Document ID: EPA-HQ-OPPT-2018-0292-0001
Agency: epa
Document Type: Notice
Title: Guidance: Creating Generic Names for Confidential Chemical Substance Identity Reporting under Toxic Substances Control Act
Posted Date: 2018-06-27T04:00Z

[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30173-30174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13832]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0292; FRL-9979-02]

Guidance for Creating Generic Names for Confidential Chemical 
Substance Identity Reporting Under the Toxic Substances Control Act; 
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the following guidance 
document: ``Guidance for Creating Generic Names for Confidential 
Chemical Substance Identity Reporting under TSCA.'' This guidance 
document, which is required by the Toxic Substances Control Act (TSCA), 
as amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 
21st Century Act, provides information to assist companies in creating 
structurally descriptive generic names for chemical substances whose 
specific chemical identities are claimed confidential, for the purposes 
of protecting the specific chemical identities from disclosure while 
describing the chemical substance as specifically as practicable, and 
for listing substances on the TSCA Chemical Substance Inventory.

DATES: Submit comments on or before August 27, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0292, 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 generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Tracy Williamson, Chemistry, 
Economics, and Sustainable Strategies Division (Mailcode 7406M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-8569; 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: 

[[Page 30174]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are a company 
needing assistance in creating structurally descriptive generic names 
for chemical substances whose specific chemical identities are claimed 
confidential, for purposes of protecting the specific chemical 
identities from disclosure and listing the substances on the TSCA 
Chemical Substance Inventory. This action may be of particular interest 
to entities that are regulated under TSCA (e.g., entities identified 
under North American Industrial Classification System (NAICS) codes 
324, 325, and 324110, among others). Since other entities also may be 
interested, 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 should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information 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 http://www.epa.gov/dockets/comments.html.

C. 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-2018-0292, is available online at http://www.regulations.gov or in person 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 that is available at http://www.epa.gov/dockets. You 
also will find this document and the ``Guidance for Creating Generic 
Names for Confidential Chemical Substance Identity Reporting under 
TSCA'' at http://www.epa.gov/tsca-inventory.

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

    As amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act in June 2016, TSCA section 14(c)(4), 15 U.S.C. 2613(c)(4), 
requires that EPA develop guidance regarding the determination of 
structurally descriptive generic names provided for chemical substances 
whose specific chemical identities have been claimed confidential in a 
TSCA notice. TSCA section 14(c)(1)(C) was amended to require submitters 
who assert a confidentiality claim for specific chemical identity to 
include a structurally descriptive generic name for the chemical 
substance that EPA may disclose to the public. The generic name must be 
consistent with EPA's guidance, and should describe the chemical 
structure of the substance as specifically as practicable while 
protecting those features of the chemical structure that are claimed as 
confidential and the disclosure of which would be likely to cause 
substantial harm to the competitive position of the claimant.

III. What action is the Agency taking?

    EPA is announcing the availability of the following guidance 
document: ``Guidance for Creating Generic Names for Confidential 
Chemical Substance Identity Reporting under TSCA.'' This guidance 
document is intended to assist companies in creating structurally 
descriptive generic names for chemical substances whose specific 
chemical identities are claimed confidential, for purposes of 
protecting the specific chemical identities from disclosure while 
describing the chemical substance as specifically as practicable, and 
for listing substances on the TSCA Chemical Substance Inventory.
    EPA previously published guidance to assist companies in creating 
structurally descriptive generic names in an appendix to the 1985 
publication of the TSCA Inventory (Appendix B, ``Generic Names for 
Confidential Chemical Substance Identities,'' in the ``TSCA Inventory, 
1985 Edition''). The new guidance document updates and replaces the 
1985 guidance. Consistent with TSCA section 14(c)(1)(C) and 14(c)(4) 
requirements, the updated guidance document provides more detail and 
clarity to companies regarding the approach for creating structurally 
descriptive generic names.
    As a nonbinding guidance document, this updated guidance document 
is a living document which may be revised periodically and without 
notice. In addition to seeking comments within the next 60 days, EPA 
welcomes public input on this guidance document at any time in the 
future.

    Authority: 15 U.S.C. 2613(c)(4).

    Dated: June 21, 2018.
E. Scott Pruitt,
Administrator.
[FR Doc. 2018-13832 Filed 6-26-18; 8:45 am]
 BILLING CODE 6560-50-P