Rule2024-19000
Ethaboxam; 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 23, 2024
Effective
August 23, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of ethaboxam in or on leaf petiole vegetable subgroup 22B. The Interregional Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 164 (Friday, August 23, 2024)</title>
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[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Rules and Regulations]
[Pages 68114-68117]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19000]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0259; FRL-12119-01-OCSPP]
Ethaboxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
ethaboxam in or on leaf petiole vegetable subgroup 22B. The
Interregional Project Number 4 (IR-4) requested this tolerance under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 23, 2024. Objections and
requests for hearings must be received on or before October 22, 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-2023-0259, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or in-person 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. For the latest status information on EPA/DC services, docket
access, visit <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#16445250445879627f7573655673667738717960"><span class="__cf_email__" data-cfemail="184a5c5e4a56776c717b7d6b587d6879367f776e">[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 Office of the
Federal Register'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(g), any person may file
an
[[Page 68115]]
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-2023-0259, 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 22, 2024. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm</a>.
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-2023-0259, 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 February 9, 2024 (89 FR 9103) (FRL-
10579-12-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 3E9052) by Interregional Project Number 4 (IR-4), North
Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210,
Raleigh, NC 27606. The petition requested that 40 CFR 180.622 be
amended to establish a tolerance for residues of the fungicide
ethaboxam, including its metabolites and degradates, in or on leaf
petiole vegetable subgroup 22B at 0.15 parts per million (ppm). That
document referenced a summary of the petition prepared by IR-4, the
petitioner, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
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 ethaboxam including exposure resulting from the
tolerance established by this action. EPA's assessment of exposures and
risks associated with ethaboxam follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for 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 of the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
ethaboxam in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to ethaboxam and established a tolerance for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. Since the toxicological doses and endpoints
for ethaboxam have not changed since the most recent risk assessment,
see Unit III.A. of the August 3, 2017, rulemaking (82 FR 36086) (FRL-
9961-69) for a discussion of the Toxicological Profile.
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
ethaboxam used for human health risk assessment, see Unit III.B. of the
August 3, 2017, rulemaking.
Exposure assessment. Much of the exposure assessment remains
unchanged from the previous rulemakings, although updates have occurred
to accommodate for exposures from the petitioned-for tolerance and
additional exposures from the tolerances established since the August
3, 2017, rulemaking. For a description of EPA's approach to and
assumptions for the exposure assessment, refer to Unit III.C. of the
August 3, 2017, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of ethaboxam in or on leaf petiole
vegetable subgroup 22B in greenhouses and the exposures assessed in
rulemakings since 2017. An acute endpoint attributable to a single dose
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exposure was not identified; therefore, an acute dietary risk
assessment is not necessary. 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 (USDA) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic
dietary exposure assessment is unrefined, assuming tolerance level
residues and 100 percent crop treated (PCT).
Drinking water exposure. The new use does not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations in the chronic dietary exposure
assessments as identified in Unit III.C.2 of the August 3, 2017,
rulemaking.
Non-occupational exposure. There are no residential (non-
occupational) uses proposed or currently registered for ethaboxam.
Therefore, residential exposures were not assessed.
Cumulative exposure. 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.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to ethaboxam and any other substances and
ethaboxam does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that ethaboxam has a common mechanism of toxicity with
other substances.
Safety factor for infants and children. Section 408(b)(2)(C)
requires the application of an additional tenfold margin of safety to
account for potential risks to infants and children, in the case of
threshold effects. EPA continues to conclude that there are reliable
data to support the reduction of the Food Quality Protection Act (FQPA)
safety factor from 10X to 1X. See Unit III.D. of the August 3, 2017,
rulemaking for a discussion of the Agency's rationale for that
determination.
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 population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic term aggregate risks are evaluated by comparing the
estimated total food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists.
An acute endpoint attributable to a single dose exposure was not
identified; therefore, an acute dietary risk assessment is not
necessary. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 39% of the cPAD for children 1 to
2 years old, the population group with the highest estimated exposure.
There is no short- or intermediate-term residential exposure expected
since there are no proposed or previously registered residential uses
of ethaboxam. Therefore, the chronic aggregate risks consist only of
the dietary risks from food and water and, as stated above, are below
the Agency's level of concern.
Ethaboxam is classified as showing ``suggestive evidence of
carcinogenic potential'' based on increased incidence of benign Leydig
cell tumors in males. The Agency determined that quantification of
cancer risk using a nonlinear approach would adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to ethaboxam. Therefore, the noncancer chronic reference dose
is protective of cancer dietary risk and is not of concern.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to ethaboxam residues, including its metabolites and
degradates. More detailed information about the Agency's analysis can
be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled
``Ethaboxam. Human Health Risk Assessment for the Proposed New Uses on
Leaf Petiole Vegetable (Crop Subgroup 22B) in Greenhouses.'' in docket
ID number EPA-HQ-OPP-2023-0259.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the August 3, 2017, rulemaking.
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).
Codex does not have established MRLs for ethaboxam in commodities
that are members of the leaf petiole vegetable subgroup 22B.
V. Conclusion
Therefore, a tolerance is established for residues of ethaboxam,
including its metabolites and degradates, in or on leaf petiole
vegetable subgroup 22B at 0.15 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
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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 20, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR part 180 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. 180.622, amend table 1 to paragraph (a) by adding in
alphabetical order an entry for ``Leaf petiole vegetable subgroup 22B''
to read as follows:
Sec. 180.622 Ethaboxam; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Leaf petiole vegetable subgroup 22B........................ 0.15
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-19000 Filed 8-22-24; 8:45 am]
BILLING CODE 6560-50-P
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