Rule2023-09872
Cyflufenamid; Pesticide Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 10, 2023
Effective
May 10, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of cyflufenamid in or on sugar beet. Nippon Soda Co., Ltd. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 90 (Wednesday, May 10, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Rules and Regulations]
[Pages 30043-30047]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09872]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0788; FRL-10880-01-OCSPP]
Cyflufenamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
cyflufenamid in or on sugar beet. Nippon Soda Co., Ltd. requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 10, 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-2021-0788 is available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: 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:
<a href="/cdn-cgi/l/email-protection#6c3e282a3e220318050f091f2c091c0d420b031a"><span class="__cf_email__" data-cfemail="a0f2e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2021-0788 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-2021-0788, by one of
the following methods:
[[Page 30044]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 22, 2022 (87 FR 16135) (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
1F8950) by Nippon Soda Co., Ltd., ShinOhtemachi Bldg., 2-1, 2-Chome
Ohtemachi, Chiyoda-ku, Tokyo, 100-8165, Japan. The petition requested
that 40 CFR 180.667 be amended by establishing a tolerance for residues
of the fungicide, cyflufenamid, [N(Z)]-N-
[[(cyclopropylmethoxy)amino][2,3-difluoro-6-
(trifluoromethyl)phenyl]methylene]benzeneacetamide, in or on sugar
beets at 0.07 parts per million (ppm). That document referenced a
summary of the petition prepared by Nippon Soda Co., Ltd., the
registrant, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. One comment was submitted by USDA on the notice of
filing which supported this action.
Based upon review of the data supporting the petition, EPA has
revised the commodity definition from Sugar beet to Beet, sugar, roots;
and amended the proposed tolerance from 0.07 ppm to 0.15 ppm. The
reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for cyflufenamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with cyflufenamid follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings and republishing the same sections are
unnecessary. 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.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The target organs for cyflufenamid consist of the liver in mice and
thyroid in rats. Liver toxicity for mice increased as the duration of
exposure increased from subchronic to chronic; increases in toxicity
with exposure duration was not observed in rats and dogs. Adverse liver
toxicity was only observed in the mouse, with rats and dogs only
exhibiting adaptive liver effects.
Thyroid effects observed in the rat included increased follicular
cell hypertrophy, increased thyroid weight, and neoplastic thyroid
follicular adenomas. There are no concerns for susceptibility
associated with cyflufenamid exposure in developing and post-natal
animals because the effects observed in the fetal and/or offspring
animals in the rat and rabbit developmental and rat two-generation
reproduction toxicity studies were at either the same dose or a higher
dose than the dose in which effects occurred in the maternal and/or
parental animals. Additionally, there are no concerns for neurotoxicity
and immunotoxicity.
EPA has classified cyflufenamid as ``suggestive evidence of
carcinogenic potential'', based on the presence of liver tumors in male
mice. The point of departure (POD) for the chronic dietary exposure
scenario (22 mg/kg/day) is protective of these effects, which were
observed at much higher doses (325 mg/kg/day); therefore,
quantification of risk using a non-linear approach (i.e., reference
dose, RfD, approach) is appropriate to adequately account for all
chronic toxicity, including potential carcinogenicity. Additionally,
there are no concerns for genotoxicity and mutagenicity.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime.
[[Page 30045]]
Table 1--Summary of Toxicological Doses and Endpoints for Cyflufenamid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
RfD, PAD, level
Exposure scenario Point of Uncertainty/FQPA of concern for Study and
departure (POD) safety factors risk assessment toxicological effects
----------------------------------------------------------------------------------------------------------------
Summary of Toxicological Doses and Endpoints for use in Dietary and Residential Human Health Risk Assessments.
----------------------------------------------------------------------------------------------------------------
Acute Dietary, General An acute dietary assessment is not necessary at this time as there were no
population (including infants toxicological effects attributable to a single dose within the cyflufenamid
and children), Females (13-49 toxicity database.
years old).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary................ NOAEL = 22 mg/kg/ UFA = 10X........ cRfD = 0.22 mg/kg/ Chronic Toxicity/
day. UFH = 10X........ day. Carcinogenicity Study
FQPA SF = 1X..... cPAD = 0.22 mg/kg/ in Rat (MRID
day. 47620511)
LOAEL = 115 mg/kg/day,
based on thyroid
effects in both sexes
(increased thyroid
weight, follicular
cell hypertrophy,
follicular and
parafollicular cell
hyperplasia,
parathyroid
hyperplasia) and
pancreas (acinar
atrophy with chronic
inflammation) effect
in females.
Incidental Oral Short-Term (1- NOAEL = 23 mg/kg/ UFA = 10X........ LOC for MOE = 100 90-day Oral Toxicity
30 days). day. UFH = 10X........ Study in Dogs (MRID
FQPA SF = 1X..... 47620504) LOAEL = 71
mg/kg/day, based on
decreased
bodyweights, brain
histopathology, and
thymus atrophy in
both sexes.
----------------------------------------------------------------------------------------------------------------
Dermal Short Term (1-30 days) A toxicity endpoint was not identified. Systemic toxicity was not seen in 28-
and Intermediate-Term (1-6 day dermal toxicity in rats up to the limit dose (1000 mg/kg/day). There are
months). no concerns for developmental or reproductive toxicity or neurotoxicity in rat
and rabbit studies.
----------------------------------------------------------------------------------------------------------------
Inhalation Short Term (1-30 Oral NOAEL = 23 UFA = 10X........ LOC for MOE = 100 90-day Oral Toxicity
days) and Intermediate-Term (1- mg/kg/day, UFH = 10X........ Study in Dogs (MRID
6 months). Inhalation FQPA SF = 1X..... 47620504) LOAEL = 71
Absorption = mg/kg/day, based on
100% Oral decreased
Absorption. bodyweights,
bodyweight gain, food
consumption, and
liver ([uarr]liver
weight, [uarr]ALP,
hepatomegaly
accompanied by
vacuolated
hepatocytes and fa
deposition), brain
histopathology, and
thymus atrophy in
both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer......................... HED classified cyflufenamid as ``suggestive evidence of carcinogenic
potential'' and quantification of risk using a non-linear approach (i.e., RfD
approach) is appropriate (TXR 0057036, J. Rowland, 12/02/2014).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed adverse-effect level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed adverse-effect
level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyflufenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyflufenamid tolerances in 40
CFR 180.667. EPA assessed dietary exposures from cyflufenamid in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyflufenamid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture's National Health and Nutrition Examination Survey, What
We Eat in America (USDA's NHANES/WWEIA). As to residue levels in food,
EPA assumed tolerance-level residues and 100% crop treated (100% CT)
for all commodities. Anticipated residues and/or percent crop treated
(PCT) data were not used.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to cyflufenamid. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., Chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residues and/or PCT information in the
dietary assessment for cyflufenamid. Tolerance level residues and/or
100% CT were assumed for all food commodities.
2. Drinking water, non-occupational, and cumulative exposures.
Drinking water and non-occupational exposures are not impacted by the
proposed use of cyflufenamid on sugar beet, and thus have not changed
since the last assessment. For a summary of the dietary exposures from
drinking water, see Unit III.C.2. of the February 9, 2018, rulemaking
(87 FR 5711). There are no proposed residential uses for cyflufenamid
at this time; however, there are existing uses that result in potential
post-application residential exposures which have been previously
[[Page 30046]]
assessed using current data and assumptions. The registered uses
anticipated to result in post-application dermal exposure to
cyflufenamid include commercial treatment of outdoor ornamentals.
Because the Agency has not identified a dermal endpoint, a quantitative
residential dermal exposure assessment was not necessary and was not
conducted. EPA's conclusions concerning cumulative risk remain
unchanged from Unit III.C.4. of the February 9, 2018, rulemaking.
D. 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 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 are no concerns for
susceptibility associated with cyflufenamid exposure in developing and
post-natal animals. Additionally, there are no concerns for
neurotoxicity and immunotoxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for cyflufenamid is complete.
ii. There is no indication that cyflufenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyflufenamid results in increased
susceptibility in utero rats or rabbits in the prenatal developmental
studies or in young rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyflufenamid in drinking water. EPA used
similarly conservative assumptions to assess post application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
cyflufenamid.
E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyflufenamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyflufenamid from food and water will utilize 1.3% of the cPAD for all
infants <1 year old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyflufenamid is not expected.
3. Short-term risk. A short-term adverse effect was identified for
inhalation and oral exposures; however, cyflufenamid is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
cyflufenamid.
4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, cyflufenamid is not registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for cyflufenamid.
5. Aggregate cancer risk for U.S. population. EPA has determined
that quantification of risk using the RfD approach is appropriate and
will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to cyflufenamid. Based
on the conclusions of the chronic dietary assessment, EPA concludes
that exposure to cyflufenamid is unlikely to pose an aggregate cancer
risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyflufenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology high-performance liquid
chromatography method with tandem mass spectrometry detection (HPLC/MS/
MS), Method No. RD-01307 is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
<a href="/cdn-cgi/l/email-protection#d1a3b4a2b8b5a4b4bcb4a5b9beb5a291b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="582a3d2b313c2d3d353d2c30373c2b183d2839763f372e">[email protected]</span></a>.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to
[[Page 30047]]
which the United States is a party. EPA may establish a tolerance that
is different from a Codex MRL; however, FFDCA section 408(b)(4)
requires that EPA explain the reasons for departing from the Codex
level. The Codex has not established a MRL for cyflufenamid.
C. Revisions to Petitioned-For Tolerances
The Agency is establishing a tolerance for beet, sugar, roots at
0.15 ppm, which is higher than what the petitioner requested at 0.07
ppm based on Organization for Economic Cooperation and Development
calculation procedures. Additionally, the Agency is establishing the
tolerance for ``beet, sugar, roots'' rather than ``sugar beet'' to
reflect the common commodity vocabulary currently used by the Agency.
V. Conclusion
Therefore, a tolerance is established for residues of cyflufenamid,
[N(Z)]-N-[[(cyclopropylmethoxy)amino][2,3-difluoro-6-
(trifluoromethyl)phenyl]methylene]benzeneacetamide, in or on Beet,
sugar, roots at 0.15 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the National Government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 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. In Sec. 180.667, amend the table in paragraph (a) by adding a
heading to the table and adding in alphabetical order the entry ``Beet,
sugar, roots'' to read as follows:
Sec. 180.667 Cyflufenamid; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Beet, sugar, roots.......................................... 0.15
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2023-09872 Filed 5-9-23; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 10, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.