Spinosad and Spinetoram Registration Review Human

UNITED STA

MEMORANDUM

DATE: 09-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

TXR 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 Review Human-Health Assessment Scoping Document

Page 1 of 72

UNITED STATES 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: D387988

Registration No.: NA

Regulatory Action: Registration Review Scoping Document 

Case No.: Spinosad: 7421 

 Spinetoram: 7448.

CAS Nos.: 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 Review Human-Health Assessment Scoping Document

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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 closely 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 interchangeably or in combination in establishing the toxicity endpoints for risk 

assessment. The mode of action in insects is thought to be disruption of nicotinic/gamma 

amino butyric acid (GABA)-gated chloride channels. Spinosad and spinetoram are both 

currently registered for use on agricultural crops, ornamentals, tree farms/plantations, 

turfgrass, home gardens, pet (cats and kittens) spot-ons (spinetoram only), and lawns 

(residential use). They can be applied as seed treatments, at-planting soil applications, 

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-OCT2010; D376415). Since spinosad and spinetoram are considered toxicologically equivalent, 

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 epididymis 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 (lymph nodes, spleen, thymus, 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 system. 

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 Review Human-Health Assessment Scoping Document

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compounds were also negative for mutagenicity and there was no evidence of carcinogenicity in 

rats or mice. The toxicity database 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) side-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. 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. 

There is sufficient information available to assess residential exposure resulting from registered 

spinosad and spinetoram uses for registration review. For spinosad, 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 

currently registered uses and maximum application rates. HED has completed residential postapplication 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 currently 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. 

Several 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 points 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 postapplication 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 Review Human-Health Assessment Scoping Document

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The data need and risk assessment updates required under Registration Review for spinosad and 

spinetoram are listed on page 27.

Hazard Identification/Toxicology

Spinetoram and spinosad can be evaluated interchangeably for hazard characterization since they 

have nearly identical chemical structures and were determined to be toxicologically 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 estimated at 6 and 12 hours for males and female rats, respectively, 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 hours 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, lymph nodes, fat, and thyroids 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 III or IV). It is 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 structurally 

related compound spinetoram). For example, following subchronic exposure to spinosad, the 

primary effects seen in the mouse were increased vacuolation of cells of the lymphoid organs, 

liver, kidney, stomach, female reproductive tract, and epididymis, and less severely in the heart, 

lung, pancreas, adrenal cortex, bone marrow, tongue, pituitary gland, and anemia. In rats, 

thyroid follicular epithelial cell vacuolation, anemia, multifocal hepatocellular granuloma, 

cardiomyopathy, and splenic histiocytosis were observed following subchronic exposure, in dogs 

microscopic changes in a variety of tissues, anemia, and possible liver damage were seen with 

short-term repeated dosing. In a chronic feeding study in dogs, increases in serum alanine 

aminotransferase, aspartate aminotransferase, and triglycerides levels, and the presence of tissue 

abnormalities, including vacuolated cell aggregations, arteritis, and glandular cell vacuolation 

(parathyroid) were seen. Vacuolation of thyroid follicular cells, increased absolute and relative 

thyroid weights were observed in a chronic oral toxicity study in rats. 

No developmental effects were seen in the rat and rabbit developmental toxicity studies with 

spinosad. In the 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 parturition with associated increases in mortality in the dams 

resulting in decreases in litter size, survival (F2 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
Spinosad and Spinetoram Registration Review Human-Health Assessment Scoping Document

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(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 requested for either spinosad or spinetoram. Preliminary review of a recently 

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 

monocytes with a concomitant decrease in lymphocytes. 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 low 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 likely 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). It is a dermal sensitizer, but not an eye or dermal 

irritant. In subchronic 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 histiocytic aggregates of macrophages in various organs and tissues (lymph nodes, 

spleen, thymus, and bone morrow). Aggregation of macrophages was indicative of immune 

stimulation in response to insults of the chemical exposure and was considered secondary effects 

of the toxic effect to the hematopoetic system. 

Dogs appear to be the most toxicologically sensitive species to spinetoram exposure. In a 

subchronic study with dogs, lower thymus weights, atrophy of the thymic 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 systemic 

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 epididymides in one male dog and 

thymus, thyroid, larynx, and urinary bladder in one female at the high dose. It is postulated that 

chronic treatment exacerbated the spontaneous areteritis in genetically predisposed Beagle dogs 

(“Beagle Pain Syndrome”).

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 by 

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 effects were observed on the offspring at dose levels 

that produced parental toxicity in the 2-generation reproductive toxicity study. 
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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 or 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 systemic inflammatory reaction. In 

future risk assessments, the evaluation of the FQPA SF will include a recently submitted 

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 by 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 spinetoram 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 by 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 

will 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 Review Human-Health Assessment Scoping Document

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spinetoram are not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Accordingly, 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, please 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 policies 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 previously concluded that translation of spinosad residue data 

to spinetoram for numerous crops was acceptable for the following reasons (T. Bloem, 12-SEP2007; 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 spinosyn A and D) provided the application scenarios were similar. HED also 

concluded that translation of the spinosad processing factors to spinetoram was acceptable (T. 

Bloem, 28-APR-2009; D357703).

The nature of spinosad residues in plants and livestock is adequately 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 spinosyns A and D 
Spinosad and Spinetoram Registration Review Human-Health Assessment Scoping Document

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(G. Herndon, 3-MAR-1998, D243816; W. Donovan, 14-JUN-2002, D264984). The nature of the 

spinetoram residues in plants and livestock 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 assessment 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 

spinetoram J, spinetoram L, ND-J, NF-J, 3’-O-deethyl-175-J, 3’-O-deethyl-175-L, and O-demethyl175-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 spinosyn 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 carbon pool. Spinosyns A and D were not detected in the rotated crops [wheat, lettuce, 

and radish; plant-back intervals (PBIs) of 30, 120, and 365 days]. 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 only be rotated to a labeled crop (P. Shah, et al., 20-SEP2007; D331741). Subsequently, a rotational crop study concerning the nature of the residue in 

rotational crops planted 120 and 365 DAT (as well as the previously reviewed 30-DAT data) was 

submitted. Based on the residue characterization/identification procedures performed in the 

study, and since the study employed a single bare-soil application of spinetoram at the maximum 

yearly 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/shellfish for tolerance 

setting purposes are spinosyn A and D; for purposes of risk assessment, HED concluded that 

adjustment of the TRRs in the edible tissues from the 19-ppb spinosyn A bioconcentration study

for the EFED water concentration resulting from the mosquito larvicide use was appropriate (T. 

Bloem, 2-August-2006; D316078). HED notes that these conclusions are appropriate for the 

currently registered uses only and will be reevaluated if the petitioner alters the aquatic 

application scenario. Residues of 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-assessment purposes, are outlined in Tables 1 and 2, respectively. 
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Table 1. Residues for Tolerance Expression and Risk Assessment for Spinosad.

Matrix Residues Included in Risk Assessment Residues Included in Tolerance Expression

Plants1spinosyn 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 Crops1spinosyn A and D spinosyn A and D

Drinking Water3total 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 D316077 (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

Plants1spinetoram J, spinetoram L, ND-J, and NF-J spinetoram J, spinetoram L, ND-J, and NF-J

Ruminant1,2 spinetoram J, spinetoram L, ND-J, and NF-J spinetoram J, spinetoram L, ND-J, and NF-J

Hen1,3 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 Crops1 Cannot be determined from the available data.

Drinking Water1

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 of 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; highperformance liquid chromatography (HPLC)/ultraviolet (UV)] has been forwarded to the Food 

and Drug Administration (FDA) for inclusion in Pesticide Analytical 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 byproducts). 

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 methods 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). 
Spinosad and Spinetoram Registration Review Human-Health Assessment Scoping Document

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Adequate plant and livestock methods are available for enforcement of the established 

spinetoram 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 forwarded 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 the similar analytical procedures for GRM 

06.08 and GRM 05.15, HED concluded that the ILV and radiovalidation data for GRM 05.15 

and Analytical Chemistry Laboratory’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 spinosyns A, D, B, and K and Ndemethyl spinosyn 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 I MRMs 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 the 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, analyses were not performed using Protocols B or G. The

test substances were not detectable through FDA PAM I Protocols 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 residues 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 by measuring only the sum of Spinosyn A: 

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1Has-indaceno[3,2-d]oxacyclododecin-7,15-dione] and Spinosyn D: 

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl1H-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 by measuring only the sum of XDE-175-J:
Spinosad and Spinetoram Registration Review Human-Health Assessment Scoping Document

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(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-

methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione; XDE-175-L: 

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-Lmannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione; ND-J: 

(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-{[(2S,5S,6R)-6-methyl5-(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-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-methylalpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo2,3,3a,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 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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Table 3. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.

Commodity

Current 

Tolerance 

(ppm)

HEDRecommended 

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 HEDrecommended tolerance of 0.30 ppm (G. Herndon, 23-FEB-1999, D252416; M. Doherty, 20-AUG1999, 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, 06-

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, leaves 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 tolerance. 

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 spinosad 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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Table 3. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.

Commodity

Current 

Tolerance 

(ppm)

HEDRecommended 

Tolerance (ppm)

Comments Regarding HED-Recommended Tolerance Updates

Vegetable, leafy, 

except Brassica,

group 4

8.0 10.0

Additional data were submitted which 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, meat12.0 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, 02-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 driver 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 reidentified the tolerance recommendations made in the 2008 memo. Subsequently, the Chemistry 

Science Advisory Council (ChemSAC) issued guidance that meat byproduct tolerances should be set 

at the highest residue level seen in any livestock commodity (minutes from 12-JAN-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, liver110 Remove from 40 

CFR

Cattle, meat 

byproducts, except 

liver1

5.0 Remove from 40 

CFR

Cattle, meat 

byproducts1 -- 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 which 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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Table 3. Spinosad and Spinetoram Tolerances That Need to be Updated in the 40 CFR.

Commodity

Current 

Tolerance 

(ppm)

HEDRecommended 

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 data 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. ClockRust et al., 05-JUN-09, D357855); therefore, the watercress tolerance should be updated 

accordingly. 

Cattle, liver10.85 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 

cattle, 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 

liver1

0.60 Remove from 40 

CFR

Cattle, meat 

byproducts1 -- 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 adequately 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:

 Side-by-side grass (n=3; forage and hay samples should be collected) and alfalfa (n=3; 

forage and hay samples should be collected) residue data comparing the SC and WP 

formulations of spinosad. If these data indicate that residues are greater following 

application of the WP formulation, then additional data may be requested. Alternately, 

the petitioner can provide a rationale as to why the WP formulation will not result in 

higher spinosyn A and D residues in/on the requested crops as compared to the SC 

formulation (should include an explanation as to why spinosyn A and D were higher in 

spinach following application of the WDG as compared to the SC; 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-1998; D235973). This 

memo waived the requirements of a nature of the residue study, field trials, and a 

pyrolysis study for the 24(c) use only, 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 for 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 pyrolysis study

[OPPTS Guideline 860.1000(f)(3); Tobacco Uses, Pyrolysis 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, 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 by 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 scientifically 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; D353933), 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.; 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, 
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 16 of 72

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 soybean. The label should be updated to read for application to foliage of 

legume vegetables (excluding soybean; 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 only 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 

levels for several commodities should be updated as outlined in Table 3. 

Dietary Exposure

The most recent chronic dietary exposure assessment for spinosad/spinetoram was performed in 

conjunction with the 12-OCT-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-OCT2010, 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 

analysis. 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 Individuals (CSFII; 1994-1996 and 1998). Acute and cancer analyses 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). 

In 2010, the registrant discontinued, by voluntary cancellation, the spinosad cattle feed through 

and ear-tag registrations. The most recent dietary exposure assessment differs 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 analysis assumed 100% crop treated for all food crop commodities; average 

spinosad field-trial residues, average spinosad USDA PDP detected residues, or spinosad tolerancelevel 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, egg and ruminant/hog/poultry tissue spinosad 

residue estimates. 
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Additionally, drinking water residues, as provided by EFED, were incorporated directly into the 

chronic dietary analyses (“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-2007;

D325409) 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 Screening Concentration In Ground Water (SCIGROW) 

models, respectively. A summary of the modeled water concentrations are included in Attachment 7. 

Based on these estimates, the chronic analysis 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 registered for residential uses including homeowner applications 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, 

sawfly larvae, certain psyllids and leaf-feeding beetles, and red imported fire ants (mound 

application is permitted). It is 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 listed 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 combining 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 assessments

were 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 by homeowners. HED believes that dermal and inhalation exposures and risks are 

negligible and are not necessary to assess because of the formulation 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 application. Therefore, quantitative analysis 

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 inhalation 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 domestic 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 tube 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, since 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 exposures 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. Ingestion 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 exposure 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 was, 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 bystander post-application

inhalation exposure assessment has 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 nearby 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 method 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 Agency’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 appropriately apply the data and the AgDRIFT®computer model 

to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic 

methods. After the policy is in place, the Agency may impose further refinements in spray drift 

management practices to reduce off-target drift with specific products with significant risks 

associated with drift.

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 been 

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 currently 

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 Risk 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 likely 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 use and from the registered spinosad and spinetoram 

turf and ornamental application scenarios, and (2) short-term inhalation exposure to adults 

(handler/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 combined 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 

of 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 intermediateterm 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 exposures. The aggregate MOE is at the LOC of 100. For the 

following reasons, HED concluded that aggregate intermediate-term assessment was 

conservative: (1) the dietary exposure analysis assumed 100% crop treated for all food 

commodities; (2) the dietary exposure analysis assumed the modeled estimated drinking water 

concentration (EDWC) resulting from the turf application scenario (turf use yielded the highest 

EDWC); the model assumed that 87% 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 analysis assumed all livestock are exposed to 

the premise (ruminants) or premise/dermal (poultry) application scenarios and consume water 

which has been treated with spinosad (mosquito larvicide application scenario).
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HED noted 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)

submission 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 incorporates 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 Exposure

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 listed 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 nonagricultural) is listed 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 

surrogate 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 chemicalresistant 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; 

D361852). 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 soybean) (subgroup 6C)

(excluding lentils and cowpea), cantaloupe, cucurbit vegetables, foliage of legume vegetables 

(excluding soybean) (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 (Memo, 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 that the label should be 

updated to reflect the use a respirator.

Based on a review of currently registered labels, occupational handler assessments have not been 

performed for the following scenarios:

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

concentrate formulations 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 sprayer, and trigger spray bottle).

 All scenarios associated with liquid bait formulations.

 Mixer/loader, applicator and mixer/loader/applicator scenarios for granular formulations

for bait stations, 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 

assessed 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 previously 

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, occupational handler assessments have not been 

performed for the following scenarios:

 Application by aerial equipment, and

 Mixing/loading/applying liquid and dry flowable formulations via backpack sprayer. 

Conclusions

There is sufficient information available to assess occupational handler exposure. For both 

spinosad and spinetoram, several 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 generally been derived 

only from PHED. However, recently 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-Application

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 endpoint 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 volatilization 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 by 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

revisit 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 PODs 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 

spinosad; 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.

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; D389821). 

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 represent anecdotal reports or allegations 

only, unless otherwise stated in the report. The Agricultural Health Study (AHS) is a highquality, 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, fully 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 higher 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 

Tables 1 and 2 at the end of this report. Additionally, since higher severity incidents are 

generally 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 by registrants as counts called aggregate summaries and are recorded in a separate 

module called Aggregate IDS. 

In Aggregate IDS, from January 1, 2006 to March 29, 2011, there are 19 incidents involving 

spinosad. 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 

spinosad, there appears to be a low potential for exposure. 

In Aggregate IDS, from January 1, 2006 to March 29, 2011, 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 Main IDS, from January 1, 2006 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 only 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 Main IDS, from January 1, 2006 to March 29, 2011, there is one case reported that 

involve the active ingredient spinetoram. This case involves the single chemical spinetoram only 

and is ranked major severity. 

For both spinosad and spinetoram, based 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 

analysis 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

Chemical: 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

Chemical: 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 (MRLs) 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 MRLs for 

export purposes.

Many of the U.S. tolerance levels for spinosad and spinetoram are harmonized with Canada and 

Codex MRLs; however, some of the tolerances and MRLs are not harmonized. In particular, the 

U.S. tolerances for livestock commodities are higher than the MRLs for Canada and Codex. 

Additionally, tolerances and MRLs 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 

MRLs 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 MRLs for export purposes. During Registration Review, efforts should be made to 

harmonize U.S. tolerances with Canadian and Codex MRLs, 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 12898, “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 

typically considers the highest potential exposures from the legal 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 significantly 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 Agency policy.

 The tolerance levels for several commodities should be updated as outlined in Table 3.
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Data Requirements:

 Side-by-side grass (n=3; forage and hay samples should be collected) and alfalfa (n=3; 

forage and hay samples should be collected) residue data comparing SC and WP 

formulations of spinosad (OPPTS Guideline 860.1500; Crop Field Trials). 

 A spinosad 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 pyrolysis study [OPPTS Guideline 

860.1000(f)(3); Tobacco Uses, Pyrolysis 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, 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 by the Agency as part of Registration Review. 

 The orange oil residue data are not considered scientifically 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 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-1587 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 soybean. The label should be updated to read for application to foliage of 

legume vegetables (excluding soybean; 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 only 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 Table 3, as needed. Additionally, the revised assessment should 
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 29 of 72

include a residue value for water chestnuts, based on the spinosad food commodities 

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 SFs. 

 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. 

References

Table 6. Memoranda Relevant to Registration Review.

Author Barcode Date Title

C. Lewis D221454 05-FEB-1996 Exposure Assessment for Spinosad EUP.

G. Herndon D219016 24-APR-1996

PP#6G04692. Section 5 Registration (62719-EUP-GE) and 

Temporary 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 -- 01-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 02-MAR-1998 Letter to Dr. Marion Clower at the FDA

G. Herndon D243816 03-MAR-1998 Spinosad. Results of the HED Metabolism Assessment Review

Committee Held on 2/10/98. 

G. Herndon D245211 05-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 06-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 06-AUG-2001

Spinosad. Residue Chemistry Review of Field Trial Data on 

Various Commodities. Joint Review 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. Memoranda 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 02-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-Jul2005). 

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

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Table 6. Memoranda 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: Review 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. 

Review 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 06-MAY-2009 Spinosad: Occupational and Residential Exposure/Risk 

Assessment of Proposed Section 3 Uses on Various Food Crops

L. Venkateshwara D358162 03-JUN-2009 Spinetoram: Occupational Exposure/Risk Assessment of Proposed 

Section 3 Uses on Various Food Crops 

M. Clock-Rust, et 

al.

D357855

D357837 05-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 01-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. Memoranda Relevant to Registration Review.

Author Barcode Date Title

T. Bloem et al. D376415 12-OCT-2010 Spinetoram. Human-Health Risk Assessment for Cat/Kitten SpotOn 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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 33 of 72

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,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-αa-Lmannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-βß-D-erythropyranosyloxy)-9-

ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-

oxacyclododeca[b]as-indacene-7,15-dione; Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS, 

16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-αa-L-mannopyranosyloxy)-13-(4-dimethylamino2,3,4,6-tetradeoxy-βß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14, 

15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

CAS name

Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-Lmannopyranosyl)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-14-methyl-1H-asindaceno[3,2-d]oxacyclododecin-7,15-dione; 

Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-Lmannopyranosyl)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-1H-asindaceno[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,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-Omethyl-α-L-mannopyranosyloxy)-13-[(2R,5S,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-hexadecahydro14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

Spinetoram L: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-Omethyl-α-L-mannopyranosyloxy)-13-[(2R,5S,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-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

CAS name

Spinetoram J: (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-Omethyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl2H-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-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione

Spinetoram L: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-3-O-ethyl-2,4-di-Omethyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-

dimethyl-1H-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,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-dioxo-2,3,3a,4,5,5a,5b,6,7,9, 

10,11,12,13,14,15,16a,16b-octadecahydro-1Has-indaceno[3,2-d]oxacyclododecin-2-yl 6-

deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-Lmannopyranoside

N-formyl-175-J

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-Lmannopyranosyl) oxy]-9-ethyl-14-methyl7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,1

6b-octadecahydro-1H-as-indaceno[3,2-

d]oxacyclododecin-13-yl}oxy)-2-

methyltetrahydro-2H-pyran-3-

yl(methyl)formamide
Spinosad Registration Review Human-Health Assessment Scoping Document

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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 – POD 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

Intermediateterm 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 long-term dermal risk assessments are not required for the following reasons: 1) lack of 

concern for pre and/or post natal toxicity; 2) the combination of molecular structure and size as well as the lack of 

dermal or systemic toxicity at 1000 mg/kg/day in a 21-day 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. 
Spinosad Registration Review Human-Health Assessment Scoping Document

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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 Maximum 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 Gardensa

0.00001 lb ai/1000 

ft2

Ornamentalsb

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 and 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 

Exposurec

(mg/lb ai)

Inhalation Dose 

(mg/kg/day)d

Short-term Inhalation 

MOEe

Mixing/

Loading/ Applying Dusts 

via Shaker Can (ORETF; 

MRID 444598-01)

0.00001 1000 Baselinef

: 

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 Estimatec Potential Dose Rate(mg /kg bw/d)d

MOEse

(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/cm2S/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 residential lawn treatment for turfgrass disease control.

c. Residue estimates based 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 108 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 108 μg/lb ai) x ( 2.47 x 10-8 A/cm2) x 0.67 cm3/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/cm2x 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/cm2x 25 cm2/day x 10-3 mg/μg)/15 kg = 3,300 mg/kg bw/day.

Soil Ingestion 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

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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 Maximum 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 

Dailyb

Baseline Inhalation 

Unit Exposure 

(mg/lb ai)c

Baseline Doses 

(mg/kg/day)d

Baseline Shortterm MOEse

Mixer/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 HoseEnd Sprayer (Residential 

ORETF data -- gardens; MRID 

444598-01; OMA006)

100 0.00082 0.00000059 8,400,000

Mixing/Loading/Applying 

Liquid Concentrates with HoseEnd 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 Inhalation: 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

Intermediateterm MOE

Hand-tomouth 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 * FAR, 0.20) / SApet)) * (SAL) * SAhands * Freq)] / BW (kg)

d. Short-term MOE = Short-term NOAEL (4.9 mg/kg/day) / PDR (mg/kg/day)

e. Intermediate-term MOE = Intermediate-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 

Lawn Uses

Exposure Scenario Application Rate

(lb ai/acre) Absorbed Dose (mg/kg/day) Short-term MOEa

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

Object to Mouth 4,900 970

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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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
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Page 41 of 72

Table A.5.1. Occupational Exposure Scenarios for Spinosad.

Crop/Use Site Application Equipment Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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. Low-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
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Page 43 of 72

Table A.5.1. Occupational Exposure Scenarios for Spinosad.

Crop/Use Site Application Equipment Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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

Litchi 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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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, Highvolume 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

Vetch Aircraft, Ground L 0.06466885 lb / a Y Y NA NA

Non-agricultural Uses

Barns/Barnyards/

Auction Barns

Bait station, Paintbrush, 

Tray, By hand, Hangboard/card bait, sprayerG 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, Hangboard/card bait, sprayerG 0.10888502 lb / a NA NA N NA

Compost/Compost 

Piles

Bait station, Paintbrush, 

Tray, By hand, Hangboard/card bait, sprayerG 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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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

Greenhouses - 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

Greenhouses- 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

Livestock 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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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 rightsofway/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, Handheld 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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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 nonflowering 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, Pumpup SprayerEC 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 Formulation 

Type(s) 1 Max. App. Rate

Scenario Covered2

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, Pumpup SprayerEC 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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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, 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

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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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, Ground DF 0.047 lb / a YY (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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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, Ground EC 0.0625lb / a Y

Y (no 

aerial) NA NA

Cranberry

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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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 YY (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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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 Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 57 of 72

Table A.6.1. Occupational Exposure Scenarios for Spinetoram. 

Crop/Use Site Application Equipment Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 58 of 72

Table A.6.1. Occupational Exposure Scenarios for Spinetoram. 

Crop/Use Site Application Equipment Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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 

(Softwoods, 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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 59 of 72

Table A.6.1. Occupational Exposure Scenarios for Spinetoram. 

Crop/Use Site Application Equipment Formulation 

Type(s) 1

Max. App. 

Rate

Scenario Covered2

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 60 of 72

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 analyses 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). 

Chronic Dietary Risk Estimates:

Table A.7.1: Summary 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 Concentrations for Spinosad/Spinetoram (ppb) Used in the 

Chronic Dietary Risk Assessment: 

Table A.7.2: Estimated Drinking Water Concentrations for Spinosad/Spinetoram (ppb).

Acute Chronic Long-Term Average

Spinosad (Turf Application Scenario; 4 x 0.4 lb ai/acre; RTI = 7 days; 87% of the Watershed is Treated)

surface 34.5 10.5 --

ground 1.1 1.1 1.1

Spinetoram (Turf and Fire Ant Mound Application; 1 x 0.454 lb ai/acre; 100% of the Watershed is Treated)

surface 14.419 6.171 --

ground 0.072 0.072 0.072
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 61 of 72

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 Mexico2 Codex3

40 CFR 180.495:

Plant and Livestock: Spinosyn A

(Factor A: CAS # 131929–60–7) or 

2-[(6-deoxy-2,3,4-tri- O -methyl-αL -manno-pyranosyl)oxy]-13-[[5-

(dimethylamino)-tetrahydro-6-

methyl-2H-pyran-2-yl]oxy]-9-

ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a

,16b-tetradecahydro-14-methyl-1Has-Indaceno[3,2-

d]oxacyclododecin-7,15-dione; and 

Spinosyn D (Factor D; CAS # 

131929–63–0) or 2-[(6-deoxy2,3,4-tri- O -methyl-α- L -mannopyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2Hpyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a

,16b-tetradecahydro-4,14-methyl1H-as-Indaceno[3,2-

d]oxacyclododecin-7,15-dione

Spinosyn A:

(2R,3aS ,5aR,5bS ,9S ,13S ,14R,16aS 

,16bR)-2-[(6-deoxy-2,3,4-tri-O-methylα-L-mannopyranosyl)oxy]-13-[[(2R,5S 

,6R)-5-(dimethylamino)-tetrahydro-6-

methyl2H-pyran-2yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b

-tetradecahydro-14-methyl-1 H-asindaceno[3,2-d ]oxacyclododecin-7,15-

dione

and

Spinosyn D:

(2S ,3aR,5aR,5bS ,9S ,13S ,14R,16aS 

,16bR)-2-[(6-deoxy-2,3,4-tri-O-methylα-L-mannopyranosyl)oxy]-13-[[(2R,5S 

,6R)-5-(dimethylamino)-tetrahydro-6-

methyl2H-pyran-2yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b

-tetradecahydro-4,14-dimethyl-1 H-asindaceno[3,2-d ]oxacyclododecin-7,15-

dione

Plants/animal: 

sum of spinosyn A 

and spinosyn D. 

The residue is fat 

soluble, but residues 

in milk should be 

determined in the 

whole milk. 

Commodity1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico2 Codex

Acerola 1.5

Alfalfa, seed 0.15

Alfalfa, seed screenings 2.0

Almond, 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 Mexico2 Codex3

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 kidney4

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 63 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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 milk4

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 64 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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, mamey 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 Mexico2 Codex3

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 

vegetables, 

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 for this action. Tolerance values should be the HED recommendations and 

not those proposed by the applicant.
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 66 of 72

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.

4

= The MRL accommodates external animal treatment.
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 67 of 72

Attachment 9: Spinetoram International 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 Mexico2 Codex3

40 CFR § 180.635:

Plant and Livestock: XDE-175-J: 1-H-asindaceno[3,2-d]oxacyclododecin-7,15-

dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-Omethyl-a-L-mannopyranosyl) oxy]-13-

[[(2R,5S,6R)-5- (dimethylamino)tetrahydro6-methyl-2H-pyran-2-yl] oxy]-9-ethyl2,3,3a,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-asindaceno[3,2-d]oxacyclododecin-7,15-

dione, 2-[(6-deoxy-3-O- ethyl-2,4-di-Omethyl-a-L-mannopyranosyl)oxy]-13-

[[(2R,5S,6R)-5-(dimethylamino)tetrahydro6-methyl-2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9, 10,11,12,13,14,16a,16btetradecahydro-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-dioxo-2,3,3a,4,5,5a,5b,6,7,9, 

10,11,12,13,14,15,16a,16b- octadecahydro1H-as- indaceno[3,2-d]oxacyclododecin-2-

yl 6-deoxy-3-O-ethyl-2,4-di-O-methylalpha-L-mannopyranoside; and NF-J: 

(2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S, 

13S,14R,16aS,16bR)- 2-[(6-deoxy-3-Oethyl-2,4-di-O- methyl-alpha-Lmannopyranosyl) oxy]-9-ethyl-14-methyl7,15-dioxo-2, 3,3a,4,5,5a,5b,6,7,9, 

10,11,12,13,14,15,16a,16b- octadecahydro1H-as- indaceno[3,2-d]oxacyclododecin-13-

yl] oxy)-2-methyltetrahydro- 2H-pyran-3-

yl(methyl)formamide

XDE-175-J:

1H-as-indaceno[3,2-

d]oxacyclododecin-7,15-dione, 

2-[(6-deoxy-3-O-ethyl-2,4-diO-methyl-a-Lmannopyranosyl)oxy]-13-

[[(2R,5S,6R)-5-

(dimethylamino)tetrahydro-6-

methyl 2H-pyran-2-yl]oxy]-9-

ethyl2,3,3a,4,5,5a,5b,6,9,10,11,12,1

3,14,16a,16 b-hexadecahydro 

14-methyl-

(2R,3aR,5aR,5bS,9S,13S,14R,1

6aS,16bR)

XDE-175-L: 

1H-as-indaceno[3,2-

d]oxacyclododecin-7,15-dione, 

2-[(6-deoxy-3-O-ethyl-2,4-diO-methyl-a-Lmannopyranosyl)oxy]-13-

[[(2R,5S,6R)-5-

(dimethylamino)tetrahydro-6-

methyl-2H-pyran-2-yl]oxy]-9-

ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14

,16a,16b-tetradecahydro-4,14-

dimethyl-

(2S,3aR,5aS,5bS,9S,13S,14R,16

aS,16bS)

Includes the following 

metabolites:

N-demethyl-175 J:

(2R,3aR,5aR,5bS,9S,13S,14R,1

6aS,16bR)-9-ethyl-14-methyl13-{[(2S,5S,6R)-6-methyl-5-

(methylamino)tetrahydro-2Hpyran-2-yl]oxy}-7,15-dioxo2,3,3a,4,5,5a,5b,6,7,9, 

10,11,12,13,14,15, 16a,16boctadecahydro-1H-asindaceno[3,2-

d]oxacyclododecin-2-yl 6-

deoxy-3-O-ethyl-2,4-di-Omethyl-alpha-Lmannopyranoside

N-formyl-175-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-alphaspinetoram. The 

residue is fat 

soluble.
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 68 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

L-mannopyranosyl) oxy]-9-

ethyl-14-methyl-7,15-dioxo2,3,3a, 

4,5,5a,5b,6,7,9,10,11,12,13,14,

15,16a,16b-octadecahydro-1Has-indaceno[3,2-d] 

oxacyclododecin-13-yl}oxy)-2-

methyltetrahydro-2H-pyran-3-

yl(methyl) formamide

Commodity1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico2 Codex

Acerola 0.30

Almond, 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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 69 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 70 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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, 

pigeon 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 byproducts 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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 71 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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, garden 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
Spinosad Registration Review Human-Health Assessment Scoping Document

Page 72 of 72

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

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.