Final Strategic Plan To Promote the Development and Implementation of Alternative Test Methods Supporting the Toxic Substances Control Act (TSCA); Notice of Availability, 30167-30168 [2018-13833]

Download as PDF Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices to seek court review of the Commission’s final order. The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at https://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Dated: June 21, 2018. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2018–13853 Filed 6–26–18; 8:45 am] BILLING CODE 6717–01–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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: scarano.louis@epa.gov. 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-managingchemicals-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: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 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. 30167 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 B. How can I get copies of this document addresses comments on the draft and other related information? Strategic Plan received through May 11, The docket for this action, identified 2018. The response to comment by docket identification (ID) number document is available in the docket. EPA–HQ–OPPT–2017–0559, is available (https://www.regulations.gov; docket ID at https://www.regulations.gov or at the number HQ–OPPT–2017–0559) Office of Pollution Prevention and II. Background Toxics Docket (OPPT Docket), OPPT hosted a public meeting on Environmental Protection Agency November 2, 2017, in which a Docket Center (EPA/DC), West William conceptual approach to this final Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. Strategic Plan was presented. Meeting materials and public comments received The Public Reading Room is open from through January 10, 2018, can be found 8:30 a.m. to 4:30 p.m., Monday through in the docket (https:// Friday, excluding legal holidays. The www.regulations.gov; docket ID number telephone number for the Public HQ–OPPT–2017–0559). Reading Room is (202) 566–1744, and A draft Strategic Plan was published the telephone number for the OPPT Docket is (202) 566–0280. Please review on March 12, 2018, along with a response to comments document that the visitor instructions and additional addressed the comments received information about the docket available through January 10, 2018. OPPT hosted at https://www.epa.gov/dockets. a second public meeting on April 10, C. What is the Agency’s authority for 2018, to receive input from the public this action? on the draft Strategic Plan. A docket was made available with the meeting On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st materials and allowed for comments to PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1 30168 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices be received through May 11, 2018 (https://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 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2017–0144; FRL–9979–59] TSCA Chemical Substances; Unique Identifier Assignment and Application Policy; Notice of Availability Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: As amended in 2016, the Toxic Substances Control Act (TSCA) requires EPA to develop a system to assign a unique identifier (UID) whenever it approves a confidential business information (CBI) claim for the specific chemical identity of a chemical substance, to apply this UID to other information concerning the same chemical substance, and to ensure that any non-confidential information received by the Agency identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure. EPA previously requested comment on several approaches for assigning and applying UIDs. EPA has determined that it will use a numerical identifier that incorporates the year the CBI claim was asserted, and will apply this UID to non-confidential information related to the chemical substance, except where the Agency’s act of applying the UID would itself disclose to the public the confidential specific chemical identity that the UID was assigned to protect. FOR FURTHER INFORMATION CONTACT: For technical information contact: Jessica Barkas, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 250–8880; email address: barkas.jessica@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave. Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 I. General Information A. Does this action apply to me? chemical substance is protected from disclosure.’’ 15 U.S.C. 2613(g)(4). You may be affected by this action if you have submitted or expect to submit information to EPA under TSCA. Persons who would use UIDs assigned by the Agency to seek information may also 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: • Manufacturers, importers, or processors of chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. B. EPA Sought Public Comment by docket identification (ID) number EPA–HQ–OPPT–2017–0144, is available at https://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 https://www.epa.gov/dockets. A. UIDs Will Be a Numerical Identifier The requirements to assign a UID and the unreconciled requirements concerning application of the UID and protection of CBI are more fully discussed in a document that published in the Federal Register on May 8, 2017. (See 82 FR 21386; May 8, 2017; hereafter ‘‘May 2017 Federal Register document’’.) EPA noted drawbacks to each of the two alternative approaches discussed in the May 2017 Federal Register document, and subsequently developed a third alternative approach for reconciling the competing requirements of TSCA section 14(g), on which it requested comment in the Federal Register on February 8, 2018. (See 83 FR 5623; hereafter ‘‘February B. How can I get copies of this document 2018 Federal Register document’’). and other related information? III. Policy The docket for this action, identified II. Background A. What is the authority for this action? The June 22, 2016, amendments to TSCA by the Frank R. Lautenberg Chemical Safety for the 21st Century Act added a requirement in TSCA section 14(g)(4) for EPA to, among other things, ‘‘assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure.’’ EPA is required to use the ‘‘unique identifier assigned under this paragraph to protect the specific chemical identity in information that the Administrator has made public’’ and to ‘‘apply that identifier consistently to all information relevant to the applicable chemical substance,’’ including ‘‘any nonconfidential information received by the Administrator with respect to a chemical substance . . . while the specific chemical identity of the PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 The UID cannot be the specific chemical identity, or a structurally descriptive generic term. TSCA section 14(a)(4)(A)(i). Consequently, EPA has developed a system to assign UIDs for each substance for which it makes a final determination approving a CBI claim for specific chemical identity. The UID is a number that incorporates the year that the claim was asserted (e.g., the first approved claim asserted in 2019 would be UID–2019–00001). Including this date will facilitate tracking of the expiration of the CBI claims for specific chemical identity made in that document, pursuant to TSCA section 14(e). The reasons for not using a preexisting identifier, such as the accession number, are further explained in the May 2017 Federal Register document. Note that in the May 2017 Federal Register document, it was suggested that the UID year would be based on year the claim was approved. See 82 FR at 21387. However, because the year of approval may be different from the year the claim was asserted (e.g., claims made in December may not be approved until the following February), and because the initial expiration date of the claim runs from the point that the claim was asserted, EPA determined that the date would better facilitate claim expiration tracking if it were based on the year the claim was asserted. B. EPA Will Apply UIDs to Related Documents, Except Where It Discloses Confidential Chemical Identity EPA is adopting the ‘‘third alternative approach,’’ as described in the February E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30167-30168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13833]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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. 
(https://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 (https://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 (https://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
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