
[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46267-46274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18420]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0304; FRL-9393-5]


Trifluralin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
trifluralin in or on the oilseed crop group 20. Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 31, 2013. Objections and 
requests for hearings must be received on or before September 30, 2013, 
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-2012-0304, 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), EPA West

[[Page 46268]]

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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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-2012-0304 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 
September 30, 2013. 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-2012-0304, 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.htm.

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 July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 
2E8011) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.207 be amended by 
establishing tolerances for residues of the herbicide trifluralin, 
(alpha, alpha, alpha-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine), 
in or on oilseed, crop group 20 at 0.05 parts per million (ppm). That 
document referenced a summary of the petition prepared by Dow 
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 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 kidney and the liver are the principal target organs for 
trifluralin in rats and dogs. In subchronic oral studies liver effects 
include increased liver weights and changes in clinical chemistry 
parameters. Kidney effects include decreased kidney weights, kidney and 
bladder tumors, increased blood urea nitrogen (BUN), increases in total 
protein, aspartate aminotransferase (AST) and lactate dehydrogenase 
(LDH) in the urine. Also, protein electrophoresis of urine samples 
showed [alpha]1-globulin and [alpha]2-globulin. Kidney effects also 
included tubular hyaline casts, minimal cortical tubular

[[Page 46269]]

epithelial regeneration, observed microscopically, and an increased 
incidence of progressive glomerulo-nephritis. In dogs exposed to 
trifluralin for 1 year, multifocal cortical tubular cytoplasmic pigment 
deposition was noted in the kidneys of both sexes. In the subchronic 
studies, blood effects such as lower hemoglobin levels and changes in 
clinical chemistry were reported in rats.
    There was qualitative evidence of increased 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). Also qualitatively, there is an 
indication of increased sensitivity in the 2-generation reproduction 
study in the rat in that 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).
    In male rats, trifluralin was associated with increased incidence 
of thyroid follicular cell combined adenoma, papillary adenoma, 
cystadenoma, and carcinoma tumors. Based on the available data, 
trifluralin has been classified as a 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. It is also not a neurotoxicant and 
does not appear to be an immunotoxicant.
    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 
Risk Assessment for the Establishment of Tolerances on Oilseed Crop 
Group 20'' pages 43-55 in docket ID number EPA-HQ-OPP-2012-0304.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for trifluralin used for 
human risk assessment is shown in the following Table.

  Table 1--Summary of Toxicological Doses and Endpoints for Trifluralin for Use in Human Health Risk Assessment
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                                    Point of Departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 100 mg/kg/    Acute RfD = 1.0 mg/  Developmental Toxicity Study Rat.
 years of age).                     day.                  kg/day.             LOAEL = 500 mg/kg/day, based on
                                   UFA = 10x...........  aPAD = 1.0 mg/kg/     reduced ossification of the
                                   UFH = 10x...........   day.                 vertebrae and ribs; thickened,
                                   FQPA SF = 1x........                        wavy or bent ribs; and increased
                                                                               total litter resorptions.
                                  ------------------------------------------------------------------------------
Acute dietary (General population    No endpoints identified from the available developmental toxicity studies
 including infants and children).       (rat and rabbit) were appropriate for an acute dietary assessment for
                                       trifluralin in the general population, including infants and children.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.4 mg/kg/day  Chronic RfD = 0.024  Chronic (capsule) Toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 40 mg/kg/day, based on
                                   UFH = 10x...........  cPAD = 0.024 mg/kg/   increased frequency of abnormal
                                   FQPA SF = 1x........   day.                 stool, decreased body weights and
                                                                               body weight gains, and decreased
                                                                               erythrocytes and hemoglobin and
                                                                               increased thrombocytes (males).
Incidental oral short-term (1 to   NOAEL= 10 mg/kg/day.  LOC for MOE = 100..  2-generation Reproduction Study in
 30 days).                         UFA = 10x...........                        Rats.
                                   UFH = 10x...........                       LOAEL = 32.5 mg/kg/day, based on
                                   FQPA SF = 1x........                        decreased pup weights in both
                                                                               generations and increased
                                                                               relative to body liver weights in
                                                                               the F2b females.
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE = 100..  30-Day Inhalation Study--Rat.
 days).                             NOAEL = 300 mg/kg/                        LOAEL = 1000 mg/m\3\ (270 mg/kg/
                                    day (inhalation                            day), based on increased
                                    absorption rate =                          methemoglobin and bilirubin in
                                    100%).                                     females and the incidence of
                                   UFA = 10x...........                        dyspnea and rufflerd fur in males
                                   UFH = 10x...........                        and females.
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------

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Cancer (Oral, dermal, inhalation)   Classification: Possible Human Carcinogen Q1 \*\ = 2.96 x 10-3 (mg/kg/day)-1
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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, PCT data for some existing uses, and DEEM default 
processing factors. Pesticide Data Program (PDP) monitoring data were 
used for carrot, orange, orange juice, pepper, potato, and tomato.
    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 are 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 the general U.S. 
population 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 
quantified using the same estimates as discussed in Unit III.C.1.ii., 
Chronic exposure.
    iv. 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, 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 average PCT for existing uses as follows:
    Almonds: 1%; asparagus: 20%; barley: 1%; green bean: 25%; broccoli: 
10%; cabbage: 40%; canola: 2.5%; cantaloupe: 25%; carrot: 40%; 
cauliflower: 10%; celery: 2.5%; corn: 1%; cotton: 30%; cucumber: 2.5%; 
dry bean/pea: 10%; garlic: 5%; grapefruit: 1%; grape: 2.5%; honeydew: 
20%; lemon: 1%; onion: 2.5%; orange: 1%; peach: 1%; peanut: 5%; pecan: 
1%; pepper: 25%; pistachio: 2.5%; potato: 2.5%; pumpkin: 5%; sorghum: 
1%; soybean: 5%; squash: 5%; sugarbeet: 2.5%; sugarcane: 5%; sunflower: 
10%; tomato: 60%; walnut: 1%; watermelon: 10%; and wheat: 1%.
    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

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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%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. 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 
is 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 estimate does 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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models 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. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
trifluralin and its major degradates TR-4 ([alpha],[alpha],[alpha]-
trifluoro-5-nitro-N4,N4-dipropyl-toluene-3,4-diamine), TR-6 (5-
trifluoromethyl-3-nitro-1,2-benzenediamine) and TR-15 (2-ethyl-7-nitro-
5-(trifluoromethyl) benzimidazole) (the residues of concern in drinking 
water) for acute exposures are estimated to be 23.83 parts per billion 
(ppb) for surface water and 0.0275 ppb for ground water. For chronic 
exposures for non-cancer assessments they are estimated to be 1.97 ppb 
for surface water and 0.0275 ppb for ground water. And for cancer 
assessments are estimated to be 1.59 ppb for surface water and 0.0275 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 23.83 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 1.97 ppb was used to 
assess the contribution to drinking water. And for cancer dietary risk 
assessment, the water concentration of value 1.59 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 including vegetable gardens, 
turf, and ornamentals. EPA assessed residential exposure using the 
following assumptions: EPA evaluated residential handler inhalation 
exposures, which are considered short-term in duration. The handler 
assessment did not consider dermal exposures because a dermal endpoint 
was not identified; in three dermal toxicity studies (21/28 days in 
rabbits; 21/28 days in rats; and 31-days in rats), trifluralin was 
tested up to the limit dose (1000 mg/kg/day) and caused no systemic 
toxicity. Handler exposure scenarios evaluated include the following:
     Loading/applying granulars with a push-type spreader;
     loading/applying granulars using a spoon, measuring scoop, 
shaker can, or via hand;
     mixing/loading/applying liquids with a hose-end sprayer;
     mixing/loading/applying liquids with low pressure handwand 
sprayer;
     mixing/loading/applying liquids with backpack sprayer; and 
applying trifluralin impregnated fabric squares to soil.
    In terms of cancer risk, the Agency considers all exposure to 
trifluralin, including the dermal and inhalation exposure expected for 
homeowners, to have an associated carcinogenic risk. Carcinogenic risk 
for homeowner applicators was assessed based on the application methods 
outlined above. An upper-end assumption was made that the users 
assessed will apply trifluralin each season, as labeled, with an 
assumed exposure period of 5 days per year for 50 years of their life. 
Specific methods (or scenarios) of application (spreader, sprayer, 
etc.) were assessed to demonstrate the full range of exposure due to 
method and area treated, although users are not expected to use one 
method for 50 years. Carcinogenic risk for homeowner applicators was 
assessed by combining dermal exposure (adjusted for an estimated 3% 
absorption based on ethalfluralin data) and inhalation exposure (100% 
absorption), calculating this exposure on a per day basis (``Lifetime 
Average Daily Dose'', in mg/kg/day), and then quantifying risk by 
multiplying the updated upper-bound carcinogenic potency factor 
(Q1*) of 2.96 x 10-3 (mg/kg/day)-1 by 
the combined exposure estimate.
    There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment (vegetable 
garden, golf course turf, turf) that has been previously treated with 
trifluralin. All residential exposures are considered to be short-term 
in duration (1-30 days). No acute dietary or short-term dermal points 
of departure have been selected for trifluralin; therefore; only 
incidental oral post-application non-cancer risk estimates for children 
1<2 years old were evaluated. This lifestage is not the only lifestage 
that could be potentially exposed for these post-application scenarios; 
however, the assessment of this lifestage is health protective for the 
exposures and risk estimates for any other potentially exposed 
lifestage. Non-cancer post-application scenarios assessed are as 
follows: Incidental oral (hand to mouth, object to mouth, and soil 
ingestion) exposure from granular applications to turf.
    Estimated post-application cancer risk for the general U.S. 
population includes infants and children; therefore, in accordance with 
Agency policy, a children's cancer risk estimate was not reported 
separately. For post-application cancer risk, the only adult post-
application residential scenarios that are applicable are the 
following:
     Dermal exposure to residues on lawns
     Dermal exposure to golf course turf
     Dermal exposure in home vegetable gardens.
    There may be post-application residential exposure scenarios for 
trifluralin which could be combined for purposes of an aggregate 
exposure assessment. Combinations for residential exposure scenarios 
should have a reasonable probability of occurring on a single day and 
the pest that an individual is attempting to

[[Page 46272]]

control must be considered. It is reasonable that an adult may treat 
their turf and garden on the same day.
    The worst case residential exposure for use in the adult non-cancer 
aggregate assessment reflects residential handler inhalation exposure 
from applying granules by hand to pre-plant ornamentals.
    The worst case residential exposure for use in the children 1<2 
years old non-cancer aggregate assessment reflects hand-to-mouth short-
term post-application exposures from granular application to 
residential turf.
    And lastly, the worst case residential exposure for use in the 
cancer aggregate assessment reflects dermal and inhalation exposure 
from loading/applying granules with a belly grinder to pre-plant 
ornamentals.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    EPA has not found trifluralin to share a common mechanism of 
toxicity with any other substances, and trifluralin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
trifluralin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 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 qualitative 
evidence of increased 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). Also qualitatively, there is an indication of increased 
sensitivity in the 2-generation reproduction study in the rat in that 
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).
    3. Conclusion. EPA has determined that the safety of infants and 
children would be adequately protected if the FQPA SF were reduced to 
1X. This determination is based on the following findings:
    i. The toxicity database for trifluralin is complete except for 
immunotoxicity testing. In the absence of specific immunotoxicity 
studies, EPA has evaluated the available trifluralin toxicity data to 
determine whether an additional uncertainty factor is needed to account 
or potential immunotoxicity. There are no indications in the available 
studies that organs associated with immune function, such as the 
thymus, are affected by trifluralin and trifluralin does not belong to 
a class of chemicals (e.g., the organotins, heavy metals, or 
halogenated aromatic hydrocarbons) that would be expected to be 
immunotoxic. Based on the above considerations in this unit, EPA does 
not believe that conducting the immunotoxicity study will result in a 
dose less than the point of departure already used in this risk 
assessment, and an additional database uncertainty factor (UF) for 
potential immunotoxicity does not need to be applied.
    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. Although qualitative evidence of increased susceptibility was 
seen in the rat developmental toxicity study, and an indication of 
increased sensitivity in the 2-generation reproduction study in the rat 
in that offspring effects, the concern for these effects is low for the 
following reasons: (1) The dose response was well characterized; (2) 
the developmental effects were seen in the presence of maternal 
toxicity; (3) clear NOAELs/LOAELs were established for maternal and 
developmental toxicities; and (4) for the rats in the 2-generation 
reproduction study, the effects were seen at a high-dose level (295 
milligrams/kilogram/day (mg/kg/day) for males and 337 mg/kg/day for 
females). Furthermore, 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. Finally, there are no residual 
uncertainties for pre-natal and post-natal toxicity since the doses 
selected for overall risk assessment are protective of the effects seen 
in these studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment for females 13-
49, the population identified as having potential acute exposure, was 
performed based on 100 PCT and tolerance-level residues. The chronic 
dietary exposure and risk estimates are somewhat refined and assumed 
tolerance level residues, some PCT data, and DEEM default processing 
factors. Pesticide Data Program (PDP) monitoring data were used for 
carrot, orange, orange juice, pepper, potato, and tomato. These 
refinements are based on reliable data and will not underestimate the 
exposure and risk to any population subgroups. 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 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-term, 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,

[[Page 46273]]

the only population subgroup 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 less than 1% of the cPAD 
for all population groups. 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 25,000 for adults 
and 26,000 for children. 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. The aggregate cancer 
risk estimate from trifluralin residues in food, drinking water, and 
residential exposure is 1 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.
    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 for the crops 
addressed in this document.

C. Revisions to Petitioned-For Tolerances

    PA has revised the tolerance expression to clarify (1) that, as 
provided in FFDCA section 408(a)(3), the tolerance covers metabolites 
and degradates of trifluralin not specifically mentioned; and (2) that 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression.

V. Conclusion

    Therefore, tolerances are established for residues of trifluralin, 
including its metabolites and degradates, in or on oilseed, crop group 
20 at 0.05 ppm. Compliance with the tolerance level is to be determined 
by only trifluralin [alpha],[alpha],[alpha]-trifluoro-2,6-dinitro-N,N-
dipropyl-p-toluidine, in or on the oilseed, crop group 20.
    Also, due to the establishment of the tolerance on oilseed, crop 
group 20, the existing tolerances for rapeseed, seed; flax, seed; 
mustard, seed; sunflower, seed; safflower, seed; and cotton undelinted 
seed are removed as unnecessary.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 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 final rule 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

[[Page 46274]]

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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: July 25, 2013.
Lois Rossi,
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. Remove the commodities cotton undelinted seed; flax, seed; mustard, 
seed; rapeseed, seed; safflower, seed; and sunflower, seed in the table 
in paragraph (a).
0
c. Add alphabetically the following commodity to the table in paragraph 
(a).
    The amendment 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 following table. Compliance with the tolerance 
levels specified in the following table is to be determined by only 
trifluralin [alpha],[alpha],[alpha]-trifluoro-2,6-dinitro-N,N-dipropyl-
p-toluidine, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Oilseed, crop group 20......................................        0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-18420 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P


