Fomesafen; Pesticide Tolerances, 29835-29839 [2023-09819]
Download as PDF
29835
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations
State
effective date
Title
*
*
2008 Ozone Moderate Area Attainment Plan.
Reasonably Available Control Technology for the 2008 8-Hour
Ozone National Ambient Air
Quality Standard (NAAQS) Moderate State Implementation Plan
(RACT SIP).
*
1/14/2017
8/2/2018
11/21/2017
6/8/2023
*
*
2008 Ozone Serious Area Attainment Plan.
*
2/14/2020
Reasonably Available Control Technology for the 2008 8-Hour
Ozone National Ambient Air
Quality Standard (NAAQS) Serious State Implementation Plan
(RACT SIP).
2/14/2020
*
*
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2019–0508; FRL–7261–05–
OCSPP]
RIN 2070–AK54
Notification of Submission to the
Secretary of Agriculture; Pesticides;
Exemptions of Certain PlantIncorporated Protectants (PIPs)
Derived From Newer Technologies;
Draft Final Rule
This document notifies the
public as required by the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) that the EPA Administrator
has forwarded to the Secretary of the
United States Department of Agriculture
(USDA) a draft regulatory document
entitled ‘‘Pesticides; Exemptions of
Certain Plant-Incorporated Protectants
(PIPs) Derived from Newer
Technologies; Final Rule.’’ The draft
regulatory document is not available to
the public until after it has been signed
and made available by EPA.
DATES: Notification effective as of May
1, 2023.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0508, is
VerDate Sep<11>2014
17:00 May 08, 2023
*
*
[insert Federal Register citation],
5/9/2023.
6/8/2023
5/9/2023 .........................................
*
*
Except for contingency measures,
RACM, enhanced monitoring,
and attainment demonstration.
Limited approval and limited disapproval.
Jkt 259001
*
*
Amanda Pierce, Biopesticides and
Pollution Prevention Division (7511M),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
566–1470; email address:
pierce.amanda@epa.gov.
I. What action is EPA taking?
Environmental Protection
Agency (EPA).
ACTION: Notification of submission to
the Secretary of Agriculture.
FIFRA section 25(a)(2)(B) requires the
EPA Administrator to provide the
Secretary of USDA with a copy of any
draft final rule at least 30 days before
signing it in final form for publication
in the Federal Register. The draft final
rule is not available to the public until
after it has been signed by EPA. If the
Secretary of USDA comments in writing
regarding the draft final rule within 15
days after receiving it, the EPA
Administrator shall include the
comments of the Secretary of USDA, if
requested by the Secretary of USDA,
and the EPA Administrator’s response
to those comments with the final rule
that publishes in the Federal Register.
If the Secretary of USDA does not
comment in writing within 15 days after
receiving the draft final rule, then the
EPA Administrator may sign the final
rule for publication in the Federal
Register any time after the 15-day
period.
PO 00000
*
6/8/2023
SUPPLEMENTARY INFORMATION:
AGENCY:
*
Except major source NOX RACT.
Previous SIP approvals 7/03/
2018, 2/24/2021, and 11/05/
2021. Limited approval/limited
disapproval of RACT regulations
5/9/2023.
FOR FURTHER INFORMATION CONTACT:
40 CFR Part 174
Comments
*
*
83 FR 31068, 7/3/2018 ..................
available at https://
www.regulations.gov. That docket
contains historical information and this
Federal Register document; it does not
contain the draft final rule.
BILLING CODE 6560–50–P
SUMMARY:
Final rule citation/date
[insert Federal Register citation],
5/9/2023.
*
[FR Doc. 2023–09229 Filed 5–8–23; 8:45 am]
ddrumheller on DSK120RN23PROD with RULES1
EPA effective
date
Frm 00021
Fmt 4700
Sfmt 4700
*
*
II. Do any statutory and Executive
Order reviews apply to this
notification?
No. This document is merely a
notification of submission to the
Secretary of USDA. As such, none of the
regulatory assessment requirements
apply to this document.
List of Subjects in 40 CFR Part 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Plant-incorporated
protectants, Reporting, and
recordkeeping requirements.
Dated: May 1, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2023–09542 Filed 5–8–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0005; FRL–10908–01–
OCSPP]
Fomesafen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fomesafen in
or on Vegetable, bulb, group 3–07;
Vegetable, cucurbit, group 9; Vegetable,
fruiting, group 8–10; and Vegetable,
legume, forage and hay, except soybean,
SUMMARY:
E:\FR\FM\09MYR1.SGM
09MYR1
29836
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations
subgroup 7–22A. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
9, 2023. Objections and requests for
hearings must be received on or before
July 10, 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 docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0005, 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. For the latest
status information on EPA/DC services,
docket access, visit 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
ddrumheller on DSK120RN23PROD with RULES1
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-
VerDate Sep<11>2014
17:00 May 08, 2023
Jkt 259001
CFR site at https://www.ecfr.gov/
current/title-40.
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–2022–0005 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 July
10, 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–
2022–0005, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-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 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 1E8957) by
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
IR–4, North Carolina State University,
1730 Varsity Drive, Venture IV, Suite
210, Raleigh, NC 27606. The petition
requested that 40 CFR 180.433 be
amended by establishing tolerances for
residues of fomesafen, 5-2-chloro-4(trifluoromethyl)phenoxy-N(methylsulfonyl)-2-nitrobenzamide in or
on the raw agricultural commodities
Vegetable, bulb, group 3–07 at 0.02 parts
per million (ppm); Vegetable, cucurbit,
group 9 at 0.025 ppm; Vegetable, foliage
of legume, except soybean, subgroup 7A
at 0.05 ppm; and Vegetable, fruiting,
group 8–10 at 0.025 ppm.
The petition also proposed to remove
established tolerances for residues of
fomesafen in or on the following:
Cantaloupe at 0.025 ppm; Cucumber at
0.025 ppm; Pepper, bell at 0.025 ppm;
Pepper, non-bell at 0.025 ppm; Pumpkin
at 0.025 ppm; Squash, summer at 0.025
ppm; Squash, winter at 0.025 ppm;
Tomato at 0.025 ppm; and Watermelon
at 0.025 ppm.
That document referenced a summary
of the petition, which is available in the
docket, https://www.regulations.gov.
One comment was submitted in
response to this petition. EPA’s
response to this comment can be found
in Unit VI.D. of this publication.
Based upon review of the data
supporting the petition and in
accordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA is
modifying some of the requested
tolerances and one of the tolerance
definitions. For details, see Unit VI.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue . . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified
E:\FR\FM\09MYR1.SGM
09MYR1
ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations
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 fomesafen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fomesafen 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 fomesafen, in
which EPA concluded, based on the
available information, that there is a
reasonable certainty that no harm would
result from aggregate exposure to
fomesafen and established tolerances for
residues of that chemical. EPA is
incorporating previously published
sections of that rulemaking that remains
unchanged, as described further in this
rulemaking. Specific information on the
risk assessment conducted in support of
this action, including on the studies
received and the nature of the adverse
effects caused by fomesafen, can be
found in the document titled
‘‘Fomesafen. Human Health Risk
Assessment for the Petition to Establish
Permanent Tolerances and Associated
Registrations for Bulb Vegetable (Group
3–07) and Vegetable, Foliage of Legume
Except Soybean (Subgroup 7A) and for
Proposed Crop Group Conversions and
Expansions for Vegetable, Cucurbit
(Group 9) and Vegetable, Fruiting
(Group 8–10).’’ (hereafter, the
Fomesafen Human Health Assessment)
which is available in the docket for this
action at https://www.regulations.gov.
Toxicological profile. Fomesafen is an
herbicide that is absorbed by leaves and
roots and inhibits potato polyphenol
oxidase (PPO), leading to irreversible
cell membrane damage. PPO inhibits a
step in the protoporphyrin synthesis
pathway and is a precursor to both
chlorophyll and hemoglobin synthesis.
The toxicological database for fomesafen
is complete. The primary target organ of
fomesafen is the liver. Generally, in rats,
after subchronic and chronic exposure,
liver histopathology (hyalinization of
hepatocytes, necrosis, etc.) provided the
VerDate Sep<11>2014
17:00 May 08, 2023
Jkt 259001
most sensitive toxicological endpoint. In
mice, liver tumors were observed after
chronic exposure, and liver
carcinogenicity has been established by
a peroxisome proliferator-activated
receptor (PPAR)-alpha mode of action.
Decreased motor activity was observed
at doses above those causing liver
toxicity. Post-implantation loss was
noted in the rat developmental study,
but no quantitative or qualitative
evidence of increased susceptibility was
seen following in utero exposure to rats
in developmental studies or in the 2generation reproduction study.
Fomesafen can result in suppression of
anti-sheep red blood cell (SRBC)
immunoglobulin M response; however,
this immunotoxic potential was noted
only at high doses. In a metabolism
study in rats, fomesafen was readily
absorbed in male and female rats after
oral dosing. The sex difference was not
evident at higher doses, where urine
was the main route of excretion after a
single oral dose of 500 mg/kg. However,
a marked sex difference in disposition
was observed at low doses, with females
excreting a higher percentage compared
to males.
Carcinogenicity was not observed in
the rat chronic toxicity/carcinogenicity
study. Liver tumors were produced in
the mouse carcinogenicity study;
however, the Agency determined that
fomesafen should be classified as ‘‘Not
Likely to be Carcinogenic to Humans.’’
This decision was based on the weightof-evidence (WOE) which supports
activation of peroxisome proliferatoractivated receptor alpha (PPARa) as the
mode of action for fomesafen-induced
hepatocarcinogenesis in mice.
Toxicological points of departure/
Levels of concern. The toxicological
endpoints for fomesafen have changed
since the last rulemaking and have been
updated in accordance with current
hazard evaluation practices. For a
summary of the Toxicological Points of
Departure/Levels of Concern used for
the safety assessment, see Section 4.5.3.
of the Fomesafen Human Health
Assessment.
Exposure assessment. Much of the
exposure assessment remains the same
since the rulemaking that published on
February 7, 2018 (83 FR 5312) (FRL–
9972–66), although the new exposure
assessment incorporates additional
dietary exposures from the petitionedfor tolerances. These updates are
discussed in this section; for a
description of the rest of EPA’s
approach to and assumptions for the
exposure assessment, see Unit III.C in
the February 7, 2018, rulemaking.
EPA conducted unrefined acute and
chronic dietary (food and drinking
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
29837
water) exposure and risk assessments
using the Dietary Exposure Evaluation
Model with the Food Commodity Intake
Database (DEEM–FCID, ver. 4.02) which
incorporates food consumption data
from the United States Department of
Agriculture (USDA) National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA;
2005–2010). The acute and chronic
dietary assessments used tolerance-level
residues, 100 percent crop treated (PCT)
and default processing factors.
Drinking water and non-occupational
exposures. The estimated drinking
water concentrations (EDWCs) have
been updated since the 2018
rulemaking. The Agency used EDWCs of
154 parts per billion for the acute
assessment and 118 ppb for the chronic
assessment.
There are no proposed or registered
residential uses of fomesafen at this
time; therefore, a quantitative
residential assessment was not
conducted.
Cumulative exposure. Section
408(b)(2)(D)(v) of FFDCA requires that,
when considering whether to establish,
modify, or revoke a tolerance, the
Agency consider ‘‘available
information’’ concerning the cumulative
effects of a particular pesticide’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
fomesafen and any other substances. For
the purposes of this action, therefore,
EPA has not assumed that fomesafen
has a common mechanism of toxicity
with other substances.
IV. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act (FQPA)
Safety Factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of increased
E:\FR\FM\09MYR1.SGM
09MYR1
29838
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
susceptibility of rat fetuses to in utero
exposure to fomesafen. Postimplantation loss was noted in the rat
developmental study, but no
quantitative or qualitative evidence of
increased susceptibility was seen
following in utero exposure to rats in
developmental studies or in the 2generation reproduction study. As the
etiology of the post-implantation loss is
unknown, it is considered to be both a
maternal and fetal endpoint and not
indicative of increased susceptibility.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the Food Quality
Protection Act Safety Factor were
reduced to 1X. That decision is based on
the following findings:
i. The toxicology database for
fomesafen is complete and sufficient for
assessing potential susceptibility to
infants and children.
ii. The potential of neurotoxicity
(decreased motor activity) was observed
in the acute neurotoxicity study in the
rat. However, there is a low degree of
concern for the potential neurotoxic
effects of fomesafen since (1) clear no
observed adverse effect levels (NOAELs)
were identified for the neurotoxic
effects; and (2) the endpoints chosen for
risk assessment are protective of any
potential neurotoxicity.
iii. There is no evidence of increased
susceptibility after exposure to
fomesafen. Post-implantation loss was
observed in the rat developmental
toxicity study. However, as the etiology
of the effect is unknown, it is
considered to be both a maternal and
fetal effect.
iv. There are no residential uses for
fomesafen, and the dietary assessment is
based on high-end exposure
assumptions including 100 PCT,
tolerance level residues, and high-end
estimates derived from ground drinking
water modeling estimates. These
exposure assessments are not likely to
underestimate the resulting estimates of
risk from exposure to fomesafen.
V. Aggregate Risks and Determination
of Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing dietary exposure
estimates to the acute populationadjusted dose (aPAD) and chronic
population-adjusted dose (cPAD).
Short-, intermediate-, and chronic-term
aggregate risks are evaluated by
comparing the estimated total food,
water, and residential exposure to the
appropriate points of departure to
ensure that an adequate margin of
exposure (MOE) exists.
VerDate Sep<11>2014
17:00 May 08, 2023
Jkt 259001
Acute dietary (food and drinking
water) risks are below the Agency’s
level of concern of 100% of the aPAD:
they are 2.8% of the aPAD for all infants
less than 1 year old, the population
group with the highest exposure
estimate. Chronic dietary (food and
drinking water) risks are below the
Agency’s level of concern of 100% of
the cPAD: they are 18% of the cPAD for
all infants less than 1 year old, which
is the population subgroup with the
highest exposure estimate.
Because there are no proposed or
registered residential uses of fomesafen,
the acute and chronic aggregate risks are
the same as the dietary (food and
drinking water) risks and are not of
concern. Finally, because fomesafen is
classified as ‘‘Not Likely to be
Carcinogenic to Humans’’ due to an
absence of carcinogenicity in the
available studies, EPA concludes that
aggregate exposure to fomesafen will not
pose a 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 fomesafen residues.
VI. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the February 7, 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).
There are currently no established
Codex MRLs for the proposed new uses
of fomesafen.
C. Revisions to Tolerances
The petitioner requested tolerances
for the Vegetable, foliage of legume,
except soybean, subgroup 7A, but EPA
is establishing the tolerance for the new
crop subgroup Vegetable, legume, forage
and hay, except soybeans, subgroup 7–
22A. As noted in EPA’s regulations,
once a revised crop group is established,
EPA no longer establishes crop groups
under the pre-existing crop group. See
40 CFR 180.40(j)(4). EPA updated
subgroup 7A in its final rule dated
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
September 21, 2022. See Pesticides;
Expansion of Crop Grouping Program VI
(87 FR 57627) (FRL–5031–13–OCSPP).
Additionally, the petitioned-for
tolerances of 0.025 ppm for the
Vegetable, cucurbit, group 9 and
Vegetable, fruiting, group 8–10 are being
established at 0.03 ppm to be consistent
with Agency rounding practice.
D. Response to Comments
One comment was received in
response to the Notice of Filing. The
commenter stated in part that they were
‘‘against approval of any of the below
applications for further pollution of the
air water soil of this earth’’ and that the
Agency should ‘‘shut down these dirty
rotten businesses. now.’’ 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 tolerances are 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 fomesafen
tolerances are safe. The commenter has
provided no information indicating that
a safety determination cannot be
supported.
VII. Conclusion
Therefore, tolerances are established
for residues of fomesafen in or on the
Vegetable, bulb, group 3–07 at 0.02
ppm; Vegetable, cucurbit, group 9 at
0.03 ppm; Vegetable, fruiting, group 8–
10 at 0.03 ppm; and Vegetable, legume,
forage and hay, except soybean,
subgroup 7–22A at 0.05 ppm.
Additionally, the established
tolerances on Cantaloupe; Cucumber;
Pepper, bell; Pepper, non-bell;
Pumpkin; Squash, summer; Squash,
winter; Tomato; and Watermelon are
removed as unnecessary.
VIII. 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
E:\FR\FM\09MYR1.SGM
09MYR1
29839
Federal Register / Vol. 88, No. 89 / Tuesday, May 9, 2023 / Rules and Regulations
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).
IX. 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 4, 2023.
Charles Smith,
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. Revise § 180.433 to read as follows:
§ 180.433 Fomesafen; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
fomesafen, including its metabolites and
degradates, in or on the following
commodities. Compliance with the
tolerance levels specified in the
following table 1 to this paragraph (a) is
to be determined by measuring only
fomesafen, 5-[2-chloro-4(trifluoromethyl)phenoxy]-N(methylsulfonyl)-2-nitrobenzamide, in
or on the commodity.
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
Berry, low growing, subgroup 13–07G, except cranberry ...................................................................................................................
Cotton, gin byproducts .........................................................................................................................................................................
Cotton, undelinted seed .......................................................................................................................................................................
Vegetable, bulb, group 3–07 ...............................................................................................................................................................
Vegetable, cucurbit, group 9 ...............................................................................................................................................................
Vegetable, fruiting, group 8–10 ...........................................................................................................................................................
Vegetable, legume, forage and hay, except soybean, subgroup 7–22A ............................................................................................
Vegetable, legume, group 6 ................................................................................................................................................................
Vegetable, tuberous and corm, subgroup 1C .....................................................................................................................................
(b)–(d) [Reserved]
[FR Doc. 2023–09819 Filed 5–8–23; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
ddrumheller on DSK120RN23PROD with RULES1
[EPA–R04–RCRA–2023–0042; FRL–10671–
02–R4]
South Carolina: Final Authorization of
State Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Final action.
AGENCY:
VerDate Sep<11>2014
17:00 May 08, 2023
Jkt 259001
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
0.02
0.025
0.025
0.02
0.03
0.03
0.05
0.05
0.025
The Environmental Protection
Agency (EPA) is taking direct final
action on the authorization of South
Carolina’s changes to its hazardous
waste program under the Resource
Conservation and Recovery Act (RCRA),
as amended. These changes were
outlined in a September 26, 2022,
application to the EPA. We have
determined that these changes satisfy all
requirements needed for final
authorization.
DATES: This authorization is effective on
July 10, 2023 without further notice
SUMMARY:
E:\FR\FM\09MYR1.SGM
09MYR1
Agencies
[Federal Register Volume 88, Number 89 (Tuesday, May 9, 2023)]
[Rules and Regulations]
[Pages 29835-29839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09819]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0005; FRL-10908-01-OCSPP]
Fomesafen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fomesafen in or on Vegetable, bulb, group 3-07; Vegetable, cucurbit,
group 9; Vegetable, fruiting, group 8-10; and Vegetable, legume, forage
and hay, except soybean,
[[Page 29836]]
subgroup 7-22A. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective May 9, 2023. Objections and
requests for hearings must be received on or before July 10, 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-2022-0005, 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. For the latest
status information on EPA/DC services, docket access, visit 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 Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
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-2022-0005 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
July 10, 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-2022-0005, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal 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
1E8957) by IR-4, North Carolina State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that
40 CFR 180.433 be amended by establishing tolerances for residues of
fomesafen, 5-2-chloro-4-(trifluoromethyl)phenoxy-N-(methylsulfonyl)-2-
nitrobenzamide in or on the raw agricultural commodities Vegetable,
bulb, group 3-07 at 0.02 parts per million (ppm); Vegetable, cucurbit,
group 9 at 0.025 ppm; Vegetable, foliage of legume, except soybean,
subgroup 7A at 0.05 ppm; and Vegetable, fruiting, group 8-10 at 0.025
ppm.
The petition also proposed to remove established tolerances for
residues of fomesafen in or on the following: Cantaloupe at 0.025 ppm;
Cucumber at 0.025 ppm; Pepper, bell at 0.025 ppm; Pepper, non-bell at
0.025 ppm; Pumpkin at 0.025 ppm; Squash, summer at 0.025 ppm; Squash,
winter at 0.025 ppm; Tomato at 0.025 ppm; and Watermelon at 0.025 ppm.
That document referenced a summary of the petition, which is
available in the docket, https://www.regulations.gov. One comment was
submitted in response to this petition. EPA's response to this comment
can be found in Unit VI.D. of this publication.
Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is modifying some of the requested tolerances and one of the tolerance
definitions. For details, see Unit VI.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified
[[Page 29837]]
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 fomesafen including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with fomesafen 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 fomesafen,
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to fomesafen and established tolerances for residues of that
chemical. EPA is incorporating previously published sections of that
rulemaking that remains unchanged, as described further in this
rulemaking. Specific information on the risk assessment conducted in
support of this action, including on the studies received and the
nature of the adverse effects caused by fomesafen, can be found in the
document titled ``Fomesafen. Human Health Risk Assessment for the
Petition to Establish Permanent Tolerances and Associated Registrations
for Bulb Vegetable (Group 3-07) and Vegetable, Foliage of Legume Except
Soybean (Subgroup 7A) and for Proposed Crop Group Conversions and
Expansions for Vegetable, Cucurbit (Group 9) and Vegetable, Fruiting
(Group 8-10).'' (hereafter, the Fomesafen Human Health Assessment)
which is available in the docket for this action at https://www.regulations.gov.
Toxicological profile. Fomesafen is an herbicide that is absorbed
by leaves and roots and inhibits potato polyphenol oxidase (PPO),
leading to irreversible cell membrane damage. PPO inhibits a step in
the protoporphyrin synthesis pathway and is a precursor to both
chlorophyll and hemoglobin synthesis. The toxicological database for
fomesafen is complete. The primary target organ of fomesafen is the
liver. Generally, in rats, after subchronic and chronic exposure, liver
histopathology (hyalinization of hepatocytes, necrosis, etc.) provided
the most sensitive toxicological endpoint. In mice, liver tumors were
observed after chronic exposure, and liver carcinogenicity has been
established by a peroxisome proliferator-activated receptor (PPAR)-
alpha mode of action. Decreased motor activity was observed at doses
above those causing liver toxicity. Post-implantation loss was noted in
the rat developmental study, but no quantitative or qualitative
evidence of increased susceptibility was seen following in utero
exposure to rats in developmental studies or in the 2-generation
reproduction study. Fomesafen can result in suppression of anti-sheep
red blood cell (SRBC) immunoglobulin M response; however, this
immunotoxic potential was noted only at high doses. In a metabolism
study in rats, fomesafen was readily absorbed in male and female rats
after oral dosing. The sex difference was not evident at higher doses,
where urine was the main route of excretion after a single oral dose of
500 mg/kg. However, a marked sex difference in disposition was observed
at low doses, with females excreting a higher percentage compared to
males.
Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Liver tumors were produced in the mouse
carcinogenicity study; however, the Agency determined that fomesafen
should be classified as ``Not Likely to be Carcinogenic to Humans.''
This decision was based on the weight-of-evidence (WOE) which supports
activation of peroxisome proliferator-activated receptor alpha
(PPAR[alpha]) as the mode of action for fomesafen-induced
hepatocarcinogenesis in mice.
Toxicological points of departure/Levels of concern. The
toxicological endpoints for fomesafen have changed since the last
rulemaking and have been updated in accordance with current hazard
evaluation practices. For a summary of the Toxicological Points of
Departure/Levels of Concern used for the safety assessment, see Section
4.5.3. of the Fomesafen Human Health Assessment.
Exposure assessment. Much of the exposure assessment remains the
same since the rulemaking that published on February 7, 2018 (83 FR
5312) (FRL-9972-66), although the new exposure assessment incorporates
additional dietary exposures from the petitioned-for tolerances. These
updates are discussed in this section; for a description of the rest of
EPA's approach to and assumptions for the exposure assessment, see Unit
III.C in the February 7, 2018, rulemaking.
EPA conducted unrefined acute and chronic dietary (food and
drinking water) exposure and risk assessments using the Dietary
Exposure Evaluation Model with the Food Commodity Intake Database
(DEEM-FCID, ver. 4.02) which incorporates food consumption data from
the United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA;
2005-2010). The acute and chronic dietary assessments used tolerance-
level residues, 100 percent crop treated (PCT) and default processing
factors.
Drinking water and non-occupational exposures. The estimated
drinking water concentrations (EDWCs) have been updated since the 2018
rulemaking. The Agency used EDWCs of 154 parts per billion for the
acute assessment and 118 ppb for the chronic assessment.
There are no proposed or registered residential uses of fomesafen
at this time; therefore, a quantitative residential assessment was not
conducted.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to fomesafen and any other substances. For the
purposes of this action, therefore, EPA has not assumed that fomesafen
has a common mechanism of toxicity with other substances.
IV. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased
[[Page 29838]]
susceptibility of rat fetuses to in utero exposure to fomesafen. Post-
implantation loss was noted in the rat developmental study, but no
quantitative or qualitative evidence of increased susceptibility was
seen following in utero exposure to rats in developmental studies or in
the 2-generation reproduction study. As the etiology of the post-
implantation loss is unknown, it is considered to be both a maternal
and fetal endpoint and not indicative of increased susceptibility.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
Food Quality Protection Act Safety Factor were reduced to 1X. That
decision is based on the following findings:
i. The toxicology database for fomesafen is complete and sufficient
for assessing potential susceptibility to infants and children.
ii. The potential of neurotoxicity (decreased motor activity) was
observed in the acute neurotoxicity study in the rat. However, there is
a low degree of concern for the potential neurotoxic effects of
fomesafen since (1) clear no observed adverse effect levels (NOAELs)
were identified for the neurotoxic effects; and (2) the endpoints
chosen for risk assessment are protective of any potential
neurotoxicity.
iii. There is no evidence of increased susceptibility after
exposure to fomesafen. Post-implantation loss was observed in the rat
developmental toxicity study. However, as the etiology of the effect is
unknown, it is considered to be both a maternal and fetal effect.
iv. There are no residential uses for fomesafen, and the dietary
assessment is based on high-end exposure assumptions including 100 PCT,
tolerance level residues, and high-end estimates derived from ground
drinking water modeling estimates. These exposure assessments are not
likely to underestimate the resulting estimates of risk from exposure
to fomesafen.
V. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
population-adjusted dose (aPAD) and chronic population-adjusted dose
(cPAD). Short-, intermediate-, and chronic-term aggregate risks are
evaluated by comparing the estimated total food, water, and residential
exposure to the appropriate points of departure to ensure that an
adequate margin of exposure (MOE) exists.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD: they are 2.8% of the
aPAD for all infants less than 1 year old, the population group with
the highest exposure estimate. Chronic dietary (food and drinking
water) risks are below the Agency's level of concern of 100% of the
cPAD: they are 18% of the cPAD for all infants less than 1 year old,
which is the population subgroup with the highest exposure estimate.
Because there are no proposed or registered residential uses of
fomesafen, the acute and chronic aggregate risks are the same as the
dietary (food and drinking water) risks and are not of concern.
Finally, because fomesafen is classified as ``Not Likely to be
Carcinogenic to Humans'' due to an absence of carcinogenicity in the
available studies, EPA concludes that aggregate exposure to fomesafen
will not pose a 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 fomesafen residues.
VI. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 7, 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).
There are currently no established Codex MRLs for the proposed new
uses of fomesafen.
C. Revisions to Tolerances
The petitioner requested tolerances for the Vegetable, foliage of
legume, except soybean, subgroup 7A, but EPA is establishing the
tolerance for the new crop subgroup Vegetable, legume, forage and hay,
except soybeans, subgroup 7-22A. As noted in EPA's regulations, once a
revised crop group is established, EPA no longer establishes crop
groups under the pre-existing crop group. See 40 CFR 180.40(j)(4). EPA
updated subgroup 7A in its final rule dated September 21, 2022. See
Pesticides; Expansion of Crop Grouping Program VI (87 FR 57627) (FRL-
5031-13-OCSPP). Additionally, the petitioned-for tolerances of 0.025
ppm for the Vegetable, cucurbit, group 9 and Vegetable, fruiting, group
8-10 are being established at 0.03 ppm to be consistent with Agency
rounding practice.
D. Response to Comments
One comment was received in response to the Notice of Filing. The
commenter stated in part that they were ``against approval of any of
the below applications for further pollution of the air water soil of
this earth'' and that the Agency should ``shut down these dirty rotten
businesses. now.'' 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
tolerances are 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 fomesafen
tolerances are safe. The commenter has provided no information
indicating that a safety determination cannot be supported.
VII. Conclusion
Therefore, tolerances are established for residues of fomesafen in
or on the Vegetable, bulb, group 3-07 at 0.02 ppm; Vegetable, cucurbit,
group 9 at 0.03 ppm; Vegetable, fruiting, group 8-10 at 0.03 ppm; and
Vegetable, legume, forage and hay, except soybean, subgroup 7-22A at
0.05 ppm.
Additionally, the established tolerances on Cantaloupe; Cucumber;
Pepper, bell; Pepper, non-bell; Pumpkin; Squash, summer; Squash,
winter; Tomato; and Watermelon are removed as unnecessary.
VIII. 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
[[Page 29839]]
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).
IX. 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 4, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Revise Sec. 180.433 to read as follows:
Sec. 180.433 Fomesafen; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide fomesafen, including its metabolites and degradates, in or on
the following commodities. Compliance with the tolerance levels
specified in the following table 1 to this paragraph (a) is to be
determined by measuring only fomesafen, 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on
the commodity.
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G, except cranberry... 0.02
Cotton, gin byproducts.................................. 0.025
Cotton, undelinted seed................................. 0.025
Vegetable, bulb, group 3-07............................. 0.02
Vegetable, cucurbit, group 9............................ 0.03
Vegetable, fruiting, group 8-10......................... 0.03
Vegetable, legume, forage and hay, except soybean, 0.05
subgroup 7-22A.........................................
Vegetable, legume, group 6.............................. 0.05
Vegetable, tuberous and corm, subgroup 1C............... 0.025
------------------------------------------------------------------------
(b)-(d) [Reserved]
[FR Doc. 2023-09819 Filed 5-8-23; 8:45 am]
BILLING CODE 6560-50-P