High-Priority Substance Designations Under the Toxic Substances Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority Substances; Notice of Availability
| Citation | 84 FR 71924 |
| Record Number | 2019-28225 |
| Published date | 30 December 2019 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 249 (Monday, December 30, 2019)
[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
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, 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 http://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
