31950 Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Rules and Regulations 

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 

EPA’s 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). 

V. 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: June 10, 2021. 

Edward Messina, 

Acting Director, 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. Add § 180.1382 to subpart D to read 

as follows: 

§ 180.1382 Purpureocillium lilacinum 

strain PL11; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Purpureocillium lilacinum strain 

PL11 in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. 

[FR Doc. 2021–12610 Filed 6–15–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0067; FRL–10024–51] 

Tolfenpyrad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tolfenpyrad in 

or on artichoke, globe. The Interregional 

Project Number 4 (IR–4) requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

16, 2021. Objections and requests for 

hearings must be received on or before 

August 16, 2021, 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–2020–0067, is 

available at http://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 is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Acting Director, 

Registration Division (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

main telephone number: (703) 305– 

7090; 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 Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2020–0067 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 

August 16, 2021. 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– 

2020–0067, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

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. 


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• 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 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 8, 2020 

(85 FR 27346) (FRL–10008–38), 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 9E8807) by the 

Interregional Project Number 4 (IR–4), 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.675 be 

amended by establishing a tolerance for 

residues of the insecticide tolfenpyrad, 

(4-choro-3-ethyl-1-methyl-N-[[4-(4- 

methylphenoxy)phenyl]methyl]-1Hpyrazole-5-carboxamide), in or on 

artichoke, globe at 5 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by IR– 

4, the petitioner, which is available in 

the docket for this action, Docket ID 

EPA–HQ–OPP–2020–0067, at http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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 toxicology database is considered 

complete. A variety of toxic effects were 

noted in the toxicology database for 

tolfenpyrad. However, the most 

consistent findings across species and 

studies were effects on bodyweight and 

bodyweight gain. Decreases in 

bodyweight and/or bodyweight gain 

were observed in adults of all species 

(rat, mice, rabbit, and dog) in the 

majority of the subchronic oral and 

dermal toxicity studies, and all chronic 

toxicity studies. Bodyweight decreases 

in rats were observed at much lower 

doses than in other species. Chronic 

exposure resulted in bodyweight and 

bodyweight gain decreases in mice and 

dogs at lower doses than the effects that 

were observed from acute and 

subchronic exposures. In addition, 

quantitative susceptibility was observed 

in the database; in the rat 

developmental study, decreased fetal 

weights and number of ossified 

metacarpals were observed in the 

absence of adverse maternal toxicity and 

in the one-generation reproduction 

study, decreased pup weights were 

observed at a lower dose than the dose 

at which parental bodyweight decreases 

reached biological significance. 

Tolfenpyrad is classified as ‘‘not likely 

to be carcinogenic to humans’’. 

A complete discussion of the 

toxicological profile for tolfenpyrad as 

well as specific information on the 

studies received and the nature of the 

adverse effects caused by tolfenpyrad as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found in the 

document titled ‘‘Tolfenpyrad—Human 

Health Risk Assessment of the New Use 

on Globe Artichoke’’ (hereinafter 

‘‘Tolfenpyrad Human Health Risk 

Assessment’’) in docket ID number 

EPA–HQ–OPP–2020–0067 at https://

regulations.gov. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (PODs) 

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 http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for tolfenpyrad used for 

human risk assessment can be found in 

the Tolfenpyrad Human Health Risk 

Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tolfenpyrad, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing tolfenpyrad tolerances in 40 

CFR 180.675. EPA assessed dietary 

exposures from tolfenpyrad 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 

tolfenpyrad. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA). As to 

residue levels in food, the acute 

assessment assumed tolerance-level 

residues and 100% crop treated (PCT) 

for all commodities. Refinements 

include a factor to account for the 

reduction in residues when wrapper 

leaves are removed from head lettuce, 

radicchio, cabbage, Chinese Napa 

cabbage, and Brussels sprouts. 

Empirical processing factors were 

available for processed commodities of 

apple, orange, cottonseed, grape, plum, 

potato and tomato, and were translated 

to other crop processed commodities 

where appropriate. Where empirical 

processing factors were not available or 

were not translated, the Agency’s 2018 

default processing factors were used. 

Several factors were used to account for 

metabolite residues in/on bulb onion 

subgroup 3–07A commodities and 

livestock commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA’s 

2003–2008 NHANES/WWEIA. As to 

residue levels in food, EPA used average 

residues from field trials. The chronic 

assessment includes estimates of PCT 

for some crops and all the refinements 


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described above for the acute 

assessment. 

iii. Cancer. Based on the data cited in 

Unit III.A., EPA has concluded that 

tolfenpyrad does not pose a cancer risk 

to humans. Therefore, a dietary 

exposure assessment for the purpose of 

assessing cancer risk is unnecessary. 

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 residue 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 to establish the 

tolerance, 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 residue 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. 

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 acute assessment assumes 100 

PCT. The Agency incorporated 

estimates of average PCT in the chronic 

assessment for the following crops: 

Grapefruit (15%), grapes (2.5%), lettuce 

(10%), onion (2.5%), oranges (5%), 

peppers (less than 2.5%), potatoes 

(2.5%), tangerines (2.5%), and tomatoes 

(2.5%). 

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 

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 

less than 1% or less than 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 less than 2.5% as the 

maximum PCT. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

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 tolfenpyrad may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for tolfenpyrad in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of tolfenpyrad. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Residues of tolfenpyrad in surface and 

ground water were modeled with the 

Pesticide in Water Calculator (PWC 

Version 1.52). Groundwater estimated 

drinking water concentrations were 

modeled with the Pesticide Root Zone 

Model Groundwater (PRZM GW) model 

within the Pesticide in Water Calculator 

(Version 1.52). For tolfenpyrad, the 

assessment uses the total residues 

approach, which is commonly used to 

assess chemicals that have residues of 

concern with similar toxicity to parent 

compound. The recommended 

estimated drinking water concentrations 

(EDWCs) for tolfenpyrad acute 

exposures are estimated to be 32.6 parts 

per billion (ppb) for surface water and 

168 ppb for ground water. For chronic 

exposures for non-cancer assessments, 

EDWCs are estimated to be 14.1 ppb for 

surface water and 125 ppb for ground 

water. For the acute dietary exposure 

assessment, EPA used an EDWC of 168 

ppm. For the chronic dietary exposure 

assessment, EPA used a value of 125 

ppb. 

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). 

Tolfenpyrad is not registered for any 

specific use patterns that would result 

in residential exposure. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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.’’ 

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 

tolfenpyrad and any other substances, 

and tolfenpyrad does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this action, therefore, EPA has not 


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assumed that tolfenpyrad has a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/pesticidecumulative-risk-assessment-framework. 

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 

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 is no evidence of increased 

quantitative or qualitative susceptibility 

in the guideline rabbit developmental 

studies, the rat two-generation 

reproduction study, or the 

developmental immunotoxicity (DIT) 

study. Quantitative susceptibility was 

observed in the developmental rat study 

and the range-finding one-generation 

reproduction study. In the 

developmental rat study, decreased fetal 

weights and number of ossified 

metacarpals were observed in the 

absence of adverse maternal toxicity 

(only a 9% decrease in bodyweight). In 

the one-generation reproduction study, 

decreased pup weights were observed at 

a dose lower than the dose at which 

parental bodyweight decreases reached 

biological significance. All of the 

reviewed studies (developmental 

toxicity studies in the rat and rabbit and 

the one- and two-generation 

reproductive toxicity studies in the rat) 

include decreased bodyweight in the 

maternal LOAEL statement, as well as 

mortality in both of the developmental 

rabbit studies and the two-generation rat 

reproduction study. Reproductive 

toxicity was seen in rats as increased 

total litter loss in the two-generation 

study and decreased pup viability in the 

one- and two-generation study. 

Decreased pup weight was observed in 

all six studies, and additional offspring 

effects include: An increase in skeletal 

variation in both developmental toxicity 

studies; blackish abdominal cavity, dark 

green intestinal contents, and decreased 

survival of offspring in the 

developmental immunotoxicity study; 

decreased pup viability in both 

reproduction studies, with the addition 

of a delay in developmental landmarks 

in the two-generation reproductive 

toxicity study. Since most of these 

effects occurred in the presence of 

comparable or more severe maternal 

toxicity, or were partially attributable to 

the maternal animal behavior, they were 

not considered evidence of qualitative 

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 to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

tolfenpyrad is complete and includes 

acceptable developmental and 

reproductive toxicity studies. 

ii. Based on the available toxicity 

database, there is no indication that 

tolfenpyrad is a neurotoxic chemical, 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

iii. While there was evidence of 

quantitative susceptibility in two 

studies, the Agency’s degree of concern 

for the susceptibility is low because the 

offspring effects consistently occurred at 

or near doses which caused maternal 

toxicity (bodyweight decrease), and 

because endpoints and doses selected 

for risk assessment are protective of the 

observed susceptibility. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary exposure assessment is 

partially refined but does not 

underestimate potential dietary 

exposure to tolfenpyrad. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to tolfenpyrad 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by tolfenpyrad. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

tolfenpyrad will occupy 69% of the 

aPAD for children 1 to 2 years of age, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to tolfenpyrad 

from food and water will utilize 59% of 

the cPAD for all infants less than 1-year 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for tolfenpyrad. 

3. Short-term and Intermediate-term 

risks. Short-term and intermediate-term 

aggregate exposures take into account 

short-term and intermediate-term 

residential exposures plus chronic 

exposures to food and water (considered 

to be a background exposure level). 

Short-term and intermediate-term 

adverse effects were identified; 

however, tolfenpyrad is not registered 

for any use patterns that would result in 

short-term or intermediate-term 

residential exposures. Short-term and 

intermediate-term risks are assessed 

based on short-term and intermediateterm residential exposures plus chronic 

dietary exposure. Because there are no 

short-term or intermediate-term 

residential exposures and chronic 

dietary exposures have already been 

assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short-term and intermediate-term risk), 

no further assessments of short-term and 

intermediate-term risks are necessary, 

and EPA relies on the chronic dietary 

risk assessment for evaluating shortterm and intermediate-term risks for 

tolfenpyrad. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

tolfenpyrad is not expected to pose a 

cancer risk to humans. 

5. 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 tolfenpyrad 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An acceptable high-performance 

liquid chromatography method with 


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tandem mass spectrometry detection 

(LC/MS/MS) is available for 

enforcement of tolfenpyrad residue 

tolerances in/on plant commodities 

(Morse Laboratories Analytical Method 

#Meth-183, Revision #2). For livestock, 

a method described in PTRL West Study 

No. 1841W is available. Residues are 

determined by LC/MS/MS analysis. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd. Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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 Codex has not established an 

MRL for tolfenpyrad in globe artichoke. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of tolfenpyrad, (4-choro-3- 

ethyl-1-methyl-N-[[4-(4- 

methylphenoxy)phenyl]methyl]-1Hpyrazole-5-carboxamide), in or on 

artichoke, globe at 5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

under FFDCA section 408(d) in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001), or to 

Executive Order 13045, entitled 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

This action does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.), nor does it require any special 

considerations under Executive Order 

12898, entitled ‘‘Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 10, 2021. 

Marietta Echeverria, 

Acting 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 § 180.675, amend paragraph 

(a)(1) by designating the table and 

adding in alphabetical order in newly 

designated Table 1 to paragraph (a)(1) 

the entry ‘‘Artichoke, globe’’ to read as 

follows: 

§ 180.675 Tolfenpyrad; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe .................... 5 

* * * * * 

* * * * * 

[FR Doc. 2021–12609 Filed 6–15–21; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 21–71; RM–11887; DA 21– 

601; FR ID 29216] 

Television Broadcasting Services 

Hannibal, Missouri 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: On March 7, 2021, the Media 

Bureau, Video Division (Bureau) issued 

a Notice of Proposed Rulemaking in 

response to a petition for rulemaking 

filed by KHQA Licensee, LLC 

(Licensee), the licensee of KMYU, 

channel 7 (CBS), Hannibal, Missouri, 

requesting the substitution of channel 

22 for channel 7 at Hannibal in the DTV 

Table of Allotments. For the reasons set 

forth in the Report and Order referenced 

below, the Bureau amends FCC 


jbell on DSKJLSW7X2PROD with RULES