
[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Rules and Regulations]
[Pages 33753-33764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14325]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 702

[EPA-HQ-OPPT-2016-0636; FRL-9964-24]
RIN 2070-AK23


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: 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 Low-Priority 
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 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.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    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 Low-Priority 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

[[Page 33754]]

impacts are therefore anticipated, and consequently EPA did not 
estimate potential incremental impacts from this action.

II. Background

A. Statutory Requirements for Prioritization

    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 to 
establish ``a risk-based screening process, including criteria for 
designating chemical substances as high-priority substances for risk 
evaluations or low-priority substances for which risk evaluations are 
not warranted 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 of High-Priority 
Substances and Low-Priority Substances, and screening criteria that EPA 
must consider in designating 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 requirements for prioritization, EPA's methodology for 
prioritizing existing chemicals for assessment under the TSCA Work Plan 
before enactment of the TSCA amendments in 2016, and pre-proposal 
stakeholder involvement activities and feedback was presented in the 
proposed rule.

B. Interagency Collaboration

    EPA is committed to engaging and collaborating with partner federal 
agencies prior to and during the prioritization process. TSCA 
specifically authorizes other federal agencies, at EPA's request, to: 
(1) Make their services, personnel, and facilities available to the 
Agency, (2) provide information, data, estimates, and statistics to the 
Agency, and (3) grant EPA access to all information in its possession 
as the Agency may reasonably determine to be necessary for the 
administration of the Act. 15 U.S.C. 2625(a). EPA has a number of 
existing mechanisms already in place to facilitate collaboration with 
the Agency's federal partners and will continue to utilize them. 
Collaboration with other federal agencies is an important step in 
identifying chemicals for prioritization, evaluating risks from 
chemicals, and during the risk management phase, if a chemical use is 
determined to present an unreasonable risk.
    EPA's collaboration with other federal agencies prior to and during 
the risk-based prioritization process gives other agencies sufficient 
time to work with the EPA in identifying any information about a 
particular chemical substance that may be useful for formulating a 
priority designation for that substance (e.g., conditions of use, 
exposure scenarios, etc.). The Agency anticipates that it will at times 
collaborate with the other 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 and Drug Administration (FDA), the 
National Cancer Institute (NCI), the National 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 Health Administration (OSHA). 15 
U.S.C. 2603(e)(2)(A). EPA also expects that such collaboration will 
extend, when appropriate, 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 and Space Administration (NASA), and the 
Office of Management and Budget (OMB). Finally, EPA anticipates that 
its collaboration with other federal agencies may include, when 
appropriate, 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 the elements required by 
statute, some additional criteria the Agency expects to consider, 
clarifications for greater transparency, and additional procedural 
steps to ensure effective implementation. In response to public 
comments on the proposal, EPA is, among other things: (1) Deleting the 
pre-prioritization provisions, and committing to further public comment 
on how the Agency will identify candidates for prioritization, (2) 
adding direct references in the final regulation to acknowledge the 
Agency's commitment to implementing the best available science and 
weight of the scientific evidence provisions in TSCA, and (3) adding a 
number of provisions to clarify the limited meaning of a priority 
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 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.

IV. Detailed Discussion of Final Rule and 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 rule in response. A separate document that summarizes all 
comments submitted on the proposal and EPA's responses to those 
comments has been prepared and is available in the docket for this 
rulemaking (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 existing 
chemical review and management to help the Agency identify priorities 
for further risk evaluation, to ensure that those priorities are 
grounded in risk-based 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 the process of prioritization, EPA is ultimately 
making a judgment as to whether or not a particular chemical substance 
warrants further assessment. As a general matter, the primary objective 
of the process should be to guide the Agency towards identifying the 
High-Priority Substances that have the greatest hazard and exposure 
potential first. The prioritization process is not intended to be an 
exact scoring or ranking exercise and, consistent with the proposed 
rule, EPA is not adopting such a system in this rule. The precise order 
(e.g., ranking or ordering chemicals based on their hazard and exposure 
potential) in which EPA identifies High-Priority Substances (all of 
which must meet the same statutory definition) should not be allowed to

[[Page 33755]]

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 the definition of Low-Priority Substances are taken 
out of consideration for further assessment. This gives the public 
notice of chemical substances for which the hazard and/or exposure 
potential is anticipated to be low or nonexistent, and provides some 
insight into which chemical substances are likely not to need 
additional evaluation and risk management under TSCA. As a policy 
matter, EPA is committed to making Low-Priority designations on an 
ongoing basis 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 condition 
of use for a chemical substance. See, e.g., 15 U.S.C. 2605(b)(1)(A) 
(``the Administrator shall establish, by rule, a risk-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 and low 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 a chemical substance as High-Priority or a Low-
Priority. In general, these commenters 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 the statute would foreclose this interpretation, 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, use-based 
approach.
    EPA disagrees that the statutory text would support such an 
interpretation for purposes of prioritization. The statute directs EPA 
to make prioritization 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 of use.'' Had 
Congress intended EPA to designate individual uses as high or low 
priority, the statute would have used a different phrase or would have 
otherwise clearly directed EPA to make determinations 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 are definitions of high and low 
priority ``substances.'' More critically, the definitions themselves 
make clear that Congress intended EPA to prioritize the chemical as a 
whole, rather than to prioritize particular uses or subsets of uses. A 
High Priority substance is one that presents ``a potential hazard and a 
potential route of exposure under the conditions of use;'' in other 
words, the statute directs that the substance is High Priority based on 
a potential risk from a single one of the chemical's various conditions 
of use. Similarly, the statute directs that EPA can only designate a 
substance 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 of use'' (emphasis added) was intended to move the Agency 
away from its past practice of assessing only narrow uses of a chemical 
substance, towards a more inclusive approach to chemical substance 
management. Note that the phrase is plural, rather than singular 
(conditions, not condition). While under the definition of ``conditions 
of use,'' the Administrator retains some discretion to ``determine'' 
the conditions of use for each chemical substance, that discretion is 
not unfettered. As EPA interprets the statute, the Agency is to 
exercise that discretion consistent with the objective of determining 
in a risk evaluation whether a chemical substance--not just individual 
uses or other individual activities--presents an unreasonable risk. In 
that regard, EPA will be guided by its best understanding, based on 
legislative text and history, of the circumstances of manufacture, 
processing, distribution in commerce, use and disposal Congress 
intended EPA to consider in risk evaluations.
    However, this does not mean that in prioritization, EPA will 
necessarily consider every activity involving the chemical substance to 
be a ``condition of use.'' TSCA 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). As discussed at greater length in the 
final rule addressing procedures for chemical risk evaluation under 
TSCA (RIN 2070-AK20), published elsewhere in this issue of Federal 
Register, based on 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 be presented 
for public comment as part of the proposed designation of the substance 
as High- or Low-Priority.
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    \1\ In the Risk Evaluation rule published elsewhere in 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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    Accordingly, those activities that the Administrator determines 
fall within the definition of ``conditions of use'' will be considered 
during prioritization. When publishing proposed and final priority 
designations pursuant to 40 CFR 702.9 and 40 CFR 702.11, the Agency 
expects to identify the information, analysis and basis used to support 
the designations, as well as the specific condition(s) of use that were 
the basis for a High- or Low-Priority designation. A chemical substance 
can only be designated as a Low-Priority if the ``conditions of use'' 
(as determined by the Administrator) do not meet the standard for High-
Priority designation.

C. Timeframe

    TSCA section 6(b)(1)(C) requires that the prioritization process be 
completed in no fewer than 9 months and no greater than 12 months. 
Accordingly, the final rule specifies that the process--from initiation 
to final designation--shall last between 9 and 12 months. EPA received 
no significant comments on these timeframes, which are statutorily 
mandated. However, some commenters requested that EPA clarify the 
points of initiation and completion. Consistent with the proposal, 
initiation of the prioritization process, for purposes of this 
timeframe, begins upon publication of a notice in the Federal Register 
that identifies a chemical substance for prioritization. Similarly, the 
prioritization process is complete upon publication of a notice

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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 
a High-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 non-governmental 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-month maximum timeframe keeps the existing chemical 
substances review pipeline in a 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 with authority to take action on 
categories of chemical substances. 15 U.S.C. 2625(c). ``Category of 
Chemical Substances'' is defined at 15 U.S.C. 2625(c)(2)(A). EPA is 
including in the final rule several provisions from the proposal with 
respect 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 a limitation on EPA's authority to 
take action with respect to categories of chemical substances. Finally, 
several commenters asked for clarification with respect to how EPA 
might define a category of chemical substances. EPA is not adopting a 
regulatory definition of a category, as the term is defined in TSCA at 
15 U.S.C. 2625(c)(2)(A). However, should EPA determine to prioritize a 
category of chemical substances, EPA would describe the basis for such 
a determination in the Federal Register notice published to initiate 
prioritization. As discussed elsewhere in this preamble, EPA has 
revised the regulation at 40 CFR 702.7(b) to state that as part of the 
initiation notice, EPA will provide an explanation of the rationale 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 of chemical substances.
    As defined in 15 U.S.C. 2625(c), a category of chemical substances 
means a group of chemical substances the members of which are similar 
in molecular structure, in physical, chemical or biological properties, 
in use, or in mode of entrance into the human body or into the 
environment, or the members of which are in some other way suitable for 
classification as such for purposes of this Act, except that such term 
does not mean a group of chemical substances which are grouped together 
solely on the basis of their being new chemical substances.
    EPA proposed to include a consideration of substitutes at the 
candidate selection phase. This consideration 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 to 
apply the March 2007 Framework for Metals Risk Assessment when 
prioritizing metals or metal compounds. The commenters were concerned 
that metals and metal compounds have unique attributes that are 
different from organic and organometallic substances, which necessitate 
special considerations when assessing their human health and ecological 
risks. TSCA mandates use of the ``Framework for Metals Risk 
Assessment'' to account for these attributes. Commenters' concerns stem 
from a statement in EPA's proposed rule that it would consider 
``relevant considerations'' from this document ``as appropriate'' when 
prioritizing chemicals.
    EPA fully recognizes the special attributes and behaviors of metals 
and metal compounds, and the mandate to use the Framework document. EPA 
did not intend the words ``as appropriate'' and ``relevant 
considerations'' to suggest that EPA was seeking to avoid that mandate 
or to otherwise diminish the significance of those considerations. 
Accordingly, EPA revised the final rule to strike those words and 
eliminate the confusion.
    However, EPA notes that TSCA does not contemplate completion of a 
full risk assessment during the prioritization phase. As the Metals 
Framework is intended to guide EPA in conducting a risk assessment on a 
metal or metal compound, the phrase ``as appropriate'' was merely 
intended to reflect that no risk 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 Framework provision in TSCA 
to require EPA to take into account the special attributes and 
behaviors of metals and metal compounds as described in the Framework 
document. For example, the document's Key Principles discuss the 
differences between inorganic metals and organic and organometallic 
compounds, and the unique attributes, properties, issues, and processes 
associated with metals and metal compounds. Nevertheless, to avoid 
confusion, EPA has deleted the phrase ``as appropriate'' from the 
regulation.

F. Chemicals Subject to Prioritization

    EPA is adopting these provisions from the proposal without 
revision. Some commenters encouraged EPA to exclude certain groups of 
chemicals from prioritization altogether, such as new chemicals 
recently reviewed under TSCA section 5 and ``inactive'' chemicals. 
Congress intended prioritization to be a public and transparent 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 this process. 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 procedures in this final rule.
    With respect to chemical substances newly added to the TSCA 
Inventory following EPA's completion of pre-manufacture 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 High-Priority 
candidates in light of the risk-related 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 the prioritization process on an 
``inactive'' chemical substance and ultimately from designating the 
priority of that chemical substance. However, similar to chemical 
substances newly added to the TSCA Inventory, such chemicals may be 
less likely to be selected as early High-Priority 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 or incorporate statutory requirements in the proposed rule in 
order for them to have effect. A number of commenters opined on EPA's 
lack of reference to the

[[Page 33757]]

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 of section 26 in the 
prioritization process. Commenters were split on whether and how EPA 
should further define some of these terms.
    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 prioritization process. Specifically, 
the final 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 the scientific evidence in 15 U.S.C. 2625(i). These 
changes clarify that EPA's proposed and final designations for both 
High- and Low-Priority Substances will be consistent with TSCA's new 
requirements in section 26 related to best available science and weight 
of the scientific evidence.

H. Definitions

    The final rule incorporates a number of key definitions. As in the 
proposed rule, the final rule includes a definition of High-Priority 
Substances and Low-Priority Substances. High-Priority Substance means a 
chemical substance that EPA determines, without consideration of costs 
or other non-risk factors, may present an unreasonable risk of injury 
to health or the environment 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 Low-Priority Substance means a 
chemical substance that EPA concludes, based on information sufficient 
to establish, without consideration of costs or other non-risk factors, 
does not meet the standard 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 definition of potentially 
exposed or susceptible subpopulation at 15 U.S.C. 2602(12). Potentially 
exposed or susceptible subpopulation means a group 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 substance or mixture, such as infants, children, 
pregnant women, workers, or the elderly.
    Finally, in response to comments that favored a definition of 
``reasonably available information,'' EPA incorporated the definition 
proposed in EPA's risk evaluation rule with some modifications to be 
consistent with the definition in the final risk evaluation rule. In 
the final rule, reasonably available information means information that 
EPA possesses or can reasonably generate, obtain and synthesize for 
use, considering the deadlines 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 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 generated 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. Thus, the final rule modifies the definition of ``reasonably 
available information'' to delete the word ``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 pathways of 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 to confidential 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 of comments regarding the pre-
prioritization phase (Sec.  702.5 in the 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 into some type of queue for input into the 
prioritization pipeline. However, in an attempt to be more transparent 
about these expected activities, EPA included in 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 importance of 
pre-prioritization activities, most took issue with the level of detail 
and criteria in EPA's proposed rule and the expected lack of 
transparency with respect to EPA's implementation, and most expressed a 
strong desire to increase public participation and opportunities for 
comment during the pre-prioritization phase. A number of commenters 
stated that the Agency's proposed pre-prioritization process was 
lacking sufficient detail, and that they were not able to provide 
meaningful comment. In short, the details of implementing pre-
prioritization activities were the subject of widely differing, and 
often irreconcilable views by commenters.
    For these reasons, EPA does not believe it would be appropriate to 
attempt 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 pre-prioritization provisions 
as part of this rule, and finalize at this time only the prioritization 
process required under TSCA. The Agency will promptly initiate an 
additional stakeholder process, to include an additional public comment 
opportunity addressing EPA pre-prioritization activities. EPA is fully 
committed to further dialogue on best practices for pre-prioritization 
activities, and to carrying out these activities in a transparent, 
science based manner, to ensure successful implementation of the 
prioritization and risk evaluation processes.
    Further, EPA appreciates the time commenters spent developing and 
sharing their views on this particular subject. Commenters should rest 
assured that these comments have been informative to the Agency and 
will be considered as EPA continues to implement the recent amendments 
to TSCA. EPA expects to re-engage the public on this matter as early as 
Fall 2017, and these comments will serve as a solid foundation for 
those discussions.

[[Page 33758]]

    Following the additional stakeholder process, and in consideration 
of public comments received, EPA will issue an appropriate final 
action. While it is premature to determine the outcome of this future 
process, it could foreseeably result in EPA formally establishing pre-
prioritization 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 public 
comments received in response to the additional stakeholder process and 
take the appropriate next steps. In the interim, the Agency fully 
expects to move forward with prioritizing chemicals in accordance with 
the procedures of the final rule. Indeed, TSCA compels the Agency to 
proceed with designating a certain number of chemicals 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 the designation 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 prioritization from 
existing Agency resources (including but not limited to, the 2014 
update of the TSCA Work Plan for Chemical Assessments (Ref. 3) and the 
Safer Chemicals Ingredients List (Ref. 4)). However, until EPA takes 
final action on pre-prioritization as discussed above, the Agency will 
not follow a formal 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 
the prioritization process. EPA must complete its prioritization 
process within 12 months once prioritization has been initiated for a 
chemical substance, and then immediately initiate a risk evaluation for 
a High-Priority Substance, and complete the risk 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, 
relative to the considerations in Sec.  702.9(a), before subjecting 
that chemical 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 for prioritization. Although EPA will not establish or 
implement a minimum information requirement of broader applicability, 
the Agency anticipates that 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 science and 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 of risk evaluation at the 
prioritization stage. While EPA has broad authorities to gather and 
require generation of information, EPA did not intend to suggest that 
it will routinely use its information gathering authorities for a 
particular chemical without first evaluating the available information 
to determine whether this is necessary. EPA expects to review and 
consider the reasonably available existing hazard and exposure-related 
information, and evaluate whether that information would be sufficient 
to allow EPA to complete the prioritization process within the 
statutory deadlines. To the extent 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 
and collected, 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 a general matter, a tiered approach to data 
gathering first involves a review of existing literature and available 
information by EPA to determine data needs. 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 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.

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 
requires that 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 
Substance candidates 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 the final rule 
during candidate selection at 40 CFR 702.5(c), without revision from 
the proposal. Aside from these statutory preferences, however, TSCA 
does not specifically limit how EPA must ultimately select a chemical 
substance to put into the prioritization process.
    As described in the proposed rule, in practice, EPA expects to 
select for High-Priority Substances those chemicals with the greatest 
hazard and exposure potential first, consistent with the policy 
objectives codified in 40 CFR 702.5(a). EPA has not revised the 
regulatory text at 40 CFR 702.5(c) to include additional preferences.
    The proposed rule included a statement 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 the discretion 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 the rule or TSCA requires EPA to 
implement an ordering or ranking system in selecting candidate chemical 
substances for prioritization.
    The proposed rule included a general objective for identifying 
candidates for High-Priority Substances. In response to comments that 
EPA more explicitly recognize Low-Priority designations as part of the 
process, the final rule now includes a general objective for selecting 
candidates for Low-Priority, consistent with the statutory definition 
for Low-Priority Substances. As defined in TSCA, Low-Priority 
Substances are those for which risk evaluation is not warranted at this 
time. 15 U.S.C. 2605(b)(1)(A). As described in the final rule, EPA will 
seek to identify

[[Page 33759]]

candidates for Low-Priority designation where the information on hazard 
and exposure under the conditions of use for the chemical substance is 
sufficient to establish that a risk evaluation is not warranted to 
determine whether the chemical substance presents an unreasonable risk 
of injury to health or the environment, including an unreasonable risk 
to potentially exposed or susceptible subpopulations identified as 
relevant by EPA.
    EPA included in its proposed rule a general statement that EPA 
``may consider the relative hazard and exposure of potential 
candidate's substitutes'' in selecting a chemical for prioritization. 
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 that considering the relative risk of substitutes had the 
potential to lead to unlawful consideration of the availability of 
substitutes at this phase--a non-risk factor the commenters assert is 
expressly excluded from consideration during the prioritization 
process. Several commenters expressed general support for consideration 
of substitutes 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 other dangerous 
chemicals. EPA has stricken the provision in question from the final 
rule. EPA agrees that the consideration of alternatives is most 
appropriately considered as part of any risk management rule.

L. Initiation of Prioritization

    The prioritization process officially begins, 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 clarifying that 
EPA generally expects to provide an explanation in this notice for why 
it chose to initiate the process for the particular 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 the prioritization process could send strong signals to the public 
regarding potential risks, even if certain uses of that chemical did 
not prompt the initiation of prioritization. Note that a proposed 
priority designation, as EPA clarified in the final rule, is not a 
finding of unreasonable risk by the Agency.
    Publication of the notice in the Federal Register also initiates a 
90-day public comment period. For each chemical substance, EPA will 
open a docket to facilitate receipt of public comments and access to 
publicly available information throughout this process. Interested 
persons are welcome and encouraged during this time to submit 
information relevant to the chemical substance. Because TSCA 
specifically requires the prioritization process to be risk-based and 
EPA's determinations to exclude non-risk factors, relevant information 
at this stage is limited to that which is risk-related.
    Although the proposed rule specified that EPA would publish the 
results of the screening review in this same notice, EPA's final rule 
shifts the timing of the screening review, which will now occur after 
the close of this initial 90-day public comment period. A number of 
commenters expressed concern that the proposed rule did not guarantee 
any opportunity for public comment prior to the screening review, and 
many felt strongly that the Agency needed to engage the public to 
inform prioritization decisions. The shift in timing 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 will consider 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 
and considerations in TSCA section 6(b)(1)(A). Those criteria and 
considerations 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 the chemical substance near significant sources of 
drinking water; (5) the chemical substance's conditions of use or 
significant changes in conditions of use; 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 for Agency Good Guidance Practices (72 FR 3432, January 25, 
2007), to describe the implications of the criteria and considerations 
and to explain how EPA generally expects to apply them during the 
screening review step.
    The final rule also includes an additional criterion, consistent 
with the proposal: (7) Other risk-based criteria that EPA determines to 
be relevant to the designation of the chemical substance's priority. As 
explained in the proposal, this final criterion allows the screening 
review to adapt with future changes in our understanding of science and 
chemical risks. Should EPA rely on this criterion to support a proposed 
designation, EPA would describe in the publication of proposed 
designation the specific factors considered for such designation, 
thereby affording the public notice and an opportunity to comment on 
the basis for the proposed designation under this criterion. The 
screening review is not a risk evaluation, but rather a review of 
reasonably available information on the chemical substance that relates 
to the screening criteria. EPA expects to review all sources of 
relevant information, consistent with the scientific 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 High-Priority 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 other non-risk factors.
    The final rule provides that EPA will publish the proposed 
designation in the Federal 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 this 
information available to the public in the docket, subject to 15 U.S.C. 
2613. Publication of this notice begins a second 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 the prioritization process to facilitate receipt of 
comments and information. Because the supporting documentation for a 
proposed High-Priority Substance designation is likely to foreshadow 
what will go into a scoping document for risk evaluation, EPA will be 
particularly interested in comments on the accuracy of scope-related 
information such as the chemical's ``conditions of use,'' at this step.
    In the event of insufficient information at the proposed 
designation

[[Page 33760]]

step, the proposed rule required EPA to propose to designate the 
chemical as a High-Priority Substance. A number of commenters felt that 
a ``default'' to High-Priority Substance would be an unfair result for 
affected industries and/or irresponsible action by the Agency. This 
provision has largely been stricken from the final rule, except for the 
circumstance that is explicitly required in 15 U.S.C. 2505(b)(1), which 
is now described in 40 CFR 702.9(e). TSCA requires that the 
prioritization process lead to one of two outcomes by the end of the 
12-month deadline: A High-Priority Substance designation or a Low-
Priority Substance designation. 15 U.S.C. 2605(b)(1)(B). On further 
consideration, EPA believes the Agency is charged by the statute, and 
will be able, to determine which of these priority 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 specifically prohibits a default to Low-Priority, requiring 
that a Low-Priority Substance designation 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 no comparable 
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 all comments 
that could be raised on the issues 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 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.
    Although the final rule makes other clarifications to the 
``Proposed Priority Designation'' provision, the standard for 
designating High- and Low-Priority Substances has not changed from the 
proposed rule. EPA will prioritize a ``chemical substance,'' and the 
standard for a High-Priority Substance (``. . . may present an 
unreasonable risk [. . .] because of a potential hazard and a potential 
route of exposure . . .'') can be met by identification of one or more 
condition of use that meet that standard. Conversely, in designating a 
Low-Priority Substance (``. . . based on sufficient information, such 
substance does not meet the standard for [. . .] a high-priority 
substance . . .''), TSCA requires EPA to determine that under none of 
the conditions of use, as determined by the Administrator, does the 
chemical substance meet the definition 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 will consider additional 
relevant information received during the proposed designation step 
before finalizing a priority designation, excluding any consideration 
of costs or other non-risk factors. 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 for the 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 
primary bases for the priority designation. This was made in response 
to some concerns that a priority designation for a chemical substance 
could send strong signals to the public regarding potential risks.

P. Repopulation of High-Priority Substances

    TSCA requires EPA to finalize a designation for at least one new 
High-Priority Substance upon completion of a risk evaluation for 
another chemical substance, other than a risk evaluation that was 
requested by a manufacturer. Because the timing for the completion of 
risk 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 the notice published in the Federal Register finalizing 
the designation of a new High-Priority Substance, EPA generally expects 
to identify the complete or near-complete risk evaluation that the new 
High-Priority Substance will replace. So long as the designation occurs 
within a reasonable time before or after the completion of the risk 
evaluation, this will satisfy Congress' intent while avoiding 
unnecessary delay and the logistical challenges that would be 
associated with more perfectly aligning a 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 with a new High-Priority Substance, slowing the pace of EPA's 
overall progress towards reviewing the backlog of existing chemicals. 
EPA has determined not to include a specific time frame in the 
regulation that may be too prescriptive to implement. However, as a 
general matter, EPA expects to designate a new High-Priority Substance 
no 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 
Substance requires EPA to immediately begin a risk evaluation on that 
chemical substance. Final designation of a chemical substance as a Low-
Priority Substance is a final agency action that means that a risk 
evaluation of the chemical substance is not warranted at the time. This 
does not preclude EPA from later revising the designation, if 
warranted. EPA has added a provision in the final rule clarifying that 
a final priority designation is neither a finding of unreasonable risk 
to health or the environment, 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 to judicial 
review. Rather, a High-Priority Substance designation prompts the 
initiation of a risk evaluation. 15 U.S.C. 2605(b)(4). Upon the 
conclusion of such a risk evaluation, EPA may determine that a chemical 
substance does not present an unreasonable risk of injury to human 
health or the environment under the conditions of use. Such a 
determination must be issued in an order, and is a final agency action 
subject to judicial review. 15 U.S.C. 2605(i). If EPA conversely 
determines that a chemical substance presents an unreasonable risk of 
injury to human health or the environment under the conditions of use, 
that determination is not a final agency action and is not

[[Page 33761]]

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

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 Substance at 
any time based on information that is reasonably available to the 
Agency. The final rule outlines the process the Agency will take to 
revise such a designation. Essentially, the revision process involves 
restarting the prioritization process, and applying the provisions in 
the same way they would apply to a chemical that has not been 
previously prioritized.
    TSCA does not require a process for revising a High-Priority 
Substance to a Low-Priority, and the final rule does not provide for 
such revision. This is for good reason. Prioritization serves a limited 
purpose: To identify chemicals for further evaluation. Once a chemical 
has been identified as a High-Priority Substance, the risk evaluation 
begins, the priority designation of the chemical having served its 
purpose, and EPA is compelled to complete that risk evaluation within a 
statutory 3-year deadline. Moreover, because the risk evaluation is 
already underway at this point, EPA believes it would not make sense 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 
substance does not pose an unreasonable risk, not to revise a priority 
designation.

S. Small Business Outreach

    A few commenters recommended that EPA conduct targeted outreach to 
small businesses early in the process of prioritization to identify 
impacts to small businesses. Commenters suggest that the small business 
community could benefit from background information on EPA's 
activities, while EPA could receive valuable input from relevant small 
businesses.
    EPA welcomes the opportunity to engage with small businesses that 
may use the subject chemical during the prioritization 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 at 
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca. EPA 
also expects to work closely with its federal partners at the Small 
Business Administration, Office of Advocacy as a means to engage with 
the small business community. TSCA mandates that both the 
prioritization and risk evaluation processes be risk-based. As such, 
EPA would be most interested in learning from small businesses and 
other stakeholders about a particular chemical's uses, and potential 
hazards and exposures. Economic impacts of any potential future 
regulation have an important role during the consideration of risk 
management measures, if and when 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 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. EPA. Procedures for Prioritization of Chemicals 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 of Chemicals 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/safer-ingredients. 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 these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/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). 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 and procedures 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 this action 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 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

[[Page 33762]]

the relationship between the Federal Government and Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes. Thus, Executive Order 13175 does not 
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 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. This rulemaking addresses internal EPA operations and 
procedures and does not impose any requirements on the public.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking 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 is not subject to environmental justice 
considerations under Executive Order 12898 (59 FR 7629, February 16, 
1994). This rulemaking addresses internal EPA operations and procedures 
and does not have any impact on human health or the environment.

VII. Congressional Review Act (CRA)

    This rule is exempt from the CRA, 5 U.S.C. 801 et seq., because it 
is a rule of agency organization, procedure or practice that does not 
substantially affect the rights or obligations of non-agency parties.

List of Subjects in 40 CFR Part 702

    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 PRACTICES AND PROCEDURES

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

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


0
2. Add subpart A to read as follows:
Subpart A--Procedures for Prioritization of Chemical 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 low-priority substance.
702.17 Effect of designation as a high-priority substance.

Subpart A--Procedures for Prioritization of Chemical Substances for 
Risk Evaluation


Sec.  702.1  General provisions.

    (a) Purpose. This regulation establishes the risk-based screening 
process for designating chemical substances as a High-Priority 
Substance or 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 to these procedures for a chemical substance, not for a 
specific condition or conditions of uses of a chemical substance.
    (c) Categories of chemical substances. Nothing in this subpart 
shall be interpreted as a limitation on EPA's authority under 15 U.S.C. 
2625(c) to take action, including the actions contemplated in this 
subpart, on a category of chemical substances.
    (d) Prioritization timeframe. The Agency will publish a final 
priority designation for a chemical substance in no fewer than 9 months 
and no longer than 1 year following initiation of prioritization 
pursuant to Sec.  702.7.
    (e) Metals or metal compounds. EPA will identify priorities for 
chemical substances that are metals or metal compounds in accordance 
with 15 U.S.C. 2605(b)(2)(E).
    (f) Applicability. These regulations do not apply to any chemical 
substance for which a manufacturer requests a risk evaluation under 15 
U.S.C. 2605(b)(4)(C).
    (g) Scientific standards and weight of the scientific evidence. 
EPA's proposed priority designations under Sec.  702.9 and final 
priority designations under Sec.  702.11 will be consistent with the 
scientific standards provision in 15 U.S.C. 2625(h) and the weight of 
the scientific evidence provision in 15 U.S.C. 2625(i).
    (h) Interagency collaboration. EPA will consult with other relevant 
Federal Agencies during the administration of this subpart.


Sec.  702.3  Definitions.

    For purposes of this subpart, the following definitions apply:
    Act means the Toxic Substances Control Act, as amended (15 U.S.C. 
2601 et seq.).
    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.
    High-priority substance means a chemical substance that EPA 
determines, without consideration of costs or other non-risk factors, 
may present an unreasonable risk of injury to health or the environment 
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.
    Low-priority substance means a chemical substance that EPA 
concludes, based on information sufficient to establish, without 
consideration of costs or other non-risk factors, does not meet the 
standard for a High-Priority Substance.
    Potentially exposed or susceptible subpopulation means a group 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 substance or mixture, such 
as infants, children,

[[Page 33763]]

pregnant women, workers, or the elderly.
    Reasonably available information means information that EPA 
possesses or can reasonably generate, obtain and synthesize for use, 
considering the deadlines specified in 15 U.S.C. 2605(b) for 
prioritization and risk evaluation. Information that meets such terms 
is reasonably available information whether or not the information is 
confidential business information that is protected from public 
disclosure under 15 U.S.C. 2613.


Sec.  702.4  [Reserved]


Sec.  702.5  Candidate selection.

    (a) General objective. In selecting candidates for a High-Priority 
Substance designation, it is EPA's general objective to select those 
chemical substances with the 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 those chemical substances with hazard and/or exposure 
characteristics under the conditions of use such that a risk evaluation 
is not warranted at the time to determine whether the chemical 
substance presents an unreasonable risk of injury to health or the 
environment, including an unreasonable risk to potentially exposed or 
susceptible subpopulations identified as relevant by EPA.
    (b) Available information. EPA expects to ensure that there is 
reasonably available information to meet the deadlines for 
prioritization under the Act.
    (c) Preferences and TSCA work plan. In selecting a candidate for 
prioritization 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 and 
bioaccumulation score of 3; and
    (ii) Chemical substances that are listed in the 2014 update of the 
TSCA Work Plan for Chemical Assessments that are known human 
carcinogens and have high acute and chronic toxicity; and
    (2) Identify a sufficient number of candidates 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 substances on the list have been 
designated as either a High-Priority Substance or Low-Priority 
Substance pursuant to Sec.  702.11.
    (d) Purpose. The purpose of the preferences and criteria in 
paragraphs (a) through (c) of this section is to inform EPA's decision 
whether or not to initiate the prioritization process pursuant to Sec.  
702.7, and the proposed designation of the chemical substance as either 
a High-Priority Substance or a Low-Priority Substance pursuant to Sec.  
702.9.
    (e) Insufficient information. If EPA believes it would not have 
sufficient information for purposes of prioritization, EPA generally 
expects to obtain the information necessary to inform prioritization 
prior to initiating the process pursuant to Sec.  702.9, using 
voluntary means of information gathering and, as necessary, exercising 
its authorities under the Act in accordance 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 in accordance with 15 U.S.C. 2603(a)(3).


Sec.  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 the substance 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 this notice for why it chose 
to initiate the process on the chemical substance.
    (c) The prioritization timeframe in Sec.  702.1(d) begins upon 
EPA's publication of the notice described in paragraph (b) of this 
section.
    (d) Publication of the notice in the Federal Register pursuant to 
paragraph (b) of this section will initiate a period of 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 Sec.  702.9(a). EPA will open a separate docket 
for each chemical 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 the extension will be based upon EPA's 
assessment of the time necessary for EPA to receive and/or evaluate 
information submitted under 15 U.S.C. 2603(a)(2)(B).


Sec.  702.9  Screening review and proposed priority designation.

    (a) Screening review. Following the close of the comment period 
described in Sec.  702.7(d), including any extension pursuant to 
paragraph (e) of that section, EPA will generally use reasonably 
available information to screen the candidate chemical substance 
against the following criteria and considerations:
    (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 substance near 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 
the designation 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 the listed criteria and consistent with the 
scientific standards provision in 15 U.S.C. 2625(h), including, as 
appropriate, sources for hazard and exposure 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 in paragraph (a) of this section, relevant information received 
from the public as described in Sec.  702.7(d), and other information 
as appropriate and consistent with 15 U.S.C. 2625(h) and (i), EPA will 
propose to designate the chemical substance as either a High-Priority 
Substance or Low-Priority Substance, along with an identification of 
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-risk factors in making a proposed priority designation.
    (e) Insufficient information. If information remains insufficient 
to enable the proposed designation of the chemical substance as a Low-
Priority Substance after any extension of the initial public comment 
period pursuant

[[Page 33764]]

to Sec.  702.7(e), EPA will propose to designate the chemical substance 
as a High-Priority Substance.
    (f) Conditions of use. EPA will propose to designate a chemical 
substance as a High-Priority Substance based on the proposed conclusion 
that the chemical substance satisfies the definition of High-Priority 
Substance in Sec.  702.3 under one or more activities that the Agency 
determines constitute conditions 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 Low-
Priority Substance in Sec.  702.3 under the activities that the Agency 
determines constitute conditions of use.
    (g) Publication. EPA will publish the proposed designation in the 
Federal Register, along with an identification of the information, 
analysis and basis used to support a proposed designation, in a form 
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.


Sec.  702.11  Final priority designation.

    (a) After considering any additional information collected from the 
proposed designation process in Sec.  702.9, as appropriate, EPA will 
finalize its designation of a chemical substance as either a High-
Priority Substance or a Low-Priority Substance consistent with 15 
U.S.C. 2625(h) and (i).
    (b) EPA will not consider costs or other non-risk factors in making 
a final priority designation.
    (c) EPA will publish each final priority designation in the Federal 
Register, along with an identification of the information, analysis, 
and basis used to support a final designation consistent with 15 U.S.C. 
2625(h), (i) and (j). For High-Priority Substance designations, EPA 
generally expects to indicate 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 a 
designation for at least one High-Priority Substance for each risk 
evaluation it completes, other than a risk evaluation that 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 at least one High-Priority Substance where such 
designation specifies the risk evaluation that the designation 
corresponds to, and where the designation occurs within a reasonable 
time before or after the completion of the risk evaluation.


Sec.  702.13  Revision of designation.

    EPA may revise a final designation of a chemical substance from 
Low-Priority to High-Priority Substance at any time based on reasonably 
available information. To revise such a designation, EPA will re-
initiate the prioritization process on that chemical substance in 
accordance with Sec.  702.7, re-screen the chemical substance and 
propose a priority designation pursuant to Sec.  702.9, and finalize 
the priority designation pursuant to Sec.  702.11.


Sec.  702.15  Effect of designation as a low-priority substance.

    Designation of a chemical substance as a Low-Priority Substance 
under Sec.  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 Sec.  702.13, if warranted. 
Designation as a Low-Priority Substance is not a finding that the 
chemical substance does not present an unreasonable risk, but rather 
that it does not meet the High-Priority Substance definition.


Sec.  702.17  Effect of designation as a high-priority substance.

    Final designation of a chemical substance as a High-Priority 
Substance under Sec.  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 the associated final rule under section 6(a). 
Designation as a High-Priority Substance is not a finding that the 
chemical substance presents an unreasonable risk.

[FR Doc. 2017-14325 Filed 7-19-17; 8:45 am]
BILLING CODE 6560-50-P


