83 FR 30167 - Final Strategic Plan To Promote the Development and Implementation of Alternative Test Methods Supporting the Toxic Substances Control Act (TSCA); Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 124 (June 27, 2018)

Page Range		30167-30168
FR Document		2018-13833

As required by TSCA, which was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, EPA is announcing the availability of a document entitled: Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Supporting the Toxic Substances Control Act (TSCA). EPA is also making available a response to comments document that addresses comments received on the draft Strategic Plan.

Federal Register, Volume 83 Issue 124 (Wednesday, June 27, 2018)

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30167-30168]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13833]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0559; FRL-9978-62]


Final Strategic Plan To Promote the Development and 
Implementation of Alternative Test Methods Supporting the Toxic 
Substances Control Act (TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required by TSCA, which was amended by the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act in June 2016, EPA 
is announcing the availability of a document entitled: Strategic Plan 
to Promote the Development and Implementation of Alternative Test 
Methods Supporting the Toxic Substances Control Act (TSCA). EPA is also 
making available a response to comments document that addresses 
comments received on the draft Strategic Plan.

FOR FURTHER INFORMATION 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-
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 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.

C. What is the Agency's authority for this action?

    On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 
21st Century Act amended TSCA (15 U.S.C. 2601 et seq.), the nation's 
primary chemicals management 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 TSCA 
section 4(h) has been added entitled Reduction of Testing on 
Vertebrates. TSCA section 4(h)(2)(A) states that EPA shall ``. . ., not 
later than 2 years after June 22, 2016, 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. . 
.''. (15 U.S.C. 2603(h)(2)(A)).

D. What action is the Agency taking?

    In fulfillment of the requirements in TSCA section 4(h)(2)(A), EPA 
has prepared a final 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 of chemical substances or 
mixtures . . .''. The Strategic Plan is being made available in both 
the docket and on the EPA website.
    In addition, making available a response to comments document that 
addresses comments on the draft Strategic Plan received through May 11, 
2018. The response to comment document is available in the docket. 
(http://www.regulations.gov; docket ID number HQ-OPPT-2017-0559)

II. Background

    OPPT hosted a public meeting on November 2, 2017, in which a 
conceptual approach to this final Strategic Plan was presented. Meeting 
materials and public comments received through January 10, 2018, can be 
found in the docket (http://www.regulations.gov; docket ID number HQ-
OPPT-2017-0559).
    A draft Strategic Plan was published on March 12, 2018, along with 
a response to comments document that addressed the comments received 
through January 10, 2018. OPPT hosted a second public meeting on April 
10, 2018, to receive input from the public on the draft Strategic Plan. 
A docket was made available with the meeting materials and allowed for 
comments to

[[Page 30168]]

be received through May 11, 2018 (http://www.regulations.gov; docket ID 
number HQ-OPPT-2017-0559).

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

    Dated: June 21, 2018.
E. Scott Pruitt,
Administrator.
[FR Doc. 2018-13833 Filed 6-26-18; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices 30167

to seek court review of the I. General Information Century Act amended TSCA (15 U.S.C.
Commission’s final order. 2601 et seq.), the nation’s primary
The Commission strongly encourages A. Does this action apply to me?
chemicals management law. Along with
electronic filings of comments, protests You may be potentially affected by new requirements and deadlines for
and interventions in lieu of paper using this action if you are required to actions related to the regulation of new
the eFiling link at http://www.ferc.gov. conduct testing of chemical substances and existing chemicals in the U.S., the
Persons unable to file electronically under the Toxic Substances Control Act new law includes changes to TSCA
should submit an original and 5 copies (TSCA). Since other entities may also be section 4 (Testing of Chemical
of the protest or intervention to the interested, the Agency has not Substances and Mixtures). Specifically,
Federal Energy Regulatory Commission, attempted to describe all the specific a new TSCA section 4(h) has been
888 First Street NE, Washington, DC entities that may be affected by this added entitled Reduction of Testing on
20426. action. The following list of North Vertebrates. TSCA section 4(h)(2)(A)
Dated: June 21, 2018. American Industrial Classification states that EPA shall ‘‘. . ., not later
Nathaniel J. Davis, Sr., System (NAICS) codes is not intended than 2 years after June 22, 2016, develop
Deputy Secretary.
to be exhaustive, but rather provides a a strategic plan to promote the
guide to help readers determine whether development and implementation of
[FR Doc. 2018–13853 Filed 6–26–18; 8:45 am]
this document applies to them. alternative test methods and strategies
BILLING CODE 6717–01–P
Potentially affected entities may to reduce, refine, or replace vertebrate
include: animal testing and provide information
• Basic Chemical Manufacturers of equivalent or better scientific quality
ENVIRONMENTAL PROTECTION (NAICS code 3251); and relevance for assessing risks of
AGENCY • Resin, Synthetic Rubber, and injury to health or the
[EPA–HQ–OPPT–2017–0559; FRL–9978–62] Artificial Synthetic Fibers and Filament environment. . .’’. (15 U.S.C.
Manufacturers (NAICS code 3252); 2603(h)(2)(A)).
Final Strategic Plan To Promote the • Pesticide, Fertilizer, and Other
D. What action is the Agency taking?
Development and Implementation of Agricultural Chemical Manufacturers
Alternative Test Methods Supporting (NAICS code 3255); In fulfillment of the requirements in
the Toxic Substances Control Act • Paint, Coating, and Adhesive TSCA section 4(h)(2)(A), EPA has
(TSCA); Notice of Availability Manufacturers (NAICS code 3255); prepared a final Strategic Plan to
• Other Chemical Product and ‘‘promote the development and
AGENCY: Environmental Protection Preparation Manufacturers (NAICS code implementation of alternative test
Agency (EPA). 3259); and Petroleum Refineries (NAICS methods and strategies to reduce, refine
ACTION: Notice. code 32411); or replace vertebrate animal testing and
SUMMARY: As required by TSCA, which • Animal Welfare Groups; provide information of equivalent or
was amended by the Frank R. • Environmental non-governmental better scientific quality and relevance
Lautenberg Chemical Safety for the 21st organizations; for assessing risks of injury to health or
Century Act in June 2016, EPA is • Toxicity testing laboratories the environment of chemical substances
announcing the availability of a (contract labs); or mixtures . . .’’. The Strategic Plan is
document entitled: Strategic Plan to • Academic/non-profit groups being made available in both the docket
Promote the Development and involved in developing and using and on the EPA website.
Implementation of Alternative Test alternative toxicity test methods. In addition, making available a
Methods Supporting the Toxic response to comments document that
B. How can I get copies of this document
Substances Control Act (TSCA). EPA is addresses comments on the draft
and other related information?
also making available a response to Strategic Plan received through May 11,
The docket for this action, identified 2018. The response to comment
comments document that addresses by docket identification (ID) number
comments received on the draft document is available in the docket.
EPA–HQ–OPPT–2017–0559, is available (http://www.regulations.gov; docket ID
Strategic Plan. at http://www.regulations.gov or at the number HQ–OPPT–2017–0559)
FOR FURTHER INFORMATION CONTACT: Office of Pollution Prevention and
For technical information contact: Toxics Docket (OPPT Docket), II. Background
Louis Scarano, Risk Assessment Environmental Protection Agency OPPT hosted a public meeting on
Division, Office of Pollution Prevention Docket Center (EPA/DC), West William November 2, 2017, in which a
and Toxics, Environmental Protection Jefferson Clinton Bldg., Rm. 3334, 1301 conceptual approach to this final
Agency, 1200 Pennsylvania Ave. NW, Constitution Ave. NW, Washington, DC. Strategic Plan was presented. Meeting
Washington, DC 20460–0001; telephone The Public Reading Room is open from materials and public comments received
number: 202–564–2851, email address: 8:30 a.m. to 4:30 p.m., Monday through through January 10, 2018, can be found
scarano.louis@epa.gov. In addition, Friday, excluding legal holidays. The in the docket (http://
progress on this activity will be telephone number for the Public www.regulations.gov; docket ID number
periodically updated at the following Reading Room is (202) 566–1744, and HQ–OPPT–2017–0559).
page on the OPPT website at https:// the telephone number for the OPPT A draft Strategic Plan was published
www.epa.gov/assessing-and-managing- Docket is (202) 566–0280. Please review on March 12, 2018, along with a
chemicals-under-tsca. the visitor instructions and additional response to comments document that
daltland on DSKBBV9HB2PROD with NOTICES

For general information contact: The addressed the comments received
information about the docket available
TSCA-Hotline, ABVI-Goodwill, 422 through January 10, 2018. OPPT hosted
at http://www.epa.gov/dockets.
South Clinton Ave., Rochester, NY a second public meeting on April 10,
14620; telephone number: (202) 554– C. What is the Agency’s authority for 2018, to receive input from the public
1404; email address: TSCA-Hotline@ this action? on the draft Strategic Plan. A docket was
epa.gov. On June 22, 2016, the Frank R. made available with the meeting
SUPPLEMENTARY INFORMATION: Lautenberg Chemical Safety for the 21st materials and allowed for comments to

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30168 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices

be received through May 11, 2018 I. General Information chemical substance is protected from
(http://www.regulations.gov; docket ID disclosure.’’ 15 U.S.C. 2613(g)(4).
A. Does this action apply to me?
number HQ–OPPT–2017–0559).
You may be affected by this action if B. EPA Sought Public Comment
Authority: 15 U.S.C. 2601 et seq.
you have submitted or expect to submit The requirements to assign a UID and
Dated: June 21, 2018. information to EPA under TSCA. the unreconciled requirements
E. Scott Pruitt, Persons who would use UIDs assigned concerning application of the UID and
Administrator. by the Agency to seek information may protection of CBI are more fully
[FR Doc. 2018–13833 Filed 6–26–18; 8:45 am] also be affected by this action. The discussed in a document that published
BILLING CODE 6560–50–P following list of North American in the Federal Register on May 8, 2017.
Industrial Classification System (See 82 FR 21386; May 8, 2017;
(NAICS) codes is not intended to be hereafter ‘‘May 2017 Federal Register
ENVIRONMENTAL PROTECTION exhaustive, but rather provides a guide document’’.) EPA noted drawbacks to
AGENCY to help readers determine whether this each of the two alternative approaches
[EPA–HQ–OPPT–2017–0144; FRL–9979–59] document applies to them. Potentially discussed in the May 2017 Federal
affected entities may include: Register document, and subsequently
TSCA Chemical Substances; Unique • Manufacturers, importers, or developed a third alternative approach
Identifier Assignment and Application processors of chemical substances for reconciling the competing
Policy; Notice of Availability (NAICS codes 325 and 324110), e.g., requirements of TSCA section 14(g), on
chemical manufacturing and petroleum which it requested comment in the
AGENCY: Environmental Protection refineries. Federal Register on February 8, 2018.
Agency (EPA). (See 83 FR 5623; hereafter ‘‘February
B. How can I get copies of this document
ACTION: Notice. 2018 Federal Register document’’).
and other related information?
SUMMARY: As amended in 2016, the The docket for this action, identified III. Policy
Toxic Substances Control Act (TSCA) by docket identification (ID) number A. UIDs Will Be a Numerical Identifier
requires EPA to develop a system to EPA–HQ–OPPT–2017–0144, is available
assign a unique identifier (UID) The UID cannot be the specific
at http://www.regulations.gov or at the
whenever it approves a confidential chemical identity, or a structurally
Office of Pollution Prevention and
business information (CBI) claim for the descriptive generic term. TSCA section
Toxics Docket (OPPT Docket),
specific chemical identity of a chemical 14(a)(4)(A)(i). Consequently, EPA has
Environmental Protection Agency
substance, to apply this UID to other developed a system to assign UIDs for
Docket Center (EPA/DC), West William
information concerning the same each substance for which it makes a
Jefferson Clinton Bldg., Rm. 3334, 1301
chemical substance, and to ensure that final determination approving a CBI
Constitution Ave. NW, Washington, DC.
any non-confidential information claim for specific chemical identity. The
The Public Reading Room is open from
received by the Agency identifies the UID is a number that incorporates the
8:30 a.m. to 4:30 p.m., Monday through
chemical substance using the UID while year that the claim was asserted (e.g.,
Friday, excluding legal holidays. The
the specific chemical identity of the the first approved claim asserted in
telephone number for the Public
chemical substance is protected from 2019 would be UID–2019–00001).
Reading Room is (202) 566–1744, and
disclosure. EPA previously requested Including this date will facilitate
the telephone number for the OPPT
comment on several approaches for tracking of the expiration of the CBI
Docket is (202) 566–0280. Please review
assigning and applying UIDs. EPA has claims for specific chemical identity
the visitor instructions and additional
determined that it will use a numerical made in that document, pursuant to
information about the docket available
identifier that incorporates the year the TSCA section 14(e). The reasons for not
at http://www.epa.gov/dockets.
CBI claim was asserted, and will apply using a preexisting identifier, such as
this UID to non-confidential information II. Background the accession number, are further
related to the chemical substance, explained in the May 2017 Federal
A. What is the authority for this action?
except where the Agency’s act of Register document. Note that in the May
applying the UID would itself disclose The June 22, 2016, amendments to 2017 Federal Register document, it was
to the public the confidential specific TSCA by the Frank R. Lautenberg suggested that the UID year would be
chemical identity that the UID was Chemical Safety for the 21st Century based on year the claim was approved.
assigned to protect. Act added a requirement in TSCA See 82 FR at 21387. However, because
section 14(g)(4) for EPA to, among other the year of approval may be different
FOR FURTHER INFORMATION CONTACT:
things, ‘‘assign a unique identifier to from the year the claim was asserted
For technical information contact: each specific chemical identity for (e.g., claims made in December may not
Jessica Barkas, Environmental which the Administrator approves a be approved until the following
Assistance Division, Office of Pollution request for protection from disclosure.’’ February), and because the initial
Prevention and Toxics, Environmental EPA is required to use the ‘‘unique expiration date of the claim runs from
Protection Agency, 1200 Pennsylvania identifier assigned under this paragraph the point that the claim was asserted,
Ave. NW, Washington, DC 20460–0001; to protect the specific chemical identity EPA determined that the date would
telephone number: (202) 250–8880; in information that the Administrator better facilitate claim expiration
email address: barkas.jessica@epa.gov. has made public’’ and to ‘‘apply that tracking if it were based on the year the
daltland on DSKBBV9HB2PROD with NOTICES

For general information contact: The identifier consistently to all information claim was asserted.
TSCA-Hotline, ABVI-Goodwill, 422 relevant to the applicable chemical
South Clinton Ave. Rochester, NY substance,’’ including ‘‘any non- B. EPA Will Apply UIDs to Related
14620; telephone number: (202) 554– confidential information received by the Documents, Except Where It Discloses
1404; email address: TSCA-Hotline@ Administrator with respect to a Confidential Chemical Identity
epa.gov. chemical substance . . . while the EPA is adopting the ‘‘third alternative
SUPPLEMENTARY INFORMATION: specific chemical identity of the approach,’’ as described in the February

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Document Created: 2018-11-06 09:52:16
Document Modified: 2018-11-06 09:52:16

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.
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 30167