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)

Page Range		10717-10719
FR Document		2018-04938

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 Issue 48 (Monday, March 12, 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

10718 Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices

For technical information contact: B. How can I get copies of this document III. Meeting
Louis Scarano, Risk Assessment and other related information?
A. Remote Access
Division, Office of Pollution Prevention The docket for this action, identified
and Toxics, Environmental Protection The meeting will be accessible
by docket identification (ID) number remotely for registered participants.
Agency, 1200 Pennsylvania Ave. NW, EPA–HQ–OPPT–2017–0559, is available Registered participants will receive
Washington, DC 20460–0001; telephone at http://www.regulations.gov or at the
number: (202) 564–2851, email address: information on how to connect to the
Office of Pollution Prevention and meeting prior to its start.
scarano.louis@epa.gov. In addition, Toxics Docket (OPPT Docket),
progress on this activity will be Environmental Protection Agency B. Public Participation at the Meeting
periodically updated at the following Docket Center (EPA/DC), West William Members of the public may register to
page on the OPPT website at https:// Jefferson Clinton Bldg., Rm. 3334, 1301 attend the public meeting and may also
www.epa.gov/assessing-and-managing- Constitution Ave. NW, Washington, DC. register to provide oral comments, in
chemicals-under-tsca. The Public Reading Room is open from person or remotely, on the day of the
For meeting logistics or registration 8:30 a.m. to 4:30 p.m., Monday through meeting, using one of the registration
contact: Klara Zimmerman, Abt Friday, excluding legal holidays. The methods described under ADDRESSES. A
Associates; telephone number: (301) telephone number for the Public registered speaker is encouraged to
634–1722; email address: klara_ Reading Room is (202) 566–1744, and focus on issues directly relevant to the
zimmerman@abtassoc.com. the telephone number for the OPPT meeting’s subject matter. Depending on
For general information contact: The Docket is (202) 566–0280. Please review time and number of people registered to
TSCA-Hotline, ABVI-Goodwill, 422 the visitor instructions and additional speak, each speaker may be limited to
South Clinton Ave., Rochester, NY information about the docket available no more than five minutes. A speaker
14620; telephone number: (202) 554– at http://www.epa.gov/dockets. must be registered in order to provide
1404; email address: TSCA-Hotline@ Meeting materials for the April 10, oral comments. To accommodate as
epa.gov. 2018 public meeting will be made many registered speakers as possible,
SUPPLEMENTARY INFORMATION:
available in the docket. (http:// speakers may present oral comments
www.regulations.gov; docket number without visual aids or written material.
I. General Information EPA–HQ–OPPT–2017–0559). Persons registered to speak (as well as
A. Does this action apply to me? others) may submit written materials to
II. Background
the docket as described under
You may be potentially affected by On June 22, 2016, the Frank R. ADDRESSES. An Agenda for the meeting
this action if you are required to Lautenberg Chemical Safety for the 21st and supporting materials will be made
conduct testing of chemical substances Century Act, which amended the Toxic available in the docket and on EPA’s
under the Toxic Substances Control Act Substances Control Act (TSCA), the website in advance of the meeting.
(TSCA). Since other entities may also be nation’s primary chemicals management
interested, the Agency has not law, was signed into law. Along with IV. How can I request to participate in
attempted to describe all the specific new requirements and deadlines for this meeting?
entities that may be affected by this actions related to the regulation of new A. Registration
action. The following list of North and existing chemicals in the U.S., the To attend the meeting in person or to
American Industrial Classification new law includes changes to TSCA receive remote access, you must register
System (NAICS) codes is not intended section 4 (Testing of Chemical online no later than April 3, 2018, using
to be exhaustive, but rather provides a Substances and Mixtures). Specifically, one of the methods described under
guide to help readers determine whether a new section (4(h)) has been added ADDRESSES. While on-site registration
this document applies to them. entitled Reduction of Testing on will be available, seating will be on a
Potentially affected entities may Vertebrates. first-come, first-served basis, with
include: TSCA section 4 (h)(2)(A) states that priority given to early registrants, until
• Basic Chemical Manufacturers EPA must ‘‘. . . develop a strategic plan room capacity is reached. For registrants
(NAICS code 3251); to promote the development and not able to attend in person, the meeting
• Resin, Synthetic Rubber, and implementation of alternative test will also provide remote access
Artificial Synthetic Fibers and Filament methods and strategies to reduce, refine, capabilities; registered participants will
Manufacturers (NAICS code 3252); or replace vertebrate animal testing and be provided information on how to
• Pesticide, Fertilizer, and Other provide information of equivalent or connect to the meetings prior to its start.
Agricultural Chemical Manufacturers better scientific quality and relevance
for assessing risks of injury to health or B. Required Registration Information
(NAICS code 3255);
the environment . . .’’. Members of the public may register to
• Paint, Coating, and Adhesive
The Strategic Plan must be completed attend as observers or to speak if
Manufacturers (NAICS code 3255);
by June 22, 2018. OPPT hosted a public planning to offer oral comments during
• Other Chemical Product and meeting on November 2, 2017 in which
Preparation Manufacturers (NAICS code the scheduled public comment period.
a conceptual approach to this Plan was To register for the meeting online, you
3259); and Petroleum Refineries (NAICS presented. The meeting materials and
code 32411). must provide your full name,
public comments received through organization or affiliation, and contact
• Animal Welfare Groups January 10, 2018, when the comment information.
• Environmental non-governmental
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period associated with the November 2,
organizations 2017 meeting closed, are available in the V. What action is the Agency taking?
• Toxicity testing laboratories docket. (http://www.regulations.gov; EPA is publishing a draft strategic
(contract labs) docket number EPA–HQ–OPPT–2017– plan, and taking comments until April
• Academic/non-profit groups 0559). Meeting materials for the April 26, 2018, to promote the use and
involved in developing and using 10, 2018 public meeting will be made development of alternative test methods
alternative toxicity test methods available in the docket as well. and strategies to reduce, refine or

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Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Notices 10719

replace vertebrate animal testing, which instructions for submitting comments. employ less than 25) on examples of
includes a list of new approach Do not submit electronically any specific additional efforts that EPA
methodologies (NAMs) that are information you consider to be could make to reduce the paperwork
‘‘scientifically reliable, relevant, and Confidential Business Information (CBI) burden for very small businesses
capable of providing information of or other information whose disclosure is affected by this collection.
equivalent or better scientific reliability restricted by statute.
II. What information collection activity
and quality to that which would be • Mail: Document Control Office
or ICR does this action apply to?
obtained from vertebrate animal testing’’ (7407M), Office of Pollution Prevention
along with criteria ‘‘for considering and Toxics (OPPT), Environmental Title: Guidance on Expanded Access
scientific reliability and relevance’’ of Protection Agency, 1200 Pennsylvania to TSCA Confidential Business
NAMs. See TSCA sections 4(h)(2)(C) Ave. NW, Washington, DC 20460–0001. Information
and (D). • Hand Delivery: To make special ICR number: EPA ICR No. 2570.01.
EPA is also holding a public meeting arrangements for hand delivery or OMB control number: OMB Control
to obtain input on the Agency’s draft delivery of boxed information, please No. 2070—[new].
Strategic Plan. Information obtained follow the instructions at http:// ICR status: This ICR addresses a new
during this meeting will be considered www.epa.gov/dockets/contacts.html. information collection activity. Under
in the Agency’s development of the final Additional instructions on the PRA, an Agency may not conduct or
Strategic Plan due in June of 2018. commenting or visiting the docket, sponsor, and a person is not required to
along with more information about respond to, a collection of information,
Authority: 15 U.S.C. 2601 et seq.
dockets generally, is available at http:// unless it displays a currently valid OMB
Dated: March 5, 2018. control number. The OMB control
www.epa.gov/dockets.
Charlotte Bertrand, numbers for EPA’s regulations in title 40
FOR FURTHER INFORMATION CONTACT:
Acting Principal Deputy Assistant For technical information contact: of the Code of Federal Regulations
Administrator, Office of Chemical Safety and
Jessica Barkas, Environmental (CFR), after appearing in the Federal
Pollution Prevention. Register when approved, are listed in 40
Assistance Division, Office of Pollution
[FR Doc. 2018–04938 Filed 3–9–18; 8:45 am]
Prevention and Toxics, Environmental CFR part 9, are displayed either by
BILLING CODE 6560–50–P
Protection Agency, 1200 Pennsylvania publication in the Federal Register or
Ave. NW, Washington, DC 20460–0001; by other appropriate means, such as on
telephone number: (202) 250–8880; the related collection instrument or
ENVIRONMENTAL PROTECTION form, if applicable. The display of OMB
email address: barkas.jessica@epa.gov.
AGENCY control numbers for certain EPA
For general information contact: The
[EPA–HQ–OPPT–2017–0652; FRL–9975–24] TSCA-Hotline, ABVI-Goodwill, 422 regulations is consolidated in 40 CFR
South Clinton Ave., Rochester, NY part 9.
Agency Information Collection Abstract: This ICR addresses the
14620; telephone number: (202) 554–
Activities; Proposed New Collection content and form of the statements of
1404; email address: TSCA-Hotline@
(EPA ICR No. 2570.01); Comment need and agreements required under
epa.gov.
Request TSCA section 14(d)(4), (5), and (6),
SUPPLEMENTARY INFORMATION: which are described in the three draft
AGENCY: Environmental Protection guidance documents that have been
Agency (EPA). I. What information is EPA particularly
interested in? developed to implement the new
ACTION: Notice. authorities in TSCA section 14(d)(4), (5),
Pursuant to PRA section 3506(c)(2)(A) and (6), and include some basic
SUMMARY: In compliance with the (44 U.S.C. 3506(c)(2)(A)), EPA logistical information on where and
Paperwork Reduction Act (PRA), this specifically solicits comments and how to submit requests to EPA. Making
document announces that EPA is information to enable it to: a request for access to TSCA CBI is a
planning to submit an Information 1. Evaluate whether the proposed voluntary activity, but is required in
Collection Request (ICR) to the Office of collection of information is necessary order to gain such access under TSCA
Management and Budget (OMB). The for the proper performance of the section 14(d).
ICR, entitled: ‘‘Guidance on Expanded functions of the Agency, including Burden statement: The annual public
Access to TSCA Confidential Business whether the information will have reporting and recordkeeping burden for
Information’’ and identified by EPA ICR practical utility. this collection of information is
No. 2570.01 and OMB Control No. 2. Evaluate the accuracy of the estimated to average 14.8 hours and cost
2070—[new], represents a new request. Agency’s estimates of the burden of the about $868 per response. Burden is
Before submitting the ICR to OMB for proposed collection of information, defined in 5 CFR 1320.3(b).
review and approval, EPA is soliciting including the validity of the The ICR, which is available in the
comments on specific aspects of the methodology and assumptions used. docket along with other related
proposed information collection that is 3. Enhance the quality, utility, and materials, provides a detailed
summarized in this document. The ICR clarity of the information to be explanation of the collection activities
and accompanying material are collected. and the burden estimate that is only
available in the docket for public review 4. Minimize the burden of the briefly summarized here:
and comment. collection of information on those who Respondents/affected entities: Entities
DATES: Comments must be received on are to respond, including through the potentially affected by this ICR are
amozie on DSK30RV082PROD with NOTICES

or before May 11, 2018. use of appropriate automated electronic, mainly government employees (federal,
ADDRESSES: Submit your comments, mechanical, or other technological state, local, tribal), as well as medical
identified by docket identification (ID) collection techniques or other forms of professionals, such as doctors and
number EPA–HQ–OPPT–2017–0652, by information technology, e.g., permitting nurses.
one of the following methods: electronic submission of responses. In Estimated total number of potential
• Federal eRulemaking Portal: http:// particular, EPA is requesting comments respondents: 6.
www.regulations.gov. Follow the online from very small businesses (those that Frequency of response: On occasion.

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Document Created: 2018-11-01 08:52:19
Document Modified: 2018-11-01 08:52:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The public meeting will be held on April 10, 2018 from 9:00 a.m. to 5:00 p.m.
Contact		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-
FR Citation		83 FR 10717