Rule2024-10559
Tetraniliprole; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 15, 2024
Effective
May 15, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 95 (Wednesday, May 15, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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#f0a2b4b6a2be9f8499939583b0958091de979f86"><span class="__cf_email__" data-cfemail="2b796f6d7965445f42484e586b4e5b4a054c445d">[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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
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 <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please
[[Page 42388]]
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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,
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
[[Page 42389]]
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
[[Page 42390]]
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) * * *
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Parts per
Commodity million
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* * * * *
Tea, dried \1\.............................................. 80
* * * * *
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\1\ There is no U.S. Registration for this commodity as of May 15, 2024.
* * * * *
[FR Doc. 2024-10559 Filed 5-14-24; 8:45 am]
BILLING CODE 6560-50-P
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