Document ID: EPA-HQ-OPP-2021-0624-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Tetraniliprole
Posted Date: 2022-12-16T05:00Z

[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Rules and Regulations]
[Pages 76946-76949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26994]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0624; FRL-10296-01-OCSPP]

Tetraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tetraniliprole in or on the grain, cereal, group 15, except rice; and 
grain, cereal, forage, fodder and straw, group 16, except field corn, 
popcorn, and sweet corn. Bayer CropScience requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 16, 2022. Objections and 
requests for hearings must be received on or before February 14, 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-2021-0624, 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: Daniel Rosenblatt, Acting Director, 
Registration Division (7505T), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-2875; 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-CFR site at the 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-2021-0624 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 
February 14, 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-2021-0624, 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 October 21, 2021 (86 FR 58239) (FRL-
8792-04-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 #1F8930) by Bayer CropScience LP, 800 N Lindbergh Blvd., 
St. Louis, MO 63167. The petition requested to establish tolerances in 
40 CFR part 180 for residues of the insecticide, tetraniliprole [1-(3-
chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-
[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-
yl]methyl]-1H-pyrazole-5-carboxamide], in or on Crop Group 15; cereal 
grains, except rice at 0.01 parts per million (ppm); and Crop Group 16; 
forage, fodder, and straw of cereal grains group, except field corn, 
popcorn, and sweet

[[Page 76947]]

corn at 0.1 ppm. 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 notice of filing.

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 tetraniliprole including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with tetraniliprole 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 rulemaking 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.
    On February 24, 2021, EPA published a tolerance rulemaking for 
tetraniliprole in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to tetraniliprole and established 
tolerances for residues of that pesticide chemical. EPA is 
incorporating previously published sections from the February 24, 2021, 
rulemaking as described further in this rulemaking, as they remain 
unchanged.

A. Toxicological Profile

    For a discussion of the Toxicological Profile of tetraniliprole, 
see Unit III.A. of the tetraniliprole tolerance rulemaking published in 
the Federal Register of February 24, 2021 (86 FR 11133) (FRL-10005-77).

B. Toxicological Points of Departure/Levels of Concern

    Based on a thorough analysis of the toxicology database of 
tetraniliprole, the Agency has determined that a qualitative risk 
assessment is more appropriate for tetraniliprole than a quantitative 
risk assessment. For more details, please reference Unit III.B. of the 
February 24, 2021, rulemaking.

C. Exposure Assessment

    There is potential for exposure to tetraniliprole via food and feed 
based on the proposed uses. However, no adverse effects were observed 
in the submitted toxicological studies for tetraniliprole regardless of 
the route of exposure. Thus, no quantitative dietary exposure 
assessments are needed for EPA to conclude with reasonable certainty 
that dietary exposures to tetraniliprole do not pose a significant 
human health risk.
    Drinking water and non-occupational exposures. There are no 
residues of toxicological concern expected in drinking water from the 
use of tetraniliprole. Thus, no drinking water exposure assessments are 
needed for the Agency to conclude with reasonable certainty that 
drinking water exposures to tetraniliprole do not pose a significant 
human health risk.
    Tetraniliprole is registered for use on golf course turf and sports 
fields that could result in residential post-application exposures. 
However, no adverse effects were observed in the submitted 
toxicological studies for tetraniliprole regardless of the route of 
exposure; therefore, a quantitative residential post-application 
exposure assessment was not conducted. Thus, no residential exposure 
assessments are needed for the Agency to conclude with reasonable 
certainty that residential exposures to tetraniliprole do not pose a 
significant human health risk.
    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 tetraniliprole and any other substances. 
Tetraniliprole does not also appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has not assumed that tetraniliprole has a common 
mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    EPA has not identified any toxicological endpoints of concern 
associated with any threshold effects and conducted a qualitative 
assessment. That qualitative assessment showed no risk of concern for 
infants and children and does not use safety factors for assessing 
risk, and no additional safety factor is needed for assessing risk to 
infants and children. EPA has also evaluated the available data and 
concluded that there are no residual uncertainties concerning the 
potential risks to infants and children that would impact its 
conclusions about threshold effects.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population-adjusted dose (aPAD) and chronic population-adjusted 
dose (cPAD). Short-, intermediate-, and chronic-term risks are 
evaluated by comparing the estimated aggregate food, water, and 
residential exposure to the appropriate points of departure to ensure 
that an adequate margin of exposure (MOE) exists. For linear cancer 
risks, EPA calculates the lifetime probability of acquiring cancer 
given the estimated aggregate exposure.
    No adverse effects were observed in the submitted toxicological 
studies at doses relevant to human health pesticide risk assessment for 
tetraniliprole regardless of the route of exposure. Effects observed in 
the data base (e.g., decreased body weight) were both marginal, and 
only seen at doses not expected to occur daily or over an extended 
period.
    Based on a lack of toxicity at exposure levels expected from 
approved application rates and an expectation that aggregate exposures 
to residues of tetraniliprole will not reach the levels

[[Page 76948]]

required to cause any adverse effects, 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 
tetraniliprole residues. More detailed information on this action can 
be found in the document titled ``Tetraniliprole: Human Health Risk 
Assessment for Registration for Uses on Cereal Grains, Except Rice, 
Crop Group 15; and Forage, Fodder, and Straw of Cereal Grains Group, 
except Field Corn, Popcorn, and Sweet Corn Crop Group 16'' in docket ID 
EPA-HQ-OPP-2021-0624.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the February 24, 2021, rulemaking.

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).
    There are no Codex MRLs for tetraniliprole on the commodities 
covered in this document.

V. Conclusion

    Therefore, tolerances are established for residues of 
tetraniliprole in or on grain, cereal, forage, fodder and straw, group 
16, except field corn, popcorn and sweet corn at 0.1 ppm; and grain, 
cereal, group 15, except rice at 0.01 ppm. In addition, EPA is removing 
the tolerance for indirect or inadvertent residues of tetraniliprole in 
or on grain, cereal, forage, fodder and straw, group 16, except field 
corn, popcorn and sweet corn at 0.1 ppm, which is no longer needed with 
the changes described above.

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 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: December 7, 2022.
Daniel Rosenblatt,
Acting 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. Amend Sec.  180.709 by:
0
a. In Table 1 to paraph (a) adding in alphabetical order entries for 
``Grain, cereal, forage, fodder and straw, group 16, except field corn, 
popcorn and sweet corn''; and ``Grain, cereal, group 15, except rice''; 
and
0
b. In Table 2 to paragraph (d) by removing the entry ``Grain, cereal, 
forage, fodder and straw, group 16, except field corn, popcorn and 
sweet corn''.
    The additions read as follows:

Sec.  180.709  Tetraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
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                              * * * * * * *
Grain, cereal, forage, fodder and straw, group 16, except            0.1
 field corn, popcorn and sweet corn........................

[[Page 76949]]

 
Grain, cereal, group 15, except rice.......................         0.01
 
                              * * * * * * *
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[FR Doc. 2022-26994 Filed 12-15-22; 8:45 am]
BILLING CODE 6560-50-P