[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Rules and Regulations]
[Pages 81010-81013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23085]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0269; FRL-12097-01-OCSPP]


Flazasulfuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
flazasulfuron in or on Avocado. ISK Biosciences Corporation requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 7, 2024. Objections and 
requests for hearings must be received on or before December 6, 2024, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0269, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room, and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, 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#7f2d3b392d31100b161c1a0c3f1a0f1e51181009"><span class="__cf_email__" data-cfemail="7a283e3c2834150e13191f093a1f0a1b541d150c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

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).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. 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 identify 
docket ID number EPA-HQ-OPP-2023-0269 in 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 
December 6, 2024. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2023-0269, by one of 
the following methods:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 20, 2023 (88 FR 64909) (FRL-
10578-08-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 3F9055) by ISK Biosciences Corporation, 7470 Auburn Road, 
Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.655 
be amended by a establishing tolerance for residues of the herbicide 
Flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-
pyridylsulfonyl)urea, in or on Avocado at 0.01 parts per

[[Page 81011]]

million (ppm). That document referenced a summary of the petition 
prepared by ISK Biosciences Corporation, the registrant, which is 
available in the docket, https://www.regulations.gov. One comment was 
received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA 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. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in 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 for flazasulfuron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with flazasulfuron 
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 rulemakings, and republishing the same sections are 
unnecessary. 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 evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by flazasulfuron as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in Unit 
II.A, of the May 25, 2017, rulemaking.
    There are no changes to the prior endpoint selections from the 2015 
Draft Risk Assessment for Registration Review. In that risk assessment 
some studies used for endpoint selection were judged to have 
conservative NOAEL/LOAEL values because they were not updated to 
reflect current standards for evaluating toxicity studies. Such updates 
would likely result in higher NOAEL/LOAEL values and given the current 
risk picture, would not impact the overall findings of this risk 
assessment. Therefore, these studies were not re-evaluated in 
conjunction with this risk assessment. A detailed description of 
endpoint selection can be found at https://www.regulations.gov, 
``Flazasulfuron: Human Health Draft Risk Assessment for Registration 
Review, dated September 15, 2015.
    The acute and chronic dietary risk assessments for flazasulfuron 
are unrefined assessments which incorporate tolerance-level residues, 
100% crop treated (CT), and modeled estimated drinking water 
concentrations (EDWCs). The processing factors were set to 1 for the 
processed commodities that are in table 1 (860.1000). A default 
processing factor was used for hazelnut. The results of acute dietary 
(food and drinking water) analysis are below the Agency's level of 
concern (LOC) for all population subgroups. The acute dietary risk 
estimates utilized <1.0% of the acute population-adjusted dose (aPAD) 
for the general U.S. population and 3.3% of the aPAD for infants (<1 
years old), the most highly exposed population subgroup. The results of 
chronic dietary (food and drinking water) analysis are below the 
Agency's LOC for all population subgroups. The chronic dietary risk 
estimates utilized 8.8% of the chronic population-adjusted dose (cPAD) 
for the general U.S. population and 32% of the cPAD for infants (<1 
years old), the most highly exposed population subgroup. Based on the 
data summarized in Unit III.A. of the May 25, 2017, rulemaking, EPA has 
concluded that flazasulfuron does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    EDWCs from the previous drinking water assessment are considered 
protective of the new use and may be used to represent EDWCs for the 
proposed new use on avocados. EDWCs include total toxic residues of 
flazasulfuron (i.e., all of the degradates: DTPU, DTPP, HTPP, TPSA, 
ADMP, and 2,3-GTF). The highest EDWCs from the previous assessment were 
from ground water and were modeled using Pesticide Root Zone Model for 
Ground Water (PRZM-GW). EPA's conclusions remain unchanged from Unit 
II. C.2 of the May 25, 2017, rulemaking.
    There is no residential exposure associated with the proposed use 
in this action; however, there is residential exposure from an existing 
registered use on turf that has been previously assessed using current 
data and assumptions for flazasulfuron. Risk estimates have been 
presented for the purpose of aggregate assessment; and conclude all 
residential risk estimates are not of concern. For more details, see 
Unit II.C.3 of the May 25, 2017, rulemaking. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    No further data are required to determine that no common mechanism 
of toxicity exists for flazasulfuron and other pesticides. As a result, 
no further cumulative evaluation is necessary for flazasulfuron as 
published in Unit II.C.4 of the May 25, 2017, rulemaking.
    The toxicity database for flazasulfuron is complete and adequate to 
assess susceptibility in the young. While there is evidence of 
increased qualitative and quantitative susceptibility in the young 
based on rat malformations and decreased fetal weight in two rat 
developmental toxicity studies, the Food Quality Protection Act (FQPA) 
Safety Factor (SF) is reduced to 1X and is protective of the observed 
offspring susceptibility because: (1) there are clear NOAELs for the 
developmental effects in the two rat studies developmental toxicity 
studies and the PODs selected for risk assessment are protective of 
those effects, (2) there is no evidence of neurotoxicity, and (3) 
exposure estimates are unlikely to underestimate risk. These 
conclusions are further discussed in Unit II.D of the May 25, 2017, 
rulemaking.

[[Page 81012]]

    There are no acute and chronic residential exposure scenarios; 
therefore, the acute and chronic aggregate risks are equivalent to the 
acute and chronic dietary (food and drinking water) risk estimates and 
are not of concern. For risk conclusions specific to flazasulfuron in/
on avocado, refer to Unit III section for acute and chronic dietary 
risk assessments within this document.
    Flazasulfuron is currently registered for a use that could result 
in short-term residential exposure, and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to flazasulfuron.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1660 for adults 
and 860 for children. Because EPA's level of concern for flazasulfuron 
is a MOE of 100 or greater, these MOEs are not of concern.
    Further, no intermediate-term adverse effect was identified, as a 
result, intermediate-term risk is not expected.
    Aggregate cancer risk for U.S. population. A cancer aggregate risk 
assessment was not conducted because there was no evidence of 
carcinogenicity to humans based on lack of carcinogenic effects in the 
rat and mouse carcinogenicity studies. Flazasulfuron was classified as 
``not likely to be carcinogenic to humans;'' therefore, a cancer 
dietary assessment was not performed.
    Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method for flazasulfuron is available. The 
method uses high-performance liquid chromatography/tandem mass 
spectrometry with multiple reaction monitoring (HPLC/MS-MS/MRM). The 
validated limit of quantitation (LOQ) is 0.01 ppm.

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). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for flazasulfuron. There are 
currently no MRLs established by Codex or Canada; therefore, there are 
no issues regarding international harmonization to date.

C. Response to Comments

    One comment was received in favor of this action from the United 
States Department of Agriculture (USDA). Given the potential herbicide 
resistance management value for flazasulfuron in avocado, USDA strongly 
supports the application for registration of flazasulfuron in avocado.

V. Conclusion

    Therefore, a tolerance is established for residues of 
flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-
pyridylsulfonyl)urea, in or on Avocado at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000), do not apply to this action. In addition, 
this action does not impose any enforceable duty or contain any 
unfunded mandate as described under title II of the Unfunded Mandates 
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 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.


[[Page 81013]]


    Dated: September 24, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
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. In Sec.  180.655, amend the table in paragraph (a) by:
0
a. Adding the table heading ``Table 1 to Paragraph (a)''; and
0
b. Adding in alphabetical order the commodity ``Avocado''.
    The additions read as follows:


Sec.  180.655  Flazasulfuron; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado...................................................         0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2024-23085 Filed 10-4-24; 8:45 am]
BILLING CODE 6560-50-P


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