UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 06/ 15/ 06 MEMORANDUM:

SUBJECT: Propiconazole ( 122101): Reregistration Eligibility Decision ( RED) Document; Revised Residue Chemistry Considerations DP Barcode: D329394 Reregistration Case: 3125 FROM: Yan Donovan, Chemist Reregistration Branch 4 Health Effects Division ( 7509C)

THROUGH: Susan V. Hummel, Branch Senior Scientist Reregistration Branch 4 Health Effects Division ( 7509C)

TO: Michael Goodis/ Christina Scheltema Reregistration Branch III Special Review & Reregistration Division ( 7508W)

Attached please find the revised Residue Chemistry Chapter for the Propiconazole RED. This document was originally prepared under contract by Dynamac Corporation ( 20440 Century Boulevard, Suite 100; Germantown, MD 20874; submitted 02/ 16/ 2000). The document has been reviewed by the Health Effects Division ( HED) to ensure that it reflects current Office of Pesticide Programs ( OPP) policies, and updated to add new information available since 2000. The product Chemistry chapter was reviewed separately. ° HED has been requested to reassess tolerances for propiconazole uses on a variety of crops ( Use Closure Memos from SRRD, dated on 01/ 28/ 02 and 04/ 22/ 05). Syngenta ( previously Novartis) recently submitted new petitions to the Registration Division ( RD) for its product TiltTM ( EPA Registration No. 100 617). The petitions propose tolerances on alfalfa, almond, beans ( dry), berry crop group, carrot, cranberry, corn, leafy petiole, mint, onion, soybean, etc..). Section B of the petition ( proposed use patterns) includes revised use patterns on existing crops, such as an increase in application rate on barley, wheat, oats, rye, and triticale. The data package for the new uses and revisions to the existing uses has not been reviewed, and are not included in this assessment of the existing uses for Reregistration Eligibility Decision ( RED), due to the fact that RD is scheduled to complete its assessment of the revised labels after the RED signature date, July 2006, the data package has yet to be reviewed. Therefore, both the new uses and revised use patterns will be assessed separately from this RED. Syngenta recently combined PP# 4F3007, 4G3075, 5F4498, PP# 9F3740, 5F4424, 5F4591, into a single petition, PP# 2F6371. IR 4 is still supporting PP# 5E4437 on mushrooms and 8E4931 on mint ( now part of 2F6371). Below are list of the pending petitions which are not included in this RED chapter.

4F3007 Pecans 4G3075 Rice, wheat 9F3740 Almonds, tree nuts ( now part of 2F6371) 5F4424 Dried beans, soybeans ( now part of 2F6371) 5F4498 Alfalfa, sorghum ( rotational crops) 5F4591 Berry crop group, carrots, onions ( green & dry bulb) ( now part of 2F6371) 6E4788 Celery 7E4860 Cranberries 8E4931 Mint 2F6371 combines PP# 4F3007, 4G3075, 5F4498, 9F3740, 5F4424, and 5F4591. 2F6371 strawberries, sugar beets, wheat, corn, rice, sorghum, carrots, onions, berry group, dry beans, soybeans, almonds, tree nuts.

Propiconazole is among the group of chemicals which generates a common metabolite called triazole. A separate document has addressed this issue ( see reference, D284131). 1,2,4 triazole and conjugates will not be further discussed in this chemistry chapter. Executive Summary Propiconazole [ 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole] is a systemic broad spectrum fungicide registered for treatment of disease in/ on a variety of crops. Propiconazole end use products are marketed in the United States under the trade names Tilt ® , Alamo ® , Banner ® , and Orbit ® . Recently, propiconazole is also registered for use on a variety of crops under the trade names of Stratego   Twin Pak   and Stratego   , which are end use products containing a mixture of trifloxystrobin and propiconazole. The amount of active ingredient range from 11.4% to 45%. The propiconazole formulations registered for food/ feed uses include emulsifiable concentrate ( EC) and flowable concentrate ( FlC) formulations. Except for pineapple and sugarcane ( seed pieces), all uses are pre harvest foliar application, ground or air. Pineapple and sugarcane uses are postharvest uses. The application rates range from 0.081 lbs ai/ A/ season ( such as wheat) to 0.90 lbs ai/ A/ season ( grass grown for seed).

Available plant metabolism data ( primary and rotated crops) show that plants absorb, metabolize and translocate propiconazole throughout the plant. A major metabolic pathway in plants appears to be hydroxylation ( primarily of the beta carbon) of the n propyl group on the dioxolane ring of the cis/ trans isomers of propiconazole. These metabolites appear to readily form sugar conjugates. The majority of TRR was found in the stalks, such as peanut stalk, wheat forage and straw, grape leaves, and celery stalks. The HED MARC concluded that for plants and animals, residues of propiconazole and all its metabolites containing the 2,4 dichlorophenyl moiety ( 2,4 DCBA), including conjugates, are of concern and should be included in the dietary ( food) risk assessments, propiconazole per se should be included in the dietary ( water) risk assessments. For tolerance expression, MARC concluded that the current tolerance expression for propiconazole should be amended to include residues of propiconazole per se only. For enforcement purpose, the Multiresidue Methods Section 302 ( Luke Method; Protocol D) picks up parent propiconazole.

Tolerances are established for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on various plant and animal commodities [ 40 CFR § 180.434]. The reassessed tolerances will be expressed as propiconazole per se. As a result, in some cases the tolerance levels will be over estimated, due to the fact that the analytical data collection method is a moiety method that detects all residues convertible to 2,4 dichlorobenzoic acid ( DCBA), and the field data were reported as propiconazole and all its metabolites containing the 2,4 DCBA, as a result, HED is unable to separate out the parent residue from the metabolites at this time. HED recommends that the registrant analyze parent and metabolites separately in all future field trials, so that more realistic tolerances can be set in the future.

With the exception of sunflower, the reregistration requirements for magnitude of the residue in/ on all the raw agricultural commodities ( RACs), based on the currently registered use patterns, will be fulfilled pending label revisions and/ or tolerance adjustments: barley, rye, rice, wheat, sweet corn; field and pop corn, oat, peanut, pineapple, stone fruits, and aspirated grain fractions. As a result of this review, new tolerances are being proposed on several commodities. The reregistration requirements for magnitude of the residue in the processed commodities have been fulfilled, except for pineapple ( juice). A rice processing study has been submitted and reviewed by the Agency as acceptable. The reregistration requirements for data depicting the magnitude of propiconazole residues of concern in meat, milk, poultry, and eggs have been fulfilled. The maximum theoretical dietary burden to livestock has been recalculated due to added new uses. Tolerances in ruminant commodities were reassessed at the existing level, while tolerances for poultry commodities are not required. Plantback restrictions have been established for propiconazole products registered for use on rotatable crops based on the confined rotational crop studies.

Regulatory Recommendations and Residue Chemistry Deficiencies ° Amend the product labels for the 41.8% EC formulations to indicate the propiconazole concentration in terms of lb ai/ gal. In addition, the following products have label restrictions prohibiting the feeding of treated forage and/ or hay of cereals and corn to livestock: the 41.8% EC ( 100 617 and 100 737) and the 45% WP ( 100 780) formulations. Such restrictions are no longer permitted and must be removed.

° The maximum number of applications for peanuts on Stratego   label is not very clear. After discussing with RD and the registrant, it is understood that the maximum number of six applications is intended only for the 7.0 oz ai/ A rate, while the restricted number of application at 14 oz ai/ A is only two. HED recommends that the registrant to amend the Stratego   label to specify these instructions.

° HED is translating the wheat grain, wheat straw, wheat hay and forage data to barley and rye grain, straw, hay and forage. The product labels for the 41.8% EC ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) formulations must be modified to make the use patterns for barley and rye identical to wheat.

° The use directions for rice on all labels should be amended to specify a 45 day PHI .

° HED recommends increasing the wheat grain tolerance to 0.3 ppm, wheat straw to 15.0 ppm, and to propose new tolerances on wheat hay and forage at 2.0 ppm, and on wheat bran at 1.0 ppm.

° A more appropriate level for the oat hay tolerance at 2.0 ppm should be established using data translated from wheat. The reassessed tolerances for barley grain and rye grain should be 0.3 ppm, for barley and rye straw should be 15.0 ppm. New tolerances for barley hay and rye forage should be established at 2.0 ppm.

° The available rice residue data support the established 3.0 ppm tolerance for propiconazole residues in/ on rice straw; however, the data also indicate that the registrant should propose increasing the tolerance for residues in/ on rice grain. An appropriate level for residues in/ on rice grain would be 0.3 ppm. The registrant needs to propose new tolerances on rice grain at 0.3 ppm, rice bran at 1.0 ppm, and rice hulls at 1.2 ppm.   HED recommends a 5.0 ppm tolerance on aspirated grain fractions for propiconazole.

° The use on sunflower for seeds can not be considered non food use, and therefore, no tolerance can be established on sunflower until field trial data are submitted.

  Pineapple processing study is required to determine the potential for concentration in pineapple juice, unless field trails conducted at 5x the maximum application rate indicated that all residues are less than LOQ.

  The registrant has generated virtually all its residue data using a common moiety method that converts the parent and all of the metabolites of concern to 2,4 dichlorobenzoic acid. HED recommends that the registrant analyze parent and metabolites separately in all future field trials, so that more realistic tolerances can be set in the future. PROPICONAZOLE PC Code No. 122101; Case 3125 Reregistration Eligibility Decision ( RED) Document; Residue Chemistry Considerations Updated by EPA June 15, 2006 Contract No. 68 D4 0010 Submitted to: U. S. Environmental Protection Agency Arlington, VA Submitted by: Dynamac Corporation The Dynamac Building 2275 Research Boulevard Rockville, MD 20850 3268 PROPICONAZOLE REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code No. 122101; Case 3125 TABLE OF CONTENTS page INTRODUCTION...................................................................................................................... 2 REGULATORY BACKGROUND ............................................................................................. 2 SUMMARY OF SCIENCE FINDINGS...................................................................................... 3 GLN 860.1200: Directions for Use ................................................................................... 3 GLN 860.1300: Nature of the Residue  Plants................................................................ 17 GLN 860.1300: Nature of the Residue  Animals ............................................................ 18 GLN 860.1340: Residue Analytical Methods................................................................... 22 GLN 860.1360: Multiresidue Methods............................................................................ 22 GLN 860.1380: Storage Stability Data............................................................................ 22 GLN 860.1500: Crop Field Trials.................................................................................... 23 GLN 860.1520: Processed Food/ Feed............................................................................. 25 GLN 860.1480: Meat, Milk, Poultry, Eggs...................................................................... 26 GLN 860.1400: Water, Fish, and Irrigated Crops ............................................................ 28 GLN 860.1460: Food Handling....................................................................................... 29 GLN 860.1850 and 860.1900: Confined/ Field Accumulation in Rotational Crops............ 29 TOLERANCE REASSESSMENT SUMMARY....................................................................... 41 Tolerances Established Under 40 CFR § 180.434.............................................................. 41 Tolerances To Be Proposed Under 40 CFR § 180.434 ...................................................... 42 Time Limited Tolerances Established Under 40 CFR § 180.434( b).................................... 43 Tolerances with Regional Registrations Established Under 40 CFR § 180.434( c) .............. 43 Pending Tolerance Petitions ............................................................................................. 44 CODEX HARMONIZATION................................................................................................... 51 ................................................................................................................................................. 52 AGENCY MEMORANDA RELEVANT TO REREGISTRATION.......................................... 53 MASTER RECORD IDENTIFICATION NUMBERS.............................................................. 67 2 PROPICONAZOLE REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code No. 122101; Case 3125 INTRODUCTION Propiconazole [ 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole] is a systemic broad spectrum fungicide registered for treatment of disease in bananas ( including plantains), barley, celery, corn ( field, pop, and sweet), grasses grown for seed, mint, oats, peanuts, pineapple, rice and wild rice, rye, stone fruits, sugarcane, and wheat. Propiconazole enduse products are marketed in the United States under the trade names Tilt ® , Alamo ® , Banner ® , and Orbit ® . Recently, propiconazole is also registered for use on a variety of crops under the trade names of Stratego   Twin Pak   and Stratego   , which are end use products containing a mixture of trifloxystrobin and propiconazole. The reregistration of propiconazole is being supported by Syngenta ( previously Novartis Crop Protection, Inc.), the basic producer. Uses on mint and mushrooms are being supported by IR 4. The propiconazole formulations registered for food/ feed uses include emulsifiable concentrate ( EC) and flowable concentrate ( FlC) formulations.

REGULATORY BACKGROUND The Propiconazole Phase 4 Review dated 6/ 25/ 92 by B. Cropp Kohlligian, F. Fort, and F. Toghrol and the subsequent Propiconazole Data Call In ( DCI) Notice dated 10/ 6/ 93 summarized the status of available residue chemistry data for the reregistration of propiconazole. The Phase 4 Review identified several data deficiencies including plant and animal metabolism, residue analytical methods, storage stability, and magnitude of the residue in plants. Several studies have been submitted and evaluated in response to the Propiconazole DCI; in addition, uses on a number of crops have been registered since the issuance of the Phase 4 Review. This document presents an overall and up to date Residue Chemistry Science Assessment with respect to the reregistration of propiconazole.

Tolerances are established for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on various plant and animal commodities [ 40 CFR § 180.434]. The established permanent tolerances for plant and animal commodities [ 40 CFR § 180.434( a)] range from 0.05 ppm ( milk) to 40 ppm ( grass hay). Timelimited tolerances, due to expire 12/ 31/ 05, are established for cranberry, dry bean forage, dry bean hay, and dry beans. In addition, time limited tolerances, due to expire 06/ 30/ 05, are established for aspirated grain fractions ( 20 ppm), sorghum grain, and stover [ 40 CFR § 180.434( b)]. Timelimited tolerances are being recommended to established in/ on soybeans at 0.5 ppm, in/ on soybean forage at 8 ppm, and in soybean hay at 25 ppm. And in/ on blueberry at 1.0 ppm. Tolerances 3 with regional registration are also established for mint at 0.3 ppm and wild rice at 0.5 ppm [ 40 CFR § 180.434( c)]. No tolerances are established for rotational crops [ 40 CFR § 180.434( d)]. This document does not include recently submitted petitions.

SUMMARY OF SCIENCE FINDINGS GLN 860.1200: Directions for Use According to an OPPIN search, there are 228 active registrations for propiconazole, and a total of six active Syngenta end use products ( see Table A1) containing the active ingredient propiconazole which are registered for use on domestically grown food/ feed crops. In addition, there are 36 SLN registrations for use of propiconazole on food/ feed crops.

A comprehensive summary of propiconazole food/ feed use patterns, based on the product labels registered to Syngenta, is presented in Table A2. A tabular summary of the residue chemistry science assessments for the reregistration of propiconazole is presented in Table B. The status of reregistration requirements for each guideline topic listed in Table B is based on the use patterns registered by the basic producer, Syngenta Crop Protection, Inc.

Table A1. Propiconazole End Use Products with Food/ Feed Uses Registered to Syngenta Crop Protection.

EPA Reg. No. Label Acceptance Date 1 Formulation 2 Product Name 100 617 3 3/ 99 ( 10/ 16/ 97) 41.8% ( 3.6 lb/ gal) EC Tilt ® Fungicide 100 702 9/ 96 41.8% ( 3.6 lb/ gal) EC Break   EC Fungicide 100 737 4 11/ 95 41.8% ( 3.6 lb/ gal) EC Tilt ® 428C or 428GS Fungicide 100 780 8/ 99 45% WP Tilt ® 45W 100 781 9/ 96 45% WP Break   Fungicide 3125 562 5 6/ 01 11.4% EC Stratego 1 Date of the most recently EPA approved label found by reviewer in the product jacket or Pesticide Product Label System ( PPLS). 2 None of the labels for the 41.8% EC formulations specify concentration in terms of lb ai/ gal; the value in parentheses is based on historical data. 3 Including SLN Nos. AL980003, AR980001, AR990002, DE980002, FL880016, GA980003, IA990002, ID950012, ID980004, IL980001, IL990006, IL990008, IN980003, IN990003, KS980002, KS990008, KY980002, MI980001, MI990003, MN980003, MN990014, MO980003, MS980004, NE990006, ND980002, OH980002, TN980004, TX980001, VA980003, WA950033, WA980018, and WI990015. 4 Also packaged as Tilt ® Gel in water soluble packets. Including SLN Nos. OR960013 and OR960007. 5 Including ND 010009, MN 010007, OH 02001, WA 030015, KS 010002, VA 100002, TX010009, AR 010005, GA 010002, IN 020001, AL 000003 In addition to the products listed above, SLN products HI910009 and PR930001, registered for use on bananas, are formulated from an unregistered source product, Tilt ® 250 EC Fungicide. Included in the product jackets for these products are Confidential Statements of Formula for the 4 source product. We note that information reflecting the active ingredient content in terms of lb ai/ gal is not presented on either label.

The above labels specify a re entry interval ( REI) of 24 hours, except for the 45% WP ( EPA Reg. Nos. 100 780 and 100 781) formulations which specify an REI of 12 hours.

The 41.8% EC ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) are the only products currently registered for use on rotatable crops. Labels for these formulations specify that soybeans may be planted as a double crop following a cereal crop which has been treated with the product, but soybean hay, forage, and fodder may not be used as any component of animal feed or bedding. The labels specify that any food/ feed crops not listed on the label should not be planted within 105 days of treatment.

Syngenta is required to amend the product labels for the 41.8% EC formulations to indicate the propiconazole concentration in terms of lb ai/ gal. In addition, the following products have label restrictions prohibiting the feeding of treated forage and/ or hay of cereals and corn to livestock: the 41.8% EC ( 100 617 and 100 737) and the 45% WP ( 100 780) formulations. Such restrictions are no longer permitted and must be removed. Label amendments are also required to incorporate the parameters of use patterns reflected in the submitted field trials; details of the crop specific label amendments are presented in the respective endnotes for each crop ( GLN 860.1500: Crop Field Trials) in Table B.

Propiconazole can be mixed with other fungicides. Formulations which contain both propiconazole and trifloxystrobin ( e. g. Stratego   Twin Pak   and Stratego   Fungicide, EPA Reg. Nos. 264 779 ) have been registered for uses on corn, peanuts, pecans, rice, and wheat. The use patterns are shown in Table A2. These uses were registered based on reviews of trifloxystrobin. Residue data for trifloxystrobin were reviewed in PP# 9F5070 ( DP Barcodes D254213, D254217, D254218, and D254221, 4/ 6/ 00, L. Cheng). After comparing the use rates of Stratego   Twin Pak   and Stratego   on corn, peanuts, pecans and rice to the use rates which current tolerances on corn, peanuts, pecans and rice are based on, HED concludes that the Stratego   use rates on these crops are below the use rates which tolerances are based on, except for wheat. Residue data for propiconazole on wheat have been recently reviewed by Y. Donovan ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). Since there are adequate field trial data to support Section 3 registration of propiconazole uses on wheat at the rate of 0.08  0.11 lbs ai/ A/ application, maximum 2 applications, and 35 day PHI ( HED memo of 02/ 02/ 05, Y. Donovan, D271790), HED can support the label use direction changes provided that the existing tolerances on wheat RAC are raised. These new reassessed tolerances will cover all 24C uses on wheat as well. HED recommends to cancel all 24C uses while revising the Section 3 label to include these 24C uses.

HED notice that the maximum number of applications for peanuts on Stratego   label is not very clear. After discussing with RD and the registrant, it is understood that the maximum number of six applications is intended only for the 7.0 oz ai/ A rate, where the 5 restricted number of application at 14 oz ai/ A is only two. HED recommends that the registrant to amend the Stratego   label to specify these instructions.

HED is translating the wheat grain, wheat straw, wheat hay and forage data to barley and rye grain, straw, hay and forage. The product labels for the 41.8% EC ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) formulations must be modified to make the use patterns for barley and rye identical to wheat.

For the purpose of generating this Residue Chemistry Science Chapter, HED examined the registered food/ feed use patterns of the basic producer and reevaluated the available residue chemistry database for adequacy in supporting these use patterns. When end use product DCIs are developed ( e. g., at issuance of the RED), RD should require that all end use product labels ( e. g., MAI labels, SLNs, and products subject to the generic data exemption) be amended such that they are consistent with the basic producer labels.

The use directions for rice on all labels should be amended to specify a 45 day PHI ( HED memo of 02/ 23/ 05, T. Morton, D240856). 6 Table A2 Food/ Feed Use Patterns on EP Labels Subject to Reregistration for Propiconazole ( Case 3125).

Site Application Type Application Equipment Formulati on 1 [ EPA Reg.

No.] Maximum Single Application Rate ( lb ai/ A) Maximum Number of Applications Per Season Maximum Seasonal Rate ( lb ai/ A) Preharvest Interval ( days) Use Directions and Limitations 2 Bananas and Plantains Preharvest foliar Ground 41.8% EC [ PR40005] 0.086 8 NS NS Apply before disease symptoms appear at the onset of the rainy season. Apply 3 fl. oz. per acre. Apply no more than 2 consecutive applications on a 21 25 day. Apply up to 8 applications. Applications should be made using an orchard oil and an emulsifier.

Applications within 100 yards of non bagged bananas or directly to non bagged bananas are prohibited.

celery Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.1125 4 0.45 14 Apply multiple treatments on a 7 day schedule. May be tank mixed with a spreader sticker. Applications should be made using a minimum of 10 ( ground) or 5 ( aerial) gal of water/ A.

Foliar Quilt [ 100 1178] 0.1138 NS 0.45 7 Aerial, ground, and sprinkler irrigation Cereals ( Including Wheat, Barley, Triticale, and Rye) 7 Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.1125 NS 0.167 NS Highest yields when applied to the emerging flag leaf; do not apply after the ligule of the flag leaf emerges ( Feekes growth stage 9) on barley , rye, oats and triticale. For wheat only, Tilt can be applied until full head emergence ( Feekes growth stage 10.5).

Grazing or feeding livestock treated forage or cutting the green crop for hay or silage is prohibited; following harvest, straw may be used for bedding or feed. Applications should be made in a minimum of 10 ( ground)

or 5 ( aerial) gal. of water/ A.

Corn ( Including Field Corn, Field Corn Grown for Seed, Sweet Corn, and Popcorn)

Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.1125 NS 0.45 14 ( sweet corn) Treatment should be started when disease appears and repeated on a 7 to 14 day schedule. Application to field corn and field corn grown for seed after silking is prohibited. Harvest of forage from field corn, field corn grown for seed, and popcorn within 30 days of application and of sweet corn forage within 14 days of application is prohibited. Applications should be made in a minimum of 10 ( ground) or 5 ( aerial) gal of water/ A. 8 Preharvest foliar Ground or aerial ( post silk) 41.8% EC ( 3.6 lb ai/ gal)

[ LA990002]

[ KS030002]

[ MN990014]

[ NE990006]

[ IL040004] 0.1125 NS 0.45 14 ( sweet corn)

30 ( seed,

field, and popcorn) Treatment should be started when disease appears and repeated on a 7 to 14 day schedule. Feeding livestock treated forage or fodder and harvest of sweet corn forage within 14 days of application are prohibited.

Applications should be made in a minimum of 10 ( ground) or 5 ( aerial) gal of water/ A.

Between V4 to after silking Stratego R [ 264 779] 0.1125 NS 0.29 30( forage ) before silking Corn Grown for Seed ( See Also " Corn")

Preharvest foliar Ground or aerial, and sprinkler irrigation 41.8% EC ( 3.6 lb ai/ gal)

[ IN990003] 0.1125 NS 0.45 30 Treatment should be started when disease appears and repeated on a 7 to 14 day schedule. Making more than two applications after 50% silk and feeding livestock treated forage or fodder are prohibited. Applications should be made in a minimum of 10 ( ground) or 5 ( aerial) gal of water/ A.

Preharvest foliar? Tilt 0.1125 NS 0.45 7 When disease first appears. Aerial, ground,

and sprinkler irrigation.

Grasses Grown for Seed 9 Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.225 ( 0.1125 bluegrass) NS 0.9 20 Use is limited to ID, MN, NE, OR, and WA.

Apply multiple treatments on a 14 to 21 day schedule. The feeding of treated hay is prohibited within 20 days of the last application, and the grazing of treated areas is prohibited within 140 days. Applications should be made in a minimum of 20 ( ground)

or 10 ( aerial) gal of water/ A.

Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ ID950012]

[ OR050012]

[ WA950033]

[ IN990003]

[ NV010004]

[ MT030004] 0.225 2 0.45 20 Apply just prior to anthesis. Make second application 7 10 days later. Should be tank mixed with an appropriate surfactant. The feeding of treated hay is prohibited within 20 days of the last application, and the grazing of treated areas is prohibited within 140 days.

Applications should be made in a minimum of 20 ( ground) or 10 ( aerial) gal of water/ A.

Mint Preharvest foliar Ground 41.8% EC ( 3.6 lb ai/ gal)

[ OR050011] 0.1125 NS 0.225 90 Apply when plants are 2 4" high. Make second application 10 14 days later.

Applications should be made in a minimum of 20 gal of water/ A.

Nectarines ( See " Stone fruits")

Oats Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617] 0.1125 NS 0.1125 40 Highest yields when applied to the emerging flag leaf; do not apply after the ligule of the flag leaf emerges ( Feekes growth stage 8).

Applications should be made in a minimum of 10 ( ground) or 5 ( aerial) gal of water/ A.

Peaches ( See " Stone fruits") 10 Peanuts Preharvest foliar Chemigation or directed ground 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

45% WP [ 100 780] 0.225 2 0.45 21 Apply to crown and pegging zones. Begin applications 45 or 60 days after planting or at the first appearance of disease; make second application 14 days or 3 4 weeks later.

Grazing livestock or feeding hay or threshings to livestock are prohibited.

Applications should be made in a minimum of 20 ( ground) gal of water/ A.

Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.1125 NS 0.45 14 Begin applications 35 40 days after planting and repeat on a 10 to 14 day schedule.

Grazing of livestock or feeding green vines to livestock is prohibited. Applications should be made in a minimum of 10 20 ( ground) or 5 ( aerial) gal of water/ A.

Preharvest foliar Ground or aerial Stratego R [ 264 779] 0.1134 6 0.68 14 Pecans Preharvest foliar Ground or aerial Stratego R [ 264 779]

Tilt [ 100 617]

Quilt [ 100

1192] 0.081 NS 0.24 30 Apply on a 14 day schedule during bud break, prepollination sprays, or during nut formation and cover sprays. Use higher rates when disease pressure is heavier. Do not apply after shuck split. Grazing of livestock in treated areas or cutting treated cover crops for feed is prohibited. Application should be made using a minimum of 20 gal. of water/ A.

Pineapple 11 Postharvest Cold or hot water dip ( Seed treatment) 45% WP [ 100 780] 0.1125 lb ai/ 500 gal water N/ A N/ A N/ A Use is limited to HI; immerse or soak crowns for control of disease. Feeding livestock treated crowns or grazing livestock on growing plants or tops before fruit is harvested is prohibited.

Plantains ( See " Bananas and Plantains")

Plums ( See " Stone fruits")

Rice Preharvest foliar Aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737] 0.2813 2@ 0.1688 lb ai/ A or 1@ 0.2813 lb ai/ A NS NS If   5% of tillers are infected, two applications should be made, the first application at first internode elongation ( up to 2 inch panicle)

and the second at swollen boot ( 10 14 days following the first but before the boot splits and head emerges). If greater than 10% of the tillers are infected, the higher single application rate should be made at first internode elongation. Use is prohibited in CA and areas of the following AR counties:

Mississippi, Poinsett, Cross, St. Francis, and Lee. The following are prohibited: use in rice fields where commercial farming of crayfish is practiced; draining water from treated rice fields into ponds used for commercial catfish farming; application to stubble or ratoon crop rice; and use of water drained from treated fields to irrigate other crops. Applications should be made in a minimum of 5 gal of water/ A.

Stratego R [ 264 779] 0.16 NS 0.31 35 12 Rye ( See " Cereals")

Stone Fruits ( Sweet or tart Cherry, Apricots, Nectarines, Peaches, and Plums or Prune)

Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 702]

45% WP [ 100 781] 0.1125 2 Not Specified ( NS) 0 Use is restricted to West of the Rocky Mountains for EPA reg# 100 781. Two applications may be made during the period beginning 10 14 days before harvest through the day of harvest; or the first application may be made at early bloom stage. A second application may be made as needed through petal fall. Applications should be made using a minimum of 50 ( ground) or 20 ( aerial) gal of water/ A.

Sugarcane Postharvest Cold or hot water dip 45% WP [ 100 780] 0.1125 lb ai/ 500 gal water N/ A N/ A N/ A Use of the federal label is limited to HI.

Immerse or soak cut seed pieces for control of disease. Use of treated seed pieces for food or feed is prohibited.

Sunflower ( Breeder's seed)

Foliar spray Tilt [ IL050002]

[ TX000006] 0.1125 0.45 N/ A N/ A Foliar spray, When disease first appears. 7

day retreatment interval.

Wheat ( See also " Cereals") 13 Preharvest foliar Ground or aerial 41.8% EC ( 3.6 lb ai/ gal)

[ AR990002]

[ GA980003]

[ ID980004]

[ IN980003]

[ MI980001]

[ MN980003]

[ MS980004]

[ VA980003]

[ WA980018]

Tilt [ 100 617]

[ AR030008]

[ MO980003]

[ KS030001]

[ OK010002]

[ TN030002]

[ OH040002]

[ DE030003]

[ KY050002] 0.1125 NS 0.1125 40 Highest yields when applied to the emerging flag leaf; do not apply after full head emergence ( Feekes growth stage 10.5).

Grazing or feeding livestock treated forage or cutting the green crop for hay or silage is prohibited; following harvest, straw may be used for bedding or feed. Applications should be made in a minimum of 15 ( ground)

or 5 ( aerial) gal of water/ A. 14 Wheat ( cont'd.)

Preharvest foliar Ground or aerial Quilt [ 100

1178]

[ AR050001]

[ WA040026]

[ MS040011]

[ AL040002]

[ OK040001]

[ GA040003]

[ TN040004]

[ MO040006]

[ TX040022]

[ ID050007] 0.1125 NS 0.1125 40 Highest yields when applied to the emerging flag leaf; do not apply after late boot, sheath split stage ( Feekes growth stage 10.0).

Grazing or feeding livestock treated forage or cutting the green crop for hay or silage is prohibited; following harvest, straw may be used for bedding or feed. Applications should be made in a minimum of 15 ( ground)

or 5 ( aerial) gal of water/ A.

Trifloxystrobin registration ( coactive ingredient with propiconazole) Stratego R [ 264 779] 0.081 2 0.162 35 ( grain)

30 ( forage)

45 ( hay)

35 ( straw) 15 Preharvest foliar Ground or aerial ( Section 24C) Stratego [ 3125 562)

ND 010009 MN 010007 OH 02001 WA 030015 KS 010002 VA 100002 TX010009 AR 010005 GA 010002 IN 020001 AL 000003 0.081 1 0.081 35 ( grain)

30 ( forage)

45 ( hay)

35 ( straw)

Wild Rice Preharvest foliar Aerial 41.8% EC ( 3.6 lb ai/ gal)

[ 100 617]

[ 100 737]

45% WP [ 100 780] 0.225 2@ 0.1688 lb ai/ A or 1@ 0.225 lb ai/ A NS NS Use is limited to MN. Applications should be made at booting and heading, or a single application may be made at the higher rate at booting. Use of water drained from treated rice fields to irrigate other crops is prohibited. Applications should be made in a minimum of 5 gal of water/ A.

Note:

1 The 41.8% EC formulations have been determined to contain 3.6 lb ai/ gal of propiconazole based on historical data.

2 Product labels specify a re entry interval ( REI) of 24 hours, except for the 45% WP ( EPA Reg. Nos. 100 780 and 100 781) formulations which specify an REI of 12 hours. Propiconazole may be tank mixed with other fungicides; however labels for EPA Reg. Nos. 100 702 and 100 781 state that tank mixing with Cyprex ® may cause crop injury.

³ The 41.8% EC ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) are the only products currently registered for use on rotatable crops. The labels for these formulations state that soybeans may be planted as a double crop following a cereal crop which has been treated with the product, but soybean hay, forage, and fodder may not be used as any component of animal feed or bedding. The labels specify that any food/ feed crops not listed on the label should not be planted within 105 days of treatment. 16 GLN 860.1300: Nature of the Residue  Plants Previous metabolism studies on peanuts, wheat, grapes, and rice demonstrated that similar metabolites were present in both the primary and rotational crops; however, quantitative information was not provided to calculate the percentage of uncharacterized residues. The Propiconazole Phase 4 Review required that additional metabolism studies be conducted on wheat, bananas, and pecans; however, on further consideration of the original data for peanuts, wheat, grapes, and rice, the Agency concluded ( DP Barcode D198815, 4/ 26/ 94, F. Fort) that an additional celery metabolism study would be adequate to determine the metabolic pathway in plants. Because only a small amount of propiconazole was metabolized in celery, the registrant submitted an additional wheat metabolism study to further delineate the nature of the residue of propiconazole in plants. The reregistration requirements for plant metabolism are fulfilled based on acceptable metabolism studies reflecting foliar treatment of propiconazole on celery and wheat.

Available plant metabolism data ( primary and rotated crops) show that plants absorb, metabolize and translocate propiconazole throughout the plant. A major metabolic pathway in plants appears to be hydroxylation ( primarily of the beta carbon) of the n propyl group on the dioxolane ring of the cis/ trans isomers of propiconazole. These metabolites appear to readily form sugar conjugates. The majority of TRR was found in the stalks, such as peanut stalk, wheat forage and straw, grape leaves, and celery stalks. A possible alternative pathway involves reductive deketalization of the dioxolane ring and sugar conjugation of the resulting metabolite. The alkyl bridge between the phenyl and triazole rings is metabolized and free triazole, as 1H 1,2,4 triazole, is released. The freetriazole is readily conjugated with the amino acid, serine/ alanine, forming triazole aniline which is further metabolized to triazole acetic acid possibly through the intermediate formation of triazole lactic acid. As mentioned earlier, the triazole issue will be addressed separately. The HED MARC concluded that residues of propiconazole and all its metabolites containing the 2,4 dichlorophenyl moiety ( 2,4 DCBA), including conjugates, are of concern and should be included in the dietary ( food) risk assessments for propiconazole, due to the fact that the registrant has generated virtually all its residue data using a method that converts the parent and all of the metabolites of concern to a common moiety, 2,4 DCBA. MARC was in agreement that the metabolites that have the basic structure of propiconazole ( e. g. alkanol, betahydroxy and conjugates) would likely exhibit some of the same toxicity as the parent compound, but would not likely be more toxic than the parent compound. For the purposes of risk assessment HED would assume these metabolites would have equal toxicity as the parent compound. ( The conjugates are included because of the possibility they could be hydrolyzed in the stomach to the unconjugated form). Only residues of propiconazole per se should be included in the dietary ( water) risk assessments ( HED memo of 04/ 04/ 02, B. Cropp Kohlligian, D279299). For tolerance expression, MARC concluded that the current tolerance expression for propiconazole should be amended to include residues of propiconazole per se only for the following reasons: 1) there are a number of pesticides that have 2,4 DCBA as common metabolite. An enforcement agency may not be able to determine if residues are due to misuse of propiconazole or the proper use of other pesticides containing 2,4 DCBA; 2) the FDA 17 multiresidue method detects parent only; 3) to harmonize with the Codex MRL which includes parent only. In rotational crops, the most blatent misuse of propiconazole would be application to unlabeled crops. If rotational crop tolerances are expressed in terms of parent, then any residues of propiconazole on rotated crops would likely be due to direct application to these crops.

GLN 860.1300: Nature of the Residue  Animals The reregistration requirements for animal metabolism are fulfilled based on acceptable goat and poultry metabolism studies. These studies were initially reviewed in conjunction with the following tolerance petitions: PP# 4F3007, PP# 1F3974, and PP# 8F3674 ( poultry), and were summarized in the Propiconazole Phase 4 Review. For one ruminant study, three lactating goats received [ phenyl 14C] propiconazole at 67 92 ppm for four consecutive days in feed. The dosing levels correspond to 2.5 3.3x the maximum theoretical dietary burden to dairy cattle ( see " Meat, Milk, Poultry, Eggs"). The parent ( 1.7 13.9% TRR), and metabolites CGA 118244 ( 9.4 34% TRR), and CGA 91305 ( 15.9 31.3% TRR) were identified in the organic extract of tissues; metabolites CGA 118244 ( 23% TRR) and CGA 91305 ( 24% TRR) were also identified in milk. In addition, an unknown was quantitated ( 6.2 31.1% TRR) in goat tissues. In a second ruminant study, a single goat was fed [ triazole 14C] propiconazole at 4.53 ppm ( 0.2x) for 10 days. The TRR in tissues and milk ranged from 0.01 ppm in muscle to 0.96 ppm in liver; TRR in milk were 0.015 ppm. On further analysis of subsamples of milk and liver, sulfate and glucuronide conjugates were found in milk, and conjugation with amino acids was suggested in liver; propiconazole per se was not identified in milk or liver.

For the poultry study, four laying hens received [ phenyl 14C] propiconazole at 67 ppm for eight consecutive days in feed. The dosing level corresponds to 560x the maximum theoretical dietary burden to poultry. The parent ( 1.4 39.0% TRR), and metabolites CGA 118244 ( 1.5 50.0% TRR), and CGA 91305 ( 17.7 78.6% TRR) were identified in the organic extracts of tissues and eggs.

MARC concluded that parent and all metabolites convertible to 2,4 DCBA are residues of concern for risk assessment, since the analytical method is a moiety method that detects all residues convertible to 2,4 dichlorobenzoic acid ( DCBA). For tolerance expression, MARC concluded that the current tolerance expression for propiconazole should be amended to include residues of propiconazole per se only for the same reasons as described above in plants. In addition, if only propoiconazole per se is regulated, there will not likely be a need for meat and milk tolerances; only meat by products would likely require a tolerance. Should there be detectable residues of the parent compound in meat and milk, it would most certainly be as a result of a misuse.

The chemical names and structures of propiconazole and its metabolites in animal commodities are depicted in Figure A.

HED MARC Meeting Summary Chart 18 Chemical: Propiconazole Date: 18 Dec 2001, and 08 Jan 2002 Residues of Concern Matrix For Risk Assessment

For Tolerance Expression Plants Parent plus all metabolites convertible to 2,4 DCBA Parent only Rotational crop Parent plus all metabolites convertible to 2,4 DCBA Parent only Livestock: Parent plus all metabolites convertible to 2,4 DCBA Parent only Water Parent only N/ A

Triazole is also residue of concern, but it will be addressed separately. 19 Figure A. Chemical Names/ Codes and Structures of Propiconazole Residues of Concern in Plant and Animal Commodities.

Common Name/ Code Chemical Name Chemical Structure Matrices Propiconazole; CGA 64250 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole Cl Cl O O N N N CH 3 Celery Wheat forage, straw, chaff and grain Goat liver, kidney, muscle, and fat Poultry eggs, liver, kidney, muscle, and fat CGA 91304 Cl Cl O N N N Celery Wheat forage, straw, chaff, and grain CGA 91305 Cl Cl OH N N N Celery Wheat forage, straw and chaff Goat milk, liver, kidney, muscle, and fat Poultry eggs, liver, kidney, muscle, and fat CGA 118244 Cl Cl O O N N N CH 3 OH Celery Wheat forage, straw, chaff, and grain Goat milk, liver, kidney, muscle, and fat Poultry eggs, liver, kidney, muscle, and fat CGA 118245 Wheat forage, straw, chaff, and grain 20 Common Name/ Code Chemical Name Chemical Structure Matrices Cl Cl O O N N N OH CGA 136735 Cl Cl O O N N N CH 3 O H Wheat straw GB XLIII 42 1 Wheat forage and straw 21 GLN 860.1340: Residue Analytical Methods Plant commodities: Residue methods AG 454, AG 454B and AG 626 ( both are modification of method AG 454) were used to determination residues of propiconazole and its metabolites on samples of raw agricultural and processed commodities from field trials and processing studies. The methods use a single moiety detection in which residues are converted to 2,4 DCBA, determined as the 2,4 DCBA methyl ester, and reported as propiconazole equivalents using a conversion factor of 1.79. The reported method LOQ is 0.05 ppm. Concurrent method recoveries were acceptable.

In the Phase 4 Review, the registrant was required to conduct enforcement method validation for Method AG 454A using bananas. These data are no longer needed.

For enforcement purposes, residue method AG 354 is available for the determination of propiconazole per se in/ on plant commodities using gas chromatography and flame ionization detection, and the reported LOQ is 0.05 ppm. The Multiresidue Methods Section 302 ( Luke Method; Protocol D) picks up parent propiconazole as well.

Animal commodities: Residue methods AG 517 and AG 629 ( a modification of method AG 517) were used for determination of propiconazole and its metabolites in animal commodities. The methods use a single moiety detection in which residues are converted to 2,4 DCBA, determined as the 2,4 DCBA methyl ester, and reported as propiconazole equivalents using a conversion factor of 1.79. The method LOQ is 0.05 ppm for residues in meat, poultry, and eggs and 0.02 ppm for residues in milk. Samples from the ruminant and poultry feeding studies were analyzed using method AG 359 ( an early version of method AG 517) and method AG 517. For enforcement purpose, the Multiresidue Methods Section 302 ( Luke Method; Protocol D) picks up parent propiconazole.

GLN 860.1360: Multiresidue Methods The reregistration requirements for multiresidue method testing for residues of propiconazole and its metabolites are satisfied. The 10/ 99 FDA PESTDATA database ( PAM Volume I, Appendix I) indicates that propiconazole is completely recovered (> 80%) using Multiresidue Methods Section 302 ( Luke Method; Protocol D). The recovery of propiconazole metabolites CGA 91305, CGA 118244, and 1,2,4 triazole is variable using Section 302. Propiconazole and metabolites CGA 91305, CGA 118244, and 1,2,4 triazole are not recovered using Multiresidue Methods Sections 303 ( Mills, Onley, and Gaither; Protocol E, nonfatty) and 304 ( Mills, fatty food).

GLN 860.1380: Storage Stability Data The reregistration requirements for storage stability data are satisfied. Adequate storage stability data for plant and animal commodities have been submitted and evaluated. 22 Plant commodities: Several storage stability studies have been submitted and evaluated. These studies showed that fortified residues of propiconazole and its metabolites determined as 2,4 DCBA are stable under frozen storage conditions in/ on: ( i) peaches, bananas, corn meal, wheat grain, celery, corn oil, and peanut nutmeat, hay, and hulls for up to 36 months at  200C; ( ii) carrots for up to 10 months at  20 0C; and ( iii) soybeans and soybean fodder for up to 4 and 6 months, respectively, at  15 0C. Weathered residues of propiconazole and metabolites were found to be stable under frozen storage conditions in/ on: ( i) grass forage, straw, and seed for up to 39 months at  20 0C; ( ii) wild rice and stone fruits for up to 25 months frozen ( temperature unspecified); ( iii) peanut shells and fodder for 25 months at  15 0C; and ( iv) extracts of silagestage corn forage and soybeans for 3 and 8 months, respectively, at 4 C. These storage stability data are adequate to validate the storage intervals and conditions of samples collected from field and processing studies.

Animal commodities: In response to the Propiconazole Phase 4 Review, data were submitted showing no degradation of residues in propiconazole in animal commodities following storage for four years. Data submitted in support of the goat and hen metabolism studies demonstrated that residues of propiconazole were stable in the following frozen matrices: goat urine for ~ 7 months, goat tissues for up to 11 months, and extracts of egg whites, yolks, and poultry muscle for up to 6 months. These data are adequate to validate the storage intervals of animal commodity samples collected from the feeding studies.

GLN 860.1500: Crop Field Trials The reregistration requirements for magnitude of the residue in/ on the following raw agricultural commodities ( RACs), based on the currently registered use patterns, will be fulfilled pending label revisions and/ or tolerance adjustments: barley, rye, rice, wheat, sweet corn; field and pop corn, oat, peanut, pineapple, stone fruits, and aspirated grain fractions. We note that the submitted field trial data for sugarcane indicate that treatment of sugarcane seed pieces according to the currently registered use pattern can be considered a non food use.

Overall, adequate field trial data depicting propiconazole residues of concern following treatments according to the maximum registered use patterns of the representative formulations that are being supported have been submitted for the RACs listed above, or have been translated where appropriate. The available crop field trials reflecting use of registered formulations at 1x the maximum label rate showed finite residues of propiconazole and its metabolites determined as 2,4 DCBA and expressed as parent in/ on the RACs of all crops for which registration exists except for mushrooms, pecans, and sugarcane; residues concentrated 10.4x in wheat aspirated grain fractions. Details of any required label amendments are presented in the endnotes for GLN 860.1200 ( Directions for Use) and respective crop sections for GLN 860.1500 ( Crop Field Trials) of Table B. Refer to " Tolerance Reassessment Summary" section for recommendations with respect to established tolerance levels. 23 Residue data for uses of Stratego   Twin Pak   and Stratego   Fungicide formulations on wheat have been submitted and reviewed ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). These data support Section 3 registration of propiconazole use on wheat with the use pattern of 0.08 lbs  0.11 lbs ai/ A/ application, maximum of two applications per growing season, and with 35 day PHI ( covers Stratego   Twin Pak   and Stratego   Fungicide formulations on wheat). The residue data also covers all 24 C wheat use patterns. These uses have higher maximum seasonal rate compared to currently registered propiconazole formulations ( maximum single application of 0.11 lb ai/ A, maximum of one application per growing season, PHI 40 days). Therefore, for the purpose of reregistration, the wheat RAC tolerances should be reassessed using data from the current submission. Based on the cited field trials associated with Stratego   Twin Pak   and Stratego   uses, HED recommends increasing the wheat grain tolerance to 0.3 ppm, wheat straw to 15.0 ppm, and to propose new tolerances on wheat hay and forage at 2.0 ppm.

As mentioned under Directions for Use, Stratego   Twin Pak   and Stratego   Fungicide ( EPA Reg. Nos. 264 779 ) have been registered for uses on corn, peanuts, pecans, rice, and wheat based on reviews of trifloxystrobin. After comparing the use rates of Stratego   Twin Pak   and Stratego   on corn, peanuts, pecans and rice to the use rates which current tolerances on corn, peanuts, pecans and rice are based on, HED concludes that except for wheat, the rest of crops have lower use rates on Stratego   label than the propiconazole application rates used in the crop field trials used to set the original tolerances. HED concludes that the current tolerances support the Stratego   label.

The Agency now recommends that wheat hay data be translated to oats to establish a more appropriate level for the oat hay tolerance at 2.0 ppm.

HED is translating the wheat grain, wheat straw, wheat hay and forage data to barley and rye grain, straw, hay and forage. Therefore, no further data requirements are needed. The reassessed tolerances for barley grain and rye grain should be 0.3 ppm, for barley and rye straw should be 15.0 ppm. New tolerances for barley hay and rye forage should be established at 2.0 ppm.

The available rice residue data support the established 3.0 ppm tolerance for propiconazole residues in/ on rice straw; however, the data also indicate that the registrant should propose new tolerance for residues in/ on rice grain. An appropriate level for residues in/ on rice grain would be 0.3 ppm ( HED memo of 02/ 23/ 05, T. Morton, D240856).

A Section 18 risk assessment has been conducted by RD ( S18 request from the States of Minnesota and South Dakota for use of propiconazole on soybeans to control soybean rust). It was recommended that time limited tolerances of 0.5 ppm in/ on soybeans, 8 ppm in/ on soybean forage, and 25 ppm in soybean hay be established ( Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299). 24 A Section 18 risk assessment has been conducted by RD ( S18 request from the States of Maine for use of propiconazole on blueberry). It was recommended that time limited tolerances of 1.0 ppm in/ on blueberry be established. ( Agency memo of 02/ 22/ 05, D. Rate, D313289).

Among all the 24C requested uses, the only tolerances required to be reassessed are mint, corn, sunflower, and banana. The rest can be considered non food uses. The use on sugarcane seed pieces is considered non food due to the fact that it takes 18 months from planting to harvesting of sugar canes ( conversation with Bernie Schneider, 02/ 03/ 05). The use on sunflower for seeds can not be considered non food use, and therefore, no tolerance can be established on sunflower until field trial data are submitted. Field trial data for bananas were generated in Honduras, Republic of Ivory Coast, Martinique, and Belize. With one exception, residues did not exceed the tolerance following 1 13 aerial or ground applications of a 250EC formulation at 41 g ai/ A/ application (= 0.90 lbs ai/ A/ application). The only registered uses are in Hawaii and Puerto Rico( 24C), with the rate of 0.084 lbs ai/ A/ application and maximum 8 applications. HED concludes that the existing tolerance on banana is adequate GLN 860.1520: Processed Food/ Feed The reregistration requirements for magnitude of the residue in the processed commodities of the following crops have been fulfilled: barley, corn, mint, oats, peanut, plums, rye, and wheat. The available data indicate that residues do not concentrate significantly in corn wet milled and drymilled processed fractions; mint oil; rolled oats, hulls, groats, oat flour, fines, light impurities, bran, and feed oats; peanut meal, soapstock, crude and refined oil, and peanut presscake; dried prunes; and wheat flour, middlings, shorts, and germ.

The most recent wheat processing study ( HED memo of 02/ 02/ 05, Y. Donovan, D271790) indicated that total propiconazole residues do not concentrate in germ, middlings, low grade flour, and patent flour processed from whole wheat grains bearing either nondetectable (< 0.05 ppm) or measurable residues, and therefore, no tolerances are needed on these commodities. The average concentration factor of residues in wheat bran is 3.3x. The maximum expected residues of total propiconazole in wheat bran is 0.99 ppm which is determined by multiplying the average concentration factor of 3.3x with the highest average field trial ( HAFT) residue value of 0.3 ppm. A tolerance for wheat bran at 1.0 ppm is needed.

A new rice processing study has been submitted and reviewed as acceptable by the Agency ( MRID 45080811. DER2), the review indicated that the concentration factor for rice bran is 2.9x, for rice hulls is 3.8x, and for polished rice is 0.12x. The registrant needs to propose new tolerances for rice bran at 1.0 ppm and for rice hulls at 1.2 ppm.

Aspirated wheat grain fractions 25 Composition of AGF: Corn 46%, wheat 32%, soybean 16%, sorghum 6% ( reference from ChemSAC minute 05/ 01/ 02).

The average concentration factor of residues in aspirated wheat grain fraction is 13.7x from the new submitted processing study ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). Based on the field trials, the proposed tolerance on wheat grain is 0.3 ppm, and therefore, the maximum AGF residue would be 4.3 ppm. The maximum expected propiconazole residues in soybean aspirated grain fractions would be 3.5 ppm ( memo of 03/ 10/ 05, T. Morton, D246884). A 20 ppm AFG tolerance was established on barley based on a Section 18 use on barley, which is based on the tolerance level for grain sorghum grain ( 0.2 ppm), and the maximum concentration factor of 100x. This Section 18 tolerance will expire on 06/ 30/ 05. No data are yet available on aspirated grain fractions derived from corn ( A 0.1 ppm tolerance on corn grain has been established). However, HED believes that residues from corn AGF will not likely to be higher than that from wheat based on the fact that wheat grain has higher residues than corn grain, therefore, HED recommends a 5.0 ppm tolerance on aspirated grain fractions for propiconazole.

The reregistration requirements for magnitude of the residue in the processed commodities of pineapple have not been fulfilled. For pineapple, data are required reflecting the potential for concentration in pineapple juice. Although processing data are now required for pineapple process residue instead of pineapple fodder, data provided with the original tolerance petition confirmed that residues were non detectable (< 0.05 ppm) in pineapple shells, cores, bran, and fodder.

Based on the available field trial data for sugarcane, treatment of sugarcane seed pieces according to the currently registered use pattern can be considered a non food use; therefore, there are no requirements for magnitude of the residue in processed sugarcane commodities.

GLN 860.1480: Meat, Milk, Poultry, Eggs The reregistration requirements for data depicting the magnitude of propiconazole residues of concern in meat, milk, poultry, and eggs have been fulfilled. Acceptable ruminant and poultry feeding studies were submitted and evaluated in conjunction with previous propiconazole petitions ( PP# 4F3074 and PP# 1F3974). Because of the addition of a number of registered uses and corresponding tolerances for crops with animal feed items since the Phase 4 Review, including grasses grown for seed, peanuts, and wheat ( increased use rate), the maximum theoretical dietary burden to livestock has been recalculated and is presented below. 26 Calculation of maximum livestock dietary burden for propiconazole.

Feed Commodity Reassessed Tolerance ( ppm) % Dry Matter % of Diet Burden ( ppm)

Beef cattle Grass, hay 40 88 60 27.3 Aspirated grain fraction 5.0 85 20 1.2 Corn, field, grain 0.1 88 20 0.03 TOTAL 100 28.53 Dairy cattle Grass, hay 40 88 60 27.3 Aspirated grain fraction 5.0 85 20 1.2 Corn, field, grain 0.1 88 20 0.03 TOTAL 100 28.53 Poultry Corn, field, grain 0.1 88 80 0.08 Peanut, meal 0.2 89 20 0.04 TOTAL 80 0.12 Swine Peanut, meal 0.2 85 15 0.03 Wheat, grain 0.1 89 80 0.08 TOTAL 95 0.11 The results of the livestock feeding studies are summarized below.

In the ruminant feeding study, cattle were fed propiconazole at dose levels of 15, 75, and 150 ppm for periods of 14, 21, or 28 days. These dose levels represent 0.54x, 2.6x, and 5.2x the maximum theoretical dietary burden to dairy cattle. Milk samples were collected daily. The results of the study are summarized in the table below.

Residues of propiconazole and metabolites in tissues of dairy cows fed propiconazole at dose levels of 15, 75, and 150 ppm.

Feeding level ( ppm)

14 days 21 days 28 days Matrix 15 75 150 15 75 150 15 75 150 Muscle < 0.05 0.11 0.18 < 0.05 0.08 0.13 < 0.05 0.05 0.11 Kidney 0.61 3.04 6.48 0.56 4.68 5.0 0.63 3.68 5.5 Liver 0.5 4.0 4.6 0.81 4.3 5.3 0.57 2.7 5.6 27 Fat < 0.05 0.23 0.26 < 0.05 0.15 0.19 < 0.05 0.08 0.17 In milk, residues were nondetectable (< 0.01 ppm) at the 15 ppm feeding level, and maximum residues of 0.1 ppm and 0.11 ppm were detected at the 75 and 150 ppm feeding levels, respectively. These results indicate that tolerances for propiconazole residues of concern in ruminant commodities are necessary. The appropriate levels for these tolerances are addressed in the Tolerance Reassessment Summary.

In the poultry feeding study, laying hens were fed propiconazole at dose levels of 7.5, 37.5, and 75 ppm for periods of 14, 21, or 28 days. These dose levels represent 63x, 310x, and 630x the maximum theoretical dietary burden to dairy cattle. Egg samples were collected daily. The results of the study are summarized in the table below.

Residues of propiconazole and metabolites in tissues of laying hens fed propiconazole at dose levels of 7.5, 37.5, and 75 ppm.

Feeding level ( ppm)

14 days 21 days 28 days Matrix 7.5 37.5 75 7.5 37.5 75 7.5 37.5 75 Muscle < 0.05   < 0.05 < 0.05 0.07 < 0.05 < 0.05 0.06 Liver < 0.1 0.1 0.47  0.08 0.39 < 0.1 0.16 0.3 Fat  < 0.05 0.11  < 0.05 0.06  < 0.05 0.05 In eggs, residues were nondetectable (< 0.05 ppm) at the 7.5 ppm feeding level, and maximum residues of 0.18 ppm and 0.37 ppm were detected at the 37.5 and 75 ppm feeding levels, respectively. These results indicate that propiconazole residues of concern are nondetectable in eggs, muscle, and liver at a feeding level corresponding to 63x the maximum dietary burden, and in fat at a feeding level corresponding to 310x the maximum dietary burden. Therefore, propiconazole can be classified as Category 3 of 180.6( a) with respect to the need for tolerances in eggs and poultry tissues. Tolerances for poultry commodities are not required. ( Also see HED memo fo 03/ 06/ 02, Bonnie Cropp Kohlligian, D281520). 28 GLN 860.1400: Water, Fish, and Irrigated Crops Propiconazole is presently not registered for direct use on water and aquatic food and feed crops. Although propiconazole is registered for use on rice, current label restrictions prohibit the use on rice in CA ( where typical agricultural practices for rice field irrigation entail a " flow through" system); typical agricultural practices concerning rice field irrigation in all other areas allow for the on site evaporation of waters used in rice fields. Label restrictions preclude the use of water drained from treated rice fields to irrigate other crops. Label restrictions also preclude use where catfish and crayfish are produced. Therefore, no residue chemistry data are required under these guideline topics.

GLN 860.1460: Food Handling Propiconazole is presently not registered for use in food handling establishments; therefore, no residue chemistry data are required under this guideline topic.

GLN 860.1850 and 860.1900: Confined/ Field Accumulation in Rotational Crops The nature of the residue in confined rotational crops is understood, and no additional confined rotational crop data are required for the purpose of reregistration. Based on acceptable studies reviewed by EFED, the metabolism of propiconazole in rotational crops is similar to that in primary crops.

Plantback restrictions have been established for propiconazole products registered for use on rotatable crops based on the confined rotational crop studies. Labels for these formulations specify that soybeans may be planted as a double crop following a cereal crop which has been treated with the product, but soybean hay, forage, and fodder may not be used as any component of animal feed or bedding. The labels specify that any food/ feed crops not listed on the label should not be planted within 105 days of treatment.

Recent data are also available depicting propiconazole residue in rotational lentils and peas to satisfy requirements for field rotational crop trial data for potential uses in the Pacific Northwest. Residues of propiconazole were < LOQ ( 0.05 ppm) in/ on all matrices harvested from rotational legume crops planted 329 376 days posttreatment. Additional field rotational crop data would be required to revise the established plantback intervals.

A petition is pending for tolerances on the rotational crops alfalfa and sorghum ( PP# 5F4498). This petition has not been reviewed. 29 Table B. Residue Chemistry Science Assessments for Reregistration of Propiconazole. GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 860.1200: Directions for Use Not applicable ( N/ A) Yes 2 See Tables A1 and A2 860.1300: Plant Metabolism N/ A No 00074496 3, 00074498 , 00074499 , 00074500 , 00074501 , 00074502 , 00129915 , 00155645 , 44049601 4, 44381402 5, 93194062 860.1300: Animal Metabolism N/ A No 6 PP# 8F3674 7, 00067905 , 00074503 , 00074504 , 41823301 8, 41823302 , 41823304 , 42564006 9, 42983001 10, 93194085 860.1340: Residue Analytical Methods  Plant commodities N/ A No 11 00137150 12, 40154501 13, 40180701 14, 40692203 15, 40692204 , 40692206 , 40783306 16, 41063801 17, 41063802 , 41486801 18, 41823305 , 42061301 19, 42182901 20, 42564005 , 42605801 21, 42634101 22, 43424601 23, 43434201 24, 43825401 25, 44411201 26, 44411206 , 44411207 , 44411208 , 93194064  Animal commodities N/ A No 40150701 27, 40154501 , 40180702 , 41823304 , 44411204 , 93194067 860.1360: Multiresidue Methods N/ A No 40100101 28, 93194066 860.1380: Storage Stability Data  Plant/ processed commodities N/ A No 00074510 , 00074511 , 00133385, 40692201 , 41063801 , 41063802 , 41486802 , 42605801 , 43314201 29, 43825402 , 44411205 , 93194068  Animal commodities N/ A No 30 40150701 , 42983001 860.1500: Crop Field Trials Leafy Vegetables ( Except Brassica Vegetables) Group  Celery 5.0 [ § 180.434( a)] No 40783301 , 41486801 Table B ( continued).

30 Legume Vegetables Group  Bean, dry 0.5 [ § 180.434( b)] No 31 Foliage of Legume Vegetables Group  Bean, dry, forage and hay 8.0, forage 8.0, hay [ § 180.434( b)] No Stone Fruits Group 1.0 [ § 180.434( a)] No 32  Apricots 1.0 [ § 180.434( a)] No 41063802  Cherries Group tolerance established No 43655609  Nectarines 1.0 [ § 180.434( a)] No 41063802  Peaches 1.0 [ § 180.434( a)] No 41063802  Plums 1.0 [ § 180.434( a)] No 41063802  Prunes, fresh 1.0 [ § 180.434( a)] No 41063802 Berries Group  Blueberries 1.0 [ § 180.434( b)] No 33  Raspberries 1.0 [ § 180.434( b)] No Tree Nuts Group  Almonds, nutmeat and hulls 0.1, nutmeat 2.5, hulls [ § 180.434( b)] No 34  Pecans 0.1 [ § 180.434( a)] No 35 00074495 , 00074508 , 00074509 , 00153327 Cereal Grains Group  Barley, grain 0.1 [ § 180.434( a)] No 36 PP# 4F3074 37, 93194072 Table B ( continued).

31  Corn, field, grain and aspirated grain fractions 0.1, grain [ § 180.434( a)] No 38 40783303 , 42564004 , 42564005  Corn, pop 0.1, grain [ § 180.434( a)] No 39  Corn, sweet ( kernels plus cobs with husks removed) 0.1 [ § 180.434( a)] No 40783303 , 42564004 , 42564005  Oats, grain 0.1 [ § 180.434( a)] No 42182901 , 43314202  Rice, grain 0.1 [ § 180.434( a)] No 40 00137861 , 42915601 41, 44411208 , 93194075  Rye, grain 0.1 [ § 180.434( a)] No  Sorghum, grain and aspirated grain fractions 0.2, grain 20, AGF [ § 180.434( b)] No 42  Wheat, grain and aspirated grain fractions 0.1, grain [ § 180.434( a)] No 43 PP# 4F3074 , 44411206 , 44411207 , 93194072  Wild rice 0.5 [ § 180.434( c)] No 41063801 , 42511401 44 Fodder, Forage, Hay, and Straw of Cereal Grains Group  Barley, hay and straw 1.5, straw [ § 180.434( a)] No , 45 PP# 4F3074 , 93194072  Corn, field, forage and stover 12, fodder and forage [ § 180.434( a)] No 40783303 , 42564004 , 42564005  Corn, pop, stover 12, fodder [ § 180.434( a)] No  Corn, sweet, forage and stover 12, fodder and forage [ § 180.434( a)] No 40783303 , 42564004 , 42564005 Table B ( continued).

32  Oats, forage, hay, and straw 10.0, forage 30.0, hay 1.0, straw [ § 180.434( a)] No 46 42182901 , 43314202  Rice, straw 3.0 [ § 180.434( a)] No 00137861 , 44411208 , 93194075  Rye, forage and straw 1.5, straw [ § 180.434( a)] No ,

 Sorghum, stover 1.5 [ § 180.434( b)] No  Wheat, forage, hay, and straw 1.5, straw [ § 180.434( a)] No 47 PP# 4F3074 , 44411206 , 4441207 , 93194072 Grass Forage, Fodder, and Hay Group  Grass, seed screenings, forage, hay, and straw 60, seed screenings 0.5, forage 40, hay ( straw) [ § 180.434( a)] No 48 40890701, 41823305 , 42634101 , 42634102 , 93194073 Miscellaneous Commodities  Bananas 0.2 [ § 180.434( a)] No 49 00137150 , 93194071  Cranberries 1.0 [ § 180.434( b)] No  Mint 0.3 [ § 180.434( c)] No 50 42061301 , 43424601  Mushrooms 0.1 [ § 180.434( a)] No 51 43434201  Peanut, nutmeat and hay 0.2, peanut 20.0, hay [ § 180.434( a)] No 52 40692201 Table B ( continued).

33  Pineapple 0.1, pineapple and fodder [ § 180.434( a)] No 40783305  Sugarcane None established No 53 44142401 , 93194077  Sunflower Breeder's Seed None established Yes 54 860.1520: Processed Food/ Feed  Barley None established No 55  Corn, field None established No 40783303 , 42564005  Mint None established No 42061301 , 43424601  Oat None established No 42182901  Peanut None established No 40692201 , 42605801  Pineapple None established Yes 56 40783305  Plum None established No 41063802  Rice None established No 57 00137861 , 42915601, 93194079  Rye None established No  Sorghum None established No 58  Sugarcane None established No Table B ( continued).

34  Wheat None established No PP# 4F3074 , 44411206 , 44411207 , 44757208, 93194080 860.1480: Meat, Milk, Poultry, Eggs  Milk and the Fat, Meat, and Meat Byproducts of Cattle, Goats, Hogs, Horses, and Sheep 0.05, milk; 0.1, fat, meat, and mbyp; 2.0, kidney and liver [ § 180.434( a)] No 00137861 , 40150701 , 93194070  Eggs and the Fat, Meat, and Meat Byproducts of Poultry 0.1, eggs, fat, meat, and mbyp; 0.2, kidney and liver [ § 180.434( a)] No 00137861 , 40150701 , 93194070 860.1400: Water, Fish, and Irrigated Crops N/ A N/ A 860.1460: Food Handling N/ A N/ A 860.1650 Submittal of Analytical Reference Standards Yes See foot note 64 860.1850: Confined Rotational Crops N/ A No 59 00074498, 00129915 60, 00138266, 00155644 61 00155645, 00164802 , 62, 41102001 63 860.1900: Field Rotational Crops None established No 64 44411206 1. Bolded references were evaluated in the Propiconazole Phase 4 Review dated 6/ 25/ 92, by B. Cropp Kohlligian, F. Fort, and F. Toghrol; because a number of the references cited in the Phase 4 Review were reviewed in connection with petitions for uses which have since been registered, in some cases the original review documents are noted as well. All other references were reviewed as noted.

2. Syngenta is required to amend the product labels for the 41.8% EC formulations ( 100 617 and 100 737) to indicate the propiconazole concentration in terms of lb ai/ gal. In addition, label restrictions which prohibit the feeding of treated forage and/ or hay of cereals and corn to livestock must be removed from the 41.8% EC ( 100 617 and 100 737) and the 45% WP ( 100 780) formulations. The use directions for rice on all labels should be amended to specify a 45 day PHI. HED notice that the maximum number of applications for peanuts on Stratego   label is not very clear. After discussing with RD and the registrant, it is Table B ( continued).

35 understood that the maximum number of six applications is intended only for the 7.0 oz ai/ A rate, where the restricted number of application at 14 oz ai/ A is only two. HED recommends that the petitioner to amend the Stratego   label to specify these instructions. Since there are adequate field trial data to support Section 3 registration of propiconazole uses on wheat at the rate of 0.08  0.11 lbs ai/ A/ application, maximum 2 applications, and 35 day PHI ( HED memo of 02/ 02/ 05, Y. Donovan, D271790), HED recommends increasing the existing tolerances on wheat RAC to cover Stratego Fungicide ( EPA Reg. No. 264 779) uses on wheat. These new reassessed tolerances will cover all 24C uses on wheat as well. HED recommends to cancel all 24C uses while revising the Section 3 label to include these 24C uses.

3. PP# 4F3007on pecans, RCB# 711, 5/ 15/ 84, A. Smith. 4. DP Barcode D233755, 9/ 14/ 99, T. Morton. 5. DP Barcode D245249, 12/ 14/ 99, T. Morton.

6. Although the Phase 4 Review concluded that additional animal metabolism data were required, the Agency concluded, based on the registrant's 90 day response to the DCI, that the available data were adequate to satisfy data requirements ( CB# 13166, DP Barcode D198815, 4/ 26/ 94, F. Fort).

7. PP# 8F3674, CB# 11976, DP Barcode D191918, 9/ 20/ 93, M. Flood. 8. PP# 1F3974 on grass seed screenings, CB No. 7822, 6/ 11/ 91, S. Willett. 9. PP# 8F3674 on corn and pineapple, CB# 10974, D185251, 5/ 6/ 93, M. Flood. 10. PP# 8F3674 on corn and pineapple, CB# 12839, DP Barcode D196789, 3/ 28/ 94, M. Flood.

11. In the Phase 4 Review, the registrant was required to conduct enforcement method validation for Method AG 454A using bananas. This requirement is no longer needed.

12. PP# 4F3026, RCB# 826, 6/ 20/ 84, K. Arne. 13. PP# 4F3074 on small grains, CB No. 2174, 5/ 7/ 87, S. Malak. 14. PP# 4F3074 on small grains, CB No. 2262, 5/ 15/ 87, S. Malak. 15. PP# 8F3654 on peanuts, CB No. 4108, 11/ 22/ 88, H. Fonouni. 16. PP# 8F3674 on legumes, CB No. 4279, 12/ 14/ 88, C. Deyrup. 17. PP# 9F3758 on rice, wild rice, stone fruits, CB Nos. 5226 5228, 11/ 28/ 89, S. Malak. 18. PP# 0F3869 on cherry, CB No. 6724, 8/ 15/ 90, W. Chin. 19. PP# 2E4027 on mint, DP Barcode D170759, 2/ 14/ 92, W. Wassell. 20. PP# 2F4086 on oats, CB# 9325, DP Barcodes D174248 and D175989, 7/ 20/ 93, R. Lascola.

21. PP# 8F3674 on peanuts, CB# 12638, DP Barcodes D186202, D186203, D186205, D186206, and D195499, 11/ 8/ 93, M. Flood.

22. PP# 1F3979 on grass grown for seed, CB# 11304, DP Barcodes D187417, D190147, and D190263, 5/ 12/ 93, M. Flood.

23. PP# 2E4037 on mint hay, CB# 14711, DP Barcode D209458, 4/ 25/ 95, W. Wassell. 24. PP# 5E4437 on mushroom, CB# 14693, DP Barcode D209195, 3/ 29/ 95, W. Cutchin 25. DP Barcode D220935, 3/ 25/ 99, T. Morton. 26. DP Barcode D240856, 02/ 23/ 05, T. Morton. 27. PP# 4F3074 on small grain/ pecans, CB No. 2172, 5/ 14/ 87, S. Malak. Table B ( continued).

36 28. PP# 4F3074 on small grain/ pecans CB No. 2108, 4/ 28/ 87, S. Malak. 29. PP# 2F4086 on rice, CB# 14941, DP Barcode D210742, 3/ 15/ 95, M. Rodriguez.

30. The Phase 4 Review concluded that additional storage stability data were required to support the livestock feeding studies. In their 90 day response to the DCI, the registrant presented data to satisfy this data requirement ( DP Barcode D198815, 4/ 26/ 94, F. Fort).

31. Section 18 Exemption with associated time limited tolerance on dry beans. Use of propiconazole on dry beans has been proposed under pending petition PP# 5F4424 ( now incorporated into PP# 2F6371).

32. Establishment of a stone fruit group tolerance was approved on further consideration of new and available data for cherries ( PP# 4F4321, DP Barcode D217199, 8/ 14/ 95, W. Cutchin and DP Barcode D210252, 4/ 25/ 95, W. Cutchin).

33. Section 18 Exemption with associated time limited tolerance on blueberry in Maine ( Agency memo of 02/ 22/ 05, D. Rate, D313289). Use of propiconazole on the berries group has been proposed under pending petition PP# 5F4591, now incorporated into PP# 2F6371.

34. Section 18 Exemption with associated time limited tolerance on tree nuts. Use of propiconazole on tree nuts has been proposed under pending petition PP# 9F3470, now incorporated into PP# 2F6371.

35. The existing tolerance covers the registered uses of propiconazole on pecans. Syngenta is petitioning for a tree nut group tolerance ( PP# 9F3740, now incorporated into PP# 2F6371), which will be handled by registration.

36. The available data pertaining to propiconazole residues of concern in/ on wheat grain and straw supporting the currently registered maximum use pattern ( D271790) can be translated to barley grain and straw and rye grain and straw.

37. PP# 4F3074, RCB# 898, 7/ 12/ 84, A. Smith.

38. PP# 8F3674 on corn and pineapple, 03/ 28/ 94, D196789, M. Flord. The new submitted storage stability data are adequate and indicate that propiconazole is stable at  20

C for up to 36 months in the following commodities: peaches, bananas, corn meal, wheat grain, celery, corn oil, and peanut nutmeat, hay, and hulls. Propiconazole is also stable in carrots for up to 10 months at  20

C ( Barcode D240856). Timelimited tolerances have been extended to 12/ 31/ 00 pending review of a modified mid dose carcinogenicity study in mice ( 64 FR 13086, 13105, 3/ 17/ 99). HED believes that residues from corn AGF will not likely to be higher than that from wheat based on the fact that wheat grain has higher residues than corn grain, therefore, HED recommends a 5.0 ppm tolerance on aspirated grain fractions for propiconazole.

39. The available data pertaining to field corn commodities may be translated to popcorn commodities.

40. The product labels for the 41.8% ECs ( EPA Reg. Nos. 100 617 and 100 737) must be modified to specify a 45 day PHI for rice.

41. DP Barcode D195566, 11/ 2/ 93, C. Swartz; preliminary 6 ( a) ( 2) data on rice. Table B ( continued).

37 42. Section 18 Exemption with associated time limited tolerance on cranberries. Use of propiconazole has been proposed by IR 4 under pending petition PP# 7E4860.

43. Data supporting the currently registered maximum use pattern ( MRID 44411207) are adequate. The product labels for the 41.8% ECs ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) must be amended to specify a PHI of no less than 45 days for wheat grain and straw. The registrant submitted data reflecting a new use pattern ( 2x the current use pattern) but did not state whether they wished to support this new use pattern. If the registrant desires to support this use pattern, then additional data would be required ( see D240856)

44. PP# 9F3758 on wild rice, apricots, nectarines, peaches, plums, prunes. DP Barcode D183633, 4/ 8/ 93, M. Rodriguez.

45. Adequate data supporting the currently registered maximum use pattern for wheat hay and forage have been received and reviewed ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). They can be translated to barley hay and rye forage. The product labels for the 41.8% EC ( EPA Reg. Nos. 100 617 and 100 737) and the 45% WP ( EPA Reg. No. 100 780) formulations must be modified to make the use patterns for barley and rye identical to wheat.

46. Outstanding deficiencies pertaining to use of propiconazole on oats ( PP# 2F04086) have been resolved by proposal of a tolerance for residues of propiconazole and its metabolites determined as 2,4 DCBA in/ on oat hay ( DP Barcode D218453, 8/ 24/ 95, M. Rodriguez). Because no data for oat hay were available, the appropriate level for this tolerance was calculated from data for oat forage using a 3x dry down factor. Currently, data for wheat hay are available, and these data can be translated to oats to determine a more appropriate level for the oat hay tolerance.

47. Adequate data on wheat have been submitted and reviewed ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). No additional data are needed.

48. PP# 1F3974, " Propiconazole ( Tilt) in/ on Grass Grown for seed Ciba Geigy Amendment dated 7/ 2/ 93". M. Flood, 9/ 20/ 93, D192904.

49. Banana field trial data were generated in Honduras, Republic of Ivory Coast, Martinique, and Belize. With one exception, residues did not exceed the tolerance following 1 13 aerial or ground applications of the 250EC formulation at 41 g ai/ A/ application (= 0.090lbs ai/ A/ application). The only registered uses are in Hawaii and Puerto Rico, with the rate of 0.084 lbs ai/ A/ application and maximum 8 applications. HED concludes that the existing tolerance on banana is adequate.

50. Use of propiconazole on mint is currently supported by IR 4 and is registered under SLN OR960007. A tolerance was established in connection with PP# 2E4037.

51. Use on mushrooms is being supported by IR 4. A tolerance was established in connection with PP# 5E4437.

52. CBTS recommended for the establishment of time limited tolerances for peanut commodities Table B ( continued).

38 pending receipt of additional storage stability data ( 8F3654, DP Barcode D197841, 1/ 25/ 94, M. Flood). These data have since been received and reviewed ( DP Barcode D240856).

53. The available data indicate that treatment of sugarcane pieces according to the currently registered use pattern can be considered a nonfood use.

54. The available data indicate that treatment of sunflower grown for seed can not be considered a nonfood use. Field trial data on sunflower are required to establish tolerance.

55. The available data for processed wheat commodities may be translated to barley and rye. ( HED memo of 02/ 02/ 05, Y. Donovan, D271790).

56. Data must be submitted depicting the potential for concentration of propiconazole residues of concern in pineapple juice.

57. A new rice processing study has been submitted and reviewed by the Agency as acceptable ( MRID45080811. DER2).

58. The Agency has determined that adequate data pertaining to magnitude of the residue in the processed commodities of sorghum are available to support the Section 18 Exemption. A tolerance was proposed in connection with PP# 5F4498.

59. EFGWB concluded that this requirement has been fulfilled ( DP Barcode D166460, 11/ 7/ 91, P. Mastrodone). 60. EFGWB No. 70298, 3/ 23/ 87, E. Regelman. 61. EFGWB No. 70297, 5/ 18/ 87, E. Regelman. 62. EFGWB No. 70102, 12/ 24/ 86, E. Regelman. 63. EFGWB No. 90613, 10/ 19/ 89, E. Regelman.

64. Additional data would be required to revise the plantback intervals currently specified on labels for products with uses on rotatable crops. Data are available depicting propiconazole residue in rotational lentils and peas to satisfy requirements for field rotational crop trial data for potential uses in the Pacific Northwest. Residues of propiconazole were < LOQ ( 0.05 ppm) in/ on all matrices harvested from rotational legume crops planted 329 376 days posttreatment.

65. An analytical reference standard for propiconazole is available in the National Pesticide Standards Repository. Analytical reference standards of propiconazole must be supplied and supplies replenished as requested by the Repository. The reference standards should be sent to the Analytical Chemistry Lab, which is located at Fort Meade, to the attention of either Theresa Cole or Frederic Siegelman at the following address: USEPA, National Pesticide Standards Repository/ Analytical 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.) 39 TOLERANCE REASSESSMENT SUMMARY Tolerances for residues in/ on plant and animal commodities are established under 40 CFR § 180.434. They are currently expressed in terms of the combined residues of propiconazole ( 1 [[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole) and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound. HED has determined that the current tolerance expressions for plant and animal commodities are not appropriate. The tolerance expressions should be revised to parent per se, that is, propiconazole ( 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole).

The Agency has recently updated the list of raw agricultural and processed commodities and feedstuffs derived from crops ( Table 1, OPPTS GLN 860.1000). As a result of changes to Table 1, tolerances are now required for RACs which have been added to Table 1. Also, some commodity definitions must be corrected. The reassessments of tolerances for some commodities are contingent upon the implementation of requested label revision( s). A summary of propiconazole tolerance reassessments is presented in Table C.

Tolerances Established Under 40 CFR § 180.434( a)

Sufficient field trial data reflecting the maximum label use pattern are available to reassess the established tolerances for the following RACs as defined: barley, grain; barley, straw; celery; corn, fodder; corn, forage; corn, grain; corn, sweet ( kernels, plus cobs with husks removed); grass, forage; grass, hay ( straw); mushrooms; oats, forage; oats, grain; oats, hay; oats, straw; peanuts; peanuts hay; pecans; pineapple; rice, grain; rice, straw; rye, grain; rye, straw; stonefruit group; wheat, grain; and wheat, straw. Likewise, acceptable feeding studies for ruminants and poultry are available to reassess the tolerances for the following animal commodities: milk, eggs, and the fat, kidney, liver, meat byproducts ( except kidney and liver), and meat of cattle, goats, hogs, horses, poultry, and sheep.

The existing tolerance covers the registered uses of propiconazole on pecans. Syngenta is petitioning for a tree nut group tolerance ( PP# 9F3740, now incorporated into PP# 2F6371), which will be handled by registration.

Field trial data for bananas were generated in Honduras, Republic of Ivory Coast, Martinique, and Belize. With one exception, residues did not exceed the tolerance following 1 13 aerial or ground applications of a 250EC formulation at 41 g ai/ A/ application (= 0.90 lbs ai/ A/ application). The only registered uses are in Hawaii and Puerto Rico( 24C), with the rate of 0.084 lbs ai/ A/ application and maximum 8 applications. HED concludes that the existing tolerance on banana is adequate The established tolerances for apricots, nectarines, peaches, plums, and prunes should be revoked because a stone fruit group tolerance has been established. The established tolerance for pineapple 40 fodder should be revoked because this commodity is no longer considered a significant livestock feed item.

The established tolerances for RACs listed under 40 CFR § 180.434( a) are reassessed at the same levels except those listed for barley, rice, rye, and wheat; higher tolerances are required for these crops to reflect the results of recent field trials.

The established tolerances for cattle, goat, hog, horse, and sheep commodities listed under 40 CFR § 180.434( a) are reassessed at the same levels as well, due to the fact that HED is unable to separate the parent residues from the metabolites, and the fact that there are several pending petitions for new uses which will likely to result in increasing of the dietary burden.

Tolerances To Be Proposed Under 40 CFR § 180.434( a)

Because of changes to Table 1 ( OPPTS 860.1000), tolerances for barley hay, rye forage, and wheat forage and hay must be proposed. The required data for wheat hay and forage will be translated to barley hay and rye forage. Because the tolerance level for oat hay was not determined from residue data but was calculated from the oat forage level using a 3x dry down factor, the required data for wheat hay should be translated to oat hay to provide a more realistic level for this tolerance. Based on the cited field trials with Stratego   Twin Pak   and Stratego   , HED proposes new tolerances on wheat hay and forage at 2.0 ppm. The Agency now recommends that wheat hay data be translated to oats to establish a more appropriate level for the oat hay tolerance at 2.0 ppm.

HED is translating the wheat grain, wheat straw, wheat hay and forage data to barley and rye grain, straw, hay and forage. Therefore, the reassessed tolerances for barley grain and rye grain should be 0.3 ppm, for barley and rye straw should be 15.0 ppm. New tolerances for barley hay and rye forage should be established at 2.0 ppm The most recent wheat processing study ( HED memo of 02/ 02/ 05, Y. Donovan, D271790) indicated that the maximum expected residues of total propiconazole in wheat bran is 0.99 ppm which is determined by multiplying the average concentration factor of 3.3x with the highest average field trial ( HAFT) residue value of 0.3 ppm. A tolerance for wheat bran at 1.0 ppm is needed.

The average concentration factor of residues in aspirated wheat grain fraction is 13.7x from the new submitted processing study ( HED memo of 02/ 02/ 05, Y. Donovan, D271790). Based on the field trials, the proposed tolerance on wheat grain is 0.3 ppm, and therefore, the maximum AGF residue would be 4.3 ppm. The maximum expected propiconazole residues in soybean aspirated grain fractions would be 3.5 ppm ( memo of 03/ 10/ 05, T. Morton, D246884). A 20 ppm AFG tolerance was established on barley based on a Section 18 use on barley, which is based on the tolerance level for grain sorghum grain ( 0.2 ppm), and the maximum concentration factor of 100x. This Section 18 tolerance will expire on 06/ 30/ 05. No data are yet available on aspirated grain 41 fractions derived from corn ( A 0.1 ppm tolerance on corn grain has been established). However, HED believes that residues from corn AGF will not likely to be higher than that from wheat based on the fact that wheat grain has higher residues than corn grain, therefore, HED recommends a 5.0 ppm tolerance on aspirated grain fractions for propiconazole.

The commodity definitions for corn RAC tolerances are currently expressed as corn per se. When the definition is revised to " corn, field", tolerances for popcorn grain and stover, expressed in terms of " corn, pop", will need to be established at levels of 0.1 ppm and 12 ppm, respectively. In addition, tolerances for " corn, sweet, forage" and " corn, sweet, stover" will need to be established at 12 ppm.

A new rice processing study has been submitted and reviewed as acceptable by the Agency ( MRID 45080811. DER2), the review indicated that the concentration factor for rice bran is 2.9x, for rice hulls is 3.8x, and for polished rice is 0.12x. The registrant needs to propose new tolerances for rice bran at 1.0 ppm and for rice hulls at 1.2 ppm.

Additional data have also been required for pineapple juice.

HED notice that due to the change of tolerance expression from parent plus all its metabolites containing the 2,4 dichlorophenyl moiety ( 2,4 DCBA) to parent only, in some cases the tolerance levels will be over estimated. Since all field data were reported as propiconazole and all its metabolites containing the 2,4 dichlorophenyl moiety ( 2,4 DCBA), due to the fact that the analytical/ data collection method is a moiety method that detects all residues convertible to 2,4 dichlorobenzoic acid ( DCBA), HED is unable to separate out the parent residue from the metabolites at this time. HED recommends that the registrant analyze parent and metabolites separately in all field trials so that more realistic tolerances can be set in the future.

Time Limited Tolerances Established Under 40 CFR § 180.434( b)

Time limited tolerances, due to expire 12/ 31/ 05, are established for cranberry, dry bean forage, dry bean hay, and dry beans. In addition, time limited tolerances, due to expire 06/ 30/ 05, are established for aspirated grain fractions ( 20 ppm), sorghum grain, and stover [ 40 CFR § 180.434( b)]. Time limited tolerances are being recommended by RD to established in/ on soybeans at 0.5 ppm, in/ on soybean forage at 8 ppm, and in soybean hay at 25 ppm, in/ on blueberry at 1.0 ppm.

Tolerances with Regional Registrations Established Under 40 CFR § 180.434( c)

Tolerances with regional registrations have been established for the following RACs as defined: mint, tops ( leaves and stems) and wild rice. The tolerance for mint is restricted to use west of the Cascade Mountains only, and the tolerance for wild rice is restricted to MN. Sufficient field trial 42 data are available to assess the established tolerances with regional registrations for mint and wild rice at the same levels.

Pending Tolerance Petitions PP# 4F3007: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on pecans.

PP# 4G3075: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on rice and wheat.

PP# 9F3470: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on tree nuts at 0.1 ppm and almond hulls at 0.1 ppm. The petitioner also proposes removal of the established tolerance for pecans on establishment of the proposed tree nut crop group tolerance. The petition is currently in reject status pending resolution of certain label deficiencies and revision of the proposed use pattern ( DP Barcodes D229114 and D234297, 3/ 27/ 97, L. Kutney; DP Barcode D229723, 3/ 26/ 97, L. Kutney; DP Barcode D222232 and D216602, 3/ 28/ 96, W. Cutchin).

PP# 2F6371: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on strawberries, sugar beets, wheat, corn, rice, sorghum, carrots, onions, berry groupdry beans, soybeans, almonds, and tree nuts as follows. This petition supercedes PP# 4F3007, 4G3075, 5F4424, 5F4498, 5F4591, 9F3740 ( DP Barcode D312277, 313278, 313693, not reviewed)

PP# 5F4591: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on the berry crop group at 1.0 ppm, green onions at 8.0 ppm, dry bulb onions at 0.3 ppm, and carrots at 0.2 ppm. Following data review, HED recommended against establishment of the proposed permanent tolerances because of deficiencies pertaining to plant metabolism, residue analytical methods, and storage stability. HED recommended for establishment of time limited tolerances for the above commodities at the proposed levels pending revisions to label and use patterns ( DP Barcode D219664, 6/ 12/ 96, L. Kutney). This petition has been superceded by PP# 2F6371. 43 PP# 5F4424: Syngenta has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in/ on soybeans at 0.5 ppm, soybean forage at 8.0 ppm, soybean fodder/ straw at 8.0 ppm, soybean hay at 25.0 ppm, dry beans at 0.5 ppm, dry bean vines/ forage at 8.0 ppm, and dry bean hay at 8.0 ppm. The petition is currently in reject status pending revision of the proposed use pattern ( DP Barcode D246884, and DP Barcodes D210266 and D210295, 3/ 5/ 97, M. Rodriguez), ( D246884, 03/ 10/ 2005, T. Morton). This petition has been superceded by PP# 2F6371.

PP# 5F4498: Syngenta Crop Protection, Inc. has proposed the establishment of inadvertent/ rtational crop tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on grain sorghum, grain at 0.2 ppm; grain sorghum, forage at 0.3 ppm; grainsorghum, fodder ( stover) at 0.3 ppm; alfalfa, forage at 0.1 ppm; and alfalfa, hay at 0.1 ppm. ( DP Barcode D216415; not reviewed). This petition has been superceded by PP# 2F6371.

PP# 9F3740: Syngenta Crop Protection, Inc. has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on almonds and the tree nuts crop group. ( DP Barcode D234716, not reviewed). This petition has been superceded by PP# 2F6371.

PP# 6E4788: Inter regional Project No. 4 ( IR 4) has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on celery. ( DP Barcode D238458, not reviewed)

PP# 7E4860: Inter regional Project No. 4 ( IR 4) has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on cranberry. ( DP Barcode D238468, not reviewed)

PP# 8E4931: Inter regional Project No. 4 ( IR 4) has proposed the establishment of tolerances for residues of propiconazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound equivalent in or on mint. ( DP Barcode D247313, D313963, not reviewed) 44 Table C. Tolerance Reassessment Summary for Propiconazole.

Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Tolerances Established Under 40 CFR § 180.434( a)

Bananas 0.2 0.2 [ Banana]

Barley, grain 0.1 0.3 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Barley, straw 1.5 15.0 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Cattle, fat 0.1 0.1 0.08 ppm combined residues in fat were expected from MTDB.

Cattle, kidney 2.0 2.0 1.01 ppm combined residues in kidney were expected from MTDB. However, several new uses are pending which may increase the MTDB.

Cattle, liver 2.0 2.0 1.33 ppm combined residues in liver were expected from MTDB. However, several new uses are pending which may increase the MTDB.

Cattle, meat byproducts, except kidney and liver 0.1 0.1 ( see comments above in fat)

Cattle, meat 0.1 0.1 0.04 ppm combined residues in meat were expected from MTDB. However, several new uses are pending which may increase the MTDB.

Celery 5.0 5.0 Corn, field, stover 12 12 Expiration date 11/ 30/ 08 [ Corn, field, stover]

Corn, field, forage 12 12 Expiration date 11/ 30/ 08 [ Corn, field, forage]

Corn, field, grain 0.1 0.1 Expiration date 11/ 30/ 08 [ Corn, field, grain]

Corn, sweet, kernels plus cobs with husks removed 0.1 0.1 Expiration date 11/ 30/ 08 [ Corn, sweet, kernels plus cobs with husks removed]

Eggs 0.1 Revoke Feeding study data indicate that tolerances for poultry commodities are not necessary.

Fruit, Stone, group 12 1.0 1.0 [ Fruit, stone, group 12]

Goat, fat 0.1 0.1 ( see comments in cattle)

Goat, kidney 2.0 2.0 ( see comments in cattle)

Goat, liver 2.0 2.0 ( see comments in cattle) 45 Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Goat, meat byproducts, except kidney and liver 0.1 0.1 ( see comments in cattle)

Goat, meat 0.1 0.1 ( see comments in cattle)

Grass, forage 0.5 0.5 Grass, hay ( straw) 40 40 [ Grass, hay]

Grass, straw 40 40 [ Grass, straw]

Hog, fat 0.1 0.1 ( see comments in cattle)

Hog, kidney 2.0 2.0 ( see comments in cattle)

Hog, liver 2.0 2.0 ( see comments in cattle)

Hog, meat byproducts, except kidney and liver 0.1 0.1 ( see comments in cattle)

Hog, meat 0.1 0.1 ( see comments in cattle)

Horse, fat 0.1 0.1 ( see comments in cattle)

Horse, kidney 2.0 2.0 ( see comments in cattle)

Horse, liver 2.0 2.0 ( see comments in cattle)

Horse, mbyp ( except kidney and liver) 0.1 0.1 [ Horse, meat byproducts, except kidney and liver]( see comments in cattle)

Horse, meat 0.1 0.1 ( see comments in cattle)

Milk 0.05 0.05 0.03 ppm combined residues in milk were expected from 26.5ppm MTDB.

Mushroom 0.1 0.1 Use of propiconazole on mushrooms is being supported by IR 4. Currently there are no registered uses of propiconazole on mushrooms. [ Mushroom]

Oat, forage 10.0 10.0 [ Oat, forage]

Oat, grain 0.1 0.1 [ Oat, grain]

Oat, hay 30.0 2.0 Translated from wheat hay. [ Oat, hay]

Oat, straw 1.0 1.0 [ Oat, straw]

Peanut 0.2 0.2 Expiration date 11/ 30/ 08 [ Peanut]. Parent accounted 30% of the TRR based on peanut metabolism ( MARC memo of 4/ 4/ 02, D279299).

Peanut, hay 20.0 20.0 Expiration date 11/ 30/ 08 [ Peanut, hay] 46 Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Pecans 0.1 0.1 Syngenta has proposed removal of the established tolerance for pecans on establishment of the proposed tree nut crop group tolerance ( pending tolerance petition PP# 9F3470).

Pineapple 0.1 0.1 Expiration date 11/ 30/ 08 Pineapple, fodder 0.1 Revoke Expiration date 11/ 30/ 08; no longer considered a significant livestock feed item.

Plum, prune, fresh 1.0 Revoke This tolerance has been replaced by the stone fruits group tolerance.

Rice, grain 0.1 0.3 The available data, reflecting the maximum registered use pattern, indicate that the maximum combined residues of propiconazole and its metabolites determined as 2,4 DCBA were 0.28 ppm in/ on rice grain. ( HED memo of 02/ 23/ 05, T. Morton, D240856).

Rice, straw 3.0 3.0 ( HED memo of 02/ 23/ 05, T. Morton, D240856).

Rye, grain 0.1 0.3 Translated from wheat data. Memo of 02/ 02/ 05, Y. Donovan, D271790.

Rye, straw 1.5 15.0 Translated from data for wheat straw.

Sheep, fat 0.1 0.1 ( see comments in cattle)

Sheep, kidney 2.0 2.0 ( see comments in cattle)

Sheep, liver 2.0 2.0 ( see comments in cattle)

Sheep, mbyp ( except kidney and liver) 0.1 0.1 ( see comments in cattle)

Sheep, meat 0.1 0.1 ( see comments in cattle)

Wheat, grain 0.1 0.30 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Wheat, straw 1.5 15.0 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Tolerances To Be Proposed Under 40 CFR § 180.434( a)

Aspirated grain fractions 20 ( sorghum) 1 5.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Grain, aspirated fraction]

Barley, hay None established 2.0 Translate from wheat hay Corn, pop, grain None established 0.1 Translate from field corn Corn, pop, stover None established 12 Translate from field corn 47 Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Corn, sweet, forage None established 12 Translate from field corn Corn, sweet, stover None established 12 Translate from field corn Rice, bran None established 1.0 Concentration factor for rice bran is 2.9x. ( MRID45080811DER2)

Rice, hulls None established 1.2 Concentration factor for rice hulls is 3.8x. ( MRID45080811DER2)

Rye, forage None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790.

Wheat forage None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ wheat, forage]

Wheat hay None established 2.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Wheat, hay]

Wheat Bran None established 1.0 Memo of 02/ 02/ 05, Y. Donovan, D271790. [ Wheat, bran]

Tolerances Established Under 40 CFR § 180.434( b)

Blueberry 1.0 N/ A Expiration date 11/ 31/ 07. Recommended in Agency memo of 02/ 22/ 05, D. Rate, D313289. [ Blueberry]

Cranberry 1.0 N/ A Expiration date 12/ 31/ 05 [ Cranberry]

Dry bean forage 8.0 N/ A Expiration date 12/ 31/ 05 [ Bean, dry, forage]

Dry bean hay 8.0 N/ A Expiration date 12/ 31/ 05 [ Bean, dry, hay]

Dry bean 0.5 N/ A Expiration date 12/ 31/ 05 [ Bean, dry]

Sorghum, aspirated grain fractions 20 N/ A Expiration date 06/ 30/ 05 Sorghum, grain, grain 0.2 N/ A Expiration date 06/ 30/ 05 [ Sorghum, , grain, grain]

Sorghum, grain, stover 1.5 N/ A Expiration date 06/ 30/ 05 Soy bean, bean 0.5 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Soybean, forage 8.0 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Soybean, hay 25.0 ( pending) N/ A Agency memo of 04/ 14/ 04, J. R. Tomerlin, D262299.

Tolerances Established Under 40 CFR § 180.434( c) 48 Commodity Current Tolerance, ppm Reassessed Tolerance, ppm Comment [ Correct Commodity Definition]

Sunflower None established TBD 2 Peppermint, tops; [ Spearmint, tops 0.3 0.3 Regional registration for use west of the Cascade Mountains only. [ Peppermint, tops] [ Spearmint, tops]

Rice, wild 0.5 0.5 MN [ Rice, wild]

1 The 20 ppm tolerance for sorghum aspirated grain fractions is a time limited tolerance to support a Section 18 Exemption.

2 Tolerance can not be established until field data are submitted. 49 CODEX HARMONIZATION The Codex Alimentarius Commission has established several maximum residue limits ( MRLs) for propiconazole in/ on various raw agricultural commodities. The Codex MRLs are expressed in terms of propiconazole per se, which is in harmonized with the US tolerance expression. HED has harmonized tolerance levels on most commodities that have Codex MRLs to the extend possible. A numerical comparison of the Codex MRLs and the corresponding reassessed U. S. tolerances is presented in Table D.

Table D. Codex MRLs for Propiconazole and applicable U. S. tolerances.

Codex Commodity ( As Defined) MRL 1 ( mg/ kg) Step Reassessed U. S. Tolerance ( ppm) Recommendation and Comments Almonds 0.05 CXL  No U. S. registration.

Banana 0.1 CXL TBD Barley 0.05 CXL 0.3 Coffee beans 0.1 CXL  No U. S. registration.

Edible offal ( mammalian) 0.05 CXL  No U. S. registration.

Eggs 0.05 (*) CXL  No U. S. registration.

Grapes 0.5 CXL  No U. S. registration Mango 0.05 CXL  No U. S. registration.

Meat ( from mammals other than marine) 0.05 (*) CXL 0.1 Milks 0.01 (*) CXL 0.05 Unable to harmonize 2 Oats 0.05 (*) CXL 0.1 Peanut 0.05 CXL 0.1 Unable to harmonize 2 Peanut, whole 0.1 CXL   Not currently regulated by U. S. EPA.

Pecan 0.05 CXL 0.1 Unable to harmonize 2 Poultry meat 0.05 (*) CXL  No U. S. registration.

Rape seed 0.05 CXL  No U. S. registration.

Rye 0.05 (*) CXL 0.3 Unable to harmonize 2 Stone fruits 1 CXL 1.0 Sugar beet 0.05 CXL  No U. S. registration.

Sugar beet leaves or tops 0.5 CXL  No U. S. registration. 50 Codex Commodity ( As Defined) MRL 1 ( mg/ kg) Step Reassessed U. S. Tolerance ( ppm) Recommendation and Comments Sugar cane 0.05 CXL  Use in the U. S. is considered a non food use.

Wheat 0.05 (*) CXL 0.30 Unable to harmonize due to higher use rate 1 Asterisk designates MRL set at the limit of quantitation. 2 Can not harmonize because current use patterns in the U. S. supports the higher value. 51 AGENCY MEMORANDA RELEVANT TO REREGISTRATION CB No.: None Subject: PP# 4F3007 ( Acc. Nos. 072212 072217 and 072219): CGA 64250 ( Tilt) in Pecans. Evaluation of Residue Data and Analytical Method From: A. Smith To: H. Jacoby and Toxicology Branch Dated: 5/ 15/ 84 MRID: 00067905, 00074495 99, 00074500 04, 00074508, 00074509, 00129915, and 00155645 CB No.: None Subject: PP# 4F0326: Tilt on Bananas. Evaluation of Analytical Methods and Residue Data. Accession Nos. 072283, 072284, 072285. From: K. Arne To: H. Jacoby and Toxicology Branch Dated: 6/ 20/ 84 MRID: 00137150 CB No.: None Subject: PP# 4F3074 ( Accession Nos. 072490, 072556, 072557): Tilt ® on Small Grains. Evaluation of Residue Data and Analytical Method. From: A. Smith To: H. Jacoby and Toxicology Branch Dated: 7/ 12/ 84 MRID: 00137861 EFGWB No.: 70289 Subject: EFGWB Review of Additional Environmental Data for Propiconazole From: E. Regelman To: L. Rossi Dated: 3/ 23/ 87 MRID: 00129915, 00155645, and 00164802 52 CB No.: 2108 Subject: PP# 4F3074, 4F3007, and 4E3026. Propiconazole ( Tilt ® or CGA 64250) on Crops and Livestock Commodities. Results of the Multiresidue Method Testing. From: S. Malak To: L. Rossi Dated: 4/ 28/ 87 MRID: 40100101 CB No.: 2174 Subject: PP#' s 4F3074, 4F3007, and 4E3026. Propiconazole ( Tilt ® or CGA 64250) on Crops and Livestock Commodities. Additional Recovery Data, Sample Chromatograms, and Sample Calculation on Analytical Methods AG 454A and AG 517. Letter of April 6, 1987. From: S. Malak To: L. Rossi Dated: 5/ 7/ 87 MRID: 40154501 CB No.: 2172 Subject: PP#' s 4F3074, 4F3007, and 4E3026. Propiconazole ( Tilt ® or CGA 64250) on Crops and Livestock Commodities. Residue Data in or on Livestock Commodities Using Ciba Geigy's Method AG 359. Amendment of April 2, 1987. From: S. Malak To: L. Rossi and Toxicology Branch Dated: 5/ 14/ 87 MRID: 40150701 CB No.: 2262 Subject: PP#' s 4F3074, 4F3007, and 4E3026. Propiconazole ( Tilt ® or CGA 64250) on Crops and Livestock Commodities. Revisions to Analytical Methods AG 454A and AG 517. Amendment of May 2, 1987. From: S. Malak To: L. Rossi and Toxicology Branch Dated: 5/ 15/ 87 MRID: 40180700 40180702 53 EFGWB No.: 70297 Subject: EFGWB Review of Submission of Metabolism Data for Propiconazole From: E. Regelman To: L. Rossi Dated: 5/ 18/ 87 MRID: 00155644 CB No.: 2303 Subject: PP#' s 4F3074. Propiconazole ( Tilt ® , Banner, or CGA 64250 ® ) on Crops and Livestock Commodities. Revised Sections F and B. Amendment of May 12, 1987. From: S. Malak To: L. Rossi and Toxicology Branch Dated: 5/ 28/ 87 MRID: None CB No.: None Subject: PP# 4F3074, 4F3007, and 4E3026. Propiconazole ( Tilt ® or CGA 64250) on Crops and Livestock Commodities. Evaluation of Method Trial Report for Ciba Geigy's Method AG454A and AG 517. From: S. Malak To: L. Rossi and Toxicology Branch Dated: 5/ 28/ 87 MRID: None CB No.: 4108 Subject: PP# 8F3654, Tilt ® ( Propiconazole) In or On Peanuts and Peanut Hulls/ Hay. Evaluation of Analytical Methodology and Residue Data. From: H. Fonouni To: L. Rossi and Toxicology Branch Dated: 11/ 22/ 88 MRID: 40692201 40692206 54 CB No.: 4279 Subject: PP# 8F3674. Propiconazole in/ on Celery, Corn, Pineapples, and Legume Vegetables. Evaluation of the Analytical Methodology and Residue Data. From: C. Deyrup To: L. Rossi and Toxicology Branch Dated: 12/ 14/ 88 MRID: 40783301, 40783303, 40783305, 40783306 CBRS No. 4687 Subject: EPA Reg. No. 100 617. Tilt ® ( propiconazole) residues on grass seed screenings incorporated into animal feed. From: L. Propst To: L. Rossi Dated: 12/ 15/ 88 MRID: None EFGWB No.: 90613 Subject: EFGWB Review of Request to Amend Federal Label to Permit Double Cropping of Treated Winter Wheat with Soybeans for Propiconazole. From: E. Regelman To: S. Lewis/ Stone Dated: 10/ 19/ 89 MRID: 41102001 CBTS No.: 5226  5228 Subject: PP# 9F3758 & Reg. Nos. 100 617 & 100 702. Propiconazole ( Tilt) in or on Wild Rice and Stone Fruit. Evaluation of Residue Data and Analytical Methods. From: S. Malak To: S. Lewis and Toxicology Branch Dated: 11/ 28/ 89 MRID: 41063800 41063803 55 CB No.: 6724 Subject: PP# 0F3869: Propiconazole ( Tilt ® ) in or on Celery. Amendment of 3/ 1/ 90. From: W. Chin To: S. Lewis and Toxicology Branch Dated: 8/ 15/ 90 MRID: 41486801 and 41486802 CB No.: 7822 Subject: PP No. 1F3974. Propiconazole on Grass Seed Screenings, Straw, and Forage. Evaluation of Residue Data and Analytical Methodology. HED Project No. 1 0964. From: S. Willett To: S. Lewis/ J. Stone and Toxicology Branch Dated: 6/ 11/ 91 MRID: 41823300 41823305 DP Barcode: D164460 Subject: EFGWB Review of Request to Remove Double Cropping Restriction from Label for Propiconazole ( EPA Reg. No. 100 617). From: P. Mastradone To: S. Lewis/ S. Jackson Dated: 11/ 7/ 91 MRID: None DP Barcode: D171368 Subject: PP No. 9F3706. Propiconazole on Grass Seed Screenings, Straw, and Forage. Ciba Geigy Request for a Waiver for Aerial Field Trial Data Requirements. From: S. Willett To: S. Lewis/ J. Stone and Toxicology Branch Dated: 12/ 18/ 91 MRID: None DP Barcode: D170759 Subject: PP# 2E04037. Propiconazole ( Tilt ® Fungicide, EPA Reg. No. 100 617) in or on mint. Evaluation of analytical method and magnitude of residue data. From: W. Wassell To: H. Jamerson and Toxicology Branch Dated: 2/ 14/ 92 MRID: 42061301 56 DP Barcode: D183633 Subject: PP# 9F3758: Propiconazole ( Tilt, Orbit) in Wild Rice, Apricots, Nectarines, Peaches, Plums, and Prunes. Amendment of October 8, 1992. EPA Reg. Nos. 100 618, 100 617, 100 702. From: M. Rodriguez To: S. Lewis/ S. Jackson Dated: 4/ 8/ 93 MRID: 42511401 DP Barcode: D189618 Subject: PP# 2E04037. Propiconazole ( Tilt ® Fungicide, EPA Reg. No. 100 617) in or on mint. Questions concerning outstanding data requirements ( letter dated 3/ 22/ 93). From: W. Wassell To: H. Jamerson Dated: 4/ 12/ 93 MRID: None DP Barcode: D185251 Subject: PP# 8F3674   Propiconazole ( Tilt ® ) in/ on Corn and Pineapple. Ciba Geigy Amendment Dated 11/ 20/ 92. From: M. Flood To: S. Lewis/ S. Jackson Dated: 5/ 6/ 93 MRID: 42564004 42564006 DP Barcode: D187417, D190147, and D190263 Subject: PP# 1F3974. Propiconazole ( Tilt ® ) in/ on Grasses Grown for Seed. Ciba Geigy Amendment Dated 1/ 14/ 93. From: M. Flood To: S. Lewis/ S. Jackson and A. Kocialski Dated: 5/ 12/ 93 MRID: 42449501, 42634101, and 42634102 57 DP Barcode: D190499 Subject: PP# 9F3758: Propiconazole ( Tilt ® , Orbit ® ) in Wild Rice, Apricots, Nectarines, Peaches, Plums, and Prunes. Amendment of April 20, 1993. EPA Reg. Nos. 100 618, 100 617, 100 702. From: M. Rodriguez To: S. Lewis/ S. Jackson and A. Kocialski Dated: 6/ 2/ 93 MRID: None DP Barcode: None Subject: PP# 8F3674   Propiconazole in/ on Corn and Pineapple. Need for DRES Analysis. From: M. Flood To: S. Lewis/ S. Jackson and A. Kocialski/ S. Willett Dated: 6/ 15/ 93 MRID: None DP Barcode: D174248 and D175989 Subject: PP# 2F4086. Propiconazole ( Tilt) in/ on Oat Grain and Straw. Evaluation of Analytical Method and Residue Data. From: R. Lascola To: S. Jackson/ S. Lewis Date: 7/ 20/ 93 MRID( S): 42182901 DP Barcode: D191918 Subject: PP# 8F3674. Propiconazole ( Tilt ® ) in/ on Corn and Pineapple. Ciba Geigy Amendment Dated 5/ 28/ 93. From: M. Flood To: S. Jackson Date: 9/ 20/ 93 MRID( S): None 58 DP Barcode: D192904 Subject: PP# 1F3974. Propiconazole ( Tilt) in/ on Grasses Grown for Seed. Ciba Geigy Amendment Dated 7/ 2/ 93. From: M. Flood To: S. Jackson and A. Kocialski Date: 9/ 20/ 93 MRID( S): None DP Barcode: D195566 Subject: Propiconazole. List C Reregistration Case No. 3125/ Chemical ID No. 112101. 6( a)( 2) Data: Over tolerance Residues in Rice Grain and Processed Fractions. From: C. Swartz To: B. Sidwell Dated: 11/ 2/ 93 MRID: 42915600 and 42915601 DP Barcodes: D186202, D186203, D186205, D186206, and D195499 Subject: PP# 8F3654. Propiconazole ( Tilt ® ) in/ on Peanuts. Amendment Dated 12/ 23/ 92. ( Received CBTS 10/ 1/ 93). From: M. Flood To: C. Lewis Dated: 11/ 8/ 93 MRID: 42605801 DP Barcode: D197841 Subject: PP# 8F3654. Propiconazole ( Tilt ® ) in/ on Peanuts. Amendment Dated 12/ 6/ 93. Request for Time Limited Tolerances. From: M. Flood To: S. Jackson/ D. Greenway and A. Kocialski Dated: 1/ 25/ 94 MRID: None DP Barcode D196789 Subject: PP# 8F3674. Propiconazole ( Tilt ® ) in/ on Corn and Pineapple. Submission Dated 10/ 25/ 93. From: M. Flood To: S. Jackson/ D. Greenway Date: 3/ 24/ 94 MRID: 42983001 59 DP Barcode: D198815 Subject: Propiconazole. 90 Day Response. Chemical I. D. No. 122101. List C Case No. 3125. From: F. Fort To: R. Gebken/ B. Sidwell Dated: 4/ 26/ 94 MRID: None DP Barcode: D210742 Subject: PP2F04086: Propiconazole in/ on Oats. Amendment Dated July 15, 1994; Response to CBTS # s 9325/ 9603. From: M. Rodriguez To: S. Lewis/ D. Greenway and J. Smith Dated: 3/ 15/ 95 MRID: 43314201 and 43314202 DP Barcode: D209195 Subject: PP# 5E04437, Evaluation of Analytical Method and Residue Data. Propiconazole on Mushrooms. Chemical # 122101. From: W. Cutchin To: H. Jamerson Dated: 3/ 29/ 95 MRID: 43434201 DP Barcode: D209468 Subject: PP# 2E04037. Propiconazole ( Tilt ® Fungicide, EPA Reg. No. 100 617) in or on mint. Amendment submitted on 10/ 24/ 94. From: W. Wassell To: H. Jamerson and J. Smith Dated: 4/ 25/ 95 MRID: 43424601 60 DP Barcode: D210252 Subject: PP# 4F04321, Propiconazole in/ on Stone Fruit. Request for Group Tolerance. Chemical # 122101. From: W. Cutchin To: C. Welch and J. Smith Dated: 4/ 25/ 95 MRID: None DP Barcode: D217199 Subject: PP# 4F04321 Amended Petition: Request for Group Tolerance. Propiconazole in/ on Stone Fruit. Crossover Studies for New Formulation. Chemical # 122101. CBTS #: 15866. From: W. Cutchin To: C. Welch Dated: 8/ 14/ 95 MRID: 43655609 DP Barcode: D218453 Subject: PP# 2F04086: Propiconazole in/ on oats. Amendment Dated April 7, 1995; Response to CBTS Review # 14941. From: M. Rodriguez To: C. Welch/ K. Scanlon Dated: 8/ 24/ 95 MRID: None DP Barcode: D209612 Subject: Propiconazole. Registrant Response. Chemical ID No. 122101. List C Case No. 3125. From: F. Fort To: R. Gebken/ B. Sidwell Dated: 12/ 19/ 95 MRID: None 61 DP Barcodes: D216602 and D222232 Subject: PP# 9F3740 Propiconazole in/ on Almonds, Almond Hulls, and Tree Nut Crop Group. Request for Group Tolerance. Revised Section Bs and New Section F. Chemical # 122101. From: W. Cutchin To: C. Welch and D. McCall Dated: 3/ 28/ 96 MRID( s): None DP Barcode: D219664 Subject: PP No. 5F04591, Propiconazole on the berry crop grouping, carrots, and onions ( green and dry bulb). Chemical No. 122101. From: L. Kutney To: D. McCall Dated: 6/ 12/ 96 MRID( s): 43786401 43786404 DP Barcode: D210266 and D210295 Subject: PP# 5F04424 and ID# 000100 00618 CGA 64250 Technical: Propiconazole in/ on Dry Beans and Soybeans. Evaluation of Residue Data and Analytical Methodology. From: M. Rodriguez To: D. McCall/ S. Robbins Dated: 3/ 5/ 97 MRID( s): 43386501 and 43386502 DP Barcode: D229723 Subject: PP# 9F3740 Propiconazole in/ on Almonds, Almond Hulls, and Tree Nut Crop Group. Revised Section B for the ORBIT 45W Formulation. Chemical # 122101. From: L. Kutney To: C. Welch and K. Scanlon and D. McCall Dated: 3/ 26/ 97 MRID: None 62 DP Barcodes: D229114 and D234297 Subject: PP# 9F3740 Propiconazole in/ on Almonds, Almond Hulls, and Tree Nut Crop Group. Revised Section B and Section F for ORBIT and ORBIT GEL. Chemical # 122101. From: L. Kutney To: C. Welch and K. Scanlon and D. McCall Dated: 3/ 27/ 97 MRID: None DP Barcode: D250861 Subject: EXTENSION OF TIME LIMITED TOLERANCES OF PROPICONAZOLE ON CORN, PINEAPPLES ( PP# 8F3674) AND PEANUTS ( PP# 8F3654) From: Margarita Collantes, To: Mary Waller, PM Team 21 Dated: 11/ 19/ 98 MRID: None DP Barcode: D220935 Subject: Propiconazole ( 122101): Residue Analytical Method ( GLN 860.1340) and Storage Stability Data ( GLN 860.1380). Case 3125. From: T. Morton To: M. Hartman/ K. Monk Date: 3/ 25/ 99 MRID: 43825401 and 43825402 DP Barcode: D233755 Subject: Propiconazole ( 122101): Nature of the Residue Celery ( GLN 860.1300) and Magnitude of the Residue in Sugar Cane ( GLN 860.1500). Case 3125. From: T. Morton To: M. Hartman/ K. Monk Dated: 9/ 14/ 99 MRID: 44049601 and 44142401 DP Barcode: D245249 Subject: Propiconazole ( 122101): Nature of the Residue in Spring Wheat ( GLN 860.1300). From: T. Morton To: M. Hartman/ K. Monk Dated: 12/ 14/ 99 MRID: 44381402 63 DP Barcode: D284131 from: Clark Swentzel TO: Richard Keigwin Dated : 07/ 08/ 02 Subject : Review of " Profile of the Triazole derivative Fungicide Compounds and their Common Metabolites". Ingredient( s) : 004401 Amitrole, 120503 Bromuconacole ,128993 Cyproconazole, 128847 Difenoconazole, 123909 Epoxiconazole, 129011 Fenbuconazole, 128835 Flusilazole, 128925 Hexaconazole, 128851 Prochloraz, 125601 Paclobutrazol, 122101 Propiconazole. MRID#: 45575501 DP Barcode: D267787, D272054. Subject: PP# 0F06121. PC Code 129112. CAS # 141517 21 7. Trifloxystrobin on Barley, Citrus, Corn ( Field and Pop), Pecan, Pistachio, Rice, and Stone Fruit. Review of Analytical Methods and Residue Data. EPA Reg # s: 3125 559, 3125 562. From: Leung Cheng, Chemist To: Cynthia Giles Parker, Team 22 Dated: 01/ 17/ 02 MRID: 45080800, 45080806, 45080808, 45080809, 45080810, 45080811, 45126200, 45269400, 45269401, 45269402, 45276400, 45276401.

DP Barcode: D281520 Subject: Propiconazole ( 122101): Reassessment of poultry and egg tolerances. From: Bonnie Cropp Kohlligian To: Eric Olson, CRM Dated: 03/ 06/ 02 MRID: None DP Barcode: D279299 Subject: Propiconazole ( 122101): Results of the HED Metabolism Assessment Review Committee ( MARC) Meetings Held on 18 December 2001 and 08 January 2002. TXR# 0050349 From: Bonnie Cropp Kohlligian To: Yan Donovan Dated: 04/ 04/ 02 MRID: None DP Barcode: D 262299 Subject: Propiconazole ( 122101): Risk Assessments for the Section 18 Request for Control of Soybean Rust 64 From: J. R. Tomerlin To: Andrew Ertman/ Section 18 Team Dated: 04/ 14/ 04 MRID: None DP Barcode: D271790 Subject: Propiconazole ( 122101): Magnitude of Residues in/ on wheat for The Registration of Stratego   use on wheat. MRID 44757208. From: Yan Donovan To: Susan Lewis/ Patrick Dobak Dated: 02/ 02/ 05 MRID: MRID 44757208 DP Barcode: D313289 Subject: Propiconazole ( 122101): Human Health Risk Assessment for the Section 18 Request for Blueberry in Maine. From: Debra Rate To: Dan Rossenblatt/ Andrea Conrath Dated: 02/ 22/ 05 MRID: None DP Barcode: D240856 Subject: Residue Analytical Method( GLN 860.1340), Storage Stability Data( GLN 860.1380), Magnitude of the Residue in Rice and Wheat ( GLN 860.1500), and Magnitude of the Residue in Processed Food/ Feed Commodities of Wheat ( GLN 860.1520) From: Thurston G. Morton, Chemist To: Mark Hartman/ Kathy Monk Date: 02/ 23/ 05 MRID: MRID # 44411201, 44411202, 44411203, 44411204, 44411205, 44411206, 44411207, 44411208.

DP Barcode: D246884 Subject: PP# 5F04424: MRP Soybean Aspirated Grain Fractions From: Thurston G. Morton, Chemist To: Mark Hartman/ Kathy Monk Dated: 03/ 10/ 05 MRID: 44549101 65 MASTER RECORD IDENTIFICATION NUMBERS References Used To Support Reregistration 00067905 Fischer, W. C.; Cassidy, J. E. ( 1980) Balance and Metabolism of Triazole 14C CGA 64250 in a Lactating Goat: Report No. ABR 80036. ( Unpublished study received Jan 28, 1981 under 100 618; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 244269 G)

00074495 Marco, G. J.; Kahrs, R. A. ( 1981) CGA 64250 Rice and Pecans: Residues Observed and Metabolism Data Including the Analytical Methods Used: Report No. ABR 81020. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070163 A)

00074496 Madrid, S.; Cassidy, J. E. ( 1980) The Uptake, Distribution and Characterization of Triazoleand Phenyl 14 C CGA 64250 and Their Metabolites in Greenhouse grown Peanuts: Report No. ABR 80006. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 A)

00074497 Madrid, S. O.; Cassidy, J. E. ( 1980) Structure Elucidation of Phase I Metabolites of CGA 64250 in Greenhouse grown Peanut Stalks: Report No. ABR 80037. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 B)

00074498 Madrid, S. O.; Cassidy, J. E. ( 1981) The Uptake, Distribution and Characterization of Triazole 14C CGA 64250 and Their Metabolites in Field grown Peanuts: Report No. ABR 81013. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 C)

00074499 Seim, V.; Brown, G. ( 1979) Biological Report for the Metabolism of Triazole 14C CGA 64250 and [ Phenyl] 14C CGA 64250 When Applied as a Foliar Spray to Greenhouse Grown Peanuts: Report No. BIOL 79007. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 D)

00074500 Blattmann, P. ( 1979) Metabolism of CGA 64 250 in Field Grown Wheat: Project Report 36/ 79. ( Unpublished study received Jun 8, 1981 under 100 EX 69; prepared by Ciba Geigy, Ltd., Switzerland, submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 E)

00074501 Blattmann, P. ( 1980) Proposed Pathways for the Degradation of CGA 64 250 in Field Grown Wheat: Project Report 17/ 80. ( Unpublished study received Jun 8, 1981 under 100 EX 69; prepared by Ciba Geigy Ltd., Switzerland, submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 F) 66 00074502 Blattmann, P. ( 1980) Metabolism of CGA 64 250 in Grapevine: Project Report 42/ 80. ( Unpublished study received Jun 8, 1981 under 100 EX 69; prepared by Ciba Geigy Ltd., Switzerland, submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 G)

00074503 Madrid, V.; Cassidy, J. E. ( 1981) Characterization of Metabolites in Urine, Milk and Liver of a Goat Treated with Triazole 14C CGA 64250: Report No. ABR 81007. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 I)

00074504 Seim, V. W.; Thomas, W. A. ( 1980) Biological Report for the Metabolism of Triazole 14CCGA 64250 in a Lactating Goat: Report No. BIOL 80004. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070164 J)

00074508 Ciba Geigy Corporation ( 1981) [ Residues of CGA 64250 in Rice Field Studies]: AG A 6144. ( Compilation; unpublished study, including AG A 6195, AG A 6196, AG A 6212..., received Jun 8, 1981 under 100 EX 69; CDL: 070165 A)

00074509 Ciba Geigy Corporation ( 1981) [ Residues of CGA 64250 in Pecans in Field Studies]: AG A 6203. ( Compilation; unpublished study, including AG A 6291, received Jun 8, 1981 under 100 EX 69; CDL: 070165 B)

00074510 Ciba Geigy Corporation ( 1981) [ Residues of CGA 64250 in Soybeans in Field Studies]: AGA 6101. ( Unpublished study received Jun 8, 1981 under 100 EX 69; CDL: 070165 C)

00074511 Ross, J. A. ( 1981) Stability of Residues of CGA 64250 under Freezer Storage Conditions: Report No. ABR 81018. ( Unpublished study received Jun 8, 1981 under 100 EX 69; submitted by Ciba Geigy Corp., Greensboro, N. C.; CDL: 070165 D)

00129915 Staley, J.; Madrid, S.; Cassidy, J. ( 1982) The Uptake of Triazole  14C CGA 64250 and Its Soil Degradation Products in Field Rotational Winter Wheat, Lettuce, Corn and Carrots: Report No.: ABR 82007. ( Unpublished study received Jul 21, 1983 under100 641; submitted by Ciba Geigy Corp., Greensboro, NC; CDL: 250783 G)

00133385 Ciba Geigy Corp. ( 1983) CGA 64250: Pecans. ( Compilation; unpublished study received Dec 12, 1983 under 100 617; CDL: 072212 A; 072213; 072214; 072215; 072216; 072217)

00137150 Ciba Geigy Corp. ( 1984) CGA 64250 Bananas. ( Compilation; unpublished study received Jan 17, 1984 under 4E3026; CDL: 072285 A)

00137861 Ciba Geigy Corp. ( 1984) [ Residue: CGA 64250 Rice]. ( Compilation; unpublished study received Apr 6, 1984 under 4F3074; CDL: 072556 A; 072557)

00138266 Honeycutt, R. ( 1983) Rotational Crop Studies with CGA 64250: Report No. EIR 83014. ( Unpublished study received Apr 4, 1984 under 100 617; submitted by Ciba Geigy Corp., Greensboro, 67 NC; CDL: 253013 A)

00153327 Cheung, M. ( 1985) CGA 64250 Pecans: Response to EPA's Questions Regarding Section D: Residue Chemistry : Report No. ABR 85050. Unpublished study prepared by Ciba Geigy Corp. 9 p.

00155644 Szolics, I.; Simoneaux, B. ( 1985) Metabolism Data and Correlation of Metabolites in Target and Rotation Crops of Propiconazole: Report No. ABR 85056. Unpublished study prepared by Ciba Geigy. 45 p.

00155645 Madrid, S.; Cassidy, J. ( 1983) Soil Uptake of Phenyl Carbon 14 vs. Triazole Carbon 14  CGA 64250 in Target Peanuts Followed by Rotational Winter Wheat and Corn  A Side by Side Comparison Study in the Greenhouse: Report No. 83030. Unpublished study prepared by Ciba Geigy. 38 p.