Rule2024-09417
Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 3, 2024
Effective
July 2, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or the Agency) is finalizing amendments to the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use. EPA reconsidered the procedural framework rule for conducting such risk evaluations and is revising certain aspects of that framework to better align with the statutory text and applicable court decisions, to reflect the Agency's experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without need to further amend the Agency's procedural rule.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 87 (Friday, May 3, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Rules and Regulations]
[Pages 37028-37058]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09417]
[[Page 37027]]
Vol. 89
Friday,
No. 87
May 3, 2024
Part V
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 702
Procedures for Chemical Risk Evaluation Under the Toxic Substances
Control Act (TSCA); Final Rule
Federal Register / Vol. 89 , No. 87 / Friday, May 3, 2024 / Rules and
Regulations
[[Page 37028]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 702
[EPA-HQ-OPPT-2023-0496; FRL-8529-02-OCSPP]
RIN 2070-AK90
Procedures for Chemical Risk Evaluation Under the Toxic
Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
finalizing amendments to the procedural framework rule for conducting
risk evaluations under the Toxic Substances Control Act (TSCA). The
purpose of risk evaluations under TSCA is to determine whether a
chemical substance presents an unreasonable risk of injury to health or
the environment, without consideration of costs or non-risk factors,
including unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by EPA,
under the conditions of use. EPA reconsidered the procedural framework
rule for conducting such risk evaluations and is revising certain
aspects of that framework to better align with the statutory text and
applicable court decisions, to reflect the Agency's experience
implementing the risk evaluation program following enactment of the
2016 TSCA amendments, and to allow for consideration of future
scientific advances in the risk evaluation process without need to
further amend the Agency's procedural rule.
DATES: This final rule is effective on July 2, 2024.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OPPT-2023-0496. All documents in the docket are listed on
the <a href="https://www.regulations.gov">https://www.regulations.gov</a> website. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available electronically through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Susanna Blair, Immediate Office, Office of Pollution Prevention and
Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460-0001; telephone number: (202) 564-4371; email
address: <a href="/cdn-cgi/l/email-protection#03616f626a712d707670626d6d62436673622d646c75"><span class="__cf_email__" data-cfemail="86e4eae7eff4a8f5f3f5e7e8e8e7c6e3f6e7a8e1e9f0">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#d682859597fb9eb9a2babfb8b396b3a6b7f8b1b9a0"><span class="__cf_email__" data-cfemail="dd898e9e9cf095b2a9b1b4b3b89db8adbcf3bab2ab">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
EPA is amending procedural requirements that apply to the Agency's
activities in carrying out TSCA risk evaluations. EPA is also amending
the process and requirements that manufacturers (including importers)
are required to follow when they request an Agency-conducted TSCA risk
evaluation on a particular chemical substance. You may be potentially
affected by this action if you manufacture or import chemical
substances regulated under TSCA. Since other entities may also be
interested, the Agency has not attempted to describe all the specific
entities and corresponding North American Industrial Classification
System (NAICS) codes for entities that may be interested in or affected
by this action. The following list of NAICS codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
<bullet> Petroleum Refineries (NAICS code 324110);
<bullet> Chemical Manufacturing (NAICS code 325);
<bullet> Unlaminated Plastics Film and Sheet (except Packaging)
Manufacturing (NAICS code 326113);
<bullet> Unlaminated Plastics Profile Shape Manufacturing (NAICS
code 326121);
<bullet> Plastics Pipe and Pipe Fitting Manufacturing (NAICS code
326122);
<bullet> Laminated Plastics Plate, Sheet (except Packaging), and
Shape Manufacturing (NAICS code 326130);
<bullet> Polystyrene Foam Product Manufacturing (NAICS code
326140);
<bullet> Urethane and Other Foam Product (except Polystyrene)
Manufacturing (NAICS code 326150);
<bullet> Plastics Bottle Manufacturing (NAICS code 326160);
<bullet> Plastics Plumbing Fixture Manufacturing (NAICS code
326191);
<bullet> All Other Plastics Product Manufacturing (NAICS code
326199);
<bullet> Tire Manufacturing (except Retreading) (NAICS code
326211);
<bullet> Tire Retreading (NAICS code 326212);
<bullet> Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220);
<bullet> Rubber Product Manufacturing for Mechanical Use (NAICS
code 326291);
<bullet> All Other Rubber Product Manufacturing (NAICS code
326299);
<bullet> Pottery, Ceramics, and Plumbing Fixture Manufacturing
(NAICS code 327110);
<bullet> Clay Building Material and Refractories Manufacturing
(NAICS code 327120);
<bullet> Flat Glass Manufacturing (NAICS code 327211);
<bullet> Other Pressed and Blown Glass and Glassware Manufacturing
(NAICS code 327212);
<bullet> Glass Container Manufacturing (NAICS code 327213);
<bullet> Glass Product Manufacturing Made of Purchased Glass (NAICS
code 327215);
<bullet> Cement Manufacturing (NAICS code 327310);
<bullet> Ready Mix Concrete Manufacturing (NAICS code 327320);
<bullet> Concrete Block and Brick Manufacturing (NAICS code
327331);
<bullet> Concrete Pipe Manufacturing (NAICS code 327332); and
<bullet> Other Concrete Product Manufacturing (NAICS code 327390).
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
EPA is promulgating this final rule pursuant to the authority in
TSCA section 6(b)(4) (15 U.S.C. 2605(b)(4)). EPA has inherent authority
to reconsider previous decisions and to revise, replace, or repeal a
decision to the extent permitted by law and supported by reasoned
explanation. See FCC v. Fox Television Stations, Inc., 556 U.S. 502,
515 (2009); see also Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto.
Ins. Co., 463 U.S. 29, 42 (1983).
C. What action is the Agency taking?
EPA is amending regulations that address how the Agency conducts
risk evaluations on chemical substances under TSCA. These changes
include, but are not limited to, targeted changes to certain
definitions, clarifications regarding the required scope of risk
evaluations, considerations related to peer review and the Agency's
implementation of the scientific standards, the approach for risk
determinations on chemical substances
[[Page 37029]]
and considerations related to unreasonable risk, and the process for
revisiting a completed risk evaluation. EPA is also amending the
process and requirements for manufacturers making a voluntary request
for an Agency-conducted risk evaluation.
D. Why is the Agency taking this action?
As further explained in Units I., II., III. and IV., EPA reexamined
the July 20, 2017, final rule (Ref. 1) (hereinafter ``2017 final
rule'') that established procedures and requirements for chemical risk
evaluation under TSCA, in consideration of:
<bullet> The statutory text and structure and Congressional intent.
<bullet> 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.
<bullet> Executive Order 13990, Protecting Public Health and the
Environment and Restoring Science to Tackle the Climate Crisis (Ref.
3).
<bullet> Lessons learned from the Agency's implementation of the
risk evaluation program to date including feedback from the National
Academies of Science Engineering and Medicine and scientific peer
reviewers.
The Agency is amending the 2017 final rule as a result of this
reexamination for the reasons explained elsewhere through the preambles
of the proposed and final rules and the response to comments.
E. What are the estimated incremental impacts of this action?
The incremental impacts of this action are associated with
procedural requirements, as described in Unit IV.J., which apply to
manufacturers when manufacturers (including importers) elect to request
that EPA perform a risk evaluation on a particular chemical substance.
EPA estimated the potential burden and costs associated with the
amended requirements for submitting a request for an Agency-conducted
risk evaluation on a particular chemical substance. The estimates of
burden and costs are available in the docket, and are discussed in Unit
VII.B. and briefly summarized here (Ref. 4).
The total estimated annual burden is 166 hours and $115,711 (per
year), which is based on an estimated per request burden of 166 hours.
In addition, EPA's evaluation of the potential costs associated
with this action is discussed in Unit VII.B. Since the incremental
impacts of this rule involve the activities that a manufacturer
requesting a risk evaluation must perform, the estimated incremental
costs to the public are expected to be negligible.
II. Background
The background for this rulemaking, including the statutory
requirements for risk evaluation, the judicial review of the 2017 final
rule, EPA's review of the 2017 final rule, and lessons learned from the
Agency's implementation of the risk evaluation program are discussed in
the notice of proposed rulemaking (Ref. 5 at pp. 74293 through 74294).
In response to public comments on the proposed rule and as
described in Units III. and IV., EPA is making a number of changes in
this final rule to provide additional clarification to EPA's process
for conducting risk evaluations under TSCA. These include, among other
changes, clarifications to: (1) Communications around which conditions
of use are significantly contributing to a determination that a
chemical substance presents unreasonable risk; (2) assumptions with
respect to worker exposures and consideration of reasonably available
information; (3) calculation of risk-based occupational exposure values
in the risk evaluation; (4) EPA's commitment to conduct risk
evaluations consistent with the ``best available science'' and based on
the weight of the scientific evidence; (5) application of systematic
review and methodological approaches consistent with those principles;
(6) the process and requirements for manufacturer-requested risk
evaluations; (7) EPA's potential identification of an overburdened
community as a potentially exposed or susceptible subpopulation; and
(8) peer review on TSCA risk evaluations.
EPA intends that the provisions of this rule be severable. While
there may be provisions of this rule that are inextricably intertwined
with other provisions, most of the provisions of this rule could
function sensibly without particular invalidated provisions.
Specifically, in many cases, the amendments to 40 CFR part 702
finalized in this rule involve separate elements of the risk evaluation
process--or even separate processes all together--and EPA's decision to
amend one portion of the rule was not dependent or reliant upon its
decision to amend other portions of the rule. Especially because of the
scope of the rule, it is not feasible to anticipate or address every
permutation of this concept here. However, EPA has considered how the
rule would function in various configurations and intends to preserve
the rule to the fullest extent possible if any individual provision or
part of this rule is invalidated.
To illustrate how various portions of this rule may be severable,
EPA proffers the following two examples. First, if a court were to find
flaw with a particular process provision (e.g., a provision pertaining
to publishing scope documents) and strike that provision, it would not
prevent EPA in any way from looking to other process provisions (e.g.,
a provision on soliciting peer review or on determining whether a
chemical presents an unreasonable risk) in conducting its risk
evaluations under this amended rule. While invalidating such provisions
could perhaps be disruptive to ongoing risk evaluations, it would not
prevent EPA from completing the rest of the evaluation consistent with
both the remaining portions of the rule and its obligations under TSCA.
Second, there are provisions that have little to no level of
interrelation in this rule. For example, EPA's processes under this
rule for conducting EPA-initiated risk evaluations and for reviewing
manufacturer requests for risk evaluations are wholly independent and
the invalidation of a provision (or even every provision) pertaining to
one such process would not impact EPA's ability to rely on the
remainder of the rule for the other process.
In additional to these examples, EPA notes that the ability of the
various provisions of this rule to function sensibly without
invalidated provisions is further illustrated by the history of the
first 10 risk evaluations following the 2016 amendments to TSCA.
Between 2016 and today, EPA has operated under the statutory mandate
itself, the 2017 final rule (82 FR 33726), and the version of that rule
that existed after Safer Chemicals, Healthy Families v. EPA, 943 F.3d
397 (9th Cir. 2019). Throughout this time, the risk evaluation process
as a whole has continued to function sensibly even as EPA promulgated
particular provisions and concepts through the 2017 rule and some of
those provisions and concepts were subsequently vacated by the Ninth
Circuit (e.g., the applicability of criminal penalties, determinations
on scientific standards, and the exclusion of legacy uses). For the
forgoing reasons, EPA finds that the amendments in this final rule are
generally severable.
III. Response to Public Comments
In response to the proposed rule, EPA received 30,434 public
comments. EPA determined that 90 were unique and responsive to the
request for comments (2 of which were form letter masters),
[[Page 37030]]
30,323 were copies of form letters, 11 were duplicates, and 10 were
non-germane. The commenters included industry trade associations,
advocacy organizations, a union, federal/state government agencies, a
tribal council, academic institutions, and individuals. Major comments
are discussed in the context of particular provisions in Unit IV. A
more detailed discussion is provided in the Response to Comment
Document for this rule and available in the docket (Ref. 6).
IV. Overview of Provisions in Final Rule
The purpose of this rulemaking is to update the risk evaluation
process established in 40 CFR part 702, subpart B outlining how EPA
will determine, pursuant to TSCA section 6(b)(4)(A), whether a chemical
substance presents an unreasonable risk of injury to health or the
environment. EPA's general objectives for the amendments to the
procedural rule are to: (1) Better align the TSCA risk evaluation
process with the statutory text and structure and Congressional intent;
(2) ensure that the risk evaluation process under TSCA is consistent
with the best available science and based on the weight of the
scientific evidence; (3) address the outcome of the Ninth Circuit
litigation on the 2017 final rule; (4) apply lessons learned to date to
improve the Agency's processes moving forward; and (5) enhance the
public's understanding of how EPA expects to carry out subsequent TSCA
risk evaluations. Improvements to the risk evaluation process in these
proposed amendments will result in stronger scientific products that
can support needed public health and environmental protections to limit
exposure to dangerous chemicals.
To accomplish these objectives, EPA is making targeted changes to
and clarifying the existing process by which the Agency evaluates risk
from chemical substances for purposes of TSCA section 6. The amended
procedural rule will ensure that the risk evaluation process and
outcomes are both scientifically and legally defensible, and
transparent, while allowing the Agency flexibility to adapt and keep
pace with changing science as it conducts TSCA risk evaluations into
the future.
A. General Provisions
EPA is finalizing the general provisions at 40 CFR 702.31 as
proposed. As stated in the rule at 40 CFR 702.31(c), the procedures
apply to all risk evaluations initiated 30 days after the date of the
final rule or later. EPA received several comments regarding the
applicability of the procedures to ongoing manufacturer-requested risk
evaluations (MRREs). For risk evaluations in process as of the date of
the final rule, EPA would expect to apply the proposed changes to those
risk evaluations only to the extent practicable, taking into
consideration the statutory requirements and deadlines. For MRRE
requests that EPA has already granted, for example, it would not be
practicable to apply the new upfront processes that occur prior to
granting requests, or the content requirements for incoming requests.
EPA believes it will be practicable, however, to make a single
determination of unreasonable risk on the chemical substance as
contemplated in the law and codified in this rule.
Similarly, EPA is finalizing the minor clarification with respect
to the applicability of this rule to risk evaluations on categories of
chemical substances in 40 CFR 702.31(d). EPA received comments in
support of this clarification, but also some comments that were more
generally apprehensive of category approaches in risk evaluations. This
rule does not prescribe how or whether the Agency will identify
categories appropriate for prioritization and risk evaluation. The
criteria for establishing categories are specified in TSCA section
26(c). If EPA does categorize chemicals as a category, EPA will
provide, on a case-by-case basis, the justification for inclusion of
the chemicals in a category. EPA fully recognizes the challenges and
complexities associated with defining categories and carrying out risk
evaluations on categories of chemical substances, and the need for its
action and decisions to be consistent with the best available science.
EPA also agrees that transparency on the rationale and approach will be
important should the Agency prioritize a category of chemical
substances for risk evaluation in the future. The intent of the rule is
simply to clarify that the procedural framework for evaluating chemical
substances also applies to risk evaluations on categories of chemical
substances.
EPA is also finalizing removal of the currently codified regulatory
text at 40 CFR 702.31(d) in accordance with the Ninth Circuit's vacatur
and remand of this provision applying criminal penalties to the
submission of inaccurate or incomplete information to EPA pursuant to a
manufacturer-requested risk evaluation (Ref. 7).
B. Technical Corrections and Reorganization
The proposed rule reflected a number of minor updates and
corrections and general organizational restructuring. Specifically,
references to 15 U.S.C. 2605(b)(2)(A) were removed in light of the fact
that the law's one-time requirement related to identification of the
first group of 10 chemicals for risk evaluation has been satisfied and
is no longer applicable for purposes of the procedural rule. EPA made
minor updates to the regulatory text to correct typos and to ensure
consistency in use of certain phrases (e.g., manufacturer-requested
risk evaluations). Additionally, EPA aimed to improve the readability
of certain provisions, and, ultimately, enhance the public's ability to
understand how EPA will undertake TSCA risk evaluations. As part of
this effort, EPA has reorganized the sequence and structure of
regulatory provisions to establish sections that distinguish between
the components of the risk evaluation, the analytic considerations to
be applied in the risk evaluation, and the associated procedural
timeframes and actions. The Agency received very few comments on these
changes and no commenter expressed confusion or decreased lack of
clarity. Therefore, EPA carried these changes through into the final
rule.
In addition, EPA made minor clarifying edits to the final rule at
40 CFR 702.35(b) regarding the number of allowable manufacturer-
requested risk evaluations as compared to the number of ongoing EPA-
initiated risk evaluations. Although this provision codifies the
statutory requirement at 15 U.S.C. 2605(b)(4)(E)(i), EPA slightly
modified the phrasing to make it easier for the reader to understand
and follow.
C. Definitions
EPA is finalizing minor updates to definitions for ``pathways,''
``routes,'' ``aggregate exposure,'' and ``sentinel exposure.'' The
final rule also maintains the definitions for ``act,'' ``conditions of
use,'' ``reasonably available information,'' ``uncertainty,'' or
``variability''--all unchanged from the 2017 final rule.
EPA proposed to eliminate the codified definitions for ``best
available science'' and ``weight of scientific evidence.'' In the
proposed rule, EPA explained that having codified definitions in the
procedural rule for these scientific terms was both unnecessary and
could inhibit the Agency's flexibility to quickly adapt to and
implement advancing scientific practices and approaches. EPA received a
number of comments on these proposed changes, including both support
for and opposition to eliminating the codified definitions. Commenters
who opposed generally expressed concern that elimination of
[[Page 37031]]
the definitions would reduce transparency and clarity about the
scientific standards that EPA will apply in risk evaluations, and/or
call into question whether EPA would still meet the scientific
standards in the law. EPA can say with confidence that the Agency is
fully committed to meeting the requirements in the law, and to being
transparent in each risk evaluation with respect to how scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models are being employed in a manner consistent with
the best available science and how decisions are based on the weight of
the scientific evidence, as required by 15 U.S.C. 2625(h) and (i). As
such, EPA is finalizing the removal of these definitions from the
codified regulatory text. Unit IV.H provides additional discussion of
how EPA will ensure that TSCA risk evaluations are consistent with the
best available science and based on the weight of the scientific
evidence.
EPA also proposed changes to the definition of ``potentially
exposed or susceptible subpopulation'' (PESS), which currently include
``infants, children, pregnant women, workers or the elderly.'' Namely,
EPA proposed to add the phrase ``overburdened communities'' to the list
of other examples of PESS that EPA might identify like ``infants,
children, pregnant women, workers, or the elderly.'' EPA received a
number of comments on the proposed changes to this definition. Many
commenters supported the change, and EPA's authority to expand upon the
illustrative list of examples Congress provided in the statutory
definition. Others opposed the change, citing concerns that it reflects
an intention by EPA to dramatically expand the scope of risk
evaluations in ways that can't conceivably be completed within
statutory deadlines. Others shared concern that the rule did not
provide objective criteria regarding how EPA would go about identifying
communities that are ``overburdened.'' After considering the comments,
EPA has determined to finalize the change to the PESS definition as
proposed. As a primary matter, the addition of ``overburdened
communities'' to this definition is not itself a determination. Rather,
it's an example of a subpopulation that EPA may identify as a PESS in
future risk evaluations, and it is reflective of the reality that--in
addition to groups like children and pregnant women--there are
communities of people that may experience disproportionate risks from
chemicals due to greater exposure or susceptibility to environmental
and health harms. EPA fully appreciates the enormity of its
responsibilities under TSCA--meeting statutory deadlines while ensuring
robust evaluations of risks to human health and the environment,
including risks to the most vulnerable populations--and is mindful that
meeting those challenges will require comprehensive approaches that are
carried out in a fit-for-purpose manner. EPA is also committed to
maximizing the transparency of its decisions--including the
identification of PESS--and believes that the requirements in this rule
will further all of these objectives. Additional discussion of EPA's
expected implementation of statutory requirements related to PESS can
be found in Unit IV.F.4.
D. Scope of TSCA Risk Evaluations
TSCA was amended in 2016 amidst a backdrop of tens of thousands of
unreviewed existing chemical substances in commerce, with no mandate
that EPA conduct any assessments to determine whether those existing
chemicals present unreasonable risk of injury to health or the
environment. The few assessments that EPA did undertake prior to 2016
were narrowly focused on specific uses of chemicals (e.g., paint and
coating removal, vapor degreasing, etc.). The 2016 amendments required
EPA to systematically prioritize those tens of thousands existing
chemicals for review, and then to evaluate their risks, holistically,
under the chemical's ``conditions of use''--a phrase that Congress
defined to capture a chemical's full lifecycle, i.e., ``the
circumstances, as determined by the Administrator, under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed
of.'' (15 U.S.C. 2602(4)). In so doing, Congress recognized that
comprehensive progress on evaluating tens of thousands of existing
chemicals would not be made without this mandate, coupled with a strong
risk-based safety standard and deadlines for completing the work. In
the absence of comprehensive risk evaluations on chemical substances
(i.e., under an approach that considered only a subset of a chemical's
uses or exposures), uncertainty as to whether EPA had fully addressed a
chemical's unreasonable risk would fester, eroding public confidence in
the safety of chemicals pervasive in our households, communities and
the environment, and encouraging states to adopt a patchwork of
regulatory measures to address chemical risks.
EPA's 2017 final rule left some ambiguities with respect to the
scope of TSCA risk evaluations, including whether EPA has discretion to
exclude conditions of use or exposure pathways, the limits of EPA's
discretion to determine what constitutes the conditions of use for a
particular chemical, and what other flexibilities that EPA may have in
its analytical approaches to ensure that comprehensive risk evaluations
can still be completed within Congress' aggressive statutory deadlines.
EPA proposed a number of important clarifications regarding the scope
of TSCA risk evaluations that EPA believes will result in stronger
scientific products that can support needed public health and
environmental protections to address risks from dangerous chemicals.
Those changes, a discussion of the public comments received, and EPA's
approach for the final rule are discussed in the sections that follow.
1. Inclusion of all conditions of use. EPA proposed a number of
changes to the regulatory text to make clear that the scope of TSCA
risk evaluations will not exclude any ``conditions of use'' (e.g., the
statement in 702.37(b)(4) that ``EPA will not exclude conditions of use
from the scope of the risk evaluation . . .''). As described in the
proposed rule, EPA believes that the better reading of TSCA's statutory
text and structure is that EPA lacks authority to exclude conditions of
use from the scope of the risk evaluation. Risk evaluations are to be
conducted on the circumstances under which the chemical is known,
intended and reasonably foreseen to be manufactured, processed,
distributed in commerce, used, and disposed of (i.e., activities that
constitute the ``conditions of use'' within the meaning of TSCA section
3(4)) (15 U.S.C 2602(4)). The plain language of TSCA section 6(b)(4)(A)
specifies that EPA must determine in a risk evaluation whether ``a
chemical substance'' presents an unreasonable risk of injury to health
or the environment ``under the conditions of use.'' Further, EPA
believes the phrase ``as determined by the Administrator'' in the
statutory definition of ``conditions of use'' means that EPA must apply
fact and professional judgment in determining whether or not a
particular circumstance is known, intended or reasonably foreseen--and
should not be viewed as authority to select among those circumstances
for inclusion or exclusion (15 U.S.C. 2602(4)).
A number of commenters supported EPA's proposed rule on this
important
[[Page 37032]]
point. Of the commenters who opposed this change, several pointed to
the language in TSCA section 6(b)(4)(D), which requires EPA to
identify--as part of the risk evaluation scope--the hazards, exposures,
and conditions of use that EPA ``expects to consider.'' EPA believes
this phrase is best read as directing the Agency to undertake a factual
identification of the conditions of use associated with the chemical
substance while acknowledging that the Agency's expectations at the
scoping phase may not always align perfectly with the conditions of use
actually considered and assessed in draft and final risk evaluations.
EPA does not interpret the ``expects to consider'' language in TSCA
section 6(b)(4)(D) to allow EPA to pick and choose which exposures to
include in a risk evaluation of a chemical substance. However, EPA has
some discretion; the identification of a chemical's conditions of use
falls squarely within EPA's purview and will necessarily involve the
Agency applying both fact and professional judgment, particularly with
respect to identifying whether a circumstance is reasonably foreseen.
See Unit IV.D.2. EPA also has discretion in tailoring its level of
analysis with respect to individual conditions of use within the scope
of the risk evaluation and may choose to, for example, take a more
qualitative approach to conditions of use that it determines are
negligible contributors to exposures and risks based on the reasonable
available information. EPA does not, however, view the statute as
providing authority to categorically exclude known conditions of use or
exposures from the scope of the risk evaluation entirely.
Contrary to some commenters' suggestions, EPA further believes that
such a reading is consistent with Congressional intent. The purpose of
the requirement to evaluate the ``chemical substance'' was to ensure
that the Agency, through the TSCA risk evaluation process, would
comprehensively determine whether a chemical substance, under the
known, intended, and reasonably foreseen circumstances of manufacture,
processing, distribution in commerce, use and disposal, presents an
unreasonable risk. If EPA were to take the approach suggested by
commenters and only evaluate a subset of a chemical's conditions of
use, the existence of unevaluated uses and exposures would perpetuate
uncertainties as to the safety of existing chemicals in the
marketplace--the very problem Congress sought to address through its
reform efforts.
Some commenters suggest that the Ninth Circuit's opinion in Safer
Chemicals, Healthy Families v. USEPA (Ref. 2) affirmatively determined
the issue of discretionary scoping authority, namely that EPA could
permissibly consider only some conditions of use in TSCA risk
evaluations. EPA disagrees; the Court did not state or imply as much
anywhere in its opinion (Ref. 2). To the contrary, the Court held that
the petitioners' challenge to the 2017 final rule on this point was not
ripe for review because EPA had not yet finalized a risk evaluation
that excluded conditions of use and the 2017 final rule text was
ambiguous on whether EPA actually would do so. Separately, the Court
was, however, unequivocal in striking down EPA's statements in the
preamble to the 2017 final rule regarding its intention to
categorically exclude ``legacy uses'' from TSCA risk evaluations,
finding that such an approach ``contradicts TSCA's plain language''
directing EPA to evaluate risks from chemical substances under the
conditions of use.
Several commenters characterized TSCA as a ``gap filling''
statute--regulating only exposures and conditions of use that are not
adequately addressed under other statutes. Although EPA is familiar
with the phrase from the legislative history of the original 1976 TSCA,
it is not found anywhere within the statute--original or as amended--
and has more recently been used in tandem with interpretive arguments
to inappropriately narrow the scope of TSCA risk evaluations. EPA
firmly rejected these arguments--that EPA should exclude conditions of
use and exposure pathways from TSCA risk evaluations when those uses/
exposures could be managed under the purview of another environmental
statute--in the proposed rule at Unit III.E. Such an interpretation
contradicts the plain language of the 2016 TSCA amendments directing
EPA to, without caveat, evaluate risks from chemical substances under
the conditions of use. EPA recognizes that there is a relevant
statutory provision (i.e., TSCA section 9) about whether risk
management to address identified risks is better achieved under TSCA or
another federal law. OCSPP is actively coordinating actions taken under
TSCA with actions taken under other Federal laws administered by EPA.
However, these risk management considerations cannot logically occur
until after risks are identified in the TSCA risk evaluation process--
not before or during--and are therefore inappropriate to use as a risk
evaluation scoping mechanism.
Finally, as described in the proposed rule, consideration of all
conditions of use in TSCA risk evaluations is also necessary from a
scientific perspective to ensure development of a technically sound
determination as to whether a chemical substance presents an
unreasonable risk of injury to health or the environment. Consideration
of all conditions of use ensures risk evaluations are consistent with
the best available science and based on the weight of scientific
evidence (15 U.S.C. 2625(h) and (i)). There may be situations where
certain individual conditions of use are associated with relatively
lower exposures, but when considered in aggregate contribute to
unreasonable risk. Exclusion of conditions of use from risk
evaluations--irrespective of the Agency's intention in so doing--may
deprive the public of a complete picture of the chemical's risk, and
prevent EPA from putting necessary protections in place to mitigate
such risk to the general population or potentially exposed or
susceptible subpopulations.
Risk evaluations that are comprehensive in scope--and therefore
consistent with the law--may also need to be balanced with fit-for-
purpose analytic approaches to keep the assessments manageable and able
to be completed within the law's deadlines. EPA is committed to
continuing to pursue and refine fit-for-purpose approaches in the
context of individual risk evaluations in a manner that enables EPA to
achieve Congress' goals for the protection of human health and the
environment, while also completing its actions within statutory
deadlines.
For these reasons, EPA is finalizing the changes to the rule
ensuring EPA will not exclude conditions of use from consideration
within the scope of TSCA risk evaluations.
2. Determination of ``conditions of use.'' As described in the
preamble to the proposed rule, EPA is distinguishing between the
Agency's lack of discretion to exclude conditions of use as described
in the previous section, and EPA's ability to exercise judgment in
making its determination as to whether a particular circumstance is
intended, known, or reasonably foreseen, and therefore falls within the
definition of ``condition of use'' for a particular chemical. For each
risk evaluation, and consistent with the phrase ``as determined by the
Administrator'' in the statutory definition of ``conditions of use,''
EPA must analyze the reasonably available information and apply the
facts, Agency expertise and professional judgment to determine that
chemical's conditions of use.
[[Page 37033]]
For example, when information suggests that a circumstance of
manufacture, processing, distribution in commerce, use or disposal is
known to be occurring, EPA will determine that known circumstance to be
a condition of use and include it within the scope of the risk
evaluation, irrespective of other factors like the likelihood of that
particular condition of use to be a significant contributor to risk.
Likewise, where, in the Agency's professional judgment, a circumstance
is reasonably foreseen to occur in the future, EPA will determine that
circumstance to be a condition of use and include it within the scope
of the risk evaluation, even where that condition of use may not
contribute significantly to the Agency's ultimate conclusions on risk.
As described in the preamble to the proposed rule, there are a
number of general categories of circumstances that are squarely
conditions of use that generally must be included within the scope of
TSCA risk evaluations, including ``legacy use'' and ``associated
disposal,'' production of a chemical as a byproduct, and the presence
of a chemical as an impurity or within an article. Conversely, the
Ninth Circuit opined that ``legacy disposal'' falls outside the
definition of conditions of use. Likewise, EPA does not expect to
consider ``intentional misuse'' of a chemical as a ``condition of
use,'' consistent with the legislative history (Ref. 8). EPA provided
several examples in the proposed rule of how the Agency would analyze
the reasonably available information to make the determination on
conditions of use--particularly with respect to determining whether or
not a circumstance is reasonably foreseen. EPA discussed, for example,
weighing whether exposures from spills, leaks, accidents and climate-
related impacts would be regular or predictable, versus those that are
unsubstantiated, speculative or otherwise not likely to occur. A future
one-time accident caused by an atypical one-time set of circumstances,
for example, would likely not be considered ``reasonably foreseen.''
EPA believes that this approach is consistent with the statutory text
and structure, as well as Congressional intent.
EPA received a number of comments in this area, including support
for considering chemical spills, accidents and other unplanned but
foreseeable chemical releases and comments urging EPA to consider such
scenarios on a more routine basis. Other commenters expressed concern
that EPA did not articulate precise criteria or a standard for
determining when a circumstance is reasonably foreseen. Consistent with
the discussion in the proposed rule preamble, EPA maintains, however,
that the determination of whether a particular circumstance is
reasonably foreseen--and therefore an exposure that must be considered
within the scope of the risk evaluation--is necessarily going to
require a fact-specific, chemical-by-chemical analysis. Ultimately,
EPA's determination on the chemical's conditions of use and the
rationale to support those conclusions will be subject to public review
and comment as part of each risk evaluation.
EPA also received comments that EPA should exclude so-called ``de
minimis'' uses from consideration in risk evaluations--such as uses
where a chemical may only be present in small amounts as an impurity or
within an article. EPA disagrees, and maintains the position described
in the preamble to the proposed rule. As described previously,
relatively low exposures individually may contribute to unreasonable
risk when considered in aggregate. Further, as EPA noted in the
proposed rule, even where a condition of use is not expected to be a
significant contributor to risk from a particular chemical, TSCA
nonetheless requires EPA to include it in the scope of the risk
evaluation. Such uses may, however, be appropriate for more tailored or
qualitative analyses--as supported by the reasonably available
information and documented in the risk evaluation--allowing EPA to
focus more detailed/intensive efforts on the conditions of use that
pose the greatest potential for exposure and therefore risk. Although
TSCA provides EPA with authority to ``determine'' the conditions of
use, it does not provide EPA with discretion to exclude from the scope
of risk evaluations known circumstances associated with the chemical
(e.g., legacy uses and associated disposal, production of the chemical
as a byproduct, presence of the chemical in trace or de minimis amounts
such as an impurity or within an article, etc.). Nonetheless, EPA
expects to conduct risk evaluations in a fit-for-purpose manner,
tailoring the level of analysis based on factors such as the
substance's physical-chemical properties; environmental fate and
transport properties; the likely duration, intensity, frequency, and
number of exposures under the condition of use; reasonably available
information about the release to the environment; and other relevant
considerations.
3. Inclusion of all exposure pathways. EPA also proposed regulatory
changes to ensure that EPA will assess all exposure routes and pathways
relevant to the chemical substance under the conditions of use. See 40
CFR 702.39(d)(9). As described in both the proposed rule and in Unit
IV.D.1 of this rule, EPA does not interpret TSCA section 6(b)(4)(D) to
provide authority to exclude conditions of use or exposure pathways
from the scope of TSCA risk evaluations. Likewise, EPA proposed
additional regulatory text to ensure that EPA would no longer exclude
from the scope of TSCA risk evaluations exposure pathways that are
addressed or could in the future be addressed by other EPA-administered
statutes and regulatory programs or under another Federal law
administered by another agency. See 40 CFR 702.39(d)(9). EPA does not
interpret TSCA section 9 to authorize exclusion of exposure pathways
from TSCA risk evaluations.
A number of commenters supported EPA's interpretation that the
plain language of the law requires the consideration of all relevant
exposure pathways in TSCA risk evaluations. Commenters who opposed
EPA's interpretation again pointed to the language in TSCA section
6(b)(4)(D), which requires EPA to identify--as part of the risk
evaluation scope--the hazards, exposures and conditions of use that EPA
``expects to consider.'' As described in Unit IV.D.1, EPA believes the
law requires the Agency to factually identify relevant exposures
associated with the chemical substance, while the ``expects to
consider'' phrasing reflects the reality of the process: that the
Agency's early expectations at the scoping phase may not always align
perfectly with the conditions of use actually considered and assessed
in the subsequent draft and final risk evaluations. For example,
exposures that EPA initially expects to consider may change as EPA
further considers and refines the reasonably available information
during the risk evaluation process. In any event, EPA does not view the
``expects to consider'' language in TSCA section 6(b)(4)(D) as
providing EPA with discretion to, for example, exclude known exposures.
Other commenters suggested that EPA's approach is inconsistent with
Congress' intent. EPA disagrees. The law's requirement that EPA
evaluate the ``chemical substance'' under the ``conditions of use'' was
to ensure that the Agency, through the risk evaluation process, would
comprehensively determine whether a chemical substance, under the
known, intended, and reasonably foreseen circumstances of manufacture,
processing, distribution in commerce, use and disposal, presents an
unreasonable risk. Further, it is only through this holistic approach
to chemical risk evaluation that EPA will
[[Page 37034]]
be able to drive forward progress on the tens of thousands of
unreviewed existing chemical substances in commerce. As described
earlier in Unit IV.D.1, the 2016 TSCA reform efforts were designed to
create more certainty and more confidence in the safety of existing
chemicals in the marketplace. However, and contrary to Congress' goals,
evaluating a subset of a chemical's exposures or conditions of use
would only perpetuate uncertainties.
EPA further disagrees with commenters that argued consideration of
a particular exposure pathway in a risk evaluation would conflict with
or duplicate other regulatory programs. First, where another regulatory
program has already assessed the risks from a chemical associated with
a particular exposure pathway, EPA would necessarily consider this
information--along with all other reasonably available information--as
part of its evaluation under TSCA. Where unreasonable risk has been
identified, EPA would consider, consistent with TSCA section 9, whether
all or part of such risk might be more appropriately managed under
another regulatory program implemented by EPA or another Federal
agency. Consideration of an exposure pathway in a TSCA risk evaluation
does not automatically mean that EPA will determine the chemical to
present unreasonable risk or that EPA will propose regulatory
requirements related to that particular exposure pathway. Nonetheless,
EPA recognizes that intra- and interagency coordination is integral to
ensuring that EPA actions are well-informed, effective, and efficient,
and expects to continue and expand upon efforts to maximize such
coordination moving forward.
Finally, EPA appreciates concerns expressed by some commenters that
this approach could result in more complex and challenging risk
evaluations. EPA disagrees, however, that considering all relevant
exposure pathways in TSCA risk evaluations is a ``missed opportunity''
to streamline its assessments. As discussed, EPA concludes in this rule
that the best interpretation of TSCA is that the law does not authorize
the exclusion of relevant exposure pathways from consideration in a
risk evaluation. EPA also observes that certain risk evaluations
published by EPA during the prior Administration were challenged,
including on the grounds that EPA's prior approach of excluding
exposure pathways was inconsistent with the requirements of TSCA. The
approach adopted in this rule may conserve judicial, EPA, and other
federal government resources by avoiding or reducing the need for such
litigation. In addition, EPA has discretion to carry out TSCA risk
evaluations in a fit-for-purpose manner, tailoring the depth or extent
of analysis commensurate with the nature and significance of the
decision, and expects to employ these approaches to enable completion
of risk evaluations within the statutory deadlines.
Accordingly, EPA is finalizing the changes in 40 CFR 702.39(d) as
proposed to ensure that EPA will assess all exposure routes and
pathways relevant to the chemical substance under the conditions of
use, including those that are regulated under other federal statutes.
4. Comprehensive but fit-for-purpose. EPA noted in the preamble to
the proposed rule that it does not believe risk evaluations under TSCA
should be so complex or procedurally cumbersome that they cannot
reliably be completed within the timeframes required by the statute. At
the same time, EPA cannot produce partial or incomplete TSCA risk
evaluations or pursue risk evaluations in a manner that is otherwise
incompatible with the statutory framework. The preamble to the proposed
rule provided a discussion of how EPA expected to balance resource
expenditure and manageability--namely by taking fit-for-purpose
approaches that allow for varying types and levels of analysis.
Some commenters supported this discussion, while others shared
reservations regarding whether fit-for-purpose approaches would ensure
adequate consideration of risks from low-volume chemicals, and whether
such approaches would meet the law's scientific standards in section
26. EPA fully recognizes that chemicals produced or used in low volumes
may not mean that such chemicals present low risk, particularly with
respect to persistent, bioaccumulative and toxic chemicals or aggregate
exposure. Any fit-for-purpose approach in a risk evaluation on such
chemicals would reflect this reality. Furthermore, EPA's fit-for-
purpose approaches will be subject to notice and numerous opportunities
for comment during the risk evaluation process. If a stakeholder
believes, for example, that EPA's qualitative approach to assessing a
particular condition of use or that its consideration of aggregate
exposures is insufficient, EPA would welcome specific feedback in the
context of that risk evaluation. EPA also agrees that it must adhere to
the scientific standards in TSCA section 26 when making science-based
decisions under TSCA section 6, including when conducting risk
evaluations in a fit-for-purpose manner, and appreciates the suggestion
that EPA consider developing guidance for how the Agency might apply
fit-for-purpose approaches in different circumstances. EPA believes
that fit-for-purpose approaches in risk evaluations are an essential
part of implementing the TSCA program and sustaining it over the long-
term.
5. Additional efficiencies. In the spirit of finding additional
efficiencies to help EPA meet the aggressive timeframes in the law for
completing risk evaluations, EPA sought comment on the idea of the
Agency publishing and taking comment during prioritization on
preliminary information to inform the scope of the potential risk
evaluation--a process that could result in the publication of the
``draft scope'' before the initiation of a risk evaluation. EPA
believes that a more sustainable process necessitates earlier--either
before or during the prioritization process--review of reasonably
available information, identification of data needs and gaps, and
preliminary efforts to scope the potential risk evaluation. EPA did not
propose to change the regulatory text requiring publication of a draft
scope ``no later than'' three months after initiation, but described an
approach where EPA would publish such information as early as the
prioritization process (e.g., concurrent with the proposed high-
priority designation), to allow the Agency more time to review and
effectively use the public input in the development of the risk
evaluation's scope.
Several commenters expressed support for this approach, noting that
it could result in clearer scopes, more efficient risk evaluations,
allow stakeholders to provide data earlier in the process, and increase
the value of public engagement. Some commenters who opposed the
approach argued that it was contrary to TSCA, which requires
publication of the risk evaluation scope ``not later than 6 months
after the initiation of the risk evaluation.'' Others suggested that
EPA instead provide a preliminary list of conditions of use during
prioritization and make it available for public comment.
EPA notes that TSCA does not actually require the development of a
draft scope. It is a regulatory requirement in the 2017 final rule (and
maintained in this rule) designed to afford the public an opportunity
to provide comment on the scope of the risk evaluation before it is
finalized. EPA will continue to abide by the statutory requirement to
publish the final scope within the first 6 months
[[Page 37035]]
after initiation of a risk evaluation. EPA has already been maintaining
the practice of publishing a preliminary list of conditions of use
during the Proposed Designation step of the prioritization process, as
some commenters suggest. However, EPA sees additional value in
publishing more robust preliminary information on the conditions of
use, hazards, exposures and potentially exposed or susceptible
subpopulations that the Agency expects to consider and any early
indications as to how the Agency may apply fit-for-purpose approaches.
Public comments received on this information can inform the final
priority designation and, if the chemical is then designated as a high
priority substance, the scope of the risk evaluation.
E. Risk Determinations
1. Single determination on the ``chemical substance.'' EPA proposed
to codify a requirement that EPA make a single risk determination on
the chemical substance at the conclusion of the TSCA risk evaluation
process, as opposed to individual risk determinations on each
individual use of the chemical. As explained in the proposed rule, EPA
believes that this approach reflects a plain reading of the statutory
text and structure. EPA also believes that this approach is consistent
with Congressional intent, and will enable the Agency's risk
determinations to better reflect the potential for combined exposures
across multiple conditions of use. TSCA section 6(b)(4)(A) specifies
that a risk evaluation must determine whether ``a chemical substance''
presents an unreasonable risk of injury to health or the environment
``under the conditions of use.'' EPA views this language as requiring
an evaluation on the chemical substance--not individual conditions of
use--and for the evaluation to be based on the chemical's ``conditions
of use.'' As further described in the proposed rule, EPA explained its
intention to continue to consider exposures associated with each
condition of use, but to no longer make separate risk determinations.
EPA received comments supportive of this interpretation and its
proposed codification, and others that disagreed with the
interpretation. Commenters who disagreed with EPA's interpretation
argued that the phrase ``under the conditions of use'' modifies the
statutory directive in TSCA section 6(b)(4)(A) requiring EPA to
determine ``whether a chemical substance presents an unreasonable risk
of injury to health or the environment'' and that EPA could therefore
not determine risks from a chemical substance independently from those
conditions of use. EPA agrees that TSCA requires consideration of the
chemical's conditions of use (i.e., the intended, known and reasonably
foreseen circumstances under which the chemical is manufactured,
processed, distributed in commerce, used or disposed of) and that the
potentially different exposure scenarios presented by different
conditions of use should be reflected in the risk evaluation's exposure
assessment. However, the plain language of the law requires EPA to
determine whether the chemical substance, rather than individual
conditions of use, presents an unreasonable risk. Moreover, the plain
language instructs EPA to do so ``under the conditions of use''
(plural), not under each individual condition of use. As such, EPA's
determination is based on analysis of the chemical's conditions of
use--rather than on each condition of use ``independently'' as
commenters would suggest. In addition to aligning EPA's process with
the statutory text and structure, this approach ensures that the Agency
is best positioned to incorporate reasonably available information,
make determinations consistent with the best available science and
based on the weight of scientific evidence, including, where
appropriate, risk determinations that consider aggregate exposure
resulting from multiple conditions of use. (15 U.S.C. 2625(h), (i), and
(k)).
As such, EPA's interpretation is unchanged from the discussion in
the proposed rule, and EPA is finalizing the regulatory text and
conforming changes that ensure risk evaluations will always culminate
in a single risk determination on the ``chemical substance,'' including
the language in 40 CFR 702.37(a)(5) and 40 CFR 702.39(f)(1).
2. Risk communication related to single risk determination. EPA is
aware of concerns that a single risk determination on the chemical
substance--especially where only certain uses are contributing to that
determination--could lead to public confusion regarding the chemical's
risks. EPA believes these risk communication issues are addressable,
and it is a priority area the Agency is committed to improve upon. As a
start, EPA is no longer referring to this as a ``whole chemical''
approach, as the Agency believes that phrase may be misinterpreted. A
single determination that a chemical substance presents an unreasonable
risk does not mean that the entirety or whole of that chemical's uses--
or even a majority of uses--presents an unreasonable risk. Where one or
more conditions of use for the chemical present an unreasonable risk,
the chemical substance itself necessarily presents an unreasonable
risk. EPA is committed to being clearer in its communications on this
point, including what to expect during risk management as described in
the next section. To provide some additional assurances, EPA proposed
regulatory text at 40 CFR 702.37(a)(5) that states: ``. . . where EPA
makes a determination of unreasonable risk, EPA intends to identify the
conditions of use that significantly contribute to such
determination.''
Commenters nonetheless continued to express concern that the single
risk determination would result in EPA determining that every chemical
presents unreasonable risk, and ultimately create confusion within the
general public regarding which uses of a chemical do or do not present
risk. EPA appreciates the concerns regarding clear risk communication
as part of each risk determination but disagrees with the suggestion
that the single risk determination approach will lead to a finding of
unreasonable risk in every instance. EPA does not pre-determine the
outcome of any risk evaluation activity. Likewise, the law does not
provide for or guarantee a particular risk determination outcome
either.
In response to these comments, EPA is strengthening its commitment
in the final rule to identify which conditions of use are significant
contributors to the unreasonable risk by changing the text to indicate
a more affirmative ``will identify'' from the proposed ``intends to''
and by moving the regulatory text directly into the section on the
``Unreasonable Risk Determination'' at 40 CFR 702.39(f). While not
necessarily a perfect indicator of how EPA will ultimately regulate to
address unreasonable risk, this communication should give industry
stakeholders significant insight and more certainty. Additionally, the
process for developing risk management rules under TSCA provides
numerous opportunities for public and stakeholder engagement, and
allows EPA to consider existing risk management controls and
approaches. In addition to providing a rationale and explanation in the
risk determination itself, the Agency is further committed to clearly
communicating on the Agency's analysis of particular uses in other
venues, and will refrain from making unqualified statements about the
risk associated with the chemical substance that could generate the
type of confusion commenters are concerned about.
EPA would caution, however, on placing too much emphasis on
[[Page 37036]]
communicative value of the risk determination itself. For those
chemical substances that EPA determines present unreasonable risk, the
risk evaluation is not the end of the TSCA process. The primary purpose
of a risk evaluation is not to provide the public with guidance or
suggested actions with respect to particular chemical uses. Risk
evaluations are scientific documents intended to inform EPA decisions
on the regulatory actions needed to address any identified unreasonable
risk to human health or the environment. Ultimately, when the TSCA
existing chemicals review process--including any TSCA section 6(a)
rulemaking to manage risk--is complete, the public should have full
confidence that the chemical can only be manufactured, processed,
distributed in commerce, used and disposed of in accordance with the
associated risk management requirements, and that the chemical
substance no longer presents an unreasonable risk.
3. Regulatory approaches based on single risk determination.
Several commenters suggested that EPA will use a singular risk
determination to regulate in an overly broad manner, creating
unnecessary and duplicative requirements, and shifting the burden to
industry to demonstrate that they should not be regulated.
An unreasonable risk determination on the chemical substance does
not mean that EPA will regulate all conditions of use for that
chemical, and EPA disagrees with commenters' suggestion to the
contrary. To be clear: a single risk determination on the chemical
substance will not increase regulatory burden. The determination itself
(i.e., ``EPA has determined that `chemical x' presents an unreasonable
risk . . .'') has no bearing on which conditions of use EPA will focus
on during the risk management phase. EPA's statutory authority to
regulate chemicals under TSCA section 6 is available only ``to the
extent necessary so that the chemical substance or mixture no longer
presents [unreasonable] risk.'' (15 U.S.C. 2605(a)). The basis for EPA
to determine the extent of necessary regulation in this context comes
from the entirety of the risk evaluation--not simply the risk
determination. Take for example, a scenario where an unreasonable risk
is driven by just a few conditions of use, and EPA determines that such
risk can be eliminated through regulations that apply narrowly to just
those conditions of use. EPA would expect to target its risk management
approaches accordingly and would not apply requirements more broadly.
Further, a single risk determination on the chemical substance does not
shift burdens from EPA to industry. It remains EPA's burden to provide
the scientific support for any proposed and final rules to address
unreasonable risk, and to demonstrate how such proposed action is
necessary to address the unreasonable risk identified in the risk
evaluation.
EPA also strongly disagrees that a single risk determination on the
chemical substance would be unscientific or arbitrary. EPA's basic
methodological approach to risk assessments is unchanged in this rule.
For every chemical, EPA will, using the best available science and
based on the weight of scientific evidence, conduct a hazard
assessment, conduct an exposure assessment based on the chemical's
conditions of use, characterize the risks, propose a determination as
to whether the risk is unreasonable under TSCA, and conduct a
transparent and independent scientific peer review with opportunities
for public comment. The process itself is embodied in this procedural
framework rule and has been subject to public notice and comment, as
will each individual draft risk evaluation.
4. Preemption of state laws/regulations. EPA received comments
suggesting that making a single risk determination on a chemical
substance would undermine Congress' intent with respect to the state
preemption provisions in TSCA section 18. Some commenters suggest that
this risk determination approach--coupled with the belief that it would
result in a determination of unreasonable risk in every case--would
either effectively eliminate the possibility of preemption for specific
conditions of use that do not present an unreasonable risk or alter the
scope of preemption applied. Some commenters also note that EPA's
approach results in a delay in application of permanent preemption.
Specifically, commenters point out that a ``no unreasonable risk''
determination for a particular condition of use under commenters'
approach could lead to a section 6(i)(1) determination triggering
permanent preemption sooner than under EPA's approach. As a result,
under EPA's approach, commenters suggest that state-specific approaches
to regulating chemicals will increase during that delay time, resulting
in the patchwork of state regulations that Congress sought to address
in the 2016 amendments.
Commenters have a fundamental misunderstanding of EPA's
interpretation of TSCA section 18 as it relates to preemption. Even if
one were to accept commenters' hypothesis that a single risk
determination would lead to a determination of unreasonable risk in
every case (which EPA rejects), such an approach does not eliminate
preemption or otherwise make any aspect of TSCA section 18 superfluous
for conditions of use EPA addresses in its risk evaluation. First,
pause preemption under section 18(b) applies only during the risk
evaluation process and is entirely unaffected by how EPA frames its
risk determination at the conclusion of that process. Permanent
preemption is triggered under section 18(a)(1)(B)(ii) if EPA issues
first a scope of the risk evaluation under section 6(b)(4)(D) and then
a section 6(a) final rule or section 6(i)(1) determination based on the
risk evaluation. The scope of this preemption is addressed in section
18(c)(3) and EPA reads this provision to apply permanent preemption to
any condition of use within the scope of the risk evaluation which is
the support document for any resulting section 6(a) rule or section
6(i)(1) determination. In the context of a section 6(a) rule, this is
the case irrespective of whether those uses contribute to the
unreasonable risk and/or are targeted for risk management. Thus, the
scope of permanent preemption is the same under either a single risk
determination for the chemical substance or the use-based approach
previously applied. Consequently, while EPA disagrees with commenters'
reading of TSCA with respect to the requirement for a single risk
determination on the chemical substance, EPA agrees with commenters
that Congress intended permanent preemption to apply to conditions of
use EPA addresses in the risk evaluation.
The real distinction between the risk determination approaches is
not whether preemption will occur or the scope of that preemption, but
when (since, under the prior use-based approach, an order of no
unreasonable risk could precede a rulemaking on other uses that do
present unreasonable risk). EPA is not persuaded that such difference
will result in a patchwork of unworkable and confusing requirements
among the states as claimed by commenters. It is entirely speculative--
and quite unlikely in EPA's view--to suggest that multiple States will
seek to inconsistently regulate a particular chemical or certain
conditions of use for a particular chemical during such a short period
of time, i.e., after issuance of the risk determination when pause
preemption ceases and prior to the effective date of a TSCA section
6(a) rule when permanent preemption
[[Page 37037]]
applies, while EPA actively works to finalize a comprehensive national
approach to risk management for that same chemical.
Regardless, as explained in Unit IV.E.1., EPA has concluded that
the chemical-based approach to risk determination is required under a
plain reading of the statutory text and structure and consistent with
Congressional intent. EPA further notes, as described in the proposed
rule, that the plain language in TSCA section 18 also supports the view
that Congress intended EPA to make a single risk determination on the
chemical substance, namely, the numerous references to ``chemical
substance'' as opposed to uses of a chemical substance, and
``determination'' in the singular.
5. ``Unreasonable risk'' considerations. Neither TSCA nor this rule
define ``unreasonable risk'' given the inherently unique nature of each
risk evaluation and the need for EPA to make this determination on a
case-by-case basis. The proposed rule included a discussion of
considerations EPA may weigh in determining unreasonable risk,
including, but not limited to: The effects of the chemical substance on
health and human exposure to such substance under the conditions of use
(including cancer and non-cancer risks); the effects of the chemical
substance on the environment and environmental exposure under the
conditions of use; the population exposed (including any potentially
exposed or susceptible subpopulations), the severity of hazard (the
nature of the hazard, the irreversibility of hazard), and
uncertainties. Additionally, the proposed rule includes a discussion of
how EPA will also consider, where relevant, the Agency's analyses on
aggregate exposures and cumulative risk in its risk determinations. EPA
also proposed to codify at 40 CFR 702.39(f)(1) the statutory
requirement to consider the risks to potentially exposed or susceptible
subpopulations as part of its risk determination on a chemical
substance. EPA did not receive significant comments on this topic and
is finalizing this rule as proposed.
F. Risk Evaluation Considerations
1. Occupational exposure assumptions. EPA proposed new regulatory
text at 40 CFR 702.39(f)(2) to ensure that ``consideration of
occupational exposure scenarios will take into account reasonably
available information'' and that EPA will ``not consider exposure
reduction based on assumed use of personal protective equipment as part
of the risk determination.'' As described in the proposed rule, EPA had
previously assumed that workers were provided and always used personal
protective equipment (PPE) in a manner that achieves the stated
assigned protection factor (APF) for respiratory protection, or used
impervious gloves for dermal protection. However, EPA believes that the
assumed use of PPE in a risk determination could lead to an
underestimation of the risk to workers. For example, as described in
the proposed rule, workers may be highly exposed because they are not
covered by Occupational Safety and Health Administration (OSHA)
standards, their employers are out of compliance with OSHA standards,
the PPE is not sufficient to address the risk from the chemical, or
their PPE does not fit or function properly. Many of OSHA's chemical-
specific permissible exposure limits were adopted in the 1970s and have
not been updated since they were established (Ref. 9). Additionally,
TSCA risk evaluations are subject to statutory science standards, an
explicit requirement to consider risks to potentially exposed or
susceptible subpopulations, and a prohibition on considering costs and
other non-risk factors when determining whether a chemical presents an
unreasonable risk that warrants regulatory actions--all requirements
that do not apply to development of OSHA regulations. The proposed
addition would codify EPA's more recent practices and ensure fulsome
consideration of exposure and risks to workers as part of TSCA risk
evaluations.
A number of commenters strongly supported EPA's proposed changes,
arguing that EPA's previous approach was inconsistent with the law.
Others disagreed, stating that the proposed changes would result in
overestimates of worker exposures, inaccurate risk determinations, and
overly restrictive risk management actions. EPA recognizes that many
companies likely have well-established occupational control measures in
place. EPA has, in various contexts, received public comments from
industry about occupational safety practices currently in use at their
facilities, including adherence to OSHA standards and non-OSHA industry
guidelines. EPA also acknowledges that other Federal agencies and their
contractors that use chemicals may similarly have well-established
occupational control measures in place. EPA would emphasize that the
proposed rule states ``in determining whether unreasonable risk is
presented, EPA's consideration of occupational exposure scenarios will
take into account reasonably available information. . . .'' Where
information on known occupational control measures is made available,
the Agency is committed to taking that information into account in the
exposure assessment. EPA has been consistent in urging industry to
provide the Agency with information regarding worker exposure controls.
Information from the risk evaluation's exposure assessment is also
considered in risk management action and can be useful in facilitating
consistency with broader industry best practices where possible. EPA
encourages commenters to continue engaging with EPA on this point on
chemical-specific actions and to provide the Agency with timely and
relevant data that can be considered during the TSCA process.
Other commenters took issue with what they characterized as EPA's
lack of support for an assumption that workers disregard PPE
requirements, or that there is widespread noncompliance with OSHA. EPA
disagrees with these characterizations. The proposed change in this
rule is that EPA will not ``assume use'' of PPE for purposes of the
risk determination--not that EPA will assume no use of PPE. Likewise,
EPA is not asserting there is widespread noncompliance with OSHA
requirements. As described earlier, EPA's exposure assessment on each
chemical will be informed by the reasonably available information, and
EPA encourages companies to submit information on their occupational
exposure control practices, including the extent to which those
practices may be standard for an industry, and any associated support.
Further, EPA distinguishes ``assumed use'' of PPE from use that is
supported by the reasonably available information and therefore known
to be inherent in the performance of an activity. For example, where
EPA has reasonably available information that substantiates use, fit,
and effectiveness of PPE (e.g., information demonstrating that
performance of a condition of use is impossible in the absence of PPE),
EPA would expect to take that information into account in the risk
determination.
A number of commenters also argue that the proposed changes in the
TSCA risk evaluation process would result in TSCA risk management
efforts that duplicate or confuse OSHA standards. EPA's development of
risk management rules under TSCA is a separate process that provides
numerous opportunities for public engagement, and allows EPA to
consider existing risk management controls and approaches to avoid or
[[Page 37038]]
minimize regulatory overlap or duplication. EPA rejects the notion that
Congress provided OSHA with exclusive jurisdiction over worker safety.
Congress explicitly directs EPA to evaluate and manage chemical risks
to workers in TSCA. Although EPA has not suggested that OSHA is not
meeting its own statutory requirements, OSHA itself acknowledges the
limits of its authority to regulate exposures to hazardous chemicals.
For example, and as described more in the proposed rule, OSHA lacks
direct jurisdiction over state and local government workers, and does
not cover self-employed workers, military personnel, and uniquely
military equipment, systems, and operations, and workers whose
occupational safety and health hazards are regulated by another Federal
agency (for example, the Mine Safety and Health Administration, the
Department of Energy, or the Coast Guard). EPA coordinates with OSHA on
TSCA actions on a regular basis. Where unreasonable risk to workers has
been identified, EPA would consider, consistent with TSCA section 9,
whether such risk might be more appropriately managed under another
regulatory program implemented by EPA or another Federal agency.
Similarly, EPA disagrees that the proposed changes regarding worker
PPE assumptions would duplicate or confuse existing standards in other
industries. Where stakeholders have information that demonstrates
effective occupational exposure control practices for the chemical
undergoing risk evaluation--whether through implementation of
regulatory requirements imposed by other Agencies or in keeping with
the standards of a particular industry--EPA encourages submission of
that information to inform both the risk evaluation and risk management
processes.
After consideration of these comments, EPA is finalizing the
regulatory text at 40 CFR 702.39(f)(2) as proposed. However, and to
further emphasize EPA's commitment to consider reasonably available
information with respect to occupational exposure control practices as
part of the risk evaluation, EPA is finalizing additional regulatory
text to that effect in the exposure assessment section at 40 CFR
702.39(d). As described in Unit IV.F.5., EPA is further committing to
make publicly available any risk-based occupational exposure values
calculated as part of the risk evaluation.
2. Aggregate exposure. The proposed rule included regulatory text
committing the Agency to consider aggregate exposures as part of TSCA
risk evaluations and, when supported by reasonably available
information, consistent with the best available science and based on
the weight of scientific evidence, to include an aggregate exposure
assessment in the risk evaluation, or otherwise explain the basis for
not doing so. See 40 CFR 720.39(d)(8). EPA also proposed minor
revisions to the definition of ``aggregate exposure.'' These changes
relate to the implementation of TSCA section 6(b)(4)(F)(ii), which
provides that EPA must ``describe whether aggregate or sentinel
exposures to a chemical substance under the conditions of use were
considered, and the basis for that consideration.'' These changes are
consistent with the definition used in General Principles for
Performing Aggregate Exposure and Risk Assessments (Ref. 10).
Several commenters expressed support for this change and offered
additional suggestions to strengthen the requirement. Other commenters,
while supportive of consideration of aggregate exposure generally,
shared some concerns that aggregate exposure assessments may extend the
time it will take EPA to complete a risk evaluation. Still other
commenters argue that consideration of aggregate exposure will
unnecessarily complicate risk evaluations and prevent the Agency from
meeting its statutory deadlines. These comments reflect two broad
competing challenges for EPA: how to carry out robust risk evaluations
that capture the full extent of risks faced by communities--including
risks from aggregate exposures--that will position EPA to protect
against those risks, and how to keep those processes manageable in
order to meet clear statutory requirements and deadlines set by
Congress and to actually provide protections via risk management.
EPA believes the consideration of an aggregate exposure assessment
may be particularly important to characterize and assess chemical risks
to overburdened communities. If a community is exposed to a chemical
substance through multiple routes and/or pathways (e.g., exposure via
air, land, and water, exposure via drinking water and water recreation,
and/or exposure via occupation-related activities) and/or from multiple
sources (e.g., through different conditions of use occurring at
multiple nearby facilities or from multiple products), the Agency has
clear authority to aggregate those exposures, subject to the scientific
standards in TSCA section 26. Furthermore, in developing a
comprehensive risk estimate for a chemical substance, it is the
Agency's responsibility, when supported by the best available science,
to consider the aggregation of individual exposures from individual
conditions of use as well as consider aggregate exposure from multiple
routes of exposure that may contribute to unreasonable risk. As
described in the proposed rule, it may be appropriate to consider
potential background exposures from non-TSCA uses that are not within
the scope of the risk evaluation as part of an aggregate exposure
assessment. Likewise, EPA could consider the disproportionate impacts
that background exposures may have on overburdened communities to
inform the final unreasonable risk determination.
On the other hand, EPA is mindful that Congress did not intend for
TSCA risk evaluations to take longer than the 3.5 years allotted in the
statute. Aside from just meeting legal responsibilities, staying within
statutory deadlines also allows EPA to keep pace on working through the
tens of thousands of unreviewed existing chemicals and propose/finalize
rules to afford meaningful protections for human health and the
environment.
EPA believes the proposed rule strikes the appropriate balance on
considering aggregate exposures in TSCA risk evaluations, and, after
considering public comments on this issue, is finalizing the new
regulatory text as proposed.
3. Cumulative risk. Although EPA did not propose any regulatory
changes regarding consideration of cumulative risk, advancing the
science of cumulative risk is a high priority for the Agency to inform
EPA's effort to better understand and mitigate risks to potentially
exposed and susceptible subpopulations. In the preamble to the proposed
rule, EPA noted that the best available science may indicate that the
development of a cumulative risk assessment--looking at the combined
health risk from multiple chemicals--is appropriate to ensure that risk
to human health and the environment is adequately characterized. EPA
further noted that TSCA provides the Agency the authority to consider
the combined risk from multiple chemical substances or a category of
chemical substances. (15 U.S.C. 2625(c)). EPA sought comment on how the
Agency could incorporate provisions for cumulative risk assessment into
the risk evaluation procedures in a way that would accommodate future
advancements in the science of cumulative risk assessment as well as
ensure that the scope and complexity of any such assessments is
consistent with what
[[Page 37039]]
Congress envisioned when it established deadlines for conducting risk
evaluations.
Some commenters offered support for EPA's discussion on cumulative
risk assessment as well as suggestions for going further, such as
including a definition of ``cumulative risk'' in the rule. Another
commenter cautioned against qualitative fit-for-purpose approaches
undermining EPA's ability to effectively carry out a cumulative risk
assessment. Another commenter, while supportive of advancing the
science on cumulative risk assessment, shared concern about such an
approach preventing EPA from timely completing risk evaluations and
proposing necessary regulatory protections. Other commenters opposed
consideration of cumulative risk. A number of commenters suggested that
provisions requiring consideration of cumulative risk would further
delay completion of risk evaluations. Others argued that such
considerations are not allowable under TSCA.
EPA appreciated the range of perspectives shared by commenters.
With respect to the comment that EPA should define cumulative risk in
the regulatory text, EPA is not inclined to do so at this time, as
there is no mention of ``cumulative risk'' in the rule or the law that
would warrant a codified definition. EPA did, however, describe
cumulative risk assessment in the preamble to the proposed rule, and
has defined the phrase in ``EPA's Framework for Cumulative Risk
Assessment'' (Ref. 11). EPA expects to continue to develop robust
methodology for the inclusion of cumulative risk assessment in TSCA
risk evaluations, and to continue to engage with stakeholders as part
of that process. EPA believes that quantitative analyses may be
necessary to support cumulative risk assessments, and will consider the
appropriate analyses carefully when developing and pursuing any fit-
for-purpose approaches. EPA disagrees with the suggestion that
cumulative risk assessment is not allowable under TSCA. As described in
the proposed rule, TSCA requires that EPA consider the reasonably
available information, consistent with the best available science, and
make decisions based on the weight of the scientific evidence (15
U.S.C. 2625(h), (i), and (k)). For some chemical substances undergoing
risk evaluation, the best available science may indicate that the
development of a cumulative risk assessment is appropriate to ensure
that risk to human health and the environment is adequately
characterized. Finally, EPA again appreciates commenters' concerns
regarding the potential for cumulative risk analyses to increase the
complexity of TSCA risk evaluation and create challenges for the Agency
to timely complete them. As described in Unit IV.D.4, EPA intends to
apply fit-for-purpose approaches in risk evaluations to ensure
completion within the statutory timeframes, while also building a
robust scientific basis for the effective characterization and
management of unreasonable risk to human health and the environment.
After considering these comments, EPA is finalizing this rule
without an explicit requirement related to cumulative risk assessment.
EPA is nonetheless committed to considering and applying cumulative
risk assessment approaches for future chemicals undergoing risk
evaluation, where supported by the reasonably available information and
best available science.
4. Potentially exposed or susceptible subpopulations. TSCA requires
EPA to evaluate risk to ``potentially exposed or susceptible
subpopulation[s]'' identified as relevant to the risk evaluation by the
Administrator, under the conditions of use. (15 U.S.C. 2605(b)(4)(A)).
TSCA defines potentially exposed or susceptible subpopulation (PESS) as
``a group of individuals within the general population identified by
the EPA who, due to either greater susceptibility or greater exposure,
may be at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture, such as
infants, children, pregnant women, workers, or the elderly.'' (15
U.S.C. 2602(12)). EPA codified the statutory definition in the 2017,
noting at that time that TSCA does not further define ``greater
susceptibility'' or ``greater exposure'' giving the Agency discretion
to interpret these terms. As such, the law authorizes EPA to identify
any subpopulation that may be at greater risk due to greater
susceptibility or exposure, and, likewise, to identify additional
subpopulations beyond those examples listed in the statute, as relevant
to a risk evaluation.
In this rule, and as described in Unit IV.C., EPA proposed to amend
the regulatory definition of PESS by adding the term ``overburdened
communities'' to the list of example subpopulations. This additional
term reflects the Agency's understanding and acknowledgment that a
chemical substance may disproportionately expose and/or may
disproportionately impact communities already experiencing
disproportionate and adverse human health or environmental burdens.
Such disproportionality can be as a result of greater exposure or
vulnerability to environmental hazards, lack of opportunity for public
participation, or other factors. Increased exposure or vulnerability
may be attributable to an accumulation of negative or lack of positive
environmental, health, economic, or social conditions within these
populations or places. The term describes situations where multiple
factors, including both environmental and socio-economic stressors, may
act cumulatively to impact health and the environment and contribute to
persistent environmental health disparities. These situations may apply
to communities with environmental justice concerns.
Many commenters supported this proposed change and agreed with EPA
that the examples provided in the statutory definition were
illustrative rather than limiting. Others urged EPA to go even further
by either specifically defining ``overburdened communities'' or
including additional factors in the definition of ``potentially exposed
and susceptible subpopulations'' like the consideration of non-chemical
stressors (Ref. 12) that may increase susceptibility. Other commenters
opposed adding ``overburdened communities'' to the definition of PESS,
arguing that EPA lacks authority to add additional criteria to the PESS
definition beyond what's included in the law. A few commenters
suggested that ``overburdened communities'' does not fit with the other
types of groups provided as examples in TSCA because they refer to
individuals rather than a subpopulation defined by its location or
geographic proximity. Some commenters argued the term was too
subjective and that EPA did not provide sufficient clarity in how it
would identify such communities or quantify ``overburdened.''
EPA does not believe it is necessary to define ``overburdened
communities'' as part of this rule. In the same way that EPA considers
whether children or workers or the elderly are a PESS in the context of
a specific risk evaluation, EPA will look to whether ``overburdened
communities'' are subject to exposure or susceptibility greater than
the general population. EPA does not intend this term to be confined to
a location or geographic proximity, but would use reasonably available
information for each chemical to determine the inclusion of specific
communities. Those experiencing ``greater exposure'' could include
individuals or communities experiencing higher levels of exposure to a
chemical substance due to
[[Page 37040]]
geography (e.g., fenceline communities in close proximity to facilities
emitting air pollutants or living near effluent releases to water),
unique exposure pathways that differ from those of the general
population (e.g., Tribal communities where reliance on subsistence
fishing results in increased chemical exposure via ingestion), and/or
aggregate exposure via multiple conditions of use (e.g., a worker who
lives in close proximity to facilities emitting air pollutants). As
discussed in Unit III.G.4. of the proposed rule, communities with
``greater susceptibility'' could include communities that due to their
proximity to a higher proportion of industrial emitters may be
experiencing greater burden or those with an increased risk of
experiencing an adverse effect due to one's lifestage or a pre-existing
condition or circumstance (Ref. 5). Although EPA certainly agrees that
non-chemical stressors can increase susceptibility to adverse health
outcomes, EPA does not believe that including such specific factors
within the PESS regulatory definition is necessary.
EPA disagrees with commenters that EPA lacks authority to add
``overburdened communities'' to the list of potential PESS examples.
Congress' inclusion of ``such as'' in the statutory definition provides
EPA with clear discretion to go beyond the statute's list of examples.
EPA further disagrees that this addition is substantively changing the
criteria for identification of PESS (i.e., greater exposure or
susceptibility and greater risk than general population). EPA believes
that an ``overburdened community'' or those that may be
disproportionately exposed or impacted by environmental harms, is
clearly an example of a group that may frequently be at greater risk
than the general population.
While EPA appreciates commenters' desire for more transparency on
how ``overburdened communities'' might be identified and associated
risks quantified, such rationale and transparency is already a
necessary component of every risk evaluation. In identifying PESS more
generally, EPA expects to engage the public throughout the TSCA
prioritization and risk evaluation processes, and to work with other
EPA offices. Currently available screening tools, such as EJSCREEN
(Ref. 13) or EnviroAtlas (Ref. 14), and other tools may allow the
Agency to capture greater susceptibility or greater exposure using the
data layers for socioeconomic factors (e.g., income/poverty, education)
or location (e.g., housing, employment, geography), and for
environmental indicators (e.g., air toxics cancer risk, respiratory
hazard index, particulate matter levels, ozone, Superfund site
proximity, hazardous waste proximity, proximity to multiple chemical
manufacturing or processing facilities). EPA also continues to develop
approaches for assessing the risk to communities at greater exposures
to chemical emissions. For example, EPA developed a screening level
methodology to evaluate the potential chemical exposures and associated
potential risks to fenceline communities (Ref. 15), and, following peer
review, EPA has been applying these approaches in subsequent risk
evaluations (e.g., Draft Risk Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP) (Ref. 16) and 1,4-dioxane Draft Supplemental Risk
Evaluation (Ref. 17)). The Agency continues to develop risk evaluation
approaches to help determine risk from all relevant exposure pathways
with an emphasis on exposures to these commonly overburdened
communities.
After considering the comments, and as described in Unit IV.C., EPA
is finalizing the changes to the PESS definition as proposed to better
reflect the Agency's commitment to fully consider the impacts a
chemical undergoing TSCA risk evaluation may present to communities
already experiencing disproportionate and adverse human health or
environmental burdens.
5. Risk-based occupational exposure values. As part of the proposed
rule, EPA solicited comment on how EPA could improve the transparency
of any risk-based occupational exposure values derived from the risk
evaluation process. Commenters generally expressed a strong desire for
more opportunity for public review and scientific input on how risk-
based occupational exposure values are derived, and a more formalized
approach for the development of any corresponding regulatory limits.
Although occupational exposure values for some of EPA's first 10
chemicals came out at a different time than the risk evaluations
themselves, EPA does not intend this to be the practice moving forward.
More recently, for example, EPA put out a draft risk-based occupational
exposure value in the Draft Risk Evaluation for TCEP (Ref. 16) released
for peer review. EPA will continue to do that as a matter of practice.
Further, and in response to comments on the proposed rule, EPA is
including a commitment in the regulatory text to calculate a risk-based
occupational exposure value in the draft risk evaluation where
unreasonable risk to workers through inhalation is identified. As part
of this commitment, EPA will explain in each risk evaluation how the
value was calculated.
To avoid confusion, EPA is no longer referring to the risk-based
occupational exposure value calculated in the risk evaluation as an
Existing Chemical Exposure Limit (ECEL). The risk-based occupational
exposure value calculated in the risk evaluation is based on the most
sensitive hazard endpoint and standard occupational exposure scenarios
assumption (i.e., 8 hours a day, 5 days a week, 250 days a year, for 40
years), and by law, cannot consider costs or other non-risk factors.
The value is not a regulatory limit or level, though it can be used to
inform risk management. The value is only relevant to workers in
occupational settings--not to consumers or the general population. The
value also does not take into account any existing occupational
exposure controls, though, as described elsewhere in this document, EPA
will consider such controls as part of developing regulations required
under TSCA section 6(a) to address unreasonable risk.
Considerations for risk management approaches are outside the scope
of this rule. However, when proposing any regulatory limit during the
risk management phase, EPA may consider costs and other non-risk
factors, such as technological feasibility, the availability of
alternatives, the continued need for critical or essential uses, the
potential for different occupational requirements for these uses, and
existing occupational exposure control approaches and technologies. As
such, any regulatory occupational existing chemical exposure limit or
ECEL for risk management purposes could differ from the occupational
exposure value calculated in the risk evaluation based on additional
consideration of exposures and non-risk factors consistent with TSCA
section 6(c).
While in many cases EPA won't be aware of all of those non-risk
factors until it actively engages in the risk management process for a
specific chemical, there are also times when EPA will be able to
describe in the risk evaluation circumstances that may lead any
regulatory limit to differ from the calculated occupational exposure
value. In the Draft Risk Evaluation for Formaldehyde (Ref. 18), for
example, EPA was able to state with certainty that any ECEL developed
for occupational safety risk management purposes would be certain to
differ from the calculated exposure value included in the draft Risk
Evaluation. In that instance, EPA was able to recognize unique
challenges
[[Page 37041]]
associated with the formaldehyde draft risk evaluation, including
indistinguishable sources of exposure and a calculated occupational
exposure value that fell below the 50th to 95th percentile of measured
concentrations in residential indoor air. Where such information is
available, EPA would expect to provide similar clarity on this point in
future risk evaluations.
EPA has valued the engagement with industry and other Federal
agency stakeholders on some of EPA's proposed risk management measures
to date, and the Agency is committed to making adjustments as
appropriate to ensure any occupational regulatory restrictions are both
protective and implementable. As described in Unit IV.F.1., EPA
recognizes that in some instances and in certain workplace locations,
particularly advanced manufacturing facilities (e.g., those involved in
the aerospace and defense industrial base industrial sectors), there
could be well-established occupational safety protections in place,
including adherence to OSHA standards and non-OSHA industry guidelines.
EPA also acknowledges that other Federal agencies and their contractors
that use chemicals may similarly have well-established occupational
control measures in place. EPA will consider comments received during
the risk evaluation process, as well as other information on use of PPE
and other ways industry and Federal agencies protect their workers, as
potential ways to address unreasonable risk during the risk management
process. As EPA moves forward with risk management rules, the Agency
will strive for consistency with existing OSHA requirements and/or best
industry practices when those measures would address the identified
unreasonable risk and would adopt a similar approach when making
decisions about managing risks for uses of chemicals that are required
to meet national security and critical infrastructure mission
imperatives for other Federal agencies.
G. Scientific Guidance and Procedures
1. In general. Congress recognized the importance of Agency
policies, procedures and guidance necessary to facilitate
implementation of the 2016 amendments to TSCA. (15 U.S.C. 2625(l)(1)).
EPA codified the use of appropriate Agency guidance (which can also
include Agency guidelines, frameworks, handbooks, or standard operating
procedures) in the development of risk evaluations in the 2017 final
rule and proposed to maintain that regulatory text in the proposed rule
(40 CFR 702.37(a)(1)). EPA received support from public commenters on
this provision and is finalizing it as proposed. TSCA risk evaluations
require the Agency to conduct hazard, exposure, and fate assessments,
quantify both acute and chronic effects, as well as assess the risks to
the environment. The breadth of risk evaluations requires a breadth of
expertise and methods, processes, protocol, and models. Agency guidance
and methodology documents have and will continue to provide process and
method transparency to Agency scientific work products. EPA will use
the appropriate guidance based on the application of methods,
approaches, and science policy decisions used in TSCA risk evaluations.
EPA will continue to use existing Agency guidances in the development
of TSCA risk evaluations. EPA may develop and use additional guidance
as needed using a transparent process. Additionally, the TSCA program
will work closely with other EPA offices to ensure the use of the best
available science, specifically where another office may have expertise
specific to a certain chemistry or method employed in a risk
evaluation.
2. Peer review. Science is the foundation that supports the work of
EPA. The use of best available science is vital to the credibility of
the Agency's determination of whether a chemical presents an
unreasonable risk, decisions on how best to manage that risk, the
Agency's effectiveness in pursuing its mission to protect human health
and the environment, and the public's trust in Agency decisions. Peer
review, as recognized by TSCA section 26(h), is an integral
consideration in ensuring Agency decisions are consistent with the best
available science. Peer review can ensure the use of reasonably
available information to make decisions is based on the weight of
scientific evidence. Conducting transparent and independent scientific
peer review, along with providing opportunities for public comment, has
been and will remain an important component of the TSCA risk evaluation
process. Peer reviews on TSCA risk evaluations to date have proven
extremely instructive and resulted in more robust and scientifically
defensible products and improvements to EPA methods used in the risk
evaluation process.
The 2017 final rule codified peer review as a component of the risk
evaluation process. In the proposed rule, EPA included amendments to
the regulatory text on peer review attempting to clarify the Agency's
flexibility in determining how and what to peer review. The proposed
regulatory text read: ``EPA expects that peer review activities on risk
evaluations conducted pursuant to 15 U.S.C. 2605(b)(4)(A), or portions
thereof will be consistent with the applicable peer review policies,
procedures, guidance documents, and methods pursuant to guidance
promulgated by Office of Management and Budget, EPA, and in accordance
with 15 U.S.C. 2625(h) and (i).'' EPA received many comments on the
proposed changes to this regulatory provision, most of which were
unsupportive. Many expressed concern that the flexibility sought in
this change may result in limited and less transparent peer reviews,
counter to the scientific standards required by the statute.
Specifically, commenters found that use of the phrase ``expected'' to
conduct peer review left open the possibility that EPA could forgo peer
review altogether. Commenters also expressed concern about a piecemeal
approach that may result if the Agency only peer reviewed ``portions''
of future risk evaluations, which commenters noted could result in
portions of a risk evaluation not undergoing peer review, or that EPA
may shield from peer review particular lines of evidence used in making
a determination of unreasonable risk.
The Agency fully intends to act consistently with the EPA Peer
Review Policy Statement, which states in part, ``For influential
scientific information intended to support important decisions, or for
work products that have special importance in their own right, external
peer review is the approach of choice . . .'' (Ref. 19). In the final
rule EPA has amended the proposed regulatory text to affirm that EPA
will conduct peer review: ``EPA will conduct peer review activities on
risk evaluations . . .'' (40 CFR 702.41). EPA agrees with commentors
that peer review is necessary and integral to robust TSCA risk
evaluations, and the Agency fully intends to continue to conduct peer
review on TSCA risk evaluations consistent with longstanding Agency and
OMB guidance.
With respect to EPA's use of ``or portions thereof'' of in the
proposed rule regulatory text, EPA did not intend that phrase to
reflect a policy change, but rather a clarification of the allowable
scope of peer review under both the EPA Peer Review Handbook 4th
Edition 2015 (EPA Handbook) (Ref. 20) and OMB's Information Quality
Bulletin for Peer Review (Peer Review Bulletin) (Ref. 21). As a general
matter, EPA believes that peer reviewing all or most of the risk
evaluation will likely be standard practice for the foreseeable future.
EPA notes that, under the Peer Review Bulletin, Agencies also have
``broad
[[Page 37042]]
discretion in determining what type of peer review is appropriate.''
The Peer Review Bulletin instructs agencies ``to consider tradeoffs
between depth of peer review and timeliness''. This includes the
consideration of costs of peer review--both direct costs and costs of
potential delay in government and private actions that result from peer
review, including delays in risk management actions to address
unreasonable risks.
After consideration of comments, EPA has removed the ``or portions
thereof'' language in the regulatory text, as this in an unnecessary
codification of a practice that is already allowed under existing
guidance documents. The final rule makes clear that EPA will conduct
peer review activities on TSCA risk evaluations, and expects those
activities and related decisions regarding the appropriate scope and
type of peer review to be consistent with the applicable guidances from
OMB and EPA.
EPA expects that, at some point in the future, risk evaluations may
use previously peer reviewed scientific approaches, models, and/or
methods for similar chemicals or exposure scenarios. In those cases,
peer review can focus on the novel information, applications, and
analysis that will benefit from independent, expert peer review. For
some risk evaluations, it may be more appropriate to peer review solely
the weight of evidence determination. The intent of the proposed
provision was to ensure Agency discretion and flexibility when
determining the approach to and scope of peer review. Both the Peer
Review Bulletin and the EPA Handbook clearly outline circumstances
where additional peer review may not be necessary. An example would
include work that has been previously peer reviewed in a manner
consistent with the Peer Review Bulletin and the EPA Handbook. For each
risk evaluation, EPA will consider the complexity, novelty, and any
prior peer review to determine the appropriate approach to and scope of
peer review to apply.
Additionally, and as discussed in the proposed rule, EPA also
expects that a TSCA risk evaluation may use peer reviewed products
(e.g., risk assessments, hazard assessments, models), or portions
thereof, developed by another EPA office or other authoritative body
(e.g., state, national, or international programs). EPA will use
existing assessments and review scientific information in a transparent
manner, including documenting how the information used represents the
best available science, is fit-for-purpose, and supports the weight of
evidence.
Some commenters question EPA's position of not seeking peer review
on the unreasonable risk determination. Consistent with the 2017 final
rule, EPA will not seek peer review of any determination as to whether
the risk is ``unreasonable,'' which is an Agency policy determination.
Consistent with OMB and EPA guidance, the purpose of peer review is the
independent review of the science underlying the TSCA risk evaluation,
not a review of EPA's policy determinations. TSCA expressly reserves to
the Agency the final determination of whether risk posed by a chemical
substance is ``unreasonable.'' (15 U.S.C. 2605(i)). This is consistent
with the statutory purpose of the SACC, ``to provide independent advice
and expert consultation, at the request of the Administrator, with
respect to the scientific and technical aspects of issues relating to
the implementation of this title'' (15 U.S.C. 2625(o)(2)).
EPA received a number of comments on the type of peer review that
may be employed for TSCA risk evaluations. Consistent with the 2017
final rule, EPA has not codified the type of peer review or specific
reviewers. The Peer Review Bulletin recognizes that ``different types
of peer review are appropriate for different types of information.''
The Peer Review Bulletin grants Agencies discretion in determining what
type of peer review is appropriate. Agencies are directed to choose a
peer review mechanism that is adequate, ``[considering] the novelty and
complexity of the science to be reviewed, the relevance of the
information to decision-making, the extent of prior peer reviews, and
the expected benefits and costs of additional review''. The level of
rigor of the peer review should be based on whether the information
contains methods or models that are precedent-setting, presents
conclusions that are likely to change prevailing practices, or will
likely affect policy decisions that have a significant impact.
EPA retains the discretion to employ various types of peer review,
including panel or letter reviews. EPA expects to use letter reviews as
appropriate, but anticipates that letter reviews will be the exception
while panel reviews will be preferred. EPA will continue to use on a
case-by-case basis the Science Advisory Committee on Chemicals (SACC)
(the advisory committee required by TSCA section 26(o)) to provide
independent advice and expert consultation with respect to the
scientific and technical aspects of issues relating to the
implementation of TSCA.
Finally, EPA proposed removing the reference to specific versions
of guidance documents. The Agency recognizes that guidance may be
updated and/or names modified and, to avoid confusion as to which
guidance documents will be used, the Agency proposed to refer instead
to ``applicable peer review policies, procedures, guidance documents,
and methods adopted by EPA and the Office of Management and Budget
(OMB) to serve as the guidance for peer review activities.'' A number
of commenters expressed concern at the ambiguity and lack of clarity
that could arise for both EPA staff and stakeholders without specific
documents named. For the final rule, EPA determined not to codify
specific titles and has retained the proposed language with minor
adjustments for additional clarity. Codifying specific documents into
regulatory text is problematic if and when documents are updated or are
supplanted by a new version. Although not named in the regulatory text,
EPA peer review activities for TSCA risk evaluations will generally by
guided by EPA Peer Review Handbook 4th Edition 2015 (Ref. 20) and OMB's
Information Quality Bulletin for Peer Review (Ref. 21), successor
versions of these documents, and/or any requirements that may later
supplant these documents.
H. Scientific Standards
TSCA section 26(h) and (i) require the Agency to make decisions
under TSCA section 6 in a manner that is consistent with the best
available science and based on the weight of scientific evidence.
Specifically, TSCA section 26(h) requires that in carrying out TSCA
sections 4, 5, and 6, to the extent the Agency makes decisions based on
science, the Agency shall ``use scientific information, technical
procedures, measures, methods, protocols, methodologies, or models,
employed in a manner consistent with the best available science.'' TSCA
section 26(i) states ``the Administrator shall make decisions under
sections 4, 5, and 6 based on the weight of scientific evidence.'' TSCA
does not define either ``best available science'' or ``weight of
scientific evidence'' and there is no requirement in the statute to
define them by rule.
As described in Unit IV.C., EPA proposed to eliminate both
definitions from the regulatory text. Aside from being unnecessary, EPA
believes codifying definitions for these scientific terms limits the
Agency's ability to adapt to the changing science of risk evaluation,
as well as the science that informs risk evaluation, and limits the
Agency's flexibility to implement and
[[Page 37043]]
advance novel science. Additional discussion on how EPA intends to
uphold TSCA's scientific standards for ``best available science'' and
``weight of scientific evidence,'' as well as EPA's expected
application of systematic review methods for identifying and assessing
reasonably available information, is provided in the sections that
follow.
1. Best available science. As described in the 2017 final rule, EPA
continues to believe that the ``best available science'' is science
that is reliable and unbiased. Use of best available science involves
the use of supporting studies conducted in accordance with sound and
objective science practices, including, when available, peer reviewed
science and supporting studies and data collected by accepted methods
or best available methods (if the reliability of the method and the
nature of the decision justifies use of the data). Additionally, as
required in TSCA section 26(h), in determining the ``best available
science,'' EPA must consider as applicable:
2.
(1) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and
consistent with the intended use of the information;
(2) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance
or mixture;
(3) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
(4) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
(5) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
EPA's implementation of the ``best available science'' standard in
TSCA is further informed by longstanding EPA and OMB guidance. The OMB
Information Quality Guidelines ``provide policy and procedural guidance
to Federal agencies for ensuring and maximizing the quality,
objectivity, utility, and integrity of information (including
statistical information) disseminated by Federal agencies'' (Pub. L.
106-554; 114 Stat. 2763A-153 through 2763A-154). The Guidelines for
Ensuring and Maximizing the Quality, Objectivity, Utility, and
Integrity, of Information Disseminated by the Environmental Protection
Agency (Ref. 22), also referred to as EPA's Information Quality
Guidelines, contain EPA's policy and procedural guidance for ensuring
and maximizing the quality of information disseminated in Agency work
products. Section 6.4 of EPA's Information Quality Guidelines discuss
how the Agency ensures and maximizes the quality of information used in
risk assessment. EPA's Information Quality Guidelines go on to say:
``In applying these principles, `best available' usually refers to the
availability at the time an assessment is made. However, EPA also
recognizes that scientific knowledge about chemical risk is rapidly
advancing and that risk information may need to be updated over time.''
As described in Unit IV.C., the Agency does not believe codifying a
definition of ``best available science'' provides any additional
transparency or improves consistency, as EPA must for each risk
evaluation determine what is the best available science based on the
reasonably available information. EPA is furthering its commitment to
transparency by finalizing the proposed regulatory text requiring EPA
to ``document that the TSCA risk evaluation is consistent with the best
available science and based on the weight of the scientific evidence''
in 40 CFR 702.37(a). With respect to ``best available science,'' EPA is
also finalizing the list of considerations for determining what
constitutes the best available science--considerations that are taken
directly from TSCA section 26(h). In response to some commenters'
concerns that the prefacing language (i.e., ``shall include, but are
not limited to, . . .'') did not match with section 26(h)--and could
imply an intention by EPA to ignore the statutory considerations or
opaquely apply different ones--EPA is adjusting that language in the
final rule to state, as the law states, that EPA ``shall consider as
applicable . . .''.
As the Agency identifies reasonably available information to inform
a TSCA risk evaluation of a given chemical, EPA may consider existing
risk assessments, or reviews performed on the chemical in question to
be the best available science. This may include assessments conducted
by EPA that adhere to existing Agency Guidance, use methodologies that
have been externally peer reviewed, and undergo public comment.
Similarly, the Agency may also look to consider assessments or portions
of assessments conducted by other federal, state or international
authoritative bodies. EPA may consider whether these existing
assessments or reviews represent the best available science as required
under TSCA and use portions of them to directly inform a risk
evaluation. Additionally, where appropriate and consistent with the
White House's Guidance for Federal Departments and Agencies on
Indigenous Knowledge, EPA will consider including and applying
Indigenous Knowledge to inform decisions related to the best available
science (Ref. 23).
As stated in 40 CFR 702.37(a)(1), the Agency will use appropriate
Agency guidance in the development of the TSCA risk evaluations under
this rule. TSCA section 26(l) provides further support for this
approach, requiring the Agency to use and develop guidance documents
that are necessary in carrying out the statute. TSCA further requires
the revisions of guidance documents as necessary to ``reflect new
scientific developments and understandings.'' Reliance on Agency
guidance for determining the ``best available science'' in TSCA risk
evaluations ensures the desired transparency and consistency, while
still allowing for more nimble adaptation over time. This approach is
also consistent with the approach taken in other EPA programs (e.g.,
Office of Water's implementation of the Clean Water Act and the Office
of Air and Radiation's implementation of the Clean Air Act), none of
which codify a definition of ``best available science.''
2. Systematic review and fit-for-purpose approaches. As described
in Unit IV.C., EPA is, as proposed, eliminating the codified definition
of ``weight of scientific evidence'' in the final rule, which EPA
believes inappropriately conflated the concepts of ``weight of
scientific evidence'' with ``systematic review.'' Many commenters
supported this approach and further support the requirement that EPA
codify the use of systematic review, but recommended further
clarification as to how EPA will incorporate systematic review into the
process for conducting TSCA risk evaluations.
TSCA risk evaluations use reasonably available information to draw
the conclusions that are supported by the best available science.
Reasonably available information is identified and evaluated
comprehensively through unbiased, transparent and objective data
collection and data evaluation, using methods consistent with the
general principles of systematic review. EPA believes that integrating
appropriate and applicable systematic review methods into the TSCA risk
evaluations is critical to meeting the scientific standards as
described in TSCA section 26(h) and (i). Systematic review methods may
include a systematic review, such as that described in the Draft TSCA
Systematic
[[Page 37044]]
Review Protocol Supporting TSCA Risk Evaluations for Chemical
Substances: A Generic TSCA Systematic Review Protocol with Chemical-
Specific Methodologies (Ref. 24) or the EPA's Office of Research and
Development Staff Handbook for Developing IRIS Assessments (Ref. 25),
or may be an approach that incorporates the principles of systematic
review. The principles of systematic review are well-established and
include ``transparent and explicitly documented methods, consistent and
critical evaluation of all relevant literature, application of a
standardized approach for grading the strength of evidence, and clear
and consistent summative language'' (Ref. 26). EPA has finalized the
requirement to use and document systematic review methods to assess
reasonably available information, and included flexibility to consider
the appropriate level of review for a given evidence stream, while
still ensuring EPA meets the requirements of TSCA sections 26(h) and
(i) (see Sec. 702.37(b)(2)).
The flexibility to apply appropriate and relevant systematic review
methods is necessary in the development of TSCA risk evaluations. The
National Academies of Science Engineering and Medicine (NASEM) report
(Ref. 27), in their review of the Application of Systematic Review in
TSCA Risk Evaluations (Ref. 28), highlights this need for alternative
approaches, stating that ``under some circumstances there may be
reasonable alternatives to carrying out a de novo systematic review;
for example, the relevant literature may be non-existent or too limited
in scope or there may be a recent systematic review that meets quality
standards. In some cases, it may be possible to use an alternative
approach to systematic review as long as it meets the transparency,
consistency, reproducibility, and comprehensiveness requirements of
evidence-based methodologies.'' EPA expects that future risk
evaluations may use, for example, an existing hazard assessment
conducted by an authoritative source, in lieu of conducting a de novo
assessment. EPA would review this assessment in a transparent, unbiased
and objective way, which may require supplementing the assessment with
more recent literature or reviewing the weight of evidence, but may not
repeat systematic review on all supporting information. In alignment
with the recommendations from the NASEM report, when EPA uses an
alternative methodology, it will document why it has done so in lieu of
the more traditional systematic review.
Traditional systematic review includes performing--as described and
documented in a defined protocol that can be applied across multiple
lines of evidence--a literature search and screening to identify
relevant information, followed by data quality evaluation (addressing
factors such as relevancy and bias), data extraction, and evidence
integration. The TSCA program recognizes that the science of systematic
review continues to evolve, and will continue to develop its systematic
review methods of data collection, data evaluation, evidence synthesis
and integration, while partnering with other EPA Offices to advance and
implement tools, methods, and efficiencies to systematically collect
and evaluate literature. The procedures required for ensuring
objectivity, transparency and limiting bias to extent possible in the
collection and review of data for TSCA risk evaluations must be
flexible enough to account for the variety of hazard and exposure
information available to inform TSCA risk evaluations, and also be
implementable within the statutory deadlines. EPA has and will continue
to implement chemical specific approaches, including the development of
chemical-specific protocols that are flexible, timely, and relevant for
the types, quality, and quantity of information available and needed in
a risk evaluation. EPA will apply and document the systemic review
methods of data collection, evaluation, and integration that are
commensurate with the relevant complexity of the assessment and nature
of the information available, and carried out in a transparent manner
that permits completion of risk evaluations within the timeframes that
Congress provided.
3. Weight of scientific evidence. As described in Unit IV.C., EPA
is, as proposed, eliminating the codified definition of ``weight of
scientific evidence''--instead relying on long-established Agency
guidance documents to guide weight of scientific evidence analyses
under TSCA.
There are certain principles of WOSE that are universal, including
foundational considerations such as objectivity, transparency and
consideration of the strengths and weaknesses of lines of evidence. The
phrase WoSE or weight of evidence (WoE) is used by EPA and other
scientific bodies to describe the strength of the scientific inferences
that can be drawn from a given body of evidence, specifically referring
to the quality of the studies evaluated, and how findings are assessed
and integrated. EPA broadly uses the WoSE approach in many existing
programs and has described the application of WoSE in Agency guidance
used to classify carcinogens (Ref. 29). EPA believes WoSE inherently
involves application of professional judgment, in which the significant
issues, strengths, limitations of the data, uncertainties, and
interpretations are presented and highlighted.
As noted by the National Academies of Science, ``because scientific
evidence used in WoE evaluations varies greatly among chemicals and
other hazardous agents in type, quantity, and quality, it is not
possible to describe the WoE evaluation in other than relatively
general terms'' (Ref. 30). EPA agrees with this assessment, and, as
such, concluded that an alternative codified definition would not
provide additional transparency or certainty to the required use of
WoSE in TSCA risk evaluations. However, as described in Unit IV.H.1.,
this rule codifies a commitment to transparency by finalizing the
proposed regulatory text requiring EPA to ``document that the TSCA risk
evaluation is consistent with the best available science and based on
the weight of the scientific evidence'' in 40 CFR 702.37(a).
To meet the law's requirement to base decisions in TSCA risk
evaluations on the ``weight of the scientific evidence,'' EPA expects
to rely on established Agency guidance documents. These peer reviewed
guidances provide consistency and formality to a process that looks to
integrate multiple and often heterogenic lines of evidence. At this
time, EPA will primarily look to four documents for implementing WoSE
in TSCA risk evaluations: Weight of Evidence in Ecological Assessment
(Ref. 31), Guidelines for Carcinogen Risk Assessment (Ref. 29),
Endocrine Disruptor Screening Program Weight-of-Evidence: Evaluating
Results of EDSP Tier 1 Screening to Identify the Need for Tier 2
Testing (Ref. 32), and ORD Staff Handbook for Developing IRIS
Assessments (Ref. 25). EPA recognizes that there are other
international approaches that may also be applicable and will
transparently document their use. These documents all similarly
describe the WoSE assessment as based on the strengths, limitations,
and interpretation of data available, information across multiples
lines of evidence and how these different lines of evidence may or may
not fit together when drawing conclusions. The results from the
scientifically relevant published or publicly available studies in the
peer reviewed scientific journals, studies conducted in accordance with
Organization for Economic Cooperation
[[Page 37045]]
and Development (OECD) or EPA guidelines, gray literature, and/or any
other studies, scientific information, or lines of evidence that are of
sufficient quality, relevance, and reliability, are evaluated across
studies and endpoints into an overall assessment. WOSE assessments
examine multiple lines of evidence considering a number of factors,
including for example the nature of the effects within and across
studies, including number, type, and severity/magnitude of effects and
strengths and limitations of the information. EPA will provide a
summary WoSE narrative or characterization to accompany a detailed
analysis to transparently describe the conclusion(s), as well as
explain the selection of the studies or effects used as the main lines
of evidence and relevant basis for conclusions.
I. Process for EPA Revisions to Scope or Risk Evaluation Documents
As part of the proposed rule, EPA added procedures and criteria for
whether and how EPA would endeavor to revise or supplement final scope
documents, and draft or final risk evaluations. The 2017 final rule did
not provide any such criteria or procedures. As described in the
proposed rule, EPA reasoned that these new procedures and criteria
would provide greater certainty and transparency for stakeholders, and
would enable EPA to make forward progress on prioritizing, reviewing
and managing existing chemicals as Congress intended, without diverting
limited resources towards continuously revisiting final risk
evaluations.
With respect to final scope documents, EPA proposed that subsequent
changes--if any--to the scope of the risk evaluation after publication
of the final scope be reflected and described in the draft risk
evaluation instead of a revised final scope document. The proposed rule
further contemplated that EPA could, in its discretion, publish a
notice in the Federal Register notifying the public that EPA has made
information regarding changes to the risk evaluation scope available in
the docket before releasing the draft risk evaluation. EPA received no
public comments on these changes and is finalizing as proposed.
With respect to draft risk evaluations, EPA proposed to reflect and
describe any changes to the draft document in the final risk evaluation
rather than reissue the risk evaluation in a second draft form. EPA
noted that, where changes from draft to final are significant in
nature, nothing in the proposed rule would prevent EPA from seeking
additional advice or feedback from its independent scientific advisors
or additional public comment on relevant topics, provided that such
actions can be completed within the timeframes Congress contemplated
for TSCA risk evaluations. Further, this ensures that feedback is
appropriately considered and reflected without unduly delaying progress
towards completion of the risk evaluation.
A few commenters objected to this aspect of the new procedures, and
argued that EPA must share significant changes to draft risk
evaluations prior to finalization under the Administrative Procedures
Act (APA) (5 U.S.C. 551 et seq.). EPA shares commenters' perspective
regarding the need for transparency during the risk evaluation process,
and the importance of considering stakeholder feedback. In light of the
improvements EPA is finalizing in this procedural rule, EPA does not
anticipate many significant changes between draft and final risk
evaluations moving forward. However, where there are significant
changes, the rule provides EPA with flexibility to seek additional
public comment or independent review of those changes prior to
finalizing. With respect to the comment about the APA, TSCA risk
evaluations are scientific work products--not regulatory actions--and
fall outside the scope of APA requirements related to proposed and
final rulemaking. As such, EPA is finalizing this provision as
proposed.
With respect to revision of final risk evaluations, EPA also
proposed a general practice and certain exceptions to that practice. As
general practice, where circumstances warrant revisiting a chemical
risk evaluation that has already been finalized--which EPA believes are
likely to be infrequent--the Agency may identify that chemical as a
potential candidate for high-priority designation, and follow the
procedures at 40 CFR part 702, subpart A. As noted in the proposed
rule, EPA believes that this general practice aligns with Congress'
intent for the Agency to work systematically through the universe of
existing chemicals within the statutory framework and aggressive
deadlines associated with prioritization, risk evaluation and risk
management. (15 U.S.C. 2605(b)(2)(C) and (b)(4)(G)). Revisiting risk
evaluations outside of re-prioritizing the chemical substance results
in unanticipated and potentially unbudgeted work that can siphon
resources from statutorily mandated responsibilities under TSCA section
6. Conversely, re-prioritizing the chemical provides the public with
ample notice and opportunity to engage, provides anticipatable
milestones and process, and better positions the Agency to maintain a
manageable workload.
EPA proposed to make exceptions to that general practice where
revisions to a final risk evaluation outside of re-prioritization of a
chemical are in the interest of protecting human health or the
environment. For example, the exception might be warranted in the event
a scientific error meaningfully impacts the evaluation or the Agency's
ability to appropriately address risks through rulemaking. Where EPA
endeavors to revise or supplement a final risk evaluation outside of
re-prioritization, the proposed rule further requires EPA to follow the
same process and requirements for TSCA risk evaluations described in
this rule, including publication of a new draft and final risk
evaluation, solicitation of public comment, and, as appropriate, peer
review.
Commenters were generally supportive of this change, noting its
potential to provide greater efficiency and increased pace of chemical
review. One commenter noted that regulatory text had a potentially
inadvertent mistake in describing the exception, referring to human
health and the environment, instead of human health or the environment
(see 40 CFR 702.43(g) as proposed--``. . . except where EPA has
determined it to be in the interest of protecting human health and the
environment to do so . . .''). EPA agrees with commenter and did not
intend to limit application of the exception to instances where there
is both a human health and environmental interest. As such, EPA is
replacing the ``and'' with an ``or'' in the final rule, but is
otherwise finalizing these provisions as proposed.
J. Process and Requirements for Manufacturer-Requested Risk Evaluations
EPA proposed a number of changes to the process and requirements
for manufacturer- requested risk evaluations (MRREs). TSCA section
6(b)(4)(C)(ii) allows a chemical manufacturer to request that the
Agency conduct a risk evaluation of a chemical substance that they
manufacture. Consistent with TSCA section 6(b)(4)(C)(ii), EPA
established the ``form . . . manner and . . . criteria'' for such
requests in the 2017 final rule. Based on experience in implementing
that process to date, EPA believes the proposed modifications are
necessary to increase clarity and expectations, and to better position
the Agency to grant and carry out MRREs moving forward.
[[Page 37046]]
As described in the proposed rule, the current process for MRREs is
unrealistic and unsustainable. Amongst other things, the current
process allows MRRE requesters to provide EPA with a narrow set of
information relevant to only certain conditions of use; requires EPA to
quickly grant or deny the request, and then starts the clock for EPA to
complete an entire risk evaluation on the chemical substance with the
three-year statutory deadline. The proposed changes would require that
more fulsome information be included in incoming requests, allow EPA
additional time to properly review requests and determine any
additional information needs prior to initiating the evaluation, and
provide flexibility in the process to accommodate additional data
collection or development during the risk evaluation.
EPA received a number of comments on the proposed changes ranging
from general support to general opposition. Some commenters provided
suggestions for further clarifying requirements, improving the
contemplated processes, and increasing overall transparency. Other
commenters shared concerns that, on the whole, the changes would make
MRREs unattractive to those who might otherwise consider submitting
requests. EPA describes these comments further in this section, as well
as in the Agency's Response to Comments document (Ref. 6). After
consideration of the comments, EPA is finalizing much of the regulatory
text at 40 CFR 702.45 as proposed, notwithstanding the changes
described in this section. EPA would refer the public to the preamble
to the proposed rule for a more fulsome discussion of each of the
substantive provisions, and EPA's expected implementation (Ref. 5).
1. Scope of request. The 2017 final rule allowed manufacturers to
request a risk evaluation on particular conditions of use of interest
to the requesting manufacturer, leaving the Agency with the heavy
burden of identifying the remaining conditions of use for the chemical
substance. For some, this provision created the misperception that, in
instances where the requesting manufacturer only identifies a narrow
set of circumstances, EPA would or could carry out a similar, narrowly-
scoped risk evaluation. Such an action would unequivocally contravene
EPA's statutory authority. In the proposed rule, EPA adjusted this
language so that manufacturers are only permitted under the law to make
requests for evaluations of a chemical substance--not individual
conditions of use or subsets of conditions of use--consistent with the
statutory language in TSCA section 6(b)(4)(C) (stating that EPA ``shall
conduct and publish risk evaluations . . . on a chemical substance . .
.'').
This aspect of the proposed rule generated a range of comments.
Several commenters supported the clarification and agreed that
conducting use-based MRREs was beyond EPA's statutory authority. Others
objected to the change as setting too broad a scope that would
eliminate incentive for submitting MRREs, and frustrate Congress'
intent in establishing this process as a ``facilitator in interstate
commerce.''
EPA would emphasize that the proposed rule does not expand the
scope of MRREs. In the 2017 final rule, EPA noted that ``Although
manufacturers may request that EPA conduct a risk evaluation based on a
subset of the conditions of use, EPA intends to conduct the risk
evaluation in the same manner as any other risk evaluation conducted
under section 6(b)(4)(A) . . . . As such, EPA intends to conduct a full
risk evaluation that encompasses both the conditions of use that formed
the basis for the manufacturer request, and any additional conditions
of use that EPA identifies, just as EPA would if EPA had determined the
chemical to be high priority.'' (Ref. 1). TSCA requires EPA to conduct
risk evaluations--including MRREs--on a chemical substance under the
conditions of use--not on an individual use or a subset of a chemical's
conditions of use. TSCA section 6(b)(4)(E)(ii) also mandates that EPA
``shall not expedite or otherwise provide special treatment'' to MRREs.
Based on public comments regarding the scope of MRREs, it is abundantly
clear that this important clarification to the regulatory text is
necessary to ensure no future misunderstandings about the required
scope of MRREs.
As part of this rule and as discussed in the next section, EPA
proposed to require MRRE submitters to provide a more holistic set of
information on the chemical as part of the request to better position
EPA to grant and successfully undertake MRREs. While EPA acknowledges
that it is possible that the additional information requirements may
dissuade some manufacturers from submitting these requests, EPA
disagrees that the rule would eliminate all incentive. The primary
benefit afforded to MRRE requesters is the opportunity to advance a
chemical of their choosing ahead of other chemicals that EPA might
prioritize, so long as they provide EPA with the requisite information
and fees. Additionally, MRRE-driven TSCA section 6(a) final rules or
section 6(i)(1) determinations will trigger preemption of state laws
and regulations. Nothing in this rule would impact the preemptive
effect of an MRRE action (and any associated risk management action) to
help reconcile discrepant state-level regulations and facilitate
interstate commerce.
Finally, EPA disagrees with commenters that suggest EPA is further
disincentivizing MRREs with the single risk determination approach on
the chemical substance. Again, the risk determination approach does not
mean EPA will, in every instance, find that a chemical substance
presents unreasonable risk. While perhaps MRRE requesters would prefer
that EPA determine that the condition(s) of use of interest of their
chemical does not present unreasonable risk, such an outcome is not
their prerogative. Further, EPA does not believe the possibility of an
unreasonable risk determination should be a deterrent to future MRRE
requesters. At the end of regulatory process, when EPA has eliminated
any identified unreasonable risks pursuant to TSCA section 6(a), the
manufacturer gets regulatory certainty. And the public can have
confidence that the chemical can be safely used in commerce.
2. Contents of request. EPA also proposed some specific updates to
the required contents of a MRRE, and the criteria upon which EPA will
judge completeness and sufficiency. A manufacturer requesting that EPA
conduct a risk evaluation should bear the primary burden of providing
EPA with all information necessary to conduct a risk evaluation on the
chemical substance. Congress also shared this sentiment in TSCA section
2, stating that ``adequate information should be developed with respect
to the effect of chemical substances and mixtures on health and the
environment and that the development of such information should be the
responsibility of those who manufacture and those who process such
chemical substances and mixtures.'' 15 U.S.C. 2601(b). With respect to
MRRE requests, Congress authorized EPA to establish the ``form . . .
manner and . . . criteria'' for such requests in order to support
successful implementation (15 U.S.C. 2605(b)(4)(C)). As described in
the proposed rule, EPA believes that the 2017 final rule
inappropriately shifted much of the information gathering burden for
MRREs to the Agency.
Amongst other criteria, EPA proposed to require that MRRE requests
identify all intended, known and reasonably foreseen circumstances of
the chemical's manufacture, processing, distribution in commerce, use
and disposal, and provide all available
[[Page 37047]]
information regarding the chemical's hazards and exposures--not just
information of relevance to the requesting manufacturer's interests.
These changes would require more fulsome information come in as part of
the request, enabling a more effective process for reviewing the
request, and making it more likely that EPA will ultimately be able to
grant and undertake the evaluation within the statutory timeline
provided.
A number of commenters supported these changes, and expressed
agreement with EPA's reasoning and proposed approach. Several
commenters offered suggestions for including more specificity in the
requirements for MRRE contents at 40 CFR 702.45(c). In response to
these comments, EPA is making a number of adjustments to the regulatory
text in the final rule.
First, EPA agrees with adding more clarity on how manufacturers
should determine the ``known or reasonably ascertainable'' information
that must be included in the request. As described in the preamble to
the proposed rule, information that is known to or reasonably
ascertainable by the manufacturer would include all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know. The standard requires an exercise of due diligence, and the
specific information-gathering activities that may be necessary for
manufacturers to achieve this standard may vary from case-to-case. In
the context of preparing a MRRE request and to meet the requirements in
40 CFR 702.45(c), EPA believes that due diligence would, at a minimum,
involve a thorough search and collection of publicly available
information on the chemical's hazards, exposures and conditions of use.
EPA would further expect that requesting manufacturers conduct a
reasonable inquiry not only within the full scope of their organization
regarding manufacturing processes and products (including imports), but
also outside of their organization to fill gaps in knowledge. For
example, such activities might include inquiries to upstream suppliers
or downstream users or employees or other agents of the manufacturer,
including persons involved in the research and development, import or
production, or marketing for information pertinent to the criteria
listed in the proposed rule. In response to comments on the proposed
rule, EPA is codifying certain additional aspects of this discussion on
the due diligence standard in regulatory text in the final rule to
further underscore and clarify expectations for information to be
submitted as part of an MRRE. Specifically, EPA is modifying 40 CFR
702.45(a) to describe the level of effort that should be undertaken to
gather information that is ``known to or reasonably ascertainable by''
the requesting manufacturer. Relatedly, EPA is clarifying in the
regulatory text that, in the event that a group of manufacturers
submits a MRRE, the information requirements in paragraphs (a), (c) and
(i) would apply to all manufacturers--not just the primary contact
submitting the request. Second, at the suggestion of several
commenters, EPA is striking the regulatory text in the final rule
regarding identification of potentially exposed or susceptible
subpopulations that the manufacturer believes to be relevant. As noted
by commenters, EPA must ultimately identify PESS--not the requesting
manufacturer. Elimination of this requirement would lessen burden on
requesters and avoid confusion that a requester's judgment on this
issue could supplant that of EPA. Third, EPA agrees with commenter that
an additional requirement of identifying the known locations where the
chemical is used, and the consumer products (if any) containing the
chemical would be helpful to EPA in ensuring consideration of all
exposures and conditions of use. While EPA believes submission of this
information already falls within the umbrella of 40 CFR 702.45(c)(5),
EPA sees value in explicitly describing this in the regulatory text as
the commenter suggests, and is adjusting the final rule accordingly.
EPA also appreciates the concern shared by some commenters that
ambiguity in the information/content requirements may create
uncertainty for manufacturers weighing whether or not to submit a
request, particularly in light of the commitment MRRE requesters make
to provide EPA with information necessary to carry out the risk
evaluation and the associated fee requirements for MRREs. While EPA
believes the changes described in the proposed rule and the additional
ones contemplated for the final rule do bring additional clarity, EPA
welcomes and encourages pre-submission consultations to discuss
information needs further. Moreover, the additional processes EPA is
contemplating in this rule for MRREs should help bring greater clarity
to information needs much earlier in the process--either before EPA has
granted request, or prior to EPA having undertaken significant amounts
of work--and therefore before significant expenses have been incurred
under the fee schedule. Lastly, EPA developed a guidance document in
2017 to assist interested persons in developing draft risk evaluations
for submittal to EPA (Ref. 33). While the MRRE process does not require
submittal of a draft risk evaluation, the guidance describes the
science standards, data quality considerations and other information
relevant to EPA's risk evaluation process that may be of use to
manufacturers interested in developing an MRRE request. As resources
allow, EPA may consider updating this 2017 guidance and further
developing particular sections to better assist potential MRRE
submitters.
A few commenters disagreed with EPA that the primary burden should
be on manufacturers to provide sufficient information for the risk
evaluation, and that EPA may be better positioned to gather the
necessary information using its various statutory authorities. EPA
believes that requesting manufacturers should be making a reasonable
amount of effort to gather all available information on the chemical--
whether that information is available to the general public, or
otherwise available to the manufacturer--and compile it for the
Agency's review as part of an MRRE. Still, EPA recognizes that
manufacturers may not, after making a reasonable amount of effort, be
able to provide the Agency with all the information necessary to
complete the risk evaluation. EPA proposed processes for how such
shortcomings will be identified and addressed, including opportunities
for manufacturers to request EPA exercise its statutory authorities to
fill in any gaps. These changes set clearer expectations for what EPA
needs to undertake in a risk evaluation, and establishes a process for
productive engagement with requesting manufacturers toward meeting
those needs.
These amendments also satisfy the Ninth Circuit's remand without
vacatur of the relevancy and consistency provisions of the currently
codified language at 40 CFR 702.37(b)(4) and (6), which address the
information requirements for, and application of the TSCA section 26
scientific standards to, an MRRE (Ref. 7).
3. EPA process for reviewing requests. EPA proposed a number of
changes to how the Agency will review MRREs in 40 CFR 702.45, including
additional measures for transparency and public engagement. EPA would
again refer the public to the preamble of the proposed rule for a
general description of the procedural steps. At a high level, the
process steps can be summarized as
[[Page 37048]]
follows: Upon receipt of a MRRE, EPA will provide the public with
notice and begin reviewing the request for completeness. Where the MRRE
request appears complete, EPA will open a docket for the MRRE and
supporting information, and solicit public comment. Following a second
review, where EPA believes there is sufficient information, EPA will
grant the request, and proceed to publish a draft list of conditions of
use and solicit additional comment. Following this comment period, and
when EPA believes it has all necessary information, EPA will formally
initiate the evaluation and follow all the same processes and
requirements for EPA-initiated risk evaluations in subpart B. The
proposed rule also included processes to resolve information needs as
they might arise during the process, and an opportunity for requesting
manufacturers to withdraw their request.
Nearly all commenters expressed support for the new process steps,
agreeing with EPA that the process in the 2017 final rule does not
allow enough time for adequate review of MRREs. Commenters also agreed
that Congress did not intend MRREs to differ from EPA-initiated risk
evaluations, that TSCA does not permit increased burdens to be placed
on EPA in evaluating MRREs, and shared their support for making the new
MRRE process and timeframes more comparable to those that precede EPA-
initiated risk evaluations. One commenter questioned EPA's
characterization of how it would publicly share supplemental
information received from the requesting manufacturer during the
process (i.e., that EPA would ``endeavor, to the extent possible'' to
publish such information). EPA agrees with the commenter that this was
not confidence-inspiring language. Instead, EPA is committing as part
of this final rule to promptly publish in the MRRE docket any
supplemental information received from the requesting manufacturer,
subject to the Agency's requirements with respect to the protection
from disclosure of CBI.
The same commenter also pointed out an inconsistency between the
``preference'' criteria in TSCA section 6(b)(4)(E)(iii) and the
language in the proposed rule. Upon further review, EPA agrees with the
commenter that the language in 40 CFR 702.45(j)(2) warrants adjustment
and is striking the phrase ``in excess of the 25% threshold'' in the
final rule accordingly, in order to be more consistent with the
statutory text on this point. Namely, when reviewing MRRE requests,
TSCA requires EPA to give preference to requests for risk evaluations
on chemical substances for which restrictions imposed by one or more
States have the potential to have a significant impact on interstate
commerce or health or the environment. To date, EPA has not had to
apply any preference criteria as the number of MRRE requests pending at
any given time has been below the 25% threshold.
For clarity and consistency with the TSCA fees provisions in 40 CFR
700.45, EPA has added a parenthetical to the regulatory text about fees
in the event of withdrawal. Specifically, the proposed text referred to
40 CFR 700.45(c)(2)(x) or (xi) and EPA has added a parenthetical to
recognize that, for subsequent fiscal years, the fees rule already
incorporates an inflation adjustment per 40 CFR 700.45(d). EPA is also
making minor changes to the regulatory text at 40 CFR 700.45(e)(8) and
(9) on unfulfilled information needs and the initiation of the risk
evaluation to increase clarity in the process, and at 40 CFR 700.45(k)
to correct a typo in the statutory citation.
Aside from the minor adjustments noted in this section, EPA is
finalizing the remainder of the regulatory text at 40 CFR 702.45 as
proposed.
K. Interagency Collaboration
EPA is also finalizing 40 CFR 702.47 as proposed. As part of EPA's
commitment to identify information earlier in the prioritization and
risk evaluation processes, the Agency expects to continue to engage and
enhance coordination with other Federal agencies that may have
chemical-specific information. EPA continues to collaborate with other
relevant Federal agencies and plans to further coordinate with them
regarding interagency engagement and collaboration when carrying out
the functions and responsibilities assigned to the Agency under TSCA
section 6(b), starting even before the initiation of the prioritization
process. EPA intends to develop and, subject to the interests of
Federal agencies involved, execute Memoranda of Understanding that
memorialize these interagency information exchange, review and comment,
and collaboration best practices. Such practices would address
engagement and collaboration with Federal partners to help ensure EPA
has timely access to information to support a comprehensive
understanding of, and not limited to, a chemical substance's conditions
of use and their importance to national security or critical
infrastructure, the hazard and exposure potential of that chemical, and
existing safety measures Federal agencies already have in place for
their uses.
With respect to critical/essential uses by other Federal agencies,
EPA recognizes that identification and documentation of such uses
requires substantial and early interagency engagement, as well as
safeguards for national security or other sensitive information. Uses
of a chemical that may be critical/essential are conditions of use of
the chemical and, as such, will be evaluated in risk evaluations.
Federal agencies should identify their uses (including those they
believe to be critical or essential uses) as early as possible (e.g.,
during the prioritization and/or risk evaluation processes) to help
inform EPA's development of regulations for chemical substances under
TSCA section 6(a) to the extent necessary to address unreasonable risk
upon completion of relevant risk evaluations. EPA will engage with
agencies that identify critical/essential uses to obtain the necessary
level of information to support the consideration of those uses in
advance of any proposed rule. For each chemical substance, EPA intends
to engage at least four times with interested Federal agencies and
departments: first, before EPA begins the prioritization process for
the substance; second, during the 9-to-12 month prioritization process;
third, during the development of the draft risk evaluation; and fourth,
after the draft risk evaluation has been released for public comment.
At each engagement, in addition to receiving any information about the
substance Federal agencies wish to share, EPA would share scientific
and other information about its progress on the risk evaluation,
including any information it has developed related to Federal agency
uses of the substance.
V. Reliance Interests
As described in the proposed rule, EPA considered to what extent
stakeholders may have reliance interests in previous statutory
interpretations underpinning the 2017 final rule, and concluded that
there are either no reliance interests on those past statutory
interpretations, or that any such interests are minor (Ref. 5 at p.
74316). The current rule and proposed changes largely pertain to
internal Agency procedures that guide the Agency's risk evaluation
activities under TSCA and mostly do not directly impact external
parties, with the exception of modified procedural requirements for
voluntary requests for risk evaluation that are submitted by
manufacturers.
A few commenters disagreed with EPA's discussion of reliance
interests. They argued, for example, that companies submitted MRREs
under the
[[Page 37049]]
2017 procedural rule with expectations related to use-specific risk
determinations and preemption outcomes. Another argued that all
manufacturers who deal with chemicals under review will become subject
to capricious regulation in light of the elimination of the ``best
available science'' and the peer review requirements. Another commenter
suggested the high likelihood of inconsistency between risk evaluations
creates substantial reliance interests.
First, with respect to commenters' arguments regarding preemption,
as described previously, EPA believes commenters fundamentally
misunderstand the applicability of TSCA section 18(a), and how the
preemptive effects of that provision are unaffected by a single
chemical risk determination. As noted earlier, permanent preemption is
triggered under section 18(a)(1)(B)(ii) if EPA issues first a scope of
the risk evaluation under section 6(b)(4)(D) and then a section 6(a)
final rule or a section 6(i)(1) determination based on the risk
evaluation. These factors are not affected by a single risk
determination approach. Further, because the 2017 rule does not mandate
use-based risk determinations, EPA disagrees that MRRE submitters, for
example, could have demonstrable reliance interests on that particular
approach or outcome. Second, with respect to ``best available
science,'' nothing in this rule modifies the statutory requirement that
EPA apply the best available science in all risk evaluations. Likewise,
nothing in this rule would eliminate peer review on future risk
evaluations. Third, EPA disagrees that this rule will create a high
level of inconsistency between risk evaluations. To the contrary, EPA
believes this rule--and the important clarifying changes it would
codify--will bring greater consistency to future risk evaluations and
more certainty and transparency for the regulated community and public.
EPA further maintains that, to the extent there were any reliance
interests on the prior interpretations, or the risk evaluations that
were developed based on the previous procedural requirements, nothing
in this rule is intended to apply retroactively. EPA does not believe
stakeholders have reliance interests pertaining to the process for
future, yet-to-be-completed risk evaluations that will be carried out
in accordance with this final rule.
VI. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act; Final Rule. Federal Register.
82 FR 33726, July 20, 2017 (FRL-9964-38). <a href="https://www.govinfo.gov/content/pkg/FR-2017-07-20/pdf/2017-14337.pdf">https://www.govinfo.gov/content/pkg/FR-2017-07-20/pdf/2017-14337.pdf</a>.
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. <a href="https://cdn.ca9.uscourts.gov/datastore/opinions/2019/11/14/17-72260.pdf">https://cdn.ca9.uscourts.gov/datastore/opinions/2019/11/14/17-72260.pdf</a>.
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. <a href="https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01765.pdf">https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01765.pdf</a>.
4. U.S. EPA. Information Collection Request (ICR) for the Final
Rule: Procedures for Chemical Risk Evaluation Under TSCA (RIN 2070-
AK90). EPA ICR No.: 2781.02 and OMB Control No. 2070-0231. April 17,
2024.
5. U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act; Proposed Rule. Federal
Register. 88 FR 74292, October 30, 2023 (FRL-8529-01). <a href="https://www.govinfo.gov/content/pkg/FR-2023-10-30/pdf/2023-23428.pdf">https://www.govinfo.gov/content/pkg/FR-2023-10-30/pdf/2023-23428.pdf</a>.
6. U.S. EPA. Procedures for Chemical Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Proposed Rule; EPA Response to Public
Comments (RIN 2070-AK90). EPA-HQ-OPPT-2023-0496. April 17, 2024.
7. Safer Chemicals, Healthy Families; et al., v. U.S. Environmental
Protection Agency, No. 17-72260, 17-72501, 17-72968, 17-73290, 17-
73383, 17-73390, 2019 WL 6041996 (9th Cir. November 14, 2019).
8. U.S. Senate Report on the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, S.697, S.Rept.114-67. June 18, 2015. <a href="https://www.congress.gov/congressional-report/114th-congress/senate-report/67/1">https://www.congress.gov/congressional-report/114th-congress/senate-report/67/1</a>.
9. OSHA. Permissible Exposure Limits Annotated Tables. <a href="https://www.osha.gov/annotated-pels">https://www.osha.gov/annotated-pels</a>.
10. U.S. EPA. General Principles for Performing Aggregate Exposure
and Risk Assessment. Office of Pesticide Programs. November 28,
2001. <a href="https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf">https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf</a>.
11. U.S. EPA. Framework for Cumulative Risk Assessment. EPA/630/P-
02/001F. Risk Assessment Forum. Washington, DC. May 2003. <a href="https://www.epa.gov/sites/default/files/2014-11/documents/frmwrk_cum_risk_assmnt.pdf">https://www.epa.gov/sites/default/files/2014-11/documents/frmwrk_cum_risk_assmnt.pdf</a>.
12. U.S. EPA. Cumulative Impacts Research: Recommendations for EPA's
Office of Research and Development. EPA 600/R-22/014a. Office of
Research and Development. Washington, DC. September 30, 2022.
<a href="https://www.epa.gov/system/files/documents/2022-09/Cumulative%20Impacts%20Research%20Final%20Report_FINAL-EPA%20600-R-22-014a.pdf">https://www.epa.gov/system/files/documents/2022-09/Cumulative%20Impacts%20Research%20Final%20Report_FINAL-EPA%20600-R-22-014a.pdf</a>.
13. U.S. EPA. EJSCREEN: Environmental Justice Screening and Mapping
Tool. <a href="https://www.epa.gov/ejscreen">https://www.epa.gov/ejscreen</a>.
14. U.S. EPA. EnviroAtlas. <a href="https://www.epa.gov/enviroatlas">https://www.epa.gov/enviroatlas</a>.
15. U.S. EPA. Draft TSCA Screening Level Approach for Assessing
Ambient Air and Water Exposures to Fenceline Communities Version
1.0. EPA/744/D/22/001. Washington, DC. 2022. <a href="https://www.epa.gov/system/files/documents/2022-01/draft-fenceline-report_sacc.pdf">https://www.epa.gov/system/files/documents/2022-01/draft-fenceline-report_sacc.pdf</a>.
16. U.S. EPA. Draft Risk Evaluation for Tris(2-chloroethyl)
Phosphate (TCEP). EPA-740-D-23-002. Office of Chemical Safety and
Pollution Prevention. Washington DC. December 2023. <a href="https://www.epa.gov/system/files/documents/2023-12/tcep_draft_risk_evaluation_20231207_hero_public-release.pdf">https://www.epa.gov/system/files/documents/2023-12/tcep_draft_risk_evaluation_20231207_hero_public-release.pdf</a>.
17. U.S. EPA. Draft Supplemental Analysis to the Draft Risk
Evaluation for 1,4-Dioxane. EPA-740-R1-8007. Office of Chemical
Safety and Pollution Prevention. November 2020. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0067">https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0238-0067</a>.
18. U.S. EPA. Draft Risk Evaluation for Formaldehyde. EPA-740-D-24-
002; EPA-740-D-24-003; and EPA-740-D-24-005. Office of Chemical
Safety and Pollution Prevention. March 2024. <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-formaldehyde">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-formaldehyde</a>.
19. U.S. EPA. Peer Review and Peer Involvement at the U.S.
Environmental Protection Agency. January 31, 2006. <a href="https://www.epa.gov/sites/default/files/2015-01/documents/peer_review_policy_and_memo.pdf">https://www.epa.gov/sites/default/files/2015-01/documents/peer_review_policy_and_memo.pdf</a>.
20. U.S. EPA. Peer Review Handbook (4th Edition). EPA/100/B-15/001.
Science and Technology Policy Council. Washington, DC. October 2015.
<a href="https://www.epa.gov/sites/default/files/2020-08/documents/epa_peer_review_handbook_4th_edition.pdf">https://www.epa.gov/sites/default/files/2020-08/documents/epa_peer_review_handbook_4th_edition.pdf</a>.
21. OMB. Final Information Quality Bulletin for Peer Review. Federal
Register. 70 FR 2664, January 14, 2005. <a href="https://www.govinfo.gov/content/pkg/FR-2005-01-14/pdf/05-769.pdf">https://www.govinfo.gov/content/pkg/FR-2005-01-14/pdf/05-769.pdf</a>.
22. U.S. EPA. Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity, of Information Disseminated by
the Environmental Protection Agency. EPA/260R-02-008. Office of
Environmental Information. Washington, DC. October 2002. https://
www.epa.gov/sites/default/files/2020-02/
[[Page 37050]]
documents/epa-info-quality-guidelines_pdf_version.pdf.
23. Executive Office of the President. Office of Science and
Technology Policy. Center on Environmental Quality. Washington DC.
Memorandum for Heads of Federal Departments and Agencies. Guidance
for Federal Departments and Agencies on Indigenous Knowledge.
November 30, 2022. <a href="https://www.whitehouse.gov/wp-content/uploads/2022/12/OSTP-CEQ-IK-Guidance.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/12/OSTP-CEQ-IK-Guidance.pdf</a>.
24. U.S. EPA. Draft TSCA Systematic Review Protocol Supporting TSCA
Risk Evaluations for Chemical Substances: A Generic TSCA Systematic
Review Protocol with Chemical-Specific Methodologies (Version 1.0).
EPA-D-20-031. Office of Chemical Safety and Pollution Prevention.
Washington, DC. December 2021. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0414-0005">https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0414-0005</a>.
25. U.S. EPA. Office of Research and Development Staff Handbook for
Developing IRIS Assessments. EPA/600/R-22/268. Office of Research
and Development. Washington, DC. 2022. <a href="https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=356370">https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=356370</a>.
26. NRC. Review of EPA's Integrated Risk Information System (IRIS)
Process. The National Academies Press. Washington, DC. 2014. <a href="https://www.nap.edu/catalog/18764/review-of-epas-integrated-riskinformation-system-iris-process">https://www.nap.edu/catalog/18764/review-of-epas-integrated-riskinformation-system-iris-process</a>.
27. National Academies of Sciences Engineering and Medicine. The Use
of Systematic Review in EPA's Toxic Substances Control Act Risk
Evaluations. The National Academies Press. Washington, DC. 2021.
<a href="https://doi.org/10.17226/25952">https://doi.org/10.17226/25952</a>.
28. U.S. EPA. Application of Systematic Review in TSCA Risk
Evaluations. EPA/740/P1/8001. Office of Chemical Safety and
Pollution Prevention. May 2018. <a href="https://www.epa.gov/sites/default/files/2018-06/documents/final_application_of_sr_in_tsca_05-31-18.pdf">https://www.epa.gov/sites/default/files/2018-06/documents/final_application_of_sr_in_tsca_05-31-18.pdf</a>.
29. U.S. EPA. Guidelines for Carcinogen Risk Assessment. EPA/630/P-
03/001F. Risk Assessment Forum. Washington, DC. March 2005. <a href="https://www.regulations.gov/document/EPA-HQ-OA-2007-0679-0001">https://www.regulations.gov/document/EPA-HQ-OA-2007-0679-0001</a>.
30. NRC. Science and Decisions: Advancing Risk Assessment. National
Academies Press. Washington, DC. 2009. <a href="https://dx.doi.org/10.17226/12209">https://dx.doi.org/10.17226/12209</a>.
31. U.S. EPA. Weight of Evidence in Ecological Assessment. EPA/100/
R-16/001. Risk Assessment Forum. Washington DC. December 2016.
<a href="https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100SFXR.txt">https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100SFXR.txt</a>.
32. U.S. EPA. Endocrine Disruptor Screening Program (EDSP); Weight-
of-Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify
the Need for Tier 2 Testing. Office of Chemical Safety and Pollution
Prevention. Washington, DC. 2011. <a href="https://www.regulations.gov/document/EPA-HQ-OPPT-2010-0877-0021">https://www.regulations.gov/document/EPA-HQ-OPPT-2010-0877-0021</a>.
33. U.S. EPA. Guidance to Assist Interested Persons in Developing
and Submitting Draft Risk Evaluations Under the Toxic Substances
Control Act. Office of Chemical Safety and Pollution Prevention. EPA
740-R17-001. Washington DC. June 2017. <a href="https://www.epa.gov/sites/default/files/2017-06/documents/tsca_ra_guidance_final.pdf">https://www.epa.gov/sites/default/files/2017-06/documents/tsca_ra_guidance_final.pdf</a>.
VII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review
This action is a ``significant regulatory action'' as defined in
Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by
Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA
submitted this action to the OMB for Executive Order 12866 review.
Documentation of any changes made in response to the Executive Order
12866 review is available in the docket. EPA prepared an analysis of
the potential costs associated with this action. This analysis, which
is in the docket, is summarized in Unit VII.B.
B. Paperwork Reduction Act (PRA)
The information collection activities in this final rule have been
submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared to
replace an existing approved ICR has been assigned EPA ICR No. 2781.02
and is identified by OMB Control No. 2070-0231. You can find a copy of
the new ICR document (Ref. 4) in the docket for this rule, and it is
briefly summarized here.
The information activities related to the current requirements for
manufacturer-requested risk evaluations are already approved by OMB in
an ICR entitled, ``Procedures for Requesting a Chemical Risk Evaluation
under TSCA'' (EPA ICR No. 2559.03 and OMB Control No. 2070-0202) (Ref
4). The rule replacement ICR addresses the information collection
requirements contained in the current regulations as well as in the
amendments identified in this final rule. As addressed in the currently
approved ICR and pursuant 40 CFR 702, subpart B, the information
collection activities are those carried out by a chemical manufacturer
in requesting a specific chemical risk evaluation under TSCA be
conducted by EPA. EPA established the process for conducting risk
evaluations under TSCA. Chemicals that will undergo this evaluation
include chemicals designated by the Agency as high-priority in
accordance with 40 CFR 702, subpart A, as well as chemicals for which
EPA has granted requests made by manufacturers to have the chemicals
evaluated under EPA's risk evaluation process. The replacement ICR
addresses amendments to information requirements for manufacturer-
requested risk evaluations, including amendments to information
requirements addressing joint submissions, the scope of the requested
risk evaluation, and the information to be provided in support of the
requested risk evaluation, and fee payment. Please see Unit IV.J. for
additional information about these amendments.
The replacement ICR addresses adjustments to the estimated number
of respondents, time for activities, and wage rates related to the
current regulatory requirements as approved under OMB Control No. 2070-
0202. In addition, the replacement ICR addresses program changes
related to the proposed amendments, including changes to content
requirements for manufacturer-requested risk evaluation request and
associated process changes. The estimated annual burden approved by OMB
under OMB Control No. 2070-0202 is 419 hours. The total estimated
annual respondent burden associated with the amended requirements in
the replacement ICR is 166 hours, a net decrease of 253 hours. The
primary driver in the burden decrease is the estimated number of
responses dropping to 1 per year based on the number of requests EPA
has received to date. Certain information included with a manufacturer-
requested risk evaluation may be claimed as TSCA CBI in accordance with
TSCA section 14 (15 U.S.C. 2613), and any such claims must be
substantiated in accordance with the Act.
Respondents/affected entities: Persons that manufacture chemical
substances and request a chemical be considered for risk evaluation by
EPA. Such persons may voluntarily request a risk evaluation but would
be required to comply with the requirements for such a request. See
Unit I.A.
Respondent's obligation to respond: Voluntary (15 U.S.C.
2605(b)(4)).
Estimated number of respondents: 1 annually.
Frequency of response: On occasion.
Total estimated burden: 166 hours (per year). Burden is defined at
5 CFR 1320.3(b).
Total estimated cost: $115,711 (per year), includes $0 annualized
capital or operation and maintenance costs.
[[Page 37051]]
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are manufacturers of chemical substances that submit
requests to EPA seeking chemical risk evaluations. The Agency has
determined that a low number of small entities may be impacted by
voluntarily submitting a request to EPA for a chemical to undergo a
risk evaluation. The 2017 final rule considered firms in 60 different
NAICS codes that may choose to pursue a manufacturer-requested risk
evaluation (approximately 30,000 firms) of which 76 percent were
classified as small business (approximately 22,000 firms). When EPA
promulgated the 2017 final rule, the Agency estimated that it would
receive 5 MRRE submissions per year. However, manufacturers have
submitted only 4 MRRE requests since 2017 (or less than one request per
year, on average). Therefore, based on the number of submissions
received by EPA since 2017, the Agency estimates it will receive only
one manufacturer-requested risk revaluation per year. That is, only one
out of approximately 22,000 small businesses is expected to choose to
incur the submission costs ($115,711) in any one year and, thus, a
significant number of small businesses would not be impacted by this
rule. The decision to request a risk evaluation for a chemical is
voluntary and manufacturers may decide not to make such a request.
Details of this analysis are presented in the rule-related ICR.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate of $100 million
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments. The
costs involved in this action are imposed only on the private sector
entities (manufacturers) that may voluntarily elect to submit a request
for a risk evaluation as they would be required to comply with the
requirements for such requests.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999) because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
TSCA section 18(c)(3) defines the scope of federal preemption with
respect to any final rule EPA issues under TSCA section 6(a). That
provision provides that federal preemption of ``statutes, criminal
penalties, and administrative actions'' applies to ``the hazards,
exposures, risks, and uses or conditions of use of such chemical
substances included in any final action the Administrator takes
pursuant to [TSCA section 6(a)].'' EPA reads this to mean that states
are preempted from imposing requirements through statutes, criminal
penalties, and administrative actions relating to any ``hazards,
exposures, risks, and uses or conditions of use'' evaluated in the
final risk evaluation and informing the risk determination that EPA
addresses in the TSCA section 6(a) rulemaking. For example, federal
preemption applies even if EPA does not regulate in that final rule a
particular COU, but that COU was evaluated in the final risk
evaluation.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000) because it will
not have substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes. Thus, Executive Order 13175 does not
apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-201 of the Executive Order. Therefore,
this action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.
Since this action does not concern human health risks, EPA's Policy
on Children's Health also does not apply. This procedural rule
addresses how EPA evaluates the risks of existing chemicals under TSCA,
including potential risks to children and other PESS. EPA must initiate
a rulemaking to address the unreasonable risk to human health or the
environment that the Agency may determine are presented by a chemical
substance as set forth in a TSCA risk evaluation. Although this
procedural rule itself does not directly affect the level of protection
provided to human health or the environment, EPA expects that this rule
will improve the Agency's consideration of risks to children and other
PESS and, in turn, better inform the Agency's determination of whether
a chemical substance presents an unreasonable risk of injury to health
under its conditions of use. An EPA rulemaking to address an
unreasonable risk of injury to health that the Administrator determines
is presented by a chemical substance following a risk evaluation could
qualify as a covered regulatory action under E.O. 13045 and could be
subject to EPA's Policy on Children's Health.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' under Executive
Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to
have a significant adverse effect on the supply, distribution or use of
energy and has not otherwise been designated by the Administrator of
OMB's Office of Information and Regulatory Affairs as a ``significant
energy action.''
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve technical standards under NTTAA
section 12(d), 15 U.S.C. 272.
[[Page 37052]]
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that it is not practicable to assess whether the human
health or environmental conditions that exist prior to this action
result in disproportionate and adverse effects on communities with
environmental justice concerns consistent with Executive Order 12898
(59 FR 7629, February 16, 1994) and Executive Order 14096 (88 FR 25251,
April 26, 2023). This action amends the procedures that EPA will use to
evaluate the risk of existing chemical substances pursuant to TSCA, and
the Agency cannot foresee the final results of those evaluations.
However, by specifically including overburdened communities in the
regulatory definition of PESS, the Agency believes that this action
will assist EPA and others (including the public) in understanding, and
will assist EPA in determining the potential exposures, hazards and
risks to the public, including for overburdened communities associated
with existing chemicals as part of a TSCA risk evaluation. The
inclusion of overburdened communities among the PESS considered in a
chemical risk evaluation will also enable the Agency to design
appropriate risk management approaches to address the unreasonable risk
that the Agency may determine is presented by a chemical to all
potentially affected people, including any unreasonable risk that is
disproportionately borne by communities with environmental justice
concerns.
The information supporting this Executive Order review is presented
in Unit IV.F.4.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action does not meet the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 702
Environmental protection, Chemicals, Chemical substances, Hazardous
substances, Health and safety, Risk evaluation.
Dated: April 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended to read as follows:
PART 702--GENERAL PRACTICES AND PROCEDURES
0
1. The authority citation for part 702 continues to read as follows:
Authority: 15 U.S.C. 2605 and 2619.
0
2. Revise and republish subpart B to read as follows:
Subpart B--Procedures for Chemical Substance Risk Evaluations
Sec.
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances subject to risk evaluation.
702.37 Evaluation requirements.
702.39 Components of risk evaluation.
702.41 Peer review.
702.43 Risk evaluation actions and timeframes.
702.45 Submission of manufacturer requests for risk evaluations.
702.47 Interagency collaboration.
702.49 Publicly available information.
Subpart B--Procedures for Chemical Substance Risk Evaluations
Sec. 702.31 General provisions.
(a) Purpose. This subpart establishes the EPA process for
conducting a risk evaluation to determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment as
required under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)).
(b) Scope. These regulations establish the general procedures, key
definitions, and timelines EPA will use in a risk evaluation conducted
pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)).
(c) Applicability. The requirements of this part apply to all
chemical substance risk evaluations initiated pursuant to TSCA section
6(b) (15 U.S.C. 2605(b)) beginning June 3, 2024. For risk evaluations
initiated prior to this date, but not yet finalized, EPA will seek to
apply the requirements in this subpart to the extent practicable. These
requirements shall not apply retroactively to risk evaluations already
finalized.
(d) Categories of chemical substances. Consistent with EPA's
authority to take action with respect to categories of chemicals under
15 U.S.C. 2625(c), all references in this part to ``chemical'' or
``chemical substance'' shall also apply to ``a category of chemical
substances.''
Sec. 702.33 Definitions.
All definitions in TSCA apply to this subpart. In addition, the
following definitions apply:
Act means the Toxic Substances Control Act (TSCA), as amended (15
U.S.C. 2601 et seq.).
Aggregate exposure means the combined exposures from a chemical
substance across multiple routes and across multiple pathways.
Conditions of use means the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
EPA means the U.S. Environmental Protection Agency.
Pathways means the physical course a chemical substance takes from
the source to the organism exposed.
Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by EPA who, due to
either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, the elderly, or overburdened communities.
Reasonably available information means information that EPA
possesses or can reasonably generate, obtain, and synthesize for use in
risk evaluations, considering the deadlines specified in TSCA section
6(b)(4)(G) for completing such evaluation. Information that meets the
terms of the preceding sentence is reasonably available information
whether or not the information is confidential business information,
that is protected from public disclosure under TSCA section 14.
Routes means the ways a chemical substance enters an organism after
contact, e.g., by ingestion, inhalation, or dermal absorption.
Sentinel exposure means the exposure from a chemical substance that
represents the plausible upper bound of exposure relative to all other
exposures within a broad category of similar or related exposures.
Uncertainty means the imperfect knowledge or lack of precise
knowledge of the real world either for specific values of interest or
in the description of the system.
Variability means the inherent natural variation, diversity, and
heterogeneity across time and/or space or among individuals within a
population.
[[Page 37053]]
Sec. 702.35 Chemical substances subject to risk evaluation.
(a) Chemical substances undergoing risk evaluation. A risk
evaluation for a chemical substance designated by EPA as a High-
Priority Substance pursuant to the prioritization process described in
subpart A or initiated at the request of a manufacturer or
manufacturers under Sec. 702.45, will be conducted in accordance with
this part, subject to Sec. 702.31(c).
(b) Percentage requirements. Pursuant to 15 U.S.C. 2605(b)(4)(E)(i)
and in accordance with Sec. 702.45(j)(1), EPA will ensure that the
number of chemical substances for which a manufacturer-requested risk
evaluation is initiated pursuant to Sec. 702.45(e)(9) is not less than
25%and not more than 50% of the number of chemical substances for which
a risk evaluation was initiated upon designation as a High-Priority
Substance under subpart A.
(c) Manufacturer-requested risk evaluations for work plan chemical
substances. Manufacturer requests for risk evaluations, described in
paragraph (a) of this section, for chemical substances that are drawn
from the 2014 update of the TSCA Work Plan for Chemical Assessments
will be granted at the discretion of EPA. Such evaluations are not
subject to the percentage requirements in paragraph (b) of this
section.
Sec. 702.37 Evaluation requirements.
(a) Considerations. (1) EPA will use applicable EPA guidance when
conducting risk evaluations, as appropriate and where it represents the
best available science.
(2) EPA will document that the risk evaluation is consistent with
the best available science and based on the weight of the scientific
evidence. In determining best available science, EPA shall consider as
applicable:
(i) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and consistent
with the intended use of the information;
(ii) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance or
mixture;
(iii) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
(iv) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
(v) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
(3) EPA will ensure that all supporting analyses and components of
the risk evaluation are suitable for their intended purpose, and
tailored to the problems and decision at hand, in order to inform the
development of a technically sound determination as to whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use, based on the weight of the
scientific evidence.
(4) EPA will not exclude conditions of use from the scope of the
risk evaluation, but a fit-for-purpose approach may result in varying
types and levels of analysis and supporting information for certain
conditions of use, consistent with paragraph (b) of this section. The
extent to which EPA will refine its evaluations for one or more
condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment.
(5) EPA will evaluate chemical substances that are metals or metal
compounds in accordance with 15 U.S.C. 2605(b)(2)(E).
(b) Information and information sources. (1) EPA will base each
risk evaluation on reasonably available information.
(2) EPA will apply systematic review methods to assess reasonably
available information, as needed to carry out risk evaluations that
meet the requirements in TSCA section 26(h) and (i), in a manner that
is objective, unbiased, and transparent.
(3) EPA may determine that certain information gaps can be
addressed through application of assumptions, uncertainty factors,
models, and/or screening to conduct its analysis with respect to the
chemical substance, consistent with 15 U.S.C. 2625. The approaches used
will be determined by the quality of reasonably available information,
the deadlines specified in TSCA section 6(b)(4)(G) for completing the
risk evaluation, and the extent to which the information reduces
uncertainty.
(4) EPA expects to use its authorities under the Act, and other
information gathering authorities, when necessary to obtain the
information needed to perform a risk evaluation for a chemical
substance before initiating the risk evaluation for such substance. EPA
will also use such authorities during the performance of a risk
evaluation to obtain information as needed and on a case-by-case basis
to ensure that EPA has adequate, reasonably available information to
perform the evaluation. Where appropriate, to the extent practicable,
and scientifically justified, EPA will require the development of
information generated without the use of new testing on vertebrates.
(5) Among other sources of information, EPA will also consider
information and advice provided by the Science Advisory Committee on
Chemicals established pursuant to 15 U.S.C. 2625(o).
Sec. 702.39 Components of risk evaluation.
(a) In general. Each risk evaluation will include all of the
following components:
(1) A Scope;
(2) A Hazard Assessment;
(3) An Exposure Assessment;
(4) A Risk Characterization; and
(5) A Risk Determination.
(b) Scope of the risk evaluation. The scope of the risk evaluation
will include all the following:
(1) The condition(s) of use the EPA expects to consider in the risk
evaluation.
(2) The potentially exposed populations, including any potentially
exposed or susceptible subpopulations as identified as relevant to the
risk evaluation by EPA under the conditions of use that EPA plans to
evaluate.
(3) The ecological receptors that EPA plans to evaluate.
(4) The hazards to health and the environment that EPA plans to
evaluate.
(5) A description of the reasonably available information and
scientific approaches EPA plans to use in the risk evaluation.
(6) A conceptual model that describes the actual or predicted
relationships between the chemical substance, its associated conditions
of use through predicted exposure scenarios, and the identified human
and environmental receptors and human and ecological health hazards.
(7) An analysis plan that includes hypotheses and descriptions
about the relationships identified in the conceptual model and the
approaches and strategies EPA intends to use to assess exposure and
hazard effects, and to characterize risk; and a description, including
quality, of the data, information, methods, and models, that EPA
intends to use in the analysis and how uncertainty and variability will
be characterized.
[[Page 37054]]
(8) EPA's plan for peer review consistent with Sec. 702.41.
(c) Hazard assessment. (1) The hazard assessment process includes
the identification, evaluation, and synthesis of information to
describe the potential health and environmental hazards of the chemical
substance under the conditions of use.
(2) Hazard information related to potential health and
environmental hazards of the chemical substance will be reviewed in a
manner consistent with best available science based on the weight of
scientific evidence and all assessment methods will be documented.
(3) Consistent with Sec. 7
[…truncated; see source link]Indexed from Federal Register on May 3, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.