2020-17202. Revocation of Significant New Use Rule for a Certain Chemical Substance (P-16-581)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is revoking the significant new use rule (SNUR) issued under the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as alpha 1-, 3-polysaccharide, which was the subject of premanufacture notice (PMN) P-16-581. EPA issued a SNUR based on this PMN which designated certain activities as significant new uses. EPA is revoking the SNUR based on new test data for the chemical substance.

DATES:

This rule is effective September 24, 2020. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on September 8, 2020.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Kenneth Moss, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-564-9232; 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 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.325 and 324110), e.g., chemical manufacturing and petroleum refineries.

To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

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. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, persons who export or intend to export the chemical that is the subject of this revocation will 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 that is being revoked.

B. How can I access the docket?

The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0595, 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 [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.

II. Background

A. What action is the Agency taking?

In the April 5, 2019 Federal Register (84 FR 13531) (FRL-9991-19), EPA promulgated a SNUR at 40 CFR 721.11193 for the chemical substance identified generically as alpha 1-, 3-polysaccharide (P-16-581). The SNUR designated certain activities as significant new uses. After that date, EPA received new data on the biosolubility of the chemical substance. Based on its review of these data, EPA proposed a revocation of the SNUR in the April 1, 2020 Federal Register (85 FR 18179) (FRL-10005-89). In Unit II.A. of the proposed revocation, EPA provides a description of the chemical substance and the results of the submitted biosolubility data, which were the basis for revoking the SNUR pursuant to 40 CFR 721.185. These new data and EPA's analysis are available in the docket EPA-HQ-OPPT-2017-0575.

EPA has determined that the criteria set forth in 40 CFR 721.185(a)(1) have been satisfied for the chemical substance. Therefore, EPA is revoking the SNUR for this chemical substance. The significant new use notification and the recordkeeping requirements at 40 CFR 721.11193 will terminate upon the effective date of this revocation. In addition, export notification under TSCA section 12(b) and 40 CFR part 707, subpart D, triggered by the SNUR will no longer be required.

In addition, EPA is making a corresponding change to 40 CFR part 9 to remove the entry from the table that appears in 40 CFR 9.1. Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. 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. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. When promulgated, the SNUR was added to the table in 40 CFR part 9, and it is now being removed to reflect the revocation of the SNUR. EPA finds that further notice and comment to amend the table in 40 CFR 9.1 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.

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

Under 40 CFR 721.185, EPA may at any time revoke a SNUR for a chemical substance which has been added to subpart E of 40 CFR part 721 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 an opportunity to comment.

III. Public Comments on Proposed Rule and EPA Responses

EPA received comments from two identifying entities on the proposed rule revocation (85 FR 18179, April 1, 2020) (FRL-10005-89) that were supportive of the action as proposed, and one anonymous public comment on the proposed rule that was general in nature and did not pertain to the proposed rule revocation. Therefore, no response is required, and EPA made no changes to the proposed action based on these comments.

IV. Statutory and Executive Order Reviews

This rule revokes or eliminates an existing regulatory requirement and does not contain any new or amended requirements. As such, the Agency has determined that this revocation would not have any adverse impacts, economic or otherwise.

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). This rule does not contain any information collections subject to approval under the PRA, (44 U.S.C. 3501 et seq.). Since this rule eliminates a reporting requirement, the Agency certifies pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C.601 et seq.), that this SNUR revocation would not have a significant economic impact on a substantial number of small entities.

For the same reasons, this action does not require any action under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This rule has neither Federalism implications, because it would not have substantial direct effects 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 entitled, Federalism (64 FR 43255, August 10, 1999), nor Tribal implications, because it would not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes, as specified in Executive Order 13175 entitled, Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000).

This action is not subject to Executive Order 13045 entitled, Protection of Children from Environmental Health Risks and Safety Risks (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. Likewise, this action is not subject to Executive Order 1311 entitled, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. Because this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) does not apply to this action. This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898 entitled, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

V. 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

Dated: July 31, 2020.

Tala Henry,

Deputy Director, Office of Pollution Prevention and Toxics.

Therefore, for the reasons stated in the preamble, EPA amends 40 CFR chapter I 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.

§ 9.1

[Amended]

2. In § 9.1, remove the entry for § 721.11193 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).

§ 721.11193

[Removed]

2. Remove § 721.11193.