Document ID: EPA-HQ-OPPT-2018-0210-0001
Agency: epa
Document Type: Notice
Title: Problem Formulations for Risk Evaluations To Be Conducted Under Toxic Substances Control Act, and General Guiding Principles To Apply Systematic Review in TSCA Risk Evaluations
Posted Date: 2018-06-11T04:00Z

[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
----------------------------------------------------------------------------------------------------------------
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]
 BILLING CODE 6560-50-P