Rule2024-30581
Ethiprole; 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
December 27, 2024
Effective
December 27, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 248 (Friday, December 27, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://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. 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#6e3c2a283c20011a070d0b1d2e0b1e0f40090118"><span class="__cf_email__" data-cfemail="e2b0a6a4b0ac8d968b818791a2879283cc858d94">[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(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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://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="http://www.epa.gov/dockets/where-send-comments-epa-dockets">http://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, are available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 (<a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>). 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
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* * * * *
Sugarcane \1\........................................... 0.07
* * * * *
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\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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