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[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Rules and Regulations]
[Pages 105470-105472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30581]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0596; FRL-12457-01-OCSPP]

Ethiprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance (without U.S. 
registrations) for residues of ethiprole in or on sugarcane. Bayer 
CropScience LP requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 27, 2024. Objections and 
requests for hearings must be received on or before February 25, 2025 
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-2023-0596, is available at http://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. 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 Federal Register 
Office'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 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-2023-0596 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 
February 25, 2025. 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-2023-0596, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, are available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 1, 2024 (89 FR 54398) (FRL-11682-
05-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 
3F9067) by Bayer CropScience LP, 800 N Lindbergh Blvd., St. Louis, MO 
63167. The petition requested to amend 40 CFR part 180 by establishing 
a tolerance for residues of ethiprole in or on the raw agricultural 
commodity sugarcane at 0.1 parts per million (ppm).
    That document referenced a summary of the petition, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing. Based upon 
review of the data supporting the petition, EPA has revised the 
tolerance from 0.1 ppm to 0.07 ppm. The reason for this change is 
explained in Unit IV.C.

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

[[Page 105471]]

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 ethiprole including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with ethiprole 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 rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, 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 tolerance rulemakings for ethiprole, 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to ethiprole and established tolerances for residues of that 
chemical. EPA is incorporating previously published sections of those 
rulemakings that remain unchanged, as described further in this 
rulemaking. Specific information on the risk assessment conducted in 
support of this action, including on the studies received and the 
nature of the adverse effects caused by ethiprole, can be found in the 
document titled ``Ethiprole. Human Health Risk Assessment for Tolerance 
without U.S. Registration in/on Imported Sugarcane'' which is available 
in the docket for this action at https://www.regulations.gov.
    Toxicological profile. For a discussion of the Toxicological 
Profile of ethiprole, see Unit III.A. of the rulemaking published in 
the Federal Register of June 28, 2019 (84 FR 30933) (FRL-9985-41).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
safety assessment of ethiprole, see Unit III.B. of the June 28, 2019, 
rulemaking.
    Exposure assessment. Much of the exposure assessment remains 
unchanged from the rulemaking published in the June 28, 2019, 
rulemaking, although the new exposure assessment incorporates the 
additional dietary exposure from the petitioned-for tolerance. Other 
changes are described below.
    Acute and chronic dietary exposure assessments were conducted using 
DEEM-FCID Version 4.02. This software uses 2005-2010 food consumption 
data from the U.S. Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). Unrefined acute and chronic dietary exposure and risk 
assessments were conducted using tolerance-level residues, empirical 
and default processing factors, and assuming 100% crop treated.
    Drinking water and non-occupational exposures. There are no 
registered or proposed U.S. uses of ethiprole. As a result, estimated 
drinking water concentrations (EDWCs) were not included in the dietary 
exposure and risk assessments because residues of ethiprole and its 
degradates are not anticipated to be present in U.S. drinking water.
    A residential handler and residential post-application assessment 
is not necessary since the action is to establish an import tolerance 
without a U.S. registration on sugarcane.
    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 ethiprole and any other substances and 
ethiprole does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this action, therefore, EPA has 
not assumed that ethiprole has a common mechanism of toxicity with 
other substances.
    In 2016, EPA's Office of Pesticide Programs released a guidance 
document titled, Pesticide Cumulative Risk Assessment: Framework for 
Screening Analysis (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework). This document provides guidance on how to screen groups of 
pesticides for cumulative evaluation using a two-step approach 
beginning with the evaluation of available toxicological information 
and if necessary, followed by a risk-based screening approach. This 
framework supplements the existing guidance documents for establishing 
common mechanism groups (CMGs) and conducting cumulative risk 
assessments (CRAs).
    Ethiprole is a phenyl-pyrazole insecticide. As part of the ongoing 
process to review registered pesticides, the Agency intends to apply 
this framework to determine if the available toxicological data for 
ethiprole suggests a candidate CMG may be established with other 
pesticides. If a CMG is established, a screening-level toxicology and 
exposure analysis may be conducted to provide an initial screen for 
multiple pesticide exposure.
    Safety Factor for Infants and Children. EPA continues to conclude 
that there is reliable data showing that the safety of infants and 
children would be adequately protected if the Food Quality Protection 
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for 
that decision are articulated in Unit III.D. of the June 28, 2019, 
rulemaking.
    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 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.
    Acute dietary (food only) risks are below the Agency's level of 
concern of 100% of the aPAD; they are 2.4% of the aPAD for all infants 
(less than 1 year old), which is the population subgroup with the 
highest exposure estimate. Chronic dietary (food only) risks are below 
the Agency's level of concern of 100% of the cPAD; they are 6% of the 
cPAD for all infants less than one year

[[Page 105472]]

old, which is the population subgroup with the highest exposure 
estimate.
    The short- and intermediate-term aggregate risks combine chronic 
dietary (food and drinking water) and short- and intermediate-term 
residential exposures. Since there are no U.S. registrations, aggregate 
risk is the same as the chronic dietary risk, which is below the 
Agency's level of concern.
    Because ethiprole is classified as ``Suggestive Evidence of 
Carcinogenicity, but Not Sufficient to Assess Human Carcinogenicity 
Potential,'' EPA has concluded that a cancer aggregate assessment was 
not required.
    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 ethiprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the June 28, 2019, 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, Canada, and Mexico have not established MRLs for residues of 
ethiprole on sugarcane commodities; therefore, there are no 
harmonization issues at this time.

C. Revisions to Petitioned-For Tolerances

    Review of the field trial data determined one of the nine 
independent sugarcane field trials was to be a replicate; therefore, 
the residues were averaged, and the pair of sites was taken to be one 
independent trial. The Organization for Economic Cooperation and 
Development (OECD) MRL calculator recommended a tolerance of 0.07 ppm 
for residues of ethiprole in sugarcane.

V. Conclusion

    Therefore, a tolerance is established for residues of ethiprole in 
or on sugarcane at 0.07 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, titled ``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, titled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or to Executive Order 13045, titled 
``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, titled ``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 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, 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, titled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, titled 
``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: December 16, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 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.  180.652, amend the table in paragraph (a) by adding a table 
heading and adding in alphabetical order the commodity ``Sugarcane'' to 
read as follows:

Sec.  180.652  Ethiprole; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane \1\...........................................            0.07
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of December
  27, 2024.

* * * * *
[FR Doc. 2024-30581 Filed 12-26-24; 8:45 am]
BILLING CODE 6560-50-P
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