Proposed Rule2025-09108
Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides; Diphenylamine, et al
Primary source
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Published
May 22, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is proposing to implement several tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency previously determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During registration review, EPA reviews all aspects of a pesticide case, including existing tolerances, to ensure that the pesticide continues to meet the standard for registration under FIFRA. The pesticide tolerances and active ingredients addressed in this rulemaking are identified and discussed in detail in Unit III. of this document.
Full Text
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<title>Federal Register, Volume 90 Issue 98 (Thursday, May 22, 2025)</title>
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[Federal Register Volume 90, Number 98 (Thursday, May 22, 2025)]
[Proposed Rules]
[Pages 21878-21885]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09108]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2025-0153; FRL-12748-01-OCSPP]
RIN 2070-ZA16
Pesticide Tolerances; Implementing Registration Review Decisions
for Certain Pesticides; Diphenylamine, et al
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
proposing to implement several tolerance actions under the Federal
Food, Drug, and Cosmetic Act (FFDCA) that the Agency previously
determined were necessary or appropriate during the registration review
conducted under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). During registration review, EPA reviews all aspects of a
pesticide case, including existing tolerances, to ensure that the
pesticide continues to meet the standard for registration under FIFRA.
The pesticide tolerances and active ingredients addressed in this
rulemaking are identified and discussed in detail in Unit III. of this
document.
DATES: Comments must be received on or before July 21, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2025-0153, through <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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. 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>.
FOR FURTHER INFORMATION CONTACT: Caleb Carr, Pesticide Re-Evaluation
Division (7508M), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-0636; email address:
<a href="/cdn-cgi/l/email-protection#9cfffdeeeeb2fffdf0f9fedcf9ecfdb2fbf3ea"><span class="__cf_email__" data-cfemail="395a584b4b175a58555c5b795c4958175e564f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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 might apply to
them:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is proposing several tolerance actions that the Agency
previously determined were necessary or appropriate during registration
review of the pesticide active ingredients identified in Unit III. The
tolerance actions for each pesticide active ingredient are described in
Unit III. and may include but are not limited to the following types of
actions:
<bullet> Revising tolerance expressions;
<bullet> Modifying commodity definitions;
<bullet> Updating crop groupings;
<bullet> Removing expired tolerances;
<bullet> Revoking tolerances that are no longer needed; and
<bullet> Harmonizing tolerances with the Codex Alimentarius
Commission (Codex) Maximum Residue Levels (MRLs).
Although it may not have been identified in the registration review
of a particular pesticide, this proposed rule
[[Page 21879]]
reflects the Agency's 2019 adoption of the Organization of Economic
Cooperation and Development (OECD) Rounding Class Practice. More
information on the OECD Rounding Class Practice can be found at <a href="https://www.oecd.org/en/publications/mrl-calculator-users-guide-and-white-paper_9789264221567-en.html">https://www.oecd.org/en/publications/mrl-calculator-users-guide-and-white-paper_9789264221567-en.html</a>. Where applicable, these adjustments are
proposed for specific pesticides as indicated in Unit III.
C. What is EPA's authority for taking this action?
Section 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA),
21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke
tolerances or exemptions from the requirement of a tolerance on its own
initiative.
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
As part of the registration review of a pesticide, EPA also evaluates
the existing tolerances and any tolerance changes identified as
necessary or appropriate during registration review of a pesticide are
summarized in the registration review decision documents for each
pesticide active ingredient or registration review case (e.g., in the
Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim
Decision (ID) and Final Decision (FD)). These documents can be found in
the public docket opened for each pesticide undergoing registration
review. Additional information about pesticide registration review is
available at <a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
Prior to issuing the final regulation, FFDCA section 408(e)(2)
requires EPA to issue a notice of proposed rulemaking for a 60-day
public comment period, unless the Administrator for good cause finds
that it would be in the public interest to have a shorter period and
states the reasons in the proposed rulemaking.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through email or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the
information that you claim to be CBI. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
E. What can I do if I want the Agency to maintain a tolerance that the
Agency proposes to revoke?
This proposed rule provides a 60-day public comment period that
allows any person to state an interest in retaining a tolerance
proposed for revocation. If EPA receives such a comment within the 60-
day period, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f), if needed. If the data are not submitted as
required in the order, EPA will take appropriate action under FFDCA.
After considering comments that are received in response to this
proposed rule, EPA will issue a final rule. At the time of the final
rule, you may file an objection or request a hearing on the action
taken in the final rule. If you fail to file an objection to the final
rule within the time period specified in the final rule, you will have
waived the right to raise any issues resolved in the final rule. After
the filing deadline specified in the final rule, issues resolved in the
final rule cannot be raised again in any subsequent proceedings.
II. Background
A. What is a tolerance?
A ``tolerance'' represents the maximum level for residues of a
pesticide chemical legally allowed in or on food, which includes raw
agricultural commodities and processed foods and feed for animals.
Under the FFDCA, residues of a pesticide chemical that are not covered
by a tolerance or exemption from the requirement of a tolerance are
considered unsafe. See 21 U.S.C. 346a(a)(1). Foods containing unsafe
residues are deemed adulterated and may not be distributed in
interstate commerce. See 21 U.S.C. 331(a) and 342(a)(2)(B).
Consequently, for a food-use pesticide (i.e., a pesticide use that is
likely to result in residues in or on food) to be sold and distributed
in the United States, the pesticide must not only have appropriate
tolerances or exemptions under the FFDCA, but also must be registered
under FIFRA. Food-use pesticides not registered in the United States
must have tolerances or exemptions in order for commodities treated
with those pesticides to be imported into the United States. For
additional information about tolerances, go to <a href="https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances">https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances</a>.
B. Why does EPA consider international residue limits?
When establishing a tolerance for residues of a pesticide, EPA must
determine whether Codex has established a MRL for that pesticide. See
21 U.S.C. 346a(b)(4). Additionally, as part the registration review of
a pesticide (see Unit II.C.), EPA determines whether Codex or other
international MRLs exist for commodities and chemicals for which U.S.
tolerances have been established. Where appropriate, EPA's intention is
to harmonize U.S. tolerances with those international MRLs to
facilitate trade. EPA's effort to harmonize with international MRLs is
summarized in the tolerance reassessment section of the individual
Human Health Draft Risk Assessments that support the pesticide
registration review.
C. What is registration review?
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
See also 40 CFR 155.40(a). The registration review program is intended
to make sure that, as the ability to assess risk evolves and as
policies and practices change, all registered pesticides can continue
to be used without causing unreasonable adverse effects on human health
and the environment. As part of the registration review of a pesticide,
EPA also evaluates whether existing tolerances are safe, whether any
changes to existing tolerances are necessary or appropriate, and
whether any new tolerances are necessary to cover residues from
registered pesticides. In addition, any tolerance changes identified as
necessary or appropriate during registration review of a pesticide are
summarized in the registration review decision documents for each
pesticide active ingredient or registration review case (e.g., in the
Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim
Decision (ID) and Final Decision (FD)). These documents can be found in
the public docket that has been opened for each pesticide, which is
available online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, using the docket ID
number listed in Unit III. for each pesticide active ingredient
included in this proposed action. Additional information about
pesticide registration review is available at
[[Page 21880]]
<a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
D. EPA's Safety Assessments
FFDCA section 408(b) authorizes EPA to establish a tolerance, if
the Agency determines that a tolerance is safe; FFDCA section 408(c)
authorizes EPA to establish an exemption from the requirement of a
tolerance if the Agency determines that the exemption is safe. See 21
U.S.C. 346a(b) and (c). If EPA determines that a tolerance or exemption
is not safe, EPA must modify or revoke that tolerance or exemption. The
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.'' 21 U.S.C.
346a(b)(2)(A)(ii), (c)(2)(A)(ii). This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. FFDCA section 408(b)(2)(C) requires EPA to give
special consideration to the 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[s.]'' 21 U.S.C. 346a(b)(2)(C). In addition, FFDCA section
408(b)(2)(D) contains several factors EPA must consider when making
determinations about establishing, modifying, or revoking tolerances.
21 U.S.C. 346a(b)(2)(D). FFDCA section 408(c)(2)(B) requires that EPA,
when making determinations about exemptions, to take into account,
among other things, the considerations set forth in FFDCA section
408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B).
Furthermore, when establishing tolerances or exemptions from the
requirement of a tolerance, FFDCA sections 408(b)(3) and (c)(3) require
that there be a practical method for detecting and measuring pesticide
chemical residue levels in or on food, unless in the case of
exemptions, EPA determines that such method is not needed and states
the reasons therefore in the rulemaking. 21 U.S.C. 346a(b) and (c).
Consistent with its obligations under FIFRA section 3(g), 7 U.S.C.
136a(g), and FFDCA section 408, 21 U.S.C. 346a, EPA has reviewed the
available scientific data and other relevant information on toxicity
and exposure of the individual chemicals represented in this
rulemaking. As part of registration review, the Agency has published
risk assessments detailing the risks from aggregate exposure, including
to infants and children, for each of the pesticides represented herein.
The chemical-specific toxicity and exposure analyses, which support the
safety determinations contained in Unit III., can be found in the human
health risk assessment documents and related registration review
decision documents, which are available in the public docket that has
been opened for each pesticide, as noted in Unit III.
After considering all available information, EPA has determined it
is appropriate based on the underlying safety assessments to take the
tolerance actions being proposed in this rulemaking and that adequate
enforcement methodology as described in the supporting documents is
available to enforce the tolerance expressions.
III. Proposed Tolerance Actions
EPA is proposing to take the specific tolerance actions identified
in this unit. All tolerance values proposed in the regulatory text of
this rulemaking, modified or otherwise, are being proposed to reflect
current OECD rounding practices.
A. 40 CFR 180.190; Diphenylamine; Case 2210 (Docket ID No. EPA-HQ-OPP-
2015-0749)
EPA is proposing to amend the current tolerances by:
<bullet> Revising the tolerance expression in paragraph (a) for
diphenylamine to describe more clearly the scope or coverage of the
tolerances and the method for measuring compliance. Consistent with EPA
policy, the revised tolerance expression would clarify that (1) as
provided in FFDCA section 408(a)(3), the tolerances cover residues of
the pesticide chemical, including its metabolites and degradates; and
(2) compliance with the specified tolerance levels is to be determined
by measuring the specific compounds mentioned in the tolerance
expression. The revisions to the tolerance expression would not
substantively change the tolerances or, in any way, modify the
permissible level of residues permitted by the tolerances.
<bullet> Revising the commodity definition in paragraph (a) from
``Apple from preharvest or postharvest use, including use of
impregnated wraps'' to ``Apple'' and from ``Pear (post-harvest)'' to
``Pear''. These revisions of commodity definitions will help facilitate
efficient commodity searches and does not substantively change the
tolerance or, in any way, modify the permissible level of residues in
or on the commodity listed in the regulation.
<bullet> Revoking the tolerances from paragraph (a) for ``Cattle,
fat'' at 0.01 ppm; ``Cattle, liver'' at 0.1 ppm; ``Cattle, meat
byproducts, except liver'' at 0.01 ppm; ``Cattle, meat'' at 0.01 ppm;
``Goat, fat'' at 0.01 ppm; ``Goat, liver'' at 0.1 ppm; ``Goat, meat
byproducts, except liver'' at 0.01 ppm; ``Goat, meat'' at 0.01 ppm;
``Horse, fat'' at 0.01 ppm; ``Horse, liver'' at 0.1 ppm; ``Horse, meat
byproducts, except liver'' at 0.01 ppm; ``Horse, meat'' at 0.01 ppm;
``Milk'' at 0.01 ppm; ``Sheep, fat'' at 0.01 ppm; ``Sheep, liver'' at
0.1 ppm; ``Sheep, meat byproducts, except liver'' at 0.01 ppm; and
``Sheep, meat'' at 0.01 ppm. During Registration Review it was
determined that these entries should be removed since the tolerances
are no longer needed based on revised amounts of pomace in livestock
diets.
<bullet> Modifying tolerances by removing trailing zeros to reflect
current OECD rounding practices.
As discussed in Unit II.D, based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the diphenylamine tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
diphenylamine residues. Adequate enforcement methodology is available.
B. 40 CFR 180.377; Diflubenzuron; Case 0144 (Docket ID No. EPA-HQ-OPP-
2012-0714)
EPA is proposing to amend the current tolerances by:
<bullet> Establishing a new tolerance in paragraph (a)(1) for
``Cotton, gin byproducts'' at 30 ppm as supported by submitted residue
data.
<bullet> Revising the commodity definitions in paragraph (a)(1)
from ``Soybean'' to ``Soybean, seed'' and in paragraph (a)(2) from
``Citrus, oil'' to ``Fruit, citrus, group 10-10, oil''. These revisions
of commodity definitions will help facilitate efficient commodity
searches and does not substantively change the tolerance or, in any
way, modify the permissible level of residues in or on the commodity
listed in the regulation.
<bullet> Modifying the tolerance value in paragraph (a)(1) for
``Mushroom'' from 0.2 ppm to 8 ppm as supported by submitted residue
data.
<bullet> Updating existing crop group tolerances in paragraph
(a)(2) for residues of diflubenzuron from ``Brassica, leafy greens,
subgroup 5B'' to the updated crop group ``Brassica, leafy greens,
subgroup 4-16B''. The newly established ``Brassica, leafy greens,
subgroup 4-16B'' will have an updated (harmonized) tolerance level of
10 ppm.
[[Page 21881]]
40 CFR 180.40(j) states that ``At appropriate times, EPA will amend
tolerances for crop groups that have been superseded by revised crop
groups to conform the pre-existing crop group to the revised crop
group.'' EPA has indicated in updates to its crop group rulemakings
that registration review is one of those appropriate times. See, e.g.,
Tolerance Crop Grouping Program V (85 FR 70985, November 6, 2020 (FRL-
10015-19)).
<bullet> EPA has identified opportunities to harmonize with Codex
MRLs for diflubenzuron and is proposing to modify the tolerance values
in paragraph (a)(1) for ``Cattle, fat'', ``Cattle, meat'', ``Goat,
fat'', ``Goat, meat'', ``Hog, fat'', ``Hog, meat'', ``Horse, fat'',
``Horse, meat'', ``Sheep, fat'', and ``Sheep, meat'' from 0.05 ppm to
0.1 ppm and in paragraph (a)(2) for the newly established crop group
``Brassica, leafy greens, subgroup 4-16B'' from 9 ppm to 10 ppm.
<bullet> Removing the time-limited tolerances from paragraph (b)
for ``Alfalfa, forage'' at 6.0 ppm; ``Alfalfa, hay'' at 6.0 ppm; and
``Lemon'' at 0.8 ppm since the tolerances are expired.
<bullet> Modifying tolerances by removing trailing zeros to reflect
current OECD rounding practices.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the diflubenzuron tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
diflubenzuron residues. Adequate enforcement methodology is available.
C. 40 CFR 180.484; Flutolanil; Case 7010 (Docket ID No. EPA-HQ-OPP-
2008-0148)
EPA is proposing to amend the current tolerances by:
<bullet> Revoking the tolerance from paragraph (a) for ``Rice,
hulls'' at 25.0 ppm. During Registration Review it was determined that
this tolerance should be removed since it is no longer considered a
significant livestock feed item.
<bullet> Modifying tolerance values in paragraph (a) for ``Peanut,
hay'' from 15.0 ppm to 20 ppm based on OECD tolerance calculation
procedures on ``Peanut, hay'', including residues from both band and
broadcast applications.
<bullet> Modifying tolerance values in paragraph (a) for ``Turnip
greens'' from 0.1 ppm to 0.2 ppm, and ``Vegetable, brassica, leafy,
group 5'' from 0.1 ppm to 0.2 ppm based on reconsideration of previous
recommendations, because detectable residues of parent were found in
one field trial on mustard greens.
<bullet> Modifying tolerances by removing trailing zeros to reflect
current OECD rounding practices.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the flutolanil tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
flutolanil residues. Adequate enforcement methodology is available.
D. 40 CFR 180.537; Isoxaflutole; Case 7242 (Docket ID No. EPA-HQ-OPP-
2010-0979)
EPA is proposing to amend the current tolerances by:
<bullet> Modifying the tolerance value for ``Grain, aspirated
fractions'' by removing the trailing zero to reflect current OECD
rounding practices.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the isoxaflutole tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
isoxaflutole residues. Adequate enforcement methodology is available.
E. 40 CFR 180.587; Famoxadone; Case 7038 (Docket ID No. EPA-HQ-OPP-
2015-0094)
EPA is proposing to amend the current tolerances by:
<bullet> Revising the tolerance expressions in paragraphs (a) and
(c) for famoxadone to describe more clearly the scope or coverage of
the tolerances and the method for measuring compliance. Consistent with
EPA policy, the revised tolerance expressions would clarify that (1) as
provided in FFDCA section 408(a)(3), the tolerances cover metabolites
and degradates of famoxadone not specifically mentioned; and (2)
compliance with the specified tolerance levels is to be determined by
measuring the specific compounds mentioned in the tolerance expression.
The revisions to the tolerance expressions would not substantively
change the tolerances or, in any way, modify the permissible level of
residues permitted by the tolerances.
<bullet> Where appropriate, it is the Agency's intention to
harmonize U.S. tolerances with those international MRLs to facilitate
trade. EPA has identified opportunities to harmonize with Codex MRLs
for famoxadone and is proposing to increase the ``Grape, raisin''
tolerance from 4.0 ppm to 5 ppm.
<bullet> Revising the commodity definition in paragraph (a) from
``Milk, fat (reflecting negligible residues in whole milk)'' to ``Milk,
fat''. This revision of commodity definition will help facilitate
efficient commodity searches and does not substantively change the
tolerance or, in any way, modify the permissible level of residues in
or on the commodity listed in the regulation.
<bullet> Updating existing crop group tolerances in paragraph (a)
for residues of famoxadone: from ``Vegetable, fruiting, group 8, except
tomato'' to the updated crop group ``Vegetable, fruiting, group 8-10,
except tomato'' at the same residue levels; and from ``Vegetable,
leafy, except Brassica, group 4, except spinach'' to the two updated
crop groups ``Leafy greens subgroup 4-16A, except spinach'' and ``Leaf
petiole vegetable subgroup 22B'' at the same residue levels. The Agency
is proposing to establish tolerances for the commodities ``Arugula'',
``Cress, garden'', ``Cress, upland'', ``Celtuce'', and ``Fennel,
florence, fresh leaves and stalk'' at 25 ppm that have been displaced
by the updating of the current ``Vegetable, fruiting, group 8, except
tomato'' and ``Vegetable, leafy, except Brassica, group 4, except
spinach'' crop groups. Upon establishment of these new crop groups, and
to prevent redundancy, the Agency proposes to remove tolerances that
will be unnecessary once they are superseded by the tolerances
established for the new crop group, including the tolerances for
``Cilantro, leaves'' that will now be covered under the updated crop
grouping ``Leafy greens subgroup 4-16A, except spinach''.
40 CFR 180.40(j) states that ``At appropriate times, EPA will amend
tolerances for crop groups that have been superseded by revised crop
groups to conform the pre-existing crop group to the revised crop
group.'' EPA has indicated in updates to its crop group rulemakings
that registration review is one of those appropriate times. See, e.g.,
Tolerance Crop Grouping Program V (85 FR 70985, November 6, 2020 (FRL-
10015-19)).
<bullet> Modifying tolerance values in paragraph (a) for
``Tomato'', ``Grape, raisin'', and ``Vegetable, cucurbit, group 9'' by
removing trailing zeros to reflect current OECD rounding practices.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the famoxadone tolerances would be safe, i.e., there is a reasonable
certainty that
[[Page 21882]]
no harm will result to the general population, or specifically to
infants and children, from aggregate exposure to famoxadone residues.
Adequate enforcement methodology is available.
F. 40 CFR 180.610; Aminopyralid; Case 7267 (Docket ID No. EPA-HQ-OPP-
2013-0749)
EPA is proposing to amend the current tolerances by:
<bullet> Modifying tolerance values for ``Corn, field, forage'',
``Corn, field, grain'', ``Corn, field, stover'', ``Wheat, forage'', and
``Wheat, hay'' by removing trailing zeros to reflect current OECD
rounding practices. Additionally, modifying the tolerance values for
``Wheat, straw'' by rounding to the nearest tenth decimal to reflect
current OECD rounding practice.
As discussed in Unit II.D, based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the aminopyralid tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
aminopyralid residues. Adequate enforcement methodology is available.
G. 40 CFR 180.632; Fenazaquin; Case 7447 (Docket ID No. EPA-HQ-OPP-
2020-0081)
EPA is proposing to amend the current tolerances by:
<bullet> Removing the tolerance from paragraph (a) for ``Fruit,
Citrus, Group 10 except Grapefruit'' at 0.5 ppm, which has expired.
<bullet> Where appropriate, it is the Agency's intention to
harmonize U.S. tolerances with those international MRLs to facilitate
trade. EPA has identified opportunities to harmonize with Japanese MRLs
for fenazaquin and is proposing to increase the ``Tea, dried''
tolerance from 9 ppm to 10 ppm and to establish a ``Tea, instant''
tolerance at 10 ppm.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the fenazaquin tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
fenazaquin residues. Adequate enforcement methodology is available.
H. 40 CFR 180.634; Tembotrione; Case 7273 (Docket ID No. EPA-HQ-OPP-
2016-0063)
EPA is proposing to amend the current tolerances by:
<bullet> Modifying tolerances by removing trailing zeros to reflect
current OECD rounding practices.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA has determined that the proposed amendments to
the tembotrione tolerances would be safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or
specifically to infants and children, from aggregate exposure to
tembotrione residues. Adequate enforcement methodology is available.
IV. Proposed Effective and Expiration Date(s)
EPA is proposing that these tolerance actions would be effective on
the date of publication of the final rule in the Federal Register. For
actions in the final rule that lower or revoke existing tolerances, EPA
is proposing to add an expiration date to the existing tolerance that
is six months after the date of publication of the final rule in the
Federal Register, to allow a reasonable interval for producers in
exporting members of the World Trade Organization's Sanitary and
Phytosanitary Measures Agreement to adapt to the requirements.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it proposes to establish or modify
a pesticide tolerance or a tolerance exemption under FFDCA section 408.
This exemption also applies to tolerance revocations for which
extraordinary circumstances do not exist. As such, this exemption
applies to the tolerance revocations in this proposed rule because the
Agency knows of no extraordinary circumstances that warrant
reconsideration of this exemption for those proposed tolerance
revocations.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this action is any significant adverse economic
impact on small entities and that the Agency is certifying that this
action will not have a significant economic impact on a substantial
number of small entities because the action has no net burden on small
entities subject to this rulemaking. This determination takes into
account an EPA analysis for tolerance establishments and modifications
that published in the Federal Register of May 4, 1981 (46 FR 24950
(FRL-1809-5)) and for tolerance revocations on December 17, 1997 (62 FR
66020 (FRL-5753-1)). Additionally, in a 2001 memorandum, EPA determined
that eight conditions must all be satisfied in order for an import
tolerance or tolerance exemption revocation to adversely affect a
significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. See
Memorandum from Denise Keehner, Division Director, Biological and
Economic Analysis Division, Office of Pesticide Programs, entitled
``RFA/SBREFA Certification for Import Tolerance Revocation'' and dated
May 25, 2001, which is available in docket ID No. EPA-HQ-OPP-2005-0322
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
For the pesticides named in this rulemaking, EPA concludes that
there is no reasonable expectation that residues of the pesticides for
tolerances listed in this rulemaking for revocation will be found on
the commodities discussed in this rulemaking, and the Agency knows of
no extraordinary circumstances that exist as to the present proposed
rule that would change EPA's previous analyses.
Any comments about the Agency's determination for this rulemaking
should be submitted to EPA along with comments on the proposed rule and
will be addressed in the final rule.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
[[Page 21883]]
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
state, local or tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children. However,
EPA's 2021 Policy on Children's Health applies to this action.
This rulemaking proposes tolerance actions under the FFDCA, which
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 . . .'' (FFDCA 408(b)(2)(C)). The Agency's
consideration is documented in the pesticide-specific registration
review documents, located in each chemical docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
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 13, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth in the preamble, EPA is proposing to
amend 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. Amend Sec. 180.190 by revising and republishing paragraph (a) to
read as follows:
Sec. 180.190 Diphenylamine; tolerances for residues.
(a) General. Tolerances are established for residues of
diphenylamine, including its metabolites and degradates, in or on the
commodities in Table 1 to Paragraph (a). Compliance with the tolerance
levels specified in Table 1 to Paragraph (a) is to be determined by
measuring only diphenylamine, in or on the commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple....................................................... 10
Apple, wet pomace........................................... 30
Pear........................................................ 5
------------------------------------------------------------------------
* * * * *
0
3. Amend Sec. 180.377 by:
0
a. Revising and republishing the table in paragraph (a)(1);
0
b. Revising and republishing the table in paragraph (a)(2);
0
c. Removing and reserving paragraph (b); and
0
d. Revising and republishing the table in paragraph (c).
The revisions and additions read as follows:
Sec. 180.377 Diflubenzuron; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Artichoke, globe............................................ 6
Cattle, fat................................................. 0.1
Cattle, meat................................................ 0.1
Cotton, gin byproducts...................................... 30
Cottonseed subgroup 20C..................................... 0.2
Egg......................................................... 0.07
Goat, fat................................................... 0.1
Goat, meat.................................................. 0.1
Hog, fat.................................................... 0.1
Hog, meat................................................... 0.1
Horse, fat.................................................. 0.1
Horse, meat................................................. 0.1
Milk........................................................ 0.05
Mushroom.................................................... 8
Poultry, fat................................................ 0.1
Poultry, meat byproducts.................................... 0.08
Poultry, meat............................................... 0.05
Sheep, fat.................................................. 0.1
Sheep, meat................................................. 0.1
Soybean, seed............................................... 0.05
Soybean, hulls.............................................. 0.5
------------------------------------------------------------------------
(2) * * *
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls............................................... 6
Barley, grain............................................... 0.06
Barley, hay................................................. 3
Barley, straw............................................... 1.8
Brassica, leafy greens, subgroup 4-16B...................... 10
Carrot, roots............................................... 0.2
Cattle, meat byproducts..................................... 0.15
Fruit, citrus, group 10-10, oil............................. 32
Fruit, citrus, group 10-10.................................. 3
Goat, meat byproducts....................................... 0.15
Grain, aspirated fractions.................................. 11
Grass, forage, fodder and hay, group 17..................... 6
Hog, meat byproducts........................................ 0.15
Horse, meat byproducts...................................... 0.15
Oat, forage................................................. 7
Oat, grain.................................................. 0.06
Oat, hay.................................................... 6
Oat, straw.................................................. 3.5
Peanut...................................................... 0.1
Peanut, hay................................................. 55
Peanut, refined oil......................................... 0.2
Peach subgroup 12-12B....................................... 0.5
Pear........................................................ 0.5
Pepper/eggplant subgroup 8-10B.............................. 1
Plum subgroup 12-12C........................................ 0.5
Nut, tree, group 14-12...................................... 0.2
[[Page 21884]]
Rice, grain................................................. 0.02
Sheep, meat byproducts...................................... 0.15
Turnip greens............................................... 9
Wheat, forage............................................... 7
Wheat, grain................................................ 0.06
Wheat, hay.................................................. 6
Wheat, straw................................................ 3.5
------------------------------------------------------------------------
(b) [Reserved]
(c) * * *
Table 3 to Paragraph (c)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................. 6
Alfalfa, hay................................................ 20
Alfalfa, seed............................................... 0.9
------------------------------------------------------------------------
* * * * *
0
4. Amend Sec. 180.484 by:
0
a. Revising and republishing the table in paragraph (a); and
0
b. Revising the table in paragraph (d) by adding the heading ``Table 2
to Paragraph (d)'' and revising the entries for ``Wheat, bran'' and
``Wheat, straw''.
The revisions and additions read as follows:
Sec. 180.484 Flutolanil; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................. 0.1
Cattle, kidney.............................................. 1
Cattle, liver............................................... 2
Cattle, meat byproducts..................................... 0.05
Cattle, meat................................................ 0.05
Cotton, gin byproducts...................................... 0.2
Cotton, undelinted seed..................................... 0.2
Egg......................................................... 0.05
Goat, fat................................................... 0.1
Goat, kidney................................................ 1
Goat, liver................................................. 2
Goat, meat byproducts....................................... 0.05
Goat, meat.................................................. 0.05
Hog, fat.................................................... 0.1
Hog, kidney................................................. 1
Hog, liver.................................................. 2
Hog, meat byproducts........................................ 0.05
Hog, meat................................................... 0.05
Horse, fat.................................................. 0.1
Horse, kidney............................................... 1
Horse, liver................................................ 2
Horse, meat byproducts...................................... 0.05
Horse, meat................................................. 0.05
Milk........................................................ 0.05
Peanut...................................................... 0.5
Peanut, hay................................................. 20
Peanut, meal................................................ 1
Potato...................................................... 0.2
Potato, wet peel............................................ 0.3
Poultry, fat................................................ 0.05
Poultry, meat............................................... 0.05
Poultry meat byproducts..................................... 0.05
Rice, bran.................................................. 10
Rice, grain................................................. 7
Sheep, fat.................................................. 0.1
Sheep, kidney............................................... 1
Sheep, liver................................................ 2
Sheep, meat................................................. 0.05
Sheep, meat byproducts...................................... 0.05
Soybean, forage............................................. 8
Soybean, hay................................................ 2.5
Soybean, seed............................................... 0.2
Turnip greens............................................... 0.2
Vegetable, brassica, leafy, group 5......................... 0.2
------------------------------------------------------------------------
* * * * *
(d) * * *
Table 2 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Wheat, bran................................................. 0.2
* * * * *
Wheat, straw................................................ 0.2
------------------------------------------------------------------------
* * * * *
0
5. Amend Sec. 180.537(a) by adding the table heading ``Table 1 to
Paragraph (a)'' and revising the entry for ``Grain, aspirated
fractions'' to read as follows:
Sec. 180.537 Isoxaflutole; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Grain, aspirated fractions.................................. 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
0
6. Amend Sec. 180.587 by:
0
a. Revising and republishing paragraph (a);
0
b. Revising the introductory text in paragraph (c); and
0
c. Adding the table heading ``Table 2 to Paragraph (c)'' to the table
in paragraph (c).
The revisions and additions read as follows:
Sec. 180.587 Famoxadone; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide famoxadone, including its metabolites and degradates, in or
on the commodities listed in Table 1 to Paragraph (a). Compliance with
the tolerance levels specified in Table 1 to Paragraph (a) is to be
determined by measuring only famoxadone (5-methyl-5-(4-phenoxyphenyl)-
3-(phenylamino)-2,4-oxazolidinedione) in or on the commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Arugula..................................................... 25
Caneberry subgroup 13-07A................................... 10
Cattle, fat................................................. 0.02
Cattle, liver............................................... 0.05
Celtuce..................................................... 25
Cress, garden............................................... 25
Cress, upland............................................... 25
Fennel, florence, fresh leaves and stalk.................... 25
Goat, fat................................................... 0.02
Goat, liver................................................. 0.05
Grape, raisin \1\........................................... 5
Hop, dried cone............................................. 80
Horse, fat.................................................. 0.02
Horse, liver................................................ 0.05
Leaf petiole vegetable subgroup 22B......................... 25
Leafy greens subgroup 4-16A, except spinach................. 25
Milk, fat................................................... 0.06
Onion, bulb, subgroup 3-07A................................. 0.45
Onion, green, subgroup 3-07B................................ 40
Potato...................................................... 0.02
Sheep, fat.................................................. 0.02
Sheep, liver................................................ 0.05
Spinach..................................................... 50
Tomato...................................................... 1
Vegetable, cucurbit, group 9................................ 0.3
Vegetable, fruiting, group 8-10, except tomato.............. 4
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of May 15, 2003.
* * * * *
(c) Tolerances with regional registrations. Tolerances with a
regional registration as defined in Sec. 180.1(l) are established for
residues of the fungicide famoxadone, including its metabolites and
degradates, in or on the commodities listed in Table 2 to Paragraph
(c). Compliance with the tolerance levels specified in Table 2 to
Paragraph (c) is to be determined by measuring only famoxadone (5-
methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-2,4-oxazolidinedione) in or
on the commodity.
Table 2 to Paragraph (c)
* * * * *
0
7. Amend Sec. 180.610 by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)(1)'' to the
table in paragraph (a)(1);
0
b. Amending the table in paragraph (a)(1) by revising the tolerance
entries
[[Page 21885]]
for ``Corn, field, forage'', ``Corn, field, grain'', ``Corn, field,
stover'', ``Wheat, forage'', ``Wheat, hay'', and ``Wheat, straw''; and
0
c. Adding the table heading ``Table 2 to Paragraph (a)(2)'' to the
table in paragraph (a)(2).
The revisions and additions read as follows:
Sec. 180.610 Aminopyralid; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Corn, field, forage......................................... 0.3
Corn, field, grain.......................................... 0.2
Corn, field, stover......................................... 0.2
* * * * *
Wheat, forage............................................... 2
* * * * *
Wheat, hay.................................................. 4
Wheat, straw................................................ 0.3
------------------------------------------------------------------------
(2) * * *
Table 2 to Paragraph (a)(2)
* * * * *
0
8. Amend Sec. 180.632 by amending the table in paragraph (a) by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)'' to the table;
0
b. Removing the entry ``Fruit, Citrus, Group 10 except Grapefruit'';
0
c. Revising the entry ``Tea, dried'';
0
d. Adding the entry ``Tea, instant'';
0
e. Revising footnote 1; and
0
f. Removing footnote 2.
The revisions and additions read as follows:
Sec. 180.632 Fenazaquin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tea, dried \1\.............................................. 10
Tea, instant \1\............................................ 10
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.
* * * * *
0
9. Amend Sec. 180.634 by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)(1)'';
0
b. In the table in paragraph (a)(1), by revising the entries for
``Cattle, liver'', ``Corn, field, forage'', ``Corn, sweet, stover'',
``Goat, liver'', ``Horse, liver'', and ``Sheep, liver'';
0
c. Adding table heading ``Table 2 to Paragraph (a)(2)'' in paragraph
(a)(2).
The revisions and additions read as follows:
Sec. 180.634 Tembotrione; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, liver............................................... 0.4
* * * * *
Corn, field, forage......................................... 0.6
* * * * *
Corn, sweet, stover......................................... 0.6
Goat, liver................................................. 0.4
* * * * *
Horse, liver................................................ 0.4
* * * * *
Sheep, liver................................................ 0.4
* * * * *
------------------------------------------------------------------------
(2) * * *
Table 2 to Paragraph (a)(2)
* * * * *
[FR Doc. 2025-09108 Filed 5-21-25; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.