[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Rules and Regulations]
[Pages 87361-87363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27654]



[[Page 87361]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0624; FRL-11517-02-OCSPP]


Kasugamycin; Extension of Time-Limited Tolerance for Emergency 
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for residues 
of kasugamycin in or on almond and almond, hulls as identified in this 
document. This action is in response to EPA's granting of an emergency 
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of this pesticide. In addition, the Federal 
Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA. Further, EPA 
issued a final rule in the Federal Register of November 3, 2023, that 
extended time-limited tolerances for multiple chemicals on various 
commodities in response to EPA's granting of emergency exemptions. EPA 
inadvertently omitted the detailed instructions for the revision of the 
tolerances for kasugamycin. Therefore, EPA is issuing this final rule 
to rectify this omission.

DATES: This regulation is effective December 18, 2023. Objections and 
requests for hearings must be received on or before February 16, 2024 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0624, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. 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 and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/ccurrent/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2023-0624 in the subject line on the first 
page of your submission. All requests must be in writing and must be 
received by the Hearing Clerk on or before February 16, 2024. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2023-0624, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA issued a final rule, published in the Federal Register of 
October 8, 2020, (85 FR 63450) (FRL-10013-94), on its own initiative, 
in accordance with FFDCA sections 408(e) and 408(l)(6), 21 U.S.C. 
346a(e) and 346a(1)(6), establishing time-limited tolerances for 
residues of kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-
2,3,4,6-tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol), 
in or on almond at 0.04 parts per million (ppm); and almond, hulls at 
0.4 ppm. These time-limited tolerances expire on December 31, 2023.
    EPA received a request to extend the use of kasugamycin for this 
year's growing season. After having reviewed this submission, EPA 
concurs that an emergency condition continues to exist. EPA assessed 
the potential risks presented by residues of kasugamycin in or on the 
pertinent commodity. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2) and decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIRA section 18. Further, EPA issued a final rule in the 
Federal Register of November 3, 2023 (88 FR 75503) (FRL-11517-01-OCSPP) 
that extended time-limited tolerances for multiple chemicals on various 
commodities in response to EPA's granting of emergency exemptions. EPA 
inadvertently omitted the detailed instructions for the revision of 40 
CFR

[[Page 87362]]

180.614 Kasugamycin; tolerances for residues. Therefore, EPA is issuing 
this final rule to correct this omission.
    The data and other relevant material have been evaluated and were 
discussed in the final rule that originally established the time-
limited tolerances. Based on those data and information considered, the 
Agency reaffirms that extension of the time-limited tolerances will 
continue to meet the requirements of FFDCA section 408(l)(6). 
Therefore, the time-limited tolerances are extended until December 31, 
2026. Although these tolerances will expire and are revoked on December 
31, 2026, under FFDCA section 408(l)(5), residues of the pesticide not 
in excess of the amounts specified in the tolerances remaining in or on 
the commodities after that date will not be unlawful, provided the 
residues are present as a result of an application or use of a 
pesticide at a time and manner that was lawful under FIFRA, the 
tolerance was in place at the time of the application, and the residues 
do not exceed the level that was authorized by the tolerance. EPA will 
take action to revoke the tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe. EPA will publish a document in 
the Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations (CFR). Time-limited tolerances for the use of the 
following pesticide chemical on a specific commodity are being 
extended:
    Kasugamycin. Pursuant to a request by the California Department of 
Pesticide Regulation, EPA authorized under FIFRA section 18 the use of 
kasugamycin on almonds for control of bacterial blast in California. 
This regulation extends time-limited tolerances for residues of the 
pesticide kasugamycin and its metabolites and degradates in or on 
almond at 0.04 (ppm); and almond hulls at 0.4 ppm for an additional 3-
year period. The tolerances will expire and are revoked on December 31, 
2026.

III. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for kasugamycin in or on the 
commodity listed in this document.

IV. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d). The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993). Because this 
action has been exempted from review under Executive Order 12866, this 
action is not subject to Executive Order 13211, entitled ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled ``Protection of Children from Environmental Health 
Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action 
does not contain any information collections subject to OMB approval 
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor 
does it require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA section 408(1)(6), such as the tolerances in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not 
apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or Tribal governments, on the relationship between the 
National Government and the States or Tribal Governments, or on the 
distribution of power and responsibilities among the various levels of 
government or between the Federal Government and Indian tribes. Thus, 
the Agency has determined that Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 
13175, entitled ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249, November 9, 2000) do not apply to this 
action. In addition, this action does not impose any enforceable duty 
or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (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 in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 11, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Amend Sec.  180.614 in paragraph (b) by designating and revising the 
table to read as follows:


Sec.  180.614   Kasugamycin; tolerances for residues.

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    (b) * * *

[[Page 87363]]



                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                      Parts per   revocation
                                                   million       date
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Almond.........................................        0.04     12/31/26
Almond, hulls..................................         0.4     12/31/26
------------------------------------------------------------------------

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[FR Doc. 2023-27654 Filed 12-15-23; 8:45 am]
BILLING CODE 6560-50-P