[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Rules and Regulations]
[Pages 4340-4345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02523]



[[Page 4340]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0530; FRL-9985-23]


Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
trifloxystrobin in or on flax seed and amends an existing tolerance for 
aspirated grain fractions. Bayer CropScience requested these tolerances 
and amendments 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 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-2017-0530, 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: [email protected].

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-2017-0530 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-2017-0530, 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
7F8595 and 7F8633) by Bayer CropScience LP2, T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petitions requested that 40 CFR 
part 180 be amended by establishing a tolerance for residues of the 
fungicide trifloxystrobin in or on flax, seed at 0.4 parts per million 
(ppm) (7F8595) and requested an amendment of the existing tolerance in 
or on grain, aspirated fractions from 5.0 ppm to 15 ppm (7F8633). That 
document referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the commodity definitions and tolerance values. The reason for 
these changes are explained in Unit IV.D.

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

[[Page 4341]]

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 trifloxystrobin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with trifloxystobin 
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.
    With repeated dosing, the liver is consistently the target organ 
for trifloxystrobin. Liver effects characterized by an increase in 
liver weights and an increased incidence of hepatocellular hypertrophy 
and/or hepatocellular necrosis were seen in rats, mice, and dogs. The 
effects of reduced body weights and food consumption were also found in 
the majority of the toxicity studies. Intestinal disturbances, as 
indicated by diarrhea and vomiting, were seen in dogs and rats at 
higher dose levels relative to those which caused liver and body weight 
effects. This finding was consistent with those produced by other 
members of the strobilurin class.
    In the rabbit developmental toxicity study, an increase in the 
incidence of fused sternabrae was seen at a dose (500 mg/kg/day) 10 
times higher than the maternal LOAEL (50 mg/kg/day). No developmental 
toxicity was seen at the limit dose (1,000 mg/kg) in the rat 
developmental toxicity study, but decreased body weight and food 
consumption was found in the maternal animals at 100 mg/kg/day or 
above. In the rat reproduction study, both parent and offspring showed 
decreases in body weight during lactation at similar dose levels (55.3 
mg/kg/day). Therefore, there is no evidence of a qualitative or 
quantitative increase in sensitivity in the fetuses and pups of the 
developmental and reproduction studies, respectively. Trifloxystrobin 
was determined not to be carcinogenic in mice or rats following long-
term dietary administration. Mutagenicity testing was positive in 
Chinese Hamster V79 cells at cytotoxic dose levels but negative in the 
remaining mutagenicity studies.
    Trifloxystrobin was not neurotoxic in the acute neurotoxicity 
study, nor in any of the repeated dose studies in the available data. 
The requirement for a subchronic neurotoxicity study was waived because 
there is no evidence of neurotoxicity in the existing trifloxystrobin 
database or that of other strobilurin pesticides, and there are no 
neurotoxicity concerns for trifloxystrobin. However, a subchronic 
inhalation toxicity study is required for trifloxystrobin at this time.
    Specific information on the studies received and the nature of the 
adverse effects caused by trifloxystrobin 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 ``Trifloxystrobin. Human 
Health Risk Assessment for the Proposed New Use on Flax Seed and 
Increase of Established Tolerance on Aspirated Grain Fractions'' on 
pages 28-30 in docket ID number EPA-HQ-OPP-2017-0530.

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 trifloxystrobin used 
for human risk assessment is shown in Table 1 of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Trifloxystrobin 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 13-50       NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Developmental--Rabbit
 years of age).                     day UFA = 10x.        kg/day.             LOAEL = 500 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 2.5 mg/kg/     increased fetal skeletal
                                   FQPA SF = 1x........   day.                 malformation such as fused
                                                                               sternabrae.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  There were no appropriate toxicological effects attributable to a single
 including infants and children).   exposure (dose) observed in oral toxicity studies including maternal effects
                                    in developmental studies in rats and rabbits. Therefore, a dose and endpoint
                                    were not identified for this risk assessment.
----------------------------------------------------------------------------------------------------------------

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Chronic dietary (All populations)  NOAEL= 3.8 mg/kg/day  Chronic RfD = 0.038  Two-Generation Reproduction--Rat
                                    UFA = 10x.            mg/kg/day.          Maternal LOAEL = 55.3 mg/kg/day
                                   UFH = 10x...........  cPAD = 0.038 mg/kg/   based on decreased body weight
                                   FQPA SF = 1x........   day.                 and histopathological lesions in
                                                                               the liver, kidney and spleen.
                                                                              Offspring LOAEL = 55.3 mg/kg/day
                                                                               based on decreased pup body
                                                                               weights during lactation.
Incidental oral short-term (1 to   NOAEL= 3.8 mg/kg/day  LOC for MOE = 100..  Two-Generation Reproduction--Rat
 30 days).                          UFA = 10x.                                Maternal LOAEL = 55.3 mg/kg/day
                                   UFH = 10x...........                        based on decreased body weight
                                   FQPA SF = 1x........                        and histopathological lesions in
                                                                               the liver, kidney and spleen.
                                                                              Offspring LOAEL = 55.3 mg/kg/day
                                                                               based on decreased pup body
                                                                               weights during lactation.
Inhalation all durations.........  Oral study NOAEL=     LOC for MOE = 1000.  Two-Generation Reproduction--Rat
                                    3.8 mg/kg/day.                            Maternal LOAEL = 55.3 mg/kg/day
                                   UFA = 10x...........                        based on decreased body weight
                                   UFH = 10x...........                        and weight gain, decreased food
                                   UFDB = 10x..........                        consumption, liver, kidney and
                                                                               spleen effects.
                                                                              Offspring LOAEL = 55.3 mg/kg/day
                                                                               based on decreased pup body
                                                                               weights during lactation.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of significant tumor increases in two adequate rodent
                                    carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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). UFDB = to account for the absence of data or other
  data deficiency. 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 trifloxystrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing trifloxystrobin 
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from 
trifloxystrobin 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 trifloxystrobin. In estimating 
acute dietary exposure, EPA used food consumption information 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 acute dietary 
assessment assuming tolerance-level residues for all crop commodities, 
with DEEM default processing factors. For ruminant and swine liver, and 
meat byproducts, a correction factor of 3x was applied to the tolerance 
to account for contribution of Metabolite L7a in these commodities (not 
applicable to kidney). All other livestock commodities used tolerance-
level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, EPA conducted a partially refined 
chronic (food and drinking water) dietary assessment assuming average 
field trial residues for selected crops (subgroup 4-16A and 4-16B; 
subgroup 5-16; subgroup 13-07F; subgroups 19A and 19B; subgroups 22A 
and 22B; oranges; apples, and rice); all other crop commodities used 
tolerance-level residues. Percent crop treated (PCT) data were 
incorporated where available. Empirical and DEEM default processing 
factors were used. To account for contribution of Metabolite L7a, a 3x 
correction factor was applied to ruminant and swine liver, and meat 
byproducts (not applicable to kidney). All other livestock commodities 
used tolerance-level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that trifloxystrobin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    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

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require registrants to submit data on PCT.
    The following average percent crop treated estimates were used in 
the chronic dietary risk assessment for the following crops for which 
trifloxystrobin is currently registered: Almonds: 5%, apples: 25%, 
apricots: 10%, artichokes: 25%, cantaloupes: 5%, carrots: 2.5%, celery: 
20%, cherries: 25%, corn: <2.5%, cucumbers: <2.5%, dry beans/peas: <1%, 
grapefruit: 30%, grapes: 25%, hazelnuts: 65%, nectarines: 5%, oranges: 
5%, peaches: <2.5%, peanuts: 5%, pears: 10%, pecans: 15%, peppers: 5%, 
pistachios: 10%, plums/prunes: <2.5%, potatoes: <1%, pumpkins: 5%, 
rice: 15%, soybeans: <2.5%, squash: <2.5%, strawberries: 5%, sugar 
beets: 5%, sweet corn: <2.5%, tangerines: 5%; tomatoes: <2.5%, walnuts: 
<2.5%, watermelons: 5%. 100% CT was assumed for the remaining 
commodities.
    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 in the dietary exposure analysis and risk 
assessment for trifloxystrobin in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. 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 trifloxystrobin for acute 
exposures are estimated to be 41 parts per billion (ppb) for surface 
water and 631 ppb for ground water; and for chronic exposures are 
estimated to be 28 ppb for surface water and 356 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 631 ppb was used to assess 
the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 356 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).
    Trifloxystrobin is currently registered for the following uses that 
could result in residential exposures: Turf and ornamentals. EPA 
assessed residential exposure using the following assumptions: 
Residential handler exposure and risk estimates from trifloxystrobin 
registrations were previously re-assessed in 2014 to reflect updates to 
the Agency's 2012 Residential SOPs along with policy changes for body 
weight assumptions. Since the 2014 assessment, it has been determined 
that all trifloxystrobin product labels with potential residential use 
sites require that handlers wear specific clothing (e.g., long sleeve 
shirt/long pants) and use personal protective equipment (PPE). 
Therefore, EPA has made the assumption that trifloxystrobin products 
are not for homeowner use, and has not conducted a quantitative 
residential handler assessment at this time. Based upon the residential 
uses, adults and children performing physical post-application 
activities on turf (e.g., golfing, mowing) or ornamentals (e.g., 
activities in or around gardens or trees) may be exposed via dermal 
exposure to trifloxystrobin residues and children 1 to <2 years old may 
also be exposed via incidental oral post-application exposure to 
trifloxystrobin from treated turf. A dermal assessment was not 
conducted because an adverse systemic dermal hazard was not identified 
for trifloxystrobin. Therefore, the quantitative exposure/risk 
assessment for residential post-application exposures is based on 
incidental oral exposures from physical activities on turf (i.e., for 
children 1 to <2 years old).
    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.''
    EPA has not found trifloxystrobin to share a common mechanism of 
toxicity with any other substances, and trifloxystrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
trifloxystrobin 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 is no increased 
quantitative or qualitative susceptibility to trifloxystrobin in the 
developing or young animals as indicated by the results of the 
developmental studies in rat and rabbits and the 2-generation 
reproduction study in rats.
    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 for all routes of exposure other than 
inhalation. The FQPA SF of 10x has been retained for

[[Page 4344]]

inhalation endpoints only to account for the lack of the subchronic 
inhalation toxicity study for trifloxystrobin at this time. This 
decision is based on the following findings:
    i. The toxicity database for trifloxystrobin is complete with the 
exception of a subchronic inhalation toxicity study.
    ii. There is no indication that trifloxystrobin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that trifloxystrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. The exposure databases are complete, and the exposure 
assessments will not underestimate the potential dietary (food and 
drinking water) or non-dietary exposures for infants and children from 
the use of trifloxystrobin. The chronic dietary food exposure 
assessment was partially refined based on average residues and PCT for 
some crops and conservative ground water drinking water modeling 
estimates. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations, and are not 
likely to be exceeded. In addition, the residential post-application 
assessment is based upon the residential SOPs employing surrogate study 
data, as well as the use of a chemical-specific turf transferable 
residue study. The Residential SOPs are based upon reasonable ``worst-
case'' assumptions and are not expected to underestimate risk. These 
data are reliable and are not expected to underestimate risk to adults 
or children.

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 trifloxystrobin will occupy 3.4% 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 
trifloxystrobin from food and water will utilize 58% of the 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 
trifloxystrobin 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).
    Trifloxystrobin 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 trifloxystrobin.
    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 an aggregate MOE of 120 for 
children 1 to less than 2 years old. Because EPA's level of concern for 
trifloxystrobin is a MOE of 100 or below, this MOE is 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, 
trifloxystrobin 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 trifloxystrobin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, trifloxystrobin is not expected to pose a cancer risk to 
humans.
    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 trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with 
nitrogen phosphorus detection (GC/NPD)) 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: [email protected].

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 trifloxystrobin in or on 
flax seed or aspirated grain fractions.

C. Response to Comments

    Two comments were received to the Notice of Filing. One appeared to 
be related to the Department of Energy and stated in part that ``any 
environmentalist policy that would drive up the cost of energy, food, 
or other essential needs in the name of protecting nature must be 
rejected.'' This comment is not relevant to this action. A second 
comment stated in part ``Do not allow this toxic pesticide to be used 
anywhere in the world. Nobody needs this toxic chemical unleashed.''
    Although the Agency recognizes that some individuals believe that 
pesticides

[[Page 4345]]

should be banned on agricultural crops, the existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) authorizes EPA to establish tolerances when it determines that 
the tolerance is safe. Upon consideration of the validity, 
completeness, and reliability of the available data as well as other 
factors the FFDCA requires EPA to consider, EPA has determined that 
these trifloxystrobin tolerances are safe. The commenter has provided 
no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing the tolerance value on flax seed as 
requested but with the addition of a significant figure based on 
current practice and establishing a tolerance on grain, aspirated 
fractions using the commodity definition that is consistent with common 
commodity vocabulary currently used by the Agency. Also, based upon the 
relevant field trial and processing studies, EPA is modifying the 
tolerance in/on aspirated grain fractions to 10 ppm, not 15 ppm as 
proposed by the registrant. This is due to differences in how the 
Agency and the registrant each calculated the processed commodity 
residues for aspirated grain fractions.

V. Conclusion

    Therefore, a tolerance is established for residues of 
trifloxystrobin, including its metabolites and degradates, in or on 
flax, seed at 0.40 ppm, and the existing tolerance for grain, aspirated 
fractions is amended from 5.0 ppm to 10 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance and amends a tolerance 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 
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 19, 2019.
Michael Goodis,
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.  180.555, add alphabetically the entry ``Flax, seed'' and 
revise the entry for ``Grain, aspirated fractions'' in the table in 
paragraph (a) to read as follows:


Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Flax, seed..............................................            0.40
 
                                * * * * *
Grain, aspirated grain fractions........................              10
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-02523 Filed 2-14-19; 8:45 am]
BILLING CODE 6560-50-P