[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 26998-27000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12520]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2018-0210; FRL-9978-40]
Problem Formulations for the Risk Evaluations To Be Conducted
Under the Toxic Substances Control Act, and General Guiding Principles
To Apply Systematic Review in TSCA Risk Evaluations; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is publishing and taking comments on the problem
formulation documents for the first 10 chemical substances undergoing
risk evaluation under the Toxic Substances Control Act (TSCA). Comments
received will inform the development of draft risk evaluation documents
for these 10 chemical substances. The 10 problem formulation documents
announced in this document refine the scope documents published in June
2017 and are an additional interim step, prior to publication of the
draft risk evaluations. EPA is also publishing and taking comments on a
document entitled: ``Application of Systematic Review in TSCA Risk
Evaluations,'' which sets out general principles to guide EPA's
application of systematic review for TSCA risk evaluations. The Office
of Pollution Prevention and Toxics (OPPT) generally intends to apply
systematic review principles in the development of risk evaluations
under TSCA. The systematic review document includes a structured
process of identifying, evaluating and integrating evidence for both
the hazard and exposure assessments developed during the TSCA risk
evaluation process. This document may be revised periodically. EPA
welcomes public input on the document.
DATES: Comments on the problem formulations must be received on or
before July 26, 2018.
EPA specifically requests comments on the Application of Systematic
Review in TSCA Risk Evaluations document for 45 days after date of
publication in the Federal Register. In addition, because this document
is a living document which may be revised periodically. EPA welcomes
public input on this document at any time.
ADDRESSES: Submit your comments, identified by the appropriate docket
identification (ID) numbers as provided in Unit IV., 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. When submitting comments, please
be as specific as possible, and please include any supporting data or
other information.
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 in general is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information on the Problem Formulation documents
contact: Christina Motilall, Risk Assessment Division, Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-1287; email address: [email protected].
For technical information on Application of Systematic Review in
TSCA Risk Evaluations contact: Iris Camacho, Risk Assessment Division,
Office of Pollution Prevention and
[[Page 26999]]
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-1229; 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. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined under TSCA to include import), process, distribute in
commerce, use or dispose of any of the 10 chemical substances
identified in this document for risk evaluation, or any future existing
chemical substances undergoing risk evaluation under TSCA. This action
may be of particular interest to entities that are regulated under TSCA
(e.g., entities identified under North American Industrial
Classification System (NAICS) codes 325 and 324110, among others).
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.
II. What is the Agency's authority for this action?
As amended in June 2016, TSCA requires that EPA prioritize and
evaluate existing chemical substances and manage identified risks (15
U.S.C. 2605). TSCA section 6(b) specifies the requirements for risk
evaluation.
III. Background
A. The First 10 Chemical Substances for Risk Evaluations Under TSCA
On December 19, 2016 (81 FR 91927) (FRL-9956-47), EPA released its
designation of the first 10 chemical substances for risk evaluations
under TSCA. EPA's designation of the first 10 chemical substances
constituted the initiation of the risk evaluation process for each of
these chemical substances, pursuant to the requirements of TSCA section
6(b)(4).
On June 22, 2017, EPA released scope documents for the first 10
chemical substances (see 82 FR 31592, July 7, 2017) (FRL-9963-57). Each
scope document includes the hazards, exposures, conditions of use, and
the potentially exposed or susceptible subpopulations that EPA expects
to consider in the risk evaluation.
EPA has prepared a Response to Comments document addressing
overarching comments received on the scope documents, which is
available in the docket (see docket ID number EPA-HQ-OPPT-2017-0736).
Chemical substance-specific comments on the scope documents are
addressed in the respective problem formulation documents.
B. Systematic Review
In the development of TSCA risk evaluations, the Agency generally
intends to apply systematic review principles. EPA described systematic
review in the preamble of the final rule Procedures for Chemical Risk
Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726,
July 20, 2017), and in the preamble of the proposed rule (82 FR 7562,
January 19, 2017) (FRL-9957-75). EPA intends to apply systematic review
to pre-specify the criteria, methods/approaches for data collection,
data evaluation and data integration to meet the TSCA science
standards. TSCA requires EPA to make scientific decisions in a manner
consistent with the best available science and base decisions on the
weight of the scientific evidence.
Supplemental documents to the scope documents of the first 10
chemical substances, published in June 2017 (e.g., Strategy for
Conducting Literature Searches for Asbestos: Supplemental Document to
the TSCA Scope Document, CASRN: 1332-21-4) already document the initial
methods for identifying, compiling and screening publicly available
information. These data collections and screening activities are
described in the Strategy for Conducting Literature Searches document
and the Bibliography document supporting each of the TSCA scope
documents for the first ten chemical substances.
IV. What action is the Agency taking?
A. Problem Formulation Documents
To refine the scope documents, EPA is publishing and taking public
comment on problem formulation documents for the first 10 chemical
substances. As indicated in the scope documents, time constraints
resulted in scope documents that were not as refined or specific as
future scope documents are anticipated to be. The 10 problem
formulation documents announced in this document are an additional
interim step, prior to publication of the draft risk evaluations, that
refine the scope documents. These refinements may apply to the
conditions of use, hazards, exposures, and the potentially exposed or
susceptible subpopulations EPA expects to consider in the risk
evaluation. EPA has incorporated scope document comments specific to
each chemical substance into the respective problem formulation
document. While EPA does not intend to revise these problem formulation
documents, comments and information provided will inform the
development of the draft risk evaluation documents.
The following table identifies the docket ID numbers and EPA
contact for each of the 10 problem formulations that EPA is taking
comments on.
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Chemical No. Docket ID No. Agency contact
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Asbestos............................ EPA-HQ-OPPT-2016-0736 Robert Courtnage,
[email protected],
202-566-1081.
1-Bromopropane...................... EPA-HQ-OPPT-2016-0741 Ana Corado,
[email protected], 202-564-
0140.
1,4-Dioxane......................... EPA-HQ-OPPT-2016-0723 Cindy Wheeler,
[email protected], 202-
566-0484.
Carbon Tetrachloride................ EPA-HQ-OPPT-2016-0733 Stephanie Jarmul,
[email protected],
202-564-6130.
Cyclic Aliphatic Bromide Cluster EPA-HQ-OPPT-2016-0735 Sue Slotnick,
(HBCD). [email protected], 202-
566-1973.
Methylene Chloride.................. EPA-HQ-OPPT-2016-0742 Ana Corado,
[email protected], 202-564-
0140.
N-Methylpyrrolidone (NMP)........... EPA-HQ-OPPT-2016-0743 Ana Corado,
[email protected], 202-564-
0140.
Pigment Violet 29 (Anthra[2,1,9- EPA-HQ-OPPT-2016-0725 Hannah Braun,
def:6,5,10-d'e'f'] diisoquinoline- [email protected], 202-
1,3,8,10(2H,9H)-tetrone). 564-5614.
Tetrachloroethylene (also known as EPA-HQ-OPPT-2016-0732 Tyler Lloyd,
perchloroethylene). [email protected], 202-
564-4016.
Trichloroethylene (TCE)............. EPA-HQ-OPPT-2016-0737 Toni Krasnic,
[email protected], 202-
564-0984.
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[[Page 27000]]
EPA invites the public to provide additional comment and
information that would be useful in conducting the risk evaluation for
each of the 10 chemical substances.
B. The Application of Systematic Review in TSCA Risk Evaluations
The Application of Systematic Review in TSCA Risk Evaluations
document is a supplemental publication which sets out general
principles to guide EPA's application of systematic review in the risk
evaluation process for the first 10 chemical substances that EPA
initiated on December 19, 2016, as well as future assessments. It also
provides the intended strategy for assessing the quality of information
that the Agency plans to use for the TSCA risk evaluations.
The Agency intends to implement a structured process of
identifying, evaluating and integrating evidence for both the hazard
and exposure assessments developed during the TSCA risk evaluation
process. As needed, EPA will develop new approaches and methods to
address specific assessment needs for the relatively large and diverse
chemical space under TSCA. Hence, the Agency will document the progress
of implementing systematic review in the draft risk evaluations and
through revisions of this document and publication of supplemental
documents. The systematic review document provides the general
expectations for evidence integration. Further additional information
will be published with the publication of the draft TSCA risk
evaluations.
Ultimately, the goal is to establish a pragmatic systematic review
process that generates high quality, fit-for-purpose risk evaluations
that rely on the best available science and the weight of the
scientific evidence within the context of TSCA.
This document is a living document which may be revised
periodically. EPA welcomes public input on this document at any time.
Authority: 15 U.S.C. 2601 et seq.
Dated: May 31, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2018-12520 Filed 6-8-18; 8:45 am]
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