
[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


