Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Rules and Regulations 68475 

EPA-APPROVED KENTUCKY NON-REGULATORY PROVISIONS

Name of non-regulatory SIP provision Applicable geographic or 

nonattainment area 

State submittal 

date/effective 

date 

EPA approval date Explanations 

*******

2015 8-hour Ozone Maintenance Plan for the 

Kentucky Portion of the Cincinnati, OH-KY 

Area.

Portions of Boone, Campbell, and Kenton Counties.9/21/2022 10/4/2023, [Insert citation of 

publication].

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 3. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 4. In § 81.318, amend the table 

entitled ‘‘Kentucky—2015 8-Hour 

Ozone NAAQS’’ by revising the entry 

for ‘‘Cincinnati, OH-KY,’’ to read as 

follows: 

§ 81.318 Kentucky. 

* * * * * 

KENTUCKY—2015 8-HOUR OZONE NAAQS 

[Primary and secondary] 

Designated area 1

Designation Classification 

Date 2 Type Date 2 Type 

Cincinnati, OH-KY ....................................................................... November 8, 2023 ... Attainment.

Boone County (part): 

The entire county except for 2010 U.S. Census Tracts 

706.01 and 706.04.

Campbell County (part): 

The entire county except for 2010 U.S. Census Tracts 

520.01 and 520.02.

Kenton County (part): 

The entire county except for 2010 US Census Tracts 

637.01 and 637.02.

* * * * * * * 

1 Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian 

country in this table, including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the state has regulatory authority under the Clean Air Act for such Indian country. 2This date is August 3, 2018, unless otherwise noted. 

* * * * * 

[FR Doc. 2023–21866 Filed 10–3–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0508 and EPA–HQ– 

OPP–2022–0672; FRL–11407–01–OCSPP] 

Cypermethrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cypermethrin 

in or on multiple commodities that are 

identified and discussed later in this 

document. The Tea Association of the 

U.S.A. Inc. and the American Spice 

Trade Association requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 4, 2023. Objections and 

requests for hearings must be received 

on or before December 4, 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–2022–0508 and 

EPA–HQ–OPP–2022–0672, 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. For the latest 

status information on EPA/DC services, 

docket access, visit 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). 


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• 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, 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–2022–0508 and EPA–HQ–OPP– 

2022–0672 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 

December 4, 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– 

2022–0508 and EPA–HQ–OPP–2022– 

0672, 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. 

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 

Tolerance 

In the Federal Register of July 20, 

2022 (87 FR 43231) (FRL–9410–03– 

OCSPP) EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP 2E8990) by 

the Tea Association of the U.S.A. Inc., 

362 5th Avenue, Suite 1002, New York, 

NY 10001. The petition requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

the insecticide cypermethrin, including 

its metabolites and degradates, in or on 

the raw agricultural commodity tea, 

dried at 15 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by the Tea 

Association of the U.S.A. Inc., the 

petitioner, which is available in the 

docket, https://www.regulations.gov. 

In the Federal Register of September 

23, 2022 (87 FR 58047) (FRL–9410–05– 

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 2E9011) by 

the American Spice Trade Association, 

1101 17th Street NW, Suite 700, 

Washington, DC 20036. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the insecticide 

cypermethrin, including its metabolites 

and degradates, in or on some raw 

agricultural spice commodities 

(Allspice; anise pepper; Ashwagandha 

fruit; Batavia-cassia, fruit; Belleric 

myrobalan; caper buds; cardamom, 

black; cardamom, Ethiopian; cardamom, 

green; cardamom, Nepal; cardamomamomum; cassia, fruit; cassia, Chinese, 

fruit; Chinese hawthorn; Chinesepepper; cinnamon, fruit; cinnamon, 

Saigon, fruit; coriander, fruit; cumin, 

black; Dorrigo pepper, berry; Dorrigo 

pepper, leaf; eucalyptus; gamboge; 

grains of Selim; juniper, berry; miracle 

fruit; pepper, black; pepper, Indian long; 

pepper, Javanese long; pepper, pink; 

pepper, Sichuan; pepper, white; 

pepperbush, berry; pepperbush, leaf; 

peppercorn, green; peppertree; 

peppertree, Peruvian; saunders, red; 

sumac, fragrant; sumac, smooth, leaf; 

tamarind, seed; Tasmanian, pepper, 

berry; Tsaoko; Vanilla), at 0.5 ppm; and 

on other spice commodities (angelica, 

seed; Asafoetida; calamus-root; chaste 

tree, Chinese, roots; coptis; coriander, 

seed; fingerroot; jalap; lovage, root; 

lovage, seed; yellow gentian, roots) at 

0.2 ppm. That document referenced a 

summary of the petition prepared by the 

American Spice Trade Association, the 

petitioner, which is available in the 

docket, https://www.regulations.gov. 

No comments were received on either 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA is revising 

the tolerance definition and the 

tolerance level for tea. The reason for 

these changes is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe’’. 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information’’. This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

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 cypermethrin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cypermethrin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The cypermethrins (cypermethrin, 

zeta-cypermethrin, and alphacypermethrin) are Type II pyrethroids 

that contain an alpha-cyano moiety. The 


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adverse outcome pathway (AOP) shared 

by pyrethroids involves the ability to 

interact with voltage-gated sodium 

channels (VGSCs) in the central and 

peripheral nervous systems leading to 

changes in neuron firing and, 

ultimately, neurotoxicity. 

While each active ingredient does not 

have its own complete database, studies 

have been bridged across the three 

isomeric mixtures and together are 

considered adequate for human health 

risk assessment. When evaluated 

together, the toxicity database for 

cypermethrin, zeta-cypermethrin, and 

alpha-cypermethrin can be used to 

characterize the overall suite of effects 

associated with cypermethrin exposure, 

including potential developmental and 

reproductive toxicity, immunotoxicity, 

and neurotoxicity. Therefore, the 

toxicology database for the 

cypermethrins together is considered 

complete with respect to guideline 

toxicity studies. 

The cypermethrins affect the nervous 

system, and neurotoxicity is the most 

sensitive effect observed throughout the 

toxicology database. Clinical signs of 

neurotoxicity were seen for all three 

compounds across species, sexes, and 

routes of administration. The endpoints 

and points of departure (PODs) selected 

for risk assessment are based on 

neurotoxicity and are protective of all 

adverse toxic effects observed in the 

database. EPA determined that the acute 

toxicity of alpha-cypermethrin is higher 

than that of cypermethrin and zetacypermethrin. To account for this 

toxicity difference, EPA applied a 5X 

toxicity factor for alpha-cypermethrin. 

As the current tolerance petitions are for 

cypermethrin, the toxicity PODs for 

cypermethrin were used for risk 

assessment. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the available rat and rabbit 

developmental toxicity studies and rat 

2-generation reproductive studies with 

the cypermethrins. A developmental 

neurotoxicity (DNT) study with zetacypermethrin indicated increased 

sensitivity in the offspring, based on 

body weight changes in pups in the 

absence of treatment-related effects in 

maternal animals at the highest dose 

tested. However, there is a clear noobserved-adverse-effect-level (NOAEL) 

for effects seen in pups, and the doses 

and endpoints selected for risk 

assessment are protective of the 

susceptibility. 

For pyrethroid chemicals, the 

pharmacokinetics indicate that the onset 

of neurotoxicity is rapid, with the time 

to peak effect for neurobehavioral effects 

occurring within hours. This is followed 

by rapid metabolism and elimination 

that does not result in bioaccumulation. 

For the cypermethrins, the PODs for 

clinical signs after single or repeated 

exposure are comparable across 

durations of exposure; thus, 

neurotoxicity does not seem to progress 

with increased exposure. Therefore, 

repeated dosing is essentially a series of 

acute exposures. As there is no apparent 

increase in hazard from repeated/ 

chronic exposures to cypermethrins, the 

acute exposure assessment is protective 

of chronic exposures. The totality of the 

information suggests that only single 

day risk assessments need to be 

conducted for the cypermethrins. 

Cypermethrin is classified as a Group 

C ‘‘Possible human carcinogen,’’ based 

on an increased incidence of benign 

lung adenomas and adenomas plus 

carcinomas combined in females in a 

mouse carcinogenicity study. No tumors 

were seen in cypermethrin cancer 

studies in rats or in a cancer study in 

mice with alpha-cypermethrin. The 

Agency has determined that 

quantification of cancer risk using a 

non-linear approach (i.e., reference dose 

or RfD) will adequately account for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to the cypermethrins. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cypermethrin as well 

as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at https:// 

www.regulations.gov in document 

‘‘Cypermethrin, Human Health Risk 

Assessment for Proposed Tolerances on 

Tea and Commodities of the Codex Crop 

Subgroups: Spices, Fruit or Berry and 

Spices, Root or Rhizome. The 

Tolerances are Proposed Without a U.S. 

Registration.’’ hereinafter 

‘‘Cypermethrin Human Health Risk 

Assessment’’ at pages 32–39 in docket 

ID numbers EPA–HQ–OPP–2022–0508 

and EPA–HQ–OPP–2022–0672. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for cypermethrin used for 

human risk assessment can be found in 

the Cypermethrin Human Health Risk 

Assessment on pages 18–21. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cypermethrin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tolerances for the 

cypermethrins in 40 CFR 180.418. EPA 

assessed dietary exposures from 

cypermethrin in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for cypermethrin. 

In conducting the acute dietary 

exposure assessment, EPA used the 

2005–2010 food consumption data from 

the U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). The acute 

dietary exposure assessment is a 

conservative assessment that assumes 

tolerance level residues for most 

commodities and 100 percent crop 

treated (PCT) for all commodities. The 

highest field trial values obtained in 

residue studies were used for the 

commodities that make the most 

significant contribution to dietary risk, 

specifically apples, peaches, pears, and 

grapes. Empirical and conservative 

default processing factors were used in 

the assessment. EPA determined that 

the toxicity of alpha-cypermethrin is 

higher than that of cypermethrin and 

zeta-cypermethrin. To account for this 


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toxicity difference, HED applied a 5X 

toxicity factor for alpha-cypermethrin. 

ii. Chronic exposure. A chronic 

dietary risk assessment is not required 

for the cypermethrins because repeated 

exposure does not result in a point of 

departure lower than that resulting from 

acute exposure. Therefore, the acute 

dietary risk assessment is protective of 

chronic dietary risk. However, HED 

performed a chronic dietary exposure 

assessment in support of the current 

aggregate human health risk assessment. 

There are residential exposures for the 

cypermethrins that were aggregated 

with background exposure from dietary 

sources. The chronic assessment is only 

being used to estimate background 

dietary exposure to all cypermethrins. 

The chronic dietary exposure 

assessment is a refined assessment 

based on Pesticide Data Program (PDP) 

monitoring data for most commodities. 

Tolerance level residues were used for 

a limited number of commodities 

including tea and spices. As with the 

acute assessment, empirical and 

conservative default processing factors 

were used for the processed 

commodities for which they were 

available. EPA made the conservative 

assumption that 100% of all 

commodities would be treated. When 

monitoring data were used, average 

residues were calculated by 

incorporating one-half limit of detection 

(LOD) values for all non-detects. No 

zeros were used to calculate the average 

residues. EPA accounted for the 5X 

toxicity difference by multiplying the 

average PDP values for commodities 

with alpha-cypermethrin tolerances by a 

factor of 5. 

The cypermethrins have food 

handling establishment (FHE) uses that 

need to be accounted for in the chronic 

dietary exposure assessment. For 

chronic dietary assessment, EPA used a 

residue value of one-half the FHE 

tolerance. EPA estimated the probability 

that a food item a person consumes 

contains residues as a result of 

treatment in an FHE at some point with 

any pesticide. This risk assessment 

paradigm is generic for all pesticides. To 

date, such modelling is not specific to 

cypermethrin. This estimate is 4.65%. 

In the chronic assessment, this value 

was used for the same commodities as 

the ones with the FHE residue value 

(0.025 ppm). For all commodities with 

tolerances, the total anticipated residue 

from the agricultural use exceeded the 

total anticipated residue from the FHE 

use. For this reason, the FHE residue 

value was only used for commodities 

that don’t have tolerances associated 

with direct application to crops. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cypermethrin is classified 

as a ‘‘possible human carcinogen.’’ The 

Agency has determined that 

quantification of risk using a non-linear 

approach (i.e., aPAD or aRfD) will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to the 

cypermethrins. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated levels of pesticide 

residues in food and the actual levels of 

pesticide residues that have been 

measured in food. If EPA relies on such 

information, EPA must require pursuant 

to FFDCA section 408(f)(1) that data be 

provided 5 years after the tolerance is 

established, modified, or left in effect, 

demonstrating that the levels in food are 

not above the levels anticipated. For the 

present action, EPA will issue such data 

call-ins as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Data 

will be required to be submitted no later 

than 5 years from the date of issuance 

of these tolerances. 

EPA assumed 100% crop treated for 

all commodities in the acute and 

chronic dietary exposure assessments. 

However, as discussed above, in the 

chronic assessment, a percent FHE 

treatment value of 4.65% was 

incorporated for commodities for which 

the FHE residue value was used. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cypermethrin in drinking water. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/modelspesticide-risk-assessment. 

In both the acute and chronic 

assessments, EPA used estimated 

drinking water concentrations (EDWCs) 

generated with the Surface Water 

Concentration Calculator (SWCC), and 

in both assessments, the EDWC was 

used for both direct and indirect water. 

For the acute dietary risk assessment, 

EPA used an (EDWC) of 3.5 ppb, and for 

the chronic exposure assessment (used 

to determine background exposure from 

food and drinking water for the purpose 

of aggregate risk assessment), EPA used 

an EDWC 0.035 ppb. EPA also 

determined groundwater EDWCs with a 

different model; however, the Agency 

used the surface water EDWCs in the 

assessments because the surface water 

EDWCs were higher than the 

groundwater EDWCs. The use of the 

surface water values in the dietary 

exposure assessment is protective of 

potential exposure through groundwater 

sources of drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). The 

cypermethrins are registered for a 

variety of non-agricultural purposes 

including recreational sites (i.e., golf 

courses, athletic fields); indoor 

residential/commercial/industrial sites/ 

structural/perimeter and lawn uses; 

gardens and trees; as well as mosquito 

adulticide, termiticide, and pet uses. 

The current action is for tolerances 

without a U.S. registration for tea and 

spices, so no residential handler or postapplication exposures are anticipated. 

For assessing aggregate exposure to 

adults, the Agency used exposures from 

the inhalation handler scenario from 

applying cypermethrin with a sprinkler 

can to home gardens. For assessing 

aggregate exposure to children, the 

Agency used exposures to children 1 to 

<2 years old (dermal and incidental 

oral) from post-application exposure to 

pets treated with the pet medallion/tag 

formulated with zeta-cypermethrin. 

The PODs for the oral and dermal 

routes are based on the same effects: 

therefore, for children, the oral and 

dermal routes can be combined. Since 

the levels of concern for incidental oral 

risk and inhalation risk are different 

(100 and 30, respectively), the aggregate 

risk index (ARI) approach was used to 

calculate aggregate exposure and risk for 

adults. An ARI ≥1 is not of concern. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-pesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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.’’ 

The Agency has determined that the 

pyrethroids and pyrethrins share a 


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common mechanism of toxicity (https:// 

www.regulations.gov; EPA–HQ–OPP– 

2008–0489–0006). As explained in that 

document, the members of this group 

share the ability to interact with voltagegated sodium channels ultimately 

leading to neurotoxicity. In 2011, after 

establishing a common mechanism 

grouping for the pyrethroids and 

pyrethrins, the Agency conducted a 

cumulative risk assessment (CRA) 

which is available at https://

www.regulations.gov; EPA–HQ–OPP– 

2011–0746. In that document, the 

Agency concluded that cumulative 

exposures to pyrethroids (based on 

pesticidal uses registered at the time the 

assessment was conducted) did not 

present risks of concern. For 

information regarding EPA’s efforts to 

evaluate the risk of exposure to this 

class of chemicals, refer to https://

www.epa.gov/ingredients-usedpesticide-products/registration-reviewpyrethrins-and-pyrethroids. 

Since the 2011 CRA, for each new 

pyrethroid and pyrethrin use, the 

Agency has conducted a screen to 

evaluate any potential impacts on the 

CRA prior to those uses being granted. 

A new turf use for the pyrethroid, taufluvalinate, was assessed after 

completion of the cumulative. The new 

use did impact the worst-case nondietary risk estimates identified in the 

2011 CRA for the turf scenario. 

However, the overall risk finding (i.e., 

pyrethroid cumulative risk is above the 

Agency’s level of concern (LOC) and 

therefore not of concern) did not change 

upon registration of this new use. 

For the requested tolerances for tea 

and spices, the Agency has conducted 

an additional screen, taking into 

account all previously approved uses 

and these proposed tolerances. The 

petitioned-for tolerances will not 

significantly impact the cumulative 

assessment because dietary exposures 

make a minor contribution to total 

pyrethroid exposure relative to 

residential exposures in the 2011 

cumulative risk assessment; 

furthermore, the petitioned-for 

tolerances are not associated with any 

increase in residential or nonoccupational exposure. Therefore, the 

results of the 2011 CRA are still valid, 

and there are no cumulative risks of 

concern for the pyrethroids/pyrethrins. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the available rat and rabbit 

developmental toxicity studies and rat 

2-generation reproductive studies with 

the cypermethrins. A developmental 

neurotoxicity (DNT) study with zetacypermethrin indicated increased 

sensitivity in the offspring, based on 

body weight changes in pups in the 

absence of treatment-related effects in 

maternal animals at the highest dose 

tested. However, there is a clear NOAEL 

for effects seen in pups, and the doses 

and endpoints selected for risk 

assessment are protective of the 

susceptibility. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced from 10X to 1X. That 

decision is based on the following 

findings: 

i. The toxicity database for the 

cypermethrins is considered complete. 

When evaluated together, the toxicity 

database for cypermethrin, zetacypermethrin, and alpha-cypermethrin 

can be used to characterize the overall 

suite of effects associated with 

cypermethrin exposure, including 

potential developmental and 

reproductive toxicity, immunotoxicity, 

and neurotoxicity. Acceptable 

developmental toxicity studies in rats 

and rabbits, reproduction studies in rats, 

neurotoxicity studies (acute, 

subchronic, and developmental 

neurotoxicity) in rats, and 

immunotoxicity studies in rats are 

available. 

ii. Like other pyrethroids, the 

cypermethrins cause neurotoxicity by 

interacting with sodium channels, 

leading to clinical signs of 

neurotoxicity. These effects are well 

characterized and adequately assessed 

by the available guideline and nonguideline studies. There are no residual 

uncertainties with regard to evidence of 

neurotoxicity for the cypermethrins. 

iii. No evidence of increased 

qualitative or quantitative susceptibility 

was noted in the developmental toxicity 

or reproduction studies for the 

cypermethrins. However, quantitative 

susceptibility was seen in the rat DNT 

study with zeta-cypermethrin with an 

increased sensitivity in the offspring 

based on body weight changes in pups 

in the absence of adverse, treatmentrelated effects in maternal animals. The 

results from the DNT study are very 

similar to results observed in the 

reproduction studies where body weight 

changes (decreased body weight gain) 

were seen in maternal and offspring 

animals at doses similar to those in the 

DNT study, with no indication of 

increased susceptibility. Therefore, 

there is no residual concern for effects 

observed in the study since a clear 

developmental NOAEL and LOAEL 

were identified for which the selected 

PODs for risk assessment are protective. 

iv. There are no residual uncertainties 

with regard to exposure. The dietary 

exposure assessments account for parent 

and metabolites of concern. In addition, 

they are refined, but could be more 

highly refined. The assessments include 

100 percent crop treated assumptions, 

tolerance level residues for most 

commodities in the acute dietary 

exposure assessment, and default 

processing factors for many of the 

processed commodities. Furthermore, 

conservative, upper-bound assumptions 

were used to determine exposure 

through drinking water and residential 

sources, such that these exposures have 

not been underestimated. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing dietary exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). Short-, 

intermediate-, and chronic-term 

aggregate risks are evaluated by 

comparing the estimated total food, 

water, and residential exposure to the 

appropriate PODs to ensure that an 

adequate MOE exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

described in this unit for acute 

exposure, EPA has concluded that acute 

exposure to cypermethrin from food and 

water will utilize 71% of the aPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

Acute aggregate risk estimates are not of 

concern for the general U.S. population 

or any population subgroup. 

2. Chronic risk. A chronic dietary risk 

assessment is not required for 

cypermethrin because repeated 


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68480 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Rules and Regulations 

exposure does not result in a POD lower 

than that resulting from acute exposure. 

Therefore, the acute dietary risk 

assessment is protective of chronic 

dietary risk. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Cypermethrin is 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

cypermethrin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 130 for children and 

an ARI of 4.5 for adults. Because EPA’s 

level of concern for cypermethrin is an 

MOE below 100, or an ARI below 1, 

these MOEs/ARIs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

While there is potential intermediateterm residential exposure, because the 

single dose and repeat dosing 

cypermethrin studies show that repeat 

exposures do not result in lower points 

of departure, the residential assessments 

are conducted as a series of acute 

exposures and the same endpoint is 

used regardless of duration. Therefore, 

the short-term aggregate assessment is 

considered protective of any 

intermediate-term exposures. 

5. Aggregate cancer risk for U.S. 

population. EPA has classified 

cypermethrin as a ‘‘possible human 

carcinogen’’ and determined that a nonlinear approach relying on the acute 

regulatory endpoints should be used for 

cancer assessment. As the acute dietary 

exposure estimates are not of concern, 

cancer risk is not of concern. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

cypermethrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate tolerance-enforcement 

methods are available in PAM (Pesticide 

Analytical Manual) Volume II for 

determining residues of zetacypermethrin in plant (Method I) and 

livestock (Method II) commodities. Both 

methods are gas chromatographic 

methods with electron-capture detection 

(GC/ECD) and have undergone 

successful Agency petition method 

validations (PMVs). These methods are 

not stereospecific; therefore, no 

distinction is made between residues of 

cypermethrin (all 8 stereoisomers), zetacypermethrin (enriched in 4 isomers) 

and alpha-cypermethrin (enriched in 2 

isomers). 

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). 

Codex has established an MRL of 15 

ppm for residues of cypermethrin in or 

on tea. The U.S. tolerance for residues 

of cypermethrin in or on Tea, dried is 

harmonized with the Codex MRL. 

Codex has established an MRL of 0.5 

ppm for residues of cypermethrin on the 

crop subgroup Spices, Fruits and Berries 

and an MRL of 0.2 ppm for residues on 

the crop subgroup Spices, Roots and 

Rhizomes. The U.S. tolerances for 

residues of cypermethrin in or on the 

individual spice commodities are 

harmonized with the relevant Codex 

MRL. 

C. Revisions to Petitioned-For 

Tolerances 

The Tea Association requested a 

tolerance of 15.0 ppm for Tea. The 

United States conforms to OECD 

rounding classes when setting 

tolerances and is establishing the 

tolerance level at 15 ppm rather than 

15.0 ppm for Tea, dried. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cypermethrin, including 

its metabolites and degradates, in or on 

Allspice at 0.5 ppm; Angelica, seed at 

0.2 ppm; Anise pepper at 0.5 ppm; 

Asafoetida at 0.2 ppm; Ashwagandha 

fruit at 0.5 ppm; Batavia-cassia, fruit at 

0.5 ppm; Belleric myrobalan at 0.5 ppm; 

Calamus-root at 0.2 ppm; Caper buds at 

0.5 ppm; Cardamom, black at 0.5 ppm; 

Cardamom, Ethiopian at 0.5 ppm; 

Cardamom, green at 0.5 ppm; 

Cardamom, Nepal at 0.5 ppm; 

Cardamom-amomum at 0.5 ppm; Cassia, 

fruit at 0.5 ppm; Cassia, Chinese, fruit 

at 0.5 ppm; Chaste tree, Chinese, roots 

at 0.2 ppm; Chinese hawthorne at 0.5 

ppm; Chinese-pepper at 0.5 ppm; 

Cinnamon, fruit at 0.5 ppm; Cinnamon, 

Saigon, fruit at 0.5 ppm; Coptis at 0.2 

ppm; Coriander, fruit at 0.5 ppm; 

Coriander, seed at 0.2 ppm; Cumin, 

black at 0.5 ppm; Dorrigo pepper, berry 

at 0.5 ppm; Dorrigo pepper, leaf at 0.5 

ppm; Eucalyptus at 0.5 ppm; Fingerroot 

at 0.2 ppm; Gamboge at 0.5 ppm; Grains 

of Selim at 0.5 ppm; Jalap at 0.2 ppm; 

Juniper, berry at 0.5 ppm; Lovage, root 

at 0.2 ppm; Lovage, seed at 0.2 ppm; 

Miracle fruit at 0.5 ppm; Pepper, black 

at 0.5 ppm; Pepper, Indian long at 0.5 

ppm; Pepper, Javanese, long at 0.5 ppm; 

Pepper, pink at 0.5 ppm; Pepper, 

Sichuan at 0.5 ppm; Pepper, white at 0.5 

ppm; Pepperbush, berry at 0.5 ppm; 

Pepperbush, leaf at 0.5 ppm; 

Peppercorn, green at 0.5 ppm; 

Peppertree at 0.5 ppm; Peppertree, 

Peruvian at 0.5 ppm; Saunders, red at 

0.5 ppm; Sumac, fragrant at 0.5 ppm; 

Sumac, smooth, leaf at 0.5 ppm; 

Tamarind, seed at 0.5 ppm; Tasmanian, 

pepper, berry at 0.5 ppm; Tea, dried at 

15 ppm; Tsaoko at 0.5 ppm; Vanilla at 

0.5 ppm; and Yellow gentian, roots at 

0.2 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 


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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Rules and Regulations 68481 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 24, 2023. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.418, revise paragraph (a)(1) 

to read as follows: 

§ 180.418 Cypermethrin and isomers 

alpha-cypermethrin and zeta-cypermethrin; 

tolerances for residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide cypermethrin (±)alpha 

cyano-(3-phenoxyphenyl)methyl 

(±)cis,trans-3(2,2-dichloroethenyl-2,2- 

dimethylcyclopropanecarboxylate in or 

on the commodities in table 1 to 

paragraph (a)(1). 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

Allspice 1 ..................................... 0.5 

Angelica, seed 1 .......................... 0.2 

Anise pepper 1 ............................ 0.5 

Asafoetida 1 ................................. 0.2 

Ashwagandha fruit 1 .................... 0.5 

Batavia-cassia, fruit 1 .................. 0.5 

Belleric myrobalan 1 .................... 0.5 

Brassica, head and stem, subgroup 5A ................................. 2.0 

Brassica, leafy greens, subgroup 

5B ............................................ 14.0 

Calamus-root 1 ............................ 0.2 

Caper buds 1 ............................... 0.5 

Cardamom, black 1 ..................... 0.5 

Cardamom, Ethiopian 1 ............... 0.5 

Cardamom, green 1 .................... 0.5 

Cardamom, Nepal 1 .................... 0.5 

Cardamom-amomum 1 ................ 0.5 

Cassia, fruit 1 .............................. 0.5 

Cassia, Chinese, fruit 1 ............... 0.5 

Cattle, fat .................................... 1.0 

Cattle, meat ................................ 0.2 

Cattle, meat byproducts ............. 0.05 

Chaste tree, Chinese, roots 1 ..... 0.2 

Chinese hawthorne 1 .................. 0.5 

Chinese-pepper 1 ........................ 0.5 

Cinnamon, fruit 1 ......................... 0.5 

Cinnamon, Saigon, fruit 1 ............ 0.5 

Coptis 1 ....................................... 0.2 

Coriander, fruit 1 .......................... 0.5 

Coriander, seed 1 ........................ 0.2 

Cotton, gin byproducts ............... 11.0 

Cotton, undelinted seed ............. 0.5 

Cumin, black 1 ............................. 0.5 

Dorrigo pepper, berry 1 ............... 0.5 

Dorrigo pepper, leaf 1 ................. 0.5 

Egg ............................................. 0.05 

Eucalyptus 1 ................................ 0.5 

Fingerroot 1 ................................. 0.2 

Gamboge 1 .................................. 0.5 

Grains of Selim 1 ......................... 0.5 

Goat, fat ...................................... 1.0 

Goat, meat .................................. 0.2 

Goat, meat byproducts ............... 0.05 

Hog, fat ....................................... 0.1 

Hog, meat ................................... 0.05 

Horse, fat .................................... 1.0 

TABLE 1 TO PARAGRAPH (a)(1)— 

Continued 

Commodity Parts per 

million 

Horse, meat ................................ 0.2 

Horse, meat byproducts ............. 0.05 

Jalap 1 ......................................... 0.2 

Juniper, berry 1 ........................... 0.5 

Lettuce, head .............................. 4.0 

Lovage, root 1 ............................. 0.2 

Lovage, seed 1 ............................ 0.2 

Milk, fat (reflecting 0.10 in whole 

milk) ......................................... 2.5 

Miracle fruit 1 ............................... 0.5 

Onion, bulb ................................. 0.1 

Onion, green ............................... 6.0 

Pecan .......................................... 0.05 

Pepper, black 1 ........................... 0.5 

Pepper, Indian long 1 .................. 0.5 

Pepper, Javanese, long 1 ........... 0.5 

Pepper, pink 1 ............................. 0.5 

Pepper, Sichuan 1 ....................... 0.5 

Pepper, white 1 ........................... 0.5 

Pepperbush, berry 1 .................... 0.5 

Pepperbush, leaf 1 ...................... 0.5 

Peppercorn, green 1 .................... 0.5 

Peppertree 1 ................................ 0.5 

Peppertree, Peruvian 1 ............... 0.5 

Poultry, fat .................................. 0.05 

Poultry, meat .............................. 0.05 

Saunders, red 1 ........................... 0.5 

Sheep, fat ................................... 1.0 

Sheep, meat ............................... 0.2 

Sheep, meat byproducts ............ 0.05 

Sumac, fragrant 1 ........................ 0.5 

Sumac, smooth, leaf 1 ................ 0.5 

Tamarind, seed 1 ........................ 0.5 

Tasmanian, pepper, berry 1 ........ 0.5 

Tea, dried 1 ................................. 15 

Tsaoko 1 ...................................... 0.5 

Vanilla 1 ....................................... 0.5 

Yellow gentian, roots 1 ................ 0.2 

1There are no U.S. registrations as of October 4, 2023. 

* * * * * 

[FR Doc. 2023–21821 Filed 10–3–23; 8:45 am] 

BILLING CODE 6560–50–P 


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