[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55281-55283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19671]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0131; FRL-10013-90]
Final Scopes of the Risk Evaluations To Be Conducted for Twenty
Chemical Substances Under the Toxic Substances Control Act; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Toxic Substances Control Act (TSCA),
which was amended by the Frank R. Lautenberg Chemical Safety for the
21st Century Act in June 2016, and implementing regulations, EPA is
announcing the availability of the final scope documents for the risk
evaluations to be conducted for the 20 High-Priority Substances
designated in December 2019. The 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.
DATES: The scope documents announced in this notice are dated August
27, 2020.
ADDRESSES: The docket for this action is identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0131, and the docket ID
numbers for the individual chemical substances are listed with the
chemical substance in Unit IV. All the dockets are available at http://www.regulations.gov or 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 closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. 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:
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 announcing the availability of the final scope documents of
the risk evaluations for the 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).
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), 2625(h) and (i)). 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).
Pursuant to 40 CFR 702.41(c)(7), EPA announced the availability of
and
[[Page 55282]]
sought public comment on the draft scope documents for the risk
evaluations to be conducted for 13 of 20 High-Priority Substances under
TSCA (85 FR 19941, April 9, 2020) (FRL-10007-11) (Ref. 2) and the
remaining 7 of 20 High-Priority Substances under TSCA (85 FR 22733,
April 23, 2020) (FRL-10008-05) (Ref. 3).
III. Information and Comments Received
A. Overview of Public Comments
Comments were received during two 45-day comment periods following
the announcement of the draft scope documents for the risk evaluations
to be conducted for 13 of 20 High-Priority Substances under TSCA (Ref.
2) and the remaining 7 of 20 High-Priority Substances under TSCA (Ref.
3). During both comment periods, the public was invited to submit
comments on EPA's draft scope documents, including additional data or
information relevant to the chemical substances or that otherwise could
be useful to the Agency in finalizing the scope of the risk
evaluations. To the extent that comments provided information on
conditions of use, as well as other elements of the draft scope
documents, those comments and other submitted information (e.g.,
relevant studies and assessments) were used to inform revisions to the
draft scope documents and may be considered in subsequent phases of the
risk evaluation process.
EPA created one general docket to receive comments regarding the
risk evaluation process and additional, individual dockets on each of
the 20 High-Priority Substances undergoing risk evaluation to receive
chemical-specific information. From all 21 dockets, EPA received 245
submissions; however, some commenters opted for one submission
describing all their comments and submitted it to multiple dockets,
other commenters chose to submit different comments to specific
chemical-specific dockets, and some commenters did both. Therefore, EPA
considered 78 of those submissions unique. EPA received submissions
from 66 different entities, including potentially affected businesses
or trade associations, environmental and public health advocacy groups
and academia (some submissions were signed by more than one group), a
group of state attorneys general, and other organizations.
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 documents
(e.g., hazard, exposure, and potentially exposed or susceptible
subpopulations (PESS)), information specific to the chemical substances
(e.g., relevant studies, assessments, and conditions of use (COUs)),
and topics beyond the draft scope document phase of the process (e.g.,
risk management). One comment (EPA-HQ-2018-0465-0028) was not related
to the risk evaluation of the 20 High-Priority Substances. EPA
considered those comments, as applicable and appropriate, in developing
the final scope documents. Concurrently with the publication of the 20
final scope documents, EPA is publishing a response to comments
document that contains a comprehensive summary of and response to
public comments received on the 20 draft scope documents. The
comprehensive response to comments document is available in the docket
EPA-HQ-OPPT-2019-0131 (Ref. 4).
IV. Final Scopes for the 20 Designated High-Priority Chemical
Substances
The chemical substances for which EPA is publishing the final
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--List of the 20 Designated High Priority Chemical Substances
----------------------------------------------------------------------------------------------------------------
Chemical substance CASRN Docket ID No.
----------------------------------------------------------------------------------------------------------------
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
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).
Butyl benzyl phthalate (1,2- 85-68-7 EPA-HQ-OPPT-2018-0501
Benzenedicarboxylic acid, 1- butyl 2-
(phenylmethyl) ester).
Dibutyl phthalate (1,2-Benzenedicarboxylic 84-74-2 EPA-HQ-OPPT-2018-0503
acid, 1,2- dibutyl ester).
Dicyclohexyl phthalate..................... 84-61-7 EPA-HQ-OPPT-2018-0504
Phthalic anhydride (1,3-Isobenzofurandione) 85-44-9 EPA-HQ-OPPT-2018-0459
Formaldehyde............................... 50-00-0 EPA-HQ-OPPT-2018-0438
Di-ethylhexyl phthalate (1,2- 117-81-7 EPA-HQ-OPPT-2018-0433
Benzenedicarboxylic acid, 1,2- bis(2-
ethylhexyl) ester).
Di-isobutyl phthalate (1,2- 84-69-5 EPA-HQ-OPPT-2018-0434
Benzenedicarboxylic acid, 1,2-bis(2-
methylpropyl) ester).
----------------------------------------------------------------------------------------------------------------
The final scope document for the risk evaluation for each of these
20 chemical substances includes the conditions of use, hazards,
exposures, and the potentially exposed or susceptible subpopulations
EPA plans to consider. Development of the scope is the first step of a
risk evaluation. The final scope document for each risk evaluation
includes the following components (40 CFR 702.41(c)):
The conditions of use, as determined by the Administrator,
that EPA plans to consider in the risk evaluation.
The potentially exposed populations that EPA plans to
evaluate; the ecological receptors 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.
[[Page 55283]]
A conceptual model that describes 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, and 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 identifies 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.
Based on public comments received, the Agency was able to update
conditions of use presented in the draft scope documents and accept
additional data or information from stakeholders that was useful to the
Agency in finalizing the scope of the risk evaluations. In addition,
public comments were considered to better inform the exposure pathways,
routes, receptors, PESS, and hazards that EPA plans to consider in the
risk evaluations for the 20 High-Priority Substances. 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.''
V. 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. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register. (84
FR 71924, December 30, 2019) (FRL-10003-15).
2. EPA. Draft Scopes of the Risk Evaluations to Be Conducted for
Thirteen Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. (85 FR 19941, April 9, 2020)
(FRL-10007-11).
3. EPA. Draft Scopes of the Risk Evaluations to Be Conducted for
Seven Chemical Substances Under the Toxic Substances Control Act;
Notice of Availability. Federal Register. (85 FR 22733, April 23, 2020)
(FRL-10008-05).
4. EPA. Summary of Public Comments Received on the Draft Scopes of
the Risk Evaluations for Twenty Chemical Substances Under the Toxic
Substances Control Act (TSCA). (August 2020).
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-19671 Filed 9-3-20; 8:45 am]
BILLING CODE 6560-50-P