Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA), 37028-37058 [2024-09417]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Rules and Regulations]
[Pages 37028-37058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09417]



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Vol. 89

Friday,

No. 87

May 3, 2024

Part V





Environmental Protection Agency





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40 CFR Part 702





Procedures for Chemical Risk Evaluation Under the Toxic Substances 
Control Act (TSCA); Final Rule

Federal Register / Vol. 89 , No. 87 / Friday, May 3, 2024 / Rules and 
Regulations

[[Page 37028]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 702

[EPA-HQ-OPPT-2023-0496; FRL-8529-02-OCSPP]
RIN 2070-AK90


Procedures for Chemical Risk Evaluation Under the Toxic 
Substances Control Act (TSCA)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
finalizing amendments to 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 reconsidered the procedural framework 
rule for conducting such risk evaluations and is revising certain 
aspects of that framework to better align with the statutory text and 
applicable court decisions, 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: This final rule is effective on July 2, 2024.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OPPT-2023-0496. All documents in the docket are listed on 
the https://www.regulations.gov website. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Susanna Blair, Immediate Office, Office of Pollution Prevention and 
Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW, Washington, DC 20460-0001; telephone number: (202) 564-4371; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    EPA is amending procedural requirements that apply to the Agency's 
activities in carrying out TSCA risk evaluations. EPA is also amending 
the process and requirements that manufacturers (including importers) 
are 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 North American Industrial Classification 
System (NAICS) codes for entities that may be interested in or affected 
by this action. The following list of 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 
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 promulgating this final rule 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. Ass'n v. State Farm Mut. Auto. 
Ins. Co., 463 U.S. 29, 42 (1983).

C. What action is the Agency taking?

    EPA is amending regulations that address how the Agency conducts 
risk evaluations on chemical 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

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and considerations related to unreasonable risk, and the process for 
revisiting a completed risk evaluation. EPA is also amending the 
process and requirements for manufacturers making a voluntary request 
for an Agency-conducted risk evaluation.

D. Why is the Agency taking this action?

    As further explained in Units I., II., III. and IV., 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.
    The Agency is amending the 2017 final rule as a result of this 
reexamination for the reasons explained elsewhere through the preambles 
of the proposed and final rules and the response to comments.

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 IV.J., which apply to 
manufacturers when manufacturers (including importers) elect to request 
that EPA perform a risk evaluation on a particular chemical substance. 
EPA estimated the potential burden and costs associated with the 
amended requirements for submitting a request for an Agency-conducted 
risk evaluation on a particular chemical substance. The estimates of 
burden and costs are available in the docket, and are discussed in Unit 
VII.B. 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 VII.B. Since the incremental 
impacts of this rule involve the activities that a manufacturer 
requesting a risk evaluation must perform, the estimated incremental 
costs to the public are expected to be negligible.

II. Background

    The background for this rulemaking, including the statutory 
requirements for risk evaluation, the judicial review of the 2017 final 
rule, EPA's review of the 2017 final rule, and lessons learned from the 
Agency's implementation of the risk evaluation program are discussed in 
the notice of proposed rulemaking (Ref. 5 at pp. 74293 through 74294).
    In response to public comments on the proposed rule and as 
described in Units III. and IV., EPA is making a number of changes in 
this final rule to provide additional clarification to EPA's process 
for conducting risk evaluations under TSCA. These include, among other 
changes, clarifications to: (1) Communications around which conditions 
of use are significantly contributing to a determination that a 
chemical substance presents unreasonable risk; (2) assumptions with 
respect to worker exposures and consideration of reasonably available 
information; (3) calculation of risk-based occupational exposure values 
in the risk evaluation; (4) EPA's commitment to conduct risk 
evaluations consistent with the ``best available science'' and based on 
the weight of the scientific evidence; (5) application of systematic 
review and methodological approaches consistent with those principles; 
(6) the process and requirements for manufacturer-requested risk 
evaluations; (7) EPA's potential identification of an overburdened 
community as a potentially exposed or susceptible subpopulation; and 
(8) peer review on TSCA risk evaluations.
    EPA intends that the provisions of this rule be severable. While 
there may be provisions of this rule that are inextricably intertwined 
with other provisions, most of the provisions of this rule could 
function sensibly without particular invalidated provisions. 
Specifically, in many cases, the amendments to 40 CFR part 702 
finalized in this rule involve separate elements of the risk evaluation 
process--or even separate processes all together--and EPA's decision to 
amend one portion of the rule was not dependent or reliant upon its 
decision to amend other portions of the rule. Especially because of the 
scope of the rule, it is not feasible to anticipate or address every 
permutation of this concept here. However, EPA has considered how the 
rule would function in various configurations and intends to preserve 
the rule to the fullest extent possible if any individual provision or 
part of this rule is invalidated.
    To illustrate how various portions of this rule may be severable, 
EPA proffers the following two examples. First, if a court were to find 
flaw with a particular process provision (e.g., a provision pertaining 
to publishing scope documents) and strike that provision, it would not 
prevent EPA in any way from looking to other process provisions (e.g., 
a provision on soliciting peer review or on determining whether a 
chemical presents an unreasonable risk) in conducting its risk 
evaluations under this amended rule. While invalidating such provisions 
could perhaps be disruptive to ongoing risk evaluations, it would not 
prevent EPA from completing the rest of the evaluation consistent with 
both the remaining portions of the rule and its obligations under TSCA. 
Second, there are provisions that have little to no level of 
interrelation in this rule. For example, EPA's processes under this 
rule for conducting EPA-initiated risk evaluations and for reviewing 
manufacturer requests for risk evaluations are wholly independent and 
the invalidation of a provision (or even every provision) pertaining to 
one such process would not impact EPA's ability to rely on the 
remainder of the rule for the other process.
    In additional to these examples, EPA notes that the ability of the 
various provisions of this rule to function sensibly without 
invalidated provisions is further illustrated by the history of the 
first 10 risk evaluations following the 2016 amendments to TSCA. 
Between 2016 and today, EPA has operated under the statutory mandate 
itself, the 2017 final rule (82 FR 33726), and the version of that rule 
that existed after Safer Chemicals, Healthy Families v. EPA, 943 F.3d 
397 (9th Cir. 2019). Throughout this time, the risk evaluation process 
as a whole has continued to function sensibly even as EPA promulgated 
particular provisions and concepts through the 2017 rule and some of 
those provisions and concepts were subsequently vacated by the Ninth 
Circuit (e.g., the applicability of criminal penalties, determinations 
on scientific standards, and the exclusion of legacy uses). For the 
forgoing reasons, EPA finds that the amendments in this final rule are 
generally severable.

III. Response to Public Comments

    In response to the proposed rule, EPA received 30,434 public 
comments. EPA determined that 90 were unique and responsive to the 
request for comments (2 of which were form letter masters),

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30,323 were copies of form letters, 11 were duplicates, and 10 were 
non-germane. The commenters included industry trade associations, 
advocacy organizations, a union, federal/state government agencies, a 
tribal council, academic institutions, and individuals. Major comments 
are discussed in the context of particular provisions in Unit IV. A 
more detailed discussion is provided in the Response to Comment 
Document for this rule and available in the docket (Ref. 6).

IV. Overview of Provisions in Final Rule

    The purpose of this rulemaking is to update the risk evaluation 
process established in 40 CFR part 702, subpart B outlining 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 amendments to the 
procedural rule 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; (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. Improvements to the risk evaluation process in these 
proposed amendments will result in stronger scientific products that 
can support needed public health and environmental protections to limit 
exposure to dangerous chemicals.
    To accomplish these objectives, EPA is making targeted changes to 
and clarifying the existing process by which the Agency evaluates risk 
from chemical substances for purposes of TSCA section 6. The amended 
procedural rule will ensure that the risk evaluation process and 
outcomes are both scientifically and legally defensible, and 
transparent, while allowing the Agency flexibility to adapt and keep 
pace with changing science as it conducts TSCA risk evaluations into 
the future.

A. General Provisions

    EPA is finalizing the general provisions at 40 CFR 702.31 as 
proposed. As stated in the rule at 40 CFR 702.31(c), the procedures 
apply to all risk evaluations initiated 30 days after the date of the 
final rule or later. EPA received several comments regarding the 
applicability of the procedures to ongoing manufacturer-requested risk 
evaluations (MRREs). 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. For MRRE 
requests that EPA has already granted, for example, it would not be 
practicable to apply the new upfront processes that occur prior to 
granting requests, or the content requirements for incoming requests. 
EPA believes it will be practicable, however, to make a single 
determination of unreasonable risk on the chemical substance as 
contemplated in the law and codified in this rule.
    Similarly, EPA is finalizing the minor clarification with respect 
to the applicability of this rule to risk evaluations on categories of 
chemical substances in 40 CFR 702.31(d). EPA received comments in 
support of this clarification, but also some comments that were more 
generally apprehensive of category approaches in risk evaluations. This 
rule does not prescribe how or whether the Agency will identify 
categories appropriate for prioritization and risk evaluation. The 
criteria for establishing categories are specified in TSCA section 
26(c). If EPA does categorize chemicals as a category, EPA will 
provide, on a case-by-case basis, the justification for inclusion of 
the chemicals in a category. EPA fully recognizes the challenges and 
complexities associated with defining categories and carrying out risk 
evaluations on categories of chemical substances, and the need for its 
action and decisions to be consistent with the best available science. 
EPA also agrees that transparency on the rationale and approach will be 
important should the Agency prioritize a category of chemical 
substances for risk evaluation in the future. The intent of the rule is 
simply to clarify that the procedural framework for evaluating chemical 
substances also applies to risk evaluations on categories of chemical 
substances.
    EPA is also finalizing removal of the currently codified regulatory 
text at 40 CFR 702.31(d) in accordance with the Ninth Circuit's vacatur 
and remand of this provision applying criminal penalties to the 
submission of inaccurate or incomplete information to EPA pursuant to a 
manufacturer-requested risk evaluation (Ref. 7).

B. Technical Corrections and Reorganization

    The proposed rule reflected a number of minor updates and 
corrections and general organizational restructuring. Specifically, 
references to 15 U.S.C. 2605(b)(2)(A) were 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. 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). Additionally, 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 has reorganized the sequence and structure of 
regulatory provisions to 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. The Agency received very few comments on these 
changes and no commenter expressed confusion or decreased lack of 
clarity. Therefore, EPA carried these changes through into the final 
rule.
    In addition, EPA made minor clarifying edits to the final rule at 
40 CFR 702.35(b) regarding the number of allowable manufacturer-
requested risk evaluations as compared to the number of ongoing EPA-
initiated risk evaluations. Although this provision codifies the 
statutory requirement at 15 U.S.C. 2605(b)(4)(E)(i), EPA slightly 
modified the phrasing to make it easier for the reader to understand 
and follow.

C. Definitions

    EPA is finalizing minor updates to definitions for ``pathways,'' 
``routes,'' ``aggregate exposure,'' and ``sentinel exposure.'' The 
final rule also maintains the definitions for ``act,'' ``conditions of 
use,'' ``reasonably available information,'' ``uncertainty,'' or 
``variability''--all unchanged from the 2017 final rule.
    EPA proposed to eliminate the codified definitions for ``best 
available science'' and ``weight of scientific evidence.'' In the 
proposed rule, EPA explained that having codified definitions in the 
procedural rule for these scientific terms was both unnecessary and 
could inhibit the Agency's flexibility to quickly adapt to and 
implement advancing scientific practices and approaches. EPA received a 
number of comments on these proposed changes, including both support 
for and opposition to eliminating the codified definitions. Commenters 
who opposed generally expressed concern that elimination of

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the definitions would reduce transparency and clarity about the 
scientific standards that EPA will apply in risk evaluations, and/or 
call into question whether EPA would still meet the scientific 
standards in the law. EPA can say with confidence that the Agency is 
fully committed to meeting the requirements in the law, and to being 
transparent in each risk evaluation with respect to how scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, or models are being employed in a manner consistent with 
the best available science and how decisions are based on the weight of 
the scientific evidence, as required by 15 U.S.C. 2625(h) and (i). As 
such, EPA is finalizing the removal of these definitions from the 
codified regulatory text. Unit IV.H provides additional discussion of 
how EPA will ensure that TSCA risk evaluations are consistent with the 
best available science and based on the weight of the scientific 
evidence.
    EPA also proposed changes to the definition of ``potentially 
exposed or susceptible subpopulation'' (PESS), which currently include 
``infants, children, pregnant women, workers or the elderly.'' Namely, 
EPA proposed to add the phrase ``overburdened communities'' to the list 
of other examples of PESS that EPA might identify like ``infants, 
children, pregnant women, workers, or the elderly.'' EPA received a 
number of comments on the proposed changes to this definition. Many 
commenters supported the change, and EPA's authority to expand upon the 
illustrative list of examples Congress provided in the statutory 
definition. Others opposed the change, citing concerns that it reflects 
an intention by EPA to dramatically expand the scope of risk 
evaluations in ways that can't conceivably be completed within 
statutory deadlines. Others shared concern that the rule did not 
provide objective criteria regarding how EPA would go about identifying 
communities that are ``overburdened.'' After considering the comments, 
EPA has determined to finalize the change to the PESS definition as 
proposed. As a primary matter, the addition of ``overburdened 
communities'' to this definition is not itself a determination. Rather, 
it's an example of a subpopulation that EPA may identify as a PESS in 
future risk evaluations, and it is reflective of the reality that--in 
addition to groups like children and pregnant women--there are 
communities of people that may experience disproportionate risks from 
chemicals due to greater exposure or susceptibility to environmental 
and health harms. EPA fully appreciates the enormity of its 
responsibilities under TSCA--meeting statutory deadlines while ensuring 
robust evaluations of risks to human health and the environment, 
including risks to the most vulnerable populations--and is mindful that 
meeting those challenges will require comprehensive approaches that are 
carried out in a fit-for-purpose manner. EPA is also committed to 
maximizing the transparency of its decisions--including the 
identification of PESS--and believes that the requirements in this rule 
will further all of these objectives. Additional discussion of EPA's 
expected implementation of statutory requirements related to PESS can 
be found in Unit IV.F.4.

D. Scope of TSCA Risk Evaluations

    TSCA was amended in 2016 amidst a backdrop of tens of thousands of 
unreviewed existing chemical substances in commerce, with no mandate 
that EPA conduct any assessments to determine whether those existing 
chemicals present unreasonable risk of injury to health or the 
environment. The few assessments that EPA did undertake prior to 2016 
were narrowly focused on specific uses of chemicals (e.g., paint and 
coating removal, vapor degreasing, etc.). The 2016 amendments required 
EPA to systematically prioritize those tens of thousands 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)). In so doing, Congress recognized that 
comprehensive progress on evaluating tens of thousands of existing 
chemicals would not be made without this mandate, coupled with a strong 
risk-based safety standard and deadlines for completing the work. In 
the absence of comprehensive risk evaluations on chemical substances 
(i.e., under an approach that considered only a subset of a chemical's 
uses or exposures), uncertainty as to whether EPA had fully addressed a 
chemical's unreasonable risk would fester, eroding public confidence in 
the safety of chemicals pervasive in our households, communities and 
the environment, and encouraging states to adopt a patchwork of 
regulatory measures to address chemical risks.
    EPA's 2017 final rule left some ambiguities with respect to the 
scope of TSCA risk evaluations, including whether EPA has discretion to 
exclude conditions of use or exposure pathways, the limits of EPA's 
discretion to determine what constitutes the conditions of use for a 
particular chemical, and what other flexibilities that EPA may have in 
its analytical approaches to ensure that comprehensive risk evaluations 
can still be completed within Congress' aggressive statutory deadlines. 
EPA proposed a number of important clarifications regarding the scope 
of TSCA risk evaluations that EPA believes will result in stronger 
scientific products that can support needed public health and 
environmental protections to address risks from dangerous chemicals. 
Those changes, a discussion of the public comments received, and EPA's 
approach for the final rule are discussed in the sections that follow.
    1. Inclusion of all conditions of use. EPA proposed 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'' (e.g., the 
statement in 702.37(b)(4) that ``EPA will not exclude conditions of use 
from the scope of the risk evaluation . . .''). As described in the 
proposed rule, EPA believes that the better reading of TSCA's statutory 
text and structure is that EPA lacks authority to exclude conditions of 
use from the scope of the risk evaluation. 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.'' Further, EPA 
believes the phrase ``as determined by the Administrator'' in the 
statutory definition of ``conditions of use'' means that EPA must apply 
fact and professional judgment in determining whether or not a 
particular circumstance is known, intended or reasonably foreseen--and 
should not be viewed as authority to select among those circumstances 
for inclusion or exclusion (15 U.S.C. 2602(4)).
    A number of commenters supported EPA's proposed rule on this 
important

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point. Of the commenters who opposed this change, several pointed to 
the language in TSCA section 6(b)(4)(D), which requires EPA to 
identify--as part of the risk evaluation scope--the hazards, exposures, 
and conditions of use that EPA ``expects to consider.'' EPA believes 
this phrase is best read as directing the Agency to undertake a factual 
identification of the conditions of use associated with 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 does not interpret the ``expects to consider'' language in TSCA 
section 6(b)(4)(D) to allow EPA to pick and choose which exposures to 
include in a risk evaluation of a chemical substance. However, EPA has 
some discretion; the identification of a chemical's conditions of use 
falls squarely within EPA's purview and will necessarily involve the 
Agency applying both fact and professional judgment, particularly with 
respect to identifying whether a circumstance is reasonably foreseen. 
See Unit IV.D.2. EPA also has discretion in tailoring its level of 
analysis with respect to individual conditions of use within the scope 
of the risk evaluation and may choose to, for example, take a more 
qualitative approach to conditions of use that it determines are 
negligible contributors to exposures and risks based on the reasonable 
available information. EPA does not, however, view the statute as 
providing authority to categorically exclude known conditions of use or 
exposures from the scope of the risk evaluation entirely.
    Contrary to some commenters' suggestions, EPA further believes that 
such a reading is consistent with Congressional intent. The purpose of 
the requirement to evaluate the ``chemical substance'' was to ensure 
that the Agency, through the TSCA 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. If EPA were to take the approach suggested by 
commenters and only evaluate a subset of a chemical's conditions of 
use, the existence of unevaluated uses and exposures would perpetuate 
uncertainties as to the safety of existing chemicals in the 
marketplace--the very problem Congress sought to address through its 
reform efforts.
    Some commenters suggest that the Ninth Circuit's opinion in Safer 
Chemicals, Healthy Families v. USEPA (Ref. 2) affirmatively determined 
the issue of discretionary scoping authority, namely that EPA could 
permissibly consider only some conditions of use in TSCA risk 
evaluations. EPA disagrees; the Court did not state or imply as much 
anywhere in its opinion (Ref. 2). To the contrary, the Court held that 
the petitioners' challenge to the 2017 final rule on this point was not 
ripe for review because EPA had not yet finalized a risk evaluation 
that excluded conditions of use and the 2017 final rule text was 
ambiguous on whether EPA actually would do so. Separately, the Court 
was, however, unequivocal in striking down EPA's statements in the 
preamble to the 2017 final rule regarding its intention to 
categorically exclude ``legacy uses'' from TSCA risk evaluations, 
finding that such an approach ``contradicts TSCA's plain language'' 
directing EPA to evaluate risks from chemical substances under the 
conditions of use.
    Several commenters characterized TSCA as a ``gap filling'' 
statute--regulating only exposures and conditions of use that are not 
adequately addressed under other statutes. Although EPA is familiar 
with the phrase from the legislative history of the original 1976 TSCA, 
it is not found anywhere within the statute--original or as amended--
and has more recently been used in tandem with interpretive arguments 
to inappropriately narrow the scope of TSCA risk evaluations. EPA 
firmly rejected these arguments--that EPA should exclude conditions of 
use and exposure pathways from TSCA risk evaluations when those uses/
exposures could be managed under the purview of another environmental 
statute--in the proposed rule at Unit III.E. Such an interpretation 
contradicts the plain language of the 2016 TSCA amendments directing 
EPA to, without caveat, evaluate risks from chemical substances under 
the conditions of use. EPA recognizes that there is a relevant 
statutory provision (i.e., TSCA section 9) about whether risk 
management to address identified risks is better achieved under TSCA or 
another federal law. OCSPP is actively coordinating actions taken under 
TSCA with actions taken under other Federal laws administered by EPA. 
However, these risk management considerations cannot logically occur 
until after risks are identified in the TSCA risk evaluation process--
not before or during--and are therefore inappropriate to use as a risk 
evaluation scoping mechanism.
    Finally, as described in the proposed rule, 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. 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)). There may be situations where 
certain individual conditions of use are associated with relatively 
lower exposures, but when considered in aggregate contribute to 
unreasonable risk. Exclusion of conditions of use from risk 
evaluations--irrespective of the Agency's intention in so doing--may 
deprive the public of a complete picture of the chemical's risk, and 
prevent EPA from putting necessary protections in place to mitigate 
such risk to the general population or potentially exposed or 
susceptible subpopulations.
    Risk evaluations that are comprehensive in scope--and therefore 
consistent with the law--may also need to be balanced with fit-for-
purpose analytic approaches to keep the assessments manageable and able 
to be completed within the law's deadlines. EPA is committed to 
continuing to pursue and refine fit-for-purpose approaches in the 
context of individual risk evaluations in a manner that enables EPA to 
achieve Congress' goals for the protection of human health and the 
environment, while also completing its actions within statutory 
deadlines.
    For these reasons, EPA is finalizing the changes to the rule 
ensuring EPA will not exclude conditions of use from consideration 
within the scope of TSCA risk evaluations.
    2. Determination of ``conditions of use.'' As described in the 
preamble to the proposed rule, EPA is distinguishing between the 
Agency's lack of discretion to exclude conditions of use as described 
in the previous section, and EPA's ability 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. For each 
risk evaluation, and consistent with the phrase ``as determined by the 
Administrator'' in the statutory definition of ``conditions of use,'' 
EPA must analyze the reasonably available information and apply the 
facts, Agency expertise and professional judgment to determine that 
chemical's conditions of use.

[[Page 37033]]

    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.
    As described in the preamble to the proposed rule, there are a 
number of general categories of circumstances that are squarely 
conditions of use that generally must be included within the scope of 
TSCA risk evaluations, including ``legacy use'' and ``associated 
disposal,'' production of a chemical as a byproduct, and the presence 
of a chemical as an impurity or within an article. Conversely, the 
Ninth Circuit opined that ``legacy disposal'' falls outside the 
definition of conditions of use. Likewise, EPA does not expect to 
consider ``intentional misuse'' of a chemical as a ``condition of 
use,'' consistent with the legislative history (Ref. 8). EPA provided 
several examples in the proposed rule of how the Agency would analyze 
the reasonably available information to make the determination on 
conditions of use--particularly with respect to determining whether or 
not a circumstance is reasonably foreseen. EPA discussed, for example, 
weighing whether exposures from spills, leaks, accidents and climate-
related impacts would be regular or predictable, versus those that are 
unsubstantiated, speculative or otherwise not likely to occur. A future 
one-time accident caused by an atypical one-time set of circumstances, 
for example, would likely not be considered ``reasonably foreseen.'' 
EPA believes that this approach is consistent with the statutory text 
and structure, as well as Congressional intent.
    EPA received a number of comments in this area, including support 
for considering chemical spills, accidents and other unplanned but 
foreseeable chemical releases and comments urging EPA to consider such 
scenarios on a more routine basis. Other commenters expressed concern 
that EPA did not articulate precise criteria or a standard for 
determining when a circumstance is reasonably foreseen. Consistent with 
the discussion in the proposed rule preamble, EPA maintains, however, 
that the determination of whether a particular circumstance is 
reasonably foreseen--and therefore an exposure that must be considered 
within the scope of the risk evaluation--is necessarily going to 
require a fact-specific, chemical-by-chemical analysis. Ultimately, 
EPA's determination on the chemical's conditions of use and the 
rationale to support those conclusions will be subject to public review 
and comment as part of each risk evaluation.
    EPA also received comments that EPA should exclude so-called ``de 
minimis'' uses from consideration in risk evaluations--such as uses 
where a chemical may only be present in small amounts as an impurity or 
within an article. EPA disagrees, and maintains the position described 
in the preamble to the proposed rule. As described previously, 
relatively low exposures individually may contribute to unreasonable 
risk when considered in aggregate. Further, as EPA noted in the 
proposed rule, 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. Such uses may, however, be appropriate for more tailored or 
qualitative analyses--as supported by the reasonably available 
information and documented in the risk evaluation--allowing EPA to 
focus more detailed/intensive efforts on the conditions of use that 
pose the greatest potential for exposure and therefore risk. Although 
TSCA provides EPA with authority to ``determine'' the conditions of 
use, it does not provide EPA with discretion to exclude from the scope 
of risk evaluations known circumstances associated with the chemical 
(e.g., legacy uses and associated disposal, production of the chemical 
as a byproduct, presence of the chemical in trace or de minimis amounts 
such as an impurity or within an article, etc.). Nonetheless, EPA 
expects to conduct risk evaluations in a fit-for-purpose manner, 
tailoring the level of analysis based on factors such as 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 to the environment; and other relevant 
considerations.
    3. Inclusion of all exposure pathways. EPA also proposed regulatory 
changes to ensure that EPA will assess all exposure routes and pathways 
relevant to the chemical substance under the conditions of use. See 40 
CFR 702.39(d)(9). As described in both the proposed rule and in Unit 
IV.D.1 of this rule, EPA does not interpret TSCA section 6(b)(4)(D) to 
provide authority to exclude conditions of use or exposure pathways 
from the scope of TSCA risk evaluations. Likewise, EPA proposed 
additional regulatory text to ensure that EPA would no longer 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 or under another Federal law 
administered by another agency. See 40 CFR 702.39(d)(9). EPA does not 
interpret TSCA section 9 to authorize exclusion of exposure pathways 
from TSCA risk evaluations.
    A number of commenters supported EPA's interpretation that the 
plain language of the law requires the consideration of all relevant 
exposure pathways in TSCA risk evaluations. Commenters who opposed 
EPA's interpretation again pointed to the language in TSCA section 
6(b)(4)(D), which requires EPA to identify--as part of the risk 
evaluation scope--the hazards, exposures and conditions of use that EPA 
``expects to consider.'' As described in Unit IV.D.1, EPA believes the 
law requires the Agency to factually identify relevant exposures 
associated with the chemical substance, while the ``expects to 
consider'' phrasing reflects the reality of the process: that the 
Agency's early expectations at the scoping phase may not always align 
perfectly with the conditions of use actually considered and assessed 
in the subsequent draft and final risk evaluations. For example, 
exposures that EPA initially expects to consider may change as EPA 
further considers and refines the reasonably available information 
during the risk evaluation process. In any event, EPA does not view the 
``expects to consider'' language in TSCA section 6(b)(4)(D) as 
providing EPA with discretion to, for example, exclude known exposures.
    Other commenters suggested that EPA's approach is inconsistent with 
Congress' intent. EPA disagrees. The law's requirement that EPA 
evaluate the ``chemical substance'' under the ``conditions of use'' 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. Further, it is only through this holistic approach 
to chemical risk evaluation that EPA will

[[Page 37034]]

be able to drive forward progress on the tens of thousands of 
unreviewed existing chemical substances in commerce. As described 
earlier in Unit IV.D.1, the 2016 TSCA reform efforts were designed to 
create more certainty and more confidence in the safety of existing 
chemicals in the marketplace. However, and contrary to Congress' goals, 
evaluating a subset of a chemical's exposures or conditions of use 
would only perpetuate uncertainties.
    EPA further disagrees with commenters that argued consideration of 
a particular exposure pathway in a risk evaluation would conflict with 
or duplicate other regulatory programs. First, where another regulatory 
program has already assessed the risks from a chemical associated with 
a particular exposure pathway, EPA would necessarily consider this 
information--along with all other reasonably available information--as 
part of its evaluation under TSCA. Where unreasonable risk has been 
identified, EPA would consider, consistent with TSCA section 9, whether 
all or part of such risk might be more appropriately managed under 
another regulatory program implemented by EPA or another Federal 
agency. Consideration of an exposure pathway in a TSCA risk evaluation 
does not automatically mean that EPA will determine the chemical to 
present unreasonable risk or that EPA will propose regulatory 
requirements related to that particular exposure pathway. Nonetheless, 
EPA recognizes that intra- and interagency coordination is integral to 
ensuring that EPA actions are well-informed, effective, and efficient, 
and expects to continue and expand upon efforts to maximize such 
coordination moving forward.
    Finally, EPA appreciates concerns expressed by some commenters that 
this approach could result in more complex and challenging risk 
evaluations. EPA disagrees, however, that considering all relevant 
exposure pathways in TSCA risk evaluations is a ``missed opportunity'' 
to streamline its assessments. As discussed, EPA concludes in this rule 
that the best interpretation of TSCA is that the law does not authorize 
the exclusion of relevant exposure pathways from consideration in a 
risk evaluation. EPA also observes that certain risk evaluations 
published by EPA during the prior Administration were challenged, 
including on the grounds that EPA's prior approach of excluding 
exposure pathways was inconsistent with the requirements of TSCA. The 
approach adopted in this rule may conserve judicial, EPA, and other 
federal government resources by avoiding or reducing the need for such 
litigation. In addition, EPA has discretion to carry out TSCA risk 
evaluations in a fit-for-purpose manner, tailoring the depth or extent 
of analysis commensurate with the nature and significance of the 
decision, and expects to employ these approaches to enable completion 
of risk evaluations within the statutory deadlines.
    Accordingly, EPA is finalizing the changes in 40 CFR 702.39(d) as 
proposed to ensure that 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.
    4. Comprehensive but fit-for-purpose. EPA noted in the preamble to 
the proposed rule that it does not believe risk evaluations under TSCA 
should 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 pursue risk evaluations in a manner that is otherwise 
incompatible with the statutory framework. The preamble to the proposed 
rule provided a discussion of how EPA expected to balance resource 
expenditure and manageability--namely by taking fit-for-purpose 
approaches that allow for varying types and levels of analysis.
    Some commenters supported this discussion, while others shared 
reservations regarding whether fit-for-purpose approaches would ensure 
adequate consideration of risks from low-volume chemicals, and whether 
such approaches would meet the law's scientific standards in section 
26. EPA fully recognizes that chemicals produced or used in low volumes 
may not mean that such chemicals present low risk, particularly with 
respect to persistent, bioaccumulative and toxic chemicals or aggregate 
exposure. Any fit-for-purpose approach in a risk evaluation on such 
chemicals would reflect this reality. Furthermore, EPA's fit-for-
purpose approaches will be subject to notice and numerous opportunities 
for comment during the risk evaluation process. If a stakeholder 
believes, for example, that EPA's qualitative approach to assessing a 
particular condition of use or that its consideration of aggregate 
exposures is insufficient, EPA would welcome specific feedback in the 
context of that risk evaluation. EPA also agrees that it must adhere to 
the scientific standards in TSCA section 26 when making science-based 
decisions under TSCA section 6, including when conducting risk 
evaluations in a fit-for-purpose manner, and appreciates the suggestion 
that EPA consider developing guidance for how the Agency might apply 
fit-for-purpose approaches in different circumstances. EPA believes 
that fit-for-purpose approaches in risk evaluations are an essential 
part of implementing the TSCA program and sustaining it over the long-
term.
    5. Additional efficiencies. In the spirit of finding additional 
efficiencies to help EPA meet the aggressive timeframes in the law for 
completing risk evaluations, EPA sought comment on the idea of the 
Agency publishing and taking comment during prioritization on 
preliminary information to inform the scope of the potential risk 
evaluation--a process that could result in the publication of the 
``draft scope'' before the initiation of a risk evaluation. EPA 
believes that a more sustainable process necessitates earlier--either 
before or during the prioritization process--review of reasonably 
available information, identification of data needs and gaps, and 
preliminary efforts to scope the potential risk evaluation. EPA did not 
propose to change the regulatory text requiring publication of a draft 
scope ``no later than'' three months after initiation, but described an 
approach where EPA would publish such information as early as the 
prioritization process (e.g., concurrent with the proposed high-
priority designation), to allow the Agency more time to review and 
effectively use the public input in the development of the risk 
evaluation's scope.
    Several commenters expressed support for this approach, noting that 
it could result in clearer scopes, more efficient risk evaluations, 
allow stakeholders to provide data earlier in the process, and increase 
the value of public engagement. Some commenters who opposed the 
approach argued that it was contrary to TSCA, which requires 
publication of the risk evaluation scope ``not later than 6 months 
after the initiation of the risk evaluation.'' Others suggested that 
EPA instead provide a preliminary list of conditions of use during 
prioritization and make it available for public comment.
    EPA notes that TSCA does not actually require the development of a 
draft scope. It is a regulatory requirement in the 2017 final rule (and 
maintained in this rule) designed to afford the public an opportunity 
to provide comment on the scope of the risk evaluation before it is 
finalized. EPA will continue to abide by the statutory requirement to 
publish the final scope within the first 6 months

[[Page 37035]]

after initiation of a risk evaluation. EPA has already been maintaining 
the practice of publishing a preliminary list of conditions of use 
during the Proposed Designation step of the prioritization process, as 
some commenters suggest. However, EPA sees additional value in 
publishing more robust preliminary information on the conditions of 
use, hazards, exposures and potentially exposed or susceptible 
subpopulations that the Agency expects to consider and any early 
indications as to how the Agency may apply fit-for-purpose approaches. 
Public comments received on this information can inform the final 
priority designation and, if the chemical is then designated as a high 
priority substance, the scope of the risk evaluation.

E. Risk Determinations

    1. Single determination on the ``chemical substance.'' EPA proposed 
to codify a requirement that EPA make a single risk determination on 
the chemical substance at the conclusion of the TSCA risk evaluation 
process, as opposed to individual risk determinations on each 
individual use of the chemical. As explained in the proposed rule, EPA 
believes that this approach reflects a plain reading of the statutory 
text and structure. EPA also believes that this approach is consistent 
with Congressional intent, and will enable the Agency's risk 
determinations to better reflect the potential for combined exposures 
across multiple conditions of use. 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.'' EPA views this language as requiring 
an evaluation on the chemical substance--not individual conditions of 
use--and for the evaluation to be based on the chemical's ``conditions 
of use.'' As further described in the proposed rule, EPA explained its 
intention to continue to consider exposures associated with each 
condition of use, but to no longer make separate risk determinations.
    EPA received comments supportive of this interpretation and its 
proposed codification, and others that disagreed with the 
interpretation. Commenters who disagreed with EPA's interpretation 
argued that the phrase ``under the conditions of use'' modifies the 
statutory directive in TSCA section 6(b)(4)(A) requiring EPA to 
determine ``whether a chemical substance presents an unreasonable risk 
of injury to health or the environment'' and that EPA could therefore 
not determine risks from a chemical substance independently from those 
conditions of use. EPA agrees that TSCA requires consideration of the 
chemical's conditions of use (i.e., the intended, known and reasonably 
foreseen circumstances under which the chemical is manufactured, 
processed, distributed in commerce, used or disposed of) and that the 
potentially different exposure scenarios presented by different 
conditions of use should be reflected in the risk evaluation's exposure 
assessment. However, the plain language of the law requires EPA to 
determine whether the chemical substance, rather than individual 
conditions of use, presents an unreasonable risk. Moreover, the plain 
language instructs EPA to do so ``under the conditions of use'' 
(plural), not under each individual condition of use. As such, EPA's 
determination is based on analysis of the chemical's conditions of 
use--rather than on each condition of use ``independently'' as 
commenters would suggest. In addition to aligning EPA's process with 
the statutory text and structure, this approach ensures 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's interpretation is unchanged from the discussion in 
the proposed rule, and EPA is finalizing the regulatory text and 
conforming changes that ensure risk evaluations will always culminate 
in a single risk determination on the ``chemical substance,'' including 
the language in 40 CFR 702.37(a)(5) and 40 CFR 702.39(f)(1).
    2. Risk communication related to single risk determination. EPA is 
aware of concerns that a single risk determination on the chemical 
substance--especially where only certain uses are contributing to that 
determination--could lead to public confusion regarding the chemical's 
risks. EPA believes these risk communication issues are addressable, 
and it is a priority area the Agency is committed to improve upon. As a 
start, EPA is no longer referring to this as a ``whole chemical'' 
approach, as the Agency believes that phrase may be misinterpreted. A 
single 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. Where one or 
more conditions of use for the chemical present an unreasonable risk, 
the chemical substance itself necessarily presents an unreasonable 
risk. EPA is committed to being clearer in its communications on this 
point, including what to expect during risk management as described in 
the next section. To provide some additional assurances, EPA proposed 
regulatory text at 40 CFR 702.37(a)(5) that states: ``. . . where EPA 
makes a determination of unreasonable risk, EPA intends to identify the 
conditions of use that significantly contribute to such 
determination.''
    Commenters nonetheless continued to express concern that the single 
risk determination would result in EPA determining that every chemical 
presents unreasonable risk, and ultimately create confusion within the 
general public regarding which uses of a chemical do or do not present 
risk. EPA appreciates the concerns regarding clear risk communication 
as part of each risk determination but disagrees with the suggestion 
that the single risk determination approach will lead to a finding of 
unreasonable risk in every instance. EPA does not pre-determine the 
outcome of any risk evaluation activity. Likewise, the law does not 
provide for or guarantee a particular risk determination outcome 
either.
    In response to these comments, EPA is strengthening its commitment 
in the final rule to identify which conditions of use are significant 
contributors to the unreasonable risk by changing the text to indicate 
a more affirmative ``will identify'' from the proposed ``intends to'' 
and by moving the regulatory text directly into the section on the 
``Unreasonable Risk Determination'' at 40 CFR 702.39(f). While not 
necessarily a perfect indicator of how EPA will ultimately regulate to 
address unreasonable risk, this communication should give industry 
stakeholders significant insight and more certainty. Additionally, the 
process for developing risk management rules under TSCA provides 
numerous opportunities for public and stakeholder engagement, and 
allows EPA to consider existing risk management controls and 
approaches. In addition to providing a rationale and explanation in the 
risk determination itself, the Agency is further committed to clearly 
communicating on the Agency's analysis of particular uses in other 
venues, and will refrain from making unqualified statements about the 
risk associated with the chemical substance that could generate the 
type of confusion commenters are concerned about.
    EPA would caution, however, on placing too much emphasis on

[[Page 37036]]

communicative value of the risk determination itself. 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 
on the regulatory actions needed to address any identified unreasonable 
risk 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.
    3. Regulatory approaches based on single risk determination. 
Several commenters suggested that EPA will use a singular risk 
determination to regulate in an overly broad manner, creating 
unnecessary and duplicative requirements, and shifting the burden to 
industry to demonstrate that they should not be regulated.
    An unreasonable risk determination on the chemical substance does 
not mean that EPA will regulate all conditions of use for that 
chemical, and EPA disagrees with commenters' suggestion to the 
contrary. To be clear: a single risk determination on the chemical 
substance will not increase regulatory burden. The determination itself 
(i.e., ``EPA has determined that `chemical x' presents an unreasonable 
risk . . .'') has no bearing on which conditions of use EPA will focus 
on during the risk management phase. 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)). The basis for EPA 
to determine the extent of necessary regulation in this context comes 
from the entirety of the risk evaluation--not simply the risk 
determination. Take for example, a scenario where an unreasonable risk 
is driven by just a few conditions of use, and EPA determines that such 
risk can be eliminated through regulations that apply narrowly to just 
those conditions of use. EPA would expect to target its risk management 
approaches accordingly and would not apply requirements more broadly. 
Further, a single risk determination on the chemical substance does not 
shift burdens from EPA to industry. It remains EPA's burden to provide 
the scientific support for any proposed and final rules to address 
unreasonable risk, and to demonstrate how such proposed action is 
necessary to address the unreasonable risk identified in the risk 
evaluation.
    EPA also strongly disagrees that a single risk determination on the 
chemical substance would be unscientific or arbitrary. EPA's basic 
methodological approach to risk assessments is unchanged in this rule. 
For every chemical, EPA will, using the best available science and 
based on the weight of scientific evidence, conduct a hazard 
assessment, conduct an exposure assessment based on the chemical's 
conditions of use, characterize the risks, propose a determination as 
to whether the risk is unreasonable under TSCA, and conduct a 
transparent and independent scientific peer review with opportunities 
for public comment. The process itself is embodied in this procedural 
framework rule and has been subject to public notice and comment, as 
will each individual draft risk evaluation.
    4. Preemption of state laws/regulations. EPA received comments 
suggesting that making a single risk determination on a chemical 
substance would undermine Congress' intent with respect to the state 
preemption provisions in TSCA section 18. Some commenters suggest that 
this risk determination approach--coupled with the belief that it would 
result in a determination of unreasonable risk in every case--would 
either effectively eliminate the possibility of preemption for specific 
conditions of use that do not present an unreasonable risk or alter the 
scope of preemption applied. Some commenters also note that EPA's 
approach results in a delay in application of permanent preemption. 
Specifically, commenters point out that a ``no unreasonable risk'' 
determination for a particular condition of use under commenters' 
approach could lead to a section 6(i)(1) determination triggering 
permanent preemption sooner than under EPA's approach. As a result, 
under EPA's approach, commenters suggest that state-specific approaches 
to regulating chemicals will increase during that delay time, resulting 
in the patchwork of state regulations that Congress sought to address 
in the 2016 amendments.
    Commenters have a fundamental misunderstanding of EPA's 
interpretation of TSCA section 18 as it relates to preemption. Even if 
one were to accept commenters' hypothesis that a single risk 
determination would lead to a determination of unreasonable risk in 
every case (which EPA rejects), such an approach does not eliminate 
preemption or otherwise make any aspect of TSCA section 18 superfluous 
for conditions of use EPA addresses in its risk evaluation. First, 
pause preemption under section 18(b) applies only during the risk 
evaluation process and is entirely unaffected by how EPA frames its 
risk determination at the conclusion of that process. Permanent 
preemption is triggered under section 18(a)(1)(B)(ii) if EPA issues 
first a scope of the risk evaluation under section 6(b)(4)(D) and then 
a section 6(a) final rule or section 6(i)(1) determination based on the 
risk evaluation. The scope of this preemption is addressed in section 
18(c)(3) and EPA reads this provision to apply permanent preemption to 
any condition of use within the scope of the risk evaluation which is 
the support document for any resulting section 6(a) rule or section 
6(i)(1) determination. In the context of a section 6(a) rule, this is 
the case irrespective of whether those uses contribute to the 
unreasonable risk and/or are targeted for risk management. Thus, the 
scope of permanent preemption is the same under either a single risk 
determination for the chemical substance or the use-based approach 
previously applied. Consequently, while EPA disagrees with commenters' 
reading of TSCA with respect to the requirement for a single risk 
determination on the chemical substance, EPA agrees with commenters 
that Congress intended permanent preemption to apply to conditions of 
use EPA addresses in the risk evaluation.
    The real distinction between the risk determination approaches is 
not whether preemption will occur or the scope of that preemption, but 
when (since, under the prior use-based approach, an order of no 
unreasonable risk could precede a rulemaking on other uses that do 
present unreasonable risk). EPA is not persuaded that such difference 
will result in a patchwork of unworkable and confusing requirements 
among the states as claimed by commenters. It is entirely speculative--
and quite unlikely in EPA's view--to suggest that multiple States will 
seek to inconsistently regulate a particular chemical or certain 
conditions of use for a particular chemical during such a short period 
of time, i.e., after issuance of the risk determination when pause 
preemption ceases and prior to the effective date of a TSCA section 
6(a) rule when permanent preemption

[[Page 37037]]

applies, while EPA actively works to finalize a comprehensive national 
approach to risk management for that same chemical.
    Regardless, as explained in Unit IV.E.1., EPA has concluded that 
the chemical-based approach to risk determination is required under a 
plain reading of the statutory text and structure and consistent with 
Congressional intent. EPA further notes, as described in the proposed 
rule, that the plain language in TSCA section 18 also supports the view 
that Congress intended EPA to make a single risk determination on the 
chemical substance, namely, the numerous references to ``chemical 
substance'' as opposed to uses of a chemical substance, and 
``determination'' in the singular.
    5. ``Unreasonable risk'' considerations. Neither TSCA nor this 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-by-case basis. The proposed rule included a discussion of 
considerations EPA may weigh in determining unreasonable risk, 
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 potentially 
exposed or susceptible subpopulations), the severity of hazard (the 
nature of the hazard, the irreversibility of hazard), and 
uncertainties. Additionally, the proposed rule includes a discussion of 
how EPA will also consider, where relevant, the Agency's analyses on 
aggregate exposures and cumulative risk in its risk determinations. EPA 
also proposed to codify at 40 CFR 702.39(f)(1) the statutory 
requirement to consider the risks to potentially exposed or susceptible 
subpopulations as part of its risk determination on a chemical 
substance. EPA did not receive significant comments on this topic and 
is finalizing this rule as proposed.

F. Risk Evaluation Considerations

    1. Occupational exposure assumptions. EPA proposed new regulatory 
text at 40 CFR 702.39(f)(2) to ensure that ``consideration of 
occupational exposure scenarios will take into account reasonably 
available information'' and that EPA will ``not consider exposure 
reduction based on assumed use of personal protective equipment as part 
of the risk determination.'' As described in the proposed rule, EPA had 
previously 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. However, EPA believes that the 
assumed use of PPE in a risk determination could lead to an 
underestimation of the risk to workers. For example, as described in 
the proposed rule, 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, 
the PPE is not sufficient to address the risk from the chemical, or 
their PPE does not fit or function properly. Many of OSHA's chemical-
specific permissible exposure limits were adopted in the 1970s and have 
not been updated since they were established (Ref. 9). 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. The proposed 
addition would codify EPA's more recent practices and ensure fulsome 
consideration of exposure and risks to workers as part of TSCA risk 
evaluations.
    A number of commenters strongly supported EPA's proposed changes, 
arguing that EPA's previous approach was inconsistent with the law. 
Others disagreed, stating that the proposed changes would result in 
overestimates of worker exposures, inaccurate risk determinations, and 
overly restrictive risk management actions. EPA recognizes that many 
companies likely have well-established occupational control measures in 
place. EPA has, in various contexts, received public comments from 
industry 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 would emphasize that the 
proposed rule states ``in determining whether unreasonable risk is 
presented, EPA's consideration of occupational exposure scenarios will 
take into account reasonably available information. . . .'' Where 
information on known occupational control measures is made available, 
the Agency is committed to taking that information into account in the 
exposure assessment. EPA has been consistent in urging industry to 
provide the Agency with information regarding worker exposure controls. 
Information from the risk evaluation's exposure assessment is also 
considered in risk management action and can be useful in facilitating 
consistency with broader industry best practices where possible. EPA 
encourages commenters to continue engaging with EPA on this point on 
chemical-specific actions and to provide the Agency with timely and 
relevant data that can be considered during the TSCA process.
    Other commenters took issue with what they characterized as EPA's 
lack of support for an assumption that workers disregard PPE 
requirements, or that there is widespread noncompliance with OSHA. EPA 
disagrees with these characterizations. The proposed change in this 
rule is that EPA will not ``assume use'' of PPE for purposes of the 
risk determination--not that EPA will assume no use of PPE. Likewise, 
EPA is not asserting there is widespread noncompliance with OSHA 
requirements. As described earlier, EPA's exposure assessment on each 
chemical will be informed by the reasonably available information, and 
EPA encourages companies to submit information on their occupational 
exposure control practices, including the extent to which those 
practices may be standard for an industry, and any associated support. 
Further, EPA distinguishes ``assumed use'' of PPE from 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, fit, 
and effectiveness of PPE (e.g., information demonstrating that 
performance of a condition of use is impossible in the absence of PPE), 
EPA would expect to take that information into account in the risk 
determination.
    A number of commenters also argue that the proposed changes in the 
TSCA risk evaluation process would result in TSCA risk management 
efforts that duplicate or confuse OSHA standards. EPA's development of 
risk management rules under TSCA is a separate process that provides 
numerous opportunities for public engagement, and allows EPA to 
consider existing risk management controls and approaches to avoid or

[[Page 37038]]

minimize regulatory overlap or duplication. EPA rejects the notion that 
Congress provided OSHA with exclusive jurisdiction over worker safety. 
Congress explicitly directs EPA to evaluate and manage chemical risks 
to workers in TSCA. Although EPA has not suggested that OSHA is not 
meeting its own statutory requirements, OSHA itself acknowledges the 
limits of its authority to regulate exposures to hazardous chemicals. 
For example, and as described more in the proposed rule, OSHA lacks 
direct jurisdiction over state and local government workers, and does 
not cover self-employed workers, military personnel, and uniquely 
military equipment, systems, and operations, and workers whose 
occupational safety and health hazards are regulated by another Federal 
agency (for example, the Mine Safety and Health Administration, the 
Department of Energy, or the Coast Guard). EPA coordinates with OSHA on 
TSCA actions on a regular basis. Where unreasonable risk to workers has 
been identified, EPA would consider, consistent with TSCA section 9, 
whether such risk might be more appropriately managed under another 
regulatory program implemented by EPA or another Federal agency.
    Similarly, EPA disagrees that the proposed changes regarding worker 
PPE assumptions would duplicate or confuse existing standards in other 
industries. Where stakeholders have information that demonstrates 
effective occupational exposure control practices for the chemical 
undergoing risk evaluation--whether through implementation of 
regulatory requirements imposed by other Agencies or in keeping with 
the standards of a particular industry--EPA encourages submission of 
that information to inform both the risk evaluation and risk management 
processes.
    After consideration of these comments, EPA is finalizing the 
regulatory text at 40 CFR 702.39(f)(2) as proposed. However, and to 
further emphasize EPA's commitment to consider reasonably available 
information with respect to occupational exposure control practices as 
part of the risk evaluation, EPA is finalizing additional regulatory 
text to that effect in the exposure assessment section at 40 CFR 
702.39(d). As described in Unit IV.F.5., EPA is further committing to 
make publicly available any risk-based occupational exposure values 
calculated as part of the risk evaluation.
    2. Aggregate exposure. The proposed rule included regulatory text 
committing the Agency to consider aggregate exposures as part of TSCA 
risk evaluations and, when supported by reasonably available 
information, consistent with the best available science and based on 
the weight of scientific evidence, to include an aggregate exposure 
assessment in the risk evaluation, or otherwise explain the basis for 
not doing so. See 40 CFR 720.39(d)(8). EPA also proposed minor 
revisions to the definition of ``aggregate exposure.'' These changes 
relate to the implementation of TSCA section 6(b)(4)(F)(ii), which 
provides that 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.'' These changes are 
consistent with the definition used in General Principles for 
Performing Aggregate Exposure and Risk Assessments (Ref. 10).
    Several commenters expressed support for this change and offered 
additional suggestions to strengthen the requirement. Other commenters, 
while supportive of consideration of aggregate exposure generally, 
shared some concerns that aggregate exposure assessments may extend the 
time it will take EPA to complete a risk evaluation. Still other 
commenters argue that consideration of aggregate exposure will 
unnecessarily complicate risk evaluations and prevent the Agency from 
meeting its statutory deadlines. These comments reflect two broad 
competing challenges for EPA: how to carry out robust risk evaluations 
that capture the full extent of risks faced by communities--including 
risks from aggregate exposures--that will position EPA to protect 
against those risks, and how to keep those processes manageable in 
order to meet clear statutory requirements and deadlines set by 
Congress and to actually provide protections via risk management.
    EPA believes the consideration of an aggregate exposure assessment 
may be particularly important to characterize and assess 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, exposure via drinking water and water recreation, 
and/or exposure via occupation-related activities) and/or from multiple 
sources (e.g., through different conditions of use occurring at 
multiple nearby facilities or from multiple products), the Agency has 
clear authority to aggregate those exposures, subject to the scientific 
standards in TSCA section 26. Furthermore, in developing a 
comprehensive risk estimate for a chemical substance, it is the 
Agency's responsibility, when supported by the best available science, 
to consider the aggregation of individual exposures from individual 
conditions of use as well as consider aggregate exposure from multiple 
routes of exposure that may contribute to unreasonable risk. As 
described in the proposed rule, it may be appropriate to consider 
potential background exposures from non-TSCA uses that are not within 
the scope of the risk evaluation as part of an aggregate exposure 
assessment. Likewise, EPA could consider the disproportionate impacts 
that background exposures may have on overburdened communities to 
inform the final unreasonable risk determination.
    On the other hand, EPA is mindful that Congress did not intend for 
TSCA risk evaluations to take longer than the 3.5 years allotted in the 
statute. Aside from just meeting legal responsibilities, staying within 
statutory deadlines also allows EPA to keep pace on working through the 
tens of thousands of unreviewed existing chemicals and propose/finalize 
rules to afford meaningful protections for human health and the 
environment.
    EPA believes the proposed rule strikes the appropriate balance on 
considering aggregate exposures in TSCA risk evaluations, and, after 
considering public comments on this issue, is finalizing the new 
regulatory text as proposed.
    3. Cumulative risk. Although EPA did not propose any regulatory 
changes regarding consideration of cumulative risk, advancing the 
science of cumulative risk is a high priority for the Agency to inform 
EPA's effort to better understand and mitigate risks to potentially 
exposed and susceptible subpopulations. In the preamble to the proposed 
rule, EPA noted that the best available science may indicate that the 
development of a cumulative risk assessment--looking at the combined 
health risk from multiple chemicals--is appropriate to ensure that risk 
to human health and the environment is adequately characterized. EPA 
further noted that TSCA provides 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)). EPA sought comment on how the 
Agency could incorporate provisions for cumulative risk assessment into 
the 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 what

[[Page 37039]]

Congress envisioned when it established deadlines for conducting risk 
evaluations.
    Some commenters offered support for EPA's discussion on cumulative 
risk assessment as well as suggestions for going further, such as 
including a definition of ``cumulative risk'' in the rule. Another 
commenter cautioned against qualitative fit-for-purpose approaches 
undermining EPA's ability to effectively carry out a cumulative risk 
assessment. Another commenter, while supportive of advancing the 
science on cumulative risk assessment, shared concern about such an 
approach preventing EPA from timely completing risk evaluations and 
proposing necessary regulatory protections. Other commenters opposed 
consideration of cumulative risk. A number of commenters suggested that 
provisions requiring consideration of cumulative risk would further 
delay completion of risk evaluations. Others argued that such 
considerations are not allowable under TSCA.
    EPA appreciated the range of perspectives shared by commenters. 
With respect to the comment that EPA should define cumulative risk in 
the regulatory text, EPA is not inclined to do so at this time, as 
there is no mention of ``cumulative risk'' in the rule or the law that 
would warrant a codified definition. EPA did, however, describe 
cumulative risk assessment in the preamble to the proposed rule, and 
has defined the phrase in ``EPA's Framework for Cumulative Risk 
Assessment'' (Ref. 11). EPA expects to continue to develop robust 
methodology for the inclusion of cumulative risk assessment in TSCA 
risk evaluations, and to continue to engage with stakeholders as part 
of that process. EPA believes that quantitative analyses may be 
necessary to support cumulative risk assessments, and will consider the 
appropriate analyses carefully when developing and pursuing any fit-
for-purpose approaches. EPA disagrees with the suggestion that 
cumulative risk assessment is not allowable under TSCA. As described in 
the proposed rule, TSCA requires that EPA 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)). 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. Finally, EPA again appreciates commenters' concerns 
regarding the potential for cumulative risk analyses to increase the 
complexity of TSCA risk evaluation and create challenges for the Agency 
to timely complete them. As described in Unit IV.D.4, EPA intends to 
apply fit-for-purpose approaches in risk evaluations to ensure 
completion within the statutory timeframes, while also building a 
robust scientific basis for the effective characterization and 
management of unreasonable risk to human health and the environment.
    After considering these comments, EPA is finalizing this rule 
without an explicit requirement related to cumulative risk assessment. 
EPA is nonetheless committed to considering and applying cumulative 
risk assessment approaches for future chemicals undergoing risk 
evaluation, where supported by the reasonably available information and 
best available science.
    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 potentially exposed or susceptible subpopulation (PESS) 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)). EPA codified the statutory definition in the 2017, 
noting at that time that TSCA does not further define ``greater 
susceptibility'' or ``greater exposure'' giving the Agency discretion 
to interpret these terms. As such, the law authorizes EPA to identify 
any subpopulation that may be at greater risk due to greater 
susceptibility or exposure, and, likewise, to identify additional 
subpopulations beyond those examples listed in the statute, as relevant 
to a risk evaluation.
    In this rule, and as described in Unit IV.C., EPA proposed to amend 
the regulatory definition of PESS by adding the term ``overburdened 
communities'' to the list of example subpopulations. This additional 
term reflects the Agency's understanding and acknowledgment that a 
chemical substance may disproportionately expose and/or may 
disproportionately impact communities already experiencing 
disproportionate and adverse human health or environmental burdens. 
Such disproportionality can be as a result of greater exposure or 
vulnerability to environmental hazards, lack of opportunity for public 
participation, or other factors. Increased exposure or vulnerability 
may be attributable to an accumulation of negative or lack of positive 
environmental, health, economic, or social conditions within these 
populations or places. The term describes situations where multiple 
factors, including both environmental and socio-economic stressors, may 
act cumulatively to impact health and the environment and contribute to 
persistent environmental health disparities. These situations may apply 
to communities with environmental justice concerns.
    Many commenters supported this proposed change and agreed with EPA 
that the examples provided in the statutory definition were 
illustrative rather than limiting. Others urged EPA to go even further 
by either specifically defining ``overburdened communities'' or 
including additional factors in the definition of ``potentially exposed 
and susceptible subpopulations'' like the consideration of non-chemical 
stressors (Ref. 12) that may increase susceptibility. Other commenters 
opposed adding ``overburdened communities'' to the definition of PESS, 
arguing that EPA lacks authority to add additional criteria to the PESS 
definition beyond what's included in the law. A few commenters 
suggested that ``overburdened communities'' does not fit with the other 
types of groups provided as examples in TSCA because they refer to 
individuals rather than a subpopulation defined by its location or 
geographic proximity. Some commenters argued the term was too 
subjective and that EPA did not provide sufficient clarity in how it 
would identify such communities or quantify ``overburdened.''
    EPA does not believe it is necessary to define ``overburdened 
communities'' as part of this rule. In the same way that EPA considers 
whether children or workers or the elderly are a PESS in the context of 
a specific risk evaluation, EPA will look to whether ``overburdened 
communities'' are subject to exposure or susceptibility greater than 
the general population. EPA does not intend this term to be confined to 
a location or geographic proximity, but would use reasonably available 
information for each chemical to determine the inclusion of specific 
communities. Those experiencing ``greater exposure'' could include 
individuals or communities experiencing higher levels of exposure to a 
chemical substance due to

[[Page 37040]]

geography (e.g., fenceline communities in close proximity to facilities 
emitting air pollutants or living near effluent releases to water), 
unique exposure pathways that differ from those of the general 
population (e.g., Tribal communities where reliance on subsistence 
fishing results in increased chemical exposure via ingestion), and/or 
aggregate exposure via multiple conditions of use (e.g., a worker who 
lives in close proximity to facilities emitting air pollutants). As 
discussed in Unit III.G.4. of the proposed rule, communities with 
``greater susceptibility'' could include communities that due to their 
proximity to a higher proportion of industrial emitters may be 
experiencing greater burden or those with an increased risk of 
experiencing an adverse effect due to one's lifestage or a pre-existing 
condition or circumstance (Ref. 5). Although EPA certainly agrees that 
non-chemical stressors can increase susceptibility to adverse health 
outcomes, EPA does not believe that including such specific factors 
within the PESS regulatory definition is necessary.
    EPA disagrees with commenters that EPA lacks authority to add 
``overburdened communities'' to the list of potential PESS examples. 
Congress' inclusion of ``such as'' in the statutory definition provides 
EPA with clear discretion to go beyond the statute's list of examples. 
EPA further disagrees that this addition is substantively changing the 
criteria for identification of PESS (i.e., greater exposure or 
susceptibility and greater risk than general population). EPA believes 
that an ``overburdened community'' or those that may be 
disproportionately exposed or impacted by environmental harms, is 
clearly an example of a group that may frequently be at greater risk 
than the general population.
    While EPA appreciates commenters' desire for more transparency on 
how ``overburdened communities'' might be identified and associated 
risks quantified, such rationale and transparency is already a 
necessary component of every risk evaluation. In identifying PESS more 
generally, EPA expects to engage the public throughout the TSCA 
prioritization and risk evaluation processes, and to work with other 
EPA offices. Currently available screening tools, such as EJSCREEN 
(Ref. 13) or EnviroAtlas (Ref. 14), and other tools may 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). EPA also continues to develop 
approaches for assessing the risk to communities at greater exposures 
to chemical emissions. For example, EPA developed a screening level 
methodology to evaluate the potential chemical exposures and associated 
potential risks to fenceline communities (Ref. 15), and, following peer 
review, EPA has been applying these approaches in subsequent risk 
evaluations (e.g., Draft Risk Evaluation for Tris(2-chloroethyl) 
Phosphate (TCEP) (Ref. 16) and 1,4-dioxane Draft Supplemental Risk 
Evaluation (Ref. 17)). 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.
    After considering the comments, and as described in Unit IV.C., EPA 
is finalizing the changes to the PESS definition as proposed to better 
reflect the Agency's commitment to fully consider the impacts a 
chemical undergoing TSCA risk evaluation may present to communities 
already experiencing disproportionate and adverse human health or 
environmental burdens.
    5. Risk-based occupational exposure values. As part of the proposed 
rule, EPA solicited comment on how EPA could improve the transparency 
of any risk-based occupational exposure values derived from the risk 
evaluation process. Commenters generally expressed a strong desire for 
more opportunity for public review and scientific input on how risk-
based occupational exposure values are derived, and a more formalized 
approach for the development of any corresponding regulatory limits.
    Although occupational exposure values for some of EPA's first 10 
chemicals came out at a different time than the risk evaluations 
themselves, EPA does not intend this to be the practice moving forward. 
More recently, for example, EPA put out a draft risk-based occupational 
exposure value in the Draft Risk Evaluation for TCEP (Ref. 16) released 
for peer review. EPA will continue to do that as a matter of practice. 
Further, and in response to comments on the proposed rule, EPA is 
including a commitment in the regulatory text to calculate a risk-based 
occupational exposure value in the draft risk evaluation where 
unreasonable risk to workers through inhalation is identified. As part 
of this commitment, EPA will explain in each risk evaluation how the 
value was calculated.
    To avoid confusion, EPA is no longer referring to the risk-based 
occupational exposure value calculated in the risk evaluation as an 
Existing Chemical Exposure Limit (ECEL). The risk-based occupational 
exposure value calculated in the risk evaluation is based on the most 
sensitive hazard endpoint and standard occupational exposure scenarios 
assumption (i.e., 8 hours a day, 5 days a week, 250 days a year, for 40 
years), and by law, cannot consider costs or other non-risk factors. 
The value is not a regulatory limit or level, though it can be used to 
inform risk management. The value is only relevant to workers in 
occupational settings--not to consumers or the general population. The 
value also does not take into account any existing occupational 
exposure controls, though, as described elsewhere in this document, EPA 
will consider such controls as part of developing regulations required 
under TSCA section 6(a) to address unreasonable risk.
    Considerations for risk management approaches are outside the scope 
of this rule. However, when proposing any regulatory limit during the 
risk management phase, EPA may consider costs and other non-risk 
factors, such as technological feasibility, the availability of 
alternatives, the continued need for critical or essential uses, the 
potential for different occupational requirements for these uses, and 
existing occupational exposure control approaches and technologies. As 
such, any regulatory occupational existing chemical exposure limit or 
ECEL for risk management purposes could differ from the occupational 
exposure value calculated in the risk evaluation based on additional 
consideration of exposures and non-risk factors consistent with TSCA 
section 6(c).
    While in many cases EPA won't be aware of all of those non-risk 
factors until it actively engages in the risk management process for a 
specific chemical, there are also times when EPA will be able to 
describe in the risk evaluation circumstances that may lead any 
regulatory limit to differ from the calculated occupational exposure 
value. In the Draft Risk Evaluation for Formaldehyde (Ref. 18), for 
example, EPA was able to state with certainty that any ECEL developed 
for occupational safety risk management purposes would be certain to 
differ from the calculated exposure value included in the draft Risk 
Evaluation. In that instance, EPA was able to recognize unique 
challenges

[[Page 37041]]

associated with the formaldehyde draft risk evaluation, including 
indistinguishable sources of exposure and a calculated occupational 
exposure value that fell below the 50th to 95th percentile of measured 
concentrations in residential indoor air. Where such information is 
available, EPA would expect to provide similar clarity on this point in 
future risk evaluations.
    EPA has valued the engagement with industry and other Federal 
agency stakeholders on some of EPA's proposed risk management measures 
to date, and the Agency is committed to making adjustments as 
appropriate to ensure any occupational regulatory restrictions are both 
protective and implementable. As described in Unit IV.F.1., 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, 
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. 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.

G. Scientific Guidance and Procedures

    1. In general. 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)). 
EPA codified the use of appropriate Agency guidance (which can also 
include Agency guidelines, frameworks, handbooks, or standard operating 
procedures) in the development of risk evaluations in the 2017 final 
rule and proposed to maintain that regulatory text in the proposed rule 
(40 CFR 702.37(a)(1)). EPA received support from public commenters on 
this provision and is finalizing it as proposed. TSCA risk evaluations 
require the Agency to conduct hazard, exposure, and fate assessments, 
quantify both acute and chronic effects, as well as assess the risks to 
the environment. The breadth of risk evaluations requires a breadth of 
expertise and methods, processes, protocol, and models. Agency guidance 
and methodology documents have and will continue to provide process and 
method transparency to Agency scientific work products. EPA will use 
the appropriate guidance based on the application of methods, 
approaches, and science policy decisions used in TSCA risk evaluations. 
EPA will continue to use existing Agency guidances in the development 
of TSCA risk evaluations. EPA may develop and use additional guidance 
as needed using a transparent process. Additionally, the TSCA program 
will work closely with other EPA offices to ensure the use of the best 
available science, specifically where another office may have expertise 
specific to a certain chemistry or method employed in a risk 
evaluation.
    2. Peer review. Science is the foundation that supports the work of 
EPA. The use of best available science is vital to the credibility of 
the Agency's determination of whether a chemical presents an 
unreasonable risk, decisions on how best to manage that risk, the 
Agency's effectiveness in pursuing its mission to protect human health 
and the environment, and the public's trust in Agency decisions. Peer 
review, as recognized by TSCA section 26(h), is an integral 
consideration in ensuring Agency decisions are consistent with the best 
available science. Peer review can ensure the use of reasonably 
available information to make decisions is based on the weight of 
scientific evidence. Conducting transparent and independent scientific 
peer review, along with providing opportunities for public comment, has 
been and will remain an important component of the TSCA risk evaluation 
process. Peer reviews on TSCA risk evaluations to date have proven 
extremely instructive and resulted in more robust and scientifically 
defensible products and improvements to EPA methods used in the risk 
evaluation process.
    The 2017 final rule codified peer review as a component of the risk 
evaluation process. In the proposed rule, EPA included amendments to 
the regulatory text on peer review attempting to clarify the Agency's 
flexibility in determining how and what to peer review. The proposed 
regulatory text read: ``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).'' EPA received many comments on the 
proposed changes to this regulatory provision, most of which were 
unsupportive. Many expressed concern that the flexibility sought in 
this change may result in limited and less transparent peer reviews, 
counter to the scientific standards required by the statute. 
Specifically, commenters found that use of the phrase ``expected'' to 
conduct peer review left open the possibility that EPA could forgo peer 
review altogether. Commenters also expressed concern about a piecemeal 
approach that may result if the Agency only peer reviewed ``portions'' 
of future risk evaluations, which commenters noted could result in 
portions of a risk evaluation not undergoing peer review, or that EPA 
may shield from peer review particular lines of evidence used in making 
a determination of unreasonable risk.
    The Agency fully intends to act consistently with the EPA Peer 
Review Policy Statement, which states in part, ``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 . . .'' (Ref. 19). In the final 
rule EPA has amended the proposed regulatory text to affirm that EPA 
will conduct peer review: ``EPA will conduct peer review activities on 
risk evaluations . . .'' (40 CFR 702.41). EPA agrees with commentors 
that peer review is necessary and integral to robust TSCA risk 
evaluations, and the Agency fully intends to continue to conduct peer 
review on TSCA risk evaluations consistent with longstanding Agency and 
OMB guidance.
    With respect to EPA's use of ``or portions thereof'' of in the 
proposed rule regulatory text, EPA did not intend that phrase to 
reflect a policy change, but rather a clarification of the allowable 
scope of peer review under both the EPA Peer Review Handbook 4th 
Edition 2015 (EPA Handbook) (Ref. 20) and OMB's Information Quality 
Bulletin for Peer Review (Peer Review Bulletin) (Ref. 21). As a general 
matter, EPA believes that peer reviewing all or most of the risk 
evaluation will likely be standard practice for the foreseeable future. 
EPA notes that, under the Peer Review Bulletin, Agencies also have 
``broad

[[Page 37042]]

discretion in determining what type of peer review is appropriate.'' 
The Peer Review Bulletin instructs agencies ``to consider tradeoffs 
between depth of peer review and timeliness''. This includes the 
consideration of costs of peer review--both direct costs and costs of 
potential delay in government and private actions that result from peer 
review, including delays in risk management actions to address 
unreasonable risks.
    After consideration of comments, EPA has removed the ``or portions 
thereof'' language in the regulatory text, as this in an unnecessary 
codification of a practice that is already allowed under existing 
guidance documents. The final rule makes clear that EPA will conduct 
peer review activities on TSCA risk evaluations, and expects those 
activities and related decisions regarding the appropriate scope and 
type of peer review to be consistent with the applicable guidances from 
OMB and EPA.
    EPA expects that, at some point in the future, risk evaluations may 
use previously peer reviewed scientific approaches, models, and/or 
methods for similar chemicals or exposure scenarios. In those cases, 
peer review can focus on the novel information, applications, and 
analysis that will benefit from independent, expert peer review. For 
some risk evaluations, it may be more appropriate to peer review solely 
the weight of evidence determination. The intent of the proposed 
provision was to ensure Agency discretion and flexibility when 
determining the approach to and scope of peer review. Both the Peer 
Review Bulletin and the EPA Handbook clearly outline circumstances 
where additional peer review may not be necessary. An example would 
include work that has been previously peer reviewed in a manner 
consistent with the Peer Review Bulletin and the EPA Handbook. For each 
risk evaluation, EPA will consider the complexity, novelty, and any 
prior peer review to determine the appropriate approach to and scope of 
peer review to apply.
    Additionally, and as discussed in the proposed rule, EPA also 
expects that a TSCA risk evaluation may use peer reviewed products 
(e.g., risk assessments, hazard assessments, models), or portions 
thereof, developed by another EPA office or other authoritative body 
(e.g., state, national, or international programs). EPA will use 
existing assessments and review scientific information in a transparent 
manner, including documenting how the information used represents the 
best available science, is fit-for-purpose, and supports the weight of 
evidence.
    Some commenters question EPA's position of not seeking peer review 
on the unreasonable risk determination. Consistent with the 2017 final 
rule, 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 evaluation, 
not a review 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)).
    EPA received a number of comments on the type of peer review that 
may be employed for TSCA risk evaluations. Consistent with the 2017 
final rule, EPA has not codified the type of peer review or specific 
reviewers. The Peer Review Bulletin recognizes that ``different types 
of peer review are appropriate for different types of information.'' 
The Peer Review Bulletin grants Agencies discretion in determining what 
type of peer review is appropriate. Agencies are directed to choose a 
peer review mechanism that is adequate, ``[considering] the novelty and 
complexity of the science to be reviewed, the relevance of the 
information to decision-making, the extent of prior peer reviews, and 
the expected benefits and costs of additional review''. The level of 
rigor of the peer review should be based on whether the information 
contains methods or models that are precedent-setting, presents 
conclusions that are likely to change prevailing practices, or will 
likely affect policy decisions that have a significant impact.
    EPA retains the discretion to employ various types of peer review, 
including panel or letter reviews. EPA expects to use letter reviews as 
appropriate, but anticipates that letter reviews will be the exception 
while panel reviews will be preferred. EPA will continue to use on a 
case-by-case basis the Science Advisory Committee on Chemicals (SACC) 
(the advisory committee required by TSCA section 26(o)) to provide 
independent advice and expert consultation with respect to the 
scientific and technical aspects of issues relating to the 
implementation of TSCA.
    Finally, EPA proposed removing the reference to specific versions 
of guidance documents. The Agency recognizes that guidance may be 
updated and/or names modified and, to avoid confusion as to which 
guidance documents will be used, the Agency proposed 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.'' A number 
of commenters expressed concern at the ambiguity and lack of clarity 
that could arise for both EPA staff and stakeholders without specific 
documents named. For the final rule, EPA determined not to codify 
specific titles and has retained the proposed language with minor 
adjustments for additional clarity. Codifying specific documents into 
regulatory text is problematic if and when documents are updated or are 
supplanted by a new version. Although not named in the regulatory text, 
EPA peer review activities for TSCA risk evaluations will generally by 
guided by EPA Peer Review Handbook 4th Edition 2015 (Ref. 20) and OMB's 
Information Quality Bulletin for Peer Review (Ref. 21), successor 
versions of these documents, and/or any requirements that may later 
supplant these documents.

H. Scientific Standards

    TSCA section 26(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.'' TSCA 
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.
    As described in Unit IV.C., EPA proposed to eliminate both 
definitions from the regulatory text. Aside from being unnecessary, EPA 
believes codifying definitions for these scientific terms limits the 
Agency's ability to adapt to the changing science of risk evaluation, 
as well as the science that informs risk evaluation, and limits the 
Agency's flexibility to implement and

[[Page 37043]]

advance novel science. Additional discussion on how EPA intends to 
uphold TSCA's scientific standards for ``best available science'' and 
``weight of scientific evidence,'' as well as EPA's expected 
application of systematic review methods for identifying and assessing 
reasonably available information, is provided in the sections that 
follow.
    1. Best available science. As described in the 2017 final rule, EPA 
continues to believe that the ``best available science'' is science 
that is reliable and unbiased. Use of best available science involves 
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). Additionally, as 
required in TSCA section 26(h), in determining the ``best available 
science,'' EPA must consider as applicable:
    2.

    (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.

    EPA's implementation of the ``best available science'' standard in 
TSCA is further informed by longstanding EPA and OMB guidance. The OMB 
Information Quality 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. 22), 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. 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 
advancing and that risk information may need to be updated over time.''
    As described in Unit IV.C., the Agency does not believe codifying a 
definition of ``best available science'' provides any additional 
transparency or improves consistency, as EPA must for each risk 
evaluation determine what is the best available science based on the 
reasonably available information. EPA is furthering its commitment to 
transparency by finalizing the proposed regulatory text requiring EPA 
to ``document that the TSCA risk evaluation is consistent with the best 
available science and based on the weight of the scientific evidence'' 
in 40 CFR 702.37(a). With respect to ``best available science,'' EPA is 
also finalizing the list of considerations for determining what 
constitutes the best available science--considerations that are taken 
directly from TSCA section 26(h). In response to some commenters' 
concerns that the prefacing language (i.e., ``shall include, but are 
not limited to, . . .'') did not match with section 26(h)--and could 
imply an intention by EPA to ignore the statutory considerations or 
opaquely apply different ones--EPA is adjusting that language in the 
final rule to state, as the law states, that EPA ``shall consider as 
applicable . . .''.
    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 federal, state or international 
authoritative bodies. EPA may consider whether these existing 
assessments or reviews represent the best available science as required 
under TSCA and use portions of them to directly inform a risk 
evaluation. Additionally, where appropriate and consistent with the 
White House's Guidance for Federal Departments and Agencies on 
Indigenous Knowledge, EPA will consider including and applying 
Indigenous Knowledge to inform decisions related to the best available 
science (Ref. 23).
    As stated in 40 CFR 702.37(a)(1), the Agency will use appropriate 
Agency guidance in the development of the TSCA risk evaluations under 
this rule. TSCA section 26(l) provides further support for this 
approach, requiring the Agency to use and develop guidance documents 
that are necessary in carrying out the statute. TSCA further requires 
the revisions of guidance 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. This approach is 
also consistent with the approach taken in other EPA programs (e.g., 
Office of Water's implementation of the Clean Water Act and the Office 
of Air and Radiation's implementation of the Clean Air Act), none of 
which codify a definition of ``best available science.''
    2. Systematic review and fit-for-purpose approaches. As described 
in Unit IV.C., EPA is, as proposed, eliminating the codified definition 
of ``weight of scientific evidence'' in the final rule, which EPA 
believes inappropriately conflated the concepts of ``weight of 
scientific evidence'' with ``systematic review.'' Many commenters 
supported this approach and further support the requirement that EPA 
codify the use of systematic review, but recommended further 
clarification as to how EPA will incorporate systematic review into the 
process for conducting TSCA risk evaluations.
    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 
comprehensively through unbiased, transparent and objective data 
collection and data evaluation, using methods consistent with the 
general principles of systematic review. EPA believes that integrating 
appropriate and applicable systematic review methods into the TSCA risk 
evaluations is critical to meeting the scientific standards as 
described in TSCA section 26(h) and (i). Systematic review methods may 
include a systematic review, such as that described in the Draft TSCA 
Systematic

[[Page 37044]]

Review Protocol Supporting TSCA Risk Evaluations for Chemical 
Substances: A Generic TSCA Systematic Review Protocol with Chemical-
Specific Methodologies (Ref. 24) or the EPA's Office of Research and 
Development Staff Handbook for Developing IRIS Assessments (Ref. 25), 
or may be an approach that incorporates the principles of systematic 
review. The principles of systematic review are well-established and 
include ``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. 26). EPA has finalized the 
requirement to use and document systematic review methods to assess 
reasonably available information, and included flexibility to consider 
the appropriate level of review for a given evidence stream, while 
still ensuring EPA meets the requirements of TSCA sections 26(h) and 
(i) (see Sec.  702.37(b)(2)).
    The flexibility to apply appropriate and relevant systematic review 
methods is necessary in the development of TSCA risk evaluations. The 
National Academies of Science Engineering and Medicine (NASEM) report 
(Ref. 27), in their review of the Application of Systematic Review in 
TSCA Risk Evaluations (Ref. 28), highlights this need for alternative 
approaches, stating that ``under some circumstances there may be 
reasonable alternatives to carrying out a de novo systematic review; 
for example, the relevant literature may be non-existent or too limited 
in scope or there may be a recent systematic review that meets quality 
standards. In some cases, it may be possible to use an alternative 
approach to systematic review as long as it meets the transparency, 
consistency, reproducibility, and comprehensiveness requirements of 
evidence-based methodologies.'' EPA expects that future risk 
evaluations may use, for example, an existing hazard assessment 
conducted by an authoritative source, in lieu of conducting a de novo 
assessment. EPA would review this assessment in a transparent, unbiased 
and objective way, which may require supplementing the assessment with 
more recent literature or reviewing the weight of evidence, but may not 
repeat systematic review on all supporting information. In alignment 
with the recommendations from the NASEM report, when EPA uses an 
alternative methodology, it will document why it has done so in lieu of 
the more traditional systematic review.
    Traditional systematic review includes performing--as described and 
documented in a defined protocol that can be applied across multiple 
lines of evidence--a literature search and screening to identify 
relevant information, followed by data quality evaluation (addressing 
factors such as relevancy and bias), data extraction, and evidence 
integration. The TSCA program recognizes that the science of systematic 
review continues to evolve, and will continue to develop its systematic 
review methods of data collection, data evaluation, evidence synthesis 
and integration, while partnering with other EPA Offices to advance and 
implement tools, methods, and efficiencies to systematically collect 
and evaluate literature. The procedures required for ensuring 
objectivity, transparency and limiting bias to extent possible in the 
collection and review of data for TSCA risk evaluations must be 
flexible enough to account for the variety of hazard and exposure 
information available to inform TSCA risk evaluations, and also be 
implementable within the statutory deadlines. EPA has and will continue 
to implement chemical specific approaches, including the development of 
chemical-specific protocols that are flexible, timely, and relevant for 
the types, quality, and quantity of information available and needed in 
a risk evaluation. EPA will apply and document the systemic review 
methods of data collection, evaluation, and integration that are 
commensurate with the relevant complexity of the assessment and nature 
of the information available, and carried out in a transparent manner 
that permits completion of risk evaluations within the timeframes that 
Congress provided.
    3. Weight of scientific evidence. As described in Unit IV.C., EPA 
is, as proposed, eliminating the codified definition of ``weight of 
scientific evidence''--instead relying on long-established Agency 
guidance documents to guide weight of scientific evidence analyses 
under TSCA.
    There are certain principles of WOSE that are universal, including 
foundational considerations such as objectivity, transparency and 
consideration of the strengths and weaknesses of lines of evidence. The 
phrase WoSE or weight of evidence (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 guidance 
used to classify carcinogens (Ref. 29). 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. 30). EPA agrees with this assessment, and, as 
such, concluded that an alternative codified definition would not 
provide additional transparency or certainty to the required use of 
WoSE in TSCA risk evaluations. However, as described in Unit IV.H.1., 
this rule codifies a commitment to transparency by finalizing the 
proposed regulatory text requiring EPA to ``document that the TSCA risk 
evaluation is consistent with the best available science and based on 
the weight of the scientific evidence'' in 40 CFR 702.37(a).
    To meet the law's requirement to base decisions in TSCA risk 
evaluations on the ``weight of the scientific evidence,'' EPA expects 
to rely on established Agency guidance documents. These peer reviewed 
guidances provide consistency and formality to a process that looks to 
integrate multiple and often heterogenic lines of evidence. At this 
time, EPA will primarily look to four documents for implementing WoSE 
in TSCA risk evaluations: Weight of Evidence in Ecological Assessment 
(Ref. 31), Guidelines for Carcinogen Risk Assessment (Ref. 29), 
Endocrine Disruptor Screening Program Weight-of-Evidence: Evaluating 
Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 
Testing (Ref. 32), and ORD Staff Handbook for Developing IRIS 
Assessments (Ref. 25). EPA recognizes that there are other 
international approaches that may also be applicable and will 
transparently document their use. 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 when drawing conclusions. The results from the 
scientifically relevant published or publicly available studies in the 
peer reviewed scientific journals, studies conducted in accordance with 
Organization for Economic Cooperation

[[Page 37045]]

and Development (OECD) or EPA guidelines, gray literature, and/or any 
other studies, scientific information, or lines of evidence that are of 
sufficient quality, relevance, 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. EPA will provide a 
summary WoSE narrative or characterization to accompany a detailed 
analysis to transparently describe the conclusion(s), as well as 
explain the selection of the studies or effects used as the main lines 
of evidence and relevant basis for conclusions.

I. Process for EPA Revisions to Scope or Risk Evaluation Documents

    As part of the proposed rule, EPA added 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 did 
not provide any such criteria or procedures. As described in the 
proposed rule, EPA reasoned that these new procedures and criteria 
would provide greater certainty and transparency for stakeholders, and 
would enable EPA to make forward progress on prioritizing, reviewing 
and managing existing chemicals as Congress intended, without diverting 
limited resources towards continuously revisiting final risk 
evaluations.
    With respect to final scope documents, EPA proposed 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. The proposed rule 
further contemplated 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. EPA received no 
public comments on these changes and is finalizing as proposed.
    With respect to draft risk evaluations, EPA proposed to reflect and 
describe any changes to the draft document in the final risk evaluation 
rather than reissue the risk evaluation in a second draft form. EPA 
noted that, 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. Further, this ensures that feedback is 
appropriately considered and reflected without unduly delaying progress 
towards completion of the risk evaluation.
    A few commenters objected to this aspect of the new procedures, and 
argued that EPA must share significant changes to draft risk 
evaluations prior to finalization under the Administrative Procedures 
Act (APA) (5 U.S.C. 551 et seq.). EPA shares commenters' perspective 
regarding the need for transparency during the risk evaluation process, 
and the importance of considering stakeholder feedback. In light of the 
improvements EPA is finalizing in this procedural rule, EPA does not 
anticipate many significant changes between draft and final risk 
evaluations moving forward. However, where there are significant 
changes, the rule provides EPA with flexibility to seek additional 
public comment or independent review of those changes prior to 
finalizing. With respect to the comment about the APA, TSCA risk 
evaluations are scientific work products--not regulatory actions--and 
fall outside the scope of APA requirements related to proposed and 
final rulemaking. As such, EPA is finalizing this provision as 
proposed.
    With respect to revision of final risk evaluations, EPA also 
proposed a general practice 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. As noted in the proposed 
rule, 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 re-prioritizing 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.
    EPA proposed to make exceptions to that general practice where 
revisions to a final risk evaluation outside of re-prioritization of a 
chemical are in the interest of protecting human health or the 
environment. For example, the exception might be warranted in the event 
a scientific error 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 rule, including publication of a new draft and final risk 
evaluation, solicitation of public comment, and, as appropriate, peer 
review.
    Commenters were generally supportive of this change, noting its 
potential to provide greater efficiency and increased pace of chemical 
review. One commenter noted that regulatory text had a potentially 
inadvertent mistake in describing the exception, referring to human 
health and the environment, instead of human health or the environment 
(see 40 CFR 702.43(g) as proposed--``. . . except where EPA has 
determined it to be in the interest of protecting human health and the 
environment to do so . . .''). EPA agrees with commenter and did not 
intend to limit application of the exception to instances where there 
is both a human health and environmental interest. As such, EPA is 
replacing the ``and'' with an ``or'' in the final rule, but is 
otherwise finalizing these provisions as proposed.

J. Process and Requirements for Manufacturer-Requested Risk Evaluations

    EPA proposed a number of changes to the process and requirements 
for manufacturer- requested risk evaluations (MRREs). TSCA section 
6(b)(4)(C)(ii) allows a chemical manufacturer to request that the 
Agency conduct a risk evaluation of a chemical substance that they 
manufacture. Consistent with TSCA section 6(b)(4)(C)(ii), EPA 
established the ``form . . . manner and . . . criteria'' for such 
requests in the 2017 final rule. Based on experience in implementing 
that process to date, EPA believes the proposed modifications are 
necessary to increase clarity and expectations, and to better position 
the Agency to grant and carry out MRREs moving forward.

[[Page 37046]]

    As described in the proposed rule, the current process for MRREs is 
unrealistic and unsustainable. Amongst other things, the current 
process allows MRRE requesters to provide EPA with a narrow set of 
information relevant to only certain conditions of use; requires EPA to 
quickly grant or deny the request, and then starts the clock for EPA to 
complete an entire risk evaluation on the chemical substance with the 
three-year statutory deadline. The proposed changes would require that 
more fulsome information be included in incoming requests, allow EPA 
additional time to properly review requests and determine any 
additional information needs prior to initiating the evaluation, and 
provide flexibility in the process to accommodate additional data 
collection or development during the risk evaluation.
    EPA received a number of comments on the proposed changes ranging 
from general support to general opposition. Some commenters provided 
suggestions for further clarifying requirements, improving the 
contemplated processes, and increasing overall transparency. Other 
commenters shared concerns that, on the whole, the changes would make 
MRREs unattractive to those who might otherwise consider submitting 
requests. EPA describes these comments further in this section, as well 
as in the Agency's Response to Comments document (Ref. 6). After 
consideration of the comments, EPA is finalizing much of the regulatory 
text at 40 CFR 702.45 as proposed, notwithstanding the changes 
described in this section. EPA would refer the public to the preamble 
to the proposed rule for a more fulsome discussion of each of the 
substantive provisions, and EPA's expected implementation (Ref. 5).
    1. Scope of request. The 2017 final rule allowed manufacturers to 
request a risk evaluation on particular conditions of use of interest 
to the requesting manufacturer, leaving the Agency with the heavy 
burden of identifying the remaining conditions of use for the chemical 
substance. For some, this provision created the misperception that, in 
instances where the requesting manufacturer only identifies a narrow 
set of circumstances, EPA would or could carry out a similar, narrowly-
scoped risk evaluation. Such an action would unequivocally contravene 
EPA's statutory authority. In the proposed rule, EPA adjusted this 
language so that manufacturers are only permitted under the law to make 
requests for evaluations of a chemical substance--not individual 
conditions of use or subsets of conditions of use--consistent with the 
statutory language in TSCA section 6(b)(4)(C) (stating that EPA ``shall 
conduct and publish risk evaluations . . . on a chemical substance . . 
.'').
    This aspect of the proposed rule generated a range of comments. 
Several commenters supported the clarification and agreed that 
conducting use-based MRREs was beyond EPA's statutory authority. Others 
objected to the change as setting too broad a scope that would 
eliminate incentive for submitting MRREs, and frustrate Congress' 
intent in establishing this process as a ``facilitator in interstate 
commerce.''
    EPA would emphasize that the proposed rule does not expand the 
scope of MRREs. In the 2017 final rule, EPA noted that ``Although 
manufacturers may request that EPA conduct a risk evaluation based on a 
subset of the conditions of use, EPA intends to conduct the risk 
evaluation in the same manner as any other risk evaluation conducted 
under section 6(b)(4)(A) . . . . As such, EPA intends to conduct a full 
risk evaluation that encompasses both the conditions of use that formed 
the basis for the manufacturer request, and any additional conditions 
of use that EPA identifies, just as EPA would if EPA had determined the 
chemical to be high priority.'' (Ref. 1). TSCA requires EPA to conduct 
risk evaluations--including MRREs--on a chemical substance under the 
conditions of use--not on an individual use or a subset of a chemical's 
conditions of use. TSCA section 6(b)(4)(E)(ii) also mandates that EPA 
``shall not expedite or otherwise provide special treatment'' to MRREs. 
Based on public comments regarding the scope of MRREs, it is abundantly 
clear that this important clarification to the regulatory text is 
necessary to ensure no future misunderstandings about the required 
scope of MRREs.
    As part of this rule and as discussed in the next section, EPA 
proposed to require MRRE submitters to provide a more holistic set of 
information on the chemical as part of the request to better position 
EPA to grant and successfully undertake MRREs. While EPA acknowledges 
that it is possible that the additional information requirements may 
dissuade some manufacturers from submitting these requests, EPA 
disagrees that the rule would eliminate all incentive. The primary 
benefit afforded to MRRE requesters is the opportunity to advance a 
chemical of their choosing ahead of other chemicals that EPA might 
prioritize, so long as they provide EPA with the requisite information 
and fees. Additionally, MRRE-driven TSCA section 6(a) final rules or 
section 6(i)(1) determinations will trigger preemption of state laws 
and regulations. Nothing in this rule would impact the preemptive 
effect of an MRRE action (and any associated risk management action) to 
help reconcile discrepant state-level regulations and facilitate 
interstate commerce.
    Finally, EPA disagrees with commenters that suggest EPA is further 
disincentivizing MRREs with the single risk determination approach on 
the chemical substance. Again, the risk determination approach does not 
mean EPA will, in every instance, find that a chemical substance 
presents unreasonable risk. While perhaps MRRE requesters would prefer 
that EPA determine that the condition(s) of use of interest of their 
chemical does not present unreasonable risk, such an outcome is not 
their prerogative. Further, EPA does not believe the possibility of an 
unreasonable risk determination should be a deterrent to future MRRE 
requesters. At the end of regulatory process, when EPA has eliminated 
any identified unreasonable risks pursuant to TSCA section 6(a), the 
manufacturer gets regulatory certainty. And the public can have 
confidence that the chemical can be safely used in commerce.
    2. Contents of request. EPA also proposed some specific updates to 
the required contents of a MRRE, and the criteria upon which EPA will 
judge completeness and sufficiency. A manufacturer requesting that EPA 
conduct a risk evaluation 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 TSCA section 
2, 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). With 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)). As described in 
the proposed rule, EPA believes that the 2017 final rule 
inappropriately shifted much of the information gathering burden for 
MRREs to the Agency.
    Amongst other criteria, EPA proposed to require that MRRE requests 
identify all intended, known and reasonably foreseen circumstances of 
the chemical's manufacture, processing, distribution in commerce, use 
and disposal, and provide all available

[[Page 37047]]

information regarding the chemical's hazards and exposures--not just 
information of relevance to the requesting manufacturer's interests. 
These changes would require more fulsome information come in as part of 
the request, enabling a more effective process for reviewing the 
request, and making it more likely that EPA will ultimately be able to 
grant and undertake the evaluation within the statutory timeline 
provided.
    A number of commenters supported these changes, and expressed 
agreement with EPA's reasoning and proposed approach. Several 
commenters offered suggestions for including more specificity in the 
requirements for MRRE contents at 40 CFR 702.45(c). In response to 
these comments, EPA is making a number of adjustments to the regulatory 
text in the final rule.
    First, EPA agrees with adding more clarity on how manufacturers 
should determine the ``known or reasonably ascertainable'' information 
that must be included in the request. As described in the preamble to 
the proposed rule, 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 
40 CFR 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. In response to comments on the proposed 
rule, EPA is codifying certain additional aspects of this discussion on 
the due diligence standard in regulatory text in the final rule to 
further underscore and clarify expectations for information to be 
submitted as part of an MRRE. Specifically, EPA is modifying 40 CFR 
702.45(a) to describe the level of effort that should be undertaken to 
gather information that is ``known to or reasonably ascertainable by'' 
the requesting manufacturer. Relatedly, EPA is clarifying in the 
regulatory text that, in the event that a group of manufacturers 
submits a MRRE, the information requirements in paragraphs (a), (c) and 
(i) would apply to all manufacturers--not just the primary contact 
submitting the request. Second, at the suggestion of several 
commenters, EPA is striking the regulatory text in the final rule 
regarding identification of potentially exposed or susceptible 
subpopulations that the manufacturer believes to be relevant. As noted 
by commenters, EPA must ultimately identify PESS--not the requesting 
manufacturer. Elimination of this requirement would lessen burden on 
requesters and avoid confusion that a requester's judgment on this 
issue could supplant that of EPA. Third, EPA agrees with commenter that 
an additional requirement of identifying the known locations where the 
chemical is used, and the consumer products (if any) containing the 
chemical would be helpful to EPA in ensuring consideration of all 
exposures and conditions of use. While EPA believes submission of this 
information already falls within the umbrella of 40 CFR 702.45(c)(5), 
EPA sees value in explicitly describing this in the regulatory text as 
the commenter suggests, and is adjusting the final rule accordingly.
    EPA also appreciates the concern shared by some commenters that 
ambiguity in the information/content requirements may create 
uncertainty for manufacturers weighing whether or not to submit a 
request, particularly in light of the commitment MRRE requesters make 
to provide EPA with information necessary to carry out the risk 
evaluation and the associated fee requirements for MRREs. While EPA 
believes the changes described in the proposed rule and the additional 
ones contemplated for the final rule do bring additional clarity, EPA 
welcomes and encourages pre-submission consultations to discuss 
information needs further. Moreover, the additional processes EPA is 
contemplating in this rule for MRREs should help bring greater clarity 
to information needs much earlier in the process--either before EPA has 
granted request, or prior to EPA having undertaken significant amounts 
of work--and therefore before significant expenses have been incurred 
under the fee schedule. Lastly, EPA developed a guidance document in 
2017 to assist interested persons in developing draft risk evaluations 
for submittal to EPA (Ref. 33). While the MRRE process does not require 
submittal of a draft risk evaluation, the guidance describes the 
science standards, data quality considerations and other information 
relevant to EPA's risk evaluation process that may be of use to 
manufacturers interested in developing an MRRE request. As resources 
allow, EPA may consider updating this 2017 guidance and further 
developing particular sections to better assist potential MRRE 
submitters.
    A few commenters disagreed with EPA that the primary burden should 
be on manufacturers to provide sufficient information for the risk 
evaluation, and that EPA may be better positioned to gather the 
necessary information using its various statutory authorities. 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. Still, EPA recognizes that 
manufacturers may not, after making a reasonable amount of effort, be 
able to provide the Agency with all the information necessary to 
complete the risk evaluation. EPA proposed processes for how such 
shortcomings will be identified and addressed, including opportunities 
for manufacturers to request EPA exercise its statutory authorities to 
fill in any gaps. These changes set clearer expectations for what EPA 
needs to undertake in a risk evaluation, and establishes a process for 
productive engagement with requesting manufacturers toward meeting 
those needs.
    These amendments also satisfy the Ninth Circuit's remand without 
vacatur of the relevancy and consistency provisions of the currently 
codified language at 40 CFR 702.37(b)(4) and (6), which address the 
information requirements for, and application of the TSCA section 26 
scientific standards to, an MRRE (Ref. 7).
    3. EPA process for reviewing requests. EPA proposed a number of 
changes to how the Agency will review MRREs in 40 CFR 702.45, including 
additional measures for transparency and public engagement. EPA would 
again refer the public to the preamble of the proposed rule for a 
general description of the procedural steps. At a high level, the 
process steps can be summarized as

[[Page 37048]]

follows: Upon receipt of a MRRE, EPA will provide the public with 
notice and begin reviewing the request for completeness. Where the MRRE 
request appears complete, EPA will open a docket for the MRRE and 
supporting information, and solicit public comment. Following a second 
review, where EPA believes there is sufficient information, EPA will 
grant the request, and proceed to publish a draft list of conditions of 
use and solicit additional comment. Following this comment period, and 
when EPA believes it has all necessary information, EPA will formally 
initiate the evaluation and follow all the same processes and 
requirements for EPA-initiated risk evaluations in subpart B. The 
proposed rule also included processes to resolve information needs as 
they might arise during the process, and an opportunity for requesting 
manufacturers to withdraw their request.
    Nearly all commenters expressed support for the new process steps, 
agreeing with EPA that the process in the 2017 final rule does not 
allow enough time for adequate review of MRREs. Commenters also agreed 
that Congress did not intend MRREs to differ from EPA-initiated risk 
evaluations, that TSCA does not permit increased burdens to be placed 
on EPA in evaluating MRREs, and shared their support for making the new 
MRRE process and timeframes more comparable to those that precede EPA-
initiated risk evaluations. One commenter questioned EPA's 
characterization of how it would publicly share supplemental 
information received from the requesting manufacturer during the 
process (i.e., that EPA would ``endeavor, to the extent possible'' to 
publish such information). EPA agrees with the commenter that this was 
not confidence-inspiring language. Instead, EPA is committing as part 
of this final rule to promptly publish in the MRRE docket any 
supplemental information received from the requesting manufacturer, 
subject to the Agency's requirements with respect to the protection 
from disclosure of CBI.
    The same commenter also pointed out an inconsistency between the 
``preference'' criteria in TSCA section 6(b)(4)(E)(iii) and the 
language in the proposed rule. Upon further review, EPA agrees with the 
commenter that the language in 40 CFR 702.45(j)(2) warrants adjustment 
and is striking the phrase ``in excess of the 25% threshold'' in the 
final rule accordingly, in order to be more consistent with the 
statutory text on this point. Namely, when reviewing MRRE requests, 
TSCA requires EPA to give preference to requests for risk evaluations 
on chemical substances for which restrictions imposed by one or more 
States have the potential to have a significant impact on interstate 
commerce or health or the environment. To date, EPA has not had to 
apply any preference criteria as the number of MRRE requests pending at 
any given time has been below the 25% threshold.
    For clarity and consistency with the TSCA fees provisions in 40 CFR 
700.45, EPA has added a parenthetical to the regulatory text about fees 
in the event of withdrawal. Specifically, the proposed text referred to 
40 CFR 700.45(c)(2)(x) or (xi) and EPA has added a parenthetical to 
recognize that, for subsequent fiscal years, the fees rule already 
incorporates an inflation adjustment per 40 CFR 700.45(d). EPA is also 
making minor changes to the regulatory text at 40 CFR 700.45(e)(8) and 
(9) on unfulfilled information needs and the initiation of the risk 
evaluation to increase clarity in the process, and at 40 CFR 700.45(k) 
to correct a typo in the statutory citation.
    Aside from the minor adjustments noted in this section, EPA is 
finalizing the remainder of the regulatory text at 40 CFR 702.45 as 
proposed.

K. Interagency Collaboration

    EPA is also finalizing 40 CFR 702.47 as proposed. 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. EPA continues to collaborate with other 
relevant Federal agencies and plans to further coordinate with them 
regarding interagency engagement and collaboration when carrying out 
the functions and responsibilities assigned to the Agency under TSCA 
section 6(b), starting even before the initiation of the prioritization 
process. EPA intends to develop and, subject to the interests of 
Federal agencies involved, execute Memoranda of Understanding that 
memorialize these interagency information exchange, review and comment, 
and collaboration best practices. Such practices would address 
engagement and collaboration with Federal partners to help ensure EPA 
has timely access to information to support a comprehensive 
understanding of, and not limited to, a chemical substance's conditions 
of use and their importance to national security or critical 
infrastructure, the hazard and exposure potential of that chemical, and 
existing safety measures Federal agencies already have in place for 
their uses.
    With respect to critical/essential uses by other Federal agencies, 
EPA recognizes that identification and documentation of such uses 
requires substantial and early interagency engagement, as well as 
safeguards for national security or other sensitive information. Uses 
of a chemical that may be critical/essential are conditions of use of 
the chemical and, as such, will be evaluated in risk evaluations. 
Federal agencies should identify their uses (including those they 
believe to be critical or essential uses) as early as possible (e.g., 
during the prioritization and/or risk evaluation processes) to help 
inform EPA's development of regulations for chemical substances under 
TSCA section 6(a) to the extent necessary to address unreasonable risk 
upon completion of relevant risk evaluations. EPA will engage with 
agencies that identify critical/essential uses to obtain the necessary 
level of information to support the consideration of those uses in 
advance of any proposed rule. For each chemical substance, EPA intends 
to engage at least four times with interested Federal agencies and 
departments: first, before EPA begins the prioritization process for 
the substance; second, during the 9-to-12 month prioritization process; 
third, during the development of the draft risk evaluation; and fourth, 
after the draft risk evaluation has been released for public comment. 
At each engagement, in addition to receiving any information about the 
substance Federal agencies wish to share, EPA would share scientific 
and other information about its progress on the risk evaluation, 
including any information it has developed related to Federal agency 
uses of the substance.

V. Reliance Interests

    As described in the proposed rule, EPA considered to what extent 
stakeholders may have reliance interests in previous statutory 
interpretations underpinning the 2017 final rule, and concluded that 
there are either no reliance interests on those past statutory 
interpretations, or that any such interests are minor (Ref. 5 at p. 
74316). 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 the exception of modified procedural requirements for 
voluntary requests for risk evaluation that are submitted by 
manufacturers.
    A few commenters disagreed with EPA's discussion of reliance 
interests. They argued, for example, that companies submitted MRREs 
under the

[[Page 37049]]

2017 procedural rule with expectations related to use-specific risk 
determinations and preemption outcomes. Another argued that all 
manufacturers who deal with chemicals under review will become subject 
to capricious regulation in light of the elimination of the ``best 
available science'' and the peer review requirements. Another commenter 
suggested the high likelihood of inconsistency between risk evaluations 
creates substantial reliance interests.
    First, with respect to commenters' arguments regarding preemption, 
as described previously, EPA believes commenters fundamentally 
misunderstand the applicability of TSCA section 18(a), and how the 
preemptive effects of that provision are unaffected by a single 
chemical risk determination. As noted earlier, permanent preemption is 
triggered under section 18(a)(1)(B)(ii) if EPA issues first a scope of 
the risk evaluation under section 6(b)(4)(D) and then a section 6(a) 
final rule or a section 6(i)(1) determination based on the risk 
evaluation. These factors are not affected by a single risk 
determination approach. Further, because the 2017 rule does not mandate 
use-based risk determinations, EPA disagrees that MRRE submitters, for 
example, could have demonstrable reliance interests on that particular 
approach or outcome. Second, with respect to ``best available 
science,'' nothing in this rule modifies the statutory requirement that 
EPA apply the best available science in all risk evaluations. Likewise, 
nothing in this rule would eliminate peer review on future risk 
evaluations. Third, EPA disagrees that this rule will create a high 
level of inconsistency between risk evaluations. To the contrary, EPA 
believes this rule--and the important clarifying changes it would 
codify--will bring greater consistency to future risk evaluations and 
more certainty and transparency for the regulated community and public.
    EPA further maintains that, 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 this 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 final 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 Final 
Rule: Procedures for Chemical Risk Evaluation Under TSCA (RIN 2070-
AK90). EPA ICR No.: 2781.02 and OMB Control No. 2070-0231. April 17, 
2024.
5. U.S. EPA. Procedures for Chemical Risk Evaluation Under the 
Amended Toxic Substances Control Act; Proposed Rule. Federal 
Register. 88 FR 74292, October 30, 2023 (FRL-8529-01). https://www.govinfo.gov/content/pkg/FR-2023-10-30/pdf/2023-23428.pdf.
6. U.S. EPA. Procedures for Chemical Risk Evaluation Under the Toxic 
Substances Control Act (TSCA); Proposed Rule; EPA Response to Public 
Comments (RIN 2070-AK90). EPA-HQ-OPPT-2023-0496. April 17, 2024.
7. 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. November 14, 2019).
8. U.S. Senate Report on the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act, S.697, S.Rept.114-67. June 18, 2015. https://www.congress.gov/congressional-report/114th-congress/senate-report/67/1.
9. OSHA. Permissible Exposure Limits Annotated Tables. https://www.osha.gov/annotated-pels.
10. 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.
11. 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.
12. 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/2022-09/Cumulative%20Impacts%20Research%20Final%20Report_FINAL-EPA%20600-R-22-014a.pdf.
13. U.S. EPA. EJSCREEN: Environmental Justice Screening and Mapping 
Tool. https://www.epa.gov/ejscreen.
14. U.S. EPA. EnviroAtlas. https://www.epa.gov/enviroatlas.
15. 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.
16. U.S. EPA. Draft Risk Evaluation for Tris(2-chloroethyl) 
Phosphate (TCEP). EPA-740-D-23-002. Office of Chemical Safety and 
Pollution Prevention. Washington DC. December 2023. https://www.epa.gov/system/files/documents/2023-12/tcep_draft_risk_evaluation_20231207_hero_public-release.pdf.
17. 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/EPA-HQ-OPPT-2019-0238-0067.
18. U.S. EPA. Draft Risk Evaluation for Formaldehyde. EPA-740-D-24-
002; EPA-740-D-24-003; and EPA-740-D-24-005. Office of Chemical 
Safety and Pollution Prevention. March 2024. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-formaldehyde.
19. U.S. EPA. Peer Review and Peer Involvement at the U.S. 
Environmental Protection Agency. January 31, 2006. https://www.epa.gov/sites/default/files/2015-01/documents/peer_review_policy_and_memo.pdf.
20. 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.
21. 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.
22. 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/

[[Page 37050]]

documents/epa-info-quality-guidelines_pdf_version.pdf.
23. Executive Office of the President. Office of Science and 
Technology Policy. Center on Environmental Quality. Washington DC. 
Memorandum for Heads of Federal Departments and Agencies. Guidance 
for Federal Departments and Agencies on Indigenous Knowledge. 
November 30, 2022. https://www.whitehouse.gov/wp-content/uploads/2022/12/OSTP-CEQ-IK-Guidance.pdf.
24. U.S. EPA. 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/EPA-HQ-OPPT-2021-0414-0005.
25. U.S. EPA. Office of Research and Development Staff Handbook for 
Developing IRIS Assessments. EPA/600/R-22/268. Office of Research 
and Development. Washington, DC. 2022. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=356370.
26. 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-integrated-riskinformation-system-iris-process.
27. 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.
28. 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.
29. 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/EPA-HQ-OA-2007-0679-0001.
30. NRC. Science and Decisions: Advancing Risk Assessment. National 
Academies Press. Washington, DC. 2009. https://dx.doi.org/10.17226/12209.
31. 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.
32. 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.
33. U.S. EPA. Guidance to Assist Interested Persons in Developing 
and Submitting Draft Risk Evaluations Under the Toxic Substances 
Control Act. Office of Chemical Safety and Pollution Prevention. EPA 
740-R17-001. Washington DC. June 2017. https://www.epa.gov/sites/default/files/2017-06/documents/tsca_ra_guidance_final.pdf.

VII. Statutory and Executive Order Reviews

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

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

    This action is a ``significant regulatory action'' as defined in 
Executive Order 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 is available in the docket. EPA prepared an analysis of 
the potential costs associated with this action. This analysis, which 
is in the docket, is summarized in Unit VII.B.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this final rule have been 
submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR) document that EPA prepared to 
replace an existing approved ICR has been assigned EPA ICR No. 2781.02 
and is identified by OMB Control No. 2070-0231. You can find a copy of 
the new ICR document (Ref. 4) in the docket for this rule, 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 rule replacement ICR addresses the information collection 
requirements contained in the current regulations as well as in the 
amendments identified in this final rule. As addressed in the currently 
approved ICR and pursuant 40 CFR 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 high-priority in 
accordance with 40 CFR 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 amendments to information requirements for manufacturer-
requested risk evaluations, including 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 IV.J. for 
additional information about these 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 manufacturer-requested 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 associated with the amended requirements 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: 1 annually.
    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.

[[Page 37051]]

    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB 
approves this ICR, the Agency will announce that approval in the 
Federal Register and publish a technical amendment to 40 CFR part 9 to 
display the OMB control number for the approved information collection 
activities contained in this final rule.

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 manufacturer-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 
rule. 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 of $100 million 
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The action imposes 
no enforceable duty on any state, local or tribal governments. 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 
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 
addresses 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 does not directly affect the level of protection 
provided to human health or the environment, EPA expects that this rule 
will 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.''

I. National Technology Transfer and Advancement Act (NTTAA)

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

[[Page 37052]]

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 12898 
(59 FR 7629, February 16, 1994) and Executive Order 14096 (88 FR 25251, 
April 26, 2023). This action amends 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 
will assist EPA and others (including the public) in understanding, and 
will assist EPA in determining the potential exposures, hazards and 
risks to the public, including for overburdened communities associated 
with existing chemicals as part of a TSCA risk evaluation. The 
inclusion of overburdened communities among the PESS considered in a 
chemical risk evaluation will 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 to all 
potentially affected people, 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 IV.F.4.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action does not meet the 
criteria set forth in 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 702

    Environmental protection, Chemicals, Chemical substances, Hazardous 
substances, Health and safety, Risk evaluation.

    Dated: April 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended to read as follows:

PART 702--GENERAL PRACTICES AND PROCEDURES

0
1. The authority citation for part 702 continues to read as follows:

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


0
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


Sec.  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 June 3, 2024. 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.''


Sec.  702.33  Definitions.

    All definitions in TSCA apply to this subpart. In addition, the 
following definitions apply:
    Act means the Toxic Substances Control Act (TSCA), 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.

[[Page 37053]]

Sec.  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 the prioritization process described in 
subpart A or initiated at the request of a manufacturer or 
manufacturers under Sec.  702.45, will be conducted in accordance with 
this part, subject to Sec.  702.31(c).
    (b) Percentage requirements. Pursuant to 15 U.S.C. 2605(b)(4)(E)(i) 
and in accordance with Sec.  702.45(j)(1), EPA will ensure that the 
number of chemical substances for which a manufacturer-requested risk 
evaluation is initiated pursuant to Sec.  702.45(e)(9) is not less than 
25%and not more than 50% of the number of chemical substances for which 
a risk evaluation was initiated upon designation as a High-Priority 
Substance under subpart A.
    (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.


Sec.  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. In determining best available science, EPA shall consider 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 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 methods to assess reasonably 
available information, as needed to carry out risk evaluations that 
meet the requirements in TSCA section 26(h) and (i), in a manner that 
is 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).


Sec.  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.

[[Page 37054]]

    (8) EPA's plan for peer review consistent with Sec.  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 Sec.  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., high-throughput 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 Sec.  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, industry practices with respect to occupational exposure control 
measures, and exposure modeling.
    (4) Chemical-specific factors, including, but not limited to 
physical-chemical 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 non-risk factors; and
    (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

[[Page 37055]]

personal protective equipment. EPA will not consider exposure reduction 
based on assumed use of personal protective equipment as part of the 
risk determination.
    (3) EPA will determine whether a chemical substance does or does 
not present an unreasonable risk after considering the risks posed 
under the conditions of use and, where EPA makes a determination of 
unreasonable risk, EPA will identify the conditions of use that 
significantly contribute to such determination.


Sec.  702.41  Peer review.

    EPA will conduct peer review activities on risk evaluations 
conducted pursuant to 15 U.S.C. 2605(b)(4)(A). EPA expects such 
activities, including decisions regarding the appropriate scope and 
type of peer review, to be consistent with the applicable peer review 
policies, procedures, and methods in guidance promulgated by the Office 
of Management and Budget and EPA, and in accordance with 15 U.S.C. 
2625(h) and (i).


Sec.  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 Sec.  
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 High-Priority Substance pursuant to Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 or 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 
Sec. Sec.  702.43(c) and (d), and peer review, as appropriate, in 
accordance with Sec.  702.41.


Sec.  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(s) 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 
Sec.  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(s) 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 Sec. Sec.  702.37 through 702.43 and 
Sec. Sec.  702.47 through 702.49 of this subpart.

[[Page 37056]]

    (8) For purposes of this section, information that is ``known to or 
reasonably ascertainable by'' the requesting manufacturer(s) would 
include all information in the requesting manufacturer's possession or 
control, plus all information that a reasonable person similarly 
situated might be expected to possess, control, or know. Meeting this 
standard requires an exercise and documentation of due diligence that 
may vary depending on the circumstances and parties involved. At a 
minimum, due diligence requires:
    (i) A thorough search and collection of publicly available 
information;
    (ii) A reasonable inquiry within the requesting manufacturer's 
entire organization; and
    (iii) A reasonably inquiry outside of the requesting manufacturer's 
organization, including inquiries to upstream suppliers; downstream 
users; and employees or other agents of the manufacturer, including 
persons involved in research and development, import or production, or 
marketing.
    (9) In the event that a group of manufacturers of a chemical 
substance submit a request for risk evaluation under this section, the 
term ``requesting manufacturer'' in paragraphs (a), (c), and (i) of 
this section shall apply to all manufacturers in the group. EPA will 
otherwise coordinate with the primary contact named in the request for 
purposes of communication, payment of fees, and other actions as 
needed.
    (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.
    (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, 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(s) 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) Industrial and commercial locations where the chemical is used 
or stored;
    (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) Consumer products containing the chemical;
    (viii) The chemical substance's production volume or significant 
changes in production volume; and
    (ix) 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 from the requesting manufacturer(s) 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.

[[Page 37057]]

    (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 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 needs are identified, EPA will notify the requesting 
manufacturer 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 may:
    (i) Provide the necessary information. EPA will set a reasonable 
amount of time, as determined by EPA, for the requesting manufacturer 
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 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 that are not fulfilled, because the requesting 
manufacturer is unable or unwilling to fulfill those needs in a timely 
manner, the requesting manufacture has produced information that is 
insufficient as determined by EPA, or 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 identified and 
received 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 Sec. Sec.  
702.37 through 702.43 and Sec. Sec.  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, the requesting manufacturer 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. The requesting manufacturer 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. The 
requesting manufacturer 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 non-payment 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 post-initiation. Where EPA identifies 
additional data needs after the risk evaluation has been initiated, the 
requesting manufacturer 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 
requesting manufacturer(s). At any point prior to the completion of a 
manufacturer-requested risk evaluation pursuant to this section, the 
requesting 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 when the 
requesting manufacturer(s) obtain the information.
    (j) Limitations on manufacturer-requested 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 High-Priority Substances identified in subpart A as 
undergoing risk evaluation. Once that level has been reached, EPA will 
initiate at least one new manufacturer-requested 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 evaluations and not more than 50%.
    (2) Preferences. In conformance with Sec.  702.35(c), in evaluating 
requests for

[[Page 37058]]

TSCA Work Plan Chemicals and requests for non-TSCA Work Plan chemicals, 
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. 2625(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) (as adjusted by 40 
CFR 700.45(d) when applicable), 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 as 
appropriate.


Sec.  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.


Sec.  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;
    (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;
    (g) Response to public comments received on the draft scope and the 
draft risk evaluation; and
    (h) Where unreasonable risk to workers is identified via 
inhalation, EPA's calculation of a risk-based occupational exposure 
value.

[FR Doc. 2024-09417 Filed 4-29-24; 8:45 am]
BILLING CODE 6560-50-P