[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11069-11079]
[FR Doc No: 2020-03869]

=======================================================================
-----------------------------------------------------------------------

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.

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

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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>    Additional instructions on visiting the docket, along with more
information about dockets generally, is available at http://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

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

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

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

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

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

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,

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

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

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)

(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).
10. EPA. Approach Document for Screening Hazard Information for Low-
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


MEMORANDUM SUBJECT: Discussion with Kubota and Carrier Representatives, March 2, 2004 FROM: Kent Helmer Assessment and Standards Division TO: EPA Air Docket # A 2001 28 This memorandum documents a telephone conference call held on Tuesday, March 2, 2004 between Mr. Kent Helmer and Mr. Cleophas Jackson of EPA OTAQ, Ann Arbor and Mr. Cameron Larsen of KUBOTA and Mr. Peter Guzman of Carrier Transicold. The call began at 2: 20 PM and had finished by 3: 00 PM. Mr. Larsen was inquiring as to whether EPA had any questions concerning data which KUBOTA had sent to EPA on the typical operation of TRU ( transport refrigeration unit) equipment. After some clarifying questions from the EPA side, we asked if Mr Larsen could provide the data that we had used in a form releaseable to the public. He responded that he would modify some of the presentation for release.

( A pdf file was received from Mr. Larsen and is included in the RIA to this rulemaking as Figure 4.3 9, " Unit Data during Pull Down to 22 degrees")


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43236-43237]
[FR Doc No: 2014-17578]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0911; Special Conditions No. 25-539-SC]

Special Conditions: Airbus Model A350-900 Airplanes; Lateral-Trim
Function Through Differential Flap Setting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for Airbus Model A350-900
airplanes. These airplanes will have a novel or unusual design feature
associated with a lateral-trim function that deploys flaps
asymmetrically for airplane lateral-trim control. This function
replaces the traditional method of providing airplane lateral trim over
a small range through flap and aileron mechanical rigging. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: Effective Date: August 25, 2014.

FOR FURTHER INFORMATION CONTACT: Robert C. Jones, FAA, Propulsion and
Mechanical Systems, ANM-112, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On August 25, 2008, Airbus applied for a type certificate for their
new Model A350-900 airplane. Later, Airbus requested, and the FAA
approved, an extension to the application for FAA type certification to
November 15, 2009. The Model A350-900 airplane has a conventional
layout with twin wing-mounted Rolls-Royce Trent XWB engines. It
features a twin-aisle, 9-abreast, economy-class layout, and
accommodates side-by-side placement of LD-3 containers in the cargo
compartment. The basic Model A350-900 airplane configuration
accommodates 315 passengers in a standard two-class arrangement. The
design cruise speed is Mach 0.85 with a maximum take-off weight of
602,000 lbs.
    On conventional airplanes, small, lateral, airplane asymmetries
typically have been addressed through flap and aileron rigging (e.g.,
using shims). On Model A350-900 airplanes, an order for asymmetric flap
deployment will be computed by the primary flight-control system as a
function of the aileron position. The current airworthiness standards
do not contain adequate safety standards for asymmetric use of the
flaps for Airbus Model A350-900 airplanes. Special conditions are
needed to account for the aspects of a function used to command an
intended flap asymmetry. The lateral-trim function is intended to be
performed once during climb and once during cruise to compensate for
airplane small lateral asymmetries.
    The lateral-trim function is not a trim-control system in the
conventional sense as it has no pilot interface and is not governed by
Title 14, Code of Federal Regulations (14 CFR) 25.677. Some fly-by-wire
airplanes have no pilot-operated lateral trim at all. The lateral-trim
function is simply an additional fly-by-wire flight-control function
that nulls small roll asymmetries in certain flight phases with small,
asymmetric flap deployments. Although the function operates under
normal conditions within the small range of the traditional rigging,
failure cases may result in a significant out-of-range asymmetric flap
condition. An asymmetry threshold protects the system against excessive
flap asymmetry.

Type Certification Basis

    Under 14 CFR 21.17, Airbus must show that the Model A350-900
airplane meets the applicable provisions of 14 CFR part 25, as amended
by Amendments 25-1 through 25-129.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model A350-900 airplane because of
a novel or unusual design feature, special conditions are prescribed
under Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model A350-900 airplane must comply with the fuel-vent
and exhaust-emission requirements of 14 CFR part 34, and the noise-
certification requirements of 14 CFR part 36. The FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19,
under Sec.  11.38, and they become part of the type-certification basis
under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Airbus Model A350-900 airplane incorporates the following novel
or unusual design features: The asymmetric use of flaps to address
lateral trim, which is not adequately addressed by Sec.  25.701.

Discussion

    Section 25.701(a) requires that, unless the airplane has safe-
flight characteristics with the flaps or slats retracted on one side
and extended on the other, flap and slat surfaces must be synchronized
by either a mechanical interconnection or any equivalent means that has
the same integrity. Synchronization is interpreted to mean that flap
movement is symmetrical throughout the full range of flap motion.
Because the lateral-trim function intentionally creates asymmetric flap
motions, the flap-system installation of the Model A350-900 airplane
does not meet the requirement of Sec.  25.701(a) and (d).
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Discussion of Comments

    Notice of proposed special conditions no. 25-13-22-SC for Airbus
Model A350-900 airplanes was published in the Federal Register on
January 8, 2014 (79 FR 1339). No comments were received, and the
special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions apply to Airbus Model
A350-900 airplanes. Should Airbus apply later for a change to the type
certificate to include another model incorporating the same novel or
unusual design feature, the special conditions would apply to that
model as well.

Conclusion

    This action affects only certain novel or unusual design features
on the Airbus Model A350-900 airplanes. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type-certification basis for Airbus Model A350-900 airplanes:

Lateral-Trim Function Through Differential Flap Setting

    Current airworthiness standards, specifically Sec.  25.701, do not
contain adequate safety standards for this airplane design. In lieu of
the requirements of Sec.  25.701(a) and (d) for the lateral-trim
function, the following special condition are issued:
    1. Airbus must demonstrate that an unsafe condition is not created
by using the flaps asymmetrically.
    2. The degree of acceptable asymmetry must be defined and justified
for all flight phases with respect to:
    a. Section 25.701(b) and (c), with the worst-case asymmetric flap
configurations, and
    b. Providing equivalent protection against excess asymmetry in the
same manner as Sec.  25.701 provides to systems that are synchronized,
or use another equivalent means to prevent asymmetry.
    3. This lateral-trim function is a flight-control system and
therefore must be shown to comply with both general system requirements
as well as general flight-control requirements. Therefore, the function
must be demonstrated not to have significant latent failures, where
practicable.

    Issued in Renton, Washington, on July 9, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-17578 Filed 7-24-14; 8:45 am]
BILLING CODE 4910-13-P