[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42387-42390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10559]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0624; FRL-11958-01-OCSPP]


Tetraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerance for residues of 
tetraniliprole in or on tea, dried at 80 ppm. Bayer CropScience LP 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective May 15, 2024. Objections and 
requests for hearings must be received on or before July 15, 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-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. Please review the 
visitor instructions and additional information about the docket 
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: 
[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 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 
July 15, 2024. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in other procedural rules governing those 
proceedings. See ``Revised Order Urging Electronic Service and 
Filing'', dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions; therefore, EPA believes the preference 
for submission via electronic means will not be prejudicial. When 
submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please

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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 July 5, 2023 (88 FR 42935) (FRL-10579-
05-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 
3E9059) by Bayer CropScience LP, 800 N Lindbergh Blvd., St. Louis, MO 
63167. The petition requested to establish a tolerance 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 Tea, dried at 80 parts per million (ppm). That document 
referenced a summary of the petition, which is available in the docket, 
https://www.regulations.gov. Two comments were received in response to 
the Notice of Filing. EPA's response to these comments can be found in 
section 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 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.
    EPA has previously 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 chemical. EPA is incorporating 
previously published sections from this 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 tolerance for residues on imported tea. 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

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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

    Section 408(b)(2)(C) requires the application of an additional 
tenfold margin of safety to account for potential risks to infants and 
children, in the case of threshold effects. For tetraniliprole, EPA has 
not identified any toxicological endpoints of concern associated with 
any threshold effects and is conducting a qualitative assessment. That 
qualitative assessment 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 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: Petition for the Establishment of a 
Tolerance without U.S. Registration for use on Tea. Summary of 
Analytical Chemistry and Residue Data'' 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 residues of tetraniliprole in or on 
Tea, dried.

C. Response to Comments

    Two comments were received in response to the Notice of Filing from 
different commenters. One commenter stated in part that ``I totally 
oppose granting any tolerance changes or added tolerances of any kind 
to any of the toxic chemicals that are listed in Federal Register 
notice''. . . ``none of them should ever be approved or used in the 
world. they are harmful . . .'' The other commenter opposed granting 
any tolerances because all active ingredients are harmful. This 
commenter also mentioned results related to birth defects from 
pesticides from a study but did not provide a citation of said study. 
Thus, the information cannot be substantiated or addressed. According 
to the commenter ``Pesticide exposure during susceptible windows and at 
certain doses are linked to numerous birth defects.'' Holoprosencephaly 
(HPE), malformation of the forebrain in humans was the focus of this 
study, according to the commenter. Although the Agency recognizes that 
some individuals believe that pesticides should be banned, the existing 
legal framework provided by section 408 of the FFDCA authorizes EPA to 
establish tolerances when it determines that the tolerances are safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that the tetraniliprole tolerance on tea 
is safe. The commenters have not provided information indicating that a 
safety determination cannot be supported.

V. Conclusion

    Therefore, tolerances are established for residues of 
tetraniliprole in or on Tea, dried at 80 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 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).
    Because 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

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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: May 9, 2024.
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.  180.709, amend table 1 to paragraph (a) by adding in 
alphabetical order an entry ``Tea, dried'' to read as follows:


Sec.  180.709  Tetraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \1\..............................................          80
 
                               * * * * *
------------------------------------------------------------------------
\1\ There is no U.S. Registration for this commodity as of May 15, 2024.

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[FR Doc. 2024-10559 Filed 5-14-24; 8:45 am]
BILLING CODE 6560-50-P