Rule2022-21159
Benzovindiflupyr; 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
September 29, 2022
Effective
September 29, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of benzovindiflupyr in or on Vegetable, root, except sugar beet, subgroup 1B. Syngenta requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 87 Issue 188 (Thursday, September 29, 2022)</title>
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[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Rules and Regulations]
[Pages 59025-59027]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21159]
[[Page 59025]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0417; FRL-10088-01-OCSPP]
Benzovindiflupyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
benzovindiflupyr in or on Vegetable, root, except sugar beet, subgroup
1B. Syngenta requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 29, 2022. Objections and
requests for hearings must be received on or before November 28, 2022
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-2021-0417, 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. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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#0d5f494b5f436279646e687e4d687d6c236a627b"><span class="__cf_email__" data-cfemail="affdebe9fde1c0dbc6cccadcefcadfce81c8c0d9">[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, 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-2021-0417 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
November 28, 2022. 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-2021-0417, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 September 22, 2021 (86 FR 52624) (FRL-
8792-03-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 1F8914) by Syngenta Crop Protection, LLC. The petition
requested that 40 CFR 180.686 be amended by establishing tolerances for
residues of the fungicide benzovindiflupyr, in or on vegetable, root,
except sugar beet, subgroup 1B, and ginseng, at 0.6 parts per million
(ppm). That document referenced a summary of the petition prepared by
Syngenta Crop Protection, LLC, the registrant, which is available in
the docket ID number EPA-HQ-OPP-2021-0417 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified a commodity definition, established the tolerance at an
increased level, and removed the existing ginseng tolerance. The
reasons for these changes are explained 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
[[Page 59026]]
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
benzovindiflupyr including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with benzovindiflupyr 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 republishing the same sections is 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 previously published a number of tolerance rulemakings for
benzovindiflupyr, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to benzovindiflupyr and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the toxicological
profile of benzovindiflupyr, see Unit III.A. of the June 22, 2018,
rulemaking (83 FR 29033) (FRL-9977-94).
Toxicological points of departure/Levels of concern. For a summary
of the toxicological points of departure/levels of concern used for the
safety assessment, see Unit III.B. of the October 2, 2015, rulemaking
(80 FR 59627) (FRL-9933-03).
Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate exposures from the
petitioned-for tolerance. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the June
22, 2018, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new use of benzovindiflupyr on the
commodities in Vegetable, root, except sugar beet, subgroup1B. The
assessments used the same assumptions considering 100 percent crop
treated and tolerance-level residues as the June 22, 2018, final rule.
Drinking water exposures are not impacted by the new uses; the
estimated drinking water concentrations are the same as in the June 22,
2018, final rule.
The proposed new use will not result in residential exposure,
although there are existing residential uses that were previously
assessed. The revisions to the residential exposure and risk
assessments in the June 22, 2018, final rule were described in the
February 9, 2021, final rule (86 FR 8704) (FRL-10017-32) and have not
changed since then.
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
benzovindiflupyr and any other substances and benzovindiflupyr does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that benzovindiflupyr 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. See Unit III.D. of the
June 22, 2018, 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
aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD
(cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD: They are 16% of the aPAD for the general population and
43% of the aPAD for children 1 to 2 years old, the population subgroup
with the highest exposure estimate. Chronic dietary risks are below the
Agency's level of concern of 100% of the cPAD: They are 6.1% of the
cPAD for the general population and 20% of the cPAD for children 1 to 2
years old, the population subgroup with the highest exposure estimate.
Because the chronic dietary risks, which were quantified using a non-
linear (i.e., RfD) approach accounting for all chronic toxicity and any
potential carcinogenic effects, are below EPA's level of concern, the
Agency concludes that benzovindiflupyr will not pose a cancer risk. The
short-term aggregate MOE (food, water, and residential) is 487 for
children 1 to 2 years old. This MOE exceeds the target level of concern
of 100, so it is not of concern. There are no intermediate or long-term
residential exposures.
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 benzovindiflupyr residues. More detailed
information about the Agency's analysis can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the documents titled ``Benzovindiflupyr. Human
Health Risk Assessment for the Proposed New Food Use on Vegetable Root,
Subgroup 1B (except sugar beets)'' in docket ID number EPA-HQ-OPP-2021-
0417.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the June 22, 2018, 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). The Codex has not established an MRL for residues of
benzovindiflupyr in or on Vegetable, root, except sugar beet, subgroup
1B.
C. Revisions to Petitioned-For Tolerances
FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a
tolerance that varies from that sought by the petition. EPA is
establishing the tolerance at 0.6 ppm for residues of benzovindiflupyr
in or on Vegetable, root, except sugar beet,
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subgroup 1B. The EPA determined a higher tolerance was required by
calculating the recommended tolerance for carrot and radish data
separately and using the highest recommended tolerance rather than
calculating the recommended tolerance using the combined carrot and
radish data as the registrant did. The Agency also revised the
commodity definition to use standard terminology for the subgroup.
Additionally, the petition requested that ginseng be excluded from
the tolerance for subgroup 1B. However, rather than exclude ginseng
from this tolerance to avoid duplicative tolerances, EPA is removing
the established tolerance of 0.3 ppm for residues of benzovindiflupyr
in or on ginseng because it is included in the crop subgroup covered by
this tolerance.
V. Conclusion
Therefore, a tolerance is established for residues of
benzovindiflupyr, in or on vegetable, root, except sugar beet, subgroup
1B at 0.6 ppm. In addition, EPA is removing the established tolerance
for residues of benzovindiflupyr in or on ginseng at 0.3 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.
Dated: September 22, 2022.
Marietta Echeverria,
Acting 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. 180.686, amend the table 1 to paragraph (a) by:
0
a. Removing the entry for ``Ginseng''; and
0
b. Adding in alphabetical order an entry ``Vegetable, root, except
sugar beet, subgroup 1B''.
The addition reads as follows:
Sec. 180.686 Benzovindiflupyr; tolerances for residues
* * * * *
Table 1 to Paragraph (a)
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Parts per
Commodity million
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* * * * *
Vegetable, root, except sugar beet, subgroup 1B......... 0.6
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-21159 Filed 9-28-22; 8:45 am]
BILLING CODE 6560-50-P
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