Document ID: EPA-HQ-OPPT-2017-0575-0090
Agency: epa
Document Type: Rule
Title: Revocation of Significant New Use Rule for a Certain Chemical Substance (P-16-581)
Posted Date: 2020-08-25T04:00Z

[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Rules and Regulations]
[Pages 52274-52275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17202]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0575; FRL-10012-90]
RIN 2070-AB27

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: moss.kenneth@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.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 
Sec.  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 (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.

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

[[Page 52275]]

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]

0
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.

Sec.  9.1  [Amended]

0
2. In Sec.  9.1, remove the entry for Sec.  721.11193 under the 
undesignated center heading ``Significant New Uses of Chemical 
Substances.''

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

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

Sec.  721.11193   [Removed]

0
2. Remove Sec.  721.11193.

[FR Doc. 2020-17202 Filed 8-24-20; 8:45 am]
BILLING CODE 6560-50-P