[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 [www.gpo.gov]
[FR Doc No: 2024-09048]



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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 
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-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:
     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 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 https://www.regulations.gov. 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

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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 https://www.regulations.gov.
    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 https://www.regulations.gov.

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.


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    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)
------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
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