Trifluralin; Pesticide Tolerance, 57894-57898 [2023-18180]
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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
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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)—
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[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 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).
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0502; FRL–11272–01–
OCSPP]
Trifluralin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
List of Subjects in 40 CFR Part 180
AGENCY:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
SUMMARY:
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)
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:
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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
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).
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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
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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
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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.
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• 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
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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
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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 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
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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.
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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).
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.
[EPA–HQ–OPP–2022–0797; FRL–10971–01–
OCSPP]
List of Subjects in 40 CFR Part 180
SUMMARY:
VerDate Sep<11>2014
15:37 Aug 23, 2023
Jkt 259001
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
ENVIRONMENTAL PROTECTION
AGENCY
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).
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
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).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0797, is
available at https://www.regulations.gov
TABLE 1 TO PARAGRAPH (a)
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
Parts
per
Commodity
in the Environmental Protection Agency
million
Docket 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.
40 CFR Part 180
Dated: August 14, 2023.
Charles Smith,
Director, Registration Division, Office of
Pesticide Programs.
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.
(a) * * *
VII. Congressional Review Act
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
lotter on DSK11XQN23PROD with RULES1
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
Aspergillus flavus strain TC16F,
TC35C, TC38B, and TC46G;
Amendment to Temporary Exemptions
From the Requirement of a Tolerance
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
AGENCY:
A. Does this action apply to me?
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
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).
Environmental Protection
Agency (EPA).
ACTION: Final rule.
PO 00000
Frm 00038
Fmt 4700
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Agencies
[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57894-57898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18180]
-----------------------------------------------------------------------
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:
[email protected].
[[Page 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 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(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-
observed-adverse-effect level (NOAEL) in the inhalation short-term (1
to 30 days) exposure/scenario should be mg/m\3\, not mg/kg/day as
presented (i.e., the inhalation study NOAEL = 300 mg/m\3\). The unit of
measurement for the lowest-observed-adverse-effect level (LOAEL) is
[[Page 57896]]
correct as presented (i.e., LOAEL = 1000 mg/m\3\).
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
[[Page 57897]]
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 population-adjusted 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 short-term 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 x 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 x 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 x 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 x 10 -7 and 3 x 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 x 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 x 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-dinitro-N,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.
[[Page 57898]]
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
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.207, 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:
Sec. 180.207 Trifluralin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tea, dried \1\.............................................. 0.05
Tea, instant \1\............................................ 0.05
* * * * *
------------------------------------------------------------------------
\1\ There 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