Rule2024-28467
Cyazofamid; 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 5, 2024
Effective
December 5, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of cyazofamid in or on multiple crops listed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 234 (Thursday, December 5, 2024)</title>
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[Federal Register Volume 89, Number 234 (Thursday, December 5, 2024)]
[Rules and Regulations]
[Pages 96566-96569]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28467]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0257; FRL-12338-01-OCSPP]
Cyazofamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyazofamid in or on multiple crops listed later in this document.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 5, 2024. Objections and
requests for hearings must be received on or before February 3, 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-2023-0257, 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#beecfaf8ecf0d1cad7dddbcdfedbcedf90d9d1c8"><span class="__cf_email__" data-cfemail="76243230243819021f1513053613061758111900">[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-2023-0257 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 3, 2025.
The 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 Filing and
Service,'' dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the 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 <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf</a>.
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-2023-0257, 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="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://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="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 26, 2023 (88 FR 73571) (FRL-
10579-09-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 3E9064) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition
requested to establish tolerances in 40 CFR 180.601 for residues of the
fungicide cyazofamid, including its metabolites and degradates, in or
on the following raw agricultural commodities: Chick pea, edible podded
at 0.5 ppm; Chick pea, succulent shelled at 0.08 ppm; Edible podded
bean subgroup 6-22A at 0.5 ppm; Parsnip root at 0.09 ppm; Pulses, dried
shelled bean, except soybean, subgroup 6-22E at 0.03 ppm; and Succulent
shelled bean subgroup 6-22C at 0.08 ppm. The petition also proposed to
remove established tolerances for residues of cyazofamid in or on the
following: Bean, succulent at 0.5 ppm and Bean, succulent shelled at
0.08 ppm.
EPA has modified some of the commodity definitions to be consistent
with Agency nomenclature, but the
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tolerance levels are being established as petitioned for.
That document referenced a summary of the petition, 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.
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 cyazofamid including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with cyazofamid 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 several tolerance rulemakings for
cyazofamid, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to cyazofamid 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 cyazofamid, can be
found in the document titled ``Cyazofamid: Human Health Risk Assessment
for New Uses of Cyazofamid on Parsnip, Root and Pulses, Dried Shelled
Bean (Except Soybean), Subgroup 6-22E and Crop Group Expansions to
Edible Podded Bean Subgroup 6-22A and Succulent Shelled Bean Subgroup
6-22C'' 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 cyazofamid, see Unit III.A. of the rulemaking published in
the Federal Register of March 18, 2020 (85 FR 15387) (FRL-10005-85).
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 cyazofamid, see Unit III.B. of the rulemaking
published in the Federal Register of February 3, 2016 (81 FR 5600)
(FRL-9940-46).
Exposure assessment. Much of the exposure assessment remains
unchanged from the March 18, 2020, rulemaking, although the new
exposure assessment incorporates the additional dietary exposure from
the petitioned-for tolerances. Other changes are described below.
No acute dietary toxicity endpoint could be identified based on the
toxicology data currently available for cyazofamid; therefore, a
quantitative acute assessment was not performed.
Chronic aggregate dietary (food and drinking water) exposure and
risk assessments were conducted using the Dietary Exposure Evaluation
Model software with the Food Commodity Intake Database (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).
The conservative chronic analysis assumed that cyazofamid residues are
present in/on all proposed and registered food commodities at tolerance
levels and 100 percent crop treated.
Anticipated residue and percent crop treated (PCT) information. EPA
did not use anticipated residue or PCT information in the dietary
assessment for cyazofamid. Tolerance-level residues and 100 PCT were
assumed for all food commodities.
Drinking water and non-occupational exposures. For a summary of the
drinking water numbers used, see Unit III.A. of the March 18, 2020,
rulemaking. A chronic estimated drinking water concentration (EDWC) of
211 parts per billion (ppb) was used in the chronic dietary exposure
assessment.
Cyazofamid is currently registered for the following uses that
could result in residential exposures: Turf and ornamentals. The post-
application assessment includes only post-application exposure (to turf
and ornamentals) from hand-to-mouth exposures for children 1 to less
than 2 years old.
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.'' In 2016, EPA's
Office of Pesticide Programs released a guidance document entitled,
Pesticide Cumulative Risk Assessment: Framework for Screening Analysis.
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 (CRA). The
Agency has utilized this framework for cyazofamid and determined that
although cyazofamid shares some chemical and/or toxicological
characteristics (e.g., chemical structure or apical endpoint) with
other pesticides, the toxicological database does not support a
testable hypothesis for a common mechanism of action. No further data
are required to determine that no common mechanism of toxicity exists
for cyazofamid and other pesticides and no further cumulative
evaluation is necessary for cyazofamid.
Safety factor for infants and children. EPA continues to conclude
that there are 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 March 18, 2020,
rulemaking.
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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.
No acute dietary toxicity endpoint could be identified based on the
toxicology data currently available for cyazofamid; therefore, a
quantitative acute assessment was not performed. Chronic dietary (food
and drinking water) risks are below the Agency's level of concern of
100% of the cPAD; they are 2.1% of the cPAD for all infants less than 1
year old, which is the population subgroup with the highest exposure
estimate.
The short-term aggregate risks combine chronic dietary (food and
drinking water) and short-term residential exposures. For the short-
term aggregate risk for children 1 to less than 2 years old, the
aggregate MOE combining dietary exposure and incidental oral (hand-to-
mouth) exposure is 6300. MOEs below 100 are of concern; this MOE is
above 100 and therefore is not of concern.
Intermediate-term exposure is not expected for the residential
exposure pathway. Therefore, the intermediate-term aggregate risk
estimate is equivalent to chronic dietary exposure estimates, which are
not of concern.
Chronic exposure is not expected for the residential exposure
pathway. Therefore, the chronic aggregate risk estimate is equivalent
to chronic dietary exposure estimates and are not of concern.
Because cyazofamid is classified as ``not likely to be carcinogenic
to humans'', EPA has concluded that aggregate exposure to cyazofamid is
not likely to pose a cancer risk.
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 cyazofamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the March 18, 2020, 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).
There are no Codex MRLs established on parsnip, root; chickpea,
edible podded; chickpea, succulent shelled; or any of the commodities
in the Vegetable, legume, pulse, bean, dried shelled, except soybean,
subgroup 6-22E.
The proposed US tolerances for expansions to crop subgroups 6-22A
and 6-22C are not harmonized with similar individually established
slightly lower Codex MRLs for these commodities. The U.S. tolerances
are slightly higher because the U.S. tolerance expression includes the
parent compound and a metabolite, while the Codex tolerance expression
includes only the parent compound.
V. Conclusion
Therefore, tolerances are established for residues of cyazofamid in
or on Chickpea, edible podded at 0.5 ppm; Chickpea, succulent shelled
at 0.08 ppm; Parsnip, roots at 0.09 ppm; Vegetable, legume, bean,
edible podded, subgroup 6-22A at 0.5 ppm; Vegetable, legume, bean,
succulent shelled, subgroup 6-22C at 0.08 ppm; and Vegetable, legume,
pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.03 ppm.
Additionally, the established tolerances on Bean, succulent; and
Bean, succulent shelled are removed as unnecessary.
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 to 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
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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: November 22, 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. 180.601, add a heading to the table in paragraph (a) and
revise and republish the table to read as follows:
Sec. 180.601 Cyazofamid; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
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Commodity Parts per million
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Brassica, leafy greens, subgroup 4-16B.............. 15
Bulb vegetables, group 3-07......................... 2.0
Carrot, roots....................................... 0.09
Chickpea, edible podded............................. 0.5
Chickpea, succulent shelled......................... 0.08
Ginseng............................................. 0.3
Herb subgroup 19A................................... 90
Hop dried cones..................................... 10.0
Kohlrabi............................................ 1.5
Leafy greens subgroup 4-16A......................... 10
Parsnip, roots...................................... 0.09
Vegetable, brassica, head and stem, group 5-16...... 1.5
Vegetable, cucurbit, group 9........................ 0.10
Vegetable, fruiting, group 8-10..................... 0.9
Vegetable, legume, bean, edible podded, subgroup 6- 0.5
22A................................................
Vegetable, legume, bean, succulent shelled, subgroup 0.08
6-22C..............................................
Vegetable, legume, pulse, bean, dried shelled, 0.03
except soybean, subgroup 6-22E.....................
Vegetable, tuberous and corm, subgroup 1C........... 0.02
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* * * * *
[FR Doc. 2024-28467 Filed 12-4-24; 8:45 am]
BILLING CODE 6560-50-P
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