### Spinosad and Spinetoram Registration Revie w Human 

## UNITED STA

**MEMORANDUM DATE:**  0 9 - AUG - 2011 **SUBJECT: Spinosad**  **and Spinetoram**

Support of Registration Review. **PC Code** : Spinosad: 110003

Spinetoram: 110008 and 110009 **Decision No.:** 446932 **Petition No.:** NA **Risk Assessment Type:** NA **T XR No.:**  NA **MRID No.:** NA 

## Reviewer: Lata Venkateshwara, Environmental Scientist

Julie L . Van Alstine Chester Rodriguez, Ph.D., Pharmacologist Risk Assessment Branch 1 (RAB1) Health Effects Division (HED, 7509P) **Through:** Dana Vogel, Branch Chief

George F. Kramer, Ph.D., Senior Chemist RAB1/HED (7509P) **To:** Anne Overstreet, Team Leader

Risk Management & Implementation Branch IV Pesticide Re - Evaluation Division ( Attached is HED’s human - health risk assessment scoping document for to support Registration Review. Registration Revie w Human- Health Assessment Scoping Document



## Page 1 of 72 **UNITED STA T**  **ES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

CHEMICAL SAFETY AND POLLUTION PREVENTION 

## and Spinetoram ; Human - Health Assessment Scoping Document in Support of Registration Review. Spinetoram: 110008 and 110009 **DP Barcode:** D 387988 **Registration No.:** NA **Regulatory Action:** Registration Review Scoping Document **Case No.:** Spinosad : 7421

S pinetoram : 7448. **CAS No s**  **.:** Spinosyn A: 131929 - 60 - 7; Spinosyn D:

Spinetoram J: 187166 - 40 - 1; Spinetoram **40 CFR:** Spinosad: §180. 495

Spinetoram: § 180.635 

## Lata Venkateshwara, Environmental Scientist Julie L . Van Alstine , MPH, Environmental Health Scientist Chester Rodriguez, Ph.D., Pharmacologist Risk Assessment Branch 1 (RAB1) Health Effects Division (HED, 7509P) Dana Vogel, Branch Chief George F. Kramer, Ph.D., Senior Chemist RAB1/HED (7509P) Anne Overstreet, Team Leader Risk Management & Implementation Branch IV

Evaluation Division ( PRD, 7508P) health risk assessment scoping document for spinosad and spinetoram support Registration Review. Health Assessment Scoping Document 

## ES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

## Health Assessment Scoping Document in

Registration Review Scoping Document

Spinosyn D: 131929 - 63 - 0 Spinetoram L: 187166 - 15 - 0



## spinosad and spinetoram

### Spinosad and Spinetoram Registration Revie w Human- Health Assessment Scoping Document



## Page 2 of 72 **Executive Summary** Spinosad and spinetoram are fermentation products of Saccharopolyspora spinosa that were developed for the control of lepidopterous larvae, leafminers, and thrips on a variety of crops. Spinosad consists of two closel y related active ingredients, spinosyn A and D, present in an approximate 85:15 ratio (A:D; see Attachment 1 for structures) , and spinetoram consists of two closely related active ingredients, spinetoram J and L(also known as XDE - 175 - J and XDE - 175 - L , respectively) , present in an approximate 3 :1 ratio (J:L ; see Attachment 1 for structures) . Spinetoram, a recently registered active ingredient, has a very

similar chemical structure as spinosad and both compounds have been determined to be toxicologically equivalent (Hazard Science Policy Council (HASPOC ) , W. Greear, 18 - JUN - 2007 ; D340521 ) ; therefore, the toxicity data of these pesticides can be used interchangeabl y or in combination in establishing the toxicity endpoints for risk assessment. The mode of action in insects is thought to be disrupti on of nicotinic/gamma amino buty

ric acid (GABA) - gated chloride channels. Spinosad and spinetoram are both currentl y registered for use on agricultural crops, ornamentals, tree farms/plantations, turfgrass, home gardens, pet (cats and kittens) spot - ons (sp inetoram onl y) , and lawns (residential use). They can be applied as seed treatment s , at -planting soil application s , and/or broadcast foliar applications . Post - harvest uses are also allowed on selected fruit and root crops. The most recent human - health risk assessment was conducted in 2010 in conjunction with a Section 3 request for the use of spinetoram as a cat/kitten spot - on use (T. Bloem, 12 - OCT 2010; D376415). Since spinosad and spinetoram are considered toxicologically equival ent , this risk assessment included dietary and aggregate exposure and risk estimates for both chemicals. HED has evaluated the status of the human - health risk assessments for spinosad and spinetoram to determine whether sufficient data are available and whether any updates are needed to support registration review. The most recent human- health risk assessments for spinosad and spinetoram were considered with respect to their toxicity , exposure, usage databases, and the most updated Agency science policy

and risk assessment methodologies to determine the scope of work necessary to support registration review . Since spinosad and spinetoram control the same pests, HED concludes that these products will not be used in combination with each other and combining residential exposures is unnecessary . Spinetoram and spinosad exhibited low acute toxicity via the oral, dermal, and inhalation routes of exposure . The critical effects noted in rodent studies following subchronic and chronic exposures to spinosad were associated with multi - organ histopathology including increased cell vacuolation in the liver, kidney, stomach, female reproductive tract, and epididy mis along with decreases in body weight and clinical chemistry changes consistent with anemia and liver damage. In the case of spinetoram, treatment - related findings include anemia in multiple species (rats, mice , and dogs) with the presence of histiocytic aggregates of macrophages in various organs and tissues (l ymph nodes, spleen, thy mus, and bone morrow). Aggregation of macrophages was indicative of immune stimulation in response to insults of the chemical exposure and was considered a secondary effect of the toxic effect to the hematopoetic s ys tem. There was no evidence of increased pre - or post - natal susceptibility based on prenatal developmental toxicity

studies (rats and rabbits) and rat two - generation reproductive toxicity studies carried out with either spinosad or spinetoram. Although these compounds are postulated to operate via a neurotoxic mode of action in target pests, no neurotoxic effects were seen in acute and subchronic neurotoxicity studies. Both

### Spinosad and Spinetoram Registration Revie w Human- Health Assessment Scoping Document



## Page 3 of 72 compounds were also negative for mutageni city and there was no evidence of carcinogenicity in rats or mice. The toxicity data base for spinosad/spinetoram is adequate to support existing registrations and registration review . The residue chemistry

database is sufficient to support the current registrations. However, the following residue chemistry data requirements remain outstanding : (1) s ide -by- side grass and alfalfa field trials comparing the soluble - concentrate (SC) and wettable -powder (WP) formulations of spinosad ; (2) a spinosad nature of the residue study for tobacco ; (3 ) reanalysis of orange oil samples using a method validated at the observed residues ; and ( 4 ) various label corrections . Additionally , three studies were submitted to the Agency that have not been reviewed. These studies provide data regarding residues of spinosad in tobacco (MRIDs 44214901 , 44214902 , and 44214903 ) and should be reviewed as part of Registration Review . Until the review is complete, HED cannot be certain the data are sufficient for risk assessment. The tolerance expressions for spinosad (40 CFR §180.495) and spinetoram (40 CFR §180.635 ) should be updated to reflect current Agency policy , and the tolerance levels for several commodities should be updated as outlined in Table 3 . The dietary

exposure database is adequate to support existing registrations; however, a revised assessment is required, which incorporates the HED - recommended tolerances changes , as needed . Additionall y, the revised assessment should include a residue value for water chestnuts, based on the spinosad food commodities tolerance of 0.02 ppm. These revisions are not expected to significantly

increase dietary

exposure estimates . There is sufficient information available to assess residential exposure resulting from registered spinosad and spinetoram uses for registration review. For spinos ad , there is a liquid formulation registered for use on home gardens and for fire ant control that has not been assessed for residential handler exposure/risk. For spinetoram, the residential assessment is reflective of the currentl y registered uses and m aximum application rates. HED has completed residential post application incidental oral exposure assessments for both pet spot - on treatment and home lawn application scenarios for children. A revised residential assessment will need to be performed for the residential handler scenarios for the home ornamental products that have application rates higher than what was previously assessed. HED is currentl y revising its Residential Standard Operating Procedures (SOPs). Reviewers should incorporate new guidance from the updated SOPs to refine exposure estimates . There is sufficient information available to assess occupational handler exposure associated with the agricultural and non - agricultural uses of spinosad and spinetoram for Registration Review . S everal occupational handler scenarios need to be assessed, which have not been assessed previously , or need to be reassessed based on higher application rates, area treated, or revised SOPs. There is sufficient information available to assess occupational post - application exposure. Currently , since there are no short - and intermediate - term dermal p oints of departure (PODs) for spinosad and spinetoram , a dermal post - application exposure assessment is not necessary for the registered uses. Based on the Agency's current practices, a quantitative occupational post application inhalation exposure assessment has not been performed for spinosad and spinetoram ; however, if new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment.

### Spinosad and Spinetoram Registration Revie w Human- Health Assessment Scoping Document



## Page 4 of 72 The data need and risk assessment updates required under Registration Review for spinosad and spinetoram are listed on page 2 7 . **Hazard Identification/Toxicology** Spinetoram and spinosad can be evaluated interchangeabl y for hazard characterization since they have nearl y identical chemical structures and were determined to be toxicologicall y equivalent. Both are fermentation products of Saccharopolyspora spinosa and were developed for the control of lepidopterous larvae, leafminers, and thrips. The pesticidal mode of action for both compounds involves disruption of nicotinic/GABA - gated chloride channels. **Spinosad** Following oral administration with radiolabeled spinosad, approximately 70 - 80% of the dose was absorbed with the remaining fraction being eliminated unabsorbed through the feces. Maximum blood levels of the radiolabel were reached within 1 hour post - dosing in both sexes. Half - lives were estimate d at 6 and 12 hours for males and female rats, respectivel y, indicating that greater accumulation may take place in female rats. There were no major differences in oral bioavailability, routes or rates of excretion or metabolism following a single low and high oral dose or repeated oral doses of spinosad in rats. Biliary /fecal excretion was the major clearance pathway . At 168 h our s after administration of the low dose (10 mg/kg bw), the kidney, liver , and fat of males and females had higher levels than other tissues. In the high dose group (100 mg/kg bw) however, the adrenals (females only), kidney , l ymph nodes, fat, and thy roids had higher levels than other tissues. The acute toxicity

profile of spinosad consists of low toxicity via the oral, dermal, and inhalation routes of exposure (Category I II or IV) . Itis neither an eye irritant (Category IV), skin irritant (Category IV), nor a dermal sensitizer. The primary toxic effect observed with spinosad was multi - organ histopathology (perhaps due to systemic inflammation as with the structurall y related compound spinetoram). For example, following subchronic exposure to spinosad, the primary effects seen in the mouse were increased vacuolation of cells of the ly mphoid organs, liver, kidney , stomach, female reproductive tract, and epididy mis, and less severel y in the heart, lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary gland, and anemia. In rats, thy roid follicular epithelial cell vacuo lation, anemia, multifocal hepatocellular granuloma, cardiomyopathy , and splenic histiocy tosis were observed following subchronic exposure, in dogs microscopic changes in a variety of tissues, anemia, and possible liver damage were seen with short - term rep eated dosing. In a chronic feeding study in dogs, increases in serum alanine aminotransferase, aspartate aminotransferase, and trigl ycerides 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 thy roid weights were observed in a chronic oral toxicity study in rats. No developmental effects were seen in the rat and rabbit developm ental toxicity studies with spinosad. Inthe 2 - generation reproductive toxicity study, spinosad produced reproductive toxicity at the highest dose tested that was characterized by an increased incidence of dystocia and/or vaginal bleeding after parturitio n with associated increases in mortality in the dams resulting in decreases in litter size, survival (F 2 

## litters only) and body weights in the offspring ; whereas , parental male rats exhibited chronic active inflammation of the prostate gland. Reproductive toxicity

was also observed with the structurally related pesticide, spinetoram, which produced reproductive effects in the female rat in the reproduction/fertility study . Because decreased litter size and survival were observed in the presence of maternal toxicity

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## Page 5 of 72 (deaths) in the 2 - generation reproduction study with spinosad and maternal and offspring toxicities were equally

severe, this study

provides no evidence of increased offspring susceptibility . Although spinosad operates via a neurotoxic mode of action in target pests, 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 . No toxicity

was seen at the limit dose in a 21 - day dermal toxicity study in rabbits. Spinosad was negative for mutagenicity in various mutagenicity assays , and there was no evidence of carcinogenicity in rats or mice. In the previous risk assessment (T. Bloem et al. , 12 - OCT - 2010; D376415) , an immunotoxicity study was re quested for either spinosad or spinetoram . Preliminary review of a recentl y submitted immunotoxicity study with spinosad suggests that this compound at the high dose of 900 ppm (141 mg/kg bw/day) induced a higher percentage of circulating neutrophils and monocy tes with a concomitant decrease in ly mphocy tes. A non - statistically

significant decrease in the anti - Susquehanna River Basin Commission **(** 

## SRBC ) response was also observed in the high dose group. The level of concern for immunotoxicity, however, is l ow since much lower POD dose levels (i.e., 2.5 - 4.9 mg/kg/day) are being used for risk assessment (T. Bloem et al. , 12 - OCT - 2010; D376415 ) and are likel y to remain the same for future actions. **Spinetoram** The acute toxicity

profile of spinetoram consists of low toxicity via the oral, dermal, and inhalation routes of exposure (Category IV). Itis a dermal sensitizer , but not an eye or dermal irritant. Insubchronic toxicity studies conducted in rats, mice , and dogs, spinetoram produced multi - organ toxicity . Treatment had no adverse effects on survival , but decreases in body weight, body- weight gain , and/or food consumption was observed in all three species. Treatment - related findings include anemia in multiple species (rats, mice , and dogs) with the presence of histiocy

tic aggregates of macrophages in various organs and tissues (ly mph nodes, spleen, thy

mus, and bone morrow). Aggregation of macrophages was indicative of immune stimulation in response to in sults of the chemical exposure and was considered secondary effects of the toxic effect to the hematopoetic s ys tem. Dogs appear to be the most toxicologicall y sensitive species to spinetoram exposure. Ina subchronic study with dogs, lower thymus weight s, atrophy of the thy

mic cortex, arteritis and/or perivascular inflammation in numerous organs with necrosis of the bone marrow leading to regenerative anemia was seen. These effects were seen in the presence of general s ys temic toxicity . In a chronic study with dogs, there were no treatment - related effects on survival, body weight, hematology , clinical chemistry , or gross pathology . Treatment - related changes were limited to areteritis and necrosis of the areterial walls of the epididy mides in one male dog and thy mus, thy roid, lary nx, and urinary

bladder in one female at the high dose. Itis postulated that chronic treatment exacerbated the spontaneous areteritis in geneticall y predisposed Beagle dogs (“Beagle Pain S yndrome”). There was no evidence of increased susceptibility following in utero exposures to spinetoram in rats or rabbits. Spinetoram produced reproductive effects in the female rat in the 2 - generation reproductive toxicity

study (NOAEL=10 mg/kg/day). The effects were characterized b y evidence of treatment- related depletion of primordial and/or “growing” ovarian follicles, dystocia and other parturition abnormalities, late resorptions/retained fetuses and increased postimplantation loss. However, no adverse effect s were observed on the offspring at dose levels that produced parental toxicity in the 2 - generation reproductive toxicity study .

### Spinosad and Spinetoram Registration Revie w Human- Health Assessment Scoping Document



## Page 6 of 72 No indication of neurotoxicity was observed in the acute neurotoxicity screening battery

in rats, or in the subchronic and chronic toxicity studies conducted on spinetoram. All the mutagenicity

studies conducted on spinetoram were negative. **Food Quality Protection Act (FQPA) Considerations**  In the last risk assessment ( T. Bloem et al. , 12 - OCT - 2010; D376415), an FQPA Safety Factor (SF) of 1X was used on the basis that there was no evidence of increased pre - and post - natal susceptibility based on prenatal developmental toxicity studies (rat and rabbit) and 2 - generation reproductive toxicity

studies (rat) with either spinosad o r spinetoram . In addition, there was no evidence of neurotoxicity in the toxicity database that included acute and subchronic neurotoxicity

studies with spinosad and an acute neurotoxicity study with spinetoram . Although there were signs of immunotoxicity (i.e., histopathology in the organs of the immune system) in the database , the effects were considered secondary to a s ys temic inflammatory reaction . In future risk assessments, the evaluation of the FQPA SF will include a recently submitte d immunotoxicity

study with spinosad whose preliminary review suggests that it is unlikely to change the POD dose levels used in the last risk assessment. **Endocrine Disruption** As required b y FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic, and chronic toxicity, including assessments of carcinogenicity , neurotoxicity, developmental, reproductive, and general or systemic toxicity . These studies include endpoints that may be susceptible to endocrine influence, including effects on endocrine target organ histopathology , organ weights, estrus cyclicity , sexual maturation, fertility , pregnancy rates, reproductive loss, and sex ratios in offspring . For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), spinosad and s pinetoram are subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced b y a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two - tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA wil l determine which, if any , of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine - related effects caused by the substance, and establish a dose - response relationship between the dose and the E, A, or T effect. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call - ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Spinosad and

### Spinosad and Spinetoram Registration Revie w Human- Health Assessment Scoping Document



## Page 7 of 72 spinetoram are not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingl y, as part of Registration Review , EPA will issue future EDSP orders/data call - ins, requiring the submission of EDSP screening assays for spinosad/spinetoram. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery , p lease visit our website : http://www.epa.gov/endo/ . **Inhalation Toxicity Study** Based on the available toxicity database and the Agency's current practices, the inhalation risk for spinosad/spinetoram was assessed using an oral toxicity study . The Agency

sought expert advice and input on issues related to this route - to - route extrapolation approach (i.e. , the use of oral toxicity

studies for inhalation risk assessment) from its Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in December 2009. The Agency received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ). The Agency is in the process of evaluating the SAP report and may , as appropriate, re - examine and develop new policies and procedures for conducting inhalation risk assessments, including route - to - route extrapolation of toxicity

data. If any

new polic ies or procedures are developed, the Agency may revisit the need for an inhalation toxicity study for spinosad/spinetoram and/or a re - examination of the inhalation toxicity

risk assessment. **Conclusions** The toxicity

database for spinosad/spinetoram is adequate to support current registration requirements . There are no missing studies at this time according to the new 40 CFR Part 158 data requirements . The current toxicity endpoint/dose selection may need to be re - evaluated along with the FQPA SF for future risk assessments. **Residue Chemistry** Spinosad and spinetoram are registered for application to numerous crops with tolerances ranging from 0.01 to 200 ppm for spinosad (40 CFR §180.495) and from 0.04 to 22 ppm for spinetoram (40 CFR §180.635). The majority of spinetoram tolerances have been translated from spinosad residue data. HED previousl y concluded that translation of spinosad residue data to spinetoram for numerous crops was acceptable for the following reasons (T. Bloem, 12 - SEP 2007; D325387): (1) spinetoram and spinosad are structurally similar; (2) the spinetoram plant metabolism studies resulted in the incorporation of radioactivity into numerous peaks with each representing ≤3% total radioactive residue [TRR; preharvest interval (PHI)= 0 - 30 days]; (3) the proposed spinetoram application rates were less than or equal to the application rates used in the spinosad field trial studies; and (4) the spinosad and spinetoram side -by- side residue data indicated that, in general, residues of spinetoram (combined spinetoram J, spinetoram L, and the N - demethyl and N

- formyl metabolites , ND - J, NF - J) were comparable to residues of spinosad (combined spinosy

n A and D) provided the application scenarios were similar. HED also concluded that translation of th e spinosad processing factors to spinetoram was acceptable (T. Bloem, 28 - APR- 2009; D357703). The nature of spinosad residues in plants and livestock is adequatel y understood based on metabolism studies conducted with apples, cabbage, cotton, tomatoes, turnips, ruminants (oral and dermal), and poultry

(oral). Based on these data, HED concluded that the residues of concern in plants and livestock, for risk assessment and tolerance enforcement purposes, are spinos yns A and D

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## Page 8 of 72 (G. Herndon, 3 - MAR- 1998, D243816; W. Donovan, 14 - JUN - 2002, D264984). The nature of the spinetoram residues in plants and lives tock is adequately understood based on metabolism studies conducted with turnips, apples, lettuce, ruminants (oral), and poultry (oral). The petitioner submitted a ruminant feeding study

that employed dosing with spinetoram ( spinetoram J: spinetoram L; 3:1) at a dietary burden of 37.85 ppm or a mixture of spinetoram J: spinetoram L: ND - J:NF - J (1:0.25:1.1:1.2) at dietary burdens of 1.18 ppm, 3.69 ppm, 11.46 ppm, and 38.59 ppm (MRID No. 47030801). HED concluded that the results from the feeding study which employed dosing with only parent will be used for determination of the magnitude of the residue in ruminants (T. Bloem, 12 - SEP - 2007; D325387). Based on the submitted data, HED concluded that the residues of concern in plants and ruminants, for risk as sessment and tolerance enforcement purposes, and in poultry for tolerance enforcement purposes are spinetoram J, spinetoram L, ND - J, and NF - J (P. Shah, et al. , 20 - SEP - 2007, D331741). The residues of concern in hens for purposes of risk assessment are spin etoram J, spinetoram L, ND - J, NF - J, 3’ - O - deethyl - 175 - J, 3’ - O - deethyl - 175 - L, and O - demethyl 175 - L (P. Shah, et al. , 20 - SEP - 2007, D331741). Based on the results of the spinosad confined rotational crop study , the HED Metabolism Assessment Review Committee (MARC) concluded that the residues of concern in rotational crops are spinosy

n A and D (G. Herndon, 3 - MAR- 1998, D243816; field rotational crop data have not been submitted). The confined study indicated that residues are incorporated into the general car

bon pool. Spinosy

ns A and D were not detected in the rotated crops [wheat, lettuce, and radish; plant -back intervals (PBIs) of 30, 120, and 365 days]. For spinetoram, the initially submitted confined rotational crop study was inadequate and the nature of the residue in rotational crops could not be determined from the available data. The submitted study did demonstrate that TRRs in rotational crops planted 30 days after treatment (DAT) are low (≤0.027 ppm), and that qualitatively, residues in rotational crops are not likely to be more toxic than the parent. As a result, HED concluded that the available spinetoram data supports a rotational crop restriction that the treated field may onl y be rotated to a labeled crop (P. Shah, et al. , 20 - SEP 2007; D331741 ). Subsequently , a rotational crop study concerning the nature of the residue in rotational crops planted 120 and 365 DAT (as well as the previousl y reviewed 30 - DAT data) was submitted. Based on the residue characterization/identification procedures perf ormed in the study , and since the study employed a single bare - soil application of spinetoram at the maximum ye arl y application rate, HED concluded that a 30 - day PBI is appropriate for all nonlabeled crops (T. Bloem, 28 - AUG - 2008; D353933). The Environmental Fate and Effects Division (EFED) reviewed a spinosad radiolabeled fish bioconcentration study

that included information concerning the nature of the residue in fish. Based on these data, HED concluded that the residues of concern in fish/shellfis h for tolerance setting purposes are spinosy n A and D; for purposes of risk assessment, HED concluded that adjustment of the TRRs in the edible tissues from the 19 -ppb spinosy n A bioconcentration study for the EFED water concentration resulting from the mo squito larvicide use was appropriate (T. Bloem, 2 - August - 2006; D316078). HED notes that these conclusions are appropriate for the currentl y registered uses only and will be reevaluated if the petitioner alters the aquatic application scenario. Residues o f spinetoram in fish/shellfish are expected to be insignificant; therefore, the nature of the residue in fish/shellfish is not pertinent to spinetoram. A summary

of the spinosad and spinetoram residues of concern, for tolerance expression and risk- asses sment purposes, are outlined in Tables 1 and 2 , respectivel y.

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## Page 9 of 72 **Table 1**  **. Residues for Tolerance Expression and Risk Assessment for Spinosad.** Matrix Residues Included in Risk Assessment Residues Included in Tolerance Expression Pla nts 1 spinosyn A and D spinosyn A and D Hog and Ruminants (oral and dermal) 1 oral and dermal - spinosyn A and D spinosyn A and D Poultry (oral and dermal) 1,2 oral - spinosyn A and D

dermal (excluding liver) - spinosyn A and D; dermal (liver) - spinosyns A, B, D, J, N

- demethyl D, and N

- demethyl J spinosyn A and D Rotational Crops 1 spinosyn A and D spinosyn A and D Drinking Water3 total spinosad -- Fish/Shellfish4 adjustment of the TRRs in the edible tissues from the spinosyn A

bioconcentration study (19 -ppb data) for the water concentration

resulting from the mosquito larvicide use spinosyn A and D 1 See D243816 (G. Herndon, 03 - MAR- 1998) and D264984 (W. Donovan, 14 - JUN - 2002) for more information. 2 See D374794 (T. Bloem, 25 - MAR- 2010) for more information. 3 See D316077 (T. Bloem et al. , 02 - AUG - 2006) for more information. 4 HED notes that these conclusions are appropriate for the mosquito larvicide current use only and will be reevaluated if the petitioner alters the aquatic application scenario; see D31607 7 (T. Bloem et al. , 02 - AUG - 2006) for more information. 

### Table **2 . Residues for Tolerance Expression and Risk Assessment for Spinetoram**  **.** Matrix Residues Included in Risk Assessment Residues Included in Tolerance Expression Pla nts 1 spinetoram J, spinetoram L, ND - J, and NF - J spinetoram J, spinetoram L, ND - J, and NF - J Ruminant 1,2 spinetoram J, spinetoram L, ND - J, and NF - J spinetoram J, spinetoram L, ND - J, and NF - J Hen 1,3 spinetoram J, spinetoram L, ND - J, NF - J, 3' - O - deethyl - 175 - J, 3' - O - deethyl - 175 - L, and O - demethyl - 175 - L 3 spinetoram J, spinetoram L, ND - J, and NF - J Rotational Crops 1 Cannot be determined from the available data. Drinking Water 1 Since identified or partially identified degradates in the fate studies contained the major ring structures of the parent compound, a total residue method was used in modeling. -- 1 See D331741 (P. Shah et al. , 20 - SEP - 2007) for more information. ND - J and NF - J are the N - demethyl and N

- formyl metabolites of spinetoram; see D331741 for additional information. 2 HED notes that feeding studies should employ dosing with parent only ( spinetoram J and spinetoram L) and should monitor for the residues of concern for risk assessment. 3 O - demethyl - 175 - L is either 2’ - O - demethyl - 175 - L or 4’ - O - demethyl - 175 - L or a mixture o f both. 

## Adequate plant, ruminant, poultry , fish, and shellfish methods are available for enforcement of the established spinosad tolerances. Method RES 94025 [ GRM 94.02; cottonseed; high performance liquid chromatography (HP LC)/ultraviolet (UV)] has been forwarded to the Food and Drug Administration (FDA) for inclusion in Pesticide Anal ytical Methods Volume II (PAM II) (G. Herndon, 02 - MAR- 1998 ; D243795 ). The following additional methods have been submitted for other crop matrices: GRM 95.17 (leafy vegetables); GRM 96.09 (citrus); GRM 96.14 (tree nuts); GRM 95.04 (fruiting vegetables); and GRM 94.02.S1 (cotton gin by products). All of these methods are essentially similar to GRM 94.02 and have been submitted to FDA for inclusion in PAM II (G. Herndon, 18 - FEB - 1998 ; D242940 ). The immunochemical methods GRM 96.10.S1 (cereal grain commodities, cucurbits, and legumes), GRM 96.11.S1 (stone fruit), and GRM 97.05 (sorghum fodder) were also proposed for tolerance enforcement and GRM 96.11.S1 and GRM 97.05 have undergone successful independent laboratory validation. A number of HPLC/UV and HPLC/MS (mass spectrometry) methods are available for confirmation (e.g., GRM 96.09, GRM 97.06). Method RES 94094 (GRM 95.03; ruminants) and GRM 95.15 (poultry) are HPLC/UV meth ods that were forwarded to the FDA for inclusion in PAM II (G. Herndon, 06 - APR- 1999 , D254677 ; M. Doherty, 24 - JUN - 1999 , D249374 ). The ruminant immunochemical method RES 95114, has also been submitted to FDA for inclusion in PAM (D245211, G. Herndon, 5 - JAN - 1999). HED assumed that the available ruminant and poultry enforcement methods were suitable for enforcement in fish and shellfish (T. Bloem, 2 - AUG - 2006; D316078).

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## Page 10 of 72 Adequate plant and livestock methods are available for enforcement of the established sp inetoram tolerances. Method GRM 05.03 (HPLC/MS/MS) has been determined to be an acceptable method for the determination of spinetoram residues in a variety of crops and was forwarded to the FDA for inclusion in PAM II ( T. Bloem, 12 - SEP - 2007; D343662). Method GRM 05.15 [HPLC/MS] has been considered to be an acceptable method for determination of spinetoram residues in bovine and poultry tissues, milk, cream, and eggs , and was f orwarded to the FDA for inclusion in PAM ( T. Bloem, 12 - SEP - 2007; D343662). Additionally , Method GRM 06.08 was developed for the determination of residues of spinetoram J and spinetoram L and the metabolites ND - J and NF - J in bovine and poultry tissues, milk, cream, and eggs, and was employed in the ruminant feeding study . Based on th e similar anal ytical procedures for GRM 06.08 and GRM 05.15, HED concluded that the ILV and radiovalidation data for GRM 05.15 and Anal ytical Chemistry L aboratory ’s (ACL’s) conclusions concerning GRM 05.15 and tolerance enforcement are also applicable to GRM 06.08 and HED forwarded method GRM 06.08 to FDA for tolerance enforcement (T. Bloem, 12 - SEP - 2007; D343662). Data pertaining to Multiresidue Method (MRM) testing of spinos yns A, D, B, and K and Ndemethyl spinos yn D were forwarded to the FDA for review (S. Willett, 23 - JAN - 1997 , D228434 ; G. Herndon, 01 - MAY - 1996). Factors A and D were not recovered from any of the Protocols (G. Herndon, 24 - APR- 1996; D219016). Spinetoram J , spinetoram L, ND - J, NF - J, ND - L, and NF - L were screened through the FDA PAM IMRMs and the results were forwarded to the FDA (T. Bloem, 18 - Jan - 2007; D335229). None of the test substances were found to be fluorescent using procedures outlined in Protocol A. All test substances were subjected to Protocol C, modules DG1, DG5, DG13, DG17, and DG18. Test substances were determined to be non - chromatographable by the chosen gas chromatography modules described in Protocol C. Due to the poor sensitivity of th e test substances to detection by methods described in Protocol C, no further analyses were performed by Protocols D, E, or F. Since the test substances are not acids, phenols, or substituted ureas, anal ys es were not performed using Protocols B or G. The test substances were not detectable through FDA PAM IProtocols A and C; therefore, these methods are unsuitable for enforcement. The tolerance expressions for spinosad (40 CFR §180.495) should be updated as follows: Tolerances are established for res idues of spinosad, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined b y measuring onl y the sum of Spinosy n A: (2R ,3aS,5a

R ,5b S,9 S,13 S,14R ,16aS,16bR ) - 2 - [(6 - deoxy- 2,3,4 - tri - O - methyl - α - L mannopy ranos yl )oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran 2 - yl ]oxy] - 9 - ethyl - 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 14 - methyl - 1 Has - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione] and Spinosy n D: (2 S,3a R ,5aS,5b S,9 S,13 S,14R ,16aS,16b S ) - 2 - [(6 - deoxy- 2,3,4 - tri - O - methyl - α - L mannopy ranos yl )oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran 2 - yl ]oxy] - 9 - ethyl - 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 4,14 - dimethyl 1 H - as - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione in or on the commodity. The tolerance expression for spinetoram (40 CFR §180.635) should also be updated as follows: Tolerances are established for residues of spinetoram, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined b y measuring onl y the sum of XDE - 175 - J:

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## Page 11 of 72 (2R ,3a R ,5a R ,5b S,9 S,13 S,14R ,16aS,16bR ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl - α - L mannopy ranos yl )oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran 2 - yl ]oxy] - 9 - ethyl - 2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b - hexadecahydro - 14 - methyl - 1 H

- as - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione; XDE - 175 - L: (2 S,3a R ,5aS,5b S,9 S,13 S,14R ,16aS,16b S ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl - α - L mannopy ranos yl )oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran 2 - yl ]oxy] - 9 - ethyl - 2,3,3a,5a,5b ,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 4,14 - dimethyl 1 H - as - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione ; ND - J: (2R ,3a R ,5a R ,5b S,9 S,13 S,14R ,16aS,16bR ) - 9 - ethyl - 14 - methyl - 13 - {[(2 S,5 S,6R ) - 6 - methyl 5 - (methyl amino)tetrahydro - 2H -py ran - 2 - yl ]oxy } - 7,15 - dioxo - 2,3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b - octadecahydro - 1 H - as - indaceno[3,2 - d]oxacyclododecin - 2 - yl 6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl - alpha - L - mannopy ranoside and NF - J: (2R ,3 S,6 S ) - 6 - ({(2R ,3a R ,5a R ,5b S,9 S,13 S,14R ,16aS,16bR ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl alpha- L - mannop yranos yl ) oxy] - 9 - ethyl - 14 - methyl - 7,15 - dioxo 2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b - octadecahydro - 1 H - as - indaceno[3,2 - d]oxacyclododecin - 13 - yl }oxy ) - 2 - methyltetrahydro - 2H

-py ran - 3 - yl (methyl )formamide in or on the commodity . Additionally, several tolerance levels that need to be updated for spinosad and spinetoram are outlined in Table 3 .

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## Page 12 of 72 **Table 3**  **. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.**  **Comm odity**  **Current**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm) Comments Regarding HED**  **- Recommended Tolerance Updates**  Spinosad (40 CFR §180.495) Acerola 1.5 0.30 The currently - established acerola spinosad tolerance is 1.5 ppm; however, HED recommended a 0.30 - ppm tolerance for residues of spinosad in/on acerola based on the citrus tolerance. The established citrus tolerance is 0.30 ppm; therefore, the acerola tolerance should be updated to reflect the HED recommended tolerance of 0.30 ppm (G. Herndon, 23 - FEB - 1999 , D252416 ; M. Doherty, 20 - AUG 1999 , D249374 ). Asparagus 0.2 0.02 HED notes that the currently established spinosad tolerance in/on asparagus is 0.2 ppm; however, the HED -recommended spinosad asparagus tolerance is 0.02 ppm (LOQ tolerance; G. Herndon, 0 6 - AUG - 2001 ; D277485 ). Citrus, oil 3.0 23 Orange processing data were submitted which indicated the need for an increase in the citrus, oil tolerance (Chemistry Memo: T. Bloem, 28 - APR- 2009, D357703; Risk assessment: M. Clock- Rust et al. , 05 - JUN - 09, D357855).

Coriander, leaves 8.0 Remove from 40 CFR The initial tolerance for coriander, leaves was translated from the vegetable, leafy, except Brassica,

group 4 tolerance of 8.0 ppm (M. Doherty, 20 - AUG - 1999; D249374). This decision agreed with the 23 - FEB - 1999 memo (G. Herndon, 23 - FEB - 1999; D252416) that outlined a proposal from IR- 4 to establish a tolerance for fresh herbs based on vegetable, leafy, except Brassica, group 4. At the time, HED agreed to this proposal pending submission of fresh basil and green onion data that showed maximum residues were within 5X. Subsequently, additional data were received for fresh basil (W. Donovan, 10 - JUL - 2002; D278777) and green onion (T. Bloem, 20 - JUL - 2005; D312374). Since fresh coriander leaves are included in herb subgroup 19A, fresh, it is appropriate to include coriander leaves in the established crop group 19A tolerance, as opposed to continuing to have a separate tolerance based on a translation from the vegetable, leafy, except Brassica, group 4 data. The removal of the separate tolerance for coriander, leav es is not expected to result in measured residues that exceed the crop group 19A tolerance (3.0 ppm). The 2009 Calendar Year Pesticide Data Program (PDP) summary reported that spinosad residues were detected in two cilantro samples out of 184 samples. The residues ranged from 0.016 - 0.030 ppm and are well below the herb subgroup 19A, fresh tolerance of 3.0 ppm; therefore, it is not expected that removing the separate tolerance for coriander leaves will result in crops with residues that exceed the toleranc e . Cranberry 0.01 0.02 This tolerance needs to be updated based on the chemistry memo by T. Bloem (10 - AUG - 2005; D319956) which reviewed the fruit fly control use and recommend for a food commodity tolerance of 0.02 ppm for the combined residues for spinosyn A and D in/on raw agricultural commodities which do not have a separate higher tolerance. Feijoa 0.05 0.30 The currently - established spinosad tolerance in/on feijoa is 0.05 ppm; however, HED recommended a 0.30 ppm tolerance for residues of spinos ad in/on feijoa based on the citrus tolerance. Since the established tolerance for spinosad residues in/on fruit, citrus, group 10 is 0.30 ppm, the feijoa tolerance should be updated accordingly (D252416, G. Herndon, 23 - FEB - 1999; D249374, M. Doherty, 20 - AUG - 1999).

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## Page 13 of 72 **Table 3**  **. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.**  **Comm odity**  **Current**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm) Comments Regarding HED**  **- Recommended Tolerance Updates**  Vegetable, leafy, except Brassica, group 4 8.0 10.0 Additional data were submitted w hich indicated the need for an increase in this tolerance (Chemistry Memo: T. Bloem, 28 - APR - 2009, D357703; Risk assessment: M. Clock- Rust et al. , 05 - JUN - 09, D357855). Watercress 8.0 10.0 The initial tolerance for watercress was translated from the vegetable, leafy, except Brassica, group 4 tolerance of 8.0 ppm (M. Doherty, 20 - AUG - 1999 ; D249374 ). Subsequently, additional data were received which resulted in an increase to the vegetable, leafy, except Brassica, group 4 tolerance to 10.0 ppm (Chemistry Memo: T. Bloem, 28 - APR- 2009, D357703; Risk assessment: M. Clock- Rust et al. , 05 - JUN - 09, D357855); therefore, the watercress tolerance should be updated accordingly. Cattle, meat 1 

### 2.0 7.0 In 2008, the registrant submitted a dairy cow feeding study to satisfy a data requirement outlined in HED in several memos (W. Cutchin, 13 - Oct - 2004, D304201; T. Bloem, 20 - JUL - 2005, D312374; T. Bloem, 0 2 - FEB - 2006, D323723). The feeding study employed dietary burdens of 23 ppm, 98 ppm, and 196 ppm. The resulting residue data were used along with the dairy cattle maximum theoretical dietary burden (MTDB) to calculate projected residues for ruminant commodities (T. Bloem, 24 - APR - 2008, D347514). The main driv er of total residues in ruminants is dietary exposure, particularly from nongrass forage, which contributed 38.18 ppm of the 48.35 ppm MTDB for dairy cattle. The calculated projected residues were higher than the established tolerances for ruminant meat and meat byproducts, and milk and milk fat; therefore, HED recommended an increase to these tolerances (T. Bloem, 24 - APR - 2008, D347514). Additionally, HED recommended that ruminant liver and meat byproduct (except liver) tolerances should be removed from the CFR, and instead tolerances should be established for ruminant meat byproducts (i.e., cattle, meat byproducts; goat, meat byproducts, etc.). In a 25 - MAR - 2010 memo (T. Bloem, D374794) that reviewed the voluntarily cancellation of the pour- on use and direct cattle spray registrations, HED noted that the cancellation of the use did not necessitate a decrease in the ruminant and milk tolerances and re identified the tolerance recommendations made in the 2008 memo. Subsequently, the Chemistry Science Adviso ry

Council (ChemSAC) issued guidance that meat byproduct tolerances should be set at the highest residue level seen in any livestock commodity (minutes from 12 - JA N - 2011). The tolerances should be updated to reflect the HED -recommendations in the 2008 memo (T. Bloem, 24 - APR - 2008, D347514) and ChemSAC guidance that meat byproduct tolerances should be updated so that they are based on the highest expected residue (in fat). Cattle, liver 1 

### 10 Remove from 40 CFR Cattle, meat byproducts, except liver 1 

### 5.0 Remove from 40 CFR Cattle, meat byproducts 1 

### -- 50 Milk 7.0 10

Milk, fat 85 100

Spinetoram (40 CFR §180.635) Citrus, oil 3.0 23 Orange processing data were submitted which indicated the need for an increase in the citrus, oil tolerance (Chemistry Memo: T. Bloem, 28 - APR- 2009, D357703; Risk assessment: M. Clock- Rust et al. , 05 - JUN - 09, D357855). Vegetable, leafy, except Brassica, group 4 8.0 10 Additional data were submitted w hich indicated the need for an increase in this tolerance (Chemistry Memo: T. Bloem, 28 - APR - 2009, D357703; Risk assessment: M. Clock- Rust et al. , 05 - JUN - 09, D357855).

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## Page 14 of 72 **Table 3**  **. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.**  **Comm odity**  **Current**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm) Comments Regarding HED**  **- Recommended Tolerance Updates** 

Watercress 8.0 10.0 The initial tolerance for residues of spinetoram in/on watercress was translated from the tolerance for residues of spinosad in/on vegetable, leafy, except Brassica, group 4 tolerance of 8.0 ppm (T. Bloem, 12 - SEP - 2007; D325387). Subsequently, additional d ata were received which resulted in an increase of the vegetable, leafy, except Brassica, group 4 tolerance for both spinosad and spinetoram to 10.0 ppm (Chemistry Memo: T. Bloem, 28 - APR - 2009, D357703; Risk assessment: M. Clock Rust et al. , 05 - JUN - 09, D3 57855); therefore, the watercress tolerance should be updated accordingly. Cattle, liver 1 

### 0.85 Remove from 40 CFR Based on the ChemSAC guidance that meat byproduct tolerances should be set at the highest residue

level seen in any livestock commodity (minutes from 12 - JAN - 2011), the meat byproduct tolerances in 40 CFR § 180.635(a) should be updated so that they are based on the highest expected residue (fat). Additionally, the established liver tolerance should be removed because it is less than the cattl e, meat byproducts recommended tolerance of 5.5 ppm. The meat byproducts tolerance definition should be updated so that it does not exclude liver. Cattle, meat byproducts, except liver 1 

### 0.60 Remove from 40 CFR Cattle, meat byproducts 1 

### -- 5.5 1 

### These updates should also be made for goat, horse, and sheep commodities.

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## Conclusions The qualitative nature of spinosad and spinetoram residues is adequatel y understood. The residue chemistry

database is sufficient to support the current registrations for spinosad and spinetoram; however, the following residue chemistry data requirement remains outstanding: Data Requirements:  S ide -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 of spinosad. If these data indicate that residues are greater following app lication of the WP formulation, then additional data may be requested. Alternatel y, the petitioner can provide a rationale as to why the WP formulation will not result in higher spinos yn A and D residues in/on the requested crops as compared to the SC for mulation (should include an explanation as to why spinos yn A and D were higher in spinach following application of the WDG as compared to the SC; ChemSAC minutes 23 - March - 2005). These data were requested in a 2005 risk assessment (T. Bloem, et al. , 15 - SEP - 2005; D310318) and would fulfill the OPPTS Guideline 860.1500 ( Crop Field Trials ) requirement for spinosad .  In 1998, a Section 24(c) special local need registration was submitted for the use of spinosad on tobacco in South Carolina (G. Herndon, 17 - FEB - 19 98; D235973). This memo waived the requirements of a nature of the residue study, field trials, and a py rol ys is study

for the 24(c) use onl y, and stated that for a Section 3 use, the studies would be required. The most recent Tracer® 

## label (EPA Reg. No. 62719 - 267) includes tobacco; however, the nature of the residue study remains outstanding. This study should be submitted as part of Registration Review and would fulfill the OPPTS Guideline 860.1300 (Nature of the Residue

—Plants, Livestock) requirement f or spinosad . Additionally, there are three studies that have been submitted to the Agency regarding residues of spinosad in tobacco that have not been reviewed including a p yrolysis study [OPPTS Guideline 860.1000(f)(3); Tobacco Uses, Py rol ys is Study], a residue method validation for the determination of spinosad and metabolites in green and cured tobacco (OPPTS Guideline 860.1340; Residue Analy tical Method) , and a magnitude of the residue of spinosad in tobacco study [OPPTS Guideline 860.1000(f)(3); Tobac co Uses, Field Trials] (MRIDs 44214901, 44214902, and 44214903). Until the review is complete, HED cannot be certain the data are sufficient for risk assessment; therefore, these studies should be reviewed b y the Agency as part of Registration Review.  As stated in the 28 - APR- 2009 chemistry memo (T. Bloem; D357703), the orange oil residue data are not considered scientificall y valid as the measured residue was 24x higher than the highest validated fortification level (MRID 47453501). The samples should be reanalyzed using control samples fortified at concentrations that encompass the measured residue, and the results should be submitted to the Agency . This study will fulfill the OPPTS Guideline 860.1520 (Processed Food/Feed) requirement for spinetoram. Label Revisions :  As requested in a 28 - AUG - 2008 chemistry memo (T. Bloem; D 353933), the PHI for popcorn grain should be increased to 28 days (GF - 1587 SC -NC and GF - 1640 WG -NC labels only).  As requested in a 24 - FEB - 2010 risk assessment (T. Bloem, et al. ; D 365744), the PHI for popcorn grain should be updated to 28 days for the Bonide ® 

## Spinosad Dust label (EPA Reg. No. 4 - 472; also known as Captain Jack’s Deadbug Brew ® 

## Dust). Additionally,

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## under the General Use Precautions and Restrictions section of the lab el, there is wording related to liquid formulation applications that should be deleted (e.g., use hand- held or backpack sprayer equipment, or ready- to - spray hose - end applicators).  As requested in a 24 - FEB - 2010 risk assessment (T. Bloem, et al. ; D365744), several updates are required for the Entrust® 

## label (EPA Reg. No. 62719 - 621). In the part of the label which references leaves of legume vegetables (crop group 7A), the label currently only excludes soy

bean. The label should be updated to read for applic ation to foliage of legume vegetables (excluding so ybean; subgroup 7A; excluding cowpea and lentil). Additionally, since spinosad can be applied as soil, foliar, and seed treatments, the label restrictions concerning the total application rate from soil and foliar applications should be updated to “total application rate from soil, foliar, and seed treatment applications.”  As requested in a 20 - SEP - 2007 risk assessment (P. Shah et al. , D331741), the leaves of root, tuber, and legume vegetable sections of the GF - 1587 SC and GF - 1640 WG labels (EPA Reg. Nos. 62719 - 544 and 62719 - 540) should indicate that root, tuber, and legume vegetables treated as described may onl y be harvested for the foliage not the root, tuber, bean, or pea. Tolerance Revisions:  Additionally, the tolerance expressions for spinosad (40 CFR §180.495) and spinetoram (40 CFR §180.635) should be updated to reflect current Agency policy , and the tolerance level s for several commodities should be updated as outlined in Table 3 . **Dietar y Exposure**  The most recent chronic dietary exposure assessment for spinosad/spinetoram was performed in conjunction with the 12 - O CT - 2010 risk assessment for a cat/kitten spot - on use of spinetoram (Dietary Memo: T. Bloem, 18 - AUG - 10 , D380915; Risk Assessment : T. Bloem et al. , 12 - O CT 2010, D376415) . Tolerances were not required for the proposed cat/kitten spot - on use; however, the proposed use results in residential exposures that necessitated a refined dietary exposure anal ys is. The assessment was performed using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM - FCID  , ver. 2.03) which uses food consumption data from the United States Department of Agriculture (USDA) Continuing Surveys of Food Intakes by Individual s (CSFII; 1994 - 1996 and 1998). Acute and cancer anal ys es were not conducted, as toxicological effects attributable to a single dose were not identified, and spinetoram and spinosad are class ified as not likely to be carcinogens (cancer risk assessment is not required). In 2010, the registrant discontinued, by voluntary

cancellation , the spinosad cattle feed through and ear - tag registrations. The most recent dietary exposure assessment dif

fers from previous dietary exposure assessments in that these uses were not included in the cattle residue estimates, refined residues from the registered ruminant spinosad premise application scenario were calculated, refined poultry residues were calculated, and Pesticide Data Program (PDP ) data were included. The most recent chronic anal ys is assumed 100% crop treated for all food crop commodities; average spinosad field- trial residues, average spinosad USDA PDP detected residues, or spinosad tolerance level residues for crop commodities (40 CFR §180.495); spinosad residue estimates for fish/shellfish (residues of spinetoram in fish/shellfish are expected to be insignificant); experimental spinosad processing factors when available; and refined milk, eg g and ruminant/hog/poultry tissue spinosad residue estimates.

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## Additionally, drinking water residues, as provided by EFED, were incorporated directl y into the chronic dietary

anal ys es ( “water, direct, all sources” and “water, indirect, all sources”) . Since the proposed use was a pet care product, the previously provided spinetoram (L. Liu, 14 - MAY - 200 7 ; D 325409 ) and spinosad ( R. Parker, 28 - JUL - 2006 ; D331271 ) estimates were used for the most recent chronic analysis. EFED generated the surface and ground water estimates using the FQPA Index Reservoir Screening Tool (FIRST) and S creening C oncentration In Ground W ater (SCIGROW) models, respectivel y. A summ ary of the modeled water concentrations are included in Attachment 7 . Based on these estimates, the chronic anal ys is assumed a water residue estimate of 10.5 ppb. The models and their description are available at the EPA internet site: http://www.epa.gov/ oppefed1/models/water/ . The resulting chronic exposure estimates do not exceed HED's level of concern [ ≤24% of the chronic population - adjusted dose ( cPAD ) ; children 1 - 2 years old were the most highly exposed population subgroup ). A summary

of the estimated exposures are included in Attachment 7 . **Conclusions** The dietary

exposure database is adequate to support existing registrations; however, a revised assessment is required, which incorporates the HED - recommended tolerances described in Table 3 , as needed . Additionally , the revised assessment should include a residue value for water chestnuts, based on the spinosad food commodities tolerance of 0.02 ppm. These revisions are not expected to significantly increase dietary

exposure estimates. **Residential Exposure** Spinosad is currently

regi stered for residential use s including homeowner application s to gardens, turfgrass , and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers , and fire ants (granular formulation). A summary of residential uses is listed in the attachments as Table A.3.1 . Spinetoram is registered for homeowner applications to gardens, lawns/ornamentals, and turfgrass for control of lepidopterous larvae (worms or caterpillars), dipterous leafminers, thrips, sawfl y larvae, certain ps yllids and leaf - feeding beetles, and red imported fire ants (mound application is permitted). Itis also registered for pet use as a spot - on formulation for cats and kittens that weigh more than 4 pounds. A summary of residential uses is liste d in the Attachments as Table A.4.1. There is potential for residential handler and post- application exposures to both spinosad and spinetoram. Since spinosad and spinetoram control the same pests, HED concludes that these products will not be used in combination with each other and combinin g the residential exposures is unnecessary. Residential Handlers The following paragraphs are summaries of the spinosad and spinetoram residential exposure estimates. See Table A.3.1 for a summary of assessed residential handler use patterns and corresponding margins of exposure (MOEs ) for spinosad and Tables A.4.1 and A.4.3 for a summary of assessed residential handler use patterns and corresponding MOEs for spinetoram .

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## Spinosad Since no dermal endpoints were identified, residential handler dermal exposure assessments were not conducted for any registered residential uses. The residential handler inhalation assessment s w ere based primarily

on the following data sources: the residential standard operating procedures (SOPs) and the Outdoor Residential Exposure Task Force (ORETF) unit exposures. A residential handler inhalation assessment was performed for a dust formulation for use on home gardens, and risks did not exceed the level of concern (i.e., MOEs greater than 100). There is a granular formulation that is a fire ant bait use . This is a ready- to - use product that may be applied b y homeowners. HED believes that dermal and inhalation exposures and risks are negligible and are not necessary to asses s because of the f ormulation and low vapor pressure. There is a registered fruit fly bait use that permits application to non - crop vegetation and this use may result in residential exposures. A comparison of the application rate ( 0.0003 lb ai/acre ) with the application rate for the turf/ornamental uses ( 0.41 lbs ai/acre) supported the conclusion that residential exposure resulting from the fruit fly application will be insignificant when compared to the exposure resulting from the turf/ornamental a pplication. Therefore, quantitative anal ys is of the residential exposure resulting from the fruit fly bait application was not performed. Based on a label review, there appears to be a liquid formulation that can be applied on home gardens and to control fire ants. These application scenarios have not been assessed. Spinetoram Since no dermal endpoints were identified, residential handler dermal exposure assessments were not conducted for any registered residential uses. The residential handler inhal ation assessments were based primarily

on the following data sources: the residential standard operating procedures (SOPs), the Pesticide Handler Exposure Database (PHED) unit exposures , and the ORETF unit exposures. For the home lawn, home garden and ornamental uses, a residential handler inhalation exposure assessment was conducted. The resulting MOEs ranged from 4,300,000 - 8,400,000 and are therefore not of concern to HED. Spinetoram is also registered for residential use in the control of fleas on do mestic pets, however, exposure/risk from spinetoram application to domestic pets was not assessed because residential handler contact is expected to be negligible. The spot- on product is designed to be self - contained as it is applied directly from the tub e to the pet with the tip of the applicator used to part the pet’s hair. Residential Post - Application There is potential for residential handler and post- application exposures to both spinosad and spinetoram . Since no dermal endpoints were identified, only incidental oral post - application exposures have been assessed. In addition, s ince spinosad and spinetoram control the same pests, HED concludes that these products will not be used in combination with each other and combining the residential exposure s is unnecessary . See Table A.3.3 for a summary of spinosad residential post - application risks and Tables A.4.3 through A.4.5 for a summary of spinetoram residential post - application risks. Spinosad

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## Spinosad is registered for use on home lawns and, therefore, there is the potential for incidental oral exposure (hand - to - mouth, object - to - mouth, and soil ingestion). The resulting combined short - term incidental oral MOE was 640 and is, therefore, not of concern to HED. There is also a granular fire ant bait that can be applied to home lawns. In gestion of spinosad granules found in treated areas is a potential source of exposure for children; however, this scenario is considered an episodic event by HED and is assessed as an acute exposure (i.e., acute dietary endpoints are used). Since there is no acute dietary endpoint applicable to children, no quantitative assessment is needed. Spinetoram Spinetoram is registered for use on pets as well as home lawns. Residential post - application incidental oral expo sure assessments have been conducted for both use sites for children. For the home lawn use, the resulting combined (hand- to - mouth, object - to - mouth, and soil ingestion) short - term incidental oral MOE was 970 and wa s, therefore, not of concern to HED. For the pet use, the short - and intermediate - term incidental oral MOEs were not of concern (i.e., all MOEs > 100). Residential Bystander Post - application Inhalation Exposure Based on the Agency's current practices, a quantitative residential b ys tander post - application inhalation exposure assessment h as not been performed for spinosad or spinetoram at this time . However, volatilization of pesticides may be a potential source of post - application inhalation exposure to individuals nearb y to pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its FIFRA SAP in December 2009. The Agency

received the SAP’s final report on March 2, 2010 (http://www.epa.gov/scipoly /SAP/meetings/2009/ 120109meeting.html ). The Agency is in the process of evaluating the SAP report and may , as appropriate, develop policies and procedures to identify the need for and, subsequently , the way to incorporate post - application inhalation exposure into the Agency's risk assessments . If new policies or procedures are put into place, the Agency may revisit the need for a quantitative post - application inhalation exposure assessment for spinosad and spinetoram. Spray Drift 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 the ground application metho d employed for spinosad and spinetoram . The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Agen cy ’s Spray Drift website for more information at http://www.epa.gov/opp00001/factsheets/spraydrift.htm). 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 database submitted by

the Spray

Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy

on how to appropriatel y apply the data and the AgDRIFT ® 

## computer model to its risk assessments for pesticides applied b y 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 produ cts with significant risks associated with drift. **Conclusions**

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## There is sufficient information available to assess residential exposure. For spinosad, there is a liquid formulation registered for use on home gardens and for fire ant control that has not b een assessed for residential handler exposure/risk . These uses will need to be assessed as part of Registration Review . For spinetoram, the residential assessments is reflective of the currentl y registered uses and maximum application rates. HED is currently revising its Residential SOPs, including those used to determine exposure associated with ornamental , turf , and pet treatments. Reviewers should incorporate new guidance from the updated SOPs to refine exposure estimates as appropriate . **Aggregate R** **isk Assessment** In the most recent HED human - health risk assessment (T. Bloem, et al. , 12 - OCT - 2010; D376415), short - term, intermediate - term, and chronic aggregate exposure assessments were conducted. An acute aggregate assessment was not conducted because an endpoint of concern attributable to a single dose was not identified. A cancer aggregate risk assessment was not performed because spinosad and spinetoram are classified as “not likel y to be carcinogenic to humans.” Short- Term Aggregate Risk Assessment: Based on the registered uses, the following short- term residential exposure are anticipated: **(1)** short - term incidental oral exposures to children from the proposed spinetoram cat/kitten spot- on u se and from the registered spinosad and spinetoram turf and ornamental application scenarios , and **(2)** short - term inhalation exposure to adult s (h andler/applicators ) from the registered spinetoram garden, turf, lawns, and ornamental application scenarios. Because the pests controlled for the spinetoram pet- care product and the spinosad/spinetoram homeowner plant- care products (garden, turfgrass, lawn, and/or ornamentals) differ , it is not likely that these types of exposures will co - occur on the same day . Therefore, the short - term aggregate assessment combine d dietary exposure with the single highest potential residential exposure. For children, short - term aggregate exposure includes chronic dietary (food and water) and incidental oral exposure resulting from the proposed spinetoram pet use (highest exposure of all possible scenarios). For adults, short - term aggregate exposure includes chronic dietary exposure (food and water) and inhalation exposure from registered spinetoram turf use (highest exposure o f all possible scenarios). Since the aggregate MOEs were ≥200, short - term aggregate exposure to spinosad and spinetoram does not exceed HED's LOC . Intermediate- Term Aggregate Risk Assessment: Based on the registered uses, only intermediate term incidental oral exposures to children from the proposed spinetoram cat/kitten spot - on use is anticipated with the intermediate - term aggregate exposure combining chronic dietary (food and water) and the incidental oral exposure s . The aggregate MOE is at the LOC of 100. For the following reasons, HED conclude d that aggregate intermediate - term assessment wa s conservative: **(1)** the dietary exposure anal ys is assumed 100% crop treated for all food commodities; **(2)** the dietary exposure anal ys is assumed the modeled estimated drinking water concentration (EDWC) resulting f rom the turf application scenario (turf use yielded the highest EDWC); the model assumed that 8 7% of the water basin is covered with crops and 100% of these crops are treated using the turf application scenario (maximum application rates and no degradation assumed) ; and **(3)** the dietary exposure anal ys is assumed all livestock are exposed to the premise (ruminants) or premise/dermal (poultry) application scenarios and consume water which has been treated w ith spinosad (mosquito larvicide application scenario) .

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## HED note d that the aggregate intermediate - term MOE is at the LOC. The following measures were recommended to the petitioner to refine the risk assessment: **(1)** submission of information concerning the magnitude of total spinosad residues in water following the mosquito larvicide application scenario (total spinosad residues) ; **(2)** restricting the minimum weight of cats that may be treated to 6 lbs (since the greater potential for exposure results from contact with smaller sized cats, and since the current assessment assumes (based on the proposed label) that cats as small as 4 lbs may

be treated) or decreasing the amount applied to younger cats; and/or **(3)** submiss ion of a hand- wipe petting study (protocol guidance available upon request). Chronic Aggregate Risk: Since there are no registered uses that result in chronic residential exposures, the chronic aggregate exposure assessment consists of exposure from food and water. The chronic dietary

exposure estimates were ≤24% cPAD and, therefore, do not exceed HED's LOC. **Conclusions** There is sufficient information available to assess aggregate exposure. However, a new aggregate exposure risk assessment that incorp orates the changes to the dietary exposure assessment will be required during Registration Review. Additionally , if the registrant submits additional data to refine the risk assessment, a new aggregate exposure assessment will be required. **Occupational E**  **xpos ure**  Spinosad is registered for use on a variety of field and vegetable crops, fruit trees, berries, herbs, grasses, ornamentals, residential turf, and other non - food uses . It can be applied as a seed treatment, an at -planting soil application, and/or broadcast foliar applications. Post - harvest uses are also allowed on selected fruit and root crops . A summary of occupational uses (agricultural and non - agricultural) is lis ted in the attachments as Table A.5.1 . Spinetoram is registered for use on several agricultural crops, ornamental turf/plants, Christmas tree plantations, forest trees, and cats. A summary of occupational uses (agricultural and non agricultural) is lis ted in the attachments as Table A.6.1 . Occupational Handlers In most cases, no chemical - specific data were available with which to assess potential exposure to pesticide handlers. Therefore, occupational handler assessments were based primarily on surrog ate unit exposures from the Pesticide Handler ’ s Exposure Database (PHED) as presented in the PHED Surrogate Exposure Guide. The risk calculations were based on the maximum application rates and assuming maximum area treated per day or gallons handled. Handler ’ s exposure and risk were calculated at baseline (long pants, a long - sleeved shirt, no chemical resistant gloves, and no respirator) and with personal protective equipment (PPE) when necessary ( e.g., chemical - resistant gloves , respirators, and engineering controls ). Spinosad The currently

registered occupational use patterns, maximum application rates and formulations are provided in Table A.5.1. The most recent commercial occupational handler exposure assessment was conducted in February of 2010 (Memo, L. Venkateshwara , 06 - FEB - 2010; D 36 1 8 5 2 ) . This assessment was for the use of spinosad as a general surface or crack and crevice

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## spray for control of darkling and hide beetles, house flies, stable flies , and little house flies in and around agricultural livestock premises as well as a direct treatment to control northern fowl mites infesting poultry . Risks were not of concern (MOEs are >100) . The most recent agricultural occupational exposure assessment was conducted in May of 2009 (Memo, L. Venkateshwara, 06 - MAY - 2009; D358165) . The risks were not of concern (MOEs are >100 ). Spinosad is also registered for seed treatment of several crops including bulb vegetables (crop group 3), dry

bulb onion, dry

shelled pea and bean (excluding soy bean) (subgroup 6C ) (excluding lentils and cowpea), cantaloupe, cucurbit vegetables, foliage of legume vegetables (excluding so ybean) (subgroup 7A), pumpkin, winter squash , and watermelon. The seed treatment occupational handler assessment was conducted in February of 2010 (Memo, L. Venkateshwara, 24 - FEB - 2010; D369096). This memo identified several risks of concern. The label (EPA Reg . No. 62719 - 282) was revised to reflect some of the mitigation recommended in the assessment. However, the review recommended the addition of the personnel protective equipment and/or engineering controls (water soluble bags) , which has not been addressed . Therefore, the label should be updated to reflect the use of water soluble bags. An assessment of spinosad was done for high pressure hand wand (Mem o , M. Dow, 04 - 26 - 2005, D 315415) which indicated the use of respirator was necessary for acceptable MOEs. A review of the most recently stamped label (EPA Reg . No. 62719 - 498) indicates th at the label should be updated to reflect the use a respirator . Based on a review of currently registered labels, o ccupational handler assessments have not been performed for the following scenarios:

 Mixer/loader, applicator and/or mixer/loader/applicator scenarios for emulsifiable concentrate for

mulations with a drencher or sprinkler can.  Mixer/loader/applicator scenarios for granular formulations with sprinkler can and bait station.  Mixer/loader scenarios for dry flowable formulations.  Mixer/loader/applicator scenarios for liquid formulations at rates of 0.66 and 0.73 lb ai/A.  Mixer/loader/applicator scenarios for granular formulations at a rate of 0.1 lb ai/A.  All handheld mixer/loader/applicator scenarios for liquid formulations ( including backpack sprayer, hand held sp rayer, and trigger spray bottle ) .  All scenarios associated with liquid bait formulations.  Mixer/loader, applicator and mixer/loader/applicator scenarios for granular formulation s for bait s tation s , paintbrush, tray , by hand, hang -board/card bait, and sprayer. There are several ORE assessments where the intermediate - term MOE was not calculated. It is now HED’s policy

to include short - term and intermediate - term exposure scenarios for occupational handlers in all ORE assessments; therefore, the risk for this duration should be as sessed for all registered uses, when applicable. Spinetoram The currently

registered occupational use patterns, maximum application rates and formulations are provided in Table A.6.1. The occupational handler scenarios that have been previousl y assessed are listed in Table A.6.2 . The most recent occupational handler exposure assessment was conducted in June 2009 (Memo, L. Venkateshwara, 03 - JUN - 2009 ). This assessment was

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## for the use of spinetoram for use on dates, pomegranate, pineapple, spice, hops, dried cones, tree nuts , and pistachios. Risks were not of concern ( MOEs >100). Based on a review of currently registered labels, o ccupational handler assessments have not been performed for the following scenarios:

 Application by

aerial equipment, and  Mix ing/loading/appl ying liquid and dry flowable formulations via backpack sprayer. **Conclusions** There is sufficient information available to assess occupational handler exposure. For both spinosad and spinetoram, s everal occupational handler scenarios need to be assessed, which have not been assessed previously , or need to be reassessed based on higher application rates and/or revised SOPs. Two label changes are required. Label 62719 - 282 should be revised to reflect the use of water soluble bags and label 62719 - 498 should be revised to require the use of a respirator. Recommended unit exposures for occupational handler assessments have generall y been derived only from PHED . However, recentl y both the ORETF and Agricultural Handler Exposure Task Force (

## AHETF ) have produced pesticide handler exposure monitoring data that the Agency is using in place of PHED (http://www.epa.gov/pesticides/science/handler- exposure - data.html ). As more reliable data become available (such as that from the AHETF and ORETF), the Agency will continue to replace existing data . Reviewers should incorporate new exposure monitoring data, as necessary , during Registration Review. Occupational Post - Applic ation Dermal Post- application Spinosad An appropriate endpoint attributable to exposure through the dermal route was not identified for either spinosad or spinetoram. Therefore, dermal postapplication exposure assessments have not been performed for either chemical. It should be noted that a turf transferable residue study was submitted for spinosad: “ Determination of Transferable Turf Residues on Turf Treated with Spinosad ” (MRID No. 448284 - 01). A review of this study has been performed (Memo, S. Weiss , 28 - SEP - 1999; D256668). Data from this study were never used since a dermal endpoint was never chosen. However, if a dermal endpoint is chosen at some point in the future, information from this study could be used to refine the risk assessment for spinosad. Spinetoram An appropriate endpo int attributable to exposure through the dermal route for spinetoram was not identified. Therefore, dermal post - application exposure assessments have not been performed for spinetoram. Inhalation Post- application Based on the Agency's current practices , a quantitative occupational post - application inhalation exposure assessment has not been performed for spinosad or spinetoram . However, there are

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## multiple potential sources of post - application inhalation exposure to individuals performing postapplication activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues related to volati lization of pesticides from its FIFRA SAP in December 2009 . The Agency is in the process of evaluating the SAP report as well as available post - application inhalation exposure data generated b y the Agricultural Reentry Task Force and may , as appropriate, develop policies and procedures, to identify the need for and, subsequently , the way

to incorporate occupational post - application inhalation exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may revi sit the need for a quantitative occupational post - application inhalation exposure assessment for spinosad or spinetoram . **Conclusions** There is sufficient information available to assess occupational post - application exposure. Currently , since there are no dermal POD s for spinosad or spinetoram , a dermal post - application exposure assessment is not necessary . Based on the Agency's current practices, a quantitative occupational post - application inhalation exposure assessment has not been performed for spinos ad ; however, i f new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post - application inhalation exposure assessment . **Public Health and Pesticide Epidemiology Data** A summary

report listing incidents for spinosad and spinetoram reported to the OPP Incident Data System (IDS) has been provided for the docket (Memo, S. Recore , 31 - MAY - 11; D38 9821 ). The report represents incidents occurring in the U.S. from 2002 to the present. **Human Incident Data: OPP IDS (2011)** For this evaluation, the OPP IDS was utilized for pesticide incident data on the active ingredient spinosad and spinetoram . The purpose of the database search is to identify potential patterns on the frequency and severity of the health effects attributed to spinosad and spinetoram exposure. The IDS includes reports of alleged human health incidents from various sources, including mandatory

FIFRA Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP compiles these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS repre sent anecdotal reports or allegations only , unless otherwise stated in the report. The Agricultural Health Study (AHS) is a high quality , prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer . The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through Registration Review , then the Agency will ensure they

are considered in the problem formulation/ scoping phase of the process and, if appropriate, full y reviewed in the risk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. IDS records incidents resulting in high er severity outcomes in more detail, in a module called the Main IDS module . This system stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature of the incident. Main IDS incidents involving only

one pesticide are considered to provide more certain information about the

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## potential effects of exposure from the pesticide , and therefore these incidents are listed in the Table s 1 and 2 at the end of this report. Additio nally , since higher severity incidents are generall y of greater concern, incidents involving death and major outcomes include a narrative summary in Table 2 . The less severe human incidents (minor, unknown, or no effects outcomes) are reported b y registrants as counts called aggregate summaries and are recorded in a separate module called Aggregate IDS . In A ggregate IDS , from January 1, 200 6 to March 29 , 201 1 , there are 19 incidents involving spinosad . Because it falls within the categories reported a s counts (which includes minor, unknown or no effects) , there is no unique report that provides details about the incident and single chemical incidents are not distinguished from multiple chemical incidents ; however, a high frequency

of incidents indicate s there is a high potential for exposure and vice versa . For spinosad, there appears to be a low potential for exposure. In A ggregate IDS , from January 1, 200 6 to March 29 , 201 1 , there is one incident involving spinetoram . Because it falls within the categories reported as counts (which includes minor, unknown or no effects) , there is no unique report that provides details about the incident and single chemical incidents are not distinguished from multiple chemical incidents ; however, a high frequency of incidents indicates there is a high potential for exposure and vice versa . For spinetoram , there appears to be a low potential for exposure. For the M ain IDS, from January 1, 200 6 to March 29, 2011, there are six cases reported that involve the active ingredient spinosad . Of these six cases, there are two cases reported for single chemical spinosad onl y in the database. All six cases are ranked moderate severity. Overall, there are few incidents involving spinosad reported to IDS and most are of lower severity . For the M ain IDS, from January 1, 200 6 to March 29, 2011, there is one case reported that involve the active ingredient spinetoram . This case involves the single chemical spinetoram onl y and is ranked major severity . For both spinosad and spinetoram, b ased on the low frequency and severity of incident cases, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional anal ys is will be included in the risk assessment. Spinosad and spinetoram are not included in the AHS. Table 4 . Main IDS Report for Spinosad . **Main IDS Report Human Incidents**  **Che mi**  **cal:** Spinosad (only) **PC code:** 110003 **Incident Number**  **Incident**

**Date Product Name**  **Registration Number**  **City State**  **Exposure Type** * 017624 - 00001 4/1/2006 ELECTOR 

### 072642 - 00001 EAGLE GROVE IA HC 020065 - 00017 1/1/2008 FERTI - LOME BORER,

BAGWORM, LEAFMINERM & TENT CATERPILLAR SPRAY 

### 062719 - 00314 - 007401 OAKWOOD TX HC

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## Table 5 . Main IDS Report for Spinetoram . **Main IDS Report Human Incidents**  **Che mi**  **cal:** Spinetoram (only) **PC code:** 110008 **Incident Number**  **Incident**

**Date Product Name**  **Registration Number**  **City State**  **Exposure Type** * 021001 - 00010 5/1/2009 DELEGATE WG INSECTICIDE 062719 -

00541 SEATTLE WA HB A 52 - year- old male applied the product for about one hour and experienced hypertension, confusion, acidosis and coma . Patient has a medical history of hypertension. * Severity Categories H Human H - A Human Fatality H - B Human Major H - C Human Moderate H - D Human Minor H - E Human Unspecified 

## Tolerance Assessment and International Harmonization U.S. permanent tolerances (listed in 40 CFR §180.495 for spinosad and §180.635 for spinetoram) and maximum residue limits (MRL s) are summarized in Attachments 8 and 9 . The U.S. spinosad residue definition is harmonized with the residue definitions of Canada and Codex. The U.S. spinetoram residue definition is harmonized with the Canadian residue definition, but not with the Codex residue definition. The U.S. and Canadian residue definitions include spinetoram (XDE - 175 - J and XDE - 175 - L) and the metabolites ND - J and NF - J , whereas , the Codex residue definition is for spinetoram only . Mexico does not have tolerance definitions for spinosad and spinetoram; however, Mexico does adopt U.S. tolerances and Codex MRL s for export purposes. Many of the U.S. tolerance levels for spinosad and spinetoram are harmonized with Canada and Codex MRL s; however, some of the tolerances and MRL s are not harmonized. In particular, the U.S. tolerances for livestock commodities are higher than the MRLs for Canada and Codex. Additionally, tolerances and MRL s exist for some commodities that have no equivalent U.S. tolerance or Canadian or Codex MRL . **Conclusions** The U.S., Canada, and Codex residue definitions are harmonized for spinosad, but not for spinetoram. For some raw agricultural and livestock commodities, the tolerance levels and MRL s for the U.S., Canada, and Codex are harmonized; however, there are a variety of commodities for which the tolerance and MRLs are not harmonized. Mexico does not have tolerance definitions for spinosad and spinetoram; however, Mexico does adopt U.S. tolerances and Codex MRL s for export purposes. During Registration Review, efforts should be made to harmonize U .S. tolerances with Canadian and Codex MRL s, if possible.

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## Environmental Justice Potential areas of environmental justice concerns, to the extent possible, were considered in the human - health risk assessment, in accordance with U.S. Executive Order 12 898, “Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations,” (http://www.hss.energy .gov/nuclearsafety/env/guidance/justice/eo12898.pdf). The OPP ty picall y considers the highest potential exposures from the le gal use of a pesticide when conducting human - health risk assessments, including, but not limited to, people who obtain drinking water from sources near agricultural areas, the variability of diets within the U.S., and people who may

be exposed when harvesting crops. Should these highest exposures indicate potential risks of concern, OPP further refines the risk assessments to ensure that the risk estimates are based on the best available information . **Cumulative** The Agency

has not determined whether spinosad/spinetoram share a common mechanism of toxicity with other chemical substances. Prior to a final Registration Review decision for spinosad and spinetoram , the Agency will determine if there is any new information, such as new hazard or exposure data or information on changes to the use pattern, which would affect the cumulative risk assessment. Should the Agency determine that new information on spinosad and spinetoram is available that could potentially affect the cumulative risk assessment and result in a risk of concern, the Agency will revisit the cumulative risk assessment. **Human Studies** Past spinosad and spinetoram risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as PHED , the ORETF and the Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies in these multi -pesticide generic exposure databases, and based on available evidence has found them to have been neither fundamentally

unethical nor significantl y deficient relative to standards of ethical research conduct prevailing when they were conducted. There is no regulatory barrier to continued reliance on these studies, and all applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied. **Data Requirements and Risk Assessment Updates Required Under Registration Review**  Data needs and risk assessment updates required under Registration Review for spinosad are as follows : Toxicology :  None . Residue Chemistry

/Dietary Exposure: Tolerance Revisions:  The tolerance expressions for spinosad (40 CFR §180.495) and spinetoram (40 CFR §180.635) should be updated to reflect current Agenc y policy .  The tolerance levels for several commodities should be updated as outlined in Table 3 .

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## Data Requirements:  S ide -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 SC and WP formulations of spinosad (OPPTS Guideline 860.1500; Crop Field Trials ) .  A sp inosad nature of the residue study for tobacco remain outstanding (OPPTS Guideline 860.1300; Nature of the Residue

—Plants, Livestock) .  Three studies that have been submitted to the Agency regarding residues of spinosad in tobacco that have not been reviewed, including a py rolysis study

[OPPTS Guideline 860.1000(f)(3); Tobacco Uses, Py rol ys is Study], a residue method validation for the determination of spinosad and metabolites in green and cured tobacco (OPPTS Guideline 860.1340; Residue Analytical Method), and a magnitude of the residue of spinosad in tobacco study[ OPPTS Guideline 860.1000(f)(3); Tobacco Uses, Field Trials] (MRIDs 44214901, 4421 4902, and 44214903). Until the review is complete, HED cannot be certain the data are sufficient for risk a ssessment; therefore, these studies should be reviewed b y the Agency

as part of Registration Review.  The orange oil residue data are not considere d scientifically valid , as the measured residue was 24x higher than the highest validated fortification level (MRID 47453501). The samples should be reanal yz ed using control samples fortified at concentrations which encompass the measured residue, and the results should be submitted to the Agency (T. Bloem, 28 - APR- 2009; D357703) (OPPTS Guideline 860.1520; Processed Food/Feed) . Label Revisions :  As requested in a 28 - AUG - 2008 chemistry memo (T. Bloem; D353933), the PHI for popcorn grain should be increased to 28 days (GF - 1 587 SC -NC, and GF - 1640 WG -NC labels only).  As requested in a 24 - FEB - 2010 risk assessment (T. Bloem, et al. ; D365744), the PHI for popcorn grain should be updated to 28 days for the Bonide ® 

## Spinosad Dust label (EPA Reg. No. 4 - 472; also known as Captain Jack’s Deadbug Brew ® 

## Dust). Additionally, under the General Use Precautions and Restrictions section of the label, there is wording related to liquid formulation applications that should be deleted (e.g., use hand- held or backpack sprayer equipment, or ready- to - spray hose - end applicators).  As requested in a 24 - FEB - 2010 risk assessment (T. Bloem, et al. ; D365744), several updates are required for the Entrust® 

## label (EPA Reg. No. 62719 - 621). In the part of the label which references leaves of legume vegetables (crop group 7A), the label currently only excludes soy

bean. The label should be updated to read for application to foliage of legume vegetables (excluding so ybean; subgroup 7A; excluding cowpea and lentil). Additionally, since spinosad can be applied as soil, foliar, and seed treatments, the label restrictions concerning the total application rate from soil and foliar applications should be updated to “total application rate from soil, f oliar, and seed treatment applications.”  As requested in a 20 - SEP - 2007 risk assessment (P. Shah et al. , D331741), the leaves of root, tuber, and legume vegetable sections of the GF - 1587 SC and GF - 1640 WG labels (EPA Reg. Nos. 62719 - 544 and 62719 - 540) shoul d indicate that root, tuber, and legume vegetables treated as described may onl y be harvested for the foliage not the root, tuber, bean, or pea.  A revised dietary

assessment is required, which incorporates the HED - recommended tolerances described in Tabl e 3, as n eeded . Additionally , the revised assessment should

### Spinosad Registration Review Human - Health Assessment Scoping Document

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## include a residue value for water chestnuts, based on the spinosad food commoditi es tolerance of 0.02 ppm. Occupational Exposure:  A revised occupational and residential exposure assessment to cover all registered uses and formulations, accounting for maximum application rates, policy changes and/or revised toxicological endpoints and SF s.  Two label changes are required. Label 62719 - 282 should be revised to reflect the use of water solubl e bags, and label 62719 - 498 should be revised to require the use of a respirator. **References Table**  **6 .**  **Mem oranda Relevant to Registration Review.**  **Author Barcode**  **Date Title**  C. Lewis D221454 0 5 - FEB - 1996 Exposure Assessment for Spinosad EUP. G. Herndon D219016 24 - APR - 1996 PP#6G04692. Section 5 Registration (62719 - EUP - GE) and Tem porary Tolerance Petition for Use of Spinosad or XDE - 105 (End -Use Product Named TRACER®) on Cotton; Evaluation of Analytical Method and Residue Data. G. Herndon -- 0 1 - MAY - 1996 Letter to B. McMahon at the FDA regarding the update of PAM I. B. Kitchens D224620 13 - MAY - 1996 Evaluate Proposed Experimental Use Permit (EUP) for Active Ingredient Spinosad (NAF - 85) on Turf and Ornamentals S. Willett D228434 23 - JAN - 1997 PP No. 6F4761/GH5754. Spinosad (110003) on Apples, Brassica/Cole Crops. Review of Residue Data and Analytical Methodology. G. Herndon D235973 17 - FEB - 1998 ID# SC970005. SECTION 24(c) SPECIAL LOCAL NEED REGISTRATION FOR THE USE OF SPINOSAD ON TOBACCO IN SOUTH CAROLINA. G. Herndon D242940 18 - FEB - 1998 Letter to Dr. Marion Clower at the FDA G. Herndon D243795 0 2 - MAR - 1998 Letter to Dr. Marion Clower at the FDA G. Herndon D243816 0 3 - MAR - 1998 Spinosad. Results of the HED Metabolism Assessment Review Committee Held on 2/10/98. G. Herndon D245211 0 5 - JAN - 1999 Letter to Dr. Marion Clower at the FDA G. Herndon D252416 23 - FEB - 1999 Spinosad on Various Commodities. IR- 4 Proposal For Reduced Residue Chemistry Data Set. G. Herndon D254677 0 6 - APR - 1999 Letter to Dr. Marion Clower at the FDA M. Doherty D249374 24 - JUN - 1999 PP8F5002. Request for Permanent Tolerances for Spinosad on Cucurbits (Crop Group 9), Legume Vegetables (Crop Group 6), Stone Fruit (Crop Group 12), Field Corn, Sweet Corn, Sorghum, and Wheat. Evaluation of Analytical Chemistry and Residue Data. M. Doherty D249374 20 - AUG - 1999 PP8F5002. Human Health Risk Assessment for Spinosad use on Cucurbit Vegetables, Legume Vegetables, Stone Fruits, Corn, Sorghum, and Wheat S. Weiss D256668 28 - SEP - 1999 Determination of Transferable Turf Residues on Turf Treated with Spinosad G. Herndon D277485 0 6 - AUG - 2001 Spinosad. Residue Chemistry Review of Field Trial Data on Various Commodities. Joint Revie w Between California Department of Pesticide Regulation (Primary Review) and HED/OPP (Secondary Review).

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 30 of 72 **Table 6**  **. Mem** **oranda Relevant to Registration Review. Author**  **Barcode Date**  **Title** W. Donovan D264984 14 - JUN - 2002 Spinosad. Request to Increase Tolerances on Cattle Commodities as a Result of Proposed Dermal/Premise Applications of Spinosad (PP#0F06115) on Cattle. Summary of Analytical Chemistry and Residue Data. W. Donovan D278777 10 - JUL - 2002 PP#2E6354. Request for the Establishment of a Spinosad Permanent Tolerance on Herb Crop Subgroup 19A. Summary of Analytical Chemistry and Residue Data. M. Dow D284802 15 - AUG - 2002 Spinosad - Assessment of Pesticide Handler, Agricultural Worker Exposure/Risk and Revised Residential Exposure as Result from Proposed New

Uses on Baneberry, Cattle, Fig, Grape, Herbs, Peanut, Root Vegetables/ M. Dow D304201 16 - JUL - 2004 Spinosad - Exposure/Risk Assessment of the Insecticide Spinosad Used as a Stored Grain Protectant W. Cutchin D304201 13 - OCT - 2004 Spinosad. Storage Treatment of Cereal Grain. Summary of Analytical Chemistry and Residue Data. PP#3F6754. M. Dow D313757 0 2 - MAR - 2005 SPINOSAD - Exposure/Risk Assessment for the Proposed Use of Spinosad on Mint, Bulb Vegetables, Banana and Plantain, Nongrass Animal Feeds (Crop Group 18 Which Includes Legume Forages and Legumes Grown for Seed), Peanut, Grasses (Corn, Teosinte, Small Grains, Sorghum, Millet Grown for Forage or Seed) and as a Broadcast Fire Ant Bait. M. Dow D315415 26 - APR - 2005 Spinosad - Exposure/Risk assessment for the Use of Spinosad on all Food Commodities. T. Bloem D312374 20 - JUL - 2005 Spinosad in/on Mint; Banana; Plantain; Peanut; Bulb 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). Summary of Analytical Chemistry and Residue Data. T. Bloem D319956 10 - AUG - 2005 Spinosad. Fruit Fly Bait. Summary of Analytical Chemistry and Residue Data. M. Dow D316077,

D316078, D316155 22 - AUG - 2005 Spinosad - Exposure/Risk assessment for the Use of Spinosad as a Mosquito and Midge Larvicide

T. Bloem et al. D310318 15 - SEP - 2005 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. T. Bloem D323723 2 - FEB - 2006 Spinosad in/on Mint; Banana; Plantain; Peanut; Bulb 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). Review of Amendment (submitted material was not dated) Submitted in Response to Residue Chemistry Deficiencies Identified in D312374 (T. Bloem, 20 - Jul 2005). M. Dow D329918 29 - JUN - 2006 SPINOSAD - Nondietary Human Exposure/Risk Assessment for the Use of Spinosad on Hops . T. Bloem D316078 2 - AUG - 2006 Spinosad. Aquatic Application of Spinosad as a Mosquito Larvicide. Summary of Analytical Chemistry and Residue Data. T. Bloem et al. D316077 2 - AUG - 2006 Application of Spinosad to Hops and as a Mosquito Larvicide. Human Health Risk Assessment. Registration Nos. 6E7068 (hops) and 62719 - LGN - GF - 1578, - 1592, and - 1593 (mosquito larvicide).

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 31 of 72 **Table 6**  **. Mem** **oranda Relevant to Registration Review. Author**  **Barcode Date**  **Title** T. Bloem D335229 18 - JAN - 2007 Letter to M. Wirtz at the FDA regarding the update of PAM I. M. Dow D335169 30 - JAN - 2007 Spinosad - Human, Non Dietary Exposure/Risk Assessment for the Proposed Use of Spinosad on Spices (Except Black Pepper) and Pineapple K. Lowe D339375 10 - JUL - 2007 Revision: Spinosad

– Exposure/Risk Assessment for the Proposed Use of Spinosad as a Mosquito and Midge Larvicide K. Lowe D325865 10 - JUL - 2007 Spinetoram: Occupational and Residential Exposure/Risk Assessment for the New Use on Agricultural Crops, Commercial Aquatic Plants, Ornamentals, Tree Farms/Plantations, Turfgrass, Home Gardens and Lawns, and for the Control of Red Imported Fire Ants T. Bloem D325387 12 - SEP - 2007 Spinetoram. Residue Chemistry Summary Concerning the Application of Spinetoram to Numerous Crops. T. Bloem D343662 12 - SEP - 2007 Letter to FDA. P. Shah, et al. D331741 20 - SEP - 2007 Spinetoram: Human - Health Risk Assessment for Agricultural and Residential Uses. T. Bloem D347514 24 - APR - 2008 Spinosad: Review of Amendment (dated 28 -Nov - 2007) Submitted in Response to Residue Chemistry Deficiencies Identified in D323723 (T. Bloem, 6 - Feb - 2006) Concerning the Application of Spinosad to Mint; Banana; Plantain; Peanut; Bulb 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). T. Bloem D353933 28 - AUG - 2008 Spinetoram: Revie w of Amendment (dated 8 - April - 2008) Submitted in Response to Residue Chemistry Deficiencies Identified in D325387 (T. Bloem, 12 - Sep - 2007) Concerning the Application of Spinetoram to Numerous Crops. M. Dow D369092 19 - JAN - 2009 Spinosad: Occupational and Residential Exposure/Risk Assessment of Proposed Section 3 Uses in Home Gardens and Ornamentals L. Venkateshwara D369092 19 - JAN - 2009 Spinosad: Occupational and Residential Exposure/Risk Assessment of Proposed Section 3 Uses in Home Gardens and Ornamentals. T. Bloem D357703 28 - APR - 2009 Spinetoram. Application of Spinetoram to Numerous Crops. Revie w of

Amendment Dated 17 - June - 2008 Submitted in Response to the Residue Chemistry Reviews D325387 (T. Bloem, 12 - Sep - 2007) and D353933 (T. Bloem, 28 - August - 2008). L. Venkateshwara D358165 0 6 - MAY - 2009 Spinosad: Occupational and Residential Exposure/Risk Assessment of Proposed Section 3 Uses on Various Food Crops L. Venkateshwara D358162 0 3 - JUN - 2009 Spinetoram: Occupational Exposure/Risk Assessment of Proposed Section 3 Uses on Various Food Crops M. Clock - Rust, et al. D357855

D357837 0 5 - JUN - 2009 Spinosad and Spinetoram. Human - Health Risk Assessment for Application of Spinosad to Date and Pomegranate and Spinetoram to Pineapple, Date, Pomegranate, Hops, and Spices (Crop Subgroup 19B, except black pepper). L. Venkateshwara D361852 26 - FEB - 2010 Spinosad: Occupational and Residential Exposure/Risk Assessment of Proposed Section 3 Uses in Egg Producing Poultry, Poultry Houses and Livestock Housing . T. Bloem D374794 25 - MAR - 2010 Spinosad. Residue Chemistry Summary for Direct- Spray Use on Poultry and Discontinuation by Voluntary Cancellation of the Cattle Pour- On and Direct Cattle Spray Registrations. L. Venkateshwara D376658 0 1 - JUL - 2010 Spinetoram: Occupational and Residential Exposure/Risk Assessment for use as a Spot - on on Cats and Kittens T. Bloem D380915 18 - AUG - 2010 Spinosad/Spinetoram. Dietary Risk Assessment in Support of the Proposed Kitten/Cat Spot - on Use.

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 32 of 72 **Table 6**  **. Mem** **oranda Relevant to Registration Review. Author**  **Barcode Date**  **Title** T. Bloem et al. D376415 12 - OCT - 2010 Spinetoram. Human - Health Risk Assessment for Cat/Kitten Spot On Use. S. Recore D389821 31 - JUL - 2011 Spinosad and Spinetoram: Review of Human Incidents 

## Attachments Attachment 1: Spinosad and Spinetoram Chemical Identity Tables Attachment 2: Spinosad and Spinetoram Endpoint Selection Table Attachment 3: Spinosad Residential Exposure Tables Attachment 4: Spinetoram Residential Exposure Tables Attachment 5: Spinosad Occupational Exposure Tables Attachment 6: Spinetoram Occupational Exposure Tables Attachment 7: Potential for Dietary Exposure of Adults and Children Attachment 8: Spinosad International Residue Limit Status Attachment 9: Spinetoram International Residue Limit Status Sheet. cc: L. Venkateshwara (RAB1) , J. Van Alstine (RAB1) , C . Rodriguez, (RAB1) RDI: RAB1 (6/ 15 /11), S. Knizner (6/23 /11) L. Venkateshwara : S - 10956 : Potomac Yard 1 (PY1): (703) 305 - 308 - 2722 : 7509P: RAB1

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## Attachment 1: **Spinosad and Spinetoram Chemical Identity Tables Table**  **A.1.1. Spinosad Nomenclature.** 

Chemical Structure Spinosyn A Spinosyn D Common name Spinosad Company experimental name XDE - 105 IUPAC name **Spinosyn A:** (2R ,3aS,5a R ,5bS,9 S,13 S,14R ,16a

S,16bR ) - 2 - (6 - deoxy- 2,3,4 - tri - O - methyl - αa- L mannopyranosyloxy) - 13 - (4 - dimethylamino - 2,3,4,6 -tetradeoxy- β ß -D - erythropyranosyloxy) - 9 - ethyl - 2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b -hexadecahydro - 14 - methyl - 1 H - 8 - oxacyclododeca[ b ] as - indacene - 7,15 - dione; **Spinosyn D:** (2 S,3a R ,5aS,5b S,9 S,13 S,14R ,16aS, 16bR ) - 2 - (6 - deoxy- 2,3,4 - tri - O - me thyl - αa- L - mannopyranosyloxy) - 13 - (4 - dimethylamino 2,3,4,6 - tetradeoxy- β ß -D - erythropyranosyloxy) - 9 - ethyl - 2,3,3a,5a,5b,6,7,9,10,11,12,13,14, 15,16a,16b - hexadecahydro - 4,14 - dimethyl - 1 H - 8 - oxacyclododeca[ b ] as - indacene - 7,15 - dione

CAS name **Spinosyn A:** (2R ,3aS,5a R ,5bS,9 S,13 S,14R ,16a

S,16bR ) - 2 - [(6 - deoxy - 2,3,4 - tri - O - methyl - α - L mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran - 2 - yl]oxy] - 9 - ethyl - 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 14 - methyl - 1 H - as indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione; **Spinosyn D:** (2 S,3a

R ,5aS,5b S,9 S,13 S,14R ,16a S,16bS ) - 2 - [(6 - deoxy - 2,3,4 - tri - O - methyl - α - L mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H -py ran - 2 - yl]oxy] - 9 - ethyl - 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 4,14 - dimethyl - 1 H - as indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione CAS # **Spinosyn A:** 131929 - 60 - 7; **Spinosyn D:** 131929 - 63 - 0 

### Table **A.1.2. Spinetoram** **Nomenclature.**

Chemical Structure

XDE - 175 - J XDE - 175 - L Common name Spinetoram (mixture of XDE - 175 - J and XDE - 175 - L) Company experimental name XDE - 175 - J (TSN104472; 3’ - O - ethyl 5,6 - dihydro spinosyn J; 175 - J) XDE - 175 - L (TSN104480; 3’ - O - ethyl spinosyn L; 175 - L)

IUPAC name **Spinetoram J:**  (2R ,3a R ,5a R ,5bS,9 S,13 S,14R ,16a

S,16bR ) - 2 - (6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - α - L - mannopyranosyloxy) - 13 - [(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methylpyran - 2 - yloxy] - 9 - ethyl - 2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b - hexadecahydro 14 - methyl - 1 H

- as - indaceno[3,2 - d

]oxacyclododecine - 7,15 - dione **Spinetoram L:**  (2 S, 3a

R ,5aS,5b S,9 S,13 S,14R ,16a S,16bS ) - 2 - (6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - α - L - mannopyranosyloxy) - 13 - [(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methylpyran - 2 - yloxy] - 9 - ethyl - 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b - tetradecahydro - 4,14 - dimethyl - 1 H

- as - indaceno[3,2 - d

]oxacyclododecine - 7,15 - dione

CAS name **Spinetoram J**  : (2R ,3a R ,5a R ,5b S,9 S,13 S,14R ,16a

S,16bR ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - α - L - mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl 2H -pyran - 2 - yl]oxy] - 9 - ethyl - 2,3,3a,4,5,5a,5b,6,9, 10,11,12,13,14,16a,16b -hexadecahydro - 14 - methyl - 1 H

- as - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione **Spinetoram L:**  (2 S,3a

R ,5aS,5b S,9 S,13 S,14R ,16a S,16bS ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - α - L - mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 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 - dimethyl - 1 H

- as - indaceno[3,2 - d

]oxacyclododecin - 7,15 - dione CAS # **Spinetoram J**  : 187166 - 40 - 1; **Spinetoram L**  : 187166 - 15 - 0

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 34 of 72 **Table A.1.3.**  **Additional Spinetoram Structures**  **.** Common name Chemical name Chemical structure N - demethyl - 175 - J ND - J (2R ,3a R ,5a R ,5bS,9 S,13 S,14R ,16a

S,16bR ) - 9 - ethyl - 14 - methyl - 13 - {[(2 S,5 S,6R ) - 6 - methyl - 5 - (methylamino)tetrahydro - 2H -pyran - 2 - yl]oxy} - 7,15 - dioxo - 2,3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b - octadecahydro - 1 Has - indaceno[3,2 - d]oxacyclododecin - 2 - yl 6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl - alpha- L mannopyranoside N - formyl - 175 - J NF - J (2R ,3 S,6 S ) - 6 - ({(2R ,3a R ,5a R ,5bS,9 S,13 S,14R ,16aS,16bR ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O - me thyl - alpha- L mannopyranosyl) oxy] - 9 - ethyl - 14 - methyl 7,15 - dioxo 2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,1 6b - octadecahydro - 1 H

- as - indaceno[3,2 - d]oxacyclododecin - 13 - yl}oxy) - 2 - methyltetrahydro - 2H

-pyran - 3 - yl(methyl)formamide

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## Attachment 2: **Spinosad and Spinetoram Endpoint Selection Table Table**  **A.2.1 . Toxicological Endpoints for Spinosad and Spinetoram.**  Exposure Scenario Dose Used for Risk Assessment

– P O D Study and Toxicological Effects Acute Dietary (all populations) Toxicological effect attributable to a single dose was not identified in the spinosad and spinetoram databases. This

risk assessment is not necessary. Chronic Dietary Oral NOAEL = 2.49 mg/kg/day

chronic RfD and cPAD = 0.0249 mg/kg/day **Chronic Toxicity Study in Dogs (spinetoram)** ; LOAEL = M/F 5.36/5.83 mg/kg/day; based on arteritis and necrosis of the arterial walls of the epididymides in males and the thymus, thyroid, larynx, and urinary bladder in females. Short - Term Incidental Oral Oral NOAEL = 4.9 mg/kg/day

LOC for MOEs <100 **Subchronic Feeding Study in Dogs (spinosad)** ; 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. Short - Term Inhalation Oral NOAEL = 4.9 mg/kg/day

LOC for MOEs <100 Intermediate term Inhalation NOAEL = 2.49 mg/kg/day

LOC for MOEs <100 **Chronic Toxicity Study in Dogs (spinetoram);**  LOAEL = M/F 5.36/5.83 mg/kg/day; based on arteritis and necrosis of the arterial walls of the epididymides in males, and the thymus, thyroid, larynx and urinary bladder in females. Dermal - All durations Short - , intermediate - , and l ong - 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 spinosad and spinetoram dermal toxicity studies in rats which indicates poor dermal absorption; and 3) the lack of long - term exposure based on the current use pattern. Cancer - Oral, Dermal, Inhalation Classification: “Not likely to be Carcinogenic to Humans” based on carcinogenicity studies with spinosad and

spinetoram.

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## Attachment 3: **Spinosad Residential Exposure Tables Table**  **A.3.1. Summary of Representative Residential Use Patterns, Formulations, and Application Rates for**  **Spinosad. Product**  **Formulation Application**  **Equipment Use Sites**  **Ma xim** **um application rates**  Spinosad ® Dust under the brand name Captain Jack’s Deadbug Brew® Dust (EPA Reg . No . 4 - UT0) Dust Dust applicator, crank garden duster or bulb duster Home Gardens a 0.00001 lb ai/1000 ft2 Ornamentals b Conserve SC Turf and Ornamental (EPA Reg . No . 62719 - 291) Soluble Concentrate Broadcast Spray Turf and Ornamentals 0.41 lbs ai/acre Conserve Fire Ant Bait (EPA Reg . No . 62719 - 304) Granular Broadcast or Mound Treatment Control Fire Ants 0.0003 lbs ai/acre Fruit fly bait? (EPA Reg . No . NAF - 550) Granular Broadcast Non - crop vegetation 0.0003lb ai/acre Spinosad 0.5% SC (EPA Reg . No . 62719 - 314) Soluble Concentrate Broadcast spray Home Gardens 0.086 lb ai/acre Spinosad 0.5% SC (EPA Reg . No . 62719 - 314) Soluble Concentrate Mound Treatment Control Fire Ants 0.0013 lb ai/mound a. Crops include apple and other pome fruits, asparagus, bushberries and caneberries, citrus trees, cole crops (brassica vegetables),

cucurbits, fruiting vegetables, grape, leafy and dried herbs, leafy vegetables, stone fruits, strawberry, succulent beans a nd peas, sweet corn and popcorn, tree nuts, tree fruits, tuberous and corm vegetables. b. Includes outdoor ornamentals (herbaceous and woody plants). **Table A.3.2. Spinosad Residential Handler Inhalation Exposures and Risks.** Exposure Scenario Application Rate (lb ai/1000 feet) a Area Treated

Daily (feet2 ) b Inhalation Unit

Exposure c (mg/lb ai) Inhalation Dose

(mg/kg/day) d Short -term Inhalation

MOE e Mixing/ Loading/ Applying Dusts via Shaker Can (ORETF; MRID 444598 - 01) 0.00001 1000 Baseline f : 0.62 Baseline: 8.9 x 10 - 8 Baseline: 55000000 a. Application rate = maximum application rate from proposed label (4 - UTO; D369092). b. Area treated value is based on Exposure SAC SOP #12. c. Unit exposure value is from ORETF study for plunger duster application used a surrogate (MRID 444598 - 01). d. Dose (mg/kg/day) = Unit exposure (mg/lb ai) x App Rate (lb ai/acre) x Area Treated (acres/day) x %Absorption (100% inhalation) / Body weight (70 kg). e. MOE = NOAEL (mg/kg/day) / Dose (mg/kg/day); where the short -term NOAEL = 4.9 mg/kg/. f. Baseline Inhalation: no respirator. **Table A.3.3. Summary of Toddler Postapplication Incidental Oral Ingestion Exposures and Risk Estimates for Residential Use of Spinosad (Modified from D284802)**  **a .**  **Activity Application Rate**  **(AR; lb ai/A) b**  **Residue Estimate c**  **Potential Dose Rate (m** **g /k g bw/d)**  **d MOEs**  **e (DAT 0)**  Hand - to - mouth 0.41 TTRt: 0.23 μg/cm2 S/T: 0.0061 S/T: 800 Object - to - mouth TTRt: 0.92 μg/cm2 S/T: 0.0015 S/T: 3,300 Soil Ingestion Soil residue: 3.08 μg/g soil 2.0 x 10 - 5 S/T: 240,000 Combined oral exposure -- -- S/T: Not given S/T: 640 a . Sources: SOPs for Residential Exposure Assessments, Draft, December 17, 1997 and Exposure SAC Policy No. 11, Feb. 22, 2001:

Recommended Revisions to the SOPs for Residential Exposure. b . AR = maximum application rate on Conserve SC Turf and Ornamental label (EPA Reg. No. 62719 - 291; ai = active ingredient

(spinosad only) for r esidential lawn treatment for turfgrass disease control. c . Residue estimates b ased on the following protocol from the Residential SOPs:

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 37 of 72 Hand - to - mouth TTRt = 0.41 lb ai/A x 0.05 x (4.54 x 108 μg/lb ai) x (2.47 x 10 - 8 A/cm2) = 0.23μg/cm2

. Object -to - mouth TTRt = 0.41 lb ai/A x 0.20 x (4.54 x 10 8 μg/lb ai) x (2.47 x 10 - 8 A/cm2 ) = 0.92μg/cm2

. Soil Residue = 0.41 lb ai/A x fraction of residue in soil (100%)/cm x (4.54 x 10 8 μg/lb ai) x ( 2.47 x 10 - 8 A/cm2 ) x 0.67 cm 3/g= 3.08 μg/g soil. d . Potential Dose Rate (PDR; normalized to body weight of toddler).

Short - term hand - to - mouth PDR = (0..23 μg/cm2 x 0.50 x 20 cm2/event x 20 events/hr x 10 - 3 mg/μg x 2 hrs/day)/15 kg = 0.061 mg/kg bw/day. Object -to - mouth PDR = (0.92 μg/cm2 x 25 cm2/day x 10 - 3 mg/μg)/15 kg = 3,3 00 mg/kg bw/day. Soil I ngestion PDR = (3.08 μg/g soil x 100 mg soil/day x 10 - 6 g/μg)/15 kg = 2.0 x 10 - 5 mg/kg bw/day. e . MOE = NOAEL/PDR, where the short - term incidental oral NOAEL = 4.9 mg/kg bw/day; intermediate - term incidental oral NOAEL =

2.7 mg/kg bw/day; HED’s level of concern is for MOEs < 100 (short - term residential).

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 38 of 72 

## Attachment 4: Spinetoram Residential Exposure Tables **Table A.4.1. Summary of Representative Residential Use Patterns, Formulations, and Application Rates for Spinetoram.**  **Product Formulation**  **Application Equipment**  **Use Sites Ma** **xim um**  **application rates** AssurityTM (EPA Reg . No . 72642 - 9) Spot - on Spot - on applicator Cats and Kittens (8 weeks or older) 0.019 fl oz or 0.55

ml: 231 mg ai/treatment GF - 1640 WG -NC (EPA Reg . No . 62719 - 540) GF - 1587 SC -NC (EPA Reg . No . 62719 - 544) Dry Flowable Soluble concentrate Handheld sprayers Home Lawns 0.0005 lb ai/gal (0.061 lb ai/acre) GF - 1640 WG -NC (EPA Reg . No . 62719 - 540) GF - 1587 SC -NC (EPA Reg . No . 62719 - 544) Dry Flowable Soluble concentrate Handheld sprayers Home Gardens 0.0005 lb ai/gal (0.061 lb ai/acre) GF - 1640 WG -NC (EPA Reg . No . 62719 - 540) GF - 1587 SC -NC (EPA Reg . No . 62719 - 544) Dry Flowable Soluble concentrate Handheld sprayers Ornamentals 0.0005 lb ai/gal (0.061 lb ai/acre)

**Table A.4.2. Spinetoram Residential Handler Inhalation Exposures and Risks**  **.** Exposure Scenario App Rate (lb ai/gallon) a Gallons

Handle d Daily b Baseline Inhalation Unit Exposure (mg/lb ai) c Baseline Doses

(mg/kg/day) d Baseline Short term MOEs e **Mi xer/Loader/Applicator**  **– Home gardens, Home lawns, Ornamentals**  Mixing/Loading/Applying Liquid Concentrates with Low Pressure Handwand (PHED)

0.0005 5 0.03 0.000001 4,600,000 Mixing/Loading/Applying Liquid Concentrates with Hose End Sprayer (Residential ORETF data -- gardens; MRID 444598 - 01; OMA006) 100 0.00082 0.00000059 8,400,000 Mixing/Loading/Applying Liquid Concentrates with Hose End Sprayer (Residential ORETF data -- fruit trees and ornamentals; MRID 445185 - 01; OMA005) 100 0.0016 0.000001 4,300,000

a Application rate = maximum application rates from label (GF - 1640 WG-NC (EPA Reg#62719 - XXX) (D325865) b Amount handled per day values are HED estimates of acres treated per day based on Exposure SAC SOP #12 “Recommended

Revisions to the Standard Operating Procedures for Residential Exposure Assessment” c Baseline I

nhalation: no respirator. **Table A.4.3. Short -**  **and Intermediate -**  **Term Residential Child (3 < 6 Years Old) Incidental Oral (Hand**  **- to**  **- Mouth)**  **Post -**  **application Risk Estimates for Spinetoram Pet Uses**  **.** Exposure Scenario Application

Rate (mg ai/ treatment) a Cat

Weight (lb) Surface

Area Cat (cm2 ) b Salivary

Extraction Factor Surface

Area Hands (cm2 ) Freq. PDR

(mg/kg/day) Short -term

MOE Intermediate term MOE Hand - to mouth 231 4 1620 0.5 20 1 0.019 260 130 10 (Avg.) 2930 0.010 490 250 16 3980 0.0077 640 320

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 39 of 72 a. Application calculated from proposed label for spinetoram spot- on use (XDE - 175, D376658). b. Surface Area (cm2 ) = ((12.3*((cat weight (lb)*454)^0.65)) c. PDR (mg/kg/day) = [((AR * F AR, 0.20) / SA pet)) * (SAL) * SA hands * Freq)] / BW (kg) d. Short - term MOE = Short - term NOAEL (4.9 mg/kg/day) / PDR (mg/kg/day) e. Intermediate - term MOE = I ntermediate - term NOAEL (2.49 mg/kg/day) / PDR (mg/kg/day) **Table A.4.4.**  **: Short** **- term**  **Residential Child (3 < 6 Years Old) Incidental Oral Risk Estimates for Spinetoram Home Law**  **n Uses** Exposure Scenario Application Rate (lb ai/acre) Absorbed Dose (mg/kg/day) Short -term MOE a Hand to Mouth Activity on Turf 0.27 0.004 1,200 Object to Mouth Activity on Turf 0.001 4,900 Incidental Soil Ingestion 0.000014 360,000 a MOE = NOAEL/Dose, where oral NOAEL = 4.9 mg/kg/day **) (D325865) Table**  **A.4.5. : Spinetoram Residential Scenarios for Combined Risk Estimates**  Postapplication Exposure Scenario MOE (Level of Concern = 100) Short - Term Oral (Non - Dietary) Total Non - Dietary Short -term Risk Toddler Turf - sprays

(0.27 lb ai/acre) Hand to Mouth 1,200 970

Object to Mouth 4,900 Incidental Soil Ingestion 360,000

### Spinosad Registration Review Human - Health Assessment Scoping Document

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## Attachment 5: **Spinosad Occupational Exposure Tables Table A.5.1. Occupational Exposure Scenarios for Spinosad.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App. Rate Scenario Covered**  **2 Mixer/**  **loader Applicator**  **M/L/A Seed**  **treatment Agricultural**  **Uses**

Artichokes Aircraft, ground WP 0 .15 lb / a Y Y NA NA Aircraft, ground EC, L 0.17838392 lb / a Y Y NA NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle Can G 6 tbsp product/1 mound NA NA N NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA

Asparagus Aircraft, ground WP 0.1 lb / a Y Y NA NA Aircraft, ground EC, L 0.10703035 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Sprinkle can EC 0.00132244 lb / mound NA NA N NA Avocados Aircraft, ground EC, L 0.17838392 lb / a Y Y NA NA

Banana High - volume sprayer WP 0.1125 lb / a Y Y NA NA Aircraft, ground WP 0.125 lb / a Y Y NA NA Aircraft, High - volume sprayer L 0.1618418 lb / a Y Y NA NA Ground L 0.13081497 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA Barley Sprayer EC 0.73131465 lb / a N N NA NA Sprayer FIC 0.66424529 lb / a N N NA NA Aircraft, ground EC 0.10703035 lb / a Y Y NA NA Sprayer WP 0.000001 lb / lb Y Y NA NA Birba Aircraft EC, L 0.17838392 lb / a Y Y NA NA Berries Group Aircraft, Ground EC, L 0.10703035 lb / a Y Y NA NA Borage Aircraft, Ground EC 0.10703035 lb / a Y Y NA NA Brassica (Head and Stem) Vegetables Ground EC 0.09085809 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Bulb Vegetables Aircraft, Ground WP 0.125lb / a Y Y NA NA Seed treatment WP 0.00000044 lb / seed NA NA NA Y Aircraft, Ground EC 0.14270714 lb / a Y Y NA NA

Bushberries/ Caneberries Aircraft, Ground WP 0.1 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Aircraft, Ground EC 0.10703035 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Aircraft, Ground B/L 0.0003125 lb / a Y Y NA NA Aircraft, Ground DF 0.07425 lb / a N Y NA NA Canistel Aircraft, ground EC 0.17838392 lb / a Y Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 41 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Canola/Rape Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Aircraft, Ground WP 0.15 lb / a Y Y NA NA Cereal grains Aircraft, ground EC, L 0.10703035 lb / a Y Y NA NA Aircraft, Ground WP 0.1 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprayer EC 0.73131465 lb / a N N NA NA Sprayer FIC 0.66424529 lb / a N N NA NA Aircraft, Ground G 0.1 lb/a N N NA NA Airblast, Mist blower EC 0.0991 lb/a Y Y NA NA Cherimoy Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Chestnut Aircraft, High - volume ground sprayer EC 0.17838392 lb / a Y Y NA NA

Citrus Aircraft, Ground WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Conifers (seed orchard) Sprinkler irrigation, sprayer WP 0.15 lb / a Y Y NA NA Hand - held sprayer WP 0.15 lb / a N N NA NA Aircraft, hand -held sprayer EC 0.76538204 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA

Corn, (field, pop, sweet) Sprayer EC 0.73131465 lb / a N N NA NA Sprayer FIC 0.66424529 lb / a N N NA NA Aircraft, ground WP 0.1 lb / a Y Y NA NA Ground, Sprinkler irrigation EC 0.10703035 lb / a Y Y NA NA Ground DF 0.07425 lb / a N Y NA NA Ground B/L 0.0003125 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle can G 6 tbsp product/1 mound NA NA N NA

Cotton Band sprayer, aircraft, sprinkler irrigation EC 0.088275 lb / a Y Y NA NA Aircraft, ground WP 0.1 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle can G 6 tbsp product/1 mound NA NA N NA Ground, aircraft B/L 0.0003125 lb / a Y Y NA NA Aircraft DF 0.072 lb / a N Y NA NA Ground L .09700327 lb / a Y Y NA NA Cranberry Aircraft, ground, sprinkler irrigation EC 0.17838392 lb / a Y Y NA NA Sprinkler irrigation WP 0.15 lb/a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle can G 6 tbsp product/1 mound NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Aircraft, ground, sprinkler irrigation DF 0.12375 lb / a N Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 42 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment** 

Cucurbit vegetables Aircraft, ground WP 0.125 lb / a Y Y NA NA Drencher EC 0 .00173815 lb / mound NA NA N NA Aircraft EC 0.13081497 lb / a Y Y NA NA Ground EC 0.14270714 lb / a Y Y NA NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Aircraft DF 0.99 lb/a N Y NA NA Coating machine (Seed treatment) WP 0.00000166 lb / seed NA NA NA Y Spreader G 0.00075 lb / a Y Y NA NA Sprinkle can, ground G 6 tbsp product/1 mound NA NA N NA Custard apple Aircraft EC 0.17838392 lb / a Y Y NA NA

Date Aircraft WP 0.1245 lb / a Y Y NA NA Ground EC 0.09085809 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Aircraft L 0 .13081497 lb / a Y Y NA NA Feijoa (pineapple guava) Ground, aircraft EC 0.17838392 lb / a Y Y NA NA

Fig Aircraft, ground WP 0.15 lb / a Y Y NA NA Aircraft, High - volume ground sprayer. Lo w - Volume ground sprayer L 0.16348678 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkle can G 6 tbsp product/1 mound NA NA N NA Ground, aircraft B/L 0.0003125 lb / a Y Y NA NA Aircraft DF 0.12375 lb / a N Y NA NA High - volume ground sprayer, Low- Volume ground sprayer DF 0.1242 lb / a N Y NA NA

Flavoring/spice crops Ground, aircraft EC 0.17838392 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA

Fruiting vegetable Ground, aircraft EC 0.17838392 lb / a Y Y NA NA Aircraft, ground WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Aircraft, Ground DF 0.12375 lb / a N Y NA NA Ginkgo Nut Sprayer EC 0.62590851 lb / a N N NA NA Gourds Ground, aircraft EC 0.14270714 lb / a Y Y NA NA Grapes Aircraft, ground WP 0.125 lb / a Y Y NA NA Ground, aircraft EC 0.14270714 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 43 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Sprinkler can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Sprinkler can EC 0 .00132244 lb / mound NA NA N NA Aircraft, Ground DF 0.099 lb / a N Y NA NA Grass Forage Fodder and Hay Group Ground, aircraft L 0.06466885 lb / a Y Y NA NA Ground, aircraft WP 0.0625 lb / a Y Y NA NA Guava Ground, aircraft EC 0.17838392 lb / a Y Y NA NA

Herb and spice Ground, aircraft EC 0.17838392 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Aircraft, ground WP 0.15lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Aircraft, Ground DF 0.07425 lb / a N Y NA NA Hops Aircraft, ground WP 0.1 lb / a Y Y NA NA Ground, aircraft EC 0.10703035 lb / a Y Y NA NA Spreader G 0.00075 lb / a Y Y NA NA Sprinkler can G 6 tbsp product/1 mound NA NA N NA Horsehound Ground, aircraft EC 0.10703035 lb / a Y Y NA NA Aircraft, ground WP 0.1 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Ground, aircraft EC 0.17838392 lb / a Y Y NA NA Ilama Ground, aircraft EC 0.17838392 lb / a Y Y NA NA Leafy vegetables Drencher EC 0.00173815 lb / mound NA NA N NA Ground, aircraft EC, L 0.17838392 lb / a Y Y NA NA Ground, aircraft WP 0.15 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA

Legume vegetables Ground, Aircraft WP 0.1 lb / a Y Y NA NA Seed treatment WP 0.00000111 lb / seed NA NA NA Y Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Ground, Aircraft EC 0.10703035 lb / a Y Y NA NA Ground, Aircraft B/L 0.0003125 lb / a Y Y NA NA Hand - held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Aircraft, Ground DF 0.07425 lb / a N Y NA NA Lettuce Ground, aircraft EC, L 0.17838392 lb / a Y Y NA NA Li tchi Nut Aircraft, Ground L 0.16167212 lb / a Y Y NA NA Longan Ground, aircraft EC, L 0.17838392 lb / a Y Y NA NA Lupine grain Ground, aircraft EC 0.10703035 lb / a Y Y NA NA Mango Ground, aircraft EC, L 0.17838392 lb / a Y Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 44 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Nongrass Animal Feeds (forage, fodder, straw, and hay) Ground, aircraft L 0.06466885 lb / a Y Y NA NA Oats Ground, Aircraft EC 0.10703035 lb / a Y Y NA NA Okra Ground, Aircraft WP 0.15 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Ground, Aircraft EC 0.16351871 lb / a Y Y NA NA Aircraft, Ground DF 0.12375 lb / a N Y NA NA Passion Fruit (Granadilla) Aircraft, ground EC 0.17838392 lb / a Y Y NA NA

Peanuts Ground, Aircraft B/L 0.0003125 lb / a Y Y NA NA Ground, Aircraft WP 0.1 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Aircraft, Ground DF 0 .07425 lb / a N Y NA NA Aircraft, Ground L 0.09700327 lb / a Y Y NA NA Peppermint Ground, Aircraft WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Backpack sprayer, hand -held sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Pineapple Ground, Aircraft WP 0.1 lb / a Y Y NA NA Aircraft, Ground L 0.09811123 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA

Pistachio Ground, Aircraft WP 0.15 lb / a Y Y NA NA Ground EC 0.09085809 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA

Plantain High - volume Ground Sprayer WP 0.1125 lb/a Y Y NA NA Ground, Aircraft WP 0.125 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Aircraft, High - volume Ground Sprayer L 0.1618418 lb / a Y Y NA NA Ground L 0.13081497 lb / a Y Y NA NA

Pome fruit Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Backpack sprayer, Hand - held Sprayer, Hose - end Sprayer, Trigger- spray Bottle EC 0.08639602 lb / a NA NA N NA Sprinkle can EC 0.00132244 lb / mound NA NA N NA Aircraft, Ground DF 0.12375 lb / a N Y NA NA Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Pomegranate Ground, Aircraft WP 0.125 lb / a Y Y NA NA Ground EC 0.09085809 lb / a Y Y NA NA Backpack sprayer, Hand - held Sprayer, Hose - end Sprayer, Trigger- spray Bottle EC 0.08639602 lb / a NA NA N NA Sprinkle can EC 0.00132244 lb / mound NA NA N NA Aircraft L 0.1309268 lb / a Y Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 45 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Pulasan Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Purslane, Garden Aircraft, ground EC 0.17838392 lb / a Y Y NA NA Rambutan Aircraft, ground EC 0.17838392 lb / a Y Y NA NA

Root and tuber vegetables Aircraft, Ground, Sprinkler Irrigation WP 0.15 lb / a Y Y NA NA Aircraft, Ground, Sprinkler Irrigation EC, L 0.17838392 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, Hand - held Sprayer, Hose - end Sprayer, Trigger- spray Bottle EC 0.08639602 lb / a NA NA N NA Ground, Aircraft B/L 0.0003125 lb / a Y Y NA NA Aircraft, Ground, Sprinkler Irrigation DF 0.07875 lb / a N Y NA NA Rye Ground, Aircraft EC 0.10703035 lb / a Y Y NA NA Sapodilla Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Sapota, White Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Sorghum Ground, Aircraft EC 0.10703035 lb / a Y Y NA NA Soursop Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Soybeans Ground, Aircraft WP 0.0625 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Aircraft, Ground, DF 0.0495 lb / a N Y NA NA Aircraft, Ground L 0.06466885 lb / a Y Y NA NA

Spearmint Aircraft, ground WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Backpack sprayer, Hand - held Sprayer, Hose - end Sprayer, Trigger- spray Bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Star Apple Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA

Stone fruit Aircraft, ground WP 0.125 lb / a Y Y NA NA High - volume spray WP 0.1245 lb / a Y Y NA NA Ground, aircraft EC, L 0.13081497 lb / a Y Y NA NA High - volume ground sprayer EC 0.14446051 lb / a Y Y NA NA Backpack sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Ground (spot treatment) B/L 0.00004688 lb / tree NA NA Y NA Aircraft, Ground DF 0.099 lb / a N Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA

Strawberry Aircraft, ground WP 0.1 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0 .00173815 lb / mound NA NA N NA Aircraft, Ground EC 0.10703035 lb / a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Ground (spot treatment) B/L 0.00004688 lb / tree NA NA Y NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 46 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Aircraft DF 0.07425 lb/a N Y NA NA

Subtropical/Tropical Fruit Aircraft, ground WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0.00173815 lb / mound NA NA N NA Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Backpack sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Ground (spot treatment) B/L 0.00004688 lb / tree NA NA Y NA Sugar apple(custard apple) Aircraft, Ground EC 0.17838392 lb / a Y Y NA NA Tobacco Aircraft, Ground EC 0.089 lb/a Y Y NA NA

Tree nuts Aircraft, High - volume ground sprayer EC 0.17838392 lb / a Y Y NA NA Aircraft, Ground, High volume Ground Sprayer WP 0.15 lb / a Y Y NA NA Drencher, Sprinkler Can EC 0 .00173815 lb / mound NA NA N NA Backpack sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA Ground B/L 0.0003125 lb / a Y Y NA NA Ground (spot treatment) B/L 0.00004688 lb / tree NA NA Y NA Aircraft DF 0.12375 lb / a N Y NA NA High - volume Ground Sprayer DF 0.1242 lb / a N Y NA NA Triticale Sprayer EC 0.73131465 lb / a N N NA NA Sprayer FIC 0.66424529 lb / a N N NA NA Aircraft, Ground EC 0.10703035 lb / a Y Y NA NA V etch Aircraft, Ground L 0.06466885 lb / a Y Y NA NA **Non -**  **agricultural Uses** Barns/B arnyards/ Auction Barns Bait station, Paintbrush, Tray, By hand, Hang board/card bait, sprayer G 0.10888502 lb / a NA NA N NA Birdseed (processed) Sprayer EC 0.73131465 lb / a N N NA NA Sprayer FIC 0.66424529 lb / a N N NA NA Christmas Tree Plantations Aircraft, ground WP 0.125 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Aircraft, ground EC 0.14270714 lb / a Y Y NA NA Commercial storages/warehouses premised Bait station, Paintbrush, Tray, By hand, Hang board/card bait, sprayer G 0.10888502 lb / a NA NA N NA Compost/Compost Piles Bait station, Paintbrush, Tray, By hand, Hang board/card bait, sprayer G 0.10888502 lb / a NA NA N NA Dairy Farm Milk Storage Rooms/Houses/Sheds Bait station G 0.10888502 lb / a NA NA N NA Deciduous Fruit Trees (unspecified) Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground, aircraft B/L 0 .0003125 lb / a Y Y NA NA Aircraft DF 0 .12375 lb / a N Y NA NA Drainage Systems By hand P/T2 0.00000401 lb / gal NA NA N NA Aircraft, ground G 0.1 lb / a N N NA NA Airblast, aircraft, ground, mist blower, sprayer EC 0.09991 lb / a Y Y NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 47 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Eating establishment food handling areas (nonfood contact) Bait station G 0.10888502 lb / a NA NA N NA Fencerows/hedgerows Knife/spatula, pneumatic(compressed air) applicator B/L 0.00893225 lb / a NA NA N NA Food processing plant premises (nonfood contact) Bait station G 0.10888502 lb / a NA NA N NA Food stores/markets/superm arkets premises Bait station G 0.10888502 lb / a NA NA N NA Forest plantings (reforestation programs)(tree farms, tree plantations, etc.) Aircraft, ground WP 0.125 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Aircraft, ground EC 0.14270714 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground, aircraft B/L 0.0003125 lb / a Y Y NA NA Aircraft, ground DF 0.099 lb / a N Y NA NA Forest trees (softwoods, conifers) Aircraft, ground WP 0.125 lb / a Y Y NA NA Golf course turf Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Grasses Grown for seed Aircraft, ground WP 0.0625 lb / a Y Y NA NA Aircraft, ground L 0.06540748 lb / a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Aircraft DF 0 .0495 lb / a N Y NA NA

Gr eenhouses - empty Sprinkler irrigation WP 0.15 lb/a Y Y NA NA Drencher WP 0.00158733 lb / mound NA NA N NA Hand - held sprayer, sprayer WP 0.15 lb/a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Drencher DF 0.001575 lb / mound NA NA N NA Drencher L 0.00161611 lb / mound NA NA N NA Backpack sprayer, hose - end sprayer, trigger- spray bottle L 0.46884916 lb / a NA N N NA Gr eenhouses - in use Sprayer WP 0.15 lb/a Y Y NA NA Household/domestic dwellings outdoor premises By Hand G 0.10888502 lb / a NA NA N NA Incinerators Bait station, By hand, sprayer G 0.10888502 lb / a NA NA N NA Industrial / construction areas (outdoor) Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Intermittently flooded areas/water Aircraft G 0.1 lb/a N N NA NA Airblast, Aircraft, Ground, Mist blower, Sprayer EC 0.9991 lb/a N N NA NA Lakes/ponds/reservoirs (without human or wildlife use) Aircraft, Ground G 0.1 lb/a N N NA NA Mist blower, Sprayer EC 0.9991 lb/a N N NA NA Li vestock Feed Lots Bait station G 0.10888502 lb / a NA NA N NA Sprayer EC 0.48127178 lb / a N N NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 48 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Meat processing plant premises (nonfood contact) Bait station, By hand, Sprayer G 0.10888502 lb / a NA NA N NA Nonagricultural areas (public health use) Knife/spatula, pneumatic(compressed air) applicator B/L 0.00893225 lb / a NA NA N NA Nonagricultural rights ofway/fencerows/hedger ows Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Nonagricultural uncultivated areas/soils Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground B/L 0 .0003125 lb / a Y Y NA NA Drencher DF 0.001575 lb / mound N N NA NA By hand (water treatment) P/T 0.00000401 lb / gal NA NA N NA Nongrass Animal Feeds Aircraft, Ground L 0.06466885 lb / a Y Y NA NA

Nursery stock Sprinkler irrigation, Hand held sprayer, Sprayer WP 0.15 lb/a Y Y NA NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, boom sprayer, hand - held sprayer, hydraulic sprayer, pump -up sprayer L 0.46884916 lb / a NA NA N NA

Ornamental and/or shade trees Drencher WP 0.00158733 lb / mound NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Ground, Aircraft B/L 0.0003125 lb / a Y Y NA NA Knife/spatula, pneumatic(compressed air) applicator B/L 0.00893225 lb / a NA NA N NA Drencher L 0.00161611 lb / mound NA NA N NA

Ornamental herbaceous plants Sprinkler irrigation, Sprayer WP 0.15 lb/a Y Y NA NA Hand - held sprayer WP 0.15 lb/a N N NA NA Drencher WP 0.00158733 lb / mound NA NA N NA Aircraft, Hand -held sprayer, Power Sprayer , Sprinkler irrigation EC 0.76538204 lb / a N N NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Backpack sprayer, hose - end sprayer, trigger- spray bottle EC 0.00167887 lb / 1 gal NA NA N NA Sprinkler can EC 0.00132244 lb / mound NA NA N NA Ground , aircraft B/L 0.0003125 lb / a Y Y NA NA Ornamental lawns and turf Drencher WP 0.00158733 lb / mound NA NA N NA Hand - held sprayer, Power Sprayer EC 0.4522712 lb / a NA NA N NA Drencher EC 0.00173815 lb / mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.08639602 lb / a NA NA N NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 49 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Sprinkler can EC 0.00132244 lb / mound NA NA N NA Drencher DF 0.001575 lb / mound NA NA N NA Ornamental non flowering plants Drencher WP 0.00158733 lb / mound NA NA N NA Ground , aircraft B/L 0.0003125 lb / a Y Y NA NA Drencher L 0.00161611 lb / mound NA NA N NA Ornamental Ponds/Acquaria By hand P/T 0.00000401 lb / gal NA NA N NA

Ornamental woody shrubs and vines Sprinkler irrigation, Sprayer WP 0.15 lb/a Y Y NA NA Drencher WP 0.00158733 lb / mound Y Y NA NA Aircraft, Hand -held sprayer, Power sprayer, Sprinkler irrigation EC 0.76538204 lb / a Y Y NA NA Drencher EC 0.00173815 lb / mound NA NA N NA Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.00167887 lb / 1 gal NA NA N NA Sprinkler can EC 0.00132244 lb / mound NA NA N NA Ground , aircraft B/L 0.0003125 lb / a Y Y NA NA Pastures Aircraft, Ground WP 0.0625 lb/a Y Y NA NA Aircraft, Ground L 0.06540748 lb / a Y Y NA NA Paths/patios Bait station B/S NDC NA NA N NA Polluted Water Aircraft G 0.1 lb/a N N NA NA Airblast, Aircraft, Ground, Mist blower, Sprayer, Pump up Sprayer EC 0.09991 lb/a Y Y NA NA Poultry (egg/meat) High - Pressure Sprayer EC 0.00004134 lb / bird Y Y NA NA Poultry processing plant premises (nonfood contact) Bait Station, Hang Board/Card Bait G 0.10888502 lb / a NA NA N NA Rangeland Aircraft, Ground WP 0.0625 lb/a Y Y NA NA Aircraft, Ground L 0.06540748 lb / a Y Y NA NA Aircraft, Ground DF 0.0495 lb / a N Y NA NA Recreational Area Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Bait station, Hang board/card bait, Paintbrush, Tray, By hand, Sprayer G 0.10888502 lb / a NA NA N NA Refuse/solid waste containers (garbage cans) Bait station, Hang board/card bait, Paintbrush, Tray, By hand, Sprayer G 0.10888502 lb / a NA NA N NA Refuse/Solid waste sites (outdoor) Bait station, Hang board/card bait, Paintbrush, Tray, By hand, Sprayer G 0.10888502 lb / a NA NA N NA

Residential Lawns Spreader G 0.0075 lb/a Y Y NA NA Sprinkler Can G 6 tbsp product/1 mound NA NA N NA Backpack sprayer, hand -held sprayer, hose - end sprayer, trigger- spray bottle EC 0.00167887 lb / 1 gal NA NA N NA Sprinkler can EC 0.00132244 lb / mound NA NA N NA Sewage Systems Aircraft, Ground G 0.1 lb/a N N NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 50 of 72 **Table A.5.1. Occupational Exposure Scenarios for Spinosad. Crop/Use Site**  **Application Equipment Form** **ulation Type(s)**  **1 Max. App. Rate**  **Scenario Covered 2**  **Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Airblast, Mist blower, Sprayer EC 0.09991 lb/a Y Y NA NA Silos Bait station, Hang board/card bait, Paintbrush, Tray, By hand, Sprayer G 0.10888502 lb / a NA NA N NA Swamp/Marshes/ Wetlands/Stagnant Water Aircraft G 0.1 lb/a N N NA NA Airblast, Aircraft, Ground, Mist blower, Sprayer, Pump up Sprayer EC 0.09991 lb/a Y Y NA NA Swimming Pool Water Systems By hand P/T 0.00000401 lb / gal NA NA N NA Urban Areas Ground B/L 0.00032813 lb / tree NA NA Y NA Aircraft B/L 0.0003125 lb / a Y Y NA NA Wide area/general outdoor treatment (public health use) Sprinkler can EC 0.00132244 lb / mound NA NA N NA Wood protection treatment to buildings/products outdoor Injection Equipment RTU 0.00055997 lb / injection N N NA NA Zoos Bait station, Hang board/card bait, Paintbrush, Tray, By hand, Sprayer G 0.10888502 lb / a NA NA N NA 1. DF = dry flowable; RTU = ready to use; WP = wettable powder; G = granular; B/L =bait/liquid; P/T= pelleted/tableted; EC=Emulsifiable concentrate; B/S=bait/solid 2. N/A = not applicable; Y = yes; N = no; M/L/A = mixer/loader/applicator

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 51 of 72 . 

## Attachment 6: Spinetoram Occupational Exposure Tables

**Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  **Agricultural Uses**

Artichokes Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.0625 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Boom sprayer, Hydraulic sprayer EC 0.0625lb / a Y Y (no aerial) NA NA

Asparagus Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.0625 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Boom sprayer, Hydraulic sprayer EC 0.0625lb / a Y Y (no aerial) NA NA

Banana Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, High volume sprayer , G

round, Boom sprayer, Hydraulic sprayer DF 0.086 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground, High Volume Sprayer, Boom sprayer, Hydraulic sprayer EC 0.061 lb / a Y Y (no aerial) NA NA Brassica ( Cole) Leafy Vegetables Aircraft, Ground DF 0.078 lb / a Y Y (no aerial) NA NA Aircraft, Ground EC 0.078 lb / a Y Y (no aerial) NA NA

Brassica (Head and Stem) Vegetables Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Boom sprayer, Hydraulic sprayer DF 0.0625 lb/a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Boom sprayer, Hydraulic sprayer EC 0.0005 lb / gal Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 52 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Bulb Vegetables Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF 0.078 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA

Bushberries/ Caneberries Backpack sprayer, , pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF 0.094 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.094 lb / a Y Y (no aerial) NA NA Cereal grains Aircraft, G round DF 0.047 lb / a Y Y (no aerial) NA NA Aircraft, Ground EC 0.047 lb / a Y Y (no aerial) NA NA Chemigation EC 0.047 lb/a Y NA NA NA

Citrus Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Low Volume Ground Sprayer, Boom sprayer, Hydraulic sprayer DF 0.094 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Low Volume Ground Sprayer, Boom sprayer, Hydraulic sprayer EC 0.094 lb / a Y Y (no aerial) NA NA

Conifers (Seed Orchard) Backpack sprayer, pump -up sprayer DF 0.0012 lb / gal NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer DF 0.0012 lb / gal Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.0012 lb / gal NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer EC 0.0012 lb / gal Y Y (no aerial) NA NA Corn, (field, pop, sweet) Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Aircraft, Ground , Sprinkler Irrigation, Boom sprayer, Hydraulic sprayer DF 0.047 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 53 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Aircraft, Ground , Sprinkler Irrigation, Boom sprayer, Hydraulic sprayer EC 0.047 lb / a Y Y (no aerial) NA NA Cotton Aircraft, Ground DF 0.0625 lb / a Y Y (no aerial) NA NA Aircraft, G

round EC 0.0625lb / a Y Y (no aerial) NA NA C ranberry Aircraft, Ground , Sprinkler Irrigation DF 0.094 lb / a Y Y (no aerial) NA NA Aircraft, Ground , Sprinkler Irrigation EC 0.094 lb / a Y Y (no aerial) NA NA

Cucurbit vegetables Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF 0.078 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA

Date Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Fig Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF .0.109 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Flavoring/spice crops Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer DF . 0.0625 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.0625lb / a Y Y (no aerial) NA NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 54 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment** 

Fruiting vegetable Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground DF . 0.078 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground EC 0.078 lb / a Y Y (no aerial) NA NA

Grapes Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground DF 0.078 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA

Herb and Spice Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.0625 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.0625lb / a Y Y (no aerial) NA NA Hops Aircraft, ground DF 0.0625 lb / a Y Y (no aerial) NA NA Aircraft, ground EC 0.0625lb / a Y Y (no aerial) NA NA Leafy greens Ground, Aircraft DF 0.078 lb / a Y Y (no aerial) NA NA Ground, Aircraft EC 0.078 lb / a Y Y (no aerial) NA NA

Leafy vegetables Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.078 lb a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA Legume vegetables Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 55 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.078 lb a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA

Mint Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.094 lb a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.094 lb / a Y Y (no aerial) NA NA Okra Ground, Aircraft DF 0.078 lb / a Y Y (no aerial) NA NA Ground, Aircraft EC 0.078 lb / a Y Y (no aerial) NA NA

Peanuts Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.0625 lb a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.0625 lb / a Y Y (no aerial) NA NA Peppermint Ground, Aircraft DF 0.094 lb / a Y Y (no aerial) NA NA Ground, Aircraft EC 0.094 lb / a Y Y (no aerial) NA NA Pineapple Ground, Aircraft DF 0.0625 lb / a Y Y (no aerial) NA NA Aircraft, Ground EC 0.0625lb / a Y Y (no aerial) NA NA Pistachio Ground, Aircraft DF 0.109 lb / a Y Y (no aerial) NA NA Ground . Aircraft EC 0.109 lb / a Y Y (no aerial) NA NA

Plantain Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.086 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 56 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.061 lb / a Y Y (no aerial) NA NA

Pome fruit Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Pomegranate Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Root and tuber vegetables Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Aircraft, Ground, Boom sprayer, Hydraulic sprayer DF 0.061 lb / a Y Y (no aerial) NA NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft., Ground, Boom sprayer, Hydraulic sprayer EC 0.078 lb / a Y Y (no aerial) NA NA Soybeans Aircraft, Ground DF 0.031 lb / a Y Y (no aerial) NA NA Aircraft, Ground EC 0.031 lb / a Y Y (no aerial) NA NA Spearmint Aircraft, ground DF 0.094 lb / a Y Y (no aerial) NA NA Aircraft, Ground EC 0.094 lb / a Y Y (no aerial) NA NA

Stone fruit Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Ground, Aircraft , Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA

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Page 57 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Strawberry Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Ground, Aircraft , Boom sprayer, Hydraulic sprayer DF 0.078 lb / a Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.078 lb/ a Y Y (no aerial) NA NA

Subtropical/Tropical Fruit Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Ground, Aircraft , Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Tree nuts Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Ground, Aircraft , Boom sprayer, Hydraulic sprayer DF 0.109 lb / a Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) Y NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.109 lb / a Y Y (no aerial) NA NA

Yautia Backpack sprayer, pump -up sprayer DF 0.0005 lb / gal NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer DF 0.061 lb / a Y Y (no aerial) NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA

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Page 58 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Backpack sprayer, pump -up sprayer EC 0.0005 lb / gal NA NA Y (no backpack) NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Aircraft, Ground , Boom sprayer, Hydraulic sprayer EC 0.0625lb/a Y Y (no aerial) NA NA **Non -**  **agricultural Uses** Cats Applicator Tip (Spot on) RTU 0.0005 lb / animal NA NA NA NA

Christmas Tree Plantations Backpack sprayer, pump -up sprayer DF 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer DF 0.086 lb / a Y Y NA NA Backpack sprayer, pump -up sprayer, Sprayer EC 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer EC 0.086 lb / a Y Y NA NA

Forest Trees (Hardwoods, Broadleaf Trees) Backpack sprayer, pump -up sprayer DF 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer DF 0.086 lb / a Y Y NA NA Backpack sprayer, pump -up sprayer EC 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer EC 0.086 lb / a Y Y NA NA

Forest trees (S oftwoods, conifers) Backpack sprayer, pump -up sprayer DF 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer DF 0.086 lb / a Y Y NA NA Backpack sprayer, pump -up sprayer EC 0.086 lb / a NA NA Y (no backpack) NA Boom sprayer, Hydraulic sprayer, EC 0.086 lb / a Y Y NA NA

Ornamental lawns and turf Backpack sprayer, pump -up sprayer DF 0.27 lb / a NA NA Y NA Boom sprayer, Hydraulic sprayer DF 0.27 lb / a Y Y NA NA Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, pump -up sprayer EC 0.27 lb / a NA NA Y NA Boom sprayer, Hydraulic sprayer, EC 0.27 lb / a Y Y NA NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA Ornamental Ponds/Acquaria Hand held Sprayer, Power Sprayer DF 0.27 lb / a Y Y NA NA Hand held Sprayer, Power Sprayer EC 0.27 lb / a Y Y NA NA Ornamental woody shrubs and vines Backpack sprayer, pump -up sprayer DF 0.0012 lb / 1 gal NA NA Y NA Boom sprayer, Hydraulic sprayer DF 0.0012 lb / 1 gal Y Y NA NA

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Page 59 of 72 **Table A.6.1**  **. Occupational Exposure Scenarios for Spinetoram.**  **Crop/Use Site Application Equipment**  **Form ulation**  **Type(s) 1**  **Max. App.**

**Rate Scenario Covered**  **2**

**Mixer/ loader**  **Applicator M/L/A**  **Seed treatment**  Sprayer (fire ant mound treatments) DF 0.0005 lb / gal NA NA Y NA Backpack sprayer, Pump -up sprayer Sprayer. EC 0.0012 lb / 1 gal NA NA Y NA Boom sprayer, Hydraulic sprayer, EC 0.0012 lb / 1 gal Y Y NA NA Sprayer (fire ant mound treatments) EC 0.0005 lb / gal NA NA Y NA 1. DF = dry flowable; EC=Emulsifiable concentrate; B/S=bait/solid 2. N/A = not applicable; Y = yes; N = no; M/L/A = mixer/loader/applicator

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## Attachment 7: Potential for Dietary Exposure of Adults and Children

(From Memo, T. Bloem, 18 - AUG - 2010; D380915) **Acute and Cancer Dietary Risk Estimates:**  Acute and cancer anal ys es were not conducted as toxicological effects attributable to a single dose were not identified and spinetoram and spinosad are classified as not likely to be carcinogens (cancer risk assessment is not required). **Chron ic Dietary Risk Estimates:**  **Table A.7.1**  **: Summ**  **ary of Chronic Dietary (food and water) Exposure and Risk for Spinosad/Spinetoram.**  **1** 

### Population Subgroup cPAD (mg/kg/day) Chronic Exposure (mg/kg/day) %cPAD General U.S. Population 0.0249 0.002430 10 All Infants (<1 year old) 0.003034 12 **Children 1 -**  **2 years old 0.005915**  **24** Children 3 - 5 years old 0.004932 20 Children 6 - 12 years old 0.003119 12 Youth 13 - 19 years old 0.001922 7.7 Adults 20 - 49 years old 0.002184 8.8 Adults 50+ years old 0.001859 7.5 Females 13 - 49 years old 0.001848 7.4 1 

### Population with the highest exposure is in bold. 

## Estimated Drinking Water Concentration **s for Spinosad/Spinetoram (ppb) Used in the Chronic Dietary Risk Assessment:**  **Table A.7.2:**  **Estim ated Drinking Water Concentrations for**  **Spinosad/Spinetoram ( ppb)**  **.** Acute Chronic Long - Term Average **Spinosad (Turf Application S cenario; 4 x 0.4 lb ai/**  **acre; RTI = 7 days; 87% of the Watershed is T**  **reated)** surface 34.5 10.5 -- ground 1.1 1.1 1.1 **S pinetoram**  **(Turf and Fire Ant Mound A pplication; 1 x**  **0.454 lb ai/acre; 100% of the Watershed is T**  **reated)** surface 14.419 6.171 -- ground 0.072 0.072 0.072

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## Attachment 8: Spinosad International Residue Limit Status International Residue Limits **Spinosad** ( 110003; 110009; 11 - MAR- 2011) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 40 CFR 180.495: Pla nt and Livestock: **Spinosyn A** (Factor A: CAS # 131929

–60

–7) or 2 - [(6 - deoxy- 2,3,4 - tri - O - methyl - α L - manno -pyranosyl)oxy] - 13 - [[5 - (dimethylamino) - tetrahydro - 6 - methyl - 2H -py

ran - 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]oxacyc lododecin - 7,15 - dione; and **Spinosyn D** (Factor D; CAS # 131929

–63

–0) or 2 - [(6 - deoxy2,3,4 - tri - O - methyl - α - L - manno pyranosyl)oxy] - 13 - [[5 - (dimethyl amino) - 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 Spinosyn A: (2R ,3a S ,5a R ,5b S ,9 S ,13 S ,14R ,16aS ,16bR ) - 2 - [(6 - deoxy- 2,3,4 - tri - O - methyl α - L - mannopyranosyl)oxy] - 13 - [[(2R ,5 S ,6R ) - 5 - (dimethylamino) - tetrahydro - 6 - methyl 2H -pyran - 2yl]oxy] - 9 - ethyl 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b

- tetradecahydro - 14 - methyl - 1 H - as indaceno[3,2 - d ]oxacyclododecin- 7,15 - dione and Spinosyn D: (2 S ,3a R ,5a R ,5b S ,9 S ,13 S ,14R ,16aS ,16bR ) - 2 - [(6 - deoxy- 2,3,4 - tri - O - methyl α - L - mannopyranosyl)oxy] - 13 - [[(2R ,5 S ,6R ) - 5 - (dimethylamino) - tetrahydro - 6 - methyl 2H -pyran - 2yl]oxy] - 9 - ethyl 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b

- tetradecahydro - 4,14 - dimethyl - 1 H - as indaceno[3,2 - d ]oxacyclododecin- 7,15 - dione Pla nts/animal: sum of spinosyn A and spinosyn D. The residue is fat soluble, but residues in milk should be determined in the whole milk.

Commodity 1 Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex Acerola 1.5 Al falfa, seed 0.15 Al falfa, seed screenings 2.0 Al mond, hulls 19 2 Amaranth, grain, grain 1.0 Amaranth, grain, stover 10 Animal feed, nongrass, group, 18 0.02 Animal feed, nongrass, group, 18, forage 35.0 Animal feed, nongrass, group, 18, hay 30.0 Apple, dry pomace 0.5 Apple, wet pomace 0.5 Artichoke, globe 0.3 0.2 Asparagus 0.2 Atemoya 0.3 Avocado 0.3 Banana 0.25 Beet, sugar, molasses 0.75 Biriba 0.3 Brassica, head and stem, subgroup 5A 2.0 7.0 (bok choy) Chinese cabbages, broccoli raab 2.0 broccoli, Brussels sprouts, cabbages, cauliflower, Chinese broccoli, Chinese mustard cabbages, kohlrabi, (napa) Chinese cabbages 2 Brassica (Cole and or Cabbage) vegetables, head cabbage, flowerhead brassicas

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 62 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Brassica, leafy greens, subgroup 5B 10.0 7.0 (bok choy) Chinese cabbages, broccoli raab, collards, kale, mustard greens, mustard spinach, rape greens 10 leafy vegetables Bushberry subgroup 13B 0.250 0.5 blueberries, currant, elderberries, gooseberries, huckleberries Caneberry subgroup 13A 0.7 0.5 blackberries, loganberries, raspberries Canistel 0.3 Cattle, fat 50 5.0 Cattle, liver 10 1.0 meat byproducts of cattle 2 cattle liver4 Cattle, meat 2.0 0.2 2 (fat) meat from mammals other than marine mammals) Cattle, meat byproducts, except liver 5.0 1.0 meat byproducts of cattle 1 cattle kidney 4 Cherimoya 0.3 Citrus, oil 3.0 3.0 Citrus, dried pulp 0.5 Coriander, leaves 8.0 Corn, sweet, kernel plus cob with husks removed 0.02 1.5 0.01 (* ) sweet corn (corn on the cob) Cotton, gin byproducts 1.5 Cotton, undelinted seed 0.02 0.01 (* ) cotton seed Cranberry 0.01 0.01 Custard apple 0.3 Date 0.10 Egg 0.30 0.01 Feijoa .05 Fig 0.10 Fish 4.0 Fish - shellfish, crustacean 4.0 Fish - shellfish, mollusc 4.0 Food commodities 0.02 Fruit, citrus, group 10 0.3 0.3 calamondins, citrus citrons, citrus hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos, tangerines, Satsuma mandarins 0.3 citrus fruits Fruit, pome, group 11 0.20 0.1 apples, crabapples, loquats, mayhaws, oriental pears, pears, quinces 0.1 apple Fruit, stone, group 12 0.20 0.2 apricots, nectarines, peaches, plumcots, plums, prune plums, sweet cherries, tart cherries 0.2 stone fruits Goat, fat 50 5.0 Goat, liver 10 1.0 meat byproducts of goats 0.5 edible offal (mammalian) except cattle Goat, meat 2.0 0.2 2 (fat) meat from mammals other than marine mammals) Goat, meat byproducts, except liver 5.0 1.0 meat byproducts of goats 0.5 edible offal (mammalian) except cattle Grain, aspirated fractions 200 Grain, cereal, group 15 1.5 1.5 barley, buckwheat, oats, pearl millet, popcorn grain, proso millet, rice, rye, sorghum, teosinte, triticale, wheat, wild rice 1 cereal grains Po 0.01 (* ) Sweet corn (corn - on - the - cob) 2 wheat bran, unprocessed

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Page 63 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Grain, cereal, group 16, forage, except rice 2.5 Grain, cereal, group 16, hay, except rice 10.0 5 maize fodder (dry) 1 wheat straw and fodder, dry Grain, cereal, group, 16, stover, except rice 10.0 5 maize fodder (dry) 1 wheat straw and fodder, dry Grain, cereal, group, 16, straw, except rice 1.0 5 maize fodder (dry) 1 wheat straw and fodder, dry Grape 0.50 0.4; 1.0 grape juice 0.5 grapes Grape, raisin 0.70 0.7 raisins 1 dried grapes (=currants, raisins and sultanas) Grass, forage, fodder and hay, group 17, forage 10.0 Grass, forage, fodder and hay, group 17, hay 5.0 Guava 0.3 Herb subgroup 19A, dried 22 Herb subgroup 19A, fresh 3.0 Hog, fat 5.0 5.0 Hog, meat 0.50 0.2 2 (fat) meat from mammals other than marine mammals) Hog, meat byproducts 2.0 1.0 meat byproducts of hogs 0.5 edible offal (mammalian) except cattle Hop, dried cones 22 Horse, fat 50 5.0 Horse, liver 10 1.0 meat byproducts of horses 0.5 edible offal (mammalian) except cattle Horse, meat 2.0 0.2 2 (fat) meat from mammals other than marine mammals) Horse, meat byproducts, except liver 5.0 1.0 meat byproducts of horses 0.5 edible offal (mammalian) except cattle Ilama 0.3 Jaboticaba 0.3 Juneberry 0.25 Lingonberry 0.250 Longan 0.3 Lychee 0.3 Mango 0.3 Milk 7.0 0.5 1 cattle milk 4 Milk, fat 85 17 5 cattle milk fat Nut, tree, group 14 0.10 0.01 (* ) almonds Okra 0.40 Onion, green 2.0 Papaya 0.3 Passionfruit 0.3

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Page 64 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Pea and bean, dried shelled, except soybean, subgroup 6C 0.02 0.02 Dry (adzuki beans, beans, Blackeyed peas, broad beans, catjang seeds, chickpeas, field peas, grain lupin, guar seeds, kidney beans, lablab beans, lentils, lima beans, moth beans, mung beans, navy beans, pigeon peas, pink beans, pinto beans, rice beans, southern peas, tepary beans, urd beans Pea and bean, succulent shelled, subgroup 6B 0.02 0.02 succulent shelled (blackeyed peas, broad beans, English peas, garden peas, green peas, lima beans, peas, pigeon peas, southern peas) 0.3 legume vegetables Peanut 0.02 Peanut, hay 11.0 Peppermint, tops 3.5 Pineapple 0.02 Pineapple, process residue 0.08 Pistachio 0.10 Pomegranate 0.30 Poultry, fat 1.3 Poultry, meat 0.10 0.2 (fat) Poultry, meat byproducts 0.20 Pulasan 0.3 Rambutan 0.3 Rice, hulls 4.0 Salal 0.250 Sapodilla 0.3 Sapote, black 0.3 Sapote, mame y 0.3 Sapote, white 0.3 Sheep, fat 50 5.0 Sheep, liver 10 meat byproducts of sheep 0.5 edible offal (mammalian) except cattle Sheep, meat 2.0 0.2 2 (fat) meat from mammals other than marine mammals) Sheep, meat byproducts, except liver 5.0 1.0 meat byproducts of sheep 0.5 edible offal (mammalian) except cattle Soursop 0.3 Soybean 0.02 0.02 dry soybeans 0.01 (* ) soya bean (dry) Spanish lime 0.3 Spearmint, tops 3.5 Spice, subgroup 19B, except black pepper 1.7 Star apple 0.3 Starfruit 0.3 Strawberry 1.0 0.7 Sugar apple 0.3 Ti, leaves 10.0 Vegetable, bulb, group 3, except green onion 0.10

### Spinosad Registration Review Human - Health Assessment Scoping Document

Page 65 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Vegetable, cucurbit, group 9 0.3 0.3 balsam apples, balsam pears, cantaloupes, chayote fruit, Chinese cucumbers, Chinese waxgourds, citron melons, cucumbers, edible gourds (other than those listed in this item), muskmelons (other than those listed in this item) pumpkins, summer squash, watermelons, west Indian gherkins, winter squash 0.2 fruiting vegetab les, cucurbits

Vegetable, foliage of legume, group 7 8.0 Vegetable, fruiting, group 8 0.4 0.2 bell peppers, eggplants. ground cherries, non - bell peppers, pepinos, pepper hybrids, tomatillos, tomatoes 0.3 Peppers, tomato 3 peppers chili, dried Vegetable, leafy, except brassica, group 4 8.0 7 amaranth, arugula, cardoon, celery, celtuce, Chinese celery, corn salad, dandelion leaves, dock, edible leaved chrysanthemum, endives, fresh chervil leaves, fresh Florence fennel leaves and stalks fresh parsley leaves, garden cress, garden purslane , garland chrysanthemum, head lettuce, leaf lettuce, New Zealand spinach, orach leaves, radicchio rhubarb, spinach, swiss chard upland cress, vine spinach winter purslane 2 celery 10 leafy vegetables

Vegetable, leaves of root and tuber, group 2 10.0 Vegetable, legume, edible podded, subgroup 6A 0.30 0.3 edible podded (dwarf peas jackbeans, moth beans, peas, pigeon peas, runner beans, snap beans, snow peas, soybeans, sugar snap peas, sword beans, wax beans, yardlong beans 0.3 legume vegetables Vegetable, root and tuber, group 1 0.10 0.02 arracacha, arrowroot, cassava, chayote, Chinese artichokes, chufa, edible canna, ginger, Jerusalem artichokes, lerens, potatoes, sweet potato, tanier corms, taro corms, turmeric, true yam, yam bean 0.1 Black salsify roots, carrot, celeriac, chicory, edible burdock, garden beet, ginseng, horseradish, oriental radish, parsnip, radish, rutabaga, salsify, skirret, Spanish salsify, sugar beet, turnip, turnip - rooted chervil, turnip - rooted parsley 0.01 (* ) potato

Watercress 8.0 Wax jambu 0.3 MRLs with No US equivalent Chokecherries 0.2 Cotton seed oil, crude 0.01 (* ) Cotton seed oil, edible 0.01 (* ) Kiwifruit 0.05 Completed by: M. Negussie; 03/31/2011 1 

### Includes only commodities of interest f or this action. Tolerance values should be the HED recommendations and not those proposed by the applicant.

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### Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 

### * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs i ndicated as proposed have not been finalized by the CCPR and the CAC. 4 

### = The MRL accommodates external animal treatment.

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## Attachment 9: Spinetoram Internati **onal Residue Limit Status Sheet** International Residue Limits **Spinetoram** ( 110008; 110009; 11 - MAR- 2011 ) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 40 CFR § 180.635: Pla nt and Livestock: **XDE -**  **175 -** **J** : 1 - H - as indaceno[3,2 - d]oxacyclododecin - 7,15 - dione, 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - a- L - mannopyranosyl) oxy] - 13 - [[(2R,5S,6R) - 5 - (dimethylamino)tetrahydro 6 - methyl - 2H -pyran - 2 - yl] oxy] - 9 - ethyl 2,3,3a,4,5,5a,5b,6,9, 10,11,12,13,14,16a,16b - hexadecahydro 14 - methyl - , (2R,3aR,5aR,5bS,9S, 13S,14R,16aS,16bR); **XDE -**  **175 -** **L** : 1H - as indaceno[3,2 - d]oxacyclododecin - 7,15 - dione, 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - a- L - mannopyranosyl)oxy] - 13 - [[(2R,5S,6R) - 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 - dimethyl - , (2S,3aR,5aS,5bS,9S, 13S,14R,16aS,16bS); **ND -** **J** : (2R,3aR,5aR,5bS,9S, 13S,14R,16aS,16bR) - 9 - ethyl - 14 -methyl - 13 - [[(2S,5S,6R) - 6 - methyl - 5 - (methylamino)tetrahydro - 2H -pyran - 2 - yl]oxy] - 7,15 - dio xo - 2,3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b - octadecahydro 1H - as - indaceno[3,2 - d]oxacyclododecin - 2 - yl 6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl alpha- L - mannopyranoside; and **NF -** **J** : (2R,3S,6S) - 6 - ([(2R,3aR,5aR,5bS,9S, 13S,14R,16aS,16bR) - 2 - [(6 - deoxy- 3 - O ethyl - 2,4 - di - O - methyl - alpha- L mannopyranosyl) oxy] - 9 - ethyl - 14 - methyl 7,15 - dioxo - 2, 3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b - octadecahydro 1H - as - indaceno[3,2 - d]oxacyclododecin - 13 - yl] oxy) - 2 - methyltetrahydro - 2H -pyran - 3 - yl(methyl)formamide XDE - 175 - J: 1 H - as - indaceno[3,2 - d ]oxacyclododecin - 7,15 - dione, 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di O- methyl - a- L mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl 2H

-py ran - 2 - yl]oxy] - 9 - ethyl 2,3,3a,4,5,5a,5b,6,9,10,11,12,1 3,14,16a,16 b - hexadecahydro 14 - methyl - (2R ,3a R ,5a R ,5bS,9 S,13 S,14R ,1 6aS,16bR ) XDE - 175 - L: 1 H - as - indaceno[3,2 - d ]oxacyclododecin - 7,15 - dione, 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di O - methyl - a- L mannopyranosyl)oxy] - 13 - [[(2R ,5 S,6R ) - 5 - (dimethylamino)tetrahydro - 6 - methyl - 2H

-py ran - 2 - yl]oxy] - 9 - ethyl 2,3, 3a,5a,5b,6,9,10,11,12,13,14 ,16a,16b - tetradecahydro - 4,14 - dimethyl - (2 S,3a R ,5a S,5b S,9 S,13 S,14R ,16 aS,16b S ) Includes the following metabolites: N - demethyl - 175 J: (2R ,3a R ,5a R ,5bS,9 S,13 S,14R ,1 6aS,16bR ) - 9 - ethyl - 14 - methyl 13 - {[ (2 S,5 S,6R ) - 6 - methyl - 5 - (methylamino)tetrahydro - 2Hpyran - 2 - yl]oxy} - 7,15 - dioxo 2,3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15, 16a,16b octadecahydro - 1 H

- as indaceno[3,2 - d]oxacyclododecin - 2 - yl 6 - deoxy- 3 - O - ethyl - 2,4 - di - O methyl - alpha- L mannopyranoside N - formyl - 175 - J: (2R ,3 S,6 S ) - 6 - ({(2R ,3a R ,5a R ,5bS,9 S,13 S, 14R ,16a S,16bR ) - 2 - [(6 - deoxy- 3 - O - ethyl - 2,4 - di - O - methyl - alphaspinetoram. The residue is fat soluble.

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Page 68 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 L - mannopyranosyl) oxy] - 9 - ethyl - 14 - methyl - 7,15 - dioxo 2,3,3a, 4,5,5a,5b,6,7,9,10,11,12,13,14, 15,16a,16b - octadecahydro - 1 Has - indaceno[3,2 - d] oxacyclododecin - 13 - yl}oxy) - 2 - methyltetrahydro - 2H

-pyran - 3 - yl(methyl) formamide Commodity 1 Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex Acerola 0.30 Al mond, hulls 19 Amaranth grain, grain 1.0 Apple, wet pomace 0.50 Artichoke, globe 0.30 Asparagus 0.04 0.04 Atemoya 0.30 Avocado 0.30 Banana 0.25 Beet, sugar, molasses 0.75 Biriba 0.30 Brassica, head and stem, subgroup 5A 2.0 7.0 (bok choy) Chinese cabbages, broccoli raab 2.0 broccoli, Brussels sprouts, cabbages, cauliflower, Chinese broccoli, Chinese mustard cabbages, kohlrabi, (napa) Chinese cabbages Brassica, leafy greens, subgroup 5B 10 7.0 (bok choy) Chinese cabbages, brocolli raab, collards, kale, mustard greens, mustard spinach, rape greens Bushberry, subgroup 13B 0.25 0.5 currants, elderberries, gooseberries, highbush blueberries, huckleberries, lowbush blueberries Caneberry, subgroup 13A 0.70 0.5 blackberries, loganberries, raspberries, wild raspberries Canistel 0.30 Cattle, fat 5.5 5.5 Cattle, liver 0.85 0.85 0.01 (* ) edible offal (mammalian) Cattle, meat 0.20 0.2 0.2 (fat) meat (from mammals other than marine mammals) Cattle, meat byproducts (except liver) 0.60 0.6 meat byproducts (except liver) of cattle 0.01 (* ) edible offal (mammalian) Cherimoya 0.30 Citrus, dried pulp 0.50 Citrus, oil 3.0 3.0 Corn, sweet, kernel plus cob with husks removed 0.04 0.04 Cotton, gin byproducts 1.5 Cotton, undelinted seed 0.04 Cranberry 0.04 0.04 Custard apple 0.30

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Page 69 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Date 0.10 Egg 0.04 0.04 Feijoa 0.30 Fig 0.10 Fruit, citrus, group 10 0.30 0.3 calamondins, citrus citrons, citrus hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos, tangerines, Satsuma mandarins 0.07 oranges, sweet, sour (including orange - like hybrids): several cultivars Fruit, pome, group 11 0.20 0.1 apples, crabapples, loquats, mayhaws, oriental pears, pears, quinces 0.05 pome fruits Fruit, stone, group 12 0.20 0.2 apricots, nectarines, peaches, plumcots, plums, prune plums, sweet cherries, tart cherries 0.01 tree nuts Goat, fat 5.5 5.5 Goat, liver 0.85 0.85 0.01 (* ) edible offal (mammalian) Goat, meat 0.20 0.2 0.2 (fat) meat from mammals other than marine mammals) Goat, meat byproducts (except liver) 0.60 0.6 meat byproducts (except liver) of goats 0.01 (* ) edible offal (mammalian) Grain, aspirated fractions 20 Grain, cereal, group 15, except rice, sorghum, pearl millet and proso millet 0.04 0.1 barley, oats, popcorn grain, rye, wheat Grain, cereal, group 16, forage 3.5 Grain, cereal, group 16, hay 10 Grain, cereal, group 16, stover 10 Grain, cereal, straw, group 16, except rice 1.0 Grape 0.50 0.4 Grape, raisin 0.70 0.7 raisins Guava 0.30 Herb, dried, subgroup 19A 22 Herb, fresh, subgroup 19A 3.0 Hog, fat 0.40 0.04 Hog, meat 0.04 0.04 0.2 (fat) meat (from mammals other than marine mammals) Hog, meat byproducts 0.04 0.04 meat byproducts of hogs Hop, dried cones 22 Horse, fat 5.5 5.5 Horse, liver 0.85 0.85 0.01 (* ) edible offal (mammalian) Horse, meat 0.20 0.2 0.2 (fat) meat (from mammals other than marine mammals) Horse, meat byproducts (except liver) 0.60 0.6 meat byproducts (except liver) of horses 0.01 (* ) edible offal (mammalian) Ilama 0.30 Jaboticaba 0.30 Juneberry 0.25 0.5 saskatoon berries (juneberries) Lingonberry 0.25 0.7 Longan 0.30 Lychee 0.30 Mango 0.30

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Page 70 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Milk 0.30 0.3 0.01 (* ) Milk, fat 7.5 7.5 0.1 Millet, pearl, grain 1.0 Millet, proso, grain 1.0 Nut, tree, group 14 0.10 0.01 tree nuts Okra 0.40 Onion, green 2.0 Papaya 0.30 Passionfruit 0.30 Pea and bean, dried shelled, except soybean, subgroup 6C 0.04 0.04 Dry (adzuki beans, beans, Blackeyed peas, broad beans, catjang seeds, chickpeas, field peas, grain lupin, guar seeds, kidney beans, lablab beans, lentils, lima beans, moth beans, mung beans, navy beans, pige on peas, pink beans, pinto beans, rice beans, southern peas, tepary beans, urd beans Pea and bean, succulent shelled, subgroup 6B 0.04 0.04 succulent shelled (blackeyed peas, broad beans, English peas, garden peas, green peas, lima beans, peas, pigeon peas, southern peas) Peanut 0.04 Peanut, hay 11 Peppermint, tops 3.5 Pineapple 0.04 Pineapple, processed residue 0.15 Pistachio 0.10 Pomegranate 0.30 Poultry, fat 0.10 0.04 Poultry, meat 0.04 0.04 Poultry, meat by

products 0.04 0.04 Pulasan 0.30 Rambutan 0.30 Salal 0.25 0.5 salal berries Sapodilla 0.30 Sapote, black 0.30 Sapote, mamey 0.30 Sapote, white 0.30 Sheep, fat 5.5 5.5 Sheep, liver 0.85 0.85 Sheep, meat 0.20 0.2 Sheep, meat products (except liver) 0.60 0.6 meat byproducts (except liver) of sheep Sorghum, grain, grain 1.0 Soursop 0.30 Soybean, seed 0.04 0.04 dry soybeans Spanish lime 0.30 Spearmint, tops 3.5 Spice, subgroup 19B, except black pepper 1.7 Star apple 0.30 Star fruit 0.30 Strawberry 1.0 0.7 Sugar apple 0.30 Ti, leaves 10 Vegetable, bulb, group 3, except green onion 0.10

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Page 71 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Vegetable, cucurbit, group 9 0.30 0.3 balsam apples, balsam pears, cantaloupes, chayote fruit, Chinese cucumbers, Chinese waxgourds, citron melons, cucumbers, edible gourds (other than those listed in this item), muskmelons (other than those listed in this item) pumpkins, summer squash, watermelons, west Indian gherkins, winter squash Vegetable, foliage of legume, group 7 8.0 Vegetable, fruiting, group 8 0.40 0.2 bell peppers, eggplants. ground cherries, non -bell peppers, okras, pepinos, pepper hybrids, tomatillos, tomatoes 0.06 tomato Vegetable, leafy, except Brassica, group 4 8.0 7 amaranth, arugula, cardoon, celery, celtuce, Chinese celery, corn salad, dandelion leaves, dock, edible leaved chrysanthemum, endives, fresh chervil leaves, fresh Florence fennel leaves and stalks fresh parsley leaves, garden cress, garden purslane , garland chrysanthemum, head lettuce, leaf lettuce, New Zealand spinach, orach leaves, radicchio rhubarb, spinach, swiss chard upland cress, vine spinach winter purslane 10 lettuce head, lettuce, leaf

Vegetable, leaves of root and tuber, group 2 10 7.0 Black salsify, cassava leaves, celeriac, chicory, edible burdock, garden beet, oriental radish, radish, rutabaga, tanier leaves, taro leaves, turnip, turnip - rooted chervil Vegetable, legume, edible podded, subgroup 6A 0.30 0.3 edible podded (dwarf peas jackbeans, moth beans, peas, pigeon peas, runner beans, snap beans, snow peas, soybeans, sugar snap peas, sword beans, wax beans, yardlong beans Vegetable, root and tuber, group 1 0.10 0.04 arracacha, arrowroot, cassava, chayote, Chinese artichokes, chufa, edible canna, ginger, Jerusalem artichokes, lerens, potatoes, sweet potato, tanier corms, taro corms, turmeric, true yam tubers, yam bean 0.1 Black salsify roots, carrot, celeriac, chicory, edible burdock, g arden beet, ginseng, horseradish, oriental radish, parsnip, radish, rutabaga, salsify, skirret, Spanish salsify, sugar beet, turnip, turnip - rooted chervil, turnip - rooted parsley 0.01 (* ) sugar beet

Watercress 8.0

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Page 72 of 72 Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 3 Wax jambu 0.30 MRLs with No US equivalent Amur river grapes 0.4 Aronia berries 0.5 Bearberries 0.7 Bilberries 0.7 Buffalo currants 0.5 Chilean guavas 0.5 Cloudberries 0.7 European barberries 0.5 Hardy kiwifruit 0.4 honeysuckle 0.5 huckleberries 0.5 jostaberries 0.5 Maypop 0.4 Muntries 0.7 Native currants 0.5 Partridgeberries 0.7 Schisandra berries 0.4 Sea buckthorn 0.5 Completed by: M. Negussie; 03/31/2011 1 

### Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant. 2 

### Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 

### * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.