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and provide no less than a 60-day
comment period, during which time thepublic may submit comment on EPA’s
draft risk evaluation.
(b) Final risk evaluation. (1) EPA willcomplete a risk evaluation for thechemical substance under theconditions of use within the scope ofthe risk evaluation as soon aspracticable, but not later than 3 years
after the date on which the Agency
initiates the risk evaluation.
(2) The Agency may extend thedeadline 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 determinationby the EPA that a chemical substanceunder one or more of the conditions ofuse within the scope of the risk
evaluation presents an unreasonablerisk of injury to health or theenvironment 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 bea final Agency action, effective on thedate of issuance of the order.

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Publically available information.

For each risk evaluation, EPA will
maintain a public docket at http://
www.regulations.gov to provide publicaccess 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, andorders;(c) Any information required to beprovided to the Agency under 15 U.S.C.
2603;(d) A nontechnical summary of therisk evaluation;(e) A list of the studies, with theresults of the studies, considered incarrying out each risk evaluation;(f) The final peer review report,
including the response to peer review
and public comments received during
peer review; andVerDate Sep<11>201419:37 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 PROTECTIONAGENCY40 CFR Part 702

33753

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

[EPA–HQ–OPPT–2016–0636; FRL–9964–24]

SUPPLEMENTARY INFORMATION:

RIN 2070–AK23

I. Executive Summary

Procedures for Prioritization ofChemicals for Risk Evaluation Under
the Toxic Substances Control Act

A. What action is the Agency taking?

AGENCY: Environmental Protection

Agency (EPA).
ACTION: Final rule.
SUMMARY: As required under section

6(b)(1) of the Toxic Substances Control
Act (TSCA), EPA is issuing a final rulethat establishes the process and criteriathat 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 thetime. The final rule describes theprocesses for formally initiating theprioritization process on a selectedcandidate, providing opportunities for
public comment, screening thecandidate against certain criteria, andproposing and finalizing designations ofpriority. Prioritization is the initial stepin 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, isavailable at http://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket) in theEnvironmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Roomis 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

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EPA is promulgating this final rule toestablish the process and criteria bywhich EPA will identify chemical
substances as either High-Priority
Substances for risk evaluation, or LowPriority Substances for which risk
evaluations are not warranted at thetime.
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 thatare manufacturing or may manufacture
or import a chemical substanceregulated under TSCA (e.g., entities
identified under North American
Industrial Classification System(NAICS) codes 325 and 324110). Sinceother entities may also be interested, theAgency has not attempted to describe all
the specific entities and corresponding
NAICS codes for entities that may beinterested 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 thosechemical substances most likely topresent risks, thereby furthering EPA’s
overall mission to protect health and theenvironment.
D. What is the Agency’s authority fortaking this action?
This final rule is issued pursuant tothe 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 theprocesses by which EPA intends todesignate 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

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impacts are therefore anticipated, andconsequently EPA did not estimate
potential incremental impacts from thisaction.
II. Background
A. Statutory Requirements forPrioritization
TSCA section 6(b)(1), as amended by
the Frank R. Lautenberg Chemical
Safety for the 21st Century Act (Pub. L.
114–182), requires EPA to establish, by
rule, a process for prioritizing chemical
substances for risk evaluation.
Specifically, the law requires EPA toestablish ‘‘a risk-based screening
process, including criteria fordesignating chemical substances as
high-priority substances for risk
evaluations or low-priority substances
for which risk evaluations are notwarranted at the time.’’ 15 U.S.C.
2605(b)(1)(A). TSCA sections 6(b)(1)through (3) provide further specificity
on both the process and criteria,
including preferences for certain
chemical substances that EPA must
apply, procedural steps, definitions ofHigh-Priority Substances and LowPriority Substances, and screening
criteria that EPA must consider indesignating a chemical substance as
either a High-Priority Substance or a
Low-Priority Substance. 15 U.S.C.
2605(b)(1)–(3).
EPA published a proposed rule on
January 17, 2017 setting forth the draft
process and criteria (Ref. 1). A detailed
summary of the statutory requirementsfor prioritization, EPA’s methodology
for prioritizing existing chemicals forassessment under the TSCA Work Plan
before enactment of the TSCA
amendments in 2016, and pre-proposal
stakeholder involvement activities andfeedback was presented in the proposedrule.

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B. Interagency Collaboration
EPA is committed to engaging andcollaborating with partner federal
agencies prior to and during theprioritization process. TSCA specificallyauthorizes other federal agencies, at
EPA’s request, to: (1) Make theirservices, personnel, and facilities
available to the Agency, (2) provide
information, data, estimates, andstatistics to the Agency, and (3) grant
EPA access to all information in its
possession as the Agency may
reasonably determine to be necessary forthe administration of the Act. 15 U.S.C.
2625(a). EPA has a number of existingmechanisms already in place tofacilitate collaboration with the
Agency’s federal partners and willcontinue to utilize them. Collaboration

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with other federal agencies is an
important step in identifying chemicals
for prioritization, evaluating risks fromchemicals, and during the risk
management phase, if a chemical use isdetermined to present an unreasonablerisk.
EPA’s collaboration with other federal
agencies prior to and during the riskbased prioritization process gives otheragencies sufficient time to work with
the EPA in identifying any information
about a particular chemical substancethat may be useful for formulating apriority designation for that substance(e.g., conditions of use, exposure
scenarios, etc.). The Agency anticipatesthat it will at times collaborate with theother statutory member agencies of the
TSCA Interagency Testing Committee(ITC), i.e., the Consumer Product Safety
Commission (CPSC), the Council on
Environmental Quality (CEQ),
Department of Commerce, the Food andDrug Administration (FDA), theNational Cancer Institute (NCI), theNational Institute of Environmental
Health Sciences (NIEHS), the National
Institute for Occupational Safety and
Health (NIOSH), the National Science
Foundation (NSF); and the
Occupational Safety and HealthAdministration (OSHA). 15 U.S.C.
2603(e)(2)(A). EPA also expects thatsuch collaboration will extend, whenappropriate, to other federal agency
partners not specifically identified in
TSCA as ITC members, such as the
Agency for Toxic Substances Disease
Registry (ATSDR), the Department of
Defense, the National Aeronautics andSpace Administration (NASA), and the
Office of Management and Budget(OMB). Finally, EPA anticipates that its
collaboration with other federal
agencies may include, whenappropriate, the Small Business
Administration’s Office of Advocacy
and various other agencies to help
facilitate outreach to the business sector.
III. Overview of the Final Rule
This final rule incorporates all of theelements required by statute, some
additional criteria the Agency expects toconsider, clarifications for greatertransparency, and additional procedural
steps to ensure effective
implementation. In response to publiccomments on the proposal, EPA is,among other things: (1) Deleting the preprioritization provisions, andcommitting to further public commenton how the Agency will identify
candidates for prioritization, (2) adding
direct references in the final regulationto acknowledge the Agency’s
commitment to implementing the best
available science and weight of the

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scientific evidence provisions in TSCA,
and (3) adding a number of provisions
to clarify the limited meaning of apriority designation, and committing the
Agency to clear and effective
communication throughout the process.
EPA intends that the provisions of
this rule be severable. In the event that
any individual provision or part of thisrule is invalidated, EPA intends that
this would not render the entire ruleinvalid, and that any individual
provisions that can continue to operate
will be left in place.
IV. Detailed Discussion of Final Ruleand Response to Comments
This unit provides a more in-depth
discussion of the provisions in the final
rule, public comments received on the
proposal, and revisions made to the rulein response. A separate document thatsummarizes all comments submitted on
the proposal and EPA’s responses tothose comments has been prepared andis available in the docket for thisrulemaking (Ref. 2).
A. Policy Objective
The final rule adopts the proposed
codification of the policy objective
without revision. The prioritization
process serves a limited, but important,purpose in the new pipeline of existingchemical review and management tohelp the Agency identify priorities forfurther risk evaluation, to ensure thatthose priorities are grounded in riskbased considerations (which may
include, among other considerations,the nature and extent of any existing
regulation that is intended to mitigate
the hazards of a chemical substance),
and to provide the public and interested
stakeholders with notice and an
opportunity to engage with the Agency
and provide relevant information prior
to the start of the risk evaluation process
on a particular chemical. Through theprocess of prioritization, EPA isultimately making a judgment as towhether or not a particular chemical
substance warrants further assessment.
As a general matter, the primaryobjective of the process should be toguide the Agency towards identifying
the High-Priority Substances that havethe greatest hazard and exposure
potential first. The prioritization process
is not intended to be an exact scoring or
ranking exercise and, consistent withthe proposed rule, EPA is not adopting
such a system in this rule. The precise
order (e.g., ranking or orderingchemicals based on their hazard andexposure potential) in which EPA
identifies High-Priority Substances (allof which must meet the same statutory
definition) should not be allowed to

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slow the Agency’s progress towards
evaluating the risks from those chemical
substances. EPA intends to conserve its
resources and the Agency’s deeper
analytic efforts for the actual risk
evaluation.
Low-Priority Substance designations
serve the same policy objectives.
Chemical substances with low hazard
and/or exposure potential that meet thedefinition of Low-Priority Substances
are taken out of consideration for further
assessment. This gives the public noticeof chemical substances for which thehazard and/or exposure potential isanticipated to be low or nonexistent,
and provides some insight into which
chemical substances are likely not toneed additional evaluation and risk
management under TSCA. As a policy
matter, EPA is committed to making
Low-Priority designations on an ongoingbasis beyond the statutory minimum.
B. Scope of Designations
Consistent with the proposed rule,
EPA will designate the priority of a‘‘chemical substance,’’ as a whole,
under this established process, and will
not limit its designation to a specific use
or subset of uses of a chemical
substance. The statute is clear that EPA
is to designate the priority of the‘‘chemical substance’’—not a conditionof use for a chemical substance. See,e.g., 15 U.S.C. 2605(b)(1)(A) (‘‘theAdministrator shall establish, by rule, arisk-based screening process, including
criteria for designating chemical
substances as high-priority substances
for risk evaluations’’) (emphasis added);2605(b)(1)(B) (definitions of high andlow priority chemical substances.)
Public comments on the proposed
rule were split with respect to this issue.
Some commenters suggested that EPA
should designate a specific use of achemical substance as High-Priority or a
Low-Priority. In general, thesecommenters argued that EPA should
focus only on chemical ‘‘uses of greatest
concern,’’ in order to conserve EPA
resources, raising concern that EPA
would be unable to meet its statutory
deadlines by focusing so broadly. These
commenters argue that nothing in thestatute would foreclose thisinterpretation, and that EPA’s reading of
the statute to require designation of‘‘chemical substances’’ as either High or
Low-Priority is strained. One
commenter pointed to the ‘‘sentinel
exposure’’ provision in the risk
evaluation context as evidence that
Congress envisioned such a partial, usebased approach.
EPA disagrees that the statutory text
would support such an interpretation
for purposes of prioritization. The

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statute directs EPA to makeprioritization determinations on a‘‘chemical substance’’ or ‘‘substance,’’not on ‘‘uses,’’ see, e.g., 15 U.S.C.
2605(b)(1)(A)–(C), and in most cases,
without reference to ‘‘the conditions ofuse.’’ Had Congress intended EPA todesignate individual uses as high or low
priority, the statute would have used a
different phrase or would haveotherwise clearly directed EPA to makedeterminations on high or low priority‘‘uses.’’ The clearest support for EPA’s
interpretation is found in the statutory
definitions of a High and Low Priority
Substance. Note, first, that these aredefinitions of high and low priority‘‘substances.’’ More critically, thedefinitions themselves make clear that
Congress intended EPA to prioritize thechemical as a whole, rather than toprioritize particular uses or subsets ofuses. A High Priority substance is one
that presents ‘‘a potential hazard and apotential route of exposure under theconditions of use;’’ in other words, thestatute directs that the substance is HighPriority based on a potential risk froma single one of the chemical’s various
conditions of use. Similarly, the statutedirects that EPA can only designate asubstance as low priority if ‘‘such
substance does not meet the standard. . . for designating a chemical
substance a high-priority substance.’’
More generally, EPA believes the
addition of the phrase ‘‘the conditions ofuse’’ (emphasis added) was intended tomove the Agency away from its pastpractice of assessing only narrow uses ofa chemical substance, towards a more
inclusive approach to chemical
substance management. Note that thephrase is plural, rather than singular(conditions, not condition). While under
the definition of ‘‘conditions of use,’’the Administrator retains somediscretion to ‘‘determine’’ theconditions of use for each chemical
substance, that discretion is not
unfettered. As EPA interprets thestatute, the Agency is to exercise that
discretion consistent with the objectiveof determining in a risk evaluation
whether a chemical substance—not justindividual uses or other individual
activities—presents an unreasonablerisk. In that regard, EPA will be guided
by its best understanding, based on
legislative text and history, of thecircumstances of manufacture,processing, distribution in commerce,
use and disposal Congress intended
EPA to consider in risk evaluations.
However, this does not mean that inprioritization, EPA will necessarily
consider every activity involving thechemical substance to be a ‘‘condition ofuse.’’ TSCA defines a chemical’s

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33755‘‘conditions of use’’ as ‘‘thecircumstances, 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).
As discussed at greater length in the
final rule addressing procedures forchemical risk evaluation under TSCA
(RIN 2070–AK20), published elsewherein this issue of Federal Register, basedon legislative history, statutory structure
and other evidence of Congressional
intent, EPA has determined that certain
activities generally should not be
considered to be ‘‘conditions of use.’’ 1
Thus early in the prioritization process,
EPA will identify the ‘‘circumstances’’
that constitute the ‘‘conditions of use’’for each chemical substance. A
proposed determination would bepresented for public comment as part ofthe proposed designation of thesubstance as High- or Low-Priority.
Accordingly, those activities that theAdministrator determines fall within
the definition of ‘‘conditions of use’’will be considered during prioritization.
When publishing proposed and finalpriority designations pursuant to 40
CFR 702.9 and 40 CFR 702.11, theAgency expects to identify the
information, analysis and basis used tosupport the designations, as well as the
specific condition(s) of use that were thebasis for a High- or Low-Priority
designation. A chemical substance canonly be designated as a Low-Priority if
the ‘‘conditions of use’’ (as determinedby the Administrator) do not meet thestandard for High-Priority designation.
C. Timeframe
TSCA section 6(b)(1)(C) requires thatthe prioritization process be completed
in no fewer than 9 months and nogreater than 12 months. Accordingly,
the final rule specifies that theprocess—from initiation to final
designation—shall last between 9 and12 months. EPA received no significant
comments on these timeframes, which
are statutorily mandated. However,some commenters requested that EPA
clarify the points of initiation andcompletion. Consistent with theproposal, initiation of the prioritization
process, for purposes of this timeframe,
begins upon publication of a notice in
the Federal Register that identifies achemical substance for prioritization.
Similarly, the prioritization process iscomplete upon publication of a notice
1 In the Risk Evaluation rule published elsewherein this issue of the Federal Register, EPA is
adopting other revisions that are applicable solely
to the risk evaluation process, based on statutory
provisions that are exclusive to risk evaluations.

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in the Federal Register announcing a
final priority designation. The
publication of a notice announcing a
final designation of a chemical as aHigh-Priority Substance simultaneously
initiates a risk evaluation pursuant to
TSCA section 6(b)(4).
As indicated in the proposed rule,
this timeframe serves dual purposes.
The minimum 9-month timeframe
ensures that the general public;
potentially-affected industries; state,tribal, and local governments;
environmental and health nongovernmental organizations; and others
have ample notice of upcoming federal
action on a given chemical substance,and opportunity to engage with EPA
early in the process. The 12-monthmaximum timeframe keeps the existingchemical substances review pipeline ina forward motion, and prevents EPA
from getting mired in analysis before
ever reaching the risk evaluation step.
D. Categories of Chemical Substances
TSCA section 26 provides EPA withauthority to take action on categories ofchemical substances. 15 U.S.C. 2625(c).
‘‘Category of Chemical Substances’’ isdefined at 15 U.S.C. 2625(c)(2)(A). EPA
is including in the final rule several
provisions from the proposal withrespect to categories of chemical
substances, without revision. EPA is
including, as proposed, a statement in
the regulation that nothing in the
subpart shall be construed as alimitation on EPA’s authority to takeaction with respect to categories ofchemical substances. Finally, several
commenters asked for clarification withrespect to how EPA might define acategory of chemical substances. EPA is
not adopting a regulatory definition of acategory, as the term is defined in TSCA
at 15 U.S.C. 2625(c)(2)(A). However,should EPA determine to prioritize acategory of chemical substances, EPA
would describe the basis for such a
determination in the Federal Register
notice published to initiate
prioritization. As discussed elsewherein this preamble, EPA has revised theregulation at 40 CFR 702.7(b) to statethat as part of the initiation notice, EPA
will provide an explanation of therationale for initiating the process on
the chemical substance, thus ensuring
the public has notice and an
opportunity to comment on any
decision to prioritize a category ofchemical substances.
As defined in 15 U.S.C. 2625(c), a
category of chemical substances meansa group of chemical substances themembers of which are similar inmolecular structure, in physical,
chemical or biological properties, in

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use, or in mode of entrance into thehuman body or into the environment, or
the members of which are in some otherway suitable for classification as suchfor purposes of this Act, except thatsuch term does not mean a group ofchemical substances which are grouped
together solely on the basis of their
being new chemical substances.
EPA proposed to include aconsideration of substitutes at thecandidate selection phase. Thisconsideration was deleted from the final
rule for the reasons discussed in Unit
IV(J).
E. Metals and Metal Compounds
A number of commenters expressed
concern that EPA may choose not toapply the March 2007 Framework for
Metals Risk Assessment whenprioritizing metals or metal compounds.
The commenters were concerned thatmetals and metal compounds haveunique attributes that are different fromorganic and organometallic substances,which necessitate special considerations
when assessing their human health andecological risks. TSCA mandates use ofthe ‘‘Framework for Metals Risk
Assessment’’ to account for these
attributes. Commenters’ concerns stemfrom a statement in EPA’s proposed rulethat it would consider ‘‘relevant
considerations’’ from this document ‘‘asappropriate’’ when prioritizing
chemicals.
EPA fully recognizes the special
attributes and behaviors of metals andmetal compounds, and the mandate touse the Framework document. EPA did
not intend the words ‘‘as appropriate’’and ‘‘relevant considerations’’ to suggestthat EPA was seeking to avoid thatmandate or to otherwise diminish thesignificance of those considerations.
Accordingly, EPA revised the final rule
to strike those words and eliminate theconfusion.
However, EPA notes that TSCA does
not contemplate completion of a fullrisk assessment during the prioritization
phase. As the Metals Framework is
intended to guide EPA in conducting arisk assessment on a metal or metalcompound, the phrase ‘‘as appropriate’’
was merely intended to reflect that norisk assessment would be conducted at
this phase, and thus certain sections of
the Framework specific to conducting
risk assessments would not be relevant.
In the context of prioritization, EPA
interprets the Metals Frameworkprovision in TSCA to require EPA totake into account the special attributes
and behaviors of metals and metalcompounds as described in the
Framework document. For example, thedocument’s Key Principles discuss the

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differences between inorganic metals
and organic and organometallic
compounds, and the unique attributes,
properties, issues, and processes
associated with metals and metalcompounds. Nevertheless, to avoid
confusion, EPA has deleted the phrase‘‘as appropriate’’ from the regulation.
F. Chemicals Subject to Prioritization
EPA is adopting these provisions fromthe proposal without revision. Some
commenters encouraged EPA to exclude
certain groups of chemicals fromprioritization altogether, such as new
chemicals recently reviewed under
TSCA section 5 and ‘‘inactive’’chemicals. Congress intended
prioritization to be a public andtransparent process of determining
which chemicals on the TSCA Inventory
deserve further evaluation. EPA does
not believe TSCA allows EPA to simply
exclude chemical substances from thisprocess. Chemical substances that do
not warrant risk evaluation would
instead be proposed as Low-Priority
Substances, and the public given an
opportunity to comment on that
determination through the proceduresin this final rule.
With respect to chemical substances
newly added to the TSCA Inventory
following EPA’s completion of premanufacture review under section 5 of
TSCA (15 U.S.C. 2604), EPA expects
that such chemical substances are not
likely to be selected as early HighPriority candidates in light of the riskrelated determination that the Agency
must make pursuant to TSCA section
5(a)(3). Chemicals that are designated as‘‘inactive’’ pursuant to the Active/
Inactive Inventory rule (RIN 2070–
AK24) are still chemicals substances on
the TSCA Inventory, and therefore
subject to prioritization. Nothing in
TSCA prohibits EPA from initiating theprioritization process on an ‘‘inactive’’chemical substance and ultimately fromdesignating the priority of that chemical
substance. However, similar to chemical
substances newly added to the TSCA
Inventory, such chemicals may be lesslikely to be selected as early HighPriority candidates. Whether or not a
chemical substance is actively
manufactured would generally be
relevant to informing EPA’s exposure
judgments during the prioritization
process.
G. Section 26 Scientific Standards
The proposed rule explained that EPA
did not need to specifically reference orincorporate statutory requirements inthe proposed rule in order for them tohave effect. A number of commenters
opined on EPA’s lack of reference to the

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new scientific standards in section 26 of
TSCA. Some encouraged EPA to broadly
address how the new scientific terms
apply to prioritization decisions/process, and to acknowledge the role ofsection 26 in the prioritization process.
Commenters were split on whether andhow EPA should further define some ofthese terms.
As a matter of practice, EPA has been,
and will continue to be, committed tobasing its decisions on the best available
science and the weight of the scientificevidence. In response to publiccomments on the proposal, EPA has
determined to make a number of
additions to the final rule to ensure thatthe science standards in TSCA are more
explicitly incorporated into theprioritization process. Specifically, thefinal rule states that EPA’s proposed
priority designations under 40 CFR
702.9 and final priority designations
under 40 CFR 702.11 will be consistent
with the scientific standards in 15
U.S.C. 2625(h) and the weight of thescientific evidence in 15 U.S.C. 2625(i).
These changes clarify that EPA’s
proposed and final designations for bothHigh- and Low-Priority Substances will
be consistent with TSCA’s new
requirements in section 26 related tobest available science and weight of thescientific evidence.
H. Definitions
The final rule incorporates a numberof key definitions. As in the proposed
rule, the final rule includes a definitionof High-Priority Substances and LowPriority Substances. High-Priority
Substance means a chemical substancethat EPA determines, without
consideration of costs or other non-riskfactors, may present an unreasonablerisk of injury to health or theenvironment because of a potential
hazard and a potential route of exposure
under the conditions of use, including
an unreasonable risk to potentially
exposed or susceptible subpopulations
identified as relevant by EPA. A LowPriority Substance means a chemical
substance that EPA concludes, based on
information sufficient to establish,
without consideration of costs or othernon-risk factors, does not meet thestandard for a High-Priority Substance.
EPA also incorporated the statutory
definition of conditions of use at 15
U.S.C. 2602(4). 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 further incorporated the statutory
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susceptible subpopulation at 15 U.S.C.
2602(12). Potentially exposed orsusceptible subpopulation means agroup of individuals within the general
population identified by the
Administrator 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 substanceor mixture, such as infants, children,
pregnant women, workers, or theelderly.
Finally, in response to comments thatfavored a definition of ‘‘reasonably
available information,’’ EPA
incorporated the definition proposed in
EPA’s risk evaluation rule with somemodifications to be consistent with thedefinition in the final risk evaluation
rule. In the final rule, reasonably
available information means
information that EPA possesses or canreasonably generate, obtain andsynthesize for use, considering thedeadlines specified in TSCA section
6(b) for prioritization and risk
evaluation. Reasonably available
information includes information in
EPA’s possession that is confidential
business information under 15 U.S.C.
2613. Several commenters encouraged
EPA to take full advantage of its new
information gathering authorities andnot limit the basis of its decisions to‘‘existing’’ information. EPA agrees thatit makes sense to view information thatcan be obtained through testing as‘‘reasonably available’’ in someinstances—especially information thatcan be generated through short-term
testing, where it can be obtained within
the relevant statutory deadlines and theinformation would be of sufficient value
to merit the testing. Thus, the final rule
modifies the definition of ‘‘reasonably
available information’’ to delete theword ‘‘existing.’’ Note that EPA will, as
appropriate, also require longer-term
testing, and at times will need to do so
to more completely consider the hazard
characteristics and exposure pathwaysof a chemical substance. However, EPA
does not think information that could be
generated through such testing should
be viewed as ‘‘reasonably available’’.
Ultimately, EPA will tailor its
information gathering efforts. Further,
the addition of the reference toconfidential business information was
intended to clarify that information in
EPA’s possession that is confidential
business information under 15 U.S.C.
2613 is also ‘‘reasonably available.’’I. Pre-Prioritization Considerations
EPA received a significant number ofcomments regarding the preprioritization phase (§ 702.5 in the

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proposed rule) included in the proposed
rule. As EPA noted in the proposal,
TSCA does not require EPA to articulate
in the prioritization rulemaking its
expected activities before prioritization,
including those related to information
gathering or putting chemicals intosome type of queue for input into theprioritization pipeline. However, in an
attempt to be more transparent about
these expected activities, EPA includedin the proposal some considerations for
identifying both potential High- and
Low-Priority candidates, and general
hazard and exposure considerations.
While commenters generally
supported the concept and importanceof pre-prioritization activities, most took
issue with the level of detail and criteria
in EPA’s proposed rule and the
expected lack of transparency withrespect to EPA’s implementation, andmost expressed a strong desire toincrease public participation andopportunities for comment during the
pre-prioritization phase. A number ofcommenters stated that the Agency’s
proposed pre-prioritization process waslacking sufficient detail, and that they
were not able to provide meaningfulcomment. In short, the details of
implementing pre-prioritization
activities were the subject of widelydiffering, and often irreconcilable viewsby commenters.
For these reasons, EPA does notbelieve it would be appropriate toattempt to finalize a pre-prioritization
process without further discussions
with interested stakeholders. As such,
EPA has determined to defer a final
decision on the proposed preprioritization provisions as part of thisrule, and finalize at this time only theprioritization process required under
TSCA. The Agency will promptly
initiate an additional stakeholder
process, to include an additional publiccomment opportunity addressing EPA
pre-prioritization activities. EPA is fullycommitted to further dialogue on bestpractices for pre-prioritization activities,
and to carrying out these activities in atransparent, science based manner, toensure successful implementation of theprioritization and risk evaluation
processes.
Further, EPA appreciates the timecommenters spent developing andsharing their views on this particularsubject. Commenters should rest
assured that these comments have been
informative to the Agency and will beconsidered as EPA continues toimplement the recent amendments to
TSCA. EPA expects to re-engage thepublic on this matter as early as Fall
2017, and these comments will serve asa solid foundation for those discussions.

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Following the additional stakeholder
process, and in consideration of publiccomments received, EPA will issue anappropriate final action. While it ispremature to determine the outcome ofthis future process, it could foreseeably
result in EPA formally establishing preprioritization procedures in a final
rule—either by first re-proposing, or by
finalizing based on the proposed rule.
Alternatively, for example, EPA may
issue a guidance document that further
describes the pre-prioritization process.
EPA will promptly evaluate publiccomments received in response to theadditional stakeholder process and takethe appropriate next steps. In theinterim, the Agency fully expects tomove forward with prioritizing
chemicals in accordance with theprocedures of the final rule. Indeed,
TSCA compels the Agency to proceedwith designating a certain number ofchemicals as High- or Low-Priority by
December of 2019. 15 U.S.C.
2605(b)(2)(B). Pre-prioritization is not
statutorily mandated, and, as a legal
matter, not a necessary precursor to thedesignation of High- and Low-Priority
substances. Pre-prioritization was
intended to be a phase of expected
activities (e.g., potential candidate
identification, information gathering/
review, etc.) to ensure a smooth process
of moving chemicals through the new
pipeline of prioritization, risk
evaluation, and (where warranted) risk
management. To illustrate, the Agency
could, as a general matter, draw
potential candidates for prioritizationfrom existing Agency resources(including but not limited to, the 2014
update of the TSCA Work Plan for
Chemical Assessments (Ref. 3) and theSafer Chemicals Ingredients List (Ref.
4)). However, until EPA takes final
action on pre-prioritization as discussed
above, the Agency will not follow aformal process that identifies a chemical
as being ‘‘in pre-prioritization.’’J. Information Availability
EPA expects to consider the existence
and availability of risk-related
information on a candidate chemical
substance before initiating theprioritization process. EPA mustcomplete its prioritization process
within 12 months once prioritization
has been initiated for a chemical
substance, and then immediately
initiate a risk evaluation for a HighPriority Substance, and complete therisk evaluation within three years of
initiation. As a general practice, EPA
intends to resolve any concerns it may
have about the sufficiency of
information about a given chemical
substance for purposes of prioritization,

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relative to the considerations in§ 702.9(a), before subjecting thatchemical substance to the prioritization
process. Should EPA identify a critical
data need after the prioritization process
has already begun, it may be difficult or
impossible for the Agency to develop or
acquire the necessary information,
consistent with statutory deadlines forprioritization. Although EPA will notestablish or implement a minimum
information requirement of broader
applicability, the Agency anticipatesthat the types of information that are
helpful to inform and support
prioritization decisions will become
clearer as the Agency gains experience
with the prioritization process while
also allowing for advances in scienceand information gathering.
Commenters argued that EPA should
not overuse its information gathering
authorities for a particular chemical
before that chemical has been identified
as a High-Priority Substance for risk
evaluation. To avoid confusion, EPA has
deleted several references to ensuring
sufficient information for purposes ofrisk evaluation at the prioritization
stage. While EPA has broad authorities
to gather and require generation of
information, EPA did not intend tosuggest that it will routinely use its
information gathering authorities for aparticular chemical without firstevaluating the available information todetermine whether this is necessary.
EPA expects to review and consider thereasonably available existing hazard andexposure-related information, andevaluate whether that information
would be sufficient to allow EPA tocomplete the prioritization process
within the statutory deadlines. To theextent the information is not currently
available or is insufficient, EPA will
determine on a case-by-case basis how
to best proceed to ensure that
information can be developed andcollected, reviewed and incorporated
into analyses and decisions in a timely
manner.
To further clarify this intent, EPA has
modified the final rule to indicate that
EPA generally expects to use a tiered
approach to information gathering. As ageneral matter, a tiered approach to data
gathering first involves a review ofexisting literature and available
information by EPA to determine dataneeds. EPA is also mindful of its
requirements with respect to the
reduction of testing on vertebrate
animals under 15 U.S.C. 2603(h). For
identified data needs, EPA may issue avoluntary call to the public for relevant
information or otherwise engage directlywith stakeholders, followed, as
necessary, by exercise of EPA’s

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authorities under TSCA to require
submission or generation of new data.
K. Candidate Selection
TSCA requires that EPA give
preference to chemical substances listed
in the 2014 update of the TSCA Work
Plan for Chemical Assessments that are
persistent and bioaccumulative; known
human carcinogens; and/or highly toxic.
TSCA section 6(b)(2)(B) further requiresthat 50 percent of all ongoing risk
evaluations be drawn from the 2014
Update to the TSCA Work Plan for
Chemical Assessments, meaning that
EPA will need to draw at least 50
percent of High-Priority Substancecandidates from the same list. By
operation of this statutory directive, all
TSCA Work Plan chemical substances
will eventually be prioritized. These
preferences are incorporated into thefinal rule during candidate selection at
40 CFR 702.5(c), without revision fromthe proposal. Aside from these statutory
preferences, however, TSCA does not
specifically limit how EPA must
ultimately select a chemical substanceto put into the prioritization process.
As described in the proposed rule, inpractice, EPA expects to select for HighPriority Substances those chemicals
with the greatest hazard and exposure
potential first, consistent with thepolicy objectives codified in 40 CFR
702.5(a). EPA has not revised theregulatory text at 40 CFR 702.5(c) toinclude additional preferences.
The proposed rule included astatement that EPA is not required to
select candidates or initiate
prioritization pursuant to 40 CFR 702.9
in any ranked or hierarchical order. EPA
is striking this statement. Some
commenters encouraged EPA to adopt
such a system and EPA is retaining thediscretion to do so by rule in the future.
EPA does not believe the statement in
the proposed rule was necessary or had
any legal effect, since nothing in therule or TSCA requires EPA to
implement an ordering or ranking
system in selecting candidate chemical
substances for prioritization.
The proposed rule included a generalobjective for identifying candidates forHigh-Priority Substances. In response tocomments that EPA more explicitly
recognize Low-Priority designations aspart of the process, the final rule now
includes a general objective for selecting
candidates for Low-Priority, consistent
with the statutory definition for LowPriority Substances. As defined in
TSCA, Low-Priority Substances arethose for which risk evaluation is notwarranted at this time. 15 U.S.C.
2605(b)(1)(A). As described in the final
rule, EPA will seek to identify

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candidates for Low-Priority designation
where the information on hazard andexposure under the conditions of use forthe chemical substance is sufficient toestablish that a risk evaluation is notwarranted to determine whether thechemical substance presents an
unreasonable risk of injury to health or
the environment, including an
unreasonable risk to potentially exposedor susceptible subpopulations identified
as relevant by EPA.
EPA included in its proposed rule ageneral statement that EPA ‘‘may
consider the relative hazard andexposure of potential candidate’s
substitutes’’ in selecting a chemical forprioritization. Some commenters believe
strongly that EPA should not consider
substitutes as part of the prioritization
phase because it is a consideration more
appropriate for the risk management
phase. Others had concern thatconsidering the relative risk of
substitutes had the potential to lead to
unlawful consideration of theavailability of substitutes at this phase—a non-risk factor the commenters assert
is expressly excluded fromconsideration during the prioritization
process. Several commenters expressed
general support for consideration ofsubstitutes to the extent that it could
help to avoid regrettable substitution,and conserve both Agency and industry
time and resources that would result
from inappropriate switches to otherdangerous chemicals. EPA has stricken
the provision in question from the final
rule. EPA agrees that the considerationof alternatives is most appropriately
considered as part of any risk
management rule.

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L. Initiation of Prioritization
The prioritization process officiallybegins, for purposes of triggering the 9
to 12-month statutory timeframe, when
EPA publishes a notice in the Federal
Register identifying a chemical
substance for prioritization. The final
rule includes a new provision clarifyingthat EPA generally expects to provide an
explanation in this notice for why it
chose to initiate the process for theparticular chemical substance (e.g.,whether EPA views this as a potential
candidate for High or Low priority).
This was in response to commenters’
concerns that initiation of theprioritization process could send strong
signals to the public regarding potential
risks, even if certain uses of thatchemical did not prompt the initiationof prioritization. Note that a proposed
priority designation, as EPA clarified in
the final rule, is not a finding of
unreasonable risk by the Agency.

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Publication of the notice in theFederal Register also initiates a 90-day
public comment period. For eachchemical substance, EPA will open adocket to facilitate receipt of publiccomments and access to publicly
available information throughout thisprocess. Interested persons are welcomeand encouraged during this time tosubmit information relevant to thechemical substance. Because TSCA
specifically requires the prioritization
process to be risk-based and EPA’s
determinations to exclude non-riskfactors, relevant information at thisstage is limited to that which is riskrelated.
Although the proposed rule specified
that EPA would publish the results ofthe screening review in this same
notice, EPA’s final rule shifts the timingof the screening review, which will now
occur after the close of this initial 90day public comment period. A numberof commenters expressed concern thatthe proposed rule did not guarantee any
opportunity for public comment prior to
the screening review, and many felt
strongly that the Agency needed toengage the public to inform
prioritization decisions. The shift intiming puts the screening review
squarely within the prioritization
process and affords the public an
opportunity to inform EPA’s screening
review before that review. Thus,
commenters are encouraged to submit
relevant information that may inform
EPA’s screening review. EPA willconsider all relevant information
received during this comment period.
M. Screening Review
Following completion of the initial
90-day public comment period, EPA
will screen the selected candidate
against the specific criteria andconsiderations in TSCA section
6(b)(1)(A). Those criteria andconsiderations are: (1) The chemical
substance’s hazard and exposure
potential; (2) the chemical substance’s
persistence and bioaccumulation; (3)potentially exposed or susceptible
subpopulations; (4) storage of thechemical substance near significant
sources of drinking water; (5) the
chemical substance’s conditions of use
or significant changes in conditions ofuse; and (6) the chemical substance’s
production volume or significant
changes in production volume. The
Agency will develop guidance,
consistent with OMB’s Final Bulletin forAgency Good Guidance Practices (72 FR
3432, January 25, 2007), to describe theimplications of the criteria andconsiderations and to explain how EPA

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generally expects to apply them during
the screening review step.
The final rule also includes anadditional criterion, consistent with theproposal: (7) Other risk-based criteriathat EPA determines to be relevant to
the designation of the chemical
substance’s priority. As explained in the
proposal, this final criterion allows thescreening review to adapt with futurechanges in our understanding of scienceand chemical risks. Should EPA rely on
this criterion to support a proposed
designation, EPA would describe in the
publication of proposed designation thespecific factors considered for suchdesignation, thereby affording the
public notice and an opportunity tocomment on the basis for the proposed
designation under this criterion. The
screening review is not a risk
evaluation, but rather a review ofreasonably available information on thechemical substance that relates to thescreening criteria. EPA expects toreview all sources of relevant
information, consistent with thescientific standards in 15 U.S.C.
2625(h), while conducting the screening
review.
N. Proposed Designation
Based on the results of the screening
review, EPA will propose to designate
the chemical substance as either a HighPriority Substance or Low-Priority
Substance, as those terms are defined in
40 CFR 702.3. In making this proposed
designation, as directed by the statute,
EPA will not consider costs or othernon-risk factors.
The final rule provides that EPA will
publish the proposed designation in theFederal Register, along with an
identification of the information,
analysis and basis used to support a
proposed designation. Pursuant to 15
U.S.C. 2625(j), EPA shall make thisinformation available to the public in
the docket, subject to 15 U.S.C. 2613.
Publication of this notice begins asecond period of public comment for 90
days, during which time the public may
submit comments on EPA’s proposed
designation. EPA will reopen the same
docket opened upon initiation of theprioritization process to facilitate
receipt of comments and information.
Because the supporting documentation
for a proposed High-Priority Substancedesignation is likely to foreshadow what
will go into a scoping document for risk
evaluation, EPA will be particularlyinterested in comments on the accuracyof scope-related information such as thechemical’s ‘‘conditions of use,’’ at thisstep.
In the event of insufficient
information at the proposed designation

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step, the proposed rule required EPA topropose to designate the chemical as aHigh-Priority Substance. A number ofcommenters felt that a ‘‘default’’ toHigh-Priority Substance would be an
unfair result for affected industries and/or irresponsible action by the Agency.
This provision has largely been strickenfrom the final rule, except for thecircumstance that is explicitly requiredin 15 U.S.C. 2505(b)(1), which is now
described in 40 CFR 702.9(e). TSCA
requires that the prioritization processlead to one of two outcomes by the endof the 12-month deadline: A HighPriority Substance designation or a LowPriority Substance designation. 15
U.S.C. 2605(b)(1)(B). On further
consideration, EPA believes the Agency
is charged by the statute, and will beable, to determine which of thesepriority categories each chemical falls
into during the prioritization process,and therefore it is not necessary or
appropriate to establish a default. EPA
notes that the statute specificallyprohibits a default to Low-Priority,
requiring that a Low-Priority Substancedesignation be based on ‘‘information
sufficient to establish’’ that a chemical
substance meets the definition. 15
U.S.C. 2605(b)(1)(B)(ii). There is nocomparable statutory requirement for
High-Priority Substance designations.
15 U.S.C. 2605(b)(1)(B)(i).
In response to a number of concerns
raised by public commenters, EPA is
striking the ‘‘issue preclusion’’provision related to proposed
designations as Low-Priority
Substances, which stated that allcomments that could be raised on theissues in the proposed designation must
be presented during the comment
period, or would be considered waived
and could not form the basis for an
objection or challenge in any
subsequent administrative or judicial
proceeding. Under general principles ofadministrative law, commenters are
required to identify relevant available
information and raise objections that
could be raised during establishedcomment periods, and courts generally
will require commenters to have done
so as a matter of exhaustion ofadministrative remedies. EPA has
concluded that these principles provide
sufficient assurance that commenterswill raise timely objections and provide
timely information and has therefore
decided to strike the proposed
regulatory text.
Although the final rule makes otherclarifications to the ‘‘Proposed Priority
Designation’’ provision, the standard fordesignating High- and Low-Priority
Substances has not changed from the
proposed rule. EPA will prioritize a

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Jkt 241001‘‘chemical substance,’’ and the standard
for a High-Priority Substance (‘‘. . . may
present an unreasonable risk [. . .]because of a potential hazard and apotential route of exposure . . .’’) canbe met by identification of one or morecondition of use that meet that standard.
Conversely, in designating a LowPriority Substance (‘‘. . . based on
sufficient information, such substancedoes not meet the standard for [. . .] ahigh-priority substance . . .’’), TSCA
requires EPA to determine that undernone of the conditions of use, as
determined by the Administrator, does
the chemical substance meet thedefinition of a High-Priority Substance.
O. Final Priority Designation
The last step in the prioritization
process is for EPA to finalize its
designation of a chemical substance as
either a High-Priority Substance or a
Low-Priority Substance. EPA willconsider additional relevant information
received during the proposed
designation step before finalizing apriority designation, excluding any
consideration of costs or other non-riskfactors. The final rule specifies that EPA
will publish a notice of the final priority
designation in the Federal Register,using the same docket that was used forthe initiation and proposal steps.
EPA has included additional
regulatory text in the final rule,
clarifying that EPA would publish an
identification of information, analysis,
and basis used to support the final
designation, as required under TSCA.
Additionally, EPA amended the
proposed rule to provide that EPA
generally expects to identify which
condition(s) of use were the primarybases for the priority designation. Thiswas made in response to some concernsthat a priority designation for achemical substance could send strong
signals to the public regarding potential
risks.
P. Repopulation of High-Priority
Substances
TSCA requires EPA to finalize adesignation for at least one new HighPriority Substance upon completion of arisk evaluation for another chemical
substance, other than a risk evaluationthat was requested by a manufacturer.
Because the timing for the completion ofrisk evaluation and/or the prioritization
process will be difficult to predict, EPA
intends to satisfy this 1-off, 1-on
replacement obligation as follows: In thenotice published in the Federal Register
finalizing the designation of a new
High-Priority Substance, EPA generally
expects to identify the complete or nearcomplete risk evaluation that the new

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High-Priority Substance will replace. So
long as the designation occurs within areasonable time before or after thecompletion of the risk evaluation, thiswill satisfy Congress’ intent while
avoiding unnecessary delay and thelogistical challenges that would be
associated with more perfectly aligninga High-Priority Substance designation
with the completion of a risk evaluation.
A few commenters suggested that EPA
define a ‘‘reasonable time’’ for these
purposes. Commenters expressed
concern that, in the absence of a defined
period of time, a completed risk
evaluation may never be replaced witha new High-Priority Substance, slowing
the pace of EPA’s overall progress
towards reviewing the backlog ofexisting chemicals. EPA has determined
not to include a specific time frame in
the regulation that may be tooprescriptive to implement. However, asa general matter, EPA expects todesignate a new High-Priority Substanceno later than 45 days following
completion of a risk evaluation.
Q. Effect of Final Priority Designation
Final designation of a chemical
substance as a High-Priority Substancerequires EPA to immediately begin arisk evaluation on that chemical
substance. Final designation of achemical substance as a Low-Priority
Substance is a final agency action thatmeans that a risk evaluation of thechemical substance is not warranted at
the time. This does not preclude EPA
from later revising the designation, if
warranted. EPA has added a provisionin the final rule clarifying that a finalpriority designation is neither a findingof unreasonable risk to health or theenvironment, nor a finding of no
unreasonable risk.
A Low-Priority Substance designation
is explicitly subject to judicial review.
15 U.S.C. 2618(a)(1)(C). A High-Priority
Substance designation is not a final
agency action and is not subject tojudicial review. Rather, a High-Priority
Substance designation prompts theinitiation of a risk evaluation. 15 U.S.C.
2605(b)(4). Upon the conclusion of sucha risk evaluation, EPA may determinethat a chemical substance does notpresent an unreasonable risk of injury tohuman health or the environment under
the conditions of use. Such a
determination must be issued in anorder, and is a final agency action
subject to judicial review. 15 U.S.C.
2605(i). If EPA conversely determinesthat a chemical substance presents an
unreasonable risk of injury to humanhealth or the environment under theconditions of use, that determination is
not a final agency action and is not

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subject to judicial review. TSCA
mandates that the Agency must issue arule to apply certain requirements sothat the chemical substance or mixture
no longer presents the unreasonablerisk. 15 U.S.C. 2605(a). Such a final rule
is a final agency action and is subject tojudicial review.

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R. Revision of Designation
TSCA provides that EPA may revise a
final designation of a chemical
substance from a Low-Priority
Substance to a High-Priority Substanceat any time based on information that isreasonably available to the Agency. The
final rule outlines the process the
Agency will take to revise such adesignation. Essentially, the revision
process involves restarting theprioritization process, and applying theprovisions in the same way they would
apply to a chemical that has not beenpreviously prioritized.
TSCA does not require a process forrevising a High-Priority Substance to a
Low-Priority, and the final rule does notprovide for such revision. This is forgood reason. Prioritization serves alimited purpose: To identify chemicals
for further evaluation. Once a chemicalhas been identified as a High-Priority
Substance, the risk evaluation begins,
the priority designation of the chemical
having served its purpose, and EPA iscompelled to complete that risk
evaluation within a statutory 3-year
deadline. Moreover, because the risk
evaluation is already underway at thispoint, EPA believes it would not makesense to revisit whether or not a risk
evaluation is warranted. EPA believes
Congress intended EPA to see the risk
evaluation process through to its
conclusion and to make a finding under
15 U.S.C. 2605(i) that the substancedoes not pose an unreasonable risk, notto revise a priority designation.
S. Small Business OutreachA few commenters recommended that
EPA conduct targeted outreach to small
businesses early in the process ofprioritization to identify impacts tosmall businesses. Commenters suggestthat the small business community
could benefit from backgroundinformation on EPA’s activities, while
EPA could receive valuable input fromrelevant small businesses.
EPA welcomes the opportunity toengage with small businesses that may
use the subject chemical during theprioritization process, particularly
during the two 90-day public comment
periods built into the prioritization
procedural rule, and will provide
current information about these
activities through the Agency’s Web site

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at https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca. EPA
also expects to work closely with its
federal partners at the Small Business
Administration, Office of Advocacy as ameans to engage with the small business
community. TSCA mandates that boththe prioritization and risk evaluation
processes be risk-based. As such, EPA
would be most interested in learningfrom small businesses and otherstakeholders about a particularchemical’s uses, and potential hazards
and exposures. Economic impacts ofany potential future regulation have an
important role during the considerationof risk management measures, if andwhen warranted, but TSCA explicitly
excludes consideration of these impacts
during prioritization and risk evaluation
actions.
V. References
The following is a listing of the
documents that are specificallyreferenced in this document. The docket
includes these documents and otherinformation considered by EPA,
including documents that are referenced
within the documents that are includedin the docket, even if the referenced
document is not physically located in
the docket. For assistance in locatingthese other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. EPA. Procedures for Prioritization ofChemicals for Risk Evaluation Under the
Toxic Substances Control Act; Proposed
Rule. Federal Register (82 FR 4825,
January 17, 2017) (FRL–9957–74).
2. EPA. Procedures for Prioritization ofChemicals for Risk Evaluation under
TSCA: Response to Public Comments;
SAN 5943; RIN 2070–AK23; EPA–HQ–
OPPT–2016–0636. 2017.
3. EPA. TSCA Work Plan for Chemical
Assessments: 2014 Update. October
2014. Available online at: https://www.epa.gov/sites/production/files/
2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
4. EPA. Safer Chemical Ingredients List
(SCIL). Available online at: https://www.epa.gov/saferchoice/saferingredients. See also Master Criteria,
September 2012, Version 2.1, available
online at: https://www.epa.gov/sites/
production/files/2013-12/documents/
dfe_master_criteria_safer_ingredients_
v2_1.pdf.

VI. Statutory and Executive Order
Reviews
Additional information about thesestatutes and Executive Orders can befound at http://www2.epa.gov/lawsregulations/laws-and-executive-orders.

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A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation andRegulatory Review
This action is a significant regulatory
action that was submitted to the Officeof Management and Budget (OMB) for
review under Executive Orders 12866(58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
Any changes made in response to OMB
recommendations have been
documented in the docket. 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 action does not
impose any costs.
B. Paperwork Reduction Act (PRA)
This action does not contain any
information collection activities that
require approval under the PRA, 44
U.S.C. 3501 et seq. This rulemaking
addresses internal EPA operations andprocedures and does not impose any
requirements on the public.
C. Regulatory Flexibility Act (RFA)
I certify under section 605(b) of the
RFA, 5 U.S.C. 601 et seq., that thisaction will not have a significant
economic impact on a substantial
number of small entities. This
rulemaking addresses internal EPA
operations and procedures and does not
impose any requirements on the public,
including 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 noenforceable 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 relationshipbetween the national government andthe states, or on the distribution of
power and responsibilities among thevarious 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

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33762Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Rules and Regulations

the relationship between the Federal
Government and Indian tribes, or on the
distribution of power andresponsibilities between the Federal
Government and Indian tribes. Thus,
Executive Order 13175 does not apply
to this action.
G. Executive Order 13045: Protection ofChildren From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045(62 FR 19885, April 23, 1997) asapplying only to those regulatory
actions that concern environmental
health or safety risks that the EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it does not concern anenvironmental 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 asignificant adverse effect on the supply,
distribution or use of energy. This
rulemaking addresses internal EPA
operations and procedures and does not
impose any requirements on the public.
I. National Technology Transfer andAdvancement Act (NTTAA)

asabaliauskas on DSKBBXCHB2PROD with RULES

J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not establish anenvironmental health or safety standard,
and is therefore not is not subject toenvironmental justice considerations
under Executive Order 12898 (59 FR
7629, February 16, 1994). This
rulemaking addresses internal EPA
operations and procedures and does nothave any impact on human health or theenvironment.
VII. Congressional Review Act (CRA)
This rule is exempt from the CRA, 5
U.S.C. 801 et seq., because it is a ruleof agency organization, procedure orpractice that does not substantiallyaffect the rights or obligations of nonagency parties.

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Environmental protection, Chemical
substances, Chemicals, Hazardous
substances, Health and safety,
Prioritization, Screening, Toxic
substances.
Dated: June 22, 2017.
E. Scott Pruitt,
Administrator.

Therefore, 40 CFR chapter I,
subchapter R, is amended as follows:
PART 702—GENERAL PRACTICESAND PROCEDURES■ 1. The authority citation for part 702

is revised to read as follows:
Authority: 15 U.S.C. 2605 and 2619.
■ 2. Add subpart A to read as follows:

Subpart A—Procedures for Prioritization ofChemical Substances for Risk Evaluation
Sec.
702.1 General provisions.
702.3 Definitions.
702.4 [Reserved]702.5 Candidate selection.
702.7 Initiation of prioritization process.
702.9 Screening review and proposed
priority designation.
702.11 Final priority designation.
702.13 Revision of designation.
702.15 Effect of designation as a lowpriority substance.
702.17 Effect of designation as a highpriority substance.

Subpart A—Procedures forPrioritization of Chemical Substances
for Risk Evaluation§ 702.1

This rulemaking does not involve any
technical standards, and is therefore notsubject to considerations under NTTAA
section 12(d), 15 U.S.C. 272 note.

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List of Subjects in 40 CFR Part 702

General provisions.

(a) Purpose. This regulation
establishes the risk-based screening
process for designating chemical
substances as a High-Priority Substanceor a Low-Priority Substance for risk
evaluation as required under section
6(b) of the Toxic Substances Control
Act, as amended (15 U.S.C. 2605(b)).
(b) Scope of designations. EPA will
make priority designations pursuant tothese procedures for a chemical
substance, not for a specific condition orconditions of uses of a chemical
substance.
(c) Categories of chemical substances.
Nothing in this subpart shall beinterpreted as a limitation on EPA’s
authority under 15 U.S.C. 2625(c) totake action, including the actions
contemplated in this subpart, on acategory of chemical substances.
(d) Prioritization timeframe. The
Agency will publish a final priority
designation for a chemical substance inno fewer than 9 months and no longer
than 1 year following initiation ofprioritization pursuant to § 702.7.

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Sfmt 4700(e) Metals or metal compounds. EPA
will identify priorities for chemical
substances that are metals or metalcompounds in accordance with 15
U.S.C. 2605(b)(2)(E).
(f) Applicability. These regulations do
not apply to any chemical substance forwhich a manufacturer requests a risk
evaluation under 15 U.S.C.
2605(b)(4)(C).
(g) Scientific standards and weight ofthe scientific evidence. EPA’s proposed
priority designations under § 702.9 andfinal priority designations under§ 702.11 will be consistent with thescientific standards provision in 15
U.S.C. 2625(h) and the weight of thescientific evidence provision in 15
U.S.C. 2625(i).
(h) Interagency collaboration. EPA
will consult with other relevant Federal
Agencies during the administration ofthis subpart.
§ 702.3

Definitions.

For purposes of this subpart, thefollowing definitions apply:
Act means the Toxic Substances
Control Act, as amended (15 U.S.C.
2601 et seq.).
Conditions of use means thecircumstances, 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.
High-priority substance means achemical substance that EPA
determines, without consideration of
costs or other non-risk factors, may
present an unreasonable risk of injury tohealth or the environment because of apotential hazard and a potential route of
exposure under the conditions of use,
including an unreasonable risk topotentially exposed or susceptible
subpopulations identified as relevant by
EPA.
Low-priority substance means achemical substance that EPA concludes,
based on information sufficient toestablish, without consideration of costs
or other non-risk factors, does not meetthe standard for a High-Priority
Substance.
Potentially exposed or susceptible
subpopulation means a group ofindividuals within the general
population identified by the
Administrator 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 substanceor mixture, such as infants, children,

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pregnant women, workers, or theelderly.
Reasonably available informationmeans information that EPA possesses
or can reasonably generate, obtain andsynthesize for use, considering thedeadlines specified in 15 U.S.C. 2605(b)for prioritization and risk evaluation.
Information that meets such terms isreasonably available information
whether or not the information is
confidential business information that is
protected from public disclosure under
15 U.S.C. 2613.
§ 702.4[Reserved]§ 702.5

Candidate selection.

(a) General objective. In selecting
candidates for a High-Priority Substancedesignation, it is EPA’s general objective
to select those chemical substances withthe greatest hazard and exposure
potential first, considering reasonably
available information on the relative
hazard and exposure of potential
candidates. In selecting candidates for
Low-Priority Substance designation, it is
EPA’s general objective to select thosechemical substances with hazard and/or
exposure characteristics under theconditions of use such that a risk
evaluation is not warranted at the time
to determine whether the chemical
substance presents an unreasonable riskof injury to health or the environment,
including an unreasonable risk topotentially exposed or susceptible
subpopulations identified as relevant by
EPA.
(b) Available information. EPA
expects to ensure that there isreasonably available information tomeet the deadlines for prioritization
under the Act.
(c) Preferences and TSCA work plan.
In selecting a candidate forprioritization as a High-Priority
Substance, EPA will:(1) Give preference to:(i) Chemical substances that are listed
in the 2014 update of the TSCA Work
Plan for Chemical Assessments as
having a persistence andbioaccumulation score of 3; and(ii) Chemical substances that arelisted in the 2014 update of the TSCA
Work Plan for Chemical Assessmentsthat are known human carcinogens andhave high acute and chronic toxicity;and(2) Identify a sufficient number ofcandidates from the 2014 update of the
TSCA Work Plan for Chemical
Assessments to ensure that, at any given
time, at least 50 percent of risk
evaluations being conducted by EPA are
drawn from that list until all substanceson the list have been designated as

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Jkt 241001

either a High-Priority Substance or LowPriority Substance pursuant to § 702.11.
(d) Purpose. The purpose of thepreferences and criteria in paragraphs(a) through (c) of this section is toinform EPA’s decision whether or not toinitiate the prioritization process
pursuant to § 702.7, and the proposed
designation of the chemical substance as
either a High-Priority Substance or a
Low-Priority Substance pursuant to§ 702.9.
(e) Insufficient information. If EPA
believes it would not have sufficient
information for purposes ofprioritization, EPA generally expects toobtain the information necessary to
inform prioritization prior to initiating
the process pursuant to § 702.9, using
voluntary means of information
gathering and, as necessary, exercising
its authorities under the Act inaccordance with the requirements of 15
U.S.C. 2603, 15 U.S.C. 2607, and 15
U.S.C. 2610. In exercising its authority
under 15 U.S.C. 2603(a)(2), EPA will
identify the need for the information inaccordance with 15 U.S.C. 2603(a)(3).
§ 702.7

Initiation of prioritization process.

(a) EPA generally expects to initiate
the prioritization process for a chemical
substance only when it believes that the
information necessary to prioritize thesubstance is reasonably available.
(b) EPA will initiate prioritization by
publishing a notice in the Federal
Register identifying a chemical
substance for prioritization. EPA will
include a general explanation in thisnotice for why it chose to initiate theprocess on the chemical substance.
(c) The prioritization timeframe in§ 702.1(d) begins upon EPA’s
publication of the notice described inparagraph (b) of this section.
(d) Publication of the notice in theFederal Register pursuant to paragraph(b) of this section will initiate a periodof 90 days during which interested
persons may submit relevant
information on that chemical substance.
Relevant information might include, but
is not limited to, any information that
may inform the screening review
conducted pursuant to § 702.9(a). EPA
will open a separate docket for eachchemical substance to facilitate receipt
of information.
(e) EPA may, in its discretion, extend
the public comment period in paragraph(d) of this section for up to three months
in order to receive or evaluate
information submitted under 15 U.S.C.
2603(a)(2)(B). The length of theextension will be based upon EPA’s
assessment of the time necessary for
EPA to receive and/or evaluate

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33763

information submitted under 15 U.S.C.
2603(a)(2)(B).
§ 702.9 Screening review and proposed
priority designation.

(a) Screening review. Following theclose of the comment period describedin § 702.7(d), including any extension
pursuant to paragraph (e) of that section,
EPA will generally use reasonably
available information to screen thecandidate chemical substance against
the following criteria andconsiderations:(1) The chemical substance’s hazard
and exposure potential;(2) The chemical substance’s
persistence and bioaccumulation;(3) Potentially exposed or susceptible
subpopulations;(4) Storage of the chemical substancenear significant sources of drinking
water;(5) The chemical substance’s
conditions of use or significant changes
in conditions of use;
(6) The chemical substance’s
production volume or significant
changes in production volume; and(7) Other risk-based criteria that EPA
determines to be relevant to thedesignation of the chemical substance’s
priority.
(b) Information sources. In conducting
the screening review in paragraph (a) of
this section, EPA expects to consider
sources of information relevant to thelisted criteria and consistent with thescientific standards provision in 15
U.S.C. 2625(h), including, as
appropriate, sources for hazard andexposure data listed in Appendices A
and B of the TSCA Work Plan
Chemicals: Methods Document(February 2012).
(c) Proposed designation. Based on
the results of the screening review inparagraph (a) of this section, relevant
information received from the public as
described in § 702.7(d), and otherinformation as appropriate andconsistent with 15 U.S.C. 2625(h) and(i), EPA will propose to designate thechemical substance as either a HighPriority Substance or Low-Priority
Substance, along with an identificationof the information, analysis, and basis
used to support the proposed
designation.
(d) Costs and non-risk factors. EPA
will not consider costs or other non-riskfactors in making a proposed priority
designation.
(e) Insufficient information. If
information remains insufficient toenable the proposed designation of thechemical substance as a Low-Priority
Substance after any extension of theinitial public comment period pursuant

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to § 702.7(e), EPA will propose to
designate the chemical substance as aHigh-Priority Substance.
(f) Conditions of use. EPA willpropose to designate a chemical
substance as a High-Priority Substancebased on the proposed conclusion thatthe chemical substance satisfies thedefinition of High-Priority Substance in§ 702.3 under one or more activities that
the Agency determines constituteconditions of use. EPA will propose to
designate a chemical substance as a
Low-Priority Substance based on the
proposed conclusion that the chemical
substance meets the definition of LowPriority Substance in § 702.3 under theactivities that the Agency determines
constitute conditions of use.
(g) Publication. EPA will publish theproposed designation in the Federal
Register, along with an identification of
the information, analysis and basis used
to support a proposed designation, in aform and manner that EPA deems
appropriate, and provide a comment
period of 90 days, during which time
the public may submit comment on
EPA’s proposed designation. EPA will
open a docket to facilitate receipt of
public comment.

Low-Priority Substance consistent with
15 U.S.C. 2625(h) and (i).
(b) EPA will not consider costs orother non-risk factors in making a finalpriority designation.
(c) EPA will publish each finalpriority designation in the Federal
Register, along with an identification of
the information, analysis, and basis
used to support a final designationconsistent with 15 U.S.C. 2625(h), (i)and (j). For High-Priority Substancedesignations, EPA generally expects toindicate which condition(s) of use were
the primary basis for such designations.
(d) As required in 15 U.S.C.
2605(b)(3)(C), EPA will finalize adesignation for at least one High-Priority
Substance for each risk evaluation it
completes, other than a risk evaluationthat was requested by a manufacturer
pursuant to subpart B of this part. The
obligation in 15 U.S.C. 2605(b)(3)(C)will be satisfied by the designation of atleast one High-Priority Substance wheresuch designation specifies the risk
evaluation that the designation
corresponds to, and where thedesignation occurs within a reasonable
time before or after the completion of
the risk evaluation.
§ 702.13§ 702.11

Final priority designation.

asabaliauskas on DSKBBXCHB2PROD with RULES(a) After considering any additional
information collected from the proposed
designation process in § 702.9, asappropriate, EPA will finalize its
designation of a chemical substance as
either a High-Priority Substance or a

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Revision of designation.

EPA may revise a final designation ofa chemical substance from Low-Priority
to High-Priority Substance at any time
based on reasonably available
information. To revise such adesignation, EPA will re-initiate theprioritization process on that chemical

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substance in accordance with § 702.7,
re-screen the chemical substance andpropose a priority designation pursuant
to § 702.9, and finalize the priority
designation pursuant to § 702.11.
§ 702.15 Effect of designation as a lowpriority substance.

Designation of a chemical substanceas a Low-Priority Substance under§ 702.11 means that a risk evaluation of
the chemical substance is not warranted
at the time, but does not preclude EPA
from later revising the designation
pursuant to § 702.13, if warranted.
Designation as a Low-Priority Substanceis not a finding that the chemical
substance does not present an
unreasonable risk, but rather that it does
not meet the High-Priority Substancedefinition.
§ 702.17 Effect of designation as a highpriority substance.

Final designation of a chemical
substance as a High-Priority Substanceunder § 702.11 initiates a risk evaluation
pursuant to subpart B of this part.
Designation as a High-Priority
Substance is not a final agency action
and is not subject to judicial review
until the date of promulgation of theassociated final rule under section 6(a).
Designation as a High-Priority
Substance is not a finding that thechemical substance presents an
unreasonable risk.
[FR Doc. 2017–14325 Filed 7–19–17; 8:45 am]
BILLING CODE 6560–50–P

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