[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Rules and Regulations]
[Pages 47778-47782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15646]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0479; FRL-11131-01-OCSPP]


Indaziflam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
indaziflam in or on multiple commodities discussed later in this 
document. Bayer CropScience has requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 25, 2023. Objections and 
requests for hearings must be received on or before September 25, 2023, 
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-2022-0479, 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. For the latest 
status information on EPA/DC services, docket access, visit 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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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-

[[Page 47779]]

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(g), 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-2022-0479 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 
September 25, 2023. 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-2022-0479, by one of 
the following methods:
     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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     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 July 20, 2022 (87 FR 43231) (FRL-9410-
03-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 
2F9002) from Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 
63141. The petition requested that 40 CFR 180.653 be amended by 
revising tolerances for residues of indaziflam N-[(1R,2S)-2,3-dihydro-
2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-
diamine, including its metabolites and degradates, in or on the 
following raw agricultural commodities: Grass Forage, Fodder, and Hay 
Group 17, forage at 50 parts per million (ppm); Grass Forage, Fodder, 
and Hay Group 17, hay at 80 ppm; and livestock fat, meat, meat 
byproducts, milk and milk, fat at 0.1, 0.01, 0.3, 0.015, and 0.4 ppm 
respectively. (The notice of filing published on July 20, 2022, 
incorrectly identified the tolerance levels for meat byproducts as 0.30 
ppm and for milk, fat as 0.04 ppm, rather than 0.3 ppm and 0.4 ppm as 
the petition requested.) That document referenced a summary of the 
petition, which is available in the docket, https://www.regulations.gov. No comments were received in response to the July 
20, 2022, notice of filing.
    EPA is establishing one tolerance at a different level than 
requested by the petitioner. The reason for this change is explained in 
Unit IV.C. In addition, EPA is not revising the established tolerances 
for meat (i.e., Cattle, meat; Goat, meat; Horse, meat; and Sheep, meat) 
because the revised anticipated residues remain lower than the current 
tolerance level (0.01 ppm).

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 therein, 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 indaziflam including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with indaziflam 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 for 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 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 tolerance rulemakings for indaziflam 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to indaziflam and established tolerances for residues of that 
chemical. EPA is incorporating previously published sections from these 
rulemakings as described further in this rulemaking, as they remain 
unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of indaziflam, see Unit III.A. of the indaziflam tolerance 
rulemaking published in the Federal Register of October 10, 2019 (84 FR 
54510) (FRL-9999-70).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
indaziflam used for human health risk assessment, please reference Unit 
III.B. of the October 10, 2019, rulemaking.
    Exposure assessment. EPA's dietary exposure assessments have been 
updated to include the additional exposure from the proposed removal of 
the grass forage grazing restriction and the grass hay cutting 
restriction from certain indaziflam product labels, resulting in 
increased associated residues on animal commodities. The acute and 
chronic (food and drinking water) dietary exposure assessments in 
support of the proposed label amendments were conducted using the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 
food consumption data from the United States Department of 
Agriculture's (USDA's) National Health and Nutrition

[[Page 47780]]

Examination Survey, What We Eat in America (NHANES/WWEIA). The 
unrefined acute and chronic dietary exposure assessments assumed 100 
percent crop treated (PCT), tolerance-level residues for all crops, and 
maximum anticipated residues to address all residues of concern in 
ruminant commodities.
    Drinking water and non-occupational exposures. The drinking water 
numbers have not changed as a result of the proposed removal of the 
grass forage grazing restriction and the grass hay cutting restriction. 
For a detailed summary of the drinking water analysis for indaziflam 
used for the human health risk assessment, please reference Unit 
III.C.2. of the October 10, 2019, rulemaking.
    Indaziflam is currently registered for the following uses that 
could result in residential exposures: turf, gardens, and trees. While 
there are no proposed residential uses in the current action, EPA's 
residential (non-occupational) exposure and risk assessment has been 
revised since the October 10, 2019, rulemaking. The following exposure 
estimates are used in the aggregate assessment for indaziflam because 
they are the most conservative of the residential handler and post-
application scenarios. The residential exposure for children 1 to <2 
years old is combined dermal and incidental oral (hand-to-mouth) 
exposure to turf (i.e., recreational premises/areas) applications via 
high contact lawn activities. The residential exposure for children 6 
to <11 years old is dermal exposure to turf applications via golfing 
activities and for adults is combined dermal and inhalation exposure 
from handling indaziflam via ready-to-use (RTU) trigger spray bottle 
applications. None of the residential exposures are of concern.
    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 indaziflam and any other substances and 
indaziflam does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this action, therefore, EPA has 
not assumed that indaziflam has a common mechanism of toxicity with 
other substances.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit 
III.D. of the October 10, 2019, rulemaking for a discussion of the 
Agency's rationale for that determination.
    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; they are 21% for all 
infants (<1 year old), the subgroup with the highest exposure. Chronic 
dietary (food and drinking water) risks are below the Agency's level of 
concern of 100% of the cPAD; they are 15% of the cPAD for the children 
1 to 2 years old, the group with the highest exposure.
    EPA aggregated short-term exposure to indaziflam based on the 
residential and dietary routes of exposure. The short-term aggregate 
MOEs were 360 for adults; 5,100 for children 6 to <11 years old; and 
540 for children 1 to <2 years old. These values do not exceed the 
level of concern, which is an MOE below 100, so the risk estimates are 
not of concern. Acute and chronic aggregate risks are equivalent to the 
acute and chronic dietary risks and are not of concern. Indaziflam is 
not registered for any use patterns that would result in intermediate-
term residential exposure, so intermediate-term aggregate risk is the 
same as the chronic dietary risk and is not of concern.
    Based on the lack of evidence of carcinogenicity or genotoxicity, 
indaziflam is classified as ``not likely to be carcinogenic to 
humans''. Therefore, EPA does not expect indaziflam to pose a cancer 
risk from aggregate exposure.
    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 indaziflam residues. More detailed information on 
this action can be found in the document titled ``Indaziflam. Human 
Health Risk Assessment for the Removal of Forage Grazing and Hay 
Cutting Intervals for Pastures, Rangeland, Natural Areas, and Grazed 
Non-Crop Areas, and the Increased Application Rate to Rights-of-Way'' 
in docket ID EPA-HQ-OPP-2022-0479.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the indaziflam tolerance rulemaking published in the 
Federal Register of June 24, 2020 (85 FR 37760) (FRL-10008-92).

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).
    Codex Alimentarius has not established any Maximum Residue Limits 
(MRLs) for indaziflam.

C. Revisions to Petitioned-For Tolerances

    EPA is amending the tolerance for residues of indaziflam in or on 
Grass, forage, fodder and hay, group 17, forage to 40 ppm rather than 
at 50 ppm as proposed by the petitioner. Both EPA and the petitioner 
entered the proportioned grass forage residue data into the 
Organization for Economic Development and Cooperation (OECD) tolerance 
calculator. The difference between the proposed and recommended 
tolerance values is likely due to a difference in rounding.

V. Conclusion

    Therefore, the established tolerances for residues of indaziflam in 
or on the following commodities are revised to these levels: Cattle, 
fat at 0.1 ppm; Cattle, meat byproducts at 0.3 ppm; Goat, fat at 0.1 
ppm; Goat, meat byproducts at 0.3 ppm; Grass, forage, fodder and hay, 
group 17, forage at 40 ppm; Grass, forage, fodder and hay, group 17, 
hay at 80 ppm; Horse, fat at 0.1 ppm; Horse, meat byproducts at 0.3 
ppm; Milk at 0.015 ppm; Milk, fat at 0.4 ppm; Sheep, fat at 0.1 ppm; 
and Sheep, meat byproducts at 0.3 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in

[[Page 47781]]

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 to 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 tolerances 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.

    Dated: July 17, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 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.  180.653:
0
a. Amend table 1 to paragraph (a)(1) by revising the entries for 
``Grass, forage, fodder and hay, group 17, forage'' and ``Grass, 
forage, fodder and hay, group 17, hay''.
0
b. Revise table 2 to paragraph (a)(2).
    The revisions read as follows:


Sec.  180.653  Indaziflam; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                     Commodity                        Parts per million
------------------------------------------------------------------------
 
                              * * * * * * *
Grass, forage, fodder and hay, group 17, forage....                   40
Grass, forage, fodder and hay, group 17, hay.......                   80
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
    (2) * * *

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                     Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat........................................                  0.1
Cattle, meat.......................................                 0.01
Cattle, meat byproducts............................                  0.3
Goat, fat..........................................                  0.1
Goat, meat.........................................                 0.01
Goat, meat byproducts..............................                  0.3
Horse, fat.........................................                  0.1
Horse, meat........................................                 0.01
Horse, meat by-products............................                  0.3
Milk...............................................                0.015

[[Page 47782]]

 
Milk, fat..........................................                  0.4
Sheep, fat.........................................                  0.1
Sheep, meat........................................                 0.01
Sheep, meat by-products............................                  0.3
------------------------------------------------------------------------

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[FR Doc. 2023-15646 Filed 7-24-23; 8:45 am]
BILLING CODE 6560-50-P


