Rule2025-08468
Sulfentrazone; 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
May 19, 2025
Effective
May 19, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is finalizing tolerance actions it previously proposed on its own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) for residues of sulfentrazone in or on corn, pop, grain and corn, pop, stover.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 95 (Monday, May 19, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 95 (Monday, May 19, 2025)]
[Rules and Regulations]
[Pages 21237-21241]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08468]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0169; FRL-12202-02-OCSPP]
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing tolerance actions it previously proposed on its own
initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) for
residues of sulfentrazone in or on corn, pop, grain and corn, pop,
stover.
DATES: This regulation is effective May 19, 2025. Objections and
requests for hearings must be received on or before July 18, 2025, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.D. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0169, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#e4b6a0a2b6aa8b908d878197a4819485ca838b92"><span class="__cf_email__" data-cfemail="4d1f090b1f032239242e283e0d283d2c632a223b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 21238]]
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 applies 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 finalizing tolerance actions that the Agency previously
proposed on its own initiative under section 408(e) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), for residues
of the herbicide sulfentrazone in or on corn, pop, grain at 0.15 parts
per million (ppm) and corn, pop, stover at 0.3 ppm. EPA had previously
registered the use of sulfentrazone on field corn and established
tolerances on corn, field, grain at 0.15 ppm, and corn, field, stover
at 0.30 ppm. As part of that process, the use on popcorn was added to
the sulfentrazone label (same use pattern as field corn), but, in
error, separate tolerances on corn, pop, grain and corn, pop, stover
were not established. EPA proposed establishing the tolerances required
to support the use on popcorn in order to rectify this oversight as
described in the proposed rule and is now finalizing that proposal in
this rulemaking.
Four comments were received in response to the proposed rule. EPA's
response to these comments is discussed in Unit III.C.
C. What is EPA's authority for taking this action?
FFDCA section 408(e), 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. 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 rulemaking.
FFDCA section 408(b)(2)(A)(i) 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.'' FFDCA section
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C)
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. . . .''
D. 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. 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.
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 include the chemical specific docket ID
number as provided in the heading of this rulemaking as part of 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 July 18, 2025.
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing for inclusion in the public docket 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 CBI or other information whose disclosure is restricted by statute.
If you wish to include CBI in your request, 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 not marked confidential pursuant to 40 CFR part 2 may
be disclosed publicly by EPA without prior notice.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), 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, consistent with FFDCA
section 408(b)(2), for tolerances for residues of sulfentrazone on
corn, pop, grain and corn, pop, stover. EPA's assessment of exposures
and risks associated with establishing these tolerances follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published several tolerance rulemakings for
sulfentrazone in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to sulfentrazone and established
tolerances for residues of that chemical. EPA is incorporating
previously published
[[Page 21239]]
sections of those rulemakings that remain unchanged, as described
further in this rulemaking. Specific information on the risk assessment
conducted in support of this action, including on the studies received
and the nature of the adverse effects caused by sulfentrazone, can be
found in the document titled ``Sulfentrazone--Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Establishment of Tolerances for Residues in/on Pop
Corn Commodities'' which is available in the docket for this action at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Toxicological profile. For a discussion of the Toxicological
Profile of sulfentrazone, see Unit III.A. of the rulemaking published
in the Federal Register of April 13, 2018 (83 FR 15977) (FRL-9975-77).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment of sulfentrazone, see Unit III.B. of the rulemaking
that published in the Federal Register of September 12, 2014 (79 FR
54620) (FRL-9915-47).
Exposure assessment. Much of the exposure assessment remains
unchanged from that discussed in Unit III.C. of the rulemaking that
published in the Federal Register of April 13, 2018, although the new
exposure assessment incorporates the additional dietary exposure from
the finalized tolerances.
In conducting both the acute and chronic dietary exposure
assessments, EPA used the Dietary Exposure Evaluation Model, Food
Consumption Intake Database (DEEM-FCID, ver.4.02), which incorporates
consumption data from United States Department of Agriculture (USDA)
National Health and Nutrition Examination Survey, What We Eat in
America, NHANES/WWEIA; 2005-2010). As to residue levels in food, EPA
assumed tolerance-level residues, 100 percent crop treated (PCT), and
EPA default processing factors.
EPA has concluded that sulfentrazone does not pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
Anticipated residue and percent crop treated information. EPA did
not use anticipated residue or PCT information in the dietary
assessment for sulfentrazone. Tolerance-level residues and 100 PCT were
assumed for all food commodities.
Drinking water and non-occupational exposures. For a summary of the
drinking water numbers used, see Unit III.C.2. of the rulemaking that
published in the Federal Register of April 13, 2018. An acute estimated
drinking water concentration (EDWC) of 134 parts per billion (ppb) and
a chronic EDWC of 98 ppb were used in the acute and chronic dietary
exposure assessments, respectively.
Sulfentrazone is currently registered for the following uses that
could result in residential exposures: Residential home lawns/turf and
recreational turf, such as golf courses. For a summary of the
assumptions used for residential exposures, see Unit III.C.3. of the
rulemaking that published in the Federal Register of April 13, 2018.
The adult residential exposure scenario used in the aggregate
assessment reflects short-term dermal exposure from applications to
turf via backpack sprayer. The residential exposure scenario used in
the combined short- and intermediate-term aggregate assessment for
children ages 1 to 2 years old, the population subgroup with the
highest exposure estimate, reflects dermal and hand-to-mouth exposures
from post-application exposure to turf applications, which is
protective of the other children subpopulations.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to sulfentrazone and any other substances. For
the purposes of this action, therefore, EPA has not assumed that
sulfentrazone has a common mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there is reliable data showing that the safety of infants and
children would be adequately protected if the Food Quality Protection
Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for
that decision are articulated in Unit III.D. of the rulemaking that
published in the Federal Register of April 13, 2018.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population-adjusted dose (aPAD)
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and
chronic-term aggregate risks are evaluated by comparing the estimated
total food, water, and residential exposure to the appropriate points
of departure to ensure that an adequate margin of exposure (MOE)
exists.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD; the risk estimate is
1.1% of the aPAD for all infants less than 1-year-old and 6.4% of the
aPAD for females 13 to 49 years old, the population group with the
highest risk estimate. Chronic dietary (food and drinking water) risks
are below the Agency's level of concern of 100% of the cPAD; they
utilize 7.6% of the cPAD for all infants less than 1-year-old, the
population group receiving the greatest exposure.
The combined short-term food, water, and residential exposures
result in an aggregate MOE of 490 for adults. The combined short- and
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 260 for children 1 to 2 years old, the population
subgroup for children with the greatest exposure, and is protective of
the older children subpopulations. MOEs below 100 are of concern; these
MOEs are above 100 and therefore are not of concern.
Because sulfentrazone is classified as ``not likely to be
carcinogenic to humans,'' EPA has concluded that aggregate exposure to
sulfentrazone is not likely to pose a cancer risk.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to sulfentrazone residues.
III. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, gas chromatography (GC), 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#027067716b6677676f67766a6d6671426772632c656d74"><span class="__cf_email__" data-cfemail="cebcabbda7aabbaba3abbaa6a1aabd8eabbeafe0a9a1b8">[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).
[[Page 21240]]
No Codex MRLs have been established for sulfentrazone on popcorn.
C. Response to Comments
Four comments were received in response to the Notices of Filing.
One comment stated in part that ``The public should not be the test
subject for companies trying new products.'' The existing legal
framework provided by section 408 of the FFDCA authorizes EPA to
establish tolerances when it determines that 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 sulfentrazone tolerance is safe.
The commenter has provided no information indicating that a safety
determination cannot be supported.
The other three comments received were in support of the tolerance
being established but requested EPA conduct enforcement checks of grain
and stover for residues of sulfentrazone, monitoring of water bodies
for sulfentrazone levels, and after the tolerance has been established,
``Develop a system for when farms do not meet requirements''. Although
the EPA sets safe residue tolerances for pesticides, EPA is not
responsible for the enforcement of the tolerances once they have been
established. Under FFDCA, the U.S. Food and Drug Administration (FDA)
is the federal agency that enforces the tolerance regulations and
ensures that pesticide residues in food and feed commodities are within
legal limits. See, e.g., 21 U.S.C. 371, 372, 374.
IV. Conclusion
Tolerances are established for residues of sulfentrazone on corn,
pop, grain at 0.15 ppm and corn, pop, stover at 0.3 ppm.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/lawsregulations/laws-and-executive-orders">https://www.epa.gov/lawsregulations/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 establishes or modifies 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 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. As discussed in the proposed rule,
this determination takes into account several EPA analyses of potential
small entity impacts for tolerance actions. EPA did not receive any
comments about the Agency's determination for this rulemaking.
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
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 as
discussed in Unit II.
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.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action does not meet the
criteria set forth in 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 6, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth in the preamble, EPA is amending 40 CFR
part 180 as follows:
[[Page 21241]]
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.498, amend table 2 to paragraph (a)(2) by adding, in
alphabetical order, entries for ``Corn, pop, grain'' and ``Corn, pop,
stover'' to read as follows:
Sec. 180.498 Sulfentrazone; tolerances for residues.
(a) * * *
(2) * * *
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Corn, pop, grain........................................... 0.15
Corn, pop, stover.......................................... 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2025-08468 Filed 5-16-25; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 19, 2025.
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.