCA section 6 risk evaluations and 

rules, including TSCA sections 4 and 5 

actions, and potentially other 

applications outside of TSCA. 

EPA received significant comment 

about the codification of definitions for 

these terms during the development of 

the 2017 proposed rule (Ref. 1 and Ref. 

44). Some commenters noted that it is 

imperative that the Agency have 

specific criteria which would allow for 

consistency and transparency for how 

EPA will implement science. Others 

argued that since interested persons 

may submit risk assessments to the 

Agency for consideration (under TSCA 

section 26(l)(5)), it is necessary for the 

Agency to provide a standard and 

expectation. Many commenters noted 

that there are a number of ways the 

Agency could and has defined these 

terms across other statutory obligations 

and suggested this could be both a 

reason to codify TSCA-specific 

definitions, or to not codify them to 

avoid future limitations in 

implementation approaches. Others 

have argued that the risk evaluation rule 

should be reserved for process and 

procedure, and that codification of 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74309 

specific process definitions would limit 

the Agency’s ability to adapt to the 

changing science of risk evaluation, as 

well as the science that informs risk 

evaluation. Further, some argued that 

defining the terms would limit the 

flexibility afforded the Agency, and 

arguably the mandate, to implement and 

advance novel science. 

EPA determined not to propose 

codifying definitions of either of these 

terms in the 2017 proposed rule (Ref. 9 

at p. 7572), citing the need to remain 

flexible to changing science and 

approaches. The Agency argued at that 

time that further defining these terms 

was unnecessary and ultimately 

problematic. EPA noted that these terms 

have and will continue to evolve with 

changing scientific methods and 

innovation, and Agency guidance does 

and will provide the necessary 

description and processes to ensure 

consistency and transparency (Ref. 9 at 

p. 7572). Ultimately, EPA did codify 

definitions for both of these terms in the 

final rule, explaining that codification of 

these definitions would instill 

confidence, increase transparency, 

predictability, and provide the public 

with assurance that EPA will adhere to 

the requirements of the statute (Ref. 1 at 

p. 33731). EPA is proposing to eliminate 

the following definitions from the 

regulatory text for the reasons described 

in Units III.H.1. and 2. 

1. Best Available Science 

In the 2017 final risk evaluation rule, 

the Agency defined best available 

science as science that is reliable and 

unbiased, and described the use of best 

available science as involving the use of 

supporting studies conducted in 

accordance with sound and objective 

science practices, including, when 

available, peer reviewed science and 

supporting studies and data collected by 

accepted methods or best available 

methods (if the reliability of the method 

and the nature of the decision justifies 

use of the data). The definition also 

identified other considerations as 

applicable, including the extent to 

which: 

• The scientific information, 

technical procedures, measures, 

methods, protocols, methodologies, or 

models employed to generate the 

information are reasonable for and 

consistent with the intended use of the 

information; 

• The information is relevant for the 

Administrator’s use in making a 

decision about a chemical substance or 

mixture; 

• The degree of clarity and 

completeness with which the data, 

assumptions, methods, quality 

assurance, and analyses employed to 

generate the information are 

documented; 

• The variability and uncertainty in 

the information, or in the procedures, 

measures, methods, protocols, 

methodologies, or models, are evaluated 

and characterized; and 

• There is independent verification or 

peer review of the information or of the 

procedures, measures, methods, 

protocols, methodologies or models. 

In general, EPA continues to believe 

this current definition of ‘‘best available 

science’’ is aligned with the Agency’s 

views and the science requirements in 

TSCA section 26(h). The first part of this 

definition originated from the Safe 

Drinking Water Act (SDWA) (42 U.S.C. 

300f et seq.) (Ref. 45), and second part 

of the definition is drawn verbatim from 

the considerations listed in TSCA 

section 26(h)(1) through (5). SDWA 

adopted a basic standard of quality for 

the use of science in agency decision 

making. Under 42 U.S.C. 300g– 

1(b)(3)(A), the Agency is directed, ‘‘to 

the degree that an Agency action is 

based on science,’’ to use ‘‘(i) the best 

available, peer-reviewed science and 

supporting studies conducted in 

accordance with sound and objective 

scientific practices; and (ii) data 

collected by accepted methods or best 

available methods (if the reliability of 

the method and the nature of the 

decision justifies use of the data).’’ The 

mandate to use the best available 

science with considerations enumerated 

in TSCA section 26(h) closely mirrors 

these requirements. Specifically, TSCA 

section 26(h)(5) refers to verified and 

peer reviewed science and scientific 

methods, and TSCA sections 26(h)(1) 

though (4) refer to the important 

considerations for the Agency when 

identifying and using data in a risk 

evaluation. This further comports with 

SDWA’s quality standard for the 

dissemination of public information 

about risks of adverse health effects (42 

U.S.C. 300g–1(b)(3)(B)). 

The precedent-setting standards in 

SDWA are further discussed in the OMB 

Information Quality Guidelines. These 

guidelines ‘‘provide policy and 

procedural guidance to Federal agencies 

for ensuring and maximizing the 

quality, objectivity, utility, and integrity 

of information (including statistical 

information) disseminated by Federal 

agencies’’ (Pub. L. 106–554; 114 Stat. 

2763A–153 through 2763A–154). The 

Guidelines for Ensuring and Maximizing 

the Quality, Objectivity, Utility, and 

Integrity, of Information Disseminated 

by the Environmental Protection Agency 

(Ref. 46, also referred to as EPA’s 

Information Quality Guidelines) contain 

EPA’s policy and procedural guidance 

for ensuring and maximizing the quality 

of information disseminated in Agency 

work products. Section 6.4 of EPA’s 

Information Quality Guidelines discuss 

how the Agency ensures and maximizes 

the quality of information used in risk 

assessment and specifically adopts the 

SDWA quality principles. EPA’s 

Information Quality Guidelines go on to 

say: ‘‘In applying these principles, ‘best 

available’ usually refers to the 

availability at the time an assessment is 

made. However, EPA also recognizes 

that scientific knowledge about 

chemical risk is rapidly changing and 

that risk information may need to be 

updated over time.’’ In general, EPA 

believes the SDWA definition of ‘‘best 

available science’’ and the associated 

guidelines and policies are all aligned 

with the science requirements 

enumerated in TSCA section 26(h). 

However, EPA believes that codifying 

a definition of ‘‘best available science’’ 

in the Risk Evaluation procedural rule is 

unnecessary and potentially 

problematic as it could limit the 

Agency’s ability, flexibility, and 

mandate to incorporate the best 

available science into TSCA risk 

evaluations. As such, EPA is proposing 

to eliminate the definition of ‘‘best 

available science’’ from § 702.33. EPA 

specifically requests public comment on 

the proposed elimination of the 

definitions, the need for such 

definitions, and the utility of definitions 

as the state of science evolves. As 

discussed previously, EPA believes the 

specifics of that definition are already 

reflected in the TSCA requirements and 

considerations for applying the best 

available science in section 26(h), and 

in the Agency’s policies and procedural 

guidance. These considerations are also 

replicated in the proposed regulatory 

text at § 702.37(a)(2). The Agency does 

not believe codifying a definition of 

‘‘best available science’’ provides any 

additional transparency or improves 

consistency. 

Furthermore, while the use and 

consideration of ‘‘best available 

science’’ is discussed at length in both 

EPA and other Federal agency guidance 

documents, the definition is not 

codified in other Agency rulemakings. 

EPA believes that a specific definition 

should not be codified in this 

rulemaking. Under proposed 

§ 702.37(a)(1), the Agency would use 

appropriate Agency guidance in the 

development of the TSCA risk 

evaluations. TSCA section 26(l) requires 

the Agency to use and develop guidance 

documents that are necessary in 

carrying out the statute. TSCA further 

requires the revisions of guidance 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74310 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

documents as necessary to ‘‘reflect new 

scientific developments and 

understandings.’’ Reliance on Agency 

guidance for determining the ‘‘best 

available science’’ in TSCA risk 

evaluations ensures the desired 

transparency and consistency, while 

still allowing for more nimble 

adaptation over time. 

As the Agency identifies reasonably 

available information to inform a TSCA 

risk evaluation of a given chemical, EPA 

may consider existing risk assessments, 

or reviews performed on the chemical in 

question to be the best available science. 

This may include assessments 

conducted by EPA that adhere to 

existing Agency Guidance, use 

methodologies that have been externally 

peer reviewed, and undergo public 

comment. Similarly, the Agency may 

also look to consider assessments or 

portions of assessments conducted by 

other United States or international 

authoritative bodies. EPA may consider 

these existing assessments or reviews to 

represent the best available science as 

required under TSCA and use portions 

of them to directly inform a risk 

evaluation. 

2. Systematic Review and Fit-forPurpose Systematic Approaches 

The 2017 final risk evaluation rule 

defined weight of scientific evidence 

(WOSE) as used in TSCA to include the 

use of a ‘‘systematic review method’’ 

with a ‘‘pre-established protocol’’ to 

‘‘identify and evaluate each stream of 

evidence.’’ In turn, in implementation of 

this regulatory requirement, EPA has 

previously viewed this definition as 

requiring the Agency to conduct 

systematic review according to a 

protocol on each evidence stream. The 

first method used was the 2018 

Application of Systematic Review in 

TSCA Risk Evaluations (Ref. 47). This 

method was reviewed by the National 

Academies of Science, Engineering, and 

Medicine (NASEM) and the study report 

published in 2021, The Use of 

Systematic Review in EPA’s Toxic 

Substances Control Act Risk 

Evaluations (Ref. 48), included several 

opportunities and recommendations to 

improve EPA’s systematic review 

process. In response to 

recommendations made by the NASEM, 

as well as comments received from the 

TSCA SACC and the public during the 

review of the first ten risk evaluations, 

EPA significantly updated the TSCA 

systematic review process and 

developed a systematic review protocol. 

The draft TSCA Systematic Review 

Protocol (Ref. 49) replaced the 

Application of Systematic Review in 

TSCA Risk Evaluations. As described in 

Unit III.I.3., EPA is proposing changes to 

the WOSE definition to ensure that the 

concepts and principles of systematic 

review and WOSE are used in the 

evaluation of existing chemicals and are 

appropriately considered separately. 

TSCA risk evaluations use reasonably 

available information to draw the 

conclusions that are supported by the 

best available science. Reasonably 

available information is identified and 

evaluated through unbiased, transparent 

and objective data collection and data 

evaluation, using systematic review 

methods. EPA believes that integrating 

appropriate and applicable systematic 

review methods and approaches into the 

TSCA risk evaluations are critical to 

meet the scientific standards as 

described in TSCA section 26(h). A 

systematic review approach to data 

collection and data evaluation provides 

more complete information than an 

informal or unstructured review and can 

reduce bias in data selection (Ref. 49). 

The principles of systematic review 

collection and evaluation of data and 

information have been well developed 

in the context of evidence-based 

medicine (e.g., evaluating efficacy in 

clinical trials) and more recently have 

been adapted for use across a more 

diverse array of scientific fields. A 2014 

report by the National Research Council 

(NRC) describes systematic review as ‘‘a 

scientific investigation that focuses on a 

specific question and uses explicit, prespecified scientific methods to identify, 

select, assess, and summarize the 

findings of similar but separate studies’’ 

(Ref. 50). There are also well-established 

principles of systematic review like 

‘‘transparent and explicitly documented 

methods, consistent and critical 

evaluation of all relevant literature, 

application of a standardized approach 

for grading the strength of evidence, and 

clear and consistent summative 

language’’ (Ref. 50). Systematic review 

includes performing—as described and 

documented in a protocol—a 

methodical literature search, collection 

and screening, followed by data quality 

evaluation (addressing factors such as 

relevancy and bias), extraction, and 

integration, using a defined protocol, 

that can be applied across multiple lines 

of evidence. Any systemic approach 

EPA uses will follow this process. 

The TSCA program will also continue 

to work with partners including EPA’s 

Office of Research and Development 

(ORD), the Office of Pesticide Programs, 

and the Office of Water (OW) to advance 

and implement tools, methods, and 

efficiencies to systematically collect and 

evaluate literature. The procedures 

required for ensuring objectivity, 

transparency and no bias in the 

collection and review of data for TSCA 

risk evaluations must be flexible enough 

to account for the diversity of both 

hazard and exposure information 

necessary to inform TSCA risk 

evaluations, and implementable within 

the statutory deadlines. EPA will 

continue to develop and evolve its 

systematic approaches to data collection 

and evaluation for use in TSCA risk 

evaluations to meet these goals. EPA 

will continue to use the principles and 

tools outlined in the draft TSCA 

Systematic Review Protocol (Ref. 49), 

but the Agency will move to implement 

more chemical specific approaches that 

are more flexible and relevant for the 

types and quantity of information used 

in an individual risk evaluation. As 

such, systemic review approaches must 

be commensurate with the relevant 

complexity of the assessment and nature 

of the information available, and carried 

out in a manner that permits completion 

within the timeframes that Congress 

provided. EPA will look to streamline 

chemical-specific protocols and 

approaches while remaining consistent 

with systematic review principles. 

These systematic approaches will be 

transparent, fit-for-purpose, and specific 

to the needs of each chemical/category, 

while better aligning with the schedules 

for completion of the risk evaluation. 

The Agency is also exploring how to 

leverage consideration of systematic 

reviews and systematic review 

approaches from other EPA offices and 

authoritative bodies, or portions thereof, 

to achieve greater efficiencies in the 

process. Ultimately, application of 

systematic review and/or systematic 

approaches are necessary to help EPA 

identify useful evidence, inform 

judgments as to the ‘‘best available 

science’’ and ‘‘weight of scientific 

evidence’’ (WOSE), and can 

transparently support risk evaluations 

that are both scientifically robust and 

defensible. 

3. Weight of Scientific Evidence 

In the 2017 Final Rule, EPA defined 

the WOSE as ‘‘a systematic review 

method, applied in a manner suited to 

the nature of the evidence or decision, 

that uses a pre-established protocol to 

comprehensively, objectively, 

transparently, and consistently identify 

and evaluate each stream of evidence, 

including strengths, limitations, and 

relevance of each study and to integrate 

evidence as necessary and appropriate 

based upon strengths, limitations, and 

relevance.’’ 40 CFR 702.33. The Agency 

believes this definition is problematic 

and inconsistent with typical risk 

assessment practice and is therefore 

proposing to eliminate the definition 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74311 

from the regulatory text—instead relying 

on long-established Agency guidance 

documents to guide weight of scientific 

evidence analyses under TSCA. 

The 2017 final rule conflates WOSE 

(also referred to as weight of evidence 

(WOE)) and systematic review. This 

conflation was identified and best 

described by NASEM’s review of EPA’s 

publication titled Application of 

Systematic Review in TSCA Risk 

Evaluations (Ref. 47). In their study 

report, The Use of Systematic Review in 

EPA’s Toxic Substances Control Act 

Risk Evaluations (Ref. 48), the NASEM 

reviewers state ‘‘this definition of WOE 

seems to say that the TSCA systematic 

review is itself a WOE evaluation. As 

such, the agency’s legal obligation to 

conduct a WOE evaluation is fulfilled 

by the fact that systematic review is the 

basis for TSCA evaluations.’’ The 

NASEM Committee goes further 

describing the confusion that results 

when the WOSE is used at one stage of 

the systematic review process to 

integrate the strength of the evidence 

judgment for each individual evidence 

stream into an overall conclusion for a 

health endpoint, whereas under the 

WOSE definition, the systematic review 

process itself is a weight of scientific 

evidence evaluation (Ref. 48). 

Throughout the report, the Committee 

notes the conflation of terms and goes 

on to suggest that changing the 

definition of WOSE within the risk 

evaluation procedural rule may alleviate 

the terminology confusion (Ref. 48). 

In developing this proposed rule, the 

Agency reviewed several alternative 

definitions or descriptions of WOSE or 

WOE. It is clear there are certain 

principles of WOSE that are universal, 

including foundational considerations 

such as objectivity and transparency. 

The phrase WOSE or WOE is used by 

EPA and other scientific bodies to 

describe the strength of the scientific 

inferences that can be drawn from a 

given body of evidence, specifically 

referring to the quality of the studies 

evaluated, and how findings are 

assessed and integrated. EPA broadly 

uses the WOSE approach in many 

existing programs and has described the 

application of WOSE in Agency 

guidelines used to classify carcinogens. 

In the 2005 Guidelines for Carcinogen 

Risk Assessment (Ref. 37), EPA refers to 

the WOE approach as ‘‘. . . a collective 

evaluation of all pertinent information 

so that the full impact of biological 

plausibility and coherence is adequately 

considered.’’ The Endocrine Disruptor 

Screening and Testing Advisory 

Committee (EDSTAC) referred to the 

WOE approach as ‘‘. . . a process by 

which trained professionals judge the 

strengths and weaknesses of a collection 

of information to render an overall 

conclusion that may not be evident from 

consideration of the individual data’’ 

(Ref. 51). EPA believes WOSE 

inherently involves application of 

professional judgment, in which the 

significant issues, strengths, limitations 

of the data, uncertainties, and 

interpretations are presented and 

highlighted. 

As noted by the National Academies 

of Science, ‘‘because scientific evidence 

used in WOE evaluations varies greatly 

among chemicals and other hazardous 

agents in type, quantity, and quality, it 

is not possible to describe the WOE 

evaluation in other than relatively 

general terms’’ (Ref. 23). EPA does not 

believe that even an alternative codified 

definition would add additional 

transparency or certainty to the required 

use of WOSE in TSCA risk evaluations. 

Additionally, the Agency believes that 

codifying a specific definition would 

inhibit the flexibility of the Agency to 

quickly adopt and implement changing 

science to ensure that each risk 

evaluation is fit-for-purpose to the 

chemical under review. As such, EPA is 

proposing to remove the current 

codified definition of weight of 

scientific evidence. The Agency 

welcomes comment on this approach. 

EPA will instead rely on established 

Agency guidance documents to guide 

the required application of WOSE in 

TSCA risk evaluations. At this time, 

EPA will primarily look to four 

documents for implementing WOSE in 

TSCA risk evaluations: 2016 Weight of 

Evidence in Ecological Assessment (Ref. 

52), Guidelines for Carcinogen Risk 

Assessment (Ref. 37), 2011 Endocrine 

Disruptor Screening Program Weight-ofEvidence: Evaluating Results of EDSP 

Tier 1 Screening to Identify the Need for 

Tier 2 Testing (Ref. 53), and 2022 ORD 

Staff Handbook for Developing IRIS 

Assessments (Ref. 54). These documents 

all similarly describe the WOSE 

assessment as based on the strengths, 

limitations, and interpretation of data 

available, information across multiples 

lines of evidence and how these 

different lines of evidence may or may 

not fit together in drawing conclusions. 

The results from the scientifically 

relevant published or publicly available 

peer-reviewed studies, gray literature, or 

any other studies or lines of evidence 

which are of sufficient quality and 

reliability, are evaluated across studies 

and endpoints into an overall 

assessment. WOSE assessments examine 

multiple lines of evidence considering a 

number of factors, including for 

example the nature of the effects within 

and across studies, including number, 

type, and severity/magnitude of effects 

and strengths and limitations of the 

information. A summary WOSE 

narrative or characterization 

accompanies the detailed analysis and 

is intended to transparently describe the 

conclusion(s) and reasoning behind it/ 

them. Specifically, the narrative or 

characterization generally explains the 

selection of the studies or effects used 

as the main lines of evidence and 

relevant basis for conclusions, and 

describes the overall strength of the 

evidence supporting a conclusion from 

the WOSE assessment. 

J. Process for EPA Revisions To Scope or 

Risk Evaluation Documents 

EPA is proposing some new 

procedures and criteria for whether and 

how EPA would endeavor to revise or 

supplement final scope documents, and 

draft or final risk evaluations. The 2017 

final rule does not provide any such 

criteria or procedures. The proposed 

procedures provide greater certainty and 

transparency for stakeholders. 

Additionally, given the tens of 

thousands of existing chemical 

substances in commerce and EPA’s 

responsibility to assess and manage 

risks from those chemicals through a 

statutory deadline-driven pipeline of 

prioritization, risk evaluation and risk 

management activities, EPA believes 

that some guardrails are necessary to 

ensure that the Agency continues to 

make forward progress on existing 

chemicals as Congress intended. 

Continuously revisiting final risk 

evaluations would drain the Agency’s 

already limited resources and divert 

attention from other chemicals actively 

in the prioritization, risk evaluation or 

risk management phases. The criteria 

and procedures in this proposed rule 

would serve the law’s purpose to move 

chemicals through the process within 

the statutory deadlines, and allow the 

Agency to move on to evaluating 

another high-priority substance, 

consistent with TSCA section 6(b)(3)(C). 

Specifically, with respect to final 

scope documents, EPA is proposing that 

subsequent changes—if any—to the 

scope of the risk evaluation after 

publication of the final scope be 

reflected and described in the draft risk 

evaluation instead of a revised final 

scope document. EPA believes that, 

moving forward, any changes to the 

scope of the risk evaluation after 

publication of a final scope document 

are likely to be minimal based on the 

improved processes proposed in this 

NPRM, and EPA’s expected rulemaking 

to implement a tiered data collection 

strategy to better inform data needs for 

prioritization and risk evaluation 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74312 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

candidates (Ref 57). However, in the 

event that changes to the risk evaluation 

scope during that period are more 

significant, EPA recognizes that public 

notice of those changes might be 

warranted. The proposal contemplates 

that EPA could, in its discretion, 

publish a notice in the Federal Register 

notifying the public that EPA has made 

information regarding changes to the 

risk evaluation scope available in the 

docket before releasing the draft risk 

evaluation. 

Likewise, EPA is proposing to refrain 

from reissuing draft risk evaluations in 

a second draft form. Draft documents 

are, by their nature, subject to change. 

Rather than spending time and 

resources to develop and issue a revised 

draft risk evaluation, EPA instead 

expects to reflect and describe any 

changes to the draft document in the 

final risk evaluation. Where changes 

from draft to final are significant in 

nature, nothing in the proposed rule 

would prevent EPA from seeking 

additional advice or feedback from its 

independent scientific advisors or 

additional public comment on relevant 

topics, provided that such actions can 

be completed within the timeframes 

Congress contemplated for TSCA risk 

evaluations. This proposed clarification 

to the Agency’s process ensures that 

feedback is appropriately considered 

and reflected without unduly delaying 

progress towards completion of the risk 

evaluation. 

EPA is proposing a general practice 

for how and when to revisit final risk 

evaluations, and certain exceptions to 

that practice. As general practice, where 

circumstances warrant revisiting a 

chemical risk evaluation that has 

already been finalized—which EPA 

believes are likely to be infrequent—the 

Agency may identify that chemical as a 

potential candidate for high-priority 

designation, and follow the procedures 

at 40 CFR part 702, subpart A. EPA 

believes that this general practice aligns 

with Congress’ intent for the Agency to 

work systematically through the 

universe of existing chemicals within 

the statutory framework and aggressive 

deadlines associated with prioritization, 

risk evaluation and risk management. 

(15 U.S.C. 2605(b)(2)(C) and (b)(4)(G)). 

Revisiting risk evaluations outside of reprioritizing the chemical substance 

results in unanticipated and potentially 

unbudgeted work that can siphon 

resources from statutorily mandated 

responsibilities under TSCA section 6. 

Conversely, re-prioritizing the chemical 

provides the public with ample notice 

and opportunity to engage, provides 

anticipatable milestones and process, 

and better positions the Agency to 

maintain a manageable workload. 

Nevertheless, there may be certain 

circumstances where revisions to a final 

risk evaluation outside of reprioritization of a chemical are in the 

interest of protecting human health and 

the environment. For example, as 

announced on June 30, 2021, EPA is 

revisiting the first 10 final risk 

evaluations to ensure they followed the 

science and EPA’s renewed 

understanding of the law, and 

determined a path forward on a casespecific, chemical-by-chemical basis 

(Ref. 7). The outcome of those risk 

evaluations, which may have 

underestimated risks based on, among 

other things, policies of excluding 

certain conditions of use and entire 

exposure pathways from assessment, 

warranted this action. Although changes 

proposed in this NPRM should prevent 

the types of issues that justified 

reanalysis of the first ten chemical risk 

evaluations, the same principle—the 

need to revise a final risk evaluation to 

protect human health and the 

environment—might apply to, for 

example, a scientific error that 

meaningfully impacts the evaluation or 

the Agency’s ability to appropriately 

address risks through rulemaking. 

Where EPA endeavors to revise or 

supplement a final risk evaluation 

outside of re-prioritization, the 

proposed rule further requires EPA to 

follow the same process and 

requirements for TSCA risk evaluations 

described in this proposed rule, 

including publication of a new draft and 

final risk evaluation, solicitation of 

public comment, and, as appropriate, 

peer review. 

K. Process and Requirements for 

Manufacturer-Requested Risk 

Evaluations 

EPA is proposing a number of changes 

to the process and requirements for 

manufacturers to request a risk 

evaluation. TSCA section 6(b)(4)(C)(ii) 

allows a manufacturer or group of 

manufacturers to request that the 

Agency conduct a risk evaluation of a 

chemical substance (or category of 

substances) that they manufacture. 

TSCA section 6(b)(4)(C)(ii) directs EPA 

to establish the ‘‘form . . . manner and 

. . . criteria’’ for such requests by rule, 

which the Agency finalized in 2017. 

Based on experience in implementing 

that process to date, EPA is proposing 

some modifications to increase clarity 

and to better position the Agency to 

carry out manufacturer-requested risk 

evaluations (MRREs) moving forward. 

The current process for MRREs, laid 

out in 40 CFR 702.37, has been 

challenging for EPA in a number of 

ways. First, the 2017 final rule allows 

requests to contain information relevant 

only to conditions of use of the 

chemical that are of interest to the 

requesting manufacturer (40 CFR 

702.37(b)(3)). Within a relatively short 

time after receiving a request, EPA must 

either grant or deny the request (40 CFR 

702.37(e)(6)). By ‘‘granting’’ an MRRE 

request under the current regulations, 

EPA is acknowledging that it has all the 

information it needs to conduct the 

evaluation, creating some ambiguity as 

to whether additional information can 

be gathered during the process, 

including through use of EPA’s TSCA 

section 4 or 8 authorities. The process 

effectively leaves the Agency with the 

heavy burden of identifying the 

remaining conditions of use, reviewing 

information that came in with the 

request, obtaining and reviewing 

additional available literature, and 

determining any missing information or 

data needs—all within a matter of 

months. The current process also 

provides that upon granting the request, 

EPA will initiate the risk evaluation, 

triggering the start of the three-year 

statutory deadline to complete the 

activity (40 CFR 702.37(e)(10)). 

EPA has found that this process is 

unrealistic. In addition to needing more 

fulsome information included in 

incoming requests, and additional time 

to properly review requests and 

determine any additional information 

needs prior to initiating the evaluation, 

EPA also needs some flexibility in the 

process to pursue data collection or 

development during the risk evaluation. 

In general, EPA believes that the process 

and timeframes for reviewing incoming 

MRRE requests should be more akin to 

the process and timeframes that precede 

EPA-initiated risk evaluations. When 

considering whether a chemical is a 

good potential candidate for 

prioritization—including the chemical’s 

readiness for evaluation from a data 

perspective—EPA has a significant 

amount of time to review and analyze 

available information, identify data gaps 

and needs, and pursue various data 

gathering strategies. On top of that, the 

prioritization process itself provides an 

additional 9 to 12 months and two 90- 

day public comment periods to help the 

Agency refine its approach and deepen 

its understanding of the chemical—all 

before initiating the risk evaluation and 

the associated deadlines. 

The proposed rule is intended to 

address these challenges. Units III.K.1. 

through 4. Describe the key proposed 

changes to the process for MRREs, and 

EPA’s expectations for implementation 

moving forward: 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74313 

1. Submission of MRRE 

The law allows for submission of a 

MRRE by one or more manufacturers of 

a chemical substance, and both the 

current and proposed rule maintain that 

requirement as part of the regulatory 

text. However, in cases where multiple 

manufacturers jointly submit a MRRE 

(i.e., a consortium), EPA expects to treat 

a consortium as a single entity for 

purposes of any regulatory 

determinations with regard to the 

requests, fee payments, and other 

general communication regarding the 

MRRE request and/or the risk 

evaluation. Joint submitters must 

designate a single point of contact for 

Agency engagement, and are otherwise 

collectively responsible for providing 

complete and sufficient information to 

the Agency to support the risk 

evaluation. 

2. Scope of Request 

Currently, the rule allows 

manufacturers to request a risk 

evaluation on particular conditions of 

use of interest, leaving the Agency with 

the heavy burden of identifying the 

remaining conditions of use. EPA is 

proposing that manufacturers only be 

permitted to make requests for 

evaluations of entire chemical 

substances—not individual conditions 

of use or subsets of conditions of use. 

In addition to better aligning with the 

statutory language in TSCA section 

6(b)(4)(C) (stating that EPA ‘‘shall 

conduct and publish risk evaluations 

. . . on a chemical substance . . .’’) and 

the scope of EPA-initiated risk 

evaluations, EPA believes this 

clarification will also encourage more 

robust, well-crafted submissions and 

better position the Agency for success in 

carrying out the evaluations. EPA 

recognizes that a requesting 

manufacturer may not have access to all 

necessary information to support the 

risk evaluation, and, as described in 

Unit III.K.4, EPA is also proposing a 

process to address these shortcomings. 

However, the proposed clarification 

regarding scope—along with changes 

described in Unit III.K.3.—would ensure 

no misgivings about the scope of MRREs 

and the information needed to support 

those requests in order for the Agency 

to undertake a risk evaluation. 

3. Contents of Request 

EPA is also proposing some key 

changes to the supporting information 

that must be included in a MRRE 

request. As a general matter, EPA 

believes that the requesting 

manufacturer(s) should bear the primary 

burden of providing EPA with all 

information necessary to conduct a risk 

evaluation on the chemical substance. 

Congress also shared this sentiment in 

section 2 of TSCA, stating that 

‘‘adequate information should be 

developed with respect to the effect of 

chemical substances and mixtures on 

health and the environment and that the 

development of such information 

should be the responsibility of those 

who manufacture and those who 

process such chemical substances and 

mixtures.’’ 15 U.S.C. 2601(b). Within 

respect to MRRE requests, Congress 

authorized EPA to establish the ‘‘form 

. . . manner and . . . criteria’’ for such 

requests in order to support successful 

implementation. (15 U.S.C. 

2605(b)(4)(C)). The 2017 final rule’s 

allowance for the requesting 

manufacturer(s) to only provide 

supporting information relevant to their 

preferred conditions of use 

inappropriately shifts much of the 

information gathering burden to the 

Agency. Instead, EPA believes, as 

discussed in Unit III.K.2., based on 

TSCA’s statutory text and structure, that 

MRRE requests should attempt to 

identify all intended, known and 

reasonably foreseen circumstances of 

the chemical’s manufacture, processing, 

distribution in commerce, use and 

disposal, and provide all available 

information regarding the chemical’s 

hazards and exposures—not just 

information of relevance to the 

submitter’s interests. As such, EPA is 

proposing changes that would require 

more fulsome information as part of the 

request, based on information that is 

known to or reasonably ascertainable by 

the requesting manufacturer. 

More specifically, EPA is proposing to 

require that manufacturers include a 

listing of the chemical’s conditions of 

use (i.e., the circumstances under which 

the chemical substance is intended, 

known, or reasonably foreseen to be 

manufactured, processed, distributed in 

commerce, used, or disposed of), and all 

information known to or reasonably 

ascertainable by the requesting 

manufacturer that supports the 

identification of those circumstances. 

While EPA must ultimately determine 

the chemical’s conditions of use for 

purposes of the risk evaluation, this 

requirement ensures a reasonable level 

of due diligence on the part of the 

requesting manufacturer to gather 

available information and provide it to 

EPA. Similarly, EPA is also proposing 

that incoming requests include ‘‘all 

information known to or reasonably 

ascertainable by the requesting 

manufacturer on the health and 

environmental hazard(s) of the chemical 

substance, human and environmental 

exposure(s), and exposed 

population(s).’’ The proposed rule also 

provides some clarifications as to the 

specific types of information that must 

be included as part of the request. 

Under the 2017 final rule, requesting 

manufacturers are required to provide 

this information only where relevant to 

the particular uses of interest, leaving 

EPA with significant work not just to 

identify the remaining conditions of 

use, but also to locate and review 

available literature and quickly 

determine whether there is sufficient 

information to carry out a risk 

evaluation. The proposed changes put 

more of this responsibility on the 

requesting manufacturer. EPA believes 

that requesting manufacturers should be 

making a reasonable amount of effort to 

gather all available information on the 

chemical—whether that information is 

available to the general public, or 

otherwise available to the 

manufacturer—and compile it for the 

Agency’s review as part of an MRRE. 

Information that is known to or 

reasonably ascertainable by the 

manufacturer would include 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. The standard requires an exercise 

of due diligence, and the specific 

information-gathering activities that 

may be necessary for manufacturers to 

achieve this standard may vary from 

case-to-case. In the context of preparing 

a MRRE request and to meet the 

requirements in the proposed rule at 

§ 702.45(c), EPA believes that due 

diligence would, at a minimum, involve 

a thorough search and collection of 

publicly available information on the 

chemical’s hazards, exposures and 

conditions of use. EPA would further 

expect that requesting manufacturers 

conduct a reasonable inquiry not only 

within the full scope of their 

organization regarding manufacturing 

processes and products (including 

imports), but also outside of their 

organization to fill gaps in knowledge. 

For example, such activities might 

include inquiries to upstream suppliers 

or downstream users or employees or 

other agents of the manufacturer, 

including persons involved in the 

research and development, import or 

production, or marketing for 

information pertinent to the criteria 

listed in the proposed rule. 

EPA nonetheless still anticipates that 

manufacturers may not be in a position 

to provide the Agency with all the 

information necessary to complete the 

risk evaluation. EPA received comments 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74314 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

on the original 2017 proposed rule, for 

example, that manufacturers who do not 

produce the chemical for a particular 

use may not be able to obtain 

information pertaining to that use. To 

address this issue, EPA is proposing a 

process described further in Unit III.K.4. 

to formalize how such shortcomings 

will be identified and addressed. In 

short, where the requesting 

manufacturer is unable to provide all 

the information EPA needs for risk 

evaluation, the requesting manufacturer 

can request EPA use its information 

collection authorities under TSCA 

sections 4 (require manufacturers 

(including importers) or processors to 

test chemicals and report their findings), 

8 (require reporting on chemical 

manufacturing, processing, and use, or 

require the submission of unpublished 

chemical health and safety information 

from manufactures (including 

importers), processors, or distributors), 

or 11 (ability to inspect facilities where 

chemicals are manufactured, processed, 

stored, or held before or after their 

distribution in commerce), to fill in the 

gaps. Where the information need is 

identified after the risk evaluation has 

already been initiated, the requesting 

manufacturer must also suspend its 

request to allow sufficient time for the 

Agency to exercise those authorities. 

These changes set clearer expectations 

for what EPA needs to undertake in a 

risk evaluation, and establish a process 

for productive engagement with 

requesting manufacturers toward 

meeting those needs. 

4. EPA Process for Reviewing Requests 

EPA is proposing a number of changes 

to how the Agency will review MRREs. 

As described in this Unit, the current 

process simply does not allow enough 

time for thoughtful review of requests 

and consideration of potential 

information needs. As such, at 

§ 702.45(e) of the regulatory text, EPA is 

proposing changes to the steps the 

Agency will take upon receipt of a 

MRRE, including additional measures 

for transparency and public 

engagement. The following is a general 

description of the proposed procedural 

steps: 

Notice of Receipt. EPA will provide 

the public with notice within 15 days 

that a MRRE has been received. 

Although the proposed rule does not 

specify the means of notice, EPA 

expects to generally do so through 

updates to its website and email listserv 

notifications. 

Initial Review for Completeness. EPA 

will then begin reviewing the request 

and supporting information against the 

requirements in the proposed rule to 

determine whether or not the request 

appears complete. Requests that are 

clearly missing key required 

information in § 702.45(c) or are 

otherwise not well-supported will be 

rejected and returned to the submitter as 

incomplete. For example, EPA would 

consider a request for evaluation of 

category of chemicals incomplete where 

the request does not provide a rationale 

as to why the categorization is 

appropriate under TSCA section 26(c). 

Likewise, where a request fails to 

describe the circumstances related to 

the full lifecycle of the chemical 

substance (i.e., manufacture, processing, 

distribution in commerce, use and 

disposal) or to provide an explanation 

as to why such information is 

unavailable to the requestor, EPA may 

reject the request as incomplete. During 

this step, EPA may also make an initial 

judgment as to the quality or quantity of 

information provided by the requesting 

manufacturer(s) and the sufficiency of 

that information to support a risk 

evaluation. Where the information is 

generally of poor quality, or when very 

little information is provided, EPA may 

also reject the request. 

This initial review step allows the 

Agency to screen incoming requests 

before advancing to the more time- and 

resource-intensive steps associated with 

reviewing a MRRE. Where EPA 

determines a request to be incomplete, 

the requesting manufacturer can simply 

supplement and resubmit the request. 

Where EPA initially determines the 

request to be complete, EPA will 

advance to the next step in the process: 

public notice and opportunity for 

comment. 

Public Notice and Comment. Where 

EPA initially determines the request to 

be complete, EPA will submit a notice 

of receipt of the MRRE for publication 

in the Federal Register within 90 days. 

EPA will also open a docket that 

includes all non-CBI and CBI-sanitized 

information included in the request and 

provide no less than a 60-day public 

comment period. EPA may also solicit 

specific comments on the request, 

including feedback on the conditions of 

use listed by the manufacturer in the 

request and information regarding 

sufficiency of available information to 

support a risk evaluation. 

Secondary Review for Sufficiency. 

From the start of the public comment 

period, EPA would expect to begin 

conducting a more in-depth review of 

the request to determine whether there 

is sufficient information to support a 

reasoned evaluation on the chemical 

substance. Concurrently, EPA expects to 

conduct an internal cursory review of 

other reasonably available information, 

however more comprehensive 

information collection would occur 

post-granting of the request. For EPAinitiated risk evaluations, EPA has 

clearly indicated that it would not 

expect to initiate the prioritization 

process until there is sufficient 

information to complete both the 

prioritization and risk evaluation 

processes. Likewise, EPA would not 

expect to grant an MRRE until confident 

that there is a similar level of 

information to support evaluation. As 

described in the proposed rule, EPA 

may determine that certain information 

gaps can be addressed through 

application of assumptions, uncertainty 

factors, models, and/or screening, 

consistent with TSCA section 26, 

without the need for additional data. 

EPA’s review during this period would 

encompass both the information 

provided with the request and any 

additional relevant information that 

may be uniquely available to EPA (e.g., 

TSCA CBI data that may not otherwise 

be known to or reasonably ascertainable 

by the requesting manufacturer). 

Following the close of the public 

comment period, EPA will further 

consider feedback from the public as to 

the sufficiency of available information. 

For example, if public comments 

indicate there are additional conditions 

of use, and the request does not identify 

or provide information relevant to those 

conditions of use, EPA may deem the 

request insufficient and return to the 

submitter for further consideration and 

possible supplementation. 

EPA may also determine during this 

period whether there are deficiencies in 

the request, including data quality 

considerations, not identified during 

EPA’s initial review for completeness. 

EPA’s review for sufficiency will be 

completed within 90 days from the end 

of the public comment period. For 

requests determined not to be supported 

by sufficient information during this 

period, EPA will reject the request— 

effectively ending the Agency’s 

review—and notify the requesting 

manufacturer. EPA generally expects to 

keep the public apprised of the status of 

requests through updates to its website. 

The requesting manufacturer would 

have the opportunity to further 

supplement and resubmit their request 

to EPA. Additionally, where the 

submitter believes that the information 

is not reasonably ascertainable by them, 

they can include in their resubmission 

a request—as described in this Unit— 

that EPA exercise its information 

gathering authorities to collect and/or 

develop information necessary to 

remedy the deficiency. For requests 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74315 

determined to be supported by 

sufficient information, EPA will proceed 

with granting the request and 

continuing the review process. 

Grant. As described elsewhere in this 

Unit III.K.4., and subject to the 

percentage limitations in TSCA section 

6(b)(4)(E)(i)(II), EPA will grant MRRE 

requests that are both complete and 

supported by sufficient information. 

Under the 2017 final rule, a ‘‘grant’’ of 

a MRRE request effectively means that 

EPA has determined it has all 

information needed to conduct such risk 

evaluation. While EPA intends to make 

every effort to ensure sufficient 

information before granting a MRRE 

request, absolute certainty is not 

possible. Given the nature of risk 

assessment and public processes 

associated with TSCA risk evaluations, 

there may be occasion where EPA 

becomes aware of critical information 

needs later in the process. As such, the 

proposed rule specifically reserves the 

right for EPA to identify additional 

information needs for the risk 

evaluation at any time, including after 

granting the MRRE request. 

Publication of Draft Conditions of Use 

and Request for Information. EPA will 

next publish a notice in the Federal 

Register that sets out, in draft form, the 

Agency’s preliminary determination on 

the chemical’s conditions of use, taking 

into account information provided in 

the MRRE request, information received 

during the first public comment period, 

and EPA’s own further review efforts. 

This notice will request relevant 

information from the public, and 

provide no less than a 60-day public 

comment period. Given that a 

chemical’s conditions of use are such an 

important component to define the 

scope of the risk evaluation, EPA felt it 

was important to share its 

understanding and provide an 

opportunity for additional feedback 

before formally initiating the MRRE. In 

the context of EPA-initiated risk 

evaluations, EPA expects this 

engagement to occur during the 

prioritization process, and, similarly, 

before the formal initiation of the risk 

evaluation and start of the statutory 

deadline for completion. Within 90 days 

following the close of the public 

comment period in this paragraph, and 

depending on the nature of comments 

received, EPA will either initiate the 

risk evaluation or notify the requesting 

manufacturer of any additional 

information needs. 

Initiation of Risk Evaluation. Upon 

initiation of the MRRE, EPA will follow 

all requirements in this proposed rule 

including but not limited to proposed 

sections 702.37 through 702.49. EPA 

will notify the manufacturer that the 

MRRE has been initiated, and similarly 

expects to keep the public apprised of 

the status through updates to its 

website. As indicated previously, EPA is 

reserving the right to identify additional 

information needs at any time during 

the risk evaluation process, including 

post-initiation. 

Identification of Information Needs. 

Where additional information needs are 

identified at any time before the MRRE 

has been granted, the proposed rule 

provides a clear process for 

supplementation and resubmittal of the 

request. However, where additional 

information needs are identified at any 

point following EPA’s grant of the 

MRRE, EPA will notify the requesting 

manufacturer(s) and set a reasonable 

amount of time, as determined by EPA, 

for manufacturers to respond to the 

Agency’s notice. In response to EPA’s 

notice, the manufacturer can choose to 

(1) provide the necessary information to 

EPA, (2) if the risk evaluation has not 

yet been initiated, withdraw the MRRE 

request, or (3) request that EPA obtain 

the information using authorities under 

TSCA sections 4, 8 or 11. 

Where a manufacturer chooses to 

provide—or develop and provide—the 

necessary information, EPA will set a 

reasonable amount of time for the 

requesting manufacturer to provide that 

information to EPA. Upon receipt of the 

new information, EPA will review the 

information within 90 days and 

determine whether or not it satisfies the 

identified need—again providing notice 

to the requesting manufacturer of its 

determination, and keeping the public 

apprised of the status of the MRRE on 

its website. EPA would further 

endeavor, to the extent possible, to 

make the supplemental information 

publicly available in the docket. 

Alternatively, in the event the risk 

evaluation has not yet been initiated, 

the requesting manufacturer may 

withdraw the MRRE request. This 

option gives the requesting 

manufacturer some flexibility in the 

event that developing the necessary 

information would be considered too 

costly or time consuming. Any fees to be 

collected or refunded would be 

determined in accordance with this 

proposed rule and the TSCA fee 

provisions in 40 CFR 700.45. MRRE 

requests cannot be withdrawn by the 

requesting manufacturer once EPA has 

initiated the risk evaluation. 

Lastly, where the requesting 

manufacturer believes that they can 

neither collect nor develop the 

identified information, they may request 

that EPA obtain the information using 

its authorities under TSCA sections 4, 8 

or 11. As part of such a request, the 

manufacturer must provide a rationale 

as to why the information is not 

reasonably ascertainable to them. EPA 

will review the request and provide 

notice of its determination to the 

requesting manufacturer as to whether 

or not use of these authorities is 

warranted. Where EPA agrees to use its 

authorities, EPA will review the new 

information within 90 days of receipt 

and determine whether or not it satisfies 

the identified need—again providing 

notice to the requesting manufacturer 

and keeping the public apprised of the 

status of the MRRE on its website. EPA 

would further endeavor, to the extent 

possible, to make the supplemental 

information publicly available in the 

docket. 

EPA recognizes that Congress clearly 

intended for those requesting MRREs to 

cover either 50% or 100% of the costs 

to carry out the risk evaluation. See 15 

U.S.C. 2625(b)(4)(D). However, in the 

event that EPA exercises its authorities 

to gather additional necessary 

information, costs may be imposed 

upon entities other than the requesting 

manufacturer. For example, if EPA 

issues a test order under TSCA section 

4 to support a MRRE, another entity 

could have to pay both the test order fee 

as well as the costs of developing the 

information. While the costs to EPA 

would be reflected in the final invoice 

to the requesting manufacturer, EPA is 

seeking comment on, to the extent that 

test orders are issued to support a 

MRRE, whether EPA should amend the 

regulation to allow the entire test order 

fee to be directed to the requesting 

manufacturer, even where an order is 

issued to another entity who is not the 

requesting manufacturer. 

Unfulfilled Information Needs. EPA 

believes it is important that the 

procedures in this proposed rule 

account for a scenario in which 

information needs are not met, and the 

Agency is simply unable to complete 

the risk evaluation. In circumstances 

where EPA has identified additional 

data needs, but the requesting 

manufacturer(s) is unable or unwilling 

to fulfill those needs in a timely 

manner, has produced information that 

is insufficient to meet the need as 

determined by EPA, or where EPA 

determines that a request to use gather 

information under TSCA sections 4, 8 or 

11 is not warranted (e.g., where the 

information is ascertainable by the 

manufacturer or the request does not 

provide a sufficient rationale), the 

proposed rule at § 702.45(g) 

contemplates that EPA can deem the 

MRRE request to be constructively 

withdrawn (i.e., EPA would construe 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74316 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

the MRRE request to be withdrawn even 

in the absence of a request to withdraw). 

Any fees to be collected or refunded 

would be determined in accordance 

with this proposed rule and the TSCA 

fee provisions in 40 CFR 700.45. 

Fees for MRRE will generally be 

determined in accordance with 40 CFR 

700.45. However, this proposed rule 

further specifies that in the event that a 

MRRE request is withdrawn after it has 

been granted—either by the requesting 

manufacturer or constructively 

withdrawn by EPA—the total fee 

amount due will be either, in 

accordance with 40 CFR 700.45(c)(2)(x) 

or (xi) (as applicable), 50% or 100% 

(respectively) of the actual costs 

expended in carrying out the risk 

evaluation as of the date of receipt of the 

withdrawal notice. The payment 

amount will be determined by EPA, and 

invoice or refund issued to the 

requesting manufacturer as appropriate. 

IV. Requests for Comment 

EPA requests comment on all aspects 

of the proposed rule discussed in this 

Unit III., including comment on whether 

the proposed rule would enhance 

transparency and public understanding 

of EPA’s TSCA risk evaluation process 

and better align with the 2016 

amendments to TSCA under the Frank 

R. Lautenberg Chemical Safety for the 

21st Century Act (Pub. L. 114–182, 130 

Stat. 448). Additionally, within this 

proposal, the Agency is soliciting 

feedback from the public on specific 

issues throughout this proposed rule. 

For ease of review, this section 

summarizes those specific requests for 

comment. 

1. EPA requests comment on how the 

Agency could consider potential 

climate-related risks in a risk 

evaluation. 

2. EPA requests comment on the 

proposed approach of publishing a draft 

scoped during the prioritization process 

when it is clear that the chemical 

undergoing the prioritization process 

will be designated as a high-priority 

chemical. 

3. EPA requests public comment on 

the proposed elimination of the 

definitions of best available science and 

weight of scientific evidence, the need 

for such definitions, and the utility of 

definitions as the state of science 

evolves. 

4. EPA requests comments on the 

proposed changes to the process of a 

manufacturer requested risk evaluation. 

In regards to cost, while the costs to 

EPA would be reflected in the final 

invoice to the requesting manufacturer, 

EPA is seeking comment on, to the 

extent that test orders are issued to 

support a MRRE, whether the entire test 

order fee should also be directed to the 

requesting manufacturer, even where 

the order is also issued to another 

entity. Additionally, EPA requests 

specific comment on the burden 

estimate of a manufacturer requested 

risk evaluation, including the 

assumptions used in estimating the 

burden (e.g., number of requests EPA 

expects). 

5. EPA requests comment on general 

approaches or best practices for 

improving engagement with small 

entities. Early engagement with and 

feedback from all those who 

manufacture, process, distribute, use or 

dispose of a chemical is critical for the 

Agency to be able to accurately identify 

and characterize that chemical’s 

conditions of use for consideration in 

the risk evaluation, EPA is seeking 

comment on how to improve its 

outreach to the stakeholder community, 

including education on the TSCA risk 

evaluation process for small entities. 

6. EPA requests public comment on 

how the Agency can provide a 

transparent and detailed basis for the 

proposed unreasonable risk 

determination and existing chemical 

exposure limits derived from the risk 

evaluation process. 

V. Reliance Interests 

The proposed rule includes some 

statutory interpretations that differ from 

those previously held by the Agency at 

the time it issued the 2017 final rule, 

and, as part of developing this proposed 

rule, EPA has considered to what extent 

stakeholders may have reliance interests 

in those previous interpretations. EPA 

believes that there are either no reliance 

interests on those past statutory 

interpretations, or that any such 

interests are minor. The current rule and 

proposed changes largely pertain to 

internal Agency procedures that guide 

the Agency’s risk evaluation activities 

under TSCA and mostly do not directly 

impact external parties, with one 

exception being modified procedural 

requirements for voluntary requests for 

risk evaluation submitted by 

manufacturers. However, to the extent 

there were any reliance interests on the 

prior interpretations, or the risk 

evaluations that were developed based 

on the previous procedural 

requirements, nothing in the proposed 

rule is intended to apply retroactively. 

EPA does not believe stakeholders have 

reliance interests pertaining to the 

process for future, yet-to-be-completed 

risk evaluations that will be carried out 

in accordance with this proposed rule. 

VI. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not itself physically located 

in the docket. For assistance in locating 

these other documents, please consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

1. U.S. EPA. Procedures for Chemical Risk 

Evaluation Under the Amended Toxic 

Substances Control Act; Final Rule. 

Federal Register (82 FR 33726, July 20, 

2017) (FRL–9964–38). https://

www.govinfo.gov/content/pkg/FR-2017- 

07-20/pdf/2017-14337.pdf. 

2. U.S. Court of Appeals for the Ninth 

Circuit. Safer Chemicals, Healthy 

Families v. USEPA, No. 17–72260 No. 

17–72501 No. 17–72968 No. 17–73290 

No. 17–73383 No. 17–73390, Opinion. 

November 14, 2019. 943 F.3d 397, 425– 

426. https://cdn.ca9.uscourts.gov/ 

datastore/opinions/2019/11/14/17- 

72260.pdf. 

3. Executive Order 13990. Protecting Public 

Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis. Federal Register (86 FR 7037, 

January 25, 2021). https://

www.govinfo.gov/content/pkg/FR-2021- 

01-25/pdf/2021-01765.pdf. 

4. U.S. EPA. Information Collection Request 

(ICR) for the Proposed Rule: Procedures 

for Chemical Risk Evaluation Under 

TSCA. EPA ICR No.: 2781.01 and OMB 

Control No. 2070–NEW. 

5. Safer Chemicals, Healthy Families; et al., 

v. U.S. Environmental Protection 

Agency, No. 17–72260, 17–72501, 17– 

72968, 17–73290, 17–73383, 17–73390, 

2019 WL 6041996 (9th Cir. Nov. 14, 

2019). 

6. The White House, Briefing Room. Fact 

Sheet: List of Agency Actions for 

Review. January 20, 2021. https://

www.whitehouse.gov/briefing-room/ 

statements-releases/2021/01/20/factsheet-list-of-agency-actions-for-review/. 

7. U.S. EPA. EPA Announces Path Forward 

for TSCA Chemical Risk Evaluations. 

Press Release. June 30, 2021. https://

www.epa.gov/newsreleases/epaannounces-path-forward-tsca-chemicalrisk-evaluations. 

8. U.S. EPA. Assessing and Managing 

Chemicals under TSCA. Chemicals 

Undergoing Risk Evaluation under 

TSCA. https://www.epa.gov/assessingand-managing-chemicals-under-tsca/ 

chemicals-undergoing-risk-evaluationunder-tsca (Accessed May 31, 2023.) 

9. U.S. EPA. Procedures for Chemical Risk 

Evaluation Under the Amended Toxic 

Substances; Proposed Rule. Federal 

Register. (82 FR 7562, January 19, 2017) 

(FRL–9957–75). https://

www.govinfo.gov/content/pkg/FR-2017- 

01-19/pdf/2017-01224.pdf. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74317 

10. U.S. EPA. Exposure Factors Handbook: 

2011 Edition. EPA/600/R–090/052F. 

Office of Research and Development, 

National Center for Environmental 

Assessment. Washington, DC. 2011. 

https://cfpub.epa.gov/ncea/cfm/ 

recordisplay.cfm?deid=236252. 

11. U.S. Senate Congressional Record, 162 

Cong. Rec. S3511–01 (daily ed. June 7, 

2016). https://www.congress.gov/114/ 

crec/2016/06/07/CREC-2016-06-07-pt1- 

PgS3511.pdf. 

12. U.S. EPA. Problem Formulation of the 

Risk Evaluation for 1,4-Dioxane. EPA/ 

740/R1/7012. Office of Chemical Safety 

and Pollution Prevention. Washington, 

DC. 2018. https://www.regulations.gov/ 

document/EPA-HQ-OPPT-2016-0723- 

0064. 

13. U.S. EPA. Risk Evaluation for Methylene 

Chloride (Dichloromethane, DCM) 

CASRN: 75–09–2. EPA–740–R1–8010. 

Office of Chemical Safety and Pollution 

Prevention. Washington, DC. 2020. 

https://www.regulations.gov/document/ 

EPA-HQ-OPPT-2016-0742. 

14. TSCA Science Advisory Committee on 

Chemicals. Peer Review for EPA Draft 

Risk Evaluation for Methylene Chloride. 

Meeting Minutes and Final Report No. 

2020–1. March 2020. https://

www.regulations.gov/document/EPAHQ-OPPT-2019-0437-0080. 

15. Comment from the Attorneys General of 

Massachusetts, California, Hawaii, 

Maine, Maryland, New Jersey, New York, 

Oregon, Vermont, Washington, and the 

District of Columbia. Comments 

submitted to EPA in response to Notice 

of Availability on Problem Formulations 

for the Risk Evaluations to be Conducted 

Under the Toxic Substances Control Act 

and General Guiding Principles to Apply 

Systematic Review in TSCA Risk 

Evaluations. https://

www.regulations.gov/comment/EPA-HQOPPT-2016-0723-0074. 

16. Safer Chemicals, Healthy Families et al. 

Comments submitted to EPA on Notice 

of Availability on Risk Evaluation 

Problem Formulations Documents for 

Ten Chemical Substances under the 

Toxic Substances Control Act. https://

www.regulations.gov/docket/EPA-HQOPPT-2016-0723-0089. 

17. U.S. EPA. Draft TSCA Screening Level 

Approach for Assessing Ambient Air and 

Water Exposures to Fenceline 

Communities Version 1.0. EPA/744/D/ 

22/001. Washington, DC. 2022. https://

www.epa.gov/system/files/documents/ 

2022-01/draft-fenceline-report_sacc.pdf. 

18. Conference Committee Report on TSCA, 

Public Law 94–469, Senate Rep. No 94– 

1302 at 85 (1976) Conf Rep. https://

www.congress.gov/bill/94th-congress/ 

senate-bill/3149. 

19. OSHA. Permissible Exposure Limits 

Annotated Tables. https://

www.osha.gov/annotated-pels. (Accessed 

May 30, 2023). 

20. U.S. EPA. General Principles for 

Performing Aggregate Exposure and Risk 

Assessment. Office of Pesticide 

Programs. November 28, 2001. https://

www.epa.gov/sites/default/files/2015-07/ 

documents/aggregate.pdf. 

21. NRC. Science and Judgment in Risk 

Assessment. The National Academies 

Press. Washington, DC. 1994. https://

dx.doi.org/10.17226/2125. 

22. NRC. Phthalates and Cumulative Risk 

Assessment: The Task Ahead. National 

Academies Press. Washington, DC. 2008. 

https://dx.doi.org/10.17226/12528. 

23. NRC. Science and Decisions: Advancing 

Risk Assessment. National Academies 

Press. Washington, DC. 2009. https://

dx.doi.org/10.17226/12209. 

24. Food Quality Protection Act. 5.U.S.C. 136 

et. seq. 

25. U.S. EPA. Framework for Cumulative 

Risk Assessment. EPA/630/P–02/001F. 

Risk Assessment Forum. Washington, 

DC. May 2003. https://www.epa.gov/ 

sites/default/files/2014-11/documents/ 

frmwrk_cum_risk_assmnt.pdf. 

26. U.S. EPA. Guidelines for the Health Risk 

Assessment of Chemical Mixtures. 

Federal Register. (51 FR 34028, 

September 24, 1986) (FRL–2984–3). 

https://www.govinfo.gov/content/pkg/ 

FR-1986-09-24/pdf/FR-1986-09- 

24.pdf#page=158. 

27. U.S. EPA. Supplementary Guidance for 

Conducting Health Risk Assessment of 

Chemical Mixtures. EPA/630/R–00/ 

002.Risk Assessment Forum. 

Washington, DC. August 2000. https://

cfpub.epa.gov/ncea/cfm/ 

recordisplay.cfm?deid=20533. 

28. U.S. EPA. Guidance on Cumulative Risk 

Assessment of Pesticide Chemicals That 

Have a Common Mechanism of Toxicity. 

Office of Pesticide Programs. 

Washington, DC. January 14, 2002. 

https://www.regulations.gov/document/ 

EPA-HQ-OPP-2007-0797-0001. 

29. U.S. EPA. Pesticide Cumulative Risk 

Assessment: Framework for Screening 

Analysis Purpose. Office of Chemical 

Safety and Pollution Prevention, Office 

of Pesticide Programs. Washington, DC. 

April 12, 2016. https://

www.regulations.gov/document/EPAHQ-OPP-2015-0422-0019. 

30. OECD. Considerations for assessing the 

risks of combined exposure to multiple 

chemicals (No. 558 296). In Series on 

Testing and Assessment No 296. Paris, 

France. 2018. https://dx.doi.org/10.1787/ 

ceca15a9-en. 

31. Meek, M.E.; Boobis, Alan R.; Crofton, 

Kevin M.; Heinemeyer, Gerhard; Van 

Raaij, Marcel; Vickers, Carolyn. Risk 

Assessment of Combined Exposure to 

Multiple Chemicals: A WHO/IPCS 

Framework. Regulatory Toxicology and 

Pharmacology. July 1, 2011. 60:S1–S14. 

https://dx.doi.org/10.1016/ 

j.yrtph.2011.03.010. 

32. U.S. EPA. Draft Proposed Principles of 

Cumulative Risk Assessment Under the 

Toxic Substances Control Act. EPA/740/ 

P/23/001. Office of Chemical Safety and 

Pollution Prevention. Washington, DC. 

February 2023. https://

www.regulations.gov/document/EPAHQ-OPPT-2022-0918-0008. 

33. U.S. EPA. Draft Proposed Approach for 

Cumulative Risk Assessment of HighPriority Phthalates and a Manufacturer 

Requested Phthalate Under the Toxic 

Substances Control Act Control Act. 

EPA/740/P/23/002. Office of Chemical 

Safety and Pollution Prevention. 

Washington, DC. February 2023. https:// 

www.regulations.gov/document/EPAHQ-OPPT-2022-0918-0009. 

34. U.S. EPA. Cumulative Impacts Research: 

Recommendations for EPA’s Office of 

Research and Development. EPA 600/R– 

22/014a. Office of Research and 

Development. Washington, DC. 

September 30, 2022. https://

www.epa.gov/system/files/documents/ 

2023-05/cumulative%20impacts%20

research-final%20report-epa%20600-r22-014a%20%2812%29.pdf. 

35. U.S. EPA. EJSCREEN: Environmental 

Justice Screening and Mapping Tool. 

https://www.epa.gov/ejscreen. 

36. U.S. EPA. EnviroAtlas. https://

www.epa.gov/enviroatlas. 

37. U.S. EPA. Guidelines for Carcinogen Risk 

Assessment. EPA/630/P–03/001F. Risk 

Assessment Forum. Washington, DC. 

March 2005. https://

www.regulations.gov/document/EPAHQ-OA-2007-0679-0001. 

38. U.S. EPA. Supplemental Guidance for 

Assessing Susceptibility from Early-Life 

Exposure to Carcinogens. EPA/630/R– 

03/003F. Risk Assessment Forum. 

Washington, DC. March 2005. https://

www.epa.gov/sites/default/files/2013-09/ 

documents/childrens_supplement_

final.pdf. 

39. U.S. EPA. Peer Review Handbook (4th 

Edition). EPA/100/B–15/001. Science 

and Technology Policy Council. 

Washington, DC. October 2015. https://

www.epa.gov/sites/default/files/2020-08/ 

documents/epa_peer_review_handbook_

4th_edition.pdf. 

40. OMB. Final Information Quality Bulletin 

for Peer Review. Federal Register. (70 FR 

2664, January 14, 2005). https://

www.govinfo.gov/content/pkg/FR-2005- 

01-14/pdf/05-769.pdf. 

41. U.S. EPA. Draft Risk Evaluation for C.I. 

Pigment Violet 29 (Anthra[2,1,9- 

def:6,5,10-d′e′f′]diisoquinoline 

1,3,8,10(2H,9H)-tetrone) CASRN: 81–33– 

4. 740R18015. Office of Chemical Safety 

and Pollution Prevention. Washington, 

DC. November 2018. https://

www.regulations.gov/document/EPAHQ-OPPT-2018-0604-0007. 

42. U.S. EPA. Draft Supplemental Analysis to 

the Draft Risk Evaluation for 1,4- 

Dioxane. EPA–740–R1–8007. Office of 

Chemical Safety and Pollution 

Prevention. November 2020. https://

www.regulations.gov/document/EPAHQ-OPPT-2019-0238-0067. 

43. TSCA Science Advisory Committee on 

Chemicals. Peer Review for EPA Draft 

Risk Evaluation for 1,4-Dioxane and 

Cyclic Aliphatic Bromide Cluster 

(HBCD). Meeting Minutes and Final 

Report No. 2019–02. October 2019. 

https://www.regulations.gov/document/ 

EPA-HQ-OPPT-2019-0238-0063. 

44. Comments submitted to EPA in response 

to Notice of Availability on U.S. EPA. 

Procedures for Chemical Risk Evaluation 

Under the Amended Toxic Substances; 

Proposed Rule. https://


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74318 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

www.regulations.gov/docket/EPA-HQOPPT-2016-0654/comments. 

45. Safe Drinking Water Act. 42 U.S.C. 300f 

et seq. 

46. U.S. EPA. Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, 

Utility, and Integrity, of Information 

Disseminated by the Environmental 

Protection Agency. EPA/260R–02–008. 

Office of Environmental Information. 

Washington, DC. October 2002. https://

www.epa.gov/sites/default/files/2020-02/ 

documents/epa-info-quality-guidelines_

pdf_version.pdf. 

47. U.S. EPA. Application of Systematic 

Review in TSCA Risk Evaluations. EPA/ 

740/P1/8001. Office of Chemical Safety 

and Pollution Prevention. May 2018. 

https://www.epa.gov/sites/default/files/ 

2018-06/documents/final_application_

of_sr_in_tsca_05-31-18.pdf. 

48. National Academies of Sciences 

Engineering and Medicine. The Use of 

Systematic Review in EPA’s Toxic 

Substances Control Act Risk Evaluations. 

The National Academies Press. 

Washington, DC. 2021. https://doi.org/ 

10.17226/25952. 

49. U.S. EPA. (2021) Draft TSCA Systematic 

Review Protocol Supporting TSCA Risk 

Evaluations for Chemical Substances: A 

Generic TSCA Systematic Review 

Protocol with Chemical-Specific 

Methodologies (Version 1.0). EPA–D–20– 

031. Office of Chemical Safety and 

Pollution Prevention. Washington, DC. 

December 2021. https://

www.regulations.gov/document/EPAHQ-OPPT-2021-0414-0005. 

50. NRC. Review of EPA’s Integrated Risk 

Information System (IRIS) Process. The 

National Academies Press. Washington, 

DC. 2014. https://www.nap.edu/catalog/ 

18764/review-of-epas-integratedriskinformation-system-iris-process. 

51. EDSTAC. Endocrine Disruptor Screening 

and Testing Advisory Committee, Final 

Report, Volume I–II. Washington, DC 

1998. https://www.epa.gov/scipoly/ 

oscpendo/pubs/edspoverview/ 

finalrpt.htm. 

52. U.S. EPA. Weight of Evidence in 

Ecological Assessment. EPA/100/R–16/ 

001. Risk Assessment Forum. 

Washington, DC. December 2016. https:// 

nepis.epa.gov/Exe/ 

ZyPURL.cgi?Dockey=P100SFXR.txt. 

53. U.S. EPA. Endocrine Disruptor Screening 

Program (EDSP); Weight-of-Evidence: 

Evaluating Results of EDSP Tier 1 

Screening to Identify the Need for Tier 

2 Testing. Office of Chemical Safety and 

Pollution Prevention. Washington, DC. 

2011. https://www.regulations.gov/ 

document/EPA-HQ-OPPT-2010-0877- 

0021. 

54. U.S. EPA. ORD Staff Handbook for 

Developing IRIS Assessments (2022). 

EPA/600/R–22/268. Office of Research 

and Development. Washington, DC. 

https://cfpub.epa.gov/ncea/iris_drafts/ 

recordisplay.cfm?deid=356370. 

55. U.S. EPA. Tiered Data Reporting to 

Inform, Prioritization, Risk Evaluation, 

and Risk Management under TSCA. 

Office of Chemical Safety and Pollution 

Prevention. https://www.epa.gov/ 

chemical-data-reporting/tiered-datareporting-inform-prioritization-riskevaluation-and-risk. (Accessed May 31, 

2023.) 

VI. 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 

12866 (58 FR 51735, October 4, 1993), 

as amended by Executive Order 14094 

(88 FR 21879, April 11, 2023). 

Accordingly, EPA submitted this action 

to the OMB for Executive Order 12866 

review. Documentation of any changes 

made in response to the Executive Order 

12866 review are documented in the 

docket. EPA prepared an analysis of the 

potential costs associated with this 

action. This analysis can be found in 

Unit VI.B. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this proposed rule have been 

submitted for approval to OMB under 

the PRA, 44 U.S.C. 3501 et seq. EPA has 

prepared a new rule-related Information 

Collection Request (ICR) document 

entitled ‘‘Procedures for Requesting a 

Chemical Risk Evaluation under TSCA 

(Proposed Rule)’’ and is identified by 

EPA ICR No. 2781.01, to replace an 

existing approved ICR. You can find a 

copy of the new ICR document (Ref. 4) 

in the docket for this rulemaking, and it 

is briefly summarized here. 

The information activities related to 

the current requirements for 

manufacturer-requested risk evaluations 

are already approved by OMB in an ICR 

entitled, ‘‘Procedures for Requesting a 

Chemical Risk Evaluation under TSCA’’ 

(EPA ICR No. 2559.03 and OMB Control 

No. 2070–0202) (Ref 4). The proposed 

rule replacement ICR addresses the 

information collection requirements 

contained in the current regulations as 

well as in the amendments identified in 

this proposed rule. As addressed in the 

currently approved ICR and pursuant 40 

CFR part 702, subpart B, the information 

collection activities are those carried out 

by a chemical manufacturer in 

requesting a specific chemical risk 

evaluation under TSCA be conducted by 

EPA. EPA established the process for 

conducting risk evaluations under 

TSCA. Chemicals that will undergo this 

evaluation include chemicals 

designated by the Agency as highpriority in accordance with 40 CFR part 

702, subpart A, as well as chemicals for 

which EPA has granted requests made 

by manufacturers to have the chemicals 

evaluated under EPA’s risk evaluation 

process. The replacement ICR addresses 

proposed amendments to information 

requirements for manufacturerrequested risk evaluations, including 

proposed amendments to information 

requirements addressing joint 

submissions, the scope of the requested 

risk evaluation, and the information to 

be provided in support of the requested 

risk evaluation, and fee payment. Please 

see Unit III.K. for additional information 

about these proposed amendments. 

The replacement ICR addresses 

adjustments to the estimated number of 

respondents, time for activities, and 

wage rates related to the current 

regulatory requirements as approved 

under OMB Control No. 2070–0202. In 

addition, the replacement ICR addresses 

program changes related to the proposed 

amendments, including changes to 

content requirements for manufacturerrequested risk evaluation request and 

associated process changes. The 

estimated annual burden approved by 

OMB under OMB Control No. 2070– 

0202 is 419 hours. The total estimated 

annual respondent burden being 

proposed in the replacement ICR is 166 

hours, a net decrease of 253 hours. The 

primary driver in the burden decrease is 

the estimated number of responses 

dropping to 1 per year based on the 

number of requests EPA has received to 

date. Certain information included with 

a manufacturer-requested risk 

evaluation may be claimed as TSCA CBI 

in accordance with TSCA section 14 (15 

U.S.C. 2613), and any such claims must 

be substantiated in accordance with the 

Act. 

Respondents/affected entities: 

Persons that manufacture chemical 

substances and request a chemical be 

considered for risk evaluation by EPA. 

Such persons may voluntarily request a 

risk evaluation but would be required to 

comply with the requirements for such 

a request. See Unit I.A. 

Respondent’s obligation to respond: 

Voluntary (15 U.S.C. 2605(b)(4)). 

Estimated number of respondents: 3. 

Frequency of response: On occasion. 

Total estimated burden: 166 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $115,711 (per 

year), 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74319 

control number. The OMB control 

numbers for the EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. 

Submit your comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates and any suggested methods 

for minimizing respondent burden to 

EPA using the docket identified at the 

beginning of this rulemaking. EPA will 

respond to any ICR-related comments in 

the final rule. You may also send your 

ICR-related comments to OMB’s Office 

of Information and Regulatory Affairs 

using the interface at https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular ICR by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. OMB must receive 

comments no later than November 29, 

2023. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA, 5 U.S.C. 601 et seq. The 

small entities subject to the 

requirements of this action are 

manufacturers of chemical substances 

that submit requests to EPA seeking 

chemical risk evaluations. The Agency 

has determined that a low number of 

small entities may be impacted by 

voluntarily submitting a request to EPA 

for a chemical to undergo a risk 

evaluation. The 2017 final rule 

considered firms in 60 different NAICS 

codes that may choose to pursue a 

manufacturer-requested risk evaluation 

(approximately 30,000 firms) of which 

76 percent were classified as small 

business (approximately 22,000 firms). 

When EPA promulgated the 2017 final 

rule, the Agency estimated that it would 

receive 5 MRRE submissions per year. 

However, manufacturers have submitted 

only 4 MRRE requests since 2017 (or 

less than one request per year, on 

average). Therefore, based on the 

number of submissions received by EPA 

since 2017, the Agency estimates it will 

receive only one manufacture-requested 

risk revaluation per year. That is, only 

one out of approximately 22,000 small 

businesses is expected to choose to 

incur the submission costs ($115,711) in 

any one year and, thus, a significant 

number of small businesses would not 

be impacted by this rulemaking. The 

decision to request a risk evaluation for 

a chemical is voluntary and 

manufacturers may decide not to make 

such a request. Details of this analysis 

are presented in the rule-related ICR. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. The action imposes no 

enforceable duty on any state, local or 

tribal governments. The costs involved 

in this action are imposed only on the 

private sector entities (manufacturers) 

that may voluntarily elect to submit a 

request for a risk evaluation as they 

would be required to comply with the 

proposed requirements for such 

requests. 

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. 

TSCA section 18(c)(3) defines the 

scope of Federal preemption with 

respect to any final rule EPA issues 

under TSCA section 6(a). That provision 

provides that Federal preemption of 

‘‘statutes, criminal penalties, and 

administrative actions’’ applies to ‘‘the 

hazards, exposures, risks, and uses or 

conditions of use of such chemical 

substances included in any final action 

the Administrator takes pursuant to 

[TSCA section 6(a)].’’ EPA reads this to 

mean that states are preempted from 

imposing requirements through statutes, 

criminal penalties, and administrative 

actions relating to any ‘‘hazards, 

exposures, risks, and uses or conditions 

of use’’ evaluated in the final risk 

evaluation and informing the risk 

determination that EPA addresses in the 

TSCA section 6(a) rulemaking. For 

example, Federal preemption applies 

even if EPA does not regulate in that 

final rule a particular COU, but that 

COU was evaluated in the final risk 

evaluation. 

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 one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Thus, Executive Order 13175 does not 

apply to this action. 

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 address 

how EPA evaluates the risks of existing 

chemicals under TSCA, including 

potential risks to children and other 

PESS. EPA must initiate a rulemaking to 

address the unreasonable risk to human 

health or the environment that the 

Agency may determine are presented by 

a chemical substance as set forth in a 

TSCA risk evaluation. Although this 

procedural rule itself would not directly 

affect the level of protection provided to 

human health or the environment, EPA 

expects that this rulemaking would 

improve the Agency’s consideration of 

risks to children and other PESS and, in 

turn, better inform the Agency’s 

determination of whether a chemical 

substance presents an unreasonable risk 

of injury to health under its conditions 

of use. An EPA rulemaking to address 

an unreasonable risk of injury to health 

that the Administrator determines is 

presented by a chemical substance 

following a risk evaluation could qualify 

as a covered regulatory action under 

E.O. 13045 and could be subject to 

EPA’s Policy on Children’s Health. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211 (66 FR 28355, May 22, 2001) 

because it is not likely to have a 

significant adverse effect on the supply, 

distribution or use of energy and has not 

otherwise been designated by the 

Administrator of OMB’s Office of 

Information and Regulatory Affairs as a 

‘‘significant energy action.’’ 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74320 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This proposed rulemaking does not 

involve technical standards. As such, 

NTTAA section 12(d), 15 U.S.C. 272 

note, does not apply to this action. 

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 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 consistent with Executive 

Order 14096 (88 FR 25251, April 26, 

2023) and Executive Order 12898 (59 FR 

7629, February 16, 1994). This action 

proposes revisions to the procedures 

that EPA will use to evaluate the risk of 

existing chemical substances pursuant 

to TSCA, and the Agency cannot foresee 

the final results of those evaluations. 

However, by specifically including 

overburdened communities in the 

regulatory definition of PESS, the 

Agency believes that this action would 

assist EPA and others in determining 

the potential exposures, hazards and 

risks to overburdened communities 

associated with existing chemicals a 

part of a TSCA risk evaluation. The 

proposed inclusion of overburdened 

communities among the PESS 

considered in a chemical risk evaluation 

would also enable the Agency to design 

appropriate risk management 

approaches to address the unreasonable 

risk that the Agency may determine is 

presented by a chemical, including any 

unreasonable risk that is 

disproportionately borne by 

communities with environmental justice 

concerns. 

The information supporting this 

Executive order review is presented in 

Unit III.G.4. 

List of Subjects in 40 CFR Part 702 

Environmental protection, Chemicals, 

Chemical substances, Hazardous 

substances, Health and safety, Risk 

evaluation. 

Dated: October 18, 2023. 

Michal Freedhoff, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, for the reasons stated in the 

preamble, EPA proposes to amend 40 

CFR part 702 as follows: 

PART 702—GENERAL PRACTICES 

AND PROCEDURES 

■ 1. The authority citation for part 702 

continues to read as follows: 

Authority: 15 U.S.C. 2605 and 2619. 

■ 2. Revise and republish subpart B to 

read as follows: 

Subpart B—Procedures for Chemical 

Substance Risk Evaluations 

Sec. 

702.31 General provisions. 

702.33 Definitions. 

702.35 Chemical substances subject to risk 

evaluation. 

702.37 Evaluation requirements. 

702.39 Components of risk evaluation. 

702.41 Peer review. 

702.43 Risk evaluation actions and 

timeframes. 

702.45 Submission of manufacturer 

requests for risk evaluations. 

702.47 Interagency collaboration. 

702.49 Publicly available information. 

Subpart B—Procedures for Chemical 

Substance Risk Evaluations 

§ 702.31 General provisions. 

(a) Purpose. This subpart establishes 

the EPA process for conducting a risk 

evaluation to determine whether a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment as required under 

TSCA section 6(b)(4)(B) (15 U.S.C. 

2605(b)(4)(B)). 

(b) Scope. These regulations establish 

the general procedures, key definitions, 

and timelines EPA will use in a risk 

evaluation conducted pursuant to TSCA 

section 6(b) (15 U.S.C. 2605(b)). 

(c) Applicability. The requirements of 

this part apply to all chemical substance 

risk evaluations initiated pursuant to 

TSCA section 6(b) (15 U.S.C. 2605(b)) 

beginning [30 DAYS AFTER DATE OF 

PUBLICATION OF THE FINAL RULE 

IN THE FEDERAL REGISTER]. For risk 

evaluations initiated prior to this date, 

but not yet finalized, EPA will seek to 

apply the requirements in this subpart 

to the extent practicable. These 

requirements shall not apply 

retroactively to risk evaluations already 

finalized. 

(d) Categories of chemical substances. 

Consistent with EPA’s authority to take 

action with respect to categories of 

chemicals under 15 U.S.C. 2625(c), all 

references in this part to ‘‘chemical’’ or 

‘‘chemical substance’’ shall also apply 

to ‘‘a category of chemical substances.’’ 

§ 702.33 Definitions. 

All definitions in TSCA apply to this 

subpart. In addition, the following 

definitions apply: 

Act means the Toxic Substances 

Control Act, as amended (15 U.S.C. 

2601 et seq.). 

Aggregate exposure means the 

combined exposures from a chemical 

substance across multiple routes and 

across multiple pathways. 

Conditions of use means the 

circumstances, as determined by the 

Administrator, under which a chemical 

substance is intended, known, or 

reasonably foreseen to be manufactured, 

processed, distributed in commerce, 

used, or disposed of. 

EPA means the U.S. Environmental 

Protection Agency. 

Pathways means the physical course a 

chemical substance takes from the 

source to the organism exposed. 

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. 

Reasonably available information 

means information that EPA possesses 

or can reasonably generate, obtain, and 

synthesize for use in risk evaluations, 

considering the deadlines specified in 

TSCA section 6(b)(4)(G) for completing 

such evaluation. Information that meets 

the terms of the preceding sentence is 

reasonably available information 

whether or not the information is 

confidential business information, that 

is protected from public disclosure 

under TSCA section 14. 

Routes means the ways a chemical 

substance enters an organism after 

contact, e.g., by ingestion, inhalation, or 

dermal absorption. 

Sentinel exposure means the exposure 

from a chemical substance that 

represents the plausible upper bound of 

exposure relative to all other exposures 

within a broad category of similar or 

related exposures. 

Uncertainty means the imperfect 

knowledge or lack of precise knowledge 

of the real world either for specific 

values of interest or in the description 

of the system. 

Variability means the inherent natural 

variation, diversity, and heterogeneity 

across time and/or space or among 

individuals within a population. 

§ 702.35 Chemical substances subject to 

risk evaluation. 

(a) Chemical substances undergoing 

risk evaluation. A risk evaluation for a 

chemical substance designated by EPA 

as a High-Priority Substance pursuant to 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74321 

the prioritization process described in 

subpart A or initiated at the request of 

a manufacturer or manufacturers under 

§ 702.45, will be conducted in 

accordance with this part, subject to 

§ 702.31(c). 

(b) Percentage requirements. EPA will 

ensure that, of the number of chemical 

substances that undergo risk evaluation 

under 15 U.S.C. 2605(b)(4)(C)(i), the 

number of chemical substances 

undergoing risk evaluation under 15 

U.S.C. 2605(b)(4)(C)(ii) is not less than 

25%, if sufficient requests that comply 

with § 702.37, and not more than 50%. 

(c) Manufacturer-requested risk 

evaluations for work plan chemical 

substances. Manufacturer requests for 

risk evaluations, described in paragraph 

(a) of this section, for chemical 

substances that are drawn from the 2014 

update of the TSCA Work Plan for 

Chemical Assessments will be granted 

at the discretion of EPA. Such 

evaluations are not subject to the 

percentage requirements in paragraph 

(b) of this section. 

§ 702.37 Evaluation requirements. 

(a) Considerations. (1) EPA will use 

applicable EPA guidance when 

conducting risk evaluations, as 

appropriate and where it represents the 

best available science. 

(2) EPA will document that the risk 

evaluation is consistent with the best 

available science and based on the 

weight of the scientific evidence. 

Considerations for determining best 

available science shall include, but are 

not limited to, the following as 

applicable: 

(i) The extent to which the scientific 

information, technical procedures, 

measures, methods, protocols, 

methodologies, or models employed to 

generate the information are reasonable 

for and consistent with the intended use 

of the information; 

(ii) The extent to which the 

information is relevant for the 

Administrator’s use in making a 

decision about a chemical substance or 

mixture; 

(iii) The degree of clarity and 

completeness with which the data, 

assumptions, methods, quality 

assurance, and analyses employed to 

generate the information are 

documented; 

(iv) The extent to which the 

variability and uncertainty in the 

information, or in the procedures, 

measures, methods, protocols, 

methodologies, or models, are evaluated 

and characterized; and 

(v) The extent of independent 

verification or peer review of the 

information or of the procedures, 

measures, methods, protocols, 

methodologies or models. 

(3) EPA will ensure that all 

supporting analyses and components of 

the risk evaluation are suitable for their 

intended purpose, and tailored to the 

problems and decision at hand, in order 

to inform the development of a 

technically sound determination as to 

whether a chemical substance presents 

an unreasonable risk of injury to health 

or the environment under the 

conditions of use, based on the weight 

of the scientific evidence. 

(4) EPA will not exclude conditions of 

use from the scope of the risk 

evaluation, but a fit-for-purpose 

approach may result in varying types 

and levels of analysis and supporting 

information for certain conditions of 

use, consistent with paragraph (b) of 

this section. The extent to which EPA 

will refine its evaluations for one or 

more condition of use in any risk 

evaluation will vary as necessary to 

determine whether a chemical 

substance presents an unreasonable risk 

of injury to health or the environment. 

(5) EPA will determine whether a 

chemical substance does or does not 

present an unreasonable risk after 

considering the risks posed under all of 

the conditions of use and, where EPA 

makes a determination of unreasonable 

risk, EPA intends to identify the 

conditions of use that significantly 

contribute to such determination. 

(6) EPA will evaluate chemical 

substances that are metals or metal 

compounds in accordance with 15 

U.S.C. 2605(b)(2)(E). 

(b) Information and information 

sources. (1) EPA will base each risk 

evaluation on reasonably available 

information. 

(2) EPA will apply systematic review 

and/or systematic approaches to 

reviewing reasonably available 

information that are objective, unbiased, 

and transparent. 

(3) EPA may determine that certain 

information gaps can be addressed 

through application of assumptions, 

uncertainty factors, models, and/or 

screening to conduct its analysis with 

respect to the chemical substance, 

consistent with 15 U.S.C. 2625. The 

approaches used will be determined by 

the quality of reasonably available 

information, the deadlines specified in 

TSCA section 6(b)(4)(G) for completing 

the risk evaluation, and the extent to 

which the information reduces 

uncertainty. 

(4) EPA expects to use its authorities 

under the Act, and other information 

gathering authorities, when necessary to 

obtain the information needed to 

perform a risk evaluation for a chemical 

substance before initiating the risk 

evaluation for such substance. EPA will 

also use such authorities during the 

performance of a risk evaluation to 

obtain information as needed and on a 

case-by-case basis to ensure that EPA 

has adequate, reasonably available 

information to perform the evaluation. 

Where appropriate, to the extent 

practicable, and scientifically justified, 

EPA will require the development of 

information generated without the use 

of new testing on vertebrates. 

(5) Among other sources of 

information, EPA will also consider 

information and advice provided by the 

Science Advisory Committee on 

Chemicals established pursuant to 15 

U.S.C. 2625(o). 

§ 702.39 Components of risk evaluation. 

(a) In general. Each risk evaluation 

will include all of the following 

components: 

(1) A Scope; 

(2) A Hazard Assessment; 

(3) An Exposure Assessment; 

(4) A Risk Characterization; and 

(5) A Risk Determination. 

(b) Scope of the risk evaluation. The 

scope of the risk evaluation will include 

all the following: 

(1) The condition(s) of use the EPA 

expects to consider in the risk 

evaluation. 

(2) The potentially exposed 

populations, including any potentially 

exposed or susceptible subpopulations 

as identified as relevant to the risk 

evaluation by EPA under the conditions 

of use that EPA plans to evaluate. 

(3) The ecological receptors that EPA 

plans to evaluate. 

(4) The hazards to health and the 

environment that EPA plans to evaluate. 

(5) A description of the reasonably 

available information and scientific 

approaches EPA plans to use in the risk 

evaluation. 

(6) A conceptual model that describes 

the actual or predicted relationships 

between the chemical substance, its 

associated conditions of use through 

predicted exposure scenarios, and the 

identified human and environmental 

receptors and human and ecological 

health hazards. 

(7) An analysis plan that includes 

hypotheses and descriptions about the 

relationships identified in the 

conceptual model and the approaches 

and strategies EPA intends to use to 

assess exposure and hazard effects, and 

to characterize risk; and a description, 

including quality, of the data, 

information, methods, and models, that 

EPA intends to use in the analysis and 

how uncertainty and variability will be 

characterized. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74322 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

(8) EPA’s plan for peer review 

consistent with § 702.41. 

(c) Hazard assessment. (1) The hazard 

assessment process includes the 

identification, evaluation, and synthesis 

of information to describe the potential 

health and environmental hazards of the 

chemical substance under the 

conditions of use. 

(2) Hazard information related to 

potential health and environmental 

hazards of the chemical substance will 

be reviewed in a manner consistent with 

best available science based on the 

weight of scientific evidence and all 

assessment methods will be 

documented. 

(3) Consistent with § 702.37(b), 

information evaluated may include, but 

would not be limited to: Human 

epidemiological studies, in vivo and/or 

in vitro laboratory studies, 

biomonitoring and/or human clinical 

studies, ecological field data, read 

across, mechanistic and/or kinetic 

studies in a variety of test systems. 

These may include but are not limited 

to: toxicokinetics and toxicodynamics 

(e.g., physiological-based 

pharmacokinetic modeling), and 

computational toxicology (e.g., highthroughput assays, genomic response 

assays, data from structure-activity 

relationships, in silico approaches, and 

other health effects modeling). 

(4) The hazard information relevant to 

the chemical substance will be 

evaluated for identified human and 

environmental receptors, including all 

identified potentially exposed or 

susceptible subpopulation(s) 

determined to be relevant, for the 

exposure scenarios relating to the 

conditions of use. 

(5) The relationship between the dose 

of the chemical substance and the 

occurrence of health and environmental 

effects or outcomes will be evaluated. 

(6) Hazard identification will include 

an evaluation of the strengths, 

limitations, and uncertainties associated 

with the reasonably available 

information. 

(d) Exposure assessment. (1) Where 

relevant, the likely duration, intensity, 

frequency, and number of exposures 

under the conditions of use will be 

considered. 

(2) Exposure information related to 

potential human health or ecological 

hazards of the chemical substance will 

be reviewed in a manner consistent with 

best available science based on the 

weight of scientific evidence and all 

assessment methods will be 

documented. 

(3) Consistent with § 702.37(b), 

information evaluated may include, but 

would not be limited to: chemical 

release reports, release or emission 

scenarios, data and information 

collected from monitoring or reporting, 

release estimation approaches and 

assumptions, biological monitoring 

data, workplace monitoring data, 

chemical exposure health data, and 

exposure modeling. 

(4) Chemical-specific factors, 

including, but not limited to physicalchemical properties and environmental 

fate and transport parameters, will be 

examined. 

(5) The human health exposure 

assessment will consider all potentially 

exposed or susceptible subpopulation(s) 

determined to be relevant. 

(6) Environmental health exposure 

assessment will characterize and 

evaluate the interaction of the chemical 

substance with the ecological receptors 

and the exposures considered, including 

populations and communities, 

depending on the chemical substance 

and the ecological characteristic 

involved. 

(7) EPA will describe whether 

sentinel exposures under the conditions 

of use were considered and the basis for 

their consideration. 

(8) EPA will consider aggregate 

exposures to the chemical substance, 

and, when supported by reasonably 

available information, consistent with 

the best available science and based on 

the weight of scientific evidence, 

include an aggregate exposure 

assessment in the risk evaluation, or 

will otherwise explain in the risk 

evaluation the basis for not including 

such an assessment. 

(9) EPA will assess all exposure routes 

and pathways relevant to the chemical 

substance under the conditions of use, 

including those that are regulated under 

other Federal statutes. 

(e) Risk characterization—(1) 

Requirements. To characterize the risks 

from the chemical substance, EPA will: 

(i) Integrate the hazard and exposure 

assessments into quantitative and/or 

qualitative estimates relevant to specific 

risks of injury to health or the 

environment, including any potentially 

exposed or susceptible subpopulations 

identified, under the conditions of use. 

(ii) Not consider costs or other nonrisk factors; 

(iii) Describe the weight of the 

scientific evidence for the identified 

hazards and exposures. 

(2) Summary of considerations. EPA 

will summarize, as applicable, the 

considerations addressed throughout 

the evaluation components, in carrying 

out the obligations under 15 U.S.C. 

2625(h). This summary will include, as 

appropriate, a discussion of: 

(i) Considerations regarding 

uncertainty and variability. Information 

about uncertainty and variability in 

each step of the risk evaluation (e.g., use 

of default assumptions, scenarios, 

choice of models, and information used 

for quantitative analysis) will be 

integrated into an overall 

characterization and/or analysis of the 

impact of the uncertainty and variability 

on estimated risks. EPA may describe 

the uncertainty using a qualitative 

assessment of the overall strength and 

limitations of the data and approaches 

used in the assessment. 

(ii) Considerations of data quality. A 

discussion of data quality (e.g., 

reliability, relevance, and whether 

methods employed to generate the 

information are reasonable for and 

consistent with the intended use of the 

information), as well as assumptions 

used, will be included to the extent 

necessary. EPA also expects to include 

a discussion of the extent of 

independent verification or peer review 

of the information or of the procedures, 

measures, methods, protocols, 

methodologies, or models used in the 

risk evaluation. 

(iii) Considerations of alternative 

interpretations. If appropriate and 

relevant, where alternative 

interpretations are plausible, a 

discussion of alternative interpretations 

of the data and analyses will be 

included. 

(iv) Additional considerations for 

environmental risk. For evaluation of 

environmental risk, it may be necessary 

to discuss the nature and magnitude of 

the effects, the spatial and temporal 

patterns of the effects, implications at 

the individual, species, population, and 

community level, and the likelihood of 

recovery subsequent to exposure to the 

chemical substance. 

(f) Risk determination. (1) As part of 

the risk evaluation, EPA will make a 

single determination as to whether the 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, without consideration 

of costs or other non-risk factors, 

including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation, under the conditions of 

use. 

(2) In determining whether 

unreasonable risk is presented, EPA’s 

consideration of occupational exposure 

scenarios will take into account 

reasonably available information, 

including known and reasonably 

foreseen circumstances where 

subpopulations of workers are exposed 

due to the absence or ineffective use of 

personal protective equipment. EPA 

will not consider exposure reduction 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74323 

based on assumed use of personal 

protective equipment as part of the risk 

determination. 

§ 702.41 Peer review. 

EPA expects that peer review 

activities on risk evaluations conducted 

pursuant to 15 U.S.C. 2605(b)(4)(A), or 

portions thereof, will be consistent with 

the applicable peer review policies, 

procedures, guidance documents, and 

methods pursuant to guidance 

promulgated by Office of Management 

and Budget, EPA, and in accordance 

with 15 U.S.C. 2625(h) and (i). 

§ 702.43 Risk evaluation actions and 

timeframes. 

(a) Draft scope. (1) For each risk 

evaluation to be conducted EPA will 

publish a document-that specifies the 

draft scope of the risk evaluation EPA 

plans to conduct and publish a notice of 

availability in the Federal Register. The 

document will address the elements in 

§ 702.39(b). 

(2) EPA generally expects to publish 

the draft scope during the prioritization 

process concurrent with publication of 

a proposed designation as a HighPriority Substance pursuant to 

§ 702.9(g), but no later than 3 months 

after the initiation of the risk evaluation 

process for the chemical substance. 

(3) EPA will allow a public comment 

period of no less than 45 calendar days 

during which interested persons may 

submit comment on EPA’s draft scope. 

EPA will open a docket to facilitate 

receipt of public comments. 

(b) Final scope. (1) EPA will, no later 

than 6 months after the initiation of a 

risk evaluation, publish a document that 

specifies the final scope of the risk 

evaluation EPA plans to conduct, and 

publish a notice of availability in the 

Federal Register. The document shall 

address the elements in § 702.39(b). 

(2) For a chemical substance 

designated as a High-Priority Substance 

under subpart A of this part, EPA will 

not publish the final scope of the risk 

evaluation until at least 12 months have 

elapsed from the initiation of the 

prioritization process for the chemical 

substance. 

(c) Draft risk evaluation. EPA will 

publish a draft risk evaluation, publish 

a notice of availability in the Federal 

Register, open a docket to facilitate 

receipt of public comment, and provide 

no less than a 60-day comment period, 

during which time the public may 

submit comment on EPA’s draft risk 

evaluation. The document shall include 

the elements in § 702.39(c) through (f). 

(d) Final risk evaluation. (1) EPA will 

complete and publish a final risk 

evaluation for the chemical substance 

under the conditions of use as soon as 

practicable, but not later than 3 years 

after the date on which EPA initiates the 

risk evaluation. The document shall 

include the elements in § 702.39(c) 

through (f) and EPA will publish a 

notice of availability in the Federal 

Register. 

(2) EPA may extend the deadline for 

a risk evaluation for not more than 6 

months. The total time elapsed between 

initiation of the risk evaluation and 

completion of the risk evaluation may 

not exceed 3 and one half years. 

(e) Final determination of 

unreasonable risk. Upon determination 

by the EPA pursuant to § 702.39(f) that 

a chemical substance presents an 

unreasonable risk of injury to health or 

the environment, EPA will initiate 

action as required pursuant to 15 U.S.C. 

2605(a). 

(f) Final determination of no 

unreasonable risk. A determination by 

the EPA pursuant to § 702.39(f) that the 

chemical substance does not present an 

unreasonable risk of injury to health or 

the environment will be issued by order 

and considered to be a final Agency 

action, effective on the date of issuance 

of the order. 

(g) Substantive revisions to scope 

documents and risk evaluations. The 

circumstances under which EPA will 

undertake substantive revisions to scope 

and risk evaluation documents are as 

follows: 

(1) Draft documents. To the extent 

there are changes to a draft scope or 

draft risk evaluation, EPA will describe 

such changes in the final document. 

(2) Final scope. To the extent there are 

changes to the scope of the risk 

evaluation after publication of the final 

scope document, EPA will describe 

such changes in the draft risk 

evaluation, or, where appropriate and 

prior to the issuance of a draft risk 

evaluation, may make relevant 

information publicly available in the 

docket and publish a notice of 

availability of that information in the 

Federal Register. 

(3) Final risk evaluation. For any 

chemical substance for which EPA has 

already finalized a risk evaluation, EPA 

will generally not revise, supplement, or 

reissue a final risk evaluation without 

first undergoing the procedures at 

§ 702.7 to re-initiate the prioritization 

process for that chemical substance, 

except where EPA has determined it to 

be in the interest of protecting human 

health and the environment to do so, 

considering the statutory 

responsibilities and deadlines under 15 

U.S.C. 2605. 

(4) Process for revisions to final risk 

evaluations. Where EPA determines to 

revise or supplement a final risk 

evaluation pursuant to paragraph (g)(3) 

of this section, EPA will follow the same 

procedures in this section including 

publication of a new draft and final risk 

evaluation and solicitation of public 

comment in accordance with 

§§ 702.43(c) and (d), and peer review, as 

appropriate, in accordance with 

§ 702.41. 

§ 702.45 Submission of manufacturer 

requests for risk evaluations. 

(a) General provisions. (1) One or 

more manufacturers of a chemical 

substance may request that EPA conduct 

a risk evaluation on a chemical 

substance. 

(2) Such requests must comply with 

all the requirements, procedures, and 

criteria in this section. 

(3) Subject to limited exceptions in 

paragraph (e)(7)(iii) of this section, it is 

the burden of the requesting 

manufacturer to provide EPA with the 

information necessary to carry out the 

risk evaluation. 

(4) In determining whether there is 

sufficient information to support a 

manufacturer-requested risk evaluation, 

EPA expects to apply the same standard 

as it would for EPA-initiated risk 

evaluations, including but not limited to 

the considerations and requirements in 

§ 702.37. 

(5) EPA may identify data needs at 

any time during the process described 

in this section, and, by submitting a 

request for risk evaluation under this 

section, the requesting manufacturer 

agrees to provide, or develop and 

provide, EPA with information EPA 

deems necessary to carry out the risk 

evaluation, consistent with the 

provisions described in this subpart. 

(6) EPA will not expedite or otherwise 

provide special treatment to a 

manufacturer-requested risk evaluation 

pursuant to 15 U.S.C. 2605(b)(4)(E)(ii). 

(7) Once initiated in accordance with 

paragraph (e)(9) of this section, EPA will 

conduct manufacturer-requested risk 

evaluations following the procedures in 

§§ 702.37 through 702.43 and §§ 702.47 

through 702.49 of this subpart. 

(b) Method for submission. All 

manufacturer-requested risk evaluations 

under this subpart must be submitted 

via the EPA Central Data Exchange 

(CDX) found at https://cdx.epa.gov. 

(c) Content of request. Requests must 

include all of the following information: 

(1) Name, mailing address, and 

contact information of the entity (or 

entities) submitting the request. If more 

than one manufacturer submits the 

request, all individual manufacturers 

must provide their contact information. 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74324 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

(2) The chemical identity of the 

chemical substance that is the subject of 

the request. At a minimum, this 

includes: all known names of the 

chemical substance, including common 

or trades names, Chemical Abstracts 

Service (CAS) number, and molecular 

structure of the chemical substance. 

(3) For requests pertaining to a 

category of chemical substances, an 

explanation of why the category is 

appropriate under 15 U.S.C. 2625(c). 

EPA will determine whether the 

category is appropriate for risk 

evaluation as part of reviewing the 

request in paragraph (e) of this section. 

(4) A description of the circumstances 

under which the chemical substance is 

intended, known, or reasonably foreseen 

to be manufactured, processed, 

distributed in commerce, used, or 

disposed of, and all information known 

to or reasonably ascertainable by the 

requesting manufacturer that supports 

the identification of the circumstances 

described in this paragraph (c)(4). 

(5) All information known to or 

reasonably ascertainable by the 

requesting manufacturer on the health 

and environmental hazard(s) of the 

chemical substance, human and 

environmental exposure(s), and exposed 

population(s), including but not limited 

to: 

(i) The chemical substance’s exposure 

potential, including occupational, 

general population and consumer 

exposures, and facility release 

information; 

(ii) The chemical substance’s hazard 

potential, including all potential 

environmental and human health 

hazards; 

(iii) The chemical substance’s 

physical and chemical properties. 

(iv) The chemical substance’s fate and 

transport properties including 

persistence and bioaccumulation; 

(v) Potentially exposed or susceptible 

subpopulations which the 

manufacturer(s) believes to be relevant 

to the EPA risk evaluation; 

(vi) Whether there is any storage of 

the chemical substance near significant 

sources of drinking water, including the 

storage facility location and the nearby 

drinking water source(s); 

(vii) The chemical substance’s 

production volume or significant 

changes in production volume; and 

(viii) Any other information relevant 

to the hazards, exposures and/or risks of 

the chemical substance. 

(6) Where information described in 

paragraph (c)(4) or (5) of this section is 

unavailable, an explanation as to why, 

and the rationale for why, in the 

requester’s view, the provided 

information is nonetheless sufficient to 

allow EPA to complete a risk evaluation 

on the chemical substance. 

(7) Copies of all information 

referenced in paragraph (c)(5) of this 

section, or citations if the information is 

readily available from public sources. 

(8) A signed certification that all 

information contained in the request is 

accurate and complete, as follows: 

I certify that to the best of my knowledge 

and belief: 

(A) The company named in this request 

manufactures the chemical substance 

identified for risk evaluation. 

(B) All information provided in the request 

is complete and accurate as of the date of the 

request. 

(C) I have either identified or am 

submitting all information in my possession 

and control, and a description of all other 

data known to or reasonably ascertainable by 

me as required under this part. I am aware 

it is unlawful to knowingly submit 

incomplete, false and/or misleading 

information in this request and there are 

significant criminal penalties for such 

unlawful conduct, including the possibility 

of fine and imprisonment. 

(9) Where appropriate, information 

that will inform EPA’s determination as 

to whether restrictions imposed by one 

or more States have the potential to 

have a significant impact on interstate 

commerce or health or the environment, 

and that as a consequence the request is 

entitled to preference pursuant to 15 

U.S.C. 2605(b)(4)(E)(iii). 

(d) Confidential business information. 

Persons submitting a request under this 

subpart are subject to EPA 

confidentiality regulations at 40 CFR 

part 2, subpart B, and 40 CFR part 703. 

(e) EPA process for reviewing 

requests. (1) Public notification of 

receipt of request. Within 15 days of 

receipt of a manufacturer-requested risk 

evaluation, EPA will notify the public 

that such request has been received. 

(2) Initial review for completeness. 

EPA will determine whether the request 

appears to meet the requirements 

specified in this section (i.e., complete), 

or whether the request appears to not 

have met the requirements specified in 

this section (i.e., incomplete). EPA will 

notify the requesting manufacturer of 

the outcome of this initial review. For 

requests initially determined to be 

incomplete, EPA will cease review 

pending actions taken by the requesting 

manufacturer pursuant to paragraph (f) 

of this section. For requests initially 

determined to be complete, EPA will 

proceed to the public notice and 

comment process described in 

paragraph (e)(3) of this section. 

(3) Public notice and comment. No 

later than 90 days after initially 

determining a request to be complete 

pursuant to paragraph (e)(2) of this 

section, EPA will submit for publication 

the receipt of the request in the Federal 

Register, open a docket for that request 

and provide no less than a 60-day 

public comment period. The docket will 

contain the CBI sanitized copies of the 

request and all supporting information. 

The notice will encourage the public to 

submit comments and information 

relevant to the manufacturer-requested 

risk evaluation, including, but not 

limited to, identifying information not 

provided in the request, information the 

commenter believes necessary to 

conduct a risk evaluation, and any other 

information relevant to the conditions of 

use. 

(4) Secondary review for sufficiency. 

Within 90 days following the end of the 

comment period in paragraph (e)(3) of 

this section, EPA will further consider 

whether public comments highlight 

deficiencies in the request not identified 

during EPA’s initial review, and/or that 

the available information is not 

sufficient to support a reasoned 

evaluation. EPA will notify the 

requesting manufacturer of the outcome 

of this review. For requests determined 

to not be supported by sufficient 

information, EPA will cease review 

pending actions taken pursuant to 

paragraph (f) of this section. For 

requests determined to be supported by 

sufficient information, EPA will proceed 

with request review process in 

accordance with paragraph (e)(5) of this 

section. 

(5) Grant. Where EPA determines a 

request to be complete and sufficiently 

supported in accordance with 

paragraphs (e)(2) and (4) of this section, 

and subject to the percentage limitations 

in TSCA section 6(b)(4)(E)(i)(II), EPA 

will grant the request. A grant does not 

mean that EPA has all information 

necessary to complete the risk 

evaluation. 

(6) Publication of draft conditions of 

use and request for information. EPA 

will publish a notice in the Federal 

Register that identifies draft conditions 

of use, requests relevant information 

from the public, and provides no less 

than a 60-day public comment period. 

Within 90 days following the close of 

the public comment period in this 

paragraph, EPA will determine whether 

further information is needed to carry 

out the risk evaluation and notify the 

requesting manufacturer(s) of its 

determination, pursuant to paragraph 

(e)(7) of this section. If EPA determines 

at this time that no further information 

is necessary, EPA will initiate the risk 

evaluation, pursuant to paragraph (e)(9) 

of this section. 

(7) Identification of information 

needs. Where additional information 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 74325 

needs are identified, EPA will notify the 

requesting manufacturer(s) and set a 

reasonable amount of time, as 

determined by EPA, for response. In 

response to EPA’s notice, and subject to 

the limitations in paragraph (g) of this 

section, the requesting manufacturer(s) 

may: 

(i) Provide the necessary information. 

EPA will set a reasonable amount of 

time, as determined by EPA, for the 

requesting manufacturer(s) to produce 

or develop and produce the information. 

Upon receipt of the new information, 

EPA will review for sufficiency and 

make publicly available to the extent 

possible, including CBI-sanitized copies 

of that information; or 

(ii) Withdraw the risk evaluation 

request. Fees to be collected or refunded 

shall be determined pursuant to 

paragraph (k) of this section and 40 CFR 

700.45; or 

(iii) Request that EPA obtain the 

information using authorities under 

TSCA sections 4, 8 or 11. The requesting 

manufacturer(s) must provide a 

rationale as to why the information is 

not reasonably ascertainable to them. 

EPA will review and provide notice of 

its determination to the requesting 

manufacturer. Upon receipt of the 

information, EPA will review the 

additional information for sufficiency 

and provide additional public notice. 

(8) Unfulfilled information needs. In 

circumstances where there have been 

additional data needs identified 

pursuant to paragraph (e)(7) of this 

section but the requesting 

manufacturer(s) is unable or unwilling 

to fulfill those needs in a timely 

manner, has produced information that 

is insufficient as determined by EPA, or 

where EPA determines that a request to 

use TSCA authorities under section 4, 8 

or 11 is not warranted, EPA may deem 

the request to be constructively 

withdrawn under paragraph (e)(7)(ii) of 

this section. 

(9) Initiation of the risk evaluation. 

Within 90 days of the end of the 

comment period provided in paragraph 

(e)(6) of this section, or within 90 days 

of EPA determining that information 

pursuant to paragraph (e)(7) of this 

section is sufficient, EPA will initiate 

the requested risk evaluation and follow 

all requirements in this subpart, 

including but not limited to §§ 702.37 

through 702.43 and §§ 702.47 through 

702.49 of this subpart, and notify the 

requesting manufacturer and the public. 

Initiation of the risk evaluation does not 

limit or prohibit the Agency from 

identifying additional data needs during 

the risk evaluation process. 

(f) Incomplete or insufficient request. 

Where EPA has determined that a 

request is incomplete or insufficient 

pursuant to paragraph (e)(2) or (4) of 

this section, requesting manufacturer(s) 

may supplement and resubmit the 

request. EPA will follow the process 

described in paragraph (e) of this 

section as it would for a new request. 

(g) Withdrawal of request. Requesting 

manufacturer(s) may withdraw a request 

at any time prior to EPA’s grant of such 

request pursuant to paragraph (e)(5) of 

this section, or in accordance with 

paragraph (e)(7) of this section and 

subject to payment of applicable fees. 

Requesting manufacturers may not 

withdraw a request once EPA has 

initiated the risk evaluation. EPA may 

deem a request constructively 

withdrawn in the event of unfulfilled 

information needs pursuant to 

paragraph (e)(8) of this section or nonpayment of fees as required in 40 CFR 

700.45. EPA will notify the requesting 

manufacturer and the public of the 

withdrawn request. 

(h) Data needs identified postinitiation. Where EPA identifies 

additional data needs after the risk 

evaluation has been initiated, the 

requesting manufacturer(s) may remedy 

the deficiency pursuant to paragraph 

(e)(7)(i) or (iii) of this section. 

(i) Supplementation of original 

request. At any time prior to the end of 

the comment period described in 

paragraph (e)(6) of this section, the 

requesting manufacturer(s) may 

supplement the original request with 

any new information that becomes 

available to the manufacturer(s). At any 

point prior to the completion of a 

manufacturer-requested risk evaluation 

pursuant to this section, manufacturer(s) 

must supplement the original request 

with any information that meets the 

criteria in 15 U.S.C. 2607(e) and this 

section, or with any other reasonably 

ascertainable information that has the 

potential to change EPA’s risk 

evaluation. Such information must be 

submitted consistent with 15 U.S.C. 

2607(e) if the information is subject to 

that section or otherwise within 30 days 

of the manufacturer’s obtaining the 

information. 

(j) Limitations on manufacturerrequested risk evaluations— 

(1) In general. EPA will initiate a risk 

evaluation for all requests from 

manufacturers for non-TSCA Work Plan 

Chemicals that meet the criteria in this 

subpart, until EPA determines that the 

number of manufacturer-requested 

chemical substances undergoing risk 

evaluation is equal to 25% of the HighPriority Substances identified in subpart 

A as undergoing risk evaluation. Once 

that level has been reached, EPA will 

initiate at least one new manufacturerrequested risk evaluation for each 

manufacturer-requested risk evaluation 

completed so long as there are sufficient 

requests that meet the criteria of this 

subpart, as needed to ensure that the 

number of manufacturer-requested risk 

evaluations is equal to at least 25% of 

the High-Priority substances risk 

evaluation and not more than 50%. 

(2) Preferences. In conformance with 

§ 702.35(c), in evaluating requests for 

TSCA Work Plan Chemicals and 

requests for non-TSCA Work Plan 

chemicals in excess of the 25% 

threshold in § 702.35(b), EPA will give 

preference to requests for risk 

evaluations on chemical substances: 

(i) First, for which EPA determines 

that restrictions imposed by one or more 

States have the potential to have a 

significant impact on interstate 

commerce, health or the environment; 

and then 

(ii) Second, based on the order in 

which the requests are received. 

(k) Fees. Manufacturers must pay fees 

to support risk evaluations as specified 

under 15 U.S.C. 2605(b)(4)(E)(ii), and in 

accordance with 15 U.S.C. 2525(b) and 

40 CFR 700.45. In the event that a 

request for a risk evaluation is 

withdrawn by the requesting 

manufacturer pursuant to paragraph (g) 

of this section, the total fee amount due 

will be either, in accordance with 40 

CFR 700.45(c)(2)(x) or (xi), 50% or 

100% of the actual costs expended in 

carrying out the risk evaluation as of the 

date of receipt of the withdrawal notice. 

The payment amount will be 

determined by EPA, and invoice or 

refund issued to the requesting 

manufacturer(s) as appropriate. 

§ 702.47 Interagency collaboration. 

During the risk evaluation process, 

not to preclude any additional, prior, or 

subsequent collaboration, EPA will 

consult with other relevant Federal 

agencies. 

§ 702.49 Publicly available information. 

For each risk evaluation, EPA will 

maintain a public docket at https://

www.regulations.gov to provide public 

access to the following information, as 

applicable for that risk evaluation: 

(a) The draft scope, final scope, draft 

risk evaluation, and final risk 

evaluation; 

(b) All notices, determinations, 

findings, consent agreements, and 

orders; 

(c) Any information required to be 

provided to EPA under 15 U.S.C. 2603; 

(d) A nontechnical summary of the 

risk evaluation; 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
74326 Federal Register / Vol. 88, No. 208 / Monday, October 30, 2023 / Proposed Rules 

(e) A list of the studies, with the 

results of the studies, considered in 

carrying out each risk evaluation; 

(f) Any final peer review report, 

including the response to peer review 

and public comments received during 

peer review; and 

(g) Response to public comments 

received on the draft scope and the draft 

risk evaluation. 

[FR Doc. 2023–23428 Filed 10–27–23; 8:45 am] 

BILLING CODE 6560–50–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS2