[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Pages 12696-12697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04676]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0443; FRL-8850-02-OCSPP]
Octamethylcyclotetra-siloxane (D4); Final Scope of the Risk
Evaluation To Be Conducted Under the Toxic Substances Control Act
(TSCA); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In accordance with the Toxic Substances Control Act (TSCA) and
implementing regulations, EPA is announcing the availability of the
final scope of the risk evaluation to be conducted for
octamethylcyclotetra-siloxane (D4) (Cyclotetrasiloxane,
2,2,4,4,6,6,8,8-octamethyl-; Chemical Abstracts Service Registry Number
(CASRN) 556-67-2), a chemical substance for which EPA received a
manufacturer request for risk evaluation. The scope document includes
the conditions of use, hazards, exposures, and the potentially exposed
or susceptible subpopulations that EPA plans to consider in conducting
the risk evaluation for this chemical substance.
ADDRESSES: The docket, identified by docket identification (ID) number
EPA-HQ-OPPT-2018-0443, is available online at https://www.regulations.gov or in-person at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Bethany Masten, Existing
Chemical Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency (Mailcode 7404T), 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8803; 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?
The final scope document is issued pursuant to TSCA section
6(b)(4)(D) and TSCA implementing regulations at 40 CFR 702.41(c)(8).
C. What action is the Agency taking?
EPA is publishing the final scope of the risk evaluation for D4
under TSCA. Through the risk evaluation process, EPA will determine
whether the chemical substance presents an unreasonable risk of injury
to health or the environment under the conditions of use, in accordance
with TSCA section 6(b)(4).
II. Background
TSCA allows chemical manufacturers to request an EPA-conducted risk
evaluation of a chemical substance under 40 CFR 702.37. On March 19,
2020, EPA received a manufacturer request for a risk evaluation of D4
(Ref. 1). On June 17, 2020, EPA opened a 45-day public comment period
to gather information relevant to the requested risk evaluation. EPA
granted the request on October 6, 2020, and subsequently initiated the
scoping process for the risk evaluation for this chemical substance.
Pursuant to 40 CFR 702.41(c)(7), EPA announced the availability of and
sought public comment on the draft scope document for the risk
evaluation to be conducted for D4 under TSCA (86 FR 50347, September 8,
2021) (FRL-8850-01-OCSPP) (Ref. 2).
The purpose of risk evaluation is to determine whether a chemical
substance, or category of chemical substances, presents an unreasonable
risk of injury 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 hazards and exposures for the
conditions of use; describe whether aggregate or sentinel exposures
were considered and the basis for consideration; not consider costs or
other nonrisk factors; take into account, where relevant, likely
duration, intensity, frequency, and number of exposures and describe
the weight of the scientific evidence for hazards and exposures (15
U.S.C. 2605(b)(4)(F)). This process will culminate in a determination
of whether the chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of use (15
U.S.C. 2605(b)(4)(A); 40 CFR 702.47).
III. Information and Comments Received on the Draft Scope
In the Federal Register of September 8, 2021 (Ref. 2), EPA
announced the availability of the draft scope document for the risk
evaluation to be conducted for D4 under TSCA and invited public
comments on EPA's draft scope document, including additional data or
information relevant to the chemical substance or that otherwise could
be useful to the Agency in finalizing the scope of the risk evaluation.
To the extent that comments provided information on conditions of use,
as well as other elements of the draft scope document, those comments
and other submitted information (e.g., relevant studies, assessments,
information on degradation products, and information on conditions of
use) were used to inform revisions to the draft scope document and may
be considered in
[[Page 12697]]
subsequent phases of the risk evaluation process.
EPA received six unique submissions for D4, including comments from
potentially affected businesses or trade associations, environmental
and public health advocacy groups, and one member of the general
public.
Comments addressed the overall approach to the risk evaluation
process (e.g., collection, consideration, and systematic review of
relevant information), the specific elements of the scope document
(e.g., hazard, exposure, and potentially exposed or susceptible
subpopulations), information specific to the chemical substance (e.g.,
relevant studies, assessments, degradation products, and conditions of
use), and topics beyond the draft scope document phase of the process
(e.g., risk management). EPA considered those comments, as applicable
and appropriate, in developing the final scope document. Concurrently
with the publication of the final scope document, EPA is publishing a
response to comments document that contains a comprehensive summary of
and response to public comments received on the D4 draft scope
document. The comprehensive response to comments document is available
in the docket EPA-HQ-OPPT-2018-0443 (Ref. 3).
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.
1. EPA. Octamethylcyclotetra-Siloxane (D4); Manufacturer Request for
Risk Evaluation Under the Toxic Substances Control Act (TSCA);
Notice of Availability and Request for Comments. Federal Register.
(85 FR 36586, June 17, 2020) (FRL-10010-49).
2. EPA. Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk
Evaluation to be Conducted Under the Toxic Substances Control Act
(TSCA); Notice of Availability and Request for Comments. Federal
Register. (86 FR 50347, September 8, 2021) (FRL-8850-01-OCSPP).
3. EPA. EPA Response to Public Comments Received on the Draft Scope
of the Risk Evaluation for Under the Toxic Substances Control Act
(TSCA) for Octamethylcyclotetra-siloxane (Cyclotetrasiloxane,
2,2,4,4,6,6,8,8-octamethyl-) (D4) CASRN 556-67-2 (March 2022).
Authority: 15 U.S.C. 2601 et seq.
Michael S. Regan,
Administrator.
[FR Doc. 2022-04676 Filed 3-4-22; 8:45 am]
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