[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 [www.gpo.gov]
[FR Doc No: 2023-09872]


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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.

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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 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, 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]]

     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 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, https://www.regulations.gov. 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
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                                                                        RfD, PAD, level
       Exposure  scenario             Point of       Uncertainty/FQPA   of  concern for          Study and
                                  departure (POD)     safety factors    risk  assessment  toxicological  effects
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 Summary of Toxicological Doses and Endpoints for use in Dietary and Residential Human Health Risk Assessments.
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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).
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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.
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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.
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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.
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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).
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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: 
[email protected].

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


