1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: January 31, 2005 Subj: Propiconazole: Revised Occupational and Residential Exposure Assessment for the Re registration Eligibility Decision Document ( RED).

PC Code: 122101 ( Propiconazole)

DP #: 324682 From: James Miller, Environmental Scientist Health Effects Division/ Re registration Branch 4 ( 7509C)

Through: Susan Hummel, Branch Senior Scientist Health Effects Division/ Re registration Branch 4 ( 7509C)

To: Yan Donovan, Risk Assessor Health Effects Division/ Registration Action Branch 4 ( 7509C)

The attached assessment is the revised occupational and non occupational ( residential) exposure and risk estimates for propiconazole to support HED's Re registration Eligibility Decision ( RED) document This assessment was reviewed by HED's Science Council for Exposure ( Expo SAC) to ensure compliance with current HED policy for conducting occupational and residential exposure ( ORE) assessments. 2 Table of Contents 1.0 Executive Summary ........................................................................................................ 4 1.1 Background and Purpose ..................................................................................... 4 1.2 Use Patterns and Formulations............................................................................. 4 1.3 Criteria for Conducting Exposure Assessments .................................................... 4 1.4 Hazard Identification .......................................................................................... 5 1.5 Occupational and Residential Non Cancer Risks             ... 6 2.0 Hazard Identification....................................................................................................... 7 2.1 Acute Toxicological Categories ........................................................................... 7 2.2 Toxicological Endpoints ...................................................................................... 8 2.3 Dermal Absorption .............................................................................................. 9 2.4 Dermal Exposure: Short Term ........................................................................... 10 2.5 Dermal Exposure: General Population ............................................................... 10 2.6 Dermal Exposure: Intermediate and Long Term ................................................ 10 2.7 Inhalation Exposure: Short Term....................................................................... 11 2.8 Inhalation Exposure: Intermediate and Long Term ............................................ 11 2.9 Margins of Exposure ........................................................................................... 11 3.0 Summary of Use Patterns and Formulations ................................................................. 12 3.1 Mode of Action and Target Pests ...................................................................... 12 3.2 Occupational/ Agricultural Use Sites .................................................................. 12 3.3 Homeowner/ Residential Use Sites ..................................................................... 13 3.4 Formulations/ Master Label Report..................................................................... 13 3.5 Application Methods and Equipment ................................................................. 16 4.0 Incident Report............................................................................................................. 17 5.0 Occupational Exposure and Risks................................................................................. 19 5.1 Occupational Handler Exposure and Risk .......................................................... 19 5.1.1 Data and Assumptions for Handler Exposure Scenarios.......................... 20 5.1.2 Exposure Data for Handler Exposure Scenarios...................................... 21 5.1.3 Agricultural Handler Scenarios............................................................... 24 5.1.4 Non Cancer Propiconazole Handler Exposure and Assessment .............. 25 <IP_ADDRESS> Non Cancer Propiconazole Handler Exposure and Risk Calculations................................................................................ 25 <IP_ADDRESS> Propiconazole Non Cancer Risk Summary ................................. 27 5.1.5 Summary of Risk Concerns and Data Gaps for Occupational Handlers... 31 5.1.6 Recommendations for Refining Occupational Handler Risk Assessment. 31 6.0 Occupational Post application Exposure and Risks....................................................... 31 6.1 Occupational Post application Exposure Scenarios ........................................... 32 3 6.1.1 Post application Exposure Scenarios and Rationale         . 32 6.1.2 Data/ Assumptions for Post application Exposure Scenarios ................... 35 <IP_ADDRESS> Agricultural Scenarios .............................................................. 35 6.1.3 Occupational Post application Exposure and Non Cancer Risk ............. 42 <IP_ADDRESS> Agricultural Scenarios/ Calculation Methods ............................ 43 6.1.4 Occupational Post application Non Cancer Risk Summary .................... 45 6.1.5 Summary of Post application Risk Concerns and Data Gaps    ... 46 <IP_ADDRESS> Recommendations for Refining Occupational Post application Risk Assessment .................................................................................... 47 7.0 Residential Exposures and Risks ................................................................................... 47 7.1 Residential Handler Exposure Scenarios and Risks................................. 47 7.1.1 Handler Exposure Scenarios................................................................... 47 7.1.2 Data and Assumptions for Exposure Risk Scenarios ............................... 48 7.1.3 Residential Handler Exposure and Non Cancer Risk Estimates .............. 50 7.1.4 Summary of Risk Concerns and Data Gaps for Handlers ........................ 51 7.1.5 Recommendations for Refining Residential Handler Risk Assessment ... 51 7.2 Residential Post application Exposures and Risks. ............................................. 51 7.2.1 Residential Post application Exposure Scenarios .................................... 51 7.2.2 Data/ Assumptions for Residential Post application Exposure Scenarios                          53 7.2.3 Residential Post application Exposure and Non Cancer Risk Estimates ................................................................................................ 55 7.2.4 Residential Post application Exposure and Non Cancer Risk Summary ................................................................................................ 57 7.2.5 Summary of Residential Post application Risk Concerns and Data Gaps                          ... 58 7.2.6 Recommendations for Refining Residential Post application Risk Assessment                        . 58 Appendix A: Occupational Handler Exposures .....................................................................  59 Appendix B: Occupational Post application Exposures ............................................................. 59 Appendix C: Residential Handler Exposures............................................................................. 59 Appendix D: Residential Post application Exposures ................................................................ 59 4 Executive Summary 1.0 Background and Purpose The Health Effects Division ( HED) has conducted an occupational and non occupational ( residential) exposure assessment for the active ingredient propiconazole [( 1[[ 2 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole for the purpose of supporting HED's Reregistration Eligibility Decision ( RED) document.

1.2 Use Patterns and Formulations Propiconazole is a systemic triazole fungicide with protective and curative action. Propiconazole is formulated as liquids ( emulsifiable, soluble, and flowable concentrates packaged as " mix your own" and " ready to use" ( RTU) products) and wettable powders in water soluble packets ( WP/ WSP). Application rates vary depending upon the application equipment and crop or use site.

Propiconazole is registered for use in a variety of occupational and residential sites. Occupational uses include conventional agricultural and commercial sites, as well as antimicrobial uses. Residential use sites include ornamentals ( herbaceous, woody, non bearing fruit/ nut trees), turf ( lawn applications), and garden crops with applications being performed by both professionals and homeowners. This document only addresses exposures and risks for the agricultural/ commercial/ residential uses; antimicrobial uses will not be addressed.

Occupational application methods include aerial, groundboom, chemigation, airblast, seed piece dip, tree injection, and handheld equipment ( i. e., low pressure handwand and handgun sprayer). Residential applications are done using handheld equipment.

1.3 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is a potential for exposure to handlers ( mixers, loaders, applicators) during use or to persons entering treated sites or exposed to vapors after application is complete. Toxicological endpoints were selected for short ( 1 30 days), intermediate ( 1 6 months), and long term (> 6 months) dermal and inhalation exposures to propiconazole; however exposure durations are expected to be only of short or intermediate term duration. There is a significant potential for exposure in a variety of occupational agricultural, commercial, as well as in residential settings. Therefore, risk assessments are required for occupational and residential handlers as well as for occupational and residential post application exposures that can occur as a result of propiconazole use. 5 1.4 Hazard Identification On February 13, 2003 the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reassessed FQPA requirements ( TXR 0052277) for propiconazole in response to questions posed by the Natural Resources Defense Council ( NRDC). No new data have been reviewed and no changes were made to the toxicology endpoints previously selected for Propiconazole ( TXR 0050439 & 0051703). In October, 2005, the registrant conducted an ACN study ( MRID 46604601) with propiconazole and submitted it to the Agency. Evaluation of this ACN study demonstrated that severe clinical signs of toxicity were not accompanied by nervous tissue damage and neurobehavioral effects were minimal. The propiconazole risk assessment team concluded that the ACN study satisfies the data gap imposed by HIARC and the 3X factor for the data base uncertainty factor ( UFDB) can be reduced to 1X. The rat acute study also serves as the basis for short term incidental oral, dermal and inhalation scenarios.

Dermal Endpoints:

The endpoint selected was based on acute clinical toxicity observed in the acute neurotoxicity study in rats ( ACN) ( MRID 46604601) discussed above. It was concluded that the LOAEL for the clinical signs of toxicity in this ACN study was 100 mg/ kg and the NOAEL was 30 mg/ kg. This endpoint is appropriate since the severe clinical effects were observed after administration of the test material within one day. Since an oral dose was selected, a 40% dermal absorption factor is used for route to route extrapolation.

The intermediate and long term dermal toxicological endpoints are the same at 10 mg/ kg/ day. The intermediate and long term dermal toxicological exposures are based on acute clinical toxicity observed in the acute neurotoxicity study in rats ( ACN) ( MRID 46604601) discussed above.

Inhalation Endpoints:

The short term inhalation toxicological endpoint is 30 mg/ kg/ day based on an acute rat acute neurotoxicity study ( MRID 46604601).

The intermediate and long term inhalation toxicological endpoint is 10 mg/ kg/ day. The intermediate and long term inhalation toxicological endpoint is based on non neoplastic liver effects { increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)} at 50 mg/ kg/ day of propiconazole administration derived from a chronic/ oncogenicity study in mice ( MRID 00129570 and 93194037). An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral absorption) will be used for route to route extrapolation.

Since the short term and intermediate/ long term dermal and inhalation toxicological endpoints of concern are the same, respectively for each duration, and based on oral studies, 6 assessments of each exposure duration combines the dermal and inhalation doses and applies the appropriate route specific absorption factor explained above.

The Agency's level of concern for non cancer risks ( i. e., target level for MOEs or Margins of Exposure) is defined by the uncertainty factors that are applied to the assessment. The Agency applies a 10X factor to account for inter species extrapolation and a 10X factor to account for intra species sensitivity. The total uncertainty factors that have been applied to non cancer risk assessments are 100 for occupational, 100 for short term residential and 100 for intermediate, long term residential scenarios ( based on the toxicology endpoint selection for General Population including infants and children.

Propiconazole is listed as a Group C, Possible Human Carcinogen. A Q1* was not identified for propiconazole, therefore a quantitative cancer risk assessment is not required.

1.5 Occupational and Residential Non cancer Risks Occupational Handler Risk Summary:

The short and intermediate term occupational handler non cancer risk assessment for propiconazole indicates that for all occupational handler scenarios, risks do not exceed HED's level of concern ( i. e., MOEs > 100).

Occupational handler data gaps identified for this assessment include:

  Seed piece dip treatments ( applicator scenario) for sugarcane; Note: Labels call for chemical resistant gloves, apron and protective eyewear.

  Tree injections; Note: Labels call for chemical resistant gloves, protective eyewear/ face shield.

  Mixing/ Loading/ Applying wettable powders in water soluble packets for handheld equipment. Note: Although there is no data to assess the M/ L/ A wettable powder scenarios, it is reasonable to assume that M/ L/ A exposures associated with this formulation are lower than M/ L/ A exposures with liquid formulations. This rationale is based on the assumption that the " application" component of the exposure will not be significantly different for the same application method ( both will be applied as a spray); however, as seen in scenarios where the activities are separate, the " mixing/ loading" exposure component is greater for liquid formulations. Therefore, the M/ L/ A liquid scenarios were used as a conservative surrogate.

Occupational Post application Risk Summary:

Data from propiconazole specific studies were used along with crop specific transfer coefficients { from Science Advisory Council for Exposure ( ExpoSAC) Policy 3.1   Agricultural Transfer Coefficients} to calculate post application exposures and risks. [ Calculations for turf 7 risks were generated using the arithmetic mean of data ( time zero residues) generated at the California, Indiana and Pennsylvania test sites.]

The non cancer occupational post application worker risk assessment indicates that for most agricultural post application exposure scenarios, risks do not exceed HED's level of concern ( i. e., MOEs > 100) on the day of the treatment ( day after treatment ( DAT) = 0). The post application exposure scenarios that exceeded HED's level of concern ( i. e., MOEs < 100) on the day of the treatment ( day after treatment ( DAT) = 0) are listed below and discussed in more detail in ( section 6.1.5).

  Ornamentals ( woody and herbaceous plants) intermediate/ long term.

Residential Handler Risk Summary:

  The non cancer residential handler risk assessment indicates that for all residential handler scenarios, risks do not exceed HED's level of concern ( i. e., MOEs > 100) assuming baseline level of protection ( for homeowners: short sleeve shirt, short pants, shoes, and socks).

Residential handler data gaps identified for this assessment include:

  M/ L/ A wettable powders in water soluble packets for handheld equipment ( see note in Occupational Handler Risk Summary).

Residential Post application Risk Summary:

There are no short term residential post application risks of concern ( MOEs > 100) on the day of application ( DAT = 0).

2.0 Hazard Identification 2.1 Acute Toxicological Categories Table 1: Propiconazole Acute Toxicity Profile Guideline No. Study Type MRID # Results Toxicity Category 81 1 Acute Oral  rat 00058591 LD50 = 1517 mg/ kg III 81 2 Acute Dermal rabbit 00058596 LD50 = > 4000 mg/ kg III 81 3 Acute Inhalation  rat 41594801 LC50 = > 50.84 mg/ L IV 81 4 Primary Eye Irritation 00058597 Corneal opacity reversed in 72 hours III 81 5 Primary Skin Irritation 00058598 No irritation IV 81 6 Dermal Sensitization 00058600 Non sensitizer  8 2.2 Toxicological Endpoints The report of the HIARC for Propiconazole identified toxicological endpoints of concern for propiconazole. All calculations completed in this document are based on the most current toxicity information available for propiconazole as reported in the HIARC document. The endpoints that were used to complete this assessment are summarized in table 2.

Table 2: Propiconazole Toxicological Endpoints Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Short Term ( 1 30 days) Incidental Oral NOAEL= 30 mg ai/ kg/ day Residential MOE = 100 Occupational = NA Acute Neurotoxicity Study Rats Clinical signs ( piloerection, diarrhea, tiptoe gait).

Intermediate Term ( 1  6 months) Incidental Oral NOAEL= 10 mg ai/ kg/ day Residential MOE = 100 Occupational = NA 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Short Term ( 1  30 days) Dermal ( General Population, including infants and children) Oral Maternal NOAEL= 30 mg ai/ kg/ day ( Dermal absorption rate = 40%) Residential MOE = 100 Occupational MOE = 100 Acute Neurotoxicity Study Rats Clinical signs ( piloerection, diarrhea, tiptoe gait).

Intermediate Term ( 1  6 months) and Long Term Dermal (> 6 months) Oral NOAEL= 10 mg ai/ kg/ day ( Dermal absorption rate = 40%) Residential MOE = 100 Occupational MOE = 100 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)

Short Term ( 1  30 days) Inhalation Oral Dev. NOAEL= 30 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 100 Occupational MOE = 100 Acute Neurotoxicity Study Rats Clinical signs ( piloerection, diarrhea, tiptoe gait Intermediate Term ( 1  6 months) and Long Term Inhalation (> 6 months) Oral NOAEL= 10 mg/ kg/ day ( Inhalation absorption rate = 100%) Residential MOE = 100 Occupational MOE = 100 24 Month Oncogenicity Study  Mice. Liver toxicity ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly) 9 Table 2: Propiconazole Toxicological Endpoints Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Cancer ( Oral, dermal, inhalation) Group C, possible human carcinogen, RfD approach for risk characterization.

Note: ¹ UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, ² LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) ³ RfD = ref. dose, MOE = margin of exposure, LOC = level of concern, NA = Not App.

Note: The Special FQPA Safety Factor recommended by the HIARC assumes that the exposure databases ( dietary food, drinking water, and residential) are complete and that the risk assessment for each potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for infants and children.

2.3 Dermal Absorption Dermal Absorption Factor: 40%

Study Selected: Dermal Absorption  Rat § 85 3 MRID No.: 42415701, 00164469, 45345901 Executive Summary: In a dermal absorption study ( MRID's 42415701, 45345901), groups ( 4/ group) of young adult male, Harlan Sprague Dawley rats ( age not given) were exposed to triazole[ 3,5] 14C CGA 64250 ( 95% radiochemical purity, specific activity 28.2 µ Ci/ mg for low and mid dose levels and 2.01 µ Ci/ mg for the high dose level) at doses of 0.1, 1.0 or 10 mg/ rat ( 0.01, 0.1 or 1 mg/ cm2, respectively) to a 10 cm2 shaven dorso lumbar area. The radioactive test compound was added to the 3.6EC formulated product ( 45.8% active ingredient and 54.2% inert substances) and applied as an aqueous suspension. One group of four rats/ dose were exposed for 24 hours, while two other groups of four rats each/ dose were exposed for 10 or 24 hours followed by a 72 hour depletion phase. This study is an addendum to an earlier study where groups of four male rats each were treated similarly but exposed for 2, 4 or 10 hours ( MRID 00164469). In both studies, following the exposure period, the test compound remaining on the skin was removed with a soap rinse. Fecal and urinary samples were collected at the end of the exposure periods and at 24 hour intervals ( for the depletion groups) following the exposure. The amount of test compound absorbed was directly proportional to the applied dose. The rate of absorption appeared to be saturated at the highest dose level; at the low dose level, there was a time dependent increase in the amount of compound absorbed. After 24 hours, 57.1, 271 and 3010 : g/ cm2 ( 57.13, 27.14 and 30.10% of total dose were absorbed at the low, mid and high dose levels, respectively). During the 72 hour depletion phase essentially allof the compound was eliminated in the urine and feces; urinary elimination predominated at the mid and high dose levels. At the end of the 72 hour depletion phase, less than 2% of the test compound was still present in the carcass. The results of the earlier study ( MRID 00164469) demonstrated that 26 10 35% of the applied radioactivity ( at all dose levels) is absorbed within the first two hours and remained fairly constant for the longer exposure periods of 4 and 8 hours except for the low dose of 0.01 mg/ cm2 where it increased to 54%. The average dermal absorption of propiconazole over a 10 hour period at an exposure level of 0.01 mg/ cm2 is approximately 40%. The two studies were classified Acceptable/ guideline and both satisfy the guideline requirement ( 870.7600; 85 3) for a dermal absorption study.

2.4 Dermal Exposure: Short Term Previously ( 12/ 11/ 01), the HIARC had selected the developmental endpoint for all populations for the short term dermal exposure scenario. The developmental endpoint is not relevant for assessing risks to infants and children from residential exposures. Therefore, the HIARC re evaluated the data and selected endpoints that are relevant/ applicable to the populations of concern via this exposure pathway. See table 2 for description of endpoint selection.

2.5 Dermal Exposure: Short Term ( 1  30 days) Gen. Pop., incl. infants and Children.

HIARC had selected a developmental NOAEL of 30 mg/ kg/ day from the developmental rat study ( MRID 40425001) to assess short term dermal risks to females 13 50, and a maternal NOAEL of 90 mg/ kg/ day from the developmental rat study to assess dermal risks to all other population subgroups. The propiconazole risk assessment team recommends that the recently submitted rat acute neurotoxicity study ( MRID 46604601) with a NOAEL of 30 mg/ kg/ day is appropriate for assessing risks of this exposure duration and is applicable to all population subgroups. Since an oral study was selected, a 40% dermal absorption factor is used for route to route extrapolation 2.6 Dermal Exposure: Intermediate Term ( 1  6 Months) and Long Term (> 6 Months)

HIARC selected NOAEL of 10 mg/ kg/ day based on non neoplastic liver effects ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)) at 50 mg/ kg/ day of propiconazole administration derived from a chronic/ oncogenicity study in mice ( MRID 00129570 and 93194037).

2.7 Inhalation Exposure: Short Term ( 1  30 days)

HIARC had selected a developmental NOAEL of 30 mg/ kg/ day based on increased incidence of rudimentary ribs, unossified sternebrae and shortened and absent renal papillae, and increased cleft palate seen at the developmental LOAEL of 90 mg/ kg/ day in a developmental rat study ( MRID 40425001). The propiconazole risk assessment team recommends that the recently submitted rat acute neurotoxicity study ( MRID 46604601) with a NOAEL of 30 mg/ kg/ day is appropriate for assessing inhalation risks of this exposure duration and is applicable to all population subgroups. An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral absorption) will be used for route to route extrapolation. 11 2.8 Inhalation Exposure: Intermediate Term ( 1  6 Months) and Long Term (> 6 Months)

HIARC selected NOAEL of 10 mg/ kg/ day based on non neoplastic liver effects ( increased liver weight in males and increase in liver lesions ( masses/ raised areas/ swellings/ nodular areas mainly)) at 50 mg/ kg/ day of propiconazole administration derived from a chronic/ oncogenicity study in mice ( MRID 00129570 and 93194037). An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral absorption) will be used for route to route extrapolation.

2.9 Margins of Exposure:

Table 3: Propiconazole Acceptable Margins of Exposure Route Short Term ( 1 30 Days) Intermediate Term ( 1  6 Months) Long Term (> 6 Months)

Occupational ( Worker) Exposure Dermal 100 100 100 Inhalation 100 100 100 Residential ( Non Dietary) Exposure Oral 100 100 NA Dermal 100 100 100 Inhalation 100 100 100 For Occupational exposure: All durations, a MOE of 100 is required. This is based on the conventional uncertainty factor of 100X ( 10X for intra species extrapolation and 10X for interspecies variation).

For Residential exposure: Short term, a MOE of 100 is required. This is based on the conventional uncertainty factor of 100X ( 10X for intra species extrapolation and 10X for interspecies variation).

Body Weight: Since the adverse effects for a study utilized in the propiconazole dermal and inhalation risk assessment is based on a developmental toxicity study of rats, the body weight used for estimating exposures is 70 kg ( ie., General Population including infants and children). 12 3.0 Use patterns and Formulations 3.1 Mode of Action and Targets Controlled Propiconazole [( 1[[ 2 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole) is used as a contact fungicide in commercial, agriculture and residential settings. The pests controlled include:

  On Terrestrial Food Crops: black sheath rot; brown blotch; brown leaf spot; brown rot; blossom blight; early blight; sheath blight; early leaf spot; fruit brown rot; late leaf spot; leaf smut; narrow brown leaf spot; sheath spot; southern stem rot; stem rot.   On Terrestrial Food Crops and Feed Crops: barley scald; brown rot blossom blight; eye spot; foot rot; fruit brown rot; early leaf spot; gray leaf spot; glume blotch; helminthosporium leaf blight; late leaf spot; leaf blight; net blotch; powdery mildew; rusts; southern stem rot; tan spot.

  On Terrestrial Non Food Crops: altrnia leaf spot; anthracnose; blackspot; cercospora leaf spot; coccomyces heimalis; collectrichum leaf spot; diplodia tip blight; downy spot; Dutch elm disease; erysiphe; fabraea maculata; greasy spot; gymnosporangium juniperivirginianae; heterosporium echinulatum; leaf diseases of crabapple; leaf scorch; melampsora occidentialis; microsphaera; monilinia; oak wilt; oidium; ovulinia; phragmidium; phomopsis blight; podospaera; puccinia; pucciniastrum goeppertianum; ray blight; scab; sphaerotheca pannosa; spilocaea pyracanthae; sycamore anthracnose; tip blight; tubakia dryina; uromyces dianthi; venturia inaequalis; zonate leaf spot.

  On Lawns/ Turf: anthracnose; brown patch; dichondria rust; dollar spot; fusarium patch; gray leafspot; gray snowmold; leaf spot; melting out; necrotic ring spot; pink patch ; pink snowmols; poa patch; powdery mildew; red thread; rusts; selenophoma stem eyespot; spring dead spot; stripe smut; summer patch; take all patch; yellow patch; zosia patch.

  On seed pieces: butt rot diseases; pineapple disease of sugarcane.

3.2 Occupational/ Agricultural Use sites:

Occupational populations are potentially exposed to propiconazole while applying and/ or during post application activities to the following targets:

  Terrestrial Food Crops: mint, peanuts, rice, wild rice, bananas, plantains, celery, sugarcane, pineapple, apricots, cherries, nectarines, peaches, plums, pecans.

  Terrestrial Food and Feed Crops: barley, rye, oats, wheat, corn, and sunflower breeder's seed. 13   Terrestrial Non Food Crop: commercial/ recreational turf, golf course turf, sod farms, grasses grown for seed, ornamentals ( herbaceous plants, non bearing fruit and nut trees, non bearing blueberries, woody shrubs and vines, shade trees), and residential lawns  lawn care operators ( LCO).

3.3 Homeowner/ Residential Use sites:

  Turf: golf courses, homeowner lawn applications   Ornamentals ( Herbaceous): calendula, carnation, chrysanthemums, delphinium, gomphrena, iris, marigold, monarada, phlox, roses, snapdragons, sweet william, zinnia.

  Ornamentals ( Woody): amelachier, ash, azalea, crabapple, crepe myrtle, dogwood, douglas fur, hawthorn, Jeffery pine, juniper, lilac, oak, pines, poplars, pyracantha, red tip, photinia, rhododendron, shasta fir.

  Ornamentals ( Non bearing fruit and nut trees): apple, cherry, citrus, peach, pecan, hazelnuts, plum, nectarine.

3.4 Formulations and Uses Based on EPA's pesticide registration database, propiconazole is available as a liquid ( emulsifiable concentrate, flowable concentrate, ready to use ( RTU) liquid, soluble concentrate) and wettable powder in water soluble packets.

Table 4: Propiconazole Uses Crop Max. Appl. Rate ( Reg. #) Maximum # Applications/ Crop Cycle Max. amt. ( lb ai/ A/ yr.) Timing Pre Harvest Interval ( Days) Minimum Retreatment Interval ( Days) Application Methods Section 3 uses Barley 0.1125 lb ai/ A ( 100 617) ( 100 780) NS ( 1 for post emergence and tillering) 0.1125 Post Emergence 14 40 NS Aerial, Groundboom, Chemigation Celery 0.1125 lb ai/ A ( 100 617) ( 100 780) 4 NS Foliar 14 45 7 Aerial, Groundboom, Chemigation Corn ( field, pop, sweet) 0.1125 lb ai/ A ( 100 617) ( 100 780) NS ( no more than 16 oz of Tilt per season) 0.45 Foliar 14 30 7 Aerial, Groundboom, Chemigation Grasses Grown for Seed ( forage fodder grasses) 0.225 lb ai/ A ( 100 617) NS ( no more than 32 fl oz/ A/ CC) ( do not feed hay cut within 20 days of last application) 0.90 Foliar N/ A 14 Aerial, Groundboom, Chemigation 14 Table 4: Propiconazole Uses Crop Max. Appl. Rate ( Reg. #) Maximum # Applications/ Crop Cycle Max. amt. ( lb ai/ A/ yr.) Timing Pre Harvest Interval ( Days) Minimum Retreatment Interval ( Days) Application Methods Non bearing Apple 0.08 lb ai/ 100 gal ( 100 741) ( 100 617) NS ( 7.2 lb/ yr for Banner, Tilt and Banner Maxx) NS 7.2 lb ai/ A/ year for Tilt Foliar N/ A As needed Airblast, LPHW, HPHW, Backpack Non bearing Cherry, Nectarine, Peach, Plum 0.04 lb ai/ 100 gal ( 100 741) ( 100 617) NS ( 7.2 lb/ yr for Banner, Tilt and Banner Maxx) NS 7.2 lb ai/ A/ year for Tilt Foliar 1yr. 14 Airblast, LPHW, HPHW, Backpack Non bearing Pecan 0.12 lb ai/ 100 gal ( 100 741) ( 100 617) Deleted nonbearing pecan for 100 702 3 NS 7.2 lb ai/ A/ yr for Tilt Nonbearing N/ A 14 Aerial, ground, Airblast, LPHW, HPHW, Backpack Non bearing Citrus 0.225 lb ai/ A ( 100 702) NS ( 7.2 lb/ yr for Banner, Tilt and Banner Maxx) NS June July August 1yr. NS Aerial, Groundboom, Airblast, LPHW, HPHW, Backpack Oats 0.1125 lb ai/ A ( 100 617) NS ( typically 1) 0.1125 Postemergence 14 40 NS Aerial, Groundboom, Chemigation Peanuts 0.225 lb ai/ A* ( 100 617) NS ( no more than 16 oz of Tilt per season) 0.45 Post plant When needed 7 14 10 Aerial, Groundboom, Chemigation Pecans 0.225 lb ai/ A 9 ( 45 oz of Super Tin 80WP NS NS N/ A 14 Aerial, Groundboom Pineapple ( HI only) 0.021 lb ai/ 100 gal ( 100 617) NS ( typically 1, water dip) NS Planting N/ A NS Seed Piece Dip Rice 0.28 lb ai/ A ( 100 617) 1 ( at 10 fl. oz rate) 2 ( at 6 fl. oz rate) 0.34 Internode Elongation N/ A 10 Aerial Rice, wild 0.225 lb ai/ A ( 100 780) 1 ( 8 fl oz) 2 ( 6 fl oz) 0.34 Boot N/ A NS Aerial Rye 0.1125 lb ai/ A ( 100 780) ( 100 617) NS ( no more than 4 oz of Tilt per season) 0.1125 Foliar Postemergence 14 40 NS Aerial, Groundboom, Chemigation Stone Fruits Apricot, Cherry, Nectarine, Peach, and 0.1125 lb ai/ A ( 100 780) ( 100 617) ( 100 702) 5 0.56 Pre harvest Bloom Petal Fall N/ A NS Aerial, Airblast, Groundboom 15 Table 4: Propiconazole Uses Crop Max. Appl. Rate ( Reg. #) Maximum # Applications/ Crop Cycle Max. amt. ( lb ai/ A/ yr.) Timing Pre Harvest Interval ( Days) Minimum Retreatment Interval ( Days) Application Methods Plum Sugarcane ( Hawaii only) 0.021 lb ai/ 100 gal ( 100 617) NS ( seed treatment) NS Seed piece N/ A NS Seed Piece Dip Triticale 0.1125 lb ai/ A ( 100 780) ( 100 617) NS ( typically 1) 0.1125 Post Emergence 14 40 NS Aerial, Groundboom, Chemigation Turf  Lawns, Golf Courses, Recreational Areas 1.78 lb ai/ A ( 100 741) NS ( 7.2 max per year) ( 100 617) 7.2 Foliar N/ A NS Handgun Sprayer, LPHW, Backpack Ornamental Shade Trees ( injection) 0.0069 lb ai/ DBH ( 100 741) 1 NS Injection N/ A NS Tree Injection 0.24 lb ai/ 100 gal ( 100 741) Ornamental Shade Trees, Herbaceous Plants, Woody Shrubs and Vines 0.37 lb ai/ A ( based on assumption of 150 gallons/ A) NS ( 7.2 max per year) ( 100 617) NS NS N/ A NS Airblast, Handgun Sprayer, LPHW, Backpack Turf  Sod Farm 1.79 lb ai/ A ( 100 741) NS ( 7.2 max per year) ( 100 617) 7.2 NS N/ A NS Aerial, Groundboom Wheat 0.08 lb ai/ A ( 264 779) 2 NS NS 14 40 NS Aerial, Groundboom, Chemigation Section ( 24C) Uses Bananas and Plantain ( Hawaii, Puerto Rico) 0.084 lb ai/ A ( HI91000900) ( PR 040005) 8 ( mist blower rest 4) 0.675 HI when needed PR April August June May October September N/ A 21 Airlbast, HPHW, Backpack Corn ( post silk) 0.1125 lb ai/ A IL 040004 NS ( no more than 16 oz of Tilt per season) 0.45 Post silk 14 30 NS Aerial, Groundboom, Chemigation Grasses Grown for Seed ( forage fodder grasses) 0.225 lb ai/ A ( ID95001200) ( WA95003300 NV 010004) 4  ( no more than 32 fl oz/ A/ CC) ( do not feed hay cut within 20 days of last application) 0.90 Pre bloom N/ A 7 Aerial, Groundboom, Chemigation 16 Table 4: Propiconazole Uses Crop Max. Appl. Rate ( Reg. #) Maximum # Applications/ Crop Cycle Max. amt. ( lb ai/ A/ yr.) Timing Pre Harvest Interval ( Days) Minimum Retreatment Interval ( Days) Application Methods Mint 0.1125 lb ai/ A ( OR 050011) 2 0.23 Foliar 14 40 10 Groundboom Non bearing Blueberries 0.169 lb ai/ A ( FL9400500) 5 ( 4 week interval from June through October) NS Nonbearing N/ A 28 HPHW, Backpack Non bearing Hazelnuts 0.225 lb ai/ A ( OR 040003) NS ( no more than 32 oz of Orbit/ A/ season) 0.90 At emergence N/ A 14 Aerial, Groundboom Sugarcane Seed Piece 0.021 lb ai/ A ( FL88001600) 1 ( at planting) NS NS N/ A NS Dip tank and conveyor belt spray Sunflower Breeder =

s Seed 0.1125 lb ai/ A ( IL000001) ( IL940001) ( MI950007) ( TX000006) NS ( no more than 16 oz of Tilt/ A/ season) 0.45 When disease first appears 14 40 7 Aerial, Groundboom, Chemigation Wheat ( past Feekes 8) 0.1125 lb ai/ A NV01000400 1 0.1125 Spring and Winter 14 40 NS Aerial, Groundboom, Chemigation Active Section 18 Blueberries ( ME) 0.169 lb ai/ A NS ( no more than 30 fl. oz/ A/ season) 0.84 Leaf bud break N/ A 7 N/ A Sorghum ( KS) 0.1125 lb ai/ A 3 application, no more than 2 fl. oz 0.34 Prior to flowering N/ A 5 N/ A Filbert ( WA) 0.225 lb ai/ A 4 application, no more than 32 fl. oz 0.90 Bud break N/ A 10 N/ A Note:  Information was provided by Syngenta Crop Protection, Inc. in a November 9, 2001 letter to the Agency, subject: Correction to Propiconazole Use Patters.  Updated use information was provided by Syngenta Crop Protection, Inc., in an e mail correspondence on 4/ 13/ 2005, to supplement the 1999 use information in the LUIS report.

3.5 Application Methods and Equipment Propiconazole is applied with the following types of equipment: aerial, groundboom, chemigation, airblast, low pressure handwand, high pressure handwand, handgun sprayer, seed piece dip, hose end sprayer, and tree injection. 17 4.0 Incident Report   Poison Control Center Data  1993 through 2003 Results for the years 1993 through 2003 are presented below for occupational and nonoccupational reports involving incidents related to Propiconazole by adults, older children and for children under age six. Cases involving exposures to multiple products or unrelated outcome are excluded. Tables A and B present the hazard information for propiconazole compared with all other pesticides on six measures: percent with symptoms, percent with moderate, major, or fatal outcome, percent with major or fatal outcome, percent of exposed cases seen in a health care facility, and percent hospitalized and percent seen in a critical care facility. Table A reports the number of cases on which the data derived in Table B is based. Table B presents this information for non occupational cases involving adults and older children.

Table A. Number of propiconazole exposures reported to the Toxic Exposure Surveillance System ( AAPCC), number with determined outcome, number seen in a health care facility for occupational and non occupational cases ( adults and children six years and older) and for children under six years of age only, 1993 2003.

Subgroup Exposures Outcome determined Seen in Health Care Facility Occupational: adults and older children 13 4 4 Non occupational: adults and older children 63 27 10 Children under age six 13 8 1 Table B. Comparison between propiconazole and all pesticides for percent cases with symptomatic outcome ( SYM), moderate or more severe outcome ( MOD), life threatening or fatal outcome ( LIFE TH), seen in a health care facility ( HCF), hospitalized ( HOSP), or seen in an intensive care unit ( ICU) reported to Poison Control Centers, 1993 2003 for non occupational cases involving adults and older children.

Pesticide SYM* MOD* LIFE TH* HCF* HOSP* ICU*

Propiconazole 0.815% 0.296% 0.00% 0.159% 0.00% 0.00%

All Pesticides 68.8% 10.98% 0.414% 15.0% 6.88% 2.94%

Ratio .012 .027 0.00 .011 0.00 0.00 * Symptomatic cases based on those cases with a minor, moderate, major, or fatal medical outcome. Denominator for SYM, MOD, and LIFE TH is the total cases where medical outcome 18 was determined. Denominator for HCF is all exposures. Denominator for HOSP and ICU is all cases seen in a health care facility. For children less than six years old, there were too few cases to warrant analysis to draw any conclusions. In the occupational category, there was only one case categorized as moderate medical outcome. For children less than six years old, there were only 2 cases with minor medical outcome. For non occupational cases involving adults and older children, there were much lower levels of minor and moderate symptoms and visits to a health care facility. There were no life threatening or hospitalized cases. The most common symptoms were headache, dermal irritation, erythema, vomiting, ataxia, dizziness, difficulty breathing, and coughing ( reported in three or more cases). In general, propiconazole appears to be less hazardous than other pesticides.

  California Data  1982 through 2003 Detailed descriptions of 13 cases submitted to the California Pesticide Illness Surveillance Program ( 1982 2003) were reviewed. In 8 of these cases, propiconazole was used alone or was judged to be responsible for the health effects. Only cases with a definite, probable or possible relationship were reviewed. In the first case, a mixer/ loader, who did not wear personal protective equipment, held a container of the product in one hand and punctured the foil shield with his finger. The product splashed into his right eye and he reported eye pain and conjunctiva. In the second case, a home health nurse, who has a history of sinus allergies, inhaled the product after it was applied to a peach orchard about 10 yards from his patient's home. The nurse reported sinus pain and dry throat. In the third case, several workers harvested nectarines in an orchard. One worker reported chest tightness and difficulty breathing and was treated by a physician. In the fourth case, a field worker inhaled the product after it was applied to an almond orchard about 150 yards away. The worker reported vomiting , nausea, diarrhea, and headache about fifteen to thirty minutes later. In the fifth case, the product was applied about 1/ 4 mile from a field. A field worker moved pipes in the field and inhaled the product. The worker reported stomach cramps, vomiting, difficulty breathing, and chest pain. In the sixth case, the product was applied on a golf course. A golfer reported repeated occurrences of dermatitis on the back of his legs and ankles after playing golf several times in the morning. In the seventh case, a worker reported a rash while picking plums. The next day, the worker was treated by a physician. In the eighth case, a pest control operator applied the product to a tree near a residential office building. An employee, who works in the building, reported a headache after it drifted through the air conditioner.

In conclusion, from the review of the Incident Data System, it appears that a majority of cases involved skin symptoms such as rash, itching, skin irritation and respiratory effects such as difficulty breathing. Poison Control Center data would tend to support the Incident Data Systems results; dermal irritation, erythema, and difficulty breathing were among the most common effects reported. [ Note: All incident report findings were taken from a Memorandum dated July 26, 2005 and written by Monica S. Hawkins, M. P. H., Environmental Health Scientist/ Chemistry and Exposure Branch/ HED]. 19 5.0 Occupational Exposure and Risk Short, and intermediate term dermal and inhalation exposures have been assessed for each occupational scenario. Long term exposure is not expected.

5.1 Occupational Handler Exposure and Risk There is potential for exposure to propiconazole in occupational scenarios from handling propiconazole products during the application process ( i. e., mixer/ loaders, applicators, flaggers, and mixer/ loader/ applicators) and a potential for post application worker exposure from entering into areas previously treated with propiconazole. As a result, risk assessments have been completed for occupational handler scenarios as well as occupational post application scenarios. HED uses the term " handlers" to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and that exposures can vary depending on the specifics of each task. Job requirements ( e. g., amount of chemical to be used in an application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure levels to differ in a manner specific to each application event. Exposure scenarios can be thought of as ways of categorizing the kinds of exposures that occur related to the use of a chemical. The use of scenarios as a basis for exposure assessment is very common as described in the U. S. EPA Guidelines for Exposure Assessment ( U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992). Information from the current labels, use and usage information, toxicology data, and exposure data were all key components in developing the exposure scenarios.

The first step in the handler risk assessment process is to identify the kinds of individuals that are likely to be exposed to propiconazole during the application process. In order to do this in a consistent manner, HED has developed a series of general descriptions for tasks that are associated with pesticide applications. Tasks associated with occupational pesticide use ( i. e., for " handlers") can generally be categorized using one of the following terms:

  M/ L: these individuals perform tasks in preparation for an application. For example, prior to application, mixer/ loaders would mix the propiconazole and load it into the holding tank of the airplane or groundboom.

  Applicators: these individuals operate application equipment during the release of a pesticide product into the environment. These individuals can make applications using equipment such as airplanes or groundboom.

  M/ L/ A: these individuals are involved in the entire pesticide application process ( i. e., they do all job functions related to a pesticide application event). These individuals would transfer propiconazole into the application equipment and then also apply it.

  Occupational Flaggers: these individuals guide aerial applicators during the release of a pesticide product onto an intended target. 20 Next, assessors must understand how exposures to propiconazole occur ( i. e., frequency and duration) and how the patterns of these occurrences can cause the effects of the chemical to differ ( referred to as dose response). Wherever possible, use and usage data determine the appropriateness of certain types of risk assessments. Other parameters are also defined from use and usage data such as application rates and application frequency. HED believes that occupational propiconazole exposures can occur over a single day or up to weeks at a time for many use patterns and intermittent exposures over several weeks are also anticipated. Custom or commercial applicators may apply propiconazole over a period of weeks completing applications for a number of different clients. HED classifies exposures up to 30 days as short term and exposures greater than 30 days up to several months as intermediate term. HED completes both short and intermediate term assessments for occupational scenarios in essentially all cases, because these kinds of exposures are likely and acceptable use/ usage data are not available to justify deleting intermediate term scenarios.

Occupational handler exposure assessments are completed by HED using different levels of personal protection. HED typically evaluates all exposures with a tiered approach. The lowest tier is represented by the baseline exposure scenario ( i. e., long sleeve shirt, long pants, shoes, and socks) followed by increasing the levels of personal protective equipment or PPE ( e. g., gloves, double layer body protection, and respirators) and engineering controls ( e. g., enclosed cabs and closed mixing/ loading systems). This approach is always used by HED in order to be able to define label language using a risk based approach. In addition, the minimal level of adequate protection for a chemical is generally considered by HED to be the most practical option for risk reduction ( i. e., over burdensome risk mitigation measures are not considered a practical alternative.

5.1.1 Data and Assumptions for Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. The assumptions and factors used in the risk calculations include:

  Occupational handler exposure estimates were based on surrogate data from: ( 1) the Pesticide Handlers Exposure Database ( PHED), ( 2) Outdoor Residential Exposure Task Force ( ORETF).

  Average body weight of an adult handler is 70 kg because a toxicity endpoint was identified for general population including infants and children. ( See section 2.2 Table 2 for toxicological information).

  Generic protection factors ( PFs) were used to calculate exposures when data were not available.

  Exposure factors used to calculate daily exposures to handlers are based on applicable data if available. For lack of appropriate data, values from a scenario deemed similar enough by the assessor might be used. 21   For non cancer assessments, HED assumes the maximum application rates allowed by labels in its risk assessments ( see Table 4).

  The average occupational workday is assumed to be 8 hours.

  The daily areas treated were defined for each handler scenario ( in appropriate units) by determining the amount that can be reasonably treated in a single day ( e. g. acres, square feet, cubic feet, or gallons per day). When possible, the assumptions for daily areas treated are taken from the HED ExpoSAC SOP # 9: Standard Values for Daily Acres Treated in Agriculture which was completed on July 5, 2000.

Aerial applications: The assumptions for the number of acres treated used in the exposure equation is 350 acres for typical field crops, grasses grown for seed, wild rice, sod farm turf and 1200 acres for high acre crops.

Flagging: The assumption for the number of acres treated used in the exposure equation is 350 acres.

Groundboom: The assumption for the number of acres treated used in the exposure equation is 80 acres for typical field crops, turf and grasses grown for seed, 200 acres for high acreage crops and 40 acres for golf course turf.

Airblast: The assumption for the number of acres treated used in the exposure equation is 40 acres.

Chemigation: The assumption for the number of acres treated used in the exposure equation is 350 acres.

Low Pressure Handwand Sprayer: The assumption for the number of gallons used in the exposure equation is 40 gallons per day.

High Pressure/ Volume Handwand: The assumption for the number of gallons used in the exposure equation is 1000 gallons per day.

Handgun Sprayer: The assumption for the number of acres, for which a worker would M/ L is 100 acres ( 20 trucks x 5 acres/ truck = 100 acres). For M/ L/ A applications, 5 acres is used.

5.1.2 Exposure Data for Handler Exposure Scenarios No chemical specific information was available for propiconazole handler exposure assessments, all analyses were completed using acceptable surrogate exposure data for the scenario in question.

HED uses a concept known as unit exposure as the basis for the scenarios used to assess handler exposures to pesticides. Unit exposures numerically represent the exposures one would 22 receive related to an application. They are generally presented as mg active ingredient exposure/ pounds of active ingredient handled ( mg ai/ lb). HED has developed different unit exposures for different types of application equipment; job functions; and levels of protection. The unit exposure concept has been established in the scientific literature and also through various exposure monitoring guidelines published by the U. S. EPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development).

  Pesticide Handler Exposure Database ( PHED) Version 1.1 ( August 1998): PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts, a database of measured exposures for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e., replicates)

Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The sub setting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g., mixing/ loading, applying), formulation type ( e. g., wettable powders, granulars), application method ( e. g., aerial, groundboom), and clothing scenarios ( e. g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data are normalized ( i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures ( milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposures for each body part ( e. g., chest upper arm) is categorized as normal, lognormal, or " other" ( i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposures for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all " other" distributions. Once selected, the central tendency values for each body part are composed into a " best fit" exposure value representing the entire body.

The unit exposures calculated by PHED generally ranges from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in Appendix A. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g., duration, acres treated, pounds of 23 active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposures for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. Unit exposures are used which represent different levels of personal protection as described above. Protection factors were used to calculate unit exposures for varying levels of personal protection if data were not available.

  ORETF Handler Studies ( MRID 449722 01): A report was submitted by the ORETF ( Outdoor Residential Exposure Task Force) that presented data in which the application of various products used on turf by homeowners and lawn care operators ( LCOs) was monitored. All of the data submitted in this report were completed in a series of studies. The study that monitored LCO exposure scenarios using a low pressure, high volume turf handgun ( ORETF Study OMA002) is summarized below. A study that monitored homeowner exposures while using a hose end sprayer ( ORETF Study OMA004) is described in a later section on residential handlers.

LCO Handgun Sprayer: A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force ( ORETF) using " Dacthal" as a surrogate compound to determine " generic" exposures to individuals applying a pesticide to turf with a low pressure " nozzle gun" or " handgun" sprayer. Dermal and inhalation exposures were estimated using whole body passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 liters per minute for light work ( NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for pounds active ingredient handled. A total of 90 replicates were monitored using 17 different subjects.

Four different formulations of dacthal [ 75% wettable powder ( packaged in 4 and 24 pound bags), 75% wettable powder in water soluble bags ( 3 pound bag), 75% water dispersable granules ( 2 pound bag) and 55% liquid flowable ( 2.5 gallon container)] were applied by five different LCOs to actual residential lawns at each site in three different locations ( Ohio, Maryland, and Georgia) for a total of fifteen replicates per formulation. An additional ten replicates at each site were monitored while they performed spray application only using the 75 percent wettable powder formulation. A target application rate of 2 pounds active ingredient was used for all replicates ( actual rate achieved was about 2.2 pounds active ingredient per acre).

Each replicate treated a varying number of actual client lawns to attain a representative target of 2.5 acres ( 1 hectare) of turf. The exposure periods averaged five hours twenty one minutes, five hours thirty nine minutes, and six hours twentyfour minutes, in Ohio, Maryland and Georgia, respectively. Average time spent spraying at all sites was about two hours. All mixing, loading, application, adjusting, calibrating, and spill clean up procedures were monitored, except for typical end of day clean up activities, e. g. rinsing of spray tank, etc. 24 In general, concurrent lab spikes produced mean recoveries in the range of 78 120 percent, with the exception of OVS sorbent tube sections which produced mean recoveries as low as 65.8 percent. Adjustment for recoveries from field fortifications were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent.

Table 5: Unit Exposures Obtained From ORETF LCO Handgun Studies ( MRID 449722 01)

Total Dermal Unit Exposure ( mg/ lb ai)

Application Method Single Layer, No Gloves Single Layer, Gloves Double Layer, Gloves 2 Inhalation Unit Exposure ( Fg/ lb ai) 1 LCO Handgun Spray Mixer/ Loader/ Applicator Liquid Flowable3 No Data 0.45 0.245 1.8 LCO Handgun Spray Mixer/ Loader/ Applicator Wettable Powder in Water Soluble Bags 3 No Data 0.64 0.37 7.2 [ Note the data were found to be lognormal distributed. As a result, all exposures are geometric means.] Note:

1Air concentration ( mg/ m3/ lb ai) calculated using NAFTA ` 99 standard breathing rate of 17 lpm ( 1 m3/ hr) 2Exposure calculated using OPP/ HED 50% protection factor ( PF) for cotton coveralls on torso, arms, legs. 3All commercial handlers wore long pants, long sleeved shirt, nitrile gloves and shoes.

5.1.3 Agricultural Handler Scenarios Mixing/ Loading:   mixing and loading liquids for aerial application.   mixing and loading liquids for groundboom application.   mixing and loading liquids for airblast application.   mixing and loading liquids for chemigation application.   mixing and loading liquids for handgun sprayer application   mixing and loading wettable powders in water soluble packets for aerial applications.   mixing and loading wettable powders in water soluble packets for chemigation application .   mixing and loading wettable powders in water soluble packets for groundboom application.   mixing and loading wettable powders in water soluble packets for airblast application.   mixing and loading wettable powders in water soluble packets for handgun sprayer application. 25 Applicators:   applying sprays aerially.   applying sprays with ground boom sprayer.   applying sprays with airblast sprayer.

Mixing/ Loading/ Applicators:   mixing, loading and applying liquids with high pressure handwand.   mixing, loading and applying liquids with low pressure handwand.   mixing, loading and applying liquids with handgun sprayer applications.   mixing, loading and applying wettable powders in water soluble packets with low pressure hand wand   mixing, loading and applying wettable powders in water soluble packets for highpressure handwand applications   mixing, loading and applying wettable powders in water soluble packets for handgun sprayer applications.

Flaggers:   flagging for aerial spray application.

5.1.4 Non cancer Propiconazole Handler Exposure and Assessment The occupational handler exposure and non cancer risk calculations are presented in this section.

<IP_ADDRESS> Non cancer Propiconazole Handler Exposure and Risk Calculations Non cancer risks were calculated using the Margin of Exposure ( MOE) which is a ratio of the daily dose to the toxicological endpoint of concern. Daily dose values are calculated by first calculating exposures by considering application parameters ( i. e., rate and area treated) along with unit exposures. Exposures are then normalized by body weight and adjusted for absorption factors as appropriate to calculate dose levels.

Daily Exposure: The daily exposure and daily dose to handlers were calculated as described below. The first step was to calculate daily exposure ( dermal or inhalation) using the following formula.

Daily exp. { mg ai/ day} = Unit exp. { mg ai/ lb ai hadl.} x Appl. rate { lbs ai/ area} x DAT { area/ day}

Where:

Daily Exposure = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; 26 Unit Exposure = Unit exposures ( mg ai/ lb ai) derived from August 1998 PHED data, from ORETF data, from CMA data, or from Proprietary data;

Application Rate = Normalized application rate based on a logical unit treatment, such as acres, square feet, gallons, or cubic feet. Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and Daily Area Treated = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons per day ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dose: Daily dose ( inhalation or dermal) was calculated by normalizing the daily dermal or inhalation exposure value by body weight and accounting for dermal or inhalation absorption. For adult handlers using propiconazole, an average body weight of 60 kilograms was used for all exposure scenarios.

Since the short term and intermediate/ long term dermal and inhalation toxicological endpoints of concern are the same, respectively for each duration, and based on oral studies, each exposure duration combines the dermal and inhalation doses and applies an appropriate route specific absorption factor. A 40% absorption factor was applied to the dermal daily dose based on a dermal absorption study while a 100% inhalation factor is assumed ( standard HED policy when no study data is available).

Ave. Daily Dose { mg/ kg/ day} = Daily exp. { mg ai/ day} x { absorption factor ( 40%)/ Bodyweight}

Where:

Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient/ kg body weight/ day);

Daily Exposure = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption;

Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as the skin or lungs (% of the total available absorbed); and Body Weight = Body weight determined to represent the population of interest in a risk assessment ( kg).

Margins of Exposure: Finally, the calculations of daily dermal dose and daily inhalation dose received by handlers were then compared to the appropriate endpoint ( i. e., NOAEL) 27 to assess the total risk to handlers for each exposure route within the scenarios. All MOE values were combined for dermal and inhalation exposure levels and calculated using the formula below:

Margin Of Exposure ( MOE) = NOAEL/ Average Daily Dose ( ADD)

Where:

MOE = Margin of exposure, value used by HED to represent risk or how close a chemical exposure is to being a concern ( unitless);

ADD = ( Average Daily Dose) or the amount as absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient/ kg body weight/ day); and NOAEL = Dose level in a toxicity study, where no observed adverse effects occurred ( NOAEL) in the study <IP_ADDRESS> Propiconazole Non cancer Risk Summary All of the non cancer risk calculations for occupational propiconazole handlers completed in this assessment are included in Appendix A. A summary of the combined, dermal plus inhalation short, and intermediate term risks for each exposure scenario are presented in Table 6. 28 Table 6: Summary of Short and Intermediate Term Propiconazole Occupational Handler Non cancer Risks S Term MOE ( Dermal+ Inhalation) I Term MOE ( Dermal+ Inhalation) Exposure Scenario Crops Appl. Rate ( lb ai/ acre or lb ai/ gallon) Area Treated ( acre/ day or 2 gal/ day) Baseline Baseline + Gloves Baseline Baseline + Gloves Mixer/ Loader  Liquid Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 1200 13 1500 4.5 500 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 350 46 5100 15 1700 Non bearing Citrus, Pecans, Non bearing Hazelnuts, Peanuts 0.225 350 23 2600 7.7 850 Grasses grown for seed ( forage and fodder grasses), Wild Rice 0.225 350 23 2600 7.7 850 Sod farm turf 1.8 350 2.9 320 1.0 110 Wheat 0.08 1200 19 2100 6.3 700 Aerial Rice 0.28 1200 5.4 600 1.8 200 Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 200 80 9000 27 3000 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 80 200 22000 67 7500 Non bearing Citrus, Nonbearing Hazelnuts, Pecans, Peanuts 0.225 80 100 11000 33 3700 Grasses grown for seed ( forage and fodder grasses) 0.225 80 100 11000 33 3700 Sod farm turf 80 13 1400 4.2 470 Golf Course turf 1.8 40 25 2800 8.4 930 Groundboom Wheat 0.08 200 110 13000 38 4200 Pecans, Non bearing Citrus 0.225 40 200 22000 67 7500 Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum) 0.1125 40 400 45000 130 15000 Ornamental ( Flowering and Woody plants) 0.37 40 120 14000 41 4500 Airblast Bananas and Plantains 0.084 40 540 60000 180 20000 Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower, Celery 0.1125 350 46 5100 15 1700 Grasses grown for seed ( forage and fodder grasses), Non bearing citrus, Peanut 0.225 350 23 2600 7.7 850 Wheat 0.08 350 65 7200 22 2400 Chemigation Rice 0.28 350 18 2100 6.2 690 Handgun Sprayer Turf 1.8 100 10 1100 3.3 370 29 Mixer/ Loader  Wettable Powder in Water Soluble Packets Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 1200 1800 3700 600 1200 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 350 6200 13000 2100 4300 Non bearing Citrus, Pecans, Non bearing Hazelnuts, Peanuts 0.225 350 3100 6400 100 2100 Grasses grown for seed ( forage and fodder grasses), Wild rice 0.225 350 3100 6400 100 2100 Sod farm turf 1.8 350 390 800 130 270 Wheat 0.08 1200 2500 5300 840 1800 Aerial Rice 0.28 1200 720 1500 240 500 Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 200 11000 22000 3600 7500 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 80 27000 56000 9000 19000 Non bearing Citrus, Nonbearing Hazelnuts, Pecans, Peanuts 0.225 80 14000 28000 4500 9300 Grasses grown for seed ( forage and fodder grasses) 0.225 80 14000 28000 4500 9300 Sod Farm turf 80 1700 3500 560 1200 Golf Course turf 1.8 40 3400 7000 110 2300 Groundboom Wheat 0.08 200 15000 32000 5100 11000 Pecans, Non bearing Citrus 0.225 40 27000 56000 9000 19000 Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum) 0.1125 40 54000 110000 18000 37000 Ornamental ( Flowering and Woody plants) 0.37 40 16000 34000 5500 11000 Airblast Bananas and Plantains 0.084 40 72000 150000 24000 50000 Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower, Celery 0.1125 350 6200 13000 2100 4300 Grasses grown for seed ( forage and fodder grasses), Non bearing citrus, Peanut 0.225 350 3100 6400 1000 2100 Wheat 0.08 200 8700 18000 2900 6000 Chemigation Rice 0.28 350 2500 5200 830 1700 Handgun Sprayers Turf 1.8 100 1400 2800 450 930 30 Applicator Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 1200 7500 16000 2500 5500 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 350 26000 56000 8600 19000 Non bearing Citrus, Pecans, Non bearing Hazelnuts, Peanuts 0.225 350 31000 28000 4300 9400 Grasses grown for seed ( forage and fodder grasses), Wild rice 0.225 350 31000 28000 4300 9400 Sod farm turf 1.8 350 1600 3500 540 1200 Wheat 0.08 1200 11000 23000 3500 7700 1 Aerial Rice 0.28 1200 3000 6600 1000 2200 Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower 0.1125 200 15000 15000 4900 4900 Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 80 37000 37000 12000 12000 Non bearing Citrus, Nonbearing Hazelnuts, Pecans, Peanuts 0.225 80 18000 18000 6100 6100 Grasses grown for seed ( forage and fodder grasses) 0.225 80 18000 18000 6100 6100 Sod Farm turf 1.8 80 2300 2300 770 770 Groundboom ( Open Cab)

Wheat 0.08 200 21000 21000 6900 6900 Pecans, Non bearing Citrus 0.225 40 1600 2300 520 770 Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum) 0.1125 40 3100 4600 1000 1500 Ornamental ( Flowering and Woody plants) 0.37 40 960 1400 320 470 Airblast Bananas and Plantains 0.084 40 4200 6200 1400 2100 Flagger Barley, Rye, Oats, Wheat ( Past Feekes 8), Corn, Sunflower Celery, Stone Fruits ( Apricots, Cherry, Nectarine, Peach, Plum), Mint, Triticale 0.1125 350 11000 10000 3700 3500 Non bearing Citrus, Pecans, Non bearing Hazelnuts, Peanuts Grasses grown for seed ( forage and fodder grasses), Wild rice 0.225 350 5600 5200 1900 1700 Sod farm turf 1.8 350 700 650 230 220 1 Aerial applications Wheat 0.08 350 16000 15000 5300 4900 31 Rice 0.28 350 4500 4200 1500 1400 Mixer/ Loader/ Applicator ( Liquid formulations)

High Pressure Handwand Non bearing Fruits and Nuts, Ornamental Woody and Flowering plants 2 1000 NA 780 NA 260 Low Pressure Handwand Non bearing Fruits and Nuts, Ornamental Woody and Flowering plants 0.0024 2 40 550 110000 180 36000 Handgun Sprayer Turf 1.8 5 NA 12000 NA 390 Seed piece Dip Sugarcane ( HI only) .00021 21000 8600 960000 2900 320000 Note:  Baseline PPE = ( long sleeve shirt, long pants, no gloves, and no respirator)  MOE = NOAEL/ Daily Dose where the NOAEL for both dermal and inhalation is 30.0 mg/ kg/ day for Short term and 10.0 mg/ kg/ day for Intermediate/ Long term exposures.  The target MOE is 100 for Short and Intermediate term Dermal/ Inhalation exposure. 1 Application and Flagging for Aerial scenarios are accessed without gloves; therefore data is ( N/ A) 2 Area treated: ( gal/ day)

5.1.5 Summary of Risk Concerns and Data Gaps for Occupational Handlers There are short and intermediate term non cancer occupational handler scenarios for propiconazole that have risks of concern; however, these risks are at baseline PPE, whereas all labels call for baseline plus glove levels of PPE.

Data gaps for occupational handler scenarios for propiconazole include:

  Mixing/ loading/ applying wettable powder in water soluble packets via high and low pressure handwands, backpack and handgun sprayers ( see note in Section 1.5);

  Seed piece dip treatments ( sugarcane); Application scenario only, whereas the M/ L scenario has been assessed.

  Tree injections.

5.1.6 Recommendations for Refining Occupational Handler Risk Assessment In order to refine this occupational risk assessment, exposure studies for many equipment types that lack data or that are not well represented in PHED ( e. g., because of low replicate numbers or data quality) should be considered based on the data gaps identified above.

6.0 Occupational Post application Exposures and Risks HED uses the term " post application" to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide ( also referred 32 to as re entry exposure). HED believes that there are distinct job functions or activities that occur in previously treated areas. These job functions ( e. g., the kinds of jobs to cultivate a crop), the nature of the crop or target that was treated, and the how chemical residues degrade in the environment can cause exposure levels to differ over time. Each factor has been considered in this assessment.

6.1 Occupational Post application Exposure Scenarios Propiconazole use is extremely varied as it can be used on a wide variety of agricultural crops ( food, feed, ornamentals, and turf). As a result, a wide array of individuals can potentially be exposed by working in areas that have been previously treated.

6.1.1 Post application Exposure Scenarios and Rationale When assessing post application exposures to agricultural crops, HED uses a concept known as the transfer coefficient to numerically represent the post application exposures one would receive ( i. e., generally presented as cm2/ hour). The transfer coefficient concept has been established in the scientific literature and through various exposure monitoring guidelines published by the U. S. EPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development). The establishment of transfer coefficients also forms the basis of the work of the Agricultural Reentry Task Force. The transfer coefficient is essentially a measure of the contact with a treated surface one would have while doing a task or activity. These values are defined by calculating the ratio of an exposure for a given task or activity to the amount of pesticide on leaves ( or other surfaces) that can rub off on the skin resulting in an exposure. For post application exposures, the amounts that can rub off on the skin are measured using techniques that specifically determine the amount of residues on treated leaves or other surfaces ( referred to as transferable residues or dislodgeable foliar residues) rather than the total residues contained both on the surface and absorbed into treated leaves. HED has developed a series of standard transfer coefficients that are unique for variety of job tasks or activities that are used in lieu of chemical and scenario specific data.

As with the handler risk assessment process, the first step in the post application risk assessment process is to identify the kinds of individuals that are likely to be exposed to propiconazole after application. In order to do this in a consistent manner, HED has developed a series of general descriptions for tasks that are associated with post application exposures. Common examples include: agricultural harvesters, scouting activities in agriculture, crop maintenance tasks ( e. g., irrigating, hoeing and weeding), and turf maintenance ( e. g., golf course mowing).

The next step in the risk assessment process is to define how and when pesticides are applied in order to determine the level of transferable residues to which individuals could be exposed over time. Wherever available, use and usage data are included in this process to define values such as application rates and application frequency. HED always completes risk assessments using maximum application rates for each scenario because what is possible under the label ( the legal means of controlling pesticide use) must be evaluated, for complete stewardship, in order to ensure HED has no concern for the specific use. Additionally, whenever 33 HED has additional information, such as typical or average application rates or frequency data, it uses the information to further evaluate the overall risks associated with the use of the chemical. In order to define the amount of transferable residues to which individuals can be exposed, HED relies on chemical and crop specific studies as described in HED guidelines for exposure data collection ( Series 875, Occupational and Residential Exposure Test Guidelines: Group B   Post application Exposure Monitoring Test Guidelines). HED has also developed a standard modeling approach that can be used to predict transferable residues over time in lieu of chemical and scenario specific data ( best described in HED's SOPs for Residential Exposure Assessment). All agricultural scenarios were evaluated using propiconazole specific DFR/ TTR dissipation data.

Next, assessors must understand how exposures to propiconazole occur ( i. e., frequency and duration) and how the patterns of these occurrences can alter the effects of the chemical in the population after being exposed ( referred to as dose response). This is supported by the fact that several areas within a work environment may be treated at different times. For example, parts of agricultural fields in a localized area might be treated over several weeks because of an infestation with a concurrent need for hand labor activities. Therefore, individuals working in those fields might be exposed from contact with treated foliage over an extended period of time that could be categorized as an intermediate term exposure as they work on different sections of fields. Two different types of non cancer risk calculations were required for each exposure duration considered. The durations of exposure that were considered for non cancer toxicity were short term (# 30 days) and intermediate term ( 30 days up to several months). [ Note: Although it is not clear if long term occupational post application scenarios exist, intermediate, and long term NOAEL's are the same, therefore possible long term exposure scenarios are covered by this assessment]. A complete array of calculations were completed for all identified exposure scenarios using the short intermediate and long term endpoint, because HED believes that propiconazole uses fit the criteria for both of these durations. These assumptions were selected based on best professional judgment and due to the fact that post application exposures can vary depending on the activity and type of worker ( i. e., migrant farm workers vs. the farmers/ growers themselves). Inhalation exposures are thought to be negligible in outdoor postapplication scenarios because of the low vapor pressure and due to the infinite dilution expected outdoors. As such, inhalation post application exposures are not considered in this assessment. The use of personal protective equipment or other types of equipment to reduce exposures for post application workers is not considered a viable alternative for the regulatory process. This is described in some detail in EPA's Worker Protection Standard ( 40CFR170). As such, an administrative approach is used by HED to reduce the risks and is referred to as the Restricted Entry Interval or REI. The REI is time period following a pesticide application during which entry into the treated area is restricted. At this time, there are some labels that have 12 hour REIs. All labels, based on acute toxicity, should have 24 hour REIs ( i. e., dermal toxicity, eye irritation potential, or skin irritation potential). Post application risk levels are generally calculated in the risk assessment process on a chemical, crop, and activity specific basis. To establish REIs, post application risks are considered on varying days after application.

HED has used the basic approach described above since the mid 1980s for calculating postapplication risks to pesticides. From that time to the present, several revisions and modifications were made to HED policies as data which warranted such changes became available. In 1995, 34 HED issued a Data Call In for post application agricultural data that prompted the formation of the Agricultural Reentry Task Force ( ARTF). This task force has generated a number of exposure studies and associated documents that are currently under review by. The work of the ARTF is not yet complete; however, sufficient data were available from the Environmental Protection Agency that warranted a significant interim change in HED's Standard Operating Procedures ( SOP's) related to the data which were already available as the efforts of the ARTF paralleled push for tolerance reassessment stipulated by the timelines established by FQPA. As a result of the need for the revision and using the latest data, HED developed a revised policy on August 7, 2000 entitled Standard Operating Procedure ( SOP 003.1) Science Advisory Council For Exposure Policy Regarding Agricultural Transfer Coefficients. The revision to this policy entailed linking worker activities to more specific crop/ agronomic groupings and making better use of the available occupational post application exposure data. In the new policy, transfer coefficients were selected to represent the activities associated with 18 distinct crop/ agronomic groupings based on different types of vegetables, trees, berries, vine/ trellis crops, turf, field crops, and bunch/ bundle crops ( e. g., tobacco). In this new scheme which HED uses to develop scenarios for occupational post application exposures, propiconazole uses were identified in the following crop groupings from ( SOP 003);

C Field/ row crops, low/ medium ( e. g., barley, rice);

C Field/ row crops, tall ( e. g., corn);

C Cut flowers ( e. g., floriculture crops);

C Trees/ fruit, deciduous ( e. g., apples, apricots, cherries, peaches, pears);

C Trees/ evergreen, deciduous ( e. g., Non bearing citrus);

C Trees/ nut ( e. g., pecans);

C Turf/ sod ( e. g., golf courses, sod farms);

C Bunch/ bundle ( e. g., bananas and plantains);

C Berry/ low ( e. g., Non bearing blueberries);

C Nursery crops ( e. g., ornamentals  woody and herbaceous plants);

Within each agronomic group, a variety of cultural practices are required to maintain the included crops. These practices are varied and typically involve light to heavy contact with immature plants as well as with more mature plants. HED selected transfer coefficient values in its revision of ( SOP 003) to represent this range of exposures within each agronomic group. In the policy, transfer coefficients were placed in 1 of 5 generic categories based on the exposures relative to that group. These 5 categories include: very low exposure, low exposure, medium exposure, high exposure, and very high exposure. Selections depended upon the actual agronomic practices that were identified for each group ( i. e., some groups had 2 assigned transfer coefficients while others had 5). The transfer coefficient values which have been used are excerpted directly from HED policy 003. The nursery crop group data have not yet been formally included in EPA Policy 3. However, the studies in this area submitted by ARTF have been reviewed and used since they will be integrated into ( SOP 003). 35 6.1.2 Data/ Assumptions for Post application Exposure Scenarios <IP_ADDRESS> Agricultural Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational post application worker risk assessments for agricultural scenarios. Each assumption and factor is detailed below on an individual basis. In addition to these values, transfer coefficient values were used to calculate risk estimates. Several chemical specific residue dissipation studies were also submitted which were used in the development of the risk estimates. The transfer coefficients were taken from HED's revised policy entitled Policy 003.1 Science Advisory Council for Exposure Policy Regarding Agricultural Transfer Coefficients ( August 7, 2000). The assumptions and factors used in the risk calculations are presented below:

  There are many factors that are common to handler and post application risk assessments such as body weights, duration, and ranges of application rates. Please refer to the assumptions and factors in Section 5.1.1 for further information concerning these values which are common to both handler and post application risk assessments. In the post application risk assessment, only maximum application rates were considered.

  Levels of Concern: HED has established the following levels of concern ( LOC) for occupational post application risks:

o Margin of Exposure of less than 100 for occupational non cancer risks;

  The transfer coefficient in Policy 003 for tree fruit thinning has been reduced since the issuance of the policy from 8000 cm2/ hour to 3000 cm2/ hour based on a re evaluation of the data from the cited study ( i. e., the change is based on an altered analytical recovery correction factor that was erroneously used in the initial study report). This modification has been made in the tree fruit group and any other scenarios which have used this value.

  The tree fruit harvester transfer coefficient used in this assessment of 1500 cm2/ hr was reduced in this assessment from a value of 3000 cm2/ hr. This modification was discussed at HED's Science Advisory Council for Exposure ( i. e., EXPOSAC) and has been permanently incorporated into its ( SOP 003) for agricultural transfer coefficients. This modification was made by considering the results of six different tree harvester studies conducted/ owned by the Agricultural Reentry Task Force. A range of crops was represented in these data including pome fruit ( apples), stone fruit ( peaches), and citrus.

  Transfer coefficients for ornamentals activities include the following:

o Outdoor ornamental pruning and tying ( TC = 110). MRID 454695 01. ARTF study No. ARF043. 36 o Ornamentals in 5, 7, and 15 gallon pots; workers transporting and re organizing potted plants ( TC = 400). MRID 454695 02. ARTF Study No. ARF044.

o Ornamentals ( Cut Flowers) hand harvesting ( TC/ short term = 5100) and ( TC/ intermediate term = 2700). MRID 465139 01 Determination of Dermal and Inhalation Exposure to Reentry Workers During Harvesting in Greenhouse Grown Cut Flowers, Study Number ARF 055, Agricultural Reentry Task Force, April 1, 2005.

  Turf/ sod crop grouping: Recent ARTF data for this cluster should be used instead of the existing transfer coefficients of 500 cm ² / hour and 16500 cm ² / hour which were based, respectively, on a chlorothalonil turf mowing study and a 5 percent transferability estimate and use of the Jazzercise approach for the high intensity contact activity. The two studies conducted by ARTF were golf course maintenance and sod farm harvesting. Both studies used chlorothanlonil and the ORETF roller technique to define turf transferable residue ( TTR) levels. There was a significant issue with the golf course maintenance study related to the manner in which the TTRs were measured, because the turf which was sampled was repeatedly mowed therefore driving down TTR values and driving the transfer coefficients up. The problem with this approach is that most TTR studies are not conducted with this technique, so an adjustment based on the exposure rates ( mg/ hour) for the workers compared to the sod farm harvesters was completed in order to use the carbaryl specific TTR data for all activities. For the sod farm harvesting activity, transfer coefficients were calculated by both the ARTF and Health Canada, and the arithmetic mean calculated by Health Canada of 6800 cm ² / hour was used to represent this activity for risk assessment purposes. When adjusted for application rate, the exposure rate ( mg/ hour) for golf courses workers ( turf maintenance) was approximately half that of sod farm harvesters, so a transfer coefficient of 3400 cm ² / hour was used to represent that activity. In the sod farm harvesting study, the majority of activity was mowing and the transferability was approximately 1 percent, whereas the 500cm ² / hour TC value was based on a transferability of 5 percent. As such, it is recommended that for occupational postapplication the TC of 3400 cm ² / hour be used to represent the mowing activity. However, for residential mowing, a transfer coefficient of 500 cm ² / hour was used to represent that activity. This modification was discussed and adopted at HED's Science Advisory Council for Exposure ( i. e., EXPOSAC).

  Chemical specific dislodgeable foliar residue ( DFR) and turf transferable residue ( TTR) data were used to complete all post application risk assessments. The chemicalspecific residue data is described in detail below and summarized in Appendix B.

  Exposure calculations reflect chemical specific residue dissipation rates over time coupled with surrogate transfer coefficients as outlined in HED's revised ( SOP's). Three DFR studies were submitted that meet current HED guidelines for sampling techniques and data quality ( a fourth, for ornamental crops, uses results from a 37 previously submitted study). Additional DFR data from two worker exposure studies ( data which was incorporated into PHED) were also used.

  A pseudo first order kinetics analysis was used to analyze propiconazole residue dissipation over time as outlined in EPA's draft Series 875 Post application Exposure Monitoring Guidelines. A more sophisticated curve fitting approach was not warranted because any sophistication gained with a curve fitting technique would be lost in an extrapolation to another crop).

  A turf transferable residue ( TTR) study was submitted and used in exposure and risk calculations. There are various techniques used to measure turf transferable residues ( TTR) all of which have varying transfer efficiencies. The transfer efficiency for the Modified California roller is less than 1 percent. This value is below the lower limit compatibility with Agency transfer coefficients for chemicals applied to turf grass, as delineated in Exposure Sac Policy 12. An appropriate study for use with TTR data generated using the modified California roller is presented in the Outdoor Residential Exposure Task Force Study entitled: The ORETF Algorithm for Defining the Relationship for Transferable Turf Residues to Post Application Dermal Exposure [ MRID 4661905 01]. In that study, post application exposure to a turf grass pesticide was measured using passive dosimetry and TTR data generated using the modified California roller. The efficiency of the TTR measurement in the ORETF study was 0.5% making it appropriate for this assessment. A preliminary review of these data suggests a transfer coefficient of 70,000 cm ² / hour representing an adult wearing short pants, a short sleeved shirt and enclosed footwear ( Residential Post application Dermal/ General Activities) as well as, a transfer coefficient of 25,000 cm ² / hour representing a child ( see Appendix D for both scenarios).

  When extrapolating the available DFR data to other crops, HED adjusted the data for differences in application rate using a simple proportional approach. This approach seems to be the most appropriate given the data which are available. This approach is commonly used in HED post application risk assessments.

  Where chemical specific data is unable or not applicable, the following HED default values are used in post application exposure calculations:

o 5% of the application rate represents the initial fraction of residue available on turf;

o 20% of the application rate represents the initial fraction of residue available on conventional agricultural crops; and o 10% for the daily residue dissipation rate for all crops. 38 Post application Studies: A total of six studies are described in this section. These studies described residue dissipation and exposure for corn, peaches, rice, pecans, ornamentals and turf. The transfer coefficients used in this assessment are from an interim transfer coefficient policy developed by HED's Science Advisory Council for Exposure using proprietary data from the Agricultural Re entry Task Force ( ARTF) database ( policy # 3.1). Each study can be identified with the following information.

  MRID 42564003: Propiconazole   Dislodgeable Residue on Corn ( North Carolina) EPA MRID 425640 03; Report dated 1991. Author Avakian, M; Sponsor: Ciba Geigy Corporation Agriculture Division. Submitted by Environmental Technologies Institute, Inc. and EN CAS Labs.

  MRID 44959701: Dissipation of Dislodgeable Foliar Residue of Two formulations of Propicoanzole ( Orbit   and Orbit   45W) Applied to Peaches. EPA MRID 44959701( 0442); Report dated 1999; Author; Rosenheck, L. Report: Lab report Number: 260 98: 44580: AG 561 Performing Laboratories: ABC Laboratories., Inc.

  MRID 45288601: Determination of Transferable Turf Residue on Turf treated with Banner MAXX; Report dated ( 2000); Authors; Rosenheck, L.; Meyer, L. Lab Project Number 990046: 179 99. Performing Laboratories: Central California Research Laboratories, Inc.

  MRID 40279806: Author; Honeycutt, R. CGA 64250 ( Tilt) Worker Exposure in Pecans Unpublished. Sponsored by: Ciba Geigy   MRID 133390: Author; Honeycutt, R. ( 1983) CGA 64250 ( Tilt) Worker Exposure in Rice: Report No. EIR 83011. ( Unpublished study received Dec 12, 1983 under 100 617; submitted by Ciba Geigy Corp., Greensboro, NC; CDL: 07222 C)

  MRID 44959702: Dissipation of Dislodgeable Foliar Residues of Propiconazole ( Banner MAXX) Applied to Commercial Ornamentals. Rosenheck, L.; Meyer, L.( 1999) Final report: Lab Project Number: 1134 99. Unpublished study prepared by Novartis Crop Protection, Inc. 51 p.

MRID 42564003 ( Corn DFR data): This DFR study is summarized below for use in the propiconazole risk assessment. This study was designed to collect data to evaluate dislodgeable foliar residue ( DFR) dissipation for propiconazole at a test site in North Carolina. Tilt ® 3.6E Emulsive, an emulsifiable formulation of propiconazole, was applied using a John Deere High Boy sprayer with CO2 propellant. One application was made at the maximum application rate of 0.11 lb. active ingredient ( ai) per acre. The site consisted of a control ( untreated) plot and a treated plot, split into six sampling subplots ( three untreated and three treated). The treated plot was sampled in triplicate at each sampling interval. One sample was collected from the control 39 plot at each sampling interval. Soil, leaf punch, tassel, and tassel stalk samples were collected from one day prior to application to 35 days following application.

The study author reported that detectable DFR values were found on leaf punch samples on the day of application ( 0.059 : g/ cm2) and up to 7 days after treatment ( DAT). DFR values for propiconazole declined to less than the limit of quantification ( LOQ) by DAT 14 for the leaf punch samples. DFR values for tassel samples were detected on one or more tassel samples on each sampling date ( DAT 0 through DAT 14), with the average residue decreasing from 11.1 : g on DAT 1 to 1.7 : g on DAT 14. Residues were detected in soil samples collected on DAT 0 and DAT 7, averaging 0.13 ppm, and 0.37 ppm, respectively.

All residues were corrected for the average recovery, if any recovery values were less than 100%. Dissipation rates were modeled by the study author assuming first order kinetics to estimate propiconazole half lives of 3.5 days and 5.1 days for leaf punch and tassel samples, respectively. All of the data points ( not averages) were utilized in conducting the regression analysis. The estimated half life, based on leaf punch samples, was 3.14 days ( R2= 0.75). Halflife was not calculated based on the tassel samples due to the number of non detect samples. One rainfall event occurred on DAT 2, with a total of 4.4 inches of rainfall occurring between DAT 0 and DAT 35.

[ Note: Today's standard is to examine double sided leaf residues.] The results of the study are presented in detail in Appendix B. The results of the pseudo first order statistical analysis of the data are summarized below in Table 7.

Table 7: Corn DFR Data ( MRID 42564003)

Location App. Rate ( lb ai/ acre) App. Method Corr. Coeff. Slope ( Ln DFR vs. t) [ T0] ( Fg/ cm2) T1/ 2 ( days) Day 0 (% trans.) NC ( Tilt 3. E) 0.1125 Groundboom 0.750  0.22061 0.0585 3.14 4.6 * LOQ = 0.0044( Fg/ cm 2 )

MRID 449597 01 ( Peach DFR data): This DFR study is summarized below for use in the propiconazole risk assessment. This study was designed to collect data to calculate dislodgeable foliar residue ( DFR) dissipation curves and to generate " time zero" dislodgeable residue for propiconazole on peach leaf foliage at three test sites in California, South Carolina and Georgia. Two different end use formulations ( emulsifiable concentrate and wettable powder in water soluble packets) were applied by ground airblast sprayer. The maximum application rate was applied ( 0.1125 pound active ingredient ( ai) per acre), and the application frequency of two applications ( 7 to 14 day intervals) were relevant to the use pattern proposed. Three sites were monitored with three replicates per sampling time per treatment site ( i. e., untreated control plot, wettable powder in water soluble packets treated plot and emulsifiable treated plot).

The authors report that the average DFR value found immediately after the second application ( for either formulation) was 12.1 percent of the amount applied. DFR declined to < LOQ by DAT 14 at the South Carolina test site, and by DAT 7 at the Georgia test site. By DAT 35, DFR had only declined to approximately 4 times LOQ at the California test site. Little difference was found between DFR measured for the two formulations. Dissipation rates were 40 modelled utilizing pseudo first order kinetics to estimate t ½ = 1.5 days in Georgia, 4.0 days in South Carolina, and 6.3 days in California where there was no rainfall during the study period.

The study met most of the Series 875.2100 Guidelines. Residues were detected within the fortification level limits and well above the quantization limits. Fortified field recovery, concurrent laboratory recovery, storage recovery, and untreated control sample data were adequate, and indicate that DFR data do not need to be corrected for losses.

The results of the studies in California, South Carolina and Georgia are presented in detail in Appendix B. To present the most conservative assessment, the data for the emulsifiable concentrate formulation applied in California was used. The results of the pseudo first order statistical analysis of this data are shown below in Table 8.

Table 8: Peach DFR Data ( MRID 449597 01)

Location App. Rate ( lb ai/ acre) App. Method Corr. Coeff. Slope ( Ln DFR vs. t) [ T0] ( Fg/ cm2) T1/ 2 ( days) Day 0 (% trans.) CA ( Break EC) 0.1125 Airblast 0.900  0.0708 0.25 9.79 20.1 MRID 452886 01 ( Turf Transferable Residue data): A TTR study was conducted at individual sites in three states using the Modified California Roller Technique. This study was designed to collect data to characterize dissipation of propiconazole turf transferable residues when applied to turf at three test sites in Indiana, California, and Pennsylvania. Banner ® MAXX, an emulsifiable concentrate formulation of the test product was applied once to each site. A tractor powered Spraying Systems Handgun was used to apply the fungicide at all three test sites. Each application was made at the maximum application rate of 1.79 pounds active ingredient ( ai) per acre. Turf transferable residues ( TTR) were collected using the modified California Roller Technique. The application method, rate, and frequency ( number and timing) were relevant to the use pattern proposed by the product label. Triplicate samples from each control plot and four treated replicate samples ( one sample from each of four sections) were collected at each test site immediately before and after the application; 4 hours, 8 hours, and 24 hours after the application as well as 2, 3, 5, 8, 10, 14, and 21 days after treatment ( DAT). At the Indiana site, the average total propiconazole residues reached a maximum of 0.0326 µ g/ cm2 immediately after the application and declined to below the minimum quantifiable limit ( MQL) of 0.00179 µ g/ cm2 by DAT 14. At the California site, the average total propiconazole residues reached a maximum of 0.195 µ g/ cm2 immediately after the application and declined to below MQL ( 0.00179 µ g/ cm2) by DAT 10. At the Pennsylvania site, the average total propiconazole residues reached a maximum of 0.0902 µ g/ cm immediately after the application and declined to below MQL ( 0.00179 µ g/ cm2) by DAT 8. However, residues were also found on DAT 14.

The average total propiconazole residues found immediately after the application at the Indiana, California, and Pennsylvania sites were approximately 0.091%, 0.542%, and 0.251% of the target application, respectively. All of the maximum average propiconazole residues occurred immediately after the application. A dissipation rate was modeled by the study author assuming first order kinetics to estimate total propiconazole half lives of 2.2 days ( R2= 0.751), 1.3 days ( R2= 0.943) and 1.9 days ( R2= 0.871) on turf at the Indiana, California, and Pennsylvania 41 sites, respectively. The registrant corrected the TTR values for the California sites since the overall average field fortification recovery was less than 90 percent ( 87.8%).

The results of the studies for California, Indiana, and Pennsylvania sites are presented in Table 9 below.

Table 9: TTR Data ( MRID 452886 01)

Location App. Rate ( lb ai/ acre) App. Method Corr. Coeff. Slope ( Ln TTR vs. t) [ T0] ( Fg/ cm2) T1/ 2 ( days) Day 0 (% trans.) Indiana 0.721  0.3145 0.0326 2.20 0.2 California 0.922  0.5451 0.1945 1.27 1.0 Pennsylvania 1.79 Power Handgun Sprayer 0.864  0.3694 0.0902 1.88 0.4 MRID 40279806 ( Pecan DFR data): A DFR study was conducted in a pecan orchard that was treated with Tilt 3.6E located in Lugoff, South Carolina. The orchard consisted of 400 acres of mature pecan trees. Four three acre plots in the orchard were treated with Tilt 3.6E. The applications rate of 12 fl. oz./ acre ( 0.34 lbs. ai. acre) in a 100 gallons/ acre, was applied using an air blast sprayer pulled by an open tractor. Three   acre plots containing 36 mature pecan trees each about 60 feet high, were treated with 8 applications through out the season. Leaf samples were collected during two periods from June 21 ( day 0) to July 5, 1982, and from September 1 ( day 0) to September 15, 1982. Samples were taken immediately before and after CGA 64250 application and on days 2, 3, 7, and 14 following the June 21 application and on days 0, 1, 3, 5, 7 and 14 following the September 1 application. Four replicate samples taken from each threeacre plot during each sampling period. The immature pecan leaves had an average surface area of 952 cm ² / 40 leaves, while the leaf discs had an average surface area of 405 cm ² / 40 leaf discs. Two replicate leaf samples were taken each day for untreated control pecan orchards. Two additional control samples were taken from control plot prior to application and on the 5th and 14th days following application for use by the analytical laboratory to determine recoveries. Dislodgeable residues were measured on pecan leaf surfaces for 14 days following applications of Tilt 3.6E. The maximum mean dislodgeable residues were 0.19 µ g/ cm ² and 0.39 µ g/ cm ² immediately ( day 0) after treatment for mature and immature pecan leaves respectively. The half life values of dislodgeable residues on immature and mature leaves were 3.1 and 5.5 days, respectively.

Table 10: Pecan DFR Data ( MRID 40279806)

Location App. Rate ( lb ai/ acre) App. Method Corr. Coeff. Slope ( Ln DFR vs. t) [ T0] ( Fg/ cm2) T1/ 2 ( days) Day 0 (% trans.) So. Carolina 0.34 Air blast 0.922  0.12589 0.385 5.50 10.1 MRID 133390 ( Rice DFR data): A DFR study was conducted in a rice field that was treated with Tilt 3.6E located in Jerome, Arkansas. Two 50 acre plots on in this field were treated with Tilt for this exposure study. Tilt 3.6E was applied to 10 fl. oz/ acre ( 0.28 lbs/ ai/ acre) in 5 gallons of water/ acre. Aerial application at 20 lbs/ in. ² was used for each application. Two applications were made throughout the season. Leaf samples were collected during the period from July 15 ( day 0) to July 27, 1982. Samples were taken immediately before and after application and on days 1, 3, 4, 7, and 14 following the July 15 application. Control samples were taken from 42 control fields prior to application on July 15 1982. Twenty leaf samples were taken from the 100 acre treated rice field. It was determined that a rice leaf had an average surface area of 1,364 cm ² ( two sides). Twenty rice leaves about 30 cm in length were placed in an 8 oz. jar. 100 ml of Sur ten wetting solution was added. Mean total exposure to workers performing mixerloader functions was 38.8 mg/ hour if a short sleeved shirt was worn and 34.4 mg/ hour for a long sleeved shirt. Aerial applications of Tilt 3.6E resulted in a mean of 0.59 mg/ hour total exposure to applicators wearing short sleeved shirts or long sleeved shirts. Respiratory exposure was 15% ( 0.09 mg/ hour) of total exposure. Flaggers who worked in the direct line of application were exposed to a mean of 4.4 mg/ hour. Dislodgeable residues were measured on rice leaf surfaces for 14 days following applications of Tilt 3.6E. Maximum mean residues of 0.18 µ g/ cm ² were measured immediately ( day 0) after treatment. The half life value of dislodgeable residues on leaves was 2.2 days. The maximum dose density rate for exposure of scouts to rice leaves was 0.03 µ g/ cm ² skin/ hour. Results maintained that aerial applicators received 0.59 mg/ hour mean total exposure if a short sleeved shirt or a long sleeved shirt was worn during application. Respiratory exposure to applicators was 0.09 mg/ hour and was 15% of total exposure. The mean exposure lever for a mixer loader was estimated to be 38.8 mg/ hour for a worker wearing a short sleeved shirt. Residues were reduced by 12% to a mean of 34.3 mg/ hour. The total exposure ( dermal and respiratory) to a flagger wearing a short sleeved shirt and stands inside was a mean total of 4.4 mg/ hour. Flaggers wearing long sleeved shorts were able to reduced exposure by 25% for a mean total of 3.3 mg/ hour. A flagger outside the area of application received 0.08 mg/ hour, whereas a 98% reduction was noted due to standing outside the spraying area.

Table 11: Rice DFR Dissipation Data ( MRID 133390)

Location App. Rate ( lb ai/ acre) App. Method Corr. Coeff. Slope ( Ln DFR vs. t) [ T0] ( Fg/ cm2) T1/ 2 ( days) Day 0 (% trans.) Arkansas 0.28 Aerial 0.946  0.30837 0.184 2.25 5.9 MRID 44959702 ( Ornamental DFR data): A propiconazole DFR study was conducted by Novartis on 1998 on peaches in fulfillment of the 1995 Agricultural Data Call In. Data from that study was used as surrogate to determine residues that would be found on commercially treated ornamental and landscape plants.

6.1.3 Occupational Post application Exposure and Non cancer Risks The occupational post application exposure and non cancer risk estimates are presented in this section. Non cancer risk estimates were calculated using the Margin of Exposure ( MOE) which is a ratio of the daily dose to the toxicological endpoint of concern. Daily dose values are calculated by first calculating exposures by considering application parameters ( i. e., rate and area treated) along with unit exposures. Exposures were calculated by multiplying these factors by an 8 hour work day. Exposures are then normalized by body weight and adjusted for dermal absorption to calculate absorbed dose. MOEs were then calculated. Post application risks diminish over time because propiconazole residues eventually dissipate in the environment. As a result, risk estimates were calculated over time based on changing residue levels. 43 <IP_ADDRESS> Agricultural Scenarios/ Calculation Methods Dissipation Kinetics: The first step in the post application risk assessment was to complete an analysis of the available dislodgeable foliar and turf transferable residue ( DFR and TTR) data. As discussed in Section <IP_ADDRESS> above, data from four DFR studies and default values for TTR were used to calculate risks for all agronomic crop groups. Best fit DFR levels were calculated based on empirical data using the equation D2 16 from Series 875 Occupational and Residential Test Guidelines: Group B Post application Exposure Monitoring Test Guidelines. The summary of the available chemical specific DFR and TTR data were developed based on a semilog regression of the empirical dissipation data using a commercial spreadsheet linear regression function. Half lives were calculated using the algorithm ( T1/ 2 =  Ln 2/ slope). The results of the regression analyses were used to calculate best fit concentrations over time using the following pseudo first order equation: Cenvir ( t) = Cenvir ( o) * e PAI ( t) * M Where:

Cenvir ( t) = dislodgeable foliar or turf transferable residue concentration (: g/ cm2) that represents the amount of residue on the surface of a contacted leaf surface that is available for dermal exposure at time ( t); Cenvir ( o) = dislodgeable foliar or turf transferable residue concentration (: g/ cm2) that represents the amount of residue on the surface of a contacted leaf surface that is available for dermal exposure at time ( 0);

e = natural logarithms base function;

PAI ( t) = post application interval or dissipation time ( e. g., days after treatment or DAT);

M = slope of line generated during linear regression of data [ ln( Cenvir) versus Post application interval ( PAI)].

In cases where no chemical specific residue dissipation data are available, HED typically uses a generic dissipation model to complete risk calculations. In this case, HED determined that it is more appropriate; however, to extrapolate using propiconazole specific dissipation data in the risk assessment for other currently labeled crops ( except for turf) than it is to use the generic dissipation model. This approach is consistent with current HED policies for generating transferable/ dislodgeable residue data. The existing residue data were extrapolated to the currently labeled crops as follows:

C Corn DFR Data: This data has been used to complete all assessments for the following agronomic crop groups defined in HED's revised transfer coefficient policy 003:

< Tall field/ row crop: corn ( field/ pop/ sweet), sunflowers breeder's seed. 44 C Peach DFR Data: This data has been used to complete all assessments for the following agronomic crop groups defined in HED's revised transfer coefficient policy 003.

< Tree fruit: non bearing citrus and non bearing fruit;

< Stone Fruit: apricot, cherry, nectarine, peach, plum;

< Bunch/ bundle: bananas, plantains;

< Ornamentals: woody and flowering plants.

C Turf TTR Data: This data has been used to complete all assessments for the following agronomic crop groups defined in HED's revised transfer coefficient policy 003:

< Turf: Sod farm, recreational areas and golf courses C Pecan DFR Data: This data has been used to complete all assessments for the following agronomic crop groups defined in HED's revised transfer coefficient policy 003:

< Tree nuts: non bearing hazelnuts and pecans C Rice DFR Data: These data have been used to complete all assessments for the following agronomic crop groups defined in HED's revised transfer coefficient policy 003:

< Field/ row crops, low/ medium: peanuts, wheat, barley, mint, rice The extrapolations noted above were completed because of similarities in application methods between the study and selected crop groups, the crop canopy, and application rates ( i. e., between the study and current labels).

Daily Exposure: The next step in the risk assessment process was to calculate dermal exposures on each day after application using the following equation ( see equation D2 20 from Series 875 Occupational and Residential Test Guidelines: Group B Post application Exposure Monitoring Test Guidelines and Residential SOP 3.2: Post application Dermal Potential Doses from Pesticide Residues On Gardens):

DE( t) ( mg/ day) = ( TR( t) ( Fg/ cm2) x TC ( cm2/ hr) x Hr/ Day)/ 1000 ( Fg/ mg) Where:

DE( t) = Daily exposure or amount deposited on the surface of the skin at time ( t) attributable for activity in a previously treated area, also referred to as potential dose ( mg ai/ day);

TR( t) = Transferable residues that can either be dislodgeable foliar or turf transferable residue at time ( t) where the longest duration is dictated by the decay time observed in the studies ( Fg/ cm2); 45 TC = Transfer Coefficient ( cm2/ hour);

hr/ day = Exposure duration meant to represent a typical workday ( hours).

Daily Dose and Margins of Exposure: Once daily exposures are calculated, the calculation of daily absorbed dose and the resulting Margin of Exposures use the same algorithms that are described above for the handler exposures ( See Section 5.1.3). These calculations are completed for each day or appropriate block of time after application.

6.1.4 Occupational Post application Non cancer Risk Summary All non cancer post application risk calculations are included in Appendix B. A summary of the post application risks for each crop/ activity combination are shown in Table 12.

Table 12: Summary of Propiconazole Non cancer Post application Worker Risk Estimates Crop Activity TC cm2/ hr Max. App. Rate ( lb ai/ A) DAT ( days) DFR ug/ cm2 ( adjusted) Short Term MOE 1Int/ Long  Term MOE irrigating, scouting, handweeding 100 0 0.184 36000 12000 irrigating, scouting 1500 0 0.184 2400 800 Celery, Mint, Wild rice, ( MN only), Barley, Oats, Rye, Wheat, Rice, Peanuts hand harvesting 2500 0.28 0 0.184 1400 500 hand weeding 100 0 0.059 110000 37000 irrigating, scouting 1000 0 0.059 1100 3700 Corn ( field, pop, sweet), Sunflower detasseling, hand harvesting 17000 0.1125 0 0.059 700 220 irrigating, scouting 1000 0 0.254 2600 860 hand weeding, hand harvesting, hand pruning, 1500 0 0.254 1700 570 Stone Fruits, Peaches, Non bearing Apples,

thinning 3000 0.1125 0 0.254 860 290 irrigation, scouting, handweeding 1000 0 0.508 1300 430 Non bearing Citrus hand pruning, thinning 3000 0.225 0 0.508 430 140 irrigation, hand weeding 100 0 0.190 35000 12000 scouting, irrigation 1300 0 0.190 2700 900 Bananas, Plantains hand harvesting,, thinning, hand weeding/ pruning 2000 0.084 0 0.190 1700 600 scouting, hand weeding/ pruning, irrigation, thinning 400 0 0.382 4300 1400 Non bearing Blueberries hand pruning 1500 0.169 0 0.382 1200 380 46 Table 12: Summary of Propiconazole Non cancer Post application Worker Risk Estimates Crop Activity TC cm2/ hr Max. App. Rate ( lb ai/ A) DAT ( days) DFR ug/ cm2 ( adjusted) Short Term MOE 1Int/ Long  Term MOE pruning, tying 110 0 0.835 7100 2040 transporting, moving potted plants 400 0 0.835 2000 560 0 0.835 150 97 Ornamentals ( Woody and Herbaceous) plants hand harvesting ( cut flowers) S Term 5100 Int term 2700 0.37 1 .725 170 112 hand weeding, thinning, irrigating, scouting 500 0 0.255 5200 1700 Pecans, Non bearing Hazelnuts hand pruning, thinning 2500 0.225 0 0.255 1000 340 Turf maintenance 3400 1.8 0 0.0106 1800 600 Turf ( grasses grown for seed, golf courses, sod farms) hand weeding/ harvesting transplanting, hand harvest mech harvesting 6800 1.8 0 0.0106 900 300 Note: ¹ Intermediate, and Long term NOAEL's are the same, therefore Intermediate term exposure scenarios represent possible long term scenario MOE's.

6.1.5 Summary of Occupational Post application Risk Concerns and Data Gaps Most occupational post application short, intermediate and long term risks do not exceed HED's level of concern ( i. e., MOEs > 100) at day 0. The occupational post application shortand intermediate and long term risks that exceed HED's level of concern ( i. e, MOE's < 100) at Day = 0 are as follows:

Short Term:

All short term occupational risks are below HED's level of concern ( i. e., MOEs > 100) at day 0.

Intermediate/ Long term:

  Post application ornamental activities, hand harvesting ( cut flowers), risks are of concern on the day of application ( DAT = 0) and do not reach the target MOE of 100 until 1day after treatment ( DAT = 1)

o Day 0 ( MOE = 97) o Day 1 ( MOE = 104)

[ Note: The day 0 intermediate/ long term MOE of concern ( 97) for hand harvesting cut flowers was calculated using the average of day 0 residues and represents a conservative estimate].

HED has used the latest information to complete this post application risk assessment for propiconazole. Several data gaps exist such as a lack of post application studies in different crop 47 groupings and lack of exposure data on mechanized or partially mechanized cultural practices where there is a potential for exposure.

<IP_ADDRESS> Recommendations for Refining Occupational Post application Risk Assessment To refine this occupational risk assessment, data on actual use patterns including rates, timing, and the kinds of tasks that are required to produce agricultural commodities typical products would better characterize propiconazole risks. Exposure studies for many cultural practices that lack data or that are not well represented in the revised transfer coefficient policy should also be considered based on the data gaps identified above.

7.0 Residential Exposures and Risks It has been determined there is a potential for exposure in residential settings during the application process for homeowners who use products containing propiconazole. There is also a potential for exposure from entering propiconazole treated areas, such as lawns or home gardens that could lead to exposures to adults and children. Risk assessments have been completed for both residential handler ( homeowner) and post application scenarios.

7.1 Residential Handler Exposures and Risks HED uses the term " handlers" to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct tasks related to applications and that exposures can vary depending on the specifics of each task as was described above for occupational handlers. Residential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all elements of an application without use of any protective equipment.

7.1.1 Handler Exposure Scenarios Scenarios are used to define risks based on the U. S. EPA Guidelines For Exposure Assessment ( U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992). Assessing exposures and risks resulting from residential uses is very similar to assessing occupational exposures and risks, with the following exceptions:

C Residential handler exposure scenarios are considered to be short term only due to the infrequent uses associated with homeowner products;

C A tiered approach for personal protection using increasing levels of PPE is not used in residential handler risk assessments. Homeowner handler assessments are based on the assumption that individuals are wearing shorts, short sleeved shirts, socks, and shoes;

C Homeowner handlers are expected to complete all tasks associated with the use of a pesticide product including mixing/ loading if needed as well as the application; 48 C Label use rates and use information specific to residential products serve as the basis for the risk calculations; and C Area/ volumes of spray or chemical used in the risk assessment are based on HED's guidance specific to residential use patterns.

The anticipated use patterns and current labeling indicate two major residential exposure scenarios based on the types of equipment and techniques that can potentially be used to make propiconazole applications. The quantitative exposure/ risk assessment developed for residential handlers is based on these scenarios:

  Mixer/ Loader/ applying liquids and wettable powder in water soluble packets via 1) Low Pressure Handwand, and 2) Hose End Sprayer.

7.1.2 Data and Assumptions for Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments. Each assumption and factor is detailed below. In addition to these factors, unit exposures were used to calculate risk estimates. Mostly, these unit exposures were taken from the Pesticide Handlers Exposure Database ( PHED) and the Outdoor Residential Exposure Task Force ( ORETF) studies. Both PHED and the individual studies are presented below. [ Note: Several of the assumptions and factors used for the assessment are similar to those used in the occupational assessment. As such, only factors that are unique to the residential scenarios are presented below.]

Assumptions and Factors: The assumptions and factors used in the risk calculations include:

C Propiconazole is a systemic fungicide. HED has developed this risk assessment on a series of representative scenarios that are believed to represent the vast majority of propiconazoles uses. Refinements to the assessment will be made as more detailed information about propiconazole use patterns become available.

C Exposure factors used to calculate daily exposures to handlers were based on applicable data if available. When appropriate data are unavailable, values from a scenario deemed similar might be used.

C HED always considers the maximum application rates allowed by labels in its risk assessments. If additional information such as average or typical rates is available, these values also may be used to allow risk managers to make a more informed risk management decision. Average/ typical application rates were not available for residential scenarios.

C Residential risk assessments are based on estimates of what homeowners would typically treat, such as the size of a lawn, or the size of a garden. The factors used for the propiconazole assessment were from the Health Effects Division Exposure Science Advisory Council Policy 12: Recommended Revisions to The Standard Operating 49 Procedures for Residential Exposure Assessment which was completed on February 22, 2001 and on best professional judgment.

Residential Handler Exposure Studies: The unit exposures that were used in this assessment were based on the Outdoor Residential Exposure Task Force studies and the Pesticide Handler Exposure Database ( PHED, Version 1.1 August 1998).

EPA MRID 449722 01 ( ORETF Handler Studies): A report was submitted by the ORETF ( Outdoor Residential Exposure Task Force) that presented data in which the application of various products used on turf by homeowners and lawn care operators ( LCOs) was monitored. All of the data submitted in this report were completed in a series of studies.

Homeowner Hose End Sprayer: A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force ( ORETF) using Diazinon as a surrogate compound to determine " generic" exposures to individuals applying a pesticide to turf with a dial type hose end sprayer. Dermal and inhalation exposures were estimated using whole body passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 liters per minute for light work ( NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for pounds active ingredient handled. A total of 30 replicates were monitored throughout the study.

Diazinon ( 25% emulsifiable concentrate) was applied by homeowners to actual residential lawns at a site in Maryland. A target application rate of 4 pounds active ingredient was used for all replicates. Each replicate monitored the test subject treating 5,000 ft2 of turf and handling a total of 0.5 lb ai/ replicate. The exposure periods ( mixing/ loading/ applying) averaged seventy five minutes. Dermal exposure was measured using inner and outer whole body dosimeters, hand washes, face/ neck washes, and personal air monitoring devices. In general, concurrent lab spikes produced mean recoveries in the range of 87 103 percent. Adjustment for recoveries from field fortifications ( 79 104 %) were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent. The unit exposures are presented in table 13. [ Note the data were found to be lognormally distributed. As a result, all exposures are geometric means.]

Table 13: Unit Exp. Obtained From ORETF Hose End Sprayer Studies ( MRID 449722 01)

Type Dermal: Short Pants, Short Sleeves ( mg ai/ lb handled) Inhalation ( Fg ai/ lb handled)

Hose end ( Mix your own) 11 17 All unit exposures are geometric means. 50 7.1.3 Residential Handler Exposure and Non Cancer Risk Estimates The residential handler exposure and non cancer risk estimations are presented in this section. Non cancer risks were estimated using the Margin of Exposure ( MOE) as described above. Assessing exposures and risks resulting from residential uses is very similar to assessing occupational exposures and risks, except as described above in Section 7.1.1. The other major difference with residential risk assessments is that the uncertainty factor which defines the level of risk concern has the additional FQPA safety factor applied. The overall uncertainty factor applied to propiconazole for residential handler risk assessments of 100 is based on the 10x for inter species extrapolation and 10x for intra species sensitivity ( see Section 1.4 for more information).

Non cancer Risk Summary: All of the non cancer risk estimates for residential handlers completed in this assessment are included in Appendix C. A brief summary of the results for each exposure scenario is also provided below.

HED believes that the scenarios assessed in this document represent worse case exposures and risks resulting from use of propiconazole in residential environments. It should also be noted that there were many other scenarios where medium to low quality PHED data were used to complete the assessment. Data quality should be considered in the interpretation of the uncertainties associated with each risk presented.

Short term risks for residential handlers are presented in Table 14. For all scenarios, risks are below HED's level of concern ( i. e., MOEs are > 100) assuming handlers are wearing shortsleeve shirt, short pants, shoes, and socks.

Table 14: Summary of Residential Handler Exposure Estimates 1 Max Appl. Rate 2 Daily Area Treated Handler Scenario Short Term MOE . Application. Equip. Crop( s)