Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 9245 

significant economic impact on a 

substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969(42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting only six hours that will 

prohibit entry within 250 feet of the pier 

along the southwest side of Coast Guard 

Island. It is categorically excluded from 

further review under paragraph L60(a) 

of Appendix A, Table 1 of DHS 

Instruction Manual 023–01–001–01, 

Rev. 1. A Record of Environmental 

Consideration supporting this 

determination is available in the docket. 

For instructions on locating the docket, 

see the ADDRESSES section of this 

preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T11–089 to read as 

follows: 

§ 165.T11–089 Safety Zone; Safety Zone; 

Coast Guard Island, Alameda, CA. 

(a) Location. The following area is a 

safety zone: All waters of the Alameda 

Estuary, from surface to bottom, within 

250 feet of the pier along the southwest 

side of Coast Guard Island. 

(b) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by phone at 415–399– 

3547. Those in the safety zone must 

comply with all lawful orders or 

directions given to them by the COTP or 

the COTP’s designated representative. 

(c) Enforcement period. This section 

will be enforced from 8 a.m. to 2 p.m. 

on February 20, 2022. 

Dated: February 14, 2022. 

Taylor Q. Lam, 

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

Port San Francisco. 

[FR Doc. 2022–03542 Filed 2–17–22; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0607; FRL–9454–01– 

OCSPP] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of fluopyram in 

or on cereal grain crop group 15 (except 

corn and rice), rapeseed subgroup 20A, 

and multiple animal commodities, 

which are identified and discussed later 

in this document. This regulation also 

establishes an import tolerance for 

residues of fluopyram in or on coffee. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 


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DATES: This regulation is effective 

February 18, 2022. Objections and 

requests for hearings must be received 

on or before April 19, 2022, 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–2020–0607, 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 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 

open to visitors by appointment only. 

For the latest status information on 

EPA/DC services and 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 Office of the Federal Register’s eCFR 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–2020–0607 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 

19, 2022. 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– 

2020–0607, 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/contacts.html. 

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 February 

25, 2021 (86 FR 11488) (FRL–10020–47), 

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 0F8855) by Bayer 

CropScience, 800 N Lindbergh Blvd., St. 

Louis, MO 63167. The petition 

requested that 40 CFR 180.661(a)(1) be 

amended by establishing a tolerance for 

residues of the fungicide fluopyram, N- 

[2-[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, in or on the 

following raw agricultural commodity: 

Coffee at 0.03 parts per million (ppm). 

The petition also requested to amend 

tolerances in 40 CFR 180.661(a)(1) for 

residues of the fungicide fluopyram in 

or on the following raw agricultural 

commodities: Grain, cereal, group 15, 

except corn and rice at 0.5 ppm; and 

Rapeseed subgroup 20A at 0.3 ppm. In 

addition, the petition requested to 

amend tolerances in 40 CFR 

180.661(a)(2) for residues of the 

fungicide fluopyram in or on the 

following animal commodities: Cattle, 

fat at 0.60 ppm; Cattle, meat at 0.60 

ppm; Cattle, meat byproducts at 6.0 

ppm; Egg at 0.06 ppm; Goat, fat at 0.60 

ppm; Goat, meat at 0.60 ppm; Goat, 

meat byproducts at 6.0 ppm; Hog, fat at 

0.01 ppm; Hog, meat at 0.01 ppm; Hog, 

meat byproducts at 0.06 ppm; Horse, fat 

at 0.60 ppm; Horse, meat at 0.60 ppm; 

Horse, meat byproducts at 6.0 ppm; 

Poultry, fat at 0.03 ppm; Poultry, meat 

at 0.03 ppm; Poultry, meat byproducts 

at 0.10 ppm; Sheep, fat at 0.60 ppm; 

Sheep, meat at 0.60 ppm; and Sheep, 

meat byproducts at 6.0 ppm. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, https://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 is 

establishing and amending, in 

accordance with section 408(d)(4)(a)(i), 

tolerances that vary in some respects 

from what the petitioner requested. The 

reasons for these changes are explained 

in Unit IV.D. 

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 


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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 fluopyram 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluopyram follows. 

In an effort to streamline its 

publications in the Federal Register, 

EPA is not reprinting sections that 

repeat what has been previously 

published for tolerance rulemakings of 

the same pesticide chemical. Where 

scientific information concerning a 

particular chemical remains unchanged, 

the content of those sections would not 

vary between tolerance rulemakings and 

republishing the same sections is 

unnecessary. EPA considers referral 

back to those sections as sufficient to 

provide an explanation of the 

information EPA considered in making 

its safety determination for the new 

rulemaking. 

EPA has previously published a 

number of tolerance rulemakings for 

fluopyram, in which EPA concluded, 

based on the available information, that 

there is a reasonable certainty that no 

harm would result from aggregate 

exposure to fluopyram and established 

tolerances for residues of that chemical. 

EPA is incorporating previously 

published sections from those 

rulemakings as described further in this 

rulemaking, as they remain unchanged. 

Toxicological profile. For a discussion 

of the Toxicological Profile of 

fluopyram, see Unit III.A. of the July 1, 

2019, rulemaking (84 FR 31208) (FRL– 

9994–36). 

Toxicological points of departure/ 

Levels of concern. For a summary of the 

Toxicological Points of Departure/ 

Levels of Concern used for the safety 

assessment, see Unit III.B. of the July 1, 

2019, rulemaking. 

Exposure assessment. Much of the 

exposure assessment remains the same, 

although updates have occurred to 

accommodate exposures from the 

petitioned-for tolerances. The updates 

are discussed in this section; for a 

description of the rest of the EPA 

approach to and assumptions for the 

exposure assessment, see Unit III.C. of 

the July 1, 2019, rulemaking. 

EPA’s dietary exposure assessments 

have been updated to include: The 

reduced exposure from the revised uses 

(lower maximum application rates) of 

fluopyram on cereal grain crop group 15 

(except corn and rice) and rapeseed 

subgroup 20A; the reduced anticipated 

residues in livestock commodities; and 

the additional exposure associated with 

the import tolerance on coffee. For the 

acute dietary exposure assessment, EPA 

used the highest average field trial 

concentrations for coffee, cereal grain 

group 15, and rapeseed 20A. All other 

commodities used tolerance-level 

residues. The acute analysis used 100 

percent crop treated (PCT) for all 

commodities. For the chronic dietary 

exposure assessment, EPA used field 

trial mean residue values and 

incorporated the same PCT data that 

were used in the July 1, 2019, 

rulemaking for existing uses, as well as 

chronic refined inputs to the livestock 

anticipated residues of field trial 

median data. EPA assumed 100 PCT for 

coffee, cereal grain crop group 15 

(except corn and rice), and rapeseed 

subgroup 20A. 

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, 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. 

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 Agency estimated the average 

PCT for existing uses for the chronic 

dietary exposure assessment as follows: 

Almonds, 20%; apples, 25%; apricots, 

5%; artichoke, 15%; broccoli, 2.5%; 

cabbage, 2.5%; carrots, 1%; cauliflower, 

1%; cherries, 25%; cotton, 1%; dry 

beans and peas, 1%; grapefruit, 10%; 

grapes, raisins, 1%; table grapes, 5%; 

wine grapes; 20%; lemons, 1%; lettuce, 

1%; onions, 1%; oranges, 15%; peaches, 

1%; peanuts, 2.5%; pears, 5%; peppers, 

5%; pistachios, 15%; potatoes, 20%; 

strawberries, 10%; tomatoes, 1%; 

walnuts, 10%; and watermelons, 15%. 

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 

<1% or <2.5% as the average PCT value, 

respectively. The maximum PCT figure 

is the highest observed maximum value 

reported within the recent 10 years of 

available public and private market 

survey data for the existing use and 

rounded up to the nearest multiple of 

5%, except where the maximum PCT is 

less than 2.5%, in which case, the 

Agency uses <2.5% as the maximum 

PCT. 

The Agency believes that the three 

conditions discussed earlier 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 


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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 fluopyram may be applied in a 

particular area. 

Drinking water, non-occupational, 

and cumulative exposures. Drinking 

water exposures and residential (nonoccupational) exposures are not 

impacted by the revised uses and import 

tolerance in this action, and thus have 

not changed from the July 1, 2019, 

rulemaking. Fluopyram is currently 

registered for use on golf course turf, 

residential lawns, fruit trees, nut trees, 

ornamentals and gardens that could 

result in residential exposures. The 

most conservative residential risk 

estimates that were used in the 

aggregate assessment are adult handler 

inhalation exposures from treating 

lawns with a hose-end spray and 

incidental oral hand-to-mouth postapplication exposure to treated lawns 

for children aged 1 to less than 2 years 

old. EPA’s conclusions concerning 

cumulative risk remain unchanged from 

the July 1, 2019, rulemaking. 

Safety factor for infants and children. 

EPA continues to conclude that there is 

reliable data to support the reduction of 

the Food Quality Protection Act (FQPA) 

safety factor. See Unit III.D. of the July 

1, 2019, rulemaking for a discussion of 

the Agency’s rationale for that 

determination. 

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 

population adjusted dose (aPAD) and 

chronic population adjusted (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 

points of departure to ensure that an 

adequate margin of exposure (MOE) 

exists. 

Acute dietary risks are below the 

Agency’s level of concern of 100% of 

the aPAD; they are 24% of the aPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

Chronic dietary risks are below the 

Agency’s level of concern of 100% of 

the cPAD; they are 78% of the cPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

As explained in the July 1, 2019, rule, 

the Agency analyzed short-term 

inhalation exposure to residential 

handlers and short-term incidental oral 

hand-to-mouth post-application 

exposure to children 1 to 2 years old on 

treated lawns. 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 aggregate MOEs of 1,500 for 

both adults (using a residential handler 

exposure scenario) and post-application 

exposure to children 1 to 2 years old. 

Because EPA’s level of concern for 

fluopyram is an MOE of 100 or below, 

these MOEs are not of concern. 

As stated in the July 1, 2019, rule, 

fluopyram is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has been assessed under the 

appropriately protective cPAD, EPA 

relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for fluopyram. 

Based on the lack of evidence of 

carcinogenicity in two adequate rodent 

carcinogenicity studies, fluopyram is 

not expected to pose a cancer risk to 

humans. 

Therefore, based on the risk 

assessments and information described 

above, 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 fluopyram residues. More 

detailed information can be found at 

https://www.regulations.gov in the 

document titled ‘‘Fluopyram. Human 

Health Risk Assessment for the Revision 

of Permanent Tolerances and 

Registration for Use on Cereal Grain 

Crop Group 15 and Rapeseed Subgroup 

20A, and for the Establishment of 

Permanent Tolerance without U.S. 

Registration for Residues in/on Coffee 

Commodities’’ in docket ID number 

EPA–HQ–OPP–2020–0607. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For a discussion of the available 

analytical enforcement method, see Unit 

IV.A. of the July 1, 2019, rulemaking. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The 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 established MRLs for 

fluopyram in or on canola at 1 ppm and 

rye grain and wheat grain both at 0.9 

ppm. EPA is not harmonizing the U.S. 

tolerances for rapeseed subgroup 20A 

and crop group 15 (except rice and corn) 

with the Codex MRLs for canola, rye 

grain, or wheat grain because the U.S. 

tolerances are being harmonized with 

the Canadian MRLs as part of a joint 

review with the U.S.’s major trading 

partner. 

The Codex has also established MRLs 

for fluopyram in or on milk at 0.8 ppm, 

cattle fat at 1.5 ppm, cattle meat at 1.5 

ppm, cattle meat byproducts at 8 ppm, 

hog fat at 1.5 ppm, hog meat at 1.5 ppm, 

hog meat byproducts at 8 ppm, eggs at 

2 ppm, poultry fat at 1 ppm, poultry 

meat at 1.5 ppm and poultry, kidney 

and poultry, liver at 5 ppm. To be 

consistent with Canada, EPA is not 

harmonizing the U.S. tolerances for 

milk, cattle fat, cattle meat, cattle meat 

byproducts, hog fat, hog meat, hog meat 

byproducts, eggs, poultry fat, poultry 

meat, and poultry meat byproducts with 

the Codex MRLs above. The U.S. and 

Canada are jointly reviewing the revised 

use pattern in the fluopyram petition. 

Because the maximum application rates 

for livestock feed items (rapeseed 

subgroup 20A and cereal grains group 

15 (except corn and rice)) are being 

reduced in both countries, the 

tolerances on both plant and livestock 

commodities are being decreased in 

both countries. 

Codex has not established an MRL for 

residues of fluopyram in or on coffee 

commodities. 


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Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 9249 

C. Response to Comments 

Two comments were submitted to the 

docket in response to the February 25, 

2021 Notice of Filing. Although the 

Agency recognizes that some 

individuals believe that pesticides 

should be banned on agricultural 

commodities, the existing legal 

framework provided by section 408 of 

the FFDCA authorizes EPA to establish 

tolerances when it determines that the 

tolerance is safe. Upon consideration of 

the validity, completeness, and 

reliability of the available data as well 

as other factors the FFDCA requires EPA 

to consider, EPA has determined that 

the fluopyram tolerances are safe. The 

commenters have provided no 

information indicating that a safety 

determination cannot be supported. 

D. Revisions to Petitioned-For 

Tolerances 

The commodity definition for coffee 

is revised to coffee, green beans and the 

tolerance is established at 0.03 ppm to 

reflect the OECD rounding class. 

Livestock tolerances are revised based 

upon expected secondary residues using 

the more reasonably balanced diet 

(MRBD) calculations and incorporating 

observed transfer factors. The petition 

states that the proposed cattle tolerances 

should be extended to all ruminants; 

however, those tolerances should be 

individually revised. Therefore, 

tolerances are amended for cattle, meat 

at 0.3 ppm; cattle, fat at 0.3 ppm; cattle, 

meat byproducts at 3 ppm; horse, meat 

at 0.3 ppm; horse, fat at 0.3 ppm; horse, 

meat byproducts at 3 ppm; goat, meat at 

0.3 ppm; goat, fat at 0.3 ppm; goat, meat 

byproducts at 3 ppm; sheep, meat at 0.3 

ppm; sheep, fat at 0.3 ppm; sheep, meat 

byproducts at 3 ppm; and hog, meat 

byproducts at 0.04 ppm. Tolerances are 

amended for egg at 0.03 ppm; poultry, 

meat at 0.02 ppm; poultry, fat at 0.01 

ppm; and poultry, meat byproducts at 

0.06 ppm. The Agency is also amending 

the tolerance for milk at 0.15 ppm. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of fluopyram, N-[2-[3- 

chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, in or on 

coffee, green beans at 0.03 ppm, and 

existing tolerances are amended to the 

following levels: Grain, cereal, group 15, 

except corn and rice at 0.5 ppm; 

rapeseed subgroup 20A at 0.3 ppm; 

cattle, fat at 0.3 ppm; cattle, meat at 0.3 

ppm; cattle, meat byproducts at 3 ppm; 

egg at 0.03 ppm; goat, fat at 0.3 ppm; 

goat, meat at 0.3 ppm; goat, meat 

byproducts at 3 ppm; hog, fat at 0.01 

ppm; hog, meat at 0.01 ppm; hog, meat 

byproducts at 0.04 ppm; horse, fat at 0.3 

ppm; horse, meat at 0.3 ppm; horse, 

meat byproducts at 3 ppm; milk at 0.15 

ppm; poultry, fat at 0.01 ppm; poultry, 

meat at 0.02 ppm; poultry, meat 

byproducts at 0.06 ppm; sheep, fat at 0.3 

ppm; sheep, meat at 0.3 ppm; sheep, 

meat byproducts at 3 ppm. For 

transparency, the following list 

identifies the established tolerances that 

are being amended to the levels listed 

above: Grain, cereal, group 15, except 

corn and rice at 4.0 ppm; rapeseed 

subgroup 20A at 5.0 ppm; cattle, fat at 

0.70 ppm; cattle, meat at 0.80 ppm; 

cattle, meat byproducts at 7.5 ppm; egg 

at 0.08 ppm; goat, fat at 0.70 ppm; goat, 

meat at 0.80 ppm; goat, meat byproducts 

at 7.5 ppm; hog, fat at 0.20 ppm; hog, 

meat at 0.02 ppm; hog, meat byproducts 

at 0.20 ppm; horse, fat at 0.70 ppm; 

horse, meat at 0.80 ppm; horse, meat 

byproducts at 7.5 ppm; milk at 0.40 

ppm; poultry, fat at 0.04 ppm; poultry, 

meat at 0.04 ppm; poultry, meat 

byproducts at 0.20 ppm; sheep, fat at 

0.70 ppm; sheep, meat at 0.80 ppm; and 

sheep, meat byproducts at 7.5 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, 

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: February 11, 2022. 

Catherine Aubee, 

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: 


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9250 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

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 § 180.661: 

■ a. Amend paragraph (a)(1) by: 

■ i. Designating the table as Table 1 to 

Paragraph (a)(1)’’; 

■ ii. Adding in alphabetical order the 

entry ‘‘Coffee, green beans’’; and 

■ iii. Revising the entries ‘‘Grain, cereal, 

group 15, except corn and rice’’ and 

‘‘Rapeseed subgroup 20A’’; 

■ b. Amend paragraph (a)(2) by: 

■ i. Designating the table as Table 2 to 

Paragraph (a)(2); and 

■ ii. Revising newly designated Table 2. 

The additions and revisions read as 

follows: 

§ 180.661 Fluopyram; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

* * * * * 

Coffee, green beans 2 ................. 0.03 

* * * * * 

Grain, cereal, group 15, except 

corn and rice ........................... 0.5 

* * * * * 

Rapeseed subgroup 20A ............ 0.3 

* * * * * 

* * * * * 2There are no U.S. registrations on coffee, 

green beans as of February 18, 2022. 

(2) * * * 

TABLE 2 TO PARAGRAPH (a)(2) 

Commodity Parts per 

million 

Cattle, fat .................................... 0.3 

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

Cattle, meat byproducts ............. 3 

Egg ............................................. 0.03 

Goat, fat ...................................... 0.3 

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

Goat, meat byproducts ............... 3 

Hog, fat ....................................... 0.01 

Hog, meat ................................... 0.01 

Hog, meat byproducts ................ 0.04 

Horse, fat .................................... 0.3 

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

Horse, meat byproducts ............. 3 

Milk ............................................. 0.15 

Poultry, fat .................................. 0.01 

Poultry, meat .............................. 0.02 

Poultry, meat byproducts ............ 0.06 

TABLE 2 TO PARAGRAPH (a)(2)— 

Continued 

Commodity Parts per 

million 

Sheep, fat ................................... 0.3 

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

Sheep, meat byproducts ............ 3 

* * * * * 

[FR Doc. 2022–03385 Filed 2–17–22; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 73 

[AU Docket No. 21–449; DA 22–125; FR ID 

71977] 

Auction of Construction Permits for 

Full Power Television Stations; Notice 

and Filing Requirements, Minimum 

Opening Bids, Upfront Payments, and 

Other Procedures for Auction 112 

AGENCY: Federal Communications 

Commission. 

ACTION: Final action; requirements and 

procedures. 

SUMMARY: This document summarizes 

the procedures, deadlines, and upfront 

payment and minimum opening bid 

amounts for the upcoming auction of 

construction permits for full power 

television (TV) stations. The Auction 

112 Procedures Public Notice 

summarized here is intended to 

familiarize potential applicants with 

details of the procedures, terms, and 

conditions governing participation in 

Auction 112, as well as an overview of 

the post-auction application and 

payment processes. 

DATES: Applications to participate in 

Auction 112 must be submitted before 

6:00 p.m. Eastern Time (ET) on March 

30, 2022. Upfront payments for Auction 

112 must be received by 6:00 p.m. ET 

on May 6, 2022. Bidding in Auction 112 

is scheduled to start on June 7, 2022. 

FOR FURTHER INFORMATION CONTACT: 

General Auction 112 Information: 

FCC Auctions Hotline at 888–225–5322, 

option two; or 717–338–2868. 

Auction 112 Legal Information: Mary 

Lovejoy or Andrew McArdell at (202) 

418–0660. 

Licensing Information: Shaun Maher 

at (202) 418–2324 or Kevin Harding at 

(202) 418–7077. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Federal Communication 

Commission’s (Commission or FCC) 

document, Auction 112 Procedures 

Public Notice, in AU Docket No. 21– 

449; DA 21–125, released on February 

10, 2022. The complete text of this 

document, including attachments and 

any related documents, is available on 

the Commission’s website at http://

www.fcc.gov/auction/112 or by using 

the search function for on the 

Commission’s Electronic Comment 

Filing System (ECFS) web page at 

www.fcc.gov/ecfs. Alternative formats 

are available to persons with disabilities 

by sending an email to FCC504@fcc.gov 

or by calling the Consumer & 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

I. General Information 

A. Introduction 

1. By the Auction 112 Procedures 

Public Notice, the Office of Economics 

and Analytics (OEA) and the Media 

Bureau (MB) establish the procedures 

and minimum opening bid amounts to 

be used for Auction 112, an auction of 

construction permits for full power 

television (TV) stations. Bidding in this 

auction is scheduled to start on June 7, 

2022. The Auction 112 Procedures 

Public Notice provides details regarding 

the procedures, terms, conditions, dates, 

and deadlines governing participation 

in Auction 112 bidding, as well as an 

overview of the post-auction application 

and payment processes. 

B. Background and Relevant Authority 

2. On November 19, 2021, OEA and 

MB released a public notice seeking 

comment on competitive bidding 

procedures to be used in Auction 112. 

One party filed comments in response to 

the Auction 112 Comment Public 

Notice, 86 FR 68203, December 1, 2021, 

and one party filed a reply. In the 

Auction 112 Procedures Public Notice, 

OEA and MB resolve all open issues 

raised in the Auction 112 Comment 

Public Notice. Auction 112 will proceed 

pursuant to the procedures described in 

the Auction 112 Procedures Public 

Notice, which have been adopted in 

accordance with 47 U.S.C. 309(j)(3). 

3. Other Commission rules and 

decisions provide the underlying 

authority for the procedures OEA and 

MB adopt for Auction 112. Auction 112 

applicants must familiarize themselves 

thoroughly with the Commission’s 

general competitive bidding rules, 

including Commission decisions in 

proceedings regarding competitive 

bidding procedures, application 

requirements, and obligations of 

Commission licensees. Prospective 

applicants should also familiarize 

themselves with the Commission’s 

television broadcast service and 


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