Rule2025-04712
Pyridate; 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
March 21, 2025
Effective
March 21, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of pyridate in or on Pea, field, forage; Pea, field, hay; Soybean, forage; Soybean, hay; Soybean, seed; and Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F. Belchim Crop Protection US Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 90 Issue 54 (Friday, March 21, 2025)</title>
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[Federal Register Volume 90, Number 54 (Friday, March 21, 2025)]
[Rules and Regulations]
[Pages 13289-13293]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04712]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0257; FRL-12388-01-OCSPP]
Pyridate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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[[Page 13290]]
SUMMARY: This regulation establishes tolerances for residues of
pyridate in or on Pea, field, forage; Pea, field, hay; Soybean, forage;
Soybean, hay; Soybean, seed; and Vegetable, legume, pulse, pea, dried
shelled, subgroup 6-22F. Belchim Crop Protection US Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective March 21, 2025. Objections and
requests for hearings must be received on or before May 20, 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-2022-0257, 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. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505P), 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#3c6e787a6e725348555f594f7c594c5d125b534a"><span class="__cf_email__" data-cfemail="41130507130f2e3528222432012431206f262e37">[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-2022-0257 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
May 20, 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-2022-0257, 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/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, 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 March 22, 2022 (87 FR 16133) (FRL-9410-
11-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
1F8978) by Belchim Crop Protection US Corporation, 2751 Centreville
Road, Suite 100, Wilmington, Delaware 19808. The petition requested
that 40 CFR part 180 be amended by establishing tolerances for residues
of the herbicide pyridate in or on dry peas and soybeans at 0.05 parts
per million (ppm). That document referenced a summary of the petition
prepared by Belchim Crop Protection US Corporation, the registrant,
which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised tolerance levels and corrected commodity definitions. The
registrant proposed tolerances of dry pea vines, dry pea hay, dry pea
seed (dried), soybean forage, soybean hay, and soybean seed (dried) at
0.05 ppm. The proposed dry pea seed (dried) was revised to vegetable,
legume, pulse, pea, dried shelled, subgroup 6-22F. The proposed dry pea
vines at 0.05 ppm were revised to pea, field, forage at 2 ppm. The
proposed dry pea hay at 0.05 ppm was revised to 5 ppm. The proposed
soybean forage at 0.05 was revised to soybean, forage at 0.4 ppm. The
proposed soybean hay at 0.05 ppm was revised to soybean, hay at 0.8
ppm, and the proposed Soybean Seed (dried) was revised to Soybean,
seed. The reason for these changes is explained in Unit IV.D.
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 revised
pesticide petition (PP 1F8978) by Belchim Crop Protection US
Corporation. The revised petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide
pyridate in or on dry pea vines, dry pea hay, dry pea seed (dried),
soybean forage, soybean hay, and soybean seed (dried) at 0.05 ppm. That
document referenced a revised summary of the petition prepared by
Belchim Crop Protection US Corporation, the registrant, which is
available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. No comments
[[Page 13291]]
were received on the revised 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 pyridate, including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with pyridate 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.
In the Federal Register of May 25, 2022 (87 FR 31738) (FRL-9298-
02), EPA published a final rule establishing tolerances for residues of
pyridate in which EPA concluded, based on available information, that
there is a reasonable certainty that no harm would result from
aggregate exposure to pyridate. EPA is incorporating previously
published sections from that rulemaking as described further in this
rulemaking, as they have not changed.
Toxicological profile. For a discussion of the toxicological
profile of pyridate, see Unit III.A. of the May 25, 2022, rulemaking.
Toxicological points of departure/levels of concern. For a summary
of the toxicological points of departure/levels of concern for pyridate
used for human health risk assessment, see Unit III.B. of the May 25,
2022, rulemaking.
Exposure assessment. Much of the exposure assessment for pyridate
remains unchanged from the discussion in Unit III.C. of the May 25,
2022, rulemaking, except as described in the following paragraphs.
Dietary exposure from food and feed uses. The exposure assessment
has been updated to include the additional dietary exposure from the
proposed new uses of pyridate on dry pea and soybean commodities using
the same previous assumptions of tolerance-level residues and 100
percent crop treated (PCT) described in Unit III.C.1. of the May 25,
2022, rulemaking.
Drinking water and non-occupational exposures. Although drinking
water and residential exposures are not impacted by the proposed new
uses of pyridate on dry pea and soybean commodities, there are proposed
new uses of pyridate for control of annual broadleaf weeds on
residential turfgrass. In the Federal Register of April 26, 2022 (87 FR
24556; FRL-9408-03-OCSPP), EPA issued a document pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), providing
notice of receipt and opportunity to comment on the application to
register these new uses on turfgrass. EPA updated the estimated
drinking water concentrations (EDWCs) of pyridate to evaluate potential
drinking water exposure from use on residential turfgrass. Based on the
Pesticides in Water Calculator (PWC; version 2.001), the EDWCs of
pyridate are estimated to be 0.580 ppm for acute dietary exposures and
0.454 ppm for chronic dietary exposures.
EPA also assessed residential post-application exposure from
contacting lawns and turf treated with pyridate using default
assumptions in lieu of chemical-specific turf transfer residue data.
The residential exposures used in the aggregate assessment are
incidental oral exposures (hand-to-mouth, object-to-mouth, and soil
ingestion) from post-application exposure to treated lawns and turf for
children 1 to <2 years old. Although dermal exposures are also
expected, no dermal toxicological point of departure was selected.
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 pyridate and any other
substances, and pyridate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that pyridate has a common mechanism of
toxicity with other substances.
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 May 25, 2022, rulemaking for a discussion of the Agency's
rationale for that determination.
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). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
The acute aggregate risk assessment considers exposures from food
and drinking water only and is equivalent to the acute dietary risk
estimates. Acute dietary risks are below the Agency's level of concern:
53% of the aPAD for all infants less than 1 year old, the population
group of concern. There are no registered or proposed uses of pyridate
that result in long-term residential exposures. Therefore, the chronic
aggregate risk assessment considers exposures from food and drinking
water only. Chronic dietary risks are below the Agency's level of
concern: 31% of the cPAD for all infants less than 1 year old, the
group with the highest exposure.
The short-term aggregate risk assessment considers dietary (food
and drinking water) and residential exposures. No residential handler
exposure is expected, and only post-application dermal and incidental
oral
[[Page 13292]]
exposures are expected from the proposed uses of pyridate in
residential areas. Residential post-application inhalation exposures
are not expected. Using the exposure assumptions described for short-
term exposures, EPA has concluded that the combined short-term food,
water, and residential exposures result in aggregate MOEs above 100.
These MOEs are not of concern, as the level of concern for all
scenarios assessed is an MOE less than 100. Intermediate-term
residential exposure is not expected so no intermediate term aggregate
assessment was conducted.
Pyridate is classified as ``Not Likely to Be Carcinogenic to
Humans.'' Therefore, EPA does not expect pyridate exposures to pose an
aggregate 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 pyridate residues. More detailed information on
the subject action to establish tolerances in or on dry pea and soybean
commodities can be found in the document titled ``Pyridate. Human
Health Risk Assessment for the Proposed New Section 3 Registration on
Soybeans and Dry Peas.'' available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in
docket ID number EPA-HQ-OPP-2022-0257.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical enforcement methodology (high-performance
liquid chromatography with ultraviolet detection (UV-HPLC)) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: <a href="/cdn-cgi/l/email-protection#fe8c9b8d979a8b9b939b8a96919a8dbe9b8e9fd0999188"><span class="__cf_email__" data-cfemail="4c3e293f252839292129382423283f0c293c2d622b233a">[email protected]</span></a>.
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 is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level. The Codex has not established MRLs
for residues of pyridate in dry pea and soybean raw agricultural
commodities.
C. Response to Comments
EPA received one comment in response to the notice of filing. The
commenter opposed any tolerances for pyridate and expressed a general
opposition to the use of ``toxic chemicals'' on food. Although the
Agency recognizes that some individuals believe that pesticide
chemicals should not be permitted on food, the existing legal framework
provided by section 408 of the FFDCA authorizes EPA to establish
tolerances when it determines the tolerances are safe. Upon
consideration of the validity, completeness, and reliability of the
available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that the pyridate tolerances are safe. The
commenter has provided no information indicating that a safety
determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
For dry pea vines and hay and soybean forage and hay, the
petitioner proposed a tolerance level equal to the LOQ of the
enforcement method, which is not appropriate as quantifiable residues
were found in these commodities. The recommended tolerance level for
dry pea vines and hay and soybean forage and hay was determined through
use of the Organization for Economic Co-operation and Development
(OECD) calculation procedures. Commodity definitions were updated to
EPA standards.
V. Conclusion
Therefore, tolerances are established for residues of pyridate, in
or on Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at
0.05 ppm; Pea, field, forage at 2.0 ppm; Pea, field, hay at 5.0 ppm;
Soybean, forage at 0.4 ppm; Soybean, hay at 0.8 ppm; and Soybean, seed
at 0.5 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 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.).
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
[[Page 13293]]
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: March 14, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended 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. Amend Sec. 180.462, by adding in alphabetical order the entries
``Pea, field, forage'', ``Pea, field, hay'', ``Soybean, forage'',
``Soybean, hay'', ``Soybean, seed'', and ``Vegetable, legume, pulse,
pea, dried shelled, subgroup 6-22F'' to table 1 to paragraph (a) to
read as follows:
Sec. 180.462 Pyridate; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * * * *
Pea, field, forage.................................. 2
Pea, field, hay..................................... 5
* * * * * * *
Soybean, forage..................................... 0.4
Soybean, hay........................................ 0.8
Soybean, seed....................................... 0.05
* * * * * * *
Vegetable, legume, pulse, pea, dried shelled, 0.05
subgroup 6-22F.....................................
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-04712 Filed 3-20-25; 8:45 am]
BILLING CODE 6560-50-P
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