Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 57887 

EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued 

State citation Title/subject 

State 

approval/ 

submittal 

date 

EPA 

approval 

date 

Explanation 

*******

Section 116.920 .... Public Participation for Initial Issuance .... 6/9/2021 8/24/2023, [Insert Federal Register citation].

*******

Section 116.930 .... Amendments and Alterations of Permits 

Issued Under this Subchapter.

5/22/2002 1/11/2011, 76 FR 1525.

*******

Subchapter M—Best Available Retrofit Technology (BART) 

*******

Section 116.1530 .. Best Available Retrofit Technology 

(BART) Control Implementation.

6/9/2021 8/24/2023, [Insert Federal Register citation].

* * * * * * * 

[FR Doc. 2023–17945 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0004; FRL–11246–01– 

OCSPP] 

Pyraclonil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclonil in 

or on rice, grain. Nichino America, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 24, 2023. Objections and 

requests for hearings must be received 

on or before October 23, 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–2020–0004, 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 OPP Docket 

is (202) 566–1744. Please review the 

visitor instructions and additional 

information about the docket available 

at https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, 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: 

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–2020–0004 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 

October 23, 2023. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b), although the Office of 

Administrative Law Judges encourages 

parties to file electronically. See https:// 

www.epa.gov/sites/default/files/2020- 

05/documents/2020-04-10_-_order_

urging_electronic_service_and_

filing.pdf. 

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– 

2020–0004, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 


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57888 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

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 March 3, 

2020 (85 FR 12454) (FRL–10005–58), 

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 9F8809) by 

Nichino America, Inc., 4550 Linden Hill 

Road, Suite 501, Wilmington, DE 19808. 

The petition requested that 40 CFR part 

180 be amended by establishing 

tolerances for residues of the herbicide 

pyraclonil, 1-(3-chloro-4,5,6,7- 

tetrahydropyrazolo[1,5-a]pyridin-2-yl)- 

5-[methyl(prop-2-ynyl)amino]pyrazole4-carbonitrile, in or on rice, grain at 0.01 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by Nichino America, Inc., the 

registrant, which is available in the 

docket https://www.regulations.gov. 

Three comments supporting the 

registration were improperly filed in the 

docket for the notice of filing (NOF); 

there were no comments on the 

tolerance action. 

Based upon review of the data 

supporting the petition, EPA has 

recommended changes to the tolerance 

expression. The reason for these 

changes is explained in Unit IV.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 

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 pyraclonil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyraclonil follows. 

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 of pyraclonil are the 

liver and the thyroid. Liver effects were 

found to be primarily adaptive 

(increased weight, hepatocellular 

hypertrophy, induction of cytochrome 

P450); however, female mice showed 

adverse liver effects (clinical chemistry 

changes, increased liver weight, and fat 

deposits after 90 days of oral exposure; 

these initial changes progressed to 

cellular alteration, liver masses, and 

hepatocellular adenomas after 78 weeks 

of oral exposure). Thyroid effects 

occurred in rats at similar doses across 

the database via oral exposures (lowest 

observed adverse effect levels (LOAELs) 

range from 74 to 207 mg/kg/day). 

Thyroid follicular cell hypertrophy was 

observed in both sexes of rats in several 

studies, after 14 or more days of oral 

exposure. Colloid degeneration was 

observed in both sexes, and thyroid 

follicular cell adenomas were observed 

in males in a chronic study. Increased 

blood levels of thyroid stimulating 

hormone (TSH) and decreased levels of 

thyroxine (T4) were detected after 1, 2, 

52, and 104 weeks of oral exposure 

(hormones only measured in one 14-day 

oral study and one chronic study), in 

either or both sexes. No thyroid effects 

were detected in mice or dogs. 

No reproductive effects were detected. 

No increased pre- or postnatal 

susceptibility was detected. Pup weights 

were decreased in the rat reproductive 

study at the same dietary concentration 

at which thyroid effects were observed 

in adults. Decreased fetal weights were 

seen in a rat developmental study at the 

same dose as maternal clinical signs and 

decreased body weight. In an acute 

neurotoxicity study, decreased motor 

activity and several functional 

observation battery (FOB) findings 

(tremors, hunchback posture and slight 

lacrimation; decreased alertness, 

exploration, approach response and 

landing foot splay; and decreased body 

temperature) were noted only at 2 hours 

post-dosing with a single dose of 400 

mg/kg in females, and at higher doses in 

males. There was no effect of treatment 

on neurological parameters measured in 

a 90-day repeat dose studies in the rat. 

Pyraclonil is classified as ‘‘Likely to 

be Carcinogenic to Humans’’, based on 

treatment-related hepatocellular tumors 

in female mice (adenomas and 

combined adenomas/carcinomas), and 

thyroid follicular cell tumors in male rat 

(adenomas and combined adenomas/ 

carcinomas). The unit risk, Q1* (mg/kg/ 

day)¥1 of pyraclonil based upon female 

mouse liver tumor rates is 1.08 × 10¥2

in human equivalents. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyraclonil as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at https:// 

www.regulations.gov in document 

Pyraclonil. Human Health Risk 

Assessment for the New Active 

Ingredient for use on Rice at 11–14 in 

docket ID number EPA–HQ–OPP–2020– 

0004. 

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 


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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. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for pyraclonil used for human 

risk assessment can be found on pages 

18–20 in the Pyraclonil Human Health 

Risk Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraclonil, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from pyraclonil 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. Such effects were identified 

for pyraclonil. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2005–2010 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA 

conducted an unrefined acute dietary 

exposure assessment for the proposed 

new use on rice and assumed 100 

percent crop treated (PCT), tolerancelevel residues and default processing 

factors. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2005–2010 NHANES/ 

WWEIA. As to residue levels in food, 

EPA conducted an unrefined chronic 

dietary exposure assessment for the 

proposed new use on rice and assumed 

100 PCT, tolerance-level residues and 

default processing factors. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

pyraclonil should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and a linear approach has been used to 

quantify cancer risk. The inputs for the 

cancer dietary exposure assessment and 

the chronic dietary exposure assessment 

were equivalent with the exception of 

the estimated drinking water 

concentrations (EDWC) used. Applying 

the Q1* of 1.08 × 10¥2 (mg/kg/day)¥1

to the exposure value (0.000136 mg/kg/ 

day) results in a cancer risk estimate of 

1 × 10¥6 for adults 20 to 49 years old. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pyraclonil. Tolerance level residues 

and/or 100PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraclonil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of pyraclonil. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/modelspesticide-risk-assessment. 

Based on the Pesticides in Flooded 

Application Model (PFAM version 2.0), 

the maximum EDWCs of 50.8 mg/L for 

the 1-in-10-year daily mean, 6.68 mg/L 

for the 1-in-10-year annual mean, and 

6.40 mg/L for the 30-year annual mean 

concentration in surface water were 

used in the acute, chronic, and cancer 

analyses, respectively. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). Pyraclonil 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found pyraclonil to share 

a common mechanism of toxicity with 

any other substances, and pyraclonil 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that pyraclonil does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at https:// 

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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 

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. 

No increased pre- or postnatal 

susceptibility was detected in 

developmental studies in rats or rabbits, 

or in a reproductive study in rats. 

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 pyraclonil 

is complete. 

ii. Potential evidence of neurotoxicity 

was observed in the pyraclonil acute 

neurotoxicity study; however, concern 

is low since a clear NOAEL was 

established and the selected endpoints 

are protective of the observed effects. 

iii. There is no evidence that 

pyraclonil results in increased 

susceptibility in utero rats or rabbits in 

the prenatal developmental studies or in 


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57890 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

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 PCT, 

tolerance-level residues and default 

processing factors. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to pyraclonil in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by pyraclonil. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

pyraclonil will occupy <1% of the aPAD 

for all infants <1 year old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to pyraclonil from 

food and water will utilize <1% of the 

cPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for pyraclonil. 

3. Short-term and Intermediate-term 

risk. Short-term and Intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A short-term and intermediate-term 

adverse effect was identified; however, 

pyraclonil is not registered for any use 

patterns that would result in short-term 

or intermediate-term residential 

exposure. Short-term or intermediateterm risk is assessed based on shortterm or intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term or 

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 short-term and intermediate-term 

risk), no further assessment of shortterm or intermediate-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term and intermediateterm risk for pyraclonil. 

4. Aggregate cancer risk for U.S. 

population. The estimated exposure of 

adults 20 to 49 years old (the most 

highly exposed adult subpopulation) to 

pyraclonil is 0.000136 mg/kg/day. 

Applying the Q1* of 1.08 × 10¥2 (mg/ 

kg/day)¥1 to the exposure value results 

in a cancer risk estimate of 1 × 10¥6 for 

adults 20 to 49 years old. EPA generally 

considers cancer risks (expressed as the 

probability of an increased cancer case) 

in the range of 1 in 1 million (or × 10¥6) 

or less to be negligible. The precision 

which can be assumed for cancer risk 

estimates is best described by rounding 

to the nearest integral order of 

magnitude on the logarithmic scale; for 

example, risks falling between 3 × 10¥7

and 3 × 10¥6 are expressed as risks in 

the range of 10¥6. This is particularly 

the case where some conservatism is 

maintained in the exposure assessment. 

The pyraclonil exposure assessment is 

unrefined and retains significant 

conservatism in that tolerance-level 

residues and 100 percent crop treated is 

assumed for the rice use. In addition, 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to pyraclonil in drinking water. These 

assessments will not underestimate the 

exposure posed by pyraclonil. 

Accordingly, EPA has concluded the 

aggregate cancer risk for all existing 

pyraclonil uses and the new uses in this 

action fall within the range of 1 × 10¥6

and are thus negligible. 

5. 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 pyraclonil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

such as high-performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/ 

MS), Method GLP–MTH–108, 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: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for pyraclonil. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency is establishing a tolerance 

for residues of pyraclonil expressed as: 

(1-(3-chloro-4,5,6,7- 

tetrahydropyrazolo[1,5-a]pyridin-2-yl)- 

5-(methyl-2-propyn-1-ylamino)-1Hpyrazole-4-carbonitrile), which is the 

CAS name, rather than the petitioned 

for expression of pyraclonil: 1-(3-chloro4,5,6,7-tetrahydropyrazolo[1,5- 

a]pyridin-2-yl)-5-[methyl(prop-2- 

ynyl)amino]pyrazole-4-carbonitrile, 

which is the IUPAC name. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyraclonil, 1-(3-chloro4,5,6,7-tetrahydropyrazolo[1,5- 

a]pyridin-2-yl)-5-(methyl-2-propyn-1- 

ylamino)-1H-pyrazole-4-carbonitrile, in 

or on rice, grain at 0.01 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 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 57891 

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: August 16, 2023. 

Edward Messina, 

Director, 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. Add § 180.725 to subpart C to read 

as follows: 

§ 180.725 Pyraclonil; tolerances for 

residues. 

(a)–(b) [Reserved] 

(c) Tolerances with regional 

registrations. Tolerances are established 

for residues of the herbicide pyraclonil, 

including its metabolites and 

degradates, in or on the commodities to 

the table to this paragraph (c). 

Compliance with the tolerance levels 

specified in the table to this paragraph 

(c) is to be determined by measuring 

only pyraclonil (1-(3-chloro-4,5,6,7- 

tetrahydropyrazolo[1,5-a]pyridin-2-yl)- 

5-(methyl-2-propyn-1-ylamino)-1Hpyrazole-4-carbonitrile). 

TABLE 1 TO PARAGRAPH (c) 

Commodity Parts per 

million 

Rice, grain ................................ 0.01 

(d) [Reserved] 

[FR Doc. 2023–18181 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0577; FRL–11274–01– 

OCSPP] 

Imazapyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of imazapyr in or 

on rice, bran and rice, grain. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 24, 2023. Objections and 

requests for hearings must be received 

on or before October 23, 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–2022–0577, is 

available at https://www.regulations.gov 

or in-person at the Office of Pesticide 

Programs Regulatory Public Docket 

(OPP Docket) in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), West William Jefferson Clinton 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW, Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room and the OPP Docket is 

(202) 566–1744. Please review the 

visitor instructions and additional 

information about the docket available 

at https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Director, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 566–1030; email address: 

RDFRNotices@epa.gov. 

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). 


lotter on DSK11XQN23PROD with RULES1