Rule2024-09048
Flonicamid; 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
April 29, 2024
Effective
April 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation amends the existing tolerance for residues of flonicamid in or on the raw agricultural commodity berry, low-growing, subgroup 13-07G by increasing the tolerance from 1.5 parts per million (ppm) to 2 ppm. ISK Biosciences Corporation requested this amended tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 83 (Monday, April 29, 2024)</title>
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[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Rules and Regulations]
[Pages 33235-33238]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09048]
[[Page 33235]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0280; FRL-11860-01-OCSPP]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the existing tolerance for residues of
flonicamid in or on the raw agricultural commodity berry, low-growing,
subgroup 13-07G by increasing the tolerance from 1.5 parts per million
(ppm) to 2 ppm. ISK Biosciences Corporation requested this amended
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 29, 2024. Objections and
requests for hearings must be received on or before June 28, 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-2023-0280, 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#194b5d5f4b57766d707a7c6a597c6978377e766f"><span class="__cf_email__" data-cfemail="6c3e282a3e220318050f091f2c091c0d420b031a">[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-2023-0280, 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
June 28, 2024. 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-2023-0280, 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 Tolerances
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
3F9050) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, OH 44077-9703. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of flonicamid in or on
the raw agricultural commodities berry, low-growing, subgroup 13-07G,
except strawberry, at 1.5 ppm and strawberry at 2.0 ppm. The petition
also requested removal of the existing tolerance for residues of
flonicamid in or on berry, low-growing, subgroup 13-07G at 1.5 ppm.
That document referenced a summary of the petition, which is
available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no
comments received on the notice of filing.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is amending the existing tolerance for residues of flonicamid in or on
berry, low-growing, subgroup 13-07G by increasing the tolerance from
1.5 ppm to 2 ppm, rather than establishing different tolerances for
berry, low-growing, subgroup 13-07G, except strawberry, and strawberry
as originally requested. A revised petition was submitted by ISK
Biosciences Corporation to support this change to the petitioned-for
tolerance. For details, see 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
[[Page 33236]]
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 flonicamid including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with flonicamid 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 flonicamid
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to flonicamid and established tolerances for residues of the
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 flonicamid, see Unit III. of the flonicamid tolerance
rulemaking published in the Federal Register of September 20, 2023 (88
FR 64819) (FRL-11393-01).
Toxicological points of departure/levels of concern. For a summary
of the toxicological points of departure/levels of concern for
flonicamid used for human health risk assessment, see Table 4.0.1. of
the ``Flonicamid. Human Health Risk Assessment for the Petition for
Amendment of Tolerances in/on Low Growing Berry Subgroup 13-07G''
(hereafter the Flonicamid Human Health Risk Assessment) in docket ID
EPA-HQ-OPP-2023-0280 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the increased tolerance
for residues of flonicamid in or on berry, low-growing, subgroup 13-
07G. The dietary exposure assessments were conducted with Dietary
Exposure Evaluation Model software using the Food Commodity Intake
Database (DEEM-FCID) Version 4.02, which uses the 2005-2010 food
consumption data from the United States Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America (NHANES/WWEIA). An unrefined chronic dietary exposure
assessment was conducted for all proposed and registered uses of
flonicamid. The analysis assumed 100 percent crop treated (100% CT) and
tolerance level residues for all commodities. Separate tolerances have
been established for potato granules/flakes, tomato paste, and tomato
puree based on processing studies. The processing factors were set to
1.0 for these commodities. The Agency's default processing factors were
used for the other processed commodities for which default processing
factors are available.
Drinking water and non-occupational exposures. The estimated
drinking water concentrations have not changed as a result of the
increased tolerance for residues of flonicamid in or on berry, low-
growing, subgroup 13-07G. For a detailed summary of the drinking water
analysis for flonicamid used for the human health risk assessment, see
Unit III.C.2. of the flonicamid tolerance rulemaking published in the
Federal Register of July 23, 2018 (83 FR 34775) (FRL-9977-82).
There are no proposed residential uses at this time; however, there
are existing registered residential handler uses that were previously
assessed and which resulted in no risks of concern. Registered
residential use patterns are expected to result in only short-term
exposures to flonicamid and, as a dermal endpoint was not selected,
residential risk estimates were calculated for the inhalation route
only.
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 flonicamid and any other substances, and
flonicamid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that flonicamid 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. of the September 20, 2023, 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 (food and drinking water) exposure estimates to the acute
population-adjusted dose (aPAD) and chronic population-adjusted dose
(cPAD). Short- and intermediate-term 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.
No adverse effect resulting from a single oral exposure was
identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk. Chronic dietary risks
are below the Agency's level of concern of 100% of the cPAD; they are
91% of the cPAD for children 1 to 2 years old, the group with the
highest exposure.
For short-term aggregate risk, adult residential handler exposure
estimates are aggregated with adult dietary exposure estimates, which
are considered background. The estimated aggregate MOE for adult
handlers is 1,100 and is not of concern because it is higher than the
level of concern of 100. Short-term aggregate risk estimates for
children are expected to be equivalent to chronic dietary risks.
A cancer dietary assessment was not conducted as flonicamid has
been determined to be ``suggestive evidence of carcinogenicity, but not
sufficient to assess human carcinogenicity potential.'' The Agency has
determined that quantification of risk using a non-linear approach
(i.e., using a chronic reference dose) adequately accounts for all
chronic toxicity, including
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carcinogenicity that could result from exposure to flonicamid. As
stated above, the chronic risks are not of concern.
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 flonicamid residues. More detailed information on
this action can be found in the Flonicamid Human Health Risk Assessment
in docket ID EPA-HQ-OPP-2023-0280 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 23, 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 tolerance expression for plant and livestock commodities are
harmonized between the U.S. and Canada, but not Codex and Japan. Codex
and Japanese residues of concern are expressed as flonicamid only,
whereas U.S. residues of concern are flonicamid and its metabolites
TFNA, TFNA-AM, and TFNG. Codex has an MRL for residues of flonicamid in
or on low growing berries at 1.5 ppm, and Canada has MRLs for residues
of flonicamid in or on bearberry; bilberry; blueberry, lowbush;
cloudberry; cranberry; and lingonberry at 1.5 ppm. The existing U.S.
tolerance for residues of flonicamid in or on berry, low-growing,
subgroup 13-07G at 1.5 ppm is harmonized with Codex and Canadian MRLs.
However, the petition requested that EPA increase the existing U.S.
tolerance from 1.5 ppm to 2 ppm in order to harmonize with the Japanese
MRL for residues of flonicamid in or on strawberry, cranberry, and
other berries at 2 ppm and minimize barriers to imports of strawberries
from Japan. Although this action is establishing a higher tolerance for
residues of flonicamid in or on low growing berry, subgroup 13-07G that
is no longer harmonized with Codex or Canadian MRLs, this is not
expected to create a trade barrier to imports of these commodities from
Codex countries and Canada since commodities that comply with the lower
Codex and Canadian MRLs could be imported into the U.S. For these
reasons, EPA has determined it is appropriate to amend the tolerance
for residues of flonicamid in or on low growing berry, subgroup 13-07G
from 1.5 ppm to 2 ppm, as petitioned.
C. Revisions to Petitioned-For Tolerances
EPA is amending the existing tolerance for residues of flonicamid
in or on berry, low-growing, subgroup 13-07G by increasing the
tolerance from 1.5 ppm to 2 ppm, rather than establishing different
tolerances for berry, low-growing, subgroup 13-07G, except strawberry,
and strawberry as originally requested. Because strawberry is the
representative commodity for berry, low-growing, subgroup 13-07G, it
may not be excepted from the crop subgroup under 40 CFR 180.40(h). A
revised petition was submitted by ISK Biosciences Corporation to
support this change to the petitioned-for tolerance.
V. Conclusion
Therefore, the established tolerance for residues of flonicamid in
or on berry, low-growing, subgroup 13-07G is amended from 1.5 ppm to 2
ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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 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.
[[Page 33238]]
Dated: April 23, 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. 180.613, revise the entry in table 1 to paragraph (a)(1)
for ``Berry, low-growing, subgroup 13-07G'' to read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Parts per
Commodity million
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* * * * * * *
Berry, low-growing, subgroup 13-07G.................... 2
* * * * * * *
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* * * * *
[FR Doc. 2024-09048 Filed 4-26-24; 8:45 am]
BILLING CODE 6560-50-P
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