Proposed Rule2024-22809
Sulfentrazone; Pesticide Tolerances
Primary source
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Published
October 3, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) proposes to establish tolerances for residues of sulfentrazone in or on corn, pop, grain and corn, pop, stover under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 192 (Thursday, October 3, 2024)</title>
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[Federal Register Volume 89, Number 192 (Thursday, October 3, 2024)]
[Proposed Rules]
[Pages 80446-80449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22809]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0169; FRL-12202-01-OCSPP]
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) proposes
to establish tolerances for residues of sulfentrazone in or on corn,
pop, grain and corn, pop, stover under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: Comments must be received on or before December 2, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2024-0169, through the Federal eRulemaking
Portal at: <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: 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#da889e9c8894b5aeb3b9bfa99abfaabbf4bdb5ac"><span class="__cf_email__" data-cfemail="05574143574b6a716c666076456075642b626a73">[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 applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
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 to establish tolerances 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 is now proposing to establish the tolerances
required to support the use on popcorn and rectify this oversight.
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. 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 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.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
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>.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
[[Page 80447]]
discussed in this document, compared to the general population.
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 actions involving the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
the tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
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 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--Human Health Risk Assessment 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
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 the rulemaking published in the April 13, 2018,
rulemaking, see Unit III.C., although the new exposure assessment
incorporates the additional dietary exposure from the proposed
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 April 13, 2018,
rulemaking. 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
April 13, 2018, rulemaking.
The recommended adult residential exposure scenario for use in the
aggregate assessment reflects short-term dermal exposure from
applications to turf via backpack sprayer. The recommended residential
exposure scenario for use in the combined short- and intermediate-term
aggregate assessment for children ages 1 to 2 years old reflects dermal
and hand-to-mouth exposures from post-application exposure to turf
applications.
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 April 13, 2018,
rulemaking.
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 groups 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. 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.
[[Page 80448]]
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#433126302a2736262e26372b2c2730032633226d242c35"><span class="__cf_email__" data-cfemail="e0928593898495858d8594888f8493a0859081ce878f96">[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).
No Codex MRLs have been established for sulfentrazone on popcorn.
IV. Conclusion
Tolerances are proposed 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/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 and Executive
Order 14094: Modernizing Regulatory Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR
21879, April 11, 2023), because it proposes to establish or modify a
pesticide tolerance or a tolerance exemption under FFDCA section 408.
B. 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.
C. 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>.
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.
D. 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.
E. 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.
F. 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.
G. 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.D. generally, and in Unit III. in the context of
the individual chemicals addressed in this action.
H. 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.
I. 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.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that the human health and environmental conditions
that exist prior to this action do not result in disproportionate and
adverse effects on communities with EJ concerns as described in
Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR
25251, April 26, 2023).
[[Page 80449]]
Furthermore, EPA believes that this action is not likely to result in
new disproportionate and adverse effects on communities with
environmental justice concerns. As discussed in more detail in the
pesticide specific risk assessments conducted as part of the
registration review for each pesticide identified in Unit III., EPA has
considered the safety risks for the pesticides subject to this
rulemaking and in the context of the tolerance actions set out in this
rulemaking. See also Unit I.D.3.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 27, 2024.
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. 180.498, by revising table 2 to paragraph (a)(2) by
adding, in alphabetical order, the commodities ``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
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* * * * *
Corn, pop, grain........................................... 0.15
Corn, pop, stover.......................................... 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-22809 Filed 10-2-24; 8:45 am]
BILLING CODE 6560-50-P
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