83 FR 10717 - TSCA Alternative Testing Methods Draft Strategic Plan; Notice of Availability and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 48 (March 12, 2018)

As required by the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, EPA is developing, pursuant to TSCA section 4(h)(2)(A), a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing. The draft Strategic Plan will be available for comment until April 26, 2018 and information obtained will be considered in the Agency's development of the final Strategic Plan which is required to be completed and published in June of 2018. EPA is also holding a public meeting to obtain input on the Agency's draft Strategic Plan. Information obtained during this meeting will be considered in the Agency's development of the final Strategic Plan due in June of 2018.

[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10717-10719]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04938]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0559; FRL-9974-13]


TSCA Alternative Testing Methods Draft Strategic Plan; Notice of 
Availability and Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required by the Toxic Substances Control Act (TSCA), as 
amended by the Frank R. Lautenberg Chemical Safety for the 21st Century 
Act in June 2016, EPA is developing, pursuant to TSCA section 
4(h)(2)(A), a Strategic Plan to promote the development and 
implementation of alternative test methods and strategies to reduce, 
refine or replace vertebrate animal testing. The draft Strategic Plan 
will be available for comment until April 26, 2018 and information 
obtained will be considered in the Agency's development of the final 
Strategic Plan which is required to be completed and published in June 
of 2018.
    EPA is also holding a public meeting to obtain input on the 
Agency's draft Strategic Plan. Information obtained during this meeting 
will be considered in the Agency's development of the final Strategic 
Plan due in June of 2018.

DATES: The public meeting will be held on April 10, 2018 from 9:00 a.m. 
to 5:00 p.m.
    Members of the public must register to make oral comments at the 
public meeting on or before April 3, 2018. Online requests to 
participate in the meeting must be received on or before April 3, 2018. 
On-site registration will be permitted, but seating and speaking 
priority will be given to those who pre-register by the deadline.
    To request accommodation of a disability, please contact the 
meetings logistics person listed under FOR FURTHER INFORMATON CONTACT, 
preferably at least 10 days prior to the meeting, to give EPA as much 
time as possible to process your request.
    EPA will accept written comments and materials submitted to the 
docket EPA-HQ-OPPT-2017-0559. The docket will remain open to receive 
comments and materials until April 26, 2018. When submitting comments 
to the docket, please be as specific as possible, and please include 
any supporting data or other information.

ADDRESSES: The meeting will be held in the Ronald Reagan Building 1300 
Pennsylvania Avenue NW, Washington, DC 20004. The meeting will also be 
available by remote access for registered participants. For further 
information, see Unit I under SUPPLEMENTARY INFORMATION.
    To participate in the meeting on April 10, 2018, you may register 
online (preferred) or in person at the meeting. To register online, go 
to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    Written comments, identified by the docket ID number EPA-HQ-OPPT-
2017-0559 can be submitted 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 in general is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 

[[Page 10718]]

    For technical information contact: Louis Scarano, Risk Assessment 
Division, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-2851, email address: 
[email protected]. In addition, progress on this activity will be 
periodically updated at the following page on the OPPT website at 
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
    For meeting logistics or registration contact: Klara Zimmerman, Abt 
Associates; telephone number: (301) 634-1722; 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?

    You may be potentially affected by this action if you are required 
to conduct testing of chemical substances under the Toxic Substances 
Control Act (TSCA). Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action. The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     Basic Chemical Manufacturers (NAICS code 3251);
     Resin, Synthetic Rubber, and Artificial Synthetic Fibers 
and Filament Manufacturers (NAICS code 3252);
     Pesticide, Fertilizer, and Other Agricultural Chemical 
Manufacturers (NAICS code 3255);
     Paint, Coating, and Adhesive Manufacturers (NAICS code 
3255);
     Other Chemical Product and Preparation Manufacturers 
(NAICS code 3259); and Petroleum Refineries (NAICS code 32411).
     Animal Welfare Groups
     Environmental non-governmental organizations
     Toxicity testing laboratories (contract labs)
     Academic/non-profit groups involved in developing and 
using alternative toxicity test methods

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0559, is 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. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.
    Meeting materials for the April 10, 2018 public meeting will be 
made available in the docket. (http://www.regulations.gov; docket 
number EPA-HQ-OPPT-2017-0559).

II. Background

    On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 
21st Century Act, which amended the Toxic Substances Control Act 
(TSCA), the nation's primary chemicals management law, was signed into 
law. Along with new requirements and deadlines for actions related to 
the regulation of new and existing chemicals in the U.S., the new law 
includes changes to TSCA section 4 (Testing of Chemical Substances and 
Mixtures). Specifically, a new section (4(h)) has been added entitled 
Reduction of Testing on Vertebrates.
    TSCA section 4 (h)(2)(A) states that EPA must ``. . . develop a 
strategic plan to promote the development and implementation of 
alternative test methods and strategies to reduce, refine, or replace 
vertebrate animal testing and provide information of equivalent or 
better scientific quality and relevance for assessing risks of injury 
to health or the environment . . .''.
    The Strategic Plan must be completed by June 22, 2018. OPPT hosted 
a public meeting on November 2, 2017 in which a conceptual approach to 
this Plan was presented. The meeting materials and public comments 
received through January 10, 2018, when the comment period associated 
with the November 2, 2017 meeting closed, are available in the docket. 
(http://www.regulations.gov; docket number EPA-HQ-OPPT-2017-0559). 
Meeting materials for the April 10, 2018 public meeting will be made 
available in the docket as well.

III. Meeting

A. Remote Access

    The meeting will be accessible remotely for registered 
participants. Registered participants will receive information on how 
to connect to the meeting prior to its start.

B. Public Participation at the Meeting

    Members of the public may register to attend the public meeting and 
may also register to provide oral comments, in person or remotely, on 
the day of the meeting, using one of the registration methods described 
under ADDRESSES. A registered speaker is encouraged to focus on issues 
directly relevant to the meeting's subject matter. Depending on time 
and number of people registered to speak, each speaker may be limited 
to no more than five minutes. A speaker must be registered in order to 
provide oral comments. To accommodate as many registered speakers as 
possible, speakers may present oral comments without visual aids or 
written material. Persons registered to speak (as well as others) may 
submit written materials to the docket as described under ADDRESSES. An 
Agenda for the meeting and supporting materials will be made available 
in the docket and on EPA's website in advance of the meeting.

IV. How can I request to participate in this meeting?

A. Registration

    To attend the meeting in person or to receive remote access, you 
must register online no later than April 3, 2018, using one of the 
methods described under ADDRESSES. While on-site registration will be 
available, seating will be on a first-come, first-served basis, with 
priority given to early registrants, until room capacity is reached. 
For registrants not able to attend in person, the meeting will also 
provide remote access capabilities; registered participants will be 
provided information on how to connect to the meetings prior to its 
start.

B. Required Registration Information

    Members of the public may register to attend as observers or to 
speak if planning to offer oral comments during the scheduled public 
comment period. To register for the meeting online, you must provide 
your full name, organization or affiliation, and contact information.

V. What action is the Agency taking?

    EPA is publishing a draft strategic plan, and taking comments until 
April 26, 2018, to promote the use and development of alternative test 
methods and strategies to reduce, refine or

[[Page 10719]]

replace vertebrate animal testing, which includes a list of new 
approach methodologies (NAMs) that are ``scientifically reliable, 
relevant, and capable of providing information of equivalent or better 
scientific reliability and quality to that which would be obtained from 
vertebrate animal testing'' along with criteria ``for considering 
scientific reliability and relevance'' of NAMs. See TSCA sections 
4(h)(2)(C) and (D).
    EPA is also holding a public meeting to obtain input on the 
Agency's draft Strategic Plan. Information obtained during this meeting 
will be considered in the Agency's development of the final Strategic 
Plan due in June of 2018.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: March 5, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-04938 Filed 3-9-18; 8:45 am]
 BILLING CODE 6560-50-P