[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]
 BILLING CODE 6560-50-P


