57894 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal Governments, on the 

relationship between the National 

Government and the States or tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 18, 2023. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.500, amend the table in 

paragraph (a) by: 

■ a. Adding a heading for the table; 

■ b. Adding in alphabetical order the 

entries ‘‘Rice, bran’’ and ‘‘Rice, grain’’; 

and 

■ c. Revising footnote 1. 

The additions and revision read as 

follows: 

§ 180.500 Imazapyr; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Rice, bran 1 ............................... 0.15 

Rice, grain 1 .............................. 0.06 

TABLE 1 TO PARAGRAPH (a)— 

Continued 

Commodity Parts per 

million 

* * * * * 

1There are no U.S. registrations as of August 24, 2023. 

* * * * * 

[FR Doc. 2023–18222 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0502; FRL–11272–01– 

OCSPP] 

Trifluralin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trifluralin in 

or on tea, dried and tea, instant. Gowan 

Company 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–2022–0502, 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. For the latest status 

information on EPA/DC services, docket 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Director, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

email address: RDFRNotices@epa.gov. 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 57895 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/ 

current/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2022–0502 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). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2022–0502, by one of the following 

methods: 

• Federal eRulemaking Portal: 

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

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/contacts.html. 

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 July 20, 

2022 (87 FR 43231) (FRL–9410–03– 

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 2E8999) by 

Gowan Company, P.O. Box 5569, Yuma, 

AZ 85366. The petition requested that 

40 CFR 180.207 be amended by 

establishing a tolerance for residues of 

the herbicide trifluralin in or on tea at 

0.05 parts per million (ppm). That 

document referenced a summary of the 

petition prepared by Gowan Company, 

which is available in the docket at 

https://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition and in 

accordance with its authority under 

FFDCA section 408(d)(4)(A)(i), EPA is 

establishing tolerances for tea, dried and 

tea, instant. For details, see 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 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 trifluralin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with trifluralin 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 for 

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 EPA considers referral back to those 

sections as sufficient to provide an 

explanation of the information EPA 

considered in making its safety 

determination for the new rulemaking. 

EPA has previously published 

tolerance rulemakings for trifluralin in 

which EPA concluded, based on the 

available information, that there is a 

reasonable certainty that no harm would 

result from aggregate exposure to 

trifluralin and established tolerances for 

residues of that chemical. EPA is 

incorporating previously published 

sections from these rulemakings as 

described further in this rulemaking, as 

they remain unchanged. 

Toxicological profile. For a discussion 

of the toxicological profile of trifluralin, 

see Unit III.A. of the trifluralin tolerance 

rulemaking published in the Federal 

Register of February 15, 2019 (84 FR 

4345) (FRL–9983–89). 

Toxicological points of departure/ 

levels of concern. A summary of the 

toxicological endpoints for trifluralin 

used for human health risk assessment 

is discussed in Unit III.B. of the 

trifluralin tolerance rulemaking 

published in the Federal Register of 

July 31, 2013 (78 FR 46267) (FRL–9393– 

5). EPA notes that the unit of 

measurement for the no-observedadverse-effect level (NOAEL) in the 

inhalation short-term (1 to 30 days) 

exposure/scenario should be mg/m3, not 

mg/kg/day as presented (i.e., the 

inhalation study NOAEL = 300 mg/m3). 

The unit of measurement for the lowestobserved-adverse-effect level (LOAEL) is 


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correct as presented (i.e., LOAEL = 1000 

mg/m3). 

Exposure assessment. EPA’s dietary 

exposure assessments have been 

updated to include the additional 

exposure from the requested tolerance 

for residues of trifluralin on tea and 

were conducted with the Dietary 

Exposure Evaluation Model with the 

Food Commodity Intake Database 

(DEEM–FCID, ver. 4.02), which 

incorporates food consumption data 

from the United States Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA; 

2005–2010). The unrefined acute dietary 

exposure and risk assessment assumed 

100 percent crop treated (PCT) for all 

commodities. The partially refined 

chronic and cancer dietary exposure 

and risk assessments incorporated 

average PCT estimates. As to residue 

levels in food, the chronic and cancer 

exposure assessments incorporated 

tolerance-level residues for the majority 

of commodities, average screening level 

usage analysis (SLUA) PCT estimates, 

EPA’s default processing factors, and 

monitoring data from the USDA’s 

Pesticide Data Program (PDP) for a 

subset of risk driving commodities that 

significantly reduced the cancer dietary 

exposure estimates. Dietary exposure 

estimates for the established uses and 

requested tolerance are below EPA’s 

level of concern for the general 

population and all population 

subgroups. 

Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require, pursuant to FFDCA 

section 408(f)(1), that data be provided 

5 years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, and the exposure 

estimate does not understate exposure 

for the population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

For the chronic dietary assessment, 

the following PCT assumptions were 

made: asparagus 15%; barley 1%; beans, 

green 25%; broccoli 10%; cabbage 35%; 

canola 2.5%; cantaloupes 25%; carrots 

15%; cauliflower 5%; celery 2.5%; corn 

1%; cotton 25%; cucumbers 5%; dry 

beans/peas 10%; honeydews 30%; 

onions 1%; peaches 1%; peanuts 2.5%; 

peas, green 10%; pecans 1%; peppers 

20%; potatoes 2.5%; pumpkins 2.5%; 

sorghum 1%; soybeans 2.5%; squash 

2.5%; sugar beets 1%; sunflowers 5%; 

tomatoes 50%; and watermelons 15%. 

EPA assumed 100 PCT for the other 

commodities including tea. In the acute 

analysis, the Agency made the 

conservative assumption of 100 PCT. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and 

California Department of Pesticide 

Regulation (CalDPR) Pesticide Use 

Reporting (PUR) for the chemical/crop 

combination for the most recent 10 

years. EPA uses an average PCT for 

chronic dietary risk analysis and a 

maximum PCT for acute dietary risk 

analysis. The average PCT figure for 

each existing use is derived by 

combining available public and private 

market survey data for that use, 

averaging across all observations, and 

rounding to the nearest 5%, except for 

those situations in which the average 

PCT is less than 1% or less than 2.5%. 

In those cases, the Agency would use 

1% or 2.5% as the average PCT value, 

respectively. The maximum PCT figure 

is the highest observed maximum value 

reported within the recent 10 years of 

available public and private market 

survey data for the existing use and 

rounded up to the nearest multiple of 

5%, except where the maximum PCT is 

less than 2.5%, in which case, the 

Agency uses 2.5% as the maximum 

PCT. 

The Agency believes that the three 

conditions discussed in this section 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations are taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimates do not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which trifluralin may be applied in a 

particular area. 

Drinking water and non-occupational 

exposures. Because there are no 

registrations for use of trifluralin on tea 

in the United States associated with the 

requested tolerance, the estimated 

drinking water concentrations and 

residential exposure assessment have 

not changed. For a detailed summary of 

the drinking water analysis and 

residential exposure assessment for 

trifluralin used for the human health 

risk assessment, see Unit III.B. and C. of 

the February 15, 2019, trifluralin 

tolerance rulemaking. 

Cumulative exposure. Section 

408(b)(2)(D)(v) of FFDCA requires that, 

when considering whether to establish, 

modify, or revoke a tolerance, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular pesticide’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

Based on a review of the toxicological 

database for trifluralin and the other 

dinitroanilines (benfluralin, butralin, 

ethalfluralin, fluazinam, flumetralin, 

oryzalin, pendimethalin, and 

prodiamine), the Agency has 

determined that although trifluralin 

shares some chemical and/or 

toxicological characteristics (e.g., 

chemical structure or apical endpoint) 

with these other dinitroanilines, the 

toxicological database does not support 

a testable hypothesis for a common 

mechanism of action. No further data 

are required to determine that no 

common mechanism of toxicity exists 

for trifluralin and the other 

dinitroanilines and no further 


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cumulative evaluation is necessary for 

trifluralin. For additional details, refer 

to the document titled ‘‘Dinitroanilines: 

Screening Analysis of Toxicological 

Profiles to Consider Whether a 

Candidate Common Mechanism Group 

Can Be Established’’ in docket ID 

number EPA–HQ–OPP–2017–0420 at 

https://www.regulations.gov. 

Safety factor for infants and children. 

EPA continues to conclude that there 

are reliable data to support the 

reduction of the Food Quality Protection 

Act (FQPA) safety factor from 10X to 

1X. See Unit III.B. of the February 15, 

2019, trifluralin tolerance rulemaking 

for a discussion of the Agency’s 

rationale for that determination. 

Aggregate risks and Determination of 

safety. EPA determines whether acute 

and chronic dietary pesticide exposures 

are safe by comparing dietary exposure 

estimates to the acute populationadjusted dose (aPAD) and chronic 

population-adjusted dose (cPAD). Short-, 

intermediate-, and chronic-term 

aggregate risks are evaluated by 

comparing the estimated total food, 

water, and residential exposure to the 

appropriate points of departures to 

ensure that an adequate margin of 

exposure (MOE) exists. 

Acute dietary (food and drinking 

water) risks are below the Agency’s 

level of concern of 100% of the aPAD; 

they are <1% of the aPAD for females 

13 to 49 years old, the only population 

group of concern. Chronic dietary (food 

and drinking water) risks are below the 

Agency’s level of concern of 100% of 

the cPAD; they are 5.6% of the cPAD for 

all infants <1 year old, the population 

group receiving the greatest exposure. 

EPA’s short-term aggregate exposure to 

trifluralin is based on residential and 

dietary routes of exposure. The shortterm aggregate MOEs are 24,000 for 

adults and 15,000 for children 1 to less 

than 2 years old and are not of concern 

(i.e., the MOEs are > the LOC of 100). 

Trifluralin is not registered for any use 

patterns that would result in 

intermediate-term residential exposure, 

so intermediate-term aggregate risk is 

the same as the chronic dietary risk and 

is not of concern. 

A cancer aggregate assessment was 

conducted for trifluralin since it is 

classified as a ‘‘Group C, Possible 

Human Carcinogen’’ with a Q1* of 2.96 

× 10¥3 (mg/kg/day)¥1 based upon male 

rat thyroid follicular cell combined 

adenoma, papillary adenoma, 

cystadenoma, and carcinoma tumor rate 

in human equivalents. The cancer 

aggregate risk assessment combines food 

and drinking water exposures with the 

residential dermal and inhalation 

exposure from post-application 

exposure from treated gardens. The 

resulting aggregate cancer risk estimate 

is 1.5 × 10¥6. 

EPA generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 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. Considering the precision with 

which cancer hazard can be estimated, 

the conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described above, cancer risk 

should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10 ¥6 until the calculated 

risk exceeds approximately 3 × 10 ¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. EPA has 

concluded the cancer risk for all 

existing trifluralin uses and the uses 

associated with the tolerances 

established in this action fall within the 

range of 1 × 10 ¥6 and are thus not of 

concern. 

Therefore, based on the risk 

assessments and information described 

above, 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 trifluralin residues. More 

detailed information on this action can 

be found in the document titled 

‘‘Trifluralin. Human Health Risk 

Assessment for a Section 3 Tolerance 

without U.S. Registration on Imported 

Tea’’ in docket ID EPA–HQ–OPP–2022– 

0502. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods, 

Methods GRM 96.12 and GRM 96.13 for 

plant commodities, are available for 

trifluralin and utilize gas 

chromatography (GC) with electron 

capture detection (ECD). The reported 

limit of quantitation (LOQ) is 0.01 ppm. 

Trifluralin was evaluated using the 

Food and Drug Administration (FDA) 

multiresidue method, which is also 

suitable for enforcement in determining 

residues of trifluralin in plant 

commodities. 

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 has not established MRLs for 

trifluralin on tea commodities. 

C. Revisions to Petitioned-For Tolerance 

The petition requested a tolerance for 

residues of trifluralin in or on tea at 0.05 

ppm. Because residue data was 

provided for a processed tea commodity 

rather than the raw agricultural 

commodity (i.e., tea, plucked leaves), 

EPA is establishing tolerances at 0.05 

ppm on all of the processed tea 

commodities (i.e., tea, dried and tea, 

instant). 

V. Conclusion 

Therefore, tolerances are established 

for residues of trifluralin, 2,6-dinitroN,N-dipropyl-4- 

(trifluoromethyl)benzenamine, in or on 

tea, dried and tea, instant at 0.05 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 


lotter on DSK11XQN23PROD with RULES1
57898 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

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 14, 2023. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.207, amend paragraph (a) 

by designating the table as table 1 and 

adding in alphabetical order in newly 

designated table 1 to paragraph (a) the 

entries ‘‘Tea, dried 1’’ and ‘‘Tea, 

instant 1’’ and footnote 1 following the 

table to read as follows: 

§ 180.207 Trifluralin; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Tea, dried 1 ................................. 0.05 

Tea, instant 1 ............................... 0.05 

* * * * * 

1There are no U.S. registrations as of August 24, 2023. 

* * * * * 

[FR Doc. 2023–18180 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0797; FRL–10971–01– 

OCSPP] 

Aspergillus flavus strain TC16F, 

TC35C, TC38B, and TC46G; 

Amendment to Temporary Exemptions 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing temporary tolerance 

exemptions for residues of Aspergillus 

flavus strains TC16F, TC35C, TC38B, 

and TC46G by establishing permanent 

tolerance exemptions for use in or on all 

food and feed commodities of field corn, 

popcorn, and sweet corn. Interregional 

Research Project Number 4 (IR–4) 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting to amend the 

existing temporary tolerance 

exemptions for Aspergillus flavus 

strains TC16F, TC35C, TC38B, and 

TC46G. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G under 

FFDCA when used in accordance with 

label directions and good agricultural 

practices. 

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–2022–0797, 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 

20004. 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. For the latest status 

information on EPA/DC services, docket 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Madison Le, Biopesticides and Pollution 

Prevention Division (7511M), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

main telephone number: (202) 566– 

1400; email address: BPPDFRNotices@

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