[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Rules and Regulations]
[Pages 52083-52088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20251]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0227; FRL-8857-01-OCSPP]
Pyraclostrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
pyraclostrobin in or on pomegranate. Interregional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 20, 2021. Objections and
requests for hearings must be received on or before November 19, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0227, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room was closed to public visitors on March 31, 2020. Our
EPA/DC staff will continue to provide customer service via email,
phone, and webform. For further information on EPA/DC services, docket
contact information and the current status of the EPA/DC and
[[Page 52084]]
Reading Room, please visit http://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 Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0227 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
November 19, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0227, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 30, 2020 (85 FR 61681) (FRL-
10014-74), 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
0E8826) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested to establish tolerances in 40 CFR
180.582 for residues of the sum of pyraclostrobin, (carbamic acid, [2-
[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-,
methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-
chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate), calculated
as the stoichiometric equivalent of pyraclostrobin, in or on the raw
agricultural commodity pomegranate at 0.3 ppm. That document referenced
a summary of the petition prepared by BASF, the registrant, which is
available in the docket, http://www.regulations.gov. No comments were
received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyraclostrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyraclostrobin
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 primary target tissues following repeated pyraclostrobin
exposure appear to be mucosal membranes, with histopathology or
secondary effects (e.g., diarrhea) observed in different species. The
primary effects were decreased body weight and food consumption in
addition to diarrhea. There was no observed neurotoxicity,
mutagenicity, genotoxicity, or immunotoxicity in the database. Also,
there was no evidence of increased susceptibility following pre-natal
exposure to rats and rabbits in the developmental toxicity studies, nor
following pre- and post-natal exposure to rats in the multi-generation
reproduction study. Pyraclostrobin is classified as ``not likely to be
carcinogenic to humans.''
Additional information on the toxicological profile can be found at
http://www.regulations.gov in the
[[Page 52085]]
document titled ``Pyraclostrobin; Human Health Risk Assessment for a
New Use on Pomegranate'' (hereinafter ``Pyraclostrobin Human Health
Risk Assessment'') in docket ID number EPA-HQ-OPP-2020-0227.
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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
A summary of the toxicological endpoints for pyraclostrobin used
for human risk assessment can be found on pages 10-11 in the
Pyraclostrobin Human Health Risk Assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyraclostrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyraclostrobin
tolerances in 40 CFR 180.582. EPA assessed dietary exposures from
pyraclostrobin 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 pyraclostrobin.
In conducting the acute dietary exposure assessment, EPA used the
2003-2008 food consumption data from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). A partially refined acute dietary
exposure assessment was conducted for pyraclostrobin. The analysis used
tolerance-level residues or highest average field trial residues (HAFT)
and 100 percent crop treated (PCT).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the 2003-2008 food consumption data from the
USDA's NHANES/WWEIA. A partially refined chronic dietary analysis was
conducted for pyraclostrobin. The chronic dietary analysis included
tolerance-level or average field trial residues and average PCT
estimates when available.
iii. Cancer. Pyraclostrobin is classified as ``Not Likely to Be
Carcinogenic to Humans'' therefore, a cancer assessment is not needed.
iv. Anticipated residue and PCT information. 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 following average PCT estimates were used in the chronic
dietary risk assessments for the crops that are currently registered
for pyraclostrobin: Almonds 45%; apples 20%; apricots 30%; barley 10%;
green beans 5%; blueberries 40%; broccoli 5%; Brussels sprouts 15%;
cabbage 10%; caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower
5%; celery 2.5%; cherries 55%; chicory 5%; corn 10%; cotton (seed
treatment) 10%; cucumber 5%; dry beans/peas 10%; garlic 10%; grapefruit
35%; grapes 30%; hazelnuts 20%; lemons 5%; lettuce 5%; nectarines 15%;
oats 5%; onions 30%; oranges 5%; peaches 25%; peanuts 20%; pears 20%;
green peas 5%; pecans 5%; peppers 15%; pistachios 30%; potatoes 20%;
pumpkins 15%; soybeans (seed treatment) 10%; spinach 5%; squash 15%;
strawberries 65%; sugar beets 50%; sugarcane 5%; sweet corn 5%;
tangerines 10%; tomatoes 25%; walnuts 10%; watermelons 25%; wheat 5%.
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
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most 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 less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. 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 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
[[Page 52086]]
consumption surveys, EPA does not have available reliable information
on the regional consumption of food to which pyraclostrobin may be
applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyraclostrobin in drinking water. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide in Water Calculator (PWC), for the acute
dietary risk assessment, EPA used an estimated drinking water
concentration (EDWC) of 22 ppb into the DEEM-FCID Model. For the
chronic exposure assessment, EPA used a value of 0.99 ppb.
3. 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).
Pyraclostrobin is currently registered for uses that may result in
residential handler and post-application exposures, including
commercial and residential use on lawns, as well as commercial use on
ornamental turf and trees, golf courses, and parks.
Based upon the hazard analysis for pyraclostrobin, short-term
residential exposure that is available to be aggregated include
incidental oral exposure (e.g., hand-to-mouth or object-to-mouth).
Hand-to-mouth and object-to-mouth scenarios are considered inter-
related, and it is likely that they occur interspersed amongst each
other across time; combining these scenarios would be overly
conservative. Residential short and intermediate-term dermal exposures
(from children, youth, or adult scenarios) are not being combined with
incidental oral exposure due to differing endpoints selected. Based
upon the available scenarios, incidental oral (hand-to-mouth) exposures
were used in the pyraclostrobin short-term aggregate assessment.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
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 pyraclostrobin and any
other substances and pyraclostrobin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pyraclostrobin
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 to account 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 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. In the rat developmental
toxicity study, skeletal variations occurred at doses greater than or
equal to those doses causing maternal toxicity (i.e., diarrhea,
decreased body weight, food consumption, and clinical signs of
toxicity). In the rabbit developmental study, increased resorptions per
litter, increased post-implantation loss, and dams with total
resorptions were observed. Since the cause of fetal death is
undetermined and may be attributed to either maternal or direct embryo
fetal toxicity, the effect is part of both the maternal and
developmental LOAEL. In one rat reproduction study, systemic toxicity
manifested as decreased body weights in both the parents and offspring,
with offspring effects occurring at a higher dose level than parental
toxicity. In the second rat reproduction study, no toxicity was
observed in both parents and offspring. Therefore, there was no
evidence of increased susceptibility (quantitatively) following pre-
natal exposure to rats and rabbits in the developmental studies nor
following pre- and post-natal exposure to rats in the multi-generation
reproduction studies.
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 pyraclostrobin is complete.
ii. There are no indications in any of the studies available
that the nervous system is a target for pyraclostrobin. In the
absence of definitive neurotoxicity or neuropathology findings in
the neurotoxicity battery or elsewhere in the database, a
developmental neurotoxicity study is not required.
iii. For the reasons summarized in section III.D.2, the degree
of concern for prenatal and postnatal toxicity is low.
iv. There are no residual uncertainties identified in the
exposure databases. The acute dietary exposure assessments were
performed assuming 100 percent of the crops were treated with
pyraclostrobin and incorporating tolerance-level or highest field
trial residues. The chronic dietary exposure assessments were
performed using average PCT estimates and tolerance-level or average
field trial residues for crops in the screening level use analysis
(SLUA), while 100 PCT was used for crops not included in the SLUA.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to pyraclostrobin in
drinking water. Although the acute and chronic assessments included
minor refinements, the use of field trial and PCT estimates ensures
that actual exposures/risks from residues in food will not be
underestimated. Although some of the residue values used in the
dietary exposure assessment were refined, these assessments will not
underestimate the dietary exposure to pyraclostrobin.
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
pyraclostrobin from food and water will utilize 86% of the aPAD for
females 13 to 49 years old, the only
[[Page 52087]]
population group of concern because no appropriate toxicological effect
attributable to a single dose was observed for the general US
population or any other population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyraclostrobin from food and water will utilize 28% of the cPAD for all
children 1 to 2 years old, the population group receiving the greatest
exposure. Chronic residential exposure to residues of pyraclostrobin is
not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyraclostrobin is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to pyraclostrobin.
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 an aggregate MOE of 430 for
children 1 to 2 years old. Because EPA's level of concern for
pyraclostrobin is a MOE of 100 or below, this MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
A separate intermediate-term adverse effect was identified for
pyraclostrobin. However, pyraclostrobin is not registered for any use
patterns that would result in intermediate-term residential exposures
that can be combined with background dietary exposures. Because there
is no intermediate-term residential aggregate exposures and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD, no further assessment of intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating intermediate-term risk for pyraclostrobin.
5. Aggregate cancer risk for U.S. population. Pyraclostrobin is
classified as ``Not Likely to Be Carcinogenic to Humans''; therefore,
EPA does not expect pyraclostrobin exposures to pose an aggregate
cancer risk.
6. 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 pyraclostrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Two adequate methods are available for enforcement purposes for
residues of pyraclostrobin and its metabolites in/on plant commodities:
a liquid chromatography with tandem mass spectroscopy (LC/MS/MS) method
(BASF Method D9908) and a high-performance liquid chromatography/
ultraviolet (HPLC/UV) method (Method D9904).
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).
There is no Codex MRL for pyraclostrobin in or on pomegranate.
V. Conclusion
Therefore, a tolerance is established for residues of
pyraclostrobin in or on pomegranate at 0.3 ppm. Additionally, the
Agency is putting back a footnote that states ``There is no U.S.
registration on coffee, bean, green as of September 30, 2009'' to the
table in paragraph (a)(1) that was inadvertently removed in 2013.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act (CRA)
Pursuant to the CRA (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,
[[Page 52088]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 13, 2021.
Marietta Echeverria,
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:
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. 180.582, amend the table in paragraph (a)(1) by adding in
alphabetical order the commodity ``Pomegranate'' and a footnote 1 at
the end of the table to read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pomegranate................................................ 0.3
* * * * *
------------------------------------------------------------------------
\1\ There is no U.S. registration on coffee, bean, green as of September
30, 2009.
* * * * *
[FR Doc. 2021-20251 Filed 9-17-21; 8:45 am]
BILLING CODE 6560-50-P