Federal Register / Vol. 88, No. 181 / Wednesday, September 20, 2023 / Rules and Regulations 64819 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by hailing Coast Guard 

Sector Los Angeles-Long Beach on 

VHF–FM Channel 16 or calling at (310) 

521–3801. Those in the safety zone must 

comply with all lawful orders or 

directions given to them by the COTP or 

the COTP’s designated representative. 

(d) Enforcement period. This section 

will be enforced from September 15, 

2023, through September 22, 2023. The 

marine public will be notified of this 

safety zone via Broadcast Notice to 

Mariners. If the COTP determines that 

the zone need not be enforced during 

this entire period, the Coast Guard will 

announce via Broadcast Notice to 

Mariners when the zone will no longer 

be subject to enforcement. 

R.D. Manning, 

Captain, U.S. Coast Guard, Captain of the 

Port Los Angeles-Long Beach. 

[FR Doc. 2023–20443 Filed 9–18–23; 11:15 am] 

BILLING CODE 9110–04–P 

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. 

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: RDFRNotices@epa.gov. 

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 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: 

• 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-sendcomments-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 


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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: 

• 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. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• 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 


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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 postapplication 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, nonoccupational 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 intermediateterm 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. 


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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 nonlinear 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). 


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Federal Register / Vol. 88, No. 181 / Wednesday, September 20, 2023 / Rules and Regulations 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.613, amend table 1 to 

paragraph (a)(1) by: 

■ 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’’. 

■ 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’’. 

■ 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’’. 

■ iv. Removing the entry for ‘‘Vegetable, 

legume, edible podded, subgroup 6A’’. 

■ 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: 

§ 180.613 Flonicamid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

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 soybean, subgroup 6–22E ............................................................................... 3 

Vegetable, legume, pulse, pea, dried shelled, subgroup 6–22F ............................................................................................................ 3 

*******

* * * * * 

[FR Doc. 2023–20273 Filed 9–19–23; 8:45 am] 

BILLING CODE 6560–50–P 


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