Rule2024-17805
Kasugamycin; Pesticide Tolerances
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
August 12, 2024
Effective
August 12, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of kasugamycin in or on tea, dried. UPL Delaware, Inc. (UPL) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 155 (Monday, August 12, 2024)</title>
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[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Rules and Regulations]
[Pages 65542-65545]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17805]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0399; FRL-12005-01-OCSPP]
Kasugamycin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
kasugamycin in or on tea, dried. UPL Delaware, Inc. (UPL) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This rule is effective August 12, 2024. Objections and requests
for hearings must be received on or before October 11, 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-2023-0399, 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, 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#57051311051938233e3432241732273679303821"><span class="__cf_email__" data-cfemail="98cadcdecad6f7ecf1fbfdebd8fde8f9b6fff7ee">[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 EPA's
tolerance regulations at 40 CFR part 180 through the Federal Register
Office's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/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-2023-0399 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 11, 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
[[Page 65543]]
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-2023-0399, 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. Summary of Petitioned-For Tolerance
In the Federal Register of November 21, 2023 (88 FR 81021) (FRL-
10579-10-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 3E9058) by UPL Delaware, Inc. (UPL), 630 Freedom Business
Center Suite 402, King of Prussia, PA 19406. The petition requested
that 40 CFR 180.614 be amended by establishing tolerances for residues
of the fungicide kasugamycin, in or on tea, dried at 3 ppm parts per
million (ppm). That document referenced a summary of the petition
prepared by UPL Delaware, Inc., the registrant, which is available in
the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There was one comment received
in response to the notice of filing. The comment was not germane to the
petition for kasugamycin tolerances.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for kasugamycin including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with kasugamycin follows. In an effort
to streamline its publications in the Federal Register, EPA is not
reprinting sections of the rule that repeat what has been previously
published in tolerance rulemakings for the same pesticide chemical.
Where scientific information concerning a particular chemical remains
unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for kasugamycin
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to kasugamycin and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from that
rulemaking as described further in this rule, as they remain unchanged.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Specific information on the studies received and the nature of the
adverse effects caused by kasugamycin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of March 6, 2018 (83 FR 9442) (FRL-
9972-96).
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
A summary of the toxicological endpoints for kasugamycin used for
human risk assessment can be found on pages 10-12 of the document
``Kasugamycin. Human Health Risk Assessment for a Section 3 Tolerance
without U.S. Registration on Tea.'', hereinafter ``Kasugamycin Human
Health Risk Assessment,'' in Docket ID number EPA-HQ-OPP-2023-0399 at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to kasugamycin, EPA considered exposure under the petitioned-
for tolerances as well as all existing kasugamycin tolerances in 40 CFR
180.614. EPA assessed dietary exposures from kasugamycin in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are conducted for a food-use pesticide if a toxicological
study has indicated the
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possibility of an effect of concern occurring as a result of a 1-day or
single exposure. No such effects were identified in the toxicological
studies for kasugamycin; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software
using the Food Commodity Intake Database (DEEM-FCID) Version 4.02,
which uses the 2005-2010 food consumption data from the United States
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic
analysis incorporated tolerance-level residues for all commodities and
recommended tolerance levels in or on tea. The assessment assumed 100
percent crop treated (PCT) for all commodities. The analysis
incorporated default processing factors for all processed commodities.
For apple juice, empirical processing factors of 1.5X were used.
iii. Cancer. Based on the data summarized in the Kasugamycin Human
Health Risk Assessment, EPA has concluded that kasugamycin does not
pose a cancer risk to humans. Therefore, a dietary exposure assessment
for the purpose of assessing cancer risk is unnecessary.
2. Dietary exposure from drinking water. The proposed tolerance
does not result in an increase in the estimated residue levels in
drinking water, so the estimated drinking water concentrations used in
the March 6, 2018, rulemaking are the same as those used in this
assessment.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Kasugamycin is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found kasugamycin to share a common mechanism of
toxicity with any other substances, and kasugamycin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
kasugamycin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
D. Safety Factor for Infants and Children
EPA continues to conclude that there are reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor.
See Unit III.D. of the March 6, 2018, rulemaking for a discussion of
the Agency's rationale for that determination.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term aggregate risks are evaluated by comparing the estimated total
food, water, and residential exposure to the appropriate PODs to ensure
that an adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
kasugamycin is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
kasugamycin from food and water will utilize 4.3% of the cPAD for all
infants (less than 1 year old), the population group receiving the
greatest exposure. There are no residential uses for kasugamycin.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because there
are no residential uses, kasugamycin is not expected to pose a short-
term risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because there are no residential uses, kasugamycin is not
expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, kasugamycin is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to kasugamycin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A practical analytical method for detecting and measuring levels of
kasugamycin has been developed and validated in all appropriate
agricultural commodities. For the tea residue studies, residues were
quantified with a liquid chromatograph-tandem mass spectrometer (LC-MS/
MS).
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#176572647e7362727a72637f7873645772677639707861"><span class="__cf_email__" data-cfemail="addfc8dec4c9d8c8c0c8d9c5c2c9deedc8ddcc83cac2db">[email protected]</span></a>.
B. 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 MRLs for kasugamycin in or on any
commodities. Japan has an established MRL on tea at 3 ppm. EPA is
proposing to harmonize with the Japanese MRL.
V. Conclusion
Therefore, tolerances are established for residues of kasugamycin,
(3-O-[2-
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amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-
arabino-hexopyranosyl]-D-chiro-inositol), in or on tea, dried at 3 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. 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 on the basis
of a petition under FFDCA section 408(d), such as the tolerance 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, 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).
VII. 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: August 5, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended 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. In Sec. 180.614, in paragraph (a), add a heading to the table and
an entry in alphabetical order for ``Tea, dried'' to read as follows:
Sec. 180.614 Kasugamycin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
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Parts per
Commodity million
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* * * * *
Tea, dried \2\.............................................. 3
* * * * *
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\2\ There is no U.S. registration as of August 12, 2024.
* * * * *
[FR Doc. 2024-17805 Filed 8-9-24; 8:45 am]
BILLING CODE 6560-50-P
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