[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10717-10719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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