[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 [www.gpo.gov]
[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 
https://www.regulations.gov 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 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 EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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 https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
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 https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.
    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:
     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. 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, https://www.regulations.gov. 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

[[Page 68116]]

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 https://www.regulations.gov 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

[[Page 68117]]

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
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2024-19000 Filed 8-22-24; 8:45 am]
BILLING CODE 6560-50-P