[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Rules and Regulations]
[Pages 9245-9250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03385]


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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.

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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).

[[Page 9246]]


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: 
RDFR[email protected].

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 e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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

[[Page 9247]]

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

[[Page 9248]]

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 (non-occupational) 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 post-application 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 intermediate-term 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.

[[Page 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:

[[Page 9250]]

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.661:
0
a. Amend paragraph (a)(1) by:
0
i. Designating the table as Table 1 to Paragraph (a)(1)'';
0
ii. Adding in alphabetical order the entry ``Coffee, green beans''; and
0
iii. Revising the entries ``Grain, cereal, group 15, except corn and 
rice'' and ``Rapeseed subgroup 20A'';
0
b. Amend paragraph (a)(2) by:
0
i. Designating the table as Table 2 to Paragraph (a)(2); and
0
ii. Revising newly designated Table 2.
    The additions and revisions read as follows:


Sec.  180.661   Fluopyram; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Coffee, green beans \2\.....................................        0.03
 
                                * * * * *
Grain, cereal, group 15, except corn and rice...............         0.5
 
                                * * * * *
Rapeseed subgroup 20A.......................................         0.3
 
                                * * * * *
------------------------------------------------------------------------
 * * * * *
\2\ There are no U.S. registrations on coffee, green beans as of
  February 18, 2022.

    (2) * * *

                       Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             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
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


