Draft Scopes of the Risk Evaluations To Be Conducted for Thirteen Chemical Substances Under the Toxic Substances Control Act; Notice of Availability
| Published date | 09 April 2020 |
| Citation | 85 FR 19941 |
| Record Number | 2020-07484 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 85 Issue 69 (Thursday, April 9, 2020)
[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Notices]
[Pages 19941-19942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07484]
[[Page 19941]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0131; FRL-10007-11]
Draft Scopes of the Risk Evaluations To Be Conducted for Thirteen
Chemical Substances Under the Toxic Substances Control Act; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: As required by the Toxic Substances Control Act (TSCA), which
was amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act in June 2016, EPA is announcing the availability of the
draft scope documents for the risk evaluations to be conducted for 13
of 20 High-Priority Substances designated in December 2019. The draft
scope document for each chemical substance includes the conditions of
use, hazards, exposures, and the potentially exposed or susceptible
subpopulations the EPA plans to consider in conducting the risk
evaluation for that chemical substance. EPA is also opening a 45-
calendar day comment period on these draft scope documents to allow for
the public to provide additional data or information that could be
useful to the Agency in finalizing the scope of the risk evaluations;
comments may be submitted to this docket and the individual dockets for
each of the chemical substances.
DATES: Comments must be received on or before May 26, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA- EPA-HQ-OPPT-2019-0131, or the applicable docket ID
number for the individual chemical substances identified in Unit III.,
by one of the following methods:
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 contact:
Ross Geredien, Risk Assessment Division, Office of Pollution Prevention
and Toxics, Environmental Protection Agency (Mailcode 7403M), 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-1864; 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].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general and may be of
interest to entities that 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-governmental organizations in
the environmental and public health sectors; state and local government
agencies; and members of the public. Since other entities may also be
interested, 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 is the Agency's authority for taking this action?
This action directly implements TSCA section 6(b)(4)(D), 15 U.S.C.
2605(b)(4)(D).
C. What action is the Agency taking?
EPA is publishing the draft scopes of the risk evaluations for 13
of 20 chemical substances designated as High-Priority Substances for
risk evaluation under TSCA. Through the risk evaluation process, EPA
will determine whether the chemical substances present an unreasonable
risk of injury to health or the environment under the conditions of
use, in accordance with TSCA section 6(b)(4). EPA will publish a second
Federal Register notice announcing the availability of the draft scope
documents for the remaining seven chemical substances.
II. Background
TSCA section 6(b)(1) requires EPA to prioritize chemical substances
for risk evaluation (15 U.S.C. 2605(b)(1)). Effective December 20,
2019, EPA designated 20 chemical substances as High-Priority Substances
for risk evaluation (Ref. 1), which initiated the risk evaluation
process for those chemical substances (15 U.S.C. 2605(b)(3)(A); 40 CFR
702.17). The purpose of risk evaluation is to determine whether a
chemical substance presents an unreasonable risk to health or the
environment, under the conditions of use, including an unreasonable
risk to a relevant potentially exposed or susceptible subpopulation (15
U.S.C. 2605(b)(4)(A)). As part of this process, EPA must evaluate both
hazard and exposure, exclude consideration of costs or other non-risk
factors, use scientific information and approaches in a manner that is
consistent with the requirements in TSCA for the best available
science, and ensure decisions are based on the weight-of-scientific-
evidence (15 U.S.C. 2605(b)(4)(F)). This process will culminate in a
determination of whether or not the chemical substance presents an
unreasonable risk of injury to health or the environment under the
conditions of use (40 CFR 702.47).
III. Draft Scopes for 13 of 20 Designated High Priority Chemical
Substances
The 13 chemical substances for which EPA is publishing the draft
scopes of the risk evaluations are identified in the following Table,
along with the corresponding Chemical Abstract System Registry Number
(CASRN) and docket ID numbers.
Table--Draft Scopes for 13 of 20 Designated High Priority Chemical Substances
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Chemical substance CASRN Docket ID No.
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1,3-Butadiene.............................. 106-99-0 EPA-HQ-OPPT-2018-0451
o-Dichlorobenzene (Benzene, 1,2-dichloro-). 95-50-1 EPA-HQ-OPPT-2018-0444
[[Page 19942]]
p-Dichlorobenzene (Benzene, 1,4-dichloro-). 106-46-7 EPA-HQ-OPPT-2018-0446
1,1-Dichloroethane......................... 75-34-3 EPA-HQ-OPPT-2018-0426
1,2-Dichloroethane......................... 107-06-2 EPA-HQ-OPPT-2018-0427
trans-1,2- Dichloroethylene (Ethene, 1,2- 156-60-5 EPA-HQ-OPPT-2018-0465
dichloro-, (1E)-).
1,2-Dichloropropane........................ 78-87-5 EPA-HQ-OPPT-2018-0428
Ethylene dibromide (Ethane, 1,2-dibromo-).. 106-93-4 EPA-HQ-OPPT-2018-0488
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- 1222-05-5 EPA-HQ-OPPT-2018-0430
hexamethylcyclopenta [g]-2-benzopyran
(HHCB).
4,4'-(1-Methylethylidene)bis[2, 6- 79-94-7 EPA-HQ-OPPT-2018-0462
dibromophenol] (TBBPA).
Phosphoric acid, triphenyl ester (TPP)..... 115-86-6 EPA-HQ-OPPT-2018-0458
1,1,2-Trichloroethane...................... 79-00-5 EPA-HQ-OPPT-2018-0421
Tris(2-chloroethyl) phosphate (TCEP) 115-96-8 EPA-HQ-OPPT-2018-0476
(Ethanol, 2-chloro-, 1,1',1''-phosphate).
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The draft scope of the risk evaluation for each of these 13
chemical substances includes the conditions of use, hazards, exposures,
and the potentially exposed or susceptible subpopulations the EPA plans
to consider. Development of the scope is the first step of a risk
evaluation. The draft scope of each risk evaluation will include the
following components (40 CFR 702.41(c)):
The conditions of use, as determined by the Administrator,
that the EPA plans to consider in the risk evaluation.
The potentially exposed populations that EPA plans to
evaluate; the ecological receptors that EPA plans to evaluate; and the
hazards to health and the environment that EPA plans to evaluate.
A description of the reasonably available information and
the science approaches that the Agency plans to use.
A conceptual model that will describe the actual or
predicted relationships between the chemical substance, the conditions
of use within the scope of the evaluation and the receptors, either
human or environmental, with consideration of the life cycle of the
chemical substance--from manufacturing, processing, distribution in
commerce, storage, use, to release or disposal--and identification of
human and ecological health hazards EPA plans to evaluate for the
exposure scenarios EPA plans to evaluate.
An analysis plan, which will identify the approaches and
methods EPA plans to use to assess exposure, hazards, and risk,
including associated uncertainty and variability, as well as a strategy
for using reasonably available information and science approaches.
A plan for peer review.
With the publication of the draft scopes, EPA is providing a 45-
calendar day public comment period. Note that, as a result of the Ninth
Circuit Court of Appeals' decision in Safer Chemicals, Healthy Families
v. U.S. EPA, 943 F.3d 397, 425 (9th Cir. 2019), EPA will no longer
exclude legacy uses or associated disposal from the definition of
``conditions of use.'' Rather, when these activities are intended,
known, or reasonably foreseen, these activities will be considered uses
and disposal, respectively, within the definition of ``conditions of
use.''
EPA encourages commenters to provide information they believe might
be missing or may further inform the risk evaluation. EPA will publish
a notice in the Federal Register announcing the availability of the
final scopes within six months of the initiation of risk evaluations
that occurred on December 20, 2019 (See Unit IV.).
IV. References
The following is a listing of the documents that are specifically
referenced in this Federal Register notice. The docket for this action
includes these documents and other information considered by EPA,
including documents that are referenced within the documents that are
included in the docket. For assistance in locating these referenced
documents, please consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act and Initiation of Risk Evaluation on High-
Priority Substances; Availability. Federal Register. (84 FR 71924,
December 30, 2019) (FRL-10003-15).
(Authority: 15 U.S.C. 2601 et seq.)
Andrew Wheeler,
Administrator.
[FR Doc. 2020-07484 Filed 4-8-20; 8:45 am]
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