Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act, 4825-4837 [2017-00051]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4825-4837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00051]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 702

[EPA-HQ-OPPT-2016-0636; FRL-9957-74]
RIN 2070-AK23


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: As required under section 6(b)(1) of the Toxic Substances 
Control Act (TSCA), EPA is proposing to establish a risk-based 
screening 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 proposed rule describes the processes for identifying 
potential candidates for prioritization, selecting a candidate, 
screening that candidate against certain criteria, formally initiating 
the prioritization process, providing opportunities for public comment, 
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 recent amendments 
to TSCA.

DATES: Comments must be received on or before March 20, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0636, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Ryan Schmit, Immediate Office, 
Office of Chemical Safety and Pollution Prevention, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (202) 564-0610; email address: 
schmit.ryan@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. Does this action apply to me?

    This proposed rule does not propose to establish any requirements 
on persons or entities outside of the Agency. This action may, however, 
be of interest to entities that are or may manufacture or import a 
chemical substance regulated under TSCA (e.g., entities identified 
under North American Industrial Classification System (NAICS) codes 325 
and 324110). Since other entities may also be interested, the Agency 
has not attempted to describe all the specific entities and 
corresponding NAICS codes for entities that may be interested in or 
affected by this action.

B. What action is the agency taking?

    EPA is proposing to establish the internal processes 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.

C. Why is the agency taking this action?

    This rulemaking is required by TSCA section 6(b)(1)(A). 
Prioritization of chemical substances for further evaluation will 
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?

    EPA is proposing this rule pursuant to the authority in TSCA 
section 6(b), 15 U.S.C. 2605(b). See also the discussion in Units II.A 
and B.

E. What are the estimated incremental impacts of this action?

    This is a proposed rule that would establish the processes by which 
EPA intends to designate chemical substances as either High or Low-
Priority Substances for risk evaluation. It would not establish any 
requirements on persons or entities outside of the Agency. EPA did not, 
therefore, estimate potential incremental impacts from this action.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that

[[Page 4826]]

you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then 
identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

II. Background

A. Recent Amendments to TSCA

    On June 22, 2016, the President signed into law the ``Frank R. 
Lautenberg Chemical Safety for the 21st Century Act'' (Pub. L. 114-
182), which imposed sweeping reforms to TSCA. The bill received broad 
bipartisan support in the U.S. House of Representatives and Senate, and 
its passage was heralded as the most significant update to an 
environmental law in over 20 years. The amendments give EPA improved 
authority to take actions to protect people and the environment from 
the effects of dangerous chemical substances. Additional information on 
the new law is available on EPA's Web site at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.
    When TSCA was originally enacted in 1976, it established an EPA-
administered health and safety review process for new chemical 
substances prior to allowing their entry into the marketplace. However, 
tens of thousands of chemical substances in existence at that time were 
``grandfathered in'' with no requirement for EPA to ever evaluate their 
risks to health or the environment. The absence of a review requirement 
or deadlines for action, coupled with a burdensome statutory standard 
for taking risk management action on existing chemical substances, 
resulted in very few chemical substances ever being assessed for safety 
by EPA, and even fewer subject to restrictions to address identified 
risks.
    One of the key features of the new law is the requirement that EPA 
now systematically prioritize and assess existing chemical substances, 
and manage identified risks. Through a combination of new authorities, 
a risk-based safety standard, mandatory deadlines for action, and 
minimum throughput requirements, TSCA effectively creates a 
``pipeline'' by which EPA will conduct existing chemical substances 
review and management. This new pipeline--from prioritization to risk 
evaluation to risk management (when warranted)--is intended to drive 
steady forward progress on the backlog of existing chemical substances 
left largely unaddressed by the original law. Prioritization is the 
initial step in this process.

B. Statutory Requirements for Prioritization

    TSCA section 6(b)(1) requires EPA to establish, by rule, the 
process and criteria 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.'' 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, the 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 High-Priority Substances or Low-Priority 
Substances. The statutory requirements related to prioritization are 
described in further detail in this unit.
    1. Prioritization Steps. Based on TSCA sections 6(b)(1) through 
(3), EPA is proposing to include four steps or phases in 
prioritization: (1) Pre-Prioritization, (2) Initiation, (3) Proposed 
Designation, and (4) Final Designation. During the Pre-Prioritization 
phase, EPA is proposing to apply the statutory preferences in TSCA 
section 6(b)(2), along with other criteria, to narrow the pool of 
potential candidates, and identify a single chemical substance (or 
category of chemical substances) to screen against the statutory 
criteria in TSCA section 6(b)(1)(A). Aside from the statutory 
preferences listed, the law does not direct or limit EPA in how it is 
to ultimately select a chemical substance on which to initiate 
prioritization, requiring only that the process be ``risk-based.'' At 
the Initiation step, EPA must announce a candidate chemical substance 
and give the public a 90-day comment period to submit relevant 
information. 15 U.S.C. 2605(b)(1)(C)(i). At the Proposed Designation 
step, EPA must propose to designate a chemical substance as either a 
High-Priority Substance or a Low-Priority Substance, publish the 
proposed designation and the information, analysis, and basis used to 
make the designation, and take public comment a second time for 90 
days. 15 U.S.C. 2605(b)(1)(C)(ii). At Final Designation, EPA must 
either finalize a High-Priority Substance designation and initiate a 
risk evaluation, or finalize a Low-Priority Substance designation in 
which case it will not conduct a risk evaluation on the chemical 
substance unless and until information leads EPA to revisit that 
priority designation. 15 U.S.C. 2605(b)(3)(A) and (B).
    2. Screening criteria and statutory preferences. The statute 
defines a High-Priority Substance as one that the Administrator 
concludes, 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 the 
Administrator. 15 U.S.C. 2605(b)(1)(B)(i). Conversely, the law 
specifies that a Low-Priority Substance is one that the Administrator 
concludes, based on information sufficient to establish, without 
consideration of costs or other non-risk factors, does not meet the 
standard for designating a chemical substance a High-Priority 
Substance. 15 U.S.C. 2605(b)(1)(B)(ii).
    In designating the priority of a chemical substance, EPA must 
screen a candidate chemical substance against certain criteria 
specified in TSCA section 6(b)(1)(A). These include the hazard and 
exposure potential of the chemical substance (e.g., persistence and 
bioaccumulation, potentially exposed or susceptible subpopulations, and 
storage near significant sources of drinking water), the conditions of 
use or significant changes in the conditions of use of the chemical 
substance, and the volume or significant changes in the volume of the 
chemical substance manufactured or processed. EPA interprets 
``significant changes in'' conditions of use to have relevance 
primarily in the context of revising a priority designation. With 
respect to an initial prioritization decision, any changes in use that 
have occurred in the past would already be captured by the concept of 
``conditions of use,'' as defined in TSCA section 3.

[[Page 4827]]

    The results of this screen will help inform EPA's proposed priority 
designation. However, given that the statutory deadlines are triggered 
at the initiation of prioritization, and that EPA will want to have a 
good understanding of the chemical substance before triggering those 
deadlines, EPA will consider these screening criteria earlier in the 
process. As discussed in more detail in Unit III., EPA is therefore 
proposing to include the screening review in the rule as part of the 
pre-prioritization phase.
    In designating High-Priority Substances, EPA is to give preference 
to chemical substances that are listed in the 2014 Update of the TSCA 
Work Plan for Chemical Assessments (Ref. 1) that: (1) Have persistence 
and bioaccumulation scores of 3; and (2) are known human carcinogens 
and have high acute and chronic toxicity. 15 U.S.C. 2605(b)(2)(D). The 
law further requires that 50% of all ongoing risk evaluations be drawn 
from the 2014 Update to the TSCA Work Plan for Chemical Assessments, 
meaning that, at least at the outset of the program, EPA will need to 
draw at least 50% of High-Priority Substance designations from the same 
list. 15 U.S.C. 2605(b)(2)(B).
    3. Metals and metal compounds. When prioritizing metals or metal 
compounds, EPA must use the March 2007 Framework for Metals Risk 
Assessment of the Office of the Science Advisor (Ref. 2) (or a 
successor document that addresses appropriate considerations for 
conducting a risk assessment on a metal or metal compound and is peer 
reviewed by the Science Advisory Board). 15 U.S.C. 2605(b)(2)(E). 
However, during the prioritization process, EPA will not be conducting 
chemical risk assessments; and, consequently, much of this guidance 
will not be directly relevant. EPA interprets this provision to ensure 
that the analysis and considerations during the prioritization process 
take into account the special attributes and behaviors of metals and 
metal compounds that are relevant to judgments of risk. For example, 
this might include consideration of the document's Key Principles that 
differentiate inorganic metals and metal compounds from organic and 
organometallic compounds, and their unique attributes, properties, 
issues, and processes. Because EPA will not conduct risk assessments on 
metals or metal compounds for purposes of prioritization, EPA will not 
refer to sections that provide guidance on how to incorporate the Key 
Principles into risk assessments.
    4. Timeframe. TSCA requires that the prioritization process last 
between nine and twelve months. 15 U.S.C. 2605(b)(1)(C). This timeframe 
takes on particular significance, given that the statute does not 
authorize EPA to ``pause'' or delay the prioritization once it has been 
initiated, and that a final High-Priority Substance designation results 
in the chemical substance moving immediately into a risk evaluation 
process that must be generally completed within three years. 15 U.S.C. 
2605(b)(4)(G).
    5. Opportunities for public participation. As already mentioned, 
TSCA requires EPA to provide two 90-day public comment periods during 
prioritization--one following initiation, and a second following a 
proposed designation. 15 U.S.C. 2605(b)(1)(C)(i) and (ii). TSCA further 
requires that EPA include a process for extending the comment deadline 
for up to three months in order to receive or evaluate information 
coming from a TSCA section 4 test order. 15 U.S.C. 2605(b)(1)(C)(iii). 
These public comment periods, coupled with the nine month minimum 
timeframe for prioritization, ensure that the public will be on notice 
of EPA's intention to further evaluate a chemical's risks and will have 
opportunity to engage early in the process before the risk evaluation 
has started.
    6. Default to High-Priority Substance Designation. If, after 
prioritization has been initiated, the public has been given an 
opportunity to submit relevant information, and EPA has extended the 
comment period pursuant to TSCA section 6(b)(1)(C)(iii) in order to 
receive or evaluate additional information, EPA determines that the 
available information is insufficient to enable the designation of the 
chemical substance as a Low-Priority Substance, the statute requires 
EPA to propose a High-Priority Substance designation. 15 U.S.C. 
2605(b)(1)(C)(iii). Based in part on this provision, and as discussed 
further in Unit III, EPA is proposing to require a default-to-high in 
all cases in which insufficient information exists to designate the 
chemical as a Low-Priority Substance at both the proposed and final 
designation.
    7. Initial ten chemicals for risk evaluation. TSCA requires EPA to, 
within six months of enactment, ensure that risk evaluations are being 
conducted on ten chemical substances drawn from the 2014 update of the 
TSCA Work Plan for Chemical Assessments, and to publish a list of those 
chemical substances during that same period. 15 U.S.C. 2605(b)(2)(A). 
The initial ten chemical substances are not subject to the 
prioritization process or the procedures in this rule. However, 
completion of these risk evaluations triggers the ongoing designation 
requirement discussed in Unit II.B.8.
    8. Ongoing designations. Upon completion of a risk evaluation 
(other than those requested by a manufacturer pursuant to TSCA section 
6(b)(4)(C)(ii)), EPA must designate at least one additional High-
Priority Substance to take its place. 15 U.S.C. 2605(b)(2)(C). Because 
designation as a High-Priority Substance results in the chemical 
substance moving immediately to risk evaluation, this provision 
prevents the number of existing chemical substances undergoing risk 
evaluation from ever decreasing over time. In addition, EPA must 
designate at least twenty chemical substances as High-Priority 
Substances by three and one half years after enactment, effectively 
doubling the number of chemical substances in the review pipeline. 15 
U.S.C. 2605(b)(2)(B). The statute also requires that at least twenty 
chemical substances be designated as Low-Priority Substances by three 
and one half years after enactment, but without a comparable 
requirement to continue designating additional Low-Priority Substances 
after that. 15 U.S.C. 2605(b)(2)(B), (b)(3)(C). Although EPA must 
continue to prioritize and evaluate chemical substances ``at a pace 
consistent with the ability of the Administrator to complete risk 
evaluations in accordance with the deadlines,'' this provision does not 
modify the minimum throughput or other ongoing designation requirements 
for High-Priority Substances. 15 U.S.C. 2605(b)(2)(C). It does, 
however, suggest that EPA must have adequate resources should EPA plan 
to designate more than twenty chemical substances as High-Priority 
Substances at any given time.
    9. Revision of designation. TSCA allows the Administrator to revise 
the designation of a Low-Priority Substance to a High-Priority 
Substance ``based on information made available to the Administrator.'' 
15 U.S.C. 2605(b)(3)(B). This provision does not restrict the basis for 
a revision to the discovery or receipt of new information. For example, 
EPA could also justify a revision based on information that was 
available but was not considered at the time of the original 
prioritization decision, or information that was considered but which 
EPA now views differently as a result of changes in scientific 
understanding (e.g., changes in scientific understanding of how a 
chemical can enter or interact with the human body).
    10. Other relevant statutory requirements. TSCA imposes new

[[Page 4828]]

requirements on EPA in a number of different areas that EPA is not 
proposing to incorporate or otherwise address in this proposed rule. 
For example, amendments to TSCA section 4 require EPA to ``. . . reduce 
and replace, to the extent practicable, [. . .] the use of vertebrate 
animals in the testing of chemical substances . . .'' and to develop a 
strategic plan to promote such alternative test methods. 15 U.S.C. 
2603(h). Likewise, TSCA section 26 requires, to the extent that EPA 
makes a decision based on science under TSCA sections 4, 5, or 6, that 
EPA use certain scientific standards and base those decisions on the 
weight of the scientific evidence. 15 U.S.C. 2625(h) and (i). While 
these requirements are relevant to the prioritization of chemical 
substances, EPA is not obliged to include them in this proposed rule. 
By their express terms, these statutory requirements apply to EPA's 
decisions under TSCA section 6, without the need for regulatory action. 
Moreover, in contrast to TSCA section 6, Congress has not directed EPA 
to implement these other requirements ``by rule;'' it is well-
established that where Congress has declined to require rulemaking, the 
implementing agency has complete discretion to determine the 
appropriate method by which to implement those provisions. E.g., United 
States v. Storer Broadcasting Co., 351 U.S. 192 (1956).
    A number of stakeholders raised questions as to whether EPA should 
define a number of important terms in this rule (e.g., ``best available 
science'', ``weight-of-the-evidence'', ``sufficiency of information'', 
``unreasonable risk'', and ``reasonably available information''). Many 
of the terms used in the proposed rule are not novel concepts and are 
already in use, and their meaning is discussed extensively in existing 
Agency guidance. For example, extensive descriptions for the phrases 
``best available science'', ``weight-of-the-evidence'', and 
``sufficiency of information'' can be found in EPA's Risk 
Characterization Handbook (Ref. 3), and in other existing Agency 
guidance.
    EPA believes further defining these and other terms in the proposed 
rule is unnecessary and ultimately problematic. These terms have and 
will continue to evolve with changing scientific methods and 
innovation. Codifying specific definitions for these phrases in this 
rule may inhibit the flexibility and responsiveness of the Agency to 
quickly adapt to and implement changing science. The Agency intends to 
use existing guidance definitions and to update definitions and 
guidance as necessary.
    While EPA is seeking public comment on all aspects of this proposed 
rule, the Agency is specifically requesting public input on this issue. 
The Agency welcomes public comments regarding the pros and cons of 
codifying these or other definitions and/or approaches for these or any 
other terms. EPA encourages commenters to suggest alternative 
definitions the Agency should consider for codification in this 
procedural rule. Please explain your views as clearly as possible, 
providing specific examples to illustrate your concerns and suggest 
alternate wording, where applicable.

C. Prioritization Under the 2012 TSCA Work Plan Methodology

    Prioritization of chemical substances for review is not a novel 
concept for the Agency. In 2012, EPA released the TSCA Work Plan 
Chemicals: Methods Document in which EPA described the process the 
Agency intended to use to identify potential candidate chemical 
substances for near-term review and assessment under TSCA (Ref. 4). EPA 
also published an initial list of TSCA Work Plan chemicals identified 
for further assessment under TSCA as part of its chemical safety 
program in 2012 (Ref. 5), and an updated list of chemical substances 
for further assessment in 2014 (Ref. 1). The process for identifying 
these chemical substances was based on a combination of hazard, 
exposure, and persistence and bioaccumulation characteristics.
    Congress expressly recognized the validity of EPA's existing 
prioritization methodology for the TSCA Work Plan. For example, the law 
requires that EPA give certain preferences to chemical substances 
listed on the 2014 Update to the TSCA Work Plan. 15 U.S.C. 
2605(b)(2)(D). Moreover, the law requires that at least 50 percent of 
all ongoing risk evaluations be drawn from the 2014 Update to the TSCA 
Work Plan. 15 U.S.C. 2605(b)(2)(B). The statutory screening criteria in 
TSCA section 6(b)(1)(A) also significantly overlaps with the 
considerations in the Work Plan methodology (e.g., persistence, 
bioaccumulation, toxicity, carcinogenicity, etc.).
    However, there are a number of key differences between EPA's TSCA 
Work Plan process and the prioritization process that TSCA now 
requires. First, the Work Plan process involved culling through 
thousands of chemical substances to create a list that EPA could, over 
time and without prescribed deadlines, focus its limited resources on. 
The TSCA Work Plan did not require EPA to assess listed chemical 
substances, and included no deadlines for completing risk assessments 
or addressing identified risks. Prioritization under this proposed rule 
will involve a similar culling, but upon designating a chemical 
substance as a High-Priority Substance, the Agency must start a risk 
evaluation, and generally complete that evaluation within a specified 
amount of time. If EPA determines in the risk evaluation that a 
chemical substance presents an unreasonable risk of injury to health or 
the environment, EPA must also initiate a risk management rulemaking 
subject to statutory deadlines. 15 U.S.C. 2605(c). As such, EPA will 
need to be judicious in selecting the chemical substances that go into 
prioritization.
    Further, while chemical substances listed on the TSCA Work Plan 
were likely to be well-characterized for hazard and have at least some 
information indicating potential exposure, Work Plan chemical substance 
assessments have generally focused on specific chemical uses. Given the 
statutory deadlines, EPA generally intends to ensure it has a more 
complete set of data upfront that would allow EPA to evaluate a 
chemical substance under all conditions of use (a broader scope) within 
the statutory deadlines. For chemical substances with insufficient 
information to conduct a risk evaluation, EPA generally expects to 
pursue a significant amount of data gathering before initiating 
prioritization.
    Finally, the TSCA Work Plan process focused solely on identifying 
potential high risk chemical substances for further review. Because the 
statute also requires the identification of Low-Priority Substances--
those chemical substances that EPA has determined, based on sufficient 
evidence, do not warrant further review at the time--EPA will need to 
undertake new and different analyses than it has done to date under the 
TSCA Work Plan.
    While EPA has drawn from the TSCA Work Plan methodology and EPA's 
experience in implementing that process in developing this proposed 
rule, EPA is proposing to tailor the process for prioritization to the 
specific requirements in the new statute.

D. Stakeholder Involvement

    On August 10, 2016, EPA held a one day public meeting to hear from 
stakeholders to better understand their viewpoints on the development 
of the prioritization rule. The meeting began with a presentation from 
EPA on how the Agency has prioritized chemicals for further review 
under the TSCA Work Plan methodology. The remainder of the day was 
reserved for public comment. Commenters had approximately four

[[Page 4829]]

minutes to present their comments orally and there was a total of 28 
oral comments on the prioritization rule. Further information is 
available on EPA's Web site at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/meetings-and-webinars-amended-toxic-substances-control.
    Stakeholders were also able to provide written comments. EPA 
received 50 written comments on the prioritization rule, although many 
of those who presented orally also submitted written versions as well. 
These comments and a transcript of the meeting are accessible in the 
meeting's docket, identified by Docket ID No. EPA-HQ-OPPT-2016-0399, 
available online at https://www.regulations.gov/.
    The commenters included representatives from industry, 
environmental groups, academics, private citizens, trade associations, 
and health care representatives, and provided a diversity of 
perspectives. Overall, there was a general expression of support for 
the new law and EPA's inclusive approach to implementation to date. 
Most groups agreed that the prioritization rule had the potential to 
increase transparency in EPA's chemical substance review and management 
process, and urged the Agency to work towards this goal.
    A number of commenters suggested codifying specific details in the 
rule, such as a system for scoring and ranking chemical substances; a 
listing of the specific hazard and exposure information upon which EPA 
will base prioritization decisions; and definitions of terms referenced 
in the statute like ``weight of evidence'' and ``best available 
science.'' Others encouraged EPA to keep the rules focused on a 
framework for general process, to retain Agency discretion where 
appropriate, and to reserve specific scientific considerations for 
Agency guidance.
    EPA considered all of these comments in the development of this 
proposed rule, and welcomes additional feedback from stakeholders on 
the Agency's proposed process for chemical substance prioritization as 
presented in this document.

III. Summary of Proposed Rule

    This proposed rule incorporates all of the elements required by 
statute, but also supplements those requirements with additional 
criteria the Agency expects to consider, some clarifications for 
greater transparency, and additional procedural steps to ensure 
effective implementation. Specific components of the approach are 
discussed in this unit. EPA requests comments on all aspects of this 
proposed rulemaking.

A. Policy Objective

    The prioritization process under TSCA is the principal gateway to 
risk evaluation. EPA is ultimately making a judgment as to whether or 
not a particular chemical substance warrants further assessment. As a 
general matter, the overall 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. EPA may also consider 
the relative hazard and exposure of a potential candidate's likely 
substitute(s) in order to avoid moving the market to a chemical 
substance of equal or greater risks. However, the prioritization 
process is not intended to be an exact scoring or ranking exercise and 
EPA is not proposing such a system in this rule. The precise order in 
which EPA identifies High-Priority Substances (all of which must meet 
the same statutory standard) should not be allowed to slow the Agency's 
progress towards fully evaluating the risks from those chemical 
substances. Further, the level of analysis necessary to support an 
exact ranking system is not appropriate at the prioritization stage, 
where the sole outcome is a decision on whether EPA will further 
evaluate the chemical substance. EPA intends to conserve its resources 
and the Agency's deeper analytic efforts for the actual risk 
evaluation. This policy objective is stated directly in the proposed 
rule.
    Low-Priority Substance designations serve some of the same policy 
objectives. Although the statute does not require EPA to designate more 
than twenty Low-Priority Substances, doing so ensures that chemical 
substances with clearly low hazard and exposure potential are taken out 
of consideration for further assessment, thereby conserving resources 
for the chemical substances with the greatest potential risks. There is 
also value in identifying Low-Priority Substances as part of this 
process, as it gives the public notice of chemical substances for which 
potential risks are likely low or nonexistent, and industry some 
insight into which chemical substances are likely not to be regulated 
under TSCA.

B. Scope of Designations

    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. EPA is proposing this in response to clear statutory 
directives: The relevant provisions of TSCA section 6 repeatedly refer 
to both the designation and evaluation of ``chemical substances'' under 
the ``conditions of use.'' ``Conditions of use'' are broadly defined as 
``the circumstances, as determined by the Administrator, under which a 
chemical substance is intended, known, or reasonably foreseen to be 
manufactured, processed, distributed in commerce, used, or disposed 
of.'' 15 U.S.C. 2602.
    Although some commenters at the public meeting suggested that the 
prioritization process should allow EPA to designate a specific use of 
a chemical substance as a High-Priority Substance or a Low-Priority 
Substance, EPA does not interpret the statute to support such an 
interpretation. To the contrary, the addition of the phrase 
``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 comprehensive approach to chemical substance 
management. While EPA clearly retains some discretion in determining 
those conditions of use, as a matter of law, EPA considers that it 
would be an abuse of that discretion to simply disregard known, 
intended, or reasonably foreseen uses in its analyses.

C. Timeframe

    As discussed in Unit II., TSCA section 6(b)(1)(C) requires that the 
prioritization process last between nine and twelve months. EPA is 
proposing in this rule that initiation of the prioritization begins 
upon publication of a notice in the Federal Register that identifies a 
chemical substance for prioritization and provides the results of the 
screening review. The process is complete upon publication of a notice 
in the Federal Register announcing a final priority designation. 
Accordingly, the proposed rule specifies that the process--from 
initiation to final designation--shall last between 9 and 12 months.
    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, coupled 
with the default-to-high provision discussed later, 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.

[[Page 4830]]

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). Although 
the proposed rule most often references ``chemical substances,'' EPA is 
also proposing to include a clear statement in the regulation that 
nothing in the proposed rule shall be construed as a limitation on 
EPA's authority to take action with respect to categories of chemical 
substances, and that, where appropriate, EPA can prioritize and 
evaluate categories of chemical substances.

E. Chemicals Subject to Prioritization

    Generally, all chemical substances listed on the TSCA Inventory are 
subject to prioritization. TSCA contemplates that, over time, all 
chemical substances on the TSCA Inventory will be prioritized into 
either High- or Low-Priority Substances, and that all High-Priority 
Substances will be evaluated. EPA notes that 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) are also 
candidates for prioritization, although EPA expects that such chemical 
substances are not likely to be High-Priority candidates in light of 
the risk-related determination that the Agency must make pursuant to 
TSCA section 5(a)(3).
    TSCA further requires EPA to go through a separate process of 
determining which chemical substances on the TSCA Inventory are still 
actively being manufactured, and EPA has initiated a separate 
rulemaking for that purpose (RIN 2070-AK24). This distinction will 
inform EPA's exposure judgments during the prioritization process. 
However, there is nothing in TSCA that prohibits EPA from initiating 
the prioritization process on an ``inactive'' chemical substance and 
ultimately designating that chemical substance as either a High-
Priority Substances (e.g., if exposures of concern arise from ongoing 
uses) or Low-Priority Substance.

F. Pre-Prioritization Considerations

    As discussed earlier, TSCA requires that EPA establish a process, 
including criteria for designating a chemical substance as either a 
High-Priority Substances or Low-Priority Substance. 15 U.S.C. 
2605(b)(1). Aside from the statutory preferences for chemical 
substances on the 2014 Update to the TSCA Work Plan (Ref. 1), the 
statute leaves EPA with broad discretion to choose which chemical 
substance to put into that process. Accordingly, this proposed rule 
includes a discussion of the criteria EPA expects to use to cull 
through the chemical substances on the TSCA Inventory. These include 
criteria that will be used to identify potential candidates for High-
Priority Substances or Low-Priority Substances, and that describe how 
the extent of available information on potential candidates will affect 
whether they are selected for prioritization.
    For example, in identifying potential candidates for High-Priority 
Substance designations, EPA is proposing to seek to identify chemical 
substances where available information suggests that the chemical 
substance may present a hazard and that exposure is present under ``one 
or more conditions of use,'' but where an ``unreasonable risk'' 
determination cannot be made without a more extensive or complete 
assessment in a risk evaluation. EPA interprets the statutory 
definition of a High-Priority Substance (``. . . may present an 
unreasonable risk [. . .] because of a potential hazard and a potential 
route of exposure . . .'') to set a fairly low bar, and EPA expects 
that a large number of chemical substances will meet this definition. 
Although EPA will prioritize a ``chemical substance'' as a whole, EPA 
may base its identification of a potential candidate as a High-Priority 
Substance, and ultimately the proposed designation, on a single 
condition of use, provided the hazard and exposure associated with that 
single use support such a designation. This proposal is based on the 
statutory definition of a High-Priority Substance, which is clear that 
the standard for the chemical as a whole can be met based on a single 
condition of use (``. . . because of a potential hazard and a potential 
route of exposure . . .'').
    Conversely, in identifying potential candidates for Low-Priority 
Substance designation, EPA is proposing that it will seek to identify 
chemical substances where the information indicates that hazard and 
exposure potential for ``all conditions of use'' are so low that EPA 
can confidently set that chemical substance aside without doing further 
evaluation. By comparison, then, TSCA's definition of Low-Priority 
Substance (``. . . based on sufficient information, such substance does 
not meet the standard for [. . .] a high-priority substance . . .'') is 
fairly rigorous, and effectively requires EPA to determine that under 
no condition of use does the chemical meet the High-Priority Substance 
standard. Consequently, EPA expects it will be more difficult to 
support such designations. Unlike High-Priority Substances, EPA will 
not be able to designate a chemical substance as a Low-Priority 
Substance without first looking at all of the conditions of use. While 
not determinative, EPA believes that its Safer Chemicals Ingredients 
List (SCIL) (Ref. 6) will be a good starting point for identifying 
potential candidates for Low-Priority Substance designations.
    EPA is also proposing to include the following list of additional 
exposure and hazard considerations that can be used to narrow the field 
of potential candidates: (1) Persistent, bioaccumulative, and toxic; 
(2) Used in children's products; (3) Used in consumer products; (4) 
Detected in human and/or ecological biomonitoring programs; (5) 
Potentially of concern for children's health; (6) High acute and 
chronic toxicity; (7) Probable or known carcinogen; (8) Neurotoxicity; 
or (9) Other emerging exposure and hazard concerns to human health or 
the environment, as determined by the Agency. These criteria are drawn 
from EPA's 2012 TSCA Work Plan methodology (Ref. 4), which, as 
discussed earlier, was the process EPA had been using to prioritize 
chemical substances for assessment under TSCA. EPA will evaluate one or 
more of these nine considerations, and chemical substances that meet 
one or more of these criteria may be identified as potential candidates 
for High-Priority Substance designations. For example, if a chemical 
substance is highly toxic and used in consumer products, EPA may wish 
to consider that chemical substance as a potential High-Priority 
Substance candidate. EPA may also choose to identify potential 
candidates based on other criteria that suggest the chemical substance 
may otherwise present a human health or environmental concern, as 
contemplated in the ``catch-all'' provision (9). The fact that a 
chemical substance meets one of these criteria is not determinative of 
an outcome, including whether or not EPA will select the chemical 
substance to go into the prioritization process and/or the priority 
designation that the chemical substance will ultimately receive. 
Conversely, chemical substances that meet none of these criteria may be 
good potential candidates for Low-Priority Substance designation. The 
considerations are intended to serve as a general guide for the Agency, 
based on EPA's current understanding of important considerations 
regarding

[[Page 4831]]

potential chemical risk. It should also be noted that while these 
considerations are drawn from EPA's 2012 Work Plan methodology (Ref. 
4), EPA will apply them differently for prioritization. In the TSCA 
Work Plan context, only chemical substances that met these initial 
criteria were eligible for listing on Work Plan. For purposes of 
prioritization under TSCA, the considerations do not determine 
eligibility, but rather are designed to help EPA to narrow its focus.

G. Information Availability

    Another key consideration in the pre-prioritization phase is the 
existence and availability of risk-related information on a candidate 
or potential candidate chemical substance. Because EPA must complete 
its prioritization process within 12 months once prioritization has 
been initiated for a chemical substance, immediately initiate a risk 
evaluation for High-Priority Substance, and complete the risk 
evaluation within three years of initiation, EPA cannot assume that it 
will be able to require the generation of critical information during 
these time frames. Furthermore, the statute does not grant EPA the 
discretion to significantly delay either of these processes, pending 
development of information. Consequently, prior to initiating the 
prioritization process for a chemical substance, EPA will generally 
review the available hazard and exposure-related information, and 
evaluate whether that information would be sufficient to allow EPA to 
complete both prioritization and risk evaluation processes. As part of 
such an evaluation, EPA expects to consider the quality, objectivity, 
utility, and integrity of the available information. To the extent the 
information is not currently available or is insufficient, EPA will 
determine whether or not information can be developed and collected, 
reviewed and incorporated into analyses and decisions in a timely 
manner. The proposed rule makes it clear that sufficiency of available 
information is likely to be a crucial factor in the selection of the 
chemical substances that EPA chooses to put into the prioritization 
process.
    As noted, if information gaps are identified during the 
prioritization or risk evaluation processes, EPA expects that it could 
be difficult to require the development of necessary chemical substance 
information, and receive, evaluate, and incorporate that information 
into analyses and decisions within the statutory timeframes. Tests 
necessary for risk evaluation, for example, could take months or years 
to develop and execute, plus additional time for EPA to issue the order 
or rule, and to collect, review and incorporate the new information. To 
avoid such a scenario, EPA believes that it will need to do a 
significant amount of upfront data gathering and review. This approach 
ensures that EPA stays on track to meet relevant statutory deadlines--
particularly those for risk evaluation.
    The proposed rule makes clear that EPA generally expects to use 
this new authority, as appropriate and necessary, to gather the 
requisite information prior to initiating prioritization. This could 
include, as appropriate, TSCA information collection, testing, and 
subpoena authorities, including those under TSCA sections 4, 8, and 
11(c), to develop needed information.
    Given the importance of ensuring that sufficient information is 
available to conduct the prioritization and risk evaluation processes, 
EPA is proposing to include this consideration during the earliest 
stage in the process: During the identification of potential 
candidates. However, this criterion remains relevant even after EPA has 
selected a candidate and screened that chemical substance against the 
statutory criteria in TSCA section 6(b)(1)(A). Thus, if at any time 
prior to the publication of a notice in the Federal Register initiating 
prioritization, EPA determines that more information will be necessary 
to support a prioritization designation or a subsequent risk 
evaluation, EPA can choose not to initiate prioritization for that 
chemical substance pending development of additional information.

H. Selection and Screening of a Candidate Chemical Substance

    As noted in Unit II., TSCA requires that EPA give preference to 
chemical substances listed in the 2014 update of the TSCA Work Plan for 
Chemical Assessments that (1) have a Persistence and Bioaccumulation 
Score of 3; and (2) are known human carcinogens and have high acute and 
chronic toxicity. 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 the statute, TSCA requires that all 
TSCA Work Plan chemical substances eventually be prioritized. However, 
it is premature to presume that those chemical substances will 
necessarily be prioritized as High-Priority Substances, or that EPA 
would find unreasonable risk.
    Aside from these statutory preferences, however, TSCA does not 
limit how EPA must ultimately select a candidate chemical substance to 
put into the prioritization process. EPA is proposing that it will 
select a candidate--for either High-Priority Substances or Low-Priority 
Substance--based on the policy objectives described in Unit III.A. and 
the pre-prioritization considerations described in Unit III. F. and G. 
The development of the proposed rule, including these policy 
objectives, considerations and criteria, was informed by EPA's 
experience implementing the 2012 TSCA Work Plan methodology, which has 
been the Agency's primary tool for identifying candidate chemical 
substances for further assessment under TSCA. In addition, EPA fully 
recognizes the important role that stakeholders can play in helping the 
Agency to identify candidates for prioritization or to better 
understand the unique uses or characteristics of a particular chemical. 
EPA continues to welcome this type of engagement and dialogue early in 
the process, including during the pre-prioritization phase. While the 
proposed rule provides multiple opportunities for public feedback 
during the prioritization process, EPA is requesting comment on whether 
and how EPA should solicit additional input at the pre-prioritization 
phase. Further, given EPA's objective to avoid simply moving the market 
to substitute chemical substances of equal or greater risks, EPA 
requests comment on whether and how information on the availability of 
chemical substitutes should be taken into account during this phase of 
the prioritization process.
    Once a single candidate chemical substance (or category of chemical 
substances) is selected, 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. Because TSCA does not prohibit EPA from expanding the statutory 
screening criteria, the proposed rule also provides an additional 
criterion: (7) Any other risk-based criteria relevant to the

[[Page 4832]]

designation of the chemical substance's priority, in EPA's discretion. 
This final criterion allows the screening review to adapt with future 
changes in our understanding of science and chemical risks. In 
addition, EPA fully recognizes the important role that stakeholders can 
play in helping the Agency to identify candidates for prioritization or 
to better understand the unique uses or characteristics of a particular 
chemical. EPA continues to welcome this type of engagement and dialogue 
early in the process, including during the pre-prioritization phase. 
While the proposed rule provides multiple opportunities for public 
feedback during the prioritization process, EPA is requesting comment 
on whether and how EPA should solicit additional input at the pre-
prioritization phase.
    The screening review is not a risk evaluation, but rather a review 
of available information on the chemical substance that relates to the 
screening criteria. EPA expects to evaluate all relevant sources of 
information while conducting the screening review, including, as 
appropriate, the hazard and exposure sources listed in Appendices A and 
B of the 2012 TSCA Work Plan methodology (Ref. 4). Ultimately, the 
screening review and other considerations during the pre-prioritization 
phase are meant to inform EPA's decisions on (1) whether to initiate 
the prioritization process on a particular chemical substance, and (2) 
once initiated, the proposed designation of that chemical substance as 
either a High-Priority Substances or Low-Priority Substance.

I. Initiation of Prioritization

    The prioritization process officially begins, for purposes of 
triggering the nine to twelve month statutory timeframe, when EPA 
publishes a notice in the Federal Register identifying a chemical 
substance for prioritization. The proposed rule also specifies that EPA 
will publish the results of the screening review in the Federal 
Register, describing the information, analysis and basis used to 
conduct that review and providing in the docket copies of relevant 
information not otherwise protected as confidential business 
information under TSCA section 14. 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 can submit information 
regarding the results of the screening review or any other information 
relevant to the chemical substance. Of particular interest to EPA will 
be information related to ``conditions of use'' that are missing from 
the screening results. EPA will consider all relevant information 
received during this comment period. Consistent with TSCA section 
6(b)(1)(C)(iii), the proposed rule further allows EPA to extend this 
initial public comment period for up to 3 months to receive and/or 
evaluate information developed from a test order, commensurate with 
EPA's need for additional time to receive and/or evaluate this 
information. As a practical matter, EPA is unlikely to often extend 
this initial public comment, given EPA's intention to ensure that all 
or most of the necessary information is available before initiating the 
prioritization process. Further, a three month window would not often 
provide a sufficient time to gather, let alone consider, new test data 
for the prioritization process. This is generally expected to be the 
case even with the authority to more quickly collect such information 
under the new test order authority in TSCA section 4.

J. Proposed Priority Designation

    Based on the results of the screening review, relevant information 
received from the public in the initial comment period, and other 
information as appropriate, EPA will propose to designate the chemical 
substance as either a High-Priority Substance or Low-Priority 
Substance, as those terms are defined in TSCA. In making this proposed 
designation, as directed by the statute, EPA will not consider costs or 
other non-risk factors.
    This proposed 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, in a form and manner that EPA deems appropriate, and 
provide a second comment period of 90 days, during which time the 
public may submit comments on EPA's proposed designation. EPA proposes 
to use the same docket for this step of the process. 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 
early comments on the accuracy of scope-related information such as the 
chemical's ``conditions of use.''
    In the event of insufficient information at the proposed 
designation step, EPA is proposing to designate a chemical substance as 
a High-Priority Substance. EPA expects this situation to occur 
infrequently based on its application of the criteria and 
considerations during the pre-prioritization phase. However, if for 
some reason the information available to EPA is insufficient to support 
a proposed designation of the chemical substance as a Low-Priority 
Substance, including after any extension of the initial public comment 
period, consistent with the statute, the proposed rule requires EPA to 
propose to designate the chemical substance as a High-Priority 
Substance. The statute 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). There is no third option to allow EPA to 
either require the development of additional information or otherwise 
toll this deadline. Further, the statute specifically requires 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). 
It is also relevant that the effect of designating a chemical as High-
Priority Substance is that EPA further evaluates the chemical 
substance; by contrast, a Low-Priority Substance designation is a final 
Agency determination that no further evaluation is warranted--a 
determination that constitutes final agency action, subject to judicial 
review. 15 U.S.C. 2618(a)(1)(C)(i).
    The logical implication of this statutory structure is that 
scientific uncertainty in this process (including as a result of 
insufficient information) is to weigh in favor of a High-Priority 
Substance designation, as it is merely an interim step that ensures 
that the chemical will be further evaluated. EPA's proposal would also 
ensure that this process would not create any incentives for parties to 
withhold readily available information, or inadvertently discourage the 
voluntary generation of data, as could occur were EPA to establish, for 
example, a default designation to Low-Priority. As a practical matter, 
however, EPA expects this situation to occur infrequently, based on its 
proposed criteria and considerations that will generally ensure that 
sufficient information is available to conduct a risk evaluation before 
initiating prioritization. Priority designations, whether they were 
based on sufficient information or a lack of sufficient information, 
are neither an

[[Page 4833]]

affirmation of risk nor safety. EPA therefore recognizes that all 
priority designations will need to be carefully communicated to the 
public.
    For proposed designations as Low-Priority Substances, EPA is 
proposing to require that all comments that could be raised on the 
issues in the proposed designation must be presented during the comment 
period. Any issues not raised will be considered to have been waived, 
and may not form the basis for an objection or challenge in any 
subsequent administrative or judicial proceeding. This is a well-
established principle of administrative law and practice, e.g., Nuclear 
Energy Institute v. EPA, 373 F.3d 1251, 1290-1291 (D.C. Cir. 2004), and 
the need for such a provision is reinforced by the statutory deadlines 
under which EPA must operate here. EPA is restricting this to Low-
Priority Substance designations, as it is the last opportunity for 
public input before EPA's action becomes final, and thus it is 
imperative that any issues are shared during this public comment 
period. By contrast, designation of a chemical substance as a High-
Priority Substance is not final agency action. The statute mandates 
additional opportunities for public input during the risk evaluation 
process, and EPA does not consider it appropriate to restrict the 
public's ability to comment during these subsequent processes based on 
this early phase proceeding.

K. Final Priority Designation

    After considering any additional information collected during the 
proposed designation step, as appropriate, 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. The proposed rule specifies that EPA will publish 
the priority designation in the Federal Register, and will use the same 
docket. Again, TSCA prohibits costs or other non-risk factors from 
being considered in this designation. And, as with the proposed 
designation step, if information available to EPA remains insufficient 
to support the final designation of the chemical substance as a Low-
Priority Substance, EPA will finalize the designation as a High-
Priority Substance. Although final High-Priority designations based on 
insufficient information are unlikely for all the reasons described in 
Unit III.J., such a designation would require EPA to conduct a risk 
evaluation on that substance, and to support the risk evaluation with 
adequate information. EPA would need to develop or require development 
of the necessary information and complete the risk evaluation within 
the 3-year statutory deadline.

L. 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 will 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.

M. 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. It is important to note that High-Priority 
Substance designation does not mean that the Agency has determined that 
the chemical substance presents a risk to human health or the 
environment--only that the Agency intends to consider the chemical 
substance for further risk review and evaluation. A High-Priority 
Substance designation is not a final agency action and is not subject 
to judicial review or review under the Congressional Review Act (CRA), 
5 U.S.C. 801 et seq.
    Final designation of a chemical substance as a Low-Priority 
Substance 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, if warranted. Notably, a Low-Priority Substance 
designation is explicitly subject to judicial review. 15 U.S.C. 
2618(a)(1)(C).

N. 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 available to the Agency. The proposed 
rule outlines the process the Agency will take to revise such a 
designation. Specifically, EPA would (1) re-screen the chemical 
substance incorporating the relevant information, (2) re-initiate the 
prioritization process and take public comment, (3) re-propose a 
priority designation and take public comment, and (4) re-finalize the 
priority designation. EPA will not revise a final designation of a 
chemical substance from High-Priority Substance to Low-Priority 
Substance, but rather see the risk evaluation process through to its 
conclusion.

IV. 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. 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.
2. EPA. Framework for Metals Risk Assessment. EPA 120/R-07/001. 
March 2007. Available online at: https://www.epa.gov/sites/production/files/2013-09/documents/metals-risk-assessment-final.pdf.
3. EPA. Science Policy Council Handbook: Risk Characterization. EPA/
100/B-00/002. December 2000. Available online at: https://www.epa.gov/risk/risk-characterization-handbook.
4. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012. 
Available online at: https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf.
5. EPA. 2012 TSCA Work Plan Chemicals. June 2012. Available online 
at: https://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf.
6. 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.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be

[[Page 4834]]

found at https://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.

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 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.

List of Subjects in 40 CFR Part 702

    Environmental protection, Chemicals, Chemical substances, Hazardous 
substances, Health and safety, Prioritization, Screening, Toxic 
substances.

    Dated: December 27, 2016
Gina McCarthy,
Administrator.
    Therefore, 40 CFR chapter I, subchapter R, is proposed to be 
amended as follows:

PART 702--[AMENDED]

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:

PART 702--GENERAL PRACTICES AND PROCEDURES

Subpart A--Procedures for Prioritization of Chemical Substances for 
Risk Evaluation
702.1 General Provisions.
702.3 Definitions.
702.5 Considerations for Potential Candidates for Prioritization.
702.7 Candidate Selection and Screening Review.
702.9 Initiation of Prioritization Process.
702.11 Proposed Priority Designation.
702.13 FinaL Priority Designation.
702.15 Revision of Designation.
702.17 Effect of Designation as a Low-Priority Substance.
702.19 Effect of Designation as a High-Priority Substance.
* * * * *

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

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 use 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 40 CFR 702.9.
    (e) Metals or metal compounds. In identifying priorities for 
chemical

[[Page 4835]]

substances that are metals or metal compounds, EPA will, as 
appropriate, refer to relevant considerations from the Framework for 
Metals Assessment of the Office of the Science Advisor, Risk Assessment 
Forum, dated March 2007, or a successor document that addresses metals 
risk assessment and is peer reviewed by the Science Advisory Board.
    (f) Applicability. These regulations do not apply to any chemical 
substance for which a manufacturer requests a risk evaluation under 
TSCA section 6(b)(4)(C) (15 U.S.C. 2605(b)(4)(C)).


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.)
    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.


Sec.  702.5  Consideration of Potential Candidates for Prioritization.

    (a) Potential High-Priority Substance Candidates. In identifying 
potential candidates for High-Priority Substances, EPA will generally 
consider whether information available to the Agency suggests there is 
hazard and exposure under a condition or conditions of use, and whether 
a risk evaluation would be needed to determine whether there is an 
unreasonable risk of injury to health or the environment.
    (b) Potential Low-Priority Substance Candidates. In identifying 
potential candidates for Low-Priority Substances, EPA will generally 
consider whether information available to the EPA suggests such low 
hazard and/or exposure under all conditions of use that EPA is 
confident the chemical substances does not present 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, even in the absence of a risk evaluation.
    (c) Exposure and Hazard Considerations for Potential Candidates.
    In identifying potential candidates for prioritization, EPA will 
generally evaluate whether or not the chemical substance meets one or 
more of the following exposure or hazard considerations:
    (1) Persistent, bioaccumulative, and toxic;
    (2) Used in children's products;
    (3) Used in consumer products;
    (4) Detected in human and/or ecological biomonitoring programs;
    (5) Potentially of concern for children's health;
    (6) High acute and chronic toxicity;
    (7) Probable or known carcinogen;
    (8) Neurotoxicity; or
    (9) Other emerging exposure and hazard concerns to human health or 
the environment, as determined by the Agency.


A chemical substance that meets one or more of these criteria will 
generally be considered as a potential candidate for further 
consideration as a High-Priority Substance. A chemical substance that 
meets none of these criteria will generally be considered as a 
potential candidate for further consideration as a Low-Priority 
Substance.
    (d) Available Information and Resources. EPA expects it will often 
be difficult to timely require development of necessary chemical 
information, and receive, evaluate, and incorporate that information 
into analyses, during the prioritization and risk evaluation processes, 
within the statutory deadlines under the Act for prioritization and 
risk evaluation at 15 U.S.C. 2605 (b)(1)(C) and (b)(4)(G). Therefore, 
EPA will generally review and analyze the information necessary for 
both prioritization and risk evaluation prior to initiating the 
prioritization process for a chemical substance pursuant to 40 CFR 
702.9. Specifically, in identifying potential candidates for 
prioritization, EPA expects to consider:
    (1) The availability of information and resources necessary and 
sufficient to support a priority designation pursuant to 40 CFR 702.11, 
a risk evaluation pursuant to 40 CFR 702, subpart B, or other such 
action as determined by the Administrator; and
    (2) The ability of EPA to timely develop or require development of 
information necessary and sufficient to support a priority designation 
pursuant to 40 CFR 702.11; a risk evaluation pursuant to 40 CFR 702, 
subpart B; or other such action as determined by the Agency.
    (e) Insufficient Information. In the absence of sufficient 
information to support a priority designation pursuant to 40 CFR 
702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other 
such action as determined by the Agency, EPA may use its authorities 
under the Act, and other information gathering authorities, to gather 
or require the generation of the needed information on a chemical 
substance before initiating the prioritization process for that 
chemical substance.


Sec.  702.7  Candidate Selection and Screening Review.

    (a) Preferences and TSCA Work Plan. In selecting a candidate for 
prioritization as a High-Priority Substance, EPA will:
    (1) Give preference to:
    (A) 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
    (B) 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 40 CFR 702.13.
    (b) 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 available information on the relative hazard and 
exposure of potential candidates. EPA may also consider the relative 
hazard and exposure of a potential candidate's substitutes. EPA is not 
required to select candidates or initiate prioritization pursuant to 40 
CFR 702.9 in any ranked or hierarchical order.
    (c) Screening Review. Following selection of a candidate chemical 
substance, EPA will generally use available information to screen the 
candidate chemical substance against the following criteria and 
considerations:
    (1) The chemical substance's hazard and exposure potential;

[[Page 4836]]

    (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) Any other risk-based criteria relevant to the designation of 
the chemical substance's priority, in EPA's discretion.
    (d) Information sources. In conducting the screening review in 
paragraph (c) of this section, EPA expects to consider sources of 
information relevant to the listed criteria, 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).
    (e) The purpose of the preferences and criteria in paragraph (a) of 
this section and the screening review in paragraph (c) of this section 
are to inform EPA's decision whether or not to initiate the 
prioritization process pursuant to 40 CFR 702.9, and the proposed 
designation of the chemical substance as either a High-Priority 
Substance or a Low-Priority Substance pursuant to 40 CFR 702.11.
    (f) If, after the screening review in paragraph (c) of this 
section, EPA believes it will not have sufficient information to 
support a proposed priority designation pursuant to 40 CFR 702.11, a 
risk evaluation pursuant to 40 CFR 702, subpart B, or other such action 
as determined by the Agency, EPA is likely to use its authorities under 
the Act, and other information gathering authorities, to generate the 
needed information before initiating prioritization pursuant to 40 CFR 
702.9.


Sec.  702.9  Initiation of Prioritization Process.

    (a) EPA generally expects to initiate the prioritization process 
for a chemical substance only when it believes that all or most of the 
information necessary to prioritize and perform a risk evaluation on 
the substance already exists.
    (b) EPA will initiate prioritization by publishing a notice in the 
Federal Register identifying a chemical substance for prioritization 
and the results of the screening review conducted pursuant to 40 CFR 
702.7(c).
    (c) The prioritization timeframe in 40 CFR 702.1(d) begins upon 
EPA's publication of the notice described in paragraph (b) of this 
section.
    (d) The results of the screening review published pursuant to 
paragraph (b) of this section will identify, in a form and manner that 
EPA deems appropriate, the information analysis and basis used in 
conducting the screening process. Subject to 15 U.S.C. 2613, copies of 
the information will also be placed in a public docket established for 
each chemical substance.
    (e) Publication of a 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 regarding the results of the screening 
review conducted pursuant to 40 CFR 702.7(c), and any additional 
information on the chemical substance that pertains to the criteria and 
considerations at 40 CFR 702.7(c).
    (f) EPA may, in its discretion, extend the public comment period in 
paragraph (b) 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.  702.11  Proposed Priority Designation.

    (a) Based on the results of the screening review in 40 CFR 
702.7(c), relevant information received from the public as described in 
40 CFR 702.9(e), and other information as appropriate and in EPA's 
discretion, EPA will propose to designate the chemical substance as 
either a High-Priority Substance or Low-Priority Substance.
    (b) EPA will not consider costs or other non-risk factors in making 
a proposed priority designation.
    (c) If information available to EPA remains insufficient to enable 
the proposed designation of the chemical substance as a Low-Priority 
Substance, including after any extension of the initial public comment 
period pursuant to 40 CFR 702.9(f), EPA will propose to designate the 
chemical substance as a High-Priority Substance.
    (d) EPA may 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 40 CFR 
702.3 under any one or more uses that the Agency determines constitute 
conditions of use as defined in 15 U.S.C. 2602. EPA will propose to 
designate a chemical substance as a Low-Priority Substance based only 
on the proposed conclusion that the chemical substance satisfies the 
definition of Low-Priority Substance in 40 CFR 702.3 under all uses 
that the Agency determines constitute conditions of use as defined in 
15 U.S.C. 2602.
    (e) 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.
    (f) For chemical substances that EPA proposes to designate as Low-
Priority Substances, EPA will specify in the notice published pursuant 
to paragraph (e) of this section that all comments that could be raised 
on the issues in the proposed designation must be presented during this 
comment period. Any issues not raised at this time will be considered 
to have been waived, and may not form the basis for an objection or 
challenge in any subsequent administrative or judicial proceeding.


Sec.  702.13  Final Priority Designation.

    (a) After considering any additional information collected from the 
proposed designation process in 40 CFR 702.11, as appropriate, EPA will 
finalize its designation of a chemical substance as either a High-
Priority Substance or a Low-Priority Substance.
    (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.
    (d) 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 40 CFR 702, 
subpart B. 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.
    (e) If information available to EPA remains insufficient to enable 
the final designation of the chemical substance as a Low-Priority 
Substance, EPA will finalize the designation of the chemical substance 
as a High-Priority Substance.

[[Page 4837]]

Sec.  702.15   Revision of Designation.

    EPA may revise a final designation of chemical substance from Low-
Priority to High-Priority Substance at any time based on information 
available to the Agency. To revise such a designation, EPA will re-
screen the chemical substance pursuant to 40 CFR 702.7(c), re-initiate 
the prioritization process on that chemical substance in accordance 
with 40 CFR 702.9, propose a priority designation pursuant to 40 CFR 
702.11, and finalize the priority designation pursuant to 40 CFR 
702.13. EPA will not revise a final designation of a chemical substance 
from a High-Priority Substance designation to Low-Priority.


Sec.  702.17  Effect of Designation as a Low-Priority Substance.

    Designation of a chemical substance as a Low-Priority Substance 
under 40 CFR 702.3 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 40 CFR 702.15, if warranted.


Sec.  702.19  Effect of Designation as a High-Priority Substance.

    Final designation of a chemical substance as a High-Priority 
Substance under 40 CFR 702.13 initiates a risk evaluation pursuant to 
40 CFR 702, subpart B. Designation as a High-Priority Substance is not 
a final agency action and is not subject to judicial review.
* * * * *
[FR Doc. 2017-00051 Filed 1-13-17; 8:45 am]
BILLING CODE 6560-50-P