
[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Rules and Regulations]
[Pages 4345-4351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02535]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0420; FRL-9983-89]


Trifluralin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
trifluralin in or on rosemary fresh leaves, rosemary dried leaves, and 
rosemary oil. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 15, 2019. Objections and 
requests for hearings must be received on or before April 16, 2019, and 
must

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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-2017-0420, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0420 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 
April 16, 2019. 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-2017-0420, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8580) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR part 180 be amended by establishing tolerances 
for residues of the herbicide trifluralin a,a,a-trifluoro-2,6-dinitro-
N,N-dipropyl-p-toluidine in or on rosemary, fresh leaves at 0.1 parts 
per million (ppm); rosemary, dry leaves at 0.1 ppm; and rosemary, oil 
at 2.18 ppm. That document referenced a summary of the petition 
prepared by Gowan Company, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the level at which the tolerance is being established for 
rosemary oil, and modified the significant figures and commodity 
definitions used to be in line with Agency policy. The reason for these 
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified 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.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as

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the relationship of the results of the studies to human risk. EPA has 
also considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    The primary target organs are the kidney and the liver in rats and 
dogs for trifluralin. Liver effects include increased liver weights and 
changes in clinical chemistry parameters. In the kidneys, tubular 
hyaline casts, minimal cortical tubular epithelial regeneration were 
observed microscopically, and an increased incidence of progressive 
glomerulonephritis was seen.
    In the rat developmental toxicity study, developmental effects 
(increased resorptions and wavy ribs) occurred in the presence of less 
severe maternal effects (decreases in body weight gain, clinical signs, 
and changes in organ weights). In the 2-generation reproduction study, 
offspring effects (decreased fetal, neonatal and litter viability) were 
observed at a dose level where there was less severe maternal toxicity 
(decreased body weight, body weight gain and food consumption). 
However, the concern was low since clear NOAELs/LOAELs were established 
for maternal and developmental toxicities and the doses selected for 
overall risk assessment would address the concerns seen in these 
studies. A 21-day dermal toxicity study in the rat showed no systemic 
toxicity at the limit dose of 1,000 mg/kg/day; dermal effects included 
sub-epidermal inflammation and ulcerations at 200 mg/kg/day. A rabbit 
21-day dermal toxicity study also did not show any systemic toxicity at 
1,000 mg/kg/day; dermal effects observed at the LOAEL (100 mg/kg/day) 
included erythema, edema, and/or scaling and fissuring. A 30-day 
inhalation exposure to rats with trifluralin at 1,000 mg/m \3\ resulted 
in increased methemoglobin and bilirubin, as well as dyspnea and 
ruffled fur. Trifluralin is not a neurotoxicant and does not appear to 
be an immunotoxicant.
    In male rats, trifluralin was associated with increased incidence 
of thyroid follicular cell combined adenoma, papillary adenoma, 
cystadenoma, and carcinoma tumors. It has been classified as ``Group C, 
possible Human Carcinogen.'' Extensive testing showed, however, that 
trifluralin is neither mutagenic nor genotoxic, and does not inhibit 
the polymerization of microtubules in mammalian cells.
    Specific information on the studies received and the nature of the 
adverse effects caused by trifluralin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Trifluralin: Human Health 
Draft Risk Assessment for Registration Review and a Proposed Section 3 
Use of Trifluralin on Rosemary'' on pages 52-59 in docket ID number 
EPA-HQ-OPP-2017-0420.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for trifluralin used for 
human risk assessment is discussed in Unit II.B. of the final rule 
published in the Federal Register of July 31, 2013 (78 FR 46267) (FRL-
9393-5).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to trifluralin, EPA considered exposure under the petitioned-
for tolerances as well as all existing trifluralin tolerances in 40 CFR 
180.207. EPA assessed dietary exposures from trifluralin in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for trifluralin. In estimating acute 
dietary exposure, EPA used 2003-2008 food consumption data from the 
U.S. Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA conducted an unrefined assessment using 
tolerance level residues, 100 percent crop treated (PCT), and default 
Dietary Exposure Evaluation Model (DEEM) processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, the chronic dietary 
exposure and risk estimates are somewhat refined and assumed tolerance-
level residues for the majority of commodities, PCT data for some 
existing uses, and DEEM default processing factors. Pesticide Data 
Program (PDP) monitoring data were used for carrots, potatoes, bell 
peppers, non-bell peppers, tomatoes, tomato paste, oranges, orange 
juice, grapes, grape juice, raisins, corn syrup, and wheat flour.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data is not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that trifluralin should be classified as a possible human 
carcinogen and a linear approach has been used to quantify cancer risk 
since no mode of action data are available.
    The aggregate cancer risk assessment for adults takes into account 
exposure estimates from dietary consumption of trifluralin from food, 
residential and drinking water sources. Exposures from residential uses 
are based on the lifetime average daily dose and assume an exposure 
period of 5 days per year and 50 years of exposure in a lifetime. 
Dietary exposure assumptions were

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quantified using the same estimates as discussed in Unit III.C.1.ii., 
Chronic exposure.
    iv. Anticipated residue and percent crop treated (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, 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.
    The Agency estimated the PCT for existing uses as follows:
    The chronic and cancer dietary exposure and risk assessments 
incorporated the following trifluralin average percent crop treated 
estimates: Almonds 2.5%; apricots 2.5%; asparagus 20%; barley 1%; 
beans, green 25%; broccoli 5%; Brussels sprouts 2.5%; cabbage 40%; 
canola 2.5%; cantaloupes 25%; carrots 30%; cauliflower 5%; celery 2.5%; 
chicory 20%; corn 1%; cotton 30%; cucumbers 2.5%; dry beans/peas 10%; 
grapefruit 2.5%; grapes 2.5%; honeydews 30%; lemons 2.5%; nectarines 
2.5%; oranges 2.5%; peaches 1%; peanuts 5%; peas, green 10%; pecans 1%; 
peppers 20%; plums/prunes 1%; potatoes 2.5%; pumpkins 5%; sorghum 2.5%; 
soybeans 2.5%; squash 2.5%; sugar beets 2.5%; sugarcane 5%; sunflowers 
5%; tomatoes 55%; walnuts 1%; watermelons 15%; and wheat 1%. For the 
remaining commodities, EPA assumed 100% crop treated.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic 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 one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models as well as monitoring data in the dietary 
exposure analysis and risk assessment for trifluralin in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of trifluralin. The 
estimated drinking water concentrations (EDWCs) were calculated using a 
Total Toxic Residues (TTR) exposure modeling method, where trifluralin 
and its major degradates of concern (TR-4, TR-6, TR-7, TR-14, and TR-
15) were combined. Further information regarding EPA drinking water 
models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC), the estimated 
drinking water concentrations (EDWCs) of trifluralin for acute 
exposures are estimated to be 57 parts per billion (ppb) for surface 
water and 1.0 ppb for ground water; for chronic exposures for non-
cancer assessments are estimated to be 15 ppb for surface water and 1.0 
ppb for ground water; and for chronic exposures for cancer assessments 
are estimated to be 4.4 ppb for surface water and 1.0 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 57 ppb was used to assess 
the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 15 ppb was used to assess 
the contribution to drinking water. For the cancer dietary risk 
assessment, the water concentration of value 4.4 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Trifluralin is currently registered for the following uses that 
could result in residential exposures: lawns, golf courses, vegetable 
and ornamental gardens. EPA assessed residential exposure using the 
following assumptions: For residential handlers, all registered 
trifluralin product labels with residential use sites (e.g., lawns, 
ornamental and vegetable gardens) require that handlers wear specific 
clothing (e.g., long sleeve shirt/long pants) and/or use personal 
protective equipment (PPE) except for one label. Therefore, EPA has 
assumed that only that one product is intended for homeowner use and 
has conducted a quantitative residential handler assessment based on 
the use sites and application rates as provided on the label. The 
quantitative exposure/risk assessment developed for residential 
handlers is based on the following scenarios: Applying granules via 
push-type spreader, spoon, cup, hand dispersal, and shaker can to 
residential vegetable and ornamental gardens.
    Although a non-cancer dermal risk assessment was not performed due 
to the lack of an adverse effect in the non-cancer dermal study, dermal 
exposure was estimated for the residential handler cancer risk 
assessment because dermal exposure does contribute to the overall 
cancer risk for trifluralin.
    There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment that has 
been previously treated with trifluralin. For the residential post-
application scenarios, all registered trifluralin product labels with 
residential use sites (e.g., turf/lawns and ornamental and vegetable 
gardens) were considered for quantitative assessment. Although there is 
the potential for dermal exposure to adults and children, a 
quantitative non-cancer dermal risk assessment was not conducted since 
no non-cancer dermal hazard was identified. The quantitative

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non-cancer exposure/risk assessment for residential post-application 
exposures is based on the following scenario: Incidental oral (hand to 
mouth, object to mouth, and soil ingestion) exposure for children (1 to 
<2) from granular formulations applied to turf.
    Episodic granular ingestion for children is a potential exposure 
pathway for granular formulations; however, this exposure scenario 
could not be assessed because an acute dietary endpoint for general 
population, including infants and children, was not selected due to no 
effect attributable to a single (or few) day(s) oral exposure observed 
in animal studies.
    Although a non-cancer dermal risk assessment was not performed due 
to the lack of an adverse effect in the non-cancer dermal study, dermal 
exposure was estimated for the residential post-application cancer risk 
assessment because dermal exposure does contribute to the overall 
cancer risk for trifluralin. Inhalation exposure is expected to 
negligible.
    The worst-case residential exposure scenario used in the adult non-
cancer aggregate assessment reflects inhalation exposure from 
applications to gardens via hand dispersal.
    The worst-case residential exposure used in the adult cancer 
aggregate assessment reflects dermal exposure from post-application 
exposure from liquid applications to treated gardens.
    The worst-case residential exposure used in the children 1<2 years 
old aggregate assessment reflects hand-to-mouth exposures from post-
application exposure to turf applications.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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 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 in 
www.regulations.gov.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10x, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was evidence of 
increased qualitative susceptibility in the rat developmental toxicity 
study, where fetal developmental effects (increased resorptions and 
wavy ribs) occurred in the presence of less severe maternal effects 
(decreases in body weight gain, clinical signs, and changes in organ 
weights); however, the concern was low since clear NOAELs/LOAELs were 
established for maternal and developmental toxicities. There was also a 
low concern for the qualitative susceptibility observed in the rat 
reproduction study since the dose-response was also well characterized; 
there was a clear NOAEL/LOAEL for maternal and developmental 
toxicities; and the effects were seen at a high-dose level (295/337 mg/
kg/day). Offspring viability was not adversely affected in the two 
other 2-generation studies with trifluralin at dose levels up to 100 
and 148 mg/kg/day. Similarly, there are no residual uncertainties for 
pre- and postnatal toxicity since the doses selected for overall risk 
assessment will address the concerns seen in these studies.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for trifluralin is complete.
    ii. There is no indication that trifluralin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. As noted in section D.2., there was evidence of increased 
qualitative susceptibility in the rat developmental toxicity study, 
however, the concern was low for the reasons outlined in that section; 
furthermore, there was also a low concern for the qualitative 
susceptibility observed in the rat reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on a refined risk assessment that incorporated some PCT and anticipated 
residue information. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
trifluralin in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by trifluralin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to trifluralin will occupy less than 1% of the aPAD for females 13-49 
years old, the only population group of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
trifluralin from food and water will utilize 3.7% of the

[[Page 4350]]

cPAD for all infants less than 1 year old, the population group 
receiving the greatest exposure. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of trifluralin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Trifluralin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to trifluralin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 24,000 for adults 
and 15,000 for children 1 to less than 2 years old. Because EPA's level 
of concern for trifluralin is a MOE of 100 or below, these MOEs are not 
of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
trifluralin is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
trifluralin.
    5. Aggregate cancer risk for U.S. population. A cancer aggregate 
assessment was conducted for trifluralin since it is classified as a 
``Group C, Possible Human Carcinogen'' with a Q \1\ * 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 dermal and inhalation 
exposure from post-application exposure from treated gardens. The 
resulting aggregate cancer risk estimate for adults 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 negligible.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to trifluralin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) with 
electron capture detection (ECD)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for trifluralin on rosemary.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance of 3.0 ppm for residues of 
trifluralin in rosemary oil rather than the proposed value of 2.18 ppm 
based on Codex rounding classes. For the other tolerances that vary 
from what the petitioner requested, EPA is establishing tolerance 
values to conform to current Agency practices on significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of trifluralin, 
including its metabolites and degradates, in or on rosemary, dried 
leaves at 0.10 ppm; rosemary, fresh leaves at 0.10 ppm; and rosemary, 
oil at 3.0 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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

[[Page 4351]]

Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 21, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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:
0
a. Revise the introductory text of paragraph (a).
0
b. Add alphabetically the entries for ``Rosemary, dried leaves''; 
``Rosemary, fresh leaves''; and ``Rosemary, oil'' to the table in 
paragraph (a).
    The revision and additions read as follows:


Sec.  180.207  Trifluralin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
trifluralin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only trifluralin (2,6-
dinitro-N,N-dipropyl-4-(trifluoromethyl)benzenamine).

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Rosemary, dried leaves..................................            0.10
Rosemary, fresh leaves..................................            0.10
Rosemary, oil...........................................             3.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-02535 Filed 2-14-19; 8:45 am]
 BILLING CODE 6560-50-P


