High-Priority Substance Designations Under the Toxic Substances Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority Substances; Notice of Availability, 71924-71935 [2019-28225]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71924-71935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28225]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0131; FRL-10003-15]


High-Priority Substance Designations Under the Toxic Substances 
Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority 
Substances; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required under section 6(b) of the Toxic Substances Control 
Act (TSCA) and implementing regulations, EPA is designating 20 chemical 
substances as High-Priority Substances for risk evaluation. This 
document identifies the final designations and Agency rationale for the 
chemical substances and provides instructions on how to access the 
chemical-specific information, analysis and basis used by EPA to 
support final designations for the chemical substances. A designation 
of a substance as a High-Priority Substance is not a finding of 
unreasonable risk. However, the designation of these chemical 
substances as high-priority substances constitutes the initiation of 
the risk evaluations on the substances.

DATES: The designations of High-Priority Substances for risk evaluation 
in this notice are effective December 20, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2019-0131, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. In addition, the docket ID 
numbers for the individual chemical substances designated in Unit IV. 
are: EPA-HQ-OPPT-2018-0451; EPA-HQ-OPPT-2018-0501; EPA-HQ-OPPT-2018-
0503; EPA-HQ-OPPT-2018-0444; EPA-HQ-OPPT-2018-0446; EPA-HQ-OPPT-2018-
0426; EPA-HQ-OPPT-2018-0427; EPA-HQ-OPPT-2018-0465; EPA-HQ-OPPT-2018-
0428; EPA-HQ-OPPT-2018-0504; EPA-HQ-OPPT-2018-0433; EPA-HQ-OPPT-2018-
0434; EPA-HQ-OPPT-2018-0488; EPA-HQ-OPPT-2018-0438; EPA-HQ-OPPT-2018-
0430; EPA-HQ-OPPT-2018-0462; EPA-HQ-OPPT-2018-0458; EPA-HQ-OPPT-2018-
0459; EPA-HQ-OPPT-2018-0421; and EPA-HQ-OPPT-2018-0476. 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 dockets available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information about the High-Priority Substances 
contact: Ana Corado, Chemical Control Division, Office of Pollution 
Prevention and Toxics, Office of Chemical Safety and Pollution 
Prevention, Environmental Protection Agency (Mailcode 7408M), 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-0140; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to entities that currently or may manufacture (including 
import) a chemical substance regulated under TSCA (e.g., entities 
identified under North American Industrial Classification System 
(NAICS) codes 325 and 324110). The action may also be of interest to 
chemical processors, distributors in commerce, and users; non-
governmental organizations in the environmental and public health 
sectors; state and local government agencies; and members of the 
public. 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 finalizing the designation 20 chemical substances as High-
Priority Substances for risk evaluation pursuant to section 6(b) of 
TSCA, 15 U.S.C. 2605(b). This document includes a summary of comments 
received during the two 90-day comment periods during

[[Page 71925]]

which the public submitted comments on EPA's initiation of 
prioritization (Ref. 1) and the proposed designations of High-Priority 
Substances for risk evaluation (Ref. 2), as well as the Agency 
responses to those comments (Ref. 3).

C. Why is the Agency taking this action?

    TSCA section 6(b) and implementing regulations at 40 CFR part 702, 
subpart A require EPA to carry out a prioritization process for 
chemical substances that may be designated as high priority for risk 
evaluation. TSCA section 6(b)(2)(B) requires that EPA ``ensure that 
risk evaluations are being conducted'' on at least 20 High-Priority 
Substances no later than three and one-half years after the June 22, 
2016 date of enactment of the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act (Pub. L. 114-182). EPA is finalizing the 
designation of the 20 chemical substances as High-Priority Substances 
for risk evaluation that EPA identified as candidates for High-Priority 
Substance designation when EPA initiated the prioritization process on 
March 21, 2019 (Ref. 1). EPA provided two 90-day comment periods during 
which the public submitted comments on the list of candidate High-
Priority Substances at the initiation of prioritization (Ref. 1) and 
the documents supporting the proposed designations of High-Priority 
Substances for risk evaluation (Ref. 2). The two comment periods are 
required by TSCA section 6(b)(1)(C) and implementing regulations (40 
CFR 702.7(d) and 702.9(g)).

D. What is the Agency's authority for taking this action?

    This document is issued pursuant to TSCA section 6(b)(1).

II. Background

    TSCA section 6(b)(1) requires EPA to prioritize chemical substances 
for risk evaluation. In accordance with TSCA section 6(b) and 40 CFR 
702.7, on March 21, 2019 (Ref. 1) EPA initiated the prioritization 
process for 20 chemical substances identified as candidates for High-
Priority Substance designation. On August 23, 2019, EPA proposed to 
designate the same 20 chemical substances as High-Priority Substances 
for risk evaluation (Ref. 2). That notice included a summary of the 
approach used by EPA to support the proposed designations, links to the 
proposed designation document for each of the chemical substances, and 
instructions on how to access the chemical-specific information, 
analysis and basis used by EPA to make the proposed designation for 
each chemical substance.
    Under TSCA section 6(b)(1)(B) and implementing regulations (40 CFR 
702.3), a High-Priority Substance is defined as ``a chemical substance 
that [EPA] concludes, without consideration of costs or other nonrisk 
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 
a potentially exposed or susceptible subpopulation identified as 
relevant by [EPA].''
    A designation of a substance as a High-Priority Substance is not a 
finding of unreasonable risk. Rather, when prioritization is complete, 
for those chemicals designated as High-Priority Substances, the Agency 
will have evidence on hazards and exposures that supports a finding 
that the substances may present an unreasonable risk of injury to 
health or the environment under the conditions of use. Final 
designation of a High-Priority Substance initiates the risk evaluation 
process (40 CFR 702.17), which culminates in a finding of whether or 
not the chemical substance presents an unreasonable risk of injury to 
health or the environment under the conditions of use.
    As described in the notice proposing to designate the 20 chemical 
substances as High-Priority Substances for risk evaluation (Ref. 2), 
``EPA will generally use reasonably available information to screen the 
candidate chemical substances against the following criteria and 
considerations:
     The chemical substance's hazard and exposure potential;
     The chemical substance's persistence and bioaccumulation;
     Potentially exposed or susceptible subpopulations;
     Storage of the chemical substance near significant sources 
of drinking water;
     The chemical substance's conditions of use or significant 
changes in conditions of use;
     The chemical substance's production volume or significant 
changes in production volume; and
     Other risk-based criteria that EPA determines to be 
relevant to the designation of the chemical substance's priority'' 40 
CFR 702.9(a). When selecting candidates for prioritization, the Agency 
also generally intends to consider (1) Agency priorities (with 
consideration of the priorities of other Federal agencies), (2) 
quantity and quality of information (to ensure that the information 
necessary to prioritize the substance is reasonably available), and (3) 
overall workload (the Agency will be mindful of the complexity 
associated with the assessment of the chemical substance to ensure 
timely completion of prioritization and risk evaluation of each 
substance) (Ref. 5).
    A more detailed discussion of the information, analysis and basis 
used to support the proposed High-Priority Substance designation can be 
found in Unit IV.A of the August 23, 2019 notice (Ref. 2).
    As described in 40 CFR 702.9(b), in conducting the screening review 
during the prioritization process, EPA considered sources of reasonably 
available information relevant to the review criteria as outlined in 
the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40 
CFR 702.9(a)) and consistent with the scientific standards of TSCA 
section 26(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), and did not consider costs 
or other non-risk factors in making a proposed High Priority Substance 
designation (see TSCA Section 6(b) and 40 CFR 702.9).
    This document is intended to fulfill the requirement in TSCA 
section 6(b)(1)(C)(ii) that the Administrator designate 20 chemical 
substances as High-Priority Substances for risk evaluation after 
conducting a review, as required by TSCA section 6(b)(1)(A) (see also 
40 CFR 702.9(a)). After considering additional information collected 
from the proposed designation process, described in Unit III., EPA is 
finalizing the High-Priority Substance designations of the same 20 
chemical substance proposed for High-Priority Substance designations, 
consistent with the scientific standards of TSCA section 26(h) and (i). 
EPA did not consider costs or other non-risk factors in making the 
final priority designations. Instructions on how to access the 
chemical-specific information, analysis, and basis used by EPA to 
support the final designation for each chemical substance can be found 
in Unit IV. A general statement of the condition(s) of use that were 
the primary basis for each designation is contained in Unit IV. In 
accordance with TSCA section 6(b)(3)(C) and 40 CFR 702.11(d), these 
designations will fulfill the statutory requirement to designate at 
least one high-priority substance upon the completion of the first 10 
chemicals selected to undergo risk evaluations from the 2014 Update to 
the TSCA Work Plan pursuant to TSCA section 6(b)(2)(A), as announced on 
December 19, 2016. Pursuant to TSCA section 6(b)(3)(A), the designation

[[Page 71926]]

of these chemical substances as High-Priority Substances constitutes 
the initiation of the risk evaluations on the substances.

III. Information and Comments Received

A. Overview of Public Comments

    For the candidate High-Priority Substances, comments were received 
in two phases:
    (1) A 90-day comment period following the initiation of the 
prioritization process for the 20 chemical substances identified as 
candidates for High-Priority Substance designation. Under TSCA section 
6(b)(1)(C)(i), EPA must ``request interested persons to submit relevant 
information on a chemical substance that [EPA] has initiated the 
prioritization process on, before proposing a priority designation for 
the chemical substance, and provide 90 days for such information to be 
provided'' (Ref. 1). At initiation of the prioritization process, EPA 
published a Federal Register notice identifying the chemical substances 
and providing a general explanation for why the Agency chose to 
initiate prioritization of these chemical substances. During this 
comment period, the public was invited to submit relevant information 
on the chemical substances undergoing prioritization, including, but 
not limited to, any information that may inform the screening review 
conducted pursuant to 40 CFR 702.9(a). The information received was 
considered when developing the proposed designations for the High-
Priority Substances.
    (2) a second 90-day comment period following the proposed High-
Priority Substance designations of the same 20 chemical substances 
identified as candidates for a High-Priority Substance designation. 
Under TSCA section 6(b)(1)(C)(ii), EPA must ``publish each proposed 
designation of a chemical substance as a high- or low-priority 
substance, along with an identification of the information, analysis, 
and basis used to make the proposed designations, and provide 90 days 
for public comment on each such proposed designation'' (Ref. 2). The 
Federal Register notice proposing the designations of these substances 
as high priority for risk evaluation identified how to access the 
chemical-specific information, analysis, and basis used to support the 
proposed designations and announced the availability of a proposed 
designation document for each of the chemical substance undergoing 
prioritization. Interested persons were invited to submit comments on 
EPA's proposed designations, including additional information relevant 
to the chemical substances.
    To the extent that comments from the first phase provided 
information on additional conditions of use for the candidate High-
Priority Substances, those conditions of use were discussed in the 
proposed designation documents for each chemical substance. Other 
submitted information specific to High-Priority Substances (e.g., 
relevant studies and assessments) was considered when making the final 
priority designations and will be considered in subsequent phases of 
the chemical-specific risk evaluations.
    EPA created one general docket to receive comments regarding the 
prioritization process and additional individual chemical dockets to 
receive chemical-specific information. From both comment periods and 
all 21 dockets, EPA received 229 submissions; however, some commenters 
opted for one submission describing all their comments and submitted it 
to multiple dockets while other commenters chose to submit different 
comments to each chemical-specific docket. Therefore, EPA considered 
106 unique comment submissions. EPA received submissions from 52 
different entities, including 11 from private citizens, 26 from 
potentially affected businesses or trade associations, 8 from 
environmental and public health advocacy groups and academia (some 
submissions were signed by more than one group), 6 from other 
organizations, and 1 from a state government. Comments addressed the 
overall prioritization process (e.g., the collection and consideration 
of relevant information), the review process (e.g., the use of data and 
approaches for screening review), information specific to the candidate 
chemical substances (e.g., relevant studies, assessments and conditions 
of use), and topics beyond this prioritization process or not related 
to the prioritization process in general (e.g., scheduling future 
chemicals for prioritization, risk evaluation, risk management, and 
concerns about risk evaluation fees). All comments received are 
identified by docket ID number EPA-HQ-OPPT-2019-0131, or by docket ID 
numbers for the 20 individual High-Priority Substances (see Unit IV.), 
and available at https://www.regulations.gov.
    EPA responded to comments related to the High-Priority Substance 
designations in two general ways: (1) General comments, including 
overarching and cross-cutting policy and process comments, received for 
the candidate High-Priority Substance designations; and (2) chemical-
specific comments received for the candidate High-Priority Substance 
designations (Ref. 3). The response to comments document (Ref. 3) is 
included in docket ID number EPA-HQ-OPPT-2019-0131 and available at 
https://www.regulations.gov. A synopsis of comments received related to 
the prioritization process, and Agency responses follows. Comments 
received, and Agency responses on the topics of ``Request to Revise the 
2014 Update of the TSCA Work Plan,'' ``Risk Evaluation,'' and ``Risk 
Management'' are included in the full response to comments document 
(Ref. 3).

B. Comments on Candidate High-Priority Designations

i. Overall Prioritization Process
a. Agency Approach and Rationale
    Several commenters requested that EPA clearly explain its approach 
to applying the statutory considerations and criteria of TSCA section 
6(b)(1)(A) during the screening review of the candidate chemical 
substances, as well as its rationale for proposed priority 
designations. Specific concerns included how EPA would address 
instances where new data indicated that some Work Plan chemicals 
identified as high-priority candidates might not satisfy the statutory 
criteria, including the TSCA section 26 science standards; how EPA 
ascertains whether the hazard potential information used to support the 
2014 TSCA Work Plan is consistent with the scientific standards of TSCA 
section 26(h); and that ``EPA should establish risk-based screening 
process and criteria'' and ``should not decouple the hazard and 
exposure elements from the risk equation and transform them into 
independent considerations.''
    As required by Congress and codified in the ``Procedures for 
Prioritization of Chemicals for Risk Evaluation Under the Toxic 
Substances Control Act'' Rule (40 CFR 702.1-702.17), there are two 
comment opportunities during the prioritization process, so that the 
public would have time to submit relevant information on the chemical 
substances considered for prioritization. EPA considered the 
information submitted as part of its proposed and final designations, 
in accordance with applicable statutory and regulatory requirements.
    EPA considered several approaches and tools for identifying 
potential candidate chemicals for prioritization. These approaches were 
presented at a December 11, 2017 public meeting (Ref. 4), and there was 
general support for using the 2014 Work Plan chemicals as the starting 
point for identifying

[[Page 71927]]

potential high-priority candidates. TSCA section 6(b)(2)(B) further 
requires that 50 percent of all ongoing risk evaluations be drawn from 
the 2014 TSCA Work Plan for Chemical Assessments. EPA described its 
prioritization in the document, ``A Working Approach for Identifying 
Potential Candidate Chemicals for Prioritization'' (Ref. 5). As 
presented during the meeting, selection of a chemical substance from 
the 2014 Work Plan as a candidate for High-Priority Substance 
designation does not constitute a finding of risk. These chemicals will 
be subject to the prioritization process for determination of high-
priority designation. EPA recognizes that additional information may 
have been identified or developed for chemicals on the 2014 Work Plan 
since its issuance. As each chemical was considered for prioritization, 
EPA has identified and reviewed reasonably available information, 
including any new information and public comments, to ensure that 
information is consistent with the TSCA scientific standards.
    For prioritization, EPA considered sources of information 
consistent with the scientific standards in TSCA section 26(h), 
including the sources listed in Appendices A and B of the ``TSCA Work 
Plan Chemicals Methods Document'' (February 2012), as required by the 
``Procedures for Prioritization of Chemicals for Risk Evaluation Under 
the Toxic Substances Control Act rule (40 CFR 702.9(b)).'' EPA has used 
the most recent information from those sources.
    EPA developed a proposed designation document for each candidate 
chemical substance to identify the information, analysis and basis used 
to support the proposed designation as a High-Priority Substance. These 
documents are available in the respective dockets of each chemical 
substance with a proposed designation as a High-Priority Substance. 
Also included in each document is an explanation of the approach used 
by EPA to conduct the review of the candidate chemical substances. Each 
document includes an overview of the requirements in TSCA section 
6(b)(1)(A) and in the regulation addressing the ``screening review 
criteria'' and considerations for proposed priority designations (40 
CFR 702.9). Those documents describe how EPA considered each of the 
applicable statutory and regulatory requirements and criteria, 
including those related to the ``conditions of use or significant 
changes in conditions of use'' and ``potentially exposed or susceptible 
subpopulations,'' to support the proposed designation.
    EPA considered the information submitted during the two comment 
periods when making its proposed and final designations, in accordance 
with applicable statutory and regulatory requirements. To the extent 
that comments from the first phase provided information on additional 
conditions of use of the candidate High-Priority Substances, those 
conditions of use were discussed in the proposed designation document 
for each chemical substance. Other submitted information specific to 
High-Priority Substances (e.g., relevant studies and assessments) was 
considered when making the final priority designations. EPA is not 
revising the proposed designation documents; however, information 
received during the two comment periods does not need to be re-
submitted and will be considered in subsequent phases of the chemical-
specific risk evaluations.
    TSCA section 6(b)(1)(A) requires EPA to determine whether a 
chemical may present unreasonable risk ``because of a potential hazard 
and a potential route of exposure'' under the conditions of use. EPA 
interpreted this as a requirement to consider hazard and exposure as 
separate factors that together inform the risk-based priority 
designations. EPA also clarifies that the prioritization process did 
not include an update of the 2014 Update to the TSCA Work Plan for 
Chemical Assessments.
b. Potentially Exposed or Susceptible Subpopulations
    A commenter urged EPA to identify relevant potentially exposed or 
susceptible subpopulations (PESS), including infants, children, 
pregnant women, workers, the elderly, and people living in proximity to 
sources of contamination, as well as consider environmental justice 
concerns in the prioritization process. Another commenter indicated 
that ``Tribes must be considered as a sensitive subpopulation under 
TSCA'' given the ``unique lifeways that place them at different risk 
due to multiple exposure pathways not experienced by the general 
population,'' such as diet, housing, worker safety protocols, untreated 
drinking water, daily and ceremonial steam baths, artisanal activities, 
subsistence activities, and recreational activities.''
    While ``potentially exposed or susceptible subpopulations'' is a 
new definition in TSCA, EPA has, in practice, evaluated risks across 
populations, with particular attention to workers, pregnant women, 
children, infants and the elderly, among others (Ref. 6). The Agency 
will continue to use and refine its processes for risk evaluations to 
determine risks to potentially exposed or susceptible subpopulations. 
Human health and environmental hazards, as well as environmental and 
human exposures, including potentially exposed or susceptible 
subpopulations, will be further considered during the development of 
the TSCA scope documents for all High-Priority Substances. 
``Potentially exposed or susceptible subpopulations'' could include 
subpopulations with unique lifeways, such as tribes, and will be 
considered as part of the risk evaluation process for each of the High-
Priority Substances. In addition to requirements under TSCA regarding 
``potentially exposed or susceptible subpopulations,'' the Agency is 
committed to consultation and coordination with Tribes (e.g., EPA 
Policy on Consultation and Coordination with Indian Tribes, https://www.epa.gov/tribal/forms/consultation-and-coordination-tribes).
    In the review conducted for the final designations, EPA considered 
reasonably available information to identify the relevant potentially 
exposed or susceptible subpopulations, such as children, women of 
reproductive age, workers or consumers. EPA analyzed processing and use 
information reported under the Chemical Data Reporting (CDR) Rule, 
which--among other data elements reported--captures manufacturer-
reported information regarding a chemical in children's products. These 
data provide an indication about whether children or other susceptible 
subpopulations may be potentially exposed to the reported chemical. EPA 
also used human health hazard information to identify potentially 
exposed or susceptible subpopulations.
c. Selection of Candidate Chemicals for Prioritization
    Some commenters offered thoughts on future efforts to select 
candidate chemicals for prioritization, including urging EPA to allow 
data to drive the priority designation, to merge the high- and low-
priority considerations into a singular section for potential 
candidates for prioritization, and to give preference in designating 
High-Priority Substances to the substances identified by TSCA section 
6(b)(2)(D).
    Generally, EPA intends to use reasonably available information in 
the prioritization process. EPA generally expects to provide an 
explanation in proposed designation documents for why it chose to 
initiate the process for

[[Page 71928]]

the particular chemical substance (e.g., whether EPA views this as a 
potential candidate for a High- or Low-Priority Substance) (Ref. 7). 
This is to avoid sending 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 or final 
priority designation is not a finding of unreasonable risk by the 
Agency. In addition, EPA further notes that the two comment periods 
provided an opportunity for any interested person to submit additional 
information before EPA finalized a designation for a candidate chemical 
substance.
    In the Federal Register notice initiating the prioritization 
process (Ref. 1) and ``A Working Approach for Identifying Potential 
Candidate Chemicals for Prioritization'' (Ref. 5), EPA described the 
three factors that the Agency generally intends to consider for 
selecting candidates for prioritization. These are (1) Agency 
priorities (with consideration of the priorities of other Federal 
agencies), (2) quantity and quality of information (to ensure that the 
information necessary to prioritize the substance is reasonably 
available), and (3) overall workload to inform the selection of 
candidates (the Agency will be mindful of the complexity associated 
with the assessment of the chemical substance to ensure timely 
completion of prioritization and risk evaluation of each substance) 
(Ref. 5). TSCA requires that EPA give preference to chemical substances 
listed in the 2014 TSCA Work Plan for Chemical Assessments that are 
persistent and bioaccumulative; known human carcinogens; and/or highly 
toxic, based on scores and criteria documented in the 2014 update of 
the TSCA Work Plan for Chemical Assessments and the Work Plans Methods 
Document. TSCA section 6(b)(2)(B) further requires that 50 percent of 
all ongoing risk evaluations be drawn from the 2014 TSCA Work Plan for 
Chemical Assessments. Aside from these statutory preferences, however, 
TSCA does not specifically limit how EPA must ultimately select a 
chemical substance for prioritization. In practice, EPA strives to 
designate as 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) (Ref. 6).
d. Stakeholder Engagement and Transparency
    Several commenters supported stakeholder engagement and 
transparency during the prioritization process, including maintaining 
an open and transparent process that ``encourages submission of the 
most relevant information,'' providing ``greater transparency and 
clarity'' and ``more information to ascertain what information [EPA] 
already has and what information is needed,'' and stating that 
``transparency and information exchange is critical to the success of 
future prioritization efforts.'' Other commenters indicated 
shortcomings with the transparency of the process and/or provided 
recommendations for improvements, including placing all the 
``reasonably available information'' in the dockets for public review, 
increasing transparency about the information received during the 
initiation of public comment period and indicating if EPA used that 
information to screen the chemical against the criteria for proposing a 
priority designation, so that members of the public can comment on such 
information during the proposed designation comment period.
    EPA appreciates the feedback regarding engaging with stakeholders 
and transparency. Regarding the process and criteria used, as described 
in Unit III.A. of the Federal Register notice initiating prioritization 
of the candidates for a high priority designation (Ref. 1), EPA used 
the 2014 Update to the TSCA Work Plan for Chemical Assessments as the 
starting point for identifying potential candidates: (1) Agency 
priorities (with consideration of the priorities of other Federal 
agencies), (2) quantity and quality of information (to ensure that the 
information necessary to prioritize the substance is reasonably 
available), and (3) overall workload (the Agency will be mindful of the 
complexity associated with the assessment of the chemical substance to 
ensure timely completion of prioritization and risk evaluation of each 
substance) (Ref. 5).
    EPA's intention was to engage with stakeholders in a transparent 
manner by publishing the notice initiating the prioritization process 
and the notice with the proposed priority designation, as well as to 
seek relevant reasonably available information from the public (Ref. 
7). EPA developed a proposed designation document for each candidate 
chemical substance to identify the information, analysis and basis used 
to support the proposed High-Priority Substance designations. These 
documents also include citations for all references used in the 
literature review of each of these chemical substances, as requested by 
the commenters, and links to those references that are publicly 
available. EPA's commitment to public engagement will continue 
throughout the risk evaluation process of the 20 chemical substances 
designated as High-Priority Substances.
e. Designation Terminology
    The Agency received comments related to designation terminology, 
including a request to clarify the definition of what is a High-
Priority Substance and that a high-priority designation indicates 
neither risk nor unreasonable risk, given the potential for marketplace 
stigmatization for a chemical substance.
    The Agency is not elaborating on or modifying statutory standards 
for High-Priority and Low-Priority Substances (Ref. 6). The Agency 
believes it is appropriate to rely on the statutory standards for 
designating High-Priority and Low-Priority Substances. These 
definitions have been codified in 40 CFR 702.3 as:

    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.

    However, the commenters are correct that designation as a High-
Priority Substance is not a finding of unreasonable risk; rather a 
final designation as a High-Priority Substance will initiate the risk 
evaluation for the chemical substance. It is through the risk 
evaluation process that EPA determines whether or not the chemical 
substance presents an unreasonable risk of injury to health or the 
environment under the conditions of use (Ref. 2). EPA has included 
clear language for the final designations of High-Priority Chemical 
Substances in that regard.
f. Timeframe for Providing Chemical Substance Information
    Commenters described the challenges in collecting, identifying, 
assessing, and submitting specific chemical data in the 90-day comment 
period following the initiation of the prioritization process including 
challenges gathering information that resides with international 
downstream suppliers, limitations of available data gathering tools, 
and time and resource requirements, including a call for additional 
time during the comment period. Another commenter agreed that EPA 
``could use its authority under

[[Page 71929]]

TSCA 4(a)(1)(A)(i) [to require the development of new information 
before initiating prioritization] and that it could also use its 
authority under 4(a)(1)(A)(ii) for chemicals that meet the statutory 
criteria of being produced and potentially released in substantial 
quantities or if there is potentially significant exposure,'' while 
noting the ``difficulty in making a may present unreasonable risk 
finding as required under 4(a)(1)(A)(i) was among the motivations for 
amending TSCA, and this difficulty would still need to be overcome.'' 
The commenter then stated that ``timing requirements might indeed be 
difficult to meet in some cases, [but] such difficulty does not remove 
the clear requirement under 4(a)(2)(B)(i) to make a priority 
designation within 90 days of receipt of any information requested.''
    EPA understands such challenges and has been committed to giving 
the public and interested stakeholders ample opportunity to provide 
relevant chemical substance information and comment on key aspects of 
the prioritization process in general, as well as for a particular 
chemical substance. The prioritization process was designed, by law, to 
take no fewer than nine months, and no greater than 12 months--a 
timeframe set by Congress to be long enough for interested stakeholders 
to provide the Agency with relevant, necessary information, but not so 
long as to stigmatize the chemical substance for being on an EPA list 
without undergoing a formal risk evaluation. Therefore, EPA does not 
have the discretion to adjust the timeframe for prioritization beyond 
the 12-month limit established by Congress. Within that nine- to 12-
month timeframe under the statute, there are two three-month comment 
periods (following initiation and proposed designation for the 
substances), for a total of six months for public comment during the 
prioritization process. In advance of that process, to facilitate the 
sharing of information by stakeholders and the general public, EPA 
opened dockets for each of the 2014 TSCA Work Plan chemicals and an 
additional general docket to provide the public with a venue for 
submitting use, hazard, and exposure information on these chemicals 
(Ref. 8). As an additional step to expedite information sharing, EPA 
has also separately met with stakeholders interested in providing 
information; summaries of those meetings are docketed for each relevant 
chemical. EPA encourages interested persons to provide chemical 
substance information and other comments as early as possible in the 
process and notes that, for High-Priority Substances, the risk 
evaluation process includes additional opportunities for comment.
    Regarding the Agency's data collection authority, 40 CFR 702.9 
outlines the type of information sources EPA will use to inform the 
screening review described in 40 CFR 702.9. For the 20 chemicals 
identified as candidates for High-Priority Designation, EPA initiated 
the prioritization process with reasonably available information 
necessary to complete the prioritization assessment and make final 
priority designations and considered additional information submitted 
during the two comment periods when making its proposed and final 
designations, in accordance with applicable statutory and regulatory 
requirements. In future prioritization actions, EPA may identify data 
needs and may use the Agency's TSCA authority under TSCA sections 4, 8, 
or 11, as appropriate. EPA may also exercise these authorities for risk 
evaluation purposes.
g. Confidential Business Information
    One commenter urged EPA to implement the requirements of TSCA 
section 14 when prioritizing chemical substances, urging adherence to 
the requirements for disclosure of certain information by the Agency 
and the timing for confidentiality claims and substantiations.
    EPA is committed to meeting its statutory obligations, including 
those in TSCA section 26(j), to make information available to the 
public relating to its basis for priority designations, including 
identification of the information and analysis used. EPA generally 
expects to make the information it uses for decision making publicly 
available, consistent with the requirements of TSCA section 14.
h. International Obligations
    One commenter suggested that EPA designate mercury as a High-
Priority Substance to enable the United States to meet its 
international obligations to reduce mercury use in product 
manufacturing and industrial processes.
    As indicated by the commenter, EPA agrees that it may take into 
consideration relevant international actions, such as multilateral 
environmental agreements, global and regional partnerships, and 
bilateral or international commitments. However, for this first 
prioritization, EPA decided to focus on chemicals listed in the 2014 
Update to the TSCA Work Plan for Chemical Assessments and considered 
three factors (i.e., Agency priorities, quantity and quality of 
information, and overall workload) to inform the selection of 
candidates (Ref. 8). Mercury and mercury compounds were not included in 
the 2014 Update to the TSCA Work Plan because, as stated in the 2014 
Work Plan Update document, their hazards are already well characterized 
and the Agency has a strong risk reduction effort in place.
i. General Support of the Prioritization Process or Proposed 
Designation
    Several commenters supported ``EPA's selection of the substances 
subject to this notice for prioritization for risk evaluation under 
TSCA'' and the pragmatic approach to initiating prioritization using 
the 2014 TSCA Work Plan for Chemical Assessments list and the approach 
to consideration of reasonably available information on exposure 
potential. Other commenters indicated that the proposed designation 
documents for the 20 High-Priority candidate substances establish that 
the chemicals ``may present an unreasonable risk of injury to health or 
the environment because of a potential hazard and potential route of 
exposure under the conditions of use'' and that the proposed chemicals 
meet the High-Priority Substance definition.
    The Agency appreciates this feedback regarding the prioritization 
process and the proposed designations.
j. Designation Conclusions for Specific Chemicals
    EPA received various comments related to its conclusions for 
designating the High-Priority Substances, including trans-1,2-
dichloroethylene, ethylene dibromide, Di-ethylhexyl phthalate (DEHP), 
formaldehyde, and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta [g]-2-benzopyran (HHCB).
    Based on the criteria and considerations set forth in 40 CFR 702.9, 
EPA determined that all candidate High-Priority Substances 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, which is required for designating a chemical 
substance as high priority. With respect to chemical-specific comments 
(including those on trans-1,2-dichloroethylene, ethylene dibromide, and 
DEHP), EPA referenced information submitted by commenters in the 
proposed designation documents and considered additional information 
submitted regarding the proposed designations when making the final 
priority designations. EPA will describe the hazards, exposures, 
conditions of

[[Page 71930]]

use, and potentially exposed or susceptible subpopulations that EPA 
expects to consider in each risk evaluation during the scoping phase of 
the respective TSCA risk evaluations. Any determination of unreasonable 
risk for a condition of use will occur as part of the risk evaluation 
process and will be presented with the draft risk evaluation for which 
the public and peer reviewers will be given an opportunity to review 
and comment on. With respect to comments related to specific candidate 
High-Priority Substances, additional responses are included in the 
Agency's full response to comments document (Ref. 3).
ii. Review Process for Priority Designation
a. Types of Information Considered for Prioritization
    Commenters urged the Agency to consider a variety of information 
sources and to outline the types and quality of data required when 
listing a chemical for the prioritization process, including EPA 
resources and programs, those administered by other domestic and 
international governmental agencies, and information from other public 
and private entities. In particular, several commenters called on the 
Agency to rely on reasonably available information and strive to use 
the best available science; to provide notice, specifications, and 
transparency should new data be required to be developed; and to rely 
on manufacturer-conducted studies ``only if it has access to and 
independently evaluates all available underlying data and discloses the 
full studies to the public without material redaction as required by 
section 14(b) of TSCA'' and industry-generated summaries that 
``faithfully reflect the study findings.''
    EPA determined that the 20 chemical substances were suitable 
candidates for the High-Priority designation based on the Agency's 
review of the reasonably available information, including relevant 
information received from the public and other information, as 
appropriate and cited in the proposed designation documents. The 
reasonably available information was reviewed against the criteria and 
considerations set forth in 40 CFR 702.9 and supported a finding that 
each substance may present unreasonable risk.
    While EPA appreciates the suggestions on information sources that 
EPA should use in its prioritization process, the Agency does not 
believe it would be appropriate to limit its analysis to certain 
specific data sources. EPA expects to consider the reasonably available 
information that is consistent with 15 U.S.C. 2625(k) in conducting its 
review, including information identified by commenters. Furthermore, 
EPA described in detail its approach to determine the quantity and 
quality of information reasonably available for prioritization in the 
document ``A Working Approach for Identifying Potential Candidate 
Chemicals for Prioritization'' (Ref. 5), and in the discussion of the 
Agency's working approach to selecting candidates for designation as 
High-Priority Substances, as described in Unit III.A of the Federal 
Register notice initiating prioritization of the candidates for a high 
priority designation (Ref. 1).
    For the 20 chemicals identified as candidates for High-Priority 
Designation, EPA initiated the prioritization process with reasonably 
available information to complete the prioritization assessment and 
make final priority designations and considered additional information 
submitted during the two comment periods when making its proposed and 
final designations, in accordance with applicable statutory and 
regulatory requirements. In future prioritization actions, EPA may 
identify data needs and may use the Agency's authority under TSCA 
sections 4, 8 or 11, as appropriate. EPA may also exercise these 
authorities for risk evaluation purposes. Human health and 
environmental hazards, as well as environmental exposures and human 
exposures including potentially exposed or susceptible subpopulations, 
will be further considered development of the TSCA scope documents for 
all High-Priority Substances.
    Through the prioritization and risk evaluation processes, EPA 
generally considers reasonably available information consistent with 
the TSCA scientific standards. For prioritization, EPA considered 
sources of information consistent with the scientific standards in TSCA 
section 26(h) and (i), including the sources listed in Appendices A and 
B of the ``TSCA Work Plan Chemicals Methods Document'' (February 2012), 
as required by the ``Procedures for Prioritization of Chemicals for 
Risk Evaluation Under the Toxic Substances Control Act'' rule (40 CFR 
702.11). EPA used the most recent information from those sources. Also, 
EPA recognizes that additional information may have been developed for 
certain chemicals on the 2014 Work Plan, and EPA considered updated 
information as appropriate during the prioritization process. EPA cited 
the references used in each of the proposed designation documents for 
High-Priority Substances.
    As part of the process of using systematic review in the 
development of risk evaluations, EPA will conduct a comprehensive 
search of the reasonably available information about the human health 
and environmental hazards, as well as environmental exposures and 
exposure to the general population, to consumers, workers, and other 
potentially exposed or susceptible subpopulations, for each of the 20 
High-Priority substances. After this data gathering effort, the Agency 
will evaluate the quality of the information and integrate the evidence 
to form overall conclusions about the potential hazards and exposures 
to support the risk characterization for each of the 20 High-Priority 
substances in the TSCA risk evaluation documents. This systematic 
review process will be documented and made public. EPA expects to make 
the information it uses for decision-making publicly available, 
consistent with the requirements of TSCA section 14.
b. Agency Efforts to Describe Data Needs
    Commenters urged EPA to ``continue explicitly outlining the types 
and quality of data required when listing a chemical for the 
prioritization process'' and to provide such information from the 
outset so that stakeholders may contribute information sooner rather 
than later. Another commenter cited the data supporting the EPA's 
chemical prioritization process in stating that ``EPA has provided only 
the barest of rationale for high priority selection, in most cases 
reiterating data used in support of the TSCA workplan listings'' and 
that access was lacking to adequate data to understand EPA's rationale 
in order to comment on this process in a meaningful way.
    The Agency points to the discussion of its working approach to 
selecting candidates for designation as High-Priority Substances: ``A 
Working Approach for Identifying Potential Candidate Chemicals for 
Prioritization'' (Ref. 5) and the explanation that EPA surveyed the 
information and checked quality data elements in a step-wise approach, 
which ensured responsible and timely completion of the prioritization 
process according to TSCA timelines, and opened dockets to allow for 
public comment on the prioritization of each of the chemicals.
    EPA developed a proposed designation document for each substance to 
identify the information, analysis, and basis used to support the 
proposed designation as a High-Priority Substance for risk evaluation. 
The proposed designation documents are available in the docket of each 
of the

[[Page 71931]]

High-Priority Substances. Moreover, these documents describe how EPA 
considered applicable statutory and regulatory requirements and 
criteria for the prioritization process and supported the High-Priority 
designations. Specifically, EPA conducted reviews of each of the 
candidate chemical substances against the criteria and considerations 
set forth in 40 CFR 702.9 and found that each chemical substance ``may 
present unreasonable risk'' under the conditions of use. The 
information sources used are relevant to the applicable criteria and 
considerations, and consistent with the scientific standards of TSCA 
section 26(h), and the sources include, as appropriate, hazard and 
exposure data listed in Appendices A and B of the ``TSCA Work Plan 
Chemicals: Methods Document'' (February 2012) (40 CFR 702.9(b)). 
Therefore, final designation of each chemical substance as a High-
Priority Substance is consistent with TSCA section 26(h) and (i) as 
required under 40 CFR 702.11. These documents also include citations 
for all references used in the literature review of each of these 
chemical substances and links to those references that are publicly 
available.
    The final designation as a High-Priority Substance immediately 
initiates the risk evaluation process as described in 40 CFR 702.17. 
EPA will conduct a systematic review to further characterize the 
hazards and exposures resulting from the relevant TSCA conditions of 
use during the scoping phase of the TSCA risk evaluations for chemicals 
designated as High-Priority Substances.
c. Identification of Conditions of Use and Persistence/Bioaccumulation 
for Prioritization Purposes
    One commenter supported the comprehensive identification of the 
conditions of use in commerce for chemicals during prioritization and 
urged EPA to ``ensure that the conditions of use are clearly 
distinguished from those that may cause a chemical to meet the 
definition for high priority for risk evaluation'' by a comprehensive 
identification of the conditions of use and identification of 
information needs, as early as possible; consideration of incidental 
presence of a chemical as an impurity or releases to the aquatic 
environment or air emissions; and identifying uses with no unreasonable 
risk as early as possible. Similarly, another commenter recommended 
that EPA evaluate chemicals in such a way as to identify the conditions 
of use that meet the high priority criteria and identify conditions of 
use that do not present an unreasonable risk at all, stating this 
approach would ``prevent stigmatizing large number of chemicals by 
incorrectly suggesting that entire categories of chemicals are unsafe 
for any type of use, regardless of exposure potential.'' Conversely, 
another commenter indicated that EPA could designate a chemical 
substance as High-Priority for risk evaluation based on only a few 
conditions of use. Other commenters offered specific suggestions for 
EPA's consideration of conditions of use, including: Exempting the 
import of articles and fluids, adhesives, greases, etc. contained 
within articles and not designed to be released during the use of the 
article; as well as a similar exemption for replacement parts; 
clarifying about the conditions of use on which a chemical is proposed 
as a High-Priority Substance and whether uses ``surrounding'' 
pesticides, food additives, drugs or cosmetics exclude them from the 
TSCA definition of a chemical substance; and consulting with downstream 
users to complement the information and to engage stakeholders to 
develop a process to improve the understanding of conditions of use. A 
commenter supported the use of physical/chemical characteristics and 
environmental fate data as indicators for ascertaining the potential 
for persistence and bioaccumulation for prioritization purposes. The 
commenter recommended that EPA consider more recent developments in 
understanding of persistence and bioaccumulation and update the 
criteria applied to the 2014 TSCA Work Plan for Chemical Assessments.
    EPA developed a proposed designation document for each substance to 
identify the information, analysis and basis used to support the 
proposed designation as a High-Priority Substance for risk evaluation. 
The proposed designation documents are available in the docket of each 
of the High-Priority Priority Substances (see Unit IV.). These 
documents describe how EPA considered applicable statutory and 
regulatory requirements and criteria for the prioritization process and 
supported the High-Priority designations. Specifically, EPA presented 
the reviews of each of the candidate chemical substances against the 
criteria and considerations set forth in 40 CFR 702.9 and found that 
each chemical substance ``may present unreasonable risk'' under the 
conditions of use. EPA determined that all candidate High-Priority 
Substances may present unreasonable risk for at least one condition of 
use, which is required for designating a chemical substance as a high 
priority for risk evaluation.
    EPA identified non-TSCA uses that were reported or known to EPA in 
the proposed designation documents to provide interested persons with a 
comprehensive description of the uses of the individual chemical 
substances undergoing prioritization. However, in the scope documents 
for each High-Priority Substance, EPA will present the conditions of 
use covered under TSCA that EPA expects to consider in the risk 
evaluation.
    Designation as a High-Priority Substance is not a finding of 
unreasonable risk; rather, a final designation as a High-Priority 
Substance initiates the risk evaluation for such chemical substance. 
Furthermore, during the risk evaluation process, EPA will determine 
whether or not the chemical substance presents an unreasonable risk of 
injury to health or the environment under the conditions of use. If 
unreasonable risk is identified, then the Agency will initiate any 
necessary risk management actions to address such risks. At that point, 
TSCA section 6(g) exemptions could be considered. EPA is also 
clarifying that the prioritization process did not include an update of 
the 2014 Update to the TSCA Work Plan for Chemical Assessments.
d. Reasonably Available Information for Prioritization
    A commenter called upon the Agency to define ``sufficiency of 
information'' and clarify how the Agency would treat exposure data gaps 
before initiating the prioritization process to ``help industry submit 
necessary information during the prioritization process.'' Similarly, 
other commenters stated that a lack of information should not lead to 
an assumption that a potential hazard or a route of exposure is absent 
and offered suggestions on minimum amounts and/or specific kinds of 
data EPA would need to make determinations for developmental toxicity, 
reproductive toxicity, carcinogenicity, and adverse endocrine effects.
    EPA has purposefully decided not to establish a threshold for 
``sufficient information.'' The Agency does not wish to create a bright 
line that could lead to High[hyphen]Priority designations and the 
initiation of risk evaluations because EPA bound itself to an 
inflexible ``sufficiency'' standard (Ref. 6). For the 20 chemicals 
identified as candidates for High-Priority Designation, EPA initiated 
the prioritization process with reasonably available information 
necessary to complete the prioritization assessment and make final 
priority

[[Page 71932]]

designations and considered additional information submitted during the 
two comment periods when making its proposed and final designations, in 
accordance with applicable statutory and regulatory requirements. In 
future prioritization actions, EPA may identify data needs and may use 
the Agency's authority under TSCA sections 4, 8 or 11, as appropriate. 
EPA may also exercise these authorities for risk evaluation purposes. 
Furthermore, EPA notes that section 4(a)(2)(1)(ii) indicates: 
``information required by the Administrator under this subparagraph 
shall not be required for the purposes of establishing or implementing 
a minimum information requirement of broader applicability.''
e. Storage Near Significant Sources of Drinking Water
    One commenter asked the Agency to define ``near'' and 
``significant'' in the context of ``near significant sources of 
drinking water'' and suggested the use of EPA's ``Drinking Water 
Mapping Application to Protect Source Waters (DWMAPS)'' to do so. 
Another commenter indicated that EPA used a reasonable approach for 
screening the first 20 chemicals as High-Priority Substances; however, 
EPA should consider use of improved exposure models that can better 
predict fate and environmental partitioning into water sources. Another 
commenter urged the Office of Pollution Prevention and Toxics within 
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) to 
coordinate with the Office of Ground Water and Drinking Water to 
``effectively prioritize chemicals which have the potential of 
impacting drinking water sources, both ground water and surface 
water.''
    EPA believes that Congress included ``storage near significant 
sources of drinking water'' as a potential human health hazard and 
exposure consideration, given that chemicals that are stored near water 
have a greater potential to enter that water (Ref. 6). In each proposed 
designation document, EPA explains its analysis of the ``storage near 
significant sources of drinking water'' under 40 CFR 702.9 as follows: 
``The statute specifically requires the Agency to consider the chemical 
substance's storage near significant sources of drinking water, which 
EPA interprets as direction to focus on the chemical substance's 
potential human health hazard and exposure. EPA reviewed reasonably 
available information, specifically looking to identify certain types 
of existing regulations or protections for the proposed chemical 
substances. EPA considered the chemical substance's potential human 
health hazards, including to potentially exposed or susceptible 
subpopulations, by identifying existing National Primary Drinking Water 
Regulations under the Safe Drinking Water Act (SDWA; 40 CFR part 141) 
and regulations under the [Clean Water Act] (40 CFR 401.15). In 
addition, EPA considered the consolidated list of chemical substances 
subject to reporting requirements under [the Emergency Planning and 
Community Right-to-Know Act] (Section 302 Extremely Hazardous 
Substances and Section 313 Toxic Chemicals), [the Comprehensive 
Environmental Response, Compensation, and Liability Act] (Hazardous 
Substances), and [the Clean Air Act] (Section 112(r) Regulated 
Chemicals for Accidental Release Prevention). Regulation by one of 
these authorities is an indication that the substance is a potential 
health or environmental hazard which, if released near a significant 
source of drinking water, could present unreasonable risk of injury to 
health or the environment.''
    EPA has also considered suggestions for how ``storage near 
significant sources of drinking water'' might be interpreted and 
applied (Ref. 6). As necessary, EPA will consider overarching Agency 
priorities in selecting chemicals for prioritization, including 
information and analysis conducted by the Office of Ground Water and 
Drinking Water. EPA's document, ``A Working Approach for Identifying 
Potential Candidate Chemicals for Prioritization'' (Ref. 5), states 
that the process to select chemicals ``may include . . . chemicals that 
other EPA program offices have deemed a priority for their program and 
suitable for current prioritization.''
iii. Submitted Data and Information
a. Data and Information on Hazard and Exposure Potential
    A commenter provided information for all candidate chemicals for 
High-Priority designation regarding: (1) Assessments conducted by other 
federal agencies/countries, (2) information from ChemView, (3) 
availability of workplace exposure data in OSHA's database, and (4) 
Registration, Evaluation, Authorisation and Restriction of Chemicals 
registration and evaluation information. The commenter highlighted the 
dermal test data for p-dichlorobenzene, 1,2-dichlorobenzene, and 1,2-
dichloropropane. Other commenters submitted chemical-specific 
information for: 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] 
(TBBPA); [d]ibutyl phthalate (DBP); HHCB; formaldehyde; Butyl benzyl 
phthalate (BBP)--1,2-Benzene- dicarboxylic acid, 1- butyl 
2(phenylmethyl) ester; phthalic anhydride; 1,2-dichloroethane; and 1,3-
butadiene. With respect to comments related to specific candidate High-
Priority Substances, additional information submitted is included in 
the Agency's full response to comments document (Ref. 3).
    EPA appreciates the chemical-specific information submitted during 
the two comment periods. EPA referenced chemical-specific information 
submitted by commenters after initiation in the proposed designation 
documents and considered additional information submitted regarding the 
proposed designations when making the final priority designations. 
While EPA is not revising the proposed designation documents, all 
information received will be considered in the chemical-specific risk 
evaluation process. EPA will describe the hazards, exposures, 
conditions of use, and potentially exposed or susceptible 
subpopulations that EPA expects to consider in each risk evaluation 
during the scoping phase of the respective TSCA risk evaluations. Any 
determination of unreasonable risk for a condition of use will occur as 
part of the risk evaluation process and will be presented with the 
draft risk evaluation that the public and peer reviewers will be given 
an opportunity to review and comment on.
    EPA identified reasonably available environmental and human health 
hazard information to evaluate potential hazard of the chemical, 
including studies reporting developmental toxicity and neurotoxicity. 
EPA will conduct a systematic review to further characterize the 
hazards and exposures resulting from the relevant TSCA conditions of 
use during the scoping phase of the TSCA risk evaluations for chemicals 
designated as High-Priority Substances.
    In the Procedures for Prioritization of Chemicals for Risk 
Evaluation Under the Toxic Substances Control Act Final Rule (Ref. 7), 
EPA agreed that the consideration of alternatives is most appropriately 
considered as part of any risk management rule.
b. Data and Information on Potentially Exposed or Susceptible 
Subpopulations
    A commenter stated ``[t]he general population, as well as 
vulnerable subpopulations, are commonly exposed to formaldehyde through 
both indoor and outdoor air pollution (e.g., industrial processes and 
automotive exhaust). Workplace exposures are also a significant 
concern, given the breadth

[[Page 71933]]

of industries in which formaldehyde is known to be used or otherwise 
present.'' Another commenter supported EPA's high-priority designation 
of 1,3-butadiene and also supports designating firefighters and 
emergency medical personnel as susceptible populations, citing 
classification of 1,3-butadiene as carcinogenic to humans. Another 
commenter provided technical reports for some of the proposed High-
Priority Substances that provide an overview of potentially exposed or 
susceptible subpopulations for these chemicals. Another commenter 
provided additional information regarding uses, production volume, 
production sites, and impurities for phthalic anhydride, butyl benzyl 
phthalate, formaldehyde and 1,3-butadiene. With respect to comments 
related to specific candidate High-Priority Substances, additional 
information is included in the Agency's full response to comments 
document (Ref. 3).
    EPA will consider reasonably available information to characterize 
the environmental and human exposures, including potentially exposed or 
susceptible subpopulations, resulting from the conditions of use during 
the scoping phase of the TSCA risk evaluations for chemicals designated 
as High-Priority Substances.
    As indicated in the proposed designation documents, when relevant, 
workers will be considered potentially exposed or susceptible 
subpopulations, such as firefighters and emergency medical personnel. 
EPA will also consider human health hazard information to identify 
potentially exposed or susceptible subpopulations, such as 
developmental effects, uterine cancer, or reproductive system effects. 
With respect to concerns raised regarding workplace exposures to 
formaldehyde, workers were identified as a subpopulation that may be 
potentially exposed or susceptible subpopulation in the proposed 
designation document for formaldehyde.
c. Conditions of Use or Significant Changes in Conditions of Use
    EPA received various comments offering information related to 
condition of use for candidate High-Priority Substances, including:
     Uses of phthalic anhydride, formaldehyde, 1,3-butadiene, 
BBP, diisobutyl phthalate, dicyclohexyl phthalate, triphenyl phosphate, 
1,1,2-trichloroethane, 1,2-dichloroethane, dibutyl phthalate, 
diethylhexyl phthalate, and TBBPA in paints, coatings, sealants and 
adhesives;
     A variety of uses in the aerospace industry for most of 
the candidate High-Priority Substances;
     Use of trans-1,2-dichloroethylene in the formulation of 
products ``which are distributed and sold to industrial end users, 
primarily for use in the area of medium and heavy-duty solvent 
precision cleaning, rinsing, and drying;''
     Use of ethylene dibromide is involved in the production of 
fuels; and
     Uses in automobiles for 15 of 20 of the proposed High-
Priority Substances (o-dichlorobenzene, trans-1,2-DCE, 1,2-
dichloroethane, 1,1,2-trichloroethane, DBP, BBP, DEHP, Di-isobutyl 
phthalate, Dicyclohexyl phthalate, TBBPA, Tris(2-chloroethyl) 
phosphate, TPP, 1,3-butadiene, formaldehyde and phthalic anhydride).
    EPA referenced information submitted by commenters in the proposed 
designation documents and considered reasonably available information, 
including public comments, when making the final priority designations. 
EPA will consider the relevant information on conditions of use 
submitted by commenters during the scoping phase of the respective TSCA 
risk evaluations. Any determination of unreasonable risk for a 
condition of use will occur as part of the risk evaluation process and 
will be presented with the draft risk evaluation that the public and 
peer reviewers will be given an opportunity to review and comment on.
    In the preamble for the Procedures for Prioritization of Chemicals 
for Risk Evaluation Under the Toxic Substances Control Act Final Rule 
(Ref. 7), EPA agreed that the consideration of alternatives is most 
appropriately addressed as part of any risk management rule. With 
respect to comments related to specific candidate High-Priority 
Substances, the full comment and description of information submitted 
are included in the Agency's full response to comments document (Ref. 
3).
iv. Comments Related to the Long-Term Prioritization Process
a. Future and Long-Term Process To Select Candidate Substances for 
Prioritization
    A commenter stated that ``[i]t is critical that the approaches EPA 
adopts for the selection of high priority and low priority candidates 
for further evaluation be consistent with the intent of the Lautenberg 
Chemical Safety Act . . . , because it will set precedent for how EPA 
identifies, evaluates and regulates chemicals in the future.'' Other 
commenters urged EPA to establish a predictable and routine schedule 
and to continue to engage stakeholders to articulate and clearly define 
its binning process. Another commenter requested that the Agency 
``finalize and release its [`]proof of concept['] white paper on 
[`]longer term['] prioritization soon.''
    The Agency appreciates this feedback and will take this information 
into consideration as it develops a longer-term prioritization 
strategy. As EPA stated in the document, ``A Working Approach for 
Identifying Potential Candidate Chemicals for Prioritization'' (Ref. 
5), the approach for identifying candidates for prioritization is 
expected to evolve over time as EPA develops expertise in identifying 
chemicals to enter prioritization, as well as in conducting 
prioritization and risk evaluations.
    For the long-term, EPA's goal is to develop a procedure to inform 
selection of candidates for prioritization that integrates information 
from new-approach methodologies (NAMs) using alternative testing data 
and information from traditional studies (e.g., hazard, exposure, 
engineering, fate), and that builds on the TSCA Work Plan for Chemical 
Assessments methodology. Consistent with the Working Approach document, 
EPA also will consider federal government priorities and other 
interests when considering candidates for prioritization.
b. Use of Categories
    One commenter indicated that in future efforts EPA may select 
categories of similar chemicals to prioritize together and, because of 
difficulties associated with categories of similar chemicals, urged EPA 
to ``make sure that the categories have clear and well-defined 
boundaries . . . [and] further clarify the criteria used to define 
chemical categories, such as similarities on structure, biology, or use 
. . . [and] provide a CAS Number for each chemical in the entire 
category . . . [and ensure] that the chemical accurately depicts the 
level of concern appropriate for all the other chemicals associated 
with the category.''
    As stated in the preamble for the Procedures for Prioritization of 
Chemicals for Risk Evaluation Under the Toxic Substances Control Act 
Final Rule (Ref. 7), ``TSCA section 26 provides EPA with authority to 
take action on categories of chemical substances.'' Furthermore, ``. . 
. 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

[[Page 71934]]

prioritization'' and ``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.''

IV. Designation as High-Priority Substances for Risk Evaluation

    Based on the information provided in the August 2019 proposed 
designation documents, as referenced in the August 23, 2019 notice 
(Ref. 2), and public comments received, including information 
pertaining to individual chemical substances, EPA is designating the 
same 20 chemicals as High-Priority Substances for risk evaluation. 
Pursuant to 40 CFR 702.11, which states: ``For High-Priority 
Substances, EPA generally expects to indicate which condition(s) of use 
were the primary basis for such designations.'' For all 20 High-
Priority Substances the manufacturing, processing, and conditions of 
use formed the primary basis for the designation. The final High-
Priority Substance designations are:

    1. 1,3-Butadiene, CASRN 106-99-0, Docket ID number: EPA-HQ-OPPT-
2018-0451.
    2. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 
1-butyl 2-(phenylmethyl) ester), CASRN 85-68-7, Docket ID number: 
EPA-HQ-OPPT-2018-0501.
    3. Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-
dibutyl ester), CASRN 84-74-2, Docket ID number: EPA-HQ-OPPT-2018-
0503.
    4. o-Dichlorobenzene (Benzene, 1,2-dichloro-), CASRN 95-50-1, 
Docket ID number: EPA-HQ-OPPT-2018-0444.
    5. p-Dichlorobenzene (Benzene, 1,4-dichloro-), CASRN 106-46-7, 
Docket ID number: EPA-HQ-OPPT-2018-0446.
    6. 1,1-Dichloroethane, CASRN 75-34-3, Docket ID number: EPA-HQ-
OPPT-2018-0426.
    7. 1,2-Dichloroethane, CASRN 107-06-2, Docket ID number: EPA-HQ-
OPPT-2018-0427.
    8. trans-1,2-Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-), 
CASRN 156-60-5, Docket ID number: EPA-HQ-OPPT-2018-0465.
    9. 1,2-Dichloropropane, CASRN 78-87-5, Docket ID number: EPA-HQ-
OPPT-2018-0428.
    10. Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-
dicyclohexyl ester), CASRN 84-61-7, Docket ID number: EPA-HQ-OPPT-
2018-0504.
    11. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic 
acid, 1,2-bis(2-ethylhexyl) ester), CASRN 117-81-7, Docket ID 
number: EPA-HQ-OPPT-2018-0433.
    12. Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid, 
1,2-bis(2-methylpropyl) ester), CASRN 84-69-5, Docket ID number: 
EPA-HQ-OPPT-2018-0434.
    13. Ethylene dibromide (Ethane, 1,2-dibromo-), CASRN 106-93-4, 
Docket ID number: EPA-HQ-OPPT-2018-0488.
    14. Formaldehyde, CASRN 50-00-0, Docket ID number: EPA-HQ-OPPT-
2018-0438.
    15. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-
2-benzopyran (HHCB), CASRN 1222-05-5, Docket ID number: EPA-HQ-OPPT-
2018-0430.
    16. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA), 
CASRN 79-94-7, Docket ID number: EPA-HQ-OPPT-2018-0462.
    17. Phosphoric acid, triphenyl ester (TPP) CASRN 115-86-6, 
Docket ID number: EPA-HQ-OPPT-2018-0458.
    18. Phthalic anhydride (1,3-Isobenzofurandione), CASRN 85-44-9, 
Docket ID number: EPA-HQ-OPPT-2018-0459.
    19. 1,1,2-Trichloroethane, CASRN 79-00-5, Docket ID number: EPA-
HQ-OPPT-2018-0421.
    20. Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-, 
1,1',1''-phosphate), CASRN 115-96-8, Docket ID number: EPA-HQ-OPPT-
2018-0476.

    The designations are based on the conclusion that each chemical 
substance satisfies the definition of High-Priority Substance in TSCA 
section 6(b)(1)(B) and 40 CFR 702.3. EPA developed a document for each 
substance to identify the information, analysis and basis used to 
support the proposed designations as a High-Priority Substance for risk 
evaluation. These documents are available in the docket of each of the 
chemical substances with a proposed designation as a High-Priority 
Substance for risk evaluation. Also included in each document is an 
explanation of the approach used by EPA to conduct the review. Each of 
the documents includes an overview of the requirements in TSCA section 
6(b)(1)(A) and the regulatory section addressing the following review 
criteria and considerations (40 CFR 702.9).
    These designated High-Priority Substances will fulfill the 
statutory requirement to designate at least one high-priority substance 
upon the completion of the first 10 chemical substances selected to 
undergo risk evaluations from the 2014 Update to the TSCA Work Plan 
pursuant to TSCA section 6(b)(2)(A), as announced on December 19, 2016 
(see TSCA section 6(b)(3)(C)). Pursuant to TSCA section 6(b)(3)(A), the 
designation of these chemical substances as High-Priority Substances 
constitutes the initiation of the risk evaluations on the substances.
    A designation of a chemical substance as a High-Priority Substance 
is not a finding of unreasonable risk; rather, a final designation as a 
High-Priority Substance initiates the risk evaluation for the chemical 
substance. This is a three-year process that will culminate in a 
finding of whether or not the chemical substance presents an 
unreasonable risk of injury to health or the environment under the 
conditions of use. The chemical-specific designation documents 
containing the information, analysis and basis used to support the 
proposed designations are located in the docket for each chemical 
substance. As previously discussed, to the extent that comments 
provided information on additional conditions of use for the candidate 
High-Priority Substances for risk evaluation, those conditions of use 
were noted in the proposed designation documents for each chemical 
substance and will be reflected in the draft scope of the risk 
evaluation for each chemical substance, which will include the 
conceptual model and analysis plan for carrying out the evaluation. As 
such, EPA will not amend the proposed designation documents. Instead, 
additional submitted information specific to High-Priority Substances 
(e.g., relevant studies and assessments) will be considered in 
subsequent phases of risk evaluation, including draft scope documents 
and draft risk evaluation documents, both of which will be subject to 
public comment opportunities.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket for this action includes these 
documents and other information considered by EPA, including documents 
that are referenced within the documents that are included in the 
docket. For assistance in locating these referenced documents, please 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

    1. EPA. Initiation of Prioritization Under the Toxic Substances 
Control Act (TSCA). Notice. Federal Register. (84 FR 10491, March 
21, 2019) (FRL-9991-06).
    2. EPA. Proposed High-Priority Substance Designations Under the 
Toxic Substances Control Act (TSCA). Federal Register. (84 FR 44300, 
August 23, 2019) (FRL-9998-29).
    3. EPA. EPA's Responses to Public Comments Received on the 
``Proposed High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA).'' December 20, 2019.
    4. EPA. Meetings: New Chemicals Review Program Implementation, 
etc. Federal Register. (82 FR 51415; November 6, 2017) (FRL-9970-
34).
    5. EPA. ``A Working Approach for Identifying Potential Candidate 
Chemicals for Prioritization.'' (https://www.epa.gov/sites/production/files/2018-09/documents/preprioritization_white_paper_9272018.pdf). September 27, 2018.

[[Page 71935]]

    6. EPA. ``Procedures for Prioritization of Chemicals for Risk 
Evaluation under TSCA''--Response to Public Comments (EPA-HQ-OPPT-
2016-0636-0076). June 21, 2017.
    7. EPA. Procedures for Prioritization of Chemicals for Risk 
Evaluation Under the Toxic Substances Control Act. Federal Register. 
(82 FR 33753, July 20, 2017) (FRL-9964-24).
    8. EPA. A Working Approach for Identifying Potential Candidate 
Chemicals for Prioritization; Notice of Availability. Federal 
Register. (83 FR 50366, October 5, 2018) (FRL-9983-38).

(Authority: 15 U.S.C. 2601 et seq.)

    Dated: December 20, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-28225 Filed 12-27-19; 8:45 am]
BILLING CODE 6560-50-P