[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Rules and Regulations]
[Pages 13640-13644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05065]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0235; FRL-9067-01-OCSPP]
Buprofezin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
buprofezin in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective March 10, 2022. Objections and
requests for hearings must be received on or before May 9, 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-2020-0235, 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 and for the OPP Docket is (202) 566-1744.
Due to the public emergency, 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, Acting Director,
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.
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-2020-0235 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
May 9, 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-2020-0235, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
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 Registers of June 24, 2020 (85 FR 37806) (FRL-10010-
82), and August 5, 2020 (85 FR 47330) (FRL-10012-32), EPA issued
documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP 0E8828) by IR-4,
North Carolina State University, 1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. These petitions requested that 40 CFR 180.511
be amended by establishing tolerances for residues of the insecticide
buprofezin, 2-[(1,1 dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one, in or on asparagus bean, edible
podded at 0.02 parts per million (ppm); bushberry subgroup 13-07B at
0.08 ppm; catjang bean, edible podded at 0.02 ppm; Chinese longbean,
edible podded at 0.02 ppm; cowpea, edible podded at 0.02 ppm; french
bean, edible podded at 0.02 ppm; garden bean, edible podded at 0.02
ppm; green bean, edible podded at 0.02 ppm; goa bean, edible podded at
0.02 ppm; guar
[[Page 13641]]
bean, edible podded at 0.02 ppm; jackbean, edible podded at 0.02 ppm;
kidney bean, edible podded at 0.02 ppm; lablab bean, edible podded at
0.02 ppm; moth bean, edible podded at 0.02 ppm; mung bean, edible
podded at 0.02 ppm; navy bean, edible podded at 0.02 ppm; rice bean,
edible podded at 0.02 ppm; scarlet runner bean, edible podded at 0.02
ppm; snap bean, edible podded at 0.02 ppm; sword bean, edible podded at
0.02 ppm; urd bean, edible podded at 0.02 ppm; vegetable soybean,
edible podded at 0.02 ppm; velvet bean, edible podded at 0.02 ppm; wax
bean, edible podded at 0.02 ppm; winged pea, edible podded at 0.02 ppm;
and yardlong bean, edible podded at 0.02 ppm.
In addition, IR-4 proposed, upon the approval of the aforementioned
tolerances, to remove the established tolerance for the residues of
buprofezin, including its metabolites and degradates in or on bean,
snap, succulent at 0.02 ppm.
Three comments were received on the notices of filings. EPA's
responses to these comments are discussed 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.
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 buprofezin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with buprofezin follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that would repeat
what has been previously published in tolerance rulemakings for the
same pesticide chemical. Where scientific information concerning a
particular pesticide chemical remains unchanged, the content of those
sections would not vary between tolerance rulemakings and republishing
the same sections is unnecessary and duplicative. EPA considers
referral back to those sections as sufficient to provide an explanation
of the information EPA considered in making its safety determination
for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
buprofezin, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to buprofezin and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of buprofezin and aniline, a substance that may be formed as a
degradate in food from buprofezin and its aniline-containing
metabolites as a result of cooking, see Unit III.A. of the August 29,
2019 rulemaking (84 FR 45426) (FRL-9997-41). There is, however, a new
discussion of the non-cancer toxicity characterization of aniline in
Appendix F of the document titled ``Buprofezin. Human Health Risk
Assessment for Proposed New Use on Bushberry Crop Subgroup 13-07B and
Proposed Amendments to Expand Use on Succulent Beans to All Members of
Proposed Edible Podded Bean Legume Vegetable Subgroup 6-XXA and Use on
Greenhouse-Grown Tomatoes and Peppers to All Members of Fruiting
Vegetable Crop Group 8-10'' (hereinafter ``Buprofezin Human Health Risk
Assessment.'')
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
risk assessment, see Unit III.B. of the August 29, 2019 rulemaking.
Exposure assessment. Much of the exposure assessment remains the
same, although the dietary exposure and risk assessments for buprofezin
and buprofezin-derived aniline were updated. These updates are
discussed in this section; for a description of the rest of EPA's
approach to and assumptions for the exposure assessment, see Unit
III.C. of the August 29, 2019 rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposures for the new uses of buprofezin. The assessment
used the same assumptions as the August 29, 2019 final rule concerning
tolerance level residues, default and empirical processing factors for
all processed commodities assumptions, and a conservative factor to
account for the presence of the BF4 Conjugate (2-(2-hydroxy-1,1-
dimethylethylimino)-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one). The
acute dietary exposure assessment assumed 100 percent crop treated
(PCT).
Updated PCT estimates were used in the chronic dietary risk
assessment for crops that are currently registered for buprofezin:
Almond 1%, apple 2.5%, apricot 5%, broccoli 2.5%, cabbage 2.5%,
cantaloupe 15%, cauliflower 5%, celery 1%, cherry 10%, cotton 1%,
cucumber 1%, grapefruit 5%, raisin grape 5%, table grape 10%, wine
grape 2.5%, honeydew 75%, lemon 2.5%, lettuce 10%, nectarine 15%, olive
1%, orange 2.5%, peach 5%, pear 15%, pepper 1%, pistachio 15%, plum/
prune 2.5%, pumpkin 1%, spinach 1%, squash 2.5%, strawberry 15%,
tangerine 10%, tomato 1%, walnut 2.5%, and watermelon 1%. These average
PCT data were also used to refine the cancer dietary exposure analysis
for buprofezin-derived aniline. All other crops assumed 100% crop
treated.
A cancer dietary exposure risk assessment for buprofezin was not
conducted because the only evidence of carcinogenicity was for benign
liver tumors in one sex (males) and one species (mouse); there was no
evidence of carcinogenicity in rats of either sex or in female mice. An
updated, highly refined cancer dietary exposure (cooked food forms
only) and risk assessment for buprofezin-derived aniline residues,
including those derived from aniline-containing metabolites of
buprofezin, was conducted. This assessment was conducted using (1)
buprofezin monitoring data for raw/uncooked agricultural commodities
(RACs) provided by the United States Department of Agriculture
Pesticide Data Program (PDP) to estimate average residues of
buprofezin; (2) buprofezin field trial data; (3) empirical and EPA's
2018 default processing factors; (4) average buprofezin PCT data; and
(5) the maximum conversion factor for buprofezin-derived aniline of
18.9%. The conversion factor of 18.9%, the highest found in a
previously submitted hydrolysis study, was applied to
[[Page 13642]]
estimate residues of buprofezin-derived aniline which may form in food
as a result of cooking. The highly refined estimated exposure of the
highest exposed adult population (adults 50 to 99 years old) to
buprofezin-derived aniline results in an upper bound cancer risk
estimate of 3 x 10-7.
Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the 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 up
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 Conditions a, b, and c discussed above
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 consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
buprofezin may be applied in a particular area.
Drinking water, non-occupational, and cumulative exposures.
Drinking water and non-occupational exposures are not impacted by the
new uses, and thus have not changed since the last assessment. EPA's
conclusions concerning cumulative risk remain unchanged from Unit
III.C.2. of the August 29, 2019 rulemaking.
Safety factor for infants and children. EPA continues to conclude
that a 10X FQPA SF must be retained for repeated exposure scenarios
because those assessments are based on a study that did not show a No
Observed Adverse Effect Level (NOAEL). EPA also continues to conclude
that there is reliable data showing that the safety of infants and
children would be adequately protected if the FQPA SF were reduced from
10X to 1X for single exposures. The reasons for these decisions are
articulated in Unit III.D. of the August 29, 2019 rulemaking.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic-term risks are evaluated by comparing the estimated
aggregate food, water, and residential exposure to the appropriate
points of departure to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 5.8% of the aPAD for females 13-49 years old,
which is the only population subgroup with an acute dietary endpoint.
Chronic dietary risks are below the Agency's level of concern of 100%
of the cPAD; they are 42% of the cPAD for children 1 to 2 years old,
the most highly exposed subpopulation. Buprofezin is classified as
``Suggestive Evidence of Carcinogenicity, but not sufficient to assess
human carcinogenic potential.'' EPA has determined that the
quantification of risk using a non-linear (i.e., reference dose)
approach will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to buprofezin. Because
the chronic dietary risks are below the Agency's level of concern,
buprofezin is not expected to pose a cancer risk to humans.
There are no data to determine an acute endpoint for aniline at
this time; hence, an acute dietary risk assessment was not conducted
for buprofezin-derived aniline. The highly refined estimated chronic
exposure of the most highly exposed adult subpopulation (adults 50 to
99 years old) to buprofezin-derived aniline is 0.000052 mg/kg/day.
Estimated chronic exposures to buprofezin-derived aniline are orders of
magnitude below any potential chronic non-cancer reference dose for
aniline. Therefore, a quantitative chronic non-cancer dietary risk
assessment for buprofezin-derived aniline is not necessary to conclude
with reasonable certainty that chronic exposures from buprofezin-
derived aniline do not pose a non-cancer dietary risk. The highly
refined estimated chronic exposure of the most highly exposed adult
subpopulation results in an upper bound cancer risk estimate of 3 x
10-7,
[[Page 13643]]
which is below the Agency's level of concern of 1 x 10-6.
There are no residential uses of buprofezin; therefore, the
aggregate risk assessment is equivalent to the acute and chronic
dietary (food and drinking water) exposure and risk assessments to
buprofezin and buprofezin-derived aniline and are not of concern.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to buprofezin residues. More detailed information
about the Agency's analysis can be found at https://www.regulations.gov
in the document ``Buprofezin Human Health Risk Assessment'' in docket
ID number EPA-HQ-OPP-2020-0235.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available in Pesticide Analytical
Manual Volume I (PAM I) and PAM II for enforcement of buprofezin
tolerances, including gas chromatography methods with nitrogen
phosphorus detection (GC/NPD), and a GC/mass spectrometry (GC/MS)
method for confirmation of buprofezin residues in plant and livestock
commodities. The GC/MS method used for plant commodities utilizes three
ions for identification of buprofezin. The validated limit of
quantitation (LOQ) was 0.05 ppm. In addition, method BF/10/97 is an
adequate enforcement method for enforcement of buprofezin tolerances
in/on bean commodities. The LOQ is 0.02 ppm.
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).
No Codex MRLs have been established for residues of buprofezin in/
on the proposed commodities in this action.
C. Response to Comments
Although three comments were submitted to the docket in response to
the June 24, 2020, and August 5, 2020 notifications of filings, only
one specifically related to this tolerance action. This comment was
from a representative from the Republic of Ecuador. The commenter's
concern was that the proposed U.S. MRLs for buprofezin on beans at 0.02
ppm would prevent beans from Ecuador from being imported and marketed
in the U.S. because of buprofezin residues higher than 0.02 ppm. The
commenter was also concerned that the U.S. would reduce the tolerance
for residues in/on beans to be more restrictive. The commenter also
stated that it is essential for pesticide tolerances to be based on
scientific evidence, conclusive data and not under the precautionary
principle.
The existing tolerance for residues in/on bean, snap, succulent is
based on previously submitted and reviewed field trial residue data
that demonstrate that residues of buprofezin in/on snap beans are less
than the limit of quantitation, which is 0.02 ppm. The petitioner
requested, and EPA agrees that it is appropriate, to extrapolate the
field trial data on succulent snap beans to support tolerances for
residues in/on the 25 specific edible podded bean commodities.
Therefore, this action is based on scientific evidence and conclusive
data and actually increases the tolerances for most of the edible
podded bean commodities from zero (not existent) to 0.02 ppm. Ecuador
has adopted the established European Union (EU) MRL of 0.01 ppm for
residues of buprofezin in/on beans (with pods) and beans (without
pods). The recommended U.S. tolerance of 0.02 ppm for residues of
buprofezin in/on individual edible podded bean commodities is not more
restrictive than this MRL. The U.S. tolerances are based on the use
pattern that is registered in the U.S. If the use pattern is different
in Ecuador, the bean growers or another organization could submit a
petition for an import tolerance for residues of buprofezin in/on
beans, with supporting field trial residue data based on the alternate
use pattern. EPA would review such a petition to determine if it meets
the statutory standard that there is a reasonable certainty that no
harm will result to the general population, or to infants and children,
from aggregate exposure to buprofezin residues.
D. Revisions to Petitioned-For Tolerances
Most of the proposed commodity definitions have been modified to be
consistent with Agency nomenclature.
V. Conclusion
Therefore, tolerances are established for residues of buprofezin,
2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-
1,3,5-thiadiazin-4-one, in or on Bean, asparagus, edible podded at 0.02
ppm; Bean, catjang, edible podded at 0.02 ppm; Bean, french, edible
podded at 0.02 ppm; Bean, garden, edible podded at 0.02 ppm; Bean, goa,
edible podded at 0.02 ppm; Bean, green, edible podded at 0.02 ppm;
Bean, guar, edible podded at 0.02 ppm; Bean, kidney, edible podded at
0.02 ppm; Bean, lablab, edible podded at 0.02 ppm; Bean, moth, edible
podded at 0.02 ppm; Bean, mung, edible podded at 0.02 ppm; Bean, navy,
edible podded at 0.02 ppm; Bean, rice, edible podded at 0.02 ppm; Bean,
scarlet runner, edible podded at 0.02 ppm; Bean, snap, edible podded at
0.02 ppm; Bean, sword, edible podded at 0.02 ppm; Bean, urd, edible
podded at 0.02 ppm; Bean, wax, edible podded at 0.02 ppm; Bean,
yardlong, edible podded at 0.02 ppm; Bushberry subgroup 13-07B at 0.08
ppm; Cowpea, edible podded at 0.02 ppm; Jackbean, edible podded at 0.02
ppm; Longbean, chinese, edible podded at 0.02 ppm; Pea, winged, edible
podded at 0.02 ppm; Soybean, vegetable, edible podded at 0.02 ppm; and
Velvetbean, edible podded at 0.02 ppm.
Upon establishment of the aforementioned tolerances, the
established tolerance for the residues of buprofezin, including its
metabolites and degradates in or on Bean, snap, succulent at 0.02 ppm
will be removed, as it is superseded by the new tolerances on the
edible podded bean commodities. In addition, EPA is revising the
tolerance expression in paragraph (a) to correct the chemical name of
buprofezin.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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
[[Page 13644]]
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: March 4, 2022.
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. 180.511, amend paragraph (a) by:
0
a. Revising the introductory text.
0
b. Adding in alphabetical order to the table the entries ``Bean,
asparagus, edible podded''; ``Bean, catjang, edible podded''; ``Bean,
french, edible podded''; ``Bean, garden, edible podded''; ``Bean, goa,
edible podded''; ``Bean, green, edible podded''; ``Bean, guar, edible
podded''; ``Bean, kidney, edible podded''; ``Bean, lablab, edible
podded''; ``Bean, moth, edible podded''; ``Bean, mung, edible podded'';
``Bean, navy, edible podded''; ``Bean, rice, edible podded''; ``Bean,
scarlet runner, edible podded''; and ``Bean, snap, edible podded''.
0
c. Removing the entry from the table for ``Bean, snap, succulent''.
0
d. Adding in alphabetical order to the table the entries ``Bean, sword,
edible podded''; ``Bean, urd, edible podded''; ``Bean, wax, edible
podded''; ``Bean, yardlong, edible podded''; ``Bushberry subgroup 13-
07B''; ``Cowpea, edible podded''; ``Jackbean, edible podded'';
``Longbean, chinese, edible podded''; ``Pea, winged, edible podded'';
``Soybean, vegetable, edible podded''; and ``Velvetbean, edible
podded''.
The revision and additions read as follows:
Sec. 180.511 Buprofezin; tolerances for residues.
(a) General. Tolerances are established for residues of buprofezin,
including its metabolites and degradates in or on the commodities in
the table in this paragraph (a). Compliance with the tolerance levels
specified in the table in this paragraph (a) is to be determined by
measuring only the buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-
3-(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Bean, asparagus, edible podded.............................. 0.02
Bean, catjang, edible podded................................ 0.02
Bean, french, edible podded................................. 0.02
Bean, garden, edible podded................................. 0.02
Bean, goa, edible podded.................................... 0.02
Bean, green, edible podded.................................. 0.02
Bean, guar, edible podded................................... 0.02
Bean, kidney, edible podded................................. 0.02
Bean, lablab, edible podded................................. 0.02
Bean, moth, edible podded................................... 0.02
Bean, mung, edible podded................................... 0.02
Bean, navy, edible podded................................... 0.02
Bean, rice, edible podded................................... 0.02
Bean, scarlet runner, edible podded......................... 0.02
Bean, snap, edible podded................................... 0.02
* * * * *
Bean, sword, edible podded.................................. 0.02
Bean, urd, edible podded.................................... 0.02
Bean, wax, edible podded.................................... 0.02
Bean, yardlong, edible podded............................... 0.02
* * * * *
Bushberry subgroup 13-07B................................... 0.08
* * * * *
Cowpea, edible podded....................................... 0.02
* * * * *
Jackbean, edible podded..................................... 0.02
* * * * *
Longbean, chinese, edible podded............................ 0.02
* * * * *
Pea, winged, edible podded.................................. 0.02
* * * * *
Soybean, vegetable, edible podded........................... 0.02
* * * * *
Velvetbean, edible podded................................... 0.02
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-05065 Filed 3-9-22; 8:45 am]
BILLING CODE 6560-50-P