Proposed Rule2025-15095
Fenoxaprop-Ethyl, Flufenpyr-Ethyl, Imazapyr, Maleic Hydrazide, Pyrazon, Quinclorac, Triflumizole, et al.; Tolerance and Tolerance Exemption Actions
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
August 8, 2025
Issuing agencies
Environmental Protection Agency
Abstract
On February 5, 2019, the Environmental Protection Agency (EPA or Agency) proposed tolerance and tolerance exemption actions for several pesticides under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is issuing this supplemental notice of proposed rulemaking to modify the previously proposed tolerance exemptions for one of those pesticides: maleic hydrazide.
Full Text
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<title>Federal Register, Volume 90 Issue 151 (Friday, August 8, 2025)</title>
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[Federal Register Volume 90, Number 151 (Friday, August 8, 2025)]
[Proposed Rules]
[Pages 38426-38429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15095]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0418; FRL-6704-02-OCSPP]
RIN 2070-ZA16
Fenoxaprop-Ethyl, Flufenpyr-Ethyl, Imazapyr, Maleic Hydrazide,
Pyrazon, Quinclorac, Triflumizole, et al.; Tolerance and Tolerance
Exemption Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: On February 5, 2019, the Environmental Protection Agency (EPA
or Agency) proposed tolerance and tolerance exemption actions for
several pesticides under the Federal Food, Drug, and Cosmetic Act
(FFDCA). EPA is issuing this supplemental notice of proposed rulemaking
to modify the previously proposed tolerance exemptions for one of those
pesticides: maleic hydrazide.
DATES: Comments must be received on or before September 8, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0418, 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: Robert Little, Pesticide Re-Evaluation
Division (7508M), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-2219; email address:
<a href="/cdn-cgi/l/email-protection#bbd7d2cfcfd7de95c9d4d9dec9cffbdecbda95dcd4cd"><span class="__cf_email__" data-cfemail="fd919489899198d38f929f988f89bd988d9cd39a928b">[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 issuing this supplemental notice of proposed rulemaking to
modify the exemptions from the requirement of a tolerance for residues
of the pesticide maleic hydrazide previously proposed in Fenoxaprop-
ethyl, Flufenpyr-ethyl, Imazapyr, Maleic hydrazide, Pyrazon,
Quinclorac, Triflumizole, et al.; Proposed Tolerance and Tolerance
Exemption Actions (FRL-9970-24; 84 FR 1691, February 5, 2019) (``2019
Proposed Rule''). Specifically, the Agency previously proposed to
establish tolerance exemptions for residues of maleic hydrazide when
used as a plant growth regulator or herbicide in or on onion, bulb and
potato, and when present in or on potato chips as a result of
application to the growing potato plant. EPA is now proposing to
establish a single tolerance exemption for residues of maleic hydrazide
when used as a plant growth regulator or herbicide, without limiting
the exemption to specific commodities. Further discussion of this
action and the Agency's rationale can be found in Unit III of this
rulemaking.
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 for the pesticide. Any tolerance changes
identified as necessary or appropriate during registration review 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), Interim Decision (ID), Proposed Final
Decision (PFD), and Final Decision (FD)). Registration review decision
documents for maleic hydrazide can be found in the public docket at
<a href="https://www.regulations.gov/">https://www.regulations.gov/</a> in docket identification (ID) number EPA-
HQ-OPP-2017-0418.
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. EPA has determined that
such good cause exists here. The Agency previously issued the 2019
[[Page 38427]]
Proposed Rule for a 60-day public comment period that closed on April
8, 2019, and did not receive any comments. In the 2019 Proposed Rule,
EPA proposed tolerance and tolerance exemption actions that were
identified as necessary or appropriate during registration review for
several pesticides. This supplemental notice of proposed rulemaking
modifies the proposed tolerance exemption for only one of those
pesticides, maleic hydrazide; the remainder of the 2019 Proposed Rule
is unchanged. EPA finds that it would be in the public interest to have
a shorter 30-day public comment period for this supplemental notice to
allow the Agency to move forward sooner with issuing a final rule
implementing the necessary or appropriate actions that it previously
proposed while also providing an adequate opportunity for public
comment on the discrete modification described in this supplemental
notice. EPA is seeking comment only on the issues discussed in this
supplemental notice and is not reopening comment on any other aspects
of the 2019 Proposed Rule. After consideration of public comments on
this supplemental notice, EPA intends to finalize this action and all
applicable actions of the 2019 Proposed Rule in one final rule.
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. How can I file an objection or hearing request?
This supplemental notice of proposed rulemaking provides a 30-day
public comment period. After considering comments that are received in
response to this supplemental notice, 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. 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. Additional
information about pesticide registration review is available at <a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
C. EPA's Safety Assessment
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 maleic hydrazide. As part of registration review, the
Agency has published a risk assessment detailing the risks from
[[Page 38428]]
aggregate exposure, including to infants and children, for maleic
hydrazide. The toxicity and exposure analyses, which support the safety
determination contained in Unit III., can be found in the human health
risk assessment document and related registration review decision
documents for maleic hydrazide in the public docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPP-2009-0387.
After considering all available information, EPA has determined it
is appropriate based on the underlying safety assessments to take the
tolerance exemption action being proposed in this supplemental notice
of proposed rulemaking.
III. Proposed Modification
During registration review, EPA determined that there are no risks
of concern from exposure to residues of maleic hydrazide, based on its
low toxicity and lack of toxicological endpoints for human health risk
assessment. The Agency concluded that it would be appropriate to revoke
the existing tolerances for residues of maleic hydrazide in or on
``Onion, bulb'', ``Potato'', and ``potato, chips'' and establish an
exemption from the requirement of a tolerance for all commodities
instead. In the registration review supporting document Maleic
Hydrazide, and its Potassium Salt: Qualitative Risk Assessment for
Registration Review and Screen of the Hydrazine Impurity, dated June
18, 2014 (``Maleic Hydrazide Risk Assessment,''), EPA identified as
appropriate a single tolerance exemption covering all commodities, to
read as follows: ``An exemption from the requirement of a tolerance is
established for residues of the pesticide maleic hydrazide, including
its metabolites and degradates, when used as a plant growth regulator
or herbicide.'' The Agency further stated that if the existing
tolerances were maintained and not replaced with a tolerance exemption,
then additional tolerances for maleic hydrazide residues in livestock
commodities would need to be established.
In the 2019 Proposed Rule, the Agency proposed to revoke the
existing tolerances for ``Onion, bulb'', ``Potato'', and ``potato,
chips''. However, rather than proposing to establish a single tolerance
exemption covering all commodities, EPA instead proposed to establish
tolerance exemptions covering only the commodities for which tolerances
existed. Specifically, the Agency proposed to establish tolerance
exemptions for residues of maleic hydrazide when used as a plant growth
regulator or herbicide in or on onion, bulb and potato, and when
present in or on potato chips as a result of application of maleic
hydrazide to the growing potato plant. Moreover, the Agency did not
propose to establish tolerances or exemptions for any livestock
commodities.
This supplemental notice of proposed rulemaking modifies the
previously proposed tolerance exemptions by proposing to establish a
single tolerance for all commodities, rather than limiting the
exemption to specific commodities. Specifically, EPA is now proposing
to establish a single tolerance exemption for residues of maleic
hydrazide when used as a plant growth regulator or herbicide. This
proposed modification is supported by the registration review of maleic
hydrazide and is consistent with the Maleic Hydrazide Risk Assessment.
Moreover, a tolerance exemption covering all commodities would
eliminate the need for the Agency to establish tolerances or exemptions
for livestock commodities. All supporting documents for the
registration review of maleic hydrazide, including the Maleic Hydrazide
Risk Assessment, can be found in the public docket online at <a href="https://www.regulations.gov">https://www.regulations.gov</a> using the docket ID number EPA-HQ-OPP-2009-0387.
As discussed in Unit II.D., based on the supporting registration
review documents, EPA concludes there is a reasonable certainty that no
harm will result to the general population, or specifically to infants
and children, from aggregate exposure to maleic hydrazide residues. The
proposed exemption from the requirement of a tolerance is considered
safe. An analytical method is not needed for enforcement purposes since
the Agency is not proposing to establish a numerical tolerance for
residues of maleic hydrazide in or on any food commodities.
IV. Proposed Effective Date
EPA is proposing that this tolerance exemption action would be
effective on the date of publication of the final rule in the Federal
Register.
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.
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 or exemptions from the
requirement of 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)).
Any comments about the Agency's determination for this rulemaking
should be submitted to EPA along with comments on the supplemental
notice of proposed rulemaking 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
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
Sate, 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
[[Page 38429]]
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 supplemental notice of proposed rulemaking modifies proposed
tolerance exemption 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 or exemption 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) and (c)(2)(B)). The
Agency's consideration is documented in the maleic hydrazide
registration review documents, located in docket ID number EPA-HQ-OPP-
2017-0418 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: August 5, 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. Remove Sec. 180.175.
0
3. Add Sec. 180.1349 to Subpart D to read as follows:
Sec. 180.1349 Maleic hydrazide; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of the pesticide maleic hydrazide, including its metabolites
and degradates, when used as a plant growth regulator or herbicide.
[FR Doc. 2025-15095 Filed 8-7-25; 8:45 am]
BILLING CODE 6560-50-P
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