Proposed Low-Priority Substance Designation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment
| Published date | 15 August 2019 |
| Citation | 84 FR 41712 |
| Record Number | 2019-17558 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 158 (Thursday, August 15, 2019)
[Federal Register Volume 84, Number 158 (Thursday, August 15, 2019)]
[Notices]
[Pages 41712-41715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17558]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0450; FRL-9997-63]
Proposed Low-Priority Substance Designation Under the Toxic
Substances Control Act (TSCA); Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: As required under section 6(b) of the Toxic Substances Control
Act (TSCA) and implementing regulations, EPA is proposing to designate
20 chemical substances as Low-Priority Substances for which risk
evaluation is not warranted at this time. This document provides a
summary of the approach used by EPA to support the proposed
designations, the proposed 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 proposed
designation for each chemical substance. EPA is providing a 90-day
comment period during which interested persons may provide comments on
the proposed designations.
DATES: Comments must be received on or before November 13, 2019.
ADDRESSES: Use one of the following methods to submit comments: For
comments not related to a specific chemical substance, including
comments on EPA's Approach Document for Screening Hazard Information
for Low-Priority Substances Under TSCA (July 2019), direct your
comments to docket identification (ID) number EPA-HQ-OPPT-2019-0450.
For comments on one or more of the 20 chemical substances, use the
applicable chemical specific docket ID number(s) identified in Unit
IV.B.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
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 (Mailcode
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].
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 proposing to designate 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 a summary
of the approach used by EPA to support the proposed designations, the
proposed 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 proposed designation for
each chemical substance. EPA is providing a 90-day comment period
during which interested persons may submit comments on the proposed
designation.
C. Why is the Agency taking this action?
EPA is proposing to designate as Low-Priority Substances 20
chemical substances for which EPA initiated the prioritization process
required by TSCA section 6(b) on March 21, 2019 (Ref. 1). EPA is
providing a 90-day comment period during which the public may submit
comments on EPA's proposed designations of Low-Priority Substances, as
required by TSCA section 6(b)(1)(C)(ii).
D. What is the Agency's authority for taking this action?
This document is issued pursuant to TSCA section 6(b)(1).
E. What are the estimated incremental impacts of this action?
This document identifies 20 chemical substances for proposed
designation 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.
F. What should I consider as I prepare my comments for EPA?
1. Submitting Confidential Business Information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
[[Page 41713]]
II. Background
TSCA, as amended in 2016 by the Frank R. Lautenberg Chemical Safety
for the 21st Century Act (Pub. L. 114-182), at section 6(b)(1),
requires EPA to prioritize chemical substances for designation. As
required by TSCA section 6(b) and described in 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.
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. A chemical substance designated as Low-
Priority indicates a risk evaluation is not warranted at that time.
This document is intended to fulfill the requirement in TSCA
section 6(b)(1)(C)(ii) and 40 CFR 702.9 that the Administrator propose
the designation of 20 chemical substances as Low-Priority Substances
for risk evaluation after conducting a screening review, as required by
TSCA section 6(b)(1)(A) and 40 CFR 702.9(a). EPA generally used
reasonably available information to screen the candidate chemical
substances against the following criteria and considerations (40 CFR
702.9(a)):
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.
As described in 40 CFR 702.9(b), in conducting the screening review
during the prioritization process, EPA considered sources of
information relevant to the screening-review criteria as outlined in
the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40
CFR 702.9(a)) and consistent with the scientific standards of TSCA
section 26(h). 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 for Screening Hazard
Information for Low-Priority Substances Under TSCA (July 2019) (Ref.
2). Information gathered according to this approach document was
included in each chemical substance's screening review, which are
provided in Unit IV.B. In addition, as required by 40 CFR 702.9, EPA
considered the hazard and exposure potential of the chemical substances
and did not consider cost or other non-risk factors in making a
proposed priority designation.
III. Information and Comments Received
The initiation of the prioritization process (docket EPA-HQ-OPPT-
2019-0131) 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. With the exception of comments providing information for
specific chemical substances being proposed as Low-Priority Substances,
EPA will respond to comments received in an upcoming notice.
During the 90-day comment period, commenters submitted information
on four chemical substances proposed for Low-Priority designation:
Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- (CAS RN
24800-44-0)
Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate (CAS
RN 88917-22-0)
Propanol, [2-(2-butoxymethylethoxy)methylethoxy]- (CAS RN
55934-93-5)
Propanol, oxybis- (CAS RN 25265-71-8)
The submitted information is addressed in the respective dossiers
(see Unit IV.B.).
IV. Chemical Substances for Which EPA Is Proposing a Low-Priority
Substance Designation for Prioritization
A. Approach for Gathering Information, Conducting Analysis and Forming
the Basis To Support the Proposed Low-Priority Substance Designation
EPA used reasonably available information, including public
comments received on specific chemical substances during the 90-day
comment period following initiation of the prioritization process 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.).
EPA developed a document to identify the information, analysis and
basis used to support the proposed designations as a Low-Priority
Substance for each chemical substance. These documents are available in
the docket of each of the chemical substances with a proposed
designation as a Low-Priority Substance. The proposed designations are
presented in Unit IV.B., along with the docket references.
Each chemical-specific document for the chemical substances
proposed for designation as a Low-Priority Substance includes the
information, analysis and basis for the proposed designation. In the
absence of experimental data for a given endpoint, EPA integrated
information using New Approach Methodologies (NAMs). Each of the
screening reviews includes an overview of the considerations in TSCA
section 6(b)(1)(A) and the regulatory section addressing the criteria
and considerations at 40 CFR 702.9:
1. Hazard potential. EPA considered reasonably available
information to screen potential hazards for each chemical substance.
EPA surveyed the reasonably available information for potential human
health and environmental hazards for a range of toxicological
endpoints. EPA benchmarked these data against low-concern thresholds.
These low-concern endpoints and thresholds are based on EPA OPPT's New
Chemicals Program, the Globally Harmonized System of Classification and
Labelling of Chemicals classifications, OPPT's criteria for high
production volume chemical categorization, EPA's Office of Pesticide
Programs categories, and the International Agency for Research on
Cancer's classifications.
2. Exposure potential. EPA gathered reasonably available
information on physical-chemical properties, production volumes, and
uses to
[[Page 41714]]
determine potential routes of exposure. Using this information, and
adhering to methodologies outlined in each chemical-specific dossier,
EPA screened for potential environmental, general population, and
potentially exposed or susceptible subpopulations exposure for each
chemical substance:
For environmental exposures, EPA considered the conditions
of use and fate properties of each chemical substance to anticipate its
presence in different environmental media.
For general population exposure, EPA considered releases
from certain conditions of use, such as manufacturing, that may result
in general population exposures via drinking water ingestion and/or
inhalation from air releases.
For exposures to potentially exposed or susceptible
subpopulations, EPA identified subpopulations such as workers,
consumers, pregnant women, and children using Chemical Data Reporting
(CDR) information and other reasonably available information specified
in each chemical substance's screening review. The CDR rule requires
manufacturers to report information on the chemical substances they
produce domestically or import into the U.S. CDR includes information
on the manufacturing, processing, and use of chemical substances. For
worker or occupational exposure, EPA identified the conditions of use
that are likely to result in workers exposures, such as manufacturing,
processing, industrial use, and commercial use. For consumer and
children's exposures, EPA identified certain conditions of use that may
result in the chemical substance's exposure to consumers and children.
3. Persistence and bioaccumulation. EPA considered reasonably
available information on the chemical substance and interpreted
persistence and bioaccumulation potential based on best available
science. In the screening reviews, EPA presents a summary of the
environmental fate characteristics of each chemical substance.
4. Potentially exposed or susceptible subpopulations. In the
screening reviews, EPA considered reasonably available information to
identify potentially exposed or susceptible subpopulations. At this
stage, EPA analyzed information regarding children, infants, pregnant
women, consumers, and workers:
For children and infants, EPA evaluated the chemical
substance's use in products and articles regulated under TSCA and
intended for children using CDR information and other reasonably
available information on uses. In the screening reviews, EPA presents
information regarding those commercial and consumer uses where the
chemical substance was used in products intended, known, or reasonably
foreseen for use by children and infants.
For pregnant women, EPA examined reasonably available
information and considered whether the chemical substance could
potentially pose reproductive or developmental adverse effects.
For workers, EPA identified the potential for occupational
exposures to workers based on the conditions of use of each chemical
substance, using CDR information and other reasonably available
information.
For consumers, EPA identified the consumer uses of the
chemical substance and the potential for consumer exposure under those
conditions of use, using CDR information and other reasonably available
information.
5. Storage near significant sources of drinking water. EPA
evaluated elements of risk associated with the chemical substance's
storage near surface and underground sources of drinking water. EPA
considered possible adverse effects that could result from an
accidental one-time-high-volume release of a substance, and from a
slower release over time. For its analysis, EPA relied in large part on
the chemical substance's potential human health hazards, including to
potentially exposed or susceptible subpopulations, and environmental
fate properties as they relate to the potential for the chemical
substance to enter a hypothetical drinking water source. Among the
reasons that EPA chose this approach for analysis is that data on
storage of the chemicals being proposed as Low-Priority Substances are
not tracked under TSCA and are not generally available. EPA also
investigated whether the chemical substance was monitored for and
detected in a range of environmental media under other federal statutes
and regulations. EPA assumed that if a chemical substance is regulated
under the National Primary Drinking Water Regulations or the Clean
Water Act, or if its release is subject to reporting requirements under
the Emergency Planning and Community Right-to-Know Act (ECPRA), the
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA) or the Clean Air Act (CAA), there is a potential human health
hazard from a potential release near a significant source of drinking
water.
6. Conditions of use or significant changes in conditions of use.
EPA evaluated conditions of use or significant changes in conditions of
use of the chemical substance by reviewing CDR data and supplementing
that data from a broad range of other sources, including information
from other governments, and information from publicly available
internet sources to develop a comprehensive list of intended, known,
and reasonably foreseen conditions of use within the TSCA regulatory
scope. To analyze the potential for concern based on the possibility of
change in known uses, EPA relied in large part on the chemical
substance's potential human health and environmental hazards.
7. Production volume or significant changes in production volume.
EPA considered current volume or significant changes in volume of the
chemical substance using manufacturers' (including importers') reported
information under the CDR rule under TSCA section 8(a). EPA assembled
information from 1986 through 2016 on the production volume reported
under the Inventory Update Rule (IUR) and CDR.
8. Other risk-based criteria that EPA determined to be relevant to
the designation of the chemical substance's priority. EPA did not find
other risk-based criteria relevant to the proposed designations of the
candidate chemical substances as Low-Priority Substances.
B. Proposed Designation as Low-Priority Substances for Risk Evaluation
EPA is proposing to designate the following 20 chemical substances
as Low-Priority Substances for which risk evaluation is not warranted
at this time. The proposed 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 (Section 6(b)(1)(B)).
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 proposed designation as 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 proposed designation as Low-
Priority Substance
[[Page 41715]]
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
proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed
designation as 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 proposed
designation as 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
proposed designation as 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
proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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 proposed designation as 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
proposed designation as 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 proposed designation as 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. 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.
Authority: 15 U.S.C. 2601 et seq.
Dated: August 9, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-17558 Filed 8-14-19; 8:45 am]
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