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