Mefenoxam; Pesticide Tolerances, 39185-39189 [2023-12544]
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Federal Register / Vol. 88, No. 115 / Thursday, June 15, 2023 / Rules and Regulations
States Court of Appeals for the
appropriate circuit by August 14, 2023.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements (see section
307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Nitrogen
oxides, Ozone, Reporting and
recordkeeping requirements.
For the reasons stated in the
preamble, the Environmental Protection
Agency amends part 52, chapter I, title
40 of the Code of Federal Regulations as
follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
adding paragraphs (c)(194)(i)(B)(5) and
(c)(518)(i)(F) to read as follows:
■
Identification of plan—in part.
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(i) * * *
(B) * * *
(5) Previously approved on March 1,
1996, in paragraph (c)(194)(1)(B)(2) of
this section and now deleted with
replacement in (c)(518)(i)(F)(1): Rule
425, adopted on August 16, 1993.
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(518) * * *
(i) * * *
(F) Eastern Kern Air Pollution Control
District.
(1) Rule 425, ‘‘Stationary Gas
Turbines (Oxides of Nitrogen),’’
amended on January 11, 2018.
(2) [Reserved]
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[FR Doc. 2023–12635 Filed 6–14–23; 8:45 am]
BILLING CODE 6560–50–P
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40 CFR Part 180
[EPA–HQ–OPP–2022–0493; FRL–10992–01–
OCSPP]
Mefenoxam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of mefenoxam in
or on multiple commodities identified
and discussed in this document.
Syngenta Crop Protection, LLC.
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective June
15, 2023. Objections and requests for
hearings must be received on or before
August 14, 2023, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
Dated: June 7, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.
§ 52.220
ENVIRONMENTAL PROTECTION
AGENCY
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0493, 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 the OPP
Docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, 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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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
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39185
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 Federal Register Office’s e-CFR site
at https://www.ecfr.gov/cgi-bin/textidx?&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–2022–0493 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 August 14, 2023. 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–
2022–0493, 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.
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• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 30,
2022 (87 FR 52868) (FRL–9410–04),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petitions (PP 1F8970 and
1F8971) by Syngenta Crop Protection,
LLC., P.O. Box 18300, Greensboro, NC
27419. The petition requested that 40
CFR part 180 be amended by
establishing tolerances for residues of
the fungicide, mefenoxam, (methyl N(2,6-dimethylphenyl)-N(methoxyacetyl)-D-alaninate), in or on
leafy greens subgroup 4–16A (except
spinach) at 5 parts per million (ppm);
Brassica leafy greens subgroup 4–16B at
5 ppm; Brassica head and stem
vegetable crop group 5–16 at 2 ppm;
stalk and stem vegetable subgroup 22A
(except celtuce, florence fennel and
kohlrabi) at 7 ppm; celtuce at 5 ppm;
florence fennel at 5 ppm; kohlrabi at 2
ppm; leaf petiole vegetable subgroup
22B at 5 ppm; fruiting vegetables
subgroup 8–10 at 1 ppm; succulent
shelled pea and bean crop subgroup 6B
at 0.2 ppm; cottonseed crop subgroup
20C at 0.1 ppm; and sugarcane at 0.1
ppm (PP 1F8971). That document
referenced a summary of the petition
prepared by Syngenta Crop Protection,
LLC., the registrant, which is available
in the docket, https://
www.regulations.gov. Two comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
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
establishing the tolerances at different
levels than requested. The reasons for
these changes are explained in Unit
IV.D.
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
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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 mefenoxam
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with mefenoxam follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections of the
rule that repeat what has been
previously published in 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 a
number of tolerance rulemakings for
mefenoxam in which EPA concluded,
based on the available information, that
there is a reasonable certainty that no
harm would result from aggregate
exposure to mefenoxam and established
tolerances for residues of that chemical.
EPA is incorporating previously
published sections from those
rulemakings as described further in this
rule, as they remain unchanged.
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
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subgroups of consumers, including
infants and children.
Mefenoxam (metalaxyl-m) is a
systemic phenylamide fungicide which
inhibits protein synthesis in fungi.
Mefenoxam is an R-isomer enriched
formulation. Metalaxyl is the racemic R/
S isomer formulation. The Agency
compared the available chemistry and
toxicity data for mefenoxam and
metalaxyl and concluded that metalaxyl
data may be used in support of
mefenoxam regulatory actions because
the two chemicals have similar toxicity.
Specific information on the studies
received and the nature of the adverse
effects caused by mefenoxam as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in Unit
III.A. of the final rule published in the
Federal Register of December 21, 2018
(83 FR 65541) (FRL–9985–52).
B. Toxicological Points of Departure/
Levels of Concern
A summary of the toxicological
endpoints for mefenoxam used for
human health risk assessment is
discussed in Unit III.B. of the final rule
published in the Federal Register of
December 21, 2018 (83 FR 65541) (FRL–
9985–52).
C. Exposure Assessment
Much of the exposure assessment
remains the same although updates have
occurred to accommodate exposures
from petitioned-for tolerances. These
updates are discussed in this section; for
a description of the rest of the EPA
approach to and assumptions for the
exposure assessment, please reference
Unit III.C of the December 2018
rulemaking.
1. Dietary exposure from food and
feed uses. EPA’s dietary exposure
assessments have been updated to
include the additional exposure from
the petitioned-for tolerances of
mefenoxam on the crops requested in
this action. In evaluating dietary
exposure to mefenoxam, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing mefenoxam and metalaxyl
tolerances in 40 CFR 180.546 and 40
CFR 180.408, respectively.
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. The acute dietary assessment
is based on tolerance levels adjusted to
account for all of the residues of
concern and assumes 100 percent crop
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treated (PCT). The assessment was
conducted using the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM–FCID) Version 4.02. EPA with
2005–2010 food consumption
information from the United States
Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). Empirical
processing factors were included where
available. Otherwise, DEEM–FCID
default processing factors were used.
ii. Chronic exposure. There is no
increase in toxicity from the acute
duration studies. Toxicity did not
increase with an increase in exposure
duration. Therefore, a chronic dietary
POD was not selected. The acute
endpoint and dietary exposure
assessment are protective of potential
effects from chronic duration dietary
exposures.
iii. Cancer. EPA has concluded that
mefenoxam does not pose a cancer risk
to humans based on no evidence of
carcinogenicity observed in the relevant
studies. Therefore, a dietary exposure
assessment for the purpose of assessing
cancer risk is unnecessary.
2. Dietary exposure from drinking
water. Exposure modeling for
mefenoxam is not necessary because
exposure estimates for metalaxyl are
expected to exceed those for mefenoxam
and are therefore protective. Maximum
annual application rates for metalaxyl,
up to 12.3 lb ai/A, were modeled. These
rates are approximately twice those of
mefenoxam. The maximum estimated
drinking water concentrations (EDWCs)
based on metalaxyl are 350 mg/L for
acute exposure (which is based on
surface water sources) and 135 mg/L for
chronic exposure (which is based on
groundwater sources).
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). There are
no uses for mefenoxam being proposed
as part of this action or that have been
added since the most recent risk
assessment that would impact the
residential (non-occupational) or
residential post-application exposure
and risk estimates found in the most
recent risk assessment of mefenoxam;
therefore, EPA relied on the previously
assessed residential exposure for
assessing aggregate risk.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
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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
mefenoxam and metalaxyl with any
other substances and mefenoxam and
metalaxyl do not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
action, therefore, EPA has not assumed
that mefenoxam and metalaxyl have a
common mechanism of toxicity with
other substances.
D. 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 to 1X. See Unit
III.D. of the December 2018 rulemaking
for a discussion of the Agency’s
rationale for that determination.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing dietary exposure
estimates to the aPAD and chronic
population-adjusted dose (cPAD).
Short-, intermediate-, and chronic-term
aggregate risks are evaluated by
comparing the estimated total aggregate
food, water, and residential exposure to
the appropriate points of departure
(PODs) to ensure that an adequate
margin of exposure (MOE) exists.
1. Acute risk. The acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water is 27% of the acute
population-adjusted dose (aPAD) for the
general U.S. population, and 56% of the
aPAD for the highest exposed
population group, children 1–2 years
old. Because these levels are below the
Agency’s level of concern (LOC) of
100% of the aPAD, the Agency
concludes that aggregate exposure to
mefenoxam will not pose an acute risk.
2. Chronic risk. No hazard endpoint
was selected for chronic dietary
exposure for mefenoxam; therefore, a
chronic aggregate assessment was not
warranted. However, chronic dietary
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exposure was estimated for inclusion in
the aggregate analysis.
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). Mefenoxam 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
mefenoxam.
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 aggregate
MOEs of 270 for children 1–2, the most
highly exposed group. Because EPA’s
level of concern for mefenoxam is 100,
which means any MOE below 100 may
indicate risks of concern, this MOE is
not of concern.
4. Intermediate-term risk. There are
no intermediate-term residential
exposures for mefenoxam, and therefore
an intermediate-term aggregate exposure
assessment was not warranted.
5. Aggregate cancer risk for U.S.
population. Mefenoxam is classified as
‘‘not likely to be carcinogenic to
humans’’, therefore, EPA concludes that
exposure to mefenoxam will not pose an
aggregate cancer risk.
6. Determination of safety. Therefore,
based on the risk assessments and
information described above, 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
mefenoxam residues. More detailed
information on this action can be found
in the document titled ‘‘Metalaxyl,
Mefenoxam (Metalaxyl-M). Human
Health Risk Assessment for the Petition
for Amendment of Tolerances for
Residues in/on Leafy Greens Subgroup,
4–16A (Except Spinach), and Brassica
Leafy Greens Subgroup 4–16B; Brassica
Head and Stem Vegetable Crop Group
5–16; Expansions of Crop Tolerances to
Stalk and Stem Vegetable Subgroup 22A
and Leaf Petiole Vegetable Subgroup
22B; Fruiting Vegetables Crop Group 8–
10; Succulent Shelled Pea & Bean
Subgroup 6B; and Cottonseed Crop
Subgroup 20C. Establishment of an
Inadvertent Tolerance for Residues in/
on Sugarcane.’’ in docket ID number
EPA–HQ–OPP–2022–0493.
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IV. Other Considerations
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A. Analytical Enforcement Methodology
For a discussion of the available
enforcement analytical methods, see
Unit IV.A. of the December 21, 2018,
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 Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
While Codex has not established
MRLs for mefenoxam, it has established
tolerances for residues of metalaxyl.
Since compliance with U.S. tolerances
for mefenoxam is determined by
measuring metalaxyl residues, EPA is
evaluating harmonization of the
mefenoxam tolerances by comparing to
the metalaxyl MRLs. Codex has not
established MRLs for metalaxyl for leafy
greens, subgroup 4–16A; Brassica leafy
greens, subgroup 4–16B; stalk and stem
vegetable, subgroup 22A; leaf petiole
vegetable, subgroup 22B; fruiting
vegetables, group 8–10; succulent
shelled pea and bean, subgroup 6B and
sugarcane; thus, harmonization with
Codex is not an issue for these
commodities and groups/subgroups.
Codex has established MRLs for
metalaxyl on several members of the
Brassica head & stem vegetable, group
5–16: 2 ppm for Chinese cabbage and
cauliflower (members of Brassica (cole)
leafy vegetables group 5–16) and 0.5
ppm for residues in/on broccoli,
cabbage, and Brussels sprouts (members
of Brassica (cole) leafy vegetables group
5–16). EPA’s tolerance for group 5–16 is
harmonized with the higher Codex MRL
for commodities in this group. Codex
has an MRL for residues in/on
cottonseed at 0.05 ppm while the U.S.
tolerance is set at 0.1 ppm. EPA is not
harmonizing since the lower tolerance
level may result in residues exceeding
the tolerance from application
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consistent with approved labeling;
however, this does not create a barrier
to import as the US tolerance is
inclusive of the Codex MRL.
C. Response to Comments
Two comments were received in
response to the notice of filing. One
comment was received from an
anonymous commenter applauding the
government’s process to petition for
new uses. The second comment argued
against the use of mefenoxam on greens
and expressed concern about the overall
toxicity of pesticides. The commenter
has provided no information that would
support a determination that these
tolerances are unsafe. Although the
Agency recognizes that some
individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by FFDCA section 408 authorizes EPA
to establish tolerances when it
determines that the tolerance is safe.
Upon consideration of the validity,
completeness, and reliability of the
available data as well as other factors
the FFDCA requires EPA to consider,
EPA has determined that these
mefenoxam tolerances are safe. The
commenter has provided no information
supporting a contrary conclusion.
D. Revisions to Petitioned-For
Tolerances
EPA is establishing the tolerance on
Leafy vegetable, Crop Group 4–16
(except spinach) at 5 ppm rather than
the petitioned-for Leafy Greens
Subgroup 4–16A (except spinach) and
Brassica Leafy Greens Subgroup 4–16B.
The entire crop group 4–16 is inclusive
of both subgroups. Additionally, the
Agency is not establishing separate
tolerances for Celtuce, Florence fennel
and Kohlrabi and excepting them from
Stalk and Stem Vegetable Subgroup
22A. The proposed tolerance of 7 ppm
for Stalk and Stem Vegetable Subgroup
22A is greater than the proposed
tolerances of 5, 5, and 2 ppm, for
celtuce, Florence fennel, and kohlrabi
respectively, and is therefore inclusive
of these tolerances. Lastly, because the
final Phase VI crop group rule has been
published, the commodity definition for
Succulent Shelled Pea and Bean Crop
Subgroup 6B has been revised to be
Vegetable, legume, bean, succulent
shelled, subgroup 6–22C and Vegetable,
legume, pea, succulent shelled,
subgroup 6–22D. The Phase VI crop
group rule was published on September
21, 2022, and was effective on
November 21, 2022 (87 FR 57627) (FRL–
5031–13–OCSPP).
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V. Conclusion
Therefore, tolerances are established
for residues of mefenoxam, [methyl N(2,6-dimethylphenyl)-N(methoxyacetyl)-D-alaninate], in or on
Cottonseed, subgroup 20C at 0.1 ppm;
Leaf petiole, subgroup 22B at 5 ppm;
Leafy Vegetable, Crop Group 4–16
(except spinach) at 5 ppm; Sugarcane at
0.1 ppm; Vegetable, Brassica, head and
stem, group 5–16 at 2 ppm; Vegetable,
fruiting, group 8–10 at 1 ppm;
Vegetable, legume, bean, succulent
shelled, subgroup 6–22C at 0.2 ppm;
Vegetable, legume, pea, succulent
shelled, subgroup 6–22D at 0.2 ppm;
Vegetable, stalk and stem, subgroup 22A
at 7 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the 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
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Federal Register / Vol. 88, No. 115 / Thursday, June 15, 2023 / Rules and Regulations
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: May 25, 2023.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
lotter on DSK11XQN23PROD with RULES1
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.546:
a. In paragraph (a) amend table 1 by
adding entries for the commodities
‘‘Cottonseed, subgroup 20C’’, ‘‘Leaf
petiole, subgroup 22B’’, ‘‘Leafy
Vegetable, Crop Group 4–16 (except
VerDate Sep<11>2014
16:27 Jun 14, 2023
Jkt 259001
(a) * * *
TABLE 1 TO PARAGRAPH (a)
*
Parts per
million
Commodity
Cottonseed, subgroup 20C .....................
Parts per
million
*
5
0.01
*
*
*
*
1 There are no US registrations as of December 23, 2014.
*
*
*
*
*
[FR Doc. 2023–12936 Filed 6–14–23; 8:45 am]
2
1
BILLING CODE 0099–10–P
0.2
0.2
7
*
*
*
*
*
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent residues of mefenoxam in
or on the food commodities when
present therein as a result of the
application of mefenoxam to growing
crops listed in paragraph (a) of this
section and other non-food crops to read
as follows:
TABLE 2 TO PARAGRAPH (d)
AGENCY FOR INTERNATIONAL
DEVELOPMENT
48 CFR Parts 726, 729, 731, and 752
RIN 0412–AB04
Acquisition Regulation: Foreign Tax
Reporting, Conference Planning, and
Trade and Investment Activities
U.S. Agency for International
Development.
ACTION: Final rule.
AGENCY:
The United States Agency for
International Development (USAID) is
amending its Acquisition Regulation
(AIDAR) regarding contractor
requirements on foreign tax reporting,
conference planning, and trade and
investment activities. These revisions
are intended to bring the AIDAR into
compliance with revised Agency
policies and procedures and statutory
requirements.
SUMMARY:
Commodity
Parts per
million
Sugarcane ....................................
0.1
DATES:
Effective July 17, 2023.
FOR FURTHER INFORMATION CONTACT:
Tolerances and Exemptions for
Pesticide Chemical Residues in Food
CFR Correction
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
Fmt 4700
*
5
*
*
*
*
*
Vegetable, Brassica, head and stem,
group 5–16 ...........................................
Vegetable, fruiting, group 8–10 ...............
Vegetable, legume, bean, succulent
shelled, subgroup 6–22C .....................
Vegetable, legume, pea, succulent
shelled, subgroup 6–22D .....................
Vegetable, stalk and stem, subgroup
22A .......................................................
Frm 00073
*
Pepper/eggplant, subgroup 8–
10B1 ........................................
*
*
*
*
*
*
Leaf petiole, subgroup 22B .....................
Leafy Vegetable, Crop Group 4–16 (except spinach) .......................................
PO 00000
*
0.1
40 CFR Part 180
1. The authority citation for part 180
continues to read as follows:
§ 180.415 Aluminum tris (Oethylphosphonate); tolerances for residues.
Commodity
ENVIRONMENTAL PROTECTION
AGENCY
■
In Title 40 of the Code of Federal
Regulations, Parts 150 to 189, revised as
of July 1, 2022, in section 180.415, in
the table to paragraph (a), revise the
entry for ‘‘Pepper/eggplant, subgroup 8–
10’’ to add a footnote to read as follows:
■
(a) * * *
BILLING CODE 6560–50–P
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
revision of the Code of Federal
Regulations.
§ 180.546 Mefenoxam; tolerances for
residues.
[FR Doc. 2023–12544 Filed 6–14–23; 8:45 am]
Therefore, 40 CFR chapter I is
amended as follows:
■
■
spinach)’’, ‘‘Vegetable, Brassica, head
and stem, group 5–16’’, ‘‘Vegetable,
fruiting, group 8–10’’, ‘‘Vegetable,
legume, bean, succulent shelled,
subgroup 6–22C’’, ‘‘Vegetable, legume,
pea, succulent shelled, subgroup 6–
22D’’, ‘‘Vegetable, stalk and stem,
subgroup 22A’’, in alphabetical order;
and
■ b. Revise paragraph (d).
The additions and revision read as
follows:
Sfmt 4700
Kelly Miskowski, USAID M/OAA/P, at
202–916–2752 or policymailbox@
usaid.gov for clarification of content or
information pertaining to status or
publication schedules. All inquiries
regarding this rule must cite RIN No.
0412–AB04.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15JNR1.SGM
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Agencies
[Federal Register Volume 88, Number 115 (Thursday, June 15, 2023)]
[Rules and Regulations]
[Pages 39185-39189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12544]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0493; FRL-10992-01-OCSPP]
Mefenoxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
mefenoxam in or on multiple commodities identified and discussed in
this document. Syngenta Crop Protection, LLC. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 15, 2023. Objections and
requests for hearings must be received on or before August 14, 2023,
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-2022-0493, 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 the OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, 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:
[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 Federal Register
Office's e-CFR site at https://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-2022-0493 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
August 14, 2023. 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-2022-0493, 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.
[[Page 39186]]
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 30, 2022 (87 FR 52868) (FRL-9410-
04), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP
1F8970 and 1F8971) by Syngenta Crop Protection, LLC., P.O. Box 18300,
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the fungicide,
mefenoxam, (methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-D-
alaninate), in or on leafy greens subgroup 4-16A (except spinach) at 5
parts per million (ppm); Brassica leafy greens subgroup 4-16B at 5 ppm;
Brassica head and stem vegetable crop group 5-16 at 2 ppm; stalk and
stem vegetable subgroup 22A (except celtuce, florence fennel and
kohlrabi) at 7 ppm; celtuce at 5 ppm; florence fennel at 5 ppm;
kohlrabi at 2 ppm; leaf petiole vegetable subgroup 22B at 5 ppm;
fruiting vegetables subgroup 8-10 at 1 ppm; succulent shelled pea and
bean crop subgroup 6B at 0.2 ppm; cottonseed crop subgroup 20C at 0.1
ppm; and sugarcane at 0.1 ppm (PP 1F8971). That document referenced a
summary of the petition prepared by Syngenta Crop Protection, LLC., the
registrant, which is available in the docket, https://www.regulations.gov. Two comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
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 establishing the tolerances at different levels than requested. The
reasons for these changes are explained in Unit IV.D.
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 mefenoxam including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with mefenoxam follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that repeat what
has been previously published in 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 a number of tolerance rulemakings for
mefenoxam in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to mefenoxam and established tolerances for residues
of that chemical. EPA is incorporating previously published sections
from those rulemakings as described further in this rule, as they
remain unchanged.
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.
Mefenoxam (metalaxyl-m) is a systemic phenylamide fungicide which
inhibits protein synthesis in fungi. Mefenoxam is an R-isomer enriched
formulation. Metalaxyl is the racemic R/S isomer formulation. The
Agency compared the available chemistry and toxicity data for mefenoxam
and metalaxyl and concluded that metalaxyl data may be used in support
of mefenoxam regulatory actions because the two chemicals have similar
toxicity.
Specific information on the studies received and the nature of the
adverse effects caused by mefenoxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are discussed in Unit III.A. of the
final rule published in the Federal Register of December 21, 2018 (83
FR 65541) (FRL-9985-52).
B. Toxicological Points of Departure/Levels of Concern
A summary of the toxicological endpoints for mefenoxam used for
human health risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of December 21, 2018 (83 FR
65541) (FRL-9985-52).
C. Exposure Assessment
Much of the exposure assessment remains the same although updates
have occurred to accommodate exposures from petitioned-for tolerances.
These updates are discussed in this section; for a description of the
rest of the EPA approach to and assumptions for the exposure
assessment, please reference Unit III.C of the December 2018
rulemaking.
1. Dietary exposure from food and feed uses. EPA's dietary exposure
assessments have been updated to include the additional exposure from
the petitioned-for tolerances of mefenoxam on the crops requested in
this action. In evaluating dietary exposure to mefenoxam, EPA
considered exposure under the petitioned-for tolerances as well as all
existing mefenoxam and metalaxyl tolerances in 40 CFR 180.546 and 40
CFR 180.408, respectively.
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. The acute dietary assessment
is based on tolerance levels adjusted to account for all of the
residues of concern and assumes 100 percent crop
[[Page 39187]]
treated (PCT). The assessment was conducted using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID) Version 4.02. EPA with 2005-2010 food consumption
information from the United States Department of Agriculture's (USDA's)
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA). Empirical processing factors were included
where available. Otherwise, DEEM-FCID default processing factors were
used.
ii. Chronic exposure. There is no increase in toxicity from the
acute duration studies. Toxicity did not increase with an increase in
exposure duration. Therefore, a chronic dietary POD was not selected.
The acute endpoint and dietary exposure assessment are protective of
potential effects from chronic duration dietary exposures.
iii. Cancer. EPA has concluded that mefenoxam does not pose a
cancer risk to humans based on no evidence of carcinogenicity observed
in the relevant studies. Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
2. Dietary exposure from drinking water. Exposure modeling for
mefenoxam is not necessary because exposure estimates for metalaxyl are
expected to exceed those for mefenoxam and are therefore protective.
Maximum annual application rates for metalaxyl, up to 12.3 lb ai/A,
were modeled. These rates are approximately twice those of mefenoxam.
The maximum estimated drinking water concentrations (EDWCs) based on
metalaxyl are 350 [mu]g/L for acute exposure (which is based on surface
water sources) and 135 [micro]g/L for chronic exposure (which is based
on groundwater sources).
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). There are no uses for
mefenoxam being proposed as part of this action or that have been added
since the most recent risk assessment that would impact the residential
(non-occupational) or residential post-application exposure and risk
estimates found in the most recent risk assessment of mefenoxam;
therefore, EPA relied on the previously assessed residential exposure
for assessing aggregate risk.
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 mefenoxam and metalaxyl
with any other substances and mefenoxam and metalaxyl do not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this action, therefore, EPA has not assumed that mefenoxam
and metalaxyl have a common mechanism of toxicity with other
substances.
D. 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
to 1X. See Unit III.D. of the December 2018 rulemaking for a discussion
of the Agency's rationale for that determination.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the aPAD
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and
chronic-term aggregate risks are evaluated by comparing the estimated
total aggregate food, water, and residential exposure to the
appropriate points of departure (PODs) to ensure that an adequate
margin of exposure (MOE) exists.
1. Acute risk. The acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water is
27% of the acute population-adjusted dose (aPAD) for the general U.S.
population, and 56% of the aPAD for the highest exposed population
group, children 1-2 years old. Because these levels are below the
Agency's level of concern (LOC) of 100% of the aPAD, the Agency
concludes that aggregate exposure to mefenoxam will not pose an acute
risk.
2. Chronic risk. No hazard endpoint was selected for chronic
dietary exposure for mefenoxam; therefore, a chronic aggregate
assessment was not warranted. However, chronic dietary exposure was
estimated for inclusion in the aggregate analysis.
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). Mefenoxam 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 mefenoxam.
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 aggregate MOEs of 270 for children
1-2, the most highly exposed group. Because EPA's level of concern for
mefenoxam is 100, which means any MOE below 100 may indicate risks of
concern, this MOE is not of concern.
4. Intermediate-term risk. There are no intermediate-term
residential exposures for mefenoxam, and therefore an intermediate-term
aggregate exposure assessment was not warranted.
5. Aggregate cancer risk for U.S. population. Mefenoxam is
classified as ``not likely to be carcinogenic to humans'', therefore,
EPA concludes that exposure to mefenoxam will not pose an aggregate
cancer risk.
6. Determination of safety. Therefore, based on the risk
assessments and information described above, 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
mefenoxam residues. More detailed information on this action can be
found in the document titled ``Metalaxyl, Mefenoxam (Metalaxyl-M).
Human Health Risk Assessment for the Petition for Amendment of
Tolerances for Residues in/on Leafy Greens Subgroup, 4-16A (Except
Spinach), and Brassica Leafy Greens Subgroup 4-16B; Brassica Head and
Stem Vegetable Crop Group 5-16; Expansions of Crop Tolerances to Stalk
and Stem Vegetable Subgroup 22A and Leaf Petiole Vegetable Subgroup
22B; Fruiting Vegetables Crop Group 8-10; Succulent Shelled Pea & Bean
Subgroup 6B; and Cottonseed Crop Subgroup 20C. Establishment of an
Inadvertent Tolerance for Residues in/on Sugarcane.'' in docket ID
number EPA-HQ-OPP-2022-0493.
[[Page 39188]]
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available enforcement analytical methods,
see Unit IV.A. of the December 21, 2018, 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 Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
While Codex has not established MRLs for mefenoxam, it has
established tolerances for residues of metalaxyl. Since compliance with
U.S. tolerances for mefenoxam is determined by measuring metalaxyl
residues, EPA is evaluating harmonization of the mefenoxam tolerances
by comparing to the metalaxyl MRLs. Codex has not established MRLs for
metalaxyl for leafy greens, subgroup 4-16A; Brassica leafy greens,
subgroup 4-16B; stalk and stem vegetable, subgroup 22A; leaf petiole
vegetable, subgroup 22B; fruiting vegetables, group 8-10; succulent
shelled pea and bean, subgroup 6B and sugarcane; thus, harmonization
with Codex is not an issue for these commodities and groups/subgroups.
Codex has established MRLs for metalaxyl on several members of the
Brassica head & stem vegetable, group 5-16: 2 ppm for Chinese cabbage
and cauliflower (members of Brassica (cole) leafy vegetables group 5-
16) and 0.5 ppm for residues in/on broccoli, cabbage, and Brussels
sprouts (members of Brassica (cole) leafy vegetables group 5-16). EPA's
tolerance for group 5-16 is harmonized with the higher Codex MRL for
commodities in this group. Codex has an MRL for residues in/on
cottonseed at 0.05 ppm while the U.S. tolerance is set at 0.1 ppm. EPA
is not harmonizing since the lower tolerance level may result in
residues exceeding the tolerance from application consistent with
approved labeling; however, this does not create a barrier to import as
the US tolerance is inclusive of the Codex MRL.
C. Response to Comments
Two comments were received in response to the notice of filing. One
comment was received from an anonymous commenter applauding the
government's process to petition for new uses. The second comment
argued against the use of mefenoxam on greens and expressed concern
about the overall toxicity of pesticides. The commenter has provided no
information that would support a determination that these tolerances
are unsafe. Although the Agency recognizes that some individuals
believe that pesticides should be banned on agricultural crops, the
existing legal framework provided by FFDCA section 408 authorizes EPA
to establish tolerances when it determines that the tolerance is safe.
Upon consideration of the validity, completeness, and reliability of
the available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that these mefenoxam tolerances are safe.
The commenter has provided no information supporting a contrary
conclusion.
D. Revisions to Petitioned-For Tolerances
EPA is establishing the tolerance on Leafy vegetable, Crop Group 4-
16 (except spinach) at 5 ppm rather than the petitioned-for Leafy
Greens Subgroup 4-16A (except spinach) and Brassica Leafy Greens
Subgroup 4-16B. The entire crop group 4-16 is inclusive of both
subgroups. Additionally, the Agency is not establishing separate
tolerances for Celtuce, Florence fennel and Kohlrabi and excepting them
from Stalk and Stem Vegetable Subgroup 22A. The proposed tolerance of 7
ppm for Stalk and Stem Vegetable Subgroup 22A is greater than the
proposed tolerances of 5, 5, and 2 ppm, for celtuce, Florence fennel,
and kohlrabi respectively, and is therefore inclusive of these
tolerances. Lastly, because the final Phase VI crop group rule has been
published, the commodity definition for Succulent Shelled Pea and Bean
Crop Subgroup 6B has been revised to be Vegetable, legume, bean,
succulent shelled, subgroup 6-22C and Vegetable, legume, pea, succulent
shelled, subgroup 6-22D. The Phase VI crop group rule was published on
September 21, 2022, and was effective on November 21, 2022 (87 FR
57627) (FRL-5031-13-OCSPP).
V. Conclusion
Therefore, tolerances are established for residues of mefenoxam,
[methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-D-alaninate], in or on
Cottonseed, subgroup 20C at 0.1 ppm; Leaf petiole, subgroup 22B at 5
ppm; Leafy Vegetable, Crop Group 4-16 (except spinach) at 5 ppm;
Sugarcane at 0.1 ppm; Vegetable, Brassica, head and stem, group 5-16 at
2 ppm; Vegetable, fruiting, group 8-10 at 1 ppm; Vegetable, legume,
bean, succulent shelled, subgroup 6-22C at 0.2 ppm; Vegetable, legume,
pea, succulent shelled, subgroup 6-22D at 0.2 ppm; Vegetable, stalk and
stem, subgroup 22A at 7 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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
[[Page 39189]]
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: May 25, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended 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. 180.546:
0
a. In paragraph (a) amend table 1 by adding entries for the commodities
``Cottonseed, subgroup 20C'', ``Leaf petiole, subgroup 22B'', ``Leafy
Vegetable, Crop Group 4-16 (except spinach)'', ``Vegetable, Brassica,
head and stem, group 5-16'', ``Vegetable, fruiting, group 8-10'',
``Vegetable, legume, bean, succulent shelled, subgroup 6-22C'',
``Vegetable, legume, pea, succulent shelled, subgroup 6-22D'',
``Vegetable, stalk and stem, subgroup 22A'', in alphabetical order; and
0
b. Revise paragraph (d).
The additions and revision read as follows:
Sec. 180.546 Mefenoxam; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cottonseed, subgroup 20C..................................... 0.1
* * * * *
Leaf petiole, subgroup 22B................................... 5
Leafy Vegetable, Crop Group 4-16 (except spinach)............ 5
* * * * *
Vegetable, Brassica, head and stem, group 5-16............... 2
Vegetable, fruiting, group 8-10.............................. 1
Vegetable, legume, bean, succulent shelled, subgroup 6-22C... 0.2
Vegetable, legume, pea, succulent shelled, subgroup 6-22D.... 0.2
Vegetable, stalk and stem, subgroup 22A...................... 7
------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of mefenoxam in or on the food
commodities when present therein as a result of the application of
mefenoxam to growing crops listed in paragraph (a) of this section and
other non-food crops to read as follows:
Table 2 to Paragraph (d)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Sugarcane................................................... 0.1
------------------------------------------------------------------------
[FR Doc. 2023-12544 Filed 6-14-23; 8:45 am]
BILLING CODE 6560-50-P