Rule2022-20332
Novaluron; Pesticide Tolerances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 21, 2022
Effective
September 21, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of novaluron in or on multiple crops that are discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 87 Issue 182 (Wednesday, September 21, 2022)</title>
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[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Rules and Regulations]
[Pages 57615-57620]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20332]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0153; FRL-10187-01-OCSPP]
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
novaluron in or on multiple crops that are discussed later in this
document. 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 21, 2022. Objections and
requests for hearings must be received on or before November 21, 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-2021-0153, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#16445250445879627f7573655673667738717960"><span class="__cf_email__" data-cfemail="4b190f0d1905243f22282e380b2e3b2a652c243d">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0153 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 21, 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-2021-0153, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C.
[[Page 57616]]
346a(d)(3), announcing the filing of a pesticide petition (PP 0E8882)
by IR-4, North Carolina State University, 1730 Varsity Drive, Venture
IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR
180.598 be amended by establishing tolerances for residues of the
insecticide novaluron in or on individual crops of proposed Crop
Subgroup 6-XXA: Edible podded bean legume vegetable subgroup at 0.7
parts per million (ppm); individual crops of proposed Crop Subgroup 6-
XXB: Edible podded pea legume vegetable subgroup at 2 ppm; individual
crops of Proposed Crop Subgroup 6-XXC: Succulent shelled bean subgroup
at 0.7 ppm; individual crops of Proposed Crop Subgroup 6-XXD: Succulent
shelled pea subgroup at 0.05 ppm; individual crops of Proposed Crop
Subgroup 6-XXE: Dried shelled bean, except soybean at 0.3 ppm;
individual crops of Proposed Crop Subgroup 6-XXF: Dried shelled pea
subgroup at 0.1 ppm; and Pea, forage at 15 ppm. The petition also
requested to amend 40 CFR part 180 by removing established tolerances
for residues of novaluron, including its metabolites and degradates, in
or on Bean, dry, seed at 0.30 ppm, and Bean, succulent at 0.70 ppm.
That document referenced a summary of the petition, which is available
in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment was received
from the United States Department of Agriculture in support of the
notice of filing.
In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-OCSPP) 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
0E8882) by IR-4, North Carolina State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.598 be amended by establishing tolerances for residues of
the insecticide novaluron in or on the following raw agricultural
commodities: Bean, phaseolus, forage at 15 ppm; Cowpea, forage at 15
ppm; Pea, field, forage at 15 ppm; Bean, phaseolus, hay at 80 ppm;
Cowpea, hay at 80 ppm; and Pea, field, hay at 80 ppm. That document
referenced a summary of the petition, which is available in the docket,
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. No substantive comments were received in
response to the notice.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is modifying many of the commodity definitions to be consistent with
Agency terminology. The tolerance levels being established are the same
as the petition requested.
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 therein, 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 novaluron including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with novaluron follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and 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 tolerance rulemakings for novaluron in
which EPA concluded, based on the available information, that there is
a reasonable certainty that no harm would result from aggregate
exposure to novaluron and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from these
rulemakings as described further in this rulemaking, as they remain
unchanged.
In addition, EPA has conducted a human health risk assessment in
support of registration review for novaluron. That document,
``Novaluron: Draft Human Health Risk Assessment to Support Registration
Review'' dated March 24, 2020, along with the Novaluron Interim
Registration Review Decision, are available in docket ID number EPA-HQ-
OPP-2015-0171 and are referenced below.
Toxicological profile. For a discussion of the Toxicological
Profile of novaluron, see Unit III.A. of the novaluron tolerance
rulemaking published in the Federal Register of July 22, 2015 (80 FR
43329) (FRL-9929-57) as well as the Novaluron: Draft Human Health Risk
Assessment to Support Registration Review and Novaluron Interim
Registration Review Decision.
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
novaluron used for human health risk assessment, please reference Unit
III.B. of the July 22, 2015, rulemaking as well as the Novaluron: Draft
Human Health Risk Assessment to Support Registration Review and
Novaluron Interim Registration Review Decision.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the proposed new uses
of novaluron on the commodities identified in this action. An acute
dietary exposure assessment was not performed as there are no
toxicological effects attributable to a single exposure (dose). A
partially refined chronic dietary (food and drinking water) exposure
and risk assessment was conducted that incorporated tolerance-level
residues for the proposed new uses. The chronic dietary exposure and
risk assessment also incorporated average percent crop treated (PCT)
data for several registered commodities as well as projected PCT data
for the proposed Field Pea and Cowpea feed commodities. For the
remaining commodities, 100 PCT was assumed. Anticipated residues for
meat, milk, hog, and poultry commodities were incorporated as well. A
cancer dietary assessment was not conducted because novaluron is
classified as ``not likely to be carcinogenic to humans.''
Anticipated residue and 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,
[[Page 57617]]
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:
<bullet> 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.
<bullet> Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
<bullet> 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.
Updated average percent crop treated values were used for the
following crops that are currently registered for novaluron: apples
(10%), broccoli (1%), cabbage (5%), cantaloupe (1%), cauliflower (1%),
cherries (1%), cotton (5%), dry beans/peas (1%), peaches (1%), peanuts
(5%), pears (25%), peppers (5%), plums/prunes (1%), potatoes (5%),
pumpkins (1%), sorghum (1%), squash (1%), strawberries (45%), sugarcane
(1%), sweet corn (1%), tomatoes (2.5%), and watermelons (1%).
In most cases, EPA uses available data from the 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% as the average PCT value, respectively.
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.
Projected PCT was used for Field Pea and Cowpea feed commodities
(10%). EPA estimates the projected PCT, also known as the percent crop
treated of a new use (PCTn), based on the PCT of the dominant pesticide
(i.e., the one with the greatest PCT) used on that crop over the three
most recent years of available data. Comparisons are only made among
pesticides of the same pesticide types (e.g., the dominant insecticide
on the crop is selected for comparison with a new insecticide). The
PCTs included in the analysis may be for the same pesticide or for
different pesticides since the same or different pesticides may
dominate for each year. Typically, EPA uses USDA NASS as the source for
raw PCT data because it is publicly available and does not have to be
calculated from available data sources. When a specific use site is not
surveyed by USDA NASS, EPA uses other appropriate public data or
private market research to calculate the PCTn.
The average PCT of the market leader(s) is appropriate for use in
the chronic dietary risk assessment. This method of estimating a PCT
for a new use of a registered pesticide or a new pesticide produces a
high-end estimate that is unlikely, in most cases, to be exceeded
during the initial five years of actual use. The predominant factors
that bear on whether the estimated PCTn could be exceeded are (1) the
extent of pest pressure on the crops in question; (2) the pest spectrum
of the new pesticide in comparison with the market; and (3) resistance
concerns with the market leaders. EPA has examined the relevant data
and concludes that it is unlikely that the actual PCT with novaluron on
the Field Pea and Cowpea feed commodities will exceed the PCTn within
the next 5 years.
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
novaluron may be applied in a particular area.
Drinking water and non-occupational exposures. The previously
recommended estimated drinking water concentrations (EDWCs) remain
current and are considered protective potential drinking water residue
levels anticipated from the proposed tolerances. As stated in Unit III
of the novaluron tolerance rulemaking published in the Federal Register
of August 13, 2020 (85 FR 49261) (FRL-10011-78), the chronic dietary
exposure and risk assessment incorporate the highest total estimated
drinking water concentration (EDWC) of 8.4 parts per billion directly
into this dietary assessment. The residential exposure assessment has
not changed since the July 22, 2015, rulemaking because there are no
proposed new residential uses. For a summary of the residential
exposure analysis for novaluron used for the human health risk
assessment, please reference Unit III.C.3. of the July 22, 2015,
rulemaking.
Cumulative exposure. 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 novaluron and any other substances and
novaluron does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this action, therefore, EPA has
not assumed that novaluron has a common
[[Page 57618]]
mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the July 22, 2015, rulemaking for a discussion of the
Agency's rationale for that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population-adjusted dose
(aPAD) and chronic population-adjusted 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.
An acute dietary exposure assessment was not performed as there
were no toxicological effects attributable to a single exposure (dose)
observed in available oral toxicity studies, including maternal
toxicity in the developmental toxicity studies. Chronic dietary risks
are below the Agency's level of concern of 100% of the cPAD; they are
29% of the cPAD for children 1 to 2 years old, the group with the
highest exposure. The combined short- and intermediate-term food,
water, and residential exposures result in aggregate margins of
exposures of 3,800 for adults and 280 for children 1 to 2 years old.
These MOEs are greater than the level of concern of 100 and are
therefore not of concern. Novaluron is classified as ``Not Likely to Be
Carcinogenic to Humans''; therefore, EPA does not expect novaluron
exposures to pose an aggregate cancer risk.
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 novaluron residues. More detailed information on
this action can be found in the document titled ``Novaluron. Human
Health Risk Assessment for Petition for Individual Commodities of
Proposed Crop Subgroup 6-XXA: Vegetable, legume, bean, edible podded,
subgroup 6-xxA; Proposed Crop Subgroup 6-XXB: Vegetable, legume, pea,
edible podded, subgroup 6-xxB; Proposed Crop Subgroup 6-XXC: Vegetable,
legume, bean, succulent shelled, subgroup 6-xxC; Proposed Crop Subgroup
6-XXD: Vegetable, legume, pea, succulent shelled, subgroup 6-xxD;
Proposed Crop Subgroup 6-XXE: Vegetable, legume, bean, dried shelled,
subgroup 6-xxE; Proposed Crop Subgroup 6-XXF: Vegetable, legume, pea,
dried shelled, subgroup 6-xxF; Proposed Crop Subgroup 7-XXA: Vegetable,
legume, forage and hay, except soybean group 7-xxA, forage; and
Proposed Crop Subgroup 7-XXA: Vegetable, legume, forage and hay, except
soybean group 7-xxA, hay'' in docket ID EPA-HQ-OPP-2021-0153.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 22, 2015, rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The U.S. and Codex levels are harmonized for edible-podded and
succulent shelled beans at 0.7 ppm. Using the Organization for Economic
Cooperation and Development (OECD) calculator for the dried shelled
beans, except soybean, subgroup gives a recommended tolerance level of
0.3 ppm, which is higher than the established Codex MRL of 0.1 ppm for
``beans (dry).'' The Agency is not lowering the tolerance level to
harmonize with Codex because doing so could cause U.S. growers to have
violative residues despite legal use of novaluron according to the
label. There are no Codex MRLs for any of the other commodities
identified in this action.
V. Conclusion
Therefore, tolerances are established for residues of novaluron in
or on Bean, adzuki, dry seed at 0.3 ppm; Bean, African yam, dry seed at
0.3 ppm; Bean, American potato, dry seed at 0.3 ppm; Bean, asparagus,
dry seed at 0.3 ppm; Bean, asparagus edible podded at 0.7 ppm; Bean,
black, dry seed at 0.3 ppm; Bean, broad, dry seed at 0.3 ppm; Bean,
broad, succulent shelled at 0.7 ppm; Bean, catjang, dry seed at 0.3
ppm; Bean, catjang edible podded at 0.7 ppm; Bean, catjang, succulent
shelled at 0.7 ppm; Bean, cranberry, dry seed at 0.3 ppm; Bean, dry
bean, dry seed at 0.3 ppm; Bean, field, dry seed at 0.3 ppm; Bean,
French, dry seed at 0.3 ppm; Bean, French, edible podded at 0.7 ppm;
Bean, garden, dry seed at 0.3 ppm; Bean, garden, edible podded at 0.7
ppm; Bean, goa, dry seed at 0.3 ppm; Bean, goa, edible podded at 0.7
ppm; Bean, goa, succulent shelled at 0.7 ppm; Bean, great northern, dry
seed at 0.3 ppm; Bean, green, dry seed at 0.3 ppm; Bean, green, edible
podded at 0.7 ppm; Bean, guar, dry seed at 0.3 ppm; Bean, guar, edible
podded at 0.7 ppm; Bean, horse gram, dry seed at 0.3 ppm; Bean, kidney,
dry seed at 0.3 ppm; Bean, kidney, edible podded at 0.7 ppm; Bean,
lablab, dry seed at 0.3 ppm; Bean, lablab, edible podded at 0.7 ppm;
Bean, lablab, succulent shelled at 0.7 ppm; Bean, lima, dry seed at 0.3
ppm; Bean, lima, succulent shelled at 0.7 ppm; Bean, morama, dry seed
at 0.3 ppm; Bean, moth, dry seed at 0.3 ppm; Bean, moth, edible podded
at 0.7 ppm; Bean, moth, succulent shelled at 0.7 ppm; Bean, mung, dry
seed at 0.3 ppm; Bean, mung, edible podded at 0.7 ppm; Bean, navy, dry
seed at 0.3 ppm; Bean, navy, edible podded at 0.7 ppm; Bean, phaseolus,
forage at 15 ppm; Bean, phaseolus, hay at 80 ppm; Bean, pink, dry seed
at 0.3 ppm; Bean, pinto, dry seed at 0.3 ppm; Bean, red, dry seed at
0.3 ppm; Bean, rice, dry seed at 0.3 ppm; Bean, rice, edible podded at
0.7 ppm; Bean, scarlet runner, dry seed at 0.3 ppm; Bean, scarlet
runner, edible podded at 0.7 ppm; Bean, scarlet runner, succulent
shelled at 0.7 ppm; Bean, snap, edible podded at 0.7 ppm; Bean, sword,
dry seed at 0.3 ppm; Bean, sword, edible podded at 0.7 ppm; Bean,
tepary, dry seed at 0.3 ppm; Bean, urd, dry seed at 0.3 ppm; Bean, urd,
edible podded at 0.7 ppm; Bean, wax, edible podded at 0.7 ppm; Bean,
wax, succulent shelled at 0.7 ppm; Bean, yardlong, dry seed at 0.3 ppm;
Bean, yardlong, edible podded at 0.7 ppm; Bean, yellow, dry seed at 0.3
ppm; Chickpea, dry seed at 0.1 ppm; Chickpea, edible podded at 2 ppm;
Chickpea, succulent shelled at 0.05 ppm; Cowpea, dry seed at 0.3 ppm;
Cowpea, edible podded at 0.7 ppm; Cowpea, forage at 15 ppm; Cowpea, hay
at 80 ppm; Cowpea, succulent shelled at 0.7 ppm; Jackbean, dry seed at
0.3 ppm; Jackbean, edible podded at 0.7 ppm; Jackbean, succulent
shelled at 0.7 ppm; Lentil, dry seed at 0.1 ppm; Lentil, edible podded
at 2 ppm; Lentil, succulent shelled at 0.05 ppm; Longbean, Chinese, dry
seed at 0.3 ppm; Longbean, Chinese, edible podded at 0.7 ppm; Lupin,
Andean, dry seed at 0.3 ppm; Lupin, Andean, succulent shelled
[[Page 57619]]
at 0.7 ppm; Lupin, blue, dry seed at 0.3 ppm; Lupin, blue, succulent
shelled at 0.7 ppm; Lupin, grain, dry seed at 0.3 ppm; Lupin, grain,
succulent shelled at 0.7 ppm; Lupin, sweet, dry seed at 0.3 ppm; Lupin,
sweet, succulent shelled at 0.7 ppm; Lupin, white sweet, dry seed at
0.3 ppm; Lupin, white sweet, succulent shelled at 0.7 ppm; Lupin,
white, dry seed at 0.3 ppm; Lupin, white, succulent shelled at 0.7 ppm;
Lupin, yellow, dry seed at 0.3 ppm; Lupin, yellow, succulent shelled at
0.7 ppm; Pea, blackeyed, dry seed at 0.3 ppm; Pea, blackeyed, succulent
shelled at 0.7 ppm; Pea, crowder, dry seed at 0.3 ppm; Pea, crowder,
succulent shelled at 0.7 ppm; Pea, dry, dry seed at 0.1 ppm; Pea,
dwarf, edible podded at 2 ppm; Pea, English, succulent shelled at 0.05
ppm; Pea, field, dry seed at 0.1 ppm; Pea, field, forage at 15 ppm;
Pea, field, hay at 80 ppm; Pea, garden, dry seed at 0.1 ppm; Pea,
garden, succulent shelled at 0.05 ppm; Pea, grass, dry seed at 0.1 ppm;
Pea, grass, edible podded at 2 ppm; Pea, green, dry seed at 0.1 ppm;
Pea, green, edible podded at 2 ppm; Pea, green, succulent shelled at
0.05 ppm; Pea, pigeon, dry seed at 0.1 ppm; Pea, pigeon, edible podded
at 2 ppm; Pea, pigeon, succulent shelled at 0.05 ppm; Pea, snap, edible
podded at 2 ppm; Pea, snow, edible podded at 2 ppm; Pea, southern, dry
seed at 0.3 ppm; Pea, southern, succulent shelled at 0.7 ppm; Pea,
sugar snap, edible podded at 2 ppm; Pea, winged, dry seed at 0.3 ppm;
Pea, winged, edible podded at 0.7 ppm; Soybean, vegetable, dry seed at
0.3 ppm; Soybean, vegetable, edible podded at 0.7 ppm; Soybean,
vegetable, succulent shelled at 0.7 ppm; Velvetbean, dry seed at 0.3
ppm; Velvetbean, edible podded at 0.7 ppm; Velvetbean, succulent
shelled at 0.7 ppm.
Additionally, the established tolerances on Bean, dry, seed and
Bean, succulent are removed as unnecessary.
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 to 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: September 15, 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 1 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. 180.598, amend the Table 1 to Paragraph (a) by:
0
a. Adding in alphabetical order the entries ``Bean, adzuki, dry seed'';
``Bean, African yam, dry seed''; ``Bean, American potato, dry seed'';
``Bean, asparagus, dry seed''; ``Bean, asparagus, edible podded'';
``Bean, black, dry seed''; ``Bean, broad, dry seed''; ``Bean, broad,
succulent shelled''; ``Bean, catjang, dry seed''; ``Bean, catjang
edible podded''; ``Bean, catjang, succulent shelled''; ``Bean,
cranberry, dry seed''; and ``Bean, dry bean, dry seed''.
0
b. Removing the entry for ``Bean, dry, seed''.
0
c. Adding in alphabetical order the entries ``Bean, field, dry seed'';
``Bean, French, dry seed''; ``Bean, French, edible podded''; ``Bean,
garden, dry seed''; ``Bean, garden, edible podded''; ``Bean, goa, dry
seed''; ``Bean, goa, edible podded''; ``Bean, goa, succulent shelled'';
``Bean, great northern, dry seed''; ``Bean, green, dry seed''; ``Bean,
green, edible podded''; ``Bean, guar, dry seed''; ``Bean, guar, edible
podded''; ``Bean, horse gram, dry seed''; ``Bean, kidney, dry seed'';
``Bean, kidney, edible podded''; ``Bean, lablab, dry seed''; ``Bean,
lablab, edible podded''; ``Bean, lablab, succulent shelled''; ``Bean,
lima, dry seed''; ``Bean, lima, succulent shelled''; ``Bean, morama,
dry seed''; ``Bean, moth, dry seed''; ``Bean, moth, edible podded'';
``Bean, moth, succulent shelled''; ``Bean, mung, dry seed''; ``Bean,
mung, edible podded''; ``Bean, navy, dry seed''; ``Bean, navy, edible
podded''; ``Bean, phaseolus, forage''; ``Bean, phaseolus, hay'';
``Bean, pink, dry seed''; ``Bean, pinto, dry seed''; ``Bean, red, dry
seed''; ``Bean, rice, dry
[[Page 57620]]
seed''; ``Bean, rice, edible podded''; ``Bean, scarlet runner, dry
seed''; ``Bean, scarlet runner, edible podded''; ``Bean, scarlet
runner, succulent shelled''; and ``Bean, snap, edible podded''.
0
d. Removing the entry for ``Bean, succulent''.
0
e. Adding in alphabetical order the entries ``Bean, sword, dry seed'';
``Bean, sword, edible podded''; ``Bean, tepary, dry seed''; ``Bean,
urd, dry seed''; ``Bean, urd, edible podded''; ``Bean, wax, edible
podded''; ``Bean, wax, succulent shelled''; ``Bean, yardlong, dry
seed''; ``Bean, yardlong, edible podded''; ``Bean, yellow, dry seed'';
``Chickpea, dry seed''; ``Chickpea, edible podded''; ``Chickpea,
succulent shelled''; ``Cowpea, dry seed''; ``Cowpea, edible podded'';
``Cowpea, forage''; ``Cowpea, hay''; ``Cowpea, succulent shelled'';
``Jackbean, dry seed''; ``Jackbean, edible podded''; ``Jackbean,
succulent shelled''; ``Lentil, dry seed''; ``Lentil, edible podded'';
``Lentil, succulent shelled''; ``Longbean, Chinese, dry seed'';
``Longbean, Chinese, edible podded''; ``Lupin, Andean, dry seed'';
``Lupin, Andean, succulent shelled''; ``Lupin, blue, dry seed'';
``Lupin, blue, succulent shelled''; ``Lupin, grain, dry seed'';
``Lupin, grain, succulent shelled''; ``Lupin, sweet, dry seed'';
``Lupin, sweet, succulent shelled''; ``Lupin, white sweet, dry seed'';
``Lupin, white sweet, succulent shelled''; ``Lupin, white, dry seed'';
``Lupin, white, succulent shelled''; ``Lupin, yellow, dry seed'';
``Lupin, yellow, succulent shelled''; ``Pea, blackeyed, dry seed'';
``Pea, blackeyed, succulent shelled''; ``Pea, crowder, dry seed'';
``Pea, crowder, succulent shelled''; ``Pea, dry, dry seed''; ``Pea,
dwarf, edible podded''; ``Pea, English, succulent shelled''; ``Pea,
field, dry seed''; ``Pea, field, forage''; ``Pea, field, hay''; ``Pea,
garden, dry seed''; ``Pea, garden, succulent shelled''; ``Pea, grass,
dry seed''; ``Pea, grass, edible podded''; ``Pea, green, dry seed'';
``Pea, green, edible podded''; ``Pea, green, succulent shelled'';
``Pea, pigeon, dry seed''; ``Pea, pigeon, edible podded''; ``Pea,
pigeon, succulent shelled''; ``Pea, snap, edible podded''; ``Pea, snow,
edible podded''; ``Pea, southern, dry seed''; ``Pea, southern,
succulent shelled''; ``Pea, sugar snap, edible podded''; ``Pea, winged,
dry seed''; ``Pea, winged, edible podded''; ``Soybean, vegetable, dry
seed''; ``Soybean, vegetable, edible podded''; ``Soybean, vegetable,
succulent shelled''; ``Velvetbean, dry seed''; ``Velvetbean, edible
podded''; and ``Velvetbean, succulent shelled''.
The additions read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
* * * * *
Bean, adzuki, dry seed........................................ 0.3
Bean, African yam, dry seed................................... 0.3
Bean, American potato, dry seed............................... 0.3
Bean, asparagus, dry seed..................................... 0.3
Bean, asparagus, edible podded................................ 0.7
Bean, black, dry seed......................................... 0.3
Bean, broad, dry seed......................................... 0.3
Bean, broad, succulent shelled................................ 0.7
Bean, catjang, dry seed....................................... 0.3
Bean, catjang edible podded................................... 0.7
Bean, catjang, succulent shelled.............................. 0.7
Bean, cranberry, dry seed..................................... 0.3
Bean, dry bean, dry seed...................................... 0.3
Bean, field, dry seed......................................... 0.3
Bean, French, dry seed........................................ 0.3
Bean, French, edible podded................................... 0.7
Bean, garden, dry seed........................................ 0.3
Bean, garden, edible podded................................... 0.7
Bean, goa, dry seed........................................... 0.3
Bean, goa, edible podded...................................... 0.7
Bean, goa, succulent shelled.................................. 0.7
Bean, great northern, dry seed................................ 0.3
Bean, green, dry seed......................................... 0.3
Bean, green, edible podded.................................... 0.7
Bean, guar, dry seed.......................................... 0.3
Bean, guar, edible podded..................................... 0.7
Bean, horse gram, dry seed.................................... 0.3
Bean, kidney, dry seed........................................ 0.3
Bean, kidney, edible podded................................... 0.7
Bean, lablab, dry seed........................................ 0.3
Bean, lablab, edible podded................................... 0.7
Bean, lablab, succulent shelled............................... 0.7
Bean, lima, dry seed.......................................... 0.3
Bean, lima, succulent shelled................................. 0.7
Bean, morama, dry seed........................................ 0.3
Bean, moth, dry seed.......................................... 0.3
Bean, moth, edible podded..................................... 0.7
Bean, moth, succulent shelled................................. 0.7
Bean, mung, dry seed.......................................... 0.3
Bean, mung, edible podded..................................... 0.7
Bean, navy, dry seed.......................................... 0.3
Bean, navy, edible podded..................................... 0.7
Bean, phaseolus, forage....................................... 15
Bean, phaseolus, hay.......................................... 80
Bean, pink, dry seed.......................................... 0.3
Bean, pinto, dry seed......................................... 0.3
Bean, red, dry seed........................................... 0.3
Bean, rice, dry seed.......................................... 0.3
Bean, rice, edible podded..................................... 0.7
Bean, scarlet runner, dry seed................................ 0.3
Bean, scarlet runner, edible podded........................... 0.7
Bean, scarlet runner, succulent shelled....................... 0.7
Bean, snap, edible podded..................................... 0.7
Bean, sword, dry seed......................................... 0.3
Bean, sword, edible podded.................................... 0.7
Bean, tepary, dry seed........................................ 0.3
Bean, urd, dry seed........................................... 0.3
Bean, urd, edible podded...................................... 0.7
Bean, wax, edible podded...................................... 0.7
Bean, wax, succulent shelled.................................. 0.7
Bean, yardlong, dry seed...................................... 0.3
Bean, yardlong, edible podded................................. 0.7
Bean, yellow, dry seed........................................ 0.3
* * * * *
Chickpea, dry seed............................................ 0.1
Chickpea, edible podded....................................... 2
Chickpea, succulent shelled................................... 0.05
* * * * *
Cowpea, dry seed.............................................. 0.3
Cowpea, edible podded......................................... 0.7
Cowpea, forage................................................ 15
Cowpea, hay................................................... 80
Cowpea, succulent shelled..................................... 0.7
* * * * *
Jackbean, dry seed............................................ 0.3
Jackbean, edible podded....................................... 0.7
Jackbean, succulent shelled................................... 0.7
* * * * *
Lentil, dry seed.............................................. 0.1
Lentil, edible podded......................................... 2
Lentil, succulent shelled..................................... 0.05
Longbean, Chinese, dry seed................................... 0.3
Longbean, Chinese, edible podded.............................. 0.7
Lupin, Andean, dry seed....................................... 0.3
Lupin, Andean, succulent shelled.............................. 0.7
Lupin, blue, dry seed......................................... 0.3
Lupin, blue, succulent shelled................................ 0.7
Lupin, grain, dry seed........................................ 0.3
Lupin, grain, succulent shelled............................... 0.7
Lupin, sweet, dry seed........................................ 0.3
Lupin, sweet, succulent shelled............................... 0.7
Lupin, white sweet, dry seed.................................. 0.3
Lupin, white sweet, succulent shelled......................... 0.7
Lupin, white, dry seed........................................ 0.3
Lupin, white, succulent shelled............................... 0.7
Lupin, yellow, dry seed....................................... 0.3
Lupin, yellow, succulent shelled.............................. 0.7
* * * * *
Pea, blackeyed, dry seed...................................... 0.3
Pea, blackeyed, succulent shelled............................. 0.7
Pea, crowder, dry seed........................................ 0.3
Pea, crowder, succulent shelled............................... 0.7
Pea, dry, dry seed............................................ 0.1
Pea, dwarf, edible podded..................................... 2
Pea, English, succulent shelled............................... 0.05
Pea, field, dry seed.......................................... 0.1
Pea, field, forage............................................ 15
Pea, field, hay............................................... 80
Pea, garden, dry seed......................................... 0.1
Pea, garden, succulent shelled................................ 0.05
Pea, grass, dry seed.......................................... 0.1
Pea, grass, edible podded..................................... 2
Pea, green, dry seed.......................................... 0.1
Pea, green, edible podded..................................... 2
Pea, green, succulent shelled................................. 0.05
Pea, pigeon, dry seed......................................... 0.1
Pea, pigeon, edible podded.................................... 2
Pea, pigeon, succulent shelled................................ 0.05
Pea, snap, edible podded...................................... 2
Pea, snow, edible podded...................................... 2
Pea, southern, dry seed....................................... 0.3
Pea, southern, succulent shelled.............................. 0.7
Pea, sugar snap, edible podded................................ 2
Pea, winged, dry seed......................................... 0.3
Pea, winged, edible podded.................................... 0.7
* * * * *
Soybean, vegetable, dry seed.................................. 0.3
Soybean, vegetable, edible podded............................. 0.7
Soybean, vegetable, succulent shelled......................... 0.7
* * * * *
Velvetbean, dry seed.......................................... 0.3
Velvetbean, edible podded..................................... 0.7
Velvetbean, succulent shelled................................. 0.7
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-20332 Filed 9-20-22; 8:45 am]
BILLING CODE 6560-50-P
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