Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974 **UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY** 

**WA SHINGTON, D.C. 20460**  **OFFICE OF PREVENTION, PESTICIDE AND TOXIC SUBSTANCES**  **MEMORANDUM Date**  **:** February

25, 2014 **SUBJECT:** Thiabendazole . PP# 3F8166 . New Seed Treatment Uses on Assorted V egetables

and S mall Grain s (vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; spinach (including bab y) ; and small grain s (wheat, barley , oats, rye, and triticale). Amendment to Increase Rate on Soy bean. Summ ary of Analy tical Chemistry

and Residue Data . Multiresidue Method Data. **PC Code:** 060101 **DP Barcode:** D 410807 , D 4108 33 , D 313507 **Decision No.:** 47671 1, 476712 **Re gistration**  **No. :**  100 - 889, 100 - 963 **Petition No .**  **:** 3F8166 **Regulatory Action:** Section 3 Registration **Risk A**  **ss essment Type**  **:** Res Chem **Case No.:**  2760 **T XR No.**  **:** NA **CAS No.:** 148 - 79 - 8 **MRID No .**  **:** See MRID Summary Table **40 CFR:** 180. 242 Ver.Apr.08 **FROM:** Susan V. Hummel, Senior Chemist

Risk Assessment Branch 4 Health Effects Division (7509P) **THROUGH:** Thurston G. Morton, Senior Chemist

Risk Assessment Branch 4 Health Effects Division (7509P) **TO:** Rosemary Kearns/Tony Kish , PM 22 Fungicide Branch, Registration Division (7505P) **MRID Summary Table MRID No.**  **Study Type Comments**  48996701 860.1 5 00 Alfalfa New DER; 48996701 .der.doc 48996702 860.1 5 00 Barley New DER; 48996702 .der.doc 48996703 860.1 5 00 Wheat

860 - 1520 Wheat Processing New DER; 4899670 3 .der 1 .doc New DER; 4899670 3 .der2 .doc 48996704 860.1 5 00 Carrot, Radish New DER: 48996704 .der.doc 48996705 860.1 5 00 Cantaloupe, Cucumber, Summer

Squash New DER; 4899670 5 .der.doc 48996706 860.1 5 00 Broccoli, Cabbage New DER; 4899670 6 .der.doc 48996707 860.1 5 00 Spinach New DER; 4899670 7 .der.docThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**MRID Summary Table MRID No.**  **Study Type Comments**  48996708 860. 1900 Field Accumulation in Rotational

Crops New DER; 4899670 8 .der.doc 48996709 860.1 500 Soybean

860.1 52 0 Soybean processing New DER; 4899670 9 .der 1 .doc New DER; 4899670 9 .der2 .doc 48996710 860.1 5 00 Dry bulb onion New DER; 489967 10 .der.doc 48996711 860.13 4 0 Analytical Method in Crops New DER; 489967 11 .der.doc 48996712 860.1380 Storage Stability

– Crops New DER: 48996712 - 13.der.doc 48996713 860.1 38 0 Storage Stability

– Processed

Comodities 46469301 860.1360 Multiresidue Method Revie wed herein **Executive Summary** Thiabendazole [2 - (4 - thiazolyl)benzimidazole] is a benzimidazole fungicide currentl y registered for use as a seed or seed piece treatment to dry pea, potato, sweet potato, soy bean, and wheat. It is also registered for use on mushrooms and is mostly used post - harvest as a dip or spray on citrus fruit s, apples, pears, bananas, mangos, papaya, plantain, carrots , and potatoes. The Thiabendazole Reregistration Eligibility Decision (RED) was issued October 20 02. A human health risk assessment was completed in June 2001 for the RED. Tolerances for plant commodities are established under 40 CFR § 180.242(a) and are expressed in terms of combined residues of thiabendazole and its metabolite benz imidazole (free and conjugated); tolerances range from 0.1 ppm for dry bean seed and soy

bean to 40.0 ppm for mushroom. Tolerances for livestock commodities are established under 40 CFR §180.242(b) and are expressed in terms of combined residues of thiabendazole, 5 - hydroxy thiabendazole (free and conjugated), and benzimidazole. Sy ngenta Crop Protection is requesting registration of new seed treatment s uses on assorted v egetables and s mall grain s (vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; spinach (including bab y); and small grain s (wheat, barley , oats, rye, and triticale). Tolerances already exist for wheat grain and wheat processed commodities. The product to be used is Mertect 34F , a 42.3% (4.1 lb ai/gal ) flowable concentrate formulation (EPA Reg. No. 10 0 - 889) . The uses are to be added to the Thiabendazole Technical label, as well (EPA Reg. No. 100 - 963). The 4.1 lb ai/gal Flowable Concentrate formulation is proposed for seed treatment use at 0.0 0 2

– 0.1 mg ai/seed , depending on the commodity . Sy ngenta is also requesting an amendment to the registration for Mertect 34F , a 42.3% (4.1 lb ai/gal) flowable concentrate formulation (EPA Reg. No. 100 - 889), to increase the application rate for so yb ean seed treatment. This amendment is not a part of th e petition; no increased tolerance is requested. Under the current action, Sy ngenta has submitted a petition for tolerances associated with the proposed use, PP# 3F8166 . Tolerances at the total limit of quantitation of 0.02 ppm were proposed for residues of thiabendazole and its metabolite benzimidazole on vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa seed, forage, and hay ; and spinach (includingThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

baby); and at 0.05 ppm on barley , oats, rye, and triticale grains; 0.15 ppm on barley hay and straw and rye straw; 0.2 ppm on wheat, oats, rye, and triticale forage; and 0.09 ppm on wheat hay and oats and triticale hay and straw. Sy

ngenta submitted res idue data to support the proposed uses. Sy

ngenta also has included field trial and processing studies on soy bean, and storage stability

data, both of which were required under the Rere gistration Eligibility Document (RED). The field trial data submitted for wheat may fulfill the RED data requirement for data for wheat, and constitute a full set of residue data , so these data may be used to reevaluate the existing wheat tolerances. The nature of the residue in plants is understood based on acceptable plant metabolism studies conducted in wheat, soy

bean, and sugar beet. The residues of concern in crops for purposes of tolerance enforcement and risk assessment are thiabendazole and its metabolite benzimidazole (free and conjugated). The nature of the resid ue in livestock is understood based on acceptable hen and goat metabolism studies. The residues of concern in livestock commodities are thiabendazole, 5 - hydrox y- thiabendazole (free and conjugated), and benzimidazole. Based on the available confined rotational crop study , the residues of concern in rotated crops are the same as those in primary

crops. Acceptable enforcement anal ytical methods are available for thiabendazole and benzimidazole in plant commodities. Four spectrophotofluorometric methods f or the determination of thiabendazole are published in the Pesticide Anal ytical Manual (PAM) Vol. II, and a high performance liquid chromatography (HPLC ) method with fluorescence detection (FLD) for the determination of benzimidazole (free and conjugated) is identified in the U.S. EPA Index of Residue Anal ytical Methods under thiabendazole as Study No. 93020. The validated limits of detection (LODs) for the thiabendazole methods range from 0.05 - 0.1 ppm, and the validated limit of quantitation (LOQ) for the benzimidazole method is 0.1 ppm. Samples from the submitted crop field trial and processing studies were analyzed for residues of thiabendazole and benzimidazole using a high performance liquid chromatography/tandem mass spectrometry

(LC/MS/MS) method, GRM040.01A. The method LOQ wa s 0.01 ppm, and the stated LOD wa s 0.004 pp m; LODs of 0.005 and 0.003 ppm were reported in the crop field trial and processing study submissions. Adequate method validation data were submitted for the method, and the method was adequatel y validated concurrently with the submitted field trial and processing studies , including validation at the LOD (0.003 ppm) in the Canadian crop field trials. HED concludes that the method is sufficiently sensitive and has been adequately val idated for the purposes of making a Threshold of Regulation determination. Adequate crop field trial data from the U.S. have been submitted to support the proposed seed treatment use s on vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; spinach (including baby); and small grain s (wheat, barley , oats, rye, and triticale) . Residues of thiabendazole and benzimidazole were each below the method LOQ of 0.01 ppm (total LOQ of 0.02 ppm) in all samples of vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; and spinach . Finite residues were reported in som e samples of barley and wheat grain, forage, hay and straw. Additionally , field trial data were submitted for soy beans, in response to a RED data requirement. The wheat and soy bean field trial data submitted with this petition satisfy the RED data requirement for additional field trial data for wheat and so yb eans.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Adequate wheat and so ybean proce ssing studies were submitted , both reflecting a 5x application rate . The so yb ean processing study was submitted in response to a RED data requirement. The wheat samples treated at a 5x application rate were processed into bran, flour, middlings, shorts and germ using simulated commercial procedures. Residues of thiabendazole were nonquantifiable in wheat grain and all wheat processed commodities. The soy bean s amples treated at a 5x application rate were processed into meal, hulls, refined oil, flour, milk, tofu, soy sauce, miso, pollard and crude oil using simulated commercial procedures. Residues of thiabendazole were nonquantifiable in soy beans and all soy

be an processed commodities. Therefore , HED concludes that residues of thiabendazole or its regulated metabolite, benzimidazole, are not likely to concentrate in the processed commodities of wheat and soy beans. A limited field rotational crop study was required in the RED and was included in the current submission . In 13 rotational crop trials, a fter application to the soil at a rate ty pical of seed treatment application rates, residues of thiabendazole and benzimidazole were nonquantifiable (< 0.02 ppm total) in samples of lettuce, radish, and wheat commodities planted 30, 60, and 270 days after treatment. This study satisfies the RED data requirement for rotational crop studies. **Regulatory Recommendations and Residue Che mistry Deficiencies**  Based on residue chemistry considerations onl y, HED concludes that tolerances can be supported for residues of thiabendazole and its regulated metabolite benzimidazole in vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; spinach (including bab y); or small grain (wheat, barley , oats, rye, and triticale) commodities grown from treated seed ; in the processed commodities of wheat ; and in rotational crops as a result of seed treatment use proposed in this petition. The recommended tolerances may be found in Table 7 of this document. The current tolerance expression is not in accord with our current guidance. See recommendation in Secti on **860.1550 Proposed Tolerances .**  Updating the tolerance expression will be accomplished during registration review. International Harmonization. Neither CODEX, nor Canada have established MRL s for thiabendazole on the proposed commodities. There is no issue with International Harmonization for the current petition. Provided that the use directions are revised as requested, anal ytical standards are submitted as requested, and the storage stability studies reported here as an interim report, are completed and submitted as final reports, HED concludes that, based on the available residue data, the requested use of thiabendazole as a seed treatment for vegetable, root (except sugar beet); subgroup1B, onion, bulb, subgroup 3 - 07A; Bras sica, head and stem, subgroup 5 A; vegetable, cucurbit group 9; alfalfa; spinach (including bab y); and small grain s (wheat, barley , oats, rye, and triticale) may be regis tered once tolerances are established as recommended in Section **860.1550 Proposed Tolerances**  **.** A human health risk assessment for thiabendazole will be conducted in connection with this action.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

860.1200 Directions for Use

 The registrant should revise the label to include the use rates in terms of weight of product per weight of seed (e.g. g/100 kg seed). 860.1380 Storage Stability

 The storage stability studies currentl y in progress (reported in an interim report) must be completed to fully

support th e field trial and processing studies for the current petition.  860.1650 Submittal of Analy tical Reference Standards

 For benzimidazole, a new standard must be submitted. For 5 - hydrox y- thiabendazole, the registrant must either rec ertify the lot in the repository

and send in an updated certificate of anal ys is (COA), or submit new standards (different lot #) if the previous lots will not be recertified. **Background** The chemical structure and nomenclature of thiabendazole and its regulated metabolites are presented in Table 1, and the physicochemical properties of the technical grade of thiabendazole are presented in Table 2. **Table 1. Test Compound Nomenclature.**  Com pound

Common name Thiabendazole Com pany experimental name None IUPAC name 2 - (thiazol - 4 - yl)benzimidazole CAS name 2 - (4 - thiazolyl) - 1 H -benzimidazole CAS registry number 148 - 79 - 8 End - use product (EP) 4.1 lb ai/gal F lC formulation ( Mertect 34F ; EPA Reg. No 100 - 889 ) Com pound

Common name Benzimidazole Chemical name 1 H -benz i midazole CAS registry number 51 - 17 - 2 Com pound

Common name 5 - hydroxy - thiabendazole N H N S

N

N H N

N H N S

N O HThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Table 1. Test Compound Nomenclature.**  Chemical name 2 - (1,3 - thiazol - 4 - yl) - 1H -benzimidazol - 5 - ol) **T able**  **2. Physicochemical Properties of the Technical Grade Test Compound: Thiabendazole.**  Parameter Value Reference Melting point/range 304 - 305 °C Thiabendazole RED 10/02 pH 5.16 - 5.97 Thiabendazole RED 10/02 Density 25 - 30 cc (tapped) Thiabendazole RED 10/02 Water solubility 0.028 - 0.030 mg/mL at 25 °C Thiabendazole RED 10/02 Solvent solubility acetone benzene chloroform dimethylformamide dimethyl sulfoxide ethanol ethyl acetate methanol 25 oC

4.2 g/L 230 mg/L 80 mg/L 39 g/L 80 g/L 7.9 g/L 2.1 g/L (R.T.) 9.3 g/L The Pesticide Manual, 8 th edition

Vapor pressure 4 x 10 - 9 mm Hg at 25 °C Thiabendazole RED 10/02 Dissociation constant, pKa Pka1 = 4.73; Pka2 = 12.00 Thiabendazole RED 10/02 Octanol/water partition coefficient Log(KOW) = 240 - 285 at pH 7 Thiabendazole RED 10/02 UV/visible absorption spectrum Neutral solution 32,170 L/mol*cm3 at 205.5 nm Acidic solution 41,520 L/mol*cm3 at 303.5 nm Neutral solution 40,553 L/mol*cm3 at 215.5 nm MRID 46286801 1

1 Data were referenced in MRID 47705121. **860.1200 Directions for Use** Sy ngenta has submitted a draft label (dated 10/23/2013 ) and a description of the proposed use for the 4.1 lb ai/gal FlC formulation (Mertect 34F Fungicide; EPA Reg No. 100 - 889 ). The proposed use directions for corn are summarized in Table 3. **Table 3**  **. Summary of Directions for Use of**  **Thiabendazole .**  Applic. Timing, Type, and Equip. Form ulation [EPA Reg. No.] Applic. Rate Max. No. Applic. per Season PHI

(days) Use Directions and Limitations Alfalfa Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0.004 mg

ai/seed or 5.8 fl oz/100 lb seed 1 N/A A ssume s an average seed size of 210,000 seeds/lb Cereal Grains

– Barley, Oats, Rye, Triticale, WheatThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Table 3**  **. Summary of Directions for Use of**  **Thiabendazole .**  Applic. Timing, Type, and Equip. Form ulation [EPA Reg. No.] Applic. Rate Max. No. Applic. per Season PHI

(days) Use Directions and Limitations Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0.03 mg ai/seed

Barley 2.6 fl oz/100 lb seed Oats 3.4 fl oz/100 lb seed Rye 3.2 fl oz/100 lb seed Triticale 2.6 fl oz/100 lb seed Wheat 3.1 fl oz/100 lb seed 1 N/A Barley - a ssume s an average seed size of 12,500 seeds/lb Oats - a ssume s an average seed size of 12,500 seeds/lb Rye - a ssume s an average seed size of 15,600 seeds/lb Triticale - a ssume s an average seed size of 12,750 seeds/lb Wheat - a ssume s an average seed size of 15,000 seeds/lb Brassica Head & Stem subgroup; Bulb Vegetables ; Vegetables, Root subgroup (except sugar beets) Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0.002 mg

ai/seed 1 N/A Cucurbit Vegetables Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0. 1 mg ai/seed 1 N/A Spinach Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0.006 mg

ai/seed 1 N/A Soy beans Seed treatment, Seed treatment application equipment 4.1 lb ai/gal F [100 - 889 ] 0.03 mg ai/seed 1 N/A No specific tank mix partners are identified; the label states , “ This product must not be tank mixed with any

pesticide unless physical compatibility and phy totoxicity tests have been completed and proved to be satisfactory . ” The label also notes that Federal law requires that bags containing treated seed shall be labeled with the following information: “This seed has been treated with thiabendazole fungicide . Do not use for feed, food, or oil purposes. Store away from feeds and foodstuffs. Do not allow children, pets or livestock to have access to treated seeds. ” The label also states, “ Wear long pants, long - sleeved shirt and protective gloves when handling treated seed . Use an EPA approved dye or colorant that imparts an unnatural color to the seed as required in 40 CFR 153.155 (c). Do not feed vines or hay grown from treated seed to livestock. Do not plant any crop, other than so yb eans, dry peas, barley , wheat, oats, rye, and triticale, brassica head and stem subgroup 5A, cucurbit vegetable crop group 9, root vegetables (except sugar beets) subgroup 1B, bulb vegetables subgroup 3 - 07A, spinach and alfalfa, within 30 days to fields in which treated seeds were planted. ” Conclusions . The proposed use directions are ade quate to allow evaluation of the residue data presented herein. The submitted corn field trials were conducted according to the proposed useThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

pattern, and the pre - grazing interval specified for corn forage is supported by the available data. Rates must al so be stated in terms of lb ai (or product)/A. **860.1300 Nature of the Residue -**  **Plants** 47705109.der.doc Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton The qualitative nature of the residue in plants is adequatel y understood based on soybean, sugar beet, and wheat metabolism studies. The residues of concern in plants include thiabendazole and benzimidazole, free and conjugated. In support of the regist ered seed treatment use on corn , Sy ngenta Crop Protection submitted a study investigating the metabolism of [ phenyl - U 14 C] thiabendazole in seed- treated corn. The test substance, formulated as a suspension concentrate (SC) formulation, was applied as a seed dressing to corn seed at 1.8x the propos ed seed treatment rate for corn. Immature corn forage was collected at the final vegetative stage (V12), 81 days after planting (DAP); sweet corn cobs, kernels, and foliage (forage) were collected at the dough stage (R4), 101 DAP; and mature corn cobs, kernels, and foliage (stover) were collected at the R6 stage, 116 DAP. TRR were 0.014 ppm in immature corn forage harvested at the V12 stage; 0.005 ppm in sweet corn forage harvested at the dough stage; and 0.002 ppm in mature corn stover harvested at the R6 stage. TRR were nondetectable in sweet corn kernels and cobs and mature corn kernels and cobs. Only immature corn forage was extracted; all other corn matrices had TRR <0.01 ppm. Approximately

43% of the radioactivity

was extracted from immature forage with ACN/water. The extract was separated into organic (13% TRR) and aqueous (16% TRR) phases; a 32% loss occurred with concentration for phase separation. Nonextractable residues accounted for ~56% TRR (0.008 ppm). Accountability was 98%. Although the extractable radioactivity was low (0.006 ppm) in immature forage, the organi c and aqueous phases were analy zed using normal and reverse phase TLC. Using normal phase TLC, radioactivity

in the aqueous fraction was immobile; radioactivity in the organic phase moved from the origin, but distinct components were not resolved. With reverse phase TLC, radioactivity

in both the aqueous and organic phases was diffused up the plate. Radioactivity was observed at the origin, near the origin, and up most of the plate, indicative of varying polarity . Using normal and reverse phase TL C, no distinct component could be resolved which corresponded to thiabendazole. The study results demonstrate that metabolism of thiabendazole in corn at early growth stages (immature forge) results in multiple minor components of greater polarity than the parent. With plant growth, the TRR in foliage decreases, either by release as CO 2 or dilution with increasing biomass. There was no evidence of translocation of residues into the reproductive parts of the plant including kernels and cobs.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**860.1300 Natur e of the Residue**  **- Livestock**  Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton The qualitative nature of the residues in livestock is adequatel y understood based upon acceptable ruminant and poultry metabolism studie s. The residues of concern in livestock commodities include thiabendazole, 5 - hydrox y- thiabendazole (free and conjugated), and benzimidazole. **860.1340 Residue Analytical Methods** 48996711 860.1340 Analytical Method in Crops Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton Residue Chemistry Memo DP#s 207850, etc., 1/8/99, S. Mason Plant commodities Enforcement a nalytical m ethod: Adequate analytical methodology is available for data collection and enforcing tolerances of residues of thiabendazole per se . PAM Vol. II lists four spectrophotofluorometric methods (Methods I, A, B, and C) for determining residues of thiabendazole per se in or on plant commodities. In all of the methods, residues are extracted with ethyl acetate, and the extracts are purified b y washing with dilute NaOH and/or HCl. The LODs range from 0.05 - 0.1 ppm. In addition, an HPL C method with fluorescence detection (FLD) is available for the enforcement of tolerances for residues of free and conjugated benzimidazole. This method is listed in the U.S. EPA Index of Residue Anal ytical Methods under thiabendazole as Study No. 93020 (MRID 43328302) . The metabolite benzimidazole (and benzimidazole - related compounds) are extracted from plant commodities with methanol and refluxing with 3 N KOH - rnethanol. The KOH is precipitated with concentrated hydrochloric acid. The enzyme β - glucosidase is used to free benzimidazo le from benzimidazole - related compounds. The residues are acidified with HCIand the aqueous portion is separated and cleaned up with ethyl acetate, pH adjusted to 9 - 12, extracted with ethyl acetate. The residue is reconstituted with 1% ammonium acetate in water and anal yz ed for benzimidazole by reverse phase HPLC using a Supelco LC - 8 - DB, column (or equivalent) with a mobile phase of 750 mL water:250 mLmethanol:1 g ammonium acetate and fluorescence detection. The reported LOQ is 0.1 ppm, and the LOD is 0.05 ppm in wheat grain, straw , and processed wheat commodities. Data collection methods: Sy ngenta Crop Protection, Inc. has submitted an LC /MS/MS method, GRM040.01A, for the determination of residues of thiabendazole and benzimidazole in crop matric es. The method was used for data collection in the submitted U.S. and Canadian corn field trials and the corn processing study . Sy ngenta noted that the extraction procedures for Method GRM040.01A were adapted from Merck Methods M - 041 and M - 056 (reviewed under DP#s 207850, etc. ) but that clean - up steps were removed, and MS/MS detection was used instead of FLD . Briefl y, h omogenized crop samples are extracted with 0.025 M KH 2 PO 4 (pH 6) :ethyl acetate (25:10, v:v) and centrifuged. The ethyl acetate phase is collected, and the resulting aqueous phase is partitioned twice more with ethyl acetate followed by centrifugation. The ethyl acetate phases are combined with the original ethyl acetate phase, and the aqueous phase is subjected toThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

evaporation at 40 °C to remove ethyl acetate, and acidified to pH 5.3 - 5.5 with concentrated H 3 PO 4 . The acidified extract is subjected to enz yme hydrol ys is with β - glucosidase (for 2 hours at 38 °C) to remove conjugates, after which the hydrol ys ate is adjusted to pH 6.0 - 6.2 with 1 M NaOH and partitioned with ethyl acetate (three times). The resulting ethyl acetate phases are combined with the ethylacetate phases that were previously collected, adjusted to volume as necessary with ethyl acetate, and redissolved in methanol for LC/MS/MS analysis . The method monitors a single ion transition for each anal yt e. The method LOQ is 0.01 ppm, and the LOD is 0.004 ppm. The registrant adequatel y explained how the LOQ and LOD were determined. The method was adequately validated using samples of field corn forage, grain, and stover, and sweet corn forage and K+CWHR fortified with each analyte at 0.01, 0.05, and 0.1 ppm. Overall recoveries were 81 - 118% (average of 104% and standard deviation of 7.4%) for thiabendazole and 71 - 119% (averag e of 95% and standard deviation of 12%) for benzimidazole. Acceptable concurrent recovery data for the method were also submitted with the submitted U.S. and Canadian field trials and the field corn processing study . Concurrent recoveries were generall y in the acceptable range of 70 - 120% for all raw agricultural and processed corn commodities. We note that fortification levels in the concurrent method validation conducted with analysis in the Canadian field trials included the stated LOD of 0.003 ppm. N o confirmatory

procedures, independent laboratory validation (ILV), or radiovalidation data were included in the method submission. Because the method is not intended as an enforcement method, confirmatory

procedures and ILV are not required. No radioval idation data are required for the method because the extraction procedures are similar to those used in the plant metabolism studies for thiabendazole (refer to DP# 165718, 3/11/92, L . Cheng). Samples from the banana and citrus storage stability study sub mitted under DP# 363974 were anal yz ed for residues of benzimidazole using Merck Methods M - 057 and M - 058, respectively . The HPLC /FLD methods are essentially identical, except that they are written for the specific crop. The reported method LOQ was 0.07 pp m for benzimidazole. Briefl y, homogenized samples were mixed with pH 8.0 buffer (adjusted as necessary with 0.2 N NaOH for citrus samples), extracted with ethylacetate (2 - 3x), and centrifuged. The ethyl acetate extracts were applied to a cation exchange solid phase extraction column, and residues of benzimidazole were eluted with acetonitrile (ACN):water (30:70, v:v) containing 0.1 M KH2 PO 4 . The eluate was adjusted to volume with ACN/water for anal ys is by cation exchange HPLC /FLD . The methods were adequate for data collection based on acceptable concurrent method recoveries; recoveries were within the acceptable range of 70 - 120% for banana and orange samples fortified with benzimidazole at 0.10 ppm. Conclusions . The residue anal ytical methods data are adequate for data collection and enforcement.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**860.1360 Multiresidue Methods** Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton MRID 46469301 The FDA PESTDATA database (June 2005) indicates that thiabendazole is completely recovered using FDA Multiresidue methods 302 and 404, and is not recovered through method 303. Thiabendazole was not tested through method 304. Data on the recovery of the m etabolites 5 - hydroxy- thiabendazole and benzimidazole through FDA Multiresidue Protocols were submitted in response to the Thiabendazole RED (MRID 46469301 ) . 5 - H ydrox y- thiabendazole was found to be amenable to GC, but was not recovered through Section 302 Multiresidue Method. 5 - Hydroxy- thiabendazole was also tested through Protocol A because it is a naturall y fluorescent compound , but it did not chromatograph well on the LC system. Testing for 5 - hydrox y- thiabendazole was terminated according to the Pesticide Analy tical Manual, Vol. I (PAM 1)1, Decision Tree. No Multiresidue Method will be suitable for anal ys is of 5 - Hydrox y- thiabendazole. Benzimidazole (CGA - 18306) was amenable to GC , but was not recovere d through Section 302 Multiresidue Method. Benzimidazol e was also tested through Protocol A because it is a naturally fluorescent compound , but di d not produce adequate responses on the LC system. Testing for benzimidazole was terminated according to PAM I Decision Tree. No Multiresidue Method will be suitable for anal ys is of CGA - l 8306. Conclusions . The data required in the Thiabendazole RED reflecting recovery of residues of benzimidazole through the FDA multiresidue methods have been provided. Thiabendazole is completely recovered using FDA Multiresidue m ethods 302 and 404, and is not recovered through method 303. Benzimidazole and 5 - hydroxy- thiabendazole are not recovered by the FDA multiresidue methods. **860.1380 Storage Stability** 48996712 860.1380 Storage Stability

– Crops 48996713 860.1380 Storage Stability

– Processed Comodities Residue Chemistry Memo DP# 270154, 2/22/01, T. Morton Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton Residue Chemistry Memo DP# 196149, 4/14/94, F. Suhre Residue Chemistry Memo DP# 186592, 7/30/93, J. Abbotts Storage stability

data reviewed prior to the Thiabendazole RED (summarized in DP# 267871) indicated that residues of thiabendazole and benzimidazole are stable for up to 28 months in mushrooms stored at - 23 °C; for up to 27 months in whole potatoes and wet peel stored at ≤0 °C; for up to 23 months in wheat grain and straw at ≤ - 15 °C ; and for up to 18 months in wheat bran and flour stored at ≤ - 15 °C. In addition, storage stability data were reviewed prior to the RED indicating that residues of thiabendazole are stable for up to 9 months in apples, apple juice, and dried pomace store at - 15 °C; for up to 3 months in whole bananas and banana pulp stored at - 20 °C; and for up to 9 months in citrus fruit, oil, molasses, and pulp stored at - 26 °C . Additional storage stability data for so ybean are available (D 267871) indicating that residues of thiabendazole are stable in soy bean forage hay

and seed stored at ~ - 20 °C for up to 1 year . DataThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

demonstrate that residues of benzimidazole are relatively stable in banana stored frozen for up to 3 months and in orange stored frozen for up to 6 months . In the current submission, Sy ngenta Crop Protection, LLC has submitted the results of storage stability studies with thiabendazole and metabolite benzimidazole in representative raw agricultural commodities (RACs; MRID 48996712), including dry navy bean, soy

bean seed (oil seed), spinach leaves (leafy vegetable), barley

grain (non - oily

grain), and orange (whole fruit; acidic fruit) , and processed commodities (MRID 48996713) soy bean oil and tomato puree. Samples in the study

were stored at - 20C. The RAC study is an interim report reflecting storage intervals of ~0, 3, and 9 months; the submission indicates that the study will be conducte d through 24 months. The processed commodity study reflects storage intervals of ~ 0, 3, 6, 9 and 12 months. For both studies, samples of untreated commodities were fortified with thiabendazole or benzimidazole at 0.1 ppm for each anal yt e and stored at ~ - 20 °C . Both studies were conducted b y Morse Laboratories (Sacramento, CA). The study indicates that residues of thiabendazole and metabolite benzimidazole are stable in dry navy bean, soy

bean seed, spinach leaves, barley grain and orange stored frozen ( - 20 ± 5 °C) for up to 8.9 - 9.9 months (271 - 300 days ; the length of the study), and that residues of these anal yt es are stable in so ybean oil and tomato puree stored frozen ( - 20 to - 10 °C) for up to 12 .0 - 12.1 months (365 - 367 days ; the length of the study) . Storage stability of benzimidazole in spinach was low at the 9 month sampling interval. The storage duration s and conditions of samples from the submitted seed treatment field trials and processing study are presented in Table 4 . **Table 4**  **. Summary of Storage Conditions and**  **Duration s of Samples from**  **the Corn Crop Field Trial** 

**and Processing Studies.**  Matrix Storage

Tem perature (°C) Actual Storage Duration Interval of Demonstrated Storage Stability Alfalfa forage ≤ - 10 40 - 366 days (1.3 - 12.0 mo nths) Thiabendazole is reasonably stable under frozen storage conditions in/on wheat grain and straw for up to 23 months and in/on soybean forage, hay, and seed for up to 1 year. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months. Alfalfa hay 40 - 426 days (1.3 - 14.0 months) Alfalfa seed 40 - 89 days (1.3 - 2.9 months) Barley Grain - 10 at prep

facility

- 25 at analytical laboratory 87 - 388 days (2.9 - 12.8 months) Barley Hay 69 - 354 days (2.3 - 11.6 months) Barley Straw 90 - 392 days (3.0 - 12.9 months) Wheat Grain 59 - 359 days (1.9 - 11.8 months) Wheat Forage 61 - 353 days (2.0 - 11.6 mo nths) Wheat Hay 81 - 361 days (2.7 - 11.9 months) Wheat Straw 58 - 323 days (1.9 - 10.6 months) Carrot - 10 at prep

facility

- 25 - - 20 at analytical laboratory 90 - 257 days (3.0 - 8.5 months) Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up ~10 months. Radish 157 - 290 days (5.2 - 9.5 mo nths) Cantaloupe 51 - 396 days (1.7 - 13.0 months) Cucumber 176 - 311 days (5.8 - 10.3 months) Summer Squash 197 - 330 days (6.5 - 10.9 months) Broccoli - 10 at prep

facility

- 20 at 93 - 308 days (3.1 - 10.1 months) Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and Cabbage 124 - 300 days (4.1 - 9.9 months) Spinach 43 - 248 days (1.4 - 8.2 months)Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Table 4**  **. Summary of Storage Conditions and**  **Duration s of Samples from**  **the Corn Crop Field Trial** 

**and Processing Studies.**  Matrix Storage

Tem perature (°C) Actual Storage Duration Interval of Demonstrated Storage Stability Dry Bulb Onion analytical

laboratory 73 - 140 days (2.4 - 4.6 months) benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months . Residues of benzimidazole may decline slightly in/on spinach during frozen storage (corrected recovery of ~66% at 9 mo nths) . Rotational Lettuce - 10 70 - 167 days (2.3 - 5.5 months) Rotational Radish 30 - 211 days ( 1.0 - 6.9 months) Rotational Wheat 71 - 348 days (2.3 - 11.4 months) Soy bean forage - 10 at prep

facility; - 20 at analytical laboratory 221 - 273 days (7.3 - 9.0 months) Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months Soy bean hay 22 - 274 days (7.3 - 9.0 months) Soy bean seed 181 - 224 days (6.0 - 7.4 months) **Processing study (samples analyzed for thiabendazole only)** Wheat Grain ≤ - 10 129 - 414 days (4.2 - 13.6 months) Thiabendazole is relatively stable in various crops, including wheat grain for up to 23 months of frozen storage and 22 mo nths in/on soybean grain . Soybean Grain 109 - 125 days (3.6 - 4.1 months) Wheat Bran 75 - 96 days (2.5 - 3.2 months) Thiabendazole is relatively stable in various processed commodities, including citrus oil for 9 months, and wheat bran and flour for up to 18 months of frozen storage, and 12 months in soybean oil Wheat Flour 47 - 68 days (1.5 - 2.2 months) Wheat Middlings 39 - 60 days (1.3 - 2.0 months) Wheat Shorts 46 - 67 days (1.5 - 2.2 months) Wheat Germ 43 - 63 days (1.4 - 2.1 months) Soybean Processed commodities 33 - 94 days (1.1

– 3.1 months) Conclusions . The available and submitted storage stability data are not adequate to support the storage durations and conditions of samples from the corn crop field trial and processing studies. The storage stability studies currentl y in progress (reported in an interim report) must be completed to adequately

support the field trial and processing studies for the current petition. **860.1400 Water, Fish, and Irrigated Crops** The proposed use is not relevant to this guideline topic . **860.1460 Food Handling** This topic is not relevant to the proposed use. **860.1480 Meat, Milk, Poultry, and Eggs** Although there are livestock feed stuffs associated with the proposed use on corn, because residues were no nquantifiable in all field trial samples, the dietary burdens to livestock will not be affected. Therefore, data requirements pertaining to meat, milk, poultry , and eggs are not relevant to this action.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**860.1500 Crop Field Trials** 48996701 860.1500 Alfal fa 48996702 860.1500 Barley 48996703 860.1500 Wheat 48996704 860.1500 Carrot, Radish 48996705 860.1500 Cantaloupe, Cucumber, Summer Squash 48996706 860.1500 Broccoli, Cabbage 48996707 860.1500 Spinach 48996708 860.1900 Field Accumulation in Rotational Crop s 48996709 860.1500 Soybean 48996710 860.1500 Dry bulb onion Alfalfa . Twelve alfalfa forage and hay field trials were conducted in the United States during the 201 1 - 2012 growing seasons in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (PA; 1 trial); 2 ( GA ; 1 trial ), 5 (MN, IA, ND, NE, WI ; 6 trials), 7 (NE; 1 trial), 9 (UT; 1 trial), 10 (CA; 1 trial), and 1 1 ( ID ; 1 trial ). Two additional trials were conducted for collection of alfalfa seed onl y in NAFTA Growing Zones 9 (ID; 1 trial) and 10 (CA; 1 trial). A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to alfalfa seeds before planting. The seeds were treated at the S yn genta Seeds facility (Stanton, MN) using commercial seed treatment procedures. The test substance was applied to the seeds using a CC20 or R12 seed treater. Application rates for thiabendazole were 0.003 - 0.05 lb ai/A (3 .4 - 56 g ai/ha). Application rates in lb ai/A were calculated b y the petitioner from approximate seeding rate (387,659 seed/A to 5,140,777 seed/A) and actual application rate (0.003 - 0.004 mg ai/seed). The nominal application rate was 0.004 mg ai/seed. Co mposite seed samples from two trials were shipped to SGS NAM GLP Laboratory (Brookings, SD) to confirm treatment rates. Actual treatment rates were 85 - 100% of the target rate. For each trial site, samples of treated seeds were planted within 8 - 138 days o f treatment (forage and hay field trials) and 207 - 347 days of treatment (seed field trials) . First, second, and third cuttings of alfalfa forage and hay were harvested from twelve trials at 45 - 253, 70 - 292, and 110 - 323 days after planting (DAP) , respective ly . Hay

samples were not dried prior to collection. Seed samples were collected from two trials 185 - 374 DAP. Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detec tion ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest l evel of method validation, LLMV) was 0.01 ppm for each analy te in each alfalfa matrix, for a combined LOQ of 0.02 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent m ethod recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples of alfalfa were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility ,

- 25 to - 10 °C at the anal ytical laboratory) from collection to anal ys is for 40 - 366 days ( 1.3 - 12.0 months) for forage, 40 - 426 days (1.3 - 14.0 months) for hay , and 40 - 89 days (1.3 - 2.9 months) forThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

seed . S amples were analyzed within 1 - 12 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable d uring frozen storage for up to ~10 months (refer to 48996712.der, interim report). In addition, storage stability data are available indicating that residues of both anal yt es are stable during frozen storage for up to 23 months in/on wheat grain and straw (refer to the Residue Chemistry Chapter of the Thiabendazole RED; DP# 267871, 9/7/00, T. Morton) and for up to 22 months in/on soy bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.02 - 0.05 lb ai/A ( 22 - 56 g ai/ha) , residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of alfalfa forage and hay harvested 45 - 253 (first cutting), 70 - 292 (second cutting), and 110 - 323 DAP (third cutting); combined residues were <0.02 ppm in/on all samples . Incrops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.003 - 0.04 lb ai/A ( 3.4 - 45 g ai/ha) , residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of alfalfa seed harvested 185 - 374 DAP; combined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Barley . Twelve field trials were conducted in the United States during the 201 1 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 2 ( VA ; 1 trial ), 5 (MN, IA , ND; 3 trials), 7 (ND and NE; 4 trials), 9 (CO; 1 trial), 10 (CA; 1 trial), and 1 1 ( ID and O R ; 2 trials ). A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to barley seed before planting. The seed was treated at the SGS North America, Inc. facility (Brookings, SD) using commercial seed treatment procedures. The test substance was applied to the seed using a Hege Treater. Application rates for thiabendazole were 0.03 - 0.20 lb ai/A (34 - 224 g ai/ha) . Application rates in lb ai/A were calculated b y the petitioner from approximate seeding rate s ( 550,349 - 3,085,519 seed/A) and actual seed treatment rate s ( 0.028 - 0.030 mg ai/seed). The nominal seed treatment rate was 0.03 mg ai/seed. Composite seed samples were shipped to SGS NAM GLP Laboratory

(Brookings, SD) to confirm treatment rates. Actual seed treatment rates were 92.1 - 101 % of the target rate. The petitioner noted that the application rate at the CA site (0.20 lb ai/A) was high due to th e use of a higher than normal seeding rate. For each trial site, treated seed w as planted within 6 - 69 days of treatment. Samples of barley hay and grain and straw , respectivel y, were harvested from all trials 52 - 242 and 83 - 256 days after planting (DAP ) . Hay samples were not dried prior to collection. Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previous ly reviewed by

the Agency

and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te in each barley

matrix, for a combined LOQ of 0.02 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. TheThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

fortification levels used in concurrent method recovery were adequate to bracket expected residue level s. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples of barley were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility , ~ - 25 °C at the anal ytical laboratory) from collection to analysis for 69 - 354 days ( 2.3 - 11.6 months) for hay , 87 - 388 days (2.9 - 12.8 months) for grain, and 90 - 392 days (3.0 - 12.9 months) for straw . S amples were generall y anal yz ed within 0 - 21 days of extraction ; one straw sample was re - anal yz ed within 76 days of extraction . Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim report). In addition, storage stability data are available indicating that residues of both analy

tes are stable during frozen storage for up to 23 months in/on wheat grain and straw (refer to the Residue Chemistry Chapter of the Thiabendazole RED; DP# 267871, 9/7/00, T. Morton) and for up to 22 months in/on soy bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . In barley grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.03 - 0.20 lb ai/A (34 - 22 4 g ai/ha) , residues of benzimidazole were below the LOQ (<0.01 ppm) in/on all samples of barley hay and grain and straw harvested 52 - 242 and 83 - 256 DAP , respectivel y. Residues (and per trial averages) of thiabendazole and combined residues of thiabendaz ole and benzimidazole, respectively , were: <0.01 - 0.12 (<0.01 - 0.12) and <0.02 - <0.13 (<0.02 - <0.13) ppm in/on hay ; <0.01 - 0.031 (<0.01 - 0.029) and <0.02 - <0.041 (<0.02 - <0.039) ppm in/on grain; and <0.01 - 0.085 (<0.01 - 0.082) and <0.02 - <0.095 (<0.02 - <0.092) ppm in/on straw . There did not appear to be a correlation between the length of the treatment- to -planting interval and residue levels in this study . Quantifiable residues of thiabendazole were observed in samples grown from seed planted 6, 15, 36, and 69 days after treatment . NOTE: The barley

field trials reflect a shorter interval between treatment and planting than some of the other crop field trial studies submitted for thiabendazole. Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Wheat . Nineteen field trials were conducted in the United States during the 201 1 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 2 (VA; 1 trial), 4 (MO; 1 trial), 5 (ND, MO, IA, and MN; 5 trials), 6 (TX; 1 trial), 7 (ND and NE; 4 trials), 8 (KS, TX, OK; 6 trials), and 11 (OR; 1 trial). HED has determined that two trials (TK0050924 - 11 and TK0050924 - 12) should be considered replicates; the abo ve field trial distribution incorporates this conclusion. A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to wheat seed before planting. The see d was treated at the SGS North America, Inc. facility (Brookings, SD) using commercial seed treatment procedures. The test substance was applied to the seed using a Hege treater. Application rates for thiabendazole were 0.08 - 0.14 lb ai/A ( 90 - 157 g ai/ha) . Application rates in lb ai/A were calculated by the petitioner from approximate seeding rate (seed/A) andThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

actual seed treatment rate (mg ai/seed). The nominal seed treatment rate was 0.03 mg ai/seed. The seeding rate ranged from ~1,111,360 - 2,156,713 s eed/A. Composite seed samples from eight trials were shipped to SGS NAM GLP Laboratory (Brookings, SD) to confirm treatment rates. Actual treatment rates were 94.9 - 107 % of the target rate. For each trial site, treated seed was planted within 4 - 96 days of treatment . S amples of wheat forage, hay , and grain and straw, respectivel y, were harvested from all trials 39 - 236 , 51 - 265 , and 84 - 3 04 days after planting (DAP ) . Hay

samples were not dried prior to collection. Samples were anal yz ed for res idues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te in each wheat matrix, for a combined LOQ of 0.02 ppm. The method was adequate f

or data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residue s in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Wheat s amples were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility, - 25 to - 10 °C at the anal yt ical laboratory) from collection to anal ys is for 61 - 353 days ( 2.0 - 11.6 months) for forage, 81 - 361 days (2.7 - 11.9 months) for hay , 59 - 359 days (1.9 - 11.8 months) for grain, and 58 - 323 days (1.9 - 10.6 months) for straw . S amples were anal yz ed within 0 - 6 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim report). In addition, storage stability

data are available indicating that residues of both anal yt es are stable during frozen storage for up to 23 months in/on wheat grain and straw (refer to the Residue Chemistry Chapter of the Thiabendazole RED; DP# 267871, 9/7/00, T. Morton) and for up to 22 months in/on soy bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . In wheat grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.08 - 0.14 lb ai/A ( 90 - 157 g ai/ha) , residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on wheat grain harvested 84 - 304 DAP; combined residues were <0.02 ppm in/on all samples of wheat grain . Residues of benzimidazole were also below the LOQ in/on all samples of wheat forage, hay , and straw harvested 39 - 236, 51 - 265, and 84 - 304 DAP, respectivel y. Residues (and per trial averages) of thiabendazole and combined residues of thiabendazole and benzimidazole, respectivel y, were: <0.01 - 0.21 (<0.01 - 0.20) and <0.02 - <0.22 (<0.02 - <0.21) ppm in/on forage; <0.01 - 0.066 (<0.01 - 0.062) and <0.02 - <0.076 (<0.02 - <0.072) ppm in/on hay ; and <0.01 - 0.078 (<0.01 - 0.073) and <0.02 - <0.088 (<0.02 - <0.083) ppm in/on straw, respectivel y. There did not appe ar to be a correlation between the length of the treatment to -planting interval and residue levels in this study . Quantifiable resid ues of thiabendazole were observed in samples grown from seed planted 4 and 96 days after treatment as well as from seed planted at treatment - to -planting interval intervals of 14, 20 - 22, 43, 50 - 52, and 76 days. NOTE : The wheat field trials reflect a s horter interval between treatment and planting than some of the other crop field trial studies submitted for thiabendazole.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of th e crop has formed . Root Vegetables (except sugar beet), subgroup 1B. Field trials were conducted on carrot and radish. Both radish roots and tops were anal yz ed. Thirteen field trials were conducted in the United States during the 2011 growing season. Eight carrot root trials were conducted in the North American Free Trade Agreement (NAFTA) Growing Zones 3 (FL; 1 trial), 5 (WI ; 1 trial), 6 ( TX ; 1 trial), 10 (CA; 4 trials), and 1 1 ( ID ; 1 trial ) and 5 radish root and tops trials were conducted in NAFTA Growing Zones 1 (NY ; 1 trial), 3 (FL ; 2 trials), 5 ( IL ; 1 trial), and 10 (CA; 1 trial). Each trial consisted of one untreated plot and one treated plot . For the treated plot, a flowable concentrate (water - dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to carrot and radish seeds before planting. The seeds were treated at the Sy ngenta Seeds facility

(Stanton, MN) using commercial seed treatment procedures (slurry). The test substance was applied to the seeds using a R6 or R12 treater. Application rates for thiabendazole were 0.0003 - 0.007 lb ai/A (0.34 - 7. 8 g ai/ha). Application rates in lb ai/A were calculated b y the petitioner from the approximate seeding rate ( 69,504 - 1,23 8,193 seed/A) and the actual seed treatment rate ( 0.0019 - 0.0024 mg ai/seed). The nominal seed treatment rate was 0.002 mg ai/seed. Composite control and treated seed samples were shipped to SGS NAM GLP Laboratory (Brookings, SD) to confirm treatment rate s. Actual treatment rates were 96 - 120 % of the target rate. Samples of treated se ed were planted within 5 - 148 days after treatment . Single control and duplicate treated samples of carrot roots and radish roots and tops were collected at normal commercial harvest 79 - 134 and 26 - 60 days after planting (DAP), respectivel y. Carrot root and radish root and top samples were anal yz ed for residues of thiabendazole and its metabolite using high p erformance l iquid chromatography with tandem mass spectrometry detection (LC/MS/MS); Sy ngenta Method GRM040.01A . This method was previously reviewed by the Agency

and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest limit of method validation, LLMV) was 0.01 ppm for each analy te in each matrix, for a combined LOQ of 0.02 ppm . The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent resi dues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility , and < - 20 °C at the analy

tical laboratory) from collection to analysis for 90 - 257 days ( 3.0 - 8.5 months) for carrot roots and 157 - 290 days (5.2 - 9.5 months) for radish roots and tops . All samples were anal yz ed within 2 - 4 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable d uring frozen storage for up to ~10 months (refer to 48996712.der, interim report). These data are adequate to support the sample sto rage conditions and durations for the submitted study .Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.0003 - 0.007 lb ai/A ( 0.34 - 7.8 g ai/ha) , residues of thiabendazole and benzimidazole were each below the LOQ (<0.01) ppm in/on all samples of carrot roots and radish roots and tops harvested at 79 - 134 and 26 - 60 DAP , respectivel y; c ombined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Brassica Head and Stem Vegetables, subgroup 5A . Twelve field trials were conducted in the United States during the 20 10 growing season . Six cabbage trials were conducted in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY ; 1 trial ), 2 (NC; 1 trial), 3 (FL; 1 trial), 5 (ND; 1 trial), 6 (TX; 1 trial), and 1 0 ( CA ; 1 trial ) , and six broccoli field trials were conducted in NAFTA Growing Zones 6 (TX; 1 trial), 10 (CA; 4 trials), and 12 (OR; 1 trial). A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to cabbage and broccoli seed before planting. The seed was treated at the Sy ngenta Seeds facility

(Stanton, MN) using commercial seed treatment procedures. The test substance was applied to the seed using a Roto Stat R- 12. Application rates for thiabendazole were 0.00019 - 0.00 0 8 lb ai/A (0.21 - 0.90 g ai/ha). Application rates in lb ai/A were calculated b y the petitioner from approximate seeding rate (seed/A) and actual seed treatment rate (mg ai/seed). The nominal seed treatment rate was 0.002 mg ai/seed. The seeding rate ranged from ~11,600 seed/A to 217,800 seed/A. In two field trials (NY and ND), the seed verification samples were lost in transit, and the actual seed treatment rates were not reported. For these trials the petitioner reported the nominal application rates (0.004 - 0.008 lb ai/A; 0.11 - 0.90 g ai/ha). Composite seed samples were shipped to SGS NAM GLP Laboratory

(Brookings, SD) to confirm treatment rates. Actual treatment rates were 70 - 130 % of the target rate. For each trial site, treated seed w as planted within 1 - 163 days of treatment . Samples of cabbage heads with wrapper leaves and broccoli head and stem were harvested from all trials 73 - 190 days after planting (DAP) . Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation ( LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for a combined LOQ of 0.02 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not pro vide for conversion of residues of benzimidazole to parent equivalents . Samples were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility , ~ - 20 °C at the anal ytical laboratory) from collection to analysis for 124 - 300 days (4.1 - 9.9 months) for cabbage and 93 - 308 days (3.1 - 10.1 months) for broccoli . S amples were analyzed within 1 - 4 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim rep ort). In addition, storage stability data are available indicating that residues of both anal yt es are stable during frozen storage for up to 2 8 months in/on whole potato and wet peel (refer to the ResidueThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Chemistry

Chapter of the Thiabendazole RED; DP# 26 7871, 9/7/00, T. Morton) and for up to 22 months in/on soy

bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . In cabbage and broccoli grown f rom seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.00019 - 0.00 0 8 lb ai/A (0.21 - 0.90 g ai/ha) , residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples harvested 73 - 190 DAP; combined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Spinach . Eight field trials were conducted in the United States during the 201 0 - 2011 growing seasons in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NJ ; 1 trial ), 2 (GA; 2 trials), 6 (TX; 2 trials), 8 (CO; 1 trial), and 10 (CA; 2 trials). A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to spinach seeds before planting. The seeds were treated at the S yn genta Seeds facility (Stanton, MN) using commercial seed treatment procedures. The test substance was applied to the seeds using a Roto Stat R- 12. Application rates for thiabendazole were 0.001 - 0.014 lb ai/A ( 0.8 - 15.7 g ai/ha). Application rates in lb ai/A were calculated by the petitioner from the approximate seeding rate ( 52,272 - 1,045,440 seed/A) and actual seed treatment rate s ( 0.006 - 0.007 mg ai/seed). The nominal seed treatment rate was 0.006 mg ai/seed. Composite seed samples were shipped to SGS NAM GLP Laboratory

(Brookings, SD) to confirm treatment rates. Actual treatment rates were 100 - 117 % of the target rate. For each trial site, samples of treated seeds were planted within 48 - 237 days of treatment . Samples of spinach leaves were harvested from all trials at 47 - to 89 - days after planting (DAP) . Additionally , samples of immature (bab y) spinach leaves were harvested from two sites at 43 - 54 DAP. Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for a combined LOQ of 0.02 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C o ncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility , ~ - 20 °C at the anal ytical laboratory) from collection to analysis for 43 - 248 days ( 1.4 - 8.2 months). All samples were anal yz ed within 2 - 3 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up ~10 months (refer to 48996712.der, interim report). These data are considered adequate to support the sample storage durations for the submitted study . We note that the study indicated that residuesThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

of benzimidazole may

decline slightly

in/on spinach during frozen storage ( corrected recovery of ~66% at 9 m onths). HED does not believe this potential loss on storage would have any appreciable effect on the residue results. In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.001 - 0.014 lb ai/A (1.3 - 15.7 g ai/ha), residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of mature and immature spin ach leaves harvested 43 - 89 DAP; combined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Soy beans. Additional data were required for thiabendazole in the RED. Additionally, Sy ngenta Crop Protectio n, LLC has requested an amendment to the registration for Mertect® 340 - F, containing 4.1 lb ai/g al thiabendazole to increase the application rate for soy bean seed tre atment. Sy ngenta Crop Protectio n, LLC has submitted field trial data for thiabendazole on soy bean . Nineteen field trials were conducted in the United States during the 201 0 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 2 (SC and NC; 2 trials), 4 (LA; 3 trials), and 5 (ND, SD, IA, OH, MO, WI, NE, and MN ; 1 4 trial s). HED has determined that two trials ( C01 - 0599 and C01 - 0607 ) should be considered replicates; the above field trial distribution incorporates this conclusion. A flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/g al thiabendazole was applied to wheat seeds before planting. The seeds were treated at the SGS North America, Inc. facility (Brookings, SD) using commercial seed treatment procedures. The test substance was applied to the seeds using a Hege treater. Application rates for thiabendazole were 0.012 - 0.024 lb ai/A (13.5 - 26.9 g ai/ha) . Application rates in lb ai/A were calculated b y the petitioner from approximate seeding rate s ( 78,400 - 169,061 seed/A) and actual seed treatment rate s ( 0.052 - 0.069 mgai/seed) , equivalent to 2x the requested amended applicatioin rate . The nominal seed treatment rate , calculated b y the study reviewe r, was 0.06 mg ai/seed, based on a treatment rate of 40 g ai/100 kg seed and 3,000 seeds/lb. Composite seed samples were shipped to SGS NAM GLP Laboratory (Brookings, SD) to confirm treatment rates. Actual treatment rates were 91 - 106 % of the target rate. F or each trial site, samples of treated seeds were planted within 3 - 30 days of treatment . S amples of soy bean forage and hay

were harvested from all trials 46 - 94 days after planting (DAP); seed was harvested 109 - 153 DAP . Hay samples were dried to approximately 10 - 20% moisture content; drying intervals were not reported. Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0 .01 ppm for each analy te in each soy

bean matrix, for a combined LOQ of 0.02 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazo le to parent equivalents .Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Samples of soy

bean were stored frozen ( frozen at the field sites, < - 10 °C at the preparation facility , ~ - 20 °C at the analy tical laboratory) from collection to analysis for 221 - 273 days ( 7.3 - 9.0 months) for forage, 222 - 274 days (7.3 - 9.0 months) for hay , and 181 - 224 days (6.0 - 7.4 months) for seed . S amples were anal yz ed within 1 - 7 days of extraction. Acceptable storage stability data are available indicating that residues of both anal yt es are stable during frozen storage for up to 22 months in/on soy bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton) . These data are adequate to support the sample storage conditions and durations for the submitted study . In crops grown from seed treated with the 4.1 lb ai/gal FS formul ation of thiabendazole at 0.012 - 0.024 lb ai/A (13.5 - 26.9 g ai/ha), residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of soy bean forage and hay

harvested 46 - 94 DAP and soy bean seed harvested 109 - 153 DAP; combined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . Dry Bulb Onions. Eight field trials were conducted in the United States during the 201 0 - 2011 growing seasons in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY ; 1 trial ), 5 (IA; 1 trial), 6 (TX; 1 trial), 8 (TX; 1 trial), 10 (CA; 2 trials), 11 (ID; 1 trial), and 12 (OR; 1 trial) . A flo wable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to dry bulb onion seeds before planting. The seeds were treated at the Syngenta Seeds facility (Stanto n, MN) using commercial seed treatment procedures. The test substance was applied to the seeds using a Roto Stat R- 12. Application rates for thiabendazole were 0.001 - 0.003 lb ai/A ( 1.1 - 3.4 g ai/ha). Application rates in lb ai/A were calculated b y the petitioner from the approximate seeding rate ( 52,800 - 620,000 seed/A) and actual seed treatment rate s ( 0.002 - 0.005 mgai/seed). The nominal seed treatment rate was 0.002 mg ai/seed. Composite seed samples were shipped to SGS NAM GLP Laboratory

(Brookings, S D) to confirm treatment rates. Actual treatment rates were 105 - 250 % of the target rate. For each trial site, samples of treated seeds were planted within 8 - 323 days of treatment . Samples of dry bulb onions were harvested from all trials 113 - 252 days after planting (DAP) . Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for a combined LOQ of 0.0 2 ppm. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples were stored frozen ( frozen at the fie ld sites, < - 10 °C at the preparation facility , ~ - 20 °CThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

at the anal ytical laboratory) from collection to analysis for 73 - 140 days ( 2.4 - 4.6 months). All samples were anal yz ed within 1 - 2 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim report). These data are considered adequate to supp ort the sample storage durations for the submitted study . In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.001 - 0.003 lb ai/A (1.1 - 3.4 g ai/ha), residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of dry bulb onion harvested 113 - 252 DAP; combined residues were <0.02 ppm in/on all samples . Residue decline data were not submitted; however none are required b ecause the pesticide is applied before the edible portion of the crop has formed . **TABLE 5.**  **Summary of Residue Data with**  **Thiabendazole.** Commodity Analyte Total Rate lb ai/A (g ai/ha) DAP

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAF T 2 HAFT 2 Median Mean Std. Dev. Al falfa Forage - 1 st Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 45 - 253 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Forage

– 2 nd Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 70 - 292 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Forage

– 3 rd Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 110 - 323 10 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 10 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 10 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Hay

– 1 st Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 42 - 253 12 <0.01 <0.01 < 0.01 <0.01 0.01 0.01 N/A Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Hay

– 2 nd Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 70 - 292 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Hay

– 3 rd Cutting Thiabendazole 0.02 - 0.05 (22 - 56) 110 - 323 10 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 10 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 10 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Al falfa Seed Thiabendazole 0.003 - 0.04 (3.4 - 45) 185 - 374 2 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 2 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 2 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Barley Hay Thiabendazole 0.03 - 0.20 52 - 242 12 <0.01 0.12 <0.01 0.12 0.010 0.023 0.032

Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/AThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 5.**  **Summary of Residue Data with**  **Thiabendazole.** Commodity Analyte Total Rate lb ai/A (g ai/ha) DAP

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAF T 2 HAFT 2 Median Mean Std. Dev. Combined Residues 3 12 <0.02 <0.13 <0.02 <0.13 0.020 0.033 0.032 Barley Grain Thiabendazole 0.03 - 0.20 83 - 256 12 <0.01 0.031 <0.01 0.029 0.010 0.012 0.005

Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.041 <0.02 <0.039 0.020 0.022 0.005 Barley Straw Thiabendazole 0.03 - 0.20 83 - 256 12 <0.01 0.085 <0.01 0.082 0.010 0.024 0.024

Benzimidazole 12 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 12 <0.02 <0.095 <0.02 <0.092 0.020 0.034 0.024 Wheat Forage Thiabendazole 0.08 - 0.14 (90 - 157) 39 - 236 19 <0.01 0.21 <0.01 0.20 0.010 0.025 0.044 Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.22 <0.02 <0.21 0.020 0.035 0.044 Wheat Hay Thiabendazole 0.08 - 0.14 (90 - 157) 51 - 265 19 <0.01 0.066 <0.01 0.062 0.010 0.015 0.015 Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.076 <0.02 <0.072 0.020 0.025 0.015 Wheat Grain Thiabendazole 0.08 - 0.14 (90 - 157) 84 - 304 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Wheat Straw Thiabendazole 0.08 - 0.14 (90 - 157) 84 - 304 19 <0.01 0.078 <0.01 0.073 0.010 0.014 0.015 Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.088 <0.02 <0.083 0.020 0.024 0.015Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 5.**  **Summary of Residue Data with**  **Thiabendazole.** Commodity Analyte Total Rate lb ai/A (g ai/ha) DAP

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAF T 2 HAFT 2 Median Mean Std. Dev. Carrot roots Thiabendazole 0.0003 - 0.007 (0.34 - 7.8) 79 - 134 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 8 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Radish roots Thiabendazole 0.002 - 0.004 (2.2 - 4.5) 26 - 60 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 5 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Radish tops Thiabendazole 0.002 - 0.004 (2.2 - 4.5) 26 - 60 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 5 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Cantaloupe Thiabendazole 0.002 - 0.008 (2.2 - 9.0) 62 - 119 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 6 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Cucumber Thiabendazole 0.005 - 0.012 (5.6 - 13.4) 49 - 81 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 6 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/AThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 5.**  **Summary of Residue Data with**  **Thiabendazole.** Commodity Analyte Total Rate lb ai/A (g ai/ha) DAP

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAF T 2 HAFT 2 Median Mean Std. Dev. Summer Squash Thiabendazole 0.001 - 0.007 (1.1 - 7.8) 33 - 62 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 5 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Cabbage heads w/wrapper leaves Thiabendazole 0.00025 - 0.00 077 (0.28 - 0.86 ) 4 84 - 190 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 6 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Broccoli head and stem Thiabendazole 0.00019 - 0.0008 (0.21 - 0.90) 73 - 137 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 6 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 6 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Spinach Leaves Thiabendazole 0 .001 - 0.014 (0.8 - 15. 7 ) 47 - 89 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 8 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Immature (Baby) Spinach Leaves Thiabendazole 0.001 - 0.014 ( 0.8 - 15. 7 ) 43 - 54 2 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 2 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 2 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Soybean Forage Thiabendazole 0.012 - 0.024 (13.5 - 26.9) 46 - 94 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Soybean Hay Thiabendazole 0.012 - 0.024 (13.5 - 26.9) 46 - 94 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Soybean Seed Thiabendazole 0.012 - 0.024 (13.5 - 26.9) 109 - 153 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 19 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 19 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A Dry Bulb Onion Thiabendazole 0.001 - 0.003 (1.1 - 3.4) 113 - 252 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Benzimidazole 8 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined Residues 3 8 <0.02 <0.02 <0.02 <0.02 0.02 0.02 N/A 1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. N/A = Not Applicable 2 LAF T = lowest average field trial; HAFT = highest average f ield trial. 3 Combined residues of thiabendazole and benzimidazole. Residues of b enzimidazole were not converted to parent equivalents . Conclusions. The submitted field trial data are adequate to support the tolerance request andThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

amended registration request . Acceptable methods were used for residue quantitation, and the study is supported b y adequate storage stability data. **860.1520 Processed Food and Feed** 48996703 Wheat Processing 48996709 Soy

bean processing Wheat Processing . S yn genta Crop Potection, LLC has submitted a processing study for thiabendazole and benzimidazole in/on wheat grain. In one trial conducted in Campbell, MN, and one trial conducted in Hinton, OK , a flowable concentrate (water - dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb /g al thiabendazole was applied to wheat seeds before planting. The seeds were treated at SGS North America, Inc. (Brookings, SD) using commercial seed treatment procedures. A Hege seed treater was used to apply an exaggerated rate (5x field rate) of 0.47 - 0.71 lb ai/A ( 5 29 - 7 91 g ai/ha) . Application rates in lb ai/A were cal culated by the petitioner from approximate seeding rate (1,530,350

– 2,065,631 seed/A) and actual seed treatment rate ( 0.14 - 0.16 mg ai/seed) ; 5x the nominal seed treatment rate of 0.03 mg ai/seed. . The nominal application rate was 0.15 mg ai/seed. Composite seed samples were shipped to SGS NAM GLP Laboratory (Brookings, SD) to confirm treatment rates. Actual treatment rates for wheat seeds associated with the processing study ( exaggerated application rate ) wer e 95.5 - 103% of the target rate. Treated wheat seeds were planted with 8 - 43 days of treatment. At the end of the growing season, wheat grain was harvested at crop maturity 98 - 216 days after planting (DAP) and processed into bran, fl our, middlings, shorts and germ using simulated commercial procedures . Processing was conducted by GLP Technologies (Navasota, TX) . Adequate descriptions of the processing procedures were provided, including material balance summaries . Samples were anal yz ed for residues of thiabendazole and metabolite benzimidazole using a liquid chromatography m ethod with tandem mass spectrometric detection (LC/MS/MS), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (re fer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for an LOQ of 0.02 ppm for combined residues. The method was adequate for dat a collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples were stored under ambient conditions (field sites) and frozen (generall y < - 10 °C at the processing facility , p reparation facility , and analy tical laboratory) from harvest/processing to anal ys is. Processing took place within 71 - 378 days of harvest. Sample analyses were completed within 129 - 414 days (4.2 - 13.6 months) of harvest for grain (RAC) and within 3 9 - 96 days (1.3 - 3.2 months) of processing for the processed commodities. All samples were anal yz ed within 2 - 5 days of extraction . Acceptable storage stability data have been submitted demonstrating that residues of thiabendazol e and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der , interim results). In addition, storage stability data are available indicating that residues of both anal yt es are stable during frozen storage for up to 23 months in/on wheat grain and for up to 18 months in wheatThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

bran, and flour (refer to DP# 267871, 9/7/00, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.47 - 0.71 lb ai/A ( 5 29 - 7 91 g ai/ha), residues of thiabendazole and benzimidazole were below the LOQ (<0.01 ppm for each anal yt e, <0.02 ppm for combined residues) in/on all samples of wheat grain (RAC) and processed commodities (bran, flour, middlings, shorts, and germ); therefore, processing factors were not calculated . The maximum theoretical concentration factor for wheat is 8x for wheat (OCSPP 860.1 520, Table 1). Theoretical concentration factors are 7.7x for bran, 1.4x for flour, and 8.3x for shorts (based on separation into components; OCSPP 860.1520, Table 3). Soy bean Processing . Syngenta Crop Potection, LLC has submitted a processing study for thiabendazole and benzimidazole in/on soy bean seeds. In one trial conducted in Richland, IA, and one trial conducted in Marysville, OH , a flowable concentrate (water- dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4 .1 lb thiabendazole/gal was applied to soy

bean seeds before planting. The seeds were treated at SGS North America, Inc. (Brookings, SD) using commercial seed treatment procedures. A Hege seed treater was used to apply the test substance at an exaggerated rate ( 5 x field rate of the concurrent field trial study) of 0.09 lb ai/A (100.9 g ai/ha) . Application rates in lb ai/A were calculated b y the petitioner from the approximate seeding rates (138,000 - 148, 459 seed/A) and the actual seed treatment rate (0.29 mg ai/seed) . The nominal seed treatment rate was 0.31 mg ai/seed, based on a treatment rate of 200 g ai/100 kg seed and 3,000 seeds/lb . Composite seed samples were shipped to SGS NAM GLP Laboratory

(Brookings, SD) to confirm treatment rate s. The actual seed treatment rate was 104 % of the target rate . Treated so yb ean seeds were planted with 8 - 20 days of treatment. At the end of the growing season, so yb ean seeds were harvested at crop maturity 126 - 130 days after planting (DAP) and processed into meal, hulls, refined oil, flour, milk, tofu, soy sauce, miso, pollard and crude oil using simulated commercial procedures . Processing was conducted b y GLP Technologies (Navasota, TX) . Adequate descriptions of the processing procedures were provided, including material balance summaries . Samples were anal y

zed for residues of thiabendazole and metabo lite benzimidazole using a liquid chromatography m ethod with tandem mass spectrometric detection (LC/MS/MS), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel ). The limit of quantitation ( LOQ ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for an LOQ of 0.02 ppm for combined residues. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. C oncurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . S amples of soy

bean seeds were shipped directl y from each field site to the processing facility under ambient or frozen conditions within 0 - 5 days of harvest. Samples were stored frozen at the processing and preparation facilities (< - 10 °C ) and at the analy tical laboratory (~ - 20 °C) . Proc essing was co mpleted within 14 - 41 days of harvest for all commodities, except for soy sauce and miso which was completed within 248 - 264 days of harvest due to a ~6 month processingThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

time . Sample analyses were completed within 109 - 125 days (3.6 - 4.1 months) of harvest fo r seed (RAC) and within 33 - 94 days (1.1 - 3. 1 months) of processing for the processed commodities. All samples were anal yz ed within 1 - 7 days of extraction . A dequate storage stability data are available indicating that residues of both anal yt es are stable d uring frozen storage for up to 22 months in/on soy

bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). In addition, storage stability

data are available indicating that residues of both anal yt es are stable during frozen storage for up to 12 months in soy bean oil (refer to 48996712.der, interim results ) and for up to 18 months in wheat bran and flour (refer to the Residue Chemistry Chapter of the Thiabendazole RED; DP# 267871, 9/7/00, T. Morton). These data are adequate to support the sample storag e conditions and durations for the submitted study . In crops grown from seed treated with the 4.1 lb ai/gal FS formulation of thiabendazole at 0.09 lb ai/A (100.9 g ai/ha), residues of thiabendazole and benzimidazole were below the LOQ (<0.01 ppm for each anal yt e, <0.02 ppm for combined residues) in/on all samples of soy bean seed (RAC) and processed commodities (meal, hulls, refined oil, flour, milk, tofu, soy sauce, miso, pollard and crude oil); therefore, processing factors were not calculated. The maximum theoretical concentration factor for soy bean is 12x (OCSPP 860.1520, Table 1). Theoretical concentration factors are 11.3x for hulls, 2.2x for meal and 12.0x for oil (based on separation into components; OCSPP 860.1520, Table 3).

**TABLE 6. Residue**  **Data from Wheat Processing Studies with Thiabendazole and Benzimidazole.**  RAC Processed

Commodity Total

Rate 1 lb ai/A (g ai/ha) DAP 2 Residues (ppm), [Average] 3 Processing Factor4

Thiabendazole Benzimidazole Combined 5 Thiaben dazole Benzimi dazole Combined 5 **Campbell, MN; 2011 (TK0050924 -**  **19 )**  Wheat Pre processed Grain (RAC) 0 .47

(529) 98 <0.01 , <0.01,

<0.01 [<0.01] <0.01 , <0.01,

<0.01 [<0.01] <0.0 2, <0.02,

<0.02 [<0.02] -- -- --

Bran <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[< 0.02] NC NC NC Flour <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Middlings <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Shorts <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Germ <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC **Hinton, OK; 2011 (TK0050924 -** **20 )**  Wheat Pre processed Grain (RAC) 0. 71

( 791 ) 216 <0.01 , <0.01,

<0.01 [<0.01] <0.01 , <0.01,

<0.01 [<0.01] <0.0 2, <0.02,

<0.02 [< 0.02] -- -- --Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 6. Residue**  **Data from Wheat Processing Studies with Thiabendazole and Benzimidazole.**  RAC Processed

Commodity Total

Rate 1 lb ai/A (g ai/ha) DAP 2 Residues (ppm), [Average] 3 Processing Factor4

Thiabendazole Benzimidazole Combined 5 Thiaben dazole Benzimi dazole Combined 5 Bran <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Flour <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Middlings <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Shorts <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Germ <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC **Richland, IA; 2011 (TK0014192 -**  **21)** Soybean Pre processed Seed (RAC) 0.09

(100.9) 126 <0.01 , <0.01,

<0.01 [<0.01] <0.01 , <0.01,

<0.01 [<0.01] <0.0 2, <0.02,

<0.02 [<0.02] -- -- --

Meal <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Hulls <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Refined oil <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Flour <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Soy milk <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Tofu <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Soy sauce <0.01 [<0.01] <0.01 [< 0.01] <0.02 [<0.02] NC NC NC Miso <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Pollard <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Crude oil <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC **Marysville, OH; 2011 (TK0014192 -**  **22)** Soybean Pre processed Seed (RAC) 0.09

(100.9) 130 <0.01 , <0.01,

<0.01 [<0.01] <0.01 , <0.01,

<0.01 [<0.01] <0.0 2, <0.02,

<0.02 [<0.02] -- -- --

Meal <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Hulls <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Refined oil < 0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NCThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 6. Residue**  **Data from Wheat Processing Studies with Thiabendazole and Benzimidazole.**  RAC Processed

Commodity Total

Rate 1 lb ai/A (g ai/ha) DAP 2 Residues (ppm), [Average] 3 Processing Factor4

Thiabendazole Benzimidazole Combined 5 Thiaben dazole Benzimi dazole Combined 5 Flour <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Soy milk <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Tofu <0.01 , < 0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Soy sauce <0.01 [<0.01] <0.01 [< 0.01] <0.02 [<0.02] NC NC NC Miso <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC Pollard <0.01 , <0.01 [<0.01] <0.01 , <0.01

[ <0.01] <0.02, <0.02

[<0.02] NC NC NC Crude oil <0.01 , <0.01 [<0.01] <0.01 , <0.01

[<0.01] <0.02, <0.02

[<0.02] NC NC NC 1 Application rates in lb ai/A were calculated by the study reviewer from the approximate seeding rate (seed/A) and the actual seed treatment rate (mg ai/seed). NOTE: Application rates in lb ai/A reported by the petitioner appear to have been calculated using the nominal seed treatment rate in mg ai/seed (0.15 mg ai/seed) instead of the actual seed treatment rates in mg ai/see d (0.14 and 0.155 mg ai/seed). 2 DAP = Days After Planting. Seeds were planted within 8 - 43 days of treatment . 3 The LOQ was 0.01 ppm for each analyte in all matrices; the combined LOQ was <0.02 ppm. Per trial averages were calculated by the study reviewer using the LOQ for values reported as <LOQ. 4 Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the RAC]. Processing factors for this study were not calculated (NC) because re sidues were below the L OQ (<0.01 ppm for both analytes) in the RAC and processed fraction. 5 Combined residu es of thiabendazole and benzimidazole . Residues of benzimidazole were not converted to parent equivalents. . **860.1650 Submittal of Analytical Reference Standards**  Analy tical standards are currentl y available for thiabendazole (expiration 3/31/2017 ) and 5 - hydrox y- thiabendazole (expiration 2/28/2014 ) in the EPA National Pesticide Standards Repository ( email from Theresa Cole , ACB, 2/25/2014 ) ; a standard is not available for benzimi dazole. For benzimidazole, a new standard must be submitted. For 5 - hydrox y- thiabendazole, the registrant must either recertify the lot in the repository

and send in an updated certificate of anal ys is (COA), or submit new standards (different lot #) if the previous lots will not be recertified. If a new COA is being submitted, it should be faxed to the repository at 410 - 305 - 2999. Reference standards should be sent to the Analy tical Chemistry

L ab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Ngygen at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755 - 5350 (Note that the mail will be returned if the extended zip code is not used.)Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**860.1850 and 860.1900**  **Confined and Field**  **Accumulation in Rotational Crops** Revised Residue Chemistry Chapter of the Thiabendazole RED DP# 267871, 9/7/00, T. Morton The available confined rotational crop data , discussed in the RED, are adequate , pending submission of information on sample storage intervals and supporting storage stability data for the metabolites benzimidazole and 5 - hydrox y- thiabendazole that were required in the RED. Based on the available data, the residues of concern are the same in rotated crops as in primary crops. A limited field rotational crop study was required in the RED, and was included in the submission of the current petition. Sy ngenta Crop Protection, LLC has submitted the re sults of a limited field rotational crop study on a leafy vegetable (lettuce), root and tuber vegetable (radish) , and cereal grain (wheat) from 13 trials conducted in the United States during the 2010 growing season. The trials were conducted in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY ; 1 trial with lettuce and radish) , 2 ( GA ; 1 trial with radish) , 4 (LA; 2 trial s, one each with lettuce and radish) , 5 (IA, OH, ND; 5 trials with wheat), 6 (TX; 2 trial s, one with lettuce and radish and one with lettuce ) , 10 ( CA; 1 trial with lettuce), and 11 (OR ; 1 trial with lettuce and radish). Together the submitted data reflect three trials for each crop at representative plantback intervals (PBI s) of 30, 90, and 270 days. At each test location, one control plot and one treated plot were established, with separate treated subplots as needed for each commodity and PBI. At each treated plot, a single bare - ground incorporated application of a flowable concentrate (water - dispersible suspension) for seed treatment (FS) formulation (Mertect® 340 - F) containing 4.1 lb ai/gal thiabendazole was applied to the soil at a target rate of 0.0275 lb ai/A; actual application rates were 0.0258 - 0.0291 lb ai/A. Applications were made in spray volumes of ~15 - 30 gal/A using ground equipment. No adjuvants were included in the spray mixtures. Rotational crops of lettuce, radish, and/or wheat were planted at target PBIs of 30, 90, and 270 days after application; actual PBIs were 26 - 3 2, 58 - 90, and 242 - 295 days . Samples of lettuce leaves, radish roots and tops, and wheat grain and straw were collected at normal crop maturity. Samples intended to be representative of fall and spring wheat forage were collected ~60 days after planting for fall forage and at the 6 - to 8 - inch stem elongation stage (approximately

25% dry matter) for spring forage. Wheat hay was collected at earl y flower (boot) to soft dough stage. Hay was dried in the field to 10 - 20% moisture content; drying intervals w ere not reported. Samples were anal yz ed for residues of thiabendazole and benzimidazole using a liquid chromatography m ethod with tandem mass spectrometry detection ( LC/MS/MS ), Method GRM040.01A. This method was previousl y reviewed b y the Agency and was found to be acceptable for data collection (refer to 47705110.DER1, DP# 363974, 11/30/09, S. Hummel). The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analy te, for a combined LOQ of 0.02 ppm . The method was adequate for data collection based on accep table concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. Concurrent recoveries were corrected for apparent re sidues in controls; residues in the treated samples wereThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

not corrected for apparent residues in controls. The method does not provide for conversion of residues of benzimidazole to parent equivalents . Samples were stored frozen from harvest to anal ys is f or 70 - 167 days (2.3 - 5.5 months) for lettuce leaves, 30 - 211 days (1.0 - 6.9 months) for radish roots and tops, 71 - 348 days (2.3 - 11.4 months) for wheat forage, 71 - 104 days (2.3 - 3.4 months) for wheat hay , 102 - 137 days (3.4 - 4.5 months) for wheat straw, and 74 - 1 15 days (2.4 - 3.8 months) for wheat grain. All samples were anal yz ed within 0 - 16 days of extraction. Acceptable storage stability data have been submitted demonstrating that residues of thiabendazole and benzimidazole in/on representative raw agricultural commodities are stable during frozen storage for up to ~10 months (refer to 48996712.der, interim report). In addition, storage stability data are available indicating that residues of both analy

tes are stable during frozen storage for up to 28 months in/on whole potato and wet peel , for up to 23 months in/on wheat grain and straw (refer to the Residue Chemistry Chapter of the Thiabendazole RE D; DP# 267871, 9/7/00, T. Morton), and for up to 22 months in/on soy bean forage, hay , and seed (DP# 280701, 12/9/10, T. Morton). These data are adequate to support the sample storage conditions and durations for the submitted study . Following a single bare - ground incorporated application of the 4.1 lb ai/gal FS formulation of thiabendazole to the soil at a rate of 0.0258 - 0.0291 lb ai/A, residues of thiabendazole and benzimidazole were each below the LOQ (<0.0 1 ppm) in/on all samples of rotational crop commoditie s of lettuce, radish, and wheat at PBIs of 26 - 32, 58 - 90, and 242 - 295 days; combined residues were <0.02 ppm.

**TABLE 7**  **. Summary of Residue Data in Rotational Crops Following Prim ary Treatment with**  **Thiabendazole.** Commodity Total Rate

(lb ai/A) PBI

(days) Residue Levels (ppm) 1

n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Thiabendazole , Benzimizole, Combined Residues**  Lettuce, leaves 0.0258 - 0.028 0 27 - 28 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0271 - 0.0282 87 - 89 3 <0.01 <0.01 < 0.01 <0.01 0.01 0.01 N/A 0.027 0 - 0.0279 242 - 295 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Radish, root 0.0275 - 0.0278 28 - 30 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0273 - 0.0277 88 - 90 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A 0.027 0 - 0.0276 242 - 2 95 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Radish, tops 0.0275 - 0.0278 28 - 30 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0273 - 0.0277 88 - 90 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A 0.027 0 - 0.0276 242 - 295 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Wheat, forage 0.0281 - 0.0291 26 - 32 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0274 - 0.028 0 58 - 88 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A 0.0271 - 0.0281 266 - 273 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Wheat, hay 0.0281 - 0.0291 26 - 32 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0274 - 0.028 0 58 - 88 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A 0.0271 - 0.0281 266 - 273 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Wheat, grain 0.0281 - 0.0291 26 - 32 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0274 - 0.028 0 58 - 88 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/AThiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**TABLE 7**  **. Summary of Residue Data in Rotational Crops Following Prim ary Treatment with**  **Thiabendazole.** Commodity Total Rate

(lb ai/A) PBI

(days) Residue Levels (ppm) 1

n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. 0.0271 - 0.0281 266 - 273 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Wheat, straw 0.0281 - 0.0291 26 - 32 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

0.0274 - 0.028 0 58 - 88 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A 0.0271 - 0.0281 266 - 273 3 <0.01 <0.01 < 0.01 <0.01 0.01 0.01 N/A Conclusions. The submitted rotational crop study is adequate . Following a single bare - ground incorporated application of the 4.1 lb ai/gal FS formulation of thiabendazole to the soil at a rate of 0.0258 - 0.0291 lb ai/A, residues of thiabendazole and benzimidazole were each below the LOQ (<0.01 ppm) in/on all samples of rotational crop commodities of lettuce, radish, and wheat at PBIs of 26 - 32, 58 - 90, and 242 - 295 days; combined residues were <0.02 ppm. An acceptable method was used for the determination of thiabendazole and benzimidazole in rotational crop commoditie s, and the study is supported by

ac ceptable storage stability data **860.1550 Proposed Tolerances** The current tolerance expression for thiabendazole is:

“ (1) Tolerances are established for the combined residues of the fungicide thiabendazole (2 - (4 - thiazolyl)benzimidazole) and its metabolite benzimidazole (free and conjugated) in or on the following food commodities: ” for plant commodities. And

“ (2) Tolerances are established for the combined residues of thiabendazole (2 - (4 - thiazolyl)benzimidazole) and its metabolites 5 - hydroxythiabendazole (free and conjugated) and benzimidazole in or on the following food commodities: ” for livestock commodities. The tolerance expression s need to be updated as follows to reflect our current guidance. Thi s will be accomplished during Registration Review. Existing tolerance for residues of thiabendazole and metabolite on wheat grain and straw . The currentl y established tolerance for wheat grain is 1.0 ppm based on the originally submitted data set, showing interferences in the analy tical method. Although the residues were all non quantifiable, the tolerance was set at 1.0 ppm because of the interference. In the RED, the tolerance for residues in wheat grain was proposed to be reduced to 0.2 ppm , and in wheat straw to 0.5 ppm; these tolerances were based on foliar applications of thiabendazole to wheat . However, in connection with the current petition, a full new data set was submitted for all wheat commodities at the currently registered use pattern . The residues of thiabendazole and benzimidazole on wheat grain were all <LOQ (<0.01 ppm each , or <0.02 ppm total residues ) . Thus, we conclude that the current tolerance for residues of thiabendazole and benzimidazole on wheat grain may

be reduced to 0.05 ppm.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

International Harmonization. There is no issue with International Harmonization. CODEX has not established any established maximum residue limits (MRL s) for thiabendazole on the requested commodities . Canada has not established maximum residue limits (MRL s) for thiabendazole on the requested commodities. We note that the U.S. tolerance expression is not harmonized with Canada, nor CODEX. An International Residue Limit Status Sheet is attached in Appendix I . **Table 8**  **. Tolerance Summary for**  **Thiabendazole . §**  **180. 242**  Commodity Current/Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition alfalfa, forage 0.02 0.02 Alfalfa, forage alfalfa, hay 0.02 0.02 Alfalfa, hay alfalfa, seed 0.02 - Tolerances are not normally set for alfalfa seed barley , grain 0.05 0.05 Barley, grain barley , hay 0.15 0. 3 Barley, hay Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. barley , straw 0.15 0. 3 Barley, straw Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. Brassica, Head and Stem, subgroup 5 - A 0.02 0.02 oats, forage 0.2 0. 3 Oats, forage Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages. oats, grain 0.05 0.05 Oats, grain oats, hay 0.09 0. 3 Oats, hay Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Table 8**  **. Tolerance Summary for**  **Thiabendazole . §**  **180. 242**  Commodity Current/Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition oats, straw 0.09 0. 3 Oats, straw Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. Onion, bulb, Subgroup 3 - 07A 0.02 0.02 radish, tops 0.02 0.02 Radish, tops rye, forage 0.2 0.2 Rye, forage rye, grain 0.05 0.05 Rye, grain rye, straw 0.15 0. 3 Rye, straw Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. spinach 0.02 0.02 Spinach triticale, forage 0.2 0.2 3 Triticale, forage Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages. triticale, grain 0.05 0.05 Triticale, grain triticale, hay 0.09 0.15 Triticale, hay Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. triticale, straw 0.09 0.15 Triticale, straw Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. Vegetable, Cucurbit group 9 0.02 0.02 Vegetable, Cucurbit, group 9 Vegetable, root (except sugarbeet), subgroup 1B 0.02 0.02 Revised level based on OECD tolerance calculation procedures.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Table 8**  **. Tolerance Summary for**  **Thiabendazole . §**  **180. 242**  Commodity Current/Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Wheat, grain 1.0 0.05 Current tolerance for wheat grain is 1.0 ppm, tolerance recommended in RED was 0.2 ppm. Current recommendation is based on full new data set showing all non- quantifiable residues. wheat, forage 0.2 0. 3 Wheat, forage Revised level based on OECD tolerance calculation procedures, and to be consistent across all cereal grain forages. wheat, hay 0.09 0. 3 Wheat, hay Revised level based on OECD tolerance calculation procedures, and to be consistent across all hays and straws. Wheat, straw 1.0 0.3 RED recommended lowering tolerance. Current recommendation is to be consistent across all hays and straws. **References** DP#: 165718 Subject: ID # 060101 - 618. Thiabendazole Phase V Review. Metabolism Studies: Wheat,

Soy bean and Sugar Beet. From: L. Cheng To: F. RubisDated: 3/11/92 MRIDs: 41872901, 41872902 and 41872903 DP# s : 207850, 218096, 245782, 245785, and 245787 Subject: Thiabendazole Reregistration . 860.1500 and 860.1340 - Response to Agency

Reviews for Magnitude of the Residue in Apples, Citrus, and Wheat; Analytic al Method in Wheat and ILV, Magnitude of the Residue in Citrus and Banana Following Post - harvest Dip Application. From: S. Mason To: W. Sproat Dated: 1/8/99 MRID s : 43328301 - 43328303, 43328306, 43328307 and 43721901 - 43721904Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

DP#: None Subject: Classification of Seed Treatments as Food or Nonfood Uses. From: Chemistry Science Advisory

Council To: HED Chemistry Interest Group Dated: 10/28/99 MRID: None DP # : 267871 Subject: Thiabendazole (060101) Reregistration Case No. 2760. Revised Product and

Residue Chemistry

Chapters for the Thiabendazole Reregistration Eligibility Decision (RED). From: T. Morton To: B. Edwards/S. Lewis Dated: 9/7/00 MRIDs: None DP#: 270154 Subject: Thiabendazole (Chemical No. 060101). Reregistration Case No. 2670. Nature of

the Residue in Soy

beans Grown form Seeds Treated with Thiabendazole (GLN 860.1300) and Magnitude of the Residues of Thiabendazole in/on Soy beans Grown from Seed Treated with Thiabendazole (GLN 860.1500). Fro m: T. Morton To: B. Edwards/S. Lewis Dated: 2/22/01 MRID: 45200301 DP#: 343139 Subject: Thiabendazole: Final Threshold of Regulation Decision to Support Proposed New

Use as a Seed Treatment for Dry Pea. Petition No: PP# 6 E6323. Fro m: D. Davis To: S. Stanton and B. Madden Dated: 8/29/07 MRID: None RDI : SHummel: 01 / 1 4/2014 PP# : none DP Barcode : D 410807 , D 4108 33 , D 313507 PC Code : 060101 Template Version September 2005Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Appendix I - International Residue Status Sheet 

### International Residue Limits

Thiabendazole (PC Code 0601 01; Date of Request 12/12/13 ) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 1 Codex 2 40 CFR 180.242 Plants: 2 - (4 - thiazolyl) benzimidazole) and its metabolite benzimidazole (free and conjugated) 2 - (4 - thiazolyl)benzimidazole Plants: thiabendazole Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 1 Codex 2 V egetable, root (except sugar beet); subgroup1B 0.02 O nion, bulb, subgroup 3 - 07A 0.02 Brassica, head and stem, subgroup 5A 0.02 V egetable, cucurbit group 9 0.02 Alf alfa 0.02 S pinach 0.02 S mall grains (barley, oats, rye, and triticale) 0.02 Wheat grain 1.0

Com pleted: M. Negussie; 12/12/2013 1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 2 * = 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.Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

Appendix II - OECD Calculator **Co mpound**  **Thiabendazole Thiabendazole**  **Thiabendazole Crop**  **Wheat Forage Wheat Hay**  **Wheat Straw Region / Country**  **US US**  **US GAP**  **0.11 lb ai/A 0.11 lb ai/A**  **0.11 lb ai/A Total number of data (n)**  19 19 19 **Percentage of censored data** 53% 79% 89% **Number of non -**  **censored data** 9 4 2 **Lowest residue** 0.020 0.020 0.020 **Highest residue** 0.210 0.072 0.083 **Median residue** 0.020 0.020 0.020 **Mean** 0.035 0.025 0.024 **Standard deviation (SD)** 0.044 0.015 0.015 **Correction factor for censoring (CF)**  0.649 0.474 0.404 **Proposed MRL estimate**

**- Highest residue**  0.210 0.072 0.083

**- Mean + 4 SD**  0.211 0.086 0.082

**- CF x 3 Mean**  0.068 0.036 0.029 **Unrounded MRL** 0.211 0.086 0.083 **Rounded MRL 0.3**  **0.09 0.09**  High uncertainty of MRL estimate due to high level of censoring. **Residues (mg/kg) Residues (mg/kg)**  **Residues (mg/kg)** 0.020 * 0.020 * 0.020 * 0.023 0.021 0.020 * 0.020 * 0.021 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.021 0.020 * 0.020 * 0.029 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.025 0.020 * 0.020 * 0.020 * 0.020 * 0.020 *Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974 0.020 * 0.020 * 0.020 * 0.037 0.020 * 0.023 * 0.071 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.210 0.072 0.032 0.027 0.065 0.083 0.020 * 0.020 * 0.020 * 0.024 0.020 * 0.020 *Thiabendazole Summary of Analytical Chemistry and Residue Data DP#: 363974

**Compound Thiabendazole**  **Thiabendazole Crop**  **Barley Hay Barley Straw**  **Region / Country US**  **US GAP**  **0.11 lb ai/A 0.11 lb ai/A**  **Total number of data (n)** 12 12 **Percentage of censored data** 58% 67% **Number of non -**  **censored data** 5 4 **Lowest residue** 0.020 0.020 **Highest residue** 0.200 0.092 **Median residue** 0.022 0.020 **Mean** 0.048 0.034 **Standard deviation (SD)** 0.057 0.024 **Correction factor for censoring (CF)**  0.611 0.556 **Proposed MRL estimate**

**- Highest residue**  0.200 0.092

**- Mean + 4 SD**  0.277 0.130

**- CF x 3 Mean**  0.088 0.056 **Unrounded MRL** 0.277 0.130 **Rounded MRL 0.3**  **0.15** High uncertainty of MRL estimate due to high level of censoring. High uncertainty of MRL estimate due to high level of censoring. **Residues (mg/kg)**  **Residues (mg/kg)** 0.020 * 0.020 * 0.028 0.038 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.020 * 0.130 0.092 0.052 0.072 0.023 0.020 * 0.026 0.040 0.200 * 0.020 *