     1    31 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: May 9, 2005 Subj: Study Review: GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Thinning and Harvesting of Apples MRID#: 463164 03 DP Barcode: D307558 PC Code( s) : 058001 From: Steven Weiss, Industrial Hygienist Health Effects Division/ Reregistration Branch 3 ( 7509C)

Through: Seyed Tadayon, Chemist Health Effects Division/ Reregistration Branch 3 ( 7509C)

To: Catherine Eiden, Chief Health Effects Division/ Reregistration Branch 3 ( 7509C)

Attached is a review of the study entitled, GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Thinning and Harvesting of Apples. A primary review of the study was performed by Versar, Inc. under the supervision of HED. It has undergone secondary review in HED and has been revised to reflect Agency policies.      2    31 STUDY TYPE: Biological and breathing zone air monitoring during postapplication activities.

TEST MATERIAL: Azinphos methyl SYNONYMS: GUTHION ® ; S( 3,4 dihydro 4 oxobenzo[ d][ 1,2,3] trizin 3 ylmethyl) O, O dimethyl phosphorodithioate; O, O dimethyl S[( 4 oxo 1,2,3 benzotriazin 3( 4H) yl) methyl] phosphorodithioate CITATION: Study Author: D. R. Fischer Title: GUTHION ® 50 WP  Biological Monitoring of Post Application Workers During Manual Thinning and Harvesting of Apples Report Date: July 8, 2004 Analytical Laboratories: Bayer CropScience Environmental Research Bayer Research Park 17745 South Metcalf Avenue Stilwell, KS 66085 9104 Identifying Codes: MRID: 463164 03 Report No.: 201042 Study Number: GU264701 PSI Number: RCGUX001 SPONSOR: Bayer CropScience Product Safety Management 2 T. W. Alexander Drive Research Triangle Park, NC 27709 COMPLIANCE: Signed and dated GLP, Data Confidentiality statements, and Quality Assurance statements were provided in the Study Report. The Study Report states that it meets FIFRA Good Laboratory Practices 40 CFR part 160 with the following exceptions: weather data, maintenance chemical applications, pesticide history data, irrigation records, and cultural practices were not collected under GLP. Other exceptions included: ( 1) not all data entries were made promptly, ( 2) sample receipt dates and weight values were recorded into a LIMS system which was not validated, ( 3) the plot map within FieldNotes was changed but the original plot map was not retained, and ( 4) the bathroom scale used to weigh the workers was not maintained/ calibrated in accordance with GLP. The GLP statement also noted that the storage containers of test material were not retained for the duration of the study as required due to the nature of the GUTHION ® 50 WP Solupack packaging system. The statement noted that none of these exceptions negatively impacted the integrity of the study.

GUIDELINE OR PROTOCOL FOLLOWED: The Bayer Crop Science Protocol was provided in the Study Report, including a list of deviations from the protocol. The Study Report states that the data requirements were U. S. EPA OPPTS      3    31 Harmonized Test Guidelines, Series 875 Occupational and Residential Exposure.

I. MATERIALS AND METHODS A. MATERIALS Test Material:

Formulation: GUTHION ® 50 WP  water soluble packets ( GUTHION ® Solupak)

Lot/ Batch # formulation: 3144032 Purity: The purity of the batch was verified at 49.91% azinphos methyl with an expiration date of April 23, 2005.

CAS #( s): CAS 86 50 0 Other Relevant Information: EPA Reg. No. 264 733 Packaging: The product was supplied in bags containing the water soluble packets.

B. STUDY DESIGN There were 3 amendments to the protocol and 17 deviations from the protocol.

The amendments included: ( 1) Applications 4, 5, and 6 for Trial GU015 03D were incorrectly referred to as applications 3, 4, and 5 within the Application Information Table. ( 2) The volume of the urine subsamples was changed from 25 mL to a minimum of 50 mL. ( 3) An amendment was added to allow shipment of the  3,  1, and 4 day time point duplicate blood samples via two different overnight express carriers to increase the probability of safe receipt at the laboratory for cholinesterase testing within the required time from sample collection. Samples collected at the 0 day time point will be hand carried from the sampling location to the laboratory by Bayer CropScience personnel, therefore, only one vial of blood will be collected at that event.

The deviations included: ( 1) The blood samples collected from the workers on the day of thinning for trial GU016 03D were transported to BRP by the Study Director on the day after collection. ( 2) Other than during actual thinning or actual harvest, the activities of the workers were not recorded during the sample collection period as required by the protocol. However, the workers were sequestered during the sample collection period and the activities were monitored so that they did not receive any exposure to other pesticides. ( 3) Control urine and blood samples were collected from an extra worker for trial GU015 03D to      4    31 increase the probability of having 15 worker participants available for the day of harvest. ( 4) FedEx delivered the  3 day and  1 day blood samples from trial GU015 03D to BRP to the laboratory one day late. The cold packs and packaging container were sufficient to maintain the samples in a cool condition during the time of shipment. ( 5) The blood samples collected from the workers on the day of harvest for GU015 03D were transported to BRP by the Study Director. The blood samples collected from the workers 4 days after harvest were transported to BRP by the Grayson Project Manager in charge of the study. ( 6) Each worker individually chose and wore clothing typical of what they normally wore when working. Therefore, this clothing may not have necessarily been ` single layer' as stated in the protocol or ` long sleeves' or ` sleeves not rolled up' as stated in the AHETF Worker Clothing Acceptability Criteria Document. ( 7) For trial GU015 03D, the first application was made when the majority of the petals had fallen and not at petal fall. The application timing was correct based on what was typical for the trial location. The second application was made at 9 days ( not 10 days) after the first application. ( 8) For trial GU015 03D and GU016 03D, the urine samples were maintained cold ( but not frozen) using either a cooler with frozen gel packs, a refrigerator or a freezer during collection and while subsampling. The protocol specifies that a refrigerator be used for storage of these urine samples during collection. ( 9) For trials GU015 03D and GU016 03D, FieldNotes did not list all field project personnel. ( 10) For trials GU015 03D and GU016 03D, the date and time that some urine samples were transferred to the refrigerators/ freezers/ coolers used for storing the workers' urine samples during collection was not recorded within FieldNotes. For the thinning activity, the control and fortified urine samples were not transferred to coolers right at the beginning of urine collection. ( 11) For trial GU016 03D, temperature records were not maintained for the coolers used to store the control urine samples. Occasionally, the urine and OVS tube sample storage temperatures were not within what would be considered normal refrigerator or freezer temperature ranges. ( 12) For trial GU016 03D, some FieldNote update transfers were sent more than 7 days after critical events and the final notebook was sent more than 30 days after final sample shipment. ( 13) For trial GU016 03D, the spray volume for the first application was higher than the spray volume calculated using estimated tree dimensions and a factor to convert the tree volume to a recommended spray volume. However, this spray volume did not initiate drip. ( 14) For trial GU016 03D, during thinning, subjects worked from 6: 30 AM to 2: 30 PM and the pumps for the field control and fortified OVS tubes were run from 7: 14 AM to 4: 15 pm or later. During the harvest event, the subjects worked from 6: 45 AM to 3PM, while the pumps for the field control and fortified OVS tubes were run from 7: 35 AM to 3 PM. ( 15) For trial GU016 03D, the second set of duplicate blood samples was discarded after successful receipt and analysis of the first set of duplicate blood samples. ( 16) For trial GU016 03D, documentation of the workers not having been exposed to organophosphate and carbamate chemicals for at least 10 days prior to the reentry activity was not available for every worker. ( 17) For trial GU015 03D, the refrigerator used during the collection of the 24 hour composite urine samples for two of the workers ( Reps 6 and 7) did not operate properly. Therefore, the urine samples collected from these individuals were not maintained in a cool condition over the 24 hour collection period as required in the protocol. The effect on the study is not known. Except for deviation # 17, these deviations from the protocol were reported to not have any adverse effects on the study. The effect of deviation # 17 on the study is not known.      5    31 1. Test Site:

The test sites were located in North Rose, New York ( EPA Region 1) and in Tygh Valley, Oregon ( EPA Region 11).

New York: At the New York site, 6.5 acres of apple trees ( Ida Red variety) were dedicated to the reentry monitoring activity of harvesting. The distance between rows within the test plot was 20 feet and the distance between trees within a row was 25 feet. No organophosphate or carbamate pesticides were used as maintenance chemicals during the current growing season. Typical cultural and irrigation practices were employed at the site.

Oregon: At the Oregon site, 10.1 acres of apple trees ( Granny Smith variety) were dedicated to the reentry monitoring activities of thinning and harvesting. The distance between rows within the test plot was 16 feet and the distance between trees within a row was 8 feet. No organophosphate or carbamate pesticides were used as maintenance chemicals for at least 45 days prior to reentry activities of apple thinning and harvest. Typical cultural and irrigation practices were employed at the site.

2. Meteorology: Meteorological conditions, including air temperature, wind speed, wind direction, percent cloud cover, and rainfall within 24 hours of application were recorded for each application event. Additionally, the Study Report provided the rainfall amount between the first application and the reentry activities. The meteorological information is provided in Table 1.

Table 1. Meteorological Conditions During Application Application No. Air Temperatu re ( ° ° F) Wind Speed ( mph) Wind Direction Percent Cloud Cover Rainfall Within 24 Hours of Application ( inches) Total Rainfall from 1st application to reentry activity ( inches) Total Irrigation from 1st application to reentry activity ( inches)

New York Site 1 62 0 NA 90 None 2 56 2 to 4 SW 30 None 3 66 2 to 4 NW 30 None 4 73 0 NA 30 None 5 60 0 NA 0 None 6 61 0 NA 0 None 11.44 None Oregon Site 1 63 0 to 10 SW 100 None 2 85 0 to 3 SW 0 None 3 64 0 to 5 N 50 None 0.02 ( thinning) 0.78 ( harvest) 2 ( thinning) 11 ( harvest)

3. Number and type of workers:

New York: 15 male workers were monitored for harvesting apples. The Study Report stated that all      6    31 participants were experienced agricultural workers who had recently been working in vineyards. The Study Report also stated that the workers were not exposed to azinphos methyl or any other organophosphate or carbamate chemicals for at least 10 days prior to harvest. The workers ranged in age from 19 years to 69 years. The weight of the workers ranged from 55.8 kg to 102 kg. The workers' years of experience performing agricultural work ranged from 1 to 24.

To increase the probability of 15 workers being available for participation in the reentry activity, the trial was initiated with 16 workers. The spare worker (# 3) was not needed and released from the study just prior to the start of harvest.

Oregon: 15 male workers were monitored for apple thinning and a second set group of 15 male workers were monitored for apple harvesting. The Study Report stated that all participants were experienced agricultural workers who had recently been picking strawberries ( apple thinning workers) or hops ( apple harvesting workers). The Study Report also stated that the workers were not exposed to azinphos methyl or any other organophosphate or carbamate chemicals for at least 10 days prior to harvest. However, a protocol deviation also states that documentation of the workers not having been exposed to organophosphate and carbamate chemicals for at least 10 days prior to the reentry activity was not available for every worker. For the apple thinning workers, their ages ranged from 24 years to 37 years, their weights ranged from 60.3 kg to 88.9 kg, and their years of experience performing agricultural work ranged from 9 to 30. For the apple harvesting workers, their ages ranged from 26 years to 39 years, their weights ranged from 59.9 kg to 83.0 kg, and their years of experience performing agricultural work ranged from 1 to 10.

4. Replicates:

Thinning: Worker exposure during thinning activities was monitored at the Oregon site. The monitoring took place 14 days after the first application of the test substance. The workers thinned apples by hand from the designated trees in the treated plot for approximately 8 hours ( including breaks). The workers entered the plot at 6: 30 AM, took a 40 minute lunch break and a 20 minute morning break, and ended the work day at 2: 30 PM.

During the thinning activity, each worker picked and discarded the unwanted and excess fruit onto the ground.

Table 11 of the Study Report provides observations of the workers recorded during the study.

Harvesting.: Worker exposure during hand harvesting activities was monitored at the New York and Oregon sites. The monitoring took place 14 days after the last application of the test substance. The workers harvested apples from the designated trees in the treated plot for 8 hours ( including breaks). At the New York site , the workers entered the plot at 7: 10 AM, took a 40 minute lunch break and a 20 minute morning break, and ended the work day at 3: 10 PM. At the Oregon site, the workers entered the plot at 6: 54 AM, took a 30 to 40 min lunch break and 20 min morning break, and ended the work day at 3: 00 PM.

During the manual harvesting activity, each worker placed the harvested fruit directly into      7    31 individual commercial harvesting bags supplied by the grower. The harvesting bag was positioned on the front side of the worker with straps fitted over the worker's shoulders to hold the bag in place. When the bag was full, the contents were transferred to a wooden bin by releasing the ties that secured the bottom of the bag shut and gently allowing the fruit to pass through the bottom of the bag.

Tables 10 and 12 of the Study Report provide observations of the workers recorded during the study.

5. Protective clothing: The Study Report stated that the workers wore clothing typical of what they would normally wear when performing agricultural work. The workers clothing is listed in Tables 10, 11 and 12 of the Study Report, and typically included long sleeve shirts and long pants. Three workers wore short sleeve or sleeveless shirts and a seven workers wore a t shirt underneath their long sleeve shirt. Each worker wore a painters hat provided by the Principle Field Investigator. No personal protective equipment, including gloves, was worn by the workers during any of the reentry activities.

6. Application Method and Rate:

Application rate( s): The application rate listed on the current product label for apples is 1 to 1.5 lb ai/ A/ application; however, applications made at rates above 1 lb ai/ A can only be made in conjunction with an Integrated Pest Management ( IPM) program. Additionally, the label states that up to 4 lb ai/ A/ season can be applied, with a minimum of 7 days between applications. According to the Study Report, application rates for this study were chosen to reflect agricultural practices within key apple growing regions within the U. S.

At both sites, the chosen target application rates were adjusted based on the actual tree size at the trial site using the tree row volume concept. The following equation was used to calculate the amount of test substance needed for each application for a given tree size:

Calculated application rate ( lb ai/ A) = Tree volume ( GPA) x target application rate ( lb ai/ A) Reference application volume ( 400 GPA)

Where tree volume ( GPA) = volume of water required to produce full coverage and initiate drip. This number can be calculated as shown in Example 3 Appendix 1 of the Study Report; or an " infield determination can be made.

New York: Actual application rates ranged from 0.274 to 0.277 lb ai/ A. Six foliar airblast spray applications were made to apple trees at a target rate of 0.5 lb ai/ A/ application based on a standard of 400 gallons of dilute spray per acre for large trees. The calculated target application rate was 0.275 lb ai/ A/ application, based on tree row volume concept described above and actual application rates ranged from 0.274 to 0.277 lb ai/ A.

Oregon: Actual application rates ranged from 0.471 to 0.479 lb ai/ A. Three foliar airblast spray applications were made to apple trees at a target rate of 1.0 lb ai/ A/ application based on a standard of 400 gallons of dilute spray per acre for large trees. The calculated target application      8    31 rate was 0.47 lb ai/ A/ application, based on tree row volume concept described above and actual application rates ranged from 0.471 to 0.479 lb ai/ A.

Application Regime: According to the current label, the minimum application interval is 7 days. Application intervals used in this study are presented below.

New York: Six applications were made to the site with 10 day application intervals between the first three and last three applications, and a 53 day application interval between the third and fourth applications. The first application occurred on May 28, 2003; the second application occurred on June 06, 2003; the third application occurred on June 16, 2003; the fourth application occurred on August 8, 2003; the fifth application occurred on August 18, 2003; and the last application occurred on August 28, 2003.

Oregon: Three applications were made to the site with a 15 day application interval between the first and second applications and a 76 day application interval between the second and third applications. The first application occurred on June 19, 2003; the second application occurred on July 4, 2003; and the last application occurred on September 18, 2003.

Application Equipment:

New York: The test product was applied to the apple trees using a Durand Wayland airblast sprayer.

Oregon: The test product was applied to the apple trees using a Pul Blast airblast sprayer.

Spray Volume: New York: The actual spray volumes ranged from 55 to 62 GPA.

Oregon: The actual spray volumes ranged from 90 to 225 GPA.

Equipment Calibration: The authors reported that the sprayers were calibrated prior to the application.

7. Exposure monitoring methodology:

Urine Samples Total urine output was collected from each worker during each 24 hour period starting 1 day prior to reentry through 4 days after reentry. Day  1 samples were those collected starting after the first void of the bladder in the morning on the day prior to reentry and ending after the first void on the day of reentry. Day 0 samples were those collected during the 24 hour period starting when the workers began the reentry activities. Samples were collected in individually labeled 4 L Urisafe ® bulk containers. Samples were kept in coolers, freezers, or refrigerators during the 24      9    31 hour collection. After collection of each 24 hour bulk sample, the total volume of each sample was recorded. The samples were mixed by shaking, and duplicate 25 mL aliquots were transferred to 90 mL urine specimen containers. The bulk samples and aliquots were kept frozen and the aliquots were shipped frozen to Bayer Research Park. The bulk samples were kept frozen until notification by Bayer, at which time they were discarded.

Blood Samples Blood samples were collected from each worker at the following time intervals: ( 1) 3 days prior to reentry, ( 2) 1 day prior to reentry; and ( 3) on the day of reentry after a full work day, and ( 4) 4 days following reentry. The control samples collected 3 days and 1 day prior to the reentry activity for each worker were used to establish baseline cholinesterase activity. The samples were collected into individually labeled collection tubes containing EDTA K3 as an additive. Prior to sample collection, the skin was thoroughly cleaned to eliminate possible contamination of pesticide residue that may have been on the skin. Blood samples were packaged in compliance with International Air Transport Association Packaging Instructions 650 and were maintained cool during transport in a styrofoam cooler containing frozen gel packs. Samples were shipped or hand delivered to Bayer Research Park on either the day of collection or the following day.

Breathing Zone Air Samples Breathing zone air samples were collected using OVS tubes containing XAD 2 sorbent and a personal air sampling pump attached to the worker's belt. The OVS tubes consisted of a glass fiber filter, secured with a Teflon ® holding ring, covering a 270 mg layer of XAD 2 sorbent in the top, primary bed and a 140 mg layer of XAD 2 sorbent in the bottom, backup bed. The OVS tube was connected to the pump using Tygon ® tubing and clipped onto the worker's outer clothing, with the inlet positioned in the breathing zone of the worker. The air samples were collected by operating the pumps over the entire workday ( including breaks). Just prior to monitoring the reentry activity, the air sampling pumps were calibrated at a rate of approximately 2 L/ min. The pump flow rates were collected before and after the monitoring period and the pumps were checked throughout the monitoring period to ensure continual operation. At the end of the work day, the OVS tube was disconnected and caps were fitted onto the ends. A label was placed on the tube, which was placed into a pre labeled plastic bag. The samples were stored and then shipped frozen to Bayer Research Park.

C. ANALYTICAL METHODOLOGY:

1. Sample Extraction/ Detection:

Urine Samples Extraction method: 0.100 mL of [ 2H3] MSMB internal standard solution ( 0.300 µ g/ mL) was added to a 10 mL aliquot of urine. The sample was added to a 10 mL Chem Elut cartridge and the cartridge was eluted with three 20 mL portions of methylene chloride into a 60 mL vial. A TurboVap was used to evaporate the methylene chloride at 35C for 45 minutes. The residue was dissolved in 0.10 mL of methanol, a 0.9 mL aliquot of 0.1% formic acid was added and the sample was mixed. An aliquot of the sample was then analyzed using high pressure liquid chromatography triple stage quadrupole mass spectrometry.      10    31 The method for urine creatinine analysis was reported to be based on the Jaffe/ Alkaline Picrate/ Kinetic method.

Detection methods: See Table 2 Table 2. Summary of HPLC and MS Conditions for Urine HPLC Conditions GC Column: Zorbax SB Aq, 5 µ m, 50 mm x 2.1 mm Solvents: 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B) Solvent Program: Time ( min) Solvent A(%) Solvent B(%) Flow ( mL/ min) Initial 68 32 0.200 2.5 68 32 0.200 2.85 15 85 0.200 2.90 68 32 0.300 5.00 68 32 0.300 5.05 68 32 0.200 Injection Volume: Autosampler with a 20 µ L loop MS Conditions Collision cell pressure: 1.5 mTorr Spray Voltage: 1900 kV Capillary temperature: 390C Sheath: 90 psi Auxilary gas: 20 Ionization mode: Positive ion Divert valve: On from 0.60 minutes to 2.60 minutes ( HPLC effluent enters the LC/ MS)

Instrument performance and calibration: Calibration curves were prepared for each calibration run. The relative response of the detector in the lc/ ms ms chromatographic system to MSMB in solvent was linear over the range of 0.05 ng/ mL to 10 ng/ mL. The correlation of coefficients were all > 99%. The limit of quantitation for urine samples was reported to be 0.10 ng/ mL of MSMB. The limit of detection for the urine samples was reported to be 0.08 ng/ mL.

Quantification: The MSMB residue level in urine was determined by comparing the LC/ MS measurement of MSMB to the measurement of the MSMB internal standard.

Blood Samples Extraction/ Detection method: Blood samples were analyzed for plasma and red blood cell cholinesterase activity. The method was reported to be a modification of the method described by Ellman ( Ellman, M. L., K. D. Cortney, V. Andres, and R. M. Featherston. 1961. A New and Rapid Colorimetric Determination of Acetylcholinesterase Activity. Biochemical Pharmocology 7: 88 95).

Breathing Zone Air Samples      11    31 Extraction method: The top and bottom sections of the OVS tubes were analyzed separately. The top portion of the OVS tube ( including the Teflon ® ring, filter, upper layer of XAD 2 resin, and the upper foam ring) was disassembled and placed into a labelled 40 mL vial. The bottom portion of the OVS tube ( lower layer of XAD 2 resin and lower foam plug) was disassembled and placed into a separate, labeled 40 mL vial. Each sample received 10 mL of acetonitrile and 0.100 mL of an internal standard solution, which contained a mixture of [ 2H6] azinphos methyl ( 10.0 µ g/ mL) and [ 2H6] azinphos methyl oxon ( 2.0 µ g/ mL). Each sample was then sonicated for 2 minutes and a 0.25 mL aliquot was removed and diluted with 0.75 mL of water. The diluted samples were analyzed by high pressure liquid chromatography triple stage quadrupole mass spectrometry.

Detection methods: See Table 3 Table 3. Summary of HPLC and MS Conditions for Breathing Zone Air Samples HPLC Conditions GC Column Xterra MS C18, 3.5 µ m, 50 mm x 4.6 mm Solvents 0.1% aqueous formic acid ( solvent A) and methanol ( solvent B) Solvent Program Isocratic at 38% Solvent A and 62% Solvent B Flow Rate 1.00 mL/ min Injection Volume Autosampler with a 20 µ L loop MS Conditions Instrument Setup LC MS/ MS with electrospray interface and 1: 4 split Collision cell pressure 1.5 m Torr Spray voltage 5.900 kV Capillary temperature 235C Sheath gas 100 psi Auxiliary gas 30 Ionization mode Positive ion Divert valve On from 0.5 min to 2.50 min ( HPLC effluent enters LC/ MS)

Instrument performance and calibration: Calibration curves were prepared for each calibration run. The relative response of the detector in the lc/ ms ms chromatographic system to MSMB in solvent was linear over the range of 30 ng to 30,000 ng. The correlation of coefficients were all > 99%. The limit of quantitation for both azinphos methyl and azinphos methyl oxon was reported to be 100 ng. The limit of detection for azinphos methyl and azinphos methyl oxon were reported as 5 ng and 9 ng, respectively.

Quantification: The azinphos methyl or azinphos methyl oxon residue level in air samples was determined by comparing the LC/ MS measurement of azinphos methyl or azinphos methyl oxon to the measurement of the azinphos methyl or azinphos methyl oxon internal standard.      12    31 2. Quality Control:

Lab Recovery: Concurrent laboratory recoveries were performed for both urine and breathing zone air samples. Urine samples were fortified at the 0.50 ng/ mL level and OVS tubes were fortified at the 500 ng level. The results provided in the Study Report were verified and these are presented in Tables 4 and 5.

Table 4. Urine Sample Concurrent Laboratory Recoveries a Sample No. Fortificati on Level ( ng/ mL) Measure d residue ( ng/ mL) Average Blank Sample Residue ( ng/ mL) Corrected residueb ( ng/ mL) Recovery (%) Average Percent Recovery (%)

TRIAL GU015 03D ( NEW YORK) HARVESTING 0.5 0.591 0.5355 107 GUO15 03D 1H 0.5 0.514 0.0555 0.4585 92 99 0.5 0.495 0.426 85 GUO15 03D+ 0H 0.5 0.515 0.069 0.446 89 87 0.5 0.506 0.08 0.426 85 GUO15 03D+ 1H 0.5 0.515 0.435 87 86 0.5 0.533 0.054 0.479 96 GUO15 03D+ 2H 0.5 0.513 0.459 92 94 0.5 0.53 0.09 0.441 88 GUO15 03D+ 3H 0.5 0.511 0.422 84 86 0.5 0.526 0.079 0.448 90 GUO15 03D+ 4H 0.5 0.511 0.433 87 88 TRIAL GU016 03D ( OREGON)  HARVESTING 0.5 0.511 0.061 0.451 90 GUO16 03D 1H 0.5 0.518 0.458 92 91 0.5 0.462 0.014 0.448 90 GUO16 03D+ 0H 0.5 0.481 0.467 93 92 0.5 0.501 0.015 0.486 97 GUO16 03D+ 1H 0.5 0.469 0.454 91 94 0.5 0.455 0.027 0.429 86 GUO16 03D+ 2H 0.5 0.455 0.429 86 86 0.5 0.503 0.026 0.477 95 GUO16 03D+ 3H 0.5 0.48 0.454 91 93 0.5 0.485 0.023 0.463 93 GUO16 03D+ 4H 0.5 0.465 0.443 89 91 TRIAL GU016 03D ( OREGON)  THINNING 0.5 0.442 0.012 0.431 86 GUO16 03D 1T 0.5 0.437 0.426 85 86 0.5 0.463 0.023 0.44 88 GUO16 03D+ 0T 0.5 0.509 0.486 97 93 0.5 0.506 0.48 96 GUO16 03D+ 1T 0.5 0.484 0.026 0.458 92 94      13    31 0.5 0.472 0.468 94 GUO16 03D+ 2T 0.5 0.493 0.005 0.489 98 96 0.5 0.569 0.547 109 GUO16 03D+ 3T 0.5 0.496 0.022 0.474 95 102 0.5 0.445 0.433 87 GUO16 03D+ 4T 0.5 0.475 0.013 0.463 93 90 a Recoveries were calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue.

Table 5. OVS Tubes Concurrent Laboratory Recoveries a Analyte Fortificati on Level ( ng) Measure d Bottom Residue ( ng) Bottom Blank Residue s ( ng) Correcte d Bottom Residue b ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residue ( ng) Total Residue ( top + bottom) ( ng) Percent recovery (%)

TRIAL GU015 03D ( NEW YORK)  HARVESTING AZMc 500 12.1 38.6  26.5e 384.3 6.2 378.1 380.6 76 AZM oxond 500 4.5f 29.3  24.8e 485.1 4.5e 480.6 485.1 97 TRIAL GU016 03D ( OREGON)  HARVESTING AZMc 500 12.1 17.5  5.4e 417.8 17.5 400.3 402.8 81 AZM oxond 500 4.5f 4.5f 0e 510.2 4.5e 505.7 510.2 102 TRIAL GU016 03D ( OREGON)  THINNING AZMc 500 11.2 20.7  9.5e 380.1 2.5e 377.6 380.1 76 AZM oxond 500 4.5f 4.5f 0e 512.6 4.5e 508.1 512.6 103 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue. c AZM = azinphos methyl d AZM oxon = azinphos methyl oxon e Since the corrected bottom residue was less than the LOD, ½ the LOD was used in subsequent calculations. F Residues < LOD are shown as 1/ 2 LOD.

Field recovery:

Urine Samples Field fortification samples were prepared at 0.50 ng/ mL and 10.0 ng/ mL for urine samples. The fortification samples were prepared from two 200 mL aliquots of control urine. One aliquot received 0.100 mL of a 1.00 µ g/ mL fortification solution containing MSMB, while the other received two mL of the fortification solution. The solutions were then mixed well and three 50 mL aliquots were removed and placed in separate containers. The results provided in the Study Report were verified are presented in Table 6. The average low and high level fortification recoveries, respectively, were 99% and 93% for the New York harvesting trial, 96% and 90% for the Oregon harvesting trial, and 70% and 77% for the Oregon thinning trial.      14    31 Table 6. Urine Sample Field Fortification Recoveries a Fortification Level ( ng/ mL) Measured residue ( ng/ mL) Blank Samples ( ng/ mL) Corrected residue b ( ng/ mL) Recovery (%) Average Recovery (%)

TRIAL GU015 03D ( NEW YORK)  HARVESTING 0.501 0.472 94 0.538 0.509 102 Low fortification level 0.5 0.538 0.509 102 99 9.186 9.157 92 9.256 9.227 92 High fortification level 10 9.406 0.029 9.377 94 93 TRIAL GU016 03D ( OREGON)  HARVESTING 0.508 0.481 96 0.469 0.442 88 Low fortification level 0.5 0.54 0.513 103 96 9.339 9.312 93 7.881 7.854 79 High fortification level 10 9.752 0.027 9.725 97 90 TRIAL GU016 03D ( OREGON)  THINNING 0.277 0.267 53 0.331 0.321 64 Low fortification level 0.5 0.471 0.461 92 70 7.59 7.58 76 9.129 9.119 91 High fortification level 10 6.4 0.01 6.39 64 77 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue.

Breathing Zone Air Samples Field fortification samples were prepared at 500 ng and 10,000 ng for OVS tubes. 0.050 mL of a fortification solution containing 10 µ g/ mL azinphos methyl and 10 µ g/ mL azinphos methyl oxon were added to blank laboratory control OVS tubes for the low field fortification samples. 0.050 mL of a fortification solution containing 200 µ g/ mL azinphos methyl and 200 µ g/ mL azinphosmethyl oxon were added to blank laboratory control OVS tubes for the high field fortification samples. Air was then drawn through the tubes for 10 minutes at a rate of 3 mL/ min to evaporate the solvent. The tubes were then capped and labeled. The results provided in the Study Report were verified and are presented in Table 7. For azinphos methyl, the average low and high level fortification recoveries, respectively, were 88% and 94% for the New York harvesting trial, 94% and 105% for the Oregon harvesting trial, and 83% and 96% for the Oregon thinning trial. For azinphos methyl oxon, the average low and high level fortification recoveries, respectively, were 105% and 102% for the New York harvesting trial, 115% and 110% for the Oregon harvesting trial, and 106% and 95% for the Oregon thinning trial.      15    31 Table 7. OVS Tubes Field Fortification Recoveries a Analyte Fortification Level ( ng) Measure d Bottom Residue ( ng) Bottom Blank Residues ( ng.) Correcte d Bottom Residue ( ng) Measured Top Residue ( ng) Top Blank Residues ( ng) Corrected Top Residue b ( ng) Total Residue ( top + bottom) ( ng) Recovery (%) Overall Average Recovery (%)

TRIAL GU015 03D ( NEW YORK)  HARVESTING 500 5.3  3.4e 419 416 419 84 500 2.5f  6.2e 426 423 426 85 500 2.5f  6.2e 469 467 469 94 88 10,000 2.5f  6.2e 9,267 9,264 9,267 93 10,000 5.4  3.3e 9,089 9,087 9,089 91 AZMc 10,000 22.2 8.7 13.5 9,693 2.5 f 9,691 9,704 97 94 500 4.5f 0e 528 523 528 106 500 4.5f 0e 545 540 545 110 500 4.5f 0e 496 492 496 100 105 10,000 4.5f 0e 10,725 10,720 10,725 107 10,000 4.5f 0e 9,950 9,945 9,950 99 AZMoxond 10,000 17.9 4.5f 13.4 10,055 4.5f 10,050 10,064 101 102 TRIAL GU016 03D ( OREGON)  HARVESTING 500 7.6  3.2e 418 412 414 83 500 2.5f  8.3e 438 431 434 87 500 2.5f  8.3e 570 563 566 113 94 10,000 11.5 0.7e 10,207 10,201 10,203 102 10,000 2.5f  8.3e 10,455 10,448 10,451 105 AZMc 10,000 2.5f 10.8  8.3e 10,980 6.4 10,973 10,976 110 105 500 4.5f 0e 585 575 579 116 500 4.5f 0e 543 533 537 107 500 4.5f 0e 618 607 612 122 115 10,000 4.5f 0e 10,833 10,823 10,827 108 10,000 4.5f 0e 11,049 11,039 11,043 110 AZMoxond 10,000 4.5f 4.5f 0e 11,058 10.3 11,048 11,053 111 110 TRIAL GU016 03D ( OREGON)  THINNING 500 2.5f 0e 392 389 392 78 500 2.5f 0e 406 403 406 81 500 2.5f 0e 444 441 444 89 83 10,000 2.5f 0e 9,283 9,281 9,283 93 10,000 2.5f 0e 9,590 9,588 9,590 96 AZMc 10,000 6.4 2.5f 3.9 9,951 2.5f 9,948 9,951 100 96 500 4.5f 0e 538 534 538 108 500 4.5f 0e 539 535 539 108 500 4.5f 0e 497 493 497 99 106 10,000 4.5f 0e 9,415 9,410 9,415 94 10,000 4.5f 0e 9,425 9,420 9,425 94 AZMoxond 10,000 4.5f 4.5f 0e 9,559 4.5f 9,555 9,559 96 95 a Recoveries calculated using raw data provided in Appendix 3 of the Study Report. b Corrected residue is the measured residue minus the average blank residue. c AZM = azinphos methyl d AZM oxon = azinphos methyl oxon e Since the corrected bottom residue was less than the LOD, ½ the LOD was used in subsequent calculations. F Residues < LOD are shown as 1/ 2 LOD LOD levels for AZM on OVS tubes were 5 ng and 9 ng      16    31 for AZM oxon.

Tank mix: No information on tank mix analysis was provided in the Study Report.

Travel Recovery: Travel recovery was not assessed in the Study Report.

Storage Stability: All samples were stored frozen prior to analysis. Urine samples were held for a maximum of 4.2 months ( 126 days) prior to extraction and all extracts were analyzed within 10 days after extraction. OVS tube samples were held for a maximum of 3.9 months ( 117 days) prior to extraction and all extracts were analyzed within 4 days after extraction. The Study Report states that the acceptable recoveries from the field fortification samples indicate that the field samples would be stable over the period of collection, storage, and shipping through sample analysis. A separate storage stability study was not performed.

II. RESULTS AND CALCULATIONS:

A. EXPOSURE CALCULATIONS:

Internal Dose The internal azinphos methyl dose was determined from the MSMB residues measured in 24 hour urine samples collected from each worker. The Registrant corrected measured residues for all field fortification recoveries, even those greater than 90%. Additionally, the Registrant corrected the MSMB residues measured in the urine samples following reentry for the amount of MSMB residue found in each worker's urine sample on the day before reentry ( day  1). For the harvesting trial in New York, the background residues were < LOD in nine of the workers and ranged from 0.056 µ g to 0.173 µ g in the remaining six workers ( Nos. 2, 4, 5, 9, 10, and 14). For the harvesting trial in Oregon, the background residues were < LOD in eight of the workers and ranged from 0.085 µ g to 0.406 µ g in the remaining seven workers ( Nos. 1, 2, 4, 6, 7, 8, 10). For the thinning trial in Oregon, the background residues were < LOD in all the workers. All sample concentrations were reported as ng/ mL equivalents of parent azinphos methyl. Equivalents were calculated using a molecular weight conversion factor of 1.328. The background corrected residue levels in ng/ mL were multiplied by the appropriate 24 hour urine volume and normalized to the worker's body weight.

By adding the daily amount excreted over the 4 day collection period and factoring for expected dose excreted over 120 hours and the percentage of AZM dose represented by MSMB, the estimated dose received after one day of exposure was estimated. Using the raw data provided in the Study Report, azinphos methyl internal dose estimates in mg/ kg body weight were estimated for each worker and each trial over the 4 sampling days ( 120 hrs). Results were presented with correction for the background ( day  1) levels of azinphos methyl demonstrated in pre reentry samples. Measured residues were corrected to 100% recovery based on recoveries of the associated field fortification samples. Residues < LOD were set to ½ LOD for all calculations. After the measured residues, corrected for background residues and/ or field fortification recoveries were adjusted for the volume of urine collected, the internal dose was calculated by adjusting the MSMB excreted during all the sampling intervals for the cumulative percent of the absorbed dose      17    31 excreted 120 hours after exposure ( as determined from a previous study  83.6%) and the percent of the total azinphos methyl dose represented by MSMB ( determined from a previous study  9.2%).

Table 8 provides the total internal azinphos methyl dose ( over 120 hrs) for each trial based on body weight. The total average azinphos methyl doses based on body weight for the harvesting trial in New York, the harvesting trial in Oregon, and the thinning trial in Oregon, are 0.00416, 0.00688, and 0.00199 mg/ kg body weight, respectively.

Breathing Zone Air Samples Air samples were collected in the breathing zone of workers using OVS sampling tubes. Residues of both azinphos methyl and azinphos methyl oxon were measured on the top and bottom portions of the sampling tubes and combined for a total azinphos methyl residue. All field samples were adjusted for field fortification recoveries. Residues that were reported as < LOD were included in calculations as ½ LOD.

Breathing zone air concentrations for harvesters at the New York test site averaged 5.16 µ g/ m3. For harvesters in Oregon the breathing zone air concentration averaged 17.64 µ g/ m3 and following thinning activities in Oregon the breathing zone air concentration averaged 3.35 µ g/ m3.

Cholinesterase Activity Cholinesterase activity ( both plasma and red blood cells) was monitored through blood sampling prior to reentry ( on days  3 and  1) and on day 0 ( following completion of the full work day) and day 4 following the postapplication activity. The depression of cholinesterase activity was then determined by comparing the pre reentry cholinesterase levels to those measured on days 0 and 4. These results are provided in Tables 15 to 17. For the harvesting activities at the New York site and the Oregon site, the percent decrease in plasma cholinesterase on day 0 ranged from 1% to 16% and from 0% to 13%, respectively, and the percent decrease in red blood cell cholinesterase on day 0 ranged from  8% to 4% and from  4% to 4%, respectively. On day 4, the percent decrease in plasma cholinesterase ranged from  11% to 28% and from  11% to  1%, respectively, and the percent decrease in red blood cell cholinesterase ranged from  7% to 5% and from  3% to 7%, respectively. For the thinning activities at the Oregon site, the percent decrease in plasma cholinesterase on day 0 ranged from 2% to 13% and the percent decrease in red blood cell cholinesterase on day 0 ranged from  10% to 7%. On day 4, the percent decrease in plasma cholinesterase ranged from  11% to 4% and the percent decrease in red blood cell cholinesterase ranged from  9% to 9%.

The average percent change in plasma cholinesterase ( ChE) immediately following the day of entry was negative eight percent with a range of ± 4 percent for apple harvesters in New York, negative six percent with a range of ± 4 percent for apple harvesters in Oregon, and negative eight percent with a range of ± 3 percent for apple thinners in Oregon. The data indicate that by day 4 following exposure, the average plasma ChE levels returned to baseline levels. The average percent change in red blood cell ( RBC) cholinesterase levels immediately following the day entry was positive one percent with a range of ± 3 percent for harvesters in New York, zero percent with a range of ± 3 percent for harvesters in Oregon, and negative two percent with a range of ± 4 percent for thinners in Oregon. That remained about constant on day 4 following exposure. III DISCUSSION:      18    31 A. LIMITATIONS OF THE STUDY:

This study met most of the Group B 875.2500 ( inhalation exposure) and 875.2600 ( biological monitoring) Guidelines. The major issues of concern are:

  The guideline states that for urine monitoring, there should also be a sufficient time period between exposures to the test substance or structurally related compounds and participation in the study to ensure adequate urinary clearance of the compound and its metabolites, based on pharmacokinetic data. The Study Report stated that workers were not exposed to azinphos methyl or any other organophosphate and carbamate chemicals for at least 10 days prior to harvest. However, it should be noted that MSMB residues were detected above the LOQ in the background urine samples from some workers participating in the harvesting activities at the New York and Oregon sites.

  The guideline states that samples should be stored in a manner that will minimize deterioration and loss of analytes between collection and analysis. Biological monitoring samples ( e. g., serum, plasma and urine) should be refrigerated or stored frozen prior to analysis. Whole blood should not be frozen. Information on storage stability should be provided. These criteria were mostly met. Urine and OVS tube samples were stored frozen prior to analysis and blood samples were stored cool prior to analysis. According to the protocol deviations reported, the refrigerator used during the collection of the 24 hour composite urine samples for two of the workers ( Reps 6 and 7) in the New York trial did not operate properly. Therefore, the urine samples collected from these individuals were not maintained in a cool condition over the 24 hour collection period as required in the protocol. The effect on the study is not known. Field fortification samples and recoveries were used to demonstrate storage stability. A separate storage stability study was not mentioned.

  The guideline states that a trapping efficiency test for the monitoring media chosen must be documented. A trapping efficiency test was not reported. However, method validation data exhibited recoveries of 103 107% for azinphos methyl and 94 101% for azinphos methyl oxon.

  The guideline states that air samples should also be tested for breakthrough to ensure that collected material is not lost from the medium during sampling and it is recommended that at least one test be carried out where the initial trap contains 10X the highest amount of residue expected in the field. A breakthrough test was not mentioned in the Study Report.

  The guideline states that if trapping media or extracts from field samples are to be stored after exposure, a stability test of the compound of interest must be documented and the media must be stored under the same conditions as field samples. Storage stability samples should be extracted and analyzed immediately before and at appropriate periods during storage and the time periods for storage should be chosen so that the longest corresponds to the longest projected storage period for field samples. There was no information in storage stability included in the study report; however, field fortification samples were collected, stored and analyzed with the field samples.      19    31   The guideline calls for creatinine determination as a qualitative measure of monitoring completeness of urine collection samples. These levels were determined and are presented in the Study Report, but the findings are never addressed in the text Other major issues of concern in evaluation of the study include:

  The baseline cholinesterase ( ChE) levels for workers were established by taking a sample 3 days prior and another sample one day prior to the day where the workers were exposed to AZM residues while performing postapplication tasks. Most guidelines recommend that baseline blood samples be taken at a time when the worker has not been exposed to organophosphates or n methyl carbamates for at least 30 days. Workers in the study stated that they had not been exposed to organophosphates or n methyl carbamates for at least 10 days prior to the study, but that could not be independently verified. Guidelines generally also recommend that establishing a stable baseline requires a minimum of two pre exposure tests taken at least 3 days, but not more than 14 days, apart. Considering these factors, the baseline ChE levels in the study may not reflect actual baseline levels in unexposed workers. The baseline ChE levels measured in the study fall within the normal range of ChE levels in the blood.

  Since the blood cholinesterase data reflect a single day of exposure, it would be expected that successive days of exposure would result in additional depression of ChE that could be cumulative. The data do not permit estimating the slope of recovery for ChE plasma and RBC levels back to normal levels, therefore it is difficult to predict the cumulative effect of successive days of exposure.

Table 8. Total Azinphos methyl Dose By Trial ( mg/ kg bw)

Trial GU015 03D ( New York)  Harvesting Trial GU016 03D ( Oregon)

Harvesting Trial GU016 03D ( Oregon)  Thinning Arithmetic Mean Geometric Mean Standard Deviation Arithmetic Mean Geometric Mean Standard Deviation Arithmetic Mean Geometric Mean Standard Deviation 0.00416 0.00374 0.0021 0.00688 0.00613 0.00359 0.00199 0.00175 0.001021      20    31 Table 9. Calculated Azinphos methyl Internal Doses in Workers During Harvesting Trial GU015 03D ( New York)

Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

1 0 day 6.26 35.05 83.6 9.2 456 101.61 0.00448 1 day 12.79 2 day 10.25 3 day 4.45 4 day 1.29 2 0 day 7.03 33.02 83.6 9.2 429 99.79 0.0043 1 day 13.26 2 day 7.39 3 day 3.63 4 day 1.72 4 0 day 7.77 22.85 83.6 9.2 297 74.39 0.004 1 day 7.18 2 day 4.93 3 day 2 4 day 0.97 5 0 day 0.14 7.17 83.6 9.2 93 65.32 0.0014 1 day 1.08 2 day 3.51 3 day 2.11 4 day 0.33 6 0 day 10.74 41.59 83.6 9.2 541 86.64 0.0062 1 day 14.87 2 day 8.83 3 day 5.44 4 day 1.7 7 0 day 6.08 29.64 83.6 9.2 385 72.58 0.0053 1 day 10.73 2 day 7.02 3 day 3.76 4 day 2.07 8 0 day 5.62 17.34 83.6 9.2 225 76.66 0.0029 1 day 6.03 2 day 3.44 3 day 1.58 4 day 0.67 9 0 day 0.98 23.07 83.6 9.2 300 76.66 0.0039 1 day 11.09 2 day 5.71 3 day 4.03 4 day 1.26 10 0 day 2.12 25.59 83.6 9.2 333 78.93 0.0042 1 day 10.19 2 day 6.19 3 day 5.41 4 day 1.69 11 0 day 15.51 94.25 83.6 9.2 1225 119.75 0.0102      21    31 Table 9. Calculated Azinphos methyl Internal Doses in Workers During Harvesting Trial GU015 03D ( New York)

Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

1 day 31.93 2 day 25.69 3 day 14.9 4 day 6.23 12 0 day 6.63 20.19 83.6 9.2 263 73.94 0.0036 1 day 6.71 2 day 4.69 3 day 1.73 4 day 0.42 13 0 day 2.76 20.03 83.6 9.2 260 97.07 0.0027 1 day 7.75 2 day 5.71 3 day 2.63 4 day 1.18 13 0 day 2.41 14.49 83.6 9.2 188 69.85 0.0027 1 day 6.63 2 day 3.2 3 day 1.53 4 day 0.73 15 0 day 1.13 7.99 83.6 9.2 104 55.79 0.0019 1 day 3.23 2 day 2.34 3 day 0.79 4 day 0.5 16 0 day 3.73 20.97 83.6 9.2 273 60.78 0.0045 1 day 9.52 2 day 3.91 3 day 3.08 4 day 0.74 a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor) x 24 hour urine volume ( mL)] 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification recovery values used for correction: 99% when residue < 2.2 ng/ mL 93% when residue > 2.2 ng/ mL b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g))/ 1000) / Body Weight ( kg)      22    31 Table 10. Calculated Azinphos methyl Internal Doses in Workers During Harvesting Trial GU016 03D ( Oregon)

Worker Number Samplin g Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

1 0 day 5.35 20.06 83.6 9.2 261 67.59 0.00386 1 day 7.79 2 day 3.91 3 day 2.33 4 day 0.69 2 0 day 5.94 30.13 83.6 9.2 392 76.66 0.0051 1 day 11.41 2 day 6.16 3 day 4.67 4 day 1.96 3 0 day 5.75 30.48 83.6 9.2 396 63.96 0.0062 1 day 14.27 2 day 5.6 3 day 3.25 4 day 1.61 4 0 day 13.89 89.77 83.6 9.2 1167 82.55 0.0141 1 day 32.77 2 day 23.47 3 day 11.62 4 day 8.03 5 0 day 14.11 74.74 83.6 9.2 972 72.12 0.0135 1 day 28.89 2 day 15.44 3 day 10.92 4 day 5.39 6 0 day 5.15 27.78 83.6 9.2 361 75.75 0.0048 1 day 10.57 2 day 5.82 3 day 4.85 4 day 1.4 7 0 day 6.89 18.07 83.6 9.2 235 59.87 0.0039 1 day 6.81 2 day 3.37 3 day 0.86 4 day 0.13 8 0 day 19.3 49.69 83.6 9.2 646 64.86 0.01 1 day 19.51 2 day 6.58 3 day 3.3 4 day 1.01 9 0 day 5.06 19.49 83.6 9.2 253 63.5 0.004 1 day 6.78 2 day 5.49      23    31 Table 10. Calculated Azinphos methyl Internal Doses in Workers During Harvesting Trial GU016 03D ( Oregon)

Worker Number Samplin g Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

3 day 2 4 day 0.16 10 0 day 11.92 42.4 83.6 9.2 551 68.04 0.0081 1 day 17.51 2 day 7.03 3 day 4.26 4 day 1.67 11 0 day 0.1 31.94 83.6 9.2 415 74.84 0.0055 1 day 16.89 2 day 8.14 3 day 4.78 4 day 2.03 12 0 day 9.73 38.8 83.6 9.2 505 79.83 0.0063 1 day 15.36 2 day 7.52 3 day 4.33 4 day 1.86 13 0 day 15.38 63.36 83.6 9.2 824 77.11 0.0107 1 day 29.6 2 day 12.53 3 day 4.47 4 day 1.38 14 0 day 4.8 22.1 83.6 9.2 287 73.03 0.0039 1 day 8.43 2 day 4.18 3 day 3.02 4 day 1.68 15 0 day 7.81 20.02 83.6 9.2 260 83.01 0.0031 1 day 6.28 2 day 3.18 3 day 2.08 4 day 0.67 a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor) x 24 hour urine volume ( mL)] 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification recovery values used for correction: 96% when residue < 2.2 ng/ mL 90% when residue > 2.2 ng/ mL b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g))/ 1000) / Body Weight ( kg)      24    31 Table 11. Calculated Azinphos methyl Internal Doses in Workers During Thinning Trial GU016 03D ( Oregon)

Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

1 0 day 0.63 6.61 83.6 9.2 86 77.57 0.01074 1 day 3.57 2 day 1.19 3 day 1.06 4 day 0.16 2 0 day 2.94 12.36 83.6 9.2 161 64.18 0.020 1 day 5.35 2 day 2.85 3 day 0.94 4 day 0.28 3 0 day 2.57 16.73 83.6 9.2 218 64.86 0.027 1 day 8.38 2 day 3.61 3 day 1.14 4 day 1.03 4 0 day 0.9 9.33 83.6 9.2 121 69.17 0.015 1 day 5.34 2 day 1.7 3 day 1.06 4 day 0.33 5 0 day 1.64 9.4 83.6 9.2 122 88.91 0.015 1 day 4.96 2 day 1.3 3 day 1.13 4 day 0.37 6 0 day 2.57 10.16 83.6 9.2 132 60.33 0.017 1 day 4.34 2 day 1.83 3 day 1.2 4 day 0.22 7 0 day 2.71 9.95 83.6 9.2 129 61.01 0.016 1 day 3.77 2 day 2.08 3 day 1.13 4 day 0.27 8 0 day 0.39 10.72 83.6 9.2 139 81.65 0.017 1 day 5.4 2 day 3 3 day 1.21 4 day 0.73 9 0 day 0 3.17 83.6 9.2 41 78.7 0.005 1 day 0.2 2 day 1.79 3 day 0.96 4 day 0.22 10 0 day 3.2 15.24 83.6 9.2 198 68.27 0.025 1 day 7.04      25    31 Table 11. Calculated Azinphos methyl Internal Doses in Workers During Thinning Trial GU016 03D ( Oregon)

Worker Number Sampling Interval MSMB excreted ( µ g) Total MSMB excreteda ( µ g) % of absorbed dose excreted in urine after 120 hours % AZM dose present as MSMB Total AZM Doseb ( µ g) Body weight ( kg) Total AZM Dosec ( mg/ kg BW)

2 day 3.22 3 day 1.44 4 day 0.35 11 0 day 0.01 6.03 83.6 9.2 78 66.23 0.010 1 day 2.71 2 day 1.29 3 day 1.29 4 day 0.73 12 0 day 1.53 9.65 83.6 9.2 125 73.94 0.016 1 day 4.38 2 day 1.72 3 day 1.58 4 day 0.42 13 0 day 3.11 23.57 83.6 9.2 306 68.95 0.038 1 day 8.26 2 day 7.14 3 day 3.34 4 day 1.73 14 0 day 1.1 4.44 83.6 9.2 58 69.85 0.007 1 day 2.05 2 day 0.77 3 day 0.41 4 day 0.1 15 0 day 0.69 10.41 83.6 9.2 135 62.82 0.017 1 day 5.16 2 day 2.55 3 day 1.83 4 day 0.19 a Total MSMB excreted ( ug) =[( measured MSMB ( AZM equivalents) ng/ mL / field fortification recovery correction factor) x 24 hour urine volume ( mL)] 1 ug/ 1000 ng. This amount was calculated for each day ( 0 4) and then summed to give a 120 hour total residue estimate. Field fortification recovery values used for correction: 70% when residue < 2.2 ng/ mL 77% when residue > 2.2 ng/ mL b Total AZM Dose ( µ g) = Total MSMB excreted ( µ g) * % of absorbed dose excreted in urine after 120 hours/ 100 * % of total AZM dose represented by MSMB/ 100 c Total AZM Dose ( mg/ kg BW) = (( Total AZM Dose ( µ g))/ 1000) / Body Weight ( kg)      26    31 Table 12. Potential Inhalation Exposure During Harvesting in Trial GU015 03D ( New York)

Worker No. Total Residue a ( ng) Flow Rate ( L/ min) Sampling Time ( min) Air Concentration b ( µ g/ m3)

1 4,530 2.06 490 4.5 2 6,574 2.06 490 6.52 4 3,609 2.1 490 3.51 5 4,602 2.13 490 4.41 6 6,747 2.11 490 6.51 7 5,317 1.99 490 5.46 8 8,032 2.1 490 7.81 9 4,376 2.14 490 4.18 10 3,290 2.13 490 3.15 11 5,174 2.08 490 5.08 12 6,310 2.08 490 6.19 13 4,768 2.03 490 4.8 14 6,048 2.13 490 5.8 15 3,186 2.14 490 3.03 16 6,693 2.11 490 6.46 Average 5.16 Geometric Mean 4.98 Standard Deviation 1.4 a Total Residue is the sum of the azinphos methyl and azinphos methyl oxon residues in both top and bottom tube sections. 1/ 2 LOD was used in calculations for residues < LOD. Data were corrected for AZM and AZM oxon field fortification recovery values of 94% and 115% , respectively were used when residues were < 2,250 ng. When residue values were > 2,250 ng recovery values of 105% and 110% were used for AZM and AZM oxon, respectively.

b Air Concentration ( µ g/ m3) = Total Residue ( µ g) [( Flow Rate ( L/ min) * Sampling Time ( min)) / 1000 L/ m3]      27    31 Table 13. Potential Inhalation Exposure During Harvesting in Trial GU016 03D ( Oregon)

Worker No. Total Inhalation Residueb ( ng) Flow Rate ( L/ min) Sampling Time ( min) Air Concentration b ( µ g/ m3)

1 13,206 2.2 486 12.36 2 22,480 2.17 486 21.29 3 23,465 2.1 486 23.03 4 22,222 2.17 486 21.09 5 15,909 2.19 486 14.97 6 13,854 1.93 486 14.75 7 16,709 2.21 486 15.58 8 19,579 2.22 486 18.12 9 11,696 2.16 486 11.12 10 28,618 2.19 486 26.85 11 13,600 2.17 486 12.88 12 46,290 2.16 486 44.03 13 13,714 2.14 486 13.21 14 5,197 2.07 486 5.18 15 10,146 2.07 486 10.08 Average 17.64 Geometric Mean 15.77 Standard Deviation 9.18 a Total Inhalation Residue is the sum of the azinphos methyl and azinphos methyl oxon residues in both top and bottom tube sections. 1/ 2 LOD was used in calculations for residues < LOD. Data were corrected for AZM and AZM oxon field fortification recovery values of 94% and 115% , respectively were used when residues were < 2,250 ng. When residue values were > 2,250 ng recovery values of 105% and 110% were used for AZM and AZM oxon, respectively.

b Air Concentration ( µ g/ m3) = Total Residue ( µ g) [( Flow Rate ( L/ min) * Sampling Time ( min)) / 1000 L/ m3]      28    31 Table 14. Potential Inhalation Dose for Exposure During Thinning in Trial GU016 03D ( Oregon)

Worker No. Total Inhalation Residue a ( ng) Flow Rate ( L/ min) Sampling Time ( min) Concentration b ( µ g/ m3)

1 6,190 2.12 478 6.11 2 1,411 2.15 478 1.37 3 4,674 2.17 478 4.5 4 2,767 1.89 478 3.06 5 1,916 2.09 478 1.92 6 5,747 2.08 478 5.59 7 2,973 2.14 478 2.91 8 2,681 2.13 478 2.64 9 4,818 2.1 478 4.79 10 5,301 2.12 478 5.23 11 1,082 2.1 478 1.08 12 2,567 2.14 478 2.51 13 2,622 1.99 478 2.76 14 1,801 2.03 478 1.86 15 3,517 1.99 478 3.69 Average 3.35 Geometric Mean 2.97 Standard Deviation 1.6 a Total Inhalation Residue is the sum of the azinphos methyl and azinphos methyl oxon residues in both top and bottom tube sections. 1/ 2 LOD was used in calculations for residues < LOD. Data were corrected for AZM and AZM oxon field fortification recovery values of 94% and 115% , respectively were used when residues were < 2,250 ng. When residue values were > 2,250 ng recovery values of 105% and 110% were used for AZM and AZM oxon, respectively.

b Air Concentration ( µ g/ m3) = Total Residue ( µ g) [( Flow Rate ( L/ min) * Sampling Time ( min)) / 1000 L/ m3]      29    31 Table 15. Percent Depression of Cholinesterase Activity for Trial GU015 03D ( New York)  Harvesting Average Cholinesterase Activity Determined on Days  1 and  3 Cholinesterase Activity and % Depression on Sampling Day 0 Cholinesterase Activity and % Depression on Sampling Day 4 Worker Number Plasma Red Blood Cells Plasma % Depression Red Blood Cells % Depression Plasma % Depression Red Blood Cells % Depression 1 3.47 13.66 3.25 6 13.91  2 3.64  5 14.14  4 2 3.78 13.33 3.69 2 13.5  1 3.99  6 13.76  3 4 3.15 13.62 2.79 11 14.03  3 3.47  10 14.02  3 5 3.64 13.67 3.11 15 13.79  1 4.05  11 14.1  3 6 4.44 13.6 4.32 3 13.03 4 4.44 0 12.98 5 7 3.6 13.66 3.27 9 13.42 2 3.79  5 14.05  3 8 4.37 13.76 4.22 3 13.57 1 3.15 28 13.75 0 9 3.97 14.12 3.65 8 14.25  1 3.96 0 14.3  1 10 3.42 13.28 3.38 1 13.99  5 3.76  10 13.47  1 11 3.67 13.6 3.42 7 13.52 1 3.65 0 13.81  2 12 3.81 13.9 3.19 16 14.17  2 3.57 6 14.16  2 13 4.56 15.8 4.08 10 15.59 1 4.53 1 15.47 2 14 3.8 14.13 3.45 9 13.91 2 3.77 1 14.62  4 15 3.41 11.12 3.09 9 11.2  1 3.43  1 11.33  2 16 3.79 13.14 3.38 11 14.16  8 4.15  9 14.06  7 Average 3.79 13.62 3.49 8.08 13.74  0.88 3.82  1.46 13.87  1.85      30    31 Table 16. Percent Depression of Cholinesterase Activity for Trial GU016 03D ( Oregon)  Harvesting Average Cholinesterase Activity Determined on Days  1 and  3 Cholinesterase Activity and % Depression on Sampling Day 0 Cholinesterase Activity and % Depression on Sampling Day 4 Worker Number Plasma Red Blood Cells Plasma % Depression Red Blood Cells % Depression Plasma % Depression Red Blood Cells % Depression 1 3.14 13.65 2.95 6 13.72  1 3.29  5 13.36 2 2 4.47 13.73 4.1 8 13.77 0 4.78  7 13.55 1 3 3.98 13.8 3.75 6 13.7 1 4.4  11 13.71 1 4 4.06 13.01 3.95 3 12.63 3 4.3  6 12.59 3 5 3.27 14.81 2.99 9 15.16  2 3.4  4 14.42 3 6 3.08 12.61 3.07 0 12.8  2 3.24  5 12.96  3 7 2.35 13.14 2.21 6 13.5  3 2.4  2 12.99 1 8 3.11 12.85 2.83 9 13.39  4 3.14  1 13.28  3 9 3.33 13.44 3.09 7 12.9 4 3.35  1 13.06 3 10 3.48 14.19 3.02 13 13.8 3 3.55  2 13.56 4 11 3.83 12.58 3.6 6 12.85  2 4.1  7 12.47 1 12 2.87 11.42 2.87 0 11.52  1 3.15  10 11.58  1 13 3.8 13.46 3.41 10 13.39 1 4.1  8 13.59  1 14 4.1 13.76 4.11 0 13.74 0 4.45  9 13.73 0 15 4.39 13.98 3.96 10 13.42 4 4.51  3 13.08 6 Average 3.55 13.36 3.33 6.13 13.35 0.07 3.74  5.34 13.2 1.14      31    31 Table 17. Percent Depression of Cholinesterase Activity for Trial GU016 03D ( Oregon)  Thinning Average Cholinesterase Activity Determined on Days  1 and  3 Cholinesterase Activity and % Depression on Sampling Day 0 Cholinesterase Activity and % Depression on Sampling Day 4 Worker Number Plasma Red Blood Cells Plasma % Depression Red Blood Cells % Depression Plasma % Depression Red Blood Cells % Depression 1 2.86 11.42 2.55 11 11.6  2 2.83 1 12.41  9 2 3.9 12.66 3.72 4 12.48 1 3.98  2 13.27  5 3 3.43 15.32 3.18 7 14.17 7 3.32 3 15.18 1 4 3.27 13.58 2.97 9 13.23 3 3.23 1 13.62 0 5 3.44 13.68 3.2 7 13.7 0 3.82  11 12.67 7 6 4.18 14.32 3.62 13 13.25 7 4.34  4 13.87 3 7 2.28 12.54 2.1 8 12.16 3 2.43  7 12.14 3 8 4.99 14.8 4.55 9 14.46 2 4.83 3 13.48 9 9 4.87 13.77 4.4 10 13.46 2 4.74 3 13.92  1 10 3.43 13.69 3.19 7 13.46 2 3.38 1 13.33 3 11 3.29 13.59 3.16 4 13.33 2 3.19 3 13.7  1 12 4.17 13.79 3.66 12 13.15 5 3.98 4 13.8 0 13 3.31 14.05 3.01 9 13.8 2 3.21 3 13.67 3 14 3.37 12.54 3.12 7 11.82 6 3.54  5 12.23 2 15 3.67 13.82 3.59 2 15.26  10 3.76  3 13.59 2 Average 3.63 13.57 3.33 7.93 13.29 2.06 3.64  0.61 13.39 1.3


[Federal Register: January 19, 2006 (Volume 71, Number 12)]
[Notices]
[Page 3081-3082]
[DOCID:fr19ja06-73]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

January 11, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER05-1506-001.
    Applicants: American Transmission Co., LLC; Midwest Independent
Transmission System Operator, Inc.
    Description: American Transmission Co., LLC et al submits Third
Revised Sheet Nos. 1346 and 1346-A to FERC Electric Tariff, Third
Revised Volume No. 1 in compliance with FERC's order dated December 20,
2005.
    Filed Date: January 4, 2006.
    Accession Number: 20060105-0146.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Docket Numbers: ER06-17-001.
    Applicants: Participating Transmission Owners.
    Description: Participating Transmission Owners correct error in
October 7, 2005 filing proposing to modify ISO-NE's OATT.
    Filed Date: January 4, 2006.
    Accession Number: 20060105-0149.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Docket Numbers: ER06-120-001.
    Applicants: Duke Energy Corporation.
    Description: Duke Energy Corp.'s response to FERC's December 21,
2005 Data Request regarding the Catawba Nuclear Station Joint Ownership
Support Agreement etc. with Piedmont Municipal Power Agency.
    Filed Date: January 4, 2006.
    Accession Number: 20060105-0067.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Docket Numbers: ER06-446-000.
    Applicants: Connecticut Light & Power Company.
    Description: Northeast Utilities Service Co. on behalf of
Connecticut Light and Power Co. et al. submits a notice of termination
to the Dispatchable System Power Sales Agreement with Sterling
Municipal Light Department.
    Filed Date: January 3, 2006.
    Accession Number: 20060105-0132.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 24, 2006.

    Docket Numbers: ER06-447-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits an executed Amended
& Restated Interconnection Agreement with SPP, Public Service Co. of
Oklahoma & Western Farmer Electric Cooperative, designated Service
Agreement No. 1160.
    Filed Date: January 3, 2006.
    Accession Number: 20060105-0133.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 24, 2006.

    Docket Numbers: ER06-448-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits unexecuted service
agreement for Network Integration Transmission Service between SPP &
Oklahoma Municipal Power Authority.
    Filed Date: January 3, 2006.
    Accession Number: 20060105-0106.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 24, 2006.

    Docket Numbers: ER06-449-000.
    Applicants: Florida Power Corporation.
    Description: Florida Power Corp. amends Exhibit A of the Revised
Contract for Interchange Service w/Orlando Utilities Commission.
    Filed Date: January 3, 2006.
    Accession Number: 20060105-0061.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 24, 2006.

    Docket Numbers: ER06-450-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits revisions to their Open Access Transmission & Energy Markets
Tariff, FERC Electric Tariff, Third Revised Volume No. 1.
    Filed Date: January 4, 2006.
    Accession Number: 20060105-0150.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Docket Numbers: ER06-451-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits proposed changes to
its Open Access Transmission Tariff to implement a real-time energy
imbalance market.
    Filed Date: January 4, 2006.
    Accession Number: 20060105-0066.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Docket Numbers: ER06-452-000.
    Applicants: East Central Area Reliability Council.
    Description: East Central Area Reliability Council, on behalf of
its members Allegheny Power et al. submits its Notice of Cancellation
of its Inadvertent Settlement Tariff with a requested effective date of
January 1, 2006.

    Filed Date: January 4, 2006.
    Accession Number: 20060109-0100.
    Comment Date: 5 p.m. Eastern Time on Wednesday, January 25, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other and the Applicant.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-559 Filed 1-18-06; 8:45 am]

BILLING CODE 6717-01-P