Document ID: EPA-HQ-OPP-2020-0038-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-09-10T04:00Z

<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007) >

<EPA Registration Division contact: [insert name and telephone number with area code] >

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action. >

<TEMPLATE: >

<Bayer CropScience >

< [Insert petition number] >

<	EPA has received a pesticide petition ([insert petition number]) from Bayer CropScience, 800 N. Lindbergh Blvd., St. Loiuis, MO 63141 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. >

< (Options (pick one) >
   
   <	1. by establishing tolerances and/or changing existing tolerances for residues of>

<	2. to establish an exemption from the requirement of a tolerance for>

<	[trifloxystrobin (benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its acid metabolite CGA - 321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid)] in or on the raw agricultural commodity [Tropical and Subtropical, Small fruit, edible peel, Crop Subgroup 23A] at [0.2] parts per million; [Caneberry, Crop Subgroup 13-07A] at [3.0] parts per million; [Currant, black and red] at [4.0] parts per million; [Edible-poddded Legume Vegetables Crop Subgroup 6A] at [1.5] parts per million; [Succulent Shelled Pea and Bean Crop Subgroup 6B] at [0.15] parts per million; [Pea, Dry, Seed] at [0.2] parts per million and [Oil, olive, refined] at [0.5] parts per million.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

<A. Residue Chemistry>

<	1. Plant metabolism. The metabolism of trifloxystrobin in plants (cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals (goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA-321113 are the residue of concern for tolerance setting purposes. >

<	2. Analytical method. A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection (LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen-phosphorus detection.  A newer analytical method is available employing identical solvent mixtures and solvent to matrix ratio (as the first method), deuterated internal standards, and liquid chromatography/mass spectrometry-mass spectrometry (LC/MS-MS) with an electrospray interface, operated in the positive ion mode.  The LODs for trifloxystrobin range from 0.002 ppm to 0.01 ppm, depending on the crops, and the LOQ of each analyte is 0.01 ppm. >

<	3. Magnitude of residues.  
Olive:

A total of eight field-residue trials (four harvest, four decline) were conducted in/on olives in Southern Europe (Portugal, Spain, Italy and Greece) following two foliar spray applications with Trifloxystrobin WG 50.

The treated plot in each trial received two foliar spray applications of Trifloxystrobin WG 50 at 60 g a.i./ha/application for a total target seasonal rate of 120 g a.i./ha.  The spray application interval ranged from 42 to 100 days.  The pre-harvest interval (PHI) in the harvest trials was 21 days.  In the decline trials, samples were collected at PHIs of -0, 0, 7, 14, 21 and 28 days.  Total trifloxystrobin residue (parent and acid metabolite) expressed as parent equivalents in olive collected 21 days after last application ranged from 0.03 to 0.11 ppm.

Olive is the representative commodity for Crop Subgroup 23A Tropical and Subtropical, Small fruit, edible peel, as such, Bayer is requesting that this European residue data in olives be used to establish an import tolerance of 0.2 ppm for Crop Subgroup 23A to facilitate trade from European countries.

Two olive processing trials were conducted in Spain and Greece.  For spray application the formulation Flint (50 WG) was used.  Flint 50 WG is a water dispersible granule formulation, containing 50 % Trifloxystrobin.  One foliar application was made at 0.060 - 0.072 kg active ingredient/ha.  A comparison of the residues in the raw agricultural commodity (RAC) with those in the processed fraction (refined oil) resulted in transfer factors of 4.8X and 3.5X with an average processing factor of 4.2X.  A review of the magnitude of residue studies with trifloxystrobin in olives shows the highest HAFT of 0.11 ppm was observed for olive.  Multiplying the olive HAFT (0.11 ppm) by the average refined oil processing factor (4.15X) gives 0.46 ppm.  Then rounding 0.46 ppm according the MRL Rounding Classes from the OECD MRL Calculator gives 0.5 ppm.

Raspberry:

A total of ten field-residue trials were conducted in/on raspberry fruit in Northern Europe (Belgium, Netherlands) or Southern Europe (France, Spain).  An additional four trials were conducted under greenhouse conditions in France.  The treatment regimen for all 14 trials was two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L).  The two applications were made at 200 g trifloxystrobin/ha/application with a target 7-day spray interval and target 3-day PHI.  Total trifloxystrobin residue expressed as parent equivalents in field-grown olives collected 3 days after last application ranged from 0.228 to 1.441 ppm, while residues in raspberries grown under greenhouse conditions and collected 3 days after last application ranged from 0.103 to 0.525 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for field-grown raspberries collected at 3-day PHI, the calculated tolerance for raspberries would be 3.0 ppm.

Raspberry is the representative crop for Crop Subgroup 13-07A Caneberry, as such,  Bayer is requesting this European residue data in field-grown raspberries be used to establish an import tolerance for Crop Subgroup 13-07A of 3.0 ppm to facilitate trade from European countries.

Currant:

A total of ten field-residue trials were conducted in/on black or red currant in Northern Europe (Northern France, Belgium, Netherlands) or Southern Europe (France, Spain).  An additional six trials were conducted under greenhouse conditions in Italy, France and Spain.  The treatment regimen for all 16 trials was two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L).  The two applications were made at 200 g trifloxystrobin/ha/application with a target 7-day spray interval and target 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents in field-grown current collected 7 days after last application ranged from 0.135 to 2.11 ppm, while residues in current grown under greenhouse conditions and collected 7 days after last application ranged from 0.16 to 0.37 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for field-grown current collected at 7-day PHI, the calculated tolerance for current would be 4.0 ppm.

Bayer is requesting that this European residue data in field-grown black and red currants be used to establish an import tolerance for currant, black and red of 4.0 ppm to facilitate trade from European countries.

Legume Vegetables (Crop Group 6):

Edible Podded legume vegetables (Subgroup 6A):
Podded bean:  Five field trials (two trials in/on French beans and three trials in/on kidney beans) were conducted in Northern Europe and eight field trials were conducted in/on kidney beans in Southern Europe.  In all 13 trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 7-day PHI.   In the kidney bean trials, the 2[nd] of the two applications was made at crop growth stages ranging from BBCH 67 to BBCH 77 followed by the collection of fresh podded bean samples 7 days later.  As such, Bayer considers the fresh kidney bean pod samples along with the French bean samples to satisfy the requirement of a succulent cultivar of edible-podded beans (Phaseolus spp.).  Total trifloxystrobin residue expressed as parent equivalents, in edible-podded beans collected 7-days after last application were 0.03 to 0.257 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for podded beans collected at a 7-day PHI, the calculated tolerance for succulent edible-podded beans would be 0.4 ppm.
Podded peas:  Twenty field trials were conducted in/on field pea in Northern and Southern Europe with two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) at 200 g trifloxystrobin/ha/application with a 7-day interval and 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents, in edible-podded peas collected 7-days after last application were 0.038 to 0.843 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for podded peas collected at a 7-day PHI, the calculated tolerance for succulent edible-podded peas would be 1.5 ppm.

Bayer is requesting that this European residue data in succulent cultivars of edible-podded beans and peas be used to establish an import tolerance of 1.5 ppm for Edible-podded legume vegetables Subgroup 6A to facilitate trade from European countries.

Succulent Shelled peas and beans (Subgroup 6B):
Shelled beans:  Five field trials were conducted in/on kidney beans in Northern and Southern Europe in which samples of green seed were collected to satisfy the requirement for a succulent shelled cultivar of bean (Phaseolus spp.).  In all five trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 14-day PHI.  In three of the trials, samples were also collected at 7-day PHI.  The 2[nd] of the two applications was made at a crop growth stage ranging from BBCH 67 (Flowering finishing: majority of petals fallen or dry) to BBCH 77 (70% of pods have reached typical length, pods still break cleanly) and green seed samples collected 7 and/or 14-days later.  As such, Bayer considers the green seed samples to satisfy the requirement for a succulent shelled cultivar of bean (Phaseolus spp.).  The total trifloxystrobin residues expressed as parent equivalent are shown in Table 1.

 Table 1:	Total trifloxystrobin residues expressed as parent (ppm)
                                    Trial #
                                  7-day PHI*
                                  14-day PHI
                                       1
                                     0.020
                                     0.020
                                       2
                                     0.020
                                     0.020
                                       3
                                     0.020
                                     0.067
                                       4
                                       -
                                     0.030
                                       5
                                       -
                                     0.061
* - = No sample

By using the 7-day PHI data along with the higher residue data seen at the 14-day PHI, the OECD MRL calculator calculates a tolerance for succulent shelled beans of 0.15 ppm.
Shelled peas: Fifteen field trials were conducted in/on field peas in Northern and Southern Europe in which samples of green seed were collected to satisfy the requirement for a succulent shelled cultivar of garden pea (pisium spp.).  In all fifteen trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 6 to 9-day interval and 7-day PHI.  Total trifloxystrobin residue expressed as parent equivalents, in succulent shelled peas collected 7-days after last application were <0.02 to 0.049 ppm.  Using the OECD MRL calculator and total trifloxystrobin residues for shelled peas collected at a 7-day PHI, the calculated tolerance for succulent shelled peas would be 0.08 ppm.

Bayer is requesting that this European residue data in succulent shelled cultivars of beans and garden peas be used to establish an import tolerance of 0.15 ppm for Succulent shelled pea and bean Subgroup 6B to facilitate trade from European countries.

Pea, Dry, Seed:
Dried peas:  Fourteen field trials were conducted in/on field peas in Northern and Southern Europe in which samples of dry seed were collected to satisfy the requirement for a dried cultivar of pea (Pisum spp.).  In all fourteen trials, two foliar spray applications of a 500 SC formulation of Fluopyram (250 g/L) and Trifloxystrobin (250 g/L) were made at 200 g trifloxystrobin/ha/application with a 7-day interval and 21-day PHI.  In three of the trials, samples were also collected at 14-day PHI.  The total trifloxystrobin residues expressed as parent equivalent are shown in Table 2.

 Table 2:	Total trifloxystrobin residues expressed as parent (ppm)
                                    Trial #
                                  14-day PHI*
                                  21-day PHI
                                       1
                                       -
                                     0.023
                                       2
                                       -
                                     0.025
                                       3
                                       -
                                     0.022
                                       4
                                       -
                                     0.138
                                       5
                                       -
                                     0.058
                                       6
                                       -
                                     0.020
                                       7
                                       -
                                     0.106
                                       8
                                     0.022
                                     0.022
                                       9
                                     0.020
                                     0.020
                                      10
                                     0.020
                                     0.020
                                      11
                                       -
                                     0.020
                                      12
                                       -
                                     0.020
                                      13
                                       -
                                     0.020
                                      14
                                       -
                                     0.020
* - = No sample

By using the 7-day PHI data along with the higher residue data seen at the 14-day PHI, the OECD MRL calculator calculates a tolerance for Dried shelled peas of 0.2 ppm.

Bayer is requesting that this European residue data in dried cultivars of field peas be used to establish an import tolerance 0.2 ppm for Pea, dry, seed to facilitate trade from European countries.

<B. Toxicological Profile>

<	1. Acute toxicity.  Trifloxystrobin is of low acute toxicity by oral, dermal, or inhalation routes of exposure (values greater than limit doses), but can cause dermal sensitization. Trifloxystrobin is a mild ocular and dermal irritant. >

<	2. Genotoxicty. Trifloxystrobin has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in an in vitro gene mutation assay in Chinese hamster V79 cells as a slight increase in mutant frequency at a very narrow range (250  -  278 g/mL) at cytotoxic and precipitating concentrations.  The chemical was found to be not genotoxic in all other in vitro and in vivo assay systems. Thus, the weight of the evidence indicates that trifloxystrobin is not genotoxic. >

<	3. Reproductive and developmental toxicity. In a developmental study in rats, reductions in body weight gain and food consumption were observed in the dams at 100 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters. The maternal and developmental NOAELs were 10 and 1000 mg/kg/day, respectively.

	In the rabbit developmental study, body weight loss and reduced food consumption were observed in the dams at 50 mg/kg/day, resulting in a maternal NOAEL of 10 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/kg/day. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40-65% lower food intake during treatment at this dose level. The developmental NOAEL was 250 mg/kg/day.

	In the 2-generation rat reproduction study, body weight gain and food consumption were decreased at 750 ppm (55.3 mg/kg/day), especially in females during lactation. Consequently, the reduced pup weight gain during lactation (750 ppm) and the slight delay in eye opening (1500 ppm; 110.6 mg/kg/day) were judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted.  Both the parental and offspring NOAELs were 50 ppm (3.8 mg/kg/day). The reproductive NOAEL was 1500 ppm (110.6 mg/kg/day). >

<	4. Subchronic toxicity. The liver was the target organ in all species tested with effects characterized by increases in liver weights and an increased incidence of hepatocellular hypertrophy and/or hepatocellular necrosis.  In subchronic testing, NOAELs were 500 ppm in rats [30.6 (M) and 32.8 (F) mg/kg/day] and mice [76.9 (M) and 110 (F) mg/kg/day] and 30 mg/kg/day in dogs. 

In a 28 - day dermal toxicity study in rats, the NOAEL was 1000 mg/kg/day, the highest dose level tested. >

<	5. Chronic toxicity. The liver was also the target organ in chronic testing in dogs and mice with findings similar to those seen in the subchronic studies.  The chronic NOAELs were 5 mg/kg/day in dogs and 300 ppm in mice [39.4 (M) and 35.7 (F) mg/kg/day].  In rats, a NOAEL of 250 ppm [9.81 (M) and 11.37 (F) mg/kg/day] was established based on decreased mean body weight and decreased mean body weight gain at the LOAEL of 750 ppm [29.7 (M) and 34.5 (F) mg/kg/day].

Trifloxystrobin did not cause any treatment-related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18-month mouse and the 24-month rat studies.  EPA determined that trifloxystrobin should be classified as "Not Likely to be Carcinogenic to Humans" based on the lack of evidence for carcinogenicity in rats and mice.  >

<	6. Animal metabolism. Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the elimination half-life is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester (hydrolysis into an acid), the methoxyimino group (O-demethylation), and the methyl side chain (oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite (CGA-321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl-phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.  >

<	7. Metabolite toxicology. Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied material remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA-321113 (formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20-times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/or soil. The studies indicate that these metabolites, including CGA-357261, CGA-373466, and NOA-414412, are not mutagenic to bacteria and are of low acute toxicity (LD50 >2000 mg/kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin. >

<	8. Endocrine disruption. Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of effects related to the endocrine system. >

<C. Aggregate Exposure>

<	1. Dietary exposure.  The most recent EPA acute and chronic dietary assessment was conducted for Registration Review (D439350, 5/31/2017).  This assessment did not include the proposed import tolerance for flax seed or proposed import tolerances on olives, legume vegetables, raspberries and currants.  The addition of proposed tolerances will have negligible impact on the dietary exposure previously conducted by EPA.  Assessments, using the most recent DEEM FCID Version 4.02 software, were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population and selected population subgroups to residues of trifloxystrobin.  Consumption data used in this program were taken from NHANES WWEIA 2005-2010.  These analyses cover all registered crops plus the proposed new uses.

A dietary assessment was evaluated based on established tolerances for all registered uses and 100% crop treated.  For the proposed new uses on pea, dry, seed, the proposed tolerance of 0.2 ppm was used in this assessment.  Dry peas can be used as alternative feedstuff serving as a source of roughage and protein.  The proposed uses are not feed to feedlot beef.  Addition of the proposed uses on feed items will have minimal effect on total burden for dairy cattle.  The current risk assessments are based on established livestock tolerances (milk = 0.02 ppm) which are more conservative than residues estimated from Maximum Reasonably Balanced Diets (MRBD).  

The EPA has established an acute Population Adjusted Dose (aPAD) of 2.5 mg/kg/day for acute dietary risk assessments based on a NOAEL of 250 mg/kg bw/day from a rabbit developmental toxicity study and an uncertainty factor or 100. The FQPA safety factor was reduced to 1x based on toxicological considerations by the FQPA Safety Factor Committee (HED Doc. No. 013545, B. Tarplee, 01/JUL/1999), the conservative residue assumptions used in the dietary exposure risk assessments, and the completeness of the residue chemistry and environmental fate databases (DP Num: 3 17330, B. O'Keefe,1 6/AUG/2006).  For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose (cPAD) of 0.038 mg/kg/day based on a NOAEL of 3.8 mg/kg bw/day from the rat reproduction toxicity study and an uncertainty factor of 100. 
                                       
Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U.S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the proposed uses on flax seed or new proposed tolerances on olives, legume vegetables, raspberries and currants. 

<	i. Food.  The acute assessments used 100% crop treated and tolerance level residue values.  The partially refined chronic assessment used percent crop treated where available, with both tolerance residue levels and average field trial residues for selected crops.  Acute exposure for food only, expressed at the 95[th] percentile of exposure, was 2.4% of the aPAD for Females 13-49 years old (only population subgroup of concern).  The chronic exposure was 9% cPAD for the Total US Population and 19% cPAD for the most sensitive population (Children 1-2 yrs. old).

<	ii. Drinking water. Additional import tolerances will have no impact on the previous estimation of trifloxystrobin in drinking water.  Estimated Drinking Water Concentrations (EDWCs) associated with trifloxystrobin use on all crops were calculated using PRZM-GW (ver. 1.07) and GENEEC to calculate ground water and surface water EDWCs, respectively.  The maximum acute and chronic ground water concentrations estimated by PRZM-GW were 631 ppb and 356 ppb, respectively, and were higher than the surface water estimates.  The value from the highest PRZM-GW exposure scenarios were incorporated into the dietary risk assessment.  The addition of the acute estimated drinking water concentration (EDWC) of 631 ppb resulted in 3.3% of the aPAD utilized for females 13-49 yrs. old.  The addition of the chronic EDWC of 356 ppb utilized 28% of the cPAD for the US Population and 79% of the cPAD for Infants (< 1 years old), the most highly exposed subpopulation.  In conclusion, the results of the acute and chronic dietary exposure analyses (including drinking water) are acceptable for all population subgroups examined.  Therefore, there is a reasonable certainty that no harm will result from exposure to potential residues of trifloxystrobin in food and water.

<	2. Non-dietary exposure. Addition of import tolerances for olives, legume vegetables, raspberries and currants will have no impact on the non-dietary exposure to trifloxystrobin. As such, non-dietary exposures from this change are covered by previous non-dietary risk assessments performed by EPA.

D. Cumulative Effects>

<	EPA has determined, as published in the Federal Register (FR Vol 73, no. 1, 02-Jan-08)), that unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. Therefore, EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances.

E. Safety Determination>

<	1. U.S. population.  Risk assessments for trifloxystrobin are based on a complete and reliable toxicity data package and highly conservative assumptions. Chronic aggregate dietary (food and water) exposure will utilize about 28% of the cPAD for the US Population.  Acute aggregate dietary exposure (food and water) for the females 13-49 yrs. old (the only population of concern) utilized 3.3% of the aPAD.  Therefore, there is a reasonable certainty that no harm will occur to the US Population from aggregate exposure (food and drinking water) to residues of trifloxystrobin. >>

<	2. Infants and children. No indication of increased susceptibility of rat or rabbit fetuses to in utero and/or postnatal exposure was noted in the developmental and reproductive toxicity studies.  EPA has determined that the toxicology database for trifloxystrobin regarding potential pre- and post-natal effects in children is complete and does not indicate any particular developmental or reproductive concerns.  The special FQPA SF has been reduced to 1X.  

Using the conservative assumptions described in the exposure section above, chronic dietary exposure to residues of trifloxystrobin in food and water for Infants (< 1 years old) (the most highly exposed sub group) is 79% of the cPAD.  There is no acute endpoint of concern for children and infants.  There are no non-dietary concerns for infants and children.>

F. International Tolerances

International and CODEX tolerances (MRLs) for trifloxystrobin are established for many crops in various countries including dry peas and beans.