EPA Registration Division contact: Laura Nollen

Interregional Research Project Number 4 (IR - 4) Petition Number 9E7652 EPA has received a pesticide petition , PP # 9E7652, from IR - 4 , 500 College Road East, Suite 201W, Princeton, NJ 08540 , 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. 442 by establishing a tolerance for residues of bifenthrin, (2 -methy l [1,1 ′-bipheny

l] - 3 - yl) methy

l - 3 - (2 - chloro - 3,3,3, - trifluoro - 1 -propeny

l) - 2,2 - dimethy

lcyclopropanecarboxyl ate), in or o n tea at 2 5 ppm (import tolerance ); and tolerances with regional registrations in or on grass , forage at 2 .5 ppm ; and grass, hay at 4.5 ppm . EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency

of the submitted data at this time or whether the data supp orts granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry

1. Plant metabolism . The metabolism of bifenthrin in plants is adequately understood. Studies have been conducted to delineate the metabolism of radiolabelled bifenthrin in various crops all showing similar results. The residue of concern is the parent compound only.

2. Analytical method. There is a practical analytical method for detecting and measuring levels of bifenthrin in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances (Gas Chromatography with Electron Capture Detection (GC/ECD).

3. Magnitude of residues . Field residue trials meeting EPA study requirements have been conducted at the maximum label rate for the crop s blueberries and celery . Results from the studies demonstrate that the highest bifenthrin residues found will not exceed the proposed tolerances for Tea at 2 5 ppm, Grass, forage at 2.5 ppm , and Grass, hay at 4 .5 ppm when bifenthrin is applied following the proposed use directions. B. Toxicological Profile

1. Acute toxicity . For the purposes of assessing acute dietary risk, F MC has used the results of the 2003 EPA completed risk assessment for bifenthrin. This acute dietary endpoint used to determine acute dietary risks to the general population including infants and children is from the acute neurotoxicity

study in rats, (LOAEL) = 70.3 mg -/kg /day, NOAEL = 32.8 mg -/kg /day, UF = 1000, Acute RfD = 0.033 mg/kg/day.2. Genotoxicty . The mouse ly mphoma mutagenesis assay g ave a weak positive result; however, the weight of the evidence from short-term mutagenicity tests indicate that bifenthrin is not mutagenic.

3. Reproductive and developmental toxicity . i. Rat reproduction study . P arental toxicity o ccurred as decreased body w eight at 5.0 mg/kg/day with a no observed adverse effect level (NOAEL) of 3.0 mg/kg/day . There were no developmental (pup) or reproductive effects up to 5.0 mg/kg/day

(highest dose tested). ii. Postnatal Sensitivity . Based on the absence of pup toxicity up to dose levels, which produced toxicity in the parental animals, there was no evidence of special postnatal sensitivity to infants and children in the rat reproduction study . In a developmental neurotoxicity study , pups were not more sensitive than the dams. The NOAELs for maternal and developmental neurotoxicity were both 50 ppm.

4. Subchronic toxicity . The result s of the 21 - day dermal toxicity

study in rats is used for short-term (1 - 30 days), intermediate -term (1 - 6 months) and long-term (> 6 months) dermal risk calculations. The 21 - day dermal toxicity

study NOAEL for systemic toxicity i s 47 mg ai/kg/day based on observations of clinical signs (exaggerated hindlimb flexion and staggered gait) .

5. Chronic toxicity . The reference dose (RfD) has been established at 0.004 mg/kg/day. This RfD is based on a one - year oral study in dogs with a LO AEL of 2.7 mg /kg/day a nd a NOAEL of 1.3 mg /kg/day, UF = 300 based on observations of increased incidence of tremors in both sexes. ii. Bifenthrin is classified as a Group C chemical (possible human carcinogen); No Q1* has been derived. 6. Animal metabolism . The metabolism of bifenthrin in animals is adequately understood. Metabolism studies in rats with single doses demonstrated that about 90% of the parent compound and its hy

droxylated metabolites are excreted. 7. Metabolite toxicology . The Agenc y has previously determined that the metabolites of bifenthrin are not of toxicological concern and need not be included in the tolerance expression . 8. Endocrine disruption . No special studies investigating potential estrogenic or other endocrine effects of bifenthrin have been conducted. H owever, no evidence of such effects was reported in the standard battery of required toxicology

studies, which have been completed and found acceptable. B ased on these studies, there is no evidence to suggest that bifenthrin has an adverse effect on the endocrine system .. C. Aggregate Exposure1. Dietary exposure . Tolerances have been established for the residues of

bifenthrin, in or on a variety of raw agricultural commodities. T olerances, in support of registrations, currentl y ex ist for residues of bifenthrin on the following crops: hops, strawberries, corn (grain, forage and fodder), sweet corn, eggplant, cottonseed, artichokes, peppers (bell and non -bell), lettuce (head), grapes, spinach, cabbage, rapeseed, tomatoes, Food Handling Esta blishments, banana (import), pears , okra, cilantro , may haw, peanut, and soy

beans . Also for the crop groups: vegetables, cucurbit, group 9, fruit, citrus, group 10 and nuts, tree, group 14 , fruiting vegetables, group 8 and the subgroups: vegetable, legume, edible podded, subgroup 6A, pea and bean, succulent shelled, subgroup 6B, caneberry subgroup 13A, and brassica, head and stem, subgroup 5A, herb subgroup 19A , leaf petioles subgroup 4B, vegetables tuberous and corm, subgroup 1C, pea and bean, dried shelled, except soy beans, subgroup 6C , root crops, subgroup 1B, bushberries, subgroup 13B . Also, for the livestock commodities of cattle, goats, hogs, horses, sheep, poultry , eggs, and milk. F or the purposes of assessing the potential dietary exposure f

or these existing and pending tolerances, EPA conducted an exposure estimate using Dietary Exposure Evaluation Model

– Food Commodity Intake Database TM (DEEM - FCID TM ) Version 2.1 4 , results from field trials and processing studies, monitoring data, consumption data from the 1989 - 1992, USDA Continuing Surveys of Food Intakes by Individuals (CSFII), and information on the percentages of the crops treated (where available) with bifenthrin were utilized. i. Food. a. Acute Dietary Exposure risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility o f an effect of concern occurring as a result of a 1 - day

or single exposure. For the purposes of assessing acute dieta ry risk, FMC has used the results of the 2003 EPA completed risk assessment for bifenthrin. This acute dietary endpoint used to determine acute dietary risks to the general population including infants and children is from the acute neurotoxicity

study in rats, LOAEL= 70.3 mg/kg /day, NOAEL

=3 2.8 mg /kg

/day, UF = 100, Acute RfD = 0. 328 mg/kg/day. Assumptions of tolerance - level resi dues and 100 percent crop treated were incorporated into a Tier I analysis. The 9 5 th percentile of exposure for the general U.S. Popula tion is estimated to be 0.0 127 mg/kg /day ( 3.88 % aPAD). The 9 5 th percentile of exposure for infants <1 year old (most highly exposed population subgroup) is estimated to be 0.0 256 mg/kg/day ( 7.80 % aPAD). The 9 5 th percentile of exposure to children 3 - 5 ye ars old is estimated to be 0.0 1 52 mg/ kg/day (4.64 % aPAD). B ased on the conservatism used in the analyses, actual dietary exposure will be less than that presented here. F MC concludes that based on adequate % aPAD for all population subgroups there is reasonable certainty that no harm will result from the proposed additional uses of bifenthrin. b. Chronic Exposure. The reference dose (Rf D) has been established at 0.013 mg/kg/day . This RfD is based on a one - ye ar oral study in dogs with a LOAEL of 2.7 mg /kg/day and a NOAEL of 1.3 mg /kg/day, UF = 1 00 based on observations of increased incidence of tremors in both sexes. The Tier I chronic exposures for the general U.S. Population are estimated to be 0.00 47 mg/kg/day

and utilize 34.9 % of the c PAD. The chronic exposures for all infants <1 year old (most highly

exposed population subgroup) is estimated to be 0.0 118 mg/kg/day and utilizes 90.6 % of the cPAD. Chronic dietary exposure estimates for children 1 - 2 year s old is estimated to be 0.00 96 mg/kg/day and utilizes 73.3 % of the cPAD. Theref ore, FMC concludes withreasonable certainty that no harm will result from the proposed additional uses of bifenthrin. ii. Drinking water . US EPA ’ s draft SOP for Incorporating Estimates of Drinking Water Exposure into Aggregate Risk Assessments was used to perform a drinking water analysis. This SOP utilizes a variety of tools to conduct drinking water assessment. These tools include water models such as FQPA Index Reservoir Screening Tool (FIRST), PRZM/EXAMS, SCIGROW and monitoring data. I f monitoring data are not available then the models are used to predict potential residues in surface water. A c omparison of the calculated Drinking Water Level of Concern (DWLOC) value to the Estimated Environmental Concentration (EEC) is made. If the DWLOC exceeds the EEC value then there is reasonable certainty t hat no harm will result from the short- or intermediate -term aggregate exposure. I n the case of bifenthrin, monitoring data do not exist, so the FIRST model was used to estimate a surface water residue a nd SCIGROW for the groundwater. Based on the analyses the acute aggregate exposures to bifenthrin residues, the DWLOC for all seasons for the general US population was 11 ppm (11,000 ppb) while the modeled EEC, was 0.1 and 0.006 ppb for surface water and ground water respectively. F or children (1 - 6 year old), the DWLOCs was 2.3 ppm (2300 ppb) while the modeled EEC was the same as that for the whole US population. F or the chronic aggregate exposures to bifenthrin residues, the DWLOC for all seasons for the US population was 291 ppb while the modeled EEC, was 0.1 and 0.006 ppb for surface water and ground water respectively. For children (1 - 6 year old), the DWLOCs was 26 ppb while the modeled EEC was the same as that for the whole US population. S ince , the calculated DWLOC values for all population subgroups exceeded the modeled EEC for surface water and ground water residues, there is reasonable certainty t hat no harm will result from aggregate exposures to bifenthrin residues .

2. Non - dietary expos ure . The aggregate residential exposure anal ys es were based on conservative screening - level assumptions. The residential risk assessments resulted in acceptable MOEs and a clear indication of reasonable certainty o f no harm. The short - term anal ys es, all of the route - and product - specific MOEs were greater than 1 00 and the aggregate MOEs were greater than 1 00 for all population subgroups. B ased on the above information, FMC concludes that bifenthrin does not pose a risk due to short - and interm ediate - term aggregate exposure. D. Cumulative Effects

To our knowledge there are currently no available data or other reliable information indicating that any

toxic effects produced by b ifenthrin would be cumulative with those of other chemical compounds; thus only the potential risks of bifenthrin have been considered in this assessment of its aggregate exposure. E. Safety Determination

1. U.S. population . Using the conservative Tier 1 exposure assessment analyses the estimated chronic exposure to the U.S. Population is 0.0047 mg/kg/day a nd utilizes 3 5.9 % of the cPAD. I n addition, the chronic exposure estimates for all population subgroups (including infants and children) are well below the cPAD of 0.013 mg/kg/day. The acute dietary exposure analyses at the 9 5 th percentile for the general U.S. Population is 0.0 127 and utilizes 3.88 % of the aPAD. I naddition, the acute exposure estimates for population subgroups of concern (infants and children)

indicate that the maximum %aPAD or %cPAD utilized is 7.80 % (aPAD) and 90.6 % (cPAD) . Based on this information FMC concludes that there is reasonable certainty that no harm will result from acute and chronic exposure to bifenthrin.

2. Infants and children . i. General. In assessing the potential for additional sensitivity

o f infants and children to residues of bifenthrin, FMC considered data from developmental toxicity

s tudies in the rat and rabbit, a developmental neurotoxicity s tudy , and a two - generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development to one or both parents. Reproduction studies provide information relating to effects from exposure to the systemic toxic ity . F FDCA Section 408 provides that the EPA may a ppl y an additional margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and completeness of the database. i i. Developmental toxicity

s tudies. In the rabbit developmental study , there were no developmental effects observed in the fetuses exposed to bifenthrin. The maternal NOAEL was 2.67 mg/kg/day based on head and forelimb twitching at the LOAELo f 4 mg/kg/day . In the rat developmental study , the maternal NOAEL was 7.4 mg/kg/day, based on treatment - related clinical signs and reductions in body

w eights, adjusted maternal body w eights, and corresponding reductions in food consumption noted among dams receiving the LOAEL of 16.3 mg/kg/day . The developmental NOAEL was greater than 16.3 mg/kg/day b ased on lack of any adverse fetal effects at levels up to and including 16.3 mg/kg/day . iii. Developmental neurotoxicity study . In a rat developmental neurotoxicity s tudy , pups were not more sensitive than the dams. The NOAEL for maternal toxicity w as 50 ppm, based on tremors at the LO ELo f 100 ppm. The NOAEL for developmental neurotoxicity w as also 50 ppm. iv. Reproductive toxicity s tudy . In the rat reproduction study , parental toxicity o c curred as decreased body w eight at 5.0 mg/kg/day with a NOAEL of 3.0 mg/kg/day . There were no developmental (pup) or reproductive effects up to 5.0 mg/kg/day

(highest dose tested). v. Conclusion. Based on the absence of fetal effects and pup toxicity

in any of the referenced studies, FMC concludes that reliable data support use of the standard 100 - fold uncertainty f actor, and that an additional uncertainty factor is not needed to protect the safety of infants and children. A s previously s tated, aggregat e exposure assessments utilized no more than 45.5 % of the aPAD or cPAD for either the entire U.S. Population or any of the population subgroups including infants and children. Therefore, it may b e concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to bifenthrin residues. F. International Tolerances

There are tolerances/MRL’s established for tea in other count ries as follows: Japan 25.0 ppm, China 5.0 ppm, I ndia 5.0 ppm, Taiwan 2.0 ppm, European Union 5.0 ppm .