Rule2023-12321
Sedaxane; 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
June 9, 2023
Effective
June 9, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of sedaxane in or on Onion, bulb, subgroup 3-07A and Vegetable, cucurbit, group 9. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 111 (Friday, June 9, 2023)</title>
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[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Rules and Regulations]
[Pages 37769-37772]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12321]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0314; FRL-10994-01-OCSPP]
Sedaxane; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
sedaxane in or on Onion, bulb, subgroup 3-07A and Vegetable, cucurbit,
group 9. Syngenta Crop Protection, LLC requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 9, 2023. Objections and
requests for hearings must be received on or before August 8, 2023, 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-2022-0314, is available at
<a href="https://www.regulations.gov">https://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#6a382e2c3824051e03090f192a0f1a0b440d051c"><span class="__cf_email__" data-cfemail="0c5e484a5e426378656f697f4c697c6d226b637a">[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 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-2022-0314 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
August 8, 2023. 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-2022-0314, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 July 20, 2022 (87 FR 43231) (FRL 9410-
03-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
2F8986) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.665 be amended by
establishing tolerances for residues of the fungicide sedaxane, N-[2-
[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-methyl-1H-
pyrazole-4-carboxamide, in or on Vegetable, dry bulb, crop subgroup 3-
07A and Vegetable, cucurbit, group 9 at 0.01 parts per million (ppm).
The July 20, 2022, notice of filing referenced a summary of the
petition prepared by Syngenta Crop Protection, LLC, the registrant,
which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 37770]]
There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is revising the commodity definition for ``Vegetable, dry bulb, crop
subgroup 3-07A'' to ``Onion, bulb, subgroup 3-07A''. 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 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 sedaxane, including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with sedaxane follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published in 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 sedaxane,
most recently in the Federal Registers of December 8, 2017 (82 FR
57867) (FRL-9970-04) and August 27, 2019 (84 FR 44703) (FRL-9998-22),
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to sedaxane and established tolerances for residues of that
pesticide chemical. EPA is incorporating previously published sections
from the 2017 and 2019 rulemakings as described further in this
rulemaking, as they remain unchanged.
A. Toxicological Profile
For a discussion of the Toxicological Profile of sedaxane, see Unit
III.A. of the 2019 rulemaking.
B. Toxicological Points of Departure/Levels of Concern
For a summary of the Toxicological Points of Departure/Levels of
Concern used for the safety assessment, see Unit III.B. of the 2017
rulemaking.
C. Exposure Assessment
Much of the exposure assessment remains the same since the 2019
rulemaking, although the new exposure assessment incorporates
additional dietary exposures from the petitioned-for tolerances. The
updates are discussed in this section; for a description of the rest of
the EPA approach to and assumptions for the exposure assessment, see
Unit III.C. of the 2019 rulemaking.
Dietary exposure from food and feed uses. In evaluating dietary
exposure to sedaxane, EPA considered exposure under the petitioned-for
tolerances as well as all existing sedaxane tolerances in 40 CFR
180.665. For the acute and chronic dietary exposure assessments, EPA
used tolerance-level residues for all registered and proposed
commodities. The acute and chronic analyses used 100 percent crop
treated (PCT) for all commodities.
Drinking water exposure. Drinking water exposures are not impacted
by the proposed seed treatment uses on Onion, bulb, subgroup 3-07A and
Vegetable, cucurbit, group 9. Since the 2019 rulemaking, EPA has
conducted a new drinking water assessment for the registration review
of sedaxane and subsequently updated that assessment with respect to
seed treatment uses. Estimated drinking water concentrations (EDWCs)
for annual potato seed treatments resulted in the highest
concentrations for total sedaxane residues. The proposed seed treatment
uses are not expected to result in total sedaxane residues at
concentrations higher than the annual potato seed treatments;
therefore, the EDWCs for annual potato seed treatments are protective.
The groundwater EDWCs are 22.0 parts per billion (ppb) for acute
exposures and 19.3 ppb for chronic exposures. These EDWCs were
calculated with the Pesticide Root Zone Model for Groundwater (PRZM-
GW).
Non-occupational exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sedaxane is not
registered for any specific use patterns that would result in
residential exposure, and residential exposures are not impacted by the
proposed seed treatment uses.
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 sedaxane and any other substances. For the
purposes of this action, therefore, EPA has not assumed that sedaxane
has a common mechanism of toxicity with other substances.
D. Safety Factor for Infants and Children
EPA continues to conclude that there is reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor
to 1X. See Unit III.D. of the 2019 rulemaking for a discussion of the
Agency's rationale for that determination.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population-adjusted dose (aPAD) and chronic population-adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate points of departure (PODs) to ensure that an
adequate margin of exposure (MOE) exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 1.4% of the aPAD for
[[Page 37771]]
all infants (<1 year old), the population group receiving the greatest
exposure. Chronic dietary risks are below the Agency's level of concern
of 100% of the cPAD; they are 1.4% of the cPAD for all infants (<1 year
old), the population group receiving the greatest exposure.
Short- and intermediate-term aggregate exposure risks take into
account short- and intermediate-term residential exposures,
respectively, plus chronic exposure to food and water (considered to be
a background exposure level). Because there are no proposed or
registered residential uses of sedaxane, short- and intermediate-term
risk assessments were not performed. The chronic risk assessment is
protective for any short- and intermediate-term exposures from food and
drinking water.
Because the chronic risk is below the Agency's level of concern,
EPA concludes the chronic dietary risk assessment adequately accounts
for any potential carcinogenicity that could result from exposure to
sedaxane.
Therefore, based on these risk assessments, 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
sedaxane residues. More detailed information can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled ``Sedaxane. Human Health
Risk Assessment for a Proposed Seed Treatment Use on Bulb Onion Crop
Subgroup 3-07A and Cucurbit Vegetables Crop Group 9'' in docket ID
number EPA-HQ-OPP-2022-0314.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the 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).
The Codex has not established an MRL for sedaxane in or on Onion,
bulb, subgroup 3-07A and Vegetable, cucurbit, group 9.
C. Revisions to Petitioned-For Tolerances
The petition requested a tolerance for ``Vegetable, dry bulb, crop
subgroup 3-07A''. Since the time of submission, EPA has updated the
preferred vocabulary for establishing pesticide tolerances, and the
correct commodity definition is ``Onion, bulb, subgroup 3-07A''. The
Agency is therefore revising the commodity definition for ``Vegetable,
dry bulb, crop subgroup 3-07A'' to ``Onion, bulb, subgroup 3-07A''.
V. Conclusion
Therefore, tolerances are established for residues of sedaxane, N-
[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-methyl-1H-
pyrazole-4-carboxamide, in or on Onion, bulb, subgroup 3-07A at 0.01
ppm and Vegetable, cucurbit, group 9 at 0.01 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 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, 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: May 26, 2023.
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. 180.665, the table in paragraph (a) is amended by:
0
a. Adding a table heading; and
[[Page 37772]]
0
b. Adding in alphabetical order the entries ``Onion, bulb, subgroup 3-
07A'' and ``Vegetable, cucurbit, group 9''.
The additions read as follows:
Sec. 180.665 Sedaxane; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Onion, bulb, subgroup 3-07A................................. 0.01
* * * * *
Vegetable, cucurbit, group 9................................ 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-12321 Filed 6-8-23; 8:45 am]
BILLING CODE 6560-50-P
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