Final Designation of Low-Priority Substances Under the Toxic Substances Control Act (TSCA); Notice of Availability, 11069-11079 [2020-03869]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11069-11079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03869]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0450; FRL-10004-82]


Final Designation of Low-Priority Substances Under the Toxic 
Substances Control Act (TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required by the Frank R. Lautenberg Chemical Safety for the 
21st Century Act amendments to the Toxic Substances Control Act (TSCA) 
and implementing regulations, EPA is designating 20 chemical substances 
as Low-Priority Substances for which risk evaluation is not warranted 
at this time. This document provides the final designation for each of 
the chemical substances and instructions on how to access the chemical-
specific information, analysis and basis used by EPA to make the final 
designation for each chemical substance.

FOR FURTHER INFORMATION CONTACT: For technical information about Low-
Priority Substances contact: Lauren Sweet, Chemistry, Economics and 
Sustainable Strategies Division, Office of Pollution Prevention and 
Toxics, Office of Chemical Safety and Pollution Prevention, 
Environmental Protection Agency (7406M), 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-0376; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].
    Additional instructions on visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to entities that currently or may manufacture (including 
import) a chemical substance regulated under TSCA (e.g., entities 
identified under North American Industrial Classification System 
(NAICS) codes 325 and 324110). The action may also be of interest to 
chemical processors, distributors in commerce, and users; non-profit 
organizations in the environmental and public health sectors; state and 
local government agencies; and members of the public. Because interest 
in this notice may be broad, the Agency has not attempted to describe 
all the specific entities and corresponding NAICS codes for entities 
that may be interested in or affected by this action.

B. What action is the Agency taking?

    EPA is designating 20 chemical substances as Low-Priority 
Substances pursuant to section 6(b) of the Toxic Substances Control Act 
(TSCA), 15 U.S.C. 2605(b). This document includes the final designation 
for each of the chemical substances and instructions on how to access 
the chemical-specific information, analysis and basis used by EPA to 
make the final designation for each chemical substance.

C. Why is the Agency taking this action?

    As required by TSCA section 6(b)(2)(B), EPA is designating 20 
chemical substances as Low-Priority Substances. EPA initiated the 
prioritization process required by TSCA section 6(b) on March 21, 2019 
(Ref. 1) and published screening reviews supporting their proposed 
designation as Low-Priority Substances on August 15, 2019 (Ref. 2).

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

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

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

    This document identifies 20 chemical substances as Low-Priority 
Substances. This document does not establish any requirements on 
persons or entities outside of the Agency. No incremental impacts are 
therefore anticipated, and

[[Page 11070]]

consequently EPA did not estimate potential incremental impacts for 
this action.

II. Background

    TSCA section 6(b), as amended in 2016 by the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act (Pub. L. 114-182), requires 
EPA to prioritize chemical substances for designation as a High-
Priority Substance or a Low-Priority Substance. In accordance with TSCA 
section 6(b) and 40 CFR 702.7, on March 21, 2019 (Ref. 1), EPA 
initiated the prioritization process for 20 chemical substances 
identified as candidates for Low-Priority Substance designation and 
sought public comment on the identified candidates. On August 15, 2019 
(Ref. 2), EPA proposed 20 chemical substances as Low-Priority 
Substances and sought additional public comment on these proposals.
    Under TSCA section 6(b)(1)(B) and implementing regulations (40 CFR 
702.3), a Low-Priority Substance is defined as a chemical substance 
that the Administrator concludes, based on information sufficient to 
establish, without consideration of costs or other non-risk factors, 
does not meet the standard for a High-Priority Substance. A High-
Priority Substance is defined as a chemical substance that the 
Administrator concludes, without consideration of costs or other non-
risk factors, may present an unreasonable risk of injury to health or 
the environment because of a potential hazard and a potential route of 
exposure under the conditions of use, including an unreasonable risk to 
a potentially exposed or susceptible subpopulation identified as 
relevant by the Administrator. Designation of a chemical substance as a 
Low-Priority Substance indicates a risk evaluation is not warranted at 
that time (TSCA Section 6(b)(1)(A) and 40 CFR 702.15).
    This document is intended to fulfill the requirement in TSCA 
section 6(b)(2)(B) that the Administrator finalize the designation of 
20 chemical substances as Low-Priority Substances. The prioritization 
rule states at 40 CFR 702.11 that EPA will publish such designations in 
the Federal Register.
    As described in the proposal notice (Ref. 2), EPA used reasonably 
available information to screen each candidate chemical substance 
against the following criteria and considerations (40 CFR 702.9(a)) and 
thereby inform the proposed designation:
     The chemical substance's hazard and exposure potential;
     The chemical substance's persistence and bioaccumulation;
     Potentially exposed or susceptible subpopulations;
     Storage of the chemical substance near significant sources 
of drinking water;
     The chemical substance's conditions of use or significant 
changes in conditions of use;
     The chemical substance's production volume or significant 
changes in production volume; and
     Other risk-based criteria that EPA determines to be 
relevant to the designation of the chemical substance's priority for 
risk evaluation.
    For the final priority designation, EPA considered comments and 
information submitted by the public during two public comment periods 
(after initiation and after proposed designation) and incorporated them 
as appropriate in finalizing the 20 chemical substances designated as 
Low-Priority Substances, as outlined in the statute (TSCA section 
6(b)(1)(A)) and implementing regulations (40 CFR 702.11(a)) and 
consistent with the scientific standards of TSCA section 26(h) and (i). 
In addition, as required by TSCA section 6(b)(1)(B)(ii) and 40 CFR 
702.11(b), EPA did not consider cost or other non-risk factors in 
making a priority designation.

III. Information and Comments Received

A. Initiation

    The initiation of the prioritization process (Ref. 1) included a 
90-day comment period during which interested persons were able to 
submit relevant information on those chemical substances identified as 
candidates for Low-Priority Substance designation.
    During the 90-day comment period, commenters submitted information 
on four chemical substances identified as candidates for Low-Priority 
designation:

 Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- (CAS RN 
24800-44-0) (Ref. 3)
 Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate (CAS RN 
88917-22-0) (Ref. 4)
 Propanol, [2-(2-butoxymethylethoxy)methylethoxy]- (CAS RN 
55934-93-5) (Ref. 5)
 Propanol, oxybis- (CAS RN 25265-71-8) (Ref. 6)

    EPA incorporated the chemical-specific information submitted during 
the initiation public comment period in the screening reviews published 
at proposal.
    EPA also received general prioritization comments during the 
initiation public comment period, as summarized below. A high-level 
synopsis of comments received during the initiation stage, and Agency 
responses to those comments, follows. Additional information is 
included in the Agency's full response to general comments document 
(Ref. 7) and in its full response to chemical-specific comments 
document (Ref. 8).
    The following provides an overview of public comments received 
during initiation and EPA's responses.
1. Agency 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. Specific concerns included how EPA would address 
instances where new data for some Work Plan chemicals identified as 
high- or low-priority chemicals might not satisfy the Section 6 
statutory criteria for prioritization, and that ``EPA should establish 
a 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 regulations 
from the ``Procedures for Prioritization of Chemicals for Risk 
Evaluation Under the Toxic Substances Control Act'' Rule (Ref. 9), 
there are two comment opportunities during the prioritization process, 
in accordance with applicable statutory and regulatory requirements. 
EPA considered the information submitted as part of its proposed and 
final designations.
    For prioritization, EPA considered sources of information 
consistent with the scientific standards in TSCA section 26(h), 
including the sources listed in EPA's ``Approach Document for Screening 
Hazard Information for Low-Priority Substances under TSCA'' (Ref. 10) 
(also referred to as ``Approach Document'').
    In response to commenter's specific concerns regarding 
implementation of the statutory considerations and criteria of TSCA 
section 6(b)(1)(A), EPA notes that the Agency developed a screening 
review document for each candidate chemical substance at proposal to 
identify the information, analysis and basis used to support the 
proposed designation as a low-priority substance. These documents are 
available in the respective dockets of each chemical substance with a 
proposed designation as a Low-Priority Substance (Ref. 2). Each 
document includes an overview of the requirements in TSCA section

[[Page 11071]]

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 hazard, exposure, the ``conditions of use or 
significant changes in conditions of use,'' and ``potentially exposed 
or susceptible subpopulations,'' to support the proposed designation.
    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,'' indicating that hazard and 
exposure potential are considerations for the risk-based priority 
designations.
2. Potentially Exposed or Susceptible Subpopulations
    Comment: One commenter urged EPA to identify relevant potentially 
exposed or susceptible subpopulations (PESS), including infants, 
children, pregnant women, workers, the elderly, and ``people living in 
proximity to sources of contamination,'' as well as to consider 
environmental justice concerns in the prioritization process.
    Response: EPA explained in the response to comments on the 
prioritization rule (Ref. 11) that EPA has, in practice, evaluated 
risks across populations, with particular attention to workers, 
pregnant women, children, infants and the elderly, among others. The 
Agency will continue to use and refine its processes for prioritization 
to determine risks to potentially exposed or susceptible 
subpopulations.
    In the screening reviews conducted for prioritization, EPA 
considered reasonably available information to identify the relevant 
potentially exposed or susceptible subpopulations, such as children, 
workers or consumers. EPA used human health hazard information, the 
conditions of use, and exposure potential to identify potentially 
exposed or susceptible subpopulations. These data provide an indication 
about whether children or other susceptible subpopulations may be 
potentially exposed to the reported chemical.
3. Future Prioritization Efforts
    Comment: Some commenters offered thoughts on future prioritization 
efforts, including urging EPA to allow data to drive the priority 
designation and to not predetermine an outcome for the candidates as 
High- or Low-Priority Substances.
    Response: EPA agrees that priority designation should be driven by 
data as explained in the Approach Document (Ref. 10). Similar to the 
process to designate the first 20 Low-Priority Substances, in the 
future, EPA intends to use reasonably available information in proposed 
designation documents to explain why it chose to initiate the process 
for the particular chemical substance (e.g., whether EPA viewed 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 (Ref. 9 at 33759)). In addition, the two 
90-day comment periods provided an opportunity for any interested 
person to submit additional information before EPA finalized a 
designation for a candidate chemical substance.
4. Stakeholder Engagement and Transparency
    Comment: Several commenters supported stakeholder engagement and 
transparency during the prioritization process, including maintaining 
an open and transparent process that ``encourages submission of the 
most relevant information,'' providing ``greater transparency and 
clarity'' and ``more information to ascertain what information [EPA] 
already has and what information is needed,'' and stating that 
``transparency and information exchange is critical to the success of 
future prioritization efforts.'' Other commenters indicated 
shortcomings with the transparency of the process and/or provided 
recommendations for improvements, including placing all the 
``reasonably available information'' in the dockets for public review, 
increasing transparency about the information received during the 
initiation of public comment period and indicating if EPA used that 
information to screen the chemical against the criteria for proposing a 
priority designation, so that members of the public can comment on such 
information during the proposed designation comment period.
    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 Initiation of Prioritization Under 
the Toxic Substances Control Act (Ref. 1), EPA used the Safer Chemical 
Ingredients List (SCIL) as a starting point for narrowing down 
potential candidates for Low-Priority Substances, but performed an 
independent review of the reasonably available information to screen 
each candidate chemical substance against all of the statutory criteria 
and considerations under TSCA section 6(b)(1)(A) and 40 CFR 702.9. This 
information was included in the screening reviews for each chemical 
substance. In addition, the two 90-day comment periods provided an 
opportunity for any interested person to submit additional information 
before EPA finalized a designation for a candidate chemical substance.
    Leading up to the nine- to twelve-month statutory window for 
prioritization, EPA worked diligently to gather stakeholder input on 
the process for identifying candidates for initiation of 
prioritization. On December 11, 2017, EPA held a public meeting to 
discuss possible approaches for identifying potential candidate 
chemicals for EPA's prioritization process under TSCA (82 FR 51415). 
EPA described and took comment on a number of possible approaches that 
could guide the Agency in identification of potential candidate 
chemicals for prioritization. EPA considered that input and on October 
5, 2018, published notice of its release of ``A Working Approach for 
Identifying Potential Candidate Chemicals for Prioritization'' and 
opened a docket for comment (83 FR 50366). When prioritization was 
actually initiated under the statutory timeline, EPA provided an 
opportunity for the public to provide information for the chemical 
substances by publishing the notice initiating the prioritization 
process (Ref. 1). In the notice with the proposed priority designation 
(Ref. 2), EPA developed a screening review document for each candidate 
chemical substance to identify the information, analysis and basis used 
to support the proposed Low-Priority Substance designation. These 
documents include linked citations to the Health and Environmental 
Research Online (HERO) database (Ref. 12) for all references used in 
the literature review for each of these chemical substances. Those 
references are accessible to the public via links provided in the HERO 
database.
5. Designation Terminology
    Comment: One commenter called for greater clarity in the 
definitions of High- and Low-Priority Substances, beyond the statutory 
definitions.
    Response: In a previous response to public comment, the Agency 
articulated its rationale for not elaborating on or modifying statutory 
standards for High-Priority and Low-Priority Substances: ``EPA did not 
establish the standard for a High-Priority designation; Congress did in 
the definitions of High- (and Low-) Priority Substances . . . The 
statutory standard for High[hyphen]Priority designations--that the 
chemical 'may present an unreasonable risk' based on a 'potential 
hazard and a potential route of exposure'--is the only place where

[[Page 11072]]

such a standard appears in TSCA.'' (Ref. 11). EPA believes it is 
appropriate to rely on the statutory standards for designating High-
Priority and Low-Priority Substances, without introducing new binding 
language. Yet to help explain the context, purpose, and timing of this 
effort, EPA wishes to offer some of the Agency's views from its 
experience in this initial round of prioritization.
    Every chemical substance may present risks of one sort or another. 
A spill of fresh water into a marine environment may present risks to 
aquatic life, and excessive consumption of water may present a risk of 
water intoxication to humans. People encounter chemicals in their daily 
lives that may present some risk. Notably, EPA's role in prioritization 
and risk evaluation under section 6 of TSCA is to scrutinize chemical 
substances for unreasonable risks. It would be inappropriate for every 
potential risk--even those from water--to be considered an unreasonable 
risk and even more inappropriate to think that the statutory text 
contemplates that the presence of potential risks forecloses a 
designation as a Low-Priority Substance. Rather, the statutory use of 
the term `unreasonable' necessarily leaves some ambiguity for the 
Agency to resolve in exercising its technical and policy discretion in 
each decision it makes under the prioritization process. A 
determination of whether or not a chemical may present unreasonable 
risk is made on a case-by-case, chemical-specific basis.
    In the final prioritization and risk evaluation rules, EPA retained 
its discretion by not promulgating a definition of unreasonable risk 
(82 FR 33726; Ref. 9). Indeed, in the risk evaluation rule's preamble, 
EPA discussed a non-exhaustive list of factors that the Agency may 
weigh in considering unreasonable risk: ``To account for the number of 
different risk characterization approaches and for changing science, 
EPA will not include any specific definition in this final rule. To 
make a risk determination, EPA may weigh a variety of factors in 
determining unreasonable risk. The Administrator will consider relevant 
factors including, but not limited to: The effects of the chemical 
substance on health and human exposure to such substance under the 
conditions of use (including cancer and non-cancer risks); the effects 
of the chemical substance on the environment and environmental exposure 
under the conditions of use; the population exposed (including any 
susceptible populations), the severity of hazard (the nature of the 
hazard, the irreversibility of hazard), and uncertainties'' (82 FR 
33726 at 33735). In recently issued draft risk evaluations, EPA further 
elaborated: ``EPA also takes into consideration the Agency's confidence 
in the data used in the risk estimate. This includes an evaluation of 
the strengths, limitations and uncertainties associated with the 
information used to inform the risk estimate and the risk 
characterization.''
    The statute tasks the Agency with first teasing apart and 
designating High-Priority Substances for risk evaluation from Low-
Priority Substances that will not proceed to risk evaluation--at least 
not at the current time based upon EPA's review of reasonably available 
information. For High-Priority Substances, EPA must proceed to risk 
evaluation and, upon any determination of unreasonable risk, to risk 
management.
    The statutory framework is thus clear that prioritization is not 
meant to be a risk evaluation. Nor can it be with the timeline provided 
under TSCA. The statute required that EPA designate 20 High-Priority 
Substances and 20 Low-Priority Substances within three and a half years 
of enactment (TSCA section 6(b)(2)(B)). Yet EPA first had to undertake 
a notice-and-comment rulemaking to lay out the process for this 
prioritization process (TSCA section 6(b)(1)(A)). The statute further 
specified the prioritization timeline: It must include multiple stages 
(initiation plus opportunity for public comment, with opportunity for 
extension; proposal plus opportunity for public comment; and final 
designation), and it must last no longer than one year but no shorter 
than nine months (TSCA section 6(b)(1)(C)). Between the statutory 
window of no more than one year for the entire prioritization process, 
the statutory requirement for EPA to designate 20 Low-Priority 
Substances by December 2019, and the plain statutory text explaining 
that EPA is to use a ``screening process'' to designate ``low-
priority'' substances ``for which risk evaluations are not warranted at 
the time,'' the statute is clear that EPA need not perform nearly as 
exhaustive a review of a chemical substance as a risk evaluation before 
designating the chemical substance as a Low-Priority Substance.
    Moreover, Congress chose not to define ``screening process'' in the 
statute, leaving EPA the discretion to create a risk-based screening 
process according to the considerations expressed in section 
6(b)(1)(A). EPA created a transparent literature review method for the 
purposes of prioritization and screening review under this section. The 
Approach Document (Ref. 10) includes a description of elements for 
weight of the scientific evidence and explains how these can be applied 
in a manner appropriate to screening-level review and Low-Priority 
Substance designations. The Approach Document (Ref. 10) explains the 
methods used to ensure comprehensive, objective, transparent and 
consistent review of reasonably available information.
    EPA included exposure and potential changes in exposure through 
considerations such as conditions of use (including all known, intended 
or reasonably foreseen uses), significant changes in the conditions of 
use, production volume, and significant changes in the production 
volume. The selection of chemical substances with consistently low-
hazard characteristics means that an increase in the frequency or 
magnitude of exposure would not significantly change the outcome of a 
screening-level review. In compliance with section 26, EPA considered 
the reasonably available information, including studies and data, on 
each proposed Low-Priority Substance relevant to the screening criteria 
and used such information in a manner consistent with best available 
science. EPA notes the following text from the Procedures for 
Prioritization of Chemicals for Risk Evaluation Under the Toxic 
Substances Control Act: ``The screening review is not a risk 
evaluation, but rather a review of reasonably available information on 
the chemical substance that relates to the screening criteria. EPA 
expects to review all sources of relevant information, consistent with 
the scientific standards in 15 U.S.C. 2625(h), while conducting the 
screening review'' (Ref. 9 at 33759).
    EPA also kept in mind the nine- to twelve-month deadline to 
complete the prioritization process, while accommodating and 
incorporating the statutorily-required cumulative six months of public 
comment. Congress recognized the important of public input and EPA has 
considered and incorporated, as appropriate, the comments that were 
received. The statutory provisions at TSCA sections 6(b)(1)(A) and 
6(b)(1)(B)(ii) direct EPA to undertake a limited screening process and 
to render priority determinations based on sufficient supporting 
information. Congress's requirement for EPA to designate twenty 
chemical substances as Low-Priority Substances within three and a half 
years after the Lautenberg amendments to TSCA, within the nine- to 
twelve-month process prescribed by the statute, and

[[Page 11073]]

only after first proposing and then promulgating a rule to lay out the 
process for prioritization, indicates that Congress expected the 
identification of such chemical substances to be a manageable exercise 
for the Agency. Low-priority designations are not determinations that 
these chemical substances do not present any risks, rather that EPA, 
through the prioritization process, has determined that sufficient 
information supports the determination that these chemical substances 
do not meet the standard provided in TSCA section 6(b)(1)(B)(i) to 
designate these chemical substances as High-Priority Substances.
    Still, the final, yet not permanent, nature of the Low-Priority 
Substance designation gives EPA the authority to revisit a Low-Priority 
Substance designation given the ever-changing reality of scientific 
discovery. EPA notes the following text from the Procedures for 
Prioritization of Chemicals for Risk Evaluation Under the Toxic 
Substances Control Act: ``Designation of a chemical substance as a Low-
Priority Substance under Sec.  702.11 means that a risk evaluation of 
the chemical substance is not warranted at the time, but does not 
preclude EPA from later revising the designation pursuant to Sec.  
702.13, if warranted'' (40 CFR 702.15; Ref. 9). EPA further notes the 
following text from Senate Report 114-67--Frank R. Lautenberg Chemical 
Safety for the 21st Century Act: ``By including these mandatory 
criteria in the statute, it is the Committee's intent to require EPA to 
ensure that important, broad science-based considerations, 
classifications and designations drive the prioritization screening 
process, without locking EPA into specific designations based upon 
ever-changing science'' (Ref. 12). EPA's prioritization rule expressly 
recognizes that EPA may revise a Low-Priority Substance designation 
based on reasonably available information (40 CFR 702.13).
6. Timeframe for Providing Chemical Substance Information
    Comment: Commenters described the challenges to collecting, 
identifying, assessing, and submitting chemical-specific data in the 
90-day comment period following the initiation of the prioritization 
process, including challenges gathering information that resides with 
international downstream suppliers, limitations of available data 
gathering tools, and time and resource requirements, including a call 
for additional time during the comment period.
    Response: EPA understands such challenges and has been committed to 
giving the public and interested stakeholders as many opportunities as 
possible, under the timing requirements of the statute, to provide 
relevant chemical substance information and comment on key aspects of 
the prioritization process in general, as well as for each chemical 
substance. The prioritization process was designed, by law, to take no 
fewer than nine months, and no more than twelve months--a timeframe set 
by Congress to allow interested stakeholders to provide the Agency with 
relevant, necessary information. EPA does not have the discretion to 
adjust the timeframe set by Congress. Within the nine- to twelve-month 
timeframe, there are two three-month comment periods (following 
initiation and proposed designation for the substances), for a total of 
six months for public comment during the prioritization process.
    Comment: A commenter stated that EPA ``could use its authority 
under TSCA 4(a)(1)(A)(i) [to require the development of new information 
before initiating prioritization] and that it could also use its 
authority under 4(a)(1)(A)(ii) for chemicals that meet the statutory 
criteria of being produced and potentially released in substantial 
quantities or if there is potentially significant exposure,'' while 
noting the ``difficulty in making a may present unreasonable risk 
finding as required under 4(a)(1)(A)(i) was among the motivations for 
amending TSCA, and this difficulty would still need to be overcome.'' 
The commenter then stated that ``timing requirements might indeed be 
difficult to meet in some cases, [but] such difficulty does not remove 
the clear requirement under 4(a)(2)(B)(i) to make a priority 
designation within 90 days of receipt of any information requested.''
    Response: EPA appreciates the comment regarding the Agency's data 
collection authority. EPA identified sufficient information to complete 
the prioritization screening review and make final priority 
designations.
7. Confidential Business Information
    Comment: One commenter urged EPA to implement the requirements of 
TSCA section 14 when prioritizing chemical substances, urging adherence 
to the requirements for disclosure of certain information by the Agency 
and the timing for confidentiality claims and substantiations.
    Response: EPA generally makes the information it uses for decision 
making publicly available, consistent with the requirements of TSCA 
section 14. EPA considered all reasonably available information, 
including CBI, to perform the screening review for Low-Priority 
Substances. All reasonably available information used in the screening 
review was publicly available for the 20 Low-Priority Substances 
designated at this time.
8. Low-Priority Substance Designations
    Comment: One commenter raised concerns that ``EPA must be in 
possession of data for all relevant health and ecological endpoints 
developed using adequate test methodologies'' to support a Low-Priority 
Substance designation. The commenter encouraged EPA to provide a 
description of ``endpoints and related testing methodologies on which 
it will rely in the upcoming Federal Register notice proposing specific 
substances for low-priority listing.''
    Response: Each chemical substance's screening review provides the 
endpoints and methodology used to screen the chemical substance. The 
data quality criteria used to screen reasonably available hazard 
information is provided in the Approach Document (Ref. 10). As 
previously explained, EPA based its selection of candidate chemicals on 
the best available science, consistent with TSCA section 26(h), and 
selected candidates with robust data sets for consideration of hazard 
and exposure potential. Before initiating the prioritization process, 
EPA reviewed the reasonably available hazard and exposure-related 
information and determined whether there was sufficient information to 
complete the prioritization process within the statutory deadlines.
    Comment: One commenter urged EPA to ``provide a focused and robust 
message on low priority designations which clearly identify low 
priority chemicals as such, so that they do not occupy a place of 
uncertainty and are not associated with statements of implied risk'' 
and ``to continue to make low priority designations.''
    Response: In the preamble of the prioritization rule (Ref. 9), EPA 
clarified the messaging associated with Low-Priority Substance 
designations by stating ``final designation of a chemical substance as 
a Low-Priority Substance is a final agency action that means that a 
risk evaluation of the chemical substance is not warranted at the 
time.'' In regard to continuing to make Low-Priority Substance 
designations, EPA appreciates the commenter's viewpoint. Each 
chemical's screening review contains the reasonably available 
information sufficient to make the final designation of the chemical 
substance as a Low-Priority Substance, which is a final agency action 
that means that a

[[Page 11074]]

risk evaluation of the chemical substance is not warranted at this 
time.

B. Screening Review and Proposed Priority Designation

    The proposed designation stage of the prioritization process (Ref. 
2) included a 90-day comment period during which interested persons 
were able to submit relevant information on those chemical substances 
proposed for Low-Priority Substance designation. All hazard and fate 
information for these proposed Low-Priority Substances was collected 
and evaluated in accordance with the methodology laid out in the 
Approach Document (Ref. 10). Information gathered according to this 
Approach Document was included in each chemical substance's screening 
review. EPA considered the information submitted during the screening 
review and the proposed priority designation public comment period for 
specific chemical substances, as appropriate, in finalizing the Low-
Priority Substance designation. During the public comment period for 
the proposed designation stage, EPA received 11 submissions from eight 
different entities, including environmental and health advocacy groups, 
a trade association, an academic institution, and anonymous commenters. 
A high-level synopsis of comments received during the proposed 
designation stage, and Agency responses to those comments, follows. 
Additional information is included in the Agency's full response to 
general comments document (Ref. 7) and in its full response to 
chemical-specific comments document (Ref. 8).
    The following provides an overview of public comments received 
during the proposal and EPA's responses.
1. Overall Strategy for Data Search, Screening, and Evaluation
    Comment: Several commenters stated EPA failed to exercise its 
information collection authorities to gather all reasonably available 
information when designating chemicals as Low-Priority Substances. Some 
commenters wrote that EPA failed to develop test data to fill gaps in 
the existing data, despite having testing authority to do so. These 
commenters stated that because TSCA section 6(b)(2)(B) requires that 
EPA designate 20 High-Priority Substances and 20 Low-Priority 
Substances within three and a half years of enactment, testing that 
could have taken up to those three and a half years should or could be 
reasonably available information. Other commenters stated that EPA's 
strategies for data search, screening relevance, and evaluating data 
quality were sound and appropriate to ensure the relevance and quality 
of sufficient, reasonably available information to support designation 
of Low-Priority Substances.
    Response: EPA found it had sufficient information to support the 
Low-Priority Substance designations and did not need to exercise its 
information gathering authorities. As explained further in section 1(a) 
of the full response to general comments document (Ref. 7), the 
timeframe for initiation, proposal, and public comment, did not allow 
for requiring, conducting, and documenting toxicological studies. More 
information on the Agency's rationale and response can be found in the 
full response to general comments document (Ref. 7).
    Comment: A few commenters generally stated that EPA changed the 
``weight of the scientific evidence'' definition to a new definition 
that is inconsistent with the definition in EPA's risk evaluation 
regulations and currently accepted scientific standards. These 
commenters also disagreed with EPA's use of weight of evidence to make 
a low-concern finding for specific endpoints. Other commenters 
supported EPA's strategies for evaluating data and stated they were 
sound, relevant, and sufficient to support designation of Low-Priority 
Substances.
    Response: The risk evaluation definition of ``weight of the 
scientific evidence'' is beyond the scope of prioritization. EPA 
ensured elements of weight of scientific evidence appropriate to 
screening-level review and Low-Priority Substance designation were 
incorporated in the screening-level reviews. The document ``A Working 
Approach for Identifying Potential Candidate Chemicals for 
Prioritization'' (Ref. 13) explains the methods used to ensure 
comprehensive, objective, transparent and consistent review of all 
reasonably available information for the Low-Priority Substances.
    Comment: Several commenters suggested that the range of studies 
considered by EPA should have been more inclusive. In particular, one 
commenter recommended additional sources of information within U.S. 
government agencies and programs, and a few commenters stated that 
EPA's review should not have excluded foreign language studies.
    Response: EPA considered all reasonably available information and 
relied on the data quality criteria outlined in the Approach Document 
(Ref. 10) to ensure sufficient information to support a Low-Priority 
Substance designation.
    Comment: One commenter pointed out a lack of clarity in the way EPA 
cited sources obtained from the European Chemicals Agency (ECHA) 
database. The commenter further stated that EPA needs to review and 
consider the full study reports corresponding to the summaries obtained 
from the ECHA database.
    Response: EPA has updated the citations in the screening reviews to 
``Reported to the ECHA database'' to reflect that ECHA is not the 
author of these studies. EPA found that the information in study 
summaries provided sufficient information to determine whether it met 
EPA's data quality metrics (Ref. 10). Where summaries provided 
insufficient information, EPA did not use that study.
2. Additional Endpoints EPA Should Have Considered
    Comment: Several commenters suggested additional endpoints that EPA 
should have considered during the prioritization process: Physical 
hazards, immunotoxicity, respiratory sensitization, endocrine effects, 
and developmental neurotoxicity.
    One commenter recommended that EPA should consider physical 
hazards, such as flammability, self-ignition, and explosive properties, 
when determining whether a substance meets the requirements for low-
priority designation. The commenter wrote that TSCA does not define 
``hazard,'' so the ordinary meaning of ``a danger or risk'' should be 
applied. The commenter pointed to the dossier for 3-methoxybutyl 
acetate as an example of EPA not considering or analyzing that 
substance's moderate flammability.
    Response: EPA considered all reasonably available information, 
which included the additional endpoints recommended by the commenters, 
in the screening review of the Low-Priority Substances. For example, 
EPA considered potential acute physical hazards, like flammability and 
explosive and self-ignition properties, for the Low-Priority Substances 
and found that the 20 Low-Priority Substances do not exhibit explosive, 
flammable, or self-ignition properties near ambient temperatures. As a 
result, EPA did not include acute physical hazard endpoints in its 
published screening review because the physical-chemical properties of 
the Low-Priority Substances indicate that these chemicals do not meet 
the standard for a High-Priority Substance for risk evaluation.
    Comment: Two commenters stated that EPA failed to consider 
immunotoxicity and respiratory sensitization for all 20 Low-Priority 
Substances, and that EPA needs to

[[Page 11075]]

consider these endpoints to fulfill its mandate under TSCA. In 
particular, commenters pointed out that immunotoxicity is relevant to 
vulnerable populations, including women, children, and the elderly, who 
may be more susceptible to immune system damage from chemical exposure, 
and respiratory sensitization is particularly relevant to children's 
health issues due to increasing childhood asthma and other illnesses.
    Response: EPA has added discussion of immunotoxicity and 
respiratory sensitization to each Low-Priority Substance's screening 
review. Inclusion of these endpoints helps to clarify that the Agency 
has addressed potential concerns for populations that could be exposed 
or susceptible to immunological toxicants.
    Comment: A few commenters stated that EPA's mandate under TSCA 
requires a consideration of potential adverse endocrine effects and 
developmental neurotoxicity for the Low-Priority Substances.
    Response: In considering the reasonably available information, EPA 
reviewed repeated dose, reproductive and developmental studies for 
documented changes in developmental neurotoxicity, such as behavioral, 
functional, or structural changes related to neurological outcomes in 
mammalian offspring. The Agency also reviewed information from high-
throughput ToxCast assays and found no evidence of endocrine activity. 
Therefore, EPA believes it has sufficient information to designate 
these chemical substances as Low-Priority Substances.
3. Sufficient Information To Support a Low-Priority Substance 
Designation
    Comment: Several commenters generally stated that EPA did not have 
sufficient information to support a low-priority designation for these 
20 substances. Commenters also contended that EPA's methods 
disregarded, without sufficient justification, pieces of evidence 
suggesting the substances may have adverse effects. One commenter 
stated that more robust and complete data are needed for low-priority 
designations than for high-priority designations, and that EPA should 
not risk an erroneous designation of a substance as low priority.
    Response: Congress chose not to define ``screening process'' in the 
statute, leaving EPA the discretion to create a risk-based screening 
process according to the considerations expressed in section 
6(b)(1)(A). EPA created a transparent literature review method for the 
purposes of prioritization and screening review under this section. The 
Approach Document (Ref. 10) includes a description of elements for 
weight of scientific evidence and explains how these can be applied in 
a manner appropriate to screening-level review and Low-Priority 
Substance designations. In compliance with section 26, EPA considered 
the reasonably available information, including studies and data, on 
each Low-Priority Substance relevant to the screening criteria and used 
such information in a manner consistent with best available science. 
EPA notes the following text from the Procedures for Prioritization of 
Chemicals for Risk Evaluation Under the Toxic Substances Control Act: 
``The screening review is not a risk evaluation, but rather a review of 
reasonably available information on the chemical substance that relates 
to the screening criteria. EPA expects to review all sources of 
relevant information, consistent with the scientific standards in 15 
U.S.C. 2625(h), while conducting the screening review'' (Ref. 9 at 
33759). EPA also kept in mind the nine- to twelve-month deadline to 
complete the prioritization process, while accommodating and 
incorporating the statutorily-required cumulative six months of public 
comment. Congress recognized the importance of public input and EPA has 
considered and incorporated, as appropriate, the comments that were 
received.
    Low-Priority Substance designations are not determinations that 
these chemical substances do not present any risks, rather that EPA, 
through the prioritization process, has determined that sufficient 
information supports the determination that these chemical substances 
do not meet the standard provided in TSCA section 6(b)(1)(B)(i) to 
designate these chemical substances as High-Priority Substances.
    Comment: Two commenters raised concerns about the adequacy of EPA's 
Low-Concern Criteria and their application to the 20 Low-Priority 
Substances. For example, commenters stated that the Low-Concern 
Criteria were not sufficiently rigorous to determine whether a 
substance had an insignificant toxicological hazard, and pointed out 
flaws in the Criteria including missing endpoints and insufficient 
consideration of expected exposure. Another commenter recommended that 
EPA use transparent and scientifically accepted methods when evaluating 
studies for consideration in the prioritization process.
    Response: In developing an approach for evaluating Low-Priority 
Substances, EPA assembled protective, pragmatic benchmarks and 
methodologies informed by precedent, routinely used by the Agency, and 
familiar to the regulated community and the public. The Approach 
Document (Ref. 10) explains the methods used to ensure comprehensive, 
objective, transparent and consistent review of all reasonably 
available information for the Low-Priority Substances, while remaining 
grounded in the view that what is required is sufficient information 
for designation.
    Comment: One commenter generally supported EPA's approach to 
considering conditions of use, but recommended that EPA apply a quality 
review to all sources of information used when assessing conditions of 
use. The commenter suggested that this quality review process be 
addressed in the Approach Document (Ref. 10). The commenter also stated 
that EPA's considerations of changes in conditions of use and changes 
in volume were pragmatic.
    Response: EPA included all known, intended, or reasonably foreseen 
uses in the Low-Priority Substance screening reviews to be as inclusive 
as possible and to account for reasonably foreseeable uses.
    Comment: One commenter supported EPA's pragmatic approach to 
considering storage near drinking water and recommended that EPA 
approach this criterion in the longer term using improved exposure 
models that can better predict fate and environmental partitioning into 
water sources. Another commenter stated that EPA's Low-Priority 
Substance dossiers did not adequately analyze storage near significant 
sources of drinking water. The commenter stated that EPA should have 
obtained data on the substances' actual storage near drinking water 
sources.
    Response: EPA has sufficient information to establish that the Low-
Priority Substances do not meet the definition for a High-Priority 
Substance based on their low-hazard profiles, biodegradation potential, 
wastewater treatment plant removal (greater than 80% for all 20 
chemicals) and related characteristics. The Agency therefore did not 
use its information gathering authorities to obtain data on storage of 
the Low-Priority Substances. Additionally, similar to longer-term 
testing that is unavailable within the prioritization timeframe, EPA 
did not find information on the storage location of the Low-Priority 
Substances that was reasonably available.
    Comment: One commenter stated that EPA dismissed, or did not seek,

[[Page 11076]]

information regarding certain subpopulations' heightened susceptibility 
to adverse effects from chemical exposure. The commenter stated that 
EPA made unjustified assumptions that subpopulations such as children 
face the same level of risk as does the general public.
    Response: EPA did consider potentially exposed or susceptible 
subpopulations (PESS) in its Low-Priority Substance designations, per 
TSCA section 6(b)(1). EPA found that a change in the conditions of use 
for the Low-Priority Substances could result in an increase in 
exposures to certain populations, but that the consistently low-hazard 
profiles associated with these chemicals are sufficient information to 
demonstrate that there are no groups with heightened susceptibility. 
Based on the weight of scientific evidence, EPA has sufficient 
information to support the Low-Priority Substance designation of these 
chemical substances as they do not meet the standard for a High-
Priority Substance for risk evaluation, including consideration of 
PESS.
    Comment: Commenters stated that EPA dismissed the importance of 
exposure by making unsubstantiated assumptions of low exposure, and 
also failed to consider data on inhalation and dermal routes of 
exposure, both of which preclude definitive low-priority designations. 
One commenter further stated that EPA must establish the absence of 
adverse effects or potential exposure to support a low-priority 
designation. Another commenter generally supported EPA's approach to 
addressing exposure potential, but suggested that EPA could improve 
public understanding of its risk-based screening approach by adding 
information to the Approach Document (Ref. 10) explaining its approach 
to identifying, screening, evaluating, and integrating relevant 
information about potential exposure. The commenter also suggested that 
EPA consider formalizing risk-based screening by presenting margins of 
exposure.
    Response: EPA developed a fit-for-purpose screening process 
appropriate for the designation of Low-Priority Substances. This 
approach focused on identifying chemicals that consistently exhibit 
low-hazard characteristics across the spectrum of endpoints. The hazard 
data included experimental data on the chemicals themselves and close 
analogs, data from New Approach Methodologies (NAMs), and data 
extrapolated across routes of exposure. For a small number of 
chemicals, EPA performed route-to-route extrapolations from available 
data to predict toxicity values from inhalation and/or dermal 
exposures. EPA included a qualitative review of exposure potential as 
requiring margin of exposure estimates or other elements of a risk 
evaluation are beyond the scope of a screening-level review for 
prioritization. EPA included potential changes in exposure, conditions 
of use and production volume, and determined that changes in conditions 
of use or production volume would be unlikely to change the Agency's 
Low-Priority Substance designations.
    Comment: Several commenters expressed that EPA did not sufficiently 
address specific human health hazard endpoints. Generally, commenters 
stated that for multiple endpoints, EPA relied on insufficient data, 
made unsupported assumptions of low risk, dismissed data, and failed to 
make appropriate use of metrics and criteria for assessing these 
endpoints. For several endpoints, one commenter stated that EPA had 
appropriately used available tools and information to designate 
substances without requiring the development of new information, 
consistent with the goals of the amended TSCA. Comments were received 
on the following human health hazard endpoints: Inhalation and dermal 
toxicity; adsorption, distribution, metabolism, and excretion (ADME); 
acute mammalian toxicity; reproductive toxicity; mutagenicity/
genotoxicity; carcinogenicity; neurotoxicity; and eye irritation.
    Response: In developing an approach for evaluating Low-Priority 
Substances, EPA assembled protective, pragmatic criteria and 
methodologies informed by precedent, routinely used by the Agency, and 
familiar to the regulated community and the public. EPA's approach was 
thorough in searching for and compiling data and information on 
individual chemicals and toxicological endpoints. At the same time, the 
approach was grounded in the view that what is required is sufficient 
information for prioritization, which would consider a chemical 
substance's overall hazard profile, application of assessment methods 
with reasonably available data, the weight of toxicological evidence, 
and the requisite definition for a Low-Priority Substance (namely, a 
chemical that at the time of its designation would not meet the 
standard for a High-Priority Substance). More detailed responses can be 
found in the full response to general comments document (Ref. 7).
    Comment: Similarly, multiple commenters stated that EPA did not 
sufficiently address environmental hazard endpoints, including chronic 
aquatic toxicity, bioaccumulation, persistence, and biodegradation. One 
commenter stated that EPA's system for environmental hazard 
classification was incomplete or not in alignment with established 
systems. Generally, commenters stated that for multiple endpoints, EPA 
relied on insufficient data or relied only on model predictions, 
dismissed possible concerns, or made unjustified assumptions. For some 
endpoints, two commenters stated that EPA designated the Low-Priority 
Substances using tools and information that were sufficient for 
prioritization purposes.
    Response: While the Low-Priority Substances may not have 
experimental data for every endpoint, new approach methods, including 
QSARs and modeling, such as ECOSAR and EPISuite, are widely accepted 
methodologies for estimating environmental hazard endpoints. More 
detailed responses can be found in the full response to general 
comments document (Ref. 7).
4. Discrepancies With Other Governing Bodies
    Comment: Several commenters noted discrepancies between EPA's 
approach to reviewing and designating low-priority candidates and 
Globally Harmonized System of Classification and Labelling of Chemicals 
(GHS) criteria, other EPA criteria and guidance, and other 
organizations' findings on specific chemicals. Several commenters 
called out discrepancies for specific human health and environmental 
endpoints, including acute mammalian toxicity, reproductive and 
developmental toxicity, carcinogenicity, neurotoxicity, immunotoxicity, 
respiratory sensitization, and acute and chronic aquatic toxicity.
    Response: EPA developed a fit-for-purpose screening process 
appropriate for the designation of Low-Priority Substances. The risk 
evaluation guidelines suggested by the commenters are not appropriate 
for the purposes of prioritization. In developing an approach for 
evaluating Low-Priority Substances, EPA assembled protective, pragmatic 
benchmarks and methodologies informed by precedent, routinely used by 
the Agency, and familiar to the regulated community and the public. As 
part of its thorough search for information on the Low-Priority 
Substances, EPA considered the hazard findings of other countries as 
noted in each chemical's screening review. It is not unusual for data 
interpretations and findings to differ among countries because every 
country assesses chemicals and makes decisions

[[Page 11077]]

based on its own governing statutes. EPA made Low-Priority Substance 
designations according to TSCA's risk-based statutory requirements. 
Based on its low-concern benchmarks, reasonably available information, 
and data screening approach, EPA finds it has sufficient information to 
designate the 20 chemical substances as Low-Priority Substances and 
that the chemical substances do not meet the standard for a High-
Priority Substance for risk evaluation.
5. Analog Selection and Use
    Comment: Multiple commenters raised concerns about the rigor and 
transparency of EPA's analog selection method and stated that EPA did 
not sufficiently justify its analog selections. Another commenter 
stated that EPA appropriately used the available tools and information, 
as well as its own expert judgement, to designate these substances 
without requiring the development of new information, consistent with 
the goals of the amended TSCA.
    Response: EPA provides more information in the full response to 
general comments document (Ref. 7) on its selection of analogs based on 
the publicly available Analog Identification Methodology (AIM) 
software, the availability of relevant data on potential analogs, and 
EPA's best professional judgement.
6. Additional Comments
    Comment: One commenter noted technical corrections related to the 
descriptions of dipropylene glycol and tripropylene glycol in Section 2 
of the respective supporting documents.
    Response: EPA updated Section 2 of both supporting documents to 
reflect these corrections.
    Comment: Several commenters provided broader comments on how EPA 
should have improved the prioritization process or how EPA could 
improve the process for future prioritization efforts. For example, one 
commenter stated that EPA underestimated the costs of prioritization in 
the TSCA fee rule, and as a result did not devote the resources 
necessary to compile sufficiently robust low priority dossiers. The 
commenter recommended that EPA incorporate additional prioritization 
costs in the TSCA fee rule.
    Response: EPA appreciates commenters' concern for Agency resources. 
The screening reviews for each Low-Priority Substance contain the 
statutorily required elements needed to support designation. Using its 
current resource base, the Agency has compiled and analyzed sufficient 
reasonably available information to support candidate identification, 
screening review, and Low-Priority Substance designation for each 
chemical substance. Comments on the TSCA fee rule are outside of this 
action's scope.
    Comment: Several commenters argued there is missing or incomplete 
information in EPA's Approach Document (Ref. 10). Commenters 
recommended that information be added or improved around several topics 
including statutory and regulatory screening criteria, EPA's approach 
to data integration, and EPA's approach to evaluating data quality. 
Commenters also stated that some criteria presented in the Approach 
Document (Ref. 10) were not supported by EPA precedent or by the 
broader scientific community. Commenters stated that EPA's criteria for 
reviewing and integrating studies was inconsistent with previous EPA 
criteria and with currently accepted approaches, and also stated that 
EPA used a new ``weight of the scientific evidence'' definition that is 
inconsistent with EPA's risk evaluation regulations and currently 
accepted scientific standards. One commenter expressed support for 
EPA's development and application of the Approach Document (Ref. 10).
    Response: The goal of the Approach Document (Ref. 10) was to 
establish a transparent process for review of the reasonably available 
hazard information presented in the Low-Priority Substance supporting 
documents. The Approach Document is not intended to address all 
elements of a systematic review or risk evaluation, which are beyond 
the scope of a screening review. The individual screening reviews 
provide further details regarding EPA's approach and the statutory 
criteria for designating Low-Priority Substances. EPA will consider 
updating its Approach Document (Ref. 10) in the future to elaborate on 
its data integration methodology.
    Comment: One commenter stated that the presence of a substance on 
the Safer Chemical Ingredients List (SCIL) is not sufficient for 
designating the substance as low-priority. The commenter stated that 
EPA should also consider, among other things, whether sufficient 
information exists on all conditions of use and hazard endpoints, what 
vulnerable subpopulations may be exposed, and whether there are 
potential environmental releases.
    Response: EPA did not base its Low-Priority Substance designations 
on a chemical's presence on SCIL. Instead, SCIL offered a pool of 
chemicals and a starting point in the Agency's search for suitable Low-
Priority Substance candidates. EPA reviewed the Low-Priority Substances 
by gathering and analyzing the reasonably available information to 
assess these chemicals and determined with sufficient information that 
these chemicals do not meet the statutory standard to be considered a 
High-Priority Substance.
    Comment: One commenter commended EPA for taking care in its 
prioritization procedures rule, in its working approach document, in 
its Approach Document, and in its notices initiating prioritization and 
proposing chemicals as low-priority to make clear what a designation of 
a chemical as a High-Priority Substance or as a Low-Priority Substance 
means.
    Response: EPA appreciates the commenter's viewpoint.
    Comment: One commenter provided recommendations for EPA's longer-
term approaches to substance prioritization. The commenter recommended 
that EPA examine the applicability of using advanced approaches for 
evaluating exposure and bioactivity/toxicity as parallel evidence for 
use at the screening review step of the prioritization process. The 
commenter also recommended that EPA consider recent developments to 
tools for assessing persistence and bioaccumulation, and generally 
recommended that EPA should rely increasingly on use of New Approach 
Methodologies (NAMs) and other 21st century tools and sources of 
information to identify and propose chemicals as low priority.
    Response: EPA appreciates the commenter's points and will consider 
them going forward.

IV. Chemical Substances Which EPA Is Designating as a Low-Priority 
Substance for Prioritization

A. Approach for Gathering Information, Conducting Analysis and Forming 
the Basis To Support the Final Low-Priority Substance Designation

    EPA used reasonably available information, including public 
comments received on specific chemical substances during the 90-day 
comment periods following initiation of the prioritization process and 
proposal of the designations for Low-Priority Substances, to screen the 
candidate chemical substances against the criteria and considerations 
in TSCA section 6(b)(1)(A) and 40 CFR 702.9 (see Unit III.).
    Each supporting document for the chemical substances designated as 
a Low-Priority Substance includes the information, analysis and basis 
for the

[[Page 11078]]

final designation. In the absence of experimental data for a given 
endpoint, EPA integrated information using New Approach Methodologies 
(NAMs), discussed further in the respective supporting documents. These 
documents are available in the docket of each of the chemical 
substances with a final designation as a Low-Priority Substance. The 
final designations are presented in Unit IV.B., along with the docket 
references.

B. Final Priority Designation as Low-Priority Substances

    EPA is publishing the final designation for the following 20 
chemical substances as Low-Priority Substances for which risk 
evaluation is not warranted at this time. Using the approach described 
in Unit IV.A., and including information provided by commentators 
during comment periods in the designation process, as appropriate, the 
final designations are based on the conclusion that the chemical 
substance satisfies the definition of Low-Priority Substance. Under 
TSCA section 6(b)(1)(B) and implementing regulations (40 CFR 702.3), a 
Low-Priority Substance is described as a chemical substance that the 
Administrator concludes does not meet the standard for designation as a 
High-Priority Substance, based on information sufficient to establish 
that conclusion, without consideration of costs or other non-risk 
factors. The chemical substances designated as Low-Priority Substances 
are listed below:
    1. 1-Butanol, 3-methoxy-, 1-acetate, CAS RN 4435-53-4, Docket 
number: EPA-HQ-OPPT-2019-0106. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    2. D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-, CAS RN 
31138-65-5, Docket number: EPA-HQ-OPPT-2019-0107. The information, 
analysis and basis used to support the final designation as a Low-
Priority Substance are in the docket for this chemical substance.
    3. D-Gluconic acid, CAS RN 526-95-4, Docket number: EPA-HQ-OPPT-
2019-0108. The information, analysis and basis used to support the 
final designation as a Low-Priority Substance are in the docket for 
this chemical substance.
    4. D-Gluconic acid, calcium salt (2:1), CAS RN 299-28-5, Docket 
number: EPA-HQ-OPPT-2019-0109. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    5. D-Gluconic acid, .delta.-lactone, CAS RN 90-80-2, Docket number: 
EPA-HQ-OPPT-2019-0110. The information, analysis and basis used to 
support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    6. D-Gluconic acid, potassium salt (1:1), CAS RN 299-27-4, Docket 
number: EPA-HQ-OPPT-2019-0111. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    7. D-Gluconic acid, sodium salt (1:1), CAS RN 527-07-1, Docket 
number: EPA-HQ-OPPT-2019-0112. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    8. Decanedioic acid, 1,10-dibutyl ester, CAS RN 109-43-3, Docket 
number: EPA-HQ-OPPT-2019-0113. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    9. 1-Docosanol, CAS RN 661-19-8, Docket number: EPA-HQ-OPPT-2019-
0114. The information, analysis and basis used to support the final 
designation as a Low-Priority Substance are in the docket for this 
chemical substance.
    10. 1-Eicosanol, CAS RN 629-96-9, Docket number: EPA-HQ-OPPT-2019-
0115. The information, analysis and basis used to support the final 
designation as a Low-Priority Substance are in the docket for this 
chemical substance.
    11. 1,2-Hexanediol, CAS RN 6920-22-5, Docket number: EPA-HQ-OPPT-
2019-0116. The information, analysis and basis used to support the 
final designation as a Low-Priority Substance are in the docket for 
this chemical substance.
    12. 1-Octadecanol, CAS RN 112-92-5, Docket number: EPA-HQ-OPPT-
2019-0117. The information, analysis and basis used to support the 
final designation as a Low-Priority Substance are in the docket for 
this chemical substance.
    13. Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-, CAS RN 
55934-93-5, Docket number: EPA-HQ-OPPT-2019-0118. The information, 
analysis and basis used to support the final designation as a Low-
Priority Substance are in the docket for this chemical substance.
    14. Propanedioic acid, 1,3-diethyl ester, CAS RN 105-53-3, Docket 
number: EPA-HQ-OPPT-2019-0119. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    15. Propanedioic acid, 1,3-dimethyl ester, CAS RN 108-59-8, Docket 
number: EPA-HQ-OPPT-2019-0120. The information, analysis and basis used 
to support the final designation as a Low-Priority Substance are in the 
docket for this chemical substance.
    16. Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate, CAS RN 
88917-22-0, Docket number: EPA-HQ-OPPT-2019-0121. The information, 
analysis and basis used to support the final designation as a Low-
Priority Substance are in the docket for this chemical substance.
    17. Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-, CAS RN 
24800-44-0, Docket number: EPA-HQ-OPPT-2019-0122. The information, 
analysis and basis used to support the final designation as a Low-
Priority Substance are in the docket for this chemical substance.
    18. 2-Propanol, 1,1'-oxybis-, CAS RN 110-98-5, Docket number: EPA-
HQ-OPPT-2019-0123. The information, analysis and basis used to support 
the final designation as a Low-Priority Substance are in the docket for 
this chemical substance.
    19. Propanol, oxybis-, CAS RN 25265-71-8, Docket number: EPA-HQ-
OPPT-2019-0124. The information, analysis and basis used to support the 
final designation as a Low-Priority Substance are in the docket for 
this chemical substance.
    20. Tetracosane, 2,6,10,15,19,23-hexamethyl-, CAS RN 111-01-3, 
Docket number: EPA-HQ-OPPT-2019-0125. The information, analysis and 
basis used to support the final designation as a Low-Priority Substance 
are in the docket for this chemical substance.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Initiation of Prioritization Under the Toxic Substances 
Control Act (TSCA). Notice. Federal Register. (84 FR 10491, March 
21, 2019) (FRL-9991-06).
2. EPA. Proposed Low-Priority Substance Designation Under the Toxic 
Substances Control Act (TSCA). Notice. Federal Register. (84 FR 
41712, August 15, 2019)

[[Page 11079]]

(FRL-9997-63).
3. EPA. Information Relevant to Prioritization for Propanol, [(1-
methyl-1,2-ethanediyl)bis(oxy)]bis-. Docket ID: EPA-HQ-OPPT-2019-
0122. Available at https://www.regulations.gov.
4. EPA. Information Relevant to Prioritization for Propanol, 1(or 
2)-(2-methoxymethylethoxy)-, acetate. Docket ID: EPA-HQ-OPPT-2019-
0121. Available at https://www.regulations.gov.
5. EPA. Information Relevant to Prioritization for Propanol, [2-(2-
butoxymethylethoxy)methylethoxy]-. Docket ID: EPA-HQ-OPPT-2019-0118. 
Available at https://www.regulations.gov.
6. EPA. Information Relevant to Prioritization for Propanol, 
oxybis-. Docket ID: EPA-HQ-OPPT-2019-0124. Available at https://www.regulations.gov.
7. EPA. Summary of General Public Comments and Responses on the 
Proposed Designation of Low-Priority Substances under the Toxic 
Substances Control Act (TSCA). January 16, 2020.
8. EPA. Summary of Chemical-Specific Public Comments and Responses 
on the Proposed Designation of Low-Priority Substances under the 
Toxic Substances Control Act (TSCA). January 16, 2020.
9. EPA. Procedures for Prioritization of Chemicals for Risk 
Evaluation Under the Toxic Substances Control Act. Notice. Federal 
Register. (82 FR 33753, September 18, 2017) (FRL-9964-24).
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Priority Substances Under TSCA. August 2019. EPA Document ID No. 
740B19008. Office of Pollution Prevention and Toxics. Washington, 
DC. Available at https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0450-0002.
11. EPA. Procedures for Prioritization of Chemicals for Risk 
Evaluation under TSCA: Response to Public Comments; SAN 5943; RIN 
2070-AK23; EPA-HQ-OPPT-2016-0636. 2017. EPA. Health and 
Environmental Research Online: A Database of Scientific Studies and 
References. Available at https://hero.epa.gov/hero/.
12. S. Rep. No. 114-67, 114th Cong., 1st Sess. 2015. Available at 
https://www.congress.gov/114/crpt/srpt67/CRPT-114srpt67.pdf.
13. EPA. ``A Working Approach for Identifying Potential Candidate 
Chemicals for Prioritization.'' (https://www.epa.gov/sites/production/files/2018-09/documents/preprioritization_white_paper_9272018.pdf). September 26, 2018.

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

    Dated: February 19, 2020.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2020-03869 Filed 2-25-20; 8:45 am]
BILLING CODE 6560-50-P