Page 1 of 28 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 MEMORANDUM Date: 15 September 2005 Subject: PP# s 3E6699, 3E6780, 3E6782, 3E6802, 3E6804, and 4E6811. Application of Spinosad to Mint; Banana; Plantain; Peanut; Bulb Vegetables; Legume Vegetables; Forage, Fodder, and Straw of Cereal Grains ( crop group 16); Grass Forage, Fodder, and Hay ( crop group 17); and Nongrass Animal Feeds ( crop group 18) and Application of Spinosad for Control of Fruit Flies. HED Risk Assessment. DP # s D310318, D310858, D310862, D310876, D310966, and D314168. PC Code 110003. Decision # s 330536, 350741, 350878, 351404, 351405, and 351510.

From: Tom Bloem, Chemist PV Shah, Ph. D., Branch Senior Scientist Mark I. Dow, Ph. D., Biologist Registration Action Branch 1/ Health Effects Division ( RAB1/ HED; 7509C)

Through: PV Shah, Ph. D., Branch Senior Scientist RAB1/ HED ( 7509C)

To: Daniel Rosenblatt/ Barbara Madden; RM 05 Robert Forest/ Sydney Jackson; RM 05 Registration Division ( RD; 7505C)

The HED of the Office of Pesticide Programs ( OPP) is charged with estimating the risk to human health from exposure to pesticides. The RD of OPP has requested that HED evaluate hazard and exposure data and conduct dietary, occupational, residential, and aggregate exposure assessments, as needed, to estimate the risk to human health that will result from all registered and proposed uses of spinosad. A summary of these findings is provided in this document. The risk assessment, residue chemistry review, and dietary exposure assessment were provided by Tom Bloem of RAB1; the hazard characterization was provided by PV Shah of RAB1; the occupational/ residential exposure and risk assessment was provided by Mark Dow of RAB1; and the drinking water assessment was provided by Ronald Parker of the Environmental Fate and Effects Division ( EFED).

NOTE: In 2002, HED completed a Section 3 risk assessment for the application of spinosad to herbs, peanut, caneberry, grape, fig, and root and tuber vegetables ( D284803, D. Vogel et al., 15 Aug 2002). The current document contains only those aspects of the risk assessment which are affected by the addition of the proposed spinosad uses. Page 2 of 28 Table of Contents 1.0 EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.0 PHYSICAL/ CHEMICAL PROPERTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3.0 HAZARD CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.1 Endocrine Disruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . 10 4.1 Summary of Registered Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.2 Summary of Proposed Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.3 Dietary Exposure/ Risk Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4.4 Water Exposure and Risk Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 4.5 Dietary Exposure Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.7Non occupational Off Target Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION . . . . . . . . . . . 20 6.0 CUMULATIVE RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 7.0 OCCUPATIONAL EXPOSURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 7.1 Handler Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 7.2 Post Application Worker Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 7.3 Restricted Entry Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 8.0 DEFICIENCIES / DATA NEEDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 8.1 Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 8.2 Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 8.3 Occupational/ Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Page 3 of 28 1.0 EXECUTIVE SUMMARY Background: Spinosad is a fermentation product of Saccharopolyspora spinosa, a naturally occurring soil organism. The product consists of two related active ingredients: Spinosyn A and Spinosyn D. The two active ingredients differ by one methyl group and are typically present at an 85: 15 ratio ( A: D). The registrant indicated that the extact mode of action is not known but is characterized by excitation of the insect nervous system, leading to involuntary muscle contractions, prostration with tremors, and paralysis ( effects are consistent with excitation of the nicotinic acetylcholine receptors). Spinosad is currently registered for application to numerous crops with tolerances for the combined residues of spinosyn A and D ranging from 0.01 200 ppm ( 40 CFR 180.495).

The Interregional Research Project No. 4 ( IR 4) is requesting the following spinosad application scenarios: foliar application to the bulb vegetable crop group, banana, plantain, legume forage, and mint; removal of the feeding restriction for peanut hay; foliar application to the grass forage, fodder, and hay group; reduction in the forage ( from 7 14 days to 3 days), fodder ( from 14 28 days to 3 days), and/ or hay ( from 14 28 days to 3 days) preharvest intervals ( PHIs) for sorghum, milo, pearl millet, proso millet, grain amaranth, teosinte, corn ( field, sweet, popcorn, and seed corn), and small grains ( wheat, barley, rye, oats, and triticale); and application to all crops for control of fruit flies. In conjunction with these requests, the petitioner is requesting the establishment of the following tolerances:

Vegetable, bulb, except green onion, group 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1 ppm Onion, green . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0 ppm Banana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.25 ppm Spearmint, tops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 ppm Peppermint, tops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0 ppm Peanut, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 ppm Animal feed, nongrass, group 18, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 ppm Animal feed, nongrass, group 18, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 ppm Grass, forage, fodder and hay, group 17, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Grass, forage, fodder and hay, group 17, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Corn, field, stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Corn, sweet, stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Corn, pop, stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Corn, field, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Corn, sweet, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Corn, pop, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Teosinte, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Millet, pearl, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Millet, pearl, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Millet, proso, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Millet, proso, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Millet, proso, straw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Sorghum, forage, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Sorghum, forage, hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Sorghum, grain, stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ppm Sorghum, grain, forage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 ppm Page 4 of 28 Food Commodities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.02 ppm Hazard Assessment: Spinosad is classified as Toxicity Category III for acute oral and dermal toxicity and Toxicity Category IV for acute inhalation toxicity, primary eye irriatation, and primary skin irritation. It is not a dermal sensitizer. No dermal toxicity was seen at the limit dose in a 21 day dermal toxicity study in rabbits. For subchronic toxicity, the primary effects seen in the mouse were increased vacuolation of cells of the lymphoid organs, liver, kidney, stomach, female reproductive tract, and epididymis, and less severely in the heart, lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary gland, and anemia. In rats, thyroid follicle epithelial cell vacuolation, anemia, multifocal hepatocellular granuloma, cardiomyopathy and spleenic histiocytosis were observed. In dogs, microscopic changes in a variety of tissues, anemia, and possible liver damage were seen.

Spinosad is not a neurotoxic agent. No neurotoxic effects were seen at the limit dose in an acute neurotoxicity study in rats and at doses up to 42.7 mg/ kg/ day in a subchronic neurotoxicity study. It is negative for mutagenicity in various mutagenicity assays. It is negative for carcinogenicity in rats and mice. In a chronic feeding study in dogs, toxicity signs such as increases in serum alanine aminotransferase, aspartate aminotransferase, and triglycerides levels, and the presence of tissue abnormalities, including vacuolated cell aggregations, arteritis, and glandular cell vacuolation ( parathyroid) were seen. Vacuolation of thyroid follicular cells, increased absolute and relative thyroid weights were observed in a chronic oral toxicity study in rats. In mice, rats and dogs, the liver, kidney, spleen, heart, thyroid, and bone marrow ( anemia) appeared to be the target organs.

No developmental effects were seen in the rat and rabbit developmental toxicity studies. Decreased litter size and survival was observed in the presence of maternal toxicity ( deaths) at the highest dose tested ( HDT) in a 2 generation reproduction study in rats. Maternal and offspring toxicity ( deaths) were equally severe, indicating no evidence of increased susceptibility in the 2 generation reproduction study in rats.

There were no major differences in the bioavailability, routes or rates of excretion or metabolism following a single low, high oral, or repeated oral doses in rats. The feces were the major route of excretion. Approximately, 70 80% of the dose was absorbed with approximately 20% of the dose eliminated unabsorbed in the feces. The excreted metabolites were the glutathione conjugates of the parent and O demethylated Factor A. Metabolites in the tissues were the N and O demethylated Factor A. Biliary excretion was rapid. Metabolites in the bile included the glutathione conjugates of the unchanged form, as well as N and O demethylated forms of Factor D.

Dose Response: The HED Hazard Identification Assessment Review Committee ( HIARC) met on 22 January 1998 ( TXR No. 012500) and 11 July 2002 ( TXR No. 0050928) to select endpoints for risk assessment and to evaluate the potential for increased susceptibility of infants and children from exposure to spinosad ( evaluated according to the February 2002 OPP 10X guidance document). HED's Food Quality Protection Act ( FQPA) Safety Factor Committee ( SFC) met on 29 July 2002 and recommended that the 10x safety factor to account for enhanced sensitivity of infants and children be reduced to 1x ( TXR No. 0051038). Based on toxicological considerations ( evaluated by FQPA SFC) and the residue assumptions used in the dietary and residential exposure analyses ( evaluated by the risk assessment team), the risk assessment team concluded that the FQPA Safety Factor should be reduced to 1x when assessing chronic dietary and short term incidental oral exposures. Table 1 is a summary the endpoints used in the current risk assessment. Page 5 of 28 Table 1. Summary of Toxicological Doses used in the Current Risk Assessment acute dietary ( all populations subgroups) no endpoint attributable to a single exposure was identified; this risk assessment is not required chronic dietary NOAEL = 2.7 mg/ kg/ day chronic RfD and cPAD = 0.027 mg/ kg/ day short term incidental oral oral NOAEL = 4.9 mg/ kg/ day level of concern ( LOC) for margins of exposure ( MOEs) < 100 ( residential)

dermal ( all intervals) dermal risk assessments are not required short term inhalation oral NOAEL = 4.9 mg/ kg/ day LOC for MOEs < 100 ( occupational)

intermediate term inhalation oral NOAEL = 2.7 mg/ kg/ day LOC for MOEs < 100 ( occupational)

cancer ( oral, dermal, inhalation) not likely to be carcinogen; cancer risk assessments are not required Occupational Exposure and Risk Assessment: No chemical specific data are available with which to assess potential exposure to pesticide handlers. Therefore, pesticide handler exposures were calculated based upon surrogate study data available in the Pesticide Handler's Exposure Database ( PHED; v. 1.1, 1998). For pesticide handlers, it is HED policy to present estimates of exposure for " baseline;" that is, with a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks, and no protective gloves and with a single layer of work clothing and the use of protective gloves or other personal protective equipment ( PPE) as might be necessary. Since the HIARC only identified inhalation endpoints ( no dermal endpoints were identified), only inhalation exposure assessments were conducted. All resulting MOEs for handlers were > 100, and therefore do not exceed HED's level of concern, except for applicators using high pressure hand wand equipment to apply GF 120 NF Naturalyte   Fruit Fly Bait and mixer/ loaders using open loading of Entrust   ( wettable powder ( WP)) in support of aerial operations. MOEs less than HED's level of concern can be calculated provided the individuals performing these tasks wear an approved organic vapor filtering respirator ( fruit fly bait application using high pressure handwand applicator) or an approved dust/ mist filtering respirator ( mixer/ loader in support of aerial application of the WP).

Residential and Non Occupational Exposure and Risk Assessment: Spinosad is currently registered for use on turf and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers and fire ants. Granular ( homeowner) and emulsifiable concentrate ( EC; commercial applicators) formulations are registered. Since no dermal endpoints were identified and based on the granular formulation and low vapor pressure for spinosad, residential handler/ applicator and postapplication dermal/ inhalation exposure assessments were not conducted. HED concluded that there is potential toddler short term non dietary oral exposures ( hand to mouth, object to mouth, ingestion of granulars, and soil ingestion). Since HIARC did not identify an acute dietary endpoint, episodic ingestion of granulars was not assessed. The resulting combined short term incidental oral MOEs were 640 and are therefore less than HED's level of concern. HED concludes that all other registered/ proposed application scenarios will not result in residential exposures.

Dietary ( food and water) Exposure and Risk Assessment: Chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model  Food Consumption Intake Database ( DEEM FCID   , ver. 2.03; acute and cancer endpoints were not identified) which incorporates the food consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII; 1994 1996 and 1998). The chronic dietary analyses assumed average/ projected percent crop treated estimates, projected percent head treated resulting from the dermal and premise treatments to ruminants, average field trial residues, experimentally determined processing factors, and anticipated livestock residues. For drinking water, the chronic analyses assumed the modeled tier 1 FIRST chronic surface water estimate resulting from the application of spinosad to turf ( highest registered/ proposed rate). The resulting exposure estimates were # 96% the cPAD and are therefore less than HED's level of concern ( children 1 2 years old were the most highly exposed subpopulation). Page 6 of 28 Aggregate Exposure and Risk Assessment: In general, aggregate exposures are calculated by summing dietary ( food and water) and residential exposures ( residential or other non occupational exposures). Based on the anticipated residential exposure scenarios and since acute and cancer risk assessments are not required, only short term ( residential, food, and water) and chronic ( food and water) aggregate exposure assessments were conducted. Since the dietary analyses incorporated drinking water estimates, calculation of drinking water levels of comparison ( DWLOCs) are unnecessary ( the dietary analyses represent exposure from food and water). Aggregate short term ( food, water, and residential) exposures resulted in MOEs $ 150 and aggregate chronic ( food and water) exposures were # 96% the cPAD; therefore, aggregate exposure to spinsoad, as a result of all registered/ proposed uses, is less than HED's level of concern.

Recommendations for Tolerances/ Registration: Separate recommendations are written for the fruit fly bait and foliar agricultural petitions. The labels for both petitions propose a 4 hour restricted reentry interval ( REI). It appears that spinosad is eligible for a reduced REI as described in the Pesticide Regulation ( PR) Notice 95 3 ( 7 June 1995). Since certain legal documents are required from the registrant and it is RD's purview to grant REIs, HED defers to RD on the issue of an acceptable REI for spinosad.

Fruit Fly Bait ( IR 4; PP# s 3E6780): Provided the petitioner submits revised Sections B and F, HED concludes that the toxicology, residue chemistry, and occupational/ residential databases support a conditional registration and establishment of the permanent tolerance listed in Table 2 for the combined residues of spinosyn A and D. Unconditional registration may be established upon submission of a 28 day rat inhalation toxicity study.

Summary of Deficiencies:

° revised Section B ( see Section 7.1) ° revised Section F ° 28 day inhalation toxicity study in rats Table 2: Recommended Tolerances Commodity Recommended Tolerance ( ppm)

raw agricultural commodities 0.02 Foliar Agricultural Applications ( IR 4; PP# s 3E6699, 3E6782, 3E6802, 3E6804, and 4E6811): Provided the petitioner submits revised Sections B and F, HED concludes that the toxicology, residue chemistry, and occupational/ residential databases support a conditional registration and establishment of the tolerances listed in Table 3 for the combined residues of spinosyn A and D. Unconditional registration upon may be established upon submission and review of the cattle feeding study, alfalfa and grass SC and WP side by side residue data, banana residue data, and a 28 day rat inhalation toxicity study.

Summary of Deficiencies:

C revised Section B ( see Sections 4.2 and 7.1)

C revised Section F ° alfalfa ( n= 3; forage and hay samples should be collected ) and grass ( n= 3; forage and hay samples Page 7 of 28 should be collected) side by side residue data comparing the SC and WP spinosad formulations or submits a rationale as to why these data are unnecessary ° banana field trial in region 3 ( n= 1) ° cattle feeding study conducted with dietary burdens of 10 ppm, 100 ppm, and 500 ppm ° 28 day inhalation toxicity study in rats Table 3: Recommended Tolerances Commodity Recommended Tolerance ( ppm)

banana 0.25 vegetable, bulb, group 3, except green onion 0.10 onion, green 2.0 spearmint, tops 3.5 peppermint, tops 3.5 animal feed, nongrass, group 18, forage 35 animal feed, nongrass, group 18, hay 30 peanut, hay 11 alfalfa, seed 0.15 alfalfa, seed screenings 2.0 grass, forage, fodder and hay, group 17, forage 10 grass, forage, fodder and hay, group 17, hay 5.0 amaranth, grain, stover 10 grain, cereal, group 16, stover, except rice1 10 grain, cereal, group 16, forage, except rice1 2.5 grain, cereal, group 16, hay, except rice1 10 grain, cereal, group 16, straw, except rice1 1.0 cattle, meat 2.0 sheep, meat 2.0 goat, meat 2.0 horse, meat 2.0 cattle, fat 50 sheep, fat 50 goat, fat 50 horse, fat 50 cattle, meat byproducts, except liver2 5.0 sheep, meat byproducts, except liver2 5.0 goat, meat byproducts, except liver2 5.0 horse, meat byproducts, except liver2 5.0 cattle, liver 10 sheep, liver 10 goat, liver 10 horse, liver 10 milk 7.0 milk, fat 85 poultry, meat 0.10 poultry, meat byproducts 0.10 poultry, fat 1.3 egg 0.30 1 HED notes that all currently established cereal grain forage, fodder, stover, hay, and straw tolerances in 180.495( a) should be eliminated in favor of the cereal grain forage, stover, hay, and straw tolerances listed in the table 2 the current ruminant meat by product tolerances of 8 ppm are based on residues in liver; HED is recommending that separate liver tolerances be established and the meat byproduct tolerance be based on residues in kidney Page 8 of 28 O O C H 3 N C H 3 C H 3 O O CH 3 OCH 3 OCH 3 O CH 3 H 3 CH 2 C O O H H H H H 3 CO R Spinosyn A: R = H Spinosyn D: R = CH 3 2.0 PHYSICAL/ CHEMICAL PROPERTIES Table 4. Test Compound Nomenclature Chemical Structure Common name Spinosad Company experimental name XDE 105 IUPAC name Spinosyn A: ( 2R, 3aS, 5aR, 5bS, 9S, 13S, 14R, 16aS, 16bR) 2( 6 deoxy 2,3,4 tri O methyl " a L mannopyranosyloxy) 13( 4 dimethylamino 2,3,4,6 tetradeoxy$ ß Derythropyranosyloxy 9 ethyl 2,3,3a, 5a, 5b, 6,7,9,10,11,12,13,14,15,16a, 16bhexadecahydro 14 methyl 1H 8 oxacyclododeca[ b] as indacene 7,15 dione Spinosyn D: ( 2S, 3aR, 5aS, 5bS, 9S, 13S, 14R, 16aS, 16bR) 2( 6 deoxy 2,3,4 tri O methyl " a L mannopyranosyloxy) 13( 4 dimethylamino 2,3,4,6 tetradeoxy$ ß Derythropyranosyloxy 9 ethyl 2,3,3a, 5a, 5b, 6,7,9,10,11,12,13,14,15,16a, 16bhexadecahydro 4,14 dimethyl 1H 8 oxacyclododeca[ b] as indacene 7,15 dione CAS name Spinosyn A: 2[( 6 deoxy 2,3,4 tri O methyl" L manno pyranosyl) oxy] 13[[ 5 ( dimethylamino) tetrahydro 6 methyl 2H pyran 2 yl] oxy] 9 ethyl 2,3,3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16b tetradecahydro 14 methyl 1H as Indaceno[ 3,2 d] oxacyclododecin 7,15 dione Spinosyn D: 2[( 6 deoxy 2,3,4 tri O methyl" L manno pyranosyl) oxy] 13[[ 5 ( dimethylamino) tetrahydro 6 methyl 2H pyran 2 yl] oxy] 9 ethyl 2,3,3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16b tetradecahydro 4,14 methyl 1H as Indaceno[ 3,2 d] oxacyclododecin 7,15 dione CAS # Spinosyn A: 131929 60 7 Spinosyn D: 131929 63 0 Table 5. Physicochemical Properties of the Technical Grade Test Compound Melting point/ range Spinosad A: 84 99.5 ° C Spinosad D: 161.5 170 ° C EPA Fact Sheet pH ( 10% slurry of spinosad in water) 7.74 Density at 20 /

C 0.512 Water solubility ( ppm) Spinosad A: 89.4 Spinosad D: 0.495 Vapor pressure at 25 /

C ( kPa) Spinosad A: 3.0 x 10 11 Spinosad D: 2.0 x 10 11 Dissociation constant ( pKa) not available Octanol/ water partition coefficient Log( KOW) pH 5 pH 7 pH 9 Spinosad A 2.8 4.0 5.2 Spinosad D 3.2 4.5 5.2 UV/ visible absorption spectrum not available Page 9 of 28 3.0 HAZARD CHARACTERIZATION A detailed hazard characterization for spinosad is presented in a previous HED risk assessment ( D284803, D. Vogel et al., 15 Aug 2002). Please refer to this document for complete information concerning the hazard characterization of spinosad.

The HIARC met on 22 January 1998 ( TXR No. 012500) and 11 July 2002 ( TXR No. 0050928) to select endpoints for risk assessment and to evaluate the potential for increased susceptibility of infants and children from exposure to spinosad ( evaluated according to the February 2002 OPP 10X guidance document). The FQPA SFC met on 29 July 2002 and recommended that the 10x safety factor to account for enhanced sensitivity of infants and children be reduced to 1x ( TXR No. 0051038). Based on toxicological considerations ( evaluated by FQPA SFC) and the residue assumptions used in the dietary ( D319957, T. Bloem, 24 Aug 2005) and residential ( D284802, M. Dow and D. Vogel, 15 Aug 2002) exposure analyses ( evaluated by the risk assessment team), it was concluded that the FQPA Safety Factor should be reduced to 1x when assessing chronic dietary and short term incidental oral exposures. Table 6 is a summary of the endpoints used in the current assessment.

Table 6. Summary of Toxicological Doses and Toxicological Endpoints for Spinosad Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary  all populations No endpoint attributable to a single exposure was identified. This risk assessment is not required.

Chronic Dietary  all populations NOAEL= 2.7 mg/ kg/ day UF = 100 cRfD = 0.027 mg/ kg/ day FQPA SF = 1x cPAD = 0.027 mg/ kg/ day Chronic Toxicity Study in Dogs; LOAEL = 8.22 mg/ kg/ day; based on vacuolation in glandular cells ( parathyroid) and lymphatic tissues, arteritis, and increases in serum alanine aminotransferase, aspartate aminotransferase, and triglycerides levels Short term Incidental Oral ( 1  30 Days) NOAEL= 4.9 mg/ kg/ day LOC for MOEs < 100 Subchronic Feeding Study in Dogs; LOAEL = 9.73 mg/ kg/ day based on microscopic changes in multiple organs, clinical signs of toxicity, decreases in mean body weights and food consumption and biochemical evidence of anemia and possible liver damage Dermal ( Any Time Period) Short, Intermediate and Long Term dermal risk assessments are not required for the following reasons: 1) lack of concern for pre and/ or post natal toxicity; 2) the combination of molecular structure and size as well as the lack of dermal or systemic toxicity at 1000 mg/ kg/ day in a 21 day dermal toxicity study in rats which indicates poor dermal absorption; and 3) the lack of long term exposure based on the current use pattern.

Short term Inhalation ( 1  30 days) Oral NOAEL= 4.9 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOEs < 100 ( occupational) Subchronic Feeding Study in Dogs; LOAEL = 9.73 mg/ kg/ day based on microscopic changes in a multiple organs, clinical signs of toxicity, decreases in mean body weights and food consumption and biochemical evidence of anemia and possible liver damage Intermediate term Inhalation ( 1  6 Months) Oral NOAEL= 2.7 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOEs < 100 ( occupational) Chronic Toxicity Study in Dogs; LOAEL = 8.22 mg/ kg/ day; based on vacuolation in glandular cells ( parathyroid) and lymphatic tissues, arteritis, and increases in serum alanine aminotransferase, aspartate aminotransferase, and triglycerides levels Cancer Classification: Not likely to be carcinogen; cancer risk assessment is not required 1 UF= Uncertainty Factor; RfD= Reference Dose; FQPA SF = Food Quality Protection Act Safety Factor; PAD = Population Adjusted Dose= RfD/ FQPA SF; LOC = level of concern; MOE = margin of exposure Page 10 of 28 3.1 Endocrine Disruption EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor and Testing Advisory Committee ( EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). In the available spinosad toxicity studies, there was no estrogen or thyroid mediated toxicity.

4.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION residue chemistry summary ( foliar agricultural applications)  D312374, T. Bloem, 20 Jul 2005 residue chemistry summary ( fruit fly bait)  D319956, T. Bloem, 10 Aug 2005 dietary exposure analysis  D319957, T. Bloem, 24 Aug 2005 residential exposure analysis  D284802, M. Dow and D. Vogel, 15 Aug 2002 drinking water summary  EFED memo; D310860, R. Parker, 14 Sep 2005 4.1 Summary of Registered Uses Spinosad is currently registered for application to numerous crops with tolerances for the combined residues of spinosyn A and D ranging from 0.01 200 ppm ( 40 CFR 180.495). Spinosad is also registered for homeowner application to turf/ ornamentals.

4.2 Summary of Proposed Uses Fruit Fly Bait: The petitioner is requesting registration for application of GF 120 NF Naturalyte   Fruit Fly Bait ( 0.002 lb ai/ gallon; EC; EPA Reg. No. 62719 498), for control of tephritid fruit flies, to any tree, nut, vine, vegetable, or food crop. Ground ( directed to a specific plant or broadcast) and aerial applications are specified ( application through irrigation equipment is prohibited). For aerial and most other applications, the formulated product is to be mixed with water at a ratio of 1 part formulated product to 1.5 parts water ( v: v). For ground applications and applications in low relative humidity, the product is to be mixed with water at a ratio of 1 part formulated product to 5 parts water ( v: v). Ground applications are to be directed to the bottoms of leaves and leaves inside the foliage canopy ( reduces exposure to sun and rain). The label states that large droplets sizes are necessary to obtain optimum control of insect pests ( 4000 6000 : m) and recommends spray volumes of < 1 gallon/ acre ( aerial application should use ultra low application volumes ( 20 80 droplets/ m2)). Applications are to begin as soon as monitoring traps indicate flies are present or 2 3 weeks before fruit ripens. Repeat applications are permitted every 7 14 days, shortening the application interval during rainy periods or as the fruit ripens. The label does not specify a PHI. The residue data submitted in support of this petition was conducted with a 0 day PHI; therefore, a PHI is unnecessary. Table 7 is a summary of the proposed application scenarios. HED concludes that the proposed use directions are adequate and supported by the available residue data. Page 11 of 28 HED notes that the label prohibits aerial application in the " immediate proximity of residential, commercial, government, institutional or other structures where people may be present including, but not limited to, homes, apartments, offices, churches, schools, and businesses." In urban areas, use is limited to ground applications.

Table 7. Summary of Proposed Application Scenarios Formulation Site Single App. Rate ( lb ai/ acre) Seasonal App. Rate ( lb ai/ acre) RTI ( days) Comments GF 120 NF Naturalyte ® Fruit Fly Bait ( 0.002 lb ai/ gallon; EC; EPA Reg. No. 62719 498) any tree, nut, vine, vegetable, or food crop; ornamentals; and noncrop vegetation for control of tephritid fruit flies 0.0003 not specified 7 14 S aerial, ground, and spot applications are permitted ( chemigation is prohibited)

S when applying aerially, ultra low application volumes should be used ( 20 80 droplets/ m2)

S for all application methods, the label specifies spray volumes of 0.20 0.94 gallons/ acre.

1 RTI = retreatment interval Foliar Agricultural Scenarios: The petitioner is requesting registration for application of spinosad to the bulb vegetable crop group, banana, plantain, legume forage, and mint; removal of the feeding restriction for peanut hay; foliar application to the grass forage, fodder, and hay group; and reduction in the forage ( from 7 14 days to 3 days), fodder ( from 14 28 days to 3 days), and/ or hay ( from 14 28 days to 3 days) PHIs for sorghum, milo, pearl millet, proso millet, grain amaranth, teosinte, corn ( field, sweet, popcorn, and seed corn), and small grains ( wheat, barley, rye, oats, and triticale). In support of these requests, that petitioner provided proposed use directions for the following labels: Success   ( 22.8% suspension concentrate ( SC), 2 lbs ai/ gallon, EPA Reg. No. 62719 292); SpinTor 2SC   ( 22.8% SC, 2 lbs ai/ gallon, EPA Reg. No. 62719 294); Conserve   ( 0.015% granular, EPA Reg. No. 62719 329); Tracer   ( 44.2% SC, 4 lb ai/ gallon, EPA Reg. No. 62719 267); and/ or Entrust   ( 80% WP). Table 8 is a summary of the proposed application scenarios.

HED has reviewed the proposed use directions and is requesting that the petitioner submit labels which incorporate the following changes:

S bulb vegetable: SpinTor 2SC   and Success   labels should specify a minimum RTI of 4 days.

S mint: Success   label should specify a minimum RTI of 4 days.

S teosinte: SpinTor 2SC   label should specify a 28 day PHI for grain and maximum seasonal application rate of 0.188 lb ai/ acre.

S legume forage: All labels should indicate a 0 day PHI for forage and indicate that hay and fodder may be cut 3 days after application. Entrust   , Success   , and Tracer   labels should specify " legume forage grown for seed" rather than " legume grown for seed."

S grass forage, fodder, and hay group: All labels should indicate a 0 day PHI for forage and indicate that hay and fodder may be cut 3 days after application.

S small grains: The Success   and Entrust   labels indicate application to cereal grains, including but not limited to barley, buckwheat, oats, rye, triticale, and wheat is permitted. Since some cereal grain crops are not currently registered, HED request that the petitioner indicate that the application instructions apply to only barley, buckwheat, oats, rye, triticale, and wheat. Page 12 of 28 Page 13 of 28 Table 8. Summary of Proposed Foliar Agricultural Application Scenarios Formulation Applic. Type Max. Single App. Rate ( lb ai/ acre) Max. Season App. Rate ( lb ai/ acre) PHI ( days) Comments bulb vegetables1  2 lb ai/ gal SC ( SpinTor 2SC   and Success   ) broadcast foliar sprays with ground or aerial equipment 0.047 0.094 0.45 1

banana and plantain1  2 lb ai/ gal SC ( Success   ) ground sprays directed to the fruit bunches 0.125 lb ai/ 100 gallon solution applied to fruit bunches until runoff max. of 4 applic 56 S do not make applications less than 7 days apart mint1  2 lb ai/ gal SC ( Success   ) broadcast foliar sprays with ground or aerial equipment 0.062 0.156 0.45 7

legume forages and legumes grown for seed1  2 lb ai/ gal SC ( Success   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment 0.031 0.062 0.186 3  hay, forage, and fodder S do not allow cattle to graze from treated field until spray has dried S do not apply more than 3x in a 21 day period; if applied 3x in succession, do not apply for 21 days; do not apply more than 6 treatments in a season  0.015% granular ( Conserve   ) broadcast foliar sprays with ground equipment 0.038 0.075 every two months during the warm part of the year; if reapp. is required a RTI 14 days is specified not indicated S distribute as evenly as possible with a calibrated rotary type hand held, PTO, electric, or ground driven spreader S if rain occurs within 12 hours of application; retreatment may be necessary peanut2  2 lb ai/ gal SC ( SpinTor 2SC   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground equipment 0.05 0.10 Entrust and Tracer

0.28 SpinTor 2SC 0.45 3  nut, forage, and hay S do not allow cattle to graze from treated field until spray has dried S do not apply more than 3x in a 30 day period; if applied 3x in succession, do not apply for 30 days S do not make applications less than 7 days apart S Entrust and Tracer  do not make more than 3 applications per year S SpinTor 2SC  do not make more than 5 applications per year Table 8. Summary of Proposed Foliar Agricultural Application Scenarios Formulation Applic. Type Max. Single App. Rate ( lb ai/ acre) Max. Season App. Rate ( lb ai/ acre) PHI ( days) Comments Page 14 of 28 grass forage, fodder, and hay group and grass crops grown for seed ( rangeland and pastures) 3  2 lb ai/ gal SC ( Success   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment 0.031 0.062 0.186 3  hay, forage, and fodder S do not allow cattle to graze from treated crop until spray has dried S do not apply more than 3x in a 21 day period; if applied 3x in succession, do not apply for 21 days S do not make more than 6 applications per season  0.015% granular ( Conserve   ) broadcast foliar sprays with ground equipment 0.038 0.075 every two months during the warm part of the year; if reapplication is required a RTI 14 days is specified not indicated A. distribute as evenly as possible with a calibrated rotary type hand held, PTO, electric, or ground driven spreader B. if rain occurs within 12 hours of application; retreatment may be necessary field corn4  2 lb ai/ gal SC ( Success   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment and by chemigation 0.025 0.100 0.188 28  grain 3 fodder and forage

sweet corn, popcorn, and corn grown for seed5  2 lb ai/ gal SC ( SpinTor 2SC   and Success   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment and by chemigation 0.023 0.100 0.45 1 grain 3  forage and fodder

 4 lb ai/ gal SC ( Tracer   ; seed corn and popcorn only) broadcast foliar sprays with ground or aerial equipment and by chemigation 0.031 0.094 0.188 seed corn; 1  grain 3  fodder and forage popcorn; 28  grain 3  fodder and forage

teosinte6  2 lb ai/ gal SC ( SpinTor 2SC   ) broadcast foliar sprays with ground or aerial equipment 0.023 0.094 0.45 1  grain 3  forage and fodder

 2 lb ai/ gal SC ( Success   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment 0.025 0.100 0.188 28  grain 3  fodder and forage  Table 8. Summary of Proposed Foliar Agricultural Application Scenarios Formulation Applic. Type Max. Single App. Rate ( lb ai/ acre) Max. Season App. Rate ( lb ai/ acre) PHI ( days) Comments Page 15 of 28 sorghum, milo, pearl millet, proso millet, and grain amaranth7  4 lb ai/ gal SC ( Tracer   ) broadcast foliar sprays with ground or aerial equipment 0.047 0.094 0.45 7  grain 3  forage and fodder

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment 0.047 0.094 0.28 21  grain 3  forage, fodder,

and hay S do not allow cattle to graze until the spray has dried small grains ( wheat, barley, rye, oats, and triticale) 8  2 lb ai/ gal SC ( Success   )

 4 lb ai/ gal SC ( Tracer   )

 80% WP ( Entrust   ) broadcast foliar sprays with ground or aerial equipment 0.025 0.100 0.28 21  straw and grain 3  forage, fodder,

and hay S do not allow cattle to graze until the spray has dried 1 spinosad is not currently registered for application to bulb vegetables, banana, plantain, and legume forages 2 The 2 lb ai/ gallon SC ( Success   , SpinTor 2SC   , and Naturalyte   ) formulation of spinosad has been approved by HED for application to peanut but with a restriction against feeding peanut hay to livestock ( 5 x 0.094 lb ai/ acre; 7 day RTI; 3 day PHI; D279380, W. Donovan, 28 Jun 2002). The petitioner is requesting that this restriction be lifted and is requesting registration for application of the 4 lb ai/ gallon SC ( Tracer   ) and 80% WP ( Entrust   ) formulations. No change in the registered application rate or the nut PHI are proposed.

3 The 0.015% granular formulation ( Entrust   ) is currently registered for application to the grass forage fodder and hay group as a fire ant bait ( mound treatment only). The petitioner is requesting broadcast application of the 0.015% granular formulation and is requesting registration for application of the 2 lb ai/ gallon SC ( Success   ) , 4 lb ai/ gallon SC ( Tracer   ) , and 80% WP ( Entrust   ) formulations.

4 The 2 lb ai/ gallon SC ( Success   ) , 4 lb ai/ gallon SC ( Tracer   ) , and 80% WP ( Entrust   ) formulations of spinosad are currently registered for application to field corn. The petitioner is proposing a 3 day PHI for forage ( currently 7 days) and fodder ( currently 28 days). No change in the application rate or PHI for grain are proposed.

5 The 2 lb ai/ gallon SC ( Success   and SpinTor 2SC   ) , 4 lb ai/ gallon SC ( Tracer   ) , and 80% WP ( Entrust   ) formulations of spinosad are currently registered for application to sweet corn, popcorn, and corn grown for seed. The petitioner is proposing a 3 day PHI for forage ( currently 7 days) and fodder ( currently 28 days). No change in the application rate or PHI for grain are proposed.

6 The 4 lb ai/ gallon ( Tracer   ) formulation of spinosad is currently registered for application to teosinte. The petitioner is requesting application of the 2 lb ai/ gallon ( Success   and SpinTor 2SC   ) and 80% WP ( Entrust   ) formulations and is requesting a 3 day PHI for PHI for forage ( currently 7 days) and fodder ( currently 28 days). Provided the petitioner submits a revised SpinTor 2SC   label incoporating the changes listed above, no change in the application rate or PHI for grain are proposed.

7 The 4 lb ai/ gallon ( Tracer   ) formulation of spinosad is currently registered for application to sorghum, milo, pearl millet, proso millet, and grain amaranth. The petitioner is requesting registration for application of the 80% WP ( Entrust   ) formulation and a 3 day PHI for forage ( currently 14 days) and fodder ( currently 7 days). No change in the application rate and grain PHI are proposed.

8 The 2 lb ai/ gallon SC ( Success   ), 4 lb ai/ gallon SC ( Tracer   ) , and 80% WP ( Entrust   ) formulations of spinosad are currently registered for application to small grains. The petitioner is proposing a 3 day PHI for forage ( currently 14 days) and hay ( currently 14 days). No change in the application rate or PHI for grain and straw are proposed. Page 16 of 28 4.3 Dietary Exposure/ Risk Pathway Nature of the Residue  Plants/ Livestock: The nature of the residue in plants and livestock is adequately understood based on metabolism studies conducted with apples, cabbage, cotton, tomatoes, turnips, ruminants, and poultry. The HED Metabolism Assessment Review Committee ( MARC) determined that the residue of concern in plants and livestock, for risk assessment and tolerance enforcement purposes, are spinosyns A and D ( D243816, G. Herndon, 3 Mar 1998).

For plants, residue levels of spinosyns A and D declined significantly with increasing PHI ( decreased 40 89% as the PHI increased from 0 to 3 days; decreased 86% to nondetectable as the PHI increased from 0 to 10 48 days). This decline was accompanied by incremental increases in nonextractable and polar 14C residues. Extensive fractionation and characterization of nonextractable and polar 14C residues in selected crops indicated that most of the radioactivity was degraded to multicomponent residues of low molecular weight which are subsequently incorporated into natural plant constituents ( D228434, S. Willett, 23 Jan 1997; D243816, J. Herndon, 3 Mar 1998).

Foliar Application Scenario: Magnitude of the Residue  Plants/ Livestock:

Plants: The petitioner submitted banana, green onion, mint, alfalfa, clover, and grass field trial studies and submitted a mint processing study ( only required processing study). HED has previously agreed to a reduced field trial data requirement for banana; mint; bulb vegetables; nongrass animal feed crop group; and grass forage, fodder, and hay crop group and concluded that the grass forage and hay residue data may be used to support the proposed reduction in the forage, fodder, and/ or hay PHIs for sorghum, milo, pearl millet, proso millet, grain amaranth, teosinte, corn ( field, sweet, popcorn, and seed corn), and small grains ( wheat, barley, rye, oats, and triticale; D252416, G. Herndon, 23 Feb 1999).

HED notes that the petitioner is citing SC residue data to support either the registration for application of the 80% WP spinosad formulation ( legume forage; peanut; grass forage, fodder, and hay group; teosinte; sorghum; milo; pearl millet; proso millet; and grain amaranth) or reduction in the forage, fodder, and/ or hay PHIs on a currently registered 80% WP label ( field corn, sweet corn, popcorn, seed corn, wheat, barley, rye, oats, and triticale). HED has previously reviewed spinach, tomato, and lettuce side by side spinosad residue data conducted with the SC and water dispersible granular ( WDG; similar to WP) formulations ( 6 x 0.045 0.134 lb ai/ acre; 0.45 lb ai/ acre/ season; RTI 2 4 days; PHI 1 and 3 days). The resulting data indicated that there were no significant difference in combined spinosyn A and D residues in lettuce and tomato. However, the WDG formulation resulted in higher residues of spinosyn A and D in spinach ( D232203, G. Herndon, 2 Mar 1998). Based on these data and since the petitioner is citing SC residue data to support either the registration of the 80% WP formulation or reduction in the forage, fodder, and hay PHIs on a currently registered 80% WP label, HED requests that the petitioner submit side by side grass ( n= 3; forage and hay samples should be collected) and alfalfa ( n= 3; forage and hay samples should be collected) residue data comparing the SC and WP formulations. If these data indicate that residues are greater following application of the WP formulation, then additional data may be requested. Alternately, the petitioner can provide a rationale as to why the WP formulation will not result in higher spinosyn A and D residues in/ on the requested crops as compared to the SC formulation ( should include an explanation as to why spinosyn A and D were higher in spinach following application of the WDG as compared to the SC; Chemistry Science Adivsory Council ( ChemSAC minutes 23 March 2005). Page 17 of 28 Provided the petitioner agrees to make the label changes recommended in the " proposed use" section, agrees to submit alfalfa ( n= 3; forage and hay samples should be collected) and grass ( n= 3; forage and hay samples should be collected) side by side field trial data comparing the SC and WP formulations or submits a rationale as to why these data are unnecessary ( see preceding paragraph), and agrees to submit a banana field trial ( region 3; n= 1), HED concludes that the currently available data support the establishment of the plant tolerances listed in Table 3 for the combined residues of spinosyn A and D ( a revised Section F is requested).

Livestock: Based on the recommended/ established plant tolerances, the maximum theoretical dietary burdens ( MTDBs) for beef cattle, dairy cattle, hog, and poultry are 89.2 ppm, 83.4 ppm, 41.2 ppm, and 4.85 ppm, respectively. The petitioner has previously submitted cattle ( conducted at 1 ppm, 3 ppm, and 10 ppm) and poultry ( conducted at 0.1 ppm, 0.3 ppm, 1.0 ppm, and 5.0 ppm) feeding studies. Provided the petitioner agrees to submit a cattle feeding study conducted at 10 ppm, 100 ppm, and 500 ppm, HED concludes that the livestock tolerances listed in Table 3 for the combined residues of spinosyn A and D are appropriate ( a revised Section F is requested). HED notes that if as part of a future petition the poultry dietary burden increases, then a new poultry feeding study may be requested.

Fruit Fly Bait: Magnitude of the Residue  Plants/ Livestock:

Plants: The petitioner submitted residue data from single mustard green ( Region 2), cowpea forage ( Region 2), spinach ( Region 10), and snap bean forage ( Region 10) field trials conducted in 2001. The field trials were treated with spinosad at 0.5x, 1.5x, or 5x the proposed rate ( samples were collected on the day of application). Based on these data, the primary crop metabolism studies, and since harvesting on the day of application is unlikely, HED concludes that the tolerance listed in Table 2, for the combined residues of spinosyn A and D, is appropriate ( a revised Section F is requested).

Livestock: Based on livestock dietary burdens and livestock tolerances recommended as result of the foliar agricultural application scenario, HED concludes that the fruit fly bait application scenario will not have a significant effect on the livestock dietary burden or the magnitude of residues in livestock commodities.

Nature/ Magnitude of the Residue  Rotational Crops: Based on the results of a confined rotational crop study, the MARC concluded that the residues of concern in rotational crops are spinosyn A and D ( D243816, G. Herndon, 3 Mar 1998; field rotational crop data have not been submitted). The confined study was conducted at 0.98 lb ai/ acre ($ 2.2x the proposed rates) and indicated that residues are incorporated into the general carbon pool. Spinosyns A and D were not detected in the rotated crops ( wheat, lettuce, and radish; plant back intervals ( PBIs) of 30, 120, and 365 days). Since the confined study was conducted at $ 2.2x the maximum proposed rate and since spinosyns A and D were not detected, HED concludes that no rotational crops restrictions are required for the currently proposed crops. Page 18 of 28 Analytical Enforcement Method  Plants: Method RES 94025 ( GRM 94.02; cottonseed) has been successfully subjected to an independent laboratory validation ( ILV) as well as an EPA laboratory validation. It has been forwarded to FDA for inclusion in the Pesticide Analytical Manual ( PAM) Volume II ( G. Herndon, 2 Mar 1998). The following methods have also been submitted to the FDA for inclusion in PAM II: GRM 95.17 ( leafy vegetables); GRM 96.09 ( citrus); GRM 96.14 ( tree nuts); GRM 95.04 ( fruiting vegetables); GRM 94.02. S1 ( cotton gin byproducts), and an immunoassay method which was validated on 17 different crop matrices ( G. Herndon, 18 Feb 1998).

Since the methods used to analyze the field trial and processed samples were similar to the methods currently available for tolerance enforcement and since adequate validation data were submitted with the field trial and processing data, HED concludes that the currently available enforcement methods are sufficient to enforce the tolerances associated with the current petitions.

Analytical Enforcement Method  Livestock: Adequate livestock methods are available for tolerance enforcement. Method RES 94094 ( GRM 95.03) is a high performance liquid chromatograph/ ultraviolet ( HPLC/ UV) method suitable for determination of spinosad residues in ruminant commodities. Method GRM 95.03 has undergone successful ILV and EPA laboratory validation, and has been forwarded to FDA for inclusion in PAM Volume II ( G. Herndon, 6 Apr 1999). Method GRM 95.15 is another HPLC/ UV method suitable for determination of spinosad residues in poultry commodities. This method has been forwarded to FDA for inclusion in PAM Volume II ( D249374, M. Doherty, 24 Jun 1999). Finally, Method RES 95114, an immunoassay method for determination of spinosad residues in ruminant commodities underwent a successful ILV and EPA laboratory validation and has been submitted to FDA for inclusion in PAM Volume II ( G. Herndon, 5 Jan 1999).

4.4 Water Exposure and Risk Pathway The following is a summary of information provided by EFED ( Memo  Larry Liu, 3 Aug 2002 and D310860, R. Parker, 14 Sep 2005).

Environmental Fate Assessment: Spinosad and its degradates are not very persistent and are relatively immobile. The potential for residues to leach to groundwater or runoff to surface water is very low. Slow metabolic degradation was observed only in flooded sediment ( half lives 161  250 days in the laboratory, > 25 days outdoors). Transformation products ( Factor B and N demethyl spinosad Factor D) are persistent in aerobic soil metabolism studies ( half lives > 6 months) and are relatively immobile.

Spinosyn A and D degrade in aerobic laboratory soil with half lives of 13 and 14 days, respectively. They photodegrade readily in sterile water (< 1 day at pH 7) and soil ( about 10 days). Based on McCall's relative mobility comparison, spinosyn A has a low to slight mobility in sandy soils and is immobile in silt loam and clay loam soils. Although no mobility data have been provided for Factor D, it is 180x less soluble than spinosyn A; therefore, spinosyn D is less likely to leach in the soil or runoff to surface water. Spinosad is not volatile ( vapor pressures ( 25 ° C) are 2.0 3.0 x 10 11 kPa). CO 2 is the only volatile degradate. In terrestrial field dissipation studies on bareground plots, the estimated halflife of spinosyn A, formulated as an EC, was 0.3 0.5 days, and residues accounted for 3.1% of the applied in the runoff but did not leach. When spinosad was applied directly to the water surface in outdoor aquatic microcosm dissipation studies, total spinosad residues in the water had an observed Page 19 of 28 half life of < 1 day. Page 20 of 28 Spinosad is stable to hydrolysis in pH 5, 7, and 9 buffer solutions. In flooded sediment, spinosad moves readily from the water to the solid phases. Spinosad degrades slowly in anaerobic sediment with half lives of 161 250 days. Degradation rates in aerobic sediment were not determined. In an aquatic microcosm study, spinosad residues in the sediment peaked at 8 days and had an observed half life of > 25 days.

The major transformation product of spinosyn A is Factor B ( N demethylated spinosyn A). The major transformation product of spinosyn D is N demethylated spinosyn D. In aerobic soil metabolism laboratory studies using the parent, both transformation products accumulated to > 50% of the applied by 28 days and had observed half lives of > 6 months. Factor B is relatively immobile; no information is available on the mobility of N demethylated spinosyn D. Neither transformation product was identified in terrestrial field dissipation studies.

Ground and Surface Water Estimates: The HED MARC determined that the residue of concern in water is spinosad per se ( D243816, G. Herndon, 3 Mar 1998). At the present time, there are no surface or ground water spinosad monitoring data available. Since the maximum single and seasonal application rates for the proposed crops are much lower than the currently registered turf application rate ( highest registered/ proposed rate), EFED recommended using the turf estimated environmental concentrations ( surface water ( peak)  25.227 ppb; surface water ( chronic; 56 day average)  2.313 ppb; ground water ( acute and chronic)  0.037 ppb). These estimates were generated using FIRST ( surface water; tier 1) and SCIGROW ( ground water screening model) models. The turf surface water estimate is the highest water value for all of the proposed/ registered spinosad uses and was therefore assumed when assessing exposure to spinosad via drinking water.

4.5 Dietary Exposure Analysis Chronic dietary risk assessments were conducted using the DEEM FCID   ( ver. 2.03; acute and cancer endpoints were not identified) which incorporates the food consumption data from the USDA's CSFII ( 1994 1996 and 1998). The chronic dietary analyses assumed average/ projected percent crop treated estimates, projected percent head treated resulting from the dermal and premise treatments to ruminants, average field trial residues, experimentally determined processing factors, and anticipated livestock residues. For drinking water, the chronic analyses assumed the modeled tier 1 FIRST chronic surface water estimate resulting from the application of spinosad to turf ( highest registered/ proposed rate). The resulting exposure estimates were # 96% the cPAD and are therefore less than HED's level of concern. Table 9 is a summary of the chronic dietary risk assessment.

Table 9: Summary of Chronic Dietary Exposure and Risk ( drinking water included)

Population cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.027 0.008175 30 All Infants (< 1 year old) 0.009605 36 Children 1 2 years old 0.025784 96 Children 3 5 years old 0.019729 73 Children 6 12 years old 0.012591 47 Youth 13 19 years old 0.007547 28 Adults 20 49 years old 0.006312 23 Adults 50+ years old 0.005524 20 Females 13 49 years old 0.006119 23 Page 21 of 28 4.6 Residential Exposure and Risk Pathway Spinosad is currently registered for use on turf and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers and fire ants. Granular ( homeowner) and EC ( commercial applicators) formulations are registered. Since no dermal endpoints were identified and based on the granular formulation and low vapor pressure for spinosad, residential handler/ applicator and postapplication dermal/ inhalation exposure assessments were not conducted. HED concluded that there is a potential for toddler short term non dietary oral exposures ( hand to mouth, object to mouth, ingestion of granulars, and soil ingestion). Since HIARC did not identify an acute dietary endpoint, episodic ingestion of granulars was not assessed. The resulting combined short term incidental oral MOEs were 640 and are therefore less than HED's level of concern (.

HED notes that proposed fruit fly bait application scenario permit's application to non crop vegetation and this use may result in residential exposures. Based on the application rates ( fruit fly bait  0.0003 lb ai/ acre; turf/ ornamental  0.41 lbs ai/ acre), HED concludes that residential exposure resulting from the fruit fly application will be insignificant when compared to the exposure resulting from the turf/ ornamental application. Therefore, quantitative analysis of the residential exposure resulting from the fruit fly bait application was not performed. HED concludes that all other registered/ proposed application scenarios will not result in residential exposures.

4.7 Non occupational Off Target Exposure Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from ground application. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, State Lead Agencies for pesticide regulation, and other parties to develop the best spray drift management practices. On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off target drift with specific products with significant risks associated with drift. Page 22 of 28 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION In general, aggregate exposures are calculated by summing dietary ( food and water) and residential exposures ( residential or other non occupational exposures). Based on the anticipated residential exposure scenarios and since acute and cancer risk assessments are not required, only short term ( residential, food, and water) and chronic ( food and water) aggregate exposure assessments were conducted. Since the dietary analyses incorporated drinking water estimates, calculation of DWLOCs are unnecessary ( the dietary analyses represent exposure from food and water). The following paragraphs are summaries of the short term and chronic aggregate exposure assessments.

Short Term Aggregate Risk Assessment: Currently, only short term incidental oral exposures to toddlers are anticipated from the registered turf and ornamental application. This incidential oral exposure is combined with chronic dietary ( food and water) exposure for determination of aggregate short term exposure. HED uses chronic dietary exposure when conducting short term aggregate assessments as it has been determined that this will more accurately reflect exposure from food over the HED defined short term interval ( 1 30 days) than will acute exposure. Table 10 is a summary of the short term aggregate exposures and risk estimates. Since the aggregate MOEs were $ 150, shortterm aggregate exposure to spinosad is less than HED's level of concern.

Table 10. Short Term Aggregate Risk and DWLOC Calculations.

Population NOAEL ( mg/ kg/ day) Target MOE Chronic Food and Water Exposure ( mg/ kg/ day) Residential Oral Exposure1 ( mg/ kg/ day) Aggregate MOE ( food, water, and residential) 2 All infants (< 1 year old) 4.9 100 0.009605 0.0076 280 Children ( 1 2 years old) 4.9 100 0.025784 0.0076 150 Children ( 3 5 years old) 4.9 100 0.019729 0.0076 180 Children ( 6 12 years old) 4.9 100 0.012591 0.0076 240 1 residential exposure = sum of hand to mouth, object to mouth, and soil ingestion residue estimates; see D284802, M. Dow and D. Vogel, 15 Aug 2002 2 Aggregate MOE = NOAEL ÷ ( Chronic Food Exposure + Residential Exposure)

Chronic Aggregate Risk Assessment: Since there are no registered/ proposed uses which result in chronic residential exposures, the chronic aggregate exposure assessment is concerned only with exposure from food and water. Since the dietary exposure analysis included drinking water, the discussion and exposure estimates exposure presented in Section 4.5 represent aggregate chronic exposure. Page 23 of 28 6.0 CUMULATIVE RISK Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for spinosad and any other substances, and spinosad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spinosad has 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 the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

7.0 OCCUPATIONAL EXPOSURE D313757, M. Dow, 2 Mar 2005 D315415, M. Dow, 26 Apr 2005 The available exposure data for combined mixer/ loader/ applicator scenarios are limited in comparison to the monitoring of these two activities separately. These exposure scenarios are outlined in the PHED Surrogate Exposure Guide ( August 1998). HED has adopted a methodology to present the exposure and risk estimates separately for the job functions in some scenarios and to present them as combined in other cases. Most exposure scenarios for hand held equipment ( such as hand wands, backpack sprayers, and push type granular spreaders) are assessed as a combined job function. With these types of hand held operations, all handling activities are assumed to be effected by the same individual. The available monitoring data support this and HED presents them in this way. Conversely, for equipment types such as fixed wing aircraft, groundboom tractors, or air blast sprayers, the applicator exposures are assessed and presented separately from those of the mixers and loaders. By separating the two job functions, HED determines the most appropriate levels of PPE for each aspect of the job without requiring an applicator to wear unnecessary PPE that may be required for a mixer/ loader ( e. g., chemical resistant gloves may only be necessary during the pouring of a liquid formulation).

Spinosad is classified as Toxicity Category III for acute oral and dermal toxicity, Toxicity Category IV for acute inhalation toxicity, and Toxicity Category IV for primary eye and primary skin irritation. It is not a dermal sensitizer. The HIARC did not identify dermal toxicological endpoints; therefore, dermal exposure assessments are unnecessary. Page 24 of 28 7.1 Handler Exposure No chemical specific data are available with which to assess potential exposure to pesticide handlers. The estimates of exposure to pesticide handlers are based upon surrogate study data available in the PHED ( v. 1.1, 1998). For pesticide handlers, it is HED policy to present estimates of exposure for " baseline;" that is, with a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks and no protective gloves and with a single layer of work clothing and the use of protective gloves or other PPE as might be necessary. The Entrust   , Success   , Tracer   , and GF 120 Naturalyte   Fruit Fly Bait labels all require applicators and other handlers to wear long sleeved shirt, long pants and shoes plus socks. The Justice   Fire Ant Bait label requires applicators and other handlers to wear long sleeved shirt, long pants, shoes plus socks and waterproof gloves when handling for uses covered under the worker protection standard ( WPS). Uses covered under the WPS are any agricultural uses where plants are grown for sale/ commerce. For uses not covered under the WPS, ( aesthetic plantings, plants/ crops not grown for commercial sale), the PPE required is short sleeved shirt, long pants and shoes plus socks. The following paragraphs are summaries of handler exposure resulting from application of spinosad to the proposed agricultural crops and as a fruit fly bait.

Fruit Fly Bait: Based upon the proposed label, HED believes most occupational pesticide handlers ( i. e., mixers, loaders, applicators) will probably be " commercial" handlers. Private ( i. e. grower) handlers are also likely to apply the material. In the State of California's efforts to control various fruit flies, the most highly exposed occupational handlers are most likely to be persons employed by or contracted by the state to provide area wide applications as are determined necessary by survey trapping of the flies. HED believes the most highly exposed handlers are: ( 1) mixer/ loaders supporting aerial operations; ( 2) aerial applicator; ( 3) applicator using open cab airblast machinery; ( 4) applicator using open cab ground boom machinery; ( 5) ultra low volume ground applications; ( 6) applicator using high pressure handwand sprayer.

It is doubtless that other methods of application might be utilized such as backpack sprayer for spot treatments ( etc.). Based on data in PHED, HED believes exposures and risks from other methods of application will be lower than those noted above. The methods list above involve much larger volumes of material to be handled per work day than could possibly be handled with smaller sprayers or methods of delivery.

Typically, private ( i. e., grower) pesticide handlers are expected to experience short term duration exposures ( 1  30 days). However, " commercial" ( i. e., state employed or contracted) handlers may also experience intermediate term duration exposures ( 1  6 months). The fruit fly control efforts in California are essentially statewide. Growing seasons for the myriad of crops grown in California are spread over most of a calendar year.

The Science Advisory Council for Exposure ( ExpoSac) Standard Operating Procedure 9.1 ( Revised 25 September 2001), " Standard Values for Daily Acres Treated in Agriculture" indicates that up to 7,500 acres per day may be treated by aerial ULV applications and that up to 3,000 acres per day may be treated with ULV ground applications. Airblast machinery is believed to treat a maximum of 40 acres per day, ground boom machinery to treat a maximum of 200 acres per day, and high pressure handwand sprayer to spray a maximum of 1,000 gallons of spray per day. As a Tier I, " worst case" screening level assessment, these values are used herein. Table 11 is a summary of the pesticidehandler exposure estimates. All inhalation MOEs are greater than 100, and therefore do not exceed HED's level of concern, except Page 25 of 28 for application using high pressure hand wand equipment ( short term MOE = 49; intermediate term MOE = 27). Data in the PHED indicate that use of an organic vapor filtering respirator can reduce inhalation exposure by 90%. Short and intermediate term inhalation MOEs for applicators using high pressure handwand equipment while wearing an organic vapor filtering respirator are 490 and 270, respectively ( less than HED's level of concern). Therefore, HED requests that a revised Section B be submitted which requires applicators who use high pressure hand wand equipment to wear an approved organic vapor filtering respirator.

HED notes that the unit exposure data for an applicator using high pressure hand wand equipment is classified as " low confidence data." The number of observations is rather low and most of the observations were from a study of an indoor application to poultry houses. It is very likely that applications out of doors would result in lesser exposure than what has been estimated. However, more suitable data are not available for use to refine the estimates. The estimate of exposure could be refined upon receipt of suitable compound specific or surrogate data that demonstrate otherwise. Foliar Application to Agricultural Crops: Based upon the proposed use pattern, HED expects commercial and private ( i. e., grower) occupational pesticide handlers ( mixers, loaders, applicators) to typically be exposed to short term duration exposures ( 1  30 days). However, the ExpoSAC maintains that it is possible for some commercial handlers to be exposed to intermediate term ( 1  6 months) exposures. It is thought that commercial handlers may move from farm to farm or area to area and continuously apply a material to the same crop over a widely spread geographic area. Therefore, estimated risks are presented for handlers who experience short term as well as intermediate term exposures. Based upon the proposed use pattern, HED believes the most highlyexposed occupational pesticide handlers are most likely to be: ( 1) mixer/ loader using open pour of liquid; ( 2) mixer/ loader using open loading of WP; ( 3) mixer/ loader using open loading of granular; ( 4) applicator using open cab, ground boom equipment; ( 5) pilot ( aerial applicator); ( 6) applicator using high pressure handwand; ( 7) applicator using open cab, granular broadcast; and ( 8) mixer/ loader/ applicator using commercial " push" type rotary spreader to apply granules. Using a conservative approach, mixer/ loaders are assumed to be supporting aerial operations ( i. e., 1,200 acres treated per day). Ground application operations are assumed to be 350 acres per day. An applicator using highpressure handwand equipment is assumed to apply 1,000 gallons of spray per day. A mixer/ loader/ applicator is assumed to treat 5 acres per day. Table 11 is a summary of the pesticidehandler exposure estimates.

All inhalation MOEs are greater than 100, and therefore do not exceed HED's level of concern, except for mixer/ loaders using open loading of WP in support of aerial operations ( short term MOE = 66; intermediate term MOE = 36). Data in the PHED indicate that use of a dust/ mist filtering respirator reduces inhalation exposure by 80%. Short and intermediate term inhalation MOEs for mixer/ loaders using open loading of WP in support of aerial operations while wearing a dust/ mist filtering respirator are 326 and 180, respectively ( less than HED's level of concern). Therefore, HED requests that a revised Section B be submitted for the Entrust   label which requires mixer/ loaders to wear an approved dust/ mist filtering respirator.

Table 11. Estimated Inhalation Handler Exposure and Risk from the Proposed Use of Spinosad Inhalation Unit Exposure1 mg ai/ lb handled Applic. Rate2 Units Treated3 Per Day Average Daily Dose4 ( mg ai/ kg bw/ day) MOE5 Table 11. Estimated Inhalation Handler Exposure and Risk from the Proposed Use of Spinosad Page 26 of 28 ST IT Fruit Fly Bait Mixer/ Loader  Liquid  Open Pour  Supporting Aerial Operation Inhal 0.0012 HC 0.0345 lb ai/ acre 7,500 A Inhal 0.00444 1100 610 Aerial Applicator Inhal 0.000068 MC 0.0345 lb ai/ acre 7,500 A Inhal 0.000251 20,000 11,000 Applicator  Open Cab  Airblast Inhal 0.0045 HC 0.0345 lb ai/ acre 40 A Inhal 0.0000887 55,000 30,500 Applicator  Ground boom  Open Cab Inhal 0.00074 HC 0.0345 lb ai/ acre 200 A Inhal 0.0000729 67,000 37,000 Applicator  Truck mounted ULV Ground  ( Groundboom  Closed Cab Used as Surrogate)

Inhal 0.000043 0.0345 lb ai/ acre 3000 A Inhal 0.0000636 77,000 42,500 Applicator  High Pressure Hand wand6 Inhal 0.079 LC 0.221 lb ai/ gallon formulation ( 0.0345 lb ai/ acre) 400 gallons formulation/ day ( 88 lb ai/ day) Inhal 0.0993 49 27 Inhal with respirator 0.00797 Inhal 0.00993 493 272 Foliar Agricultural Application Mixer/ Loader  Liquid  Open Pour  Supporting Aerial Operation Inhal 0.0012 HC 0.16 lb ai/ acre 1,200 acres Inhal 0.0033 1,500 800 Mixer/ Loader  WP  Open Load Inhal 0.0434 MC 0.1 lb ai/ acre 1,200 acres Inhal 0.074 66 36 Inhal with respirator 0.00877 Inhal 0.015 326 180 Mixer/ Loader  Granular  Open Load Inhal 0.0017 HC 0.00075 lb ai/ acre 200 acres Inhal 0.0000036 1.4 million 750,000 Applicator  Aerial Inhal 0.000068 MC 0.16 lb ai/ acre 1,200 acres Inhal 0.00019 26,000 14,000 Applicator  Ground boom  Open Cab Inhal 0.00074 HC 0.16 lb ai/ acre 200 acres Inhal 0.00034 14,400 7,500 Applicator  Broadcast Granular  Open Cab Inhal 0.0012 LC 0.00075 lb ai/ acre 200 acres Inhal 0.0000026 1.9 million > 1 million Mix/ Load/ Applicator  High Pressure Hand wand Inhal 0.12 LC 0.125 lb ai/ 100 gallon 1,000 gal/ day ( 1.25 lb ai/ day) Inhal 0.00214 2,300 1,300 Mixer/ Loader/ Applicator  Open Pour Granular  (" Belly grinder")

Inhal 0.0063 HC 0.00075 lb ai/ acre 5.0 acres Inhal 0.00000034 > 14 million 8 million 1 unit exposures are taken from " PHED SURROGATE EXPOSURE GUIDE", Estimates of Worker Exposure from The Pesticide Handler Exposure Database Version 1.1, August 1998; inhal. = inhalation; units = mg ai/ pound of active ingredient handled; data confidence: LC = low confidence, MC = medium confidence, HC = high confidence 2 applic. rate. = taken from sections A & B ( proposed labeling) 3 units treated are taken from " Standard Values for Daily Acres Treated in Agriculture"; SOP No. 9.1. ExpoSAC; Revised 5 Jul 2000 4 average daily dose = unit exposure x applic. Rate x units treated ÷ body weight ( 70 kg). 5 MOE = NOAEL ÷ ADD; ST = short term MOE; IT = intermediate term MOE 6 the label indicates that the most effective dilution for aerial and most other applications is 1: 1.5 ( GF 120: water); to mix 10 gallons of spray solution, 4 gallons of GF 120 would be mixed with 6 gallons of water; HED assumes an applicator using a high pressure handwand sprayer will apply 1,000 gallons of spray per day; therefore, 400 gallons of GF 120 would be mixed with 600 gallons of water. And 400 gallons * 0.221 lb ai/ gallon = 88.4 lb ai handled per day 7 PHED indicates that organic vapor filtering respirator ( fruit fly bait application with high pressure handwand) and dust/ mist filtering respirator ( application of WP in support of aerial applications) will provide 90% and 80%, respectively, reduction in inhalation exposure Page 27 of 28 7.2 Post Application Worker Exposure There is potential for agricultural workers to experience post application exposure to pesticides during the course of typical agricultural activities such as crop scouting, hand weeding, thinning, or other irrigation activities. However, in this case the HIARC did not identify dermal toxicological endpoints and post application inhalation exposure for agricultural workers is considered negligible; therefore, a post application risk assessments are not necessary for the proposed application scenarios.

7.3 Restricted Entry Interval The REI on the proposed labels is 4 hours. It appears that spinosad is eligible for a reduced REI as described in the Pesticide Regulation ( PR) Notice 95 3 ( 7 June 1995). Since certain legal documents are required from the registrant and it is RD's purview to grant REIs, HED defers to RD on the issue of an acceptable REI for spinosad.

8.0 DEFICIENCIES / DATA NEEDS 8.1 Toxicology Fruit Fly Bait and Foliar Agricultural Application ° 28 day inhalation toxicity study in rats 8.2 Chemistry Fruit Fly Bait ° revised Section F Foliar Agricultural Application C revised Section B C revised Section F ° alfalfa ( n= 3; forage and hay samples should be collected ) and grass ( n= 3; forage and hay samples should be collected) side by side residue data comparing the SC and WP spinosad formulations or submits a rationale as to why these data are unnecessary ° banana field trial in region 3 ( n= 1) ° cattle feeding study conducted with dietary burdens of 10 ppm, 100 ppm, and 500 ppm 8.3 Occupational/ Residential Fruit Fly Bait and Foliar Agricultural Application ° revised Section B Attachment 1: Chemical Structures RDI: RAB1 Branch ( 7 Sept 2005) T. Bloem: 806R: CM# 2:( 703) 605 0217: 7590C Page 28 of 28 O O C H 3 N C H 3 C H 3 O O CH 3 OCH 3 OCH 3 O CH 3 H 3 CH 2 C O O H H H H H 3 CO R Spinosyn A: R = H Spinosyn D: R = CH 3 Rhamnose portion Macrolide portion Forosamine portion O O C H 3 NH C H 3 O O CH 3 OCH 3 OCH 3 O CH 3 H 3 CH 2 C O O H H H H H 3 CO CH 3 Attachment 1: Chemical Names and Structures Common Name Chemical Name Structure Spinosyn A ( Factor A)

2[( 6 deoxy 2,3,4 tri O methyl" L mannopyranosyl oxy] 13[[ 5( dimethylamino) tetrahydro 6 methyl 2H pyran 2 yl] oxy] 9 ethyl 2,3,3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16btetradecahydro 14 methyl 1H as Indaceno[ 3,2 d] oxacyclododecin 7,15 dione Spinosyn D ( Factor D)

2[( 6 deoxy 2,3,4 tri O methyl" L mannopyranosyl oxy] 13[[ 5( dimethylamino) tetrahydro 6 methyl 2H pyran 2 yl] oxy] 9 ethyl 2,3,3a, 5a, 5b, 6,9,10,11,12,13,14,16a, 16btetradecahydro 4,14 methyl 1H as Indaceno[ 3,2 d] oxacyclododecin 7,15 dione N Demethyl Spinosyn D ( Factor B of D)

2[( 6 deoxy 2,3,4 tri O methyl" L mannopyranosyl oxy] 9 ethyl 2,3,3a, 5a, 5b, 6,9, 10,11,12,13,14,16a, 16b tetradecahydro 4,14 dimethyl 13[[ tetrahydro 6 methyl 5( methylamino) 2H pyran 2 yl] oxy] 1H as Indaceno[ 3,2 d] oxacyclododecin 7,15 dione Spinosyn J sturcutue was not provided based on MS analysis, structure is similar to spinosyn A Spinosyn L and Spinosyn O structure was not provided based on MS analysis, structure is similar to spinosyn D with loss of methyl from the rhamnose sugar structure was not provided based on MS analysis, structure is similar to spinosyn D with loss of methyl from the rhamnose sugar 15 pk4 and 15 pk6 structure was not provided based on MS analysis, structure is similar to spinosyn D with loss of methyl from the forosamine sugar dimethylamino group and loss of a methyl from rhamnose sugar


[Federal Register Volume 85, Number 93 (Wednesday, May 13, 2020)]
[Rules and Regulations]
[Pages 28488-28490]
[FR Doc No: 2020-09652]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0242]
RIN 1625-AA00

Safety Zone; Tug Kimberly Anne and Barge Big Digger Operating in
the Straits of Mackinac, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 500-yard radius of a tug and barge in the
Straits of Mackinac. The safety zone is needed to protect personnel,
vessels, and the marine environment from potential hazards created by
the work, inspection, and surveying of underwater infrastructure. Entry
of vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Sault Sainte Marie or their
designated representative.

DATES: This rule is effective without actual notice from May 13, 2020
through October 30, 2020. For the purposes of enforcement, actual
notice will be used from May 4, 2020 through May 13, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0242 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LT Sean V. Murphy, Sector Sault Sainte Marie Waterways
Management Division, U.S. Coast Guard at telephone<PHONE_NUMBER> or
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are

``impracticable, unnecessary, or contrary to the public interest.''
Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists
for not publishing a notice of proposed rulemaking (NPRM) with respect
to this rule because doing so would be impracticable. The final details
of the specific dates, vessel names, and safety zone distances
concerning the safety zones were not finalized within a sufficient time
to allow for notice and a subsequent 30-day comment period before work,
inspections, and surveying of underwater infrastructure. Delaying this
rule to allow for a notice and comment period would be impracticable
because it would inhibit the Coast Guard's ability to protect the
public from the potential hazards associated with aforementioned
operation commencing on May 4, 2020.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, delaying the effective date of this rule would
be impracticable because immediate action is needed to respond to the
potential safety hazards associated with the work, inspections, and
surveying of underwater infrastructure.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sault Sainte
Marie (COTP) has determined that potential hazards associated with the
work, inspection, and surveying of underwater infrastructure in the
Straits of Mackinac starting May 4, 2020, will be a safety concern for
anyone within a 500-yard radius of the tug and barge. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone while the operation is
conducted.

IV. Discussion of the Rule

    This rule establishes a safety zone from May 4, 2020, to October
30, 2020. The safety zone will cover all navigable waters within 500
yards of a tug and barge being used to work, inspect, and survey
underwater infrastructure in the Straits of Mackinac. The duration of
the zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters while the operation is conducted.
No vessel or person will be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size and
location of the safety zone. Vessel traffic will be able to safely
transit around this safety zone which would impact a small designated
area of the Straits of Mackinac. Moreover, the Coast Guard will issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, and the rule would allow vessels to seek permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule

will not result in such an expenditure, we do discuss the effects of
this rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that will prohibit entry within 500 yards of a tug and
barge used to work, inspect, and survey underwater infrastructure in
the Straits of Mackinac. It is categorically excluded from further
review under paragraph L[60(a)] of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0242 to read as follows:

Sec.  165.T09-0242  Safety Zone; Tug Kimberly Anne and Barge Big Digger
operating in the Straits of Mackinac, MI.

    (a) Location. The following areas are safety zones: All navigable
waters within 500 yards of Tug Kimberly Anne and Barge Big Digger while
conducting work, inspection, and surveying of underwater infrastructure
in the Straits of Mackinac.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sault Sainte Marie (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within the safety
zone described in paragraph (a) is prohibited unless authorized by the
Captain of the Port, Sault Sainte Marie or his designated
representative.
    (2) Before a vessel operator may enter or operate within the safety
zones, they must obtain permission from the Captain of the Port, Sault
Sainte Marie, or his designated representative via VHF Channel 16 or
telephone at<PHONE_NUMBER>. Vessel operators given permission to enter
or operate in the safety zone must comply with all orders given to them
by the Captain of the Port, Sault Sainte Marie or his designated
representative.
    (d) Enforcement period. This section will be enforced from May 4,
2020 to October 30, 2020.

    Dated: May 1, 2020.
P.S. Nelson,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2020-09652 Filed 5-12-20; 8:45 am]
 BILLING CODE 9110-04-P