Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 11133 

2018 Opinion, affirm that the State 

revised the title V program provisions 

for judicial review as codified in NDAC 

section 33.1–15–14–6.8, effective as 

amended January 1, 2019. Therefore, 

North Dakota timely submitted revisions 

to address the deficiencies identified in 

our interim approval action within six 

months prior to the interim approval’s 

expiration. Accordingly, the EPA finds 

that the North Dakota title V program 

fulfills all criteria for full final approval 

of the transfer. The EPA is now acting 

to fully approve the North Dakota title 

V program under 40 CFR part 70 and 

CAA section 502. 

V. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a state title V 

program submittal that complies with 

the provisions of the Act and applicable 

federal regulations. 42 U.S.C. 7661a(d); 

40 CFR 70.1(c), 70.4(i). Thus, in 

reviewing title V program submittals, 

the EPA’s role is to approve state 

choices, provided they meet the criteria 

of the CAA and the criteria, standards 

and procedures defined in 40 CFR part 

70. Accordingly, this action merely 

approves state law as meeting federal 

requirements and does not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Is not an Executive Order 13771 (82 

FR 9339, February 2, 2017) regulatory 

action because Operating Permits 

Program approvals are exempted under 

Executive Order 12866; 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Public Law 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this action is not 

approved to apply on any Indian 

reservation land or in any other area 

where the EPA or an Indian tribe has 

demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by April 26, 2021. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2)). 

List of Subjects in 40 CFR Part 70 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Title V. 

Dated: February 11, 2021. 

Debra Thomas, 

Acting Regional Administrator, Region 8. 

40 CFR part 70 is amended as follows: 

PART 70—STATE OPERATING PERMIT 

PROGRAMS 

■ 1. The authority citation for part 70 

continues to read as follows: 

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

■ 2. In appendix A to part 70 the entry 

for ‘‘North Dakota’’ is amended by 

revising paragraph (d) to read as 

follows: 

Appendix A to Part 70—Approval 

Status of State and Local Operating 

Permits Programs 

* * * * * 

North Dakota 

* * * * * 

(d) The State of North Dakota submitted on 

August 6, 2018, operating permit program 

revisions and a request to transfer authority 

to implement and enforce the operating 

permit program from the North Dakota 

Department of Health to the North Dakota 

Department of Environmental Quality. The 

recodified North Dakota title V operating 

permits program is codified in N.D. Admin. 

Code sections 33.1–15–14–06, 33.1–15–23– 

04, and 33.1–15–21. North Dakota also 

submitted on August 16, 2018 the, ‘‘Attorney 

General’s Opinion Operating Permits 

Program,’’ which was supplemented on 

December 12, 2018, with an ‘‘Addendum to 

August 16, 2018 Attorney General’s Opinion 

Operating Permits Program,’’ stating that the 

laws of the State provide adequate legal 

authority to carry out all aspects of the 

program. North Dakota also submitted 

revisions to state law effective January 1, 

2019; full approval effective on April 26, 

2021. 

* * * * * 

[FR Doc. 2021–03267 Filed 2–23–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0233; FRL–10005–77] 

Tetraniliprole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tetraniliprole 

in or on multiple commodities that are 

identified and discussed later in this 

document. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 24, 2021. Objections and 


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11134 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 

requests for hearings must be received 

on or before April 26, 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–2017–0233, 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, 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–2017–0233 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 April 26, 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– 

2017–0233, 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. 

• 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 http://

www.epa.gov/dockets/contacts.html. 

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 December 

15, 2017 (82 FR 59604) (FRL–9970–50), 

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 7F8558) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the insecticide, 

tetraniliprole in or on tuberous and 

corm vegetables, crop group 1C at 0.015 

parts per million (ppm); potato, wet peel 

at 0.02 ppm; leafy vegetables, crop 

group 4–16 at 20 ppm; Brassica head 

and stem vegetables, crop group 5–16 at 

1.5 ppm; fruiting vegetables, crop group 

8–10 at 0.40 ppm; tomato paste at 1.5 

ppm; citrus fruit, orange subgroup 10– 

10A at 0.50 ppm; citrus fruit, lemon/ 

lime subgroup 10–10B at 0.80 ppm; 

citrus fruit, grapefruit subgroup 10–10C 

at 0.50 ppm; citrus oil at 4.0 ppm; pome 

fruit, crop group 11–10 at 0.40 ppm; 

stone fruit, crop group 12–12 at 1.0 

ppm; plum, dried (prune) at 2.0 ppm; 

small fruit, vine climbing subgroup, 

except fuzzy kiwi, crop subgroup 13– 

07F at 1.5 ppm; tree nuts, crop group 

14–12 at 0.03 ppm; almond hulls at 4.0 

ppm; corn, field, grain at 0.015 ppm; 

corn, field, forage at 4.0 ppm; corn, 

field, stover at 15 ppm; corn, pop, grain 

at 0.015 ppm; corn, pop, stover at 15 

ppm; corn, sweet, kernel plus cobs with 

husks removed at 0.01 ppm; corn, 

sweet, forage at 6.0 ppm; corn, sweet, 

stover at 20 ppm; cottonseed, crop 

group 20C at 0.40 ppm; cotton, gin 

byproducts at 30 ppm; soybean seed at 

0.20 ppm; soybean hulls at 0.60 ppm; 

aspirated grain fractions at 45 ppm; 

soybean forage at 0.07 ppm; soybean 

hay at 0.20 ppm; alfalfa, forage and hay 

at 0.06 ppm; forage, fodder and straw of 

cereal grains, crop group 16, except 

field, pop and sweet corn at 0.10 ppm; 

foliage of legume vegetables, crop group 

7, except soybeans at 0.03 ppm; milk at 

0.06 ppm; fat of cattle, horses, sheep 

and goats at 0.30 ppm; muscle of cattle, 

horses, sheep and goats at 0.03 ppm; 

meat by-products of cattle, horses, sheep 

and goats at 0.30 ppm. That document 

referenced a summary of the petition 

prepared by Bayer CropScience, the 

registrant, which is available in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established as well as some of 

the commodity definitions used. The 

reasons for these changes are explained 

in Unit IV.D. 


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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 11135 

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 tetraniliprole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with tetraniliprole 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 submitted animal toxicity studies 

on tetraniliprole demonstrate low 

toxicity, which is expected based on 

two factors. Tetraniliprole is an 

anthranilimide insecticide that targets 

the activation of insect ryanodine 

receptors, which leads to insect 

paralysis and death. In contrast, 

mammalian ryanodine receptors are 

substantially less sensitive (i.e., 350 to 

>2,500 times less sensitive) to the effects 

of anthranilic diamides than insect 

ryanodine receptors. Moreover, 

available data indicate that 

tetraniliprole has limited absorption at 

the higher dose levels (>20 mg/kg), 

which may contribute to the low 

toxicity seen in the animal testing. 

In subchronic toxicity studies (28-day 

and 90-day) in rats and mice, no adverse 

effects were seen at dose levels ranging 

from approximately 600 to 1,228 mg/kg/ 

day. In the subchronic studies (28-day 

and 90-day) in dogs, an increase in the 

incidence and frequency of salivation 

was found, but this finding did not 

show a dose related-response, was a 

common occurrence in dogs, and was 

not considered to be adverse. 

No systemic or dermal toxicity was 

seen in a 28-day dermal toxicity study 

at 1,000 mg/kg/day; this finding was 

consistent with rather low dermal 

absorption as the DAF for humans was 

estimated to be approximately 9% 

(upper limit). 

No adverse maternal or 

developmental effects were found at the 

limit dose (1,000 mg/kg/day) in the 

developmental toxicity studies in rats 

and rabbits. In the reproduction study, 

the offspring effect, slight decrease in 

pup weight near and above the limit 

dose, was found in the absence of any 

adverse parental effect. Because the 

potential increase in susceptibility 

occurred at the limit dose and on 

postnatal days (PND) 14 to 21 at which 

time the pups were exposed to the test 

material through both milk and food 

resulting in a higher compound intake, 

the Agency’s concern for the potential 

risk to infants and children is low. 

Tetraniliprole did not cause any effects 

on reproductive parameters. 

The combined chronic/ 

carcinogenicity study in rats showed a 

decrease in body weights, increased 

incidence of squamous cell hyperplasia 

in the cervix and vagina, and corpora 

lutea depletion in the ovary at the limit 

dose. In addition, a slight increase in the 

incidence of uterine tumor was 

observed at a dose slightly above the 

limit dose. No genotoxic potential was 

detected in the battery of genotoxicity 

studies. There were no treatment-related 

tumors seen in mice and no adverse 

effects were observed in male rats. The 

only adverse effects observed in female 

rats occurred at the limit dose, which 

was the only dose where pre-neoplastic 

or neoplastic lesions were observed. 

Furthermore, there is no concern for 

mutagenicity and none of the identified 

structurally-related compounds induced 

tumors in rats or mice. Based on the 

available data that indicates that the 

increased incidence of uterine tumor 

was seen in only one species (rat), one 

sex (female), and is only slightly outside 

of the historical control range, EPA has 

classified tetraniliprole as having 

‘‘suggestive evidence of carcinogenic 

potential.’’ 

Typically, for chemicals so classified, 

EPA recommends that a non-linear or 

RfD approach be used because the RfD 

would be protective for all toxicity, 

including carcinogenicity. However, in 

the case of tetraniliprole, EPA 

determined that the existing data do not 

support establishing toxicity endpoints 

and that a qualitative assessment is 

more appropriate for assessing 

tetraniliprole. This analysis is discussed 

more fully in Unit III.B. below. 

Similarly, because of the suggestive 

nature of the carcinogenicity effects and 

the fact that the only tumor effects are 

seen at doses above the limit dose, EPA 

has determined that a qualitative risk 

assessment would be appropriate in this 

case to account for all toxicity including 

carcinogenicity. 

No acute and subchronic 

neurotoxicity studies were submitted for 

tetraniliprole because this requirement 

was waived. However, no evidence of 

neurotoxicity was seen in any of the 

other studies in the tetraniliprole 

database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by tetraniliprole as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Tetraniliprole: New Active 

Ingredient, First Food Use. Human 

Health Risk Assessment for the 

Establishment of Permanent Tolerances 

on Brassica Head and Stem Vegetables, 

Corn (Field, Pop and Sweet), Citrus 

Fruit, Fruiting Vegetables, Leafy 

Vegetables, Pome Fruit, Small Fruit 

Vine Growing (except Fuzzy Kiwifruit) 

including Grape, Soybean, Stone Fruit, 

Tree Nuts, and Tuberous and Corm 

Vegetables, Plus Registration for Seed 

Treatment Uses on Corn (Field, Pop and 

Sweet), Use on Tobacco, and Use on 

Golf Course Turf, Sport Fields, and Sod 

Farms’’ on pages 33–69 in docket ID 

number EPA–HQ–OPP–2017–0233. 

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 


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11136 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 

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. 

Based on a thorough analysis of the 

toxicology database of tetraniliprole, the 

Agency has determined that a 

qualitative risk assessment is more 

appropriate for tetraniliprole based on 

the following reasons: 

• All the adverse effects (decrease in 

pup body weights and non-neoplastic 

uterine lesions, characterized by 

prolapsed vagina, squamous cell 

hyperplasia in the cervix) in rats were 

found at or slightly above the limit dose. 

Although informative for hazard 

characterization for purposes of risk 

assessment, a toxicity test dose at or 

above the limit dose of 1,000 mg/kg/day 

represents an exposure that is not 

expected to occur either daily or over an 

extended period of time and therefore is 

not relevant to exposure levels expected 

from the use of tetraniliprole. 

• EPA determined that the body 

weight reduction effects seen in the 90- 

day and 1-year oral studies with the 

dog, (approximately 500 mg/kg/day) 

were not robust enough to be employed 

as a toxicity endpoint for risk 

assessment, due to the marginal nature 

of those effects and the fact that the rat 

(for which effects were seen at the 1,000 

mg/kg/day, limit dose) was more 

sensitive, based on a human equivalent 

dose analysis. 

• Available data indicate no potential 

inhalation risk of concern. 

• Available data indicate no adverse 

systemic effects at the limit dose (1,000 

mg/kg/day) for dermal exposure. 

• Potential offspring susceptibility 

was not of concern as the decrease in 

pup weight seen in the reproduction 

study was marginal and occurred at or 

above the limit dose (890/1,032 mg/kg/ 

day (males/females)). In addition, the 

decrease occurred on postnatal days 

(PND) 14 to 21, at which time the pups 

were likely to be exposed to the test 

material through both milk and feed 

resulting in a much higher compound 

intake. 

• Finally, taking into account 

expected exposures, EPA does not 

anticipate dietary exposure levels to 

occur daily, or over an extended period 

of time that would reach levels 

anywhere near that of the limit dose 

(1,000 mg/kg/day). An unrefined 

chronic dietary (food only) exposure 

estimate of tetraniliprole was calculated 

using tolerance-level residues for all 

crops and assuming 100% crop treated, 

as well as default processing factors. 

The screening estimate indicated that 

the highest exposure group is children 

1 to 2 years old, with an estimated 

exposure of 0.027 mg/kg/day. To reach 

a dose of 1,000 mg/kg/day, an 

individual of this subpopulation would 

need to ingest 37,000 times the 

estimated dietary exposure. Further, the 

highest current application rate is 

approximately 0.18 lb ai/acre; and in 

order to yield residues that would lead 

to dietary exposures of 1,000 mg/kg/day, 

the application rate would have to be 

greater than 6,000 lb ai/acre. 

Consequently, EPA does not believe that 

an effect at or about the limit dose is 

relevant to human health risk 

assessment for tetraniliprole. 

Taking all the foregoing into 

consideration, EPA has concluded that 

a qualitative analysis of tetraniliprole is 

appropriate. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. There is potential for 

exposure to tetraniliprole via food and 

feed based on the proposed uses. 

However, no adverse effects were 

observed in the submitted toxicological 

studies for tetraniliprole regardless of 

the route of exposure. Thus, no 

quantitative dietary exposure 

assessments are needed for EPA to 

conclude with reasonable certainty that 

dietary exposures to tetraniliprole do 

not pose a significant human health 

risk. 

2. Dietary exposure from drinking 

water. There are no residues of 

toxicological concern expected in 

drinking water from the use of 

tetraniliprole. Thus, no drinking water 

exposure assessments are needed for the 

Agency to conclude with reasonable 

certainty that drinking water exposures 

to tetraniliprole do not pose a 

significant human health risk. 

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). 

Based upon the proposed labels, EPA 

does not anticipate residential handler 

exposures. Tetraniliprole is being 

proposed for registration as a liquid 

formulation for use on golf course turf 

and sports fields that could result in 

residential post-application exposures. 

However, no adverse effects were 

observed in the submitted toxicological 

studies for tetraniliprole regardless of 

the route of exposure; therefore, a 

quantitative residential post-application 

exposure assessment was not 

conducted. Thus, no residential 

exposure assessments are needed for the 

Agency to conclude with reasonable 

certainty that residential exposures to 

tetraniliprole do not pose a significant 

human health risk. 

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.’’ 

EPA has not found tetraniliprole to 

share a common mechanism of toxicity 

with any other substances, and 

tetraniliprole does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that tetraniliprole does not 

have 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 http:// 

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

D. Safety Factor for Infants and 

Children 

Section 408(b)(2)(C) requires the 

application of an additional tenfold 

margin of safety to account for potential 

risks to infants and children, in the case 

of threshold effects. For tetraniliprole, 

EPA has not identified any toxicological 

endpoints of concern associated with 

any threshold effects and is conducting 

a qualitative assessment. That 

qualitative assessment does not use 

safety factors for assessing risk, and no 

additional safety factor is needed for 

assessing risk to infants and children. 

EPA has also evaluated the available 

data and concluded that there are no 

residual uncertainties concerning the 


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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 11137 

potential risks to infants and children 

that would impact its conclusions about 

threshold effects. 

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. 

No adverse effects were observed in 

the submitted toxicological studies at 

doses relevant to human health 

pesticide risk assessment for 

tetraniliprole regardless of the route of 

exposure. Effects observed in the data 

base (e.g., decreased body weight) were 

both marginal, and only seen at doses 

not expected to occur daily or over an 

extended period. Based on a lack of 

toxicity at exposure levels expected 

from approved application rates and an 

expectation that aggregate exposures to 

residues of tetraniliprole will not reach 

the levels required to cause any adverse 

effects, 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 tetraniliprole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate analytical method 

(01414) which uses high-performance 

liquid chromatography with tandem 

mass spectrometry (HPLC/MS/MS) to 

quantitate residues of tetraniliprole in 

various crops is available for 

enforcement. An adequate HPLC/MS/ 

MS method, Method FV–002–A16–01, 

is proposed as the enforcement method 

for determination of residues of 

tetraniliprole in livestock matrices. The 

methods 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 Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established any MRLs for tetraniliprole. 

C. Response to Comments 

Five comments were received to the 

notice of filing. Four of the comments 

were not related specifically to 

tetraniliprole or pesticides in general, 

dealing instead with ‘‘antienvironmental morons’’, electric cars, 

and wind farms and their impact on 

birds and bats. The fifth comment was 

submitted on behalf of the Center for 

Biological Diversity that was primarily 

concerned about EPA’s consideration of 

the impacts of tetraniliprole on the 

environment, pollinators, and 

endangered species. None of these 

comments are relevant to the Agency’s 

evaluation of safety of the tetraniliprole 

tolerances under section 408 of the 

FFDCA, which requires the Agency to 

evaluate the potential harms to human 

health, not effects on the environment. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency is establishing tolerances 

based on the Organization for Economic 

Cooperation and Development (OECD) 

rounding class practice and to reflect 

the preferred commodity definitions 

currently used by the Agency, which 

results in some variations between 

established tolerances and the 

tolerances the petitioner requested. 

For field corn and popcorn, the 

available data support a tolerance of 

0.01 ppm, slightly lower than the 

petitioned-for tolerance (0.015 ppm). 

The petitioner requested tolerances on 

dried fruit (prune) and potato wet peel. 

The available data indicates that 

residues on those commodities do not 

concentrate so the new tolerances on 

stone fruit group 12–12 (1.0 ppm) and 

vegetable, tuberous and corm, subgroup 

1C (0.015 ppm), respectively, are 

adequate to cover residues in these 

commodities. 

For citrus fruits (subgroups 10–10A, 

10B, and 10C), the Agency used the 

OECD statistical calculation procedures 

to determine the appropriate tolerance 

value based on the available field trial 

residue data, which resulted in a higher 

tolerance value for each of these 

subgroups than what the petitioner 

requested. 

Based on the highest average field 

trial (HAFT) (0.767 ppm) for lime and 

using a processing factor of 8.6, the 

Agency calculated that a tolerance of 7 

ppm is necessary to cover residues in 

citrus oil. Similarly, based on the HAFT 

(0.136 ppm) for soybean seed and using 

a processing factor of 2.6, the Agency 

determined that a tolerance of 0.4 ppm 

is appropriate for soybean hulls. 

Although the petitioner did not 

expressly identify certain tolerances as 

intended to cover indirect or 

inadvertent residues in rotational crops, 

because certain crops are only approved 

as crops that may be rotated into treated 

fields on the label, EPA is establishing 

tolerances for indirect or inadvertent 

residues for those commodities: alfalfa, 

forage at 0.015 ppm; alfalfa, hay at 0.06 

ppm; cottonseed subgroup 20C at 0.4 

ppm; cotton, gin byproducts at 30 ppm; 

grain, cereal, forage, fodder, and straw, 

group 16, except field corn, popcorn, 

and sweet corn at 0.1 ppm; and 

vegetable, foliage of legume, except 

soybean, subgroup 7A. 

All the proposed tolerances for 

livestock commodities were revised 

based on calculation of the dietary 

burden. 

V. Conclusion 

Therefore, tolerances are established 

for residues of tetraniliprole, including 

its metabolites and degradates. 

Compliance with the tolerance levels is 

to be determined by measuring only 

tetraniliprole 1-(3-chloro-2-pyridinyl)- 

N-[4-cyano-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-3-[[5- 

(trifluoromethyl)-2H-tetrazol-2- 

yl]methyl]-1H-pyrazole-5-carboxamide, 

in or on almond, hulls at 4 ppm; cattle, 

fat at 0.04 ppm; cattle, meat at 0.02 

ppm; cattle, meat byproducts at 0.3 

ppm; corn, field, forage at 4 ppm; corn, 

field, grain at 0.01 ppm; corn, field, 

stover at 15 ppm; corn, pop, grain at 

0.01 ppm; corn, pop, stover at 15 ppm; 

corn, sweet, forage at 6 ppm; corn, 

sweet, kernel plus cob with husks 

removed at 0.01 ppm; corn, sweet, 

stover at 20 ppm; fruit, citrus, group 10– 

10, oil at 7 ppm; fruit, pome, group 11– 

10 at 0.5 ppm; fruit, small vine 

climbing, except fuzzy kiwifruit, 

subgroup 13–07F at 1.5 ppm; fruit, 

stone, group 12–12 at 1 ppm; goat, fat 

at 0.04 ppm; goat, meat at 0.02 ppm; 

goat, meat byproducts at 0.3 ppm; grain, 

aspirated fractions at 50 ppm; grapefruit 


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11138 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 

subgroup 10–10C at 0.9 ppm; horse, fat 

at 0.04 ppm; horse, meat at 0.02 ppm; 

horse, meat byproducts at 0.3 ppm; 

lemon/lime subgroup 10–10B at 1.5 

ppm; milk at 0.05 ppm; nut, tree, group 

14–12 at 0.03 ppm; orange subgroup 10– 

10A at 1 ppm; sheep, fat at 0.04 ppm; 

sheep, meat at 0.02 ppm; sheep, meat 

byproducts at 0.3 ppm; soybean, forage 

0.07 ppm; soybean, hay at 0.2 ppm; 

soybean, hulls at 0.4 ppm; soybean, seed 

at 0.2 ppm; tomato, paste at 1.5 ppm; 

vegetable, brassica, head and stem, 

group 5–16 at 1.5 ppm; vegetable, 

fruiting, group 8–10 at 0.4 ppm; 

vegetable, leafy, group 4–16 at 20 ppm; 

and vegetable, tuberous and corm, 

subgroup 1C at 0.015 ppm. 

Additionally, tolerances are 

established for inadvertent residues of 

tetraniliprole, including its metabolites 

and degradates. Compliance with the 

tolerance levels is to be determined by 

measuring only tetraniliprole 1-(3- 

chloro-2-pyridinyl)-N-[4-cyano-2- 

methyl-6- 

[(methylamino)carbonyl]phenyl]-3-[[5- 

(trifluoromethyl)-2H-tetrazol-2- 

yl]methyl]-1H-pyrazole-5-carboxamide 

in or on alfalfa, forage at 0.015 ppm; 

alfalfa, hay at 0.06 ppm; cotton, gin 

byproducts at 30 ppm; cottonseed 

subgroup 20C at 0.4 ppm; grain, cereal, 

forage, fodder and straw, group 16, 

except field corn, popcorn, and sweet 

corn at 0.1 ppm; and vegetable, foliage 

of legume, except soybean, subgroup 7A 

at 0.03 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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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: January 19, 2021. 

Edward Messina, 

Acting Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Add § 180.709 to read as follows: 

§ 180.709 Tetraniliprole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of tetraniliprole, 

including its metabolites and 

degradates, in or on the commodities in 

table 1 in this paragraph (a). Compliance 

with the tolerance levels specified in 

table 1 in this paragraph (a) is to be 

determined by measuring only 

tetraniliprole 1-(3-chloro-2-pyridinyl)- 

N-[4-cyano-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-3-[[5- 

(trifluoromethyl)-2H-tetrazol-2- 

yl]methyl]-1H-pyrazole-5-carboxamide. 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Almond, hulls ....................................................................................................................................................................................... 4 

Cattle, fat ............................................................................................................................................................................................. 0.04 

Cattle, meat ......................................................................................................................................................................................... 0.02 

Cattle, meat byproducts ....................................................................................................................................................................... 0.3 

Corn, field, forage ................................................................................................................................................................................ 4 

Corn, field, grain .................................................................................................................................................................................. 0.01 

Corn, field, stover ................................................................................................................................................................................ 15 


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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Rules and Regulations 11139 

TABLE 1 TO PARAGRAPH (a)—Continued 

Commodity Parts per 

million 

Corn, pop, grain ................................................................................................................................................................................... 0.01 

Corn, pop, stover ................................................................................................................................................................................. 15 

Corn, sweet, forage ............................................................................................................................................................................. 6 

Corn, sweet, kernel plus cob with husks removed ............................................................................................................................. 0.01 

Corn, sweet, stover .............................................................................................................................................................................. 20 

Fruit, citrus, group 10–10, oil ............................................................................................................................................................... 7 

Fruit, pome, group 11–10 .................................................................................................................................................................... 0.5 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ................................................................................................... 1.5 

Fruit, stone, group 12–12 .................................................................................................................................................................... 1 

Goat, fat ............................................................................................................................................................................................... 0.04 

Goat, meat ........................................................................................................................................................................................... 0.02 

Goat, meat byproducts ........................................................................................................................................................................ 0.3 

Grain, aspirated fractions .................................................................................................................................................................... 50 

Grapefruit subgroup 10–10C ............................................................................................................................................................... 0.9 

Horse, fat ............................................................................................................................................................................................. 0.04 

Horse, meat ......................................................................................................................................................................................... 0.02 

Horse, meat byproducts ...................................................................................................................................................................... 0.3 

Lemon/lime subgroup 10–10B ............................................................................................................................................................. 1.5 

Milk ....................................................................................................................................................................................................... 0.05 

Nut, tree, group 14–12 ........................................................................................................................................................................ 0.03 

Orange subgroup 10–10A ................................................................................................................................................................... 1 

Sheep, fat ............................................................................................................................................................................................ 0.04 

Sheep, meat ........................................................................................................................................................................................ 0.02 

Sheep, meat byproducts ...................................................................................................................................................................... 0.3 

Soybean, forage .................................................................................................................................................................................. 0.07 

Soybean, hay ....................................................................................................................................................................................... 0.2 

Soybean, hulls ..................................................................................................................................................................................... 0.4 

Soybean, seed ..................................................................................................................................................................................... 0.2 

Tomato, paste ...................................................................................................................................................................................... 1.5 

Vegetable, brassica, head and stem, group 5–16 .............................................................................................................................. 1.5 

Vegetable, fruiting, group 8–10 ........................................................................................................................................................... 0.4 

Vegetable, leafy, group 4–16 .............................................................................................................................................................. 20 

Vegetable, tuberous and corm, subgroup 1C ..................................................................................................................................... 0.015 

(b)–(c) [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of tetraniliprole, 

including its metabolites and 

degradates, in or on the commodities in 

table 2 in this paragraph (d). 

Compliance with the tolerance levels 

specified in table 2 in this paragraph (d) 

is to be determined by measuring only 

tetraniliprole 1-(3-chloro-2-pyridinyl)- 

N-[4-cyano-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-3-[[5- 

(trifluoromethyl)-2H-tetrazol-2- 

yl]methyl]-1H-pyrazole-5-carboxamide. 

TABLE 2 TO PARAGRAPH (d) 

Commodity Parts per 

million 

Alfalfa, forage ....................................................................................................................................................................................... 0.015 

Alfalfa, hay ........................................................................................................................................................................................... 0.06 

Cotton, gin byproducts ......................................................................................................................................................................... 30 

Cottonseed subgroup 20C ................................................................................................................................................................... 0.4 

Grain, cereal, forage, fodder and straw, group 16, except field corn, popcorn and sweet corn ........................................................ 0.1 

Vegetable, foliage of legume, except soybean, subgroup 7A ............................................................................................................ 0.03 

[FR Doc. 2021–03624 Filed 2–23–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 160 and 164 

Enforcement Discretion Regarding 

Online or Web-Based Scheduling 

Applications for the Scheduling of 

Individual Appointments for COVID–19 

Vaccination During the COVID–19 

Nationwide Public Health Emergency 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notification of Enforcement 

Discretion. 

SUMMARY: This Notification is to inform 

the public that the Department of Health 

and Human Services (HHS) is exercising 

its discretion in how it applies the 

Privacy, Security, and Breach 

Notification Rules promulgated under 

the Health Insurance Portability and 

Accountability Act of 1996 and the 

Health Information Technology for 

Economic and Clinical Health (HITECH) 

Act (‘‘HIPAA Rules’’). As a matter of 


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