Document ID: EPA-HQ-OPPT-2018-0434-0027
Agency: epa
Document Type: Notice
Title: Draft Scopes of the Risk Evaluations to be Conducted for Seven Chemical Substances under the Toxic Substances Control Act
Posted Date: 2020-04-23T04:00Z

[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Pages 22733-22735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08613]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0131; FRL-10008-05]

Draft Scopes of the Risk Evaluations To Be Conducted for Seven 
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 7 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 June 8, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number 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: 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.

[[Page 22734]]

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 7 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 announced the availability of 
the draft scopes of the risk evaluations for 13 of 20 chemical 
substances designated as High-Priority Substances for risk evaluation 
under TSCA on April 6, 2020 (Ref. 1).

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. 2), 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 7 of 20 Designated High Priority Chemical 
Substances

    The 7 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 7 of 20 Designated High Priority Chemical Substances
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             Chemical substance                   CASRN                         Docket ID No.
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Butyl benzyl phthalate (BBP) (1,2-                  85-68-7  EPA-HQ-OPPT-2018-0501
 Benzenedicarboxylic acid, 1-butyl 2-
 (phenylmethyl) ester).
Dibutyl phthalate (DBP) (1,2-                       84-74-2  EPA-HQ-OPPT-2018-0503
 Benzenedicarboxylic acid, 1,2-dibutyl
 ester).
Dicyclohexyl phthalate (1,2-                        84-61-7  EPA-HQ-OPPT-2018-0504
 Benzenedicarboxylic acid, 1,2-dicyclohexyl
 ester).
Di-ethylhexyl phthalate (DEHP) (1,2-               117-81-7  EPA-HQ-OPPT-2018-0433
 Benzenedicarboxylic acid, 1,2-bis(2-
 ethylhexyl) ester).
Di-isobutyl phthalate (DIBP) (1,2-                  84-69-5  EPA-HQ-OPPT-2018-0434
 Benzenedicarboxylic acid, 1,2-bis(2-
 methylpropyl) ester).
Formaldehyde...............................         50-00-0  EPA-HQ-OPPT-2018-0438
Phthalic anhydride (1,3-Isobenzofurandione)         85-44-9  EPA-HQ-OPPT-2018-0459
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    The draft scope of the risk evaluation for each of these 7 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

[[Page 22735]]

announcing the availability of the final scopes within six months of 
the initiation of risk evaluations that occurred on December 20, 2019 
(Ref. 2).

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. 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 FRxx, April 9, 2020 
(FRL-10007-11).
2. 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. 2020-08613 Filed 4-22-20; 8:45 am]
 BILLING CODE 6560-50-P