Document ID: EPA-HQ-OPP-2020-0421-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Pyflubumide
Posted Date: 2021-12-15T05:00Z

[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71158-71162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27147]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0421; FRL-9282-01-OCSPP]

Pyflubumide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyflubumide in or on tea, dried and tea, instant. Nichino America, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 15, 2021. Objections and 
requests for hearings must be received on or before February 14, 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-2020-0421, 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 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: 
[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-2020-0421 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 
February 14, 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-2020-0421, 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.

[[Page 71159]]

     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 April 22, 2021 (86 FR 21317) (FRL-10022-
59), 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 
0E8829) by Nichino America, Inc. 4550 Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the insecticide 
pyflubumide, including its metabolites and degradates, in or on the raw 
agricultural commodity tea, dried at 70 parts per million (ppm). That 
document referenced a summary of the petition prepared by Nichino 
America, Inc., the registrant, which is available in the docket, 
https://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance for tea, dried at a different level than 
requested and is also establishing a tolerance for tea, instant. The 
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Neither of these exposures are relevant to this action, however. 
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 pyflubumide. EPA's assessment 
of exposures and risks associated with pyflubumide 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 toxicological database for pyflubumide is complete for the 
establishment of a tolerance without U.S. registration. Based on a 
weight-of-evidence approach and considering all available pyflubumide 
hazard and exposure information, EPA waived the requirement for a 
subchronic neurotoxicity (SCN) study, an immunotoxicity study, and a 
comparative thyroid assay (CTA). The affected target organs following 
the administration of pyflubumide included the thyroid (rat, mouse, and 
dog), liver (rat, mouse, rabbit, and dog), kidney (rat and dog), 
adrenal gland (mouse, rat, and dog), heart (rat and dog), and lung 
(developing rat).
    No evidence of increased qualitative or quantitative susceptibility 
was seen in the rat and rabbit developmental toxicity studies. 
Increased quantitative susceptibility was observed in the 
multigeneration reproduction toxicity study where lung lesions in 
offspring were observed at a lower dose (6 mg/kg/day) than the dose 
eliciting parental toxicity (29 mg/kg/day).
    There was no evidence of neurotoxicity in the available acute 
neurotoxicity (ACN) study or throughout the database (subchronic, 
chronic, and mechanistic studies). The chronic point of departure (POD) 
(1 mg/kg/day) is protective of effects seen in the multigeneration 
reproduction toxicity study.
    For the acute dietary exposure scenario (females of childbearing 
age and infants), the point of departure (POD) is based on the 
increased incidence of lung lesions (alveolar dilatation) from dosing 
on two consecutive days (post-natal day (PND) 4-5 or PND 6-7) in a 
mechanistic study that evaluated the occurrence of alveolar dilatation 
in rat pups by short term oral administration of pyflubumide. Since 
these lung effects resulted from at most two exposures, this finding 
was selected to be protective of potential acute lung effects that 
could occur due to a single day's exposure to pyflubumide during the 
perinatal period. The increased incidence of lung lesions was observed 
in rat pups and was not found in maternal rats. Nursing pups may be 
exposed through the mother's milk which can result in the observed lung 
effects.
    The POD selected for chronic dietary is based on bile duct 
hyperplasia and decreased triglycerides in both sexes; increased liver 
weights in females; increased urinary protein, urine volume, increased 
incidence of kidney urinary casts; and increased incidence of tubular 
basophilic change in the kidney in males in a one-year chronic rat 
toxicity study. This POD is protective of all adverse effects observed 
in the multigeneration reproductive, the chronic dog, the rat 
carcinogenicity, and the mouse carcinogenicity studies. It is also 
protective of lung effects observed across studies.
    Pyflubumide is classified as: ``Suggestive Evidence of Carcinogenic 
Potential'' based on treatment-related hepatocellular adenomas in male 
mice at a dose level of 176 mg/kg/day. There is no mutagenic concern 
for pyflubumide. The quantification of risk using a non-linear approach 
(i.e., a chronic population adjusted dose) will adequately account for 
all chronic toxicity, including potential carcinogenicity, that could 
result from exposure to pyflubumide.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyflubumide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Pyflubumide. Human Health Risk 
Assessment for a Petition for the Establishment of Permanent Tolerances 
for Residues on Tea without a U.S. Registration. New Active 
Ingredient.'' hereinafter ``Pyflubumide Human Health Risk Assessment'' 
at pages 24-67 in docket ID number EPA-HQ-OPP-2020-0421.

[[Page 71160]]

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for pyflubumide used for 
human risk assessment can be found in the Pyflubumide Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyflubumide, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pyflubumide in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for pyflubumide for only infants (<1 year old). Although no adverse 
effects were observed for females of childbearing age (13 to 49 years 
old), risk estimates for females of childbearing age (13 to 49 years 
old) are provided since there is still the potential for nursing 
infants to be exposed to pyflubumide from breast milk of mothers who 
consume treated tea. Thus, the risk estimate for females of 
childbearing age (13 to 49 years old) is protective for nursing 
infants. No acute dietary analysis was performed for the general 
population because an appropriate acute toxicological endpoint was not 
identified for the general population. In estimating acute dietary 
exposure, EPA used 2003-2008 food consumption data from the United 
States Department of Agriculture (USDA), National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA used the Maximum Residue Limit (MRL) 
calculator to estimate the upper bound limit for combined residues of 
pyflubumide (parent) and pyflubumide-NH (metabolite) with 100 percent 
crop treated (PCT) assumptions.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used 2003-2008 food consumption data from the USDA 
NHANES/WWEIA. As to residue levels in food, EPA used the MRL calculator 
to estimate the upper bound limit for combined residues of pyflubumide 
and pyflubumide-NH with 100 PCT assumptions.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Based on the data discussed in Unit III.A., EPA has concluded that a 
chronic reference dose (cRfD) and chronic population-adjusted dose 
(cPAD) are protective for all chronic toxicity, including any potential 
carcinogenicity. Thus, a separate quantitative cancer dietary exposure 
assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyflubumide. An estimated upper bound limit 
based on the combined residue levels of pyflubumide and pyflubumide-NH 
at a 7-day preharvest interval, and 100 PCT, were assumed for all food 
commodities.
    2. Dietary exposure from drinking water. EPA assumes that there is 
no exposure through drinking water because pyflubumide is not 
registered for use in the United States. Because residues are not 
expected in drinking water, dietary risk estimates include exposures 
from food only.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Pyflubumide is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 considers ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pyflubumide and any other 
substances. In addition, pyflubumide does not appear to produce a toxic 
metabolite that is produced by other substances. For the purposes of 
this action, therefore, EPA has not assumed that pyflubumide has a 
common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects. The margin of safety 
accounts for prenatal and postnatal toxicity and the completeness of 
the database on toxicity and exposure unless EPA determines, based on 
reliable data, that a different margin of safety will be safe for 
infants and children. This additional margin of safety is commonly 
referred to as the Food Quality Protection Act (FQPA) Safety Factor 
(SF). In applying this provision, EPA either retains the default value 
of 10X, or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
qualitative or quantitative susceptibility was seen in the rat and 
rabbit developmental toxicity studies. However, increased quantitative 
susceptibility was observed in the offspring of the multigeneration 
reproduction toxicity study where lung lesions in offspring were 
observed at a lower dose than the dose eliciting parental toxicity. A 
mechanistic study found that the increased incidence of lung lesions 
(alveolar dilatation and hemorrhage), following exposure to 
pyflubumide, was observed during post-natal exposure without any 
effects seen during in utero exposure. Although

[[Page 71161]]

quantitative susceptibility was observed in the multigeneration 
reproduction study at 6 mg/kg/day, a clear level at which no adverse 
effects occurred was identified at 1 mg/kg/day. In two mechanistic 
studies where lung lesions were identified, a clear NOAEL was 
established. Oral gavage administration of the parent compound 
(pyflubumide) to rat pups led to the increased incidence of lung 
lesions at a lower dose (10 mg/kg/day) than the metabolites (50 mg/kg/
day) and a clear NOAEL was established at 2 mg/kg/day. In addition, 
oral gavage administration of the parent (50 mg/kg/day) over a two-day 
period (post-natal day [PND] 4-5 or PND 6-7), led to the increased 
incidence of lung (alveolar enlargement) lesions in the pups and a 
clear NOAEL was established at 10 mg/kg/day. An acute exposure below 10 
mg/kg/day is not likely to result in the development of lung lesions. A 
point of departure was established for both the acute (10 mg/kg/day) 
and chronic dietary (1 mg/kg/day) exposure scenario which is protective 
of lung effects observed in the aforementioned studies. The combination 
of these factors provided a weight of the evidence to support reducing 
the FQPA safety factor to 1X.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for pyflubumide is complete for evaluating 
and characterizing toxicity, assessing offspring susceptibility under 
FQPA, and selecting endpoints for the exposure pathways of concern. The 
developmental toxicity studies in rats and rabbits, a multigeneration 
reproduction toxicity study, an acute neurotoxicity study in rats, and 
mechanistic studies on the incidence of lung lesions in rat pups are 
available for FQPA consideration.
    ii. There is no indication that pyflubumide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors to account for neurotoxicity.
    iii. As stated above, no evidence of increased qualitative or 
quantitative susceptibility was seen in the rat and rabbit 
developmental toxicity studies. However, increased quantitative 
susceptibility was observed in the offspring of the multigeneration 
reproduction toxicity study where lung lesions in offspring were 
observed at a lower dose than the dose eliciting parental toxicity. The 
concern for the susceptibility observed in the multigeneration 
reproductive toxicity study is low, as there is a clear NOAEL 
established for the offspring effects and the PODs selected for risk 
assessment are protective of the observed susceptibility.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% PCT and combined residue levels for pyflubumide and 
pyflubumide-NH at a 7-day preharvest interval. These assessments will 
not underestimate the exposure and risks posed by pyflubumide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to 
pyflubumide from food only will utilize 3.5% of the aPAD for females 
(13 to 49 years old). The acute dietary risk estimate for females (13 
to 49 years old) is protective for nursing infants because lactating 
mothers who consume tea with pyflubumide residues are not expected to 
have lower exposures than infants who subsequently consume the mother's 
breast milk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pyflubumide from food only will utilize 7.7% of the cPAD for adults (50 
to 99 years old), the most highly exposed population subgroup. There 
are no residential uses for pyflubumide.
    3. Short and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because pyflubumide is 
not registered in the United States, the only exposures will be 
dietary, from residues in or on imported tea; therefore, no short-term 
or intermediate-term residential exposure is expected. Because there is 
no short- or intermediate-term residential exposure and chronic dietary 
exposure has already been assessed under the appropriately protective 
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short- or intermediate-term risk 
is necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and intermediate-term risk for pyflubumide.
    4. Aggregate cancer risk for U.S. population. As stated in Unit 
III.A, EPA has concluded that the chronic reference dose (cRfD) will 
adequately account for all repeated exposure/chronic toxicity, 
including carcinogenicity, which could result from exposure to 
pyflubumide. Based on the lack of chronic risk at regulated levels of 
exposure, EPA concludes that exposure to pyflubumide will not pose an 
aggregate cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pyflubumide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (QuEChERS-based high-performance 
liquid chromatography method with tandem mass spectrometry detection 
(LC/MS/MS), Method A) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    The Codex has not yet established a MRL for pyflubumide residues in 
or on tea, dried or tea, instant. The Joint Food and Agriculture 
Organization (FAO)/World Health Organization (WHO) Meeting on Pesticide 
Residues (JMPR)

[[Page 71162]]

evaluated toxicology and residue data for apple and tea submitted by 
Nichino in September 2019. JMPR proposed an MRL level of 80 ppm for 
tea, dried (Pesticide Residues in Food 2019--Joint FAO/WHO Meeting on 
Pesticide Residues, pg 1620-1622; https://www.fao.org/3/ca7455en/ca7455en.pdf). The U.S. tolerance of 80 ppm for residues of pyflubumide 
in/on tea, dried is harmonized with the MRL proposed by JMPR.

C. Revisions to Petitioned-For Tolerances

    The petition requested tolerances for residues of pyflubumide in or 
on tea, dried at 70 ppm. EPA is establishing the tolerance for residues 
of pyflubumide in or on tea, dried at 80 ppm. Two of the submitted 
field residue trials were conducted at half the label rate. EPA 
normalized those resulting residues to a 1X rate using proportionality 
and used the Organization for Economic Co-operation and Development 
(OECD) MRL calculation procedures, which resulted in a tolerance level 
of 80 ppm for tea, dried. EPA is also establishing a tolerance for tea, 
instant, which is another processed commodity of tea, plucked leaves, 
and EPA has determined that the same tolerance of 80 ppm is appropriate 
for instant tea.

V. Conclusion

    Therefore, tolerances are established for residues of pyflubumide, 
including its metabolites and degradates, in or on tea, dried at 80 ppm 
and tea, instant at 80 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: December 9, 2021.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

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

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. Add Sec.  180.722 to subpart C to read as follows:

Sec.  180.722  Pyflubumide; tolerances for residues.

    (a) General. Tolerances are established for residues of 
pyflubumide, including its metabolites and degradates, in or on the 
commodities in Table 1 to this paragraph (a). Compliance with the 
tolerance levels specified in Table 1 to this paragraph (a) is to be 
determined by measuring residues of pyflubumide (1,3,5-trimethyl-N-(2-
methyl-1-oxopropyl)-N-[3-(2-methylpropyl)-4-[2,2,2-trifluoro-1-methoxy-
1-(trifluoromethyl)ethyl]phenyl]-1H-pyrazole-4-carboxamide) in or on 
the following commodities:

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Tea, dried..................................................          80
Tea, instant................................................          80
------------------------------------------------------------------------

    (b)-(d) [Reserved].

[FR Doc. 2021-27147 Filed 12-14-21; 8:45 am]
BILLING CODE 6560-50-P