2559.03 Attachment 2

33726

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 702
[EPA–HQ–OPPT–2016–0654; FRL–9964–38]
RIN 2070–AK20

Procedures for Chemical Risk
Evaluation Under the Amended Toxic
Substances Control Act
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:

As required under section
6(b)(4) of the Toxic Substances Control
Act (TSCA), EPA is issuing a rule that
establishes a process for conducting risk
evaluations to determine whether a
chemical substance presents an
unreasonable risk of injury to health or
the environment, without consideration
of costs or other non-risk factors,
including an unreasonable risk to a
potentially exposed or susceptible
subpopulation, under the conditions of
use. This process incorporates the
science requirements of the amended
statute, including best available science
and weight of the scientific evidence.
Risk evaluation is the second step, after
Prioritization, in a new process of
existing chemical substance review and
management established under recent
amendments to TSCA. This rule
identifies the steps of a risk evaluation
process including: scope, hazard
assessment, exposure assessment, risk
characterization, and finally a risk
determination. This process will be
used for the first ten chemical
substances undergoing evaluation from
the 2014 update of the TSCA Work Plan
for Chemical Assessments (to the
maximum extent practicable). Chemical
substances designated as High-Priority
Substances during the prioritization
process and those chemical substances
for which EPA has initiated a risk
evaluation in response to a
manufacturer request, will always be
subject to this process. The final rule
also includes the required ‘‘form and
criteria’’ applicable to such
manufacturer requests.
DATES: This final rule is effective
September 18, 2017.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0654, is
available at http://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,

asabaliauskas on DSKBBXCHB2PROD with RULES

SUMMARY:

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Susanna W. Blair, Immediate Office,
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–4321; email address:
[email protected].
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
EPA is primarily establishing
requirements on the Agency. However,
this rule also includes the process and
criteria that manufacturers (including
importers) must follow when they
request an Agency-conducted risk
evaluation on a particular chemical
substance. This action may, therefore,
be of interest to entities that are
manufacturing or importing, or may
manufacture or import a chemical
substance regulated under TSCA (e.g.,
entities identified under North
American Industrial Classification
System (NAICS) codes 325 and 324110).
Since other entities may also be
interested, the Agency has not
attempted to describe all the specific
entities and corresponding NAICS codes
for entities that may be interested in or
affected by this action.
B. What action is the Agency taking?
EPA is establishing, by rule, the
process by which the Agency will
conduct risk evaluations on chemical
substances under TSCA. The rule
identifies the necessary components of
a risk evaluation, including a scope
(including a conceptual model and an
analysis plan), a hazard assessment, an
exposure assessment, a risk
characterization, and a risk
determination. The rule also establishes
the process by which manufacturers
would request an Agency-conducted
risk evaluation, and the criteria by
which the EPA will evaluate such
requests. This rule also incorporates the

PO 00000

Frm 00002

Fmt 4701

Sfmt 4700

statutory science requirements,
including best available science and
weight of the scientific evidence.
C. What is the Agency’s authority for
taking this action?
EPA is issuing this rule pursuant to
the authority in TSCA section 6(b)(4), as
amended (15 U.S.C. 2605(b)(4)). See also
the discussion in Units II.A. and B.
D. What are the estimated incremental
impacts of this action?
The incremental impacts of this
action are the result of the process and
requirements that manufacturers
(including importers) must perform if
they elect to submit a chemical
substance for a risk evaluation. EPA has
estimated the potential burden and costs
associated with the proposed
requirements for submitting a request
for an Agency-conducted risk evaluation
on a particular chemical substance
which is available in the docket, is
discussed in Unit V. and is briefly
summarized here. (Ref. 1).
The total estimated annual burden is
419.2 hours and $282,861, which is
based on an estimated per request
burden of 83.8 hours.
In addition, EPA’s evaluation of the
potential costs associated with this
action is discussed in Unit V. Since this
rule focuses on the activities that a
manufacturer must perform, the
estimated incremental costs are
expected to be de minimis.
II. Background
A. Statutory Requirements for Risk
Evaluation
TSCA section 6(b)(4) requires EPA to
establish, by rule, a process to conduct
risk evaluations. Specifically, EPA is
directed to use this process to
‘‘determine whether a chemical
substance presents an unreasonable risk
of injury to health or the environment,
without consideration of costs or other
non-risk factors, including an
unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant to the risk
evaluation by the Administrator under
the conditions of use.’’ 15 U.S.C.
2605(b)(4)(A). TSCA sections 6(b)(4)(A)
through (H) enumerate the deadlines
and minimum requirements applicable
to this process, including provisions
that direct which chemical substances
must undergo evaluation, the
development of criteria for
manufacturer-requested evaluations, the
minimum components of an Agency
risk evaluation, and the timelines for
public comment and completion of the
risk evaluation. The law also requires

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
that EPA operate in a manner that is
consistent with the best available
science and make decisions based on
the weight of the scientific evidence. 15
U.S.C. 2625(h) and (i).
1. Chemical substances to undergo
risk evaluation. TSCA section 6(b)
identifies the chemical substances that
are subject to this process; these are: (1)
The ten chemical substances the Agency
was required to identify from the 2014
update to the TSCA Work Plan within
the first 180 calendar days after the
signing of TSCA); (2) the chemical
substances determined to be HighPriority Substances through the
prioritization process published
elsewhere in this Federal Register; and
(3) chemicals selected in response to a
manufacturer request that meets the
criteria established by this rule. 15
U.S.C. 2605(b)(4)(C). Assuming EPA
receives a sufficient number of
compliant requests, the statute specifies
that EPA shall ensure that the number
of manufacturer-requested evaluations
is not less than 25 percent and not more
than 50 percent of the number of the ongoing ‘‘High Priority’’ risk evaluations.
15 U.S.C 2605(b)(4)(E). Since the
number of manufacturer-requested
evaluations is expressed as a percentage
of the number of High-Priority
Substance evaluations, not as a
percentage of the total, the number of
manufacturer-requested evaluations will
likely comprise between 1⁄5 and 1⁄3 of
the number of total ongoing evaluations,
assuming a sufficient number of
compliant requests are received. Any
manufacturer requested risk evaluations
for chemical substances on the 2014
update of the TSCA Work Plan (Ref. 2)
will be granted at the discretion of the
Administrator, and are exempt from the
percentage limitations.
2. Manufacturer-requested risk
evaluations. TSCA section 6(b)(4)(C)
directs EPA to establish the ‘‘form and
manner’’ and ‘‘criteria’’ that govern
manufacturer requests that EPA conduct
a risk evaluation on a substance that
they manufacture. EPA has broad
discretion to establish these criteria, but
relatively less discretion over whether
to grant requests that comply with
EPA’s criteria. EPA must grant any
request if it determines that it complies
with EPA’s criteria, until the statutory
minimum of 25 percent has been met.
Assuming EPA receives requests in
excess of this threshold, EPA interprets
this provision to grant EPA discretion to
determine whether to grant further
requests, up to the maximum 50 percent
level. In such circumstances, EPA is
directed to give preference to
manufacturer requests for which EPA
determines that restrictions imposed by

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

one or more states have the potential to
significantly impact interstate
commerce, or health or the
environment. 15 U.S.C.
2605(b)(4)(E)(iii).
3. Components of a risk evaluation.
The statute identifies the minimum
components EPA must include in all
chemical substance risk evaluations. For
each risk evaluation, EPA must publish
a document that outlines the scope of
the risk evaluation that EPA expects to
conduct, which includes the hazards,
exposures, conditions of use, and the
potentially exposed or susceptible
subpopulations that EPA expects to
consider. 15 U.S.C 2605(b)(4)(D). The
statute further provides that the scope of
the risk evaluation must be published
no later than six months after the
initiation of the risk evaluation. Id.
Each risk evaluation must also: (1)
Integrate and assess available
information on hazards and exposure
for the conditions of use of the chemical
substance, including information on
specific risks of injury to health or the
environment and information on
potentially exposed or susceptible
subpopulations; (2) describe whether
aggregate or sentinel exposures were
considered and the basis for that
consideration; (3) take into account,
where relevant, the likely duration,
intensity, frequency, and number of
exposures under the conditions of use;
and (4) describe the weight of the
scientific evidence for the identified
hazards and exposure. 15 U.S.C.
2605(b)(4)(F)(i), and (iii)–(v). The risk
evaluation must not consider costs or
other non-risk factors. 15 U.S.C.
2605(b)(4)(F)(ii).
4. Science requirements. TSCA
section 26 requires that, to the extent
that EPA makes a decision based on
science under TSCA sections 4, 5, or 6,
EPA must use scientific standards and
base those decisions on the best
available science and on the weight of
the scientific evidence. 15 U.S.C.
2625(h) and (i). TSCA does not however
explicitly define either of these terms.
Section 26(h) lists factors for the Agency
to consider, as applicable, in employing
best available science. These are: (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

PO 00000

Frm 00003

Fmt 4701

Sfmt 4700

33727

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. As statutory
requirements, they apply to EPA’s
decisions under TSCA sections 4, 5, and
6.
5. Timeframe. TSCA requires that the
risk evaluation process last no longer
than three years, with a possible
additional six-month extension. 15
U.S.C. 2605(b)(4)(G).
6. Opportunities for public
participation. The statute requires that
the Agency allow for no less than a 30day public comment period on the draft
risk evaluation, prior to publishing a
final risk evaluation. 15 U.S.C.
2605(b)(4)(H).
7. Metals and metal compounds.
When evaluating metals or metal
compounds, EPA must use the March
2007 Framework for Metals Risk
Assessment of the Office of the Science
Advisor (Ref. 3) or a successor
document that addresses metals risk
assessment and is peer- reviewed by the
Science Advisory Board.
8. Non-vertebrate testing. Although
not an explicit section 6 requirement,
TSCA imposes new requirements on
EPA regarding the reduction of
vertebrate testing. Amendments to
TSCA section 4 require EPA to ‘‘. . .
reduce and replace, to the extent
practicable, [. . .] the use of vertebrate
animals in the testing of chemical
substances . . .’’ and to develop a
strategic plan to promote such
alternative test methods. 15 U.S.C.
2603(h). Under the risk evaluation
process, EPA may require development
of new information relating to a
chemical substance. Prior to developing
this information EPA must first take into
account reasonably available existing
information, and additionally, must
encourage and facilitate the use of test
methods that reduce or replace the use
of vertebrate animals, group chemicals
into categories to reduce testing, and
encourage the formation of industry
consortia to jointly conduct testing and
other data gathering to avoid
unnecessary duplication of tests.
B. Overview of Final Rule
This final rule incorporates all the
elements required by statute, as
discussed in Unit II.A., some additional
criteria the Agency plans to include and

E:\FR\FM\20JYR2.SGM

20JYR2

33728

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

consider, clarifications for greater
transparency, and additional procedural
steps to ensure effective and transparent
implementation. In response to public
comments on the proposal, EPA is,
among other things: (1) Adding direct
references in the final rule to
acknowledge the Agency’s commitment
to implementing the best available
science and weight of the scientific
evidence provisions in TSCA, (2)
codifying the Agency’s commitment to
interagency collaboration, (3) allowing
manufacturers to limit their requests for
EPA-conducted risk evaluations to one
or more specified conditions of use, and
(4) allowing for risk determinations to
be made on individual conditions of use
or categories of conditions of use at any
time once the Final Scope is published.
EPA intends that the provisions of
this rule be severable. In the event that
any individual provision or part of this
rule is invalidated, EPA intends that
this would not render the entire rule
invalid, and that any individual
provisions that can continue to operate
will be left in place.
III. Discussion of Final Rule and
Response to Comments

asabaliauskas on DSKBBXCHB2PROD with RULES

A. Policy Objectives
The risk evaluation process under
TSCA will provide the basis for the
EPA’s determination as to whether a
chemical substance presents an
unreasonable risk of injury to health or
the environment. The overall objective
of this action is to codify the process by
which the Agency evaluates risks from
chemical substances under TSCA
section 6. In this rule, the Agency
details those components of TSCA risk
evaluation and key factors that EPA
deems are necessary to consider in each
risk evaluation to ensure that the public
has a full understanding of how risk
evaluations will be conducted and to
provide predictability in how they will
be conducted. However, EPA is not
establishing highly detailed provisions
that will address every eventuality or
possible consideration that might arise.
Due to the rapid advancement of the
science of risk evaluation and the
science and technology that inform risk
evaluation, this rule seeks to balance the
need for the risk evaluation procedures
to be transparent, without unduly
restricting the specific science that will
be used to conduct the evaluations,
allowing the Agency flexibility to adapt
and keep current with changing science
as it conducts TSCA evaluations into
the future.

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

B. Scope of Evaluations
TSCA requires risk evaluations to
determine whether or not a chemical
substance presents an unreasonable risk
of injury to health or the environment
under the conditions of use, with
conditions of use being defined as ‘‘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 the proposed rule, EPA explained
that it interpreted TSCA to require that
risk evaluations encompass all
manufacture, processing, distribution in
commerce, use, and disposal activities
that constitute the conditions of use
within the meaning of TSCA section 3.
EPA further proposed that the
conditions of use would need to
encompass all known, intended, and
reasonably foreseen activities associated
with the subject chemical substance.
EPA also noted, however, that a use or
other activity constitutes a condition of
use under the definition only if EPA
determines that it does, and that EPA
has authority to exercise judgment in
making its determination of whether a
condition of use is known, intended, or
reasonably foreseen.
This was one of the issues on which
EPA received the most comments.
Comments covered a number of
considerations regarding conditions of
use: How the Agency will define ‘‘the
conditions of use’’, how the Agency will
scope conditions of use (e.g., are there
conditions of use which will not be
included in the Scope of the risk
evaluation for one reason or another),
and finally how the Agency will treat
the conditions of use identified in the
scope, in the final risk determination.
EPA discusses the first two
considerations in this unit; the third
consideration will be discussed in the
risk determination Unit III.G.1.e.
In defining conditions of use, many
commenters raised concern about EPA’s
interpretation that ‘‘the conditions of
use’’ must include ‘‘all conditions of
use.’’ Concerns were raised in this
regard was specifically about the ability
of EPA to meet the statutory risk
evaluation deadlines if all intended,
known and reasonably foreseen
activities must be considered conditions
of use, and that attempting to identify
every activity relating to the chemical
substance was unnecessary and
impractical. Concerns were also raised
about ensuring that EPA can act
promptly to address any unreasonable
risks identified for particular conditions
of use. Commenters who agreed with

PO 00000

Frm 00004

Fmt 4701

Sfmt 4700

the proposed interpretation of ‘‘all
conditions of use’’ stated that the law in
a number of locations signals the intent
that EPA evaluate all activities
associated with the chemical. The
identified locations include the section
on Final Agency Action which states
that decisions will be on a ‘‘chemical
substance’’ without mention of
condition of use, indicating that EPA
must consider all conditions of use (15
U.S.C. 2605(i)), and the requirement to
account for the ‘‘likely duration,
intensity, frequency, and number of
exposures under the conditions, where
relevant’’ (15 U.S.C. 2605(b)(4)(F)(iv)),
which refers to the consideration of
whether a combination of activities
involving the chemical substance
presents a risk, and therefore EPA must
look at the full spectrum of the activities
associated with a chemical (all
intended, known, or reasonably foreseen
manufacturing, processing, distribution,
use and disposal).
As EPA acknowledged in the
proposal, different interpretations of the
statute are possible. Given the strength
and variety of the concerns presented in
the comments, EPA has reevaluated its
proposal. Accordingly, EPA went back
to the direction on risk evaluation
provided in section 6(b) of the statute
and legislative history, and developed
an approach to the term, ‘‘the conditions
of use’’ that is firmly grounded in the
law, while accounting for the various
policy considerations necessary for
effective implementation of section 6.
EPA’s final approach is informed in part
by the legislative history of the amended
TSCA, which explicitly states that the
Agency is given the discretion to
determine the conditions of use that the
Agency will address in its evaluation of
the priority chemical, in order to ensure
that the Agency’s focus is on the
conditions of use that raise the greatest
potential for risk. See, June 7, 2016 Cong
Rec, S3519–S3520.
In sum, EPA’s overall objective of this
rule is to ensure that it is able to focus
on conducting a timely, relevant, highquality, and scientifically credible
evaluation of a chemical substance as a
whole, and that it always includes an
evaluation of the conditions of use that
raise greatest potential for risk. EPA
wants also to ensure that the Agency
can effectively assess, and where
necessary, regulate chemical substances,
within the statutory deadlines. These
same principles will also serve to guide
EPA’s implementation of the
procedures.
To begin, EPA will identify the
‘‘circumstances’’ that constitute the
‘‘conditions of use’’ for each chemical
substance on a case-by-case basis. TSCA

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
defines a chemical’s ‘‘conditions of use’’
as ‘‘the circumstances, as determined by
the Administrator, under which a
chemical substance is intended, known,
or reasonably foreseen to be
manufactured, processed, distributed in
commerce, used, or disposed of.’’ 15
U.S.C. 2602(4). While EPA interprets
this as largely a factual determination—
i.e., EPA is to determine whether a
chemical substance is actually involved
in one or more of the activities listed in
the definition—the determination will
inevitably involve the exercise of some
discretion. As EPA interprets the
statute, the Agency is to exercise that
discretion consistent with the objective
of conducting a technically sound,
manageable evaluation to determine
whether a chemical substance—not just
individual uses or activities—presents
an unreasonable risk. In that regard,
EPA will be guided by its best
understanding, informed by legislative
text and history, of the circumstances of
manufacture, processing, distribution in
commerce, use and disposal Congress
intended EPA to consider in risk
evaluations.
For most chemical substances EPA
expects to make this determination
primarily during the prioritization of a
chemical substances. For chemicals that
are the subject of a manufacturer request
(which are not subject to prioritization),
EPA intends to make this determination
as part of the process for determining
whether the request satisfies EPA’s
criteria, as discussed in greater detail in
Unit III.G.
Although EPA intends this to
primarily be a case-by-case
determination, as discussed in greater
detail in Unit III.B.1, based on
legislative history, statutory structure
and other evidence of Congressional
intent, EPA has identified certain
activities that may generally not be
considered to be conditions of use. As
EPA gains experience in conducting risk
evaluations, EPA may determine that
other activities do not constitute
conditions of use, based on the same
type of analysis of Congressional intent.
Second, in developing the scope of the
risk evaluation, TSCA section 6(b)(4)(D)
requires EPA to identify ‘‘the conditions
of use that the Agency expects to
consider in a risk evaluation,’’
suggesting that EPA is not required to
consider all conditions of use.
Consequently, EPA may, on a case-bycase basis, exclude certain activities that
EPA has determined to be conditions of
use in order to focus its analytical
efforts on those exposures that are likely
to present the greatest concern, and
consequently merit an unreasonable risk
determination. For example, EPA may,

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

on a case-by-case basis, exclude uses
that EPA has sufficient basis to
conclude would present only ‘‘de
minimis’’ exposures. This could include
uses that occur in a closed system that
effectively precludes exposure, or use as
an intermediate. During the scoping
phase, EPA may also exclude a
condition of use that has been
adequately assessed by another
regulatory agency, particularly where
the other agency has effectively
managed the risks. EPA elaborates
further on this step in Unit III.B.2.
EPA intends to identify any
conditions of use excluded during these
first and second steps in the draft scope,
along with the basis for EPA’s
preliminary determination, to provide
the public with an opportunity to
comment on the exclusions. The final
scope, which specifies the conditions of
use that EPA expects to consider in the
risk evaluation, will also identify
whether particular conditions of use
have been excluded as a result of this
process, along with the Agency’s
rationale.
Finally, consistent with its original
proposal, EPA may conduct its risk
evaluations in stages. While the
proposal only addressed the situation in
which EPA determined that risk
mitigation was necessary to address an
unreasonable risk from a chemical
substance under certain conditions of
use, EPA has extended the logic in the
final rule to apply whenever EPA has
sufficient information to support a
determination as to whether a chemical
substance presents an unreasonable risk
under particular conditions of use.
Thus, at any point after EPA has issued
its final scope document, in cases where
EPA has sufficient information to
determine whether or not the chemical
substance presents an unreasonable risk
under particular conditions of use, the
Agency may issue an early
determination for that subset of
conditions of use, while EPA continues
to evaluate the remaining conditions of
use. All early determinations would be
portions of the final, complete risk
evaluation and would therefore be made
using the procedures applicable to
TSCA risk evaluations established in
this rule. This would include the
requirement that EPA publish a draft
risk evaluation for no less than a 60-day
public comment period, and the
regulatory requirement for peer review.
This may result in separate peer reviews
for the separate determinations.
In the interest of efficiency, EPA
envisions that, in general, it would
attempt to identify the subset of
conditions of use that are candidates for
an early determination as part of the

PO 00000

Frm 00005

Fmt 4701

Sfmt 4700

33729

draft scope document. In such cases,
EPA may publish its draft risk
evaluation for public comment along
with the final Scope document.
Depending on the information received
during the comment period, EPA would
either determine that it needed to
continue to evaluate those conditions of
use, or proceed to issue final
determinations for those conditions of
use.
1. Exclusions from the Definition of
Conditions of Use. As noted, the statute
grants EPA the discretion to determine
the circumstances that are appropriately
considered to be the chemical’s
‘‘conditions of use.’’ In exercising that
discretion, for example, EPA would not
generally consider that a single
unsubstantiated or anecdotal statement
(or even a few isolated statements) on
the internet that a chemical can be used
for a particular purpose would
necessitate concluding that this
represented part of the chemical
substance’s ‘‘conditions of use.’’ As a
further example, although the definition
could be read literally to include all
intentional misuses (e.g., inhalant
abuse), as a ‘‘known’’ or ‘‘reasonably
foreseen’’ activity in some
circumstances, EPA does not generally
intend to include such activities in
either a chemical substance’s
prioritization or risk evaluation. EPA’s
judgment is supported by the legislative
history, and public comment suggesting
that ‘‘the term ‘conditions of use’ is not
intended to include ‘intentional misuse’
of chemicals.’’ See, for example Senate
Report 114–67, page 7. Without these
exclusions, the concept of ‘‘conditions
of use’’ would likely result in no
meaningful limitation on EPA risk
evaluations, and risk evaluations could
present unmanageable challenges—an
outcome that EPA does not expect
Congress intended.
Similarly, the statute is ambiguous as
to whether the conditions of use
identified by EPA should include the
circumstances associated with activities
that do not reflect ongoing or
prospective manufacturing, processing,
or distribution, which EPA will refer to
as ‘‘legacy uses.’’ The statute is also
ambiguous as to disposals from such
uses (e.g., the future disposal of
insulation that contains a chemical
substance that is no longer
manufactured, processed, or distributed
for use in insulation), which EPA will
call ‘‘associated disposal,’’ and
disposals that have already occurred
(e.g., a chemical substance currently in
a landfill or in groundwater), which
EPA will call ‘‘legacy disposal.’’ No
statutory text expressly addresses these
issues. The absence of express statutory

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33730

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

text on legacy use, associated disposal,
and legacy disposal, as well as the plain
language in ‘‘conditions of use’’
charging EPA to determine the
circumstances appropriately considered
to be the ‘‘conditions of use,’’ leads the
Agency to resolve the statutory
ambiguity by considering all the tools of
statutory interpretation (e.g., reliance on
legislative history, and general maxims
of statutory construction).
EPA interprets the mandates under
section 6(a)–(b) to conduct risk
evaluations and any corresponding risk
management to focus on uses for which
manufacturing, processing, or
distribution in commerce is intended,
known to be occurring, or reasonably
foreseen to occur (i.e., is prospective or
on-going), rather than reaching back to
evaluate the risks associated with legacy
uses, associated disposal, and legacy
disposal, and interprets the definition of
‘‘conditions of use’’ in that context. For
instance, the conditions of use for
purposes of section 6 might reasonably
include the use of a chemical substance
in insulation, where the manufacture,
processing, or distribution in commerce
for that use is prospective or onongoing, but would not include the use
of the chemical substance in previously
installed insulation, if the manufacture,
processing or distribution for that use is
not prospective or on-going. In other
words, EPA interprets the risk
evaluation process of section 6 to focus
on the continuing flow of chemical
substances from manufacture,
processing and distribution in
commerce into the use and disposal
stages of their lifecycle. EPA believes
the statute is better interpreted to focus
on the prospective flow of the chemical
substance. That said, in a particular risk
evaluation, EPA may consider
background exposures from legacy use,
associated disposal, and legacy disposal
as part of an assessment of aggregate
exposure or as a tool to evaluate the risk
of exposures resulting from non-legacy
uses.
Overall, EPA has determined that the
statutory text better supports a
prospective interpretation. Section 3
defines the ‘‘conditions of use’’ as ‘‘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.’’ (emphasis
added). The ‘‘to be’’ phrasing suggests
that the term is focused prospectively.
Moreover, throughout the legislative
history, there are a number of references
to TSCA as a statute for the regulation
of chemicals ‘‘in commerce,’’ suggesting
the intent to focus on current activities

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

associated with chemicals rather than
legacy issues. In addition, EPA notes
that section 6(a) of TSCA does not
authorize EPA to directly regulate noncommercial use, meaning that EPA
would not have an effective tool to
address risks found to arise from uses in
consumer settings if there were no ongoing commercial manufacture,
processing or distribution.
EPA’s interpretation finds support in
the general presumption against
construing a statute (or implementing
regulation) to be retroactive or have
retrospective effect. While Congress can
make a law retroactive, absent clear
intent from Congress, courts will not
hold a statute to be retroactive, or
uphold an agency regulation that seeks
to have such an effect. Republic of Iraq
v. Beaty, 556 U.S. 848 at 862 (2009)
(citing to Landgraf v. Usi Film Products,
511 U.S. 244, 267–68 (1994). See also,
Bowen v. Georgetown Univ. Hosp., 488
U.S. 204, 208 (1988) (citing several
sources). This general presumption also
extends to statutes that affect ‘‘vested
rights and past transactions,’’ which
have been considered to be retroactive
(or ‘‘retrospective’’) in nature. E.g.,
Landgraf, 511 U.S. at 268–69, 296
(quotation marks and citations omitted)
(citing several other Supreme Court
cases using alternate formulations of
this principle).
Finally, even if these activities were
not excluded from the definition of
conditions of use, EPA generally expects
that it would exercise its discretion
under section 6(b)(4)(D) to exclude them
from the scope of risk evaluations, as
discussed in section B.2., below.
2. Conditions of use that may be
excluded from the Scope of the risk
evaluation. In exercising its discretion
under section 6(b)(4)(D), EPA believes it
is important for the Agency to have the
discretion to make reasonable,
technically sound scoping decisions in
light of the overall objective of
determining whether chemical
substances in commerce present an
unreasonable risk. For example, EPA
intends to exercise discretion in
addressing circumstances where the
chemical substance subject to scoping is
unintentionally present as an impurity
in another chemical substance that is
not the subject of the pertinent scoping.
In some instances, it may be most
appropriate from a technical and policy
perspective to evaluate the potential
risks arising from a chemical impurity
within the scope of the risk evaluations
for the impurity itself. In other cases, it
may be more appropriate to evaluate
such risks within the scope of the risk
evaluation for the separate chemical
substances that bear the impurity. (EPA

PO 00000

Frm 00006

Fmt 4701

Sfmt 4700

has previously taken an analogous
approach, in requiring chemical testing
of certain chemical substances under 40
CFR part 766, based on the potential for
the chemical substance to be
manufactured in such a manner as to be
contaminated with dioxins.) In still
other cases, EPA may choose not to
include a particular impurity within the
Scope of any risk evaluation, where EPA
has a basis to foresee that the risk from
the presence of the impurity would be
‘de minimis’ or otherwise insignificant.
Finally, as stated, EPA received a
number of comments offering ideas
regarding conditions of use that should
not be considered in a risk evaluation,
for example, on the ground that certain
uses are not ‘‘reasonably foreseen.’’
Some of the many uses that commenters
asked to be excluded from a risk
evaluation include: Uses where other
agencies hold jurisdiction, misuse,
illegal use, speculative future conditions
of use, uses that are inconsistent with
labeling requirements or PPE
requirements, chemicals used in articles
or replacement parts, uses that are
inconsistent with manufacturers’
instructions, accidental conditions of
use of a chemical, or uses where
residuals from an industrial process are
completely destroyed. In connection
with these suggestions, several of these
commenters also requested that EPA
clearly define precisely how the Agency
will determine whether a condition of
use is ‘‘known or reasonably foreseen.’’
At this stage of EPA’s
implementation, EPA believes that it
would be premature to definitively
exclude a priori specific conditions of
use from risk evaluation. For the same
reason, EPA believes that it would be
premature to establish a specific test or
restrictive definition to determine
whether a condition of use is
‘‘reasonably foreseen.’’ The Agency is
committed to exercising its discretion to
determine the conditions of use in a
reasonable manner and will not base
this determination upon hypotheticals
or conjecture. The identification of
‘‘reasonably foreseen’’ conditions of use
will necessarily be a case by case
determination, and will be highly factspecific. Sources of facts to support
such determinations may include
known activities associated with similar
chemicals, knowledge of a chemical’s
properties that may allow it to replace
a function currently being performed by
non-chemical means, or information on
research and development activities
applying a chemical substance to a
particular new use. It is reasonable to
foresee a condition of use, for example,
where facts suggest the activity is not

E:\FR\FM\20JYR2.SGM

20JYR2

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
only possible but, over time under
proper conditions, probable.
As EPA gains experience in
conducting risk evaluations, it will
likely develop additional scoping
principles, consistent with the
discussion in this preamble. EPA has
issued Guidance to Assist Interested
Persons in Developing and Submitting
Draft Risk Evaluation Under the Toxic
Substances Control Act and section 26(l)
requires EPA to reevaluate guidance
every 5 years. This document may be
the appropriate venue for EPA to
provide additional transparency
regarding conditions of use included/
excluded as a part of scoping as the
Agency becomes better versed in this
process.

asabaliauskas on DSKBBXCHB2PROD with RULES

C. General Provisions
The general provisions of the final
rule outline the purpose, scope,
applicability and enforcement of this
rule.
D. Definitions
TSCA defines a number of key terms
necessary for interpretation of the new
law, and the statutory definitions apply
to this rule. To increase clarity and
transparency, EPA has included a
number of additional definitions in the
rule. In the proposed rule, EPA asked
for comments specifically on whether to
codify definitions of terms including
‘‘best available science,’’ ‘‘weight-of-thescientific evidence,’’ ‘‘sufficiency of
information,’’ ‘‘unreasonable risk,’’ and
‘‘reasonably available information,’’
among others. EPA identified the
sources of possible definitions, and in
some instances provided extensive
discussion of its current interpretation
of the terms. EPA also encouraged
commenters to suggest alternative
definitions the Agency should consider
for codification in this rule.
EPA received a number of comments
on this subject; in general, many
comments acknowledged that there are
numerous ways these phrases can be
defined and ultimately implemented.
Many also acknowledged that the
science is changing and the Agency
must maintain flexibility to implement
advancing and novel science. Some
commenters agreed with EPA’s
proposed conclusion that not defining
the terms allows for flexibility to change
as the science changes and that strict
definitions may impede TSCA
implementation. A number of comments
discussed the legislative history behind
these terms, specifically the fact that
previous versions of the statute did
include some of these definitions and
that they were removed in the final
version. Other commenters argued that

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

since these terms are not defined in the
statute and there is no requirement in
the statute to define them by rule, there
was no Congressional intent to codify
definition of these terms in this rule.
Additionally, it was reasoned that any
codified definitions would apply not
only to TSCA section 6 actions and
rules, but also to TSCA sections 4 and
5, and potentially other applications
outside of TSCA. They argued this
makes it much more difficult to develop
and implement universally appropriate
definitions.
A significant number of commenters
did encourage EPA to define, or at the
very least, to provide additional
principles and concepts that will be
applied to implement these terms,
arguing that this will add transparency
and better articulate how EPA will
implement the scientific criteria of the
statute. Some commenters stated that
the definitions of these terms have not
changed with changing science, only the
data sets used to inform the definitions.
Other commenters, who agreed these
terms do have a number of different
meanings believed it was therefore more
important to define them in this rule so
the public knew which definition would
be applied. Commenters also stated
these terms are the ‘‘cornerstones’’ of
risk evaluations under TSCA, and
definitions were necessary to alleviate
potential confusion in implementation
of these requirements. Many
commenters who believed it is
necessary for EPA to define these terms
did include proposed definitions and/or
descriptions.
EPA has chosen to only define terms
in this final rule that appear in the
statute, including best available science,
reasonably available information, and
weight of the scientific evidence, among
others. EPA agrees with many of the
public comments that the definitions of
these terms in the final rule will instill
confidence, increase transparency, and
provide the public with assurance that
EPA will adhere to the requirements of
the statute. Based on review of the
public comments received, EPA has also
revised the proposed definitions to
increase their clarity, while also adding
additional discussion in the preamble.
EPA will first discuss definitions
included in the regulation (in the order
they appear in the regulation), and then
will discuss additional terms that have
not been codified, but are important
components of the risk evaluation
process.
1. Aggregate exposure. TSCA requires
EPA, as a part of the risk evaluation, to
document whether the Agency has
considered aggregate exposure, and the
basis for that decision. 15 U.S.C.

PO 00000

Frm 00007

Fmt 4701

Sfmt 4700

33731

2605(b)(4)(F)(ii). This term is not
statutorily defined; however, EPA has
defined aggregate exposure to be
consistent with current Agency policies
and practices. ‘‘Aggregate exposure’’
means the combined exposures to an
individual from a single chemical
substance across multiple routes and
across multiple pathways (Ref.4). This is
consistent with the proposed rule and
consistent with agency policy.
2. Best available science. Section
26(h) of amended TSCA requires that
‘‘in carrying out sections 4, 5, and 6, to
the extent that the Administrator makes
a decision based on science, the
Administrator shall use scientific
information, technical procedures,
measures, methods, protocols,
methodologies, or models, employed in
a manner consistent with the best
available science.’’ As stated, many
commenters encouraged EPA to codify a
definition of the ‘‘best available
science.’’ In response to these
comments, EPA determined that ‘best
available science’ is an integral
component of section 6 risk evaluations,
and has incorporated a definition of
‘best available science’ into the
regulatory text. The first part of the
definition originates from the Safe
Drinking Water Act (SDWA) (42 U.S.C.
300f et seq.) and is also included in the
EPA’s Information Quality Guidance
(Ref. 5). The SDWA definition was cited
by a number of commenters, and EPA
agrees this definition, already in use at
the Agency, is appropriate. The second
part of the definition is taken directly
from TSCA section 26(h), which
identifies mandatory approaches to
fulfilling the science standards under
TSCA. By basing its definition of ‘best
available science’ on these two sources,
EPA believes that the Agency is
remaining consistent with the current
approach already used Agency-wide,
while also acknowledging the specific
standards under TSCA.
The final rule defines ‘‘best available
science’’ as science that is reliable and
unbiased. This 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, EPA will
consider as applicable:—
—The extent to which the scientific
information, technical procedures,
measures, methods, protocols,
methodologies, or models employed
to generate the information are

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33732

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

reasonable for and consistent with the
intended use of the information;
—The extent to which the information
is relevant for the Administrator’s use
in making a decision about a chemical
substance or mixture;
—The degree of clarity and
completeness with which the data,
assumptions, methods, quality
assurance, and analyses employed to
generate the information are
documented;
—The 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;
—The extent of independent
verification or peer review of the
information or of the procedures,
measures, methods, protocols,
methodologies or models.
3. Conditions of use as defined in 15
U.S.C. 2602(4), 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. This definition
was not included in the proposed rule,
but has been added for clarity.
Additional discussion of conditions of
use can be found in Unit B.
4. Pathways. Pathways of exposure
refers to the mode through which one is
exposed to a chemical substance,
including but not limited to: Food,
water, soil, and air (Ref. 4). This
definition is consistent with EPA’s
policies and practices, and did not
change from the proposed rule.
5. 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 this as ‘‘the term ‘potentially
exposed or susceptible subpopulation’
means 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
proposed a definition to clarify how the
Agency interprets this provision.
Specifically, EPA proposed to substitute
the phrase ‘‘including but is not limited
to’’ for the statutory phrase ‘‘such as,’’
to clarify that the statutory list of
potential subpopulations is not

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

exclusive. EPA also proposed to include
additional examples of subpopulations
that have been previously considered. In
response to comments, the final rule
simply codifies the statutory definition
without revision.
EPA received a number of comments
regarding this definition. Some stated
that EPA was correct in expanding and
clarifying the definition in the proposed
rule, while others stated that EPA
should use the statutory definition.
Many comments that supported the
proposed definition also identified other
subpopulations that EPA should
include. EPA’s view of the
interpretation of the statutory definition
has not changed since proposal—EPA
interprets the statutory definition
broadly and believes it does not prevent
EPA from including any subpopulation
that may be at greater risk due to greater
susceptibility or exposure, or from
identifying additional subpopulations
other than those listed in the statute,
where warranted. The definition in the
final rule uses the statutory definition
because, due to EPA’s broad
interpretation, EPA does not think that
it limits any consideration of a
particular subpopulation. Also,
regarding EPA’s proposed inclusion of
more examples than those provided by
the statute (e.g., life-stage, age, gender,
geography), and in reading public
comments, which listed numerous other
important subpopulations EPA should
consider, it was clear that it would be
difficult for the Agency to list all the
potential subpopulations that the
Agency might have reason to include in
a risk evaluation. Codification of the
statutory definition does not limit the
subpopulations that may be evaluated
and ensures there is no misconception
that a partial list was intended as a
deliberate exclusion of other
subpopulations.
6. Reasonably available information.
TSCA section 26(k) (15 U.S.C. 2625(k))
states that in carrying out risk
evaluations, EPA shall consider
information that is ‘‘reasonably
available,’’ but the statute does not
further define this phrase. EPA is
defining ‘‘reasonably available
information’’ to mean information that
EPA possesses, or can reasonably obtain
and synthesize for use in risk
evaluations, considering the deadlines
for completing the evaluation. However,
there is a preference for reasonably
available information that is consistent
with the required quality standards.
Information that meets the terms of the
preceding sentence is reasonably
available information whether or not it
is claimed as confidential business

PO 00000

Frm 00008

Fmt 4701

Sfmt 4700

information. This definition is slightly
revised from the proposed definition.
First, EPA deleted the word
‘‘existing’’ to address concerns that this
would prevent the Agency from
considering (or requiring) data
generated in response to EPA data
gathering, including testing, authorities.
Several commenters encouraged EPA to
take full advantage of its new
information gathering authorities and
not limit the basis of its decisions to
‘‘existing’’ information. EPA agrees that
it makes sense to view information that
can be obtained through testing as
‘‘reasonably available’’ in some
instances—especially information that
can be obtained through short-term
testing, where it can be obtained within
the relevant statutory deadlines and the
information would be of sufficient value
to merit the testing. As discussed in a
related rulemaking on prioritization
under TSCA, EPA will seek to generally
ensure that sufficient information to
complete a risk evaluation exists and is
available to the Agency prior to
initiating the evaluation. The proposed
definition was drafted to reflect that
intention. However, EPA also recognizes
that there may be circumstances where
additional information may need to be
developed within the time frames of the
risk evaluation process. This may
include information developed through
the use of novel and advancing
chemical assessment procedures,
measures, methods, protocols,
methodologies, or models (e.g., highthroughput chemical assessment
techniques). While EPA disagrees that
its original definition would have
precluded the generation of additional
data, to avoid any confusion, EPA has
modified the definition to clarify the
point. Note that EPA will, as
appropriate, also require longer-term
testing, and at times will need to do so
to address data gaps. However, EPA
does not think information that could be
generated through such testing should
be viewed as ‘‘reasonably available’’.
EPA will tailor its information gathering
efforts as appropriate.
Second, EPA added a statement
regarding CBI to clarify to the public
that EPA does consider CBI under
section 14 of TSCA to be ‘‘reasonably
available,’’ and will utilize it in risk
evaluations where relevant.
7. Routes. The final rule defines
routes of exposure to mean the
particular manner which a chemical
substance may contact the body,
including absorption via ingestion,
inhalation, or dermally (Ref. 4). This
definition is consistent with EPA’s
policies and practices and with the
proposed definition.

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
8. Sentinel exposure. The final rule
defines sentinel exposure to mean the
exposure to a single chemical substance
that represents the plausible upper
bound of exposure relative to all other
exposures within a broad category of
similar or related exposures. As
mentioned in the proposed rule, this
term previously had not been defined by
the Agency. In light of the comments
received, many of which requested
revisions to the proposed definition,
EPA believes it most appropriate to
revise the definition in the proposed
rule. The majority of comments
explained that the concept of sentinel
exposures is narrower than the
definition EPA had proposed (‘‘the
exposure of greatest significance, which
may be the plausible maximum
exposure’’); rather, as one comment
explained, sentinel exposures are
employed to represent broad categories
of use so that the assessor does not have
to go into each specific subcategory of
use. While sentinel exposures do
represent upper-bound exposures—
which is part of what EPA proposed—
it is the upper bound within those broad
use categories. Under this approach,
because the exposures are expected to
be much greater than other sources or
pathways, if the margin of exposure is
at an acceptable level, there is no need
to specifically evaluate the other
individual exposure pathways in the
category. A number of commenters also
suggested that EPA adopt the approach
to ‘sentinel exposure’ used by the
European Union’s (EU) European
Chemicals Agency (ECHA) Registration,
Evaluation, Authorization, and
Restriction of Chemicals (REACH)
program and Health Canada (Ref. 6 and
7). The final definition, although not the
same as the one used by ECHA and
Health Canada, more closely tracks their
approach. Specifically, the definition
seeks to address situations including but
not limited to: (1) The same chemical
substance is added to a number of
related products, and EPA is evaluating
exposure to the chemical substance in
these related products under the same
exposure scenario (e.g., adults who
could use these products for the same
task). If EPA identifies and evaluates the
product associated with the upper
bound of exposure from use of these
products, then EPA could reach risk
conclusions for the chemical substance
in the entire category of these products,
because the range of potential exposures
is no greater than the magnitude of the
exposure to the chemical substance in
the upper-bound product. (2) A number
of different workers are exposed to the
same chemical substance. If EPA

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

identifies or evaluates the worker whose
exposure represents the upper bound of
exposure, EPA would have confidence
that the other workers exposed would
be less exposed than the worker with
the upper bound or ‘‘sentinel’’ exposure.
In the proposed rule, EPA used the
phrase ‘‘maximum exposure’’ in
defining sentinel exposure. This phrase
has been changed to ‘‘upper bound of
exposure’’ in the final rule. This change
was a result of public comment that
suggested that the term ‘‘maximum’’
could indicate that EPA intended to use
only the 99.99th percentile exposure.
This was not EPA’s intent, and so EPA
has substituted the phrase ‘‘upperbound of exposure,’’ which is consistent
with EPA’s existing practice, and allows
EPA the flexibility to consider the
available data and its quality in
determining the appropriate exposure
scenario (e.g., sentinel exposure
scenarios).
9. Uncertainty and variability. The
statute requires EPA to consider ‘‘the
extent to which the variability and
uncertainty . . . are evaluated and
characterized.’’ 15 U.S.C. 2625(h). EPA
proposed definitions for both
‘‘variability’’ and ‘‘uncertainty’’ based
on existing Agency guidance
(Framework for Human Health Risk
Assessment). The final rule adopts the
proposed definition of ‘‘uncertainty’’
with minor modification. EPA added
the phrase ‘‘the real world’’ to exactly
reflect the definition in Agency
guidance. In the final rule, uncertainty
means the imperfect knowledge of the
real world or lack of precise knowledge
of the real world either for specific
values of interest or in the description
of the system (Ref. 8). The final rule
adopts the proposed definition of
‘‘variability’’ without modification. The
regulation thus states: ‘‘Variability’’
means the inherent natural variation,
diversity, and heterogeneity across time
and/or space or among individuals
within a population (Ref. 8). Both
definitions are consistent with EPA’s
policies and practices.
10. Weight of the scientific evidence.
The Agency is required by the statute to
use a weight of scientific evidence
approach in a risk evaluation and the
Agency is codifying a definition of this
term in this final rule. In responding to
public comment, EPA notes that
inclusion of the definition will provide
the much requested transparency to the
public regarding the processes for how
the Agency reviews scientific
information used in risk evaluations
without stifling scientific advances. In
the preamble to the proposed rule, EPA
provided an extensive discussion of
how the weight of the scientific

PO 00000

Frm 00009

Fmt 4701

Sfmt 4700

33733

evidence is applied by EPA and the
National Toxicology Program of the
National Institutes of Environmental
Health. This discussion formed part of
the basis for the definition EPA is
promulgating in this final rule.
The application of weight of the
scientific evidence has generated much
discussion in the scientific community,
and EPA agrees with the National
Academies who stated ‘‘because
scientific evidence use in weight of the
scientific evidence (WoSE) evaluations
varies greatly among chemical and other
hazardous agents in type, quantity and
quality, it is not possible to describe the
WoSE evaluation in other than relative
general terms’’ (Ref. 9). Application of
weight of the scientific evidence
analysis is an integrative and
interpretive process. It is more than a
simply tallying of the number of
positive and negative studies. It also is
applicable to both human health and
ecological risk evaluations.
There are certain principles of weight
of the scientific evidence that are
universal, including foundational
considerations, such as objectivity and
transparency, and the general process.
This process starts with assembling the
relevant information, evaluating the
information for quality and relevance,
and synthesizing and integrating the
different lines of evidence to support
conclusions (Ref. 10). Given these
overarching and inclusive principles,
EPA does not think that providing a
general definition restricts flexibility or
scientific advancement. For the
purposes of this rule the definition EPA
is adopting states: ‘‘Weight of the
scientific evidence means a systematic
review method, applied in a manner
suited to the nature of the evidence or
decision, that uses a pre-established
protocol to comprehensively,
objectively, transparently, and
consistently identify and evaluate each
stream of evidence, including strengths,
limitations, and relevance of each study
and to integrate evidence as necessary
and appropriate based upon strengths,
limitations, and relevance.’’ This
definition was suggested by a few public
commenters, it is consistent with
practices under TSCA before it was
amended, and was generally outlined in
the lengthy discussion in the proposal.
The bulk of the definition, aside from
the phrase ‘‘applied manner suited to
the nature of the evidence or decision’’
clarification, is taken directly from
TSCA’s legislative history. See
Congressional Record at S3519, June 7,
2016. The additional phrase was added
to be consistent with the concept (also
discussed in the proposal) that the
components of its risk evaluations will

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33734

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

be ‘‘fit-for-purpose.’’ As explained in the
proposed rule at 82 FR 7566, all
conditions of use will not warrant the
same level of evaluation, and EPA
expects that it may, in some cases, be
able to reach conclusions without
extensive or quantitative evaluations of
risk. The addition of this phrase to the
definition is intended to clarify that
different weight of the scientific
evidence review methods may be
appropriate for different information,
types of evaluations, or decisions.
Specifically, fit-for-purpose means that
while EPA will always apply the
principles contained in the definition,
the depth or extent of the analysis will
be commensurate with the nature and
significance of the decision.
11. Systematic Review. EPA requested
comment on the need for regulatory text
prescribing a specific systematic review
approach for hazard identification,
including the appropriateness of
elements that might be included or
concerns about codifying an approach.
Commenters both supported and
opposed the inclusion of systematic
review in the rule text. Those opposing
the codification of systematic review
argued that EPA should retain flexibility
and the ability to change the process as
improved methods for systematic
review are developed. Some
commenters did encourage a description
of the intended approach in the
preamble, but suggested that EPA
reserve the specific process for
guidance. Those in support of codifying
a description of systematic review in the
rule text stated that inclusion would
increase transparency and would
provide the public with an indication of
how the statutory requirement of weight
of the scientific evidence, requirements
of sections 6 and 26, and an integral
component of systematic review, will be
applied.
EPA intends to use the systematic
review approach, described in the
proposed rule, but is not codifying a
definition in the regulatory text. To be
clear, although EPA asked for comment
on the need for regulatory text for
systematic review on hazard
identification specifically, EPA will not
limit the use of this approach solely to
the hazard assessment, but will use it
throughout the risk evaluation process.
The inclusion of a description of
systematic review in the preamble is the
most appropriate approach in light of
public comment and the requirements
of the statute. First, systematic review is
not required under the statute, only a
weight of the scientific evidence
analysis. The definition the Agency is
adopting for ‘‘weight of the scientific
evidence’’ uses the phrase ‘‘systematic

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

review,’’ which addresses to some
extent the commenters who favored
including the concept in this regulation.
EPA sees weight of the scientific
evidence approach as an interrelated
part of systematic review, and further
believes that integrating systematic
review into the TSCA risk evaluations is
critical to meet the statutory
requirements of TSCA. Although, as
EPA discusses elsewhere in this
preamble, there are universal
components of systematic review that
EPA intends to apply in conducting risk
evaluations, this is one area where EPA
concluded it would be premature to
codify specific methods and criteria that
may change as the Agency gains more
experience conducting TSCA risk
evaluations. As requested by
commenters, EPA does believe the
addition of discussion of the systematic
review approach the Agency intends on
utilizing is necessary for transparency,
and so provides the description herein.
Section 26(l) also requires EPA to
develop and revise Agency guidance.
The Agency intends to provide further
details on systematic review and weight
of scientific evidence approaches under
TSCA in future guidance documents.
As defined by the Institute of
Medicine (Ref. 11) systematic review ‘‘is
a scientific investigation that focuses on
a specific question and uses explicit,
pre-specified scientific methods to
identify, select, assess, and summarize
the findings of similar but separate
studies. The goal of systematic review
methods is to ensure that the review is
complete, unbiased, reproducible, and
transparent’’ (Ref. 11).
The principles of systematic review
have been well developed in the context
of evidence-based medicine (e.g.,
evaluating efficacy of medical
interventions tested in multiple clinical
trials) (Ref. 12) and are being adapted
for use across a more diverse array of
systematic review questions, through
the use of a variety of computational
tools. For instance, the National
Academies’ National Research Council
(NRC) has encouraged EPA to move
towards systematic review processes to
enhance the transparency of scientific
literature review that support chemicalspecific risk assessments to inform
regulatory decision making (Ref. 13).
Key elements of systematic review
include:
—A clearly stated set of objectives
(defining the question);
—Developing a protocol which
describes the specific criteria and
approaches that will be used
throughout the process;
—Applying the search strategy criteria
in a literature search;

PO 00000

Frm 00010

Fmt 4701

Sfmt 4700

—Selecting the relevant papers using
predefined criteria;
—Assessing the quality of the studies
using predefined criteria;
—Analyzing and synthesizing the data
using the predefined methodology;
—Interpreting the results and presenting
a summary of findings (Ref. 14)
12. Sufficiency of information. EPA
did not propose to codify this phrase,
but discussed it in the context of having
‘‘enough’’ information to conduct a risk
evaluation within the statutory
timeframe. However, EPA also
specifically requested comment on
whether to define sufficiency of
information. Commenters who opposed
codifying a definition stated that the
phrase was ‘‘vague’’ and could have a
number of definitions and that the
information needs for chemical risk
evaluations can vary significantly, so
not one definition would be
appropriate. Commenters who
supported codifying a definition of this
phrase stated that, specifically for risk
evaluation conducted and submitted by
third parties, knowledge of what
constitutes sufficient information is
necessary. Consistent with the proposed
rule, the final rule does not codify this
term because EPA agrees that the
information required for chemical risk
evaluations can be highly variable, and
that given the case-by-case nature of the
hazard and exposure scenarios, it is
difficult to have an overarching
definition of ‘‘sufficient information’’
applicable to all evaluations. EPA does
not believe that the definitions offered
by the commenters would provide any
greater clarity that would effectively
inform third party risk evaluations and
expansion of this concept is more
appropriate for the statutorily required
guidance documents.
13. Unreasonable risk. In the
proposed rule, EPA said that the Agency
did not think it was appropriate to
define ‘‘unreasonable risk’’ because each
risk evaluation will be unique. For
example, defining specific risk measures
for use in all risk evaluations would be
inappropriate to capture the broad set of
health and environmental risk measures
and information that might be relevant
to chemical substances. In the preamble
to the proposed rule, EPA did discuss
some of the considerations the Agency
will use in making a risk determination.
The public overwhelmingly agreed with
the proposed approach. EPA did take
public comment on this approach and
the public agreed that a definition was
not appropriate, but appreciated EPA’s
approach to including considerations.
For the final rule. the Agency will be
taking the same approach, and has

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
identified, a revised list of some of the
considerations that the Agency will use
in making a risk determination. This is
not intended as an exhaustive list, but
merely identifies some of the
considerations that are likely to be
among the most commonly used.
However, the list of considerations has
changed slightly in response to public
comment. In the proposed rule
preamble a few considerations were too
specific and were not expected to be
widely applicable to TSCA risk
evaluations. For example, the proposed
rule included the specific mention of
margin of exposure (MOE), which is just
one approach for risk characterization.
EPA acknowledges that MOE is just one
of several approaches to risk
characterization, and agrees that it does
not make sense to single out this one
particular approach. There will be risk
scenarios where one approach may be
better than another and, as commenters
correctly pointed out, the science of risk
characterization is still evolving,
particularly for non-cancer hazards. The
proposed preamble had also included
the consideration of cumulative
exposure in making a risk
determination. A number of
commenters pointed out, this is not a
requirement under the statute; EPA
agrees that this may not be widely
applicable to many TSCA risk
assessments, and so EPA has not
included it in the list below.
Additionally, commenters correctly
pointed out that EPA did not mention
environmental risks in the proposed
definition. Considerations of
environmental hazards and exposures
have been added.
To account for the number of different
risk characterization approaches and for
changing science, EPA will not include
any specific definition in this final rule.
To make a risk determination, EPA may
weigh a variety of factors in determining
unreasonable risk. The Administrator
will consider relevant factors including,
but not limited to: The effects of the
chemical substance on health and
human exposure to such substance
under the conditions of use (including
cancer and non-cancer risks); the effects
of the chemical substance on the
environment and environmental
exposure under the conditions of use;
the population exposed (including any
susceptible populations), the severity of
hazard (the nature of the hazard, the
irreversibility of hazard), and
uncertainties.
E. Timing of Risk Evaluations
A risk evaluation is initiated upon the
final designation of a high priority
substance at the completion of the

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

prioritization process or through the
completed manufacturer request
process. A risk evaluation is complete
upon the publication of the final risk
evaluation, which includes the final risk
determination for all the conditions of
use identified in the Scope document.
As indicated, the statute requires EPA to
complete risk evaluations within three
years, with the possibility of a single
six-month extension. This rule adopts
these timeframes without modification
or elaboration.
F. Chemical Substances for Risk
Evaluation
As identified previously, chemical
substances that will undergo risk
evaluation can be put into three groups:
(1) The first ten chemical substances the
Agency is required to identify within
the first 180 calendar days of enacting
the amendments to TSCA (15 U.S.C.
2605(b)(2)); (2) the chemical substances
determined as High-Priority Substances
through the prioritization process
proposed in a separate rulemaking; and
(3) chemical substances requested by
manufacturers, when the requests meet
the criteria for EPA to conduct an
Agency risk evaluation.
Public comment requested that EPA
be explicit about what constitutes a
chemical substance under TSCA. The
statute defines a chemical substance to
mean any organic or inorganic
substance of a particular molecular
identity, including: (1) Any combination
of such substances occurring in whole
or in part as a result of a chemical
reaction or occurring nature, and (2) and
element or uncombined radical.
Chemical substances do not include: (1)
Any mixture, (2) any pesticide (as
defined in the Federal Insecticide,
Fungicide, and Rodenticide Act) when
manufactured, processed, or distributed
in commerce for use as a pesticide, (3)
tobacco or any tobacco product, (4) any
source material, special nuclear
material, or byproduct material (as such
terms are defined in the Atomic Energy
Act of 1954 and regulations issued
under such Act), (5) any article the sale
of which is subsequent to the tax
imposed by section 4181 of the Internal
Revenue Code of 1954 (determined
without regard to any exemptions from
such tax provided by section 4182 or
4221 or any other provision of such
Code), and (6) any food, food additive,
drug, cosmetic, or device (as such terms
are defined in section 201 of the Federal
Food, Drug, and Cosmetic Act) when
manufactured, processed, or distributed
in commerce for use as a food, food
additive, drug, cosmetic, or device. 15
U.S.C. 2602(2)(B). The list constitutes
what is commonly referred to as ‘‘non-

PO 00000

Frm 00011

Fmt 4701

Sfmt 4700

33735

TSCA uses.’’ It may be appropriate for
EPA to consider potential risk from nonTSCA uses (as identified above) in
evaluating whether a chemical
substance presents an unreasonable risk,
although these uses would not be within
the scope of the risk evaluation. EPA
would explain the basis for such
consideration in any risk evaluation.
EPA may not in a risk management rule
under section 6(a) regulate non-TSCA
uses. TSCA § 6(a) generally provides
that if EPA determines that the
manufacture, processing, distribution in
commerce, use, or disposal of a
chemical substance or mixture, or that
any combination of such activities,
presents an unreasonable risk of injury
to health or the environment, the
Agency must apply certain regulatory
requirements to the extent necessary so
that the chemical substance or mixture
no longer presents such risk. The
potential risks of non-TSCA uses may
help inform the Agency’s risk
determination for the exposures from
uses that are covered under TSCA (e.g.,
as background exposures that would be
accounted for, should EPA decide to
evaluate aggregate exposures).
G. Process and Criteria for Manufacturer
Requested Risk Evaluations.
TSCA allows a manufacturer or group
of manufacturers to request that the
Agency conduct a risk evaluation of a
chemical substance (or group of
substances) that they manufacture. The
statute further directs EPA to establish
the ‘‘form . . . manner and . . .
criteria’’ for such requests as part of this
rule.
1. Scope of request. In the proposed
rule, EPA required the manufacturers
submitting the request to include all
information necessary to conduct a risk
evaluation on all conditions of use. EPA
received numerous public comments on
this provision. EPA did receive
comments that supported the proposed
approach, indicating that the approach
was consistent with EPA’s own process
for evaluating high priority chemicals,
and because the chemicals evaluated as
the result of a manufacturer request will
have not gone through the Prioritization
process, where the bulk of information
may be gathered, it was appropriate to
have manufacturers submit all
information necessary to conduct a risk
evaluation for all conditions of use.
Those opposed to the proposed
approach stated that manufacturers are
not always privy to every downstream
use, and therefore would find it very
difficult to obtain all the required
information. Commenters also
expressed concern that the bar set in the
proposed rule overall was too high and

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33736

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

would make it extremely difficult for
manufacturers to submit a compliant
request, and that the extensive
requirements EPA had proposed could
create a disincentive to submit requests
for risk evaluation.
EPA agrees with many of these
concerns in opposition to the proposed
approach. EPA believes that Congress
intended for EPA to establish a process
under which the 25%–50% target
would most likely be met. The law
instructs EPA to ‘‘ensure’’ that that
target is met. Section 6(b)(4)(E)(i). While
this is conditioned on EPA’s receipt of
a sufficient number of compliant
requests, EPA believes it signals an
intent that the criteria for requests make
it reasonably likely that the target will
be met. Legislative history supports this
reading. See S3516 (June 7, 2016) (‘‘The
Administrator should set up a system to
ensure that those percentages are met
and not exceeded in each fiscal year.’’)
Upon consideration of these
comments, among others, EPA is
modifying its proposal in several ways.
First, the final rule allows
manufacturers to submit requests for
risk evaluation on only the conditions of
use of the chemical substances that are
of interest to the manufacturer.
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). This is clear from
subsections (A) and (C), and from
section 6(b)(4)(E)(ii), which expressly
directs that the Administrator shall not
expedite or otherwise provide special
treatment to manufacturer-requested
risk evaluations. 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. However, rather than require
the manufacturer to identify any
additional conditions of use that EPA
will evaluate, EPA will determine the
additional conditions of use during the
process of determining whether to grant
or deny the manufacturer request. From
receipt of a compliant request to
initiation of a risk evaluation EPA
anticipates 195 days. This includes: (1)
Public notification of request within 15
days of receipt; (2) Within 60 days after
receipt of the request, EPA will publish
the request in the Federal Register; (3)
EPA will open a docket to facilitate a no
less than 45-day public comment
period; (4) Within 60 days of the end of

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

the comment period EPA will issue the
decision to grant or deny the request; (5)
Upon a decision to grant a request, the
requester has 30 days to withdraw the
request or EPA will move to initiate the
risk evaluation.
Upon receipt of a request, EPA will
evaluate whether the circumstances of
manufacture, processing, distribution in
commerce, use, and/or disposal
identified by the submitter constitute
conditions of use that warrant risk
evaluation and whether additional
conditions of use need to be included in
the risk evaluation. EPA will apply the
same criteria in the same manner
outlined earlier in this preamble in
making these evaluations.
EPA must complete the 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 the
Administrator determines under section
15 U.S.C. 2605(b)(4)(A), within the
statutory three-year deadline. However,
as discussed elsewhere in this preamble,
EPA may make an early risk
determination on any condition of use
included in the Agency’s scope, after
peer review of the risk evaluation for
that condition of use. Thus, since
manufacturers are required to submit all
of the information necessary to
complete risk evaluation for the
identified conditions of use, EPA
expects these conditions of use may be
good candidates for an early
determination.
2. Information that must be submitted
as part of request. Consistent with the
proposal, a request must include the
chemical identity—all known names,
CAS number, and molecular structure.
Manufacturers may also submit requests
for categories of chemical substances,
and such requests must include an
explanation of why the category is
appropriate under 15 U.S.C. 2625(c).
EPA will grant such request only upon
determining that the requested category
is appropriate for risk evaluation. As
described above, manufacturers may
now request a risk evaluation based on
a subset of conditions of use. The
manufacturer’s request must include all
of the information necessary for EPA to
conduct the evaluation for the requested
conditions of use, consistent with the
requirements in sections 15 U.S.C.
2605(b)(4)(A), and 15 U.S.C. 2625(h).
This includes all of the necessary
information, as relevant to the requested
conditions of use, on the chemical
substance’s hazard and exposure
potential; the chemical substance’s
persistence and bioaccumulation; any
relevant potentially exposed or
susceptible subpopulation; whether

PO 00000

Frm 00012

Fmt 4701

Sfmt 4700

there is any storage of the chemical
substance near significant sources of
drinking water, including the storage
facility location and nearby drinking
source; the chemical substance’s
production volume or significant
changes in production volume; and any
other information relevant to the risks
potentially presented by the chemical
substance. The requesting manufacturer
does not need to supply a copy of the
information if it is publicly available,
but must list all references. These are
the same requirements EPA listed in the
proposed rule; however, the scope of the
request may be narrower, specifically
regarding the conditions of use
requested. Some comments argued that
it would be exceedingly difficult to
obtain information for uses that the
requesting manufacturer may have no
knowledge of. EPA agrees with that, and
that is a large part of the motivation
behind EPA’s decision to allow
manufacturers to request risk
evaluations on limited conditions of
use. However, for those conditions of
use requested, the manufacturer must
provide all the information EPA needs
for risk evaluation.
Any information submitted by a
manufacturer must be consistent with
the scientific standards in 15 U.S.C.
2625(h). Although the judgement of
consistency is ultimately EPA’s, holding
the requester to the statutory standard
helps to ensure that if EPA grants the
request, the Agency can effectively
utilize the information provided.
Additionally, any information
submitted that is claimed as CBI must
be accompanied by a redacted version of
the information, including as necessary
an accession number and a structurally
descriptive generic name. Instructions
for submitting CBI are also included in
this rule. Consistent with EPA’s general
interpretation of section 14, the rule
requires upfront substantiation of nonexempt CBI claims.
The final rule also includes a number
of other revisions to the information that
must be submitted for the request to be
considered. In the proposed rule, EPA
required manufacturers to submit in the
request any risk assessment or
evaluation that they might possess. This
was added to the proposed rule to
provide the Agency with additional
information, specifically, as it relates to
the hazard assessment. The Agency’s
intent was to use this as purely another
source of information, not base any
decision solely on the information in
this document. Commenters argued that
these risk assessments or evaluations
may have been conducted under a
different statute or for a particular
purpose, and therefore may not be

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
useful or appropriate under TSCA.
Additionally, commenters stated that a
risk evaluation may have been
conducted in response to litigation and
therefore would be protected under
attorney client privilege. In response to
public comments, EPA is removing the
requirement that the manufacturer must
commit to providing EPA existing risk
assessments on the chemical. EPA
believes that all relevant risk
assessments would be required to be
provided pursuant to TSCA section 8(e),
and/or would be submitted in response
to the regulatory provision that requires
that the requesters provide any
information relevant to the potential
risks of the chemical substance under
the circumstances identified in the
request.
Many commenters also requested that
EPA rephrase the certification
statement. Commenters stated that the
content of the certification was overly
aggressive and unnecessary given the
enforcement provision at the beginning
of the regulation and the enforcement
that applies to all of TSCA.
3. Process for evaluating requests.
Upon receipt of the request, EPA will
verify that the request appears to be
valid, i.e., that information has been
submitted that is consistent with the
regulatory requirements. Within 15
business days of receiving a facially
valid request, EPA will publish a public
notice of the receipt, which will include
the manufacturer request. This notice is
intended to give the public early notice
of the chemical substance that may be
under evaluation from a manufacturer
request. Due to the 15 day turn around
on this public notice this will not be a
Federal Register Notice, but an
announcement on the Agency’s Web site
and/or an email announcement.
Between receipt of the request and the
subsequent end of public comment
period (discussed in this next part), EPA
will work to identify any additional
conditions of use, if any, of the chemical
requested. Within 60 days from receipt,
EPA will submit for publication an
announcement of the receipt of the
request in the Federal Register, open a
docket for the request, make available
the information that has been submitted
(taking into account any valid CBI
claims), and provide no less than a 45day comment period. This notice will
include the manufacturer request and
EPA’s proposed determinations as to
whether the activities identified in the
request are conditions of use that
warrant risk evaluation, and whether
there are additional conditions of use
that need to be included in the risk
evaluation. This public comment period
will allow the public to comment on

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

EPA’s proposed determinations and to
identify and/or submit any reasonably
available information regarding hazard,
exposure, potentially exposed
populations and subpopulations, and
conditions of use that may help inform
a risk evaluation. The requesting
manufacturer may also submit any
additional material during this time.
Chemical substances that EPA has
prioritized through the prioritization
process (the subject of separate
rulemaking (EPA–HQ–OPPT–2016–
0636)), are subject to two separate
public comment periods prior to the
completion of the prioritization process.
These comment periods are designed to
ensure that EPA has the necessary
information to evaluate the chemical
substances, including, in particular,
information on the relevant conditions
of use. EPA is adopting the similar
structure described here for
manufacturer requests, under which
EPA will solicit input from the public
prior to the decision on whether to grant
the request, as part of the method by
which EPA will identify and gather
information on the additional
conditions of use to be addressed in the
final risk evaluation. Since
manufacturers are required to submit all
the information necessary to complete
risk evaluation on the identified
conditions of use, EPA generally expects
that the submitted information would
include reasonably complete toxicity
information on the chemical, even
though it would likely not include
exposure information relevant to the
other conditions of use. While this prerisk evaluation process for manufacturer
request differs from the process of highpriority substances and compresses the
period in which EPA will identify
conditions of use and supporting
information, EPA believes that some
differences are necessary in order to
effectuate Congress’ intent to create a
workable process for manufacturer
requests that is reasonably likely to hit
the numerical target in the statute.
Through this mechanism, EPA expects
that in many cases, the available
information will be comparable to what
EPA will identify or generate through
the measures identified in the
prioritization framework rule. During
the public comment period associated
with each manufacturer request, EPA
encourages public commenters to
identify additional information to
inform a risk evaluation that was not in
the manufacturer request, including any
additional conditions of use.
At any time prior to the end of the
comment period, the manufacturer may
supplement the original request with
new information they receive or obtain.

PO 00000

Frm 00013

Fmt 4701

Sfmt 4700

33737

At any point prior to the completion of
a risk evaluation conducted on a
chemical substance at the request of a
manufacturer(s), manufacturer(s) are
required to supplement the original
request upon receipt of information that
meets the criteria in 15 U.S.C. 2607(e)
and 40 CFR 702.37, or other information
that has the potential to change EPA’s
risk evaluation for the requested
conditions of use.
Within 60 days after the end of the
comment period, EPA will review the
request along with any additional
information received during the
comment period to determine whether
the request meets the regulatory criteria
and will notify the manufacturer(s)
accordingly. If EPA determines that the
request is compliant (i.e., that the
activities for which risk evaluation is
requested constitute ‘‘conditions of use’’
as EPA interprets the term, and are
conditions of use that EPA concludes
warrant inclusion in the scope of a risk
evaluation for the chemical, and that
EPA has the required information
necessary for conducting a risk
evaluation on the condition(s) of use
requested), EPA will grant the request.
Otherwise, EPA will deny the request.
Requesters may resubmit any denied
request. Within 30 days of the notice
that EPA will grant the request, the
requestor may withdraw the request for
any other reason after the Agency has
notified the requester of the decision to
grant or deny. For EPA to proceed with
a risk evaluation on the chemical
requested, it would have to go through
the Prioritization process. The process
for conducting the risk evaluation will
follow the regulatory requirements
applicable to high-priority chemical risk
evaluations and will not be expedited or
otherwise afforded special treatment.
EPA will initiate the risk evaluation
consistent with TSCA section
6(b)(4)(E)(i) upon payment of required
fees requirements as established in the
Fees Rule. EPA is not addressing in this
rulemaking the fee amount for
manufacturer requested evaluations.
The fee amount will be addressed in a
separate rulemaking process.
Consistent with TSCA section
6(b)(4)(E)(iii), EPA will give preference
to requests where there is evidence that
restrictions imposed by one or more
States have the potential to have a
significant impact on interstate
commerce or health or the environment,
and is therefore proposing to allow (but
not require) manufacturers to include
any evidence to support such a finding.
Following this required initial
preference, EPA will give further
preference to requests in the order in
which a request is received. This last

E:\FR\FM\20JYR2.SGM

20JYR2

33738

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

asabaliauskas on DSKBBXCHB2PROD with RULES

provision regarding preference is a
change from the proposed rule, where
EPA indicated that preference would be
given to chemicals where EPA
determined that there were relatively
high estimates of hazard and/or
exposure for the chemical substance.
EPA received a number of comments
arguing that this was not an appropriate
way to order chemicals to be evaluated.
First, comments asked for a definition of
‘‘high estimates of hazard or exposure.’’
Other commenters suggested that
manufacturers may submit a request for
a low hazard or exposure chemical to
get the EPA determination of no
unreasonable risk. There were also a few
comments that stated that the proposed
preference scheme was appropriate in
addressing the worst chemicals first.
While EPA agrees that this is the best
way to approach the identification of
high priority substances, EPA does not
believe this is necessarily the best
approach for selecting among
manufacturer-requested evaluations.
EPA believes, on reflection, that
Congress intentionally established the
process for industry requests, to operate
outside of the prioritization process,
under which lower risk chemicals might
be identified for risk evaluation.
Therefore, EPA has dropped this
proposed preference. EPA also
acknowledges it is possible that
manufacturers could request an
evaluation seeking to get an Agency
determination of no unreasonable risk.
H. Interagency Collaboration
In the proposed rule, EPA committed
to ensuring there will be interagency
engagement and dialogue throughout its
risk evaluation process; however, EPA
chose not limit the potential interagency
collaboration by proposing to codify any
particular process. EPA requested
specific public comment on whether
codifying this collaboration at a specific
point regulation was appropriate.
Overwhelmingly, commenters were
supportive of collaboration with other
agencies, and some comments
encouraged additional collaboration
with state and local agencies, global
partners, and tribes. There were mixed
comments regarding the codification of
interagency collaboration at a particular
point in the risk evaluation process.
Those in support of the collaboration
stated that other agencies, such as the
Occupational Safety and Health
Administration (OSHA) and the
National Institute of Occupational
Safety and Health (NIOSH), may have
additional information on worker
exposure that will undoubtedly be
useful for EPA in conducting the risk
evaluation. Those opposing the

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

codification argued that this would be
overly bureaucratic and a waste of
resources, as not all agencies would
have an interest/information on every
chemical so there would not always be
the necessity to consult with them.
EPA has codified collaboration to give
the public confidence that EPA will
work with other agencies to gain
appropriate information on chemical
substances. As stated a number of times
in this preamble, EPA is committed to
transparency and communication with
the public. Codification of interagency
collaboration is just one more example
of this commitment. Through this
interagency process, EPA expects to
gain additional information into uses
and exposure scenarios, with which
other agencies may be more familiar.
Additionally, during interagency
meetings (under the Office of
Management and Budget process of
reviewing the proposed rule), other
federal agencies expressed significant
interest in early and frequent
collaboration. Agencies such as NIOSH
and OSHA have resources available and
information for assessing exposure to
workers that EPA may not have.
Communication with the Small
Business Administration (SBA) Office of
Advocacy was requested by a number of
commenters. Collaboration with
Consumer Product Safety Commission
(CPSC), which some commenters argued
will be necessary, was requested as EPA
evaluates chemicals commonly found in
consumer products. There are a number
of other agencies that have information
and expertise that will undoubtedly be
useful to the EPA, and codified
collaboration, along with mechanisms
already in place, further guarantees that
this information will be utilized.
By mandating consultation at any
particular stage, EPA does not intend to
imply that collaboration with agencies
will solely occur at this step of the
process, but including this collaboration
upon initiation gives other agencies
sufficient time to work with the EPA to
identify any information that will be
useful for EPA risk evaluation (e.g.,
existing regulations or mission critical
uses) of the chemical substance. EPA
anticipates that this collaboration would
include agencies that may also regulate
the chemical substance or the
environment in which the chemical
substance may be present, as well as
agencies that may have critical
operations that require the chemical
being evaluated, or may otherwise be
affected by regulation of the chemical
substance. EPA will also consult with
the SBA Office of Advocacy and other
federal agencies, as appropriate, to help

PO 00000

Frm 00014

Fmt 4701

Sfmt 4700

facilitate outreach to the small business
sector.
This provision also is not intended to
suggest that EPA will not collaborate
with federal agencies prior to the
initiation of the risk evaluation. EPA has
a number of existing mechanisms
already in place to facilitate
collaboration between EPA’s federal
partners and will continue to utilize
them. Collaboration with other agencies
is an important step in identifying
chemicals prior to prioritization, as well
as during the risk management phase, if
a chemical use is determined to present
an unreasonable risk.
As requested in the comments, EPA
also plans to engage with state and local
agencies where they may have
information to inform risk evaluations.
Similarly, EPA looks to increase
collaboration with tribes, as they can be
impacted by chemical substances
differently due to unique traditional
activities and lifestyles, as discussed in
comments.
H. Risk Evaluation Requirements
1. Considerations. This subpart
identifies and discusses what EPA will
consider in conducting a risk
evaluation. The first subpart identifies
the necessary components of the risk
evaluation process—a scope, which will
include a Conceptual Model and
Analysis Plan, a hazard assessment, an
exposure assessment, a risk
characterization, and a risk
determination.
a. Agency guidance. EPA has a
number of existing guidance documents
that inform Agency risk assessment.
EPA has been using risk assessments as
a tool to characterize the nature and
magnitude of health risks to humans
and ecological receptors from chemical
contaminants and other stressors that
may be present in the environment
since its inception. Over the years, EPA
has worked with the scientific
community and other stakeholders to
develop a variety of guidance,
guidelines, methods and models for use
in conducting different kinds of
assessments. A compendium of existing
Agency guidance related to risk
assessments is maintained on EPA’s
Web site (Ref. 15). Additionally, on
EPA’s Web site is a compendium of
guidance, databases and models used
for assessing pesticide risks (Ref. 16)
and information about available
predictive models and tools for
assessing chemicals under TSCA (Ref.
17). Each of these Web sites identify and
link to a number of written guidance
documents, tools and models.
In the proposed rule, EPA made it
clear that the Agency would be taking

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
advantage of existing guidance, tools
and models that are relevant and
available for use in conducting a risk
evaluation under this program. Since
each risk evaluation is based on the
specific circumstances surrounding the
chemical being assessed, EPA did not
propose to mandate the use of any
specific guidance, method or model, to
ensure that there is flexibility. EPA
asked for comments about this
approach.
The majority of the commenters did
not think the Agency should mandate
the use of or otherwise codify a list of
guidance documents. Many public
comments mentioned that many of the
guidance documents were potentially
outdated and were in need of updates.
These commenters asserted that
codifying these outdated documents
would not be appropriate, nor
accurately indicate to the public how
risk evaluations will be conducted.
Additionally, many commenters
pointed out the provision in section
26(l) of TSCA that requires EPA to
develop and to regularly review and
update, the necessary policies,
procedures, and guidance. This cuts
against mandating use of particular
guidance documents in regulation.
Other commenters expressed concern
that existing guidance did not take into
account new science requirements in
TSCA. By contrast, some expressed the
view that the list should be codified, as
it would result in added transparency to
the process.
EPA is not codifying a list of guidance
(with the exception of the Metals
Framework as mandated by TSCA), but
states in the regulation that guidance
may be used if it constitutes the best
available science, and consistent with
the weight of the scientific evidence.
This approach is consistent with the
proposed rule, and in line with the
majority of the comments received on
this subject. Rather than starting anew,
EPA intends to take advantage of
existing guidance, tools and models that
are relevant and available for use in
conducting a risk evaluation under this
program. EPA added a new clause
regarding the use of best available
science and weight of the scientific
evidence to the regulation; this addition
of the clause regarding the use of best
available science and weight of the
scientific evidence was done to ensure
that while the documents may have
been developed under another statute,
EPA will take care to ensure their use
would be compliant with the various
requirements of section 26 of TSCA.
While EPA does think many of the
current guidance documents can be
utilized effectively under the statute, the

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

Agency agrees with many of the
comments that it will be necessary to
modify some documents to further
adhere to the amendments in the
statute, as well as to reflect changing
science and technology. Additionally,
section 26(l) requires the development
of any policies, procedures, and
guidance that may be necessary to carry
out the amendments of the law, and to
routinely review and revise them as
necessary to reflect scientific
developments. Codifying documents
that may be changed, while not
codifying others that have yet to be
developed, could potentially lead to
long processes to change the rule
language.
The scope of each risk evaluation will
identify those guidance documents that
the Agency expects to utilize to inform
the risk evaluation. EPA will use the
guidance only to the degree that it
represents the best available science
appropriate for the particular risk
evaluation. EPA recognizes that some
guidance may be outdated and may rely
on defaults where no data exists
currently to replace those defaults.
b. Categories of chemical substances.
TSCA provides EPA with authority to
take action on categories of chemical
substances: Groups of chemical
substances which are, for example,
similar in molecular structure, in
physical, chemical, or biological
properties, in use, or in mode of
entrance into the human body or into
the environment. Although the rule
most often references ‘‘chemical
substances,’’ EPA includes a clear
statement in the final regulation that
nothing in the rule shall be construed as
a limitation on EPA’s authority to take
action with respect to categories of
chemical substances, and that, where
appropriate, EPA can evaluate
categories of chemical substances. This
is the same provision that EPA included
in the proposal, but EPA has removed
the statement regarding the Agency’s
consideration of hazards and exposures
associated with the category of
chemicals, and the populations likely
exposed. EPA believed that this was
duplicative, because EPA is required to
treat categories of chemicals in the same
manner as individual chemical
substances.
c. Science requirements. EPA has
incorporated into the regulatory text the
statutory requirements regarding best
available science and weight of the
scientific evidence. Definitions of those
terms have also been added. While EPA
prefers high quality data, where
available, EPA recognizes that data is
not always necessary to reach a
scientifically grounded conclusion on

PO 00000

Frm 00015

Fmt 4701

Sfmt 4700

33739

the potential risks of a chemical
substance, within the timeframes
dictated by the statute.
As a matter of practice, EPA has been,
and will continue to be, committed to
basing its decisions on the best available
science and the weight of the scientific
evidence. In response to public
comments on the proposal, EPA has
determined to make a number of
additions to the final rule to ensure that
the science standards in TSCA are more
explicitly incorporated into the risk
evaluation process. Specifically, EPA
has added specific language to the final
rule stating that EPA will evaluate
hazard and exposure data in a manner
consistent with the section 26 science
standards including documenting the
use of the standards in 15 U.S.C.
2625(h) and the weight of the scientific
evidence in 15 U.S.C. 2625(i). These
changes clarify that EPA’s risk
evaluations will be consistent with
TSCA’s new requirements in section 26
related to best available science and
weight of the scientific evidence.
d. Fit-for-purpose risk evaluations. As
described in the proposed rule and in
Unit III.D.10, each risk evaluation will
be fit-for-purpose—that is to say, the
level of refinement will vary as
necessary to determine whether the
chemical substance presents an
unreasonable risk, given the nature of
the evidence, for the conditions of use
of a specific chemical substance. A
number of the public comments
received stated their support for this
approach, as it conserves the Agency’s
resources to focus on the most
important components of a given risk
evaluation.
EPA introduced the idea that risk
evaluations would be conducted in a fitfor-purpose manner in the proposed
rule. Specifically, EPA stated that all
conditions of use evaluated will not
warrant the same level of evaluation,
and that EPA expects, that in some
cases, it may be able to reach
conclusions without extensive or
quantitative evaluations of risk. For
example, a lower-volume or less
dispersive (those uses that do not spread
as far in the environment, either indoors
or outdoors as compared to a different
use) condition of use might require a
less quantitative, data-driven
evaluations to credibly characterize the
risks than uses with more extensive or
complicated exposure patterns.
Consistent with EPA’s current practice
in conducting risk assessments,
technically sound risk determinations
can be made, consistent with the best
available science, through a
combination of different types of
information and methods approaches.

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33740

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

EPA will continue to utilize this
approach and has retained it in the final
rule. The concept of fit-for-purpose risk
evaluations is further explained in the
regulation as follows: EPA will refine, as
necessary, its evaluations for one or
more conditions of use in any risk
evaluation and when information and
analysis are sufficient to make a risk
determination using assumptions,
uncertainty factors, and models or
screening methodologies, EPA may
decide not to refine its analysis further.
Both of these provisions give EPA the
flexibility to conduct risk evaluations in
a manner that best suits the available
information and the decisions that will
be made. These are generally consistent
with the proposed text, however some
changes have been made, namely the
exclusion of the phrase ‘‘accepted
science policies.’’ A number of
commenters expressed concern
regarding the lack of clarity of this
language. Commenters asked for specific
examples of science policies and some
commenters expressed concern that the
Agency would confuse science with
regulatory policy, and specifically
encouraged separation between the two,
to ensure that EPA’s decisions would be
science-based. To address these
concerns EPA has deleted the reference
to ‘‘science policies’’ from the rule text.
Many commenters suggested that this
fit-for-purpose approach would be
necessary to evaluate chemical
substances within the statutory
timeframe, and agreed that this is
appropriate because due to the nature of
some uses, some will not necessitate the
same level of evaluation as others. By
contrast, some commenters were
concerned that the fit-for-purpose
approach is not scientifically sound and
can never be objective. To clarify, EPA
will not sacrifice best available science
in implementing this approach. The
speed of an evaluation does not equate
to less rigorous science. EPA will
always be transparent about the data
and assumptions used.
e. Timing of a risk determinations. In
the proposed rule, EPA explicitly
allowed for the expedited evaluation for
a particular condition of use to, if
necessary, move more rapidly to risk
management under TSCA section 6(a)
(15 U.S.C. 2605(a). This could include a
situation in which a single use
presented an unreasonable risk of injury
for the population as a whole or for a
susceptible subpopulation (e.g., one use
results in risks that EPA would
determine unreasonable regardless of
the risk posed by other uses). A number
of commenters raised concern about the
apparent one-sided nature of this
provision, arguing that this appeared to

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

preclude a similar determination that a
chemical substance did not present an
unreasonable risk. EPA agrees that
logically such determinations could be
appropriate in either case, and has
revised its approach to apply more
generally. Accordingly, the final
regulation at 720.41(a)(7) has been
revised to clarify that EPA may make
early risk determinations that a
chemical substance does or does not
present an unreasonable risk under
particular conditions of use. The final
rule also makes clear that any expedited
determination may be issued at any
point after the final scope is published.
As discussed previously, all early
determinations would be portions of the
final, complete risk evaluation and
would therefore be made using the
procedures applicable to TSCA risk
evaluations established in this rule.
TSCA is very clear that unreasonable
risk determinations cannot be made
until after a risk evaluation that meets
the requirements of section 6(b)(4) is
complete. Any risk evaluation for a
chemical under particular conditions of
use will therefore be consistent with all
statutory requirements as well as the
procedures established in this
regulation. This would also include the
requirement that EPA publish a draft
risk evaluation for no less than a 60-day
public comment period, and the
regulatory requirement for peer review.
The final regulation also continues to
explicitly state that in any case where
EPA would find it necessary to issue an
early risk determination for a chemical
substance under particular conditions of
use of a chemical, the Agency will still
complete a risk evaluation on all
conditions of use identified in the final
scope, within the statutory 3-year
deadline. In sum, the final rule
explicitly recognizes that EPA may
make early risk determinations, to either
to manage unreasonable risks as they are
identified, through the issuance of a
regulation under TSCA section 6(a) or to
notify the public as soon as possible of
the safety of a chemical substance under
a particular condition of use.
f. Metals or metal compounds. As
required by the statute, when evaluating
metals or metal compounds, EPA must
use the March 2007 Framework for
Metals Risk Assessment of the Office of
the Science Advisor (Ref. 3) or a
successor document that addresses
metals risk assessment and is peerreviewed by the Science Advisory
Board. The final rule, consistent with
the proposal, merely reiterates this
statutory mandate.
2. Information and information
sources. For those chemical substances
designated as high priority for risk

PO 00000

Frm 00016

Fmt 4701

Sfmt 4700

evaluation, EPA expects to initiate the
process when EPA has determined that
most of the information necessary to
complete the evaluation is reasonably
available, which in most cases means
the information already exists. In the
proposal, EPA had stated that the goal
would be to ‘‘only’’ initiate the process
once most of the information necessary
to complete the evaluation was
reasonably available. In the final rule
the word ‘‘only’’ has been deleted to
account for the fact that EPA may use
its regulatory authorities to obtain or
require the generation of additional
information even after the risk
evaluation has been initiated.
For manufacturer requested risk
evaluations, EPA acknowledges it may
potentially be difficult to gather all of
the necessary information prior to risk
evaluation, as these chemicals will not
have gone through the prioritization
process. Nevertheless, EPA generally
expects that it will be feasible to obtain
the necessary information to complete a
risk evaluation within the statutory
timeframe. As discussed previously, the
final rule requires a manufacturer to
submit all of the necessary hazard
information for EPA to complete a risk
evaluation on the one or more
conditions of use that have been
requested. Although there may be other
hazards associated with other
conditions of use that present different
routes of exposure, EPA expects that the
majority of the necessary hazard
information will be obtained through
the request. EPA has then allotted 195
days from receipt of request to gather
additional information required to
assess both requested uses and any
additional conditions of use EPA has
determined warrant evaluation. For both
EPA- and manufacturer-initiated risk
evaluations, EPA may also rely on
information developed through the use
of novel and advancing chemical
assessment procedures, measures,
methods, protocols, methodologies, or
models (e.g., high-throughput chemical
assessment techniques).
For identified data needs, EPA may
issue a voluntary call to the public for
relevant information or otherwise
engage directly with stakeholders,
followed, as necessary, by exercise of
EPA’s authorities under TSCA to require
submission or generation of new data.
Accordingly, as appropriate, EPA will
exercise its TSCA information
collection, testing, and subpoena
authorities, including those under TSCA
sections 4, 8, and 11(c) to obtain the
information needed for a risk
evaluation. EPA notes as well that TSCA
section 8(e) requires that any person
who manufacturers, processes, or

E:\FR\FM\20JYR2.SGM

20JYR2

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

asabaliauskas on DSKBBXCHB2PROD with RULES

distributes in commerce a chemical
substance or mixture and who obtains
information which supports the
conclusion that this substance or
mixture presents a substantial risk of
injury to health or the environment,
shall immediately inform the Agency,
and EPA may obtain some information
through this route.
EPA also expects to obtain scientific
advice from the Science Advisory
Committee on Chemicals (SACC), which
the Agency is required to develop and
convene under TSCA section 26(o).
When conducting a risk evaluation,
EPA will ensure that risk evaluations
are consistent with the scientific
standards in section 26(h) and (i),
including reliance on the best available
science and the weight of the scientific
evidence. EPA will rely on data, models,
and screening methods, as needed. The
use of these methods will be balanced
by the quality of the information
(consistent with standards in section
26(h) and (i)) and the statutory
deadlines for completing a risk
evaluation. In the final rule, EPA will
use the scope to focus on the reasonably
available information and science
approaches, and reserve uncertainty
considerations specifically for the
remainder of the risk evaluation.
EPA does not intend to preclude the
generation of new scientific information
to inform risk evaluations, however, as
mentioned in the discussion of
reasonably available information, the
extent to which EPA will consider any
newly generated information in a risk
evaluation will depend on the statutory
deadlines.
In compliance with the statute, EPA
will work to reduce and replace, to the
extent practicable, the use of vertebrate
animals in testing chemical substances
as outlined in TSCA section 4(h). The
intent to reduce testing on animals was
in the proposed text, however
comments suggested the language was
not exactly as the statute intended, and
that it should refer to the development
of new information, not all existing
information, as it could have been
interpreted. The final rule text has been
amended to more closely hew to the
statute.
I. Risk Evaluation Steps
1. Scope. The first step of a risk
evaluation is the development of the
scope. The scope of each risk evaluation
will include the following components.
The conditions of use, as determined by
the Administrator, that the EPA plans to
consider in the risk evaluation will be
included in the scope. This is amended
from the proposed rule to address the
approach to conditions of use as

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

explained in Unit III.B. The EPA will
identify the potentially exposed or
susceptible subpopulations EPA expects
to consider, the ecological receptors,
and the hazards to human health and
the environment the Agency plans to
evaluate will also be included. From the
proposed rule, EPA changed ‘‘ecological
characteristics’’ to ‘‘ecological
receptors.’’ This was done to clarify that
the Agency will be evaluating
specifically the impact of the chemical
stressor, and EPA believes that
characteristics was too broad, and
receptors more closely hew a chemical
risk assessment. The scope will include
a description of the reasonably available
information and the science approaches
that the Agency plans to use. In the
proposed rule EPA had included that
the reasonably available information
would include ‘‘accepted science
policies (e.g., defaults and uncertainty
factors), models, and screening
methodologies.’’ As already discussed, a
number of commenters expressed their
concern with this language and in
response EPA removed this provision.
Under the final rule, the scope will
focus on the reasonably available
information and science approaches,
and reserve uncertainty considerations
specifically for the remainder of the risk
evaluation.
EPA will include a conceptual model
that will describe the actual or predicted
relationships between the chemical
substance and the receptors, either
human or environmental, with
consideration of potential hazards
throughout the life cycle of the chemical
substance—from manufacturing,
processing, distribution in commerce,
storage, use, to release or disposal.
Also included will be an analysis
plan, which will identify the
approaches and methods EPA plans to
use to assess exposure, hazards, which
will include dose-response, and risk,
including associated uncertainty and
variability. The analysis plan will also
include a description of the reasonably
available information and science
approaches the EPA plans to use.
As requested by a number of
commenters, the scope will also include
the plan for peer review the Agency
expects to consider. This may include
the plan for peer review for those
conditions of use that EPA expects to
make early risk determinations on. This
plan may also include the Agency’s plan
to have any methods or models peer
reviewed, along with the risk
evaluation, as well as the EPA’s
anticipated use of the SACC or another
peer review body or whether the Agency
anticipates a letter peer review or a
committee consensus peer review. The

PO 00000

Frm 00017

Fmt 4701

Sfmt 4700

33741

Peer Review Handbook walks through
the numerous options the Agency can
use, and the plan will give the public an
idea of what the Agency intends to use
for a particular risk evaluation.’’
EPA will publish a notice in the
Federal Register, announcing the
availability of the final scope within six
months of the initiation of the risk
evaluation. Although not required under
the statute, EPA will publish a draft
scope and provide for no less than a 45
calendar day public comment period
during this six-month period. As a
number of commenters pointed out,
there was a mistake in the proposed
rule—the length of the commenter
period on the draft scope was 30 days
in the preamble, but 45 days in the
regulatory text. EPA has corrected this
mistake. EPA welcomes all public
participation, but specifically
encourages commenters to provide
information they believe might be
missing or may further inform the risk
evaluation. That said, the prioritization
process requires two public comment
opportunities, and EPA expects this will
reduce the likelihood of significant
comments on the draft scope for those
High-priority chemicals.
EPA has deleted the issue preclusion
clause included in the proposed rule
stating that ‘‘any issues related to the
scope not raised in the comments at that
time cannot form the basis for an
objection or challenge in a future
administrative or judicial hearing’’ in
response to a significant number of
comments. However, under general
principles of administrative law,
commenters are required to identify
relevant available information and raise
objections that could be raised during
established comment periods, and
courts generally will require
commenters to have done so as a matter
of exhaustion of administrative
remedies. EPA has concluded that these
principles provide sufficient assurance
that commenters will raise timely
objections and provide timely
information and has therefore decided
to strike the proposed regulatory text.
2. Hazard assessment. In compliance
with TSCA section 6(b)(4)(F), EPA will
conduct a hazard assessment on each
chemical substance or category, under
the conditions of use as identified in the
scope. A hazard assessment identifies
the types of adverse health or
environmental effects or hazards that
can be caused by exposure to the
chemical substance in question, and to
characterize the quality and weight of
the scientific evidence supporting this
identification. Hazard identification is
the process of determining whether
exposure to a chemical stressor can

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33742

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

cause an increase in the incidence of
specific adverse health or
environmental effects (e.g., cancer,
developmental toxicity). All information
used in this assessment will be
reviewed in a manner consistent with
reliance on the best available science
and a weight of the scientific evidence
approach.
As the rule text indicates, EPA will
present the hazard information, as
identified in the scope, for the identified
exposure scenarios, and including any
identified potentially exposed or
susceptible subpopulation. From the
proposed rule, EPA changed the word
‘‘endpoints’’ to ‘‘hazards,’’ as hazards is
more general and inclusive.
The hazard assessment will identify
the types of hazards to human health
and the environment. The information
will be reviewed in a manner consistent
with use of the best available science
and with the weight of scientific
evidence. This will include the
identification, evaluation, and synthesis
of information to describe the potential
health and environmental hazards of the
chemical, under the conditions of use,
and all assessment methods will be
documented. This hazard assessment
may include, but may not be limited to,
evaluation of the potential toxicity of
the chemical substance with respect to
cancer, mutation, reproductive,
developmental, respiratory, immune,
and cardiovascular impacts, and
neurological impairments. The
assessment may evaluate effects at life
stage(s) most appropriate for a receptor
target.
A hazard assessment also will include
a dose-response assessment. A doseresponse relationship describes how the
likelihood and severity of adverse
health effects (the responses) are related
to the amount and condition of
exposure to an agent (the dose
provided). The same principles
generally apply for studies where the
exposure is to a concentration of the
agent (e.g., airborne concentrations
applied in inhalation exposure studies
or water or other media concentrations
for ecological exposure studies), and the
resulting information is referred to as
the concentration-response.
Potential information sources that
may support the hazard assessment
include but are not limited to:
Population based epidemiological
studies that identify risk factors and
susceptible subpopulations; information
related to geographic location of
subpopulations; models that represent
health effects of relevant subpopulation;
in vivo and/or in vitro laboratory
studies; mechanistic or kinetic studies
in a variety of test systems, including

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

but not limited to toxicokinetics and
toxicodynamics, and computational
toxicology, which the final rule makes
clear may include high-throughput
assays, genomic response assays, data
from structure-activity relationships,
and ecological field data. The hazard
identification will also include an
evaluation of the strength, limitations,
and uncertainties associated with the
reasonably available information. The
final rule was amended to include
uncertainties as commenters encouraged
EPA to further discuss how
uncertainties will be addressed in this
process.
Specifically, for human health
hazards, the assessment will consider
all potentially exposed or susceptible
subpopulation(s) identified in the scope.
EPA will use an appropriate
combination, if available, of populationbased epidemiological studies,
information related to geographic
location of susceptible subpopulations,
models representing health effects to the
population, and any other information
or methodology consistent with
scientific standards.
An environmental hazard assessment
will evaluate the relationship between
the chemical substance and the
occurrence of an ecological response.
This assessment may be conducted
using reasonably available information
from field or laboratory data, modeling
strategies, and species extrapolations, if
needed.
Changes from the proposed rule
include the addition of EPA’s
commitment to using the best available
science and a weight of the evidence
approach. Some specific details
regarding the available information that
may be used in hazard assessments have
been moved to this preamble. The
proposal stated that EPA ‘‘may include’’
followed by a list of types of
information, and although the phrase
‘‘may include’’ provides flexibility, EPA
believes that it is more appropriate to
not codify this level of specific detail in
the regulation. Many public comments
encouraged transparency in the
Agency’s risk evaluation process, but
because this rule must cover the process
for all risk evaluations, which by nature
will necessitate the consideration of
many types of information sources, EPA
believes the better (and ultimately more
accurate) approach is to ensure that it
provides full transparency in the
individual risk evaluations.
3. Exposure assessment. Pursuant to
TSCA section 6(b)(4)(F), EPA, ‘‘where
relevant, will take into account the
likely duration, intensity, frequency,
and number of exposures under the
conditions of use in an exposure

PO 00000

Frm 00018

Fmt 4701

Sfmt 4700

assessment.’’ An exposure assessment
will include information on chemicalspecific factors, including but not
limited to: Physical-chemical properties
and environmental fate and transport
parameters. These considerations were
included in the proposed rule; however
‘‘transport’’ has been added to the final
text. Fate and transport in
environmental media are commonly
assessed together, and this is more
consistent with EPA’s current practices.
EPA has also added a statement in the
rule text regarding the use of best
available science and weight of
scientific evidence approaches. As
stated elsewhere in the preamble, EPA
is committed to upholding these
statutory requirements.
An exposure assessment includes
some discussion of the size, nature, and
types of individuals or populations
exposed to the agent, as well as
discussion of the uncertainties in this
information. Exposure can be measured
directly, but when data is unavailable it
is estimated indirectly through
consideration of measured
concentrations in the environment,
consideration of models of chemical
transport and fate in the environment,
and estimates of human intake or
environmental exposure over time. A
number of commenters encouraged the
use of probabilistic approaches as they
provide better estimates of exposure
when compared to specific ‘‘bright line’’
approaches. In response EPA will strive
to utilize probabilistic approaches for
exposure assessments included in a risk
evaluation but has not revised the
proposed regulation, consistent with its
approach to other provisions, where
EPA has moved many of the specific
approaches that appeared in the
proposed rule text into the final
preamble. EPA believes that this level of
detail regarding the specific information
types used in risk evaluation is more
appropriate for guidance. Commenters
had also suggested that guidance is
more appropriate for specific methods
and approaches because it can be
amended easily to adopt to changing
science. Codifying specific methods
could unnecessarily restrict the
Agency’s ability to review all pertinent
information.
Using reasonably available
information, exposures will be
estimated (usually quantitatively) for
the identified conditions of use. For
human health exposure, the assessment
would consider all potentially exposed
or susceptible subpopulation(s)
identified in the scope and utilize any
combination, as available, of
population-based epidemiological
studies, information related to

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
geographic location of susceptible
subpopulations, models representing
exposures to the population,
measurements in human tissues or
relevant environmental or exposure
media, and any other relevant,
scientifically valid information or
methodology. In an environmental
health exposure assessment the
interaction of the chemical substance
with any ecological characteristics
identified in the scope will be
characterized and evaluated. As with
the hazard assessment, specific details
on the source of information EPA will
use have been moved to this preamble
to allow for flexibility in identifying the
appropriate sources of information.
4. Risk characterization. TSCA
requires that a risk evaluation ‘‘integrate
and assess available information on
hazards and exposures.’’ (15 U.S.C
2605(b)(4)(F)). A risk characterization
conveys the risk assessor’s judgment as
to the nature and presence or absence of
risks, along with information about how
the risk was assessed, where
assumptions and uncertainties still
exist, and where policy choices will
need to be made. Risk characterization
takes place for both human health risk
assessments and ecological risk
assessments. The proposed text only
included the necessity for EPA to
describe whether aggregate or sentinel
exposures were considered during the
risk evaluation and the basis for that
consideration. The final rule text was
amended to include all of the statutory
requirements of the risk evaluation
process, including: Not considering
costs or other non-risk factors; taking
into account the likely duration,
intensity, frequency, and number of
exposures under the condition(s) of use;
and a description of the weight of
scientific evidence for the identified
hazards and exposures. The statute
requires a risk evaluation to include all
of these components, so EPA believed it
was necessary to codify them all, rather
than to single out just one of the
requirements.
In the risk characterization summary,
EPA will further carry out the
obligations under TSCA section 26; for
example, by identifying and assessing
uncertainty and variability in each step
of the risk evaluation, discussing
considerations of data quality such as
the reliability, relevance and whether
the methods utilized were reasonable
and consistent, explaining any
assumptions used, and discussing
information generated from
independent peer review. 15 U.S.C.
2625(h). EPA may include a discussion
of alternative interpretations, where
these interpretations are plausible, of

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

results generated from the risk
evaluation. EPA amended the regulation
text to include the phrase ‘‘where these
interpretations are plausible,’’ because
EPA believes, in agreement with a
commenter, that through the use of best
available science and weight of
scientific evidence approaches, it is
feasible that not every risk evaluation
will have alternative interpretations.
EPA wants to be clear that alternative
interpretations will be presented in the
risk characterization on a case-by-case
basis, but may not be the norm, as
requested by another commenter.
For environmental evaluations
specifically, EPA plans to include a
discussion of the nature and magnitude
of the effects, the spatial and temporal
patterns of the effects, implications at
the species, population, and community
level, and the likelihood of recovery
subsequent to exposure to the chemical
substance. A few commenters suggested
that when conducting an ecological risk
assessment, it is important to consider
the population level, as this was not
included in the proposed rule. The
commenters’ suggestion more accurately
reflects EPA’s general practices for
ecological risk assessments and this
change has been made in the final rule.
In practice, each component of the
risk assessment (e.g., hazard assessment,
dose-response assessment, exposure
assessment) has an individual
characterization written to carry forward
the key findings, assumptions,
limitations, and uncertainties. The set of
these individual characterizations
provide the information basis to write
an integrative risk characterization
analysis. The final, overall risk
characterization thus consists of the
individual component characterizations
plus an integrative analysis. Each risk
evaluation will quantitatively and/or
qualitatively estimate and characterize
risk for the identified populations and
ecological characteristics under the
conditions of use.
EPA has historically used a MOE
approach in risk characterization of
TSCA risk assessments. The proposed
rule asked the public to comment on the
strengths and weaknesses of the MOE
approach. EPA received many
comments with thoughtful reasoning
both for and against using this
approach. As discussed by commenters,
the benefits of the MOE approach
include the assertion that the approach
is more transparent than other
approaches, such as a hazard index or
hazard quotient, because the application
of uncertainty factors is transparent, and
that the MOE approach can incorporate
data from multiple pathways and
endpoints. Some supporters of the MOE

PO 00000

Frm 00019

Fmt 4701

Sfmt 4700

33743

approach did encourage EPA to not
prescribe a single value that would be
used for all risk evaluations, but to
select a MOE value that is fit-forpurpose and specifically associated with
the evidence of the evaluation.
Commenters that were not supportive
of this approach expressed their concern
for this ‘‘bright line’’ approach, in that
it does not reflect knowledge about what
the potential risks are above or below
the ‘line,’ and that it assumes a safe
level of exposure below which harm
will not occur. Others commented that
the MOE approach is not always easily
communicated to the public. Many
commenters suggested alternatives,
including the use of probabilistic
approaches, arguing that they better
account for variability and uncertainty.
Finally, others commented that it was
not appropriate to call out specific
methods, as this is more appropriate for
guidance.
Agreeing with the consensus from the
comments, EPA acknowledges that MOE
is just one of many ways to characterize
risk. There will be risk scenarios where
one approach may be better than
another, and as commenters correctly
pointed out, the science of risk
characterization is still evolving,
particularly for non-cancer hazards. To
account for the number of different
approaches and for changing science,
EPA will not codify any specific method
in this final rule.
Finally, EPA will utilize EPA’s
Information Quality Guidelines in the
risk characterization section of the risk
evaluation, as it provides guidance for
presenting risk information (Ref. 5). As
explained in that document, EPA
should identify: (1) Each population
addressed by an estimate of applicable
risk effects; (2) the expected risk or
central estimate of risk for the
potentially exposed or susceptible
subpopulations affected; (3) each
appropriate upper-bound or lowerbound estimate of risk; (4) each
significant uncertainty identified in the
process of the assessment of risk effects
and the studies that would assist in
resolving the uncertainty; and (5) peerreviewed studies known to the Agency
that support, are directly relevant to, or
fail to support any estimate of risk
effects and the methodology used to
reconcile inconsistencies in the
scientific information.
5. Peer review. For each risk
evaluation conducted on chemicals
identified pursuant to TSCA section
6(b)(4)(A), EPA will conduct a peer
review using the guidance provided in
executive branch peer review directives,
including in the Office of Management
and Budget Final Information Quality

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33744

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

Bulletin for Peer Review (OMB Bulletin)
(Ref. 18) and in the EPA Peer Review
Handbook (2015) (Ref. 19) or its
updates. For those conditions of use that
may receive an early determination of
no unreasonable risk, EPA will ensure
that the risk assessments underlying
these determinations are reviewed in a
manner consistent with the OMB
Bulletin and the EPA Peer Review
Handbook. These documents do provide
some latitude for the type of peer review
that EPA can conduct, which EPA will
take advantage of. For example, in
determining the appropriate type of peer
review, EPA can consider the
complexity of the information and any
prior peer review of underlying
information. EPA may also utilize the
SACC in reviewing the science that
underlies these determinations.
As discussed in the proposed rule,
EPA will identify aspects of the analysis
on which peer review will be
conducted, and the planned
methodologies, as part of the draft
scoping document that will undergo
public comment for each chemical
substance that undergoes risk
evaluation. These may include novel
models or analyses that warrant an indepth peer review. In addition to any
targeted peer review of specific aspects
of the analysis, the entire risk
assessment will also undergo peer
review, as it is important for peer
reviewers to consider how the various
underlying analyses fit together to
produce an integrated risk
characterization, which will form the
basis of an unreasonable risk
determination. A number of
commenters argued for involvement of
the public into the peer review process.
To respond to this, EPA plans to take
public comment on the charge questions
given to peer reviewers.
The peer review will address aspects
of the science underlying the
assessment, including, but not limited
to hazard assessment, assessment of
dose-response, exposure assessment,
and risk characterization. Consistent
with the proposed rule, EPA will not
seek review of any determination as to
whether the risks are ‘‘unreasonable,’’
which is an Agency policy
determination. EPA did receive public
comment requesting that the risk
determination also be subject to peer
review; however, EPA strongly believes
that the purpose of peer review is for the
independent review of the science
underlying the risk assessment, not an
evaluation of EPA’s policy
determinations. TSCA expressly
reserves to the Agency the final
determination of whether risk posed by
a chemical substance is ‘‘unreasonable.’’

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

15 U.S.C. 2605(i). EPA nevertheless will
include its risk determination as part of
the risk evaluation that is subject to
public review and comment.
EPA specifically requested public
comment on whether there are
circumstances where conducting peer
review may not be warranted, (e.g., what
circumstances may require peer review
and if there are others that may not) and
whether the regulatory text should be
adjusted to require EPA to make a case
by case determination of whether and to
what extent, consistent with the EPA
Peer Review Handbook, peer review is
warranted for the chemical substance
undergoing a risk evaluation. The
comments received were generally very
supportive of conducting a peer review
on all risk evaluations. There were some
comments that encouraged discretion as
to whether peer review had to be
conducted on a particular risk
evaluation (e.g., determinations of no
unreasonable risk, or on evaluations
were the result was consistent with
other national or international
conclusions). Commenters also raised
issues regarding the timing of peer
review in the risk evaluation process
(e.g., after public comment), what
should and should not be included in
peer review (e.g., the risk
determination), and views on what type
of peer review should be conducted
(e.g., full panel review). EPA’s responses
to specific comments are addressed in
the response to comment document.
Accordingly, EPA has retained the
provision from the proposed rule
requiring peer review on all risk
evaluations. Guidance on how peer
review will be conducted will remain
consistent with the EPA Peer Review
Handbook. For clarity, EPA did move
the peer review provision to its own
section of the rule, as suggested by a
commenter. EPA agrees with comments
that peer reviewed evaluations will
instill greater confidence and provide
transparency to the process. EPA
postulated in the proposed rule that
there may be circumstances that may
not necessitate peer review (e.g., where
a chemical substance is found to not
present an unreasonable risk or that
findings are similar or the same as other
jurisdictions (states or countries) that
have reached similar conclusions based
on the same information). Public
comment presented arguments to why
this is not appropriate. Although a
substance may not present an
unreasonable risk, the consequence of a
‘false negative’ could be extremely
problematic. For the second scenario
where EPA’s results may be similar to
another jurisdiction’s, commenters
argued that it will also be necessary to

PO 00000

Frm 00020

Fmt 4701

Sfmt 4700

peer review the evaluation. It would be
necessary to make certain the best
available science and weight of the
scientific evidence approaches were
used properly, as they may not have
been required under the process by
which the comparable evaluation was
conducted. As such, EPA will require
peer review on all risk evaluations.
6. Unreasonable risk determination.
The final step of a risk evaluation is for
EPA to determine whether the chemical
substance, under the conditions of use,
presents an unreasonable risk of injury
to health or the environment. EPA will
make individual risk determinations for
all uses identified in the scope. This
part of the regulation is slightly
amended from the proposed rule, to
clarify that the risk determination is part
of the risk evaluation, as well as to
account for the revised approach to that
ensures each condition of use covered
by the risk evaluation receives a risk
determination. Due to EPA’s decision to
allow for early determinations on one or
more conditions of use, where
appropriate, risk determinations may be
published in multiple documents or in
a single document containing all risk
determinations for all identified uses. If
the determinations are published in
multiple documents, the final
determination will be a composite
document of all determinations made.
EPA’s determinations will specify
whether each condition of use identified
for a chemical substance does or does
not present an unreasonable risk of
injury to health or the environment. A
determination that a condition of use
does not present an unreasonable risk is
considered to be a final EPA action. If
EPA determines that the chemical
substance, under one or more condition
of use, does present an unreasonable
risk, EPA must initiate a rulemaking
pursuant to TSCA section 6(a) to impose
requirements to the extent necessary so
that the substance no longer presents
such risk. 15 U.S.C. 2605(a). Any rule
would apply only to the condition(s) of
use that present an unreasonable risk,
and those that do not present an
unreasonable risk will not be subject to
risk management. A number of
commenters asked EPA to communicate
clearly which uses may go to risk
management following the evaluation.
EPA will clarify in the draft and final
risk evaluation documents specifically
which condition(s) of use warrant risk
management and which do not.
7. Reassessment of unreasonable risk
determination. EPA stated in the
proposed rule that it may reassess
determinations of unreasonable risk. A
number of commenters requested
clarification on when and how this

E:\FR\FM\20JYR2.SGM

20JYR2

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
might happen. Following review of the
comments, EPA has deleted the
provision as it was unnecessary.
Generally, agencies are authorized to
revisit determinations they are charged
by statute to make, and nothing in TSCA
prevents EPA from doing that. EPA is
also concerned that the provision could
have been read as an effort to limit,
expand, or otherwise alter the statutory
authority.
8. Additional publicly available
information. Pursuant to TSCA section
26(j), and subject to TSCA section 14,
the final regulation specifies that EPA
will make available: (1) The draft scope,
final scope, draft risk evaluation, and
final risk evaluation; (2) All notices,
determinations, findings, consent
agreements, and orders; (3) Any
information required to be provided to
the Agency under 15 U.S.C. 2603; (4) A
nontechnical summary of the risk
evaluation; (5) A list of the studies, with
the results of the studies, considered in
carrying out each risk evaluation; (6)
Each determination as to whether the
chemical substance presents an
unreasonable risk under one or more
conditions of use, along with an
identification of the information,
analysis, and basis used to make the
designation; (7) The final peer review
report, including the response to peer
review and public comments received
during peer review; and (8) Response to
public comments received on the draft
scope and the draft risk evaluation. In
this final rule there are a few slight
changes from the proposed regulation,
largely to conform to changes made to
other sections of the rule. The final rule
now includes number 6, which has been
slightly amended from the statute to
make clear that EPA will be making
public its risk determinations (the
statute uses the term ‘‘designations’’). In
addition, the final regulation now
specifies and that these determinations
will be made for the chemical under the
one or more conditions of use identified
in the risk evaluation.

asabaliauskas on DSKBBXCHB2PROD with RULES

IV. Summary of Request for Specific
Public Comment on the Proposed Rule
In the Proposed Risk Evaluation Rule,
EPA requested specific public input on
a number of subjects. These subjects are
listed below along with reference of the
particular section where EPA has
discussed the public comment.
1. Redefining scientific terms. Unit
III.D.
2. Margin of Exposure. Unit III.D.13.
3. Systematic Review. Unit III.D.12.
4. Manufacturer requests. Unit II.A.2.
5. Peer Review. Unit III.G.5.

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

6. Reliance on existing guidance and
procedures for conducting risk
evaluations. Unit III.G.1.a.
7. Interagency collaboration. Unit
III.H.
V. Cost Analysis
Industry costs for this rule are limited
to activities a manufacturer must
perform in order to meet the
requirements outlined in previous
sections. Manufacturers are not required
to submit a chemical substance for risk
evaluation, therefore these costs will
only be experienced when a given
manufacturer chooses to make a
submission to the Agency. The fully
loaded wage rate of a technical
professional (i.e., toxicologist) of $78.40
was used to calculate the cost of labor
burden.
A. Number of Entities Affected
EPA developed estimates for the
number of manufacturers who are likely
to elect to submit a chemical substance
for risk evaluation. Since submissions of
this nature have never been collected by
the Agency before, the actual number of
expected submittals is relatively
unknown. However, EPA assumes 5
chemical manufacturers may submit
requests to the Agency in any given
year. The Agency will not be required
to perform 20 risk evaluations at any
given time until 2 years after rule
finalization. Based on this, assuming 25
percent of total risk evaluations coming
from manufacturer submissions was
considered a best estimate with the lack
of actual data. The total number of
entities affected by the recordkeeping
and reporting requirements of the rule,
therefore, is estimated to be 5 chemical
manufacturers per year.
B. Rule Familiarization Burden
EPA assumes that each manufacturer
who elects to submit a chemical
substance for risk evaluation
consideration is assumed to spend one
hour becoming familiar with the
requirements of the rule and developing
an understanding of what actions are
necessary to complete the forms and
submission package. This is separate
from the time it takes to create the
submission package itself.
The total cost of rule familiarization is
estimated to be $392 per year (5 × 1 ×
78.40 = 392).
C. CDX Electronic Reporting Burden
Manufacturers requesting a chemical
substance be considered by EPA for risk
evaluation are required to provide the
submission package to the Agency via
the CDX electronic system. While
several manufacturers may be familiar

PO 00000

Frm 00021

Fmt 4701

Sfmt 4700

33745

with the CDX system and are registered
users because the same system is used
for new chemical submissions to the
Agency (e.g., pre-manufacture notice,
significant new use notice, low volume
exemptions) there is no way to estimate
which manufacturers submitting risk
evaluation requests are familiar with
CDX and which are new to the system.
Therefore, EPA assumes submissions
under this rule are performed by new
users of CDX which may result in an
overestimate of burden.
The CDX electronic reporting burden
includes registration to CDX,
familiarization with the subscriber
agreements, potential use of the help
desk, and problem resolution. The
burden estimates used in this rule are
based off of estimates in EPA ICR No.
2502.02, resulting in a burden of 2.83
hours per respondent.
The total cost of CDX electronic
reporting burden is estimated to be
$1,109 per year (5 × 2.83 × 78.40 =
1,109).
D. Submission Package Burden
Chemical manufacturers electing to
request EPA consider a chemical
substance for risk evaluation must
provide a submission package including
the following information: Contact
information of requesting entity(s), full
chemical identity information, complete
list of reasonably available information
consistent with TSCA section 26(h)
standards that is relevant to an
unreasonable risk determination,
addresses all the circumstances that
constitute conditions of use, of interest
to the manufacturer, within the meaning
of TSCA section 3, contain a
commitment to provide EPA any
referenced information upon request of
the Agency, and provide a signed
certification that all information in the
submission is accurate and complete.
While submissions of this nature have
never been required or requested by
EPA in the past, the Agency has
performed similar tasks internally while
conducting previous Risk Evaluations.
The average contractor expense and
labor time the Agency spends on the
types of activities required to prepared
the submission package covered by this
rule were used to develop the burden
and cost estimates.
EPA estimates the cost of having a
contractor conduct an in-depth
literature review and screen the
literature found for relevance costs an
average of $50,000 per chemical. This
includes the cost of using literature
review databases and the contractor
labor time involved in performing the
review and screening activities. In
addition to the contractor cost, the

E:\FR\FM\20JYR2.SGM

20JYR2

33746

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

manufacturer is expected to spend an
average of 80 hours per chemical
reviewing the data found during the
literature, refining the searches as
needed, and preparing the submission
package. Therefore, the estimated
burden for developing and submitting a
risk evaluation request is 80 hours per
respondent with an additional direct
cost of $50,000 per submission package.
Total cost for submission package
burden is estimated to be $281,360 per
year (5 × 50,000 × 80 × 78.40 = 281,360).
E. Total Cost
The total annual cost for this rule is
estimated to be $282,861 per year (392
+ 1,109 + 281,360 = 282,861) under the
assumption EPA receives 5
manufacturer requests per year.
Manufacturers choosing to submit a
chemical substance for risk evaluation
may be a small entity. Due to the low
cost ($56,572) of a single submission
package, the cost of the voluntary
submission is expected to impact less
than 1% of the small business at greater
than 3% of average revenue in the
estimated universe of small businesses.

asabaliauskas on DSKBBXCHB2PROD with RULES

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 physically located in
the docket. For assistance in locating
these other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. USEPA. Information Collection Request
(ICR) for the Proposed Rule: Procedures
for Chemical Risk Evaluation Under
TSCA. EPA ICR No.: 2559.01 and OMB
No. 2070—[NEW].
2. EPA. TSCA Work Plan Chemical
Assessments: 2014 Update-Final. Office
of Pollution Prevention and Toxics.
October 2014. https://www.epa.gov/sites/
production/files/2015-01/documents/
tsca_work_plan_chemicals_2014_
update-final.pdf.
3. EPA. Framework for Metals Risk
Assessment of the Office of the Science
Advisor, Risk Assessment Forum.
Washington, DC. March 2007.
4. USEPA. Exposure Factors Handbook. EPA/
600/R–090/052F. Office of Research and
Development, National Center for
Environmental Assessment. Washington,
DC. 2011. https://cfpub.epa.gov/ncea/
risk/recordisplay.cfm?deid=236252.
5. Guidelines for Ensuring and Maximizing
the Quality, Objectivity, Utility, and
Integrity of Information Disseminated by
the Environmental Protection Agency.
EPA/260R–02–008. Washington, DC.

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

2002. https://www.epa.gov/sites/
production/files/2015-08/documents/
epa-info-quality-guidelines.pdf.
6. European Centre for Ecotoxicology and
Toxicology of Chemicals (ECETOC).
Targeted Risk Assessment User Guide.
version 3.1. June 2014. http://
www.ecetoc.org/wp-content/uploads/
2014/06/Ecetoc_Tra_Standalone_
Consumer_Tool_User_Guide_
Jun2014.pdf.
7. Toxicology Excellence for Risk Assessment
(TERA). Complex Exposure Tool
(ComET) Meeting Materials. 2009. http://
www.tera.org/Peer/Exposure/
ExposureMeetingMaterials.htm.
8. USEPA. Framework for Human Health
Risk Assessment to Inform Decision
Making. EPA/100/R–14/001 Office of the
Science Advisor, Risk Assessment
Forum. 2014. https://archive.epa.gov/
raf/web/pdf/hhra-framework-final2014.pdf.
9. National Research Council. Science and
Decisions: Advancing Risk Assessment.
The National Academies Press.
Washington, DC. 2009.
10. USEPA. Weight of Evidence in ecological
risk assessment. Office of Research and
Development. Washington, DC. 2016.
11. Institute of Medicine. Finding What
works in Health Care: Standards for
Systematic Reviews. p. 13–34. The
National Academies Press. Washington,
DC. 2011.
12. J. Higgins and S. Green. Cochrane
Handbook for Systematic Reviews of
Interventions. John Wiley & Sons. 2011.
13. National Research Council. Review of
EPA’s Integrated Risk Information
System (IRIS) Process. Board on
Environmental Studies and Toxicology.
Washington, DC. 2014.
14. Stephens, M.F., Betts, K., Beck, N.B.,
Cogliano, V., Dickersin, K., Fitzpatrick
S., Freeman, J., Gray, G., Hartung T.,
McPartland, J., Rooney A.A., Scherer
R.W., Verloo, D., Hoffmann, S. The
Emergence of Systematic Review in
Toxicology. Toxicological Sciences. 152
(1): 10–16. 2016. DOI: https://doi.org/
10.1093/toxsci/kfw059.
15. USEPA. Risk Assessment Guidelines.
https://www.epa.gov/risk/riskassessment-guidelines.
16. USEPA. Pesticide Science and Assessing
Pesticide Risks. https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks.
17. USEPA. Predictive Models and Tools for
Assessing Chemicals under the Toxic
Substances Control Act (TSCA). https://
www.epa.gov/tsca-screening-tools.
18. Office of Management and Budget Final
Information Quality Bulletin for Peer
Review. Washington, DC. 2004. https://
19january2017snapshot.epa.gov/sites/
production/files/2015-01/documents/
omb_final_info_quality_bulletin_peer_
review_2004_1.pdf.
19. USEPA. Peer Review Handbook. 3rd ed.
EPA/100/B–06/002. Science Policy
Council. Washington, DC. 2006. https://
www.epa.gov/osa/peer-reviewhandbook-4th-edition-2015.

PO 00000

Frm 00022

Fmt 4701

Sfmt 4700

VII. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at http://www2.epa.gov/lawsregulatios/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review under Executive Orders 12866
(58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011),
and any changes made in response to
OMB recommendations are documented
in the docket. EPA conducted an
analysis of the potential costs associated
with this action. This analysis, can be
found in Unit V. This action is not
subject to the requirements of Executive
Order 13771, entitled ‘‘Reducing
Regulation and Controlling Regulatory
Costs’’ (82 FR 9339, February 3, 2017)
because this rule results in no more than
de mimimis costs.
B. Paperwork Reduction Act (PRA)
The information collection activities
associated with this rule have been
submitted to OMB for review and
approval under the PRA, 44 U.S.C. 3501
et seq. Specifically, EPA has prepared
an ICR to estimate the potential burden
and costs associated with the
requirements for submitting a request
for an Agency-conducted risk evaluation
on a particular chemical substance. The
ICR, which is available in the docket,
has been assigned the EPA ICR number
2559.01. You can find a copy of the ICR
in the docket for this rule (Ref. [Insert
reference #]), and it is briefly
summarized here.
Respondents/Affected Entities:
Manufacturers (including importers).
Respondent’s Obligation to Respond:
Optional, i.e., needed only if they are
requesting an EPA-conducted risk
evaluation for a particular chemical
substance.
Estimated Number of Respondents: 5.
Frequency of Response: On occasion.
Total Estimated Annual Burden:
419.2 hours. Burden is defined in 5 CFR
1320.3(b).
Total Estimated Annual Cost:
$282,861 for burden hours. There are no
O&M costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9.

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
C. Regulatory Flexibility Act (RFA)
EPA certifies under section 605(b) of
the RFA, 5 U.S.C. 601 et seq., that this
action will not have a significant
economic impact on a substantial
number of small entities. Although this
rule primarily addresses internal EPA
procedures and activities associated
with conducting risk evaluations for
chemical substances as required by
TSCA, EPA is also including the process
and content requirements for a
manufacturer (including importer) to
request that EPA conduct a risk
evaluation on particular uses of interest
of a chemical substance. EPA has
determined that the process and content
requirements proposed will have
minimal impact on an entity, regardless
of size, because there is no mandate for
them to make such a request, and the
information they must provide should
they decide to make such a request,
which involves basic information about
the chemical substance and the
manufacturer’s reasons for requesting
the EPA-conducted risk evaluation on
that chemical substance, should be
readily available to the manufacturer.
Estimated potential burden and costs
are presented in the ICR (Ref. 1).
EPA developed estimates for the
number of manufacturers likely to
submit a request for a chemical
substance to be considered for a risk
evaluation. EPA has never collected
submissions of this nature in the past,
so the actual number of expected
submissions is unknown. EPA estimates
five manufacturer-requested
submissions may be sent to EPA in any
given year. Based on the average
number of manufacturers (and small
businesses) per chemical for the ten
chemicals initially identified by EPA for
risk evaluation, EPA estimates an
average of 35 manufacturers will be
involved with the five manufacturerrequested submissions for risk
evaluations each year. Of the 35 affected
manufacturers, 15 are estimated to be
small businesses. Based on the ten
chemicals initially identified by EPA for
risk evaluations, there are an average of
seven manufacturers per chemical.
Assuming that submission costs are
shared equally within a consortium of
seven manufacturers, the one-time
respondent cost of $56,572 per
submission would be $8,082 per
manufacturer.
Based on revenue data from U.S.
Census Statistics of US Business and an
estimated cost of $8,082 per
manufacturer, EPA estimated the
proportion of small manufacturer firms
that could have a cost impact of less
than 1%; between 1% and 3%; and

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

more than 3% of the average revenues.
The proportion of small business firms
which may incur a cost impact of less
than 1% of the average revenues is 76%
of the small firms (approximately 11 of
the 15 affected small manufacturers).
The proportion of small business firms
which may incur a cost impact between
1% and 3% of the average revenues is
23% of the small firms (approximately
3 of the 15 affected small manufactures).
The proportion of small business firms
which may incur a cost impact greater
than 3% of the average revenues is 1%
of the small firms (approximately 1 of
the 15 small manufacturers).
The decision to request a risk
assessment for a chemical is voluntary
and manufacturers may decide not to
make such a request. But if such a
request is made, the burden for the
needed paperwork still does not result
in a significant economic impact on a
substantial number of small entities.
D. Unfunded Mandates Reform Act
(UMRA)
This Action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999). It will not have substantial direct
effects on the states, on the relationship
between the national government and
the states, or on the distribution of
power and responsibilities among the
various levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). 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
The EPA interprets Executive Order
13045 (62 FR 19885, April 23, 1997) as
applying only to those regulatory
actions that concern environmental

PO 00000

Frm 00023

Fmt 4701

Sfmt 4700

33747

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. This action is not
subject to Executive Order 13045
because it does not concern an
environmental health risk or safety risk.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not likely to have a
significant adverse effect on the supply,
distribution or use of energy.
I. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve any
technical standards, and is therefore not
subject to considerations under NTTAA
section 12(d), 15 U.S.C. 272 note.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not establish an
environmental health or safety standard,
and is therefore not subject to
environmental justice considerations
under Executive Order 12898 (59 FR
7629, February 16, 1994). This is a
procedural rule that will not affect the
level of protection provided to human
health or the environment.
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 the U.S. Senate, and the
U.S. House of Representatives, and the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 702
Environmental protection, Chemicals,
Chemical substances, Hazardous
substances, Health and safety, Risk
evaluation.
Dated: June 22, 2017.
E. Scott Pruitt,
Administrator.

Therefore, 40 CFR chapter I,
subchapter R, is amended as follows:
PART 702—[AMENDED]
1. The authority citation for part 702
is revised to read as follows:

■

Authority: 15 U.S.C. 2605 and 2619.
■

2. Add subpart B to read as follows:

E:\FR\FM\20JYR2.SGM

20JYR2

33748

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

Subpart B—Procedures for Chemical
Substance Risk Evaluations
Sec.
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances designated for
risk evaluation.
702.37 Submission of manufacturer
requests for risk evaluations.
702.39 Interagency collaboration.
702.41 Evaluation requirements.
702.43 Risk Characterization.
702.45 Peer review.
702.47 Unreasonable risk determination.
702.49 Risk evaluation timeframes and
actions.
702.51 Publically available information.
§ 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)).
(d) Enforcement. Submission to EPA
of inaccurate, incomplete, or misleading
information pursuant to a risk
evaluation conducted pursuant to 15
U.S.C. 2605(b)(4)(B) is a prohibited act
under 15 U.S.C. 2614, subject to
penalties under 15 U.S.C. 2615 and Title
18 of the U.S. Code.

asabaliauskas on DSKBBXCHB2PROD with RULES

§ 702.33

Definitions.

All definitions in TSCA apply to this
subpart. In addition, the following
definitions apply:
Act means the Toxic Substances
Control Act, as amended (15 U.S.C.
2601 et seq.).
Aggregate exposure means the
combined exposures to an individual
from a single chemical substance across
multiple routes and across multiple
pathways.
Best available science means 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, EPA will
consider as applicable:

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

(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.
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 mode through
which one is exposed to a chemical
substance, including but not limited to:
Food, water, soil, and air.
Potentially exposed or susceptible
subpopulation means a group of
individuals within the general
population identified by the Agency
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.
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 particular manner
by which a chemical substance may
contact the body, including absorption

PO 00000

Frm 00024

Fmt 4701

Sfmt 4700

via ingestion, inhalation, or dermally
(integument).
Sentinel exposure means the exposure
from a single 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.
Weight of scientific evidence means a
systematic review method, applied in a
manner suited to the nature of the
evidence or decision, that uses a preestablished protocol to
comprehensively, objectively,
transparently, and consistently, identify
and evaluate each stream of evidence,
including strengths, limitations, and
relevance of each study and to integrate
evidence as necessary and appropriate
based upon strengths, limitations, and
relevance.
§ 702.35 Chemical substances designated
for risk evaluation.

(a) Chemical substances undergoing
risk evaluation. A risk evaluation for a
chemical substance designated by the
Agency as a High-Priority Substance
pursuant to the prioritization process
described in subpart A, identified under
15 U.S.C. 2605(b)(2)(A), or initiated at
the request of a manufacturer or
manufacturers under § 702.37, will be
conducted in accordance with this part,
except that risk evaluations that are
initiated prior to the effective date of
this rule will be conducted in
accordance with this part to the
maximum extent practicable.
(b) Percentage requirements. The
Agency will ensure that, of the number
of chemical substances that undergo risk
evaluation under 15 U.S.C.
2605(b)(4)(C)(i), the number of chemical
substances undergoing risk evaluation
under 15 U.S.C. 2605(b)(4)(C)(ii) is not
less than 25%, if sufficient requests that
comply with 702.37, and not more than
50%.
(c) Manufacturer requests 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 the Agency.
Such evaluations are not subject to the
percentage requirements in paragraph
(b) of this section.

E:\FR\FM\20JYR2.SGM

20JYR2

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

asabaliauskas on DSKBBXCHB2PROD with RULES

§ 702.37 Submission of manufacturer
requests for risk evaluations.

(a) General provision. Any request
that EPA conduct a risk evaluation
pursuant to this part must comply with
all the procedures and criteria in this
section to be eligible to be granted by
EPA.
(b) Method for submission. One or
more manufacturers of a chemical
substance may request that EPA conduct
a risk evaluation. All requests submitted
to EPA under this subpart must be
submitted via the EPA Central Data
Exchange (CDX) found at http://
cdx.epa.gov. Requests must include all
of the following information:
(1) Name, mailing address, and
contact information of the entity (or
entities) submitting the request. If more
than one manufacturer submits the
request, all individual manufacturers
must provide their contact information.
(2) The chemical identity of the
chemical substance that is the subject of
the request. At a minimum, this
includes, all known names of the
chemical substance, including common
or trades names, CAS number, and
molecular structure of the chemical
substance A request for risk evaluations
of a category of chemical substances
must include an explanation of why the
category is appropriate under 15 U.S.C.
2625(c), and EPA will grant such
request only upon determining that the
requested category is appropriate for
risk evaluation.
(3) The manufacturer must identify
the circumstances on which they are
requesting that EPA conduct a risk
evaluation and include a rationale for
why these circumstances constitute
conditions of use under § 702.33.
(4) The request must also include a
list of all the existing information that
is relevant to whether the chemical
substance, under the circumstances
identified by the manufacturer(s),
presents an unreasonable risk of injury
to health or the environment. The list
must be accompanied by an explanation
as to why such information is adequate
to permit EPA to complete a risk
evaluation addressing the circumstances
identified by the manufacturer(s), The
request need not include copies of the
information; citations are sufficient, if
the information is publically available.
The request must include or reference
all available information on the health
and environmental hazard(s) of the
chemical substance, human and
environmental exposure(s), and exposed
population(s), as relevant to the
circumstances identified in the request.
At a minimum, this must include all the
following, as relevant to the
circumstances identified:

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

(i) The chemical substance’s hazard
and exposure potential;
(ii) The chemical substance’s
persistence and bioaccumulation;
(iii) Potentially exposed or susceptible
subpopulations which the
manufacturer(s) believes to be relevant
to the EPA risk evaluation;
(iv) Whether there is any storage of
the chemical substance near significant
sources of drinking water, including the
storage facility location and the nearby
drinking water source(s);
(v) The chemical substance’s
production volume or significant
changes in production volume; and
(vi) Any other information relevant to
the potential risks of the chemical
substance under the circumstances
identified in the request.
(5) The request must include a
commitment to provide to EPA any
referenced information upon request.
(6) Scientific information submitted
must be consistent with the scientific
standards in 15 U.S.C. 2625(h).
(7) A signed certification that all
information contained in the request is
accurate and complete, as follows:
(i) I certify that to the best of my
knowledge and belief:
(A) The company named in this
request manufacturers the chemical
substance identified for risk evaluation.
(B) All information provided in the
notice is complete and accurate as of the
date of the request.
(C) I have either identified or am
submitting all information in my
possession, control, and a description of
all other data known to or reasonably
ascertainable by me as required for this
request under this part. I am aware it is
unlawful to knowingly submit
incomplete, false and/or misleading
information in this request and there are
significant criminal penalties for such
unlawful conduct, including the
possibility of fine and imprisonment.
(ii) [Reserved]
(c) Optional elements. A manufacturer
may provide information that will
inform EPA’s determination as to
whether restrictions imposed by one or
more States have the potential to have
a significant impact on interstate
commerce or health or the environment,
and that as a consequence the request is
entitled to preference pursuant to 15
U.S.C. 2605(b)(4)(E)(iii).
(d) Confidential business information.
(1) Persons submitting a request under
this subpart are subject to EPA
confidentiality regulations at 40 CFR
part 2, subpart B.
(2) In submitting a claim of
confidentiality, a person must certify
the accuracy of the following statements
concerning all information claimed as
confidential:

PO 00000

Frm 00025

Fmt 4701

Sfmt 4700

33749

(i) I hereby certify to the best of my
knowledge and belief that all
information entered on this form is
complete and accurate. I further certify
that, pursuant to 15 U.S.C. 2613(c), for
all claims for confidentiality made with
this submission, all information
submitted to substantiate such claims is
true and correct, and that it is true and
correct that:
(A) My company has taken reasonable
measures to protect the confidentiality
of the information;
(B) I have determined that the
information is not required to be
disclosed or otherwise made available to
the public under any other Federal law;
(C) I have a reasonable basis to
conclude that disclosure of the
information is likely to cause substantial
harm to the competitive position of my
company; and
(D) I have a reasonable basis to believe
that the information is not readily
discoverable through reverse
engineering.
(ii) [Reserved]
(3) Each claim of confidentiality,
other than a claim pertaining to
information described in TSCA section
14(c)(2), must be accompanied by a
substantiation in accordance with 15
U.S.C. 2613.
(4) Manufacturers must supply a
structurally descriptive generic name
where specific chemical identity is
claimed as CBI.
(5) Any knowing and willful
misrepresentation, under this section, is
subject to criminal penalty pursuant to
18 U.S.C. 1001.
(e) EPA process for evaluating
manufacturer requests—(1) Review for
completeness. Upon receipt of the
request, EPA will verify that the request
is facially complete, i.e., that
information has been submitted that
appears to be consistent with the
requirements in paragraphs (b) through
(d) of this section. EPA will inform the
submitting manufacturer(s) if EPA has
determined that the request is
incomplete, and cannot be processed.
Facially complete requests will be
processed as described in this subpart.
(2) Public notification of receipt of
request. Within 15 business days of
receipt of a facially complete
submission, EPA will notify the public
of receipt of the manufacturer request.
This notification will include any
information submitted by the
manufacturer that is not CBI, including
the condition(s) of use for which the
evaluation is requested.
(3) Conditions of use to be evaluated.
EPA will assess whether the
circumstances identified in the request
constitute condition of use under

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33750

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

§ 702.33, and whether those conditions
of use warrant inclusion within the
scope of a risk evaluation for the
chemical substance. EPA will also
assess what, if any, additional
conditions of use that warrant inclusion
within the scope of a risk evaluation for
the chemical substance. EPA will
conduct these assessments and make
proposed determinations based on the
same considerations applied in the same
manner as it would for a risk evaluation
for a high-priority substance.
(4) Public notice and comment. No
later than 60 business days of receiving
a request that EPA has determined to be
complete under paragraph (e)(1) of this
section, EPA will submit for publication
the receipt of the request in the Federal
Register, open a docket for that request
and provide no less than a 45 calendar
day public comment period. The docket
will contain the manufacturer request
(excluding information claimed as CBI)
and EPA’ proposed additions of
conditions of use as described in
paragraph (e)(3) of this section, and the
basis for these proposed additions.
During the comment period the public
may submit comments and information
relevant to the requested risk
evaluation, in particular, commenters
are encouraged to identify any
information not included in the request
or the proposed determinations that the
commenters believe would be needed to
conduct a risk evaluation, and to
provide any other information relevant
to EPA’s proposed determinations of the
conditions of use, such as information
on other conditions of use of the
chemical than those included in the
request or in EPA’s proposed
determinations
(5) Supplementation of original
request. (i) At any time prior to the end
of the comment period, the requesting
manufacturer(s) may supplement the
original request with any new
information it receives.
(ii) At any point prior to the
completion of a risk evaluation pursuant
to this section, manufacturer(s) must
supplement the original request with
any information that meets the criteria
in 15 U.S.C. 2607(e) and this section, or
with any other information that has the
potential to change EPA’s risk
evaluation with respect to the
conditions of use as requested by the
manufacturer. Such information must be
submitted consistent with section 8(e) if
the information is subject to that section
or otherwise within 30 calendar days of
the manufacturer’s obtaining the
information.
(6) EPA’s decision. (i) Within 60 days
of the end of the comment period
provided in paragraph (e)(4) of this

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

section, EPA will review the request
along with any additional information
received during the comment period to
determine whether the request meets
the criteria and requirements of this
section.
(ii) EPA will grant the request if it
determines that all of the following have
been met:
(A) That the circumstances identified
in the request constitute conditions of
use that warrant inclusion in a risk
evaluation for the chemical substance;
(B) That EPA has all of the
information needed to conduct such risk
evaluation on the conditions of use that
were the subject of the request; and
(C) All other criteria and requirements
of this section have been met.
(iii) At the end of this 60-day period,
EPA will notify the submitting
manufacturer(s) of its decision and
include the basis for granting or denying
the request. Bases for a denial, include
the manufacturer has not provided
sufficient information to complete the
risk evaluation on the condition(s) of
use requested, or that the circumstances
identified in the request either do not
constitute conditions of use, or the
conditions of use do not warrant
inclusion in a risk evaluation for the
chemical substance. This notification
will also identify any additional
conditions of use, as determined by the
Administrator, that will be included in
this risk evaluation.
(iv) Within 30 days of receipt of EPA’s
notification the requester(s) may
withdraw the request.
(7) Public notice of decision. EPA will
make public EPA’s decision to grant or
deny the request at the time that EPA
notifies the manufacturer.
(8) Compliant request. EPA will
initiate a risk evaluation for all requests
for non-TSCA Work Plan Chemicals that
meet the criteria in this subpart, until
EPA determines that the number of
manufacturer-requested chemical
substances undergoing risk evaluation is
equal to 25% of the High-Priority
Substances identified in subpart A as
undergoing risk evaluation. Once that
level has been reached, EPA will initiate
at least one new manufacturer-requested
risk evaluation for each manufacturerrequested risk evaluation completed so
long as there are sufficient requests that
meet the criteria of this subpart, as
needed to ensure that the number of
manufacturer-requested risk evaluations
is equal to at least 25% of the HighPriority substances risk evaluation and
not more than 50%.
(9) Preferences. In conformance with
§ 702.35(c), in evaluating requests for
TSCA Work Plan Chemicals and
requests for non-TSCA Work Plan

PO 00000

Frm 00026

Fmt 4701

Sfmt 4700

chemicals in excess of the 25%
threshold in § 702.35(b), EPA will first
give preference to requests for risk
evaluations on chemical substances:
(i) First, for which the Agency
determines that restrictions imposed by
one or more States have the potential to
have a significant impact on interstate
commerce, health or the environment;
and then
(ii) Second, based on the order in
which the requests are received.
(10) No preferential treatment. Once
granted, EPA will initiate the risk
evaluation and thereafter will conduct
the risk evaluation following the
procedures in §§ 702.39 through 702.51.
EPA will not expedite or otherwise
provide special treatment to a risk
evaluation conducted as a result of a
manufacturer’s request.
(11) Fees. Manufacturers must pay
fees to support risk evaluations as
specified under 15 U.S.C.
2605(b)(4)(E)(ii).
§ 702.39

Interagency collaboration.

During the risk evaluation process,
not to preclude any additional, prior, or
subsequent collaboration, EPA will
consult with other relevant Federal
agencies.
§ 702.41

Evaluation requirements.

(a) Considerations. (1) Each risk
evaluation will include all of the
following components:
(i) A Scope, including a Conceptual
Model and an Analysis Plan;
(ii) A Hazard Assessment;
(iii) An Exposure Assessment;
(iv) A Risk Characterization; and
(v) A Risk Determination.
(2) EPA guidance will be used, as
applicable where it represents the best
available science appropriate for the
particular risk evaluation.
(3) Where appropriate, a risk
evaluation will be conducted on a
category of chemical substances. EPA
will determine whether to conduct an
evaluation on a category of chemical
substances, and the composition of the
category based on the considerations
listed in 15 U.S.C. 2625(c).
(4) EPA will document that it has
used the best available science and
weight of scientific evidence approaches
in the risk evaluation process.
(5) EPA will ensure that all
supporting analyses and components of
the risk evaluation are suitable for their
intended purpose, and well-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

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
conditions of use within the scope of
the risk evaluation, based on the weight
of the scientific evidence.
(6) 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.
(7) To the extent a determination as to
the level of risk presented by a
condition of use can be made, for
example, using assumptions,
uncertainty factors, and models or
screening methodologies, EPA may
determine that no further information or
analysis is needed to complete its risk
evaluation of the condition(s) of use.
(8) In general, EPA intends to
determine whether a chemical
substance does or does not present an
unreasonable risk under all of the
conditions of use within the scope of
the risk evaluations, and intends to
identify the individual conditions of use
or categories of conditions of use that
are responsible for such determinations.
(9) Within the time frame in
§ 702.43(d), EPA will complete the risk
evaluation of the chemical substance
addressing all of the conditions of use
within the scope of the evaluation.
However, EPA may complete its
evaluation of the chemical substance
under specific conditions of use or
categories of conditions of use at any
point following the issuance of the final
scope document, and issue its
determination as to whether the
chemical substance under those
conditions of use does or does not
present an unreasonable risk to health
or the environment under those
conditions of use. EPA will follow all of
the requirements and procedures in this
Subpart when it conducts its evaluation
of the chemical substance under any
individual or specific conditions of use.
(10) 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 generally expects to initiate a
risk evaluation for a chemical substance
when EPA believes that all or most of
the information necessary to perform
the risk evaluation is reasonably
available. 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.

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

EPA will use such authorities on a caseby-case basis during the performance of
a risk evaluation to obtain information
as needed to ensure that EPA has
adequate, reasonably available
information to perform the evaluation.
(3) Among other sources of
information, the Agency will consider
information and advice provided by the
Science Advisory Committee on
Chemicals established pursuant to 15
U.S.C. 2625.
(4) In conducting risk evaluations,
EPA will utilize reasonably available
information including information,
models, and screening methodologies,
as appropriate. The approaches used
will be determined by the quality of the
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.
(5) 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 in
performing risk evaluation.
(c) Scope of the risk evaluation. The
scope of the risk evaluation will include
all the following:
(1) The condition(s) of use, as
determined by the Administrator, that
the EPA plans 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 the Agency under the
conditions of use, that EPA plans to
evaluate; the ecological receptors that
EPA plans to evaluate; and the hazards
to health and the environment that EPA
plans to evaluate.
(3) A description of the reasonably
available information and science
approaches EPA plans to use in the risk
evaluation.
(4) A conceptual model:
(i) The scope documents will include
a Conceptual Model that describes
actual or predicted relationships
between the chemical substance, the
conditions of use within the scope of
the evaluation and human and
environmental receptors.
(ii) The conceptual model will
identify human and ecological health
hazards the EPA plans to evaluate for
the exposure scenarios EPA plans to
evaluate.
(iii) Conceptual model development
will consider the life cycle of the
chemical substance, including
manufacture, processing, distribution in
commerce, storage, use, and disposal,

PO 00000

Frm 00027

Fmt 4701

Sfmt 4700

33751

relevant to the conditions of use within
the scope of the evaluation
(5) An analysis plan:
(i) The scope documents will include
an analysis plan that identifies the
approaches, methods, and/or metrics
that EPA plans to use to assess
exposures, effects, and risk, including
associated uncertainty and variability
for each risk evaluation. The analysis
plan will also identify the strategy for
using information, accepted science
policies, models, and screening
methodologies.
(ii) Hypotheses about the
relationships identified in the
conceptual model will be described.
The relative strengths of alternative
hypotheses if any will be evaluated to
determine the appropriate risk
assessment approaches.
(6) The Agency’s plan for peer review.
(7) Developing the scope.
(i) Draft scope. For each risk
evaluation to be conducted EPA will
publish a document in the Federal
Register that specifies the draft scope of
the risk evaluation the Agency plans to
conduct. The document will address the
elements in paragraphs (c)(1) through
(6) of this section.
(ii) Timeframes. EPA generally
expects to publish the draft scope no
later than 3 months from the initiation
of the risk evaluation process for the
chemical substance.
(iii) Public comments. EPA will allow
a public comment period of no less than
45 calendar days during which
interested persons may submit comment
on EPA’s draft risk evaluation scope.
EPA will open a docket to facilitate
receipt of public comments.
(8) Final scope:
(i) The Agency will, no later than 6
months after the initiation of a risk
evaluation, publish a document in the
Federal Register that specifies the final
scope of the risk evaluation the Agency
plans to conduct. The document shall
address the elements in paragraphs
(c)(1) through (6) of this section.
(ii) For a chemical substance
designated as a High-Priority Substance
under subpart A of this part, EPA will
not publish the final scope of the risk
evaluation until at least 12 months have
elapsed from the initiation of the
prioritization process for the chemical
substance.
(d) Hazard assessment. (1) The hazard
information relevant to the chemical
substance will be evaluated using
hazards identified in the final scope
document published pursuant to
paragraph (c)(8) of this section, for the
identified exposure scenarios, including
any identified potentially exposed or
susceptible subpopulation(s).

E:\FR\FM\20JYR2.SGM

20JYR2

asabaliauskas on DSKBBXCHB2PROD with RULES

33752

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

(2) The hazard assessment process
will identify the types of hazards to
health or the environment posed by the
chemical substance under the
condition(s) of use within the scope of
the risk evaluation. Hazard information
related to potential health and
environmental hazards of the chemical
substance will be reviewed in a manner
consistent with best available science
and weight of scientific evidence as
defined in § 702.33 and all assessment
methods will be documented. This
process includes the identification,
evaluation, and synthesis of information
to describe the potential health and
environmental hazards of the chemical
substance.
(3) Relevant potential human and
environmental hazards will be
evaluated.
(4) The relationship between the dose
of the chemical substance and the
occurrence of health and environmental
effects or outcomes will be evaluated.
(5) Studies evaluated may include,
but would not be limited to: Human
epidemiological studies, in vivo and/or
in vitro laboratory studies,
biomonitoring studies, mechanistic and/
or kinetic studies in a variety of test
systems, including but not limited to
toxicokinetics and toxicodynamics,
computational toxicology such as highthroughput assays, genomic response
assays, data from structure-activity
relationships, and ecological field data.
(6) Hazard identification will include
an evaluation of the strengths,
limitations, and uncertainties associated
with the reasonably available
information.
(7) The human health hazard
assessment will consider all potentially
exposed and susceptible
subpopulation(s) determined to be
relevant, as identified in the final scope
document published pursuant to
paragraph (c)(8) of this section.
(8) The environmental health hazard
assessment will consider the
relationship between the chemical
substance and the occurrence of an
ecological hazard elicited.
(e) Exposure assessment. (1) Where
relevant, the likely duration, intensity,
frequency, and number of exposures
under the conditions of use will be
considered.
(2) Chemical-specific factors
including, but not limited to: Physicalchemical properties and environmental
fate and transport parameters will be
examined.
(3) Exposure information related to
potential human health or ecological
hazards of the chemical substance will
be reviewed in a manner consistent with
the description of best available science

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

and weight of scientific evidence in
§ 702.33 and all methods will be
documented.
(4) The human health exposure
assessment will consider all potentially
exposed and susceptible
subpopulation(s) determined to be
relevant, as identified in the final scope
document published pursuant to
paragraph (c)(8) of this section.
(5) Environmental health exposure
assessment:
(i) The environmental health exposure
assessment will characterize and
evaluate the interaction of the chemical
substance with the ecological receptors
identified in the final scope document
published pursuant to paragraph (c)(8)
of this section.
(ii) Exposures considered will include
populations and communities,
depending on the chemical substance
and the ecological characteristic
involved.
§ 702.43

Risk Characterization.

(a) Risk Characterization
considerations. EPA will:
(1) Integrate the hazard and exposure
assessments into quantitative and/or
qualitative estimates of risk for the
identified populations (including any
potentially exposed or susceptible
subpopulation(s)) identified in the final
scope document published pursuant to
§ 702.41(c)(8) and ecological
characteristics for the conditions of use
within the scope of the risk evaluation;
(2) Describe whether aggregate or
sentinel exposures under the conditions
of use were considered and the basis for
their consideration;
(3) Not consider costs or other nonrisk
factors;
(4) Take into account, where relevant,
the likely duration, intensity, frequency,
and number of exposures under the
condition(s) of use of the chemical
substance; and
(5) Describe the weight of the
scientific evidence for the identified
hazards and exposures.
(b) Risk Characterization summary.
The Risk Characterization will
summarize, as applicable, the
considerations addressed throughout
the evaluation components, in carrying
out the obligations under 15 U.S.C.
2625(h). This summary will include, as
appropriate, a discussion of:
(1) Considerations regarding
uncertainty and variability. Information
about uncertainty and variability in
each step of the risk evaluation (e.g., use
of default assumptions, scenarios,
choice of models, and information used
for quantitative analysis) will be
integrated into an overall
characterization and/or analysis of the

PO 00000

Frm 00028

Fmt 4701

Sfmt 4700

impact of the uncertainty and variability
on estimated risks. EPA may describe
the uncertainty using a qualitative
assessment of the overall strength and
limitations of the data used in the
assessment.
(2) Considerations of data quality. A
discussion of data quality (e.g.,
reliability, relevance, and whether
methods employed to generate the
information are reasonable for and
consistent with the intended use of the
information), as well as assumptions
used, will be included to the extent
necessary. EPA also expects to include
a discussion of the extent of
independent verification or peer review
of the information or of the procedures,
measures, methods, protocols,
methodologies, or models used in the
risk evaluation.
(3) Considerations of alternative
interpretations. If appropriate and
relevant, where alternative
interpretations are plausible, a
discussion of alternative interpretations
of the data and analyses will be
included.
(4) Considerations for environmental
risk evaluations. For environmental risk
evaluations, it may be necessary to
discuss the nature and magnitude of the
effects, the spatial and temporal patterns
of the effects, implications at the
individual, species, population, and
community level, and the likelihood of
recovery subsequent to exposure to the
chemical substance.
§ 702.45

Peer review.

The EPA Peer Review Handbook
(2015), the Office of Management and
Budget Final Information Quality
Bulletin for Peer Review (OMB
Bulletin), and other available, relevant
and applicable methods consistent with
15 U.S.C. 2625, will serve as the
guidance for peer review activities. Peer
review will be conducted on the risk
evaluations for the chemical substances
identified pursuant to 15 U.S.C.
2605(b)(4)(A).
§ 702.47

Unreasonable risk determination.

As part of the risk evaluation, EPA
will determine whether the chemical
substance presents an unreasonable risk
of injury to health or the environment
under each condition of uses within the
scope of the risk evaluation, either in a
single decision document or in multiple
decision documents.
§ 702.49
actions.

Risk evaluation timeframes and

(a) Draft risk evaluation timeframe.
EPA will publish a draft risk evaluation
in the Federal Register, open a docket
to facilitate receipt of public comment,

E:\FR\FM\20JYR2.SGM

20JYR2

Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations
and provide no less than a 60-day
comment period, during which time the
public may submit comment on EPA’s
draft risk evaluation.
(b) Final risk evaluation. (1) EPA will
complete a risk evaluation for the
chemical substance under the
conditions of use within the scope of
the risk evaluation as soon as
practicable, but not later than 3 years
after the date on which the Agency
initiates the risk evaluation.
(2) The Agency may extend the
deadline for a risk evaluation for not
more than 6 months. The total time
elapsed between initiation of the risk
evaluation and completion of the risk
evaluation may not exceed 3 and one
half years.
(3) EPA will publish the final risk
evaluation in the Federal Register.
(c) Final determination of
unreasonable risk. Upon determination
by the EPA that a chemical substance
under one or more of the conditions of
use within the scope of the risk
evaluation presents an unreasonable
risk of injury to health or the
environment as described in § 702.47,
the Agency will initiate action as
required pursuant to 15 U.S.C. 2605(a).
(d) Final determination of no
unreasonable risk. A determination by
EPA that the chemical substance, under
one or more of the conditions of use
within the scope of the risk evaluation,
does not present an unreasonable risk of
injury to health or the environment will
be issued by order and considered to be
a final Agency action, effective on the
date of issuance of the order.

asabaliauskas on DSKBBXCHB2PROD with RULES

§ 702.51

Publically available information.

For each risk evaluation, EPA will
maintain a public docket at http://
www.regulations.gov to provide public
access to the following information, as
applicable for that risk evaluation:
(a) The draft scope, final scope, draft
risk evaluation, and final risk
evaluation;
(b) All notices, determinations,
findings, consent agreements, and
orders;
(c) Any information required to be
provided to the Agency under 15 U.S.C.
2603;
(d) A nontechnical summary of the
risk evaluation;
(e) A list of the studies, with the
results of the studies, considered in
carrying out each risk evaluation;
(f) The final peer review report,
including the response to peer review
and public comments received during
peer review; and

VerDate Sep<11>2014

19:37 Jul 19, 2017

Jkt 241001

(g) Response to public comments
received on the draft scope and the draft
risk evaluation.
[FR Doc. 2017–14337 Filed 7–19–17; 8:45 am]
BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 702

33753

Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–4321; email address:
[email protected].
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.

[EPA–HQ–OPPT–2016–0636; FRL–9964–24]

SUPPLEMENTARY INFORMATION:

RIN 2070–AK23

I. Executive Summary

Procedures for Prioritization of
Chemicals for Risk Evaluation Under
the Toxic Substances Control Act

A. What action is the Agency taking?

Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:

As required under section
6(b)(1) of the Toxic Substances Control
Act (TSCA), EPA is issuing a final rule
that establishes the process and criteria
that EPA will use to identify chemical
substances as either High-Priority
Substances for risk evaluation, or LowPriority Substances for which risk
evaluations are not warranted at the
time. The final rule describes the
processes for formally initiating the
prioritization process on a selected
candidate, providing opportunities for
public comment, screening the
candidate against certain criteria, and
proposing and finalizing designations of
priority. Prioritization is the initial step
in a new process of existing chemical
substance review and risk management
activity established under TSCA.
DATES: This final rule is effective
September 18, 2017.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0636, is
available at http://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Susanna W. Blair, Immediate Office,
Office of Pollution Prevention and
SUMMARY:

PO 00000

Frm 00029

Fmt 4701

Sfmt 4700

EPA is promulgating this final rule to
establish the process and criteria by
which EPA will identify chemical
substances as either High-Priority
Substances for risk evaluation, or LowPriority Substances for which risk
evaluations are not warranted at the
time.
B. Does this action apply to me?
This final rule does not establish any
requirements on persons or entities
outside of the Agency. This action may,
however, be of interest to entities that
are manufacturing or may manufacture
or import a chemical substance
regulated under TSCA (e.g., entities
identified under North American
Industrial Classification System
(NAICS) codes 325 and 324110). Since
other entities may also be interested, the
Agency has not attempted to describe all
the specific entities and corresponding
NAICS codes for entities that may be
interested in or affected by this action.
C. Why is the Agency taking this action?
This rulemaking is required by TSCA
section 6(b)(1)(A), 15 U.S.C.
2605(b)(1)(A). Prioritization of chemical
substances for further evaluation will
help to ensure that the Agency’s limited
resources are conserved for those
chemical substances most likely to
present risks, thereby furthering EPA’s
overall mission to protect health and the
environment.
D. What is the Agency’s authority for
taking this action?
This final rule is issued pursuant to
the authority in TSCA section 6(b), 15
U.S.C. 2605(b).
E. What are the estimated incremental
impacts of this action?
This final rule establishes the
processes by which EPA intends to
designate chemical substances as either
High or Low-Priority Substances for risk
evaluation. It does not establish any
requirements on persons or entities
outside of the Agency. No incremental

E:\FR\FM\20JYR2.SGM

20JYR2