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**EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER**  **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 instr uctions that appear in**  **green , i.e., “**  **[ insert**  **company name ]**  **,” with the information specific to your action. TEMPLATE:**  [ Cheminova A/S ] [Insert petition number] EPA has received a pesticide petition ( [insert petition number] ) from [ Cheminova A/S ] , [ 1600 Wilson Blvd, Suite 700, Arlington, VA 22209 - 2510 ] request ing, 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 1. by establishing an import tolerance for residues of [ Gamma - cy

ha lothrin ] in or on the raw agricultural commodit ies [ Fruit, Citrus, Group 10 - 10 ] at [ 0. 07 ] p arts per million (ppm) , [ Citrus, dried pulp ] at [ 0. 2 ] parts per million (ppm) , and [ Citrus, oil ] at [ 3.5 ] parts per million (ppm) . EPA has determined that the petit ion contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not full y 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. [ No new plant metabolism data are being submitted with this petition. The relevant data to satisfy this data requirement have been previously submitted to the Age ncy . EPA has reviewed and evaluated the metabolism studies in granting Section 3 approvals for a variet y of crops, for both lambda - cy halothrin and gamma - cy

halothrin. ] 2. Analytical method. [ An adequate anal yt ical method for determining lambda cy halothri n in plant matrices has been previousl y s ubmitted and accepted by EPA. (Note: the anal yt ical enforcement methods for lambda - cy halothrin are applicable for2

determination of gamma - cy halothrin residues.) ] 3. Magnitude of residues. [ R esidue trials were con ducted on oranges, lemons, and grapefruits. The application rate used two foliar applications at 0.0134 lb a.i./A with a pre - harvest interval (PHI) of 7 day s and a 15 - day spray interval. As part of the same residue stud y, processing trials were also cond ucted. Using the results of the residue study , separate tolerances were calculated for oranges, grapefruits, and lemons rang ing from 0.03 ppm to 0.07 ppm. Therefore, a tolerance of 0.07 ppm is proposed for the citrus crop group. The results of the proce ssing stud y led to additional tolerances of 0.2 ppm and 3.5 ppm being proposed for citrus, dried pulp and citrus, oil, respectively . ] B. Toxicological Profile No new toxicological data are being submitted with this package since the toxicology

database for gamma - cy

halothrin is complete. EPA has reviewed the entire database and , according to EPA’s June 2011 L ambda - cy halothrin and Gamma cy halothrin Final Work Plan (FWP) for Registration Review and EPA’s March 31, 2008 Gamma - Cy

halothrin risk assessment (PC Code: 128807 and DP Barcodes: 333324, 346771, and 348227), and EPA’s March 18, 2004 Gamma Cy halothrin Toxicology Disciplinary

Chapter for the Registration Support Document (PC Code: 128807, DP Barcode: D288053), no additional toxicology studies were noted as being required . The only exception is for an immunotoxicity study and this requirement was recently waived for all sy

nthetic py rethroids, including gamma - cy halothrin (please refer to EPA’s August 12, 2013 memorandum regarding a July 25, 2013 HASPOC m eeting for details). Therefore, the toxicology database currently at EPA can be considered complete. 1. Acute toxicity. [ See above. ] 2. Genotoxicty. [ See above. ] 3. Reproductive and developmental toxicity. [ See above.] 4. Subchronic toxicity. [ S ee above.] 5. Chronic toxicity. [ See above.] 6. Animal metabolism: [ No new animal metabolism data are being submitted with this petition. The relevant data to satisfy this data requirement have been previously submitted to the Agency . EPA has review ed and evaluated the metabolism studies in granting Section 3 approvals for a variet y of crops, for both lambda - cy halothrin and gamma - cy

halothrin . ] 7. Endocrine disruption . **[** As required under FFDCA section 408(p), EPA has developed the Endocrine Disrupt or Screening Program (EDSP) to determine whether certain substances may

have an effect in humans or wildlife similar to an effect produced by a naturall y occurring estrogen. EPA has issued test orders/data call - ins for the first 673

chemicals identified fo r the screening program. Lambda - and gamma - cy halothrin are not among the 58 pesticide active ingredients on the initial EDSP screening list **. ]**  C. Aggregate Exposure 1. Dietary exposure. [ Import tolerances are proposed for residues of gamma cy halothri n on fruit, citrus, group (10 - 10); citrus, dried pulp; and citrus, oil. For the purposes of assessing the potential dietary exposure, tolerances were calculated using the OECD MRLcalculator for the above crops. As per EPA guidelines, the tolerances on p rocessed commodities were derived b y multiplying the highest average citrus field trial (HAFT) b y the relevant processing factor and then rounding up. However, for the purposes of the risk assessment, since all anal yz ed pulp samples for oranges, lemons, and grapefruits contained residues less than the LOD of 0.003 ppm, a value of 0.0015 ppm (1/2 the LOD) was used for all commodities except for citrus peel (for which the proposed citrus group tolerance of 0.07 ppm was used) and citrus oil (for which the pro posed citrus, oil tolerance of 3.5 ppm was used). To add conservatism to the acute assessment, 100% of all citrus available for consumption in the US was assumed to be treated. For the chronic assessment, percent import adjustments were incorporated. Th ese are both conservative assumptions since only imported citrus could potentially be treated (thereb y bringing conservatism to the acute assessment), and, furthermore, not all imported citrus would be treated (thereb y bring ing conservatism to the chronic assessment). T he food handling establishment ( FHE ) tolerance of 0.01 ppm is greater than the anticipated pulp residue of 0.0015 ppm , so 0.01 ppm was used for the non - oil and peel commodities in the chronic assessment . Since FHE is not incorporated into a cute assessments, 0.0015 ppm was used for all citrus commodities in the acute assessment except for citrus peel (0.07 ppm) and citrus oil (3.5 ppm). The citrus residue values (as described above) were incorporated into the March 12, 2007 dietary risk asse ssment for lambda - cy halothrin (which included gamma - cyhalothrin as well) conducted b y EPA (PC Code: 128897; DP Number: 334944; Decision Number: 361053). In addition, a few minor residue (chicory, eggplant, and okra) and percent crop treated (filbert and w alnuts) corrections were made to the EPA risk assessments. The assessment was conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM - FCID) software, consumption data derived from the 2003 - 2008 National Health and Nutrition Examination Survey (NHANES), residue data derived from market basket data, USDA’s Pesticide Data Program (PDP) data, field trial data, and tolerance level residues. Estimated potential residues in drinking water were not modified because the propose d citrus use is for imported citrus only . Due to the low proposed import tolerance for the animal feed item citrus, dried pulp at 0.20 ppm relative to other feed items, the proposed citrus use is not anticipated to result in increases to any of the currently

established meat and milk tolerances for gamma - cy halothrin. ] i. Food. [ Acute Dietary Exposure . The acute population adjusted dose (aPAD) of 0.005 mg/kg bw/day

was used to characterize risk associated with acute dietary exposure. It is derived from a NOAELof 0.5 mg/kg bw/day from a chronic dog study (lambda cy halothrin) based on clinical signs of neurotoxicity (ataxia) observed from Day 2, 3 - 74

hours post - dosing at the LOAEL of 3.5 mg/kg/bw/day . In the 2007 Lambda - cy halothrin risk assessment, EPA d etermined that the appropriate uncertainty factor was 100 and that the FQPA safet y factor could be reduced to 1. Cheminova has conducted an acute dietary exposure assessment with DEEM - FCID as discussed above. The acute dietary assessment was conducted fo r the overall US population and select subpopulations (i.e., all infants <1 year old, children 1 - 2 years old, children 3 - 5 years old, children 6 - 12 years old, youths 13 - 19 years old, adults 20 - 49 years old, adults 50+ years old, and females 13 - 49 years old). The results of this acute anal ys is indicate that the most highly exposed population is children 1 - 2 years old, with an estimated acute dietary exposure of 0.002648 mg/kg bw/day , which corresponds to 53.0% of the aPAD. For the overall US population, th e acute exposure is calculated to be 0.001939 mg/kg bw/day , which corresponds to 38.8% of the aPAD. ii. Chronic Dietary Exposure . The chronic population adjusted dose (cPAD) of 0.001 mg/kg bw/day

was used to characterize risk associated with chronic di etary exposures. Itis derived from a NOAEL of 0.1 mg/kg bw/day from a chronic dog study (lambda - cy

halothrin) based on clinical signs of neurotoxicity (abnormal gait) observed in the two dogs at the LOAELof 0.5 mg/kg/bw/day . In the 2007 Lambda - cyhalothrin risk assessment, EPA determined that the appropriate uncertainty factor was 100 and that the FQPA safety

factor could be reduced to 1. Cheminova has conducted a chronic dietary exposure assessment with DEEM - FCID as discussed above. The chronic dietary assessment was conducted for the overall US population and select subpopulations (i.e., all infants <1 year old, children 1 - 2 years old, children 3 - 5 years old, children 6 - 12 years old, youths 13 - 19 years old, adults 20 - 49 years old, adults 50+ years old, and females 13 - 49 years old). The results of this chronic anal ys is indicate that the most highly exposed population is children 1 - 2 years old, with an estimated chronic dietary exposure of 0.000516 mg/kg bw/day , which corresponds to 51.6% of the cPAD. F or the overall US population, the chronic exposure is calculated to be 0.000159 mg/kg bw/day , which corresponds to 15.9% of the cPAD. 2. Non - dietary exposure . Gamma - cy halothrin is currentl y registered for use on residential non - food sites. The additio n of the proposed citrus import tolerance will not impact the residential exposures. After the citrus commodities were included in the dietary risk assessment, the resulting dietary exposures were similar to what they were previously , so the impact on ove rall aggregate exposures is expected to be minimal. ] D. Cumulative Effects [ Gamma - cy

halothrin is a py

rethroid insecticide that shares the same general mode of action as other insecticides in this chemical class. EPA’s 2011 cumulative risk assessment fo r p yr ethroids indicated that exposures from the man y current uses of py rethrins and py

rethroid insecticides do not pose risk concerns for children or adults. Further, the cumulative assessment supports consideration of registering additional new uses (dom estic or import) of these pesticides. ] E. Safety Determination5 1. U.S. population . [ Using the assumptions described above and based on the completeness of the toxicity database, it can be concluded that dietary exposure to gamma - cy

halothrin and lambda - cy

halothrin from all uses (including the proposed import crop use) will be 38. 8 % of the aPAD and 1 5 . 9 % of the cPAD for the overall US population. EPA generally has no concern for exposures below 100% of the PAD because the PAD represents the level at or b elow which daily aggregate (food plus water) exposures will not pose appreciable risks to human health. Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate (food plus water) exposure to residues arising f rom the proposed tolerances that are the subject of this petition. ] 2. Infants and children. [ Using the assumptions described above and based on the completeness of the toxicity database, it can be concluded that dietary exposure to gamma - cy

halothrin and lambda - cy

halothrin from all uses (including the proposed import crop use) will be 53% of the aPAD and 5 1.6% of the cPAD for infants and children. EPA generall y has no concern for exposures below 100% of the PAD because the PAD represents the level at or below which dail y aggregate (food plus water) exposures will not pose appreciable risks to human health. Thus, it can be concluded that there is a reasonable certainty

that no harm will result from aggregate (food plus water) exposure to residues arising from the proposed tolerances that are the subject of this petition. ] F. International Tolerances [ There are established MRL s (maximum residue limits) for gamma - cy halothrin for Mexico, but not for Canad a or Codex . ]