UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHE.\llCAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: 

Subject: 

From: 

Through: 

l 9-November-2015 

Spinosad/Spinetoram. Addendwn to Human Health Aggregate Risk Assessment 

D415812 (T. Bloem et al., 10-Mar-2015) to Support a New Use on Quinoa. 

PC Codes: I I 0003 and I I 0008 DP Barcodes: 429673 and 429674 

Decision Nos.: 483254 and 483225 Registration Nos.: several 

Petition Nos.: 3E8203 and 3E8204 Regulatory Action: Section 3 Registration 

Risk Assessment Type: Single Chemical/Aggregate Case Nos.: 7448 and 7421 

TXR No.: not applicable CAS Nos.: 187166-40-1 , 187166-15-0, and 

13 1929-60-7 

MRID No.: not applicable 40 CFR: 180.495 and 180.635 

Tom 

Risk Assessment 

Bloem, ChemiBranch ~ 1 (RABI)\~ , Health Effects Division (HED, 7509P) 

Charles 

George F. 

W. 

Kramer

Smith 

, 

III

Ph.D.

, Branch 

, Senior 

Chief 

Chemist 

C ~ 

---~~_.. ........ -z..-z---

RAB l/HED (7509P) 

To: Sidney Jackson/Barbara Madden RM 5 

Registration Division (7505P) 

The Interregional Research Project No. 4 (IR-4) submitted an amendment to a recently 

completed spinosad/spinetoram human health risk assessment (D415812, T. Bloem et al., 10-

Mar-2015) which proposed a Section 3 registration for application of spinosad and spinetoram to 

quinoa and the establishment of permanent spinosad and spinetoram tolerances in/on quinoa 

grain of 1.0 ppm and 0.04 ppm, respectively. This document provides an addendwn to this 

recently-completed hwnan health risk assessment in order to assess the additional proposed . . qumoa gram uses. 

Proposed Application Scenario: A summary of the proposed spinosad and spinetoram quinoa 

applications scenarios are provided in Attachment 1. The proposed spinetoram quinoa 

application scenario is identical to the currently registered spinetoram cereal grain application 

scenario. For spinosad, the proposed quinoa application scenario is identical to the currently 

registered foliar cereal grain application scenario; post-harvest application to quinoa grain, as is 

currently registered for several cereal grains, is not proposed. HED concludes that the proposed 

application directions are adequate. 

Page I of 5 
Spinosad and Spinetoram Human Health Risk Assessment 0429673 

Tolerances: Residue data in/on quinoa grain have not been submitted (grain is the only quinoa 

commodity). It is noted that quinoa is considered similar to the small grains (cereal grains) and 

will be proposed for addition to the revised cereal grain crop group (wheat or wheat and barley 

will be the representative crop(s)). Based on this, the HED Chemistry Science Advisory Council 

(ChemSAC) recently implemented a policy allowing translation of wheat, barley, or crop group 

15 tolerances (residue data) to quinoa grain provided the application scenarios are similar 

(minutes of27-May-2015; 10-Jun-2015; 29-Jul-2015). The proposed spinetoram quinoa 

application scenario is identical to that registered for the cereal grains. Therefore, translation of 

the 0.04-ppm spinetoram cereal grain crop group 15 (except rice, sorghum, and millet) tolerance 

to quinoa grain is acceptable (0.04-ppm tolerance proposed by the petitioner). 

For spinosad, foliar and post-harvest treatment of cereal grains are registered, while only fol iar 

application to quinoa is proposed (foliar scenarios are identical). Therefore, translation of the 

l .5-ppm spinosad cereal grain crop group 15 tolerance to quinoa grain is not appropriate. IR-4 -

proposed a 1.0 ppm spinosad quinoa grain tolerance for purposes of harmonizing with the Codex 

cereal grain maximum residue limit (MRL; quinoa is currently part of the Codex cereal grain 

crop group). However, the Codex MRL is also based on post-harvest treatment and, therefore, is 

not reflective of the proposed foliar only quinoa application scenario. Based on the available 

wheat grain data (summarized below) and adjusting these data for the proposed application rate, 

HED concludes that a 0.02-ppm spinosad tolerance in/on quinoa grain is appropriate. It is noted 

that the spinetoram cereal grain tolerance is also based on the spinosad wheat grain residue data 

adjusted for application rate (0325387, T. Bloem, 12-Sep-2007). A 0.04-ppm spinetoram 

tolerance was established rather than 0.02 ppm as spinetoram has four compounds in the 

tolerance expression while spinosad as only two (LOQ-tolerances). 

The available spinosad wheat grain processing data (translated to spinetoram) indicate that 

tolerances in/on the processed commodities are unnecessary (030420 I, W. Cutchin, 12-0ct2004). Based on the ChemSAC decision to translate the small grain residue data to quinoa, these 

data are sufficient to conclude that tolerances in/on quinoa processed commodities are also 

unnecessary. 

Spinosad Wheat Grain Residue Data: Spinosad was applied to wheat as three foliar applications 

at 0.45 lb ai/acre (4.8x) for a total seasonal application rate of 1.35 lb ai/acre (4.5x). 

Applications were made at early tillering, boot stage, and at 21 days before harvest. The samples 

were analyzed using an adequately validated method (storage intervals were also validated). 

Residues of spinosad were <0.005- 0.09 ppm. 

Aggregate Exposure and Risk Considerations: HED recently completed a spinosad/spinetoram 

chronic dietary exposure analysis which resulted in exposure estimates 64% the chronic 

population adjusted dose (cPAD; 0423657, T. Bloem, 10-Mar-2015); based on toxicological 

considerations, acute and caner analyses are unnecessary. This analysis was performed using the 

consumption data fonn the 2003-2008 U.S. Department of Agriculture's (USDA's) National Health 

and Nutrition Examination Survey What We Eat in America (NHANES/WWEIA). Although 

consumption estimates for quinoa are not available in the NHANES/WWEIA data, HED concludes 

that the dietary exposure estimates from the previous assessment are protective for all 

spinosad/spinetoram uses including the proposed quinoa use for the following reasons: 

Page 2 of 5 
Spinosad and Spinetoram Human Health Risk Assessment 0429673 

• Spinosad/spinetoram tolerances are established in/on all food crops with the previous assessment 

assuming 100% crop treated and residue estimates based on field trail data (maximum application 

rate, minimum retreatment interval, and minimum preharvest interval). 

• Quinoa is prepared like other whole grains, such as rice and barley, and may be used to make flour 

in a manner similar to wheat and other cereal grains. Therefore. the Agency concludes that quinoa 

will likely substitute in the diet for cereal grain foods, which, as discussed above, will contain 

similar residues. 

• The quinoa use pattern is similar to that for wheat and barl ey. Therefore, increased exposures to 

individuals through drinking water is not expected. 

Since the proposed quinoa use will not result in higher dietary exposure estimates (see above) and 

will not result in residential exposure, HED concludes that the aggregate exposure and risk 

estimates presented in the most recent human health risk assessment document (D4158 12, T. 

Bloem et al., I O-Mar-20 15), which were not of concern to HED, adequately account for 

exposures and risk resulting from all spinosad/spinetoram uses including the proposed quinoa use. 

Occupatio11al Exposure and Risk Considerations: HED concludes that the most recent 

assessment of occupational exposure assessment, which resulted in MO Es 2:.1600, is protective of 

potential exposures resulting from application of spinosad/spinetoram to quinoa. Therefore, a 

revised occupational exposure assessment is unnecessary. 

HED Recomme11dations: The most recently-completed comprehensive risk assessment for 

spinosad/spinetoram did not identify any toxicological deficiencies (D415812, T. Bloem et al. , 

10-Mar-20 15). As indicated above, the aggregate and occupational exposure estimates provided 

in this document, which were not of concern to HED, are adequate to account for the proposed 

quinoa use. Therefore, HED concludes that there are no human health concerns which would 

preclude the proposed registration and establishment of the tol erances recommended in Table 1. 

A revised Section F is requested. 

Table I: Tolerance Summary. 

Commodity Proposed Tolerance I-I ED-Recommended Comments (ppm)' Tolerance (ppm) 

Spinosad (40 C FR 180.495(a)) 

IR-4 proposed a 1.0-ppm spinosad quinoa grain tolerance for purposes of 

harmonizing with the Codex cereal grain MRL (quinoa will be proposed 

for inclusion in the revised cereal grain crop group). However. the Codex 

MRL is based on post-harvest treatment and, therefore. is not reflective of 

the proposed foliar only quinoa application scenario. Based on the 

available wheal grain data and adjusting these data for the proposed 

quinoa. grain 1.0 0.02 application rate. HED concludes that a 0.02-pprn spinosad tolerance inion 

quinoa grain is appropriate. II is noted that the spinetoram cereal grain 

toleranct: is also based on the spinosad wheat grain residue data adjusted 

for application rate (0325387. T. Bloem. I 2-Sep-2007): a 0.0.t-ppm 

tolerance was established rather than 0.02 ppm as spinetoram has four 

compounds in the tolerance expression while spinosad as only two (LOQtolerances). 

Spinetoram (40 C FR 180.635(a)) 

quinoa. grain 0.04 0.04 --

Attachment I: Proposed Appl ication Scenario 

Attachment 2: IRLs 

Page 3 of 5 
Spinosad and Spinetoram Human Health Risk Assessment D429673 

Attachment 1: Proposed Application Scenario 

IR-4 requested Section 3 Registrations for application of spinosad and spinetoram to quinoa. Table 

A. I. I is a summary of the end-use products and target pests and Table A. I .2 is a summary of the 

proposed application scenarios. 

The proposed labels also specify the following: (1) adjuvants may be added to the spray solution; 

(2) the labels specify a minimum spray volume for ground and aerial application of 5 gallons per 

acre (GPA) and 3 GPA, respectively; (3) the spinosad label does not specify any rotational crop 

restrictions while the spinetoram labels indicate that labeled crops may be rotated immediately to a 

treated field and nonlabeled crops may be rotated 30 days after application; and (5) REI = 4 hours. 

Table A.1.1: S ummary of End-Use Products. 

Trade Name Cone. Formulation Label Date Target Crops Target Pests 

Soinosad 

Entrust® SC 2 lb a i/gallon soluble concentrate 8-0ct-2015 quinoa armyworms: loopers: 

(EPA Reg. No. 627 19-62 1) lcafminers; thrips; cutworms 

Spinetoram 

Delegate® WG 25% water-dispersible granule 8-0ct-2015 (EPA Reg. No. 627 19-541) armyworms; loopers; 

Radiant® SC quinoa leafminers: thrips: cutwom1s 

(EPA Reg. No. 627 19-545) I lb ai/gallon soluble concentrate 8-0ct-2015 

rrable A. 1.2: S ummary of P r oposed Q uinoa Aoolic ation Scena r ios. 

App. Timing; Fommlation Single App. Rate Max. # Apps. Max. App. Rate PHI Use Directions and Limitations Type; and EQuip. (lb ai/acre) (lb ai/acre) (days) 

Spinetoram - RTl = 4 

Radiant® 0.02-0.05 3 0. 14 2 1 For resistance management purposes do 

Delegate® not make more than two consecutive 

foliar broadcast aoolications. 

~pray RTl = 4 

Spinosad - 0.05-0.09 3 0.30 21 For resistance management purposes do not 

Entrust® make more than two consecutive 

annlications. 

Page 4 of 5 
Spinosad and Spinetoram Human Health Risk Assessment 

Attachment 2: IRLs 

Spinosad - Summary of US and International Tolerances and Maximum Residue Limits 

Residue Delinition 

us Canada 

Spinosad ( 180.495): Srinosvn A (Factor A: CAS # 131929-60-7: 2-[(6-dcoxy-2.3.-1-

tri-0 -methyl-a-L-manno-pyranosyl)oxy )-13-[[5-( dimethylamino )-tctrahydro-6-

methyl-211-pyran-2-yl]oxy ]-9-ethyl-2.3.3a.5a.5b.6.9. I 0. I I .12.13.14. 16a. I 6btctradccahydro-14-methyl-111-as-lndaceno[3.2-d)oxacyclododccin-7. I 5-dione: and 

Sninosvn D (Factor D: CAS # 131929-63-0: 2-f (6-deoxy-2.3.4-tri-0-methyl-a-Lmanno-pyranosyl)oxy )-1 3-[[ 5-( d imcthy I-amino )-tctrahydro-6-methyl-211-pyran-2-

yl]oxy l-9-ethyl-2,3.3a.5a.5b.6.9. I 0. 11 , 12. 13. I 4. I 6a, I 6b-tetradecahydro-4. I-I-methyl111-as-lndaceno[3.2-d]oxacyclododecin-7, 15-dione. 

Tolerance/Maximum Residue Limit (ppm) 

Commodity1 us Canada Mcxico2 

quinoa. grain O.Q2 cereal grains - 1.5 --

Completed: 1 I ncludcs only commodities of interest for this action. Tolerance values arc I I ED recommendations. 2 Mexico adopts U tolerances and/or Codex MRLs for its expon purposes. 

Po = post harvest treatment such as treatment of stored grains. 

0 429673 

Mexico2 Codex 

Codcx3 

I cereal grains Po; 0.0 I 

(*)sweet corn (corn-onthe-cob): 

2 wheat bran, 

unprocessed 

Spinetoram - Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition 

us Canada 

Spinetoram ( 180.635): X DE-175-J ( l-H-as-indaceno[3.2-d]oxacyclododccin7. I 5-dione. 2-((6-dcoxy-3-0-ethyl-2.4-di-O-methyl-a-L-mannopyranosyl) oxy]-

I 3-lf(2R.5 .6R)-5- (dimethylamino)tetrahydro-6-methyl-21-1 -pyran-2-yl I oxy J-9-

ethyl-2.3.3a.4.5.5a.5b.6.9. I 0. I I, 12. I 3. 14. 16a, 16b- hexadecahydro 14-mcthyl-. 

(2R.3aR,5aR.5bS. 9 . I 3S. I 4R. I 6aS. I 6bR); XDE-1 75-L: I H-as-indaccno[3.2-

d]oxacyclododccin-7. I 5-dione. 2-[(6-deoxy-3-0 - ethyl-2.4-di-O-mcthyl-a-Lmannopyranosyl)oxy J- 13-ll(2R.5S.6R)-5-( dimethylamino )1e1rahydro-6-mc1hyl211-pyran-2-yJloxy l-9-cthyl-2,3.3a.5a.5b,6.9, I 0, 11 , 12. 13. 14, 16a. 16b1e1radecahydro-4, I 4-dimethyl-, (2S,3aR.5aS.5bS,9S, 13S, 14R. I 6aS. I 6bS): ND-J 

((2R.3aR.5aR.5bS.9S. I 3S. I 4R. l 6aS, I 6bR)-9-ethyl-14-methyl- I 3-fr(2S.5S.6R)-6-

me1hyl-5-(methylamino)te1rahydro- 2H-pyran-2-yl)oxy]-7, I 5-dioxo2.3.3a,4.5,5a.5b.6. 7.9. I 0, I I, 12. 13, 14 . I 5, 16a, I 6b- octadccahydro- 1 I-I-asindaccno[3,2-d loxacyclododccin-2-yl 6-deoxy-3-0 -ethyl-2.4-di-O-mcthyl- alphaL-mannopyranoside): and NF-J ((2R,3S.6S)-6-([(2R,3aR.5aR.5bS.9S. 

I 3S, I 4 R. I 6aS. I 6bR)- 2-[(6-dcoxy-3-0 -ethyl-2,4-di-O- methyl-alpha-Lmannopyranosyl) oxy)-9-ethyl-14-meLhyl-7, I 5-dioxo-2. 3.3a.4.5,5a.5b.6. 7.9. 

I 0. 1 I .12, 13, 14, 15, I 6a. I 6b- octadccahydro-1 H-as- indaceno(3.2-

d]oxacyclododecin-I 3-yl] oxy)-2-methyltetrahydro- 2H-pyran-3-

iY l(mcthyl)fonnamidc) 

Tolerance/Maximum Residue Limit (oom) 

Commodity' us Canada Mexico2 

quinoa. grain 0.0-1 0. I barley. oats. rye. "heat: 0.04 licld 

com. popcorn J?rain 

Completed: 1 Includes only commodities of interest for this action. Tolerance values arc I IED recommendations. 2 Mexico adopts U tolerances and/or Codex MRLs for its expon purposes. 

Page 5of5 

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Mexico2 Codex 

Codex3 

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