2018-13832. 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.

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: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

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 [phone], and the telephone number for the OPPT Docket is [phone]. 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.