Rule2023-27654
Kasugamycin; Extension of Time-Limited Tolerance for Emergency Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 18, 2023
Effective
December 18, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 241 (Monday, December 18, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#36647270647859425f5553457653465718515940"><span class="__cf_email__" data-cfemail="9cced8daced2f3e8f5fff9efdcf9ecfdb2fbf3ea">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/ccurrent/title-40">https://www.ecfr.gov/ccurrent/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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.
* * * * *
(b) * * *
[[Page 87363]]
Table 2 to Paragraph (b)
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Almond......................................... 0.04 12/31/26
Almond, hulls.................................. 0.4 12/31/26
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-27654 Filed 12-15-23; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on December 18, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.