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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 andBudget (OMB) has exempted these typesof 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’’ (66FR 28355, May 22, 2001), or Executive
Order 13045, entitled ‘‘Protection ofChildren from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does notcontain 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 thatare 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 etseq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and foodretailers, not States or tribes, nor does
this action alter the relationships or
distribution of power andresponsibilities established by Congressin the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will nothave a substantial direct effect on States
or tribal Governments, on therelationship between the National
Government and the States or tribal
Governments, or on the distribution of
power and responsibilities among thevarious levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determinedthat 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

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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).

TABLE 1 TO PARAGRAPH (a)—Continued
Parts permillionCommodity
*

*

*

*

*

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

*

*

*

*

*

[FR Doc. 2023–18222 Filed 8–23–23; 8:45 am]VII. Congressional Review Act

BILLING CODE 6560–50–P

Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA willsubmit a report containing this rule andother required information to the U.S.
Senate, the U.S. House ofRepresentatives, 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).

ENVIRONMENTAL PROTECTIONAGENCY40 CFR Part 180[EPA–HQ–OPP–2022–0502; FRL–11272–01–
OCSPP]

Trifluralin; Pesticide Tolerance
AGENCY: Environmental Protection

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 ofPesticide Programs.

Therefore, 40 CFR chapter I isamended as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDECHEMICAL 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 inparagraph (a) by:■ a. Adding a heading for the table;■ b. Adding in alphabetical order theentries ‘‘Rice, bran’’ and ‘‘Rice, grain’’;and■ c. Revising footnote 1.
The additions and revision read as
follows:§ 180.500 Imazapyr; tolerances forresidues.

(a) * * *TABLE 1 TO PARAGRAPH (a)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, andCosmetic Act (FFDCA).
DATES: This regulation is effective
August 24, 2023. Objections andrequests for hearings must be received
on or before October 23, 2023, and mustbe 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, isavailable 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 Roomis 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 Docketis (202) 566–1744. For the latest status
information on EPA/DC services, docket
access, visit https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:

Parts permillionCommodity****
Rice, bran 1 ...............................
Rice, grain 1 ..............................

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*
0.15
0.06

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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SUPPLEMENTARY INFORMATION:

I. General Information
A. Does this action apply to me?
You may be potentially affected bythis 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 readersdetermine whether this document
applies to them. Potentially affected
entities may include:• Crop production (NAICS code 111).
• Animal production (NAICS code112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).

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B. How can I get electronic access toother related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 throughthe 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 regulationand may also request a hearing on thoseobjections. You must file your objection
or request a hearing on this regulationin 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 mailand hand delivery of objections andhearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection orhearing request with the Hearing Clerk
as described in 40 CFR part 178, pleasesubmit 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 bedisclosed publicly by EPA without priornotice. Submit the non-CBI copy of yourobjection 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

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online instructions for submittingcomments. Do not submit electronicallyany information you consider to be CBIor 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 ordelivery of boxed information, please
follow the instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions oncommenting 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 filingof 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 byestablishing 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 thepetition prepared by Gowan Company,
which is available in the docket athttps://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 inaccordance with its authority under
FFDCA section 408(d)(4)(A)(i), EPA isestablishing tolerances for tea, dried andtea, instant. For details, see Unit IV.C.
III. Aggregate Risk Assessment andDetermination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (thelegal 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 areasonable certainty that no harm will
result from aggregate exposure to thepesticide chemical residue, including
all anticipated dietary exposures and allother exposures for which there isreliable information.’’ This includes
exposure through drinking water and inresidential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA togive special consideration to exposureof infants and children to the pesticide
chemical residue in establishing a

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57895

tolerance and to ‘‘ensure that there is areasonable certainty that no harm will
result to infants and children fromaggregate 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 dataand other relevant information in
support of this action. EPA has
sufficient data to assess the hazards ofand to make a determination on
aggregate exposure for trifluralinincluding exposure resulting from thetolerances 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 forthe same pesticide chemical. Where
scientific information concerning aparticular chemical remains unchanged,
the content of those sections would notvary between tolerance rulemakings,
and EPA considers referral back to thosesections as sufficient to provide an
explanation of the information EPA
considered in making its safety
determination for the new rulemaking.
EPA has previously publishedtolerance rulemakings for trifluralin inwhich EPA concluded, based on theavailable information, that there is areasonable certainty that no harm would
result from aggregate exposure totrifluralin and established tolerances forresidues of that chemical. EPA isincorporating previously publishedsections from these rulemakings as
described further in this rulemaking, as
they remain unchanged.
Toxicological profile. For a discussionof 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 trifluralinused for human health risk assessment
is discussed in Unit III.B. of thetrifluralin tolerance rulemaking
published in the Federal Register ofJuly 31, 2013 (78 FR 46267) (FRL–9393–
5). EPA notes that the unit ofmeasurement for the no-observedadverse-effect level (NOAEL) in theinhalation short-term (1 to 30 days)
exposure/scenario should be mg/m3, not
mg/kg/day as presented (i.e., theinhalation study NOAEL = 300 mg/m3).
The unit of measurement for the lowestobserved-adverse-effect level (LOAEL) is

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

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 andwere conducted with the Dietary
Exposure Evaluation Model with theFood Commodity Intake Database(DEEM–FCID, ver. 4.02), which
incorporates food consumption datafrom the United States Department ofAgriculture (USDA) National Health andNutrition 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 allcommodities. The partially refined
chronic and cancer dietary exposureand 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, andmonitoring data from the USDA’s
Pesticide Data Program (PDP) for asubset of risk driving commodities thatsignificantly reduced the cancer dietary
exposure estimates. Dietary exposure
estimates for the established uses andrequested 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 anticipatedresidue levels of pesticide residues infood and the actual levels of pesticide
residues that have been measured infood. 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, demonstratingthat the levels in food are not above thelevels 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 statesthat the Agency may use data on theactual percent of food treated forassessing chronic dietary risk only if:• Condition a: The data used arereliable and provide a valid basis toshow what percentage of the foodderived from such crop is likely tocontain the pesticide residue.

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Jkt 259001• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available onpesticide use and food consumption ina particular area, and the exposure
estimate does not understate exposurefor the population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimatesused. 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%; drybeans/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 othercommodities including tea. In the acuteanalysis, the Agency made theconservative assumption of 100 PCT.
In most cases, EPA uses available datafrom United States Department ofAgriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, andCalifornia 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 amaximum PCT for acute dietary risk
analysis. The average PCT figure foreach existing use is derived by
combining available public and private
market survey data for that use,averaging across all observations, androunding 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 figureis the highest observed maximum value
reported within the recent 10 years ofavailable public and private market
survey data for the existing use androunded up to the nearest multiple of
5%, except where the maximum PCT isless than 2.5%, in which case, theAgency 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

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from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certainthat the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information andconsumption information for significant
subpopulations are taken into accountthrough EPA’s computer-based modelfor evaluating the exposure ofsignificant subpopulations including
several regional groups. Use of thisconsumption 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 noregional population is exposed toresidue levels higher than thoseestimated by the Agency. Other than thedata available through national foodconsumption surveys, EPA does nothave available reliable information on
the regional consumption of food towhich trifluralin may be applied in aparticular area.
Drinking water and non-occupational
exposures. Because there are no
registrations for use of trifluralin on tea
in the United States associated with therequested tolerance, the estimateddrinking water concentrations andresidential exposure assessment havenot changed. For a detailed summary ofthe drinking water analysis andresidential exposure assessment fortrifluralin used for the human healthrisk 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, theAgency consider ‘‘available
information’’ concerning the cumulative
effects of a particular pesticide’s
residues and ‘‘other substances thathave 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, andprodiamine), the Agency has
determined that although trifluralinshares some chemical and/or
toxicological characteristics (e.g.,chemical structure or apical endpoint)with these other dinitroanilines, thetoxicological database does not support
a testable hypothesis for a common
mechanism of action. No further data
are required to determine that nocommon mechanism of toxicity exists
for trifluralin and the other
dinitroanilines and no further

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cumulative evaluation is necessary fortrifluralin. For additional details, referto the document titled ‘‘Dinitroanilines:
Screening Analysis of Toxicological
Profiles to Consider Whether a
Candidate Common Mechanism GroupCan Be Established’’ in docket ID
number EPA–HQ–OPP–2017–0420 athttps://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 ofsafety. EPA determines whether acuteand 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 bycomparing the estimated total food,water, and residential exposure to theappropriate points of departures toensure 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 populationgroup of concern. Chronic dietary (foodand 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 populationgroup receiving the greatest exposure.
EPA’s short-term aggregate exposure totrifluralin is based on residential anddietary routes of exposure. The shortterm aggregate MOEs are 24,000 for
adults and 15,000 for children 1 to lessthan 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 inintermediate-term residential exposure,
so intermediate-term aggregate risk isthe same as the chronic dietary risk andis not of concern.
A cancer aggregate assessment was
conducted for trifluralin since it isclassified 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 foodand drinking water exposures with theresidential dermal and inhalation
exposure from post-application

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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 anincreased cancer case) in the range of 1
in 1 million (or 1 × 10 ¥6) or less to be
negligible. The precision which can beassumed for cancer risk estimates is best
described by rounding to the nearest
integral order of magnitude on thelogarithmic scale; for example, risks
falling between 3 × 10 ¥7 and 3 × 10 ¥6are expressed as risks in the range of
10 ¥6. Considering the precision withwhich 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 concernof the range of 10 ¥6 until the calculated
risk exceeds approximately 3 × 10 ¥6.
This is particularly the case where someconservatism 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 therange of 1 × 10 ¥6 and are thus not ofconcern.
Therefore, based on the risk
assessments and information describedabove, EPA concludes that there is areasonable certainty that no harm will
result to the general population, or toinfants and children, from aggregate
exposure to trifluralin residues. Moredetailed information on this action canbe 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 forplant commodities, are available fortrifluralin and utilize gas
chromatography (GC) with electron
capture detection (ECD). The reported
limit of quantitation (LOQ) is 0.01 ppm.
Trifluralin was evaluated using theFood and Drug Administration (FDA)
multiresidue method, which is also
suitable for enforcement in determining
residues of trifluralin in plantcommodities.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances withinternational standards wheneverpossible, consistent with U.S. foodPO 00000

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57897

safety standards and agricultural
practices. EPA considers theinternational 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 fortrifluralin on tea commodities.
C. Revisions to Petitioned-For Tolerance
The petition requested a tolerance forresidues of trifluralin in or on tea at 0.05
ppm. Because residue data wasprovided for a processed tea commodity
rather than the raw agriculturalcommodity (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 establishedfor residues of trifluralin, 2,6-dinitroN,N-dipropyl-4(trifluoromethyl)benzenamine, in or ontea, 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 andBudget (OMB) has exempted these typesof 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’’ (66FR 28355, May 22, 2001), or Executive
Order 13045, entitled ‘‘Protection ofChildren from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does notcontain 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 thatare 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 etseq.) do not apply.

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This action directly regulates growers,
food processors, food handlers, and foodretailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power andresponsibilities established by Congressin the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will nothave a substantial direct effect on Statesor Tribal governments, on therelationship between the National
Government and the States or Tribal
governments, or on the distribution of
power and responsibilities among thevarious levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determinedthat 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).

■ 1. The authority citation for part 180

continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.

DATES: This regulation is effective

by designating the table as table 1 andadding in alphabetical order in newly
designated table 1 to paragraph (a) the
entries ‘‘Tea, dried 1’’ and ‘‘Tea,
instant 1’’ and footnote 1 following thetable to read as follows:

August 24, 2023. Objections andrequests for hearings must be received
on or before October 23, 2023 and mustbe filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).

§ 180.207 Trifluralin; tolerances forresidues.

identified by docket identification (ID)number EPA–HQ–OPP–2022–0797, isavailable at https://www.regulations.gov
TABLE 1 TO PARAGRAPH (a)or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
Parts
per
Commodityin the Environmental Protection Agency
millionDocket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
*
*
*
*
*
Constitution Ave. NW, Washington, DC
1
Tea, dried .................................
0.05
20004. The Public Reading Room is
Tea, instant 1 ...............................
0.05
open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
*
*
*
*
*
holidays. The telephone number for the
1 There are no U.S. registrations as of AuPublic Reading Room and OPP Docket
gust 24, 2023.
is (202) 566–1744. For the latest status
*
*
*
*
*
information on EPA/DC services, docket[FR Doc. 2023–18180 Filed 8–23–23; 8:45 am]access, visit https://www.epa.gov/
BILLING CODE 6560–50–P
dockets.
FOR FURTHER INFORMATION CONTACT:ENVIRONMENTAL PROTECTIONAGENCYPursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA willsubmit a report containing this rule andother required information to the U.S.
Senate, the U.S. House ofRepresentatives, 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).

[EPA–HQ–OPP–2022–0797; FRL–10971–01–
OCSPP]

List of Subjects in 40 CFR Part 180

SUMMARY: This regulation amends the

Therefore, for the reasons stated in thepreamble, EPA is amending 40 CFR
chapter I as follows:

VerDate Sep<11>201415:37 Aug 23, 2023

Jkt 259001

ADDRESSES: The docket for this action,(a) * * *40 CFR Part 180

Dated: August 14, 2023.
Charles Smith,Director, Registration Division, Office ofPesticide Programs.

need to establish a maximum
permissible level for residues ofAspergillus flavus strains TC16F,
TC35C, TC38B, and TC46G under
FFDCA when used in accordance withlabel directions and good agricultural
practices.

■ 2. In § 180.207, amend paragraph (a)VII. Congressional Review Act

Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.

lotter on DSK11XQN23PROD with RULES1PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDECHEMICAL RESIDUES IN FOOD

Madison Le, Biopesticides and Pollution
Prevention Division (7511M), Office ofPesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (202) 566–
1400; email address: BPPDFRNotices@
epa.gov.

Aspergillus flavus strain TC16F,
TC35C, TC38B, and TC46G;
Amendment to Temporary Exemptions
From the Requirement of a Tolerance

I. General Information

AGENCY: Environmental Protection

A. Does this action apply to me?

Agency (EPA).
ACTION: Final rule.

You may be potentially affected bythis 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 readersdetermine whether this document
applies to them. Potentially affected
entities may include:• Crop production (NAICS code 111).
• Animal production (NAICS code112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).

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 theFederal Food, Drug, and Cosmetic Act(FFDCA), requesting to amend theexisting temporary tolerance
exemptions for Aspergillus flavus
strains TC16F, TC35C, TC38B, andTC46G. This regulation eliminates the

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SUPPLEMENTARY INFORMATION:

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