EPA's Responses to Public Comments Received on the
"Initiation of Prioritization Under the Toxic Substances Control Act (TSCA)" and
"Proposed High-Priority Substance Designations Under the Toxic Substances Control Act
(TSCA)"
December 19, 2019
In this document, EPA is responding to overarching, cross-cutting policy and process comments, as well
as chemical-specific comments received during the two public comment periods regarding the
announcement of candidates to initiate prioritization and the proposed designations for High-Priority
Substances for risk evaluation.
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 (84 FR
10491, March 21, 2019). 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 (84 FR 44300, August 23, 2019). 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 a total of 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 of
those submissions unique. In addition, one submission, which was submitted to all 21 dockets, is
considered a mass mailing campaign since it was endorsed by 60 individuals. For those submissions in
multiple dockets that were identical or very similar, only one docket is referenced in the summary
below. EPA received submissions from 52 different entities, including 11 from private citizens, 26 from
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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 (e.g., scheduling future chemicals for prioritization, risk
evaluation, risk management and concerns about risk evaluation fees). Two comments were on topics
not related to prioritization.
Overall Prioritization Process
Approach and Rationale
Comment: 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 (EPA-HQ-OPPT-2019-
0131 -0005, EPA-HQ-OPPT-2019-0131 -0006, EPA-HQ-OPPT-2019-0131-0011).
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0006/EPA-HQ-OPPT-2019-0131-0018) requested
an explanation of how EPA would address instances where new data indicated that "some Work Plan
chemicals identified as high priority candidates might not satisfy the TSCA Section 6 prioritization
screening criteria and/or definition of a high priority or even the TSCA Section 26 science standards."
The commenter also requested clarification on 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), inclusion of more detail of TSCA section 26(h) review in its proposed designation
support documents, and indication of whether the Agency has updated an information source.
Comment. Another comment (EPA-HQ-OPPT-2019-0131-0013) stated 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."
Response: 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 sections 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 andfinal 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, 2017public meeting (EPA-HQ-
general support for using the 2014 Work Plan chemicals as the starting point for identifying 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 efforts in the document "A Working Approach for Identifying Potential Candidate
Chemicals for Prioritization " https://www.eva.sov/sites/productkm/files/2018-
09/documents/preprioritization white paper 92 72018.pdf. As presented during the meeting, selection
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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 developedfor 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 andB 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
andfinal 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. " 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.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0011) urged EPA to "accurately 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." The same
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commenter called for "ensuring] that environmental justice is appropriately considered, analyzed, and
addressed in the prioritization process." Another commenter (EPA-HQ-OPPT-2019-0131-0016)
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. The
commenter cited a Scientific Advisory Committee on Chemicals (SACC) recommendation to include an
illustration of the exposure routes for potentially sensitive or highly exposed populations.
Response: 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 ("Procedures for Prioritization of Chemicals
for Risk Evaluation under TSCA " - Response to Public Comments (EPA-HQ-OPPT-2016-0636-0076)).
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 (The EPA Policy on Consultation
and Coordination with Indian Tribes httm://www.eim.sov/tribal/fbrms/comultatkm-and-coordinatkm-
tribes).
In the review conducted for the final designations, EPA considered reasonably available information1
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.
Comment: Other comments (EPA-HQ-OPPT-2019-0131-0012, EPA-HQ-OPPT-2019-0131-0013)
cautioned that TSCA prioritization is a process without a pre-determined outcome and the data should
drive the priority designation. One commenter (EPA-HQ-OPPT-2019-0131-0013) suggested that "EPA
should instead merge the high- and low-priority considerations into a singular section for potential
candidates for prioritization."
Response: 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
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain and synthesize
for use, considering the deadlines specified in 15 U.S.C. 20605(b) for prioritization and risk evaluation. Information that
meets such terms is reasonably available information whether or not the information is confidential business information that
is protected from public disclosure under 15 U.S.C. 2613. (40 CFR 702.3 Definitions).
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initiate the process for the particular chemical substance (e.g., whether EPA views this as a potential
candidate for High or Low priority) ("Procedures for Prioritization of Chemicals for Risk Evaluation
Under the Toxic Substances Control Act rule (82 FR 33759)). 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.
Comment: A commenter (EPA-HQ-OPPT-2019-0131 -001 l/EPA-HQ-OPPT-2019-0131 -0019) stated,
"EPA has violated TSCA § 6(b)(2)(D) by failing to give preference in designating high priority
substances to the substances identified by that provision."
Response: In the Federal Register notice initiating the prioritization process and "A Working Approach
for Identifying Potential Candidate Chemicals for Prioritization "
(https://www.eva.gov/sites/production/files/2018-
09/documents/preprioritization white paper 9272018.pdf), 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). 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 Plan
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) (82 FR 33 753 at 33758, July 20, 2017).
Comment: Several commenters supported stakeholder engagement and transparency during the
prioritization process. According to one commenter (EPA-HQ-OPPT-2019-0131-0004), EPA should
continue to engage stakeholders to maintain an open and transparent process that "encourages
submission of the most relevant information." Another commenter (EPA-HQ-OPPT-2019-0131-0006)
called upon the Agency to provide "greater transparency and clarity" and "more information to ascertain
what information [EPA] already has and what information is needed." The commenter also requested
that EPA "makes its most up-to-date literature review of each of these candidate chemicals available at
the initiation of prioritization stage to interested stakeholders," and that the Agency "clarify what criteria
it used to 'narrow' the candidate chemicals from the large sets of chemicals to the candidate lists of 20
high priorities and 20 low priorities." Another commenter (EPA-HQ-OPPT-2019-0131-0011) indicated
appreciation for EPA's efforts to keep the regulated community engaged and stated 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. A commenter (EPA-HQ-OPPT-2019-0131-0011) called for placing all the "reasonably
available information" in the dockets for public review. A commenter (EPA-HQ-OPPT-2019-0131-
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0018) indicated that EPA must be more transparent about the information received during the public
comment period following the initiation of the prioritization process and indicate whether 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 comment period following the
proposed designations. The commenter suggested that EPA should strive to be more transparent about
the basis for its prioritization decisions and the information used to decide inclusion of a chemical in the
2014 TSCA Work Plan for Chemical Assessments.
Response: 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 (84 FR 10491, March 21,
2019), EPA used the 2014 Update to the TSCA Work Plan for Chemical Assessments as the starting
point for identifying potential candidates and then considered three factors to inform the selection of
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 ofprioritization
and risk evaluation of each substance) ("A Working Approach for Identifying Potential Candidate
Chemicals for Prioritization " httm://www.eva.sov/sites/vroductkm/files/2()18-
09/documents/preprioritizalion white papet 018.pdf).
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 ("Procedures for Prioritization of
Chemicals for Risk Evaluation Under the Toxic Substances Control Act Final Rule " (82 FR 33 753-
33764, July 20, 2017)). 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 designation. These documents also include citations for all references used in the literature
review of each of these chemical substances, as requested by the commenter s, 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.
Designation Terminology
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0006) called for "greater clarity" for the
definitions of High- and Low-Priority Substances and noted that EPA "largely recite[d] the statutory
definitions."
Response:
The Agency is not elaborating on or modifying statutory standards for High-Priority and Low-Priority
Substances ("Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA " - Response
to Public Comments (EPA-HQ-OPPT-2016-0636-0076)). 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
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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 standardfor a High-Priority Substance.
Comments: Several comments (EPA-HQ-OPPT-2019-0131-0006, EPA-HQ-OPPT-2019-0131-0012,
EPA-HQ-OPPT-2019-0131-0013, EPA-HQ-OPPT-2019-0131-0018) reiterated EPA's explanation that
designation of a substance as a High-Priority Substance is not a finding of risk. Rather, when
prioritization is completed, if a chemical is designated as a High-Priority Substance, EPA will initiate
the risk evaluation process. One commenter (EPA-HQ-OPPT-2019-0131-0013) encouraged EPA to
provide such disclaimer language widely (e.g. website, Federal Register designation notice, etc.).
Response: The commenter s 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 (84 FR 44300, August 23, 2019). EPA has included clear
language for the final designations of High-Priority Chemical Substances in that regard.
Timeframe for Providing Chemical Substance Information
Comments: Two commenters (EPA-HQ-OPPT-2019-0131-0007, EPA-HQ-OPPT-2019-0131-0013)
described the challenges to 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. One commenter (EPA-HQ-OPPT-2019-0131-
0013) called for additional time during the comment period.
Response: 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 9 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 9- to 12-month timeframe under the statute, there are two 3-month comment periods
(following initiation and proposed designation for the substances), for a total of 6 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 (Federal Register Notice announcing the
availability of the "Working Approach for Identifying Potential Candidate Chemicals for Prioritization"
(83 FR 50366, October 5, 2018). As an additional step to expedite information sharing, EPA has also
separately met with stakeholders interested in providing information; summaries of those meetings are
docketedfor 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.
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Comment: One commenter (EPA-HQ-OPPT-2019-0131-0005) agreed that EPA "could use its authority
under TSCA 4(a)(l)(A)(i) [to require the development of new information before initiating
prioritization] and that it could also use its authority under 4(a)(l)(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)(l)(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."
Response: EPA appreciates the 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 Substance 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 authority under TSCA sections 4, 8 or 11, as
appropriate. EPA may also exercise these authorities for risk evaluation purposes.
Confidential Business Information
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0011/EPA-HQ-OPPT-2019-0131-0019) urged
EPA to implement the requirements of TSCA section 14 when prioritizing chemical substances or
during risk evaluation, urging adherence to the requirements for disclosure of certain information by the
Agency and the timing for confidentiality claims and substantiations. The commenter stated, "EPA must
disclose information as provided under TSCA § 14 and cannot rely on its general FOIA regulations to
withhold information that must be disclosed by statute. All claims for confidential protection must be
asserted at the time of submission of the information to EPA and must be substantiated at that time
unless they meet one of the exceptions specified in TSCA section 14(c)(2)." The commenter indicates
that CDR information regarding conditions of use claimed CBI should be timely reviewed by EPA in
accordance with TSCA section 14.
Response: 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.
International Obligations
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0009/EPA-HQ-OPPT-2019-0131-0023)
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.
Response: 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
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workload) to inform the selection of candidates ("A Working Approach for Identifying Potential
Candidate Chemicals for Prioritization " https://www.eDa.sov/sites/Droduction/files/2018-
09/documents/preprioritization white papei vdf). 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.
General Support of the Prioritization Process or Proposed Designation
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0005) supported "EPA's selection of the
substances subject to this notice for prioritization for risk evaluation under TSCA." Another commenter
(EPA-HQ-OPPT-2019-0131-0006/EPA-HQ-OPPT-2019-0131-0018) supported the pragmatic approach
to initiating prioritization using the 2014 TSCA Work Plan for Chemical Assessments list and the
approach to consider reasonably available information on exposure potential.
Comment: One comment (EPA-HQ-OPPT-2019-0131-0019) 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." Similarly (EPA-HQ-OPPT-2019-0131-0020) indicated that the
proposed chemicals meet the High-Priority Substance definition.
Response: The Agency appreciates this feedback regarding the prioritization process and the proposed
designations.
Designation Conclusions for Specific Chemicals
Comment: Four commenters (EPA-HQ-OPPT-2018-0465-0013, EPA-HQ-OPPT-2018-0465-0014,
EPA-HQ-OPPT-2018-0465-0015, EPA-HQ-OPPT-2018-0465-0016) supported the proposed
designation of trans-1,2-dichloroethylene as a High-Priority Substance for risk evaluation due to their
concerns over the lack of research regarding the human health and environmental impacts of long-term
exposure, especially given the likely increase in use since trans-1,2-dichloroethylene could be an
alternative to solvents like trichloroethylene. The commenters believe that "additional risk evaluation for
this chemical is needed" and urged the Agency to conduct systematic research that can better inform
pollution release limits for trans-l,2-dichloroethylene.
Comment: Another commenter (e.g., EPA-HQ-OPPT-2018-0465-0003), stated that "[trans-1,2-
dichloroethylene], when used in commercially available mixtures, is nonflammable, non-ozone
depleting, and nontoxic to the environment as well as human beings," that "[trans-l,2-dichloroethylene]
has been included in the SNAP program, and 15 years of research have not determined the chemical to
be toxic or carcinogenic. Additionally, no substitutions have been identified that perform as well. Of the
available solvents, [trans-1,2-dichloroethylene] is used less frequently than other chemicals and is the
best available, as well as a cost effective, option for a cleaning solvent in Electronics Cleaning; Metal
Cleaning; Precision Cleaning; and Aerosol Solvent Cleaning whether it be in vapor degreasing, cold
cleaning, ultrasonic or aerosol." As such, the commenter requested the chemical be removed from the
list of candidates for proposed designation as a High-Priority Substance or create exemptions for
"electronics, aviation and metal cleaning."
Comment: A commenter (EPA-HQ-OPPT-2018-0488-0006) described how ethylene dibromide "is
supplied as a ready formulated blend into the US in dedicated ISO tanks, with no exposure to the general
public or the environment, presenting no risk to human or ecological health."
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Comment. A commenter (EPA-HQ-OPPT-2018-0458-0015) stated "more details are needed regarding
the data analysis serving as justification for the proposed designation [for Phosphoric acid, triphenyl
ester (TPP)]" and that "[a] more detailed explanation regarding the rationale for the Agency's decision
would help manufacturers, importers, and downstream users." The same commenter provided
information on TPP's PBT characteristics, as well as the relative age of data EPA used to evaluate
environmental hazards and general population exposure, and stated "[a]ny data used to evaluate
potential environmental hazards should reflect the current state of the science."
Comment: Another commenter (EPA-HQ-OPPT 2018-0433-0005/EPA-HQ-OPPT-2018-0446-0012),
cited challenges to determining objective grounds for selecting Di-ethylhexyl phthalate (DEHP) as one
of the candidates for proposed designation as a High-Priority Substance and recommended that EPA
"endeavor to follow the scientifically clarified mechanisms with specific endpoints even if reproductive
toxicity and endocrine disruption may result in the same outcome."
Comment: A commenter (EPA-HQ-OPPT-2018-0501-0013) suggested that EPA should designate Butyl
Benzyl Phthalate (BBP) as "low priority for further action" and submitted information on production
levels, exposure levels, toxicity profile, and environmental exposure.
Comment. A commenter (EPA-HQ-OPPT-2018-043 8-0005) provided information on the potential
releases and existing EPA regulations for formaldehyde in stating "there is no basis to conclude that
formaldehyde releases from asphalt roofing manufacturing and related industries may present an
unreasonable risk of injury to health or the environment warranting a risk evaluation under TSCA "
Another commenter (EPA-HQ-OPPT-2018-0438-0008) asked EPA to "find formaldehyde to be a Low
Priority Substance. If EPA finds it must rank formaldehyde as a High Priority, the commenter urges
EPA to make a determination that the use of formaldehyde in fiber glass and mineral wool insulation
production does not present an unreasonable risk and should not be subject to further regulation."
Another commenter (EPA-HQ-OPPT-2019-0131-0012) noted "recent and dedicated rulemaking for
formaldehyde in composite wood products includes an emission limit that was the product of an
extensive risk evaluation. As a result, this use should not trigger the high priority criteria, providing the
emission standard is adequately considered."
Comment: A commenter (EPA-HQ-OPPT-2018-043 8-0016) provided general support for designating
formaldehyde as a High-Priority Substance, as well as designating fire fighters and emergency medical
responders as a susceptible subpopulation, and provided studies of occupational exposures, including
studies specific to fire fighters, to formaldehyde and particulates.
Comment. One commenter (EPA-HQ-OPPT-2018-0430-0004) stated that the Agency "effectively
classified l,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- hexamethylcyclopenta [y]-2-benzopyran (HHCB) as a low-
priority substance. EPA's 2014 Risk Assessment of HHCB 'determined that further assessment of
human health risk was not currently needed' for the TSCA uses (as an ingredient in detergents, fabric
softeners, dishwashing detergents, and commercial and consumer general purpose cleaners). This
conclusion was echoed in OECD's SIDS Initial Assessment Profile (SIAP) for HHCB. The final
prioritization rule states that, '[t]hrough the process of prioritization, EPA is ultimately making a
judgment as to whether or not a particular chemical substance warrants further assessment.' Low-
priority substances are those 'for which risk evaluations are not warranted at the time.'" The commenter
(EPA-HQ-OPPT-2018-0430-0012) also stated that EPA "is not required to conduct a risk evaluation of
HHCB" and "EPA has still not justified its designation of HHCB as high priority for risk evaluation."
However, if EPA designates HHCB as a High-Priority Substance, the commenter is bringing to EPA's
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attention a list of toxicity studies that are in progress, as well as information regarding volumes of use
and concentration of HHCB in products.
Response: 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-l,2-dichloroethylene, ethylene dibromide, TPP, BBP 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 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 formaldehyde, EPA was directed by Congress to develop a final rule implementing
statutorily establishedformaldehyde emission standards in composite wood products, by 15 U.S.C. 2697
or the Formaldehyde Standards for Composite Wood Products Act. The emission standards for
composite wood products were established by Congress and the Formaldehyde Standards for Composite
Wood Products Act did not provide EPA with the authority to alter them. The Formaldehyde Standards
for Composite Wood Products Act gave the Agency the authority to establish a regulatory program that
ensures specific emission standards are met through a certification and testing program for three
composite wood products - hardwood plywood, medium-density fiberboard, and particleboard. The
Formaldehyde Emission Standards for Composite Wood Products regulatory program does not address
or otherwise provide regulatory oversight of the other conditions of use identifiedfor formaldehyde in
the August 2019 Proposed Designation of Formaldehyde (CASRN 50-00-0) as a High Priority
Substance for Risk Evaluation (see EPA-HQ-OPPT-2018-0438). EPA will consider, as appropriate, the
information available through the Formaldehyde Emission Standards for Composite Wood Products'
regulatory program during the scoping for the risk evaluation process as it relates to composite wood
products.
With respect to HHCB, EPA recognizes that a TSCA Work Plan Chemical Risk Assessment was
published in August 2014, concluding no risk concerns to aquatic organisms and that no further
assessment of human health risk was needed, given the analysis done by EPA and information presented
in a risk assessment performed by the European Union. However, as part of the prioritization process,
during the review conductedfor HHCB, EPA identified updated production volume and conditions of
use based on information reported to the Agency in 2016; and new environmental studies (e.g., aquatic
and terrestrial media, which are listed in the proposed designation document, EPA-HQ-OPPT-2018-
0430-0010, hitm://www.regulations.gov/docMment?D=EPA-HQ-OPPT-2018-0430-0010). EPA is
designating HHCB as a High-Priority Substance due to consideration of all of the prioritization criteria,
including hazard and exposure potential to HHCB. Other public comments included lists of published
studies since the 2014 risk assessment. Reasonably available information will be considered as part of
the risk evaluation process under amended TSCA. Additionally, the exposure information will be
updated.
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Review Process for Priority Designation
Types of Information Considered for Prioritization
Comment: Commenters urged the Agency to consider a variety of information sources during 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 (e.g. Chem
View data, OSHA occupational exposure monitoring, REACH registration information) (EPA-HQ-
OPPT-2019-0131-0006, EPA-HQ-OPPT-2019-0131-0009, EPA-HQ-OPPT-2019-0131-0011, EPA-HQ-
OPPT-2019-0131-0013, EPA-HQ-OPPT-2018-0421-0004, EPA-HQ-OPPT-2018-0433-0006, EPA-HQ-
OPPT-2018-0458-0005, EPA-HQ-OPPT-2019-0131-0018). One commenter (EPA-HQ-OPPT-2019-
0131-0018) noted that EPA should only rely on conditions of use/exposure information in assessments
from other countries if it is applicable in the U.S. and relevant to the prioritization. Another commenter
(EPA-HQ-OPPT-2019-0131-0011) noted that EPA needs to obtain full copies of the studies supporting
REACH registration and make them publicly available.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0006) insisted that EPA should rely on
reasonably available information and take pragmatic and systematic steps to provide notice and
communicate data needs to potentially affected parties should new data be required to be developed (e.g.
reasonably available information and read across information, then voluntary call-ins, then TSCA
section 8(a) and 8(d) rules, and then section 4). However, another comment (EPA-HQ-OPPT-2019-
0131-0011) indicated that EPA must use its authorities under TSCA sections 4 and 8 to obtain
information that it "can reasonably generate, obtain, and synthesize" since it is part of the definition of
"reasonably available" information in the prioritization rule and in the risk evaluation rule. Furthermore,
the commenter indicated that relying on voluntary submissions of information would result in "limited,
biased, inaccurate, or incomplete information on the chemicals."
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0010) indicated that "it is critical for EPA to
obtain all reasonably available information for high priority candidates needed to complete
comprehensive, scientifically accurate risk evaluations, including all conditions of use throughout
lifecycle."
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0013) "urged EPA to strive to use the most
current data and not rely on older data." Similarly, another commenter (EPA-HQ-OPPT-2019-0131-
0018) urged EPA to use the most current and best available science, to address the application of the
TSCA scientific standards in the screening review step of the prioritization process, to examine the
applicability of advanced approaches for evaluating exposure and bioactivity or toxicity under "other
risk-based" screening criteria. This commenter (EPA-HQ-OPPT-2019-0131-0018) recognized that
prioritization screening does not warrant the same level of data quality review that a draft risk evaluation
does; however, the commenter provided recommendations for improving the exposure potential for
prioritization screening purposes, such as looking for up to date and reliable information, paying
attention to how the Agency communicates exposure potential in the proposed designation documents to
avoid giving the impression of an unreasonable risk finding, clarifying that not every chemical identified
as a high priority candidate will have the potential for exposure to general populations or other
subpopulations, and improving the public's understanding of how EPA will approach exposure (e.g.
consumer uses, use by children, use of an article, etc.).
Comment. One commenter (EPA-HQ-OPPT-2019-0131-0020) stated that "EPA's approach for
identifying, evaluating and summarizing data on human health hazards for the first 20 chemicals
designated as high-priority substances are ad hoc, non-transparent, inconsistent with the Agency's
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mandate, and likely to have resulted in a biased evidence base." The commenter (EPA-HQ-OPPT-2019-
0131-0020) argues that EPA has not used an approach consistent with the TSCA scientific standards or
used valid methods to systematically search, evaluate and synthesize data to inform the conclusions on
human health hazards.
Comment. Another commenter (EPA-HQ-OPPT-2018-0458-0005) stated that "EPA should review and
consider all available scientific information regarding the potential for human health and environmental
risk associated with Phosphoric acid, triphenyl ester (TPP)," such as biodegradability and the United
Kingdom's Environment Agency risk conclusions.
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0020) pointed out that "despite previously stating
that the formaldehyde [Integrated Risk Information System (IRIS) Program] assessment will inform the
prioritization process, the Agency fails to reference the stalled IRIS assessment" and instead cites the
1989 IRIS assessment and the 2011 NRC review in the proposed designation document for
formaldehyde. The commenter raises concerns regarding the release of the updated IRIS assessment for
public comment.
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0009/EPA-HQ-OPPT-2019-0131-0023) requested
that EPA "[disclose] the full studies to the public without material redaction as required by section 14(b)
of TSCA," and that EPA not solely rely on industry-generated summaries that may not faithfully reflect
the study findings, in particular studies conducted outside the U.S. under REACH, which EPA should
evaluate before using. Similarly, another commenter (EPA-HQ-OPPT-2019-0131-0011) called for EPA
obtaining copies of the full studies on which it relies and to make those studies available to the public.
Response: 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(h) 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, " f.https://www .eDa.gov/sites/Droduction/_files/2018-
09/documents/vreiyrioritizQtion white pave] .vdf), 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 (84 FR 10491, March 21, 2019).
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 andfinal designations, in accordance with
applicable statutory and regulatory requirements. In future prioritization actions, EPA may identify data
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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. Human health and environmental
hazards, as well as environmental exposures 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.
With respect to the use of the IRIS assessment for formaldehyde, EPA will consider the body of scientific
information, such as that included in IRIS assessments, in the risk evaluation process. Similarly,
additional information regarding biodegradability of TPP and the United Kingdom's Environment
Agency risk conclusions will be considered in the risk evaluation process. The scientific information
from any previous assessment will be incorporated into the supplemental documentation on systematic
review that will be publishedfor the scoping documents for the High-Priority Substances; this
documentation will detail how the scientific information will be considered in the risk evaluation.
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 developedfor 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.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0004) urged EPA to "continue explicitly
outlining the types and quality of data required when listing a chemical for the prioritization process."
Another commenter (EPA-HQ-OPPT-2019-0131-0012) would like as much information from the outset
to allow the commenter to identify information gaps and areas for comment as the prioritization unfolds,
since it is important for stakeholders to contribute information sooner rather than later and most of the
information for the risk evaluation will be obtained during the prioritization process.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0007) commented on the data supporting the
EPA's chemical prioritization process. The commenter claims 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." The commenter explains that they do not have access to adequate data to understand EPA's
rationale in order to comment on this process in a meaningful way, explaining that "As manufacturers
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and importers of products (articles, components, etc.), we do not have access to information about
storage, production volumes or other information specific to the chemical itself. These limitations
combined with the broad scope of EPA's comment request make it extremely difficult to collect and
provide responses to EPA's information request."
Response: 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, " (https://www .eva.gov/sites/production/_files/2018-
09/documents/preprioriiization white paver 9272018.pdf) 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 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 andfound 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 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.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0012) supported the comprehensive
identification of the conditions of use in commerce for chemicals during prioritization. The commenter
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 (EPA-
HQ-OPPT-2019-0131-0013), based on their interpretation of the "fit-for-purpose" approach of the
prioritization rule, urged EPA to 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." Another commenter (EPA-HQ-OPPT-2019-0131-0025) requested "that EPA consider
exempting the import of articles and fluids, adhesives, greases, etc. contained within articles and not
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designed to be released during the use of the article as early in the prioritization process as possible" and
requested a similar exemption for replacement parts. However, another commenter (EPA-HQ-OPPT-
2019-0131-0018) indicated that EPA could designate a chemical substance as High-Priority for risk
evaluation based on only a few conditions of use.
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0018) indicated that EPA should be clearer about
the conditions of use on which a chemical is proposed as a High-Priority Substance. In particular, the
commenter suggests that EPA should clarify that uses "surrounding" pesticides, food additives, drugs or
cosmetics excludes them from the TSCA definition of a chemical substance. The commenter supported
the use of information from the Chemical Data Reporting rule and reports from the Toxic Release
Inventory but encouraged consulting with downstream users to complement the information and to
engage stakeholders to develop a process to improve the understanding of conditions of use.
Comment: One comment (EPA-HQ-OPPT-2019-0131-0018) 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 comment 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.
Response: EPA developed a proposed designation document for each chemical 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 in the docket of each of the High-Priority
Substances (https:/Avww.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-
under going-vrioritizaiion-high):
1. 1,3-Butadiene, CASRN106-99-0, Docket ID number: EPA-HQ-OPPT-2018-0451.
2. Butyl benzylphthalate (BBP) (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester),
CASRN 85-68-7, Docket ID number: EPA-HQ-OPPT-2018-0501.
3. Dibutylphthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester), CASRN84-74-2,
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-, (IE)-), 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. Dicyclohexylphthalate ( 1,2-Benzenedicarboxylic acid, 1,2-dicyclohexyl ester), CASRN84-61-7,
Docket ID number: EPA-HQ-OPPT-2018-0504.
11. Di-ethylhexylphthalate (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-isobutylphthalate (DIBP) (1,2-Benzenedicarboxylic acid, l,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.
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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'-(l-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.
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 andfound 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 requiredfor
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 document 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 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.
Comment: A commenter (EPA-HQ-OPPT-2018-0459-0003) mentioned that in June 2015, the Phthalic
Anhyride Producers Panel "submitted a request for correction (RFC) for information pertaining to
phthalic anhydride in the Workplan." The commenter noted that "correction of this information would
result in the conclusion that phthalic anhydride no longer qualifies for inclusion in the workplan." The
commenter also raised concerns about the process, stating that the "Methods Document, 2014 Update,
and recent [Regulatory Cooperation Council] summaries were not made available for public review and
comment prior to their release." The commenter argued that phthalic anhydride is not widely used in
consumer products, is not present in groundwater and ambient air, and release of phthalic anhydride
does not suggest the potential for significant environmental and population exposure. The commenter
also stated "[f] oil owing EPA's denial of the [Request for Correction], the Panel submitted a Request for
Reconsideration . . . and rais[ed] additional concerns about the quality, objectivity, utility, and
transparency of the Work Plan process." The commenter urged EPA to "first determine if phthalic
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anhydride meets the criteria for consideration as a high priority substance before considering which
'data sources [it] plans to use to support such designation.'" The commenter also objected to EPA
responding to "issues raised ... as part of its response to comments to the current rulemaking, rather
than through a separate response mechanism," which would be "not consistent with [Information
Quality Act] guidance provided by the Office of Management and Budget." However, on December 16,
2019, the commenter submitted a request to the Agency to withdraw the December 2015 Request for
Reconsideration and stated that they "will continue to raise these important issues as the Agency
conducts its evaluation of phthalic anhydride under Section 6(b) of TSCA."
Response: EPA is not revising the 2014 Update of the TSCA Work Plan in response to this comment.
EPA responded to the request for correction in November 2015 (see
https://www.eva.siov/sites/vroduction/files/2Q15-12/documenis/150Q3-resDonse.vdf). Please refer to
EPA 's response to the request for a detailed response.
In response to the technical points raised regarding the use ofphthalic anhydride in consumer products,
its presence in groundwater and ambient air, and its potential for significant environmental and general
population exposure, EPA points to the following information taken from the "Proposed Designation of
Phthalic Anhydride (CASRN 85-44-9) as a High-Priority Substance for Risk Evaluation " (EPA-HQ-
OPPT-2018-0459-0011):
• Based on CDR reporting and information from the National Institutes of Health Consumer
Product Database and the Chemical and Products Database (CPDat), phthalic anhydride does
not appear to be used in consumer products (Table 12). (Note: This is an update per information
not available at the time of the 2014 Update of the TSCA Work Plan) However, consumers may
be exposed to phthalic anhydride from the use of plastics, furniture, glues, coatings, and home
products from which phthalic anhydride may leach (OECD 2005). Consumers may be exposed to
(non-synthetic) phthalic anhydride from natural flavor and oak smoke; oak smoke and its
aqueous preparations are used in the production of several smokedfoods and alcoholic
beverages, furthermore phthalic anhydride is reported to occur in the volatile flavor of baked
potatoes (OECD 2005). (Note: This information will be considered as part of the regulatory
nexus analysis of the scoping and risk evaluation).
• Although EPA did not identify environmental concentration, human and ecological
biomonitoring data to inform phthalic anhydride's exposure potential, releases from certain
conditions of use, such as manufacturing and disposal, may result in general population
exposures to phthalic anhydride via drinking water ingestion, dermal contact, and inhalation
from air releases. (Note: This information will be considered as part of the scoping and risk
evaluation).
• For Reporting Year 2017, 123facilities submitted TRI reports for phthalic anhydride. The total
quantities of phthalic anhydride these facilities released on-site to air (as fugitive and stack
emissions), surface water and land are: 247,208 pounds; 23 pounds; and 29,748 pounds,
respectfully. These facilities reported 25,788 pounds of the chemical transferred to publicly
owned treatment works (POTW) and 15,461 pounds transferred off-site to other non-POTW
wastewater treatment facilities for the purpose of wastewater treatment. These transfer
categories represent two types of off-site transfers for wastewater treatment that may lead to
releases from the receiving facilities. They do not include quantities sent off-site for other types
of waste management activities that include, or may lead to, releases of the chemical. Quantities
transferred off-site represent the amount of a toxic chemical a facility sent off-site prior to any
waste management (e.g., treatment) at a receiving facility. Some of the quantities ofphthalic
anhydride received by the non-POTW wastewater treatment facilities may have been released to
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surface waters or to air during treatment processes at the facilities. (Note: High-priority
designation includes consideration of occupational exposures to workers from manufacturing,
processing, and disposal; this information will also be addressed as part of scoping and risk
evaluation).
In sum, the information provided was considered for the final designation of phthalic anhydride as a
High-Priority Substance. This information will also be considered during the risk evaluation of phthalic
anhydride. Finally, in light of the withdrawal of the December 2015 Request for Reconsideration, the
Agency considers the November 2015 response from the Agency to close this matter within the context of
EPA's "Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of
Information Disseminated by the Environmental Protection Agency, " with the understanding that the
commenter will continue to participate in the risk evaluation process.
Reasonably Available Information for Prioritization
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0009) stated that "EPA has failed to evaluate
whether the available data on the 20 High-Priority candidates are sufficient to conduct robust risk
evaluations and, if not, to require testing necessary to fill any data gaps," such as the ones identified in
the 2014 TSCA Work Plan Chemical Risk Assessment of HHCB. Similarly, a commenter (EPA-HQ-
OPT-2019-0131-0010) stated that "EPA is mandated to make decisions on high and low priority
chemicals based on adequate or sufficient information, respectively." The commenter (EPA-HQ-OPPT-
2019-0131-0010/EPA-HQ-OPPT-2019-0131-0020) cited an EPA response to a TSCA section 21
petition and called for EPA to proceed to fill data gaps and generate adequate information for risk
evaluation of Tris(2-chloroethyl) phosphate (TCEP) and 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA). Both commenters (EPA-HQ-OPPT-2019-0131-0009, EPA-HQ-OPPT-2019-
0131-0010) provided a list of health endpoints that EPA could consider based on EPA's Design for the
Environment program and the Green Screen protocol. And another commenter (EPA-HQ-OPPT-2019-
0131-0013) called upon EPA to define "sufficiency of information" and clarify how the Agency would
treat exposure data gaps before initiating the prioritization process in order to "help industry submit
necessary information during the prioritization process."
Response: 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-Priority designations and the
initiation of risk evaluations because EPA bound itself to an inflexible "sufficiency " standard
("Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA " - Response to Public
Comments (EPA-HQ-OPPT-2016-0636-0076)). 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 andfinal
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)(B)(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. "
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Storage Near Significant Sources of Drinking Water
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0004) 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.
Comment: Another comment (EPA-HQ-OPPT-2019-0131-0018) 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.
Response: 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 ("Procedures for Prioritization of Chemicals for Risk
Evaluation under TSCA" - Response to Public Comments (EPA-HQ-OPPT-2016-0636-0076)).
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 CWA (40 CFR 401.15). In addition, EPA
considered the consolidated list of chemical substances subject to reporting requirements
under EPCRA (Section 302 Extremely Hazardous Substances and Section 313 Toxic
Chemicals), CERCLA (Hazardous Substances), and CAA (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, but the Agency has not attempted to specifically define the individual
terms in this phrase ("Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA " -
Response to Public Comments (EPA-HQ-OPPT-2016-0636-0076)).
Comment: Another commenter (EPA-HQ-OPPT-2019-0131-0004) 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."
Response: EPA expects to 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," (htps:/Avww.epa.«ov/sites/production/flles/2018-
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09/documents/preprioritization white paper pdf), 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. "
Submitted Data and Information
Hazard and Exposure Potential:
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0011) 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) REACH registration and evaluation information. The commenter highlights
the dermal test data for p-dichlorobenzene, 1,2-dichlorobenzene, and 1,2-dichloropropane.
Comment: A commenter (EPA-HQ-OPPT-2018-0430-0005) provided a list of "new scientific literature
on l,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) published since
the 2008 EPA Work Plan Risk Assessment, which indicates greater potential harm from this chemical
than previously assumed."
Comments: An anonymous commenter (EPA-HQ-OPPT-2018-0438-0003) raised issues concerning
formaldehyde and pointed to "extensive review within the European Union due to its classification as a
carcinogen and mutagen." Another commenter (EPA-HQ-OPPT-2018-043 8-0009), concerned about
formaldehyde, mentioned that "exposure to formaldehyde presents numerous cancer and non-cancer
hazards to human health. These include (but are not limited to): Headache, Nausea, Respiratory
irritation, Eye irritation, Skin irritation, Allergic contact dermatitis, Eczema, Pulmonary edema, Asthma,
Changes in lung function, Gastrointestinal irritation, Neurological effects, Impaired fetal development,
Carcinogenicity (in general and specifically Nasopharyngeal cancer, Sinonasal cancer,
Lymphohematopoietic cancers). Assessments of formaldehyde by authoritative bodies (U.S. National
Toxicology Program; International Agency for Research on Cancer) have concluded that it is
carcinogenic—presenting several types of cancer in humans. In addition, recent studies provide
mechanistic support for the relationship between formaldehyde and leukemia."
Comment: A commenter (EPA-HQ-OPPT-2018-0501-0012) provided a reference related to the
biodegradability that was not included in the proposed designation document for Butyl benzyl phthalate
(BBP).
Comment: A commenter (EPA-HQ-OPPT-2018-0427-0004) stated that EPA has not addressed the
issues raised by the commenter related to potential exposure to and persistence and bioaccumulation
potential of 1,2-dichloroethane in the 2014 TSCA Work Plan. The commenter indicates that correction
of the information would result in the conclusion that 1,2-dichloroethane no longer qualifies for
inclusion in the Work Plan. The commenter (EPA-HQ-OPPT-2018-0427-0004) further indicated that
three data sources (NHANES, NATA, NCOD) indicate a low potential for exposure. More recent data
also provides further evidence for a low potential for exposure. The commenter provided information
that "may not be new; however, it is relevant and readily available and should be considered."
Comment. A commenter (EPA-HQ-OPPT-2018-0427-0006) provided information to inform the
screening review conducted pursuant to 40 CFR 702.9(a) for 1,2-dichloroethane. The commenter (EPA-
HQ-OPPT-2018-0427-0016) supplemented and updated their previous submission.
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Comment: A commenter (EPA-HQ-OPPT-2018-0446-0004/ EPA-HQ-OPPT-2018-0446-0011)
provided information to inform the review conducted pursuant to 40 CFR 702.9(a) for p-
dichlorobenzene and stated that many small businesses and households use p-dichlorobenzene in
toilet/urinal care products since it is an inexpensive product that is proven effective. In the opinion of the
commenter, "[s]ince there are no direct replacement products that are as effective or as long-lasting as
PDCB, consumers may use more of the alternative product causing greater risk for exposure."
Comment. A commenter (EPA-HQ-OPPT-2018-0446-0013) provided information regarding the use of
p-dichlorobenzene, as well as a summary of existing regulations and comments regarding the proposed
designation document. The commenter urged EPA to consider the extensive existing regulatory
framework for manufacturers and polymerization users of p-dichlorobenzene during scoping.
Comment. A commenter (EPA-HQ-OPPT-2018-0428-0013) indicated that 1,2-dichloropropane is used
as an intermediate to produce other products in closed systems and urged EPA to take into account the
extensive regulatory framework already in place as it defines the scope of the risk evaluation to be
conducted under TSCA.
Comment: A commenter (EPA-HQ-OPPT-2018-0451-0004) mentioned that it is "working to provide a
central resource for the 1,3-butadiene industry in the US . . . [and] is currently updating its factual
product stewardship manual with information regarding the uses and handling of 1,3-butadiene. This
information will be provided to EPA when available." In a follow up comment (EPA-HQ-OPPT-2018-
0451-0018) described additional hazard and exposure information that EPA should use, such as
information relating to human health and occupational exposure. The commenter (EPA-HQ-OPPT-
2018-0451-0018) emphasized that commercial and consumer products that contain 1,3-butadiene are
most likely limited to rubber and plastic products, and exposure to 1,3-butadiene is very limited because
1,3-butadiene is used as a monomer to create polymers and is not used as a formulated ingredient.
Comment: A commenter (EPA-HQ-OPPT-2018-043 8-0008) stated "[s]ince promulgation of the 1999
MACT Standard, the fiber glass industry has voluntarily undertaken a major effort to replace phenol
formaldehyde ([']PF[']) binders. Non-PF binder products now represent the vast majority of the fiber
glass industry. Mineral wool companies that use formaldehyde are starting to use or explore the use of
non-formaldehyde substitutes. According to 2010 emissions data, there has been a dramatic decrease in
hazardous air pollutants since 1999."
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0014) provided additional information
regarding uses, production volume, production sites, and impurities for phthalic anhydride, butyl benzyl
phthalate, formaldehyde and 1,3-butadiene.
Response: 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. 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.
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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 preamble for the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic
Substances Control Act Final Rule (82 FR 33 753-33 764), EPA agreed that the consideration of
alternatives is most appropriately considered as part of any risk management rule.
Potentially Exposed or Susceptible Subpopulations
Comment: A commenter (EPA-HQ-OPPT-2018-0438-0007) 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 of industries in which formaldehyde is known to be used or otherwise
present."
Comment. A commenter (e.g. EPA-HQ-OPPT-2018-0421-0013) provided technical reports for some of
the proposed High-Priority Substances that provide an overview of potentially exposed or susceptible
subpopulations for these chemicals.
Comment. A commenter (EPA-HQ-OPPT-2018-0451-0014) supported EPA's high-priority designation
of 1,3-butadiene and also supports designating firefighters and emergency medical personnel as
susceptible populations. Firefighters are exposed to 1,3-butadiene in municipal and wildland smoke that
emanates from fires, and emergency medical personnel are exposed to 1,3-butadiene from the diesel
exhaust that emanates from fire apparatus and ambulances. The commenter cites IARC classification of
1,3-butadiene as carcinogenic to humans.
Comment: A commenter (EPA-HQ-OPPT-2018 0462-0007) pointed to data from the National
Toxicology Program showing that 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) can
induce aggressive uterine cancer in rats, potentially by altering steroid activity." The same commenter
(EPA-HQ-OPPT-2018-0503-0005) specified that "[djibutyl phthalate (DBP) is estrogenic and anti-
androgenic, and has been associated with increased fetal weight and epigenetic transgenerational
inheritance of adult-onset obesity in animal models. DBP has effects on the female and male
reproductive system; some of these include alterations in pubertal timing and alterations in mammary
gland development. DBP also has potential effects on thyroid hormone levels and dose- and age-
dependent effects on neuroendocrine systems." The commenter (EPA-HQ-OPPT-2018-0501-0005) also
indicates that "benzyl butyl phthalate (BBP) inhibits testosterone production and has effects on sexual
differentiation in male animals and mammary gland growth in female animals." And the same
commenter (EPA-HQ-OPPT-2018-0433-0006) indicated that di-ethylhexyl phthalate (DEHP) has a
"wide range of effects," such as DNA modifications, metabolic disorders, effects on the female
reproductive system, adverse birth outcomes and disrupt thyroid hormone biology.
Comment: A commenter (EPA-HQ-OPPT-2018-0459-0003) forwarded an analysis that included the
results of 3 years of reporting under Washington State's Children's Safe Product Act (CSPA) and the
authors "assigned phthalic anhydride the lowest total priority index score of zero (based on toxicity and
exposure)" The commenter indicated that this conclusion reflects the low potential for exposure to
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phthalic anhydride and contributed to the removal of the chemical from the list of chemicals subject to
reporting under the CSPA.
Response: 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.
Conditions of Use or Significant Changes in Conditions of Use
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0008) described the uses of phthalic anhydride,
formaldehyde, 1,3-butadiene, butyl benzyl phthalate, diisobutyl phthalate, dicyclohexyl phthalate,
triphenyl phosphate, 1,1,2-trichloroethane, 1,2-dichloroethane, dibutyl phthalate, diethylhexyl phthalate,
and tetrabromo BPA in paints, coatings, sealants and adhesives, with the goal of "assisting] EPA with
identifying accurate uses, exposures and environmental releases."
Comment: A commenter (e.g., EPA-HQ-OPPT-2018-0421-0006) identified a variety of uses in the
aerospace industry for most of the candidate High-Priority Substances.
Comment: A commenter fEPA-HQ-OPPT-2018-0465-0009) provided information regarding the 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."
Comment: Two commenters (EPA-HQ-OPPT-2018-0488-0006, EPA-HQ-OPPT-2018-0488-0007)
described how ethylene dibromide is involved in the production of fuels: "AvGas ... a fuel that powers
piston-engine agricultural aircrafts" and that there is "no current replacement or alternative fuel for
AvGas." Furthermore, the use in fuels is "subject to the EPA/FAA Piston Fuel Aviation Program which
was formed in response to EPA's request to reduce or eliminate [tetraethyllead] based additives in
aviation fuels. This is a multi-industry stakeholder process that is not due to be complete until mid-2020.
Once a suitable alternative is identified, it will take a further 2-3 years to get the fuel on the market and
specifications and legislative changes."
Comment. Another commenter (EPA-HQ-OPPT-2019-0131-0019) indicated that EPA has failed to
identify instances where the chemical substances are known or reasonably foreseen to be used or
disposed of in hydraulic fracturing fluids or produced water associated with oil and gas extraction,
including: 1,1-dichloroethane, triphenyl phosphate, 1,3-butadiene, formaldehyde, phthalic anhydride,
dibutyl phthalate, benzyl butyl phthalate, di(2-ethylhexyl)phthalate, 1,4-dichlorobenzene, 1,2-
dichlorobenene, and benzyl butyl phthalate.
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Comment: A commenter (EPA-HQ-OPPT-2019-0131-0022) indicated that they use four of the proposed
chlorinated solvents (o-dichlorobenzene, trans-1,2-DCE, 1,2-dichloroethane, and 1,1,2-trichloroethane);
each of the five proposed phthalates (DBP, BBP, DEHP, DIBP, and DCHP); all three of the halogenated
flame retardants (TBBPA, TCEP, and TPP) and three of the other substances (1,3-butadiene,
formaldehyde, and phthalic anhydride). The comment includes additional information describing how
the chemicals are used in automobiles and stated that "exposure to passengers to those substances
resulting from their use in automobiles is expected to be negligible."
Comment: One commenter (EPA-HQ-OPPT-2018-0451-0004) described varying degrees of purity in
1,3-butadiene used in certain manufacturing processes. Another commenter (EPA-HQ-OPPT-2018-
0451-0003) argued that 1,3-butadiene is "added in controlled quantities through a closed system so that
occupational and environmental exposure is minimal . . . [and that cjonsumer exposure is negligible
because the polymerization process results in the complete conversion of the monomer . . . Therefore,
EPA should conclude that 1,3-butadiene presents negligible risk and these uses should be excluded from
the scoping document." Another commenter (EPA-HQ-OPPT-2019-0131-0012) described how 1,3-
butadiene "may be indirectly present at low levels" in synthetic rubber and "generally would favor
including impurities as a condition of use in the risk evaluation in exchange for the future benefit
associated with the preemptive effect of EPA's review."
Comment: A commenter (EPA-HQ-OPPT-2018-0430-0005) provided a list of information related to use
of HHCB in fragranced products and suggested that "[t]here is considerably more information available
now about which consumer products contain HHCB than there has been previously due to significant
advancements in both voluntary and regulated fragrance ingredient disclosure effort" and that EPA
should request that manufacturers identify additional uses.
Comment: A commenter (e.g. EPA-HQ-OPPT-2018-0421-0013) provided technical reports for all
proposed High-Priority Substances that provide an overview of the manufacturing, processing,
importation, distribution in commerce, and disposal of these chemicals.
Comment. A commenter (EPA-HQ-OPPT-2018-0427-0018) further refined their initial statements and
indicated that "1,2-dichloroethane appears in trace amounts as an impurity in industrial adhesives only,"
and such adhesives "are used in a wide range of uses that include paper converting, labeling, and tissue
and towel applications."
Response: 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
commenter s 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 (82 FR 33 753-33 764), EPA agreed that the consideration of
alternatives is most appropriately considered as part of any risk management rule.
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Comments Related to the Long-Term Prioritization Process
Future and Long-Term Process to Select Candidate Substances for Prioritization
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0007) 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 (LCSA), because it will
set precedent for how EPA identifies, evaluates and regulates chemicals in the future." Another
commenter (EPA-HQ-OPPT-2019-0131-0012) reiterated the importance of a timely and transparent
process for prioritization and assessing existing chemicals; to that end, the commenter suggested that
EPA "move ahead with scheduling all 2014 Work Plan chemicals for prioritization to make the process
predictable and routine" and "engage in further stakeholder discussions on its vision for the long-term to
'bin' all of the other chemicals on the TSCA Inventory for prioritization."
Comment: Another commenter (EPA-HQ-OPPT-2019-0131 -0006/EPA-HQ-OPPT-2019-0131 -0018)
requested that EPA "finalize and release its 'proof of concept' white paper on 'longer term'
prioritization soon" with explanations on the use of New Approach Methodologies and other 21st
century tools and sources of information. In addition the commenter suggested the inclusion of the
following topics on the long-term "white paper": binning; screening criteria; approach to both High- and
Low-Priority candidates; sources of information for Low-Priority candidates; exposure (use of advanced
approaches and models); evaluating Unknown or Variable Composition (UVCB substances); storage
near significant sources of drinking water; and how prioritization approaches are evolving. The
commenter indicated that EPA should also develop guidance on how the Agency will address best
available science and reduction in animal testing. Another commenter (EPA-HQ-OPPT-2019-0131-
0013) urged EPA to "clearly define binning and to make sure it is well understood that 'binning' is not
the same as 'categories.'"
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0010) indicated that "EPA must proceed with
identifying, expeditiously evaluating, and limiting dangerous chemicals from the more than 40,000
existing chemicals on the active TSCA inventory in a manner based on the best available science that
will protect our most vulnerable populations."
Response: 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, "
(https://www.eva.sov/sites/vroduction/files/2018-
09/documents/preprioritization white paper 9272018.pdf), 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. Additionally, this document
states that "subsequent steps will include a white paper andfuture public workshops and discussion. "
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 for Identifying Potential Candidate Chemicals for Prioritization" document, EPA also will
consider federal government priorities and other interests when considering candidates for
prioritization.
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Use of Categories
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0013) indicated that in future efforts, EPA may
select categories of similar chemicals to prioritize together. The commenter emphasized the difficulties
associated with categories of similar chemicals and 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."
Response: As stated in the preamble for the Procedures for Prioritization of Chemicals for Risk
Evaluation Under the Toxic Substances Control Act Final Rule (82 FR 33753-33764), "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 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."
Comments Related to Risk Evaluation
Types of Information Considered and Overall Approach for Risk Evaluation
Comment: Commenters also urged the Agency to consider a variety of information sources during the
overall risk evaluation process, including EPA resources and programs (e.g., the Integrated Risk
Information System (IRIS) Program), those administered by other domestic and international
governmental agencies (e.g. local governments, OSHA, NIOSH), and information from other public and
private entities (EPA-HQ-OPPT-2019-0131-0009, EPA-HQ-OPPT-2019-0131-0010, EPA-HQ-OPPT-
2019-0131-0011, EPA-HQ-OPPT-2019-0131-0012, EPA-HQ-OPPT-2019-0131-0013, EP A-HQ-OPPT-
2019-0131-0014, EP A-HQ-OPPT-2018-0421-0004, EPA-HQ-OPPT-2019-0131-0019, EPA-HQ-OPPT-
2018-0421-0013). One commenter (EPA-HQ-OPPT-2019-0131-0010) cited the National Academies of
Sciences 2017 report on implementation of systematic review and recommended that "EPA should build
on existing high-quality reviews to incorporate new studies, and then use this updated systematic review
as basis for its assessment," including IRIS assessments. Similarly, a commenter (EPA-HQ-OPPT-2019-
0131-0009/EPA-HQ-OPPT-2019-0131-0023) stated that EPA should rely on IRIS assessments and not
revisit the findings unless new peer-reviewed data, evaluated with accepted systematic review
methodologies, informs the IRIS assessment evaluation on the weight of the evidence. Another
commenter (EPA-HQ-OPPT-2019-0131-0019) indicated that EPA must accurately describe the
information it relies on, particularly the data from the European Chemicals Agency (ECHA).
Comment: A commenter (EPA-HQ-OPPT-2019-0131-001 l/EPA-HQ-OPPT-2019-0131-0019) raised
concerns related to public disclosure and urged EPA to "obtain the full studies if it is to rely on them for
its risk evaluations," to "request that submitters always provide copies of full studies, as well as
underlying data whenever reasonably available or obtainable," and to make these studies and data
publicly available.
Comment: Commenters (EPA-HQ-OPPT-2019-0131-0019, e.g. EP A-HQ-OPPT-2018-0421-0013) urged
EPA to accurately identify all relevant potentially exposed or susceptible subpopulations (PESS), since
the lists presented in the proposed designation documents are far from complete. Similarly, another
commenter (e.g. EPA-HQ-OPPT-2018-0421-0013) called for EPA to "consider the special vulnerability
of fetuses and children to chemicals."
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Comment. A commenter (EPA-HQ-OPPT-2019-0131-0019) indicated that EPA needs to ensure that
environmental justice is appropriately considered, analyzed, and addressed in the risk evaluation process
by incorporating an environmental justice analysis into the final prioritization designations and ensuring
meaningful involvement of environmental justice communities as it moves forward. Another commenter
(EPA-HQ-OPPT-2019-0131-0016) urged EPA to use rates of consumption of fish and other aquatic life
that are representative of tribal lifeways. Similarly, another commenter (e.g. EPA-HQ-OPPT-2018-
0421-0013) called for consideration of environmental justice and tribal concerns in the risk evaluations,
for EPA "to implement a systematic approach to identifying and reducing toxic exposures experienced
by minority, low-income, and tribal populations" during scoping.
Comment: Another commenter (EPA-HQ-OPPT-2019-0131-0017) encouraged EPA to thoroughly
understand the conditions of use once risk evaluation is initiated. The information influences the
characterization of potential exposures and releases. Also, EPA should understand which "uses can be
critical to, and provide, important societal benefits." The commenter also offered to assist EPA in future
efforts to gather information regarding conditions of use and identify and accommodate chemical
substitution.
Comment: A commenter (EPA-HQ-OPPT-2018-0427-0012) indicated that 1,2-dichloroethylene is "used
almost exclusively as a precursor in the production of vinyl chloride which is subsequently used to
produce polyvinyl chloride (PVC)." They urged EPA to take into account the regulatory framework
already in place that manage the release of 1,2-dichloroethylene into the environment administered by
several EPA environmental statutes.
Comment: A commenter (EPA-HQ-OPPT-2018-0459-0003/EPA-HQ-OPPT-2018-0459-0013) provided
a summary of ways that facilities that manufacture and use phthalic anhydride comply with regulatory
and analytical processes, including the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), the
Clean Water Act (CWA) and the Resource Conservation and Recovery Act (RCRA). The same
commenter (EPA-HQ-OPPT-2018-0459-0003) stated that "phthalic anhydride is not widely used in
consumer products, is not present in groundwater and ambient air, and release of phthalic anhydride
does not suggest the potential for significant environmental and population exposure."
Comment. One commenter (EPA-HQ-OPPT-2018-043 8-0018) provided a list of "adequately regulated"
conditions of use, citing existing regulations and standards implemented by EPA, the Department of
Housing and Urban Development, the Food and Drug Administration, the Occupational Safety and
Health Administration, and the Consumer Product Safety Commission, and suggested for consideration
finalized and ongoing international chemical reviews, information on potential susceptible
subpopulations, human health hazards and environmental hazards, and information on refractive index
and dielectric constants.
Comment: Commenters urged EPA to consider all conditions of use (EPA-HQ-OPPT-2019-0131-0012,
EPA-HQ-OPPT-2019-0131-0023). Other commenters urged EPA to consider all exposure pathways
(EPA-HQ-OPPT-2019-0131-0019, EPA-HQ-OPPT-2019-0131-0023), even when regulated under other
EPA authorities. One of those commenters (EPA-HQ-OPPT-2019-0131-0019) indicated that EPA does
not need to attribute every environmental release of a chemical to a particular condition of use during
the risk evaluation stage. One of the commenters (EPA-HQ-OPPT-2019-0131-0023) also indicated that
by EPA excluding "discontinued manufacturing, processing and use activities from the definition of
'conditions of use' and therefore from the scope of risk evaluations," EPA is excluding 'reasonably
foreseen' conditions of use, and the goals of TSCA would be defeated if EPA completes a risk
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evaluation and then the chemical re-enters the market place free from any restriction or determination of
risk.
Comment. Another commenter (EPA-HQ-OPPT-2019-0131-0008) raised concerns regarding excluding
conditions of use, stating that "a situation could arise where EPA excludes a condition of use in a
manner that compromises comprehensive review and limits federal pre-emption." The commenter went
on to state that even when a condition of use is adequately controlled, "EPA should still include it in the
final risk evaluation to describe EPA's rationale for concluding the use poses no unreasonable risk."
Another commenter (EPA-HQ-OPPT-2019-0131-0016) indicated that environmental statutes do not
guarantee protection from exposures (e.g., landfills in Alaska, unregulated groundwater well systems,
open barrels for burning) and indicated that "EPA must evaluate disposal as a condition of use for all 20
of the proposed high priority chemicals in order to comply with TSCA" and described why disposal of
the proposed High-Priority chemicals should be evaluated to properly characterize the risk to tribal
peoples. Similarly, another commenter (EPA-HQ-OPPT-2018-0465-0018) indicated that risk
evaluations fail to "conduct health-protective aggregate exposures" by excluding exposures from
scenarios that could be regulated under other statues. However, another commenter (EPA-HQ-OPPT-
2019-0131-0025) "encourage[d] EPA to focus on conditions of use that are not currently regulated by
other federal regulatory agencies" and to recognize standards set by other federal agencies as protective.
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0025) indicated that it is critical "that decisions
on conditions of use be made rapidly and with certainty" and, once risk evaluations are completed,
clearly articulate "findings of 'no unreasonable risk' associated with specified conditions of use."
Comment. A commenter (EPA-HQ-OPPT-2018-0446-0011) requested that EPA exclude p-
dichlorobenzene conditions of use related to toilet care in the scoping document due to its low
production volume and low exposure, since EPA has already assessed potentially exposed populations
and hazard potentials of toilet care uses in the Human Health Risk Assessment in support of Registration
Review (September 27, 2018) and the Final Guidelines for Carcinogen Risk Assessment (March 2005).
These assessments "determined the minimal exposure to urinal/toilet blocks is not significant" and p-
Dichlorobenzene as "Not Likely to be Carcinogenic to Humans."
Comment: Another commenter (EPA-HQ-OPPT-2018-0458-0005) requested that "[i]f EPA determines
that TPP is a high priority substance for TSCA risk evaluation, it should transparently and objectively
consider only relevant conditions of use when identifying exposure scenarios and determining any future
regulatory actions."
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0016) urged "EPA to consider the impacts of
legacy use of these 20 chemicals on tribal populations." Similarly, other commenter (EPA-HQ-OPPT-
2019-0131-0023, e.g. EPA-HQ-OPPT-2018-0421-0013) also indicated that EPA must address all
ongoing uses of legacy products and associated disposal activities.
Comment. Another commenter (EPA-HQ-OPPT-2019-0131-0019) stated that EPA should include
byproducts, metabolites or degradation products in the risk evaluations. Similarly, another commenter
(EPA-HQ-OPPT-2018-0465-0018) pointed out arbitrary exclusion of exposure scenarios impacting non-
worker populations, such as EPA did in the 1,4-dioxane draft risk evaluation.
Comment. Several commenters raised concerns with de minimis amounts and impurities in products.
One commenter (EPA-HQ-OPPT-2019-0131-0008) supports a "case-by-case approach" to exclude de
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minimis exposures from scope when justified: "We would discourage EPA from adopting a blanket
policy of excluding such exposures. [The commenter] can envision a situation where EPA could include
de minimis exposure in a final risk evaluation, if only to document and integrate evidence of de minimis
exposures to support a conclusion of no unreasonable risk." Another commenter (EPA-HQ-OPPT-2019-
0131-0012) indicated that EPA consider the incidental presence of a chemical as impurity during
prioritization and risk evaluation. Another commenter (EPA-HQ-OPPT-2019-0131-0014) requested a
clarification from EPA regarding the manufacture or import of High-Priority Substances "if they are
distributed in commerce solely as an impurity or in small amounts." Another commenter (EPA-HQ-
OPPT-2019-0131-0025) indicated the challenges to identifying de minimis amounts of chemicals in
articles and components in their supply chain. The commenter explains that such de minimis amounts
are not tracked because "the underlying assumption [is] that the risk of exposure is negligible." The
commenter (EPA-HQ-OPPT-2019-0131-0025) provided the following examples: 1,2-dichloropropane
(CAS# 378-87-5) was identified as a chemical that may be used in the manufacturing and/or present in
the front windshield assembly of certain vehicles; the presence of this chemical, bound up in the
windshield assembly, poses little to no risk of exposure. Similarly, the use of 1,3-butadiene (CAS# 106-
99-0) in manufacturing a bumper or door handle assembly does not mean that either of those articles
present a concern (condition of use) that warrants further evaluation.
Comment: A commenter (EPA-HQ-OPPT-2018-0465-0018) pointed out EPA's failure to determine
robustness of the databases on human health and ecological hazard and exposure, and to account for
such deficiencies, with two main consequences: EPA does not take advantage of its enhanced ability to
fill data gaps before a risk evaluation, and impacts the adequacy of the benchmark by not including an
additional uncertainty factor to account for the data deficiencies.
Comment. Another commenter (e.g. EPA-HQ-OPPT-2018-0421-0004) indicated that several studies
provide evidence that 18 of the 20 candidate High-Priority Substances should be treated as endocrine
disruption compounds, and the "risk evaluation should review this evidence in determining whether they
pose unreasonable risk to human health due to the adverse outcomes caused by endocrine disruption."
The commenter offered suggestions on tests that should be performed to evaluate endocrine disruption
and requested that the Agency require testing for 1,1-dichloroethane and phthalic anhydride.
Comment: A commenter (EPA-HQ-OPPT-2019-0131 -0010/EPA-HQ-OPPT-2019-0131 -0020) stated
that "EPA should conduct a cumulative risk assessment for phthalates, chlorinated solvents, and any
other chemicals that may contribute to common adverse health outcomes." According to the commenter
"it is critical that EPA incorporate information on non-chemical stressors in this cumulative assessment"
and EPA should "issue orders for data needed to complete such assessments." The commenter also
provided a list of endpoints to be considered for a cumulative evaluation of phthalates and chlorinated
solvents. Similarly, a commenter (EPA-HQ-OPPT-2019-0131-0023) called for conducting a cumulative
risk assessment of a phthalates category formed by the five phthalates candidates for High-Priority and
the two phthalates for which industry has requested risk evaluations since "the seven phthalates merit
treatment as a category because they are similar in molecular structure, toxicity, use and exposure."
Another commenter (EPA-HQ-OPPT-2018-0465-0018) suggested that DIDP and DINP, as well as that
Di-n-octyl phthalate (DnOP), should be added and "assessed along with the other five (or seven)
phthalates." The same commenter (EPA-HQ-OPPT-2018-0465-0018) also indicated that the two sets of
isomers: o-dichlorobenzene and p-dichlorobenzene, and 1,1-dichloroethane and 1,2-
dichloroentaneshould be subject to aggregate and cumulative risk evaluation. An additional commenter
(EPA-HQ-OPPT-2019-0131-0016) noted "that to fulfill the intent of Congress, EPA must evaluate true
risk of a chemical in commerce, and to consider aggregate and cumulative exposures."
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Comment. A commenter (EPA-HQ-OPPT-2018-0465-0018) raised concerns with the implementation of
an out-of-sync process for solicitation of public comment and conduct of the SACC scientific peer
review, "depriving the peer reviewers of the ability to consider useful and robust feedback from the
interested stakeholder community."
Response: EPA appreciates the suggestions on information sources that EPA should use in the risk
evaluation process. EPA determined that the 20 chemical substances were suitable candidates for the
High-Priority designation based on review of reasonably available information, including relevant
information received from the public and other information, as appropriate, as cited in the proposed
designation documents. The reasonably available information was reviewed against the criteria and
considerations set forth in 40 CFR 702.9for a finding that each substance may present an unreasonable
risk. While EPA appreciates the suggestions on specific information sources that EPA should avoid 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 or submitted
by commenters, and such information does not need to be resubmitted to the Agency. Reasonably
available information will be considered during the 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. This systematic review
process will be documented and made public as part of the risk evaluation. EPA expects to make the
information it uses for decision-making publicly available, consistent with the requirements of TSCA
section 14.
EPA agrees with commenter s that EPA should thoroughly understand conditions of use as part of the
risk evaluation process for each chemical. EPA will consider information submitted by such commenter s
that pertains to risk evaluation during the scoping and analysis phase of the TSCA risk evaluations for
any High-Priority Substances, including information on conditions of use when developing exposure
scenarios for the respective chemicals. Also note that EPA will conduct a comprehensive search of the
reasonably available information about the human health and environmental hazards as well as
environmental exposures and exposures to the general population and to consumers, workers and other
potentially exposed susceptible subpopulations for each of the 20 High-Priority Substances. This
comprehensive search is part of the systematic review process supporting the development of the risk
evaluation. 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.
EPA also appreciates the comments regarding improvements to the risk evaluation process and
continues to implement the requirements of the "Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act" (40 CFR Part 702), including addressing comments from the
peer reviewers and the public, as well as complying with the recent court decision regarding legacy uses
and associated disposal.
However, please note that the provision of TSCA addressing aggregate exposures does not require EPA
to conduct cumulative risk evaluations; it requires EPA to describe whether aggregate or sentinel
exposure were considered, and the basis for that consideration. TSCA section 6(b)(4)(F)(ii).
In the preamble for the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic
Substances Control Act Final Rule (82 FR 33 753-33 764), EPA agreed that the consideration of
alternatives is most appropriately considered as part of any risk management rule.
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Use of Existing Agency Assessments
Comments: Several commenters (EPA-HQ-OPPT-2019-0131-0009/EPA-HQ-OPPT-2019-0131-0023,
EPA-HQ-OPPT-2019-0131-0010) suggested that the risk evaluation for formaldehyde under TSCA
should be based on its draft IRIS assessment and this assessment should be released for public comment
and peer review. One commenter (EPA-HQ-OPPT-2019-0131-0009) indicated "Formaldehyde is a
chemical of high concern. It has been linked to several types of cancer and other adverse health effects
and has multiple uses with the potential for widespread consumer and worker exposure." Similarly, a
commenter (EPA-HQ-OPPT-2019-0131-0010) stated that "EPA needs to immediately release the
recently updated IRIS assessment for public comment and NAS review. A 2019 report from the
Government Accountability Office raised concerns about EPA leadership's unexplained directive to stop
the release of the formaldehyde assessment. EPA must release the assessment so that the TSCA office
can directly utilize the extensive work already done by NAS and IRIS scientists." Another commenter
(EPA-HQ-OPPT-2019-0131 -001 l/EPA-HQ-OPPT-2019-0131 -0019), stated that "[a]ny future risk
evaluation of formaldehyde under TSCA must include its carcinogenicity. In addition, IRIS should be
allowed to complete its revised human health hazard assessment of formaldehyde and EPA OPPT
should integrate the results of a finalized IRIS assessment in any future risk evaluation of
formaldehyde." The commenter (EPA-HQ-OPPT-2019-0131-0019) further elaborated on the health
hazards of formaldehyde, which were acknowledged in the recent EPA rulemaking of composite wood
products, the carcinogenicity of formaldehyde, and recent studies that support the relationship between
formaldehyde and leukemia. The commenter (EPA-HQ-OPPT-2019-0131-0019) also calls for the
completion of the IRIS revised human health hazard assessment of formaldehyde. Another commenter
(EPA-HQ-OPPT-2018-0465-0018) stated the IRIS draft hazard assessment "should be utilized, with
minimal or no alteration, as the hazard component of the TSCA risk evaluation".
Comment: Another commenter (EPA-HQ-OPPT-2018-0462-0006/EPA-HQ-OPPT-2018-0462-0017)
offered that EPA utilize information previously gathered for TBBPA as an initial starting point (2015
Work Plan Chemical Problem Formulation and Initial Assessment), to focus the prioritization review.
The commenter stated that if EPA moves forward with a risk evaluation, it should focus its review on
the most relevant exposure scenarios and on the parent chemical and not metabolites or degradation
products. The commenter (EPA-HQ-OPPT-2018-0462-0017) further recommends using international
assessments as reference, focusing on the main TBBPA use in printed circuit boards or laminates, and
offered a description of the epoxy resin creation to laminate fabrication processes. The commenter
(EPA-HQ-OPPT-2018-0462-0017) also requested clarification of EPA's analysis of general population
exposure and welcomed an opportunity to discuss their peer reviewed research.
Response: EPA will consider the body of scientific information, such as that included in IRIS
assessments and previous problem formulations, during the risk evaluation process. The information
will be analyzed during the 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. This systematic review process will
be documented and made public as part of the risk evaluation.
The focus of the TBBPA's risk evaluation will be discussed during the scoping phase of risk evaluation.
EPA typically considers the role of the parent compound, its metabolites and/or degradation products
during the risk evaluation of a chemical substance.
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Future Data Gathering
Comment: Several commenters (EPA-HQ-OPPT-2019-0131-0009/EPA-HQ-OPPT-2019-0131-0023,
EPA-HQ-OPPT-2019-0131 -0010, EPA-HQ-OPPT-2019-0131 -0011/EPA-HQ-OPPT-2019-0131 -0019,
e.g. EPA-HQ-OPPT-2018-0421-0013) suggested that the Agency assess the quality and adequacy of
available data, identify significant information gaps on hazards or exposures, and, if necessary, employ
testing and information collection authorities in TSCA sections 4 and 8, respectively. One commenter
(EPA-HQ-OPPT-2019-0131 -0009/EPA-HQ-OPPT-2019-0131 -0023) further called for EPA to establish
a systematic process to obtain health and safety studies and exposure data, including using TSCA
section 8(d) to obtain unpublished health and safety studies and expanding reporting under the Chemical
Data Reporting (CDR) rule. A commenter (EPA-HQ-OPPT-2019-0131-0019) indicated that EPA must
use its authorities under TSCA sections 4 and 8 to obtain information that it "can reasonable generate,
obtain, and synthesize" since it is part of the definition of "reasonably available" information in the
prioritization rule and in the risk evaluation rule. Similarly, another comment (EPA-HQ-OPPT-2019-
0131-0009/EPA-HQ-OPPT-2019-0131-0023) indicated that EPA must use its section 4 authority so that
the "upcoming evaluations are based on all reasonably available data on hazard and exposure." The
commenter (EPA-HQ-OPPT-2019-0131-0023) indicated that TSCA section 4 authorities should include
health and environmental effects testing, monitoring of workplace exposure levels, environmental
releases and presence in environmental media. The commenter (EPA-HQ-OPPT-2019-0131-0019)
pointed out how rules under section 8 can provide current health and safety studies or additional
information beyond the (CDR) rule, and TSCA section 4 rules can fill any information gaps.
Furthermore, the commenter indicated that relying on voluntary request for information will result in
limited, biased, inaccurate, or incomplete information on the chemicals. One commenter (e.g. EPA-HQ-
OPPT-2018-0421-0013) called for data gathering "with particular emphasis on potentially exposed and
susceptible subpopulations, as TSCA requires" and recommended gathering information from
"manufacturers, processors, storage facilities, recyclers, and other handlers" of the High-Priority
chemicals. The commenter (e.g. EPA-HQ-OPPT-2018-0421-0013) also called for EPA to add all High-
Priority chemicals to the Toxic Release Inventory and seek information directly from communities.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0005/EPA-HQ-OPPT-2019-0131-0021)
welcomed "EPA's statement that, in the absence of measured data on chemicals being evaluated, it may
use new approach methods that can reduce vertebrate testing to obtain relevant data" or the use of
physical chemical properties of the chemicals. The commenter (EPA-HQ-OPPT-2019-0131-0021) also
indicated that they expect scoping documents to indicate if EPA determines that there is a need to
develop new information, and such finding will be subject to public comment. In addition, the
commenter (EPA-HQ-OPPT-2019-0131-0021) called for EPA to "remind anyone developing
information for submission on a voluntary basis that they must first attempt to develop the information
by means of an alternative test method or strategy."
Response: 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 (Federal Register Notice announcing the availability of the "Working Approach for
Identifying Potential Candidate Chemicals for Prioritization" (83 FR 50366, October 5, 2018). This
allowedfor public comment on these chemicals, including submission of data that could be used by the
Agency in the risk evaluation process. EPA initiated the prioritization process for chemical substances
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 andfinal designations, in accordance with applicable statutory and
regulatory requirements.
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At the initiation of the risk evaluation process for each of the High-Priority Substances, EPA will gather
reasonably available information and will evaluate it following the process outlined in the supplemental
documentation on systematic review that will be published during risk evaluation. For any data needs
identified through the process, EPA may use the Agency's TSCA authorities under sections 4, 8 or 11, as
appropriate.
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0010) indicated that "EPA should not use
'Application of systematic review in TSCA risk evaluations' because it is inconsistent with empirically
based methods, and the data quality criteria are arbitrary and not science-based." The commenter (EPA-
HQ-OPPT-2019-0131-0020) also indicated that in the risk evaluations of the 20 chemicals designated as
High-Priority "EPA must address the comments from the Science Advisory Committee on Chemicals
(SACC)" on previous draft risk assessments "through changes to its systematic review process." The
commenter further stated that "the TSCA systematic review method should not be used, as it is not peer-
reviewed or validated." Another commenter (EPA-HQ-OPPT-2019-0131-0016) noted that the criteria
used by EPA in the systematic review is "not conducive to the inclusion of reliable and valid tribal
data." Similarly, another commenter (EPA-HQ-OPPT-2019-0131-0023) stated that the systematic
review protocol used by EPA in its initial risk evaluations is "deeply flawed and unscientific and is
compromising the quality, validity and protectiveness of these evaluations" and should instead use a
methodology endorsed by the National Academy of Sciences and other peer review bodies. Another
commenter (EPA-HQ-OPPT-2018-0465-0018) indicated that the "flawed, non-peer-reviewed 'TSCA
systematic review'" excludes evidence and doesn't allow to "reach credible, scientifically supported
conclusions," and recommends using the IRIS systematic review process for evaluation of chemical
risks under TSCA.
Response: While it is outside the scope of the prioritization process or these final designations, EPA
appreciates the feedback regarding systematic review and will continue to address peer reviewers' and
public comments to ensure that the risk evaluations fulfill TSCA sections 26(h) and 26(i) requirements.
In addition, the Agency plans to obtain peer review input from the National Academies of Sciences,
Engineering, and Medicine to strengthen the systematic review process and methods described in the
Application of Systematic Review in TSCA Risk Evaluations document.
Adherence to Warning Labels and Personal Protective Equipment
Comment: One commenter (EPA-HQ-OPPT-2019-0131 -001 l/EPA-HQ-OPPT-2019-0131 -0019) stated
that EPA "should account for, and acquire information needed to accurately evaluate, real world
occupational and consumer exposures" and "not inaccurately assume that people comply with all
warning labels and always use personal protective equipment (PPE)." EPA should adhere to the
hierarchy of controls to limit workplace exposures and should collect or require the development of data
to assess the actual extent of use and exposure reduction resulting from labeling and PPE. Similarly,
another commenter (EPA-HQ-OPPT-2019-0131-0023) stated that the approach used by EPA to
"determine that risk to workers are not unreasonable where the assumed use of [PPE] would reduce
exposures to 'acceptable' levels" "lacks any legal basis, departs from established federal workplace
protection policy and practice, and is contrary to the realities of worker exposure to unsafe chemicals."
The commenter further indicates that "EPA should base unreasonable risk determinations for workers on
measured or estimated exposure levels in the absence of PPE." Another commenter (e.g. EPA-HQ-
OPPT-2018-0421-0013 ) indicated that "if EPA expects to consider PPE usage in its risk
characterization, it should seek information from employers at facilities where it knows this substances
is manufactured, processed, use, disposed of, or recycled regarding the specific type of PPE that is
provided (what type of glove, what type of respirator), which employees receive this PPE and which do
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not, what training is provided regarding proper usage and how often, procedures for respirator fit-
testing, and any information about exposure notwithstanding PPE use." And another commenter (EPA-
HQ-OPPT-2018-0465-0018) raised concerns with making no unreasonable risk determinations for
workers based on the assumption of use of PPE and excluding high-end exposures.
Comment. A commenter (EPA-HQ-OPPT-2019-0131-0025) provided an example of exposure controls
and personal protection required for a chemical and information about the use of the candidate High-
Priority chemicals in vehicles.
Response: EPA recognized the factors that might affect worker exposures, including PPE; however,
EPA did not consider the potential exposure reductions due to the use of personal protective equipment
(PPE) during the prioritization process. The Agency appreciates this feedback regarding consideration
in the risk evaluations of worker protection practices such as the use ofpersonal protective equipment
(PPE). EPA's approach for developing exposure assessments for workers is to use the reasonably
available information to construct exposure scenarios that are anchored in the real-world use of
chemicals. When appropriate, in the risk evaluation, EPA will use exposure scenarios both with and
without engineering controls and/or PPE that may be applicable to particular worker tasks on a case-
specific basis for a given chemical ("EPA's Responses to Public Comments Received on the Scope
Documents for the First Ten Chemicals for Risk Evaluation under TSCA "
https:/Avww.eva.eov/assessine-and-manaeine-chemicals-under-tsca/response-comments-issues-
impactme-firsi-lO-chemicals). Similarly, for consumers, in the risk evaluation the Agency will use
exposure scenarios that assume real-world consumer use of chemicals, which does not assume reliable
use of PPE. The effect of labeling to address unreasonable risk will be considered during the
development of risk management actions.
Applicability of Risk Evaluation Fees
Comment: Two commenters (EPA-HQ-OPPT-2019-0131-0007, EPA-HQ-OPPT-2019-0131-0014)
raised concerns about TSCA section 26 risk evaluation fees that might apply to chemical substances if
present in "articles, components or replacement parts" or as impurities. One of those commenters (EPA-
HQ-OPPT-2019-0131-0007) further requested an exemption from such fees for "companies that
purchase articles or components that will then be assembled into a complex durable good" or "in lieu of
an exemption, ... a clear cost sharing guidance that recognizes the relative volume of the chemical
contributed by each responsible company." The other commenter (EPA-HQ-OPPT-2019-0131-0014) is
concerned that it will have to participate in a consortium and pay a fee for the formulations containing
these impurities.
Response: The TSCA fees rule imposes certain obligations on manufacturers and importers of a
chemical designated as High-Priority for risk evaluation. There are no exemptions in the rule for
importers of articles, components, or replacement parts that contain High-Priority chemical, or for
those who manufacture the chemical as a byproduct or impurity. As such, these manufacturers and
importers are subject to the TSCA fees rule requirements. Per the rule, the distribution of fees amongst
responsible payers is based on the number of identified manufacturers and importers, and the number of
entities who qualify for a discountedfee as a "small business concern. " Fee payers may choose to form
or join a consortium and allocate fee responsibility amongst its members based on other factors such as
market share or production volume. EPA does not require participation in a consortium.
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Consideration of Downstream Users
Comment: One commenter (EPA-HQ-OPPT-2019-0131-0012) asked EPA to consider downstream users
and their "unique stake and perspective when implementing TSCA" due to their likely interaction with
consumers and retailers, as opposed to chemical manufacturers, and stressed the need for "clarity and an
efficient, scientifically sound, decision-making process that addresses those substances that may present
the greatest potential risk."
Comment. One commenter (EPA-HQ-OPPT-2019-0131-0025) "urge[d] EPA to justify their low risk
and exemption determinations in as robust and clear a manner as possible to ensure regulatory certainty
and an even playing field across all states."
Response: The Agency appreciates this feedback from potentially affected persons. 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. Please note that exemptions and low risk determinations are
outside the scope of the prioritization process or these final designations, and a final risk determination
will be part of the risk evaluation process.
Comments Related to Risk Management
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0017) encouraged EPA to develop a robust body
of information concerning the chemical substances under consideration for regulatory action, including
the conditions of use, so that a careful consideration of such information can be used to more effectively
develop and implement requirements to protect health and the environment while enabling the regulated
community to pursue innovation and sustainable economic development. Also, information concerning
the level of effort required to develop suitable products for specialized uses will enable EPA to better
understand the potential consequences that can follow from a risk evaluation.
Comment: A commenter (EPA-HQ-OPPT-2018-0451-0009) described how "[106-99-0] illustrates the
challenge facing industry in investing in and implementing alternatives for specific uses. The EPA
report on 'Flame Retardant Alternatives for Hexabromocyclododecane (HBCD)' published in 2014
recommended a butadiene styrene brominated copolymer (CASRN 1195978-93-8). If this guidance had
been acted upon, there would now be potential for applications to be adversely impacted by restrictions
to 1,3-butadiene."
Comment: A commenter (EPA-HQ-OPPT-2019-0131-0007/EPA-HQ-OPPT-2019-0131-0025) raised
concerns regarding the potential regulation of automotive articles and components and cited "very real
and significant impact on our ability to produce and maintain automobiles that meet all federal, state and
local safety requirements." As EPA "moves forward from the prioritization stage to the risk evaluation
phase," the commenter requested "clarity for how and when in the process it will make determinations
about "articles" relative to identified conditions of use," and how EPA will interpret and implement
TSCA section 6(c). The commenter also raised similar concerns regarding replacement parts and
indicated that "replacement parts typically do not present the same exposure risks as bulk chemicals or
formulated products." The commenter requested EPA to "develop and publish for comments its policy
for implementation of TSCA section 6(c)(2)(D) before the risk evaluation of any selected high priority
chemicals begins." The commenter (EPA-HQ-OPPT-2019-0131-0025) also provided examples of how
EPA has addressed regulatory actions regarding articles (e.g., CDR, PBT proposed rule). Similarly,
another commenter (EPA-HQ-OPPT-2019-0131-0022) asked EPA to "keep in mind the requirements of
TSCA section 6(c)(2)(D)(i) regarding the application of risk management measures to replacement parts
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for complex durable goods, such as automobiles" and "obligations with respect to applying risk
management rules to substances in articles, such as parts for automobiles."
Comments: One commenter (e.g., EPA-HQ-OPPT-2018-0421-0006) identified a variety of uses in the
aerospace industry for most of the candidates for proposed designation as High-Priority Substances and
stated if such substances are "restricted or unavailable, it may have serious implications to the aerospace
industry and its customers. If [such substances] cannot be used, the industry would need sufficient time
to conduct research to reformulate or develop a product with equivalent performance and characteristics.
Aerospace products are extremely complex and a qualified drop-in substitution with identical or superior
performance is not always guaranteed or readily available."
Response: The Agency appreciates this feedback from potentially affected persons. Please note that the
final designation of a chemical substance as a High-Priority Substance is not a finding of unreasonable
risk. Rather, it initiates the risk evaluation process. During the risk evaluation process, EPA determines
whether or not the chemical substance presents an unreasonable risk to health or the environment under
the conditions of use. If unreasonable risk is identified, then the Agency will initiate any necessary risk
management action to address such risk.
In the preamble for the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic
Substances Control Act Final Rule (82 FR 33 753-33 764), EPA agreed that the consideration of
alternatives is most appropriately considered as part of any risk management rule.
EPA notes that TSCA section 6(c)(2)(D) (replacementparts) and (E) (articles) applies to risk
management, not prioritization. The chemical must first be designated as a High-Priority Substance
and, if during the risk evaluation process unreasonable risk is identified, then any regulatory action will
consider articles and replacement parts. As such, EPA will consider the evaluation of articles,
components, and replacement parts as necessary during the risk evaluations of High-Priority
Substances following their final designations, and, if needed, will follow TSCA section 6(c)(2)(D)-(E)
during any risk management phase.
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