[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 [www.gpo.gov]
[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: https://www.regulations.gov. 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 https://www.epa.gov/dockets.

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 
https://www.regulations.gov. If you wish to include CBI in your 
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov/dockets/commenting-epa-dockets.
    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 https://www.regulations.gov.
    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 https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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 https://www.regulations.gov.
    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
------------------------------------------------------------------------
 
                                * * * * *
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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