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Updated Working Approach To Making New Chemical Determinations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment

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Environmental Protection Agency (EPA).




EPA is announcing the availability of and soliciting public comment on a document entitled: “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5” (the “Working Approach”). This document builds upon EPA's November 2017 document entitled: “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under section 5 of TSCA”. Feedback received will help inform the Agency's ongoing efforts to improve policy and processes relating to the review of new chemicals under TSCA.


Comments must be received on or before February 18, 2020.

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Submit your comments, identified by docket identification ID number EPA-HQ-OPPT-2019-0684, by one of the following methods:

  • Federal eRulemaking Portal: 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​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally is available at​dockets.

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For technical information contact: Ryan Schmit, Office of Pollution Prevention and Toxics (7101M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-0610; email address:

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:

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I. General Information

A. Does this action apply to me?

This action is directed to the public in general and may be of interest to entities that currently or may manufacture (including import) a chemical substance regulated under TSCA (e.g., entities identified under North American Industrial Classification System (NAICS) codes 325 and 324110). The action may also be of interest to chemical processors, distributors in commerce, and users; non-governmental organizations in the environmental and public health sectors; state and local government agencies; and members of the public. The Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action.

B. What action is the Agency taking?

EPA is announcing the availability of and seeking public comment on the revised document entitled “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5” (the “Working Approach”).

C. Why is the Agency taking this action?

EPA expects the updated document will provide further clarity and detail on EPA's approaches and practices related to the review of new chemicals under TSCA, including: (1) EPA's general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations in TSCA section 5(a)(3).

D. What should I consider as I prepare my comments for EPA?

1. Submitting Confidential Business Information (CBI). Do not submit this information to EPA through or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at​dockets/​comments.html.

II. Background

EPA released an initial version of the Working Approach document for public comment in November 2017, and subsequently held a public meeting on implementing the new chemicals program under amended TSCA on December 14, 2017 (82 FR 51415, November 6, 2017) (FRL-9970-34). After consideration of comments received on the 2017 version and based on additional implementation experience, EPA updated the Working Approach. On December 10, 2019 (84 FR 64063, November 20, 2019) (FRL-10002-09), EPA held a public meeting to preview the document and to provide an update on other aspects of EPA's implementation of the new chemicals program under TSCA. EPA is now announcing the availability of the updated Working Approach for public review and comment.

Additional information on the TSCA amendments can be found at​assessing-and-managing-chemicals-under-tsca/​frank-r-lautenberg-chemical-safety-21st-century-act.

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

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Dated: December 20, 2019.

Alexandra Dapolito Dunn,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

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[FR Doc. 2019-28325 Filed 12-31-19; 8:45 am]