[Federal Register Volume 88, Number 181 (Wednesday, September 20, 2023)]
[Rules and Regulations]
[Pages 64819-64823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20273]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0832; FRL-11393-01-OCSPP]


Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flonicamid in or on multiple crops listed later in this document. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 20, 2023. Objections and 
requests for hearings must be received on or before November 20, 2023, 
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-2022-0832, 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: 
<a href="/cdn-cgi/l/email-protection#65372123372b0a110c060016250015044b020a13"><span class="__cf_email__" data-cfemail="37657371657958435e5452447752475619505841">[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 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-2022-0832 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 20, 2023. 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-2022-0832, by one of 
the following methods:
    <bullet> 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.
    <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 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 January 3, 2023 (88 FR 38) (FRL-9410-08-
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 
2E9000) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
flonicamid in or on the raw agricultural commodities: Bushberry crop 
subgroup 13-07B at 1.5 ppm; Caneberry crop subgroup 13-07A at 3 ppm; 
Cherry subgroup 12-12A at 0.6 ppm; Corn, sweet, kernel plus cob with 
husks removed at 0.4 ppm; Corn, sweet, forage at 9 ppm; Corn, sweet, 
stover at 20 ppm; Peach crop subgroup 12-12B at 1.5 ppm; Plum subgroup 
12-12C at 0.6 ppm; Pomegranate at 0.5 ppm; Prickly pear, fruit at 2 
ppm; Prickly pear, pads at 3 ppm; Edible podded bean subgroup 6-22A and 
Edible podded pea subgroup 6-22B at 4 ppm; Succulent shelled bean 
subgroup 6-22C and Succulent shelled

[[Page 64820]]

pea subgroup 6-22D at 7 ppm; and Pulses, dried shelled bean (except 
soybean) subgroup 6-22E and Pulses, dried shelled pea subgroup 6-22F at 
3 ppm.
    The petition also requested to remove the following established 
flonicamid tolerances: Fruit, stone group 12-12, at 0.6 ppm; Pea and 
bean, dried shelled, except soybean, subgroup 6C at 3.0 ppm; Pea and 
bean, succulent shelled, subgroup 6B at 7.0 ppm; and Vegetable, legume, 
edible podded, subgroup 6A at 4.0 ppm.
    That document referenced a summary of the petition, which is 
available in the docket, https://www.regulations.gov. No comments on 
the tolerance action were received.

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 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 as well as a 
Flonicamid Interim Registration Decision for Registration Review 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 that chemical. EPA is incorporating previously published 
sections from these rulemakings as described further in this 
rulemaking, as they remain unchanged.
    Toxicological profile. The kidney and liver effects are seen via 
the oral route in rats and dogs. Increased kidney weight and hyaline 
droplet deposition as well as liver centrilobular hypertrophy were 
observed in the subchronic, developmental, and reproductive studies in 
rats. The subchronic dog study showed effects on kidney adrenals and 
thymus. No dermal or systemic toxicity was seen in the 28-day dermal 
study at the limit dose (1,000 mg/kg/day). There is no concern for 
increased susceptibility of developing young or for neurotoxicity or 
immunotoxicity for flonicamid. Flonicamid is classified by the Agency 
as ``suggestive evidence of carcinogenicity, but not sufficient to 
assess human carcinogenic potential.'' The chronic reference dose 
(cRfD) approach was used as a quantitation method for cancer risk.
    Toxicological points of departure/Levels of concern. For a full 
summary of the Toxicological points of departure/Levels of concern for 
flonicamid used for human risk assessment, see ``Flonicamid. Human 
Health Risk Assessment for the Proposed New Uses and Tolerance 
Establishment in/on Bushberry Subgroup 13-07B, Caneberry Subgroup 13-
07A, Cherry Subgroup 12A, Peach Subgroup 12-12B, Plum Subgroup 12C, 
Pomegranate, Prickly Pear Cactus, Sweet Corn, and Crop Group 
Conversions/Expansions for Legume Vegetables New Crop Group 6-22A-F'' 
(hereafter the Flonicamid Human Health Review) in docket EPA-HQ-OPP-
2022-0832 and the ``Flonicamid: Human Health Draft Risk Assessment for 
Registration Review'' by going to docket ID number EPA-HQ-OPP-2014-0777 
at https://www.regulations.gov.
    Exposure assessment. EPA's dietary exposure assessments have been 
updated since the previous published rules as well as Registration 
Review to include the additional exposure from the requested tolerances 
for residues of flonicamid and 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). A slightly refined chronic dietary exposure 
assessment was conducted for all proposed and registered uses of 
flonicamid. The analysis assumed 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. 
Percent crop treated (PCT) estimates were incorporated where available. 
Default processing factors were used for the other processed 
commodities for which default processing factors are available.
    Anticipated residues and PCT information. EPA has not relied on 
anticipated residues in assessing exposures to flonicamid. Section 
408(b)(2)(F) of FFDCA states that the Agency may use data on the actual 
percent of food treated for assessing chronic dietary risk only if:
    <bullet> Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The following average PCT estimates were used in the chronic 
dietary risk assessment for the following crops that are currently 
registered for flonicamid: celery, 65%; potatoes, 15%; spinach, 20%; 
and strawberries, 55%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use

[[Page 64821]]

Reporting (PUR) for the chemical/crop combination for the most recent 
10 years. EPA uses an average PCT for chronic dietary risk analysis and 
a maximum PCT for acute dietary risk analysis. The average PCT figure 
for each existing use is derived by combining available public and 
private market survey data for that use, averaging across all 
observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than 1% or less than 2.5%. 
In those cases, the Agency would use 1% or 2.5% as the average PCT 
value, respectively. The maximum PCT figure is the highest observed 
maximum value reported within the most recent 10 years of available 
public and private market survey data for the existing use and rounded 
up to the nearest multiple of 5%, except where the maximum PCT is less 
than 2.5%, in which case, the Agency uses 2.5% as the maximum PCT.
    The Agency believes that Conditions a, b, and c discussed above 
have been met. With respect to Condition a, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions b and c, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
reliable information on the regional consumption of food to which 
flonicamid may be applied in a particular area.
    Drinking water and non-occupational exposures. The estimated 
drinking water concentrations have not changed since the 2018 
rulemaking. 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 residential uses that have been previously assessed using 
current data and assumptions. The residential uses for flonicamid 
include residential handler application to roses, flowers, shrubs, and 
small (non-fruit bearing) ornamental trees. Residential handler 
exposure is expected to be short-term in duration. Intermediate-term 
exposures are not likely because of the intermittent nature of 
applications by homeowners. Since no hazard was identified for the 
dermal route of exposure, dermal risks were not assessed, but the 
Agency did assess risks to residential handlers from inhalation 
exposure.
    Residential post-application dermal and inhalation exposures for 
adults and children entering an environment previously treated with 
flonicamid are also possible; incidental oral exposures are not 
expected with the registered use patterns. Since no hazard was 
identified for the dermal route of exposure, dermal risks were not 
assessed. Outdoor post-application inhalation exposures are considered 
negligible. Therefore, residential post-application scenarios were not 
assessed at this time.
    The recommended residential exposure for use in the adult aggregate 
assessment is inhalation exposure from applications to roses, flowers, 
shrubs, and small (non-fruit bearing) ornamental trees via backpack 
spray equipment.
    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 concludes that there 
are reliable data to support the reduction of the Food Quality 
Protection Act (FQPA) safety factor from 10X to 1X.
    The toxicity database is adequate for FQPA safety factor evaluation 
and the quantification of risk for dietary, non-occupational and 
occupational exposure scenarios. The acceptable studies available for 
evaluation of neurotoxicity and susceptibility include prenatal 
developmental toxicity studies in rats and rabbits; a reproduction and 
fertility effects study in rats; an acute neurotoxicity study in rats; 
and a subchronic neurotoxicity study in rats.
    The current database includes acute and subchronic neurotoxicity 
studies. The clinical effects seen in these studies, while suggestive 
of an adverse effect on nervous tissue and/or function, occurred in the 
presence of other effects. In the acute study, the increase in 
mortality along with impaired respiration (seen only at the highest 
dose level of 1,000 mg/kg) suggest the animals were in an extreme 
condition. In the subchronic study, food consumption and body weight 
measurements suggest the animals were otherwise compromised and in a 
state of general malaise. Also, these types of clinical effects were 
not observed in the other subchronic or chronic studies in mice, rats 
or dogs. Thus, there is not clear evidence of neurotoxicity. Lastly, 
clear NOAELs and LOAELs were defined for these effects, which are above 
the levels currently used for risk assessment purposes. The current 
risk assessment is protective of these clinical effects, and a 
developmental neurotoxicity study is not required.
    There was no evidence of increased susceptibility following pre-/
post-natal exposure in prenatal developmental toxicity studies or the 
reproduction and fertility effects study.
    The exposure databases are complete or are estimated based on data 
that reasonably account for potential exposures. The chronic dietary 
food exposure assessment was slightly refined based on PCT assumptions 
and conservative ground water drinking water modeling estimates. All of 
the exposure estimates are based on conservative assumptions and, the 
Agency is confident the risk is not under-estimated in these 
assessments.
    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.

[[Page 64822]]

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 97% 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.
    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 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 Review in 
docket ID EPA-HQ-OPP-2022-0832 and ``Flonicamid: Human Health Draft 
Risk Assessment for Registration Review'' in docket ID EPA-HQ-OPP-2014-
0777.

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 is not 
harmonized with Codex. Codex residues of concern are expressed as 
flonicamid only. There are no Codex established MRLs for bushberry 
subgroup 13-07B, caneberry subgroup 13-07A, sweet corn, pomegranate, or 
prickly pear. There are established Codex MRLs for nectarine and peach. 
The U.S. tolerance of 1.5 ppm being established for the peach subgroup 
is higher than the Codex MRLs of 0.7 ppm. Harmonization is not possible 
because decreasing the tolerance to harmonize would put U.S. growers at 
risk of violative residues despite legal use of the pesticide according 
to the label.
    With respect to crop groups 6-22A-F, the U.S. tolerances and Codex 
MRLs are not harmonized. Most commodities have no established Codex MRL 
or the established Codex MRL is lower than the U.S. tolerances. 
Therefore, harmonization is not possible because decreasing the 
tolerance to harmonize would put U.S. growers at risk of violative 
residues despite legal use of the pesticide according to the label.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid in 
or on Bushberry subgroup 13-07B at 1.5 ppm; Caneberry subgroup 13-07A 
at 3 ppm; Cherry subgroup 12-12A at 0.6 ppm; Corn, sweet, forage at 9 
ppm; Corn, sweet, kernel plus cob with husks removed at 0.4 ppm; Corn, 
sweet, stover at 20 ppm; Peach subgroup 12-12B at 1.5 ppm; Plum 
subgroup 12-12C at 0.6 ppm; Pomegranate at 0.5 ppm; Prickly pear, fruit 
at 2 ppm; Prickly pear, pads at 3 ppm; Vegetable, legume, bean, edible 
podded, subgroup 6-22A at 4 ppm; Vegetable, legume, bean, succulent 
shelled, subgroup 6-22C at 7 ppm; Vegetable, legume, pea, edible 
podded, subgroup 6-22B at 4 ppm; Vegetable, legume, pea, succulent 
shelled, subgroup 6-22D at 7 ppm; Vegetable, legume, pulse, bean, dried 
shelled, except soybean, subgroup 6-22E at 3 ppm; and Vegetable, 
legume, pulse, pea, dried shelled, subgroup 6-22F at 3 ppm.
    Additionally, the following existing tolerances are removed as 
unnecessary: Fruit, stone, group 12-12; Pea and bean, dried shelled, 
except soybean, subgroup 6C; Pea and bean, succulent shelled, subgroup 
6B; and Vegetable, legume, edible podded, subgroup 6A.

VI. Statutory and Executive Order Reviews

    This 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances 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).

[[Page 64823]]

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 7, 2023.
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, amend table 1 to paragraph (a)(1) by:
0
i. Adding in alphabetical order entries for ``Bushberry subgroup 13-
07B''; ``Caneberry subgroup 13-07A''; ``Cherry subgroup 12-12A''; 
``Corn, sweet, forage''; ``Corn, sweet, kernel plus cob with husks 
removed''; and ``Corn, sweet, stover''.
0
ii. Removing the entries for ``Fruit, stone, group 12-12''; ``Pea and 
bean, dried shelled, except soybean, subgroup 6C'' and ``Pea and bean, 
succulent shelled, subgroup 6B''.
0
iii. Adding in alphabetical order entries for ``Peach subgroup 12-
12B''; ``Plum subgroup 12-12C''; ``Pomegranate''; ``Prickly pear, 
fruit''; and ``Prickly pear, pads''; ``Vegetable, legume, bean, edible 
podded, subgroup 6-22A''; and ``Vegetable, legume, bean, succulent 
shelled, subgroup 6-22C''.
0
iv. Removing the entry for ``Vegetable, legume, edible podded, subgroup 
6A''.
0
v. Adding in alphabetical order entries for ``Vegetable, legume, pea, 
edible podded subgroup 6-22B''; ``Vegetable, legume, pea, succulent 
shelled, subgroup 6-22D''; ``Vegetable, legume, pulse, bean, dried 
shelled, except soybean, subgroup 6-22E''; and ``Vegetable, legume, 
pulse, pea, dried shelled, subgroup 6-22F''.
    The additions read as follows:


Sec.  180.613   Flonicamid; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Bushberry subgroup 13-07B..................................          1.5
Caneberry subgroup 13-07A..................................            3
 
                              * * * * * * *
Cherry subgroup 12-12A.....................................          0.6
Corn, sweet, forage........................................            9
Corn, sweet, kernel plus cob with husks removed............          0.4
Corn, sweet, stover........................................           20
 
                              * * * * * * *
Peach subgroup 12-12B......................................          1.5
 
                              * * * * * * *
Plum subgroup 12-12C.......................................          0.6
Pomegranate................................................          0.5
 
                              * * * * * * *
Prickly pear, fruit........................................            2
Prickly pear, pads.........................................            3
 
                              * * * * * * *
Vegetable, legume, bean, edible podded, subgroup 6-22A.....            4
Vegetable, legume, bean, succulent shelled, subgroup 6-22C.            7
Vegetable, legume, pea, edible podded, subgroup 6-22B......            4
Vegetable, legume, pea, succulent shelled, subgroup 6-22D..            7
Vegetable, legume, pulse, bean, dried shelled, except                  3
 soybean, subgroup 6-22E...................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6-              3
 22F.......................................................
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-20273 Filed 9-19-23; 8:45 am]
BILLING CODE 6560-50-P


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