Rule2025-03000
Fludioxonil; 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
February 25, 2025
Effective
February 25, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of fludioxonil in or on cranberry. 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 90 Issue 36 (Tuesday, February 25, 2025)</title>
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[Federal Register Volume 90, Number 36 (Tuesday, February 25, 2025)]
[Rules and Regulations]
[Pages 10605-10608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-03000]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0644; FRL-11524-01-OCSPP]
Fludioxonil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
fludioxonil in or on cranberry. The Interregional Project Number 4 (IR-
4) requested this tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 25, 2025. Objections and
requests for hearings must be received on or before April 28, 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-2022-0644, is available online 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/">https://www.epa.gov/</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#6c3e282a3e220318050f091f2c091c0d420b031a"><span class="__cf_email__" data-cfemail="9ac8dedcc8d4f5eef3f9ffe9daffeafbb4fdf5ec">[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, 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-2022-0644 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
April 28, 2025. Addresses for mail and hand delivery of objections and
hearing
[[Page 10606]]
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-2022-0644, 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/">https://www.epa.gov/</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 October 24, 2022 (87 FR 64196) (FRL-
9410-06-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petition (PP2E9007) by the Interregional Research Project No. 4 (IR-4),
North Carolina State University, 1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition requests to amend 40 CFR 180.516
by establishing a tolerance for residues of the fungicide fludioxonil,
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile in or
on the raw agricultural commodity: cranberry at 0.04 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 fludioxonil including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with fludioxonil 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 for the new rulemaking.
EPA has previously published tolerance rulemakings for fludioxonil
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to fludioxonil and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile for fludioxonil used for human risk assessment, see Unit III.A.
of the final rule published in the Federal Register of November 6, 2018
(83 FR 55491) (FRL-9982-75).
Toxicological points of departure/Levels of concern. A summary of
the toxicological endpoints for fludioxonil used for human health risk
assessment is discussed in Unit III.B. of the final rule published in
the Federal Register of August 14, 2015 (80 FR 48743) (FRL-9931-06).
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the requested tolerance
for residues of fludioxonil on cranberry. The assessments were
conducted with 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). An acute dietary risk
assessment was not performed since no endpoint attributable to a single
exposure (dose) was identified from the available oral toxicity
database as indicated in Unit III.B., of the August 14, 2015, final
rule. The chronic assessment is unrefined and is based on tolerance-
level residues and 100 percent crop treated (PCT). EPA has classified
fludioxonil as a group D carcinogen, i.e., not classifiable as to human
carcinogenicity. Therefore, quantification of risk using a non-linear
approach will adequately account for all chronic toxicity, including
carcinogenicity, which could result from exposure to fludioxonil.
Drinking water and non-occupational exposures. The estimated
drinking water concentrations have not changed since the 2018
rulemaking. For a detailed summary of the drinking water analysis for
fludioxonil used for the human health risk assessment, see Unit
III.C.2. of the November 6, 2018, tolerance rulemaking.
There are no new residential uses in this action, but fludioxonil
is currently registered for the following uses that could result in
residential exposures: parks, golf courses, athletic fields,
residential lawns, ornamentals, and greenhouses. The residential
exposure assessment used the same assumptions as described in the
November 6, 2018, final rule. EPA assessed residential exposure based
on the following: The residential exposure for use in the adult
aggregate assessment reflects inhalation exposures from handler
exposure to applying paints with airless sprayers. The residential
exposure for use in the children 1 to <2 years old aggregate assessment
reflects incidental oral exposures (hand-to-mouth) from post-
[[Page 10607]]
application exposure to outdoor treated turf.
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.''
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 fludioxonil and any other
substances. For the purposes of this action, therefore, EPA has not
assumed that fludioxonil has 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/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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 from 10X to 1X. See Unit
III.D. of the November 6, 2018, rulemaking for a discussion of the
Agency's rationale for that determination.
Aggregate risk 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 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.
An acute dietary exposure assessment was not performed as there
were no indications of an adverse effects attributable to a single
dose. Fludioxonil is not expected to pose an acute risk. Chronic
dietary risks are below the Agency's level of concern of 100% of the
cPAD; they are 49% of the cPAD for children 1 to 2 years old, the
population subgroup receiving the highest exposure. Chronic residential
exposure to residues of fludioxonil is not expected, therefore,
aggregate chronic risks are equal to the chronic dietary risks and are
not of concern.
EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate MOEs of 1,200 for adults and
290 for children 1 to 2 years old. Because EPA's level of concern for
fludioxonil is an MOE of 100 or below, short-term aggregate risks are
not of concern. Intermediate- and long-term aggregate risk assessments
were not performed because there are no registered or proposed uses of
fludioxonil that result in intermediate- or long-term residential
exposures. EPA has determined that the chronic assessment will account
for all chronic toxicity, including carcinogenicity, that could result
from exposure to fludioxonil. Because there is no chronic risk of
concern from aggregate exposure to fludioxonil, EPA concludes that
exposure to fludioxonil will not pose a cancer risk.
Therefore, based on the risk assessments and information described
above, 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 fludioxonil residues. More detailed information
on this action can be found in the document titled ``Fludioxonil. Human
Health Risk Assessment for Section 3 Registration to Establish an
Individual Tolerance for Residues in/on Cranberry.'' in docket ID
number EPA-HQ-OPP-2022-0644.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the November 6, 2018, 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).
The Codex has not established a MRL for fludioxonil on cranberry.
V. Conclusion
Therefore, a tolerance is established for residues of fludioxonil,
[4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile],
including its metabolites and degradates, in or on cranberry at 0.04
ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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
[[Page 10608]]
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: January 9, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I 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. 180.516, amend Table 1 to Paragraph (a)(1) by adding in
alphabetical order the entry ``Cranberry'' to read as follows:
Sec. 180.516 Fludioxonil; tolerance for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Cranberry.................................................. 0.04
* * * * *
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* * * * *
[FR Doc. 2025-03000 Filed 2-24-25; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on February 25, 2025.
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