Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 1 of 16 UNITED STA

TES ENVIRONMENTA L PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDE AND TOXIC SUBSTANCES 

### MEMORANDUM Date : October 30, 2009 SUBJECT: Triticonazole . Application for New Seed Treatment Uses o n Cereal Grains

(Except Rice) (PP#8F7420) . Amendment to L abel and Request for Removal of P lant Back Interval Restrictions Requirement PC Code: 125620 DP Barcode s : D P 325956 , DP 370705 Decision No.: 399231 Registration No. : 7969 - xxx Petition No.: #8 F7420 Regulatory Action: Section 3 Registration Risk Assessment Type: NA Case No.: NA T XR No.: NA CAS No.: 131983 - 72 - 7 MRID No.: None 40 CFR: § 180. 583 Ver.Apr.08 

### From : Stephen Funk, Senior Science Advisor

Risk Assessment Branch 3 Health Effect s Division (7509P) Through: Paula Deschamp, Branch Chief

Risk Assessment Branch III Health Effects Division (7509P) To: Shaja Joy

ner, RM #20 Fungi cide Branch Registration Division (7505P) Background The Registration Division has requested HED re evaluation of a BASF Crop Protection a pplication (P P# 8 F7420) for n ew s eed treatment u ses on Cereal Grains (Except Rice) . The HED review (A. Acierto, 06/12/2009, D325956, D353372, D360624) : concluded that (1) The label must be modified to specify a 120 - day

(4 - month) plantback restriction for leafy vegetables, a 365 - day (12 - month) plantback restriction for root and tuber vegetables, and to prohibit the planting of all other crops not listed on the label; (2) To support a proposed 30 - day plantback restriction on the label, limited field rotational crop data for leafy vegetables, root and tuber vegetables, foliage of root and tuber vegetables , and a cereal grain are required ; (3)Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 2 of 16 A revised Section F must be submitted to reflect the tolerance 

## recom mend ation of 0.25 ppm for the forage, fodder, and straw of cereal grains, group 16 (except rice). The individual tolerances established for barley

hay and straw, and wheat forage, hay and straw in 40 CFR §180.583(a) should be deleted when the crop group tolerance is established; (4) A revised Section F must submitted to reflect the tolerance 

## recom mend ation of 0.01 ppm for cereal grains, group 15 (except rice). The individual tolerances established for barley grain and wheat grain at 0.05 ppm in 40 CFR §180.583(a) should be deleted when the crop group tolerance is established; (5) To support the reported results for 1,2,4 - triazole and the triazole conjugates, the final report of the ongoing storage stability

study with free triazole and triazole conjugates in plant must be submitted. Inresponse to conclusions #1 and #2 (above) only, the registrant has proposed reduction in the application rate and reconsideration of the conditional requirem ent for limited field rotational crop studies and associated plant back restrictions . Executive Summary Triticonazole is a systemic triazole fungicide that is currently registered for seed treatment on barley and wheat for the control of various seed - borne diseases. Triticonazole is formulated as liquid flowable formulation s . The first food/ feed use was requested under PP#9F6051 in 2001 by Aventis Crop Science (EPA Company No. 264 ) ; the Aventis products have since been transferred to BASF (EPA Company No. 7969). BASF C ro p Protection previously submitted a tolerance petition, PP#8F7420, and Section 3 request to register Triticonazole HL Fungicide (EPA Reg. No. 7969 - xxx , a 4.17 lb ai/gal liquid flowable formulation) for seed treatm ent use s on cereal grains (except rice) at a maximum rate of 0.05 lb ai/100 lb seed . HED RAB3 reviewed the petition and 

## recom mend ed for the conditional registration for the requested seed treatment uses on cereal grain crops (except rice) and the establ ishment of tolerances for residues of the fungicide triticonazole, (1 RS ) - ( E) - 5 - [(4 - chlorophenyl)methylene] - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl)cyclopentanol, from the treatment of seed prior to planting in/on (A. Acierto, 06/12/2009, D325956, D35 3372, D360624) : Grain, cereal, group 15 (except rice) ....................................... 0 .0 1 ppm Grain, cereal, forage, fodder, and straw, group 16 (except rice) ...... 0. 25 ppm RAB 3 also 

## recom mend ed that upon establishment of the above tolerances for grain, cereal, group 15 (except rice) and grain, cereal, forage, fodder, and straw, group 16 (except rice), the existing tolerances listed in 40 CFR 180 (a) should be removed: barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; wheat, straw. HED 

## recom mend

ed for a conditional registration until two deficiencies were satisfied (A. Acierto, 06/12/2009, D325956, D353372, D360624) 

### : First, the adequacy of the additional triazole storage stability

data to support the storage durations of cereal grain forages, fodders and/or straws, corn kernel plus cob with husk removed ( K+CWHR) , and sorghum stalks from the cerealTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 3 of 16 grain field trial studies need to be determined when the final results of an ongoing triazole storage stability study

are submitted to the Agency . According to current Agency policy, storage stability in the raw agricultural commodity (RAC) can be translated to the processed commodity . Second , limited field rotational crop studies are needed. The confined rotational crop study data in dicate that residues of triticonazole may be present at >0.01 ppm in 30 - DAT rotated lettuce (0.017 ppm), radish tops (0.049 ppm) and wheat forage (0.041 ppm), straw (0.133 ppm) and chaff (0.139 ppm); 120 - DAT rotated radish tops (0.016 ppm), and wheat forag e (0.019 ppm), straw (0.150 ppm), and chaff (0.114 ppm); and 365 - DAT rotated wheat forage (0.025 ppm), straw (0.086 ppm) and chaff (0.133 ppm). Wheat hay was not analy

ze d but forage and straw were analy

zed, and residues of triticonazole were found in forage and straw. The originally proposed label for the 4.17 lb/gal FS specifies that “planting of any crop not listed on the label within 30 days after planting treated seed is not allowed”. The results of the submitted confined rotational crop study do not support this restriction. The data from the confined rotational crop study indicate that triticonazole residues greater than 0.01 ppm were detected at the 30 - day

PBI . To support a 30 - day plantback restriction on the label, limited field rotational crop data for leafy vegetables, root and tuber vegetables, foliage of root and tuber vegetables , and a cereal grain are required. Until the requested data are provided, HED previously

concluded that the label must be modified to specify a 120 - day

(4 - month) plantback restriction for leafy

vegetables, a 365 - day

(12 - month) plantback restriction for root and tuber vegetables, and prohibit the planting of all other crops not listed on the label . The present submission addresse s the second deficiency (rotational crop requirement) and the associated plant back restrictions on the label. The registrant has responded with a request to amend the label to delete the high seed treatment rates (0.05 lbs ai/100 lbs seed) for wheat, barley, rye, and oats and to retain only the 0.005 lbs ai/100 lbs seed treatment rates for wheat, barley, rye, and oats. The registrant also presents an extrapolation of the new seed treatment rates to equivalent ground application rates and contends that these rates would not lead to quantifi able residues (<0.01 ppm) in rotational crops at a 30 day plant back interval. The reduction in the application rate by a factor of 10 for the seed treatment of wheat, rye, barley and oats has no effect on the previous 

## recom mend ation of tolerance for cereal grains (except rice). The available data support a tolerance level of 0.01 ppm for cereal grains, group 15 (except rice). The value of 0.05 ppm proposed by the petitioner is excessive, when rice is excluded. Moreover, the 0.01 ppm level harmoniz es with Canada. A revised Section F must be submitted to reflect the tolerance 

## recom mend ation of 0.01 ppm for cereal grains, group 15 (except rice). The individual tolerances established for barley grain and wheat grain at 0.05 ppm in 40 CFR §180.583(a) should be deleted when the crop group tolerance is established. The reduction in the application rate by a factor of 10 for the seed treatment of wheat, rye, barley and oats does have an effect on the previous 

## recom mend ation of tolerance for forage and s tover of cereal grains (except rice). Residues of triticonazole were nonquantifiable in treated field and sweet corn forage and stover, and sorghum forage and stover. Quantifiable residues of triticonazole were observed in treated wheat forage, hay and straw, and rice straw. Highest residues were observed in the wheat feed commodities, where the application rate was 10X the label specification. Appropriate tolerance levels were determined from the highest residuesTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 4 of 16 observed. The residue data for ric e straw was excluded because the petitioner is not applying for use on rice. HED 

## recom mend s a crop group tolerance of 0.10 ppm based on the highest observed residue value for wheat feed commodities from the 10X study . This is in agreement with the peti tioner’s proposal and replaces the previous HED 

## recom mend ation of 0.25 ppm (A. Acierto, 06/12/2009, D325956, D353372, D360624) Further consideration of the confined rotational crop study with the proposed label change (maximum seed treatment rate reduce d from 0.05 to 0.005 lb ai/100 lbs seed) leads to the conclusion that residues are not anticipated (<0.01 ppm) on rotational crops from use of triticonazole as a seed treatment under the revised label conditions. Therefore, limited field rotational crop s tudies are not required. This deficiency f rom the previous memo (A. Acierto, 06/12/2009, D325956, D353372, D360624) is resolved. Regulatory 

## Recom mend ations and Residue Chemistry Deficiencies HED has examined the residue chemistry database for triticonazole and concludes that pending submission of a revised Section B (see requirements under Directions for Use) and a revised Section F (see requirements under Proposed Tolerances), there are no residue chemistry issues that would preclude granting conditional registration for the requested seed treatment uses on cereal grain crops (except rice) and the establishment of tolerances for residues of the fungicide triticonazole, (1 RS

) - ( E) - 5 - [(4 - chlorophenyl)methylene] - 2,2 - dimethyl - 1 - (1 H - 1,2 ,4 - triazol - 1 - ylmethyl)cyclopentanol, from the treatment of seed prior to planting in/on: Grain, cereal, group 15 (except rice) ....................................... 0 .0 1 ppm Grain, cereal, forage, fodder, and straw, group 16 (except rice) ...... 0. 10 ppm Moreover, upon establis hment of the above tolerances for grain, cereal, group 15 (except rice) and grain, cereal, forage, fodder, and straw, group 16 (except rice), the existing tolerances listed in 40 CFR 180 (a) should be removed: barley, grain; barley, hay ; barley, straw; wh eat, forage; wheat, grain; wheat, hay ; wheat, straw. A human health risk assessment has been conducted (N. Tsaur et al, D358614, 08/07/2009). The changes 

## recom mend ed herein have no effect on that assessment and it remains valid. 860.1200 Directions fo r Use • The previous 

## recom mend ation for a label change to add various plant back intervals is withdrawn. The existing plantback interval (30 days) for Triticonazole HLFungicide is adequate. This change results from the proposal to reduce the maximum application rate for seed treatment to 0.005 lbs. ai/100 lbs seed. 860.1550 Proposed Tolerances • A revised Section F must be submitted to reflect the tolerance 

## recom mend ation of 0.01 ppm for cereal grains, group 15 (except rice); to reflect the toleranceTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 5 of 16 

## recom mend

ation of 0.10 ppm for grain , cereal, forage, fodder, and straw, group 16 (except rice); and to reflect the correct commodity definition s as listed in Table 7 . HED 

## recom mend

s conversion of conditional registration to unconditional reg istration for the cereal grains (except rice) upon adequate resolution of data pertaining to storage stability. Tolerance Expression: The tolerance expression in 40CFR180§583(a) should be modified to the following:

“ Tolerances are established for resid ues of the fungicide triticonazole, including its metabolites and degradates, from the treatment of seed prior to planting, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only 5 - [(4 - chlorophenyl)methylene] - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl)cyclopentanol .” 860.1380 Storage Stability • To support the reported results for 1,2,4 - triazole and the triazole conjugates, the final report of the ongoing storage stability study with free triazole and triazole conjugates in plant commodities must be submitted (A. Acierto, 06/12/2009, D325956, D353372, D360624) . 860.1900 Field Accumulation in Rotational Crops • The previous deficiency is resolved. Data from l imited field accumulation studies on rotational crop s are not required, because the confined rotational crop study shows that quantifiable residues are unlikely in rotated commodities from use of triticonazole as a seed treatment for cereal grains (except rice) in accordance with the use instructions of the revised label for Triticonazole HL Fungicide . Background The chemical structure and n omenclature of triticonazole and triazole - related metabolites , and the physicochemical properties of the technic al grade of triticonazole are , respectively, presented in Tables 1 and 2. Table 1. Triticonazole Nom enclature .Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 6 of 16 Table 1. Triticonazole Nom enclature . Chemical structure

C H 3 C H 3 O H N N N

Cl Common name Triticonazole Company experimental name BAS 595 F (formerly RPA 4000727) IUPAC name (±)(E) - 5 - (4 - chlorobenzylidene) - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl)cyclopentanol CAS name 5 - [(4 - chlorophenyl)methylene] - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl)cyclopentanol CAS registry number 131983 - 72 - 7 End - use product (EP) Triticonazole HL (4.17 lb ai/gal flowable liquid; EPA Reg. No. 7969 - xxx) Chemical structure of T metabolite 

### N H N N 1,2,4 - Triazole Chemical structure of TA metabolite N N N O H NH 2 O Triazole alanine or triazolylalanine Chemical structure of TAA metabolite N N N O H O

Triazole acetic acid or triazolylacetic acid Table 2. Physicochemical Properties of Chemical : Triticonazole . Parameter Value Reference Melting point/range 140 oC; PAI displays two crystalline forms melting at 137 and 141 oC BASF document number 2002/1016091 1 pH Not available Density 1.21 g/mL (PAI) BASF document number 2002/1016091 1 Water solubility 8.4 mg/L at 20 oC Solvent solubility (at 20 oC) Hexane 0.12 g/L Methanol 18.2 g/L Acetone 74.5 g/L Toluene 12.6 g/L Dichloromethane 191 g/L Ethyl acetate 48.6 g/L n - Octanol 6.2 g/L Vapor pressure <0.1 x 10 - 5 PA at 50 oCTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 7 of 16 Table 2. Physicochemical Properties of Chemical : Triticonazole . Parameter Value Reference Dissociation constant, pKa Does not dissociate Octanol/water partition coefficient, Log(KOW) Log P = 3.29 at 20 oC UV/visible absorption spectrum Not available 1 As referenced in MRID 47470203. 

### 860 .1200 Directions for Use A summary

of the revised proposed use directions is presented in Table 3. Information pertaining to the proposed use pattern was obtained from a September 2009 specimen label submitted for Triticonazole HL Fungicide Seed Treatment (4.17 lb/gal FS). The EP is proposed for the control of various seed - borne diseases in cereal crops except rice. Table 3 shows that Triticonazole HL Fungicide Seed Treatment is proposed for seed treatment on cereal grains (except rice) at a maximum rate of 0. 0 05 lb ai/100 lb seed for oats, rye, barley, and wheat; at 0.01 lbs ai/100 lbs seed for sweet corn; at 0.050 lbs ai/a00 lbs seed for field corn, and at 0.020 lb s ai/100 lbs sorghum. The end - use product Charter® Fungicide Treatment (EPA Reg. No. 7 969 - 386; accepted 6/27/2007) is currently registered on barley

and wheat for preplant seed treatment at a maximum rate of 0.005 lb ai/100 lb seed. Table 3. S ummary of Proposed Seed Treatm ent Use of Triticonazole . Application Ty pe Formulation [EPA Reg. No .] Seed Treatment

Applic ation Rate (lb ai/100 lb seed) Maximum Seeding Rate 1 (lb seed planted/A) Maximum Equivalent

Field Applic ation Rate , 2 lb ai/A (kg ai/ha) Barley Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.005 96 0.0 0 48 (0 .0054 ) Field Corn and Popcorn (includes seed production) Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.005 - 0.050 1 5 0.0075 ( 0.0084) Sweet Corn Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.010 15 0.0015 (0.0017) Oats Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.005 128 0. 0 06 4 (0.0072) Rye Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.005 112 0.056 (0.0063) Sorghum Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.010 - 0.020 10 0.002 0 (0.0022) Wheat and TriticaleTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 8 of 16 Table 3. S ummary of Proposed Seed Treatm ent Use of Triticonazole . Application Ty pe Formulation [EPA Reg. No .] Seed Treatment

Applic ation Rate (lb ai/100 lb seed) Maximum Seeding Rate 1 (lb seed planted/A) Maximum Equivalent

Field Applic ation Rate , 2 lb ai/A (kg ai/ha) Seed Treatment 4.17 lb/gal FS

[7969 - xxx] 0.005 150 0. 0 075 (0.0084) G eneral Use Directions and Limitations : T o be applied as a water -based mixture using standard or mist - type seed treatment application equipment . A colorant must be added to identify the treated seed. The proposed label does not include water amounts need ed to provide the mixture or slurry rate for optimum coverage, but 

## recom mend

s consulting a seed - treatment specialist. The product may be tank- mixed with other water -based seed treatments. U se of treated seed for food, feed, or oil processing is prohibite d . P lanting of any crop not listed on the label within 30 days after planting treated seed is not allowed . 1 From Science Advisory Council for Exposure, Standard Operating Procedure, SOP #15, 3/2/04 . 2 Calculated by the study reviewer using the maximu m seed treatment rate and maximum seeding rate. 

### Conclusions . The revised submitted label for Triticonazole HL Fungicide Seed Treatment reduced the maximum treatment rate for wheat, oats, barley, and rye by a factor of 10. The submitted confined rotational crop study (see below) , which was conducted at 14x to 71x the proposed maximum equivalent field application rate for cereal grains, indicates that residues of triticonazole will likely

be absent at >0.01 ppm in 30 - DAT rotated lettuce, radish tops and roots, and wheat forage, straw and chaff; , and grain The proposed 30 - day plantback interval for all crop s not listed on the label is now acceptable . 860.1300 Nature of the Residue - Plants Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP #9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### 860.1300 Nature of the Residue - Livestock Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto ( PP#8F7420) 

### 860.1340 Residue Analytical Methods Enforcement method Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### Data - Collection Method DER Reference: 47511 902.der.doc Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### 860.1360 Multiresidue Methods Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 9 of 16 Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### 860.1380 Storage Stability Storage Stability

Study with Triticonazole on Wheat DER Refere nce: 45595401.der.doc Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### Interim Results of a Storage Stability Data Study

with 1,2,4 - Triazole (T), Triazolyl alanine (TA), and Triazolyl a cetic Acid (TAA) In Apples, Wheat Flour, Peanut Butter, Milk, and Eggs DER Reference: 46568301.der.doc Residue Chemistry Memo DP# 325956, 3533 72, 360624; A. Acierto (PP#8F7420) 

### 860.1400 Water, Fish, and Irrigated Crops There are no proposed uses relevant to this guideline topic . The petitioner noted that they are not seeking to register use on rice , a crop which may be irrigated, at this tim e. 860.1460 Food Handling There are no proposed uses that are relevant to this guideline topic. 860.1480 Meat, Milk, Poultry, and Eggs Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### 860.1500 Crop Field Trials DER Reference : 47470203.der.doc Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### Wheat, corn, sorghum, and rice crop field trials were previously reviewed. The seed treatment application rate for all crop seeds was 50 g ai/100 kg seed. or 0. 05 lbs ai/100 lbs seed. This is 10x the revised maximum proposed seed treatment use on oats, rye, wheat, and triticale . The residues found on the mature crop commodities will be elevate d relative to those resulting from use according to the revised label. The summary

table of field trial results is repeated below. Residues of triticonazole were <0.01 ppm on field corn, sweet corn, and sorghum commodities from treatments at 1 X to 5X the label rate. The maximum triticonazole residues on wheat forage, hay, straw, and grain were 0.10 ppm, 0.08 ppm, 0.08 ppm, and <0.01 ppm , respectively, from treatments at 10X the label rate. T able 4 . S ummary of Residue Data fromCrop Field Trials with Triticonazole . Commodity Applic. DAP Residue Levels (ppm) 1Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 10 of 16 Rate g ai/100 kg seed (lb ai/100 lbs seed) (days) n Min. Max. HAFT 2 Median (STMdR) Mean

(STMR) Std.

Dev. 3 Proposed Rate on Barley, Oats, Rye, Wheat, and Triticale = 0. 0 050 lb ai/1 00 lb seed

Propsed Rate on Corn (Field and Pop) = 0.050 lb ai/100 lb seed Proposed Rate on Sweet Corn = 0.010 lb ai/100 lb seed P roposed Rate on Sorghum = 0.020 lb ai/100 lb seed) Triticonazole Wheat, forage 50

(0.05) 35 - 102 30 <0.01 0.10 0.10 0.02 0.04 0.028 Wheat, hay 50

(0.05) 56 - 135 30 <0.01 0.08 0.08 0.02 0.03 0.026 Wheat, grain 50

(0.05) 90 - 177 30 <0.01 <0.01 <0.01 0.01 0.01 NA Wheat, straw 50

(0.05) 90 - 177 30 <0.01 0.08 0.08 0.03 0.03 0.024 Corn, forage 4 50

(0.05) 78 - 155 38 <0.01 <0.01 <0.01 0 .01 0.01 NA Corn, grain 50

(0.05) 112 - 161 30 <0.01 <0.01 <0.01 0.01 0.01 NA Corn, stover 4 50

(0.05) 92 - 176 38 <0.01 <0.01 <0.01 0.01 0.01 NA Corn, K+CWHR 50

(0.05) 71 - 114 18 <0.01 <0.01 <0.01 0.01 0.01 NA Sorghum, forage 50

(0.05) 61 - 113 24 <0.01 <0.0 1 <0.01 0.01 0.01 NA Sorghum, grain 50

(0.05) 90 - 199 24 <0.01 <0.01 <0.01 0.01 0.01 NA Sorghum, stover 50

(0.05) 90 - 199 24 <0.01 <0.01 <0.01 0.01 0.01 NA Rice, grain 50

(0.05) 114 - 182 24 <0.01 0.02 0.02 0.01 0.01 0.003 Rice, straw 50

(0.05) 114 - 182 24 <0.01 0.04 0.04 0.01 0.02 0.009 Triazole (T) Wheat, forage 50

(0.05) 35 - 102 30 <0.05 <0.05 <0.05 0.05 0.05 NA Wheat, hay 50

(0.05) 56 - 135 30 <0.05 <0.05 <0.05 0.05 0.05 NA Wheat, grain 50

(0.05) 90 - 177 30 <0.01 <0.01 <0.01 0.01 0.01 NA Wheat, straw 50

(0.05) 90 - 177 30 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, forage 4 50

(0.50) 78 - 155 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, grain 50

(0.05) 112 - 161 30 <0.01 <0.01 <0.01 0.01 0.01 NA Corn, stover 4 50

(0.05) 92 - 176 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, K+CWHR 50

(0.05) 71 - 114 18 <0.01 <0.01 <0.01 0.01 0.01 NA Sorghum, forage 50

(0.05) 61 - 113 24 <0.05 <0.05 <0.05 0.05 0.05 NATriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 11 of 16 T able 4 . S ummary of Residue Data fromCrop Field Trials with Triticonazole . Commodity Applic.

Rate g ai/100 kg seed (lb ai/100 lbs seed) DAP

(days) Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median (STMdR) Mean

(STMR) Std.

Dev. 3 Sorghum, grain 50

(0.50) 90 - 199 24 <0.01 <0.01 <0.01 0.01 0.01 NA Sorghum, stover 50

(0.05) 90 - 199 24 <0.05 <0.05 <0.05 0.05 0.05 NA Rice, grain 50

(0.05) 114 - 182 24 <0.01 <0.01 <0.01 0.01 0.01 NA Rice, straw 50

(0.05) 114 - 182 24 <0.05 <0.05 <0.05 0.05 0.05 NA Triazolylalanine (TA) Wheat, forage 50

(0.05) 35 - 102 30 <0.05 0.12 0.11 0.05 0.05 0.015 Wheat, hay 50

(0.05) 56 - 135 30 <0.05 0.14 0.13 0.05 0.06 0.021 Wheat, grain 50

(0.05) 90 - 177 30 <0.05 0.26 0.24 0.06 0.10 0.063 Wheat, straw 50

(0.05) 90 - 177 30 <0.05 0.07 0.07 0.05 0.05 0.004 Corn, forage 4 50

(0.05) 78 - 155 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, grain 50

(0.05) 11 2 - 161 30 <0.05 0.35 0.31 0.05 0.07 0.065 Corn, stover 4 50

(0.05 ) 92 - 176 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, K+CWHR 50

(0.05) 71 - 114 18 <0.05 0.26 0.24 0.05 0.07 0.061 Sorghum, forage 50

(0.05) 61 - 113 24 <0.05 0.10 0.08 0.05 0.05 0.010 Sorghum, grain 50

(0.05) 90 - 199 24 <0.05 0.39 0.38 0.05 0.08 0.091 Sorghum, stover 50

(0.05) 90 - 199 24 <0.05 0.26 0.25 0.05 0.07 0.057 Rice, grain 50

(0.05) 114 - 182 24 <0.05 0.29 0.29 0.05 0.07 0.066 Rice, straw 50

(0;05) 114 - 182 24 <0.05 <0.05 <0.05 0.05 0.05 NA Triazolyl - acetic acid (TAA) Wheat, forage 50

(0.05) 35 - 102 30 <0.05 <0.05 <0.05 0.05 0.05 NA Wheat, hay 50

(0.05) 56 - 135 30 <0.05 0.13 0.11 0.05 0.06 0.016 Wheat, grain 50

(0.05) 90 - 177 30 <0.01 0.20 0.20 0.04 0.05 0.046 Wheat, straw 50

(0.05) 90 - 177 3 0 <0.05 0.10 0.10 0.05 0.05 0.011 Corn, forage 4 50

(0.05) 78 - 155 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, grain 50

(0.05) 112 - 161 30 <0.01 <0.01 <0.01 0.01 0.01 NATriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 12 of 16 T able 4 . S ummary of Residue Data fromCrop Field Trials with Triticonazole . Commodity Applic.

Rate g ai/100 kg seed (lb ai/100 lbs seed) DAP

(days) Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median (STMdR) Mean

(STMR) Std.

Dev. 3 Corn, stover 4 50

(0.05) 92 - 176 38 <0.05 <0.05 <0.05 0.05 0.05 NA Corn, K+CWHR 50

(0.05) 71 - 114 18 <0.01 <0.01 <0.01 0.01 0.01 NA Sorghum, forage 50

(0.05) 61 - 113 24 <0.05 0.07 0.06 0.05 0.05 0.004 Sorghum, grain 50

(0.05) 90 - 199 24 <0.01 0.37 0.35 0.01 0.04 0.095 Sorghum, stover 50

(0.05 90 - 199 24 <0.05 <0.05 <0.05 0.05 0.05 NA Rice, grain 50

(0.05) 114 - 182 24 <0.01 0.50 0.50 0.03 0.07 0.134 Rice, straw 50

(0.05) 114 - 182 24 <0.05 0.34 0.34 0.05 0.08 0.082 

### 860.1520 Processed Food and Feed DER Reference : 47511901.der.doc Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (P P#8F7420) 

### 860.1650 Submittal of Analytical Reference Standards Analy tical standards for triticonazole are currently available in the EPA National Pesticide Standards Repository (personal communication with Dallas Wright, ACB, 2 /23/0 9 ) , expiration date 7/8/2014 . 860.1850 Confined Accumulation in Rotational Crops DER Reference : 47399201.der.doc Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051) Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420) 

### The results from the previously reviewed confined rotational crop study are summarized in Table 5 ( 

### DP# 262566, 6/6/2001, N. Dodd). The application rate to the soil was 120 g ai/ha. (0.107 lb ai/acre)

Table 5. Total Radioactive Residues and Tritico nazole in Rotated Lettuce, Radish, and Wheat Matrices Matrix Plantback Interval (days) TRR Phenyl Label (ppm) TRR Triazole Label (ppm) Triticonazole (ppm) Combustion Calculated 1 Combustion Calculated 1 Lettuce 30 0.020 0.024 0.065 0.065 0.017 120 0.014 0.014 0.026 0.025 0.006Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 13 of 16 365 0.005 0.004 0.029 0.024 0.003 Radish, roots 30 0.009 0.009 0.099 0.094 0.007 120 0.006 0.006 0.055 0.056 0..003 365 0.003 0.003 0.031 0.029 0.002 Radish, tops 30 0.072 0.067 0.279 0.256 0.049 120 0.052 0.040 0.3 31 0.286 0.016 365 0.011 0.009 0.128 0.043 0.003 Wheat, forage 30 0.067 0.042 0.199 0.129 0.041 120 0.049 0.035 0.155 0.095 0.019 365 0.029 0.015 0.141 0.107 0.025 Wheat, straw 30 0.209 0.181 0.629 0.580 0.133 120 0.345 0.298 0.675 0.576 0.150 365 0.282 0.198 0.520 0.455 0.086 Wheat, chaff 30 0.181 0.174 0.509 0.571 0.139 120 0.151 0.141 0.848 0.786 0.114 365 0.106 0.095 0.562 0.549 0.133 Wheat, grain 30 0.008 0.008 0.453 0.948 0.00 120 0.054 0.053 0.689 0.706 0.00 365 0.025 0.028 0.68 2 0.773 0.00 1 Calculated by the summation of extractable and nonextractable radioactivity; these values were used by the petitioner for all further calculations. 

### The application rate used in the confined rotational crop study is significantly

higher th an the equivalent application rate achieved from the proposed seed treatment rates. The comparison is given in Table 6. Table 6. Equivalent Field Rates from Proposed L abel for Triticonazole Seed Treatment Crop Maximum seed

treatment rate (lbs ai/100 lb s seed) Maximum

seeding rate (lb seed/acre) Maximum

Equivalent Field Application Rate (lbs ai/acre) Exaggeration

Factor from Confined Rotational Crop 1 

### Field corn 0.050 15 0.0075 14 Sweet corn 0.010 15 0.0015 71 Sorghum 0.020 10 0.0020 54 Wheat 0.005 15 0 0.0075 14 Barley 0..05 96 0.0048 22 Rye 0.005 112 0.0056 19 Oat 0.005 128 0.0064 17 1 

### Confined rotational crop application rate (0.107 lb ai/acre) / maximum equivalent field application rate from seed treatment. The confined rotational crop study wa s conducted at a minimum exaggerated rate of 14X. Assuming a proportionality between the concentration of triticonazole in the soil and the triticonazole residue in the rotated crop commodities, all triticonazole residues on all commodities would be <0.01 ppm at all plant back intervals with the exception of wheat straw and wheat chaff. These commodities might contain about 0.01 ppm triticonazole at all plant back intervals , e.g., 0.150 ppm wheat straw at 120 days / 14 = 0.0107 ppm. However, given that a confined study

represents the worst possible case, it is likely that triticonazole residues onTriticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 14 of 16 wheat chaff and straw would not achieve a level of 0.01 ppm under field conditions. Conclusion . . The application rate used in the confined rotational crop study reflects 14 to 71X the e quivalent per acre rate proposed for cereal grain crops. Itis unlikely that quantifiable residues of triticonazole (>0.01 ppm) will be found in rotated crop commodities at plant back intervals of 30 days or greater when triticonazole is used as a seed treatment at the label rates proposed. 860.1900 Field Accumulation in Rotational Crops The proposed label for the 4.17 lb/gal FS specifies that “planting of any crop not listed on the label within 30 days after planting treated seed is not allowed”. The results of the submitted confined rotational crop study support this restriction. The data from the confined rotational crop study indicate that triticonazole residues greater than 0.01 ppm w ere detected at the 30 - day PB I . However, when the exaggerated treatment rate of the confined study (14X minimum) is taken into consideration, it is likely that triticonazole residues will be < 0.01 ppm on rotated food commodities. Although significant triticonazole was quantitat ed at >0.01 ppm in the rotated livestock feed commodities wheat straw, forage, and chaff planted at the 30 - , 120 - and 365 - day PBI s from a confined rotational crop study conducted at an exaggerated rate of 14X, the levels of triticonazole anticipated from 1X treatment are estimated to be <0.01 ppm . . Conclusion . Field accumulation in rotational crops studies will not be required . The confined study indicates that residues of triticonazole will be non - quantifiable in rotated crops resulting from the use of triticonazole as a seed treatment for cereal grains (except rice) used according to the proposed label application rates. 860.1550 Proposed Tolerances Tolerances have been established under 40 CFR §180.583(a) for residues of the fungicide tritico nazole, (1 RS

) - ( E) - 5 - [(4 - chlorophenyl)methylene] - 2,2 - dimethyl - 1 - (1 H - 1,2,4 - triazol - 1 - ylmethyl)cyclopentanol , from the treatment of seed prior to planting in/on barley grain, hay

and straw, and wheat grain, forage, hay and straw, each at 0.05 ppm. HED has p reviously determined that triticonazole is the residue of concern in barley and wheat from seed treatment uses . This regulatory

decision may

be extended to include all crop commodities in the cereal grains crop group . The petitioner has not specified the tolerance expression with the proposed tolerances in Section F of the petition . The submitted residue data for field corn grain, sweet corn K+CWHR, sorghum grain, and wheat grain , which are the rep resentative c ommodities of the cereal grain group , do n ot support the proposed tolerance for the ‘ Grain, cereal, group 15 (except rice) ’ at 0. 0 5 ppm . The data do support a tolerance for ‘Grain, cereal, group 15 (except rice)’ at 0.01 ppm. A revised Section F must be submitted to reflect the tolerance 

## recom mend ation of 0.01 ppm for “Grain, cereal, group 15 (except rice)” at 0.01 ppm. The established individual tolerances for wheat grain and barley grain must be deleted when the crop group tolerance is established.Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 15 of 16 The submitted residue data for corn forage an d stover, sorghum forage and stover, and wheat f o rage, hay, and straw are adequate to determine a tolerance level for the forage, fodder, and straw of cereal grains crop group (except rice). The residues in wheat commodities were highest , but resulted fro m a 10X exaggerated rate study . The HAFT residues resulting from the study were used to establish , the tolerance levels for wheat forage, wheat hay, and wheat straw . The data support the proposed Section F tolerance of 0.10 ppm for “Grain, cere al, forage, fodder, and straw, group 16 (except rice) . ” The established individual tolerances for barley hay and straw, and wheat forage, hay and straw must be deleted when the crop group tolerance is established. The considerations for processed commodities and livestock commodities remain unchanged from the previous review (A. Acierto, 06/12/2009, D325956, D 353372, D 360624) A summary

of the 

## recom mend

ed tolerances for the petition is listed in Table 7 Table 7 . Tolerance Sum ma ry for Triticonazole Commodity Established/Proposed Tolerance (ppm) 

## Recom mend ed Tolerance (ppm) Comments ; C orrect Commodity D efinition Established tolerances under 180.583 (a) Barley, grain 0.05 Remove Barley grain will be covered with the establishment of the cereal grain, group 15 (except rice) tolerance . Barley, hay 0.05 Remove Increase in the tolerance based on residues resulting from new uses. Barley hay and straw and wheat forage will be covered with the establishment of the cereal grain group 16 (except rice) tolerance . Barley, straw 0.05 Remove Wheat, forage 0.05 Remove Wheat grain 0.05 Remove Barley grain will be covered with the establishment of the cereal grain, group 15 (except rice) tolerance Wheat, hay 0.05 Remove Increase in the tolerance based on residues resulting from new uses. Wheat hay and straw and will be covered with the establishment of the cereal grain group 16 (except rice) tolerance. Wheat, straw 0.05 Remove

T olerances to be established under 180.583 (a) Grain, cereal, group 15 (except rice) 0.05 0.01 . Grain, cereal, forage, fodder, and straw , group 16 (except rice) 0.10 0. 10 1

. 1 The only change from the previous tolerance summary (A. Acierto, 06/12/2009, D325956, 353372, 360624) is the replacement of 0.25 with 0.10 ppm.Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705



### Page 16 of 16 References DP #: 262566 Subject: PP#9F6051. Triticonazole Seed Treatment on Barley and Wheat. Review of Analy tical Methods and Residue Data. First Food Use Review. From: N. Dodd To: S. Gardner - Jenkins/M. Waller Dated: 6/6/2001 MRIDs: 44904515 - 25, 44995701 - 06 DP# 325956; 353372; 360624 Subject: Triticonazole. Application for New Seed Treatment Uses on Cereal Grains

(Except Rice) (PP#8F7420) . Summary of Analy tical Chemistry

and Residue Data . . From: A. Acierto To: S. Joy

ner Dated: 6/12/2009 MRIDs: 4751190 2; 45595401; 46568301; 47470203; 47511901; 47399201 Template Vers ., ion September 2005