Document ID: EPA-HQ-OPPT-2018-0426-0028
Agency: epa
Document Type: Notice
Title: Final Scopes of the Risk Evaluations To Be Conducted for Twenty Chemical Substances Under the Toxic Substances Control Act; Notice of Availability
Posted Date: 2020-09-04T04:00Z

[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]

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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.

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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: geredien.ross@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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
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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
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]
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