[Federal Register Volume 88, Number 208 (Monday, October 30, 2023)]
[Proposed Rules]
[Pages 74292-74326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23428]
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Vol. 88
Monday,
No. 208
October 30, 2023
Part III
Environmental Protection Agency
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40 CFR Part 702
Procedures for Chemical Risk Evaluation Under the Toxic Substances
Control Act (TSCA); Proposed Rule
Federal Register / Vol. 88 , No. 208 / Monday, October 30, 2023 /
Proposed Rules
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 702
[EPA-HQ-OPPT-2023-0496; FRL-8529-01-OCSPP]
RIN 2070-AK90
Procedures for Chemical Risk Evaluation Under the Toxic
Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA, ``the Agency'') is
proposing to amend the procedural framework rule for conducting risk
evaluations under the Toxic Substances Control Act (TSCA). The purpose
of risk evaluations under TSCA is to determine whether a chemical
substance presents an unreasonable risk of injury to health or the
environment, without consideration of costs or non-risk factors,
including unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by EPA,
under the conditions of use. EPA has reconsidered the procedural
framework rule for conducting such risk evaluations and determined that
certain aspects of that framework should be revised to better align
with applicable court decisions and the statutory text, to reflect the
Agency's experience implementing the risk evaluation program following
enactment of the 2016 TSCA amendments, and to allow for consideration
of future scientific advances in the risk evaluation process without
need to further amend the Agency's procedural rule.
DATES: Comments must be received on or before December 14, 2023. Under
the Paperwork Reduction Act, comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before November 29, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0496, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Susanna W. Blair, Immediate
Office, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-4371; email address:
[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 primarily proposing to amend procedural requirements that
apply to the Agency's activities in carrying out TSCA risk evaluations.
However, EPA is also proposing certain amendments to the process and
requirements that manufacturers (including importers) would be required
to follow when they request an Agency-conducted TSCA risk evaluation on
a particular chemical substance. You may be potentially affected by
this action if you manufacture or import chemical substances regulated
under TSCA. Since other entities may also be interested, the Agency has
not attempted to describe all the specific entities and corresponding
NAICS codes for entities that may be interested in or affected by this
action. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Petroleum Refineries (NAICS code 324110);
Chemical Manufacturing (NAICS code 325);
Unlaminated Plastics Film and Sheet (except Packaging)
Manufacturing (NAICS code 326113);
Unlaminated Plastics Profile Shape Manufacturing (NAICS
code 326121);
Plastics Pipe and Pipe Fitting Manufacturing (NAICS code
326122);
Laminated Plastics Plate, Sheet (except Packaging), and
Shape Manufacturing (NAICS code 326130);
Polystyrene Foam Product Manufacturing (NAICS code
326140);
Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS code 326150);
Plastics Bottle Manufacturing (NAICS code 326160);
Plastics Plumbing Fixture Manufacturing (NAICS code
326191);
All Other Plastics Product Manufacturing (NAICS code
326199);
Tire Manufacturing (except Retreading) (NAICS code
326211);
Tire Retreading (NAICS code 326212);
Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220);
Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291);
All Other Rubber Product Manufacturing (NAICS code
326299);
Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110);
Clay Building Material and Refractories Manufacturing
(NAICS code 327120);
Flat Glass Manufacturing (NAICS code 327211);
Other Pressed and Blown Glass and Glassware Manufacturing
(NAICS code 327212);
Glass Container Manufacturing (NAICS code 327213);
Glass Product Manufacturing Made of Purchased Glass (NAICS
code 327215);
Cement Manufacturing (NAICS code 327310);
Ready Mix Concrete Manufacturing (NAICS code 327320);
Concrete Block and Brick Manufacturing (NAICS code
327331);
Concrete Pipe Manufacturing (NAICS code 327332); and
Other Concrete Product Manufacturing (NAICS code 327390).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
EPA is issuing this Notice of Proposed Rulemaking (NPRM) pursuant
to the authority in TSCA section 6(b)(4) (15 U.S.C. 2605(b)(4)). EPA
has inherent authority to reconsider previous decisions and to revise,
replace, or repeal a decision to the extent permitted by law and
supported by reasoned explanation. See FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Assn v.
State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). See also the
discussion in Units II.A. and B.
C. What action is the Agency taking?
EPA is proposing to amend regulations that address how the Agency
conducts risk evaluations on chemical
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substances under TSCA. These changes include, but are not limited to,
targeted changes to certain definitions, clarifications regarding the
required scope of risk evaluations, considerations related to peer
review and the Agency's implementation of the scientific standards, the
approach for risk determinations on chemical substances and
considerations related to unreasonable risk, and the process for
revisiting a completed risk evaluation. EPA is also proposing to amend
the process and requirements for manufacturers making a voluntary
request for an Agency-conducted risk evaluation on a particular
chemical substance. EPA is requesting public comment on all aspects of
this proposal.
D. Why is the Agency taking this action?
As further explained in Units I., II., and III., EPA reexamined the
July 20, 2017, final rule (Ref. 1) (hereinafter ``2017 final rule'')
that established procedures and requirements for chemical risk
evaluation under TSCA, in consideration of:
The statutory text and structure and Congressional intent.
The November 14, 2019, opinion issued by U.S. Court of
Appeals for the Ninth Circuit in response to petitions for judicial
review, consolidated under Safer Chemicals, Healthy Families v. USEPA
(Ref. 2), of the 2017 final rule and related court orders.
Executive Order 13990, Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis (Ref.
3).
Lessons learned from the Agency's implementation of the
risk evaluation program to date including feedback from the National
Academies of Science Engineering and Medicine and scientific peer
reviewers.
As a result of this reexamination, the Agency is proposing targeted
amendments of the 2017 final rule.
E. What are the estimated incremental impacts of this action?
The incremental impacts of this action are associated with
procedural requirements, as described in Unit III.K., which apply to
manufacturers when manufacturers (including importers) elect to request
that EPA perform a risk evaluation on a particular chemical substance.
EPA has estimated the potential burden and costs associated with the
proposed requirements for submitting a request for an Agency-conducted
risk evaluation on a particular chemical substance. These estimates of
burden and costs are available in the docket, and are discussed in Unit
V. and briefly summarized here (Ref. 4).
The total estimated annual burden is 166 hours and $115,711 (per
year), which is based on an estimated per request burden of 166 hours.
In addition, EPA's evaluation of the potential costs associated
with this action is discussed in Unit VI.B. Since this rulemaking
focuses on the activities that a manufacturer must perform, the
estimated incremental costs to the public are expected to be
negligible. EPA requests specific comment on the burden estimate and
assumptions associated with the calculation associated with the burden
(e.g., number of requests EPA expects).
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through https://www.regulations.gov or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that
you claim to be CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.
II. Background
A. Statutory Requirements for Risk Evaluation
TSCA section 6(b)(4) requires EPA to establish, by rule, a process
to conduct risk evaluations. Specifically, EPA is directed to use this
process to ``determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator,
under the conditions of use.'' (15 U.S.C. 2605(b)(4)(A)). TSCA sections
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements
applicable to this process, including provisions that direct which
chemical substances must undergo risk evaluation, the development of
criteria for manufacturer-requested risk evaluations, the minimum
components of an Agency risk evaluation, and the timelines for public
comment and completion of the risk evaluation. The law also requires
EPA to consider reasonably available information and operate in a
manner that is consistent with the best available science and make
decisions based on the weight of the scientific evidence. (15 U.S.C.
2625(h) and (i)).
B. Judicial Review of the 2017 Final Rule
In the preamble of the 2017 final rule, EPA explained that it
interpreted the requirements of TSCA section 6 to apply to conditions
of use for which manufacturing, processing, or distribution in commerce
is intended, known to be occurring, or reasonably foreseen to occur,
rather than to legacy uses, which EPA used as a term for continuing,
in-situ uses of chemicals for which manufacturing, processing, or
distribution in commerce had ceased (e.g., certain phased-out flame
retardants present in textiles or furniture that continue to be used,
asbestos-containing pipe wrap, etc.), or associated disposal. In
addition, among other regulatory provisions, the 2017 final rule
established that the submission of inaccurate, incomplete, or
misleading information pursuant to a manufacturer-requested risk
evaluation is a prohibited act subject to penalties under title 18 of
the U.S. Code. The 2017 final rule also established requirements for
information that must be submitted by a manufacturer when requesting
that EPA conduct a risk evaluation (40 CFR 702.37(b)(4)) and that the
submitted information be held to the scientific standards established
in TSCA section 26(h) (40 CFR 702.37(b)(6)).
Several non-governmental organizations filed petitions for judicial
review of the 2017 final rule, which were consolidated in the U.S.
Court of Appeals for the Ninth Circuit (hereafter, the ``Ninth
Circuit'') under Safer Chemicals, Healthy Families v. USEPA, on August
10, 2017 (Ref. 2). The Ninth Circuit issued its opinion on November 14,
2019, holding that the EPA unlawfully excluded ``legacy uses and
associated disposals'' from the conditions of use that the agency would
consider in any risk evaluation (Ref. 2). Also, at the Agency's
request, the Ninth Circuit (1) vacated and remanded the rule provisions
applying criminal penalties to the submission of inaccurate or
incomplete information to
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EPA pursuant to a manufacturer-requested risk evaluation, and (2)
remanded without vacatur the rule provisions addressing the information
requirements for, and application of the TSCA section 26 scientific
standards to, a manufacturer-requested risk evaluation (Ref. 5).
The Court declined to rule on several other aspects of the
challenge, including that the rule suggested EPA would make risk
determinations on individual uses of a chemical instead of on the
chemical itself, and statements in the preamble regarding broad
discretion to choose to exclude conditions of use from the scope of the
risk evaluations. The Court reasoned that petitioners' claim that EPA
would make risk determinations on individual uses instead of on the
chemical itself as the law required was not justiciable due to
ambiguity in the 2017 final rule text. The Court noted it was unclear
``whether the Agency will actually conduct risk evaluations in the
manner [those litigants] fear[ed]'' and that the claim was therefore
not justiciable (Ref. 2). With regard to petitioners' claim that EPA
intended to exclude conditions of use out of the scope of the risk
evaluations, the court held that claim not ripe, but noted that it did
``not interpret the language in the [2017 final rule] to say anything
about exclusion of conditions of use'' (Ref. 2).
C. Review of the 2017 Final Rule Under Executive Order 13990
Executive Order 13990 instructs that the Federal Government be
guided by the best science and be protected by processes that ensure
the integrity of Federal decision-making, and established the
Administration's policy of, among other concerns, following the
science, improving public health and protecting the environment,
limiting exposure to dangerous chemicals, reducing greenhouse gas
emissions, and prioritizing environmental justice (EJ) when delivering
on these concerns. Executive Order 13990 also instructs agencies to (1)
review actions issued between January 20, 2017, and January 20, 2021,
that may be inconsistent with or present obstacles to implementing the
policy established in the order and, (2) consider suspending, revising,
or rescinding such actions. Also on January 20, 2021, the Biden-Harris
Administration issued a list of specific actions to be reviewed in
accordance with Executive Order 13990 that included the 2017 final rule
(Ref. 6).
EPA announced certain policy changes for TSCA risk evaluations on
June 30, 2021 (Ref. 7) to ensure that risk evaluations follow the
science and the law, including:
1. Expanded Consideration of Exposure Pathways
Prior to June 30, 2021, the first 10 risk evaluations did not
consistently assess air, water or disposal exposures to the general
population based on an argument that these exposure pathways were
already regulated, or could be regulated, under other statutes
administered by EPA, such as the Clean Air Act, Safe Drinking Water
Act, Clean Water Act, Resource Conservation and Recovery Act, or
Comprehensive Environmental Response, Compensation, and Liability Act.
The approach to exclude certain exposure pathways conflicted with the
plain language of the law to evaluate chemical substances under the
known, intended or reasonably foreseen circumstances associated with
the full lifecycle of the chemical substance. It prevented
consideration of relevant exposure information (e.g., information
indicating presence of the chemical in air or water) in spite of
statutory requirements that the Agency base its decisions on the best
available science. The approach also resulted in a failure to
consistently and comprehensively address potential exposures to the
general population, as well as to certain potentially exposed or
susceptible subpopulations. EPA announced it would no longer exclude
consideration of such exposure pathways from TSCA risk evaluations.
2. Assumptions About Use of Personal Protective Equipment (PPE)
Prior to June 30, 2021, EPA's TSCA risk evaluations generally
assumed that workers were always provided and appropriately used PPE.
However, as described in Unit III.G.1., data on violations of PPE use
suggest that assumptions that PPE is always provided to workers, worn
properly, and effective at eliminating exposures are not justified. In
addition, TSCA requires that risk evaluations consider the known,
intended or reasonably foreseen circumstances associated with the
chemicals substance--including circumstances that result or could
result in exposures to workers. For the reasons described further in
Unit III.E.1., EPA believes that circumstances that result in
occupational exposures to chemicals are reasonable to foresee, and, in
many cases, known. As such, continued application of this general
assumption could result in risk evaluations that underestimate risks,
and in turn, prevent risk management rules from affording necessary
protections. EPA announced that it would no longer assume that PPE is
always used in occupational settings when making unreasonable risk
determinations for a chemical.
3. ``Whole Chemical'' Risk Determination Approach
Prior to June 30, 2021, EPA made separate unreasonable risk
determinations for each condition of use identified in the risk
evaluation scope. EPA announced that, going forward, it would make the
determination of unreasonable risk on ``the chemical substance,''
rather than for each individual condition of use in isolation. As
described further in Unit III.F.1., doing so going forward better
aligns with the statute and Congress' intent, and enables the Agency's
risk determinations to better reflect the potential for combined
exposures across multiple conditions of use.
EPA invites public comment on the adoption of these changes in the
amended procedural rule.
D. Agency Implementation
Since the 2017 final rule, EPA has finalized ten chemical risk
evaluations under TSCA and published a draft supplement to the risk
evaluation for 1,4-Dioxane. Additionally underway are 20 more risk
evaluations on high-priority substances, a part 2 of the asbestos risk
evaluation that will cover additional fiber types and ``legacy''
conditions of use, and several manufacturer-requested risk evaluations
(Ref. 8). EPA is also developing a number of rulemakings to address
unreasonable risks identified in these risk evaluations. The Agency has
gained valuable experience in carrying out these actions and received a
wealth of feedback on our procedures from public commenters and through
scientific peer review. The proposed rule reflects lessons learned,
efforts to increase efficiencies, and includes improvements to the
process and requirements for manufacturer-requested risk evaluations
that are more consistent with Agency scientific practices and policies.
The proposed rule also includes some structural and substantive
revisions for greater clarity and readability, and, more generally, to
enhance the public's understanding of how EPA expects to carry out TSCA
risk evaluations.
EPA intends that the provisions of this rulemaking be severable. In
the event that any individual provision or part of this rulemaking is
invalidated, EPA intends that this would not render the entire
rulemaking invalid, and that any individual provisions that can
continue to operate will be left in place.
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III. Proposed Amendments
A. Policy Objectives
The risk evaluation process established in 40 CFR part 702, subpart
B outlines how EPA will determine, pursuant to TSCA section 6(b)(4)(A),
whether a chemical substance presents an unreasonable risk of injury to
health or the environment. EPA's general objectives for the proposed
amendments, in keeping with the considerations addressed in Unit II,
are to (1) better align the TSCA risk evaluation process with the
statutory text and structure and Congressional intent, (2) ensure that
the risk evaluation process under TSCA is consistent with the best
available science and based on the weight of the scientific evidence,
maintains the integrity of Federal decision-making, and upholds the
policy in various Executive orders, (3) address the outcome of the
Ninth Circuit litigation on the 2017 final rule, (4) apply lessons
learned to date to improve the Agency's processes moving forward, and
(5) enhance the public's understanding of how EPA expects to carry out
subsequent TSCA risk evaluations. Through improvements to the risk
evaluation process in these proposed amendments, EPA anticipates that
any risk management actions following any determination that a chemical
substance presents unreasonable risk will result in needed public
health and environmental protections that limit exposure to dangerous
chemicals, and, where applicable, address the climate crisis and
advance environmental justice.
To accomplish these objectives, EPA is proposing targeted changes
and clarifying edits to the existing process by which the Agency
evaluates risk from chemical substances for purposes of TSCA section 6.
Additionally, this proposal includes structural changes to the
regulatory text to accomplish these goals. EPA is not proposing to
establish highly detailed provisions that will address every
eventuality or possible consideration that might arise. Due to the
rapid advancement of the science of risk evaluation and the science and
technology that inform risk evaluation, this proposed rule seeks to
ensure that the risk evaluation process is transparent, without unduly
restricting the science that will be used to conduct the evaluations,
allowing the Agency flexibility to adapt and keep pace with changing
science as it conducts TSCA risk evaluations into the future.
B. General Provisions
1. Applicability of Updated Procedures
EPA is proposing that the changes to the procedures as part of this
rulemaking would be applied to all risk evaluations initiated on or
after the date of the final rule. For risk evaluations in process as of
the date of the final rule, EPA would expect to apply the proposed
changes to those risk evaluations only to the extent practicable,
taking into consideration the statutory requirements and deadlines.
Where a change to a risk evaluation would prevent the Agency from
meeting the statutory deadline, for example, EPA would generally not
view that change as practicable. However, where applying a proposed
change would impact timeliness but also ensure compliance with other
statutory obligations (e.g., conducting an appropriately scoped risk
evaluation), EPA would make a judgment on practicability by weighing
the implications for public health and environment, defensibility from
both a scientific and legal perspective, Agency priorities and the
availability of resources. As a general matter, EPA believes that most
of its ongoing risk evaluations, including the ongoing supplement to
the 1,4-Dioxane risk evaluation and part two of the Asbestos risk
evaluation, will likely conform to the changes contemplated in this
NPRM, and does not anticipate significant challenges in this area.
Finally, EPA does not expect to apply these procedures retroactively to
risk evaluations already completed.
2. Categories of Chemical Substances
EPA is proposing to clarify the regulations with respect to their
applicability to risk evaluations on categories of chemical substances.
Pursuant to TSCA section 26(c), wherever TSCA requires or authorizes
EPA to take action on a chemical substance, EPA can take that same
action with respect to a category of chemical substances (i.e., groups
of chemical substances which are, for example, similar in molecular
structure, in physical, chemical, or biological properties, in use, or
in mode of entrance into the human body or into the environment).
Although the rule's procedural requirements generally refer to
``chemicals'' or ``chemical substances,'' EPA is proposing to clarify
in the regulatory text at Sec. 702.31(d) that those references also
apply to categories of chemical substances.
C. Definitions
EPA is proposing changes to a number of definitions codified in the
existing regulatory text. EPA is proposing to eliminate the codified
definitions for ``best available science'' and ``weight of scientific
evidence.'' As described in greater detail in Unit III.I., EPA believes
that defining these concepts in the rulemaking is both unnecessary and
inhibits the Agency's flexibility to quickly adapt to and implement
changing science. Not codifying regulatory definitions of these
scientific terms is consistent with the approach in the 2017 proposed
rule (Ref. 9) (hereinafter ``2017 proposed rule'') and was supported by
public comment. Instead, as described in Unit III.I. EPA intends to
ensure that its risk evaluations are consistent with Agency guidance
and methodologies in applying these terms. As TSCA requires, at 15
U.S.C. 2625(h), EPA's risk evaluations will continue to use scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models, employed in a manner consistent with the best
available science. Further, both risk evaluation and risk management
decisions under TSCA section 6 will be based on the weight of the
scientific evidence, as required by 15 U.S.C. 2625(i). EPA's expected
application of these terms is more fully described in Unit III.G.
regarding Risk Evaluation Considerations.
Second, and as described further in Unit III.G.4., EPA is proposing
an addition to the examples identified in the definition of
``potentially exposed or susceptible subpopulation'' which currently
include ``infants, children, pregnant women, workers, or the elderly.''
The Agency proposes to add ``overburdened communities'' to better
reflect the Agency's intent to consider risks to particular communities
in the United States that potentially experience disproportionate
environmental harms and risks, while also ensuring environmental
justice--the fair treatment and meaningful involvement of all people
regardless of race, color, culture, national origin, income, and
educational levels with respect to the development, implementation, and
enforcement of protective environmental laws, regulations, and
policies--is considered where appropriate, including as part of any
subsequent risk management action.
Finally, EPA is proposing minor updates to a number of other
definitions to better align with existing Agency guidance.
Specifically, the definitions for ``pathways'' and ``routes'' have been
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adjusted for consistency with EPA's Exposure Factors Handbook (Ref.
10). Additionally, EPA is also proposing clarifying edits to the
definitions for ``aggregate exposure'' and ``sentinel exposure'' to
align with Agency guidance, and to make clear that the terms can apply
not only to individual persons, but to the populations and environment
when doing so is consistent with the best available science. EPA is not
proposing to amend the definitions for ``act,'' ``conditions of use,''
``reasonably available information,'' ``sentinel exposure,''
``uncertainty,'' or ``variability.''
D. Technical Corrections and Reorganization
The proposed rule reflects a number of minor updates and
corrections and general organizational restructuring. For example,
references to 15 U.S.C. 2605(b)(2)(A) have been removed in light of the
fact that the law's one-time requirement related to identification of
the first group of 10 chemicals for risk evaluation has been satisfied
and is no longer applicable for purposes of the procedural rule.
Additionally, EPA made minor updates to the regulatory text to correct
typos and to ensure consistency in use of certain phrases (e.g.,
manufacturer-requested risk evaluations). More generally, EPA aimed to
improve the readability of certain provisions, and, ultimately, enhance
the public's ability to understand how EPA will undertake TSCA risk
evaluations. As part of this effort, EPA is proposing to reorganize the
sequence and structure of regulatory provisions to, for example,
establish sections that distinguish between the components of the risk
evaluation, the analytic considerations to be applied in the risk
evaluation, and the associated procedural timeframes and actions. EPA
welcomes comment on these changes to enhance clarity and readability.
EPA has provided a short description of the reorganization:
Proposed Sec. Sec. 702.31, 702.33, and 702.35 have
retained the same organization.
Proposed Sec. 702.37 ``Evaluation requirements'' includes
many of the components of Sec. 702.41 of the 2017 final rule,
including statutory requirements of a risk evaluation, upholding the
science requirements of section 26(h), inclusion of conditions of use,
and clarity regarding making an unreasonable risk determination on the
chemical substance. This section also includes EPA's approach to
information and information sources, much of which is moved from Sec.
702.41(b) in the 2017 final rule. New proposed language included in
this proposed section is EPA's approach to conducting a fit-for-purpose
risk evaluation, addressing information gaps, and use of data gathering
authorities.
Proposed Sec. 702.39 is a newly titled section
``Components of risk evaluation'' that is composed of 2017 final rule
Sec. Sec. 702.41, 702.43, 702.45. This one section includes the
components of a risk evaluation (e.g., scope, hazard assessment,
exposure assessment, risk characterization, risk determination) and
what they must contain. Some of the specific requirements of the hazard
and exposures assessment have been streamlined and reconfigured from
the 2017 final rule.
Proposed Sec. 702.41 ``Peer review'' was Sec. 702.47 in
the 2017 final rule.
Proposed Sec. 702.43 contains the parts of a risk
evaluation (e.g., draft scope, final scope, draft risk evaluation and
final risk evaluation) and the process and timelines associated with
the development and publication of these parts. Much of this section
was moved from the 2017 final rule Sec. 702.41. This proposed section
now includes provisions pertaining to substantive revisions to these
documents post publication.
Proposed Sec. 702.45 is the revised process for
submitting a manufacturer requested risk evaluation, moved from the
2017 final rule 702.37.
Proposed Sec. 702.47 ``Interagency collaboration''
remains unchanged from 2017 final rule Sec. 702.39. As part of EPA's
commitment to identify information earlier in the prioritization and
risk evaluation processes, the Agency expects to continue to engage and
enhance coordination with other Federal agencies that may have
chemical-specific information. Doing so will not only serve to inform
the Agency's work in the risk evaluation, but can also help to
proactively identify conditions of use that may be essential to
national security, critical infrastructure, and/or mission critical
uses, identify existing safety measures Federal agencies already have
in place for their uses, and inform any subsequent risk management
approaches.
Proposed Sec. 702.49 ``Publicly available information''
remains substantively unchanged from Sec. 702.51 from the 2017 final
rule.
E. Scope of TSCA Risk Evaluations
1. Inclusion of All Conditions of Use
EPA is proposing a number of changes to the regulatory text to make
clear that the scope of TSCA risk evaluations will not exclude any
``conditions of use'' (i.e., any circumstance, based on reasonably
available information, under which a chemical substance is known,
intended or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of) to better align with the
statutory text and structure, including modification to various
provisions in the current rule that state or imply that EPA has broad
discretion to choose which conditions of use it will or will not
evaluate. These proposed amendments are intended to ensure that the
scopes of future risk evaluations are determined in accordance with the
law.
When TSCA was originally signed into law in 1976, there were tens
of thousands of chemicals in commerce and the law imposed no mandate
that EPA conduct any assessments to determine whether those existing
chemicals present unreasonable risk of injury to health or the
environment. While EPA did conduct some risk assessments on a handful
of these existing chemicals prior to 2016, those assessments were
focused on a specific subset of individual conditions of use of
chemicals (e.g., paint and coating removal, vapor degreasing, etc.).
The net effect of this use-by-use approach was that--even if EPA were
to identify risks through a risk assessment and successfully promulgate
a rule under TSCA to manage those particular risks--the public would
still not have certainty regarding risks from the full spectrum of uses
of the chemical substance. This uncertainty, in turn, would continue to
erode public confidence in the safety of chemicals pervasive in our
households, communities and the environment, and encourage states to
adopt an increasingly complex patchwork of regulatory measures to
address chemical risks.
One of the defining features of the 2016 amendments to TSCA was the
mandate for EPA to systematically prioritize those thousands of
existing chemicals for review, and then to evaluate their risks,
holistically, under the chemical's ``conditions of use''--a phrase that
Congress defined to capture a chemical's full lifecycle, i.e., ``the
circumstances, as determined by the Administrator, under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed
of.'' (15 U.S.C. 2602(4)). While clearly a significant undertaking,
Congress recognized that comprehensive progress on evaluating the
universe of thousands of existing chemicals would not be made without
this mandate, coupled with a strong risk-based safety standard and
deadlines
[[Page 74297]]
for completing the work (Ref. 11). To allow EPA to continue to address
only a subset of each chemical's uses as part of the new TSCA process
would deny such comprehensive progress.
The question of whether the Agency has broad discretion under the
law to exclude conditions of use from the scope of risk evaluations was
the source of much discussion publicly during the development of the
2017 proposed and final rules. EPA believes the approach proposed
herein is more consistent with congressional intent and reflects
consensus of technical discussion with congressional negotiators
leading up to the passage of the 2016 amendments. See also Ref. 11 at
p. S3516 (implying the lack of discretion in the ``mandate to consider
conditions of use'') and p. S3519 (referencing the prior TSCA risk
assessments that did not consider ``all conditions of use'' and
Congress' desire to nonetheless allow EPA to proceed with risk
management based on those select ``partial'' risk evaluations).
However, in the preamble to the 2017 final rule the Agency asserted
that it retained discretion to exclude conditions of use from the scope
of TSCA risk evaluations. Ref. 1 at p. 33729.
In support of this assertion of discretionary scoping authority in
the 2017 final rule, EPA pointed to language in TSCA section 6(b)(4)(D)
that requires EPA to identify the conditions of use in a scope document
that the Agency ``expects to consider'' in a risk evaluation and the
``as determined by the Administrator'' phrasing in the statutory
definition of ``conditions of use'' itself (Ref. 1 at p. 33729). EPA
argued that such language gave the Agency discretion to select among
the conditions of use and, ultimately, to exclude conditions of use
from the scope of TSCA risk evaluations. EPA expressed at that time
that those provisions empowered the Agency to exclude, for example,
conditions of use that the Agency deemed ``de minimis'' in nature, or
conditions of use where opportunities for exposure were likely to be
limited (e.g., closed system or intermediate) (Ref. 1 at p. 33729). As
discussed further in Unit III.E.3., EPA has also relied on this
interpretation to exclude consideration of exposure pathways in TSCA
risk evaluations where EPA or another regulatory agency had or could
assess and regulate the same chemical--a policy that excluded exposures
to the general population through air, water and disposal, and left
potential risks unaccounted for.
Upon further review, and as described in the preamble to the 2017
proposed rule and supported by legislative history, EPA believes that
the better reading of TSCA's statutory text and structure is that EPA
does not have discretionary scoping authority, and that risk
evaluations are to be conducted on the circumstances under which the
chemical is known, intended and reasonably foreseen to be manufactured,
processed, distributed in commerce, used, and disposed of (i.e.,
activities that constitute the ``conditions of use'' within the meaning
of TSCA section 3(4)) (15 U.S.C. 2602(4)). The plain language of TSCA
section 6(b)(4)(A) specifies that EPA must determine in a risk
evaluation whether ``a chemical substance'' presents an unreasonable
risk of injury to health or the environment ``under the conditions of
use.'' Similar language appears throughout section 6 of the law. See,
for example, 15 U.S.C. 2605(b)(4)(G)(i) and (ii) stating that the risk
evaluation ``for a chemical substance'' must be completed within 3 to
3.5 years of initiation. As such, while EPA at one time interpreted the
statue to permit a different approach, the statute is better
interpreted as requiring that the evaluation must be on the chemical
substance--not a subset of individual conditions of use of the chemical
substance. EPA also believes the purpose of the requirement to evaluate
the ``chemical substance'' was to ensure that the Agency, through the
risk evaluation process, would comprehensively determine whether a
chemical substance, under the known, intended, and reasonably foreseen
circumstances of manufacture, processing, distribution in commerce, use
and disposal, presents an unreasonable risk. This reading also aligns
with the requirements under the 2016 TSCA amendments to establish a
constant pipeline of activity on assessing chemical substances and
managing risks, effectively driving forward progress on the tens of
thousands of unreviewed existing chemical substances in commerce (15
U.S.C. 2605(b)(2) and (b)(3)(C)). In the absence of comprehensive risk
evaluations on chemical substances (i.e., an approach that considered
only a subset of a chemical's uses), the unevaluated uses would create
uncertainty as to whether EPA had fully addressed a chemical's
unreasonable risk and further delay progress on the backlog of existing
chemicals.
Given these considerations, EPA believes that the phrase ``as
determined by the Administrator'' in the statutory definition of
``conditions of use'' requires application of fact and professional
judgment in determining whether or not a particular circumstance is
known, intended or reasonably foreseen--and should not be viewed as
license to select among those circumstances in determining which should
be included or excluded from the scope of a risk evaluation that is to
be completed on a chemical substance (15 U.S.C. 2602(4)). Likewise, the
instruction in TSCA section 6(b)(4)(D) for the Agency to--during the
scoping phase--identify the conditions of use it ``expects to
consider'' in a risk evaluation, is best read as directing the Agency
to identify the uses and other activities that it has determined
constitute the conditions of use of the chemical substance, while
acknowledging that the Agency's expectations at the scoping phase may
not always align perfectly with the conditions of use actually
considered and assessed in draft and final risk evaluations. EPA may,
for example, mistakenly identify a condition of use in the scope
document, and later remove it from analysis in the risk evaluation.
Alternatively, EPA might be unaware of or inadvertently exclude a
condition of use during the scoping phase, but later incorporate it
into its risk evaluation. While EPA at one time interpreted the
language differently, EPA no longer believes that the ``expects to
consider'' language in TSCA section 6(b)(4)(D) gives the Agency broad
discretion to choose among conditions of use that it will include in a
risk evaluation of a chemical substance. The Ninth Circuit agreed with
this view, noting that the phrase ``conditions of use that the EPA
plans to consider'' in the 2017 final rule and the similar phrase
``expects to consider'' in TSCA section 6(b)(4)(D) simply refer to the
Agency's role in determining what the conditions of use are for a
particular substance, and do not grant EPA discretion to exclude
conditions of use from the scope of a risk evaluation (Ref. 2).
Consideration of all conditions of use in TSCA risk evaluations is
also necessary from a scientific perspective to ensure development of a
technically sound determination as to whether a chemical substance
presents an unreasonable risk of injury to health or the environment.
Thus, consideration of all conditions of use ensures risk evaluations
are consistent with the best available science and based on the weight
of scientific evidence (15 U.S.C. 2625(h) and (i)). As discussed
further in Unit III.G.2., there may be situations where certain
conditions of use are associated with relatively lower exposures, but
nonetheless in the aggregate those uses may contribute to
[[Page 74298]]
unreasonable risk. Exclusion of conditions of use from risk
evaluations--irrespective of the Agency's intention in so doing--
deprives the public of a complete picture of the chemical's risk, and
may leave significant risk to human health or the environment
unaccounted for and ultimately unaddressed.
For these reasons, the proposed rule clarifies that EPA will not
exclude conditions of use (i.e., any circumstances under which the
chemical is known, intended or reasonably foreseen to be manufactured,
processed, distributed in commerce, used or disposed of) from the scope
of a risk evaluation by amending the regulatory text where it was
either stated or implied that the Agency had broad discretion to
exclude certain conditions of use from analysis.
2. Determination of ``Conditions of Use''
Although EPA no longer interprets TSCA to allow the Agency to
exclude any intended, known or reasonably foreseen conditions of use
from the scope of a risk evaluation, EPA nonetheless retains authority
to exercise judgment in making its determination as to whether a
particular circumstance is intended, known, or reasonably foreseen, and
therefore falls within the definition of ``condition of use'' for a
particular chemical. As such, for each risk evaluation, EPA has and
will continue to undergo a process to determine each chemical's
conditions of use, analyzing reasonably available information and
applying the facts, Agency expertise and professional judgment on a
case-by-case basis. As described previously, the phrase ``as determined
by the Administrator'' in the statutory definition of ``conditions of
use'' requires EPA to review the reasonably available information and
exercise judgment in determining whether a particular circumstance is
intended, known or reasonably foreseen. For example, when information
suggests that a circumstance of manufacture, processing, distribution
in commerce, use or disposal is known to be occurring, EPA will
determine that known circumstance to be a condition of use and include
it within the scope of the risk evaluation, irrespective of other
factors like the likelihood of that particular condition of use to be a
significant contributor to risk. Likewise, where, in the Agency's
professional judgment, a circumstance is reasonably foreseen to occur
in the future, EPA will determine that circumstance to be a condition
of use and include it within the scope of the risk evaluation, even
where that condition of use may not contribute significantly to the
Agency's ultimate conclusions on risk.
In the preamble to the 2017 final rule (Ref. 1) EPA identified
legacy disposal as falling outside the definition of ``conditions of
use.'' EPA interpreted the TSCA definition for ``conditions of use'' as
focusing on circumstances that are prospective or on-going, rather than
reaching back to evaluate risks associated with legacy disposal (i.e.,
disposal that has already occurred) (Ref. 1 at p. 33730). The Ninth
Circuit agreed, holding that TSCA unambiguously does not require legacy
disposals to be considered as conditions of use (Ref. 2 at pp. 425-
426). The Court reasoned that a substance that has already been
disposed of will not ordinarily be intended, known, or reasonably
foreseen to be prospectively manufactured, processed, distributed in
commerce, used, or disposed of again (Ref. 2). EPA is not reconsidering
that issue in this proposal. However, EPA generally does not view any
other categorical exclusions from the definition of condition of use as
appropriate.
With respect to legacy use and associated disposal, however, EPA
now believes that such circumstances are, in fact, ``conditions of
use'' and must be considered in risk evaluations. (Ref. 2, pp. 420-
421). An example would be in-situ asbestos insulation, a product no
longer manufactured but nevertheless an ongoing downstream use. Future
disposal of asbestos insulation is clearly an example of a chemical
substance being ``disposed of'' and to the extent it is ``intended''
that such a substance be disposed of, or ``known'' that it will be, or
if such disposal is ``reasonably foreseen,'' that circumstance
unambiguously falls within TSCA's definition of ``conditions of use.''
(Ref. 2, pp. 420-421). As such, EPA is already developing a ``part 2''
of the TSCA risk evaluation for asbestos in order to include analysis
of exposures and potential risks from legacy uses and expects future
risk evaluations to also consider legacy uses and associated disposals
as conditions of use (i.e., circumstances associated with ``use'' and
``disposal''). EPA believes that this approach is consistent with the
statutory text and structure, as well as Congressional intent.
There are other categories of circumstances that EPA intends to
consider in future risk evaluations associated with conditions of use
that also bear mention. The known, intended, and reasonably foreseen
production of a chemical as a byproduct or the known presence of a
chemical as an impurity or within an article, for example, are squarely
``conditions of use'' that generally must be included within the scope
of risk evaluations.
Likewise, where EPA has reasonably available information
demonstrating that certain exposures associated with a spill or leak
are known or reasonably foreseen to occur during a condition of use
that is part of a risk evaluation (e.g., regular or predictable
exposures from equipment leaks as part of the manufacturing process),
EPA would expect to include that exposure within the scope of the risk
evaluation. However, EPA would not expect to include within the scope
of the risk evaluation exposures from releases of a chemical substance
that are unsubstantiated, speculative or otherwise not likely to occur.
For example, a future one-time accident involving the chemical
substance that could be caused by an atypical one-time set of
circumstances would generally not be assessed as part of a risk
evaluation. Additionally, EPA would generally not include within the
scope of the risk evaluation exposures associated with future extreme
weather events (e.g., hurricanes and wildfires). However, if
information reasonably available to the Agency indicated that factors
such as rising sea levels or extreme temperatures made worse by climate
change were leading to regular and predictable changes in exposures
associated with a given condition of use of a chemical substance, EPA
would expect to consider those exposures within the scope of the risk
evaluation. EPA requests comment on alternative proposals for
considering potential climate-related risks. As discussed further in
Units III.E.4. and III.I.2., EPA may adjust the level of refinement for
a particular exposure assessment by conducting a ``fit-for-purpose''
assessment. While EPA will always apply the scientific standards
required under TSCA, the depth or extent of analysis will be
commensurate with the nature and significance of the decision. For
example, EPA may find that the types of exposures described in this
paragraph warrant consideration as part of an exposure assessment,
either in a qualitative or a quantitative exposure assessment.
Additionally, the Agency will decide the level of analysis warranted
based on a number of factors, including but not limited to: the
substance's physical-chemical properties; environmental fate and
transport properties; the likely duration, intensity, frequency, and
number of exposures under the condition of use; reasonably available
information about the release; and other relevant considerations.
[[Page 74299]]
Even where a condition of use is not expected to be a significant
contributor to risk from a particular chemical, TSCA nonetheless
requires EPA to include it in the scope of the risk evaluation.
However, and as described in Unit III.E.4., EPA has discretion to
conduct its evaluations in a fit-for-purpose manner, which may justify
tailoring the level of analyses to focus more detailed--and therefore
more time and resource intensive--quantitative efforts on the
conditions of use that pose the greatest potential for exposure and
therefore risk.
3. Inclusion of All Exposure Pathways
In carrying out the first ten risk evaluations under TSCA, EPA
narrowed the scope of those evaluations by excluding analysis of
certain exposures to the general population from releases to air, water
and land. The approach, which was not contemplated in the procedural
framework rule but was first articulated in ``Problem Formulation''
documents published in 2018 (after the Final Scope documents) for each
of the first ten chemicals undergoing risk evaluation, was premised on
an argument that those pathways were already adequately assessed and
managed--or could theoretically in the future be assessed and managed--
under other EPA statutes and regulatory programs (Ref. 12). EPA further
stated at that time that its intention was to use Agency resources
efficiently under the TSCA program, avoid duplicating efforts taken
pursuant to other Agency programs, maximize scientific and analytical
efforts, and meet TSCA's statutory deadline for completing risk
evaluations. In the final risk evaluations for the first ten chemicals,
EPA excluded exposure pathways that could be covered by regulatory
programs under the Clean Air Act (CAA), Clean Water Act (CWA), Safe
Drinking Water Act (SDWA), Resource Conservation and Recovery Act
(RCRA), and Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) (e.g., drinking water pathways covered under the
SDWA due to the existence of National Primary Drinking Water
Regulations (NPDWRs) with chemical-specific, enforceable Maximum
Contaminant Levels (MCL), or the inclusion of the chemical as an
unregulated chemical on the Candidate Contaminant List (CCL)). EPA
further asserted that this approach was supported by several TSCA
authorities, including TSCA section 6(b)(4)(D), which gives the Agency
authority to include the conditions of use that the Administrator
``expects to consider'' and section 9(b)(1), which allows Administrator
to use other EPA administered statutes, if the Administrator determines
there is risk to health or the environment (Ref. 13).
This approach was criticized by the Science Advisory Committee on
Chemicals (SACC), public commenters, and others (Ref. 14, 15, 16). As
announced on June 30, 2021, EPA will no longer follow the approach and
no longer intends to apply it to risk evaluations. Additionally, the
Agency applied the Draft TSCA Screening Level Approach for Assessing
Ambient Air and Water Exposures to Fenceline Communities Version 1.0
(Ref. 17) and additional feedback from peer review and public comment
in order to consider whether its past failure to have assessed the
risks associated with these exposures--along with its application of
other past policies and interpretations--may have resulted in
unaccounted potential risks. EPA has reconsidered the text of the
relevant statutory provisions, overarching statutory structure and
context, and legislative history, and no longer interprets the law to
authorize exclusion of exposure pathways from the scope of TSCA risk
evaluations because other EPA offices have already or could in the
future regulate those chemicals. EPA's prior interpretation in support
of that approach was premised in large part on the Agency's
interpretation of TSCA section 6(b)(4)(D) as providing the
discretionary authority to tailor the scope of exposures evaluated in
TSCA risk evaluations. See, e.g., Risk Evaluation for Methylene
Chloride, sec. 1.4.2 (Ref. 13). For the reasons explained in Unit
III.B., EPA no longer interprets TSCA section 6(b)(4)(D) to provide
broad discretionary authority to exclude conditions of use or exposure
pathways from the scope of TSCA risk evaluations.
EPA also cited TSCA section 9(b)(1) as support for its approach,
asserting that the instruction in that provision for the Administrator
to ``coordinate actions taken under [TSCA] with actions taken under
other Federal laws administered [by EPA]'' provided a broad,
freestanding authority to exclude from the scope of TSCA risk
evaluations exposure pathways that are addressed or could in the future
be addressed by other EPA-administered statutes and regulatory
programs. See, e.g., Risk Evaluation for Methylene Chloride, section
1.4.2 (Ref. 13). EPA asserted that such exclusions from TSCA risk
evaluations were also permitted under the remaining text of TSCA
section 9(b)(1), which establishes a process for determining whether to
use EPA-administered authorities other than TSCA to protect against a
risk ``[i]f the Administrator determines that a risk to health or the
environment associated with a chemical substance or mixture could be
eliminated or reduced to a sufficient extent by actions taken under the
authorities contained in such other Federal laws.'' But upon
reconsideration, neither provision in TSCA section 9(b)(1) is properly
interpreted as authorizing exposure pathways to be excluded from TSCA
risk evaluations.
Intra-agency coordination is integral to ensuring that EPA actions
are well-informed, effective, and efficient, but a general requirement
under TSCA section 9(b)(1) to ``coordinate actions'' cannot be read to
displace the more specific requirements under TSCA section 6(b)(4)(F)
to conduct a risk evaluation that shall ``integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance,'' and ``take into account . . . the
likely duration, intensity, frequency, and number of exposures under
the conditions of use of the chemical substance.'' And the remaining
text of TSCA section 9(b) is directed at risk management action, which
cannot logically take place until after EPA has conducted an evaluation
and determined that a risk is presented. If exposure pathways covered
by other laws are not assessed in TSCA risk evaluations, it is unclear
how the Administrator would have sufficient information to determine
under TSCA section 9(b) that a risk to health or the environment
associated with a chemical substance could be eliminated or reduced to
a sufficient extent under another Federal law, or whether it is in the
public interest to protect against such risk by actions taken under
TSCA--a finding that must, pursuant to TSCA section 9(b)(2), consider
``all relevant aspects of the risk.'' Legislative history from TSCA's
original 1976 enactment supports this understanding that TSCA section
9(b)--the text of which was at that time split between TSCA section
9(b) and TSCA section 6(c) (pertaining to risk management rulemaking
procedures)--is properly interpreted in the context of risk management
action rather than any preceding evaluation of risk (Ref. 18). As
explained in the Conference Committee's 1976 report (Ref. 18) ``the
requirement to examine other EPA laws and to make determinations
applies only when the Administrator takes regulatory action to protect
against an unreasonable risk under this Act.''
EPA recognizes that there may be exposure-reducing impacts from
existing regulations and intends to
[[Page 74300]]
consider reasonably available information when estimating exposures,
including available monitoring data. There may also be circumstances
where an unreasonable risk identified in the risk evaluation may be
eliminated or reduced to a sufficient extent under the authorities
contained in other Federal laws, such that a referral under TSCA
section 9 might be appropriate. However, the mere existence of
authority to assess or regulate a chemical, exposure pathway, or use
under a statute other than TSCA does not equate to effective risk
management of that chemical, exposure pathway or use, and an assumption
that risk will--or could be--managed in the future cannot be used to
satisfy the Agency's statutory obligations to evaluate existing
chemical substances under TSCA and manage identified risks. Wholesale
exclusion of identified exposure pathways for a chemical substance from
the scope of the TSCA risk evaluation for that substance is
inconsistent with EPA's obligations under TSCA section 6(b)(4)(F), as
noted, as well as with requirements under TSCA section 26(h), (i) and
(k) to make decisions based on science that are consistent with the
best available science and are based on the weight of the scientific
evidence, and to take into consideration reasonably available
information relating to a chemical substance, ``including . . .
exposure information,'' under the conditions of use. Furthermore, TSCA
section 9 already contemplates a time and place for determination of
whether EPA or another Federal agency can adequately address chemical
risks under the authority of another Federal law: during the risk
management rulemaking process after the risk has been identified in a
risk evaluation.
Accordingly, EPA is proposing changes in the rule to ensure that
risk evaluations include all relevant exposure pathways, thereby
providing the basis for development of strong, scientifically and
legally defensible regulatory protections. Specifically, EPA is
proposing to explicitly require that each risk evaluation assess all
exposure routes and pathways relevant to the chemical substance under
the conditions of use, including those that are regulated under other
Federal statutes.
4. Comprehensive But Fit-For-Purpose
While the changes described in Unit III.E.1. through 3. could all
lead to future TSCA risk evaluations that are more comprehensive in
scope, EPA recognizes the enormity of the challenge to complete these
responsibilities within the timeframes set forth by Congress. The law
provides the Agency with only 3 to 3.5 years to finalize a TSCA risk
evaluation. The primary purpose of a TSCA risk evaluation is to support
regulatory decision making--either to form the basis of a subsequent
rulemaking to eliminate identified unreasonable risk under TSCA section
6(a), or to determine that the chemical does not present unreasonable
risk and therefore rulemaking is not necessary. Given the tens of
thousands of existing chemicals, Congress further mandated that risk
evaluations be completed on an ongoing basis and within specified
timeframes.
Risk evaluations under TSCA should not be so complex or
procedurally cumbersome that they cannot reliably be completed within
the timeframes required by the statute. At the same time, EPA cannot
produce partial or incomplete TSCA risk evaluations or otherwise pursue
risk evaluations in a manner that is incompatible with the statutory
framework. Although EPA must balance resource expenditure and
manageability, it must do so within the confines of its statutory
mandate. As such, EPA is proposing some changes to the rule to ensure
consistency with TSCA's text, structure, and purpose, while also
clarifying where the statute provides flexibilities in how EPA conducts
TSCA risk evaluations. For example, the proposed rule makes clear that
a risk evaluation must assess the full range of conditions of use and
all exposure routes and pathways, and that a single risk determination
will be made on the chemical substance, but these can be accomplished
with a fit-for-purpose approach that allows for varying types and
levels of analysis.
In order for TSCA implementation efforts to be sustainable, risk
evaluations must be fit-for-purpose such that the Agency meets both the
substantive statutory and regulatory requirements for conducting risk
evaluations, while completing those evaluations within the statutory
deadlines. (15 U.S.C. 2605(b)(4)). For example, while risk evaluations
must consider the full spectrum of the chemical's conditions of use,
not all of those conditions of use will warrant the same level of
evaluation. As described in the 2017 final rule, EPA expects it may be
able to complete its analysis on certain conditions of use and/or
exposure pathways without extensive or quantitative evaluations of
exposure. For example, lower-volume or less dispersive uses could
receive less quantitative evaluations than uses with more extensive or
complicated exposure patterns. In addition, not all identified
toxicological endpoints may need the same level of analysis and
consideration. Efficiencies may be gained in similarly tailoring
approaches to peer review and/or systematic review. EPA can make
scientifically sound risk determinations, considering reasonably
available information, consistent with the best available science, and
based on the weight of scientific evidence, through a combination of
different types of information and risk assessment approaches.
Ultimately, the proposed changes--TSCA risk evaluations that are both
more comprehensive (e.g., that consider all exposure pathways) and
better incorporate fit-for-purpose approaches that ensure EPA is
meeting its statutory deadlines--will lead to more scientifically sound
and legally defensible risk evaluations that support robust TSCA
section 6(a) risk management rules that address any unreasonable risks
of injury to human health or the environment.
5. Additional Efficiencies
Based on the Agency's early implementation efforts and experience
using the data gathering authorities afforded under the amended
statute, it has become clear that EPA should identify, obtain, review,
and synthesize data and information for risk evaluations much earlier
in the TSCA existing chemical risk assessment and risk management
process. Doing so will enable the Agency to finalize risk evaluations
in the aggressive timeframes provided by the law, and as necessary,
initiate risk management actions in a timely manner. EPA believes a
more sustainable process would involve--either during prioritization or
before--review of reasonably available information, identification of
data needs and gaps, and preliminary efforts to scope the potential
risk evaluation. Prioritization is the statutorily required initiating
step in the TSCA existing chemical risk evaluation and risk management
process. (15 U.S.C. 2605(b)). This 9- to 12-month process includes a
risk-based screening to ultimately designate a chemical substance as a
high-priority substance for risk evaluations or low-priority substance
for which a risk evaluation is not warranted at the time. In the
interest of creating additional efficiencies, EPA is proposing a
process in which the Agency would publish and take comment during
prioritization on preliminary information to inform the scope of the
potential risk evaluation, which may result in the publication of the
``draft scope'' before the initiation of the subsequent risk
evaluation.
More specifically, when early indications suggest the chemical is
[[Page 74301]]
likely to meet the criteria for a high-priority designation, EPA
expects to publish the draft scope for public comment, to correspond
with one of the two statutorily required 90-day comment periods
associated with prioritization. Publishing this information early will
allow the Agency to give an early indication as to the conditions of
use, hazards, exposures and potentially exposed or susceptible
subpopulations that the Agency expects to consider and may provide
early indications as to how the Agency expects to conduct a fit-for-
purpose risk evaluation. This information will accompany the
prioritization screening review criteria, and EPA will look to public
comment and submission of available relevant data to inform both the
final priority designation but also, if the chemical is then designated
as a high priority, the information to inform the scope.
As the first statutorily required step of the risk evaluation
process, TSCA requires the Agency to publish the scope of the risk
evaluation no later than 6 months after initiating the risk evaluation.
(15 U.S.C. 2605(b)(4)(D)). This scope must include the hazards,
exposures, conditions of use, and the potentially exposed or
susceptible subpopulations the Administrator expects to consider. Under
the 2017 final rule, however, EPA must publish the scope in a ``draft''
form, followed by no less than a 45-day public comment period. The 2017
final rule states that the Agency generally expects to publish this
draft no later than 3 months after initiation of the risk evaluation.
Stakeholders supported this provision during the development of the
2017 proposed rule; due to the gravity of the ``final'' scope on the
risk evaluation process and possible state preemption, it was important
for stakeholders to have the ability to comment on the draft scope. The
proposed rule would maintain the requirement to publish a draft scope
but set forth an expectation to publish the information as early as the
prioritization process (e.g., concurrent with the proposed 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. EPA requests comment on this proposed approach of
publishing a draft scope during the prioritization process when it is
clear that the chemical undergoing the prioritization process will be
designated as a high-priority chemical.
F. Risk Determinations
1. Determinations on the ``Chemical Substance''
EPA is proposing to clarify the regulations with respect to the way
EPA makes a risk determination at the conclusion of the TSCA risk
evaluation process. As described earlier, EPA believes, as supported by
the plain language in the law, that the chemical's full spectrum of
conditions of use must be included and assessed in the risk evaluation.
EPA fully intends to continue to consider exposures associated with
each condition of use. However, following that analysis, and for the
reasons described in this Unit, the Agency no longer intends to make
separate risk determinations for individual conditions of use. Instead,
EPA is proposing changes to the regulations to clarify and codify the
approach that the Agency originally proposed in the 2017 proposed rule
(i.e., to make a single risk determination on the whole chemical
substance). EPA believes that this approach is consistent with the
statutory text and structure, as well as Congressional intent, and will
enable the Agency's risk determinations to better reflect the potential
for combined exposures across multiple conditions of use.
In the 2017 proposed rule, EPA proposed that risk determinations be
made on the ``chemical substance,'' consistent with the plain language
of the law and Agency's interpretation of the new requirements in TSCA
at that time. (Ref. 9 at pp. 7572, 7565 through 7566, and 7580). As
described in the preamble, ``TSCA section 6(b)(4)(A) specifies that a
risk evaluation must determine whether `a chemical substance' presents
an unreasonable risk of injury to health or the environment `under the
conditions of use.' The evaluation is on the chemical substance--not
individual conditions of use--and it must be based on `the conditions
of use.' ''. Thus, in the 2017 proposed regulatory text, EPA proposed
to determine whether the chemical substance presents an unreasonable
risk of injury to health or the environment under the conditions of
use. (Ref. 9 at p. 7480).
The 2017 proposed rule provided an exception that would allow EPA
to make an ``early determination'' for a specific use that was deemed
to present unreasonable risk. Where such an early determination was
made, the risk management efforts to address that specific use could
begin more expeditiously and not wait until the end of the 3 to 3.5
year risk evaluation process (Ref. 8 at pp. 7568 and 7578). EPA did not
propose a similar process for use-specific early determinations of no
unreasonable risk. This exception made logical sense, in that, if a
specific use of a chemical--in isolation--presented an unreasonable
risk under TSCA, that chemical itself would necessarily present an
unreasonable risk irrespective of risks posed by other uses. The
converse may not be true. Where a specific use might not present an
``unreasonable risk'' on its own, it may nonetheless contribute to an
unreasonable risk determination when considered together with other
uses of the chemical (e.g., when considering it in an aggregate
exposure scenario).
EPA received comment on the 2017 proposed rule that limiting
``early determinations'' only to uses that present unreasonable risk
was unfair, and encouraged the Agency to extend this concept of early,
use-specific risk determinations to those uses determined not to
present unreasonable risk. The 2017 final rule stated that ``EPA will
determine whether the chemical substance presents an unreasonable risk
of injury to health or the environment under each condition of uses
[sic] within the scope of the risk evaluation, either in a single
decision document or in multiple decision documents'' (Ref. 1). There
was one particular passage in the preamble to the 2017 final rule which
stated that EPA would make individual risk determinations for all
conditions of use identified in the scope. (Ref. 1 at p. 33744).
Concerns about a use-specific approach to risk determinations were
raised as part of litigation on the final rule in Safer Chemicals v.
EPA (Ref. 2 at p. 413), including that such an approach ignores the
potential risks when the same individuals are exposed to the same
chemical through multiple conditions of use (e.g., in the workplace and
in the home). Those exposures, when combined, may present unreasonable
risk, whereas, when viewed in isolation, may not. A panel of the Ninth
Circuit Court of Appeals recognized the ambiguity of the regulation on
this point, and ultimately held that a challenge regarding ``use-by-use
risk evaluations [was] not justiciable because it is not clear, due to
the ambiguous text of the Risk Evaluation Rule, whether the Agency will
actually conduct risk evaluations in the manner Petitioners fear''
(Ref. 2 at p. 413). Subsequent to the Ninth Circuit's decision, EPA
made individual risk determinations for each condition of use evaluated
in the first ten risk evaluations (i.e., the condition of use-specific
approach to risk determinations). That approach was
[[Page 74302]]
based on the particular passage in the preamble to the 2017 final rule
stating that EPA would make individual risk determinations for all
conditions of use identified in the scope. (Ref. 1 at p. 33744). The
approach resulted in a mix of findings that certain conditions of use
for a chemical ``present unreasonable risk'' while others ``do not
present unreasonable risk.''
As announced in June 2021 as the path forward for the first ten
risk evaluations, EPA has revisited this decision and determined to
revise the use-specific risk determinations for most of the first ten
chemicals to reflect a single determination on the chemical substance
itself (Ref. 7). These revisions did not require the Agency to change
any of its underlying analyses in the risk evaluations. In the case of
many of these first 10 chemicals, EPA had already determined that many
or most of the individual conditions of use presented an unreasonable
risk.
In revising the risk determinations for the first 10 chemicals, EPA
noted that in contrast to the portion of the preamble of the 2017 final
rule that discusses the intent of the Agency to make multiple risk
determinations, the regulatory text itself and other statements in the
preamble reference a risk determination for the chemical substance
under its conditions of use, rather than separate risk determinations
for each of the conditions of use of a chemical substance. See for
example, the revised risk determination for Methylene Chloride (Ref.
13). Notwithstanding the one preambular statement about condition of
use-specific risk determinations, the preamble to the 2017 final rule
also contains support for a risk determination on the chemical
substance as a whole.
Although the Agency indicated in its June 2021 announcement that it
would make a single risk determination on a chemical when it was
``clear that majority of conditions of use warrant one determination,''
EPA now believes a better understanding of the statute is that a single
determination on the chemical substance is required in every instance,
and is proposing to make this clear in this procedural rule. TSCA
section 6(b)(4)(A) specifies that in a risk evaluation, EPA must
determine whether ``a chemical substance'' presents an unreasonable
risk of injury to health or the environment ``under the conditions of
use.'' This language clarifies that the risk determination is on the
chemical substance--not individual conditions of use--and it must be
based on ``the conditions of use.''
Although EPA previously found ambiguity in TSCA section 6(b)(4)(A),
it now believes that a better reading of the statute in light of its
content and structure (and other reasons described in this paragraph)
is that it requires EPA to simultaneously evaluate all conditions of
use of a chemical substance. TSCA section 6(a) requires EPA to apply
risk-management requirements ``to the extent necessary so that the
chemical substance or mixture no longer presents such risk.'' This
phrasing suggests that the chemical substance presents the unreasonable
risk, and not specific conditions of use. Further, TSCA section 6(i)(1)
explains that ``a determination by the Administrator under subsection
(b)(4)(A) that a chemical substance does not present an unreasonable
risk of injury to health or the environment shall be issued by order
and considered to be a final agency action, effective beginning on the
date of issuance of the order.'' Similarly, TSCA section 6(i)(2)
explains that ``a final rule promulgated under subsection (a),
including the associated determination by the Administrator under
subsection (b)(4)(A) that a chemical substance presents an unreasonable
risk of injury to health or the environment, shall be . . . a final
agency action, effective beginning on the date of promulgation of the
final rule.'' Both of these provisions speak in terms of whether the
chemical substance presents unreasonable risk. Neither provision
mentions the conditions of use. The structure of TSCA section 6(i) also
implies a binary decision by not addressing a scenario in which a
chemical substance would be subject to TSCA section 6(i)(1) and (2).
EPA's view that there should be one determination on the chemical
substance is further bolstered by TSCA's preemption provisions at
Section 18, and its numerous references to ``chemical substance.'' In
TSCA section 18(a)(1)(B)--titled ``Chemical substances found not to
present an unreasonable risk or restricted''--the law states that
preemption applies, for example, when EPA issues ``the determination''
in TSCA section 6(i)(1) (i.e., a determination that the chemical
substance does not present an unreasonable risk). EPA notes in
particular that the word ``determination'' in this provision is
singular, suggesting Congress did not envision multiple determinations
under TSCA section 6(i)(1). Additionally, TSCA section 18(a)(1)(B)(ii)
states that permanent preemption is triggered by a final TSCA section
6(a) risk management rule for ``the chemical substance,'' suggesting
again that Congress did not envision that TSCA section 6(a) risk
management rules would address only risks presented by individual uses
or some subset of a chemical's uses, but rather unreasonable risk
presented by the chemical as a whole.
Based on its text and structure, EPA now reads TSCA as requiring
the Agency, in each risk evaluation, to make a single risk
determination of the chemical substance. EPA does not believe that the
statutory text and structure permit the Agency to make separate risk
determinations for each condition of use. The legislative history also
tends to favor this reading, including Congressional floor statements
made on the day of passage supporting the risk determination being for
the chemical substance. ``. . . EPA's understanding of a chemical's
conditions of use . . . will be critical to EPA's final determination
of whether a chemical is safe or presents an unreasonable risk that
must be controlled'' and S3520 ``A Section 6(i) order, determining that
a chemical substance does not present an unreasonable risk under
conditions of use, is similarly final Agency action applicable to all
those conditions of use that were identified in the scope of EPA's risk
evaluation on the chemical substance'').'' (Ref. 11).
Although the Agency has previously referred to this as a ``whole
chemical'' approach, this descriptor may have created some confusion
regarding the Agency's intent and purpose. EPA believes that a more
accurate description of the approach is simply one where the Agency
makes its risk determination for the chemical substance. A
determination that a chemical substance presents an unreasonable risk
does not mean that the entirety or whole of that chemical's uses--or
even a majority of uses--presents an unreasonable risk. Rather, EPA may
determine that a chemical substance presents an unreasonable risk based
on risk associated with even a single condition of use.
Some have criticized this approach in public comments on the
revised risk determinations. They have noted, for example, that a
singular risk determination could create confusion as to whether all
uses or only certain uses of a chemical pose unreasonable risk.
Fundamentally, EPA believes these concerns are risk communication
issues that the Agency can and intends to continue to improve on. EPA
will in every risk evaluation provide a rationale and explanation as to
which conditions
[[Page 74303]]
of use or exposure pathways are significant contributors to risk. The
Agency is committed to clearly communicating on the Agency's analysis
of particular uses within the risk evaluation and will not make
statements about the risk associated with the chemical substance absent
such explanation. Rather, as indicated in the proposed regulatory text
at 40 CFR 702.37(a)(5), and in order to inform risk management
requirements, EPA generally expects every risk determination to
identify which conditions of use are--or are not--significant
contributors to EPA's determination that the risk presented is
unreasonable. That said, for those chemical substances that EPA
determines present unreasonable risk, the risk evaluation is not the
end of the TSCA process. The primary purpose of a risk evaluation is
not to provide the public with guidance or suggested actions with
respect to particular chemical uses. Risk evaluations are scientific
documents intended to inform EPA decisions as to whether regulatory
action is needed to address unreasonable risks to human health or the
environment. Ultimately, when the TSCA existing chemicals review
process--including any TSCA section 6(a) rulemaking to manage risk--is
complete, the public should have full confidence that the chemical can
only be manufactured, processed, distributed in commerce, used and
disposed of in accordance with the associated risk management
requirements, and that the chemical substance no longer presents an
unreasonable risk.
Likewise, others have expressed concern that EPA will use a
singular risk determination to regulate in an overly broad manner. A
determination of unreasonable risk for a chemical substance does not
mean that EPA will, by default, propose or finalize a section 6(a) risk
management rule requiring all manufacture or use of the chemical
substance to be banned. EPA's statutory authority to regulate chemicals
under TSCA section 6 is available only ``to the extent necessary so
that the chemical substance or mixture no longer presents
[unreasonable] risk.'' (15 U.S.C. 2605(a)). EPA has a range of
authorities available under TSCA section 6(a) to address unreasonable
risk, including--but not limited to--requiring additional occupational
safety measures, product labels, or concentration limits. Where such
measures can eliminate unreasonable risk, EPA may propose them as part
of the risk management rulemaking process. EPA's determination of
appropriate regulatory requirements will be on a case-by-case basis,
and will not regulate chemical substances in a manner that is
inconsistent with the requirements of TSCA sections 6(a) and (c)(2).
For example, EPA may derive an exposure limit in the risk evaluation.
Such a limit would necessarily be based solely on risk-related
information, adhering to the statutory directive not to consider costs
or other non-risk factors during the risk evaluation. However, because
EPA is required to consider costs and other non-risk factors during the
risk management phase, including whether uses of a substance are
critical to Federal mission needs, or whether alternatives for a use of
a substance exist, the exposure limit presented in a risk evaluation
may not always or automatically signal the manner in which EPA will
regulate occupational risks during the risk management phase.
It is important to note, however, in exercising EPA's authority
under TSCA section 6(a) to ensure that ``the chemical substance . . .
no longer presents such risk,'' EPA may regulate conditions of use that
do not themselves contribute to unreasonable risk for a given chemical.
For example, where a risk evaluation's underlying analysis suggests
that particular use downstream in the supply chain is significantly
contributing to unreasonable risk determination for the chemical
substance, EPA's risk management actions need not apply only to the
downstream use. EPA may, for example, determine that elimination of the
unreasonable risk requires regulation of the chemical's upstream
manufacture, processing or distribution in commerce--even where the
upstream activity itself does not directly result in the exposures that
present the unreasonable risk.
EPA considered whether to re-propose a process for making use-
specific early determinations of unreasonable risk prior to completing
the risk evaluation for the remaining conditions of use, as
contemplated in the original 2017 proposed rule. However, based on
experience in conducting risk evaluations on the first 10 chemicals and
implementing the new requirements in TSCA section 6, the notion of
early, use-specific risk determinations is not practical or realistic
within the statutory deadlines. The theoretical benefit of such an
approach--enabling the early start of risk management efforts for the
subset of uses that are clearly of highest risk--is outweighed by the
burdens of managing the completion of multiple risk evaluation
processes on a single chemical followed by potentially multiple
rulemakings, each of which must comply with statutory deadlines. In the
event that there is a known, imminent and unreasonable risk of serious
or widespread injury to health or the environment (i.e., imminent
hazard) associated with a use or chemical that the Agency needs to
address immediately, TSCA section 7 provides EPA the authority to take
such immediate action.
EPA believes the approach, consistent with the 2017 proposed rule,
(i.e., to make a single risk determination on the chemical substance)
is aligned with the statutory text and structure, and will ensure that
the Agency is best positioned to incorporate reasonably available
information, make determinations consistent with the best available
science and based on the weight of scientific evidence, including,
where appropriate, risk determinations that consider aggregate exposure
resulting from multiple conditions of use. (15 U.S.C. 2625(h), (i), and
(k)). As such, EPA is proposing that risk evaluations will always
culminate in a single risk determination on the ``chemical substance''
instead of individual risk determinations on individual conditions of
use. EPA is proposing related conforming changes throughout the
regulatory text, including the proposed addition of 702.37(a)(5) and
the explicit mention of a single determination in 702.39(f)(1).
2. ``Unreasonable Risk'' Considerations
TSCA requires that a risk evaluation include a determination of
whether or not a chemical presents unreasonable risk, and further
requires that this determination be independent of cost or other non-
risk factors. (15 U.S.C. 2506(b)(4)(A) and (F)(iii)). Neither TSCA nor
the 2017 final rule define ``unreasonable risk'' given the inherently
unique nature of each risk evaluation and the need for EPA to make this
determination on a case-by-case basis. As described in the preamble to
the 2017 final rule (Ref. 1 at p. 33735), EPA may weigh a variety of
factors in determining unreasonable risk. The Administrator will
consider relevant factors including, but not limited to: The effects of
the chemical substance on health and human exposure to such substance
under the conditions of use (including cancer and non-cancer risks);
the effects of the chemical substance on the environment and
environmental exposure under the conditions of use; the population
exposed (including any susceptible subpopulations), the severity of
hazard (the nature of the hazard, the irreversibility of hazard), and
uncertainties.
[[Page 74304]]
The 2016 amendments also required that EPA's determination of
unreasonable risk consider the risks to potentially exposed or
susceptible subpopulations. Where EPA identifies risks as part of the
risk evaluation, the risks to a potentially exposed or susceptible
population may be more significant or severe than the risks to the
general population. EPA would more explicitly reflect this statutory
requirement in proposed Sec. 702.39(f), as the 2017 final rule did not
explicitly reference the statutory requirement to consider the risk to
potentially exposed or susceptible subpopulations when making the final
risk determination. Additionally, as discussed more fully in Unit
III.G.4., the proposed rule clarifies that ``overburdened communities''
are one example of a group that may be considered as potentially
exposed or susceptible subpopulations within a given risk evaluation.
``Overburdened communities'' may include various populations or
communities in the United States that potentially experience
disproportionate environmental harms and risks or multiple burdens from
chemical exposure. The proposed change clarifies that EPA will consider
the risk to potentially exposed or susceptible subpopulations as part
of its determination of whether or not the chemical presents
unreasonable risk.
Likewise, and as discussed further in Units III.G.2. and 3., EPA's
determination of unreasonable risk from the chemical substance will
also consider, where relevant, the Agency's analyses on aggregate
exposures and cumulative risk. For example, where a single population
is exposed to a chemical through multiple routes or pathways, EPA's
assessment of those aggregate exposures may inform the determination of
whether that chemical presents an unreasonable risk. Similarly, a
cumulative risk assessment may be conducted on a category of chemicals,
where the science supports this type of assessment, and the findings
may inform the unreasonable risk determination for the category.
G. Risk Evaluation Considerations
1. Occupational Exposure Assumptions
EPA is proposing some clarifications to the assumptions that it
will and will not apply in risk evaluations related to worker exposure.
In carrying out the first ten TSCA chemical risk evaluations, as
part of the unreasonable risk determinations, EPA assumed that workers
were provided and always used personal protective equipment (PPE) in a
manner that achieves the stated assigned protection factor (APF) for
respiratory protection, or used impervious gloves for dermal
protection. In support of this assumption, EPA relied on public
comments indicating that some employers, particularly in the industrial
setting, provide PPE to their employees and follow established worker
protection standards (e.g., OSHA requirements for protection of
workers). As EPA noted in prior risk evaluations (e.g., Risk Evaluation
for Methylene Chloride (Dichloromethane, DCM), 126 (Ref. 13 at p. 126),
the consideration of assumed use of PPE in a risk determination could
lead to an underestimation of the risk to workers. Further, parties in
litigation as well as public commenters on several TSCA risk
evaluations argued that making risk determinations based on assumptions
of PPE conflates the risk evaluation and risk management phases. In
June 2021, the Agency announced it would be revisiting the risk
determinations that were based on these assumptions and noted its plans
to consider information on use of PPE and other ways industry protects
its workers during the risk management process (Ref. 7).
TSCA requires that EPA evaluate the chemical substance under the
intended, known, or reasonably foreseen circumstances associated with
the chemical's manufacture, processing, distribution in commerce, use
and disposal. EPA believes that the blanket occupational exposure
assumptions on PPE do not reflect the known or reasonably foreseen
chemical exposures that impact workers, and their continued application
in TSCA risk evaluations would result in underestimates of risk. For
example, workers may be highly exposed because they are not covered by
Occupational Safety and Health Administration (OSHA) standards, their
employers are out of compliance with OSHA standards, or because the PPE
is not sufficient to address the risk or their PPE does not fit or
function properly. Further, many of OSHA's chemical-specific
permissible exposure limits were largely adopted in the 1970s and have
not been updated since they were established (Ref. 19). Additionally,
TSCA risk evaluations are subject to statutory science standards, an
explicit requirement to consider risks to potentially exposed or
susceptible subpopulations, and a prohibition on considering costs and
other non-risk factors when determining whether a chemical presents an
unreasonable risk that warrants regulatory actions--all requirements
that do not apply to development of OSHA regulations. As such, EPA may
find unreasonable risk for purposes of TSCA notwithstanding OSHA
requirements. Where risk evaluations assume fully protective PPE use,
and therefore little or no exposures for workers, the risk evaluations
may underestimate and/or fail to identify unreasonable risk. EPA is
requesting public comment on how the Agency can provide a transparent
and detailed basis for the proposed unreasonable risk determination and
existing chemical exposure limits derived from the risk evaluation
process.
EPA is not suggesting that there is widespread non-compliance with
applicable OSHA standards. In fact, EPA has received public comments
from industry in response to various EPA documents associated with TSCA
risk evaluations about occupational safety practices currently in use
at their facilities, including adherence to OSHA standards and non-OSHA
industry guidelines. EPA also acknowledges that other Federal agencies
and their contractors that use chemicals may similarly have well-
established occupational control measures in place. EPA will consider
comments received during the risk evaluation process, as well as other
information on use of PPE and other ways industry and Federal agencies
protect their workers, as potential ways to address unreasonable risk
during the risk management process. EPA recognizes that in some
instances and in certain workplace locations, particularly advanced
manufacturing facilities (e.g., those involved in the aerospace and
defense industrial base industrial sectors) there could be well-
established occupational safety protections in place. As EPA moves
forward with risk management rules, the Agency will strive for
consistency with existing OSHA requirements and/or best industry
practices when those measures would address the identified unreasonable
risk and would adopt a similar approach when making decisions about
managing risks for uses of chemicals that are required to meet national
security and critical infrastructure mission imperatives for other
Federal agencies. EPA will proactively communicate with Federal
agencies to identify such circumstances with an aim to propose measures
in the risk management process to address occupational risk that will
meet TSCA's statutory requirement to eliminate unreasonable risk of
injury to health and the environment, while also leveraging ongoing
interagency dialogue and striving to avoid potential
[[Page 74305]]
impacts to mission and infrastructure critical uses.
EPA is proposing regulatory amendments to clarify that, in future
risk evaluations, EPA's consideration of occupational exposure
scenarios in the exposure assessments will take into account reasonably
available information, including information regarding known and
reasonably foreseen circumstances where subpopulations of workers are
exposed due to absence or ineffective use of personal protective
equipment. The EPA intends to assess and include in the risk evaluation
the use of PPE, any engineering controls, and other industrial hygiene
practices at industrial, commercial, and Federal facilities. Where
information is made available, the Agency will take into account known
occupational control measures in the exposure assessments. However, the
Agency will not consider, as part of the unreasonable risk
determination, exposure reduction based on assumed use of PPE by
workers. For purposes of the risk determination at Sec. 702.39(f)(2),
EPA would distinguish between an ``assumed'' use of PPE and a use that
is supported by the reasonably available information and therefore
known to be inherent in the performance of an activity. For example,
where EPA has reasonably available information that substantiates use
and effectiveness of PPE (e.g., information demonstrating that
performance of a condition of use is impossible in the absence of PPE),
EPA generally expects to take that information into account in the risk
determination. The exposure reduction information (e.g., use of PPE)
from the risk evaluation's exposure assessment would then be considered
and incorporated in a future risk management action, as appropriate and
as required pursuant to TSCA section 6(a), and we encourage commenters
with interests or concerns on this to offer comments on this point in
connection with such a future action.
2. Aggregate Exposure
Pursuant to TSCA section 6(b)(4)(F)(ii), when conducting a risk
evaluation, EPA must ``describe whether aggregate or sentinel exposures
to a chemical substance under the conditions of use were considered,
and the basis for that consideration.'' While there is no mandate to
conduct aggregate exposure analyses, EPA may conduct aggregate exposure
analyses at its discretion. In the 2017 final rule EPA defined
aggregate exposure as ``the combined exposures to an individual from a
single chemical substance across multiple routes and across multiple
pathways.'' In this proposed rule, EPA is proposing slight revisions to
the definition. Aggregate exposure analysis is not only used to assess
exposure to an individual, but may also be used to assess exposure for
a population, subpopulation or the environment. Thus, EPA is proposing
to strike ``to an individual'' from the definition, which is consistent
with the definition used in General Principles for Performing Aggregate
Exposure and Risk Assessments (Ref. 20). Additionally, EPA is proposing
to strike ``single'' chemical, as TSCA allows the Agency to conduct
risk evaluations on categories of chemicals.
The consideration of an aggregate exposure assessment may be
particularly important for assessing chemical risks to overburdened
communities. If a community is exposed to a chemical substance through
multiple routes and/or pathways (e.g., exposure via air, land, and
water or exposure via drinking water and water recreation) and/or from
multiple sources (e.g., through different conditions of use occurring
at multiple facilities), the Agency has the authority to aggregate
those exposures, subject to the best available science standard, per
TSCA section 26(h). Not only does the Agency have the authority, but in
developing a comprehensive risk estimate for a chemical substance, it
is the Agency's responsibility to consider the aggregation of what may
be lower individual exposures from individual conditions of use and
routes of exposure. EPA is committed to conducting an aggregate
assessment, as supported by the science, in future TSCA risk
evaluations. In an aggregate exposure assessment, it may be appropriate
to also consider potential background exposures from non-TSCA uses that
are not within the scope of the risk evaluation. EPA could also
consider the disproportionate impacts that background exposures may
have on overburdened communities to inform the final unreasonable risk
determination.
3. Cumulative Risk
Advancing the science to support cumulative risk assessment is a
high priority for the Agency. Cumulative risk assessment is applicable
to all lifestages, and could inform the Agency's efforts to understand
and mitigate those risks to potentially exposed or susceptible
subpopulations, including children and overburdened communities.
Several reports from the National Research Council (NRC)--including the
1994 report Science and Judgment in Risk Assessment (Ref. 21) the 2008
report Phthalates and Cumulative Risk Assessment: The Tasks Ahead (Ref.
22), and the 2009 report Science and Decisions: Advancing Risk
Assessment (Ref. 23)--have highlighted the importance of understanding
the combined risk from multiple chemical stressors. These reports, as
well as statutory requirements such as those presented in the Food
Quality Protection Act of 1996 (Ref. 24), have helped drive EPA's
evolving work on cumulative risk assessment. Because individuals are
co-exposed to many chemicals in their daily lives, some of which may
have the same health effects, EPA believes that in some cases the best
approach to assess risk to human health may be to look at the combined
risk to health from multiple chemicals.
Although TSCA does not mandate that EPA must conduct cumulative
risk assessments, TSCA does require that EPA, when conducting TSCA risk
evaluations in 3 to 3.5 years (15 U.S.C. 2605(b)(4)(G)), consider the
reasonably available information, consistent with the best available
science, and make decisions based on the weight of the scientific
evidence (15 U.S.C. 2625(h), (i), and (k)). EPA recognizes that for
some chemical substances undergoing risk evaluation, the best available
science may indicate that the development of a cumulative risk
assessment is appropriate to ensure that risk to human health and the
environment is adequately characterized. TSCA also gives the Agency the
authority to consider the combined risk from multiple chemical
substances or a category of chemical substances. (15 U.S.C. 2625(c)).
Under TSCA section 26(c), EPA may take ``any action authorized'' under
any provision of TSCA, in accordance with that provision with respect
to a category of chemical substances or mixtures of chemical
substances. TSCA defines ``category of chemical substances'' as a group
of chemical substances the members of which are similar in molecular
structure, in physical, chemical, or biological properties, in use, or
in mode of entrance into the human body or into the environment, or the
members of which are in some other way suitable for the classification
as such for purposes of [TSCA].'' (15 U.S.C. 2625(c)). This definition
provides EPA with the flexibility to group chemical substances for
inclusion in a risk evaluation and a cumulative risk assessment when
supported by the best available science.
There are multiple definitions of the term ``cumulative risk
assessment.'' For TSCA risk evaluations, the Agency is
[[Page 74306]]
currently relying on the definition in EPA's Framework for Cumulative
Risk Assessment that defines cumulative risk assessment as ``an
analysis, characterization, and possible quantification of the combined
risks to health and/or the environment from multiple agents and/or
stressors'' (Ref. 25). This could include evaluation of multiple
chemical substances that jointly exert a common toxic effect. Exposures
to these chemicals could occur through multiple exposure pathways and
through multiple routes of exposure. EPA expects to use available EPA
(Refs. 26, 27, 28, 29), OECD (Ref. 30), and World Health Organization/
International Programme on Chemical Safety (WHO/IPCS) (Ref. 31)
guidances that outline two principal considerations for grouping
chemicals for inclusion in a cumulative risk assessment: (1)
Toxicologic similarity; and (2) Evidence of co-exposure over a relevant
timeframe.
A risk evaluation on a single chemical may not accurately provide a
complete understanding of the risks to an exposed population, given
simultaneous exposure to multiple chemicals. In turn, without
considering the cumulative risk of chemicals, the Agency's risk
mitigation may not fully be able to consider the public-health
implications of various risk management options for reducing exposure.
EPA is committed to considering applying cumulative risk assessment
approaches, as appropriate and where such analysis, based on reasonably
available information, represents the best available science, for
future chemicals undergoing risk evaluation. The Agency developed and
released a Draft Proposed Principles of Cumulative Risk Assessment
Under the Toxic Substances Control Act (Ref. 32) and Draft Proposed
Approach for Cumulative Risk Assessment of High-Priority Phthalates and
a Manufacturer Requested Phthalate Under the Toxic Substances Control
Act (Ref. 33) for public comment and peer review in February 2023. The
Agency is considering feedback from both stakeholders and peer
reviewers and EPA will continue to develop robust methodology for the
inclusion of cumulative risk assessment in TSCA risk evaluations. EPA
seeks comment on how the Agency could incorporate provisions for
cumulative risk assessment into our risk evaluation procedures in a way
that would accommodate future advancements in the science of cumulative
risk assessment as well as ensure that the scope and complexity of any
such assessments is consistent with that envisioned by Congress when it
established deadlines for conducting risk evaluations.
As described in Unit III.G.4., TSCA also explicitly requires EPA's
risk evaluations to consider unreasonable risk to ``potentially exposed
or susceptible subpopulations,'' and the statute provides authority to
consider non-chemical as well as chemical stressors when identifying
these subpopulations. Non-chemical stressors are factors found in the
built, natural, and social environments including physical factors
(e.g., geographic location) and psychosocial factors (e.g., poor
nutrition) (Ref. 34). EPA's Office of Research and Development has
defined cumulative impacts as the totality of exposures to combinations
of chemical and non-chemical stressors and their effects on health,
well-being, and quality of life outcomes (Ref. 34) and may or may not
include toxicologically defined risk. EPA has not to date considered
cumulative impacts in TSCA risk evaluations, but may in the future as
appropriate data, methods, and guidance are available.
4. Potentially Exposed or Susceptible Subpopulations
TSCA requires EPA to evaluate risk to ``potentially exposed or
susceptible subpopulation[s]'' identified as relevant to the risk
evaluation by the Administrator, under the conditions of use. (15
U.S.C. 2605(b)(4)(A)). TSCA defines the term as ``a group of
individuals within the general population identified by the EPA who,
due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.'' (15 U.S.C. 2602(12)). TSCA
does not further define ``greater susceptibility'' or ``greater
exposure,'' giving the Agency discretion to interpret these terms.
Greater susceptibility could include increased risk of experiencing an
adverse effect due to one's lifestage or a pre-existing condition or
circumstance (e.g., immune-compromised conditions, lifestyle factors
such as smoking status or alcohol abuse, age, ethnicity, or sex). This
is consistent with EPA's Policy on Children's Health to protect
children from environmental exposures by consistently and explicitly
considering early life exposures and lifelong health in all human
health decisions. The Agency will use its discretion and interpret
``greater exposure'' to potentially include fenceline communities
(e.g., those communities in close proximity to facilities emitting air
pollutants or living near effluent releases to water) or body burden.
Additionally, Congress' inclusion of ``such as'' allows EPA to
potentially identify communities who ``may be at greater risk than the
general population.'' Thus, EPA may evaluate any subpopulation that may
be at greater risk due to greater susceptibility or exposure, and
identify additional subpopulations other than those examples listed in
the statute, where warranted.
To ensure that the TSCA risk evaluations conducted for existing
chemicals fully consider and evaluate the risks to these vulnerable
communities, EPA is proposing to amend the regulatory definition of
``potentially exposed or susceptible subpopulations.'' Specifically,
EPA is proposing to add ``overburdened communities''--communities that
may be disproportionately exposed or impacted by environmental harms--
to the list of example subpopulations. The disproportionality can be as
a result of greater vulnerability to environmental hazards, lack of
opportunity for public participation, or other factors. Increased
vulnerability may be attributable to an accumulation of negative or
lack of positive environmental, health, economic, or social conditions
within these populations or places. The term describes situations where
multiple factors, including both environmental and socio-economic
stressors, may act cumulatively to impact health and the environment
and contribute to persistent environmental health disparities. These
situations may apply to communities with environmental justice
concerns.
EPA's 2017 proposed rule proposed a definition of PESS that
included more examples of PESS than set forth by Congress in the
statutory definition. EPA did not finalize that definition as proposed.
In response to public comments, the Agency explained that ``it would be
difficult for the Agency to list all the potential subpopulations that
the Agency might have reason to include in a risk evaluation'' and that
EPA did not want to imply exclusion of other subpopulations. However,
EPA now believes that it is appropriate to propose the addition of
``overburdened communities'' to the definition of PESS because it
reflects the Agency's understanding and acknowledgment that exposure to
a chemical substance may disproportionately impact communities already
experiencing disproportionate and adverse human health or environmental
burdens. Nothing in TSCA or this proposed rule
[[Page 74307]]
would prevent the Agency from identifying another group or
subpopulation as a ``potentially exposed or susceptible subpopulation''
in a given TSCA risk evaluation and specifically considering those
exposures and risks within.
To identify overburdened communities when conducting a risk
evaluation, EPA will engage the public throughout the TSCA
prioritization and risk evaluation processes, work with EPA offices
such as the Office of Environmental Justice and External Civil Rights
and the Office of Research and Development, and may use available
screening tools, such as EJSCREEN (Ref. 35) or EnviroAtlas (Ref. 36).
These and other tools may also allow the Agency to capture greater
susceptibility or greater exposure using the data layers for
socioeconomic factors (e.g., income/poverty, education) or location
(e.g., housing, employment, geography), and for environmental
indicators (e.g., air toxics cancer risk, respiratory hazard index,
particulate matter levels, ozone, Superfund site proximity, hazardous
waste proximity, proximity to multiple chemical manufacturing or
processing facilities), which may provide information for future
cumulative assessment. EPA also continues to develop approaches for
assessing the risk to overburdened communities. For example, in 2022
EPA submitted for peer review the Screening Level Approach for
Assessing Ambient Air and Water Exposures to Fenceline Communities (Ref
16). This proposed screening level methodology evaluated the potential
chemical exposures and associated potential risks to fenceline
communities, or communities in close proximity, and thus commonly at
greater exposure, to chemical emission sources. The Agency continues to
develop risk evaluation approaches to help determine risk from all
relevant exposure pathways with an emphasis on exposures to these
commonly overburdened communities.
H. Science Policy and Scientific Standards
1. Scientific Guidelines and Procedures
Congress recognized the importance of Agency policies, procedures
and guidance necessary to facilitate implementation of the 2016
amendments to TSCA. (15 U.S.C. 2625(l)(1)). This proposed rule, as does
the 2017 final rule, codifies the use of appropriate Agency guidance in
the development of risk evaluations (proposed Sec. 702.37(a)(1)).
Agency guidance and methodology documents, which may include publicly
available handbooks, frameworks, protocols, or any other process
support documents have long provided process and method transparency to
Agency scientific work products. The appropriateness of the documents
relates to their application in the methods, approaches, and science
policy decisions used in TSCA risk evaluations. For example, the
Exposure Factors Handbook: 2011 Edition (Ref. 10), provides exposure
assessors inside the Agency as well as outside, with data on standard
factors to calculate human exposure to environmental agents. Other EPA
guidance and methodology documents provide background for the
development of the TSCA risk evaluations, specifically the EPA
Guidelines for Carcinogen Risk Assessment (Ref. 37), and the EPA
Supplemental Guidance for Assessing Susceptibility from Early-Life
Exposure to Carcinogens (Ref. 38). EPA will continue to use these and
other existing Agency guidances in the development of TSCA risk
evaluations. EPA may develop and use additional guidance as needed
using a transparent process.
2. Peer Review
Science is the foundation that supports the work of EPA, and this
is equally true for TSCA risk evaluations. The quality and integrity of
the science are vital to the credibility of the Agency's decisions and
processes, including but not limited to the evaluation of risks from
chemicals, determination of whether a chemical presents an unreasonable
risk, decisions on how best to manage that risk, and ultimately the
Agency's effectiveness in pursuing its mission to protect human health
and the environment. One important element in ensuring that decisions
are consistent with the best available science and based on the weight
of scientific evidence is to have an open, transparent and independent
scientific peer review process along with opportunities for public
comment.
EPA has a long-standing history of peer review and has shown its
commitment to peer review in the TSCA program. TSCA section 26(o)
required EPA to establish an advisory committee, known as the Science
Advisory Committee on Chemicals (SACC), to provide independent advice
and expert consultation with respect to the scientific and technical
aspects of issues relating to the implementation of TSCA. EPA expects
to continue to obtain scientific advice and peer review from the SACC.
The 2017 final rule explicitly required peer review to be conducted on
all risk evaluations, which the Agency did for each of the first ten
risk evaluations (Ref. 8). Reports from those peer review committees
proved extremely instructive and resulted in more robust and
scientifically defensible products and improvements to EPA methods used
in the risk evaluation process.
The Agency remains committed to using peer review in the
development of TSCA risk evaluations and any associated methods or
approach type documents and proposes to retain the provision to require
peer review in the risk evaluation process. However, EPA is proposing
some modifications to the language from the 2017 final rule to provide
increased clarity on both the guidance the Agency will use to conduct
peer review and on what peer review will be conducted. First, the
Agency proposes removing the reference to specific versions of guidance
documents. The 2017 final rule names specifically the EPA Peer Review
Handbook 4th Edition 2015 (Ref. 39) and OMB's Information Quality
Bulletin for Peer Review (Ref. 40). While at the time of this proposed
rule these documents were and still are applicable, the Agency
recognizes that these documents may be updated and/or their names
modified and seeks to avoid confusion as to which guidance documents
will be used. The Agency proposes at Sec. 702.41 to refer instead to
``applicable peer review policies, procedures, guidance documents, and
methods adopted by EPA and the Office of Management and Budget (OMB) to
serve as the guidance for peer review activities. EPA interprets
``applicable'' to reference the most current versions and believes this
change will appropriately incorporate any future versions of peer
review guidance documents from both the Agency and OMB (i.e., the EPA
Peer Review Handbook and OMB Final Information Quality Bulletin for
Peer Review).
The peer review guidance documents discussed in this Unit III.H.2.,
as well as their predecessors, provide guidance on all aspects of the
peer review process. This includes guidance on when to conduct peer
review and on what should be considered in selecting the appropriate
peer review approach, including allowable latitude for the type of peer
review that EPA can conduct. In determining the appropriate type of
peer review, EPA can consider the complexity of the information and any
prior peer review of underlying information. EPA has previously used
this flexibility in the TSCA program and sought a letter peer review,
as opposed to, for instance, a committee established under the Federal
Advisory Committee Act (FACA) (5 U.S.C. 10), to peer review new and
updated information used in
[[Page 74308]]
the revised draft risk evaluation for Pigment Violet 29 (Ref. 41).
The Agency fully intends to uphold the EPA Peer Review Policy
Statement, which states in part, ``. . . For highly influential
scientific assessments, external peer review is the expected procedure.
For influential scientific information intended to support important
decisions, or for work products that have special importance in their
own right, external peer review is the approach of choice . . .''
However, as discussed in the EPA Peer Review Handbook 4th Edition,
there are circumstances when the additional peer review of influential
products that have had adequate prior peer review may not be necessary
(Ref. 39). As the Agency looks to the future of TSCA risk evaluations,
it is expected that specific approaches may be used repeatedly, after
due consideration of complexity, novelty, and prior peer review. That
is, there may be situations when repeated peer review is not warranted.
For example, EPA did not peer review the 2020 1,4-Dioxane;
Supplemental Analysis to the Draft TSCA Risk Evaluation (Ref. 42). In
response to peer review of the draft risk evaluation for 1,4-dioxane,
published in September 2019 (Ref. 43), members of the SACC, as well as
public commenters, highlighted omissions in the draft evaluation,
specifically 1,4-dioxane exposures as a byproduct in products and
general population exposure from the surface water pathway. As a
result, those conditions of use from the presence of 1,4-dioxane as a
byproduct in consumer use were included in the scope of a supplemental
analysis to the draft risk evaluation. In that situation, because the
analytical approaches to assessing the unreasonable risk associated
with these conditions of use mirrored those approaches used for the
conditions of use evaluated in the peer reviewed September 2019 draft
risk evaluation and there was not new or novel scientific information
to consider, the Agency determined that additional peer review was not
warranted, but sought public comment on the supplemental analysis.
EPA believes that future risk evaluations and associated analyses
may present similar circumstances for EPA's consideration. Rather than
peer reviewing an entire risk evaluation, in adhering to applicable
guidance, it may be appropriate for EPA to conduct peer review on only
portions or sections that constitute unreviewed influential
information. EPA also expects that a TSCA risk evaluation may use peer
reviewed products (e.g., risk assessments, hazard assessments, models),
or portions thereof, conducted by another EPA office or other
authoritative body (e.g., state, national, or international programs),
for which both the best available science and weight of scientific
evidence standards were adhered to (see Unit III.I.1.). EPA's Peer
Review Handbook specifically references circumstances that may not
necessitate additional peer review including ``work that has been
previously reviewed in a manner consistent with the OMB Peer Review
[Bulletin] and EPA's Peer Review Handbook'' (Ref. 39). Thus, this
portion or section of a TSCA assessment may not need additional peer
review. To this end, EPA proposes to add clarity around what will be
peer reviewed. The 2017 final rule stated that ``the risk evaluation''
will be peer reviewed. The proposed regulatory text at Sec. 702.41
provides EPA's expectation that peer review activities could be
conducted on risk evaluations ``or portions thereof.'' EPA believes
this provides the needed flexibility to conserve Agency resources and
avoid redundant peer review. EPA requests comments on the proposed
changes with respect to peer review, including whether the proposed
addition of ``or portions thereof'' is consistent with OMB and Agency
guidance.
Consistent with the 2017 proposed and final rules, EPA will not
seek peer review of any determination as to whether the risk is
``unreasonable,'' which is an Agency policy determination. Consistent
with OMB and EPA guidance, the purpose of peer review is the
independent review of the science underlying the TSCA risk assessment
not an evaluation of EPA's policy determinations. TSCA expressly
reserves to the Agency the final determination of whether risk posed by
a chemical substance is ``unreasonable.'' (15 U.S.C. 2605(i)). This is
consistent with the statutory purpose of the SACC, ``to provide
independent advice and expert consultation, at the request of the
Administrator, with respect to the scientific and technical aspects of
issues relating to the implementation of this title'' (15 U.S.C.
2625(o)(2)).
I. Scientific Standards
TSCA section 6(h) and (i) require the Agency to make decisions
under TSCA section 6 in a manner that is consistent with the best
available science and based on the weight of scientific evidence.
Specifically, TSCA section 26(h) requires that in carrying out TSCA
sections 4, 5, and 6, to the extent the Agency makes decisions based on
science, the Agency shall ``use scientific information, technical
procedures, measures, methods, protocols, methodologies, or models,
employed in a manner consistent with the best available science.'' The
statute then lists considerations: (1) The extent to which the
scientific information, technical procedures, measures, methods,
protocols, methodologies, or models employed to generate the
information are reasonable for and consistent with the intended use of
the information; (2) The extent to which the information is relevant
for the Administrator's use in making a decision about a chemical
substance or mixture; (3) The degree of clarity and completeness with
which the data, assumptions, methods, quality assurance, and analyses
employed to generate the information are documented; (4) The extent to
which the variability and uncertainty in the information, or in the
procedures, measures, methods, protocols, methodologies, or models, are
evaluated and characterized; and (5) The extent of independent
verification or peer review of the information or of the procedures,
measures, methods, protocols, methodologies or models. Section 26(i)
states ``the Administrator shall make decisions under sections 4, 5,
and 6 based on the weight of scientific evidence.'' TSCA does not
define either ``best available science'' or ``weight of scientific
evidence'' and there is no requirement in the statute to define them by
rule. Codification of definitions has potentially broader impacts
beyond TSCA section 6 risk evaluations and rules, including TSCA
sections 4 and 5 actions, and potentially other applications outside of
TSCA.
EPA received significant comment about the codification of
definitions for these terms during the development of the 2017 proposed
rule (Ref. 1 and Ref. 44). Some commenters noted that it is imperative
that the Agency have specific criteria which would allow for
consistency and transparency for how EPA will implement science. Others
argued that since interested persons may submit risk assessments to the
Agency for consideration (under TSCA section 26(l)(5)), it is necessary
for the Agency to provide a standard and expectation. Many commenters
noted that there are a number of ways the Agency could and has defined
these terms across other statutory obligations and suggested this could
be both a reason to codify TSCA-specific definitions, or to not codify
them to avoid future limitations in implementation approaches. Others
have argued that the risk evaluation rule should be reserved for
process and procedure, and that codification of
[[Page 74309]]
specific process definitions would limit the Agency's ability to adapt
to the changing science of risk evaluation, as well as the science that
informs risk evaluation. Further, some argued that defining the terms
would limit the flexibility afforded the Agency, and arguably the
mandate, to implement and advance novel science.
EPA determined not to propose codifying definitions of either of
these terms in the 2017 proposed rule (Ref. 9 at p. 7572), citing the
need to remain flexible to changing science and approaches. The Agency
argued at that time that further defining these terms was unnecessary
and ultimately problematic. EPA noted that these terms have and will
continue to evolve with changing scientific methods and innovation, and
Agency guidance does and will provide the necessary description and
processes to ensure consistency and transparency (Ref. 9 at p. 7572).
Ultimately, EPA did codify definitions for both of these terms in the
final rule, explaining that codification of these definitions would
instill confidence, increase transparency, predictability, and provide
the public with assurance that EPA will adhere to the requirements of
the statute (Ref. 1 at p. 33731). EPA is proposing to eliminate the
following definitions from the regulatory text for the reasons
described in Units III.H.1. and 2.
1. Best Available Science
In the 2017 final risk evaluation rule, the Agency defined best
available science as science that is reliable and unbiased, and
described the use of best available science as involving the use of
supporting studies conducted in accordance with sound and objective
science practices, including, when available, peer reviewed science and
supporting studies and data collected by accepted methods or best
available methods (if the reliability of the method and the nature of
the decision justifies use of the data). The definition also identified
other considerations as applicable, including the extent to which:
The scientific information, technical procedures,
measures, methods, protocols, methodologies, or models employed to
generate the information are reasonable for and consistent with the
intended use of the information;
The information is relevant for the Administrator's use in
making a decision about a chemical substance or mixture;
The degree of clarity and completeness with which the
data, assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
The variability and uncertainty in the information, or in
the procedures, measures, methods, protocols, methodologies, or models,
are evaluated and characterized; and
There is independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
In general, EPA continues to believe this current definition of
``best available science'' is aligned with the Agency's views and the
science requirements in TSCA section 26(h). The first part of this
definition originated from the Safe Drinking Water Act (SDWA) (42
U.S.C. 300f et seq.) (Ref. 45), and second part of the definition is
drawn verbatim from the considerations listed in TSCA section 26(h)(1)
through (5). SDWA adopted a basic standard of quality for the use of
science in agency decision making. Under 42 U.S.C. 300g-1(b)(3)(A), the
Agency is directed, ``to the degree that an Agency action is based on
science,'' to use ``(i) the best available, peer-reviewed science and
supporting studies conducted in accordance with sound and objective
scientific practices; and (ii) data collected by accepted methods or
best available methods (if the reliability of the method and the nature
of the decision justifies use of the data).'' The mandate to use the
best available science with considerations enumerated in TSCA section
26(h) closely mirrors these requirements. Specifically, TSCA section
26(h)(5) refers to verified and peer reviewed science and scientific
methods, and TSCA sections 26(h)(1) though (4) refer to the important
considerations for the Agency when identifying and using data in a risk
evaluation. This further comports with SDWA's quality standard for the
dissemination of public information about risks of adverse health
effects (42 U.S.C. 300g-1(b)(3)(B)).
The precedent-setting standards in SDWA are further discussed in
the OMB Information Quality Guidelines. These guidelines ``provide
policy and procedural guidance to Federal agencies for ensuring and
maximizing the quality, objectivity, utility, and integrity of
information (including statistical information) disseminated by Federal
agencies'' (Pub. L. 106-554; 114 Stat. 2763A-153 through 2763A-154).
The Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity, of Information Disseminated by the
Environmental Protection Agency (Ref. 46, also referred to as EPA's
Information Quality Guidelines) contain EPA's policy and procedural
guidance for ensuring and maximizing the quality of information
disseminated in Agency work products. Section 6.4 of EPA's Information
Quality Guidelines discuss how the Agency ensures and maximizes the
quality of information used in risk assessment and specifically adopts
the SDWA quality principles. EPA's Information Quality Guidelines go on
to say: ``In applying these principles, `best available' usually refers
to the availability at the time an assessment is made. However, EPA
also recognizes that scientific knowledge about chemical risk is
rapidly changing and that risk information may need to be updated over
time.'' In general, EPA believes the SDWA definition of ``best
available science'' and the associated guidelines and policies are all
aligned with the science requirements enumerated in TSCA section 26(h).
However, EPA believes that codifying a definition of ``best
available science'' in the Risk Evaluation procedural rule is
unnecessary and potentially problematic as it could limit the Agency's
ability, flexibility, and mandate to incorporate the best available
science into TSCA risk evaluations. As such, EPA is proposing to
eliminate the definition of ``best available science'' from Sec.
702.33. EPA specifically requests public comment on the proposed
elimination of the definitions, the need for such definitions, and the
utility of definitions as the state of science evolves. As discussed
previously, EPA believes the specifics of that definition are already
reflected in the TSCA requirements and considerations for applying the
best available science in section 26(h), and in the Agency's policies
and procedural guidance. These considerations are also replicated in
the proposed regulatory text at Sec. 702.37(a)(2). The Agency does not
believe codifying a definition of ``best available science'' provides
any additional transparency or improves consistency.
Furthermore, while the use and consideration of ``best available
science'' is discussed at length in both EPA and other Federal agency
guidance documents, the definition is not codified in other Agency
rulemakings. EPA believes that a specific definition should not be
codified in this rulemaking. Under proposed Sec. 702.37(a)(1), the
Agency would use appropriate Agency guidance in the development of the
TSCA risk evaluations. TSCA section 26(l) requires the Agency to use
and develop guidance documents that are necessary in carrying out the
statute. TSCA further requires the revisions of guidance
[[Page 74310]]
documents as necessary to ``reflect new scientific developments and
understandings.'' Reliance on Agency guidance for determining the
``best available science'' in TSCA risk evaluations ensures the desired
transparency and consistency, while still allowing for more nimble
adaptation over time.
As the Agency identifies reasonably available information to inform
a TSCA risk evaluation of a given chemical, EPA may consider existing
risk assessments, or reviews performed on the chemical in question to
be the best available science. This may include assessments conducted
by EPA that adhere to existing Agency Guidance, use methodologies that
have been externally peer reviewed, and undergo public comment.
Similarly, the Agency may also look to consider assessments or portions
of assessments conducted by other United States or international
authoritative bodies. EPA may consider these existing assessments or
reviews to represent the best available science as required under TSCA
and use portions of them to directly inform a risk evaluation.
2. Systematic Review and Fit-for-Purpose Systematic Approaches
The 2017 final risk evaluation rule defined weight of scientific
evidence (WOSE) as used in TSCA to include the use of a ``systematic
review method'' with a ``pre-established protocol'' to ``identify and
evaluate each stream of evidence.'' In turn, in implementation of this
regulatory requirement, EPA has previously viewed this definition as
requiring the Agency to conduct systematic review according to a
protocol on each evidence stream. The first method used was the 2018
Application of Systematic Review in TSCA Risk Evaluations (Ref. 47).
This method was reviewed by the National Academies of Science,
Engineering, and Medicine (NASEM) and the study report published in
2021, The Use of Systematic Review in EPA's Toxic Substances Control
Act Risk Evaluations (Ref. 48), included several opportunities and
recommendations to improve EPA's systematic review process. In response
to recommendations made by the NASEM, as well as comments received from
the TSCA SACC and the public during the review of the first ten risk
evaluations, EPA significantly updated the TSCA systematic review
process and developed a systematic review protocol. The draft TSCA
Systematic Review Protocol (Ref. 49) replaced the Application of
Systematic Review in TSCA Risk Evaluations. As described in Unit
III.I.3., EPA is proposing changes to the WOSE definition to ensure
that the concepts and principles of systematic review and WOSE are used
in the evaluation of existing chemicals and are appropriately
considered separately.
TSCA risk evaluations use reasonably available information to draw
the conclusions that are supported by the best available science.
Reasonably available information is identified and evaluated through
unbiased, transparent and objective data collection and data
evaluation, using systematic review methods. EPA believes that
integrating appropriate and applicable systematic review methods and
approaches into the TSCA risk evaluations are critical to meet the
scientific standards as described in TSCA section 26(h). A systematic
review approach to data collection and data evaluation provides more
complete information than an informal or unstructured review and can
reduce bias in data selection (Ref. 49). The principles of systematic
review collection and evaluation of data and information have been well
developed in the context of evidence-based medicine (e.g., evaluating
efficacy in clinical trials) and more recently have been adapted for
use across a more diverse array of scientific fields. A 2014 report by
the National Research Council (NRC) describes systematic review as ``a
scientific investigation that focuses on a specific question and uses
explicit, pre-specified scientific methods to identify, select, assess,
and summarize the findings of similar but separate studies'' (Ref. 50).
There are also well-established principles of systematic review like
``transparent and explicitly documented methods, consistent and
critical evaluation of all relevant literature, application of a
standardized approach for grading the strength of evidence, and clear
and consistent summative language'' (Ref. 50). Systematic review
includes performing--as described and documented in a protocol--a
methodical literature search, collection and screening, followed by
data quality evaluation (addressing factors such as relevancy and
bias), extraction, and integration, using a defined protocol, that can
be applied across multiple lines of evidence. Any systemic approach EPA
uses will follow this process.
The TSCA program will also continue to work with partners including
EPA's Office of Research and Development (ORD), the Office of Pesticide
Programs, and the Office of Water (OW) to advance and implement tools,
methods, and efficiencies to systematically collect and evaluate
literature. The procedures required for ensuring objectivity,
transparency and no bias in the collection and review of data for TSCA
risk evaluations must be flexible enough to account for the diversity
of both hazard and exposure information necessary to inform TSCA risk
evaluations, and implementable within the statutory deadlines. EPA will
continue to develop and evolve its systematic approaches to data
collection and evaluation for use in TSCA risk evaluations to meet
these goals. EPA will continue to use the principles and tools outlined
in the draft TSCA Systematic Review Protocol (Ref. 49), but the Agency
will move to implement more chemical specific approaches that are more
flexible and relevant for the types and quantity of information used in
an individual risk evaluation. As such, systemic review approaches must
be commensurate with the relevant complexity of the assessment and
nature of the information available, and carried out in a manner that
permits completion within the timeframes that Congress provided. EPA
will look to streamline chemical-specific protocols and approaches
while remaining consistent with systematic review principles. These
systematic approaches will be transparent, fit-for-purpose, and
specific to the needs of each chemical/category, while better aligning
with the schedules for completion of the risk evaluation. The Agency is
also exploring how to leverage consideration of systematic reviews and
systematic review approaches from other EPA offices and authoritative
bodies, or portions thereof, to achieve greater efficiencies in the
process. Ultimately, application of systematic review and/or systematic
approaches are necessary to help EPA identify useful evidence, inform
judgments as to the ``best available science'' and ``weight of
scientific evidence'' (WOSE), and can transparently support risk
evaluations that are both scientifically robust and defensible.
3. Weight of Scientific Evidence
In the 2017 Final Rule, EPA defined the WOSE as ``a systematic
review method, applied in a manner suited to the nature of the evidence
or decision, that uses a pre-established protocol to comprehensively,
objectively, transparently, and consistently identify and evaluate each
stream of evidence, including strengths, limitations, and relevance of
each study and to integrate evidence as necessary and appropriate based
upon strengths, limitations, and relevance.'' 40 CFR 702.33. The Agency
believes this definition is problematic and inconsistent with typical
risk assessment practice and is therefore proposing to eliminate the
definition
[[Page 74311]]
from the regulatory text--instead relying on long-established Agency
guidance documents to guide weight of scientific evidence analyses
under TSCA.
The 2017 final rule conflates WOSE (also referred to as weight of
evidence (WOE)) and systematic review. This conflation was identified
and best described by NASEM's review of EPA's publication titled
Application of Systematic Review in TSCA Risk Evaluations (Ref. 47). In
their study report, The Use of Systematic Review in EPA's Toxic
Substances Control Act Risk Evaluations (Ref. 48), the NASEM reviewers
state ``this definition of WOE seems to say that the TSCA systematic
review is itself a WOE evaluation. As such, the agency's legal
obligation to conduct a WOE evaluation is fulfilled by the fact that
systematic review is the basis for TSCA evaluations.'' The NASEM
Committee goes further describing the confusion that results when the
WOSE is used at one stage of the systematic review process to integrate
the strength of the evidence judgment for each individual evidence
stream into an overall conclusion for a health endpoint, whereas under
the WOSE definition, the systematic review process itself is a weight
of scientific evidence evaluation (Ref. 48). Throughout the report, the
Committee notes the conflation of terms and goes on to suggest that
changing the definition of WOSE within the risk evaluation procedural
rule may alleviate the terminology confusion (Ref. 48).
In developing this proposed rule, the Agency reviewed several
alternative definitions or descriptions of WOSE or WOE. It is clear
there are certain principles of WOSE that are universal, including
foundational considerations such as objectivity and transparency. The
phrase WOSE or WOE is used by EPA and other scientific bodies to
describe the strength of the scientific inferences that can be drawn
from a given body of evidence, specifically referring to the quality of
the studies evaluated, and how findings are assessed and integrated.
EPA broadly uses the WOSE approach in many existing programs and has
described the application of WOSE in Agency guidelines used to classify
carcinogens. In the 2005 Guidelines for Carcinogen Risk Assessment
(Ref. 37), EPA refers to the WOE approach as ``. . . a collective
evaluation of all pertinent information so that the full impact of
biological plausibility and coherence is adequately considered.'' The
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC)
referred to the WOE approach as ``. . . a process by which trained
professionals judge the strengths and weaknesses of a collection of
information to render an overall conclusion that may not be evident
from consideration of the individual data'' (Ref. 51). EPA believes
WOSE inherently involves application of professional judgment, in which
the significant issues, strengths, limitations of the data,
uncertainties, and interpretations are presented and highlighted.
As noted by the National Academies of Science, ``because scientific
evidence used in WOE evaluations varies greatly among chemicals and
other hazardous agents in type, quantity, and quality, it is not
possible to describe the WOE evaluation in other than relatively
general terms'' (Ref. 23). EPA does not believe that even an
alternative codified definition would add additional transparency or
certainty to the required use of WOSE in TSCA risk evaluations.
Additionally, the Agency believes that codifying a specific definition
would inhibit the flexibility of the Agency to quickly adopt and
implement changing science to ensure that each risk evaluation is fit-
for-purpose to the chemical under review. As such, EPA is proposing to
remove the current codified definition of weight of scientific
evidence. The Agency welcomes comment on this approach.
EPA will instead rely on established Agency guidance documents to
guide the required application of WOSE in TSCA risk evaluations. At
this time, EPA will primarily look to four documents for implementing
WOSE in TSCA risk evaluations: 2016 Weight of Evidence in Ecological
Assessment (Ref. 52), Guidelines for Carcinogen Risk Assessment (Ref.
37), 2011 Endocrine Disruptor Screening Program Weight-of-Evidence:
Evaluating Results of EDSP Tier 1 Screening to Identify the Need for
Tier 2 Testing (Ref. 53), and 2022 ORD Staff Handbook for Developing
IRIS Assessments (Ref. 54). These documents all similarly describe the
WOSE assessment as based on the strengths, limitations, and
interpretation of data available, information across multiples lines of
evidence and how these different lines of evidence may or may not fit
together in drawing conclusions. The results from the scientifically
relevant published or publicly available peer-reviewed studies, gray
literature, or any other studies or lines of evidence which are of
sufficient quality and reliability, are evaluated across studies and
endpoints into an overall assessment. WOSE assessments examine multiple
lines of evidence considering a number of factors, including for
example the nature of the effects within and across studies, including
number, type, and severity/magnitude of effects and strengths and
limitations of the information. A summary WOSE narrative or
characterization accompanies the detailed analysis and is intended to
transparently describe the conclusion(s) and reasoning behind it/them.
Specifically, the narrative or characterization generally explains the
selection of the studies or effects used as the main lines of evidence
and relevant basis for conclusions, and describes the overall strength
of the evidence supporting a conclusion from the WOSE assessment.
J. Process for EPA Revisions To Scope or Risk Evaluation Documents
EPA is proposing some new procedures and criteria for whether and
how EPA would endeavor to revise or supplement final scope documents,
and draft or final risk evaluations. The 2017 final rule does not
provide any such criteria or procedures. The proposed procedures
provide greater certainty and transparency for stakeholders.
Additionally, given the tens of thousands of existing chemical
substances in commerce and EPA's responsibility to assess and manage
risks from those chemicals through a statutory deadline-driven pipeline
of prioritization, risk evaluation and risk management activities, EPA
believes that some guardrails are necessary to ensure that the Agency
continues to make forward progress on existing chemicals as Congress
intended. Continuously revisiting final risk evaluations would drain
the Agency's already limited resources and divert attention from other
chemicals actively in the prioritization, risk evaluation or risk
management phases. The criteria and procedures in this proposed rule
would serve the law's purpose to move chemicals through the process
within the statutory deadlines, and allow the Agency to move on to
evaluating another high-priority substance, consistent with TSCA
section 6(b)(3)(C).
Specifically, with respect to final scope documents, EPA is
proposing that subsequent changes--if any--to the scope of the risk
evaluation after publication of the final scope be reflected and
described in the draft risk evaluation instead of a revised final scope
document. EPA believes that, moving forward, any changes to the scope
of the risk evaluation after publication of a final scope document are
likely to be minimal based on the improved processes proposed in this
NPRM, and EPA's expected rulemaking to implement a tiered data
collection strategy to better inform data needs for prioritization and
risk evaluation
[[Page 74312]]
candidates (Ref 57). However, in the event that changes to the risk
evaluation scope during that period are more significant, EPA
recognizes that public notice of those changes might be warranted. The
proposal contemplates that EPA could, in its discretion, publish a
notice in the Federal Register notifying the public that EPA has made
information regarding changes to the risk evaluation scope available in
the docket before releasing the draft risk evaluation.
Likewise, EPA is proposing to refrain from reissuing draft risk
evaluations in a second draft form. Draft documents are, by their
nature, subject to change. Rather than spending time and resources to
develop and issue a revised draft risk evaluation, EPA instead expects
to reflect and describe any changes to the draft document in the final
risk evaluation. Where changes from draft to final are significant in
nature, nothing in the proposed rule would prevent EPA from seeking
additional advice or feedback from its independent scientific advisors
or additional public comment on relevant topics, provided that such
actions can be completed within the timeframes Congress contemplated
for TSCA risk evaluations. This proposed clarification to the Agency's
process ensures that feedback is appropriately considered and reflected
without unduly delaying progress towards completion of the risk
evaluation.
EPA is proposing a general practice for how and when to revisit
final risk evaluations, and certain exceptions to that practice. As
general practice, where circumstances warrant revisiting a chemical
risk evaluation that has already been finalized--which EPA believes are
likely to be infrequent--the Agency may identify that chemical as a
potential candidate for high-priority designation, and follow the
procedures at 40 CFR part 702, subpart A. EPA believes that this
general practice aligns with Congress' intent for the Agency to work
systematically through the universe of existing chemicals within the
statutory framework and aggressive deadlines associated with
prioritization, risk evaluation and risk management. (15 U.S.C.
2605(b)(2)(C) and (b)(4)(G)). Revisiting risk evaluations outside of
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.
Nevertheless, there may be certain circumstances where revisions to
a final risk evaluation outside of re-prioritization of a chemical are
in the interest of protecting human health and the environment. For
example, as announced on June 30, 2021, EPA is revisiting the first 10
final risk evaluations to ensure they followed the science and EPA's
renewed understanding of the law, and determined a path forward on a
case-specific, chemical-by-chemical basis (Ref. 7). The outcome of
those risk evaluations, which may have underestimated risks based on,
among other things, policies of excluding certain conditions of use and
entire exposure pathways from assessment, warranted this action.
Although changes proposed in this NPRM should prevent the types of
issues that justified reanalysis of the first ten chemical risk
evaluations, the same principle--the need to revise a final risk
evaluation to protect human health and the environment--might apply to,
for example, a scientific error that meaningfully impacts the
evaluation or the Agency's ability to appropriately address risks
through rulemaking.
Where EPA endeavors to revise or supplement a final risk evaluation
outside of re-prioritization, the proposed rule further requires EPA to
follow the same process and requirements for TSCA risk evaluations
described in this proposed rule, including publication of a new draft
and final risk evaluation, solicitation of public comment, and, as
appropriate, peer review.
K. Process and Requirements for Manufacturer-Requested Risk Evaluations
EPA is proposing a number of changes to the process and
requirements for manufacturers to request a risk evaluation. TSCA
section 6(b)(4)(C)(ii) allows a manufacturer or group of manufacturers
to request that the Agency conduct a risk evaluation of a chemical
substance (or category of substances) that they manufacture. TSCA
section 6(b)(4)(C)(ii) directs EPA to establish the ``form . . . manner
and . . . criteria'' for such requests by rule, which the Agency
finalized in 2017. Based on experience in implementing that process to
date, EPA is proposing some modifications to increase clarity and to
better position the Agency to carry out manufacturer-requested risk
evaluations (MRREs) moving forward.
The current process for MRREs, laid out in 40 CFR 702.37, has been
challenging for EPA in a number of ways. First, the 2017 final rule
allows requests to contain information relevant only to conditions of
use of the chemical that are of interest to the requesting manufacturer
(40 CFR 702.37(b)(3)). Within a relatively short time after receiving a
request, EPA must either grant or deny the request (40 CFR
702.37(e)(6)). By ``granting'' an MRRE request under the current
regulations, EPA is acknowledging that it has all the information it
needs to conduct the evaluation, creating some ambiguity as to whether
additional information can be gathered during the process, including
through use of EPA's TSCA section 4 or 8 authorities. The process
effectively leaves the Agency with the heavy burden of identifying the
remaining conditions of use, reviewing information that came in with
the request, obtaining and reviewing additional available literature,
and determining any missing information or data needs--all within a
matter of months. The current process also provides that upon granting
the request, EPA will initiate the risk evaluation, triggering the
start of the three-year statutory deadline to complete the activity (40
CFR 702.37(e)(10)).
EPA has found that this process is unrealistic. In addition to
needing more fulsome information included in incoming requests, and
additional time to properly review requests and determine any
additional information needs prior to initiating the evaluation, EPA
also needs some flexibility in the process to pursue data collection or
development during the risk evaluation. In general, EPA believes that
the process and timeframes for reviewing incoming MRRE requests should
be more akin to the process and timeframes that precede EPA-initiated
risk evaluations. When considering whether a chemical is a good
potential candidate for prioritization--including the chemical's
readiness for evaluation from a data perspective--EPA has a significant
amount of time to review and analyze available information, identify
data gaps and needs, and pursue various data gathering strategies. On
top of that, the prioritization process itself provides an additional 9
to 12 months and two 90-day public comment periods to help the Agency
refine its approach and deepen its understanding of the chemical--all
before initiating the risk evaluation and the associated deadlines.
The proposed rule is intended to address these challenges. Units
III.K.1. through 4. Describe the key proposed changes to the process
for MRREs, and EPA's expectations for implementation moving forward:
[[Page 74313]]
1. Submission of MRRE
The law allows for submission of a MRRE by one or more
manufacturers of a chemical substance, and both the current and
proposed rule maintain that requirement as part of the regulatory text.
However, in cases where multiple manufacturers jointly submit a MRRE
(i.e., a consortium), EPA expects to treat a consortium as a single
entity for purposes of any regulatory determinations with regard to the
requests, fee payments, and other general communication regarding the
MRRE request and/or the risk evaluation. Joint submitters must
designate a single point of contact for Agency engagement, and are
otherwise collectively responsible for providing complete and
sufficient information to the Agency to support the risk evaluation.
2. Scope of Request
Currently, the rule allows manufacturers to request a risk
evaluation on particular conditions of use of interest, leaving the
Agency with the heavy burden of identifying the remaining conditions of
use. EPA is proposing that manufacturers only be permitted to make
requests for evaluations of entire chemical substances--not individual
conditions of use or subsets of conditions of use. In addition to
better aligning with the statutory language in TSCA section 6(b)(4)(C)
(stating that EPA ``shall conduct and publish risk evaluations . . . on
a chemical substance . . .'') and the scope of EPA-initiated risk
evaluations, EPA believes this clarification will also encourage more
robust, well-crafted submissions and better position the Agency for
success in carrying out the evaluations. EPA recognizes that a
requesting manufacturer may not have access to all necessary
information to support the risk evaluation, and, as described in Unit
III.K.4, EPA is also proposing a process to address these shortcomings.
However, the proposed clarification regarding scope--along with changes
described in Unit III.K.3.--would ensure no misgivings about the scope
of MRREs and the information needed to support those requests in order
for the Agency to undertake a risk evaluation.
3. Contents of Request
EPA is also proposing some key changes to the supporting
information that must be included in a MRRE request. As a general
matter, EPA believes that the requesting manufacturer(s) should bear
the primary burden of providing EPA with all information necessary to
conduct a risk evaluation on the chemical substance. Congress also
shared this sentiment in section 2 of TSCA, stating that ``adequate
information should be developed with respect to the effect of chemical
substances and mixtures on health and the environment and that the
development of such information should be the responsibility of those
who manufacture and those who process such chemical substances and
mixtures.'' 15 U.S.C. 2601(b). Within respect to MRRE requests,
Congress authorized EPA to establish the ``form . . . manner and . . .
criteria'' for such requests in order to support successful
implementation. (15 U.S.C. 2605(b)(4)(C)). The 2017 final rule's
allowance for the requesting manufacturer(s) to only provide supporting
information relevant to their preferred conditions of use
inappropriately shifts much of the information gathering burden to the
Agency. Instead, EPA believes, as discussed in Unit III.K.2., based on
TSCA's statutory text and structure, that MRRE requests should attempt
to identify all intended, known and reasonably foreseen circumstances
of the chemical's manufacture, processing, distribution in commerce,
use and disposal, and provide all available information regarding the
chemical's hazards and exposures--not just information of relevance to
the submitter's interests. As such, EPA is proposing changes that would
require more fulsome information as part of the request, based on
information that is known to or reasonably ascertainable by the
requesting manufacturer.
More specifically, EPA is proposing to require that manufacturers
include a listing of the chemical's conditions of use (i.e., the
circumstances under which the chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of), and all information known to or
reasonably ascertainable by the requesting manufacturer that supports
the identification of those circumstances. While EPA must ultimately
determine the chemical's conditions of use for purposes of the risk
evaluation, this requirement ensures a reasonable level of due
diligence on the part of the requesting manufacturer to gather
available information and provide it to EPA. Similarly, EPA is also
proposing that incoming requests include ``all information known to or
reasonably ascertainable by the requesting manufacturer on the health
and environmental hazard(s) of the chemical substance, human and
environmental exposure(s), and exposed population(s).'' The proposed
rule also provides some clarifications as to the specific types of
information that must be included as part of the request. Under the
2017 final rule, requesting manufacturers are required to provide this
information only where relevant to the particular uses of interest,
leaving EPA with significant work not just to identify the remaining
conditions of use, but also to locate and review available literature
and quickly determine whether there is sufficient information to carry
out a risk evaluation. The proposed changes put more of this
responsibility on the requesting manufacturer. EPA believes that
requesting manufacturers should be making a reasonable amount of effort
to gather all available information on the chemical--whether that
information is available to the general public, or otherwise available
to the manufacturer--and compile it for the Agency's review as part of
an MRRE.
Information that is known to or reasonably ascertainable by the
manufacturer would include all information in a person's possession or
control, plus all information that a reasonable person similarly
situated might be expected to possess, control, or know. The standard
requires an exercise of due diligence, and the specific information-
gathering activities that may be necessary for manufacturers to achieve
this standard may vary from case-to-case. In the context of preparing a
MRRE request and to meet the requirements in the proposed rule at Sec.
702.45(c), EPA believes that due diligence would, at a minimum, involve
a thorough search and collection of publicly available information on
the chemical's hazards, exposures and conditions of use. EPA would
further expect that requesting manufacturers conduct a reasonable
inquiry not only within the full scope of their organization regarding
manufacturing processes and products (including imports), but also
outside of their organization to fill gaps in knowledge. For example,
such activities might include inquiries to upstream suppliers or
downstream users or employees or other agents of the manufacturer,
including persons involved in the research and development, import or
production, or marketing for information pertinent to the criteria
listed in the proposed rule.
EPA nonetheless still anticipates that manufacturers may not be in
a position to provide the Agency with all the information necessary to
complete the risk evaluation. EPA received comments
[[Page 74314]]
on the original 2017 proposed rule, for example, that manufacturers who
do not produce the chemical for a particular use may not be able to
obtain information pertaining to that use. To address this issue, EPA
is proposing a process described further in Unit III.K.4. to formalize
how such shortcomings will be identified and addressed. In short, where
the requesting manufacturer is unable to provide all the information
EPA needs for risk evaluation, the requesting manufacturer can request
EPA use its information collection authorities under TSCA sections 4
(require manufacturers (including importers) or processors to test
chemicals and report their findings), 8 (require reporting on chemical
manufacturing, processing, and use, or require the submission of
unpublished chemical health and safety information from manufactures
(including importers), processors, or distributors), or 11 (ability to
inspect facilities where chemicals are manufactured, processed, stored,
or held before or after their distribution in commerce), to fill in the
gaps. Where the information need is identified after the risk
evaluation has already been initiated, the requesting manufacturer must
also suspend its request to allow sufficient time for the Agency to
exercise those authorities. These changes set clearer expectations for
what EPA needs to undertake in a risk evaluation, and establish a
process for productive engagement with requesting manufacturers toward
meeting those needs.
4. EPA Process for Reviewing Requests
EPA is proposing a number of changes to how the Agency will review
MRREs. As described in this Unit, the current process simply does not
allow enough time for thoughtful review of requests and consideration
of potential information needs. As such, at Sec. 702.45(e) of the
regulatory text, EPA is proposing changes to the steps the Agency will
take upon receipt of a MRRE, including additional measures for
transparency and public engagement. The following is a general
description of the proposed procedural steps:
Notice of Receipt. EPA will provide the public with notice within
15 days that a MRRE has been received. Although the proposed rule does
not specify the means of notice, EPA expects to generally do so through
updates to its website and email listserv notifications.
Initial Review for Completeness. EPA will then begin reviewing the
request and supporting information against the requirements in the
proposed rule to determine whether or not the request appears complete.
Requests that are clearly missing key required information in Sec.
702.45(c) or are otherwise not well-supported will be rejected and
returned to the submitter as incomplete. For example, EPA would
consider a request for evaluation of category of chemicals incomplete
where the request does not provide a rationale as to why the
categorization is appropriate under TSCA section 26(c). Likewise, where
a request fails to describe the circumstances related to the full
lifecycle of the chemical substance (i.e., manufacture, processing,
distribution in commerce, use and disposal) or to provide an
explanation as to why such information is unavailable to the requestor,
EPA may reject the request as incomplete. During this step, EPA may
also make an initial judgment as to the quality or quantity of
information provided by the requesting manufacturer(s) and the
sufficiency of that information to support a risk evaluation. Where the
information is generally of poor quality, or when very little
information is provided, EPA may also reject the request.
This initial review step allows the Agency to screen incoming
requests before advancing to the more time- and resource-intensive
steps associated with reviewing a MRRE. Where EPA determines a request
to be incomplete, the requesting manufacturer can simply supplement and
resubmit the request. Where EPA initially determines the request to be
complete, EPA will advance to the next step in the process: public
notice and opportunity for comment.
Public Notice and Comment. Where EPA initially determines the
request to be complete, EPA will submit a notice of receipt of the MRRE
for publication in the Federal Register within 90 days. EPA will also
open a docket that includes all non-CBI and CBI-sanitized information
included in the request and provide no less than a 60-day public
comment period. EPA may also solicit specific comments on the request,
including feedback on the conditions of use listed by the manufacturer
in the request and information regarding sufficiency of available
information to support a risk evaluation.
Secondary Review for Sufficiency. From the start of the public
comment period, EPA would expect to begin conducting a more in-depth
review of the request to determine whether there is sufficient
information to support a reasoned evaluation on the chemical substance.
Concurrently, EPA expects to conduct an internal cursory review of
other reasonably available information, however more comprehensive
information collection would occur post-granting of the request. For
EPA-initiated risk evaluations, EPA has clearly indicated that it would
not expect to initiate the prioritization process until there is
sufficient information to complete both the prioritization and risk
evaluation processes. Likewise, EPA would not expect to grant an MRRE
until confident that there is a similar level of information to support
evaluation. As described in the proposed rule, EPA may determine that
certain information gaps can be addressed through application of
assumptions, uncertainty factors, models, and/or screening, consistent
with TSCA section 26, without the need for additional data. EPA's
review during this period would encompass both the information provided
with the request and any additional relevant information that may be
uniquely available to EPA (e.g., TSCA CBI data that may not otherwise
be known to or reasonably ascertainable by the requesting
manufacturer). Following the close of the public comment period, EPA
will further consider feedback from the public as to the sufficiency of
available information. For example, if public comments indicate there
are additional conditions of use, and the request does not identify or
provide information relevant to those conditions of use, EPA may deem
the request insufficient and return to the submitter for further
consideration and possible supplementation.
EPA may also determine during this period whether there are
deficiencies in the request, including data quality considerations, not
identified during EPA's initial review for completeness. EPA's review
for sufficiency will be completed within 90 days from the end of the
public comment period. For requests determined not to be supported by
sufficient information during this period, EPA will reject the
request--effectively ending the Agency's review--and notify the
requesting manufacturer. EPA generally expects to keep the public
apprised of the status of requests through updates to its website. The
requesting manufacturer would have the opportunity to further
supplement and resubmit their request to EPA. Additionally, where the
submitter believes that the information is not reasonably ascertainable
by them, they can include in their resubmission a request--as described
in this Unit--that EPA exercise its information gathering authorities
to collect and/or develop information necessary to remedy the
deficiency. For requests
[[Page 74315]]
determined to be supported by sufficient information, EPA will proceed
with granting the request and continuing the review process.
Grant. As described elsewhere in this Unit III.K.4., and subject to
the percentage limitations in TSCA section 6(b)(4)(E)(i)(II), EPA will
grant MRRE requests that are both complete and supported by sufficient
information. Under the 2017 final rule, a ``grant'' of a MRRE request
effectively means that EPA has determined it has all information needed
to conduct such risk evaluation. While EPA intends to make every effort
to ensure sufficient information before granting a MRRE request,
absolute certainty is not possible. Given the nature of risk assessment
and public processes associated with TSCA risk evaluations, there may
be occasion where EPA becomes aware of critical information needs later
in the process. As such, the proposed rule specifically reserves the
right for EPA to identify additional information needs for the risk
evaluation at any time, including after granting the MRRE request.
Publication of Draft Conditions of Use and Request for Information.
EPA will next publish a notice in the Federal Register that sets out,
in draft form, the Agency's preliminary determination on the chemical's
conditions of use, taking into account information provided in the MRRE
request, information received during the first public comment period,
and EPA's own further review efforts. This notice will request relevant
information from the public, and provide no less than a 60-day public
comment period. Given that a chemical's conditions of use are such an
important component to define the scope of the risk evaluation, EPA
felt it was important to share its understanding and provide an
opportunity for additional feedback before formally initiating the
MRRE. In the context of EPA-initiated risk evaluations, EPA expects
this engagement to occur during the prioritization process, and,
similarly, before the formal initiation of the risk evaluation and
start of the statutory deadline for completion. Within 90 days
following the close of the public comment period in this paragraph, and
depending on the nature of comments received, EPA will either initiate
the risk evaluation or notify the requesting manufacturer of any
additional information needs.
Initiation of Risk Evaluation. Upon initiation of the MRRE, EPA
will follow all requirements in this proposed rule including but not
limited to proposed sections 702.37 through 702.49. EPA will notify the
manufacturer that the MRRE has been initiated, and similarly expects to
keep the public apprised of the status through updates to its website.
As indicated previously, EPA is reserving the right to identify
additional information needs at any time during the risk evaluation
process, including post-initiation.
Identification of Information Needs. Where additional information
needs are identified at any time before the MRRE has been granted, the
proposed rule provides a clear process for supplementation and
resubmittal of the request. However, where additional information needs
are identified at any point following EPA's grant of the MRRE, EPA will
notify the requesting manufacturer(s) and set a reasonable amount of
time, as determined by EPA, for manufacturers to respond to the
Agency's notice. In response to EPA's notice, the manufacturer can
choose to (1) provide the necessary information to EPA, (2) if the risk
evaluation has not yet been initiated, withdraw the MRRE request, or
(3) request that EPA obtain the information using authorities under
TSCA sections 4, 8 or 11.
Where a manufacturer chooses to provide--or develop and provide--
the necessary information, EPA will set a reasonable amount of time for
the requesting manufacturer to provide that information to EPA. Upon
receipt of the new information, EPA will review the information within
90 days and determine whether or not it satisfies the identified need--
again providing notice to the requesting manufacturer of its
determination, and keeping the public apprised of the status of the
MRRE on its website. EPA would further endeavor, to the extent
possible, to make the supplemental information publicly available in
the docket.
Alternatively, in the event the risk evaluation has not yet been
initiated, the requesting manufacturer may withdraw the MRRE request.
This option gives the requesting manufacturer some flexibility in the
event that developing the necessary information would be considered too
costly or time consuming. Any fees to be collected or refunded would be
determined in accordance with this proposed rule and the TSCA fee
provisions in 40 CFR 700.45. MRRE requests cannot be withdrawn by the
requesting manufacturer once EPA has initiated the risk evaluation.
Lastly, where the requesting manufacturer believes that they can
neither collect nor develop the identified information, they may
request that EPA obtain the information using its authorities under
TSCA sections 4, 8 or 11. As part of such a request, the manufacturer
must provide a rationale as to why the information is not reasonably
ascertainable to them. EPA will review the request and provide notice
of its determination to the requesting manufacturer as to whether or
not use of these authorities is warranted. Where EPA agrees to use its
authorities, EPA will review the new information within 90 days of
receipt and determine whether or not it satisfies the identified need--
again providing notice to the requesting manufacturer and keeping the
public apprised of the status of the MRRE on its website. EPA would
further endeavor, to the extent possible, to make the supplemental
information publicly available in the docket.
EPA recognizes that Congress clearly intended for those requesting
MRREs to cover either 50% or 100% of the costs to carry out the risk
evaluation. See 15 U.S.C. 2625(b)(4)(D). However, in the event that EPA
exercises its authorities to gather additional necessary information,
costs may be imposed upon entities other than the requesting
manufacturer. For example, if EPA issues a test order under TSCA
section 4 to support a MRRE, another entity could have to pay both the
test order fee as well as the costs of developing the information.
While the costs to EPA would be reflected in the final invoice to the
requesting manufacturer, EPA is seeking comment on, to the extent that
test orders are issued to support a MRRE, whether EPA should amend the
regulation to allow the entire test order fee to be directed to the
requesting manufacturer, even where an order is issued to another
entity who is not the requesting manufacturer.
Unfulfilled Information Needs. EPA believes it is important that
the procedures in this proposed rule account for a scenario in which
information needs are not met, and the Agency is simply unable to
complete the risk evaluation. In circumstances where EPA has identified
additional data needs, but the requesting manufacturer(s) is unable or
unwilling to fulfill those needs in a timely manner, has produced
information that is insufficient to meet the need as determined by EPA,
or where EPA determines that a request to use gather information under
TSCA sections 4, 8 or 11 is not warranted (e.g., where the information
is ascertainable by the manufacturer or the request does not provide a
sufficient rationale), the proposed rule at Sec. 702.45(g)
contemplates that EPA can deem the MRRE request to be constructively
withdrawn (i.e., EPA would construe
[[Page 74316]]
the MRRE request to be withdrawn even in the absence of a request to
withdraw). Any fees to be collected or refunded would be determined in
accordance with this proposed rule and the TSCA fee provisions in 40
CFR 700.45.
Fees for MRRE will generally be determined in accordance with 40
CFR 700.45. However, this proposed rule further specifies that in the
event that a MRRE request is withdrawn after it has been granted--
either by the requesting manufacturer or constructively withdrawn by
EPA--the total fee amount due will be either, in accordance with 40 CFR
700.45(c)(2)(x) or (xi) (as applicable), 50% or 100% (respectively) of
the actual costs expended in carrying out the risk evaluation as of the
date of receipt of the withdrawal notice. The payment amount will be
determined by EPA, and invoice or refund issued to the requesting
manufacturer as appropriate.
IV. Requests for Comment
EPA requests comment on all aspects of the proposed rule discussed
in this Unit III., including comment on whether the proposed rule would
enhance transparency and public understanding of EPA's TSCA risk
evaluation process and better align with the 2016 amendments to TSCA
under the Frank R. Lautenberg Chemical Safety for the 21st Century Act
(Pub. L. 114-182, 130 Stat. 448). Additionally, within this proposal,
the Agency is soliciting feedback from the public on specific issues
throughout this proposed rule. For ease of review, this section
summarizes those specific requests for comment.
1. EPA requests comment on how the Agency could consider potential
climate-related risks in a risk evaluation.
2. EPA requests comment on the proposed approach of publishing a
draft scoped during the prioritization process when it is clear that
the chemical undergoing the prioritization process will be designated
as a high-priority chemical.
3. EPA requests public comment on the proposed elimination of the
definitions of best available science and weight of scientific
evidence, the need for such definitions, and the utility of definitions
as the state of science evolves.
4. EPA requests comments on the proposed changes to the process of
a manufacturer requested risk evaluation. In regards to cost, while the
costs to EPA would be reflected in the final invoice to the requesting
manufacturer, EPA is seeking comment on, to the extent that test orders
are issued to support a MRRE, whether the entire test order fee should
also be directed to the requesting manufacturer, even where the order
is also issued to another entity. Additionally, EPA requests specific
comment on the burden estimate of a manufacturer requested risk
evaluation, including the assumptions used in estimating the burden
(e.g., number of requests EPA expects).
5. EPA requests comment on general approaches or best practices for
improving engagement with small entities. Early engagement with and
feedback from all those who manufacture, process, distribute, use or
dispose of a chemical is critical for the Agency to be able to
accurately identify and characterize that chemical's conditions of use
for consideration in the risk evaluation, EPA is seeking comment on how
to improve its outreach to the stakeholder community, including
education on the TSCA risk evaluation process for small entities.
6. EPA requests public comment on how the Agency can provide a
transparent and detailed basis for the proposed unreasonable risk
determination and existing chemical exposure limits derived from the
risk evaluation process.
V. Reliance Interests
The proposed rule includes some statutory interpretations that
differ from those previously held by the Agency at the time it issued
the 2017 final rule, and, as part of developing this proposed rule, EPA
has considered to what extent stakeholders may have reliance interests
in those previous interpretations. EPA believes that there are either
no reliance interests on those past statutory interpretations, or that
any such interests are minor. The current rule and proposed changes
largely pertain to internal Agency procedures that guide the Agency's
risk evaluation activities under TSCA and mostly do not directly impact
external parties, with one exception being modified procedural
requirements for voluntary requests for risk evaluation submitted by
manufacturers. However, to the extent there were any reliance interests
on the prior interpretations, or the risk evaluations that were
developed based on the previous procedural requirements, nothing in the
proposed rule is intended to apply retroactively. EPA does not believe
stakeholders have reliance interests pertaining to the process for
future, yet-to-be-completed risk evaluations that will be carried out
in accordance with this proposed rule.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act; Final Rule. Federal Register
(82 FR 33726, July 20, 2017) (FRL-9964-38). https://www.govinfo.gov/content/pkg/FR-2017-07-20/pdf/2017-14337.pdf.
2. U.S. Court of Appeals for the Ninth Circuit. Safer Chemicals,
Healthy Families v. USEPA, No. 17-72260 No. 17-72501 No. 17-72968
No. 17-73290 No. 17-73383 No. 17-73390, Opinion. November 14, 2019.
943 F.3d 397, 425-426. https://cdn.ca9.uscourts.gov/datastore/opinions/2019/11/14/17-72260.pdf.
3. Executive Order 13990. Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis.
Federal Register (86 FR 7037, January 25, 2021). https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01765.pdf.
4. U.S. EPA. Information Collection Request (ICR) for the Proposed
Rule: Procedures for Chemical Risk Evaluation Under TSCA. EPA ICR
No.: 2781.01 and OMB Control No. 2070-NEW.
5. Safer Chemicals, Healthy Families; et al., v. U.S. Environmental
Protection Agency, No. 17-72260, 17-72501, 17-72968, 17-73290, 17-
73383, 17-73390, 2019 WL 6041996 (9th Cir. Nov. 14, 2019).
6. The White House, Briefing Room. Fact Sheet: List of Agency
Actions for Review. January 20, 2021. https://www.whitehouse.gov/briefing-room/statements-releases/2021/01/20/fact-sheet-list-of-agency-actions-for-review/.
7. U.S. EPA. EPA Announces Path Forward for TSCA Chemical Risk
Evaluations. Press Release. June 30, 2021. https://www.epa.gov/newsreleases/epa-announces-path-forward-tsca-chemical-risk-evaluations.
8. U.S. EPA. Assessing and Managing Chemicals under TSCA. Chemicals
Undergoing Risk Evaluation under TSCA. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca (Accessed May 31, 2023.)
9. U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances; Proposed Rule. Federal Register. (82 FR
7562, January 19, 2017) (FRL-9957-75). https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01224.pdf.
[[Page 74317]]
10. U.S. EPA. Exposure Factors Handbook: 2011 Edition. EPA/600/R-
090/052F. Office of Research and Development, National Center for
Environmental Assessment. Washington, DC. 2011. https://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=236252.
11. U.S. Senate Congressional Record, 162 Cong. Rec. S3511-01 (daily
ed. June 7, 2016). https://www.congress.gov/114/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf.
12. U.S. EPA. Problem Formulation of the Risk Evaluation for 1,4-
Dioxane. EPA/740/R1/7012. Office of Chemical Safety and Pollution
Prevention. Washington, DC. 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0723-0064.
13. U.S. EPA. Risk Evaluation for Methylene Chloride
(Dichloromethane, DCM) CASRN: 75-09-2. EPA-740-R1-8010. Office of
Chemical Safety and Pollution Prevention. Washington, DC. 2020.
https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0742.
14. TSCA Science Advisory Committee on Chemicals. Peer Review for
EPA Draft Risk Evaluation for Methylene Chloride. Meeting Minutes
and Final Report No. 2020-1. March 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0437-0080.
15. Comment from the Attorneys General of Massachusetts, California,
Hawaii, Maine, Maryland, New Jersey, New York, Oregon, Vermont,
Washington, and the District of Columbia. Comments submitted to EPA
in response to Notice of Availability on Problem Formulations for
the Risk Evaluations to be Conducted Under the Toxic Substances
Control Act and General Guiding Principles to Apply Systematic
Review in TSCA Risk Evaluations. https://www.regulations.gov/comment/EPA-HQ-OPPT-2016-0723-0074.
16. Safer Chemicals, Healthy Families et al. Comments submitted to
EPA on Notice of Availability on Risk Evaluation Problem
Formulations Documents for Ten Chemical Substances under the Toxic
Substances Control Act. https://www.regulations.gov/docket/EPA-HQ-OPPT-2016-0723-0089.
17. U.S. EPA. Draft TSCA Screening Level Approach for Assessing
Ambient Air and Water Exposures to Fenceline Communities Version
1.0. EPA/744/D/22/001. Washington, DC. 2022. https://www.epa.gov/system/files/documents/2022-01/draft-fenceline-report_sacc.pdf.
18. Conference Committee Report on TSCA, Public Law 94-469, Senate
Rep. No 94-1302 at 85 (1976) Conf Rep. https://www.congress.gov/bill/94th-congress/senate-bill/3149.
19. OSHA. Permissible Exposure Limits Annotated Tables. https://www.osha.gov/annotated-pels. (Accessed May 30, 2023).
20. U.S. EPA. General Principles for Performing Aggregate Exposure
and Risk Assessment. Office of Pesticide Programs. November 28,
2001. https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf.
21. NRC. Science and Judgment in Risk Assessment. The National
Academies Press. Washington, DC. 1994. https://dx.doi.org/10.17226/2125.
22. NRC. Phthalates and Cumulative Risk Assessment: The Task Ahead.
National Academies Press. Washington, DC. 2008. https://dx.doi.org/10.17226/12528.
23. NRC. Science and Decisions: Advancing Risk Assessment. National
Academies Press. Washington, DC. 2009. https://dx.doi.org/10.17226/12209.
24. Food Quality Protection Act. 5.U.S.C. 136 et. seq.
25. U.S. EPA. Framework for Cumulative Risk Assessment. EPA/630/P-
02/001F. Risk Assessment Forum. Washington, DC. May 2003. https://www.epa.gov/sites/default/files/2014-11/documents/frmwrk_cum_risk_assmnt.pdf.
26. U.S. EPA. Guidelines for the Health Risk Assessment of Chemical
Mixtures. Federal Register. (51 FR 34028, September 24, 1986) (FRL-
2984-3). https://www.govinfo.gov/content/pkg/FR-1986-09-24/pdf/FR-1986-09-24.pdf#page=158.
27. U.S. EPA. Supplementary Guidance for Conducting Health Risk
Assessment of Chemical Mixtures. EPA/630/R-00/002.Risk Assessment
Forum. Washington, DC. August 2000. https://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=20533.
28. U.S. EPA. Guidance on Cumulative Risk Assessment of Pesticide
Chemicals That Have a Common Mechanism of Toxicity. Office of
Pesticide Programs. Washington, DC. January 14, 2002. https://www.regulations.gov/document/EPA-HQ-OPP-2007-0797-0001.
29. U.S. EPA. Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis Purpose. Office of Chemical Safety and Pollution
Prevention, Office of Pesticide Programs. Washington, DC. April 12,
2016. https://www.regulations.gov/document/EPA-HQ-OPP-2015-0422-0019.
30. OECD. Considerations for assessing the risks of combined
exposure to multiple chemicals (No. 558 296). In Series on Testing
and Assessment No 296. Paris, France. 2018. https://dx.doi.org/10.1787/ceca15a9-en.
31. Meek, M.E.; Boobis, Alan R.; Crofton, Kevin M.; Heinemeyer,
Gerhard; Van Raaij, Marcel; Vickers, Carolyn. Risk Assessment of
Combined Exposure to Multiple Chemicals: A WHO/IPCS Framework.
Regulatory Toxicology and Pharmacology. July 1, 2011. 60:S1-S14.
https://dx.doi.org/10.1016/j.yrtph.2011.03.010.
32. U.S. EPA. Draft Proposed Principles of Cumulative Risk
Assessment Under the Toxic Substances Control Act. EPA/740/P/23/001.
Office of Chemical Safety and Pollution Prevention. Washington, DC.
February 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2022-0918-0008.
33. U.S. EPA. Draft Proposed Approach for Cumulative Risk Assessment
of High-Priority Phthalates and a Manufacturer Requested Phthalate
Under the Toxic Substances Control Act Control Act. EPA/740/P/23/
002. Office of Chemical Safety and Pollution Prevention. Washington,
DC. February 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2022-0918-0009.
34. U.S. EPA. Cumulative Impacts Research: Recommendations for EPA's
Office of Research and Development. EPA 600/R-22/014a. Office of
Research and Development. Washington, DC. September 30, 2022.
https://www.epa.gov/system/files/documents/2023-05/cumulative%20impacts%20research-final%20report-epa%20600-r-22-014a%20%2812%29.pdf.
35. U.S. EPA. EJSCREEN: Environmental Justice Screening and Mapping
Tool. https://www.epa.gov/ejscreen.
36. U.S. EPA. EnviroAtlas. https://www.epa.gov/enviroatlas.
37. U.S. EPA. Guidelines for Carcinogen Risk Assessment. EPA/630/P-
03/001F. Risk Assessment Forum. Washington, DC. March 2005. https://www.regulations.gov/document/EPA-HQ-OA-2007-0679-0001.
38. U.S. EPA. Supplemental Guidance for Assessing Susceptibility
from Early-Life Exposure to Carcinogens. EPA/630/R-03/003F. Risk
Assessment Forum. Washington, DC. March 2005. https://www.epa.gov/sites/default/files/2013-09/documents/childrens_supplement_final.pdf.
39. U.S. EPA. Peer Review Handbook (4th Edition). EPA/100/B-15/001.
Science and Technology Policy Council. Washington, DC. October 2015.
https://www.epa.gov/sites/default/files/2020-08/documents/epa_peer_review_handbook_4th_edition.pdf.
40. OMB. Final Information Quality Bulletin for Peer Review. Federal
Register. (70 FR 2664, January 14, 2005). https://www.govinfo.gov/content/pkg/FR-2005-01-14/pdf/05-769.pdf.
41. U.S. EPA. Draft Risk Evaluation for C.I. Pigment Violet 29
(Anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline 1,3,8,10(2H,9H)-
tetrone) CASRN: 81-33-4. 740R18015. Office of Chemical Safety and
Pollution Prevention. Washington, DC. November 2018. https://www.regulations.gov/document/EPA-HQ-OPPT-2018-0604-0007.
42. U.S. EPA. Draft Supplemental Analysis to the Draft Risk
Evaluation for 1,4-Dioxane. EPA-740-R1-8007. Office of Chemical
Safety and Pollution Prevention. November 2020. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0067.
43. TSCA Science Advisory Committee on Chemicals. Peer Review for
EPA Draft Risk Evaluation for 1,4-Dioxane and Cyclic Aliphatic
Bromide Cluster (HBCD). Meeting Minutes and Final Report No. 2019-
02. October 2019. https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0063.
44. Comments submitted to EPA in response to Notice of Availability
on U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances; Proposed Rule. https://
[[Page 74318]]
www.regulations.gov/docket/EPA-HQ-OPPT-2016-0654/comments.
45. Safe Drinking Water Act. 42 U.S.C. 300f et seq.
46. U.S. EPA. Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity, of Information Disseminated by
the Environmental Protection Agency. EPA/260R-02-008. Office of
Environmental Information. Washington, DC. October 2002. https://www.epa.gov/sites/default/files/2020-02/documents/epa-info-quality-guidelines_pdf_version.pdf.
47. U.S. EPA. Application of Systematic Review in TSCA Risk
Evaluations. EPA/740/P1/8001. Office of Chemical Safety and
Pollution Prevention. May 2018. https://www.epa.gov/sites/default/files/2018-06/documents/final_application_of_sr_in_tsca_05-31-18.pdf.
48. National Academies of Sciences Engineering and Medicine. The Use
of Systematic Review in EPA's Toxic Substances Control Act Risk
Evaluations. The National Academies Press. Washington, DC. 2021.
https://doi.org/10.17226/25952.
49. U.S. EPA. (2021) Draft TSCA Systematic Review Protocol
Supporting TSCA Risk Evaluations for Chemical Substances: A Generic
TSCA Systematic Review Protocol with Chemical-Specific Methodologies
(Version 1.0). EPA-D-20-031. Office of Chemical Safety and Pollution
Prevention. Washington, DC. December 2021. https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0414-0005.
50. NRC. Review of EPA's Integrated Risk Information System (IRIS)
Process. The National Academies Press. Washington, DC. 2014. https://www.nap.edu/catalog/18764/review-of-epas-integrated-riskinformation-system-iris-process.
51. EDSTAC. Endocrine Disruptor Screening and Testing Advisory
Committee, Final Report, Volume I-II. Washington, DC 1998. https://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm.
52. U.S. EPA. Weight of Evidence in Ecological Assessment. EPA/100/
R-16/001. Risk Assessment Forum. Washington, DC. December 2016.
https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100SFXR.txt.
53. U.S. EPA. Endocrine Disruptor Screening Program (EDSP); Weight-
of-Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify
the Need for Tier 2 Testing. Office of Chemical Safety and Pollution
Prevention. Washington, DC. 2011. https://www.regulations.gov/document/EPA-HQ-OPPT-2010-0877-0021.
54. U.S. EPA. ORD Staff Handbook for Developing IRIS Assessments
(2022). EPA/600/R-22/268. Office of Research and Development.
Washington, DC. https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=356370.
55. U.S. EPA. Tiered Data Reporting to Inform, Prioritization, Risk
Evaluation, and Risk Management under TSCA. Office of Chemical
Safety and Pollution Prevention. https://www.epa.gov/chemical-data-reporting/tiered-data-reporting-inform-prioritization-risk-evaluation-and-risk. (Accessed May 31, 2023.)
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/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 are documented in the docket. EPA prepared an analysis of
the potential costs associated with this action. This analysis can be
found in Unit VI.B.
B. Paperwork Reduction Act (PRA)
The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. EPA has prepared a new rule-related Information Collection Request
(ICR) document entitled ``Procedures for Requesting a Chemical Risk
Evaluation under TSCA (Proposed Rule)'' and is identified by EPA ICR
No. 2781.01, to replace an existing approved ICR. You can find a copy
of the new ICR document (Ref. 4) in the docket for this rulemaking, and
it is briefly summarized here.
The information activities related to the current requirements for
manufacturer-requested risk evaluations are already approved by OMB in
an ICR entitled, ``Procedures for Requesting a Chemical Risk Evaluation
under TSCA'' (EPA ICR No. 2559.03 and OMB Control No. 2070-0202) (Ref
4). The proposed rule replacement ICR addresses the information
collection requirements contained in the current regulations as well as
in the amendments identified in this proposed rule. As addressed in the
currently approved ICR and pursuant 40 CFR part 702, subpart B, the
information collection activities are those carried out by a chemical
manufacturer in requesting a specific chemical risk evaluation under
TSCA be conducted by EPA. EPA established the process for conducting
risk evaluations under TSCA. Chemicals that will undergo this
evaluation include chemicals designated by the Agency as high-priority
in accordance with 40 CFR part 702, subpart A, as well as chemicals for
which EPA has granted requests made by manufacturers to have the
chemicals evaluated under EPA's risk evaluation process. The
replacement ICR addresses proposed amendments to information
requirements for manufacturer-requested risk evaluations, including
proposed amendments to information requirements addressing joint
submissions, the scope of the requested risk evaluation, and the
information to be provided in support of the requested risk evaluation,
and fee payment. Please see Unit III.K. for additional information
about these proposed amendments.
The replacement ICR addresses adjustments to the estimated number
of respondents, time for activities, and wage rates related to the
current regulatory requirements as approved under OMB Control No. 2070-
0202. In addition, the replacement ICR addresses program changes
related to the proposed amendments, including changes to content
requirements for 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 being proposed in the replacement ICR is 166
hours, a net decrease of 253 hours. The primary driver in the burden
decrease is the estimated number of responses dropping to 1 per year
based on the number of requests EPA has received to date. Certain
information included with a manufacturer-requested risk evaluation may
be claimed as TSCA CBI in accordance with TSCA section 14 (15 U.S.C.
2613), and any such claims must be substantiated in accordance with the
Act.
Respondents/affected entities: Persons that manufacture chemical
substances and request a chemical be considered for risk evaluation by
EPA. Such persons may voluntarily request a risk evaluation but would
be required to comply with the requirements for such a request. See
Unit I.A.
Respondent's obligation to respond: Voluntary (15 U.S.C.
2605(b)(4)).
Estimated number of respondents: 3.
Frequency of response: On occasion.
Total estimated burden: 166 hours (per year). Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $115,711 (per year), includes $0 annualized
capital or operation and maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB
[[Page 74319]]
control number. The OMB control numbers for the EPA's regulations in 40
CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to EPA using the docket identified at the
beginning of this rulemaking. EPA will respond to any ICR-related
comments in the final rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs using the
interface at https://www.reginfo.gov/public/do/PRAMain. Find this
particular ICR by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. OMB must receive comments
no later than November 29, 2023.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are manufacturers of chemical substances that submit
requests to EPA seeking chemical risk evaluations. The Agency has
determined that a low number of small entities may be impacted by
voluntarily submitting a request to EPA for a chemical to undergo a
risk evaluation. The 2017 final rule considered firms in 60 different
NAICS codes that may choose to pursue a manufacturer-requested risk
evaluation (approximately 30,000 firms) of which 76 percent were
classified as small business (approximately 22,000 firms). When EPA
promulgated the 2017 final rule, the Agency estimated that it would
receive 5 MRRE submissions per year. However, manufacturers have
submitted only 4 MRRE requests since 2017 (or less than one request per
year, on average). Therefore, based on the number of submissions
received by EPA since 2017, the Agency estimates it will receive only
one manufacture-requested risk revaluation per year. That is, only one
out of approximately 22,000 small businesses is expected to choose to
incur the submission costs ($115,711) in any one year and, thus, a
significant number of small businesses would not be impacted by this
rulemaking. The decision to request a risk evaluation for a chemical is
voluntary and manufacturers may decide not to make such a request.
Details of this analysis are presented in the rule-related ICR.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments. The costs involved in this action are
imposed only on the private sector entities (manufacturers) that may
voluntarily elect to submit a request for a risk evaluation as they
would be required to comply with the proposed requirements for such
requests.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999) because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
TSCA section 18(c)(3) defines the scope of Federal preemption with
respect to any final rule EPA issues under TSCA section 6(a). That
provision provides that Federal preemption of ``statutes, criminal
penalties, and administrative actions'' applies to ``the hazards,
exposures, risks, and uses or conditions of use of such chemical
substances included in any final action the Administrator takes
pursuant to [TSCA section 6(a)].'' EPA reads this to mean that states
are preempted from imposing requirements through statutes, criminal
penalties, and administrative actions relating to any ``hazards,
exposures, risks, and uses or conditions of use'' evaluated in the
final risk evaluation and informing the risk determination that EPA
addresses in the TSCA section 6(a) rulemaking. For example, Federal
preemption applies even if EPA does not regulate in that final rule a
particular COU, but that COU was evaluated in the final risk
evaluation.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-201 of the Executive order. Therefore,
this action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk. Since this action
does not concern human health risks, EPA's Policy on Children's Health
also does not apply. This procedural rule would address how EPA
evaluates the risks of existing chemicals under TSCA, including
potential risks to children and other PESS. EPA must initiate a
rulemaking to address the unreasonable risk to human health or the
environment that the Agency may determine are presented by a chemical
substance as set forth in a TSCA risk evaluation. Although this
procedural rule itself would not directly affect the level of
protection provided to human health or the environment, EPA expects
that this rulemaking would improve the Agency's consideration of risks
to children and other PESS and, in turn, better inform the Agency's
determination of whether a chemical substance presents an unreasonable
risk of injury to health under its conditions of use. An EPA rulemaking
to address an unreasonable risk of injury to health that the
Administrator determines is presented by a chemical substance following
a risk evaluation could qualify as a covered regulatory action under
E.O. 13045 and could be subject to EPA's Policy on Children's Health.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not otherwise been designated by the Administrator of
OMB's Office of Information and Regulatory Affairs as a ``significant
energy action.''
[[Page 74320]]
I. National Technology Transfer and Advancement Act (NTTAA)
This proposed rulemaking does not involve technical standards. As
such, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this
action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on communities with
environmental justice concerns consistent with Executive Order 14096
(88 FR 25251, April 26, 2023) and Executive Order 12898 (59 FR 7629,
February 16, 1994). This action proposes revisions to the procedures
that EPA will use to evaluate the risk of existing chemical substances
pursuant to TSCA, and the Agency cannot foresee the final results of
those evaluations. However, by specifically including overburdened
communities in the regulatory definition of PESS, the Agency believes
that this action would assist EPA and others in determining the
potential exposures, hazards and risks to overburdened communities
associated with existing chemicals a part of a TSCA risk evaluation.
The proposed inclusion of overburdened communities among the PESS
considered in a chemical risk evaluation would also enable the Agency
to design appropriate risk management approaches to address the
unreasonable risk that the Agency may determine is presented by a
chemical, including any unreasonable risk that is disproportionately
borne by communities with environmental justice concerns.
The information supporting this Executive order review is presented
in Unit III.G.4.
List of Subjects in 40 CFR Part 702
Environmental protection, Chemicals, Chemical substances, Hazardous
substances, Health and safety, Risk evaluation.
Dated: October 18, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR part 702 as follows:
PART 702--GENERAL PRACTICES AND PROCEDURES
0
1. The authority citation for part 702 continues to read as follows:
Authority: 15 U.S.C. 2605 and 2619.
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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 [30 DAYS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE FEDERAL REGISTER]. For risk evaluations
initiated prior to this date, but not yet finalized, EPA will seek to
apply the requirements in this subpart to the extent practicable. These
requirements shall not apply retroactively to risk evaluations already
finalized.
(d) Categories of chemical substances. Consistent with EPA's
authority to take action with respect to categories of chemicals under
15 U.S.C. 2625(c), all references in this part to ``chemical'' or
``chemical substance'' shall also apply to ``a category of chemical
substances.''
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, 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.
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
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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. EPA will ensure that, of the number of
chemical substances that undergo risk evaluation under 15 U.S.C.
2605(b)(4)(C)(i), the number of chemical substances undergoing risk
evaluation under 15 U.S.C. 2605(b)(4)(C)(ii) is not less than 25%, if
sufficient requests that comply with Sec. 702.37, and not more than
50%.
(c) Manufacturer-requested risk evaluations for work plan chemical
substances. Manufacturer requests for risk evaluations, described in
paragraph (a) of this section, for chemical substances that are drawn
from the 2014 update of the TSCA Work Plan for Chemical Assessments
will be granted at the discretion of EPA. Such evaluations are not
subject to the percentage requirements in paragraph (b) of this
section.
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. Considerations for determining best available science shall
include, but are not limited to, the following as applicable:
(i) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and consistent
with the intended use of the information;
(ii) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance or
mixture;
(iii) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
(iv) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
(v) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
(3) EPA will ensure that all supporting analyses and components of
the risk evaluation are suitable for their intended purpose, and
tailored to the problems and decision at hand, in order to inform the
development of a technically sound determination as to whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use, based on the weight of the
scientific evidence.
(4) EPA will not exclude conditions of use from the scope of the
risk evaluation, but a fit-for-purpose approach may result in varying
types and levels of analysis and supporting information for certain
conditions of use, consistent with paragraph (b) of this section. The
extent to which EPA will refine its evaluations for one or more
condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment.
(5) EPA will determine whether a chemical substance does or does
not present an unreasonable risk after considering the risks posed
under all of the conditions of use and, where EPA makes a determination
of unreasonable risk, EPA intends to identify the conditions of use
that significantly contribute to such determination.
(6) EPA will evaluate chemical substances that are metals or metal
compounds in accordance with 15 U.S.C. 2605(b)(2)(E).
(b) Information and information sources. (1) EPA will base each
risk evaluation on reasonably available information.
(2) EPA will apply systematic review and/or systematic approaches
to reviewing reasonably available information that are objective,
unbiased, and transparent.
(3) EPA may determine that certain information gaps can be
addressed through application of assumptions, uncertainty factors,
models, and/or screening to conduct its analysis with respect to the
chemical substance, consistent with 15 U.S.C. 2625. The approaches used
will be determined by the quality of reasonably available information,
the deadlines specified in TSCA section 6(b)(4)(G) for completing the
risk evaluation, and the extent to which the information reduces
uncertainty.
(4) EPA expects to use its authorities under the Act, and other
information gathering authorities, when necessary to obtain the
information needed to perform a risk evaluation for a chemical
substance before initiating the risk evaluation for such substance. EPA
will also use such authorities during the performance of a risk
evaluation to obtain information as needed and on a case-by-case basis
to ensure that EPA has adequate, reasonably available information to
perform the evaluation. Where appropriate, to the extent practicable,
and scientifically justified, EPA will require the development of
information generated without the use of new testing on vertebrates.
(5) Among other sources of information, EPA will also consider
information and advice provided by the Science Advisory Committee on
Chemicals established pursuant to 15 U.S.C. 2625(o).
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.
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(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, 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;
(iii) Describe the weight of the scientific evidence for the
identified hazards and exposures.
(2) Summary of considerations. EPA will summarize, as applicable,
the considerations addressed throughout the evaluation components, in
carrying out the obligations under 15 U.S.C. 2625(h). This summary will
include, as appropriate, a discussion of:
(i) Considerations regarding uncertainty and variability.
Information about uncertainty and variability in each step of the risk
evaluation (e.g., use of default assumptions, scenarios, choice of
models, and information used for quantitative analysis) will be
integrated into an overall characterization and/or analysis of the
impact of the uncertainty and variability on estimated risks. EPA may
describe the uncertainty using a qualitative assessment of the overall
strength and limitations of the data and approaches used in the
assessment.
(ii) Considerations of data quality. A discussion of data quality
(e.g., reliability, relevance, and whether methods employed to generate
the information are reasonable for and consistent with the intended use
of the information), as well as assumptions used, will be included to
the extent necessary. EPA also expects to include a discussion of the
extent of independent verification or peer review of the information or
of the procedures, measures, methods, protocols, methodologies, or
models used in the risk evaluation.
(iii) Considerations of alternative interpretations. If appropriate
and relevant, where alternative interpretations are plausible, a
discussion of alternative interpretations of the data and analyses will
be included.
(iv) Additional considerations for environmental risk. For
evaluation of environmental risk, it may be necessary to discuss the
nature and magnitude of the effects, the spatial and temporal patterns
of the effects, implications at the individual, species, population,
and community level, and the likelihood of recovery subsequent to
exposure to the chemical substance.
(f) Risk determination. (1) As part of the risk evaluation, EPA
will make a single determination as to whether the chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible
subpopulation, under the conditions of use.
(2) In determining whether unreasonable risk is presented, EPA's
consideration of occupational exposure scenarios will take into account
reasonably available information, including known and reasonably
foreseen circumstances where subpopulations of workers are exposed due
to the absence or ineffective use of personal protective equipment. EPA
will not consider exposure reduction
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based on assumed use of personal protective equipment as part of the
risk determination.
Sec. 702.41 Peer review.
EPA expects that peer review activities on risk evaluations
conducted pursuant to 15 U.S.C. 2605(b)(4)(A), or portions thereof,
will be consistent with the applicable peer review policies,
procedures, guidance documents, and methods pursuant to guidance
promulgated by Office of Management and Budget, EPA, and in accordance
with 15 U.S.C. 2625(h) and (i).
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 and the environment to do
so, considering the statutory responsibilities and deadlines under 15
U.S.C. 2605.
(4) Process for revisions to final risk evaluations. Where EPA
determines to revise or supplement a final risk evaluation pursuant to
paragraph (g)(3) of this section, EPA will follow the same procedures
in this section including publication of a new draft and final risk
evaluation and solicitation of public comment in accordance with
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 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 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.
(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.
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(2) The chemical identity of the chemical substance that is the
subject of the request. At a minimum, this includes: all known names of
the chemical substance, including common or trades names, Chemical
Abstracts Service (CAS) number, and molecular structure of the chemical
substance.
(3) For requests pertaining to a category of chemical substances,
an explanation of why the category is appropriate under 15 U.S.C.
2625(c). EPA will determine whether the category is appropriate for
risk evaluation as part of reviewing the request in paragraph (e) of
this section.
(4) A description of the circumstances under which the chemical
substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of,
and all information known to or reasonably ascertainable by the
requesting manufacturer that supports the identification of the
circumstances described in this paragraph (c)(4).
(5) All information known to or reasonably ascertainable by the
requesting manufacturer on the health and environmental hazard(s) of
the chemical substance, human and environmental exposure(s), and
exposed population(s), including but not limited to:
(i) The chemical substance's exposure potential, including
occupational, general population and consumer exposures, and facility
release information;
(ii) The chemical substance's hazard potential, including all
potential environmental and human health hazards;
(iii) The chemical substance's physical and chemical properties.
(iv) The chemical substance's fate and transport properties
including persistence and bioaccumulation;
(v) Potentially exposed or susceptible subpopulations which the
manufacturer(s) believes to be relevant to the EPA risk evaluation;
(vi) Whether there is any storage of the chemical substance near
significant sources of drinking water, including the storage facility
location and the nearby drinking water source(s);
(vii) The chemical substance's production volume or significant
changes in production volume; and
(viii) Any other information relevant to the hazards, exposures
and/or risks of the chemical substance.
(6) Where information described in paragraph (c)(4) or (5) of this
section is unavailable, an explanation as to why, and the rationale for
why, in the requester's view, the provided information is nonetheless
sufficient to allow EPA to complete a risk evaluation on the chemical
substance.
(7) Copies of all information referenced in paragraph (c)(5) of
this section, or citations if the information is readily available from
public sources.
(8) A signed certification that all information contained in the
request is accurate and complete, as follows:
I certify that to the best of my knowledge and belief:
(A) The company named in this request manufactures the chemical
substance identified for risk evaluation.
(B) All information provided in the request is complete and
accurate as of the date of the request.
(C) I have either identified or am submitting all information in
my possession and control, and a description of all other data known
to or reasonably ascertainable by me as required under this part. I
am aware it is unlawful to knowingly submit incomplete, false and/or
misleading information in this request and there are significant
criminal penalties for such unlawful conduct, including the
possibility of fine and imprisonment.
(9) Where appropriate, information that will inform EPA's
determination as to whether restrictions imposed by one or more States
have the potential to have a significant impact on interstate commerce
or health or the environment, and that as a consequence the request is
entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).
(d) Confidential business information. Persons submitting a request
under this subpart are subject to EPA confidentiality regulations at 40
CFR part 2, subpart B, and 40 CFR part 703.
(e) EPA process for reviewing requests. (1) Public notification of
receipt of request. Within 15 days of receipt of a manufacturer-
requested risk evaluation, EPA will notify the public that such request
has been received.
(2) Initial review for completeness. EPA will determine whether the
request appears to meet the requirements specified in this section
(i.e., complete), or whether the request appears to not have met the
requirements specified in this section (i.e., incomplete). EPA will
notify the requesting manufacturer of the outcome of this initial
review. For requests initially determined to be incomplete, EPA will
cease review pending actions taken by the requesting manufacturer
pursuant to paragraph (f) of this section. For requests initially
determined to be complete, EPA will proceed to the public notice and
comment process described in paragraph (e)(3) of this section.
(3) Public notice and comment. No later than 90 days after
initially determining a request to be complete pursuant to paragraph
(e)(2) of this section, EPA will submit for publication the receipt of
the request in the Federal Register, open a docket for that request and
provide no less than a 60-day public comment period. The docket will
contain the CBI sanitized copies of the request and all supporting
information. The notice will encourage the public to submit comments
and information relevant to the manufacturer-requested risk evaluation,
including, but not limited to, identifying information not provided in
the request, information the commenter believes necessary to conduct a
risk evaluation, and any other information relevant to the conditions
of use.
(4) Secondary review for sufficiency. Within 90 days following the
end of the comment period in paragraph (e)(3) of this section, EPA will
further consider whether public comments highlight deficiencies in the
request not identified during EPA's initial review, and/or that the
available information is not sufficient to support a reasoned
evaluation. EPA will notify the requesting manufacturer of the outcome
of this review. For requests determined to not be supported by
sufficient information, EPA will cease review pending actions taken
pursuant to paragraph (f) of this section. For requests determined to
be supported by sufficient information, EPA will proceed with request
review process in accordance with paragraph (e)(5) of this section.
(5) Grant. Where EPA determines a request to be complete and
sufficiently supported in accordance with paragraphs (e)(2) and (4) of
this section, and subject to the percentage limitations in TSCA section
6(b)(4)(E)(i)(II), EPA will grant the request. A grant does not mean
that EPA has all information necessary to complete the risk evaluation.
(6) Publication of draft conditions of use and request for
information. EPA will publish a notice in the Federal Register that
identifies draft conditions of use, requests relevant information from
the public, and provides no less than a 60-day public comment period.
Within 90 days following the close of the public comment period in this
paragraph, EPA will determine whether further information is needed to
carry out the risk evaluation and notify the requesting manufacturer(s)
of its determination, pursuant to paragraph (e)(7) of this section. If
EPA determines at this time that no further information is necessary,
EPA will initiate the risk evaluation, pursuant to paragraph (e)(9) of
this section.
(7) Identification of information needs. Where additional
information
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needs are identified, EPA will notify the requesting manufacturer(s)
and set a reasonable amount of time, as determined by EPA, for
response. In response to EPA's notice, and subject to the limitations
in paragraph (g) of this section, the requesting manufacturer(s) may:
(i) Provide the necessary information. EPA will set a reasonable
amount of time, as determined by EPA, for the requesting
manufacturer(s) to produce or develop and produce the information. Upon
receipt of the new information, EPA will review for sufficiency and
make publicly available to the extent possible, including CBI-sanitized
copies of that information; or
(ii) Withdraw the risk evaluation request. Fees to be collected or
refunded shall be determined pursuant to paragraph (k) of this section
and 40 CFR 700.45; or
(iii) Request that EPA obtain the information using authorities
under TSCA sections 4, 8 or 11. The requesting manufacturer(s) must
provide a rationale as to why the information is not reasonably
ascertainable to them. EPA will review and provide notice of its
determination to the requesting manufacturer. Upon receipt of the
information, EPA will review the additional information for sufficiency
and provide additional public notice.
(8) Unfulfilled information needs. In circumstances where there
have been additional data needs identified pursuant to paragraph (e)(7)
of this section but the requesting manufacturer(s) is unable or
unwilling to fulfill those needs in a timely manner, has produced
information that is insufficient as determined by EPA, or where EPA
determines that a request to use TSCA authorities under section 4, 8 or
11 is not warranted, EPA may deem the request to be constructively
withdrawn under paragraph (e)(7)(ii) of this section.
(9) Initiation of the risk evaluation. Within 90 days of the end of
the comment period provided in paragraph (e)(6) of this section, or
within 90 days of EPA determining that information pursuant to
paragraph (e)(7) of this section is sufficient, EPA will initiate the
requested risk evaluation and follow all requirements in this subpart,
including but not limited to 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, requesting manufacturer(s) may
supplement and resubmit the request. EPA will follow the process
described in paragraph (e) of this section as it would for a new
request.
(g) Withdrawal of request. Requesting manufacturer(s) may withdraw
a request at any time prior to EPA's grant of such request pursuant to
paragraph (e)(5) of this section, or in accordance with paragraph
(e)(7) of this section and subject to payment of applicable fees.
Requesting manufacturers may not withdraw a request once EPA has
initiated the risk evaluation. EPA may deem a request constructively
withdrawn in the event of unfulfilled information needs pursuant to
paragraph (e)(8) of this section or 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(s) may remedy the deficiency pursuant to
paragraph (e)(7)(i) or (iii) of this section.
(i) Supplementation of original request. At any time prior to the
end of the comment period described in paragraph (e)(6) of this
section, the requesting manufacturer(s) may supplement the original
request with any new information that becomes available to the
manufacturer(s). At any point prior to the completion of a
manufacturer-requested risk evaluation pursuant to this section,
manufacturer(s) must supplement the original request with any
information that meets the criteria in 15 U.S.C. 2607(e) and this
section, or with any other reasonably ascertainable information that
has the potential to change EPA's risk evaluation. Such information
must be submitted consistent with 15 U.S.C. 2607(e) if the information
is subject to that section or otherwise within 30 days of the
manufacturer's obtaining the information.
(j) Limitations on 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 evaluation and not more than 50%.
(2) Preferences. In conformance with Sec. 702.35(c), in evaluating
requests for TSCA Work Plan Chemicals and requests for non-TSCA Work
Plan chemicals in excess of the 25% threshold in Sec. 702.35(b), EPA
will give preference to requests for risk evaluations on chemical
substances:
(i) First, for which EPA determines that restrictions imposed by
one or more States have the potential to have a significant impact on
interstate commerce, health or the environment; and then
(ii) Second, based on the order in which the requests are received.
(k) Fees. Manufacturers must pay fees to support risk evaluations
as specified under 15 U.S.C. 2605(b)(4)(E)(ii), and in accordance with
15 U.S.C. 2525(b) and 40 CFR 700.45. In the event that a request for a
risk evaluation is withdrawn by the requesting manufacturer pursuant to
paragraph (g) of this section, the total fee amount due will be either,
in accordance with 40 CFR 700.45(c)(2)(x) or (xi), 50% or 100% of the
actual costs expended in carrying out the risk evaluation as of the
date of receipt of the withdrawal notice. The payment amount will be
determined by EPA, and invoice or refund issued to the requesting
manufacturer(s) as appropriate.
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;
[[Page 74326]]
(e) A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation;
(f) Any final peer review report, including the response to peer
review and public comments received during peer review; and
(g) Response to public comments received on the draft scope and the
draft risk evaluation.
[FR Doc. 2023-23428 Filed 10-27-23; 8:45 am]
BILLING CODE 6560-50-P