Ethalfluralin; Pesticide Tolerances, 21107-21111 [2023-07456]
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001), or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999), and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000), do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 31, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend table 1 to
180.920, by revising the entry for
‘‘Acetophenone’’ to read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
*
Acetophenone (CAS Reg. No. 98–86–2) .......................................................
........................
*
*
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2021–0130 and EPA–HQ–
OPP–2021–0555; FRL–10449–01–OCSPP]
Ethalfluralin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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This regulation is effective April
10, 2023. Objections and requests for
hearings must be received on or before
June 9, 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).
The dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2021–0130 and
EPA–HQ–OPP–2021–0555, are available
at https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
ADDRESSES:
This regulation establishes
tolerances for residues of ethalfluralin
in or on multiple crops that are
referenced later in this document. The
Interregional Research Project Number 4
16:14 Apr 07, 2023
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Attractant, solvent, co-solvent.
DATES:
40 CFR Part 180
VerDate Sep<11>2014
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(IR–4) and Gowan Company LLC.,
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
[FR Doc. 2023–07459 Filed 4–7–23; 8:45 am]
SUMMARY:
Uses
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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 https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, 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: RDFRNotices@
epa.gov.
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Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Rules and Regulations
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40/chapter-I/subchapter-E/
part-180?toc=1.
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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–2021–0130 and/or EPA–HQ–OPP–
2021–0555 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 June
9, 2023. At this time, the Office of
Administrative Law Judges, in which
the Hearing Clerk is located, encourages
people to utilize the electronic system
for filing. See Order Urging Electronic
Service and Filing, https://
www.epa.gov/sites/default/files2020-05/
documents/2020-04-10_-_order_urging_
electronic_service_and_filing.pdf. The
system for filing electronically can be
found at this website, https://
www.epa.gov/alj.
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
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(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–
2021–0130 and/or EPA–HQ–OPP–2021–
0555, by one of the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov//where-send-commentsepa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of October 21,
2021 (86 FR 58239) (FRL–8792–04–
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 0E8876) in
docket EPA–HQ–OPP–2021–0130, by
IR–4, North Carolina State University,
1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.416 be
amended by adding tolerances for
ethalfluralin, N-ethyl-N-(2-methyl-2propenyl)-2,6-dinitro-4-(trifluoromethyl)
benzenamine in or on the raw
agricultural commodities: Hemp, seed at
0.05 ppm; stevia, dried leaves at 0.05
ppm; vegetable, tuberous and corm,
subgroup 1C at 0.01 ppm; individual
crops of Proposed Crop Subgroup 6–
XXE: Dried shelled bean, except
soybean, subgroup at 0.05 ppm; and
individual crops of Proposed Crop
Subgroup 6–XXF: Dried shelled pea
subgroup at 0.05 ppm. Due to the length
of the list of commodities, please refer
to the document EPA issued in the
Federal Register on October 21, 2021,
for a complete list of commodities to be
established. The petition also requested
to remove established tolerances for
residues of ethalfluralin in or on the raw
agricultural commodities: Bean, dry,
seed at 0.05 ppm; pea, dry, seed at 0.05
ppm; and potato at 0.05 ppm. That
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document referenced a summary of the
petition, which is available in the
docket, https://www.regulations.gov. No
comments were received in response to
the notice of filing.
In the Federal Register of March 22,
2022 (87 FR 16133) (FRL–9410–11–
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 1F8929) in
docket EPA–HQ–OPP–2021–0555 by
Gowan Company LLC, 370 S Main
Street, Yuma, AZ 85366. The petition
requested that 40 CFR 180.416 be
amended by adding a tolerance for
residues of ethalfluralin in or on the
onion, bulb crop subgroup 3–07A at
0.01 ppm. There was one comment
received in response to the notice of
filing. EPA’s response to this comment
is addressed in section IV.C.
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 0E8876) in
docket EPA–HQ–OPP–2021–0130 by
IR–4, North Carolina State University,
1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.416 be
amended by establishing a tolerance for
residues of ethalfluralin in or on the raw
agricultural commodity stevia, fresh
leaves at 0.05 ppm. There was one
comment received in response to the
notice of filing. EPA’s response to this
comment is addressed in section IV.C.
Some of the commodity definitions
have been modified to be consistent
with Agency nomenclature and one
requested tolerance is not being
established, as explained in section
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
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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 ethalfluralin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with ethalfluralin 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 rulemaking of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemaking, 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
tolerance rulemaking for ethalfluralin in
which EPA concluded, based on the
available information, that there is a
reasonable certainty that no harm would
result from aggregate exposure to
ethalfluralin and established tolerances
for residues of that chemical. EPA is
incorporating previously published
sections from that rulemaking as
described further in this rulemaking, as
they remain unchanged.
Toxicological profile. For a discussion
of the Toxicological Profile of
ethalfluralin, see Unit III.A. of the
ethalfluralin tolerance rulemaking
published in the Federal Register of
July 28, 2020 (85 FR 45336) (FRL–
10008–20).
Toxicological points of departure/
Levels of concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern for ethalfluralin used
for human risk assessment, please
reference Unit III.B. of the July 28, 2020,
rulemaking.
Exposure assessment from residues in
or on food. EPA’s dietary exposure
assessments have been updated to
include the additional exposure from
the petitioned-for tolerances as well as
existing ethalfluralin tolerances in 40
CFR 180.416. The acute and chronic
dietary (food and drinking water)
assessments used tolerance-level
residues and assumed 100 percent crop
treated (PCT). The cancer dietary (food
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and drinking water) analysis was
refined and used half the field trial limit
of detection value for all potato
commodities; data from the United
States Department of Agriculture
(USDA’s) Pesticide Data Program (PDP)
for dried bean/pea, soybean grain, soy
infant formula, cucurbit vegetables, and
peanut butter; tolerance-level residues
for the remaining commodities, as well
as average PCT data for canola/rapeseed,
cantaloupe, cucumber, peanut,
pumpkin, summer/winter squash,
sunflower, and watermelon and 100
PCT for the remaining commodities.
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,
EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, and the exposure
estimate does not understate exposure
for the population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The cancer assessment incorporated
average PCT data for the following
commodities: canola/rapeseed (2.5%);
cantaloupe (5%); cucumber (55%);
peanut (25%); pumpkin (20%);
summer/winter squash (35%);
sunflower (5%); and watermelon (25%).
In most cases, EPA uses available data
from United States Department of
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Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and
California Department of Pesticide
Regulation (CalDPR) Pesticide Use
Reporting (PUR) for the chemical/crop
combination for the most recent 10
years. EPA uses an average PCT for
chronic dietary risk analysis and a
maximum PCT for acute dietary risk
analysis. The average PCT figure for
each existing use is derived by
combining available public and private
market survey data for that use,
averaging across all observations, and
rounding to the nearest 5%, except for
those situations in which the average
PCT is less than 1% or less than 2.5%.
In those cases, the Agency would use
less than 1% or less than 2.5% as the
average PCT value, respectively. The
maximum PCT figure is the highest
observed maximum value reported
within the most recent 10 years of
available public and private market
survey data for the existing use and
rounded up to the nearest multiple of
5%, except where the maximum PCT is
less than 2.5%, in which case, the
Agency uses less than 2.5% as the
maximum PCT.
The Agency believes that 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 ethalfluralin may be applied in a
particular area.
Drinking water and non-occupational
exposures. An updated drinking water
assessment for all proposed and
registered uses was conducted. The
acute, chronic, and cancer assessments
incorporated modeled surface water
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estimated drinking water concentrations
of 26.1 ppb, 0.57 ppb, and 0.41 ppb,
respectively.
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.’’
The Agency has determined that
although ethalfluralin shares some
chemical and/or toxicological
characteristics (e.g., chemical structure
or apical endpoint) with other
pesticides, the toxicological database
does not support a testable hypothesis
for a common mechanism of action. See:
Dinitroanilines: Screening Analysis of
Toxicological Profiles to Consider
Whether a Candidate Common
Mechanism Group Can Be Established.
Consequently, no further review of
cumulative effects is required for
ethalfluralin at this time.
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 28, 2020,
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.
Acute dietary risks are below the
Agency’s level of concern of 100% of
the aPAD; they are less than 1% of the
aPAD for females 13 to 49 years old, the
only population group of concern.
Chronic dietary risks are below the
Agency’s level of concern of 100% of
the cPAD; they are less than 1% of the
cPAD for children 1 to 2 years old, the
group with the highest exposure.
Because there are no proposed or
previously registered residential uses of
ethalfluralin, short- and intermediateterm residential exposure is not
expected; therefore, aggregate risk is
equal to the chronic dietary risk, which
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is below the Agency’s level of concern.
A refined cancer dietary assessment was
conducted, using the Q1* for
ethalfluralin of 0.089 (mg/kg/day)¥1,
resulting in a cancer risk estimate for
adults of 1 × 10¥6, which the Agency
considers to be a negligible 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 ethalfluralin residues. More
detailed information on this action can
be found in the document titled
‘‘Ethalfluralin. Human Health Risk
Assessment for Proposed Section 3
Registration for the New Uses on Hemp,
Bulb Onion, and Stevia plus Crop Group
Expansions’’ in docket ID EPA–HQ–
OPP–2021–0130.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the July 28, 2020, 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).
Codex has not established
ethalfluralin MRLs in/on any of the
commodities for which tolerances were
requested. Therefore, harmonization is
not an issue.
C. Response to Comments
One comment was received in
response to the March 22, 2022, Notice
of Filing. The comment reads in part
‘‘deny application for fluoride use on
onions by gowan profiteering co. the
detriment to healthy life on earth [sic].’’
It is unclear whether the commenter
intended to submit a comment on the
present action, which includes a request
for a tolerance for residues of
ethalfluralin, not fluoride, on onions,
among many other commodities. To the
extent the comment is about fluoride
residues, this comment is irrelevant to
the present action. To the extent the
comment is about ethalfluralin, the
commenter has provided no information
to support a conclusion that the
tolerances requested would not meet the
FFDCA safety standard. The existing
legal framework provided by section
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408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute.
One comment was received in
response to the April 28, 2022, Notice
of Filing. The commenter opposed EPA
approving the requested tolerances,
stating that doing so would poison the
food and feed in the U.S. Although the
Agency recognizes that some
individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by section 408 of the FFDCA 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 the trinexapacethyl tolerances are safe. The
commenter has provided no information
indicating that a safety determination
cannot be supported.
D. Revisions to Petitioned-For
Tolerances
Several of the commodity definitions
have been modified to conform to
Agency nomenclature. Additionally,
although the petitioner requested that
EPA establish individual tolerances for
the commodities contained in the
proposed crop subgroups 6–XXE (Dried
shelled bean, except soybean) and 6–
XXF (Dried shelled pea subgroup), EPA
is establishing tolerances for the
corresponding subgroups that have
recently been established by EPA in a
final rule. See the Federal Register of
September 21, 2022 (87 FR 57627)
(FRL–5031–13–OCSPP). The
corresponding subgroups that are being
established are ‘‘Vegetable, legume,
pulse, bean, dried shelled, except
soybean, subgroup 6–22E’’ and
‘‘Vegetable, legume, pulse, pea, dried
shelled, subgroup 6–22F’’. The
commodities in the established
subgroups are the same as the
individual commodities for which the
petitioner sought tolerances.
EPA is not establishing a tolerance for
Soybean, vegetable, dry seed because it
is not a commodity that requires a
tolerance. Edamame (vegetable soybean)
exists only in the succulent seed and
edible podded forms.
V. Conclusion
Therefore, tolerances are established
for residues of ethalfluralin in or on
Hemp, seed at 0.05 ppm; Onion, bulb,
subgroup 3–07A at 0.01 ppm; Stevia,
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dried leaves at 0.05 ppm; Stevia, fresh
leaves at 0.05 ppm; Vegetable, legume,
pulse, bean, dried shelled, except
soybean, subgroup 6–22E at 0.05 ppm;
Vegetable, legume, pulse, pea, dried
shelled, subgroup 6–22F at 0.05 ppm;
and Vegetable, tuberous and corm,
subgroup 1C at 0.01 ppm.
Additionally, the following tolerances
are removed as unnecessary: Bean, dry,
seed at 0.05 ppm; pea, dry, seed at 0.05
ppm; and potato at 0.01 ppm. Finally,
EPA is removing the tolerance on potato
at 0.05 ppm as a housecleaning
measure, since that tolerance expired on
January 28, 2021.
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
VerDate Sep<11>2014
16:14 Apr 07, 2023
Jkt 259001
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides,
and pests, Reporting and recordkeeping
requirements.
Dated: March 31, 2023.
Daniel Rosenblatt,
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
1. The authority citation for part 180
continues to read as follows:
■
Authority : 21 U.S.C. 321(q), 346a and 371.
2. In § 180.416, amend paragraph (a)
by revising the table to read as follows:
■
§ 180.416 Ethalfluralin; tolerances for
residues.
PO 00000
(a) * * *
Frm 00053
Fmt 4700
Sfmt 4700
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
Dill, dried leaves ...................
Dill, fresh leaves ...................
Hemp, seed ..........................
Onion, bulb, subgroup 3–07A
Peanut ..................................
Rapeseed subgroup 20A ......
Soybean ................................
Stevia, dried leaves ..............
Stevia, fresh leaves ..............
Sunflower subgroup 20B ......
Vegetable, cucurbit, group 9
Vegetable, legume, pulse,
bean, dried shelled, except
soybean, subgroup 6–22E
Vegetable, legume, pulse,
pea, dried shelled, subgroup 6–22F ......................
Vegetable, tuberous and
corm, subgroup 1C ...........
*
*
*
*
0.05
0.05
0.05
0.01
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.01
*
[FR Doc. 2023–07456 Filed 4–7–23; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket No. 17–310; FCC 23–6; FR ID
135131]
Promoting Telehealth in Rural
America; Correction
Federal Communications
Commission.
ACTION: Final rule; correction.
AGENCY:
The Federal Communications
Commission (Commission) is correcting
a final rule that appeared in the Federal
Register on March 23, 2023. In the
document, amendatory instruction 4 of
the rules incorrectly removed the
subparagraphs to paragraph (a) when
paragraph (a) was revised. This
correction is made to amend instruction
4 so that only paragraph (a) introductory
text be revised and the subparagraphs
remain in place.
DATES: Effective April 10, 2023.
FOR FURTHER INFORMATION CONTACT:
Bryan P. Boyle, Bryan.Boyle@fcc.gov,
Telecommunications Access Policy
Division, Wireline Competition Bureau,
(202) 418–7400 or TTY: (202) 418–0484.
SUPPLEMENTARY INFORMATION: In FR Doc.
2023–04991, appearing on page 17379
in the Federal Register of Thursday,
March 23, 2023, the following
correction is made:
SUMMARY:
§ 54.619
[Corrected]
1. On page 17396, in the first column,
in part 54, in amendment 4, the
■
E:\FR\FM\10APR1.SGM
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[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Rules and Regulations]
[Pages 21107-21111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07456]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0130 and EPA-HQ-OPP-2021-0555; FRL-10449-01-OCSPP]
Ethalfluralin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
ethalfluralin in or on multiple crops that are referenced later in this
document. The Interregional Research Project Number 4 (IR-4) and Gowan
Company LLC., requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 10, 2023. Objections and
requests for hearings must be received on or before June 9, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2021-0130 and EPA-HQ-OPP-2021-
0555, are 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. For the latest status information on EPA/DC services,
docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, 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:
[email protected].
[[Page 21108]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.
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-2021-0130 and/or EPA-HQ-OPP-2021-0555 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 June 9, 2023. At this time, the Office
of Administrative Law Judges, in which the Hearing Clerk is located,
encourages people to utilize the electronic system for filing. See
Order Urging Electronic Service and Filing, https://www.epa.gov/sites/default/files2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. The system for filing
electronically can be found at this website, https://www.epa.gov/alj.
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-2021-0130 and/or
EPA-HQ-OPP-2021-0555, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov//where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-04-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 0E8876) in docket EPA-HQ-OPP-2021-0130, by IR-4, North
Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210,
Raleigh, NC 27606. The petition requested that 40 CFR 180.416 be
amended by adding tolerances for ethalfluralin, N-ethyl-N-(2-methyl-2-
propenyl)-2,6-dinitro-4-(trifluoromethyl) benzenamine in or on the raw
agricultural commodities: Hemp, seed at 0.05 ppm; stevia, dried leaves
at 0.05 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm;
individual crops of Proposed Crop Subgroup 6-XXE: Dried shelled bean,
except soybean, subgroup at 0.05 ppm; and individual crops of Proposed
Crop Subgroup 6-XXF: Dried shelled pea subgroup at 0.05 ppm. Due to the
length of the list of commodities, please refer to the document EPA
issued in the Federal Register on October 21, 2021, for a complete list
of commodities to be established. The petition also requested to remove
established tolerances for residues of ethalfluralin in or on the raw
agricultural commodities: Bean, dry, seed at 0.05 ppm; pea, dry, seed
at 0.05 ppm; and potato at 0.05 ppm. That document referenced a summary
of the petition, which is available in the docket, https://www.regulations.gov. No comments were received in response to the
notice of filing.
In the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-
11-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
1F8929) in docket EPA-HQ-OPP-2021-0555 by Gowan Company LLC, 370 S Main
Street, Yuma, AZ 85366. The petition requested that 40 CFR 180.416 be
amended by adding a tolerance for residues of ethalfluralin in or on
the onion, bulb crop subgroup 3-07A at 0.01 ppm. There was one comment
received in response to the notice of filing. EPA's response to this
comment is addressed in section IV.C.
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
0E8876) in docket EPA-HQ-OPP-2021-0130 by IR-4, North Carolina State
University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC
27606. The petition requested that 40 CFR 180.416 be amended by
establishing a tolerance for residues of ethalfluralin in or on the raw
agricultural commodity stevia, fresh leaves at 0.05 ppm. There was one
comment received in response to the notice of filing. EPA's response to
this comment is addressed in section IV.C.
Some of the commodity definitions have been modified to be
consistent with Agency nomenclature and one requested tolerance is not
being established, as explained in section 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
[[Page 21109]]
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 ethalfluralin including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with ethalfluralin 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 rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking, 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 tolerance rulemaking for
ethalfluralin in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to ethalfluralin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from that rulemaking as described further
in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of ethalfluralin, see Unit III.A. of the ethalfluralin
tolerance rulemaking published in the Federal Register of July 28, 2020
(85 FR 45336) (FRL-10008-20).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
ethalfluralin used for human risk assessment, please reference Unit
III.B. of the July 28, 2020, rulemaking.
Exposure assessment from residues in or on food. EPA's dietary
exposure assessments have been updated to include the additional
exposure from the petitioned-for tolerances as well as existing
ethalfluralin tolerances in 40 CFR 180.416. The acute and chronic
dietary (food and drinking water) assessments used tolerance-level
residues and assumed 100 percent crop treated (PCT). The cancer dietary
(food and drinking water) analysis was refined and used half the field
trial limit of detection value for all potato commodities; data from
the United States Department of Agriculture (USDA's) Pesticide Data
Program (PDP) for dried bean/pea, soybean grain, soy infant formula,
cucurbit vegetables, and peanut butter; tolerance-level residues for
the remaining commodities, as well as average PCT data for canola/
rapeseed, cantaloupe, cucumber, peanut, pumpkin, summer/winter squash,
sunflower, and watermelon and 100 PCT for the remaining commodities.
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, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The cancer assessment incorporated average PCT data for the
following commodities: canola/rapeseed (2.5%); cantaloupe (5%);
cucumber (55%); peanut (25%); pumpkin (20%); summer/winter squash
(35%); sunflower (5%); and watermelon (25%).
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that 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
ethalfluralin may be applied in a particular area.
Drinking water and non-occupational exposures. An updated drinking
water assessment for all proposed and registered uses was conducted.
The acute, chronic, and cancer assessments incorporated modeled surface
water
[[Page 21110]]
estimated drinking water concentrations of 26.1 ppb, 0.57 ppb, and 0.41
ppb, respectively.
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.'' The Agency has
determined that although ethalfluralin shares some chemical and/or
toxicological characteristics (e.g., chemical structure or apical
endpoint) with other pesticides, the toxicological database does not
support a testable hypothesis for a common mechanism of action. See:
Dinitroanilines: Screening Analysis of Toxicological Profiles to
Consider Whether a Candidate Common Mechanism Group Can Be Established.
Consequently, no further review of cumulative effects is required for
ethalfluralin at this time.
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 28, 2020, 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.
Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are less than 1% of the aPAD for females 13 to 49
years old, the only population group of concern. Chronic dietary risks
are below the Agency's level of concern of 100% of the cPAD; they are
less than 1% of the cPAD for children 1 to 2 years old, the group with
the highest exposure. Because there are no proposed or previously
registered residential uses of ethalfluralin, short- and intermediate-
term residential exposure is not expected; therefore, aggregate risk is
equal to the chronic dietary risk, which is below the Agency's level of
concern. A refined cancer dietary assessment was conducted, using the
Q1* for ethalfluralin of 0.089 (mg/kg/day)-\1\,
resulting in a cancer risk estimate for adults of 1 x
10-\6\, which the Agency considers to be a negligible 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 ethalfluralin residues. More detailed information
on this action can be found in the document titled ``Ethalfluralin.
Human Health Risk Assessment for Proposed Section 3 Registration for
the New Uses on Hemp, Bulb Onion, and Stevia plus Crop Group
Expansions'' in docket ID EPA-HQ-OPP-2021-0130.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the July 28, 2020, 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).
Codex has not established ethalfluralin MRLs in/on any of the
commodities for which tolerances were requested. Therefore,
harmonization is not an issue.
C. Response to Comments
One comment was received in response to the March 22, 2022, Notice
of Filing. The comment reads in part ``deny application for fluoride
use on onions by gowan profiteering co. the detriment to healthy life
on earth [sic].'' It is unclear whether the commenter intended to
submit a comment on the present action, which includes a request for a
tolerance for residues of ethalfluralin, not fluoride, on onions, among
many other commodities. To the extent the comment is about fluoride
residues, this comment is irrelevant to the present action. To the
extent the comment is about ethalfluralin, the commenter has provided
no information to support a conclusion that the tolerances requested
would not meet the FFDCA safety standard. The existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute.
One comment was received in response to the April 28, 2022, Notice
of Filing. The commenter opposed EPA approving the requested
tolerances, stating that doing so would poison the food and feed in the
U.S. Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the FFDCA 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 the trinexapac-ethyl tolerances are
safe. The commenter has provided no information indicating that a
safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
Several of the commodity definitions have been modified to conform
to Agency nomenclature. Additionally, although the petitioner requested
that EPA establish individual tolerances for the commodities contained
in the proposed crop subgroups 6-XXE (Dried shelled bean, except
soybean) and 6-XXF (Dried shelled pea subgroup), EPA is establishing
tolerances for the corresponding subgroups that have recently been
established by EPA in a final rule. See the Federal Register of
September 21, 2022 (87 FR 57627) (FRL-5031-13-OCSPP). The corresponding
subgroups that are being established are ``Vegetable, legume, pulse,
bean, dried shelled, except soybean, subgroup 6-22E'' and ``Vegetable,
legume, pulse, pea, dried shelled, subgroup 6-22F''. The commodities in
the established subgroups are the same as the individual commodities
for which the petitioner sought tolerances.
EPA is not establishing a tolerance for Soybean, vegetable, dry
seed because it is not a commodity that requires a tolerance. Edamame
(vegetable soybean) exists only in the succulent seed and edible podded
forms.
V. Conclusion
Therefore, tolerances are established for residues of ethalfluralin
in or on Hemp, seed at 0.05 ppm; Onion, bulb, subgroup 3-07A at 0.01
ppm; Stevia,
[[Page 21111]]
dried leaves at 0.05 ppm; Stevia, fresh leaves at 0.05 ppm; Vegetable,
legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at
0.05 ppm; Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F
at 0.05 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm.
Additionally, the following tolerances are removed as unnecessary:
Bean, dry, seed at 0.05 ppm; pea, dry, seed at 0.05 ppm; and potato at
0.01 ppm. Finally, EPA is removing the tolerance on potato at 0.05 ppm
as a housecleaning measure, since that tolerance expired on January 28,
2021.
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: March 31, 2023.
Daniel Rosenblatt,
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. 180.416, amend paragraph (a) by revising the table to read
as follows:
Sec. 180.416 Ethalfluralin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Dill, dried leaves...................................... 0.05
Dill, fresh leaves...................................... 0.05
Hemp, seed.............................................. 0.05
Onion, bulb, subgroup 3-07A............................. 0.01
Peanut.................................................. 0.05
Rapeseed subgroup 20A................................... 0.05
Soybean................................................. 0.05
Stevia, dried leaves.................................... 0.05
Stevia, fresh leaves.................................... 0.05
Sunflower subgroup 20B.................................. 0.05
Vegetable, cucurbit, group 9............................ 0.05
Vegetable, legume, pulse, bean, dried shelled, except 0.05
soybean, subgroup 6-22E................................
Vegetable, legume, pulse, pea, dried shelled, subgroup 6- 0.05
22F....................................................
Vegetable, tuberous and corm, subgroup 1C............... 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-07456 Filed 4-7-23; 8:45 am]
BILLING CODE 6560-50-P