AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is revoking the significant new use rule (SNUR) promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for a chemical substance which was identified generically as fatty acid amide and was the subject of premanufacture notice (PMN) P-13-267. EPA issued a SNUR based on the PMN designating certain activities as significant new uses. EPA has received a significant new use notice (SNUN) and test data for the chemical substance and is revoking the SNUR based on the information in the SNUN submission.

DATES:

This final rule is effective December 9, 2019.

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0399, 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.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-8974; email address: alwood.jim@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.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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 or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. Importers of the chemical that is the subject of this action would no longer be required to certify compliance with the SNUR requirements if the revocation becomes effective. In addition, persons who export or intend to export the chemical that is the subject of this action would no longer be subject to the TSCA section 12(b) (15 U.S.C. 2611(b) export notification requirements at 40 CFR part 707, that are currently triggered by the SNUR.

B. What action is the Agency taking?

In the Federal Register of July 24, 2019 (84 FR 35585) (FRL-9991-17), EPA proposed a revocation of the SNUR at 40 CFR 721.10691 for the chemical substance identified generically as fatty acid amide (PMN P-13-267). The SNUR designated certain activities as significant new uses. Subsequently, EPA received a SNUN that included human health and environmental toxicity testing for the chemical substance and, based on its review of these data, which demonstrated inherently low toxicity of the chemical substance, EPA proposed to revoke the SNUR pursuant to 40 CFR 721.185. EPA received one comment on the proposed revocation that recommended that EPA not revoke the rule for safety reasons, but the commenter did not submit any additional data to support this recommendation. Because the available data continues to demonstrate low toxicity of the chemical substance, EPA is now revoking the SNUR pursuant to 40 CFR 721.185.

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

EPA is revoking this SNUR under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) and the related implementing regulations in 40 CFR part 721. Upon conclusion of the review for P-13-267, EPA designated certain activities as significant new uses, based on a finding that the chemical substance may cause significant adverse environmental effects and that it met the concern criteria at 40 CFR 721.170(b)(4)(ii). Under 40 CFR 721.185, EPA may at any time revoke a SNUR for a chemical substance which has been added to 40 CFR part 721, subpart E, if EPA makes one of the determinations set forth in 40 CFR 721.185(a)(1) through (6). Revocation may occur on EPA's initiative or in response to a written request. Under 40 CFR 721.185(b)(3), if EPA concludes that a SNUR should be revoked, the Agency will propose the changes in the Federal Register, briefly describe the grounds for the action, and provide interested parties with an opportunity to comment.

EPA has determined that the criteria set forth in 40 CFR 721.185(a)(4) have been satisfied for the chemical substance, i.e., the Agency has examined new information and concluded it no longer warrants the SNUR that was previously established. Therefore, EPA is revoking the SNUR for this chemical substance. The significant new use notification and the recordkeeping requirements at 40 CFR 721.10691 will terminate when this revocation becomes effective. In addition, export notification under TSCA section 12(b) and 40 CFR part 707, subpart D, that were triggered by the SNUR will no longer be required.

II. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/​laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review

The Office of Management and Budget (OMB) has exempted these types of regulatory actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

This rule does not contain any information collections subject to approval under the PRA (44 U.S.C. 3501 et seq.). The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to remove the entry for 40 CFR 721.10691. Given the revocation of the codified information collection requirements and the technical nature of the table, EPA finds that further notice and comment to amend the table to remove the applicable listing is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

C. Regulatory Flexibility Act (RFA)

Since this rule eliminates a reporting requirement, the Agency certifies pursuant to RFA section 605(b) (5 U.S.C.601 et seq.), that this SNUR revocation will not have a significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

For the same reasons, this action does not require any action under UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

This action does not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined under Executive Order 12866, and it does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to this action because it does not involve any technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

K. Congressional Review Act (CRA)

Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

• Environmental protection
• Reporting and recordkeeping requirements

40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9—[AMENDED]

1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. In § 9.1, remove the listing for § 721.10691 that appears in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances.”

PART 721—[AMENDED]

3. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

4. Remove § 721.10691.