UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: April 24, 2002 MEMORANDUM SUBJECT: REVISION OF EXPOSURE ASSESSMENT FOR PLANTING OF SEED TREATED WITH LINDANE FROM David Jaquith Reregistration Action Branch 4 Health Effect Division (7509C)

TO: Becky Daiss Reregistration Branch 4 Health Effect Division (7509C)

THRU Susan Hummel, Senior Scientist Reregistration Branch 4 Health Effects Division (7509C)

Please find attached the occupational and residential exposure assessment for lindane DP BARCODE D282418 Pesticide Chemical Codes: 009001 EPA Reg Nos:

EPA MRID Nos.: 42251901 PHED: No 1.0 INTRODUCTION In March 2001 HED provided an exposure/ risk assessment for seed treatment use of lindane (1). The document included on farm treatments (using wheat as the typical treatment), planting the treated seed, and commercial seed treatment facilities. The treatment of seeds using on farm technology has not changed. The assessment of exposure during planting was derived from PHED V1.1 using the assumption that exposure from planting treated seed would be similar to that received from application of granular formulations of pesticides. Since that time HED has received a study actually measuring exposure during planting. The seed planting exposure assessment has been reviewed by HED personnel. The results and review of this study are presented in Appendix A.

2.0 CONCLUSIONS HED has reevaluated the estimates of exposure and risk from planting of wheat and canola seed with lindane using a study specifically addressing this scenario rather than using PHED as a model for planting seeds. Using an oral NOAEL of 1.2 mg/ kg/ day to assess dermal risk and an inhalation NOAEL of 0.13 mg/ kg/ day the MOEs are :

Estimation of Dermal and Respiratory Exposures or Risksof Workers Planting Wheat and Canola Seed Treated with Lindane Dermal Exposure (mg/ kg/ day) Respiratory Exposure (mg/ kg/ day) MOE Derma l Respiratory Wheat 0.0013 0.00011 920 1200 Canola 0.0015 0.00013 800 1000 Examination of the data from the revised assessment, derived from a planting study (not included in PHED) and the previous assessment from PHED indicates that there are a large number of non detect samples in both of the data sets. Since the original PHED derived estimates, which separated loading from planting showed large numbers of non detects for the planting function, it is evident that the loading contributes the majority of the exposure and that the actual planting task contributes relatively little to the total exposure.

3.0 CALCULATION OF EXPOSURES In order to estimate the exposures of workers planting seed treated with lindane a number of assumptions regarding amount of seed planted and other parameters were required.

1) It is assumed that 250 acres of wheat or canola can be planted in a day (2). 2) An average worker has a body weight of 60 kg (a change from the previous assessment due to changes in the toxicological parameters) for dermal assessment. A weight of 70 kg is used for inhalation assessments.

3) Wheat is planted at a rate of 120 lbs of seed per acre. Canola is planted at a rate of 4 lbs seed per acre.

4) The application rate of lindane on wheat seed is 0.68 oz/ cwt (0.043 lb/ cwt). For canola the rate is 23.3 oz/ cwt (1.5 lb ai/ cwt). See Appendix B.

5) The dermal absorption of lindane is 10 percent (1).

3.1 Exposure Assessment for Wheat Amount of lindane handled per day:

Lbs ai/ day = 250 A/ day x 120 lb seed/ A x 0.043 lb ai/ 100 lbs seed = 12.9 lb ai/ day The resulting dermal exposure using arithmetic mean values from Appendix A is:

Dermal Exposure (mg/ kg/ day) = 0.0597 mg/ lb ai x 12.9 lb ai/ day x 0.1 (abs) ÷ 60 kg bw = 0.0013 mg/ kg/ day The resulting dermal MOE using a NOAEL of 1.2 mg/ kg/ day is:

MOE = 1.2 mg/ kg/ day/ 0.0013 mg/ kg/ day = 920 The respiratory exposure is:

Respiratory Exposure (mg/ kg/ day) = 12.9 lb ai/ day x 0.0006 mg/ lb ai ÷ 70 kg = 0.00011 mg/ kg/ day The resulting respiratory MOE using a NOAEL of 0.13 mg/ kg/ day is:

MOE = 0.13 mg/ kg/ day/ 0.00011 mg/ kg/ day = 1200 3.1 Exposure Assessment for Canola Amount of lindane handled per day:

Lbs ai/ day = 250 A/ day x 4 lb seed/ A x 1.5 lb ai/ 100 lbs seed = 15 lb ai/ day The resulting dermal exposure using arithmetic mean values from Appendix A is: Dermal Exposure (mg/ kg/ day) = 0.0597 mg/ lb ai x 15 lb ai/ day x 0.1 (abs) ÷ 60 kg bw = 0.0015 mg/ kg/ day The resulting dermal MOE using a NOAEL of 1.2 mg/ kg/ day is:

MOE = 1.2 mg/ kg/ day/ 0.0015 mg/ kg/ day = 800 The respiratory exposure is:

Respiratory Exposure (mg/ kg/ day) = 15 lb ai/ day x 0.0006 mg/ lb ai ÷ 70 kg = 0.00013 mg/ kg/ day The resulting respiratory MOE using a NOAEL of 0.13 mg/ kg/ day is:

MOE = 0.13 mg/ kg/ day/ 0.00013 mg/ kg/ day = 1000 REFERENCES 1) Memorandum from D. Jaquith (RRB4) to S. Shallal (RRB4) titled "OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE RE REGISTRATION ELIGIBILITY DECISION DOCUMENT FOR LINDANE", dated March 16, 2001.

2) Memorandum from S. Tadayon (CEB) to A. Khasawinah (RRB4) titled "OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE RE REGISTRATION ELIGIBILITY DECISION DOCUMENT FOR IMAZALIL" dated April 15, 2,000.

cc: Lindane file (009001) R. Kent (RRB4/ 7509C) Correspondence file D. Jaquith (7509C) APPENDIX A.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 03, 2002 Memorandum SUBJECT: Exposures of Workers to Isofenphos During Planting of Oftanol Treated Canola FROM: Seyed Tadayon, Chemist Chemistry Exposure Branch Health Effect Division (7509C)

TO: Jeff Evans, Biologist Chemistry Exposure Branch Health Effect Division (7509C)

DP Barcode: D281351 EPA MRID No: 42251901 Attached is a review of the applicator exposure during planting of treated seed with Oftanol® which was submitted by Mobay Inc. This review was completed by Versar, Inc. on February 15, 2002, under supervision of HED. It has undergone secondary review in the HED and has been revised to reflect Agency policies.

Executive Summary Oftanol® Technical is an insecticide incorporated into a seed coating material that forms a hard, dry, shell like layer on the outside of the canola seed. The purpose of this study was to quantify inhalation and dermal exposure to workers planting treated seed using the active ingredients isofenphos. The study met most of the criteria specified in Subdivision K (currently referred to as Series 875 .1100 and 875.1300 Group B).

Summary This study was conducted in Domain, Manitoba. Oftanol® Technical was applied to canola seeds prior to this study at a rate of 12 g ai (isofenphos) per kg of seed. Four workers were monitored four times, for a total of 16 replicates, as they opened and poured both the contents of the treated seed bags (25 kg) and fertilizer into their plant hoppers. The workers then drove a tractor, pulling the planter around the field planting between six and eight pounds of seed per acre. The workers used closed cab tractors with a ground speed ranging between 5 to 7 mph. Both seed and fertilizer traveled down a tube to the ground, where they were immediately covered with soil by a disc. Each replicate lasted an average of 3.22 hours and each worker handled an average of 4.33 lbs active ingredient per replicate All workers wore long sleeved shirts, coveralls, and chemical resistant gloves, in addition to their normal clothing. Air temperatures ranged from 69 o F to 82 o F and relative humidity ranged from 30 to 73%.

Exposure to the treated seed was quantified by the following methods:

a) Dermal exposure was estimated by 10 dermal patches. Dosimeters were attached to the worker's coverall at 10 locations: With this arrangement, the coveralls represented a single layer of normal clothing and the inner dosimeters collected the isofenphos that could reach the workers'skin if they were wearing only a single layer of clothing.

b) Exposure to the workers' hands was determined by the hand rinse method.

c) Inhalation exposure was monitored by attaching a quartz microfiber (QMA) filters in polystyrene cassettes to the workers' lapels.

d) Cholinesterase activity was monitored by collecting blood samples.

Exposure values for both potential (based on exterior patches) and actual (based on interior patches) dermal exposures was calculated. The Registrant corrected all data for field fortification recoveries, including recoveries above 90%. For those values below the LOD, the Registrant used ½ the recovery corrected LOD value. Versar only corrected data for field fortification recoveries less <90% and reported non detect values as ½ LOD.

Total potential dermal exposures ranged from 0.0095 to 1.2369 mg/ lb ai handled. The primary body region contributors were the lower arm (0.1110 mg/ lb ai handled) and the lower leg (0.0712 mg/ lb ai handled). The overall average total potential dermal exposure was 0.3326 ± 0.3555 mg/ lb ai handled. The actual dermal exposure estimates ranged from 0.0028 to 0.1053 mg/ lb ai handled with an overall average actual dermal exposure of 0.0296 ± 0.0314 mg/ lb ai handled. Total dermal exposure estimates included both actual dermal exposures and hand exposures and averaged 0.0597 ± 0.1001 mg/ lb ai handled. Total exposure was calculated by taking the sum of all exposure routes (dermal hands, dermal body, and inhalation). The Registrant calculated a geometric mean total exposure of 0.15 mg/ lb ai applied. Versar's calculated total exposure is presented in Table 8 and averaged 0.060 ± 0.101 mg/ lb ai handled.

Conclusions Dermal and inhalation exposures were assessed during the planting of treated canola seed. The workers performed both loading of the treated seed into seed hoppers and planting of the seed. Table 1 provides a summary of the total exposure to isofenphos during loading and planting of treated seed, as calculated by Versar. Versar's calculated average total exposure was 0.060 ± 0.101 mg/ lb ai handled. The geometric mean total exposure, as calculated by the Registrant, to isofenphos during planting of treated canola seed was 0.15 mg/ lb ai applied. The study author also reported total exposure in mg/ replicate and assumed that a worker is able to complete three replicates per day. The study author estimated an average daily exposure of 1.9 mg, but noted that a worker would probably not routinely work what is equivalent to three replicates per day during the planting season so that actual daily exposure would likely be less than 1.9 mg/ day.

Table 1: Summary of Total Exposure to Oftanol During Loading and Planting Treated Canola. Replicate Exposure (mg/ lb ai handled)

Dermal body Dermal hands Dermal Total Inhalation Inhalation + Dermal Total 1 0. 0731 0.0104 0.0835 0.0011 0.085 2 0. 1053 0.0069 0.1122 0.0018 0.114 3 0. 0033 0.0034 0.0067 0.0002 0.007 4 0. 0053 0.0046 0.01 0.0002 0.01 5 0. 0249 0.0046 0.0295 0.029 6 0. 016 0.0056 0.0216 0.0002 0.022 8 0. 0028 0.0028 0 0. 003 9 0. 0411 0.3333 0.3745 0.0024 0.377 11 0.0108 0.0068 0.0176 0.0004 0.018 13 0.058 0.0043 0.0623 0 0. 062 14 0.0124 0.0051 0.0174 0 0. 017 15 0.0199 0.0032 0.0231 0.0002 0.023 16 0.0117 0.0037 0.0153 0.0002 0.016 Average 0. 0296 0.0327 0.0597 0.0006 0.06 Standard Deviation 0.101 9 Attachment Versar Review Memo dated Febuary 15, 2002 10 Reviewer: Kelly McAloon/ Marit Espevik Date February 15, 2002 STUDY TYPE: Applicator Passive Dosimetry Study Using Patch Dosimetry, Hand Washes, Inhalation Monitoring, and Cholinesterase Monitoring.

TEST MATERIAL: OFTANOL® Technical insecticide, a viscous liquid material formulation containing 90% isofenphos as the active ingredient.

SYNONYMS: 1 Methylethyl 2[[ ethoxy[( 1 methylethyl) amino] phosphinothioyl] oxy] benzoate (CAS # 25311 71 1); Isofenphos (ISO E, BSI); Isophenphos (ISO F)

CITATION: Author: V. C. Dean Title: Exposures of Workers to Isofenphos During Planting of Oftanol Treated Canola Seeds Report Date: January 20, 1990 Performing Organization: Mobay Corporation Corporate Occupational and Product Safety Agricultural Chemicals Division P. O. Box 4913, Hawthorn Rd. Kansas City, MO 64120 Identifying Codes: MRID 422519 01; Report Number 99799;

SPONSOR: Mobay Corporation Agricultural Chemicals Division Research & Development Department EXECUTIVE SUMMARY:

The purpose of this study was to quantify inhalation and dermal exposure of workers handling canola seed treated with OFTANOL® Technical, containing 90% isofenphos as the active ingredient. The seeds had been treated with OFTANOL® Technical prior to this study and 25 kg bags of treated seed were provided for this exposure study. The study was conducted in Domain, Manitoba from May 16 23, 1989. Four workers were monitored four times, for a total of 16 replicates, as they loaded the treated seed into seed hoppers and drove tractors, planting between six and eight pounds of seed per acre. Each replicate lasted an average of 3.22 hours and each worker handled an average of 4.33 lbs active ingredient per replicate.

Dermal exposure was estimated by handwashes and by dermal patches attached to the inner and outer clothing of each worker. Total dermal exposure was calculated by adding the dermal exposure to the hand exposure values. Inhalation exposure was measured using a conventional industrial hygiene methodology. The Registrant provided exposure values expressed in mg/ hr, mg/ replicate, and mg/ lb ai applied. Total dermal exposure to isofenphos, determined by the Registrant, ranged from 0.076 mg/ lb ai applied to 0.42 mg/ lb ai applied. The geometric mean total dermal exposure was estimated as 0.15 mg/ lb ai applied. The geometric mean inhalation exposure to isofenphos was estimated as 0.0003 mg/ lb ai applied. Total exposure to isofenphos ranged from 0.076 mg/ lb ai applied to 0.43 mg/ lb ai applied and the geometric mean was 0.15 mg/ lb ai applied. The study author also reported an average daily total exposure of 1.9 mg/ day, assuming that a worker is able to complete three replicates per day.

Versar calculated exposure estimates in mg/ lb ai handled, as per EPA's request. Raw residue data were corrected using the field fortification recoveries. Versar only corrected for field recoveries less than 90%. Versar calculated a mean potential 11 inhalation exposure of 0.0006 ± 0.0008 mg/ lb ai handled. The overall average dermal exposure and the average hand exposure, as calculated by Versar, were 0.0296 ± 0.0314 and 0.0327 ± 0.0947 mg/ lb ai handled, respectively. Total dermal exposure was calculated as the sum of the overall dermal exposure and hand exposure and averaged 0.0597 ± 0.1001 mg/ lb ai handled. Versar also calculated total exposure as the sum of all exposure routes. The average total exposure was estimated 0.060 ± 0.101 mg/ lb ai handled.

The Study Report also included cholinesterase monitoring results. These results show that the isofenphos exposures to the workers were well within the acceptable limits. The greatest deviations observed were 7.7% in the plasma and 3.7 % in the erythrocytes. The study author attributed these deviations to natural variations.

The study met most of the Series 875.1100 and 875.1300 Guidelines. The major issues of concern were: (1) this study was performed at only one test site, (2) raw field data were corrected for all recoveries, even those greater than 90%, (3) concurrent laboratory fortification recoveries were not provided in the Study Report, (4) the limit of quantification was not provided for any media, only the limit of detection, (5) the analysis dates were not provided for any of the samples in this study in order to verify storage stability results, (6) individual field blank results were not provided in the Study Report, (7) there was only one field fortification level for air filter samples, (8) the Registrant used ½ the recovery corrected sample quantification limits for non detect values, rather than ½ the method limit of detection for that media, (9) method validation recoveries were not provided for handwash samples, (10) information on the individuals who participated in this study was not provided, (11) the inhalation methodology was calibrated with an airflow of 1L/ min instead of 2L/ min, (12) the Registrant used the inhalation geometric mean for replicate 5 since no sample was collected, (13) the Registrant used values slightly different from the NAFTA recommended body region surface areas, and (14) the Registrant calculated face exposures from head exposures.

COMPLIANCE: A signed and dated Data Confidentiality statement was provided. The study sponsor waived claims of confidentiality within the scope of FIFRA Section 10( d) (1) (A), (B), or (C). The study sponsor stated that the EPA Good Laboratory Practice Standards (40 CFR part 160) did not apply to the study.

GUIDELINE OR PROTOCOL FOLLOWED: A study protocol was provided with the Study Report. OPPTS Series 875, Occupational and Residential Exposure Test Guidelines, Group A: 875.1100 (dermal exposure), and 875.1300 (inhalation exposure) were followed for the compliance review of this study.

I. MATERIALS AND METHODS A. MATERIALS 1. Test Material:

Formulation: OFTANOL® Technical insecticide contains 90% (by weight) of isofenphos as the active ingredient (ai). This product is a viscous liquid material that is used as a seed treatment.

Lot/ Batch # technical: 8 00 5270A Lot/ Batch # formulation: Not provided. Purity in technical: The OFTANOL® Technical was assayed during production at 91.8% isofenphos. CAS #( s): 25311 71 1 Other Relevant Information: EPA Registration number is 3125 326.

2. Relevance of Test Material to Proposed Formulation( s):

The product label was not provided for the test material used in this study. Versar was able to locate a product label with the same product name as the one used in this study. .

3. Packaging: 12 The packaging of the test product was not reported in the study. All seed coating was performed prior to this study and 25 kg bags of treated seed were provided for this study.

B. STUDY DESIGN There were 3 deviations to the protocol: (1) in addition to the analyses of plasma and erythrocyte levels, whole blood levels were also evaluated. Mobay Corporation's cholinesterase analysis procedure includes whole blood and it was, therefore, routinely included in the analysis, (2) one blood sample was collected the morning after a worker completed his monitored work cycle rather than immediately afterwards, and (3) for replicate sampling, three of the sixteen replicates monitored were not included in the data evaluation. No adverse effects due to these deviations were reported in the Study Report.

1. Number and type of workers and sites:

Four individuals participated in the study at one test site, each serving as a subject four times, for a total of sixteen replicates. Each test subject was a private grower. The number of years of experience per worker was not provided. Each participant signed an informed consent form prior to the initiation of the study after being provided the proper information regarding the study, products being used, and proper precautions.

The seed treatment was performed on canola seed prior to this study in Nisku, Alberta, Canada, from January 17 19, 1989. This study took place in Domain, Manitoba where the treated canola seeds were planted from May 16 23, 1989.

2. Meteorology:

Air temperatures, relative humidity, and wind speed and direction were reported for the four sampling days. Air temperatures ranged from 69 o F to 82 o F and relative humidity ranged from 30 to 73%. Wind speed was reported as gusty for the first two sampling days, with wind speeds ranging from 10 30 mph. Wind speed on the remaining two sampling days ranged from 0 10 mph. Wind direction was reported as variable.

3. Replicates:

Each of the four workers were monitored for four replicates as they opened and poured both the contents of the seed bags and fertilizer into their plant hoppers. The workers then drove a tractor, pulling the planter around the field planting between six and eight pounds of seed per acre. Table 1 presents a summary of the hours worked and the lb ai handled for all of the replicates.

Table 1. Summary of Replicates 13 Date Replicates * Worker ID Hours Worked lb ai handled 37391 1 A 2.73 1.92 37391 2 A 2.25 2.88 37391 3 B 4.33 5.95 37391 4 B 3.08 4.32 37391 5 C 3.03 4.32 37391 6 C 3.08 3.6 37392 8 D 1.83 4.32 37392 9 A 4.75 5.76 37392 11 B 3. 62 2. 94 37393 13 D 2. 87 4. 62 37393 14 D 2. 58 3. 96 37398 15 C 4. 62 6. 24 37398 16 C 3. 13 5. 46 * Replicates 7, 10, and 12 not used.

4. Protective clothing:

All workers wore long sleeved 65% polyester/ 35% cotton work shirts, 65% polyester/ 35% cotton coveralls, and chemical resistant (nitrile, Best No. 730) gloves, in addition to their normal clothing (denim trousers, cotton shirts, boots or tennis shoes, and baseball caps). The long sleeved shirts, coveralls and caps were supplied by Mobay Corporation and served as attachment sites for dermal dosimeters. The gloves, also supplied by Mobay Corporation, were used only as protective equipment.

5. Planting method:

Worker A: Worker A used an International 310 Diskall pulled by a closed cab tractor at a ground speed of 7 mph. The worker opened the bags of treated seed and poured them into the seeder hopper. Fertilizer was also loaded into a hopper. Both seed and fertilizer dropped to the ground and were immediately covered with soil by a disc. This equipment arrangement provided for a 45 ft swath.

Worker B: Worker B used a Coop Implements  G 100 Disker pulled by a John Deer 8630 close cab tractor at a ground speed of 5 mph. The worker cut the bags open with a pocket knife, stood on the back of the seeder and poured the 25 kg bag of treated seed into the trough of the seeder. Fertilizer was also poured into the seeder. Both seed and fertilizer traveled down a tube to the ground, where they were immediately covered with soil by a disc. This equipment arrangement provided for a 30 ft swath.

Worker C: Worker C used an Air System 1502 Concord seeder, pulled by a Steiger/ Cougar 1000 closed cab tractor at a ground speed of 6 mph. The Concord Air tank is attached to an EZZE On Cultivator. The worker loaded the bags of treated seed into the back of a fertilizer truck. The truck was driven to the field and poured into the hopper of the seeder. Fertilizer was conveyed from the truck by an auger to a hopper on the seeder. Both seed and fertilizer were conveyed by air up to the planter, where they were deposited into the soil. This equipment arrangement provided for a 36 ft swath.

Worker D: Worker D used a Chinook 1203, pulled by a Steiger CP 1360 closed cab tractor at a ground speed of 6 mph. The Chinook 1203 has two hoppers, one for seed and one for fertilizer. The worker opened the 25 kg bags of treated seed and poured them into the seed hopper of the Chinook 1203. Seed and fertilizer traveled from the hoppers through tubing to the ground and were deposited into the soil. This equipment arrangement provided for a 40 ft. swath.

6. Application Rate: 14 OFTANOL® Technical is an insecticide incorporated into a seed coating material that forms a hard, dry, shell like layer on the outside of the canola seed. According to the study author, the coated seeds are virtually dust free, when applied in this manner. The insecticide protects newly sprouted canola plants against the flee beetle.

OFTANOL® Technical was applied to canola seeds prior to this study at a rate of 12 g ai (isofenphos) per kg of seed. All of the seed coating was done in Nisku, Alberta, Canada, from January 17 19, 1989. A product label was not provided in the Study Report. Versar was able to obtain a product label, but the label did not provide a recommended application rate.

Since OFTANOL® Technical is not registered in Canada, this study was conducted under Research Permit Sub. No. 89 007.

7. Exposure monitoring methodology:

Dermal dosimeters: Dermal exposure was estimated by 10 dermal patches. Dosimeter units consisted of a 3 inch by 3 inch 12 ply gauge surgical sponge enclosed in an aluminized paperboard holder. Dosimeters were attached to the worker's coverall at 10 locations: both upper arms, both palmar forearms three inches above the wrists, right chest just above the pocket, left back at the shoulder blade, the front of both thighs, and both shins. Each paperboard holder had a circular opening, 5.6 cm in diameter, which faced away from the body to allow isofenphos to collect on the gauze sponge. One dosimeter was also attached to the worker's cap just above the bill and a second set of dosimeters was attached to the worker's clothing inside the coveralls at the following locations: both upper arms, both palmar forearms, left chest, right back, both thighs, and both shins. With this arrangement, the coveralls represented a single layer of normal clothing and the inner dosimeters collected the isofenphos that could reach the workers' skin if they were wearing only a single layer of clothing.

Dosimeters were worn until the completion of the monitoring period, including maintenance, checking seed and fertilizer levels, and changing sites. At the end of the monitoring interval, the dosimeters were removed from the clothing and placed on a table. When all the dosimeters were removed, the gauze sponges were removed from their paperboard holders with tweezers and placed in labeled 1 ounce glass bottles which were capped with polyseal lined screw caps and stored on dry ice.

Hand: Exposure to the workers' hands was determined by the hand rinse method. At the end of the monitoring period, and at intermediate times when hands would normally be washed, the worker's hands were rinsed using the following procedure: 200 mL portion of absolute ethanol was placed into a 42 oz Whirl Pak bag. The worker placed one hand into the bag and the bag was held tightly around the wrist. The hand and bag were shaken 50 times. The ethanol was stored in the plastic bag and used for subsequent washes during the monitoring period until the final wash. After the final wash, it was transferred into a 800 mL bottle for storage. Each hand was washed twice, for a total of four washed per replicate. After each of the four washes, the solution was transferred into a 800 mL bottle and vigorously shaken 50 times. An aliquot of the combined solution (left and right hand) was then transferred into a one ounce labeled sample bottle and placed on dry ice. The remaining solution was discarded. On seven occasions, the outsides of the workers' gloves were washed by the same method to provide a comparison of the amounts of isofenphos residues on hands and gloves.

Inhalation: Inhalation exposure was monitored using a conventional industrial hygiene methodology. Quartz microfiber (QMA) filters in polystyrene cassettes were attached to the workers' lapels. Air was drawn through the filters at approximately 1 L/ min by a portable, battery powered pump (Gilian HFS 113A) attached to the workers' belt and connected to the filter cassette with PVC tubing. The filters removed particulates and aerosols containing isofenphos from the air during exposure sampling. When sampling was complete, the cassette was removed, capped, placed in a Whirl Pak and stored on dry ice.

Cholinesterase: Blood samples were collected by venipuncture for determination of cholinesterase activity in the erythrocyte and plasma fractions. The puncture site was washed thoroughly with alcohol before sampling to sterilize and remove any isofenphos contamination that could affect the cholinesterase results. The following schedule was used: 1) Three pre exposure samples were collected to establish the baseline value for each participant. They were collected during the week before planting began. Participants and Chemargro Ltd. technical personnel gave assurances that participants had not 15 worked with cholinesterase inhibiting materials for a two week period prior to the baseline sampling; and 2) one sample was collected at the end of each workday, when all work with isofenphos was completed. All samples were collected by a locally licensed nurse. They were shipped by overnight express to the Mobay Corporation Toxicology Laboratory in Stilwell, Kansas. The samples were analyzed the following morning, using an automated modified Ellman method. Results were communicated by telephone to the study site at mid day on the day following sample collection.

All samples collected during mornings were stored in ice chests on dry ice for approximately four hours until field collection activities for the afternoon replicates were complete. All samples were then repacked on dry ice for shipping to the Mobay Corporation Analytical Laboratory in Kansas City, Missouri. At the analytical laboratory, the samples were stored in freezers at 7 degrees Celsius.

8. Analytical Methodology:

Extraction method( s):

Dermal Exposure Patches  15 mL of ethanol was pipetted into sample vials and the vials were recapped. The sample vials were placed in a vertical position on a rotator and spun for 30 minutes to ensure complete absorption. Five mL of the sample solution was pipetted into a clean 15 mL vial and 0.5 mL of a 0.5% carbowax solution was added. The solvent was evaporated from the sample solution using a stream of dry nitrogen and a heating block at 43 o C. The sample residue was reconstituted by pipetting 5 mL of t butyl methyl ether (MTBE) into the sample vial. The vial was capped with a polyseal and shaken for 30 seconds.

Handrinse Samples  The samples were shaken vigorously and then a portion was filtered using a LID/ X filter. A portion of the filtered solution was immediately transferred into an autosampler vial and the vial was capped.

Air Filters Filters were transferred to 0.5 ounce vials and 2.0 mL of MTBE was added. The vial was sealed with a polyseal lid and gently swirled to wet the filter thoroughly. The sample vial was placed on a rotator, the rotator wheel was put in a vertical position, and the vial was spun for 30 minutes to ensure complete desorption.

Detection method( s): See Table 2. 16 Table 2. Summary of GC Chromatographic and HPLC Conditions Media Air Filters Dermal pads Hand Rinses Instrument Varian Model 3400 Varian Model 3400 Shimadzu CR 3A /Varian 4270 Column J& W, 0.541mm i. d. x 15m length DB Wax fused silica capillary column with a 1.0 : m film thickness J& W, 0.541mm i. d. x 15m length DB Wax fused silica capillary column with a 1.0 : m film thickness DuPont Zorbax C 8 column, 4.6mm i. d. x 25 cm length with a 0.45 : m pore size Detector Nitrogen/ phosphorous detector Nitrogen/ phosphorous detector Temperatures Column: Initial: 100 o C Final: 185 o Injector: 250 o C Detector: 300 o C Column: Initital: 100 o C Final: 185 o Injector: 250 o C Detector: 300 o C Column: Ambient Injection Volume 9 µL 9 µL 100 µL Retention Time Isofenphos: 12.3 min Isofenphos oxygen analog: 13.5 min Isofenphos: 11.6 min Isofenphos oxygen analog: 12.7 min Isofenphos: 10.5 min Isofenphos oxygen analog: 3.8 min Quantitative Range 0.0025 0.05 ng/ : L 0. 0025 0.05 ng/ : L 0. 2 10 ng/ : L Method validation: The limit of detection (LOD) for air filters, gauze pads, and handwash samples was approximately 5ng/ sample, 38 ng/ sample, and 40 : g/ sample, respectively. For method validation, five air filter samples were fortified at the 0.2 : g level for both isofenphos and its oxygen analog. Fourteen dermal gauze samples were fortified at loadings of 1.0, 10, 100, and 1000 : g of isofenphos under field conditions. Handwash samples were fortified at loadings of 100 and 1000 : g using field samples. Method validation recoveries for the air filter samples averaged 109.0% ± 3.6% for isofenphos and 94.4% ± 7.3% for its oxygen analog. Recoveries for the dermal gauze pads averaged 96.9%± 6% and 94.2%± 3%, for the 1.0 and 1000 : g loadings respectively. Method validation recoveries for handwash samples were not reported in the Study Report.

Instrument performance and calibration: According to the Study Report, analytical calibration standard curve data were generated before and after each set of samples analyzed. Standard concentrations were chosen to bracket the sample concentrations. Only concentrations within the validated range for each media were used.

Quantification: Sample concentrations were calculated using the linear regression function of a chromatography software. Concentrations of isofenphos in the samples were determined directly from the standard curve.

9. Quality Control:

Lab Recovery: Laboratory recoveries were not reported in the Study Report.

Field blanks: Field blanks were collected for each media. All values were reported to be less than the LOD, except for 2 gauze pad samples (0.170 and 11.7 : g).

Field recovery: Handwash Samples: Duplicate handwash samples were fortified at 200 and 2000 : g levels each sampling 17 day at the site by spiking a 200 mL ethanol portion with isofenphos formulation solutions. The spiked solutions were transferred into separate polyethylene bags and shaken 50 times. A portion of each sample was transferred from the plastic bags into 1 oz bottles and the bottles were capped with polyseal lids to simulate the procedure for collecting field samples.

Air Filters: Seven replicate filter samples were prepared each day by spiking 37 mm, acetonitrile washed Whatman QM A filters with isofenphos formulation solution at a loading of approximately 0.2 : g of isofenphos. The spiked filters were then placed in separate filter cassettes. Each filter was supported by a stainless steel screen. Each cassette was then sealed tight with a cellulose shrink band and the two open ends were capped. To simulate the collection of field samples, the caps of each cassette were removed immediately before sampling and each filter unit was connected to a sampling pump which had been calibrated to a sampling rate of 1.0 L per minute. In addition, two blank filters were prepared at the same time to determine potential interference or contamination problems.

Dermal samples: Seven replicate samples were generated at loading levels of approximately 1.0, 10, 100, and 1000 : g of isofenphos to simulate anticipated exposure levels for the outer gauze and 1.0, and 10 : g to simulate inner gauze pads. To spike the outer gauze pads, 0.5 mL of spiking solutions containing approx 2.0, 20, 200, and 2000 : g/ mL of isofenphos was pipetted onto separate gauze pads. Once the gauze pads were spiked, the solvent was allowed to evaporate. The spiked pads were placed in direct sunlight and exposed to the environment for approximately the same duration as the field samples. The inner pads were spiked in the same manner, but were placed under coverall material and were not exposed to sunlight.

Field fortification recoveries for isofenphos are presented in Table 3. 18 Table 3. Field Fortification Recoveries for Isofenphos Sample Type Fortification Level ( : g) Sampling Day Average Fortification Recovery per Day (%) Average Isofenphos Recovery per Level (%) Overall Average (%) Standard Deviation Handwash samples 200 1234 111.3 109.1 97.5 98.3 104.1 102.4 6. 6 2000 1234 108.1 103.4 98.2 92.8 100.6 Filters 0.2 1234 100.1 69.9 86.0 93.9 88.1 88.1 12.2 Outer Gauze Pads 1 1234 107.3 73.3 100.8 88.9 92.6 90.1 12.1 10 1234 98.2 73.0 84.2 97.0 88.2 100 1234 87.0 86.1 78.4 110.4 90.9 1000 1234 82.7 89.8 85.4 96.2 88.6 Inner Gauze Pads 1 1234 112.7 78.2 84.8 116.3 98.5 96.3 17.1 10 1234 92.9 75.8 92.8 114.6 94.1 Formulation: The test products used were not characterized for this study.

Storage Stability: The Study Report indicated that storage stability experiments were performed prior to the commencement of this study.

Air filters: Approximately 0.2 : g isofenphos and its oxygen analog were field spiked onto QM A filters. Air 19 was pulled through the spiked filters at 1.0 L/ min ± 5% for 3.5 hours. The samples were then shipped to the Environmental Analysis Laboratory in Kansas City and stored in the freezer at 7 o C for up to 72 days. Average recoveries ranged from 91.9% ± 12 to 110% ± 24.

Gauze pads: A field study was conducted at Vero Beach, Florida, using isofenphos canola seed formulation to fortify gauze pads. Seven pads were fortified at 0.990 : g isofenphos and exposed to outdoor environmental conditions for 4.5 hours. The samples were shipped to the Environmental Analysis Laboratory in Kansas City and stored in the freezer for 40 days prior to analysis. The average total recovery from the gauze pad samples was 104% ± 2%. Three indoor sampling field studies were also conducted at a seed coating facility in Nisku, Alberta, Canada. Gauze pads were fortified with isofenphos canola seed formulation and exposed to the indoor environment of the seed coating facility for 8 hours. The samples were shipped to the Environmental Analysis Laboratory in Kansas City and stored for up to 159 days. Average recoveries ranged from 94.0% ± 1.7% to 118% ± 4%.

Hand Rinses: The study author reported an average storage recovery of 110% ± 5% for storing samples of isofenphos in absolute ethanol at a 100 : g loading for 117 days at 7 o C. The study author also reported average recoveries for storing samples spiked with 203 or 2031 : g isofenphos at 7 o C for 158 days of 112% ± 1% and 110% ± 3%, respectively.

10. Relevancy of Study to Proposed Use:

The study monitored workers performing their normal duties during planting of treated canola seed.

II. RESULTS AND CALCULATIONS:

A. EXPOSURE CALCULATIONS:

The study author provided exposure values expressed as mg/ replicate, mg/ hour, and mg/ lb ai applied for both dermal and inhalation exposure. The total amount of isofenphos recovered from the air filters was divided by the total volume of air sample, multiplied by the respiration rate and hours worked per replicate to provide the amount of isofenphos in mg/ replicate. The dermal gauze pad values were multiplied by the location area in cm 2 to provide the exposure in mg isofenphos per location. These values were summed to provide dermal gauze exposure values in mg/ replicate. Handwash samples were calculated using the same calculations as dermal exposures, assuming an area of 410 cm 2 .

Versar estimated exposure values as mg/ lb ai handled as per EPA's request. Versar calculated both potential (based on exterior patches) and actual (based on interior patches) dermal exposures. The Registrant corrected all data for field fortification recoveries, including recoveries above 90%. For those values below the LOD, the Registrant used ½ the recovery corrected LOD value. Versar only corrected data for field fortification recoveries less <90% and reported non detect values as ½ LOD.

Inhalation Exposure Inhalation exposures were calculated by both the Registrant and Versar from the breathing zone air concentrations determined from the amount of isofenphos found on the air sampling filters and the volume of air sample. A moderate workrate respiratory rate of 0.029 m 3 /min was assumed by the Registrant for the duration of the sampling period. Versar used the NAFTA recommended inhalation rate of 0.029 m 3 /min for moderate activities. According to the Registrant's calculations, the geometric mean of the inhalation exposure was 0.0003 mg/ lb ai with a geometric standard deviation of 3.7. Since no sample was collected for replicate 5, the Registrant used the geometric mean of all inhalation exposures as the value for replicate 5 in their calculations. Table 4 provides the Versar calculated potential inhalation exposures. The average exposure was 0.0006 ± 0.0008 mg/ lb ai handled.

Potential Dermal Exposure Potential dermal exposure estimates were calculated by extrapolating values from exterior patches to the total surface area of the appropriate region. The Registrant did not report potential dermal exposures, although exterior dermal patches were analyzed and raw data were reported in the Study Report. Versar calculated potential dermal estimates for each region of the 20 body using the exterior patches (see Table 5). The total surface area of the exposed surfaces of the dermal patches was 24.63 cm 2 . Versar used the default NAFTA surface areas to calculate the potential dermal exposure for each body region. Total potential dermal exposures ranged from 0.0095 to 1.2369 mg/ lb ai handled. The primary body region contributors were the lower arm (0.1110 mg/ lb ai handled) and the lower leg (0.0712 mg/ lb ai handled). The overall average total potential dermal exposure was 0.3326 ± 0.3555 mg/ lb ai handled.

Actual Dermal Exposure Actual dermal exposure estimates were calculated by extrapolating patch values from interior patches to the total surface area of the appropriate region. The Registrant extrapolated these values using recommended surface area estimates found in the EPA Pesticide Registration Guidelines, Subdivision U, Applicator Exposure. The surface area of the exposed surfaces of the dermal patches was 24.63 cm 2 . For actual dermal exposure to the head, the Registrant used the interior head patch value multiplied by a penetration factor of 0.13. This factor was calculated from the gauze dosimeter data by dividing the amount on an inner dosimeter by the amount on the adjacent outer dosimeter, in every case where both dosimeters had measurable amounts. The Registrant reported total dermal exposure as the sum of the values for covered skin, head and neck, and hands. The Registrant calculated hand exposures assuming an exposed area of 410 cm 2 and followed the same calculations as those used for dermal exposure. According to the Registrant's calculations, hand exposures ranged from 0.059 to 0.42 mg/ lb ai applied, with an average hand exposure of 0.11 mg/ lb ai applied. Versar's calculated hand exposures are reported in Table 6. These exposures ranged from 0.003 to 0.333 mg/ lb ai handled. The overall average hand exposure was 0.033 ± 0.095 mg/ lb ai handled.

The Registrant calculated a geometric mean total dermal exposure of 0.15 mg/ lb ai applied. Versar calculated actual dermal estimates for each region of the body using the interior patches (except for the head) (see Table 7). Versar used the default NAFTA surface areas to calculate the actual dermal exposure for each body region. The actual dermal exposure estimates ranged from 0.0028 to 0.1053 mg/ lb ai handled with an overall average actual dermal exposure of 0.0296 ± 0.0314 mg/ lb ai handled. Total dermal exposure estimates included both actual dermal exposures and hand exposures and averaged 0.0597 ± 0.1001 mg/ lb ai handled.

Total Exposure Total exposure was calculated by taking the sum of all exposure routes (dermal hands, dermal body, and inhalation). The Registrant calculated a geometric mean total exposure of 0.15 mg/ lb ai applied. Versar's calculated total exposure is presented in Table 8 and averaged 0.060 ± 0.101 mg/ lb ai handled. 21 III DISCUSSION A. LIMITATIONS OF THE STUDY:

The study met most of the Series 875.1100 and 875.1300 Guidelines. The major issues of concern were: (1) this study was performed at only one test site, (2) raw field data were corrected for all recoveries, even those greater than 90%, (3) concurrent laboratory fortification recoveries were not provided in the Study Report, (4) the limit of quantification was not provided for any media, only the limit of detection, (5) the analysis dates were not provided for any of the samples in this study in order to verify storage stability results, (6) individual field blank results were not provided in the Study Report, (7) there was only one field fortification level for air filter samples, (8) the Registrant used ½ the recovery corrected sample quantification limits for non detect values, rather than ½ the method limit of detection for that media, (9) method validation recoveries were not provided for handwash samples, (10) information on the individuals who participated in this study was not provided, (11) the inhalation methodology was calibrated with an airflow of 1L/ min instead of 2L/ min, (12) the Registrant used the inhalation geometric mean for replicate 5 since no sample was collected, (13) the Registrant used values slightly different from the NAFTA recommended body region surface areas, and (14) the Registrant calculated face exposures from head exposures.

B. CONCLUSIONS:

Dermal and inhalation exposures were assessed during the planting of treated canola seed. The workers performed both loading of the treated seed into seed hoppers and planting of the seed. Table 8 provides a summary of the total exposure to isofenphos during loading and planting of treated seed, as calculated by Versar. Versar's calculated average total exposure was 0.060 ± 0.101 mg/ lb ai handled. The geometric mean total exposure, as calculated by the Registrant, to isofenphos during planting of treated canola seed was 0.15 mg/ lb ai applied. The study author also reported total exposure in mg/ replicate and assumed that a worker is able to complete three replicates per day. The study author estimated an average daily exposure of 1.9 mg, but noted that a worker would probably not routinely work what is equivalent to three replicates per day during the planting season so that actual daily exposure would likely be less than 1.9 mg/ day. 22 Table 4. Potential Inhalation (mg/ lb ai handled) Based on Residue Levels Found on Air Filters.

Replicate Residue ( :

g/ sample) Corrected Value ( :

g/ sample) b Replicate length (min) Volume of air sampled (L) Concentration (mg/ m 3 ) c lb ai handled Respiration Rate (m 3 /min) Inhalation exposure (mg/ lb ai handled) d 1 0. 0664 0.0754 164 164 0.00046 1.92 0.029 0.00114 2 0. 1530 0.1737 135 135 0.00129 2.88 0.029 0.00175 3 0. 0339 0.0385 260 286 0.00013 5.95 0.029 0.00017 4 0. 0289 0.0328 185 203.5 0. 00016 4.32 0.029 0.00020 6 0. 0219 0.0249 185 203.5 0. 00012 3.60 0.029 0.00018 8 a 0.0050 110 107.8 0. 00002 4.32 0.029 0.00002 9 0. 2260 0.1793 285 107.8 0. 00166 5.76 0.029 0.00239 11 0.0608 0.0482 217 238.7 0. 00020 2.94 0.029 0.00043 13 a 0. 0050 172 189.2 0. 00001 4.62 0.029 0.00001 14 a 0. 0050 155 170.5 0. 00001 3.96 0.029 0.00002 15 0.0426 0.0454 277 304.7 0. 00015 6.24 0.029 0.00019 16 0.0460 0.0490 188 206.8 0. 00024 5.46 0.029 0.00024 Mean 0.0006 Geometric Mean 0.0002 Standard Deviation 0.0008 Coefficient of Variance (%) 138.58 a Residue was not detected. Therefore, ½ the LOD (0. 005 :

g/ sample) was used.

b Corrected for average field fortification recovery (88.1%)

c Concentration (mg/ m 3 ) = (Residue ( :

g/ sample) x 0.001)/( sample volume (L) x m 3 /1000L)

d Exposure (mg/ lb ai handled) = [( Concentration (mg/ m 3 ) x Respiration rate (m 3 /min) x replicate length (min)]/ lb ai handled 23 Table 5. Potential Dermal Exposure (mg/ lb ai handled) Based on Exterior Patches Replicate Residues (ug/ cm 2 ) a Body Region Exposure (mg/ lb ai handled) c Head Back Chest Upper Arm Lower Arm Upper Leg Lower Leg lb ai applied Head (1300 cm 2 ) Back (3550 cm 2 ) Chest (3550 cm 2 ) Upper Arm (2910 cm 2 ) Lower Arm (1210 cm 2 ) Upper Leg (382 cm 2 ) Lower Leg (2380 cm 2 ) Total 1 0. 008 0.007 0.016 0.026 0.333 0.510 0.069 1.92 0.0054 0.1306 0.0302 0.0388 0.2096 0.1014 0.0856 0.6015 2 0. 041 0.007 0.229 0.107 1.473 0.327 0.096 2.88 0.0185 0.0856 0.2828 0.1085 0.6188 0.0434 0.0794 1.2369 3 0. 001 b 0.001 b 0.014 0.017 0.140 0.353 0.093 5.95 0 0. 005 0.009 0.0083 0.0284 0.0227 0.0373 0.1101 4 0. 001 b 0.001 b 0.001 b 0.011 0.029 0.294 0.037 4.32 0 0. 006 0 0. 0077 0.0083 0.026 0.0201 0.0693 5 0. 008 0.006 0.147 0.003 0.190 0.308 0.519 4.32 0.0025 0.05 0.1211 0.002 0.0531 0.0272 0.2861 0.5421 6 0. 020 0.001 b 0.097 0.013 0.043 0.179 0.161 3.6 0. 0071 0.008 0.0961 0.0103 0.0143 0.019 0.1066 0.2609 8 0. 001 b 0.001 b 0.001 b 0.001 b 0.007 0.001 b 0.001 b 4.32 0 0. 006 0 0. 001 0.002 0 0 0.0103 9 0. 050 0.024 0.217 0.074 0.353 0.522 0.036 5.76 0.0113 0.1491 0.1339 0.0373 0.0742 0.0346 0.0148 0.4552 11 0.010 0.001 b 0.001 b 0.007 0.038 0.073 0.035 2.94 0.0044 0.009 0 0. 0072 0.0158 0.01 0.028 0.0751 13 0.008 0.008 0.073 0.029 1.469 0.327 0.183 4.62 0.0021 0.0608 0.0565 0.0184 0.3847 0.027 0.0941 0.6437 14 0.001 b 0.001 b 0.001 b 0.001 b 0.001 0.004 0.001 b 3.96 0 0. 007 0 0. 001 0 0 0 0. 0095 15 0.008 0.006 0.026 0.047 0.143 0.184 0.299 6.24 0.0017 0.0321 0.0133 0.022 0.0278 0.0113 0.1139 0.2222 16 0.001 b 0.001 b 0.014 0.001 b 0.024 0.127 0.134 5.46 0 0. 005 0.009 0 0. 0053 0.009 0.0585 0.0877 Average 0.012 0.005 0.064 0.026 0.326 0.247 0.128 4.33 0.0042 0.0427 0.0581 0.0202 0.111 0.0255 0.0712 0.3326 Standard Deviation 0.3555 a Residue ( :

g/ cm 2 ) = Residue ( :

g/ sample)/ Patch surface area (24.63 cm 2 )

b Residue was not detected. Therefore, ½ the LOD (0. 038 :

g/ sample) was used.

c Body Region Exposure (mg/ lb ai)= (Exposure ( u g/ cm 2 ) x Body Region (cm 2 )/ lb ai applied) x 0.001 24 Table 6. Summary of Hand Exposure (mg/ lb ai handled) based on Hand Washes Replicate Residue  both hands ( :

g/ sample ) lb ai handled Hand exposure ( :

g /lb ai handled) Hand exposure (mg/ lb ai handled)

1 0. 33333333333 1.92 10.4 0. 010 2 0. 33333333333 2.88 6.9 0. 007 3 0. 33333333333 5.95 3.4 0. 003 4 0. 33333333333 4.32 4.6 0. 005 5 0. 33333333333 4.32 4.6 0. 005 6 0. 33333333333 3.60 5.6 0. 006 9 1920 5.76 333.3 0. 333 11 0.33333333333 2.94 6.8 0. 007 13 0.33333333333 4.62 4.3 0. 004 14 0.33333333333 3.94 5.1 0. 005 15 0.33333333333 6.24 3.2 0. 003 16 0.33333333333 5.46 3.7 0. 004 Mean 0.033 Geometric Mean 0.007 Standard Deviation 0.095 Coefficient of Variance (%) 289.98 a Residue value not detected. Therefore, ½ the LOD (40 :

g/ sample) was used.

Table 7. Actual Dermal Exposure (mg/ lb ai handled) Based on Interior Patches (except for Head) 25 Replicate Residues (ug/ cm 2 ) a Body Region Exposure (mg/ lb ai handled) c Neck b Head Back Chest Upper Arm Lower Arm Upper Leg Lower Leg lb ai applied Neck b Head (1300 cm 2 ) Back (3550 cm 2 ) Chest (3550 cm 2 ) Upper Arm (2910 cm 2 ) Lower Arm (1210 cm 2 ) Upper Leg (382 cm 2 ) Lower Leg (2380 cm 2 ) Total 1 0. 023 0.008 0.001 0.001 0.001 0.081 0.033 0.004 1.92 0.002 0.005 0 0 0 0.05 0.007 0.004 0.073 2 0. 236 0.041 0.001 0.022 0.006 0.076 0.036 0.004 2.88 0.0122 0.0185 0 0. 03 0 0.03 0.005 0.003 0.1053 30. 0150. 0010. 0010. 0010. 0010. 0010. 0160. 0015. 95000 0 0 00. 00100 40. 0020. 0010. 0010. 0010. 0010. 0060. 0130. 0014. 32000 0 0 00. 00100. 01 50. 1540. 0080. 0010. 0010. 0010. 0170. 0240. 0154. 320. 0050. 0030 0 0 00. 0020. 0080. 025 60. 0980. 0200. 0010. 0010. 0010. 0010. 0040. 0033. 60. 0040. 0070 0 0 000. 0020. 016 8 0. 0015 0.001 0.001 0.001 0.001 0.001 0.001 0.001 4.32 0 0 0 0 0 0000 9 0. 241 0.030 0.001 0.014 0.003 0.020 0.061 0.012 5.76 0.006 0.0113 0 0 0 00. 0040. 0050. 041 11 0.0015 0.010 0.001 0.001 0.001 0.004 0.010 0.001 2.94 0 0. 004 0 0 0 00. 00100. 011 13 0.081 0.008 0.016 0.003 0.016 0.030 0.059 0.029 4.62 0.003 0.002 0.01 0 0. 01 0 0.005 0.0152 0.058 14 0.0015 0.001 0.005 0.001 0.001 0.001 0.010 0.009 3.96 0 0 0 0 0 00. 0010. 0050. 012 15 0.0291 0.008 0.001 0.007 0.001 0.041 0.023 0.009 6.24 0 0. 002 0 0 0 00. 0010. 0030. 02 16 0.0152 0.001 0.001 0.001 0.008 0.003 0.011 0.010 5.46 0 0 0 0 0 000. 0040. 012 Average 0. 0690. 0120. 0020. 0040. 0030. 0220. 0230. 0084. 330. 0030. 0040 0 0 00. 0020. 0040. 03 Standard Deviation 0.031 a Residue ( :

g/ cm 2 ) = Residue ( :

g/ sample)/ Patch surface area (24.63 cm 2 )

b Sum of the calculations for both front and back neck (Areas: 150 and 110 cm 2 , respectively)

c Body Region Exposure (mg/ lb ai handled)= (Exposure (ug/ cm 2 ) x Body Region (cm 2 )/ lb ai applied) x 0.001 26 Table 8. Total Exposure (mg/ lb ai handled)

Replicate Exposure (mg/ lb ai handled)

Dermal body Dermal hands Dermal Total Inhalation Inhalation + Dermal Total 1 0. 0731 0.0104 0.0835 0.0011 0.085 2 0. 1053 0.0069 0.1122 0.0018 0.114 3 0. 0033 0.0034 0.0067 0.0002 0.007 4 0. 0053 0.0046 0.01 0.0002 0.01 5 0. 0249 0.0046 0.0295 0.029 6 0. 016 0.0056 0.0216 0.0002 0.022 8 0. 0028 0.0028 0.00002 0.003 9 0. 0411 0.3333 0.3745 0.0024 0.377 11 0.0108 0.0068 0.0176 0.0004 0.018 13 0.058 0.0043 0.0623 0.00001 0.062 14 0.0124 0.0051 0.0174 0.00002 0.017 15 0.0199 0.0032 0.0231 0.0002 0.023 16 0.0117 0.0037 0.0153 0.0002 0.016 Average 0.0296 0.0327 0.0597 0.0006 0.06 Standard Deviation 0.101 27 _______ ___________________________ Name: Name: Evaluator Peer Reviewer Occupational Exposure Assessment Section Occupational Exposure Assessment Section __________________ ____________________ Date Date _________________________ Name: Head, Occupational Exposure Assessment Section _________________________ Date 28 Compliance Checklist Compliance with OPPTS Series 875, Occupational and Residential Exposure Test Guidelines, Group A: Guidelines, 875.1300 (inhalation), and 875.1100 (dermal) is critical. The itemized checklist below describes compliance with the major technical aspects of OPPTS 875.1300, and 875.1100.

875.1300 S Investigators should submit protocols for review purposes prior to the inception of the study. This criterion was probably met.

3) Expected deviations from GLPs should be presented concurrently with any protocol deviations and their potential study impacts. The study sponsor stated that GLP's did not apply to this study.

4) The test substance should be a typical end use product of the active ingredient. This criterion was met.

5) The application rate used in the study should be provided and should be the maximum rate specified on the label. However, monitoring following application at a typical application rate may be more appropriate in certain cases. It is uncertain whether this criterion was met. A product label was not provided in the study and the label obtained by Versar did not provide a maximum application rate.

6) Selected sites and seasonal timing of monitoring should be appropriate to the activity. It is uncertain whether these criteria were met. The study site was located in Canada and the study occurred during the month of May.

7) A sufficient number of replicates should be generated to address the exposure issues associated with the population of interest. For outdoor exposure monitoring, each study should include a minimum of 15 individuals (replicates) per activity. This criterion was met. Four individuals participated in this study, for a total of 16 replicates.

8) The quantity of active ingredient handled and the duration of the monitoring period should be reported for each replicate. This criterion was met.

9) Test subjects should be regular workers, volunteers trained in the work activities required, or typical homeowners. This criterion was met.

10) The monitored activity should be representative of a typical working day for the specific task in order to capture all related exposure activities. This criterion was met.

11) When both dermal and inhalation monitoring are required, field studies designed to measure exposure by both routes on the same subjects may be used. This criterion was met.

12) The analytical procedure must be capable of measuring exposure to 1 µg/ hr (or less, if the toxicity of the material under study warrants greater sensitivity). This criterion was met.

13) A trapping efficiency test for the monitoring media chosen must be documented. This criterion was not met. Trapping efficiency tests were not documented for any of the media used in this study.

14) Air samples should also be tested for breakthrough to ensure that collected material is not lost from the medium during sampling. 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. This criterion was not met. There was no mention of any breakthrough tests being run on the air filters used in the study.

15) The extraction efficiency of laboratory fortified controls is considered acceptable if the lower limit of the 95% confidence interval is greater than 75%, unless otherwise specified by the Agency. At a minimum, seven determinations should be made at each fortification level to calculate the mean and standard deviation for recovery. Total recovery from field fortified samples must be greater than 50% for the study. These criteria were partially met. The number of laboratory fortified controls and types of laboratory controls were not provided in the Study Report. 29 Field fortification results were provided and all were greater than 50%.

16) 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. 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. The time periods for storage should be chosen so that the longest corresponds to the longest projected storage period for field samples. This criterion was met. A storage stability test was conducted. The Registrant, however, did not provide the actual dates of analysis.

17) A personal monitoring pump capable of producing an airflow of at least 2 L/ min. should be used and its batteries should be capable of sustaining maximum airflow for at least 4 hours without recharging. Airflow should be measured at the beginning and end of the exposure period. This criterion was probably not met. Personal monitoring pumps were calibrated to 1 L/ min and it was not reported if airflow was measured at the beginning and/ or end of the exposure period.

18) Appropriate air sampling media should be selected. The medium should entrap a high percentage of the chemical passing through it, and it should allow the elution of a high percentage of the entrapped chemical for analysis. This criterion was met. The study utilized personal air samplers containing air filters and absorption tubes.

19) If exposed media are to be stored prior to extraction, storage envelopes made from heavy filter paper may be used. The envelope must be checked for material that will interfere with analysis. Unwaxed sandwich bags should be used to contain the filter paper envelopes to help protect against contamination. This criterion was probably met. The Registrant states that after collection of the fiberglass filters, the air filter cassettes were removed, capped, and place in Whirl Pak bags.

20) Personal monitors should be arranged with the intake tube positioned downward, as near as possible to the nose level of the subject. This criterion was met. The cassette containing the air filter was attached to the worker's lapel.

21) Field calibration of personal monitors should be performed at the beginning and end of the exposure period. It is uncertain whether this criterion was met. There was no mention of calibration procedures in the Study Report.

22) Field fortification samples and blanks should be analyzed for correction of residue losses occurring during the exposure period. Fortified samples and blanks should be fortified at the expected residue level of the actual field samples. Fortified blanks should be exposed to the same weather conditions. These criteria were met. The Registrant mentioned that both field fortified samples and field blanks were collected.

23) Data should be corrected if any appropriate field fortified, laboratory fortified or storage stability recovery is less than 90 percent. This criterion was met. The Registrant corrected all data for field recoveries, even those greater than 90%.

24) Respirator pads should be removed using clean tweezers and placed in protective white crepe filter paper envelopes inside sandwich bags. The pads should be stored in a chest containing ice until they are returned to the laboratory, where they should be stored in a freezer prior to extraction. This criterion was not applicable to this study.

25) Field data should be documented, including chemical information, area description, weather conditions, application data, equipment information, information on work activity monitored, sample numbers, exposure time, and any other observations. These criteria were partially met. Brief descriptions of the test product used, the work activities being monitored, the planting equipment used, the application rate, the location of the study, and weather conditions were provided in the Study Report. However, no information regarding the individuals used in the study was provided.

26) Analysis methods should be documented and appropriate. This criterion was met.

27) A sample history sheet must be prepared by the laboratory upon receipt of samples. This criterion was not met.

875.1100 30 28) Investigators should submit protocols for review purposes prior to the inception of the study. This criterion was probably met.

29) Expected deviations from GLPs should be presented concurrently with any protocol deviations and their potential study impacts. The study sponsor stated that GLP's did not apply to this study.

30) The test substance should be a typical end use product of the active ingredient. This criterion was met.

31) The application rate used in the study should be provided and should be the maximum rate specified on the label. However, monitoring following application at a typical application rate may be more appropriate in certain cases. It is uncertain whether this criterion was met. A product label was not provided in the study and the label obtained by Versar did not provide a maximum application rate.

32) Selected sites and seasonal timing of monitoring should be appropriate to the activity. It is uncertain whether these criteria were met. The study site was located in Canada and the study occurred during the month of May.

33) A sufficient number of replicates should be generated to address the exposure issues associated with the population of interest. For outdoor exposure monitoring, each study should include a minimum of 15 individuals (replicates) per activity. This criterion was met. Four individuals participated in this study, for a total of 16 replicates.

34) The quantity of active ingredient handled and the duration of the monitoring period should be reported for each replicate. This criterion was met.

35) Test subjects should be regular workers, volunteers trained in the work activities required, or typical homeowners. This criterion was met.

36) Any protective clothing worn by the test subjects should be identified and should be consistent with the product label. This criterion was met. The protective clothing worn by the test subjects was identified and was consistent with the product label obtained by Versar.

37) The monitored activity should be representative of a typical working day for the specific task in order to capture all related exposure activities. This criterion was met.

38) Dermal exposure pads used for estimating dermal exposure to sprays should be constructed from paper making pulp or similar material (i. e., alpha cellulose), approximately 1 mm thick, that will absorb a considerable amount of spray without disintegrating. The alpha cellulose material should not typically require preextraction to remove substances that interfere with residue analysis. This should be determined prior to using the pads in exposure tests .This criterion is not applicable to this study.

39) Dermal exposure pads used for estimating dermal exposure to dust formulations, dried residues, and to dust from granular formulation should be constructed from layers of surgical gauze. The pad should be bound so that an area of gauze at least 2.5 inch square is left exposed. The gauze must be checked for material that would interfere with analysis and be preextracted if necessary. These criteria were partially met. The exposure pads were constructed from a surgical sponge and had a circular opening 5.6 cm (2.2 in) in diameter. It was not stated whether the gauze was checked for material that would interfere with analysis.

40) A complete set of pads for each exposure period should consist of 10 to 12 pads. If the determination of actual penetration of work clothing is desired in the field study, additional pads can be attached under the worker's outer garments. Pads should be attached under both upper and lower outer garments, particularly in regions expected to receive maximum exposure. Pads under clothing should be near, but not covered by, pads on the outside of the clothing. This criterion was met.

41) If exposed pads are to be stored prior to extraction, storage envelopes made from heavy filter paper may be used. The envelope must be checked for material that will interfere with analysis. Unwaxed sandwich bags should be used to contain the filter paper envelopes to help protect against contamination. This criterion was not met. Gauze pads were stored in 1 ounce glass bottles capped with poly seal screw caps and stored on dry ice. 31 42) Hand rinses should be performed during preliminary studies to ensure that interferences are not present. Plastic bags designed to contain 0.5 gal and strong enough to withstand vigorous shaking (i. e., at least 1 mil inch thickness) should be used. During preliminary studies, plastic bags must be shaken with the solvent to be used in the study to ensure that material which may interfere with analysis is not present. It is unknown if this criterion was met. The study author made no mention of preliminary hand rinse studies.

43) The analytical procedure must be capable of quantitative detection of residues on exposure pads at a level of 1 ug/ cm 2 (or less, if the dermal toxicity of the material under study warrants greater sensitivity). It is unknown if this criterion was met. The limit of quantification was not provided in the study. The limit of detection for exposure pads was reported as 38 ng/ sample.

44) The extraction efficiency of laboratory fortified controls is considered acceptable if the lower limit of the 95% confidence interval is greater than 75%, unless otherwise specified by the Agency. At a minimum, seven determinations should be made at each fortification level to calculate the mean and standard deviation for recovery. Total recovery from field fortified samples must be greater than 50% for the study. These criteria were partially met. The number of laboratory fortified controls and types of laboratory controls were not provided in the Study Report. Field fortification recovery results were provided and all were greater than 50%.

45) If the stability of the material of interest is unknown, or if the material is subject to degradation, the investigator must undertake and document a study to ascertain loss of residues while the pads are worn. It is recommended that collection devices be fortified with the same levels expected to occur during the field studies. The dosimeters should be exposed to similar weather conditions and for the same time period as those expected during field studies. These criteria were met. A storage stability test was conducted. The Registrant, however, did not provide the actual dates of analysis.

46) Data should be corrected if any appropriate field fortified, laboratory fortified or storage stability recovery is less than 90 percent. This criterion was met. The Registrant corrected all raw residue data for field recoveries.

47) Field data should be documented, including chemical information, area description, weather conditions, application data, equipment information, information on work activity monitored, sample numbers, exposure time, and any other observations. These criteria were partially met. Brief descriptions of the test produce used, the work activities being monitored, the planting equipment used, the application rate, the location of the study, and the weather conditions were provided in the Study Report. However, no information regarding the individuals used in the study was provided.

48) A sample history sheet must be prepared by the laboratory upon receipt of samples. This criterion was not met. 32 APPENDIX B Comparison of Application Rates of Lindane Among Registered Crops Group Crop Ounce ai/ cwt Max Seed Lb ai/ acre Max Seed cwt/ acre Max Ounce ai/ acre Max Pound ai/ acre Root & Tuber Radish 0.53 20 0.2 0. 106 0.0066 Leafy Veggies Celery 1.31 2 0. 02 0. 0262 0.0016 Lettuce 1.31 3 0. 03 0. 0393 0.0025 Swiss 1. 31 8 0.08 0.1048 0.0066 Spinach 1. 31 15 0. 15 0. 1965 0.0123 Cereal Grains Corn 2 18 0. 18 0. 36 0. 0225 Barley 0.5 96 0. 96 0. 48 0. 0300 Oats 0.6 128 1.28 0.768 0.0480 Rye 0. 5 112 1.12 0.56 0.0350 Soughum 1.13 75 0.75 0.8475 0.0530 Wheat 0.68 120 1.2 0. 816 0.0510 Misc. Canola 23.3 4 0.04 0.932 0.0583 Brassica Broccoli 1.91 1.5 0. 015 0.02865 0.0018 Brussels 1.91 1.5 0. 015 0.02865 0.0018 Cabbage 1.91 1.5 0. 015 0.02865 0.0018 Cauli 1. 91 1. 5 0.015 0.02865 0.0018 Collards 1. 91 4 0.04 0.0764 0.0048 Kale 1.91 4 0. 04 0. 0764 0.0048 Kohlrabi 1.91 5 0. 05 0. 0955 0.0060 Mustard 1.91 5 0. 05 0. 0955 0.0060 Source for Maximum Lb Seed per Acre: Martin, J. H., W. H. Leonard, and D. L. Stamp, "Principles of Field Crop Production, Third Edition:, Macmillan Publishing Co., Inc., 1976.


[Federal Register Volume 76, Number 214 (Friday, November 4, 2011)]
[Notices]
[Pages 68521-68523]
[FR Doc No: 2011-27916]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket Number DOT-OST-2011-0189]

Agency Information Collection Activities: Request for Comments;
Clearance of a New Information Collection; U.S. DOT Mentor
Prot[eacute]g[eacute] Pilot Program

AGENCY: Office of the Secretary (OST), (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, Public
law 104-13 (44 U.S.C. 3501 et seq) this notice announces the
information collection request on Mentor Prot[eacute]g[eacute] Pilot
Program annual report form, and the Mentor Prot[eacute]g[eacute] Pilot
Program evaluation form.
    DOT's Mentor-Prot[eacute]g[eacute] Pilot Program enhances the
capability of disadvantaged and small business owners to compete more
successfully for federal procurement opportunities. The program
encourages private-sector relationships and expands DOT's efforts to
identify and respond to the developmental needs of small and
disadvantaged businesses. The program is administered by the DOT OST
Office of Small and Disadvantaged Business Utilization (OSDBU).

Purpose

    In accordance with Public Law 95-507, an amendment to the Small
Business Act and the Small Business Investment Act of 1953, OSDBU is
responsible for the implementation and execution of the U.S. Department
of Transportation (DOT) activities on behalf of small businesses, in
accordance with Section 8, 15 and 31 of the Small Business Act (SBA),
as amended. The Office of Small and Disadvantaged Business Utilization
also administers the provisions of Title 49, of the United States Code,
Section 332, the Minority Resource Center (MRC), which includes the
design and carry-out programs to encourage, promote, and assist
minority entrepreneurs and businesses in getting contracts,
subcontracts, and projects related to those business opportunities
    The U.S. Department of Transportation (DOT) is implementing a
Mentor-Prot[eacute]g[eacute] Pilot Program that encourages agreements
between large and small business prime contractors and eligible small
business prot[eacute]g[eacute]s.
    Small business concerns include small disadvantaged businesses,
8(a) firms, women owned businesses, HUBZone small businesses, veteran-
owned-businesses and service disabled veteran-owned small businesses.
The program is also designed to improve the performance of DOT
contractors and subcontractors, foster the establishment of long-term
business relationships between small businesses and prime contractors,
and increase the overall number of small businesses that receive DOT
contract and subcontract awards.

General Policy

    1. Eligible business prime contractors (not under a suspension or
debarment action and not in the Excluded Parties List System (ELPS)
database) approved as mentor firms may enter into agreements with
eligible prot[eacute]g[eacute]s. Mentors provide appropriate
developmental assistance to enhance the capabilities of
prot[eacute]g[eacute]s to perform as contractors and/or subcontractors.
    2. Eligible small business prime contractors (not under a
suspension or debarment action and not in the ELPS database) capable of
providing developmental assistance may act as mentors.
    3. Prot[eacute]g[eacute]s may participate in the program in pursuit
of a prime contract or as subcontractors under the mentor's prime
contract with the Department of Transportation.
    4. Mentors and Prot[eacute]g[eacute]s are solely responsible for
finding their counterpart. Therefore, we strongly encourage firms to
explore existing business relationships in an effort to establish a
Mentor-Prot[eacute]g[eacute] relationship.
    5. Mentor-Prot[eacute]g[eacute] agreements should be for up to 24
months.
    6. The duration of this pilot program will be for two years.

Measurement of Program Success

    The overall success of the Mentor-Prot[eacute]g[eacute] Program
will be measured by the extent to which it results in:
    a. An increase in the quality of the technical capabilities of the
prot[eacute]g[eacute] firms.
    b. An increase in the number, dollar value and percentage of
contracts or subcontracts awarded to prot[eacute]g[eacute]s since the
date of entry into the program.
    c. An increase in the number and dollar value of contract and
subcontract awards to prot[eacute]g[eacute] firms since the time of
their entry into the program.

    Annual reports should be submitted by the mentor and
prot[eacute]g[eacute] firms to the OSDBU on program progress. Only one
report per agreement will be submitted for review. The OSDBU will
evaluate these reports by considering the following:
    1. Detailed actions taken by the mentor, to increase the
participation of prot[eacute]g[eacute] as seller to the Federal
Government.
    2. Detailed actions taken by the mentor, to develop the technical
capabilities of a prot[eacute]g[eacute] as defined in the agreement.
    3. The degree to which the prot[eacute]g[eacute] has met the
developmental objectives in the agreement.
    4. The degree to which the mentor firm's participation in the
Mentor-Prot[eacute]g[eacute] Program resulted in the
prot[eacute]g[eacute] receiving contract(s) and subcontract(s) from
private firms, DOT or any other Federal agency.
    5. In addition to the annual report, mentor and
prot[eacute]g[eacute] firms should submit an evaluation to the OSDBU at
the conclusion of the mutually agreed upon program period, or the
voluntary withdrawal by either party from the program, whichever comes
first.

Mentor Firms

    Eligibility. The mentor can be a business that has graduated from
the 8(a) Business Development program, a firm in the transitional stage
of the program, or a small or large business. In addition, the mentor
must be able to show that it is currently eligible for Federal
contracting opportunities, is not under a suspension or debarment
action, and is not in the ELPS database. Mentors may have multiple
prot[eacute]g[eacute]s.

Prot[eacute]g[eacute] Firms

    (1) Eligibility. A prot[eacute]g[eacute] should be:
    (a) A Small Business (SB), HUBZone, Small Disadvantaged Business
(SDB), Women Owned Small Business, Veteran Owned Small Business, or
Service Disabled Veteran Owned Small Business
    (b) Able to show that it is currently eligible for Federal
contracting opportunities, is not under a suspension or debarment
action, and is not in the Excluded Parties List System (ELPS) database.
    (2) Prot[eacute]g[eacute]s may have multiple mentors.
Prot[eacute]g[eacute]s participating in mentor-prot[eacute]g[eacute]
programs in addition to the DOT program should maintain a system for
preparing separate reports of mentoring activity for each agency's
program.

Selection of Mentor or Prot[eacute]g[eacute] Firms

    Mentor and prot[eacute]g[eacute] firms are responsible for
selecting their counterpart. The mentor is encouraged to select from a
broad base of Small Businesses including SB, SDB, WOSB, VOSB, SDVOSB,
and HUBZone firms whose core competencies support the Department of
Transportation's mission.

Mentor-Protege Agreement Process

    Firms interested in becoming a mentor firm should submit copy of a
signed mentor-prot[eacute]g[eacute] agreement for each mentor-
prot[eacute]g[eacute] relationship to DOT OSDBU for review. This will
provide OSDBU the opportunity to evaluate the nature and extent of
technical and managerial support, and traditional subcontracting
support involved in the mentor-prot[eacute]g[eacute] relationship,
enabling OSDBU to provide advice and assistance to the parties.
    The Mentor Prot[eacute]g[eacute] agreement should contain:
    (1) Name, address, phone, and email of mentor and
prot[eacute]g[eacute] firm(s) and a point of contact within both firms
who will oversee the agreement.
    (2) A description of the type of developmental program that will be
provided by the mentor firm to the prot[eacute]g[eacute] firm,
including a schedule for providing assistance, and criteria for
evaluation of the prot[eacute]g[eacute]'s developmental success.
    (3) Program participation term .
    (4) Other terms and conditions, as appropriate
    (5) Procedures for the mentor's voluntary withdrawal from the
program including notification of the prot[eacute]g[eacute] firm and
the OSDBU. The Mentor should provide at least 30 days' written notice
to OSDBU before withdrawing from the program.
    (6) OSDBU will review a Mentor Prot[eacute]g[eacute] agreement no
later than 30 days after receipt.
    (7) Following OSDBU review, the mentor may implement the
developmental assistance program.

OSDBU Review of Mentor-Prot[eacute]g[eacute] agreement

    (1) The agreement defines the relationship between the mentor and
prot[eacute]g[eacute] firms only. The agreement itself does not create
any privity of contract between the mentor or prot[eacute]g[eacute] and
DOT.
    (2) OSDBU will review the information to ensure the mentor and
prot[eacute]g[eacute] are both eligible for the program and provide
appropriate advice and assistance to the firms concerning the agreement
and its implementation.
    (3) OSDBU will notify the parties if changes in the agreement are
advisable in order to make the agreement meet the objectives of the
mentor-prot[eacute]g[eacute] program. The mentor and
prot[eacute]g[eacute] should incorporate OSDBU recommendations before
implementing the agreement.
    (4) Upon completion of the review, the mentor may implement the
developmental assistance program.

Developmental Assistance

    The forms of developmental assistance a mentor can provide to a
prot[eacute]g[eacute] include:
     Management, financial and/or technical assistance.
     Overall business management/planning.
     Cooperation on joint venture projects.
     Rent-free use of facilities and/or equipment.
     Temporary assignment of personnel to prot[eacute]g[eacute]
for the purpose of training.
     Any other types of mutually beneficial assistance.

Internal Controls

    1. The OSDBU will oversee the program to achieve program
objectives.
    2. OSDBU will review and evaluate mentor-prot[eacute]g[eacute]
agreements for practicality, and accuracy of provided information.
    3. OSDBU can perform site visits where Mentor-Prot[eacute]g[eacute]
activity is performed.
    4. OSDBU will review annual reports to measure
prot[eacute]g[eacute] progress against the established developmental
assistance included in the approved agreement.
    5. If OSDBU determines that the objectives of the agreement are not
met, OSDBU may conclude the existing Mentor-Prot[eacute]g[eacute]
agreements if it determines that such actions are in the best interest
of the agency. The OSDBU will communicate this decision in writing, and
will be sent to the mentor and prot[eacute]g[eacute] after approval by
the Director, OSDBU or representative.

DATES: Written comments should be submitted by January 3, 2012.

FOR FURTHER INFORMATION CONTACT: Leonardo San Roman, Small Business
Specialist, Procurement Assistance Division, Office of Small and
Disadvantaged Business Utilization, U.S. Department of Transportation,
1200 New Jersey Ave SE., Room W56-497, Washington, DC 20590. Telephone:
1-(800) 532-1169 or<PHONE_NUMBER>, by email<EMAIL_ADDRESS>or
visit our Web site at http://www.osdbu.dot.gov.

SUPPLEMENTARY INFORMATION:

    Title: U.S. DOT Mentor Prot[eacute]g[eacute] Pilot program.
    OMB Control Number: This is a proposed new information collection.
    Forms: Mentor Prot[eacute]g[eacute] pilot program annual report;
and Mentor Prot[eacute]g[eacute] pilot program evaluation form.
    Type of Review: New Information Collection.
    Affected Public: Prime contractors and small businesses
participating in DOT's Mentor Prot[eacute]g[eacute] Pilot Program.
    Respondents: Approximately 20.
    Frequency: One-time.
    Estimated Average Burden Per Response: 1 hour.
    Estimated Total Annual Burden Hours: 20 hours.

Abstract

    In accordance with Public Law 95-507, an amendment to the Small
Business Act and the Small Business Investment Act of 1953, OSDBU is
responsible for the implementation and execution of the U. S.
Department of Transportation (DOT) activities on behalf of small
businesses, in accordance with Section 8, 15 and 31 of the Small
Business Act (SBA), as amended. The Office of Small and Disadvantaged
Business Utilization also administers the provisions of Title 49, of
the United States Code, Section 332, the Minority Resource Center (MRC)
which includes the design and carry out programs to encourage, promote,
and assist minority entrepreneurs and businesses in getting contracts,
subcontracts, and projects related to those business opportunities.
    The information collected will be from prime contractors and small
business owners. The information collected will be used by DOT OSDBU to
determine whether or not the type of technical assistance provided to
the prot[eacute]g[eacute] was in accordance with Mentor-
Prot[eacute]g[eacute] agreement.

Abstract

    In accordance with Public Law 95-507, an amendment to the Small
Business Act and the Small Business Investment Act of 1953, OSDBU is
responsible for the implementation and execution of the U. S.
Department of Transportation (DOT) activities on behalf of small
businesses, in accordance with Section 8, 15 and 31 of the Small
Business Act (SBA), as amended. The Office of Small and Disadvantaged
Business Utilization also administers the provisions of Title 49, of
the United States Code, Section 332, the Minority Resource Center (MRC)
which includes the design and carry out programs to encourage, promote,
and assist minority entrepreneurs and businesses in getting contracts,
subcontracts, and projects related to those business opportunities.
    The information collected will be from prime contractors and small
business owners, and it will be used by DOT OSDBU to determine Mentor-
Prot[eacute]g[eacute] program success and recommendations to the pilot
program.

    Authority:  49 U.S.C. Section 332(4).

    Issued in Washington, DC on October 11, 2011.
Brandon Neal,
Director, Office of Small and Disadvantaged Business Utilization.
[FR Doc. 2011-27916 Filed 10-27-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Rules and Regulations]
[Pages 71493-71495]
[FR Doc No: 2013-28583]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0917]
RIN 1625-AA00

Special Local Regulation; Lake Havasu City Christmas Boat Parade
of Lights; Colorado River; Lake Havasu, AZ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is temporarily modifying the dates for the
special local regulation in support of the Lake Havasu City Christmas
Boat Parade of Lights on the Colorado River. This modification is
necessary to reflect the actual dates of the event for this year which
are December 6th and December 7th, 2013. Additionally, this temporary
final rule adds a third evening, December 14th, 2013. This rule is
necessary to provide for the safety of the participants, crew,
spectators, participating vessels, and other vessels and users of the
waterway. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within this zone unless authorized by
the Captain of the Port, or his designated representative.

DATES: This rule is effective from 5 p.m. to 9 p.m. on December 6th,
December 7th, and December 14th, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0917]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Bryan Gollogly, Waterways Management, U.S.
Coast Guard Sector San Diego; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

BNM Broadcast Notices to Mariners
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because logistical details pertaining to this
year's dates were not known by the Coast Guard in time to publish an
NPRM and wait for the comment period to run.
    Immediate action is needed to ensure the special local regulations
listed in 33 CFR 100.1102 (table 1, item 10) will be in effect on the
actual dates of the event, which are December 6th, December 7th, and
December 14th, 2013.
    Under 5 U.S.C. 553(d)(3), for the same reasons mentioned above, the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. Any delay
in the effective date of this rule would be contrary to the public
interest, because immediate action is necessary to protect the parade
vessels from the dangers associated with non participant vessels
transiting the event area.

B. Basis and Purpose

    The legal basis and authorities for this rulemaking establishing a
special local regulation are found in 33 U.S.C. 1233, which authorize
the Coast Guard to establish and define special local regulations.
    This temporary final rule and notice of enforcement will protect
the participating vessels over the three evenings in December in a
marine event sponsored by the London Bridge Yacht Club.
    The annual Lake Havasu City Christmas Boat Parade of Lights will
involve fifty vessels in Lake Havasu, AZ transiting Thompson Bay,
proceeding through Bridgewater Channel, circling in front of Windsor
Beach and returning through Bridgewater Channel. The regulated zone
will encompass the navigable waters in the northern portion of Thompson
Bay, the Bridgewater Channel, and waters off Windsor Beach. Vessel
participants will be traveling in a parade line that will affect normal
traffic patterns. In addition, event participants will be utilizing
additional holiday lighting that will obscure or confuse required
normal Navigation Lights and increase the dangers associated with non
participating vessels transiting the area.
    This temporary special local regulation is necessary to prevent
vessels from transiting the area and to protect the participating
vessels and passengers from potential damage and injury.

C. Discussion of the Final Rule

    The Coast Guard is changing the dates of the special local
regulation currently listed in 33 CFR 100.1102 (table 1, item 10). This
change differs from the existing regulation by specifying that the
event will be held on December 6, December 7 and December 14, 2013,
instead of the first weekend in December. The special local regulations
for the Lake Havasu City Christmas Boat Parade of Lights will be
enforced from 5 p.m. to 9 p.m. on Friday, December 6,

2013; Saturday, December 7, 2013 and Saturday December 14, 2013. The
special local regulation zone will encompass the waters in the northern
portion of Thompson Bay, the Bridgewater Channel, and waters off
Windsor Beach. The zone is necessary to provide for the safety of the
spectators, participants, and other vessels and users of the waterway.
Persons and vessels are prohibited from entering into, transiting
through, or anchoring within this zone unless authorized by the Captain
of the Port, or his designated representative. Persons or vessels
requiring entry into or passage through the special local regulation
must request permission from the Captain of the Port, or his designated
representative. Before the effective period, the Coast Guard will
publish a local notice to mariners (LNM).

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. We expect the economic
impact of this proposed rule to be so minimal that a full Regulatory
Evaluation is unnecessary. This determination is based on the size and
location of the zone. Commercial vessels will not be hindered by the
zone. Recreational vessels will not be allowed to transit through the
designated zone during the specified times.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule would affect the following entities, some of
which might be small entities: the owners or operators of vessels
intending to transit or anchor in the impacted portion of Lake Havasu
from 5 p.m. to 9 p.m. on December 6, 7, and 14, 2013.
    These special local regulations will not have a significant
economic impact on a substantial number of small entities for the
following reasons. This rule will be enforced only in the evening when
vessel traffic is low. Before the effective period, the Coast Guard
will publish a local notice to mariners (LNM).

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations

That Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves establishing a special local
regulation, upon the navigable waters of Lake Havasu. This rule is
categorically excluded from further review under paragraph 34(h) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the U.S. Coast Guard
amends 33 CFR Part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for Part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Suspend item 10 in Table 1 of Sec.  100.1102.

0
3. Add Sec.  100.T11-607 to read as follows:

Sec.  100.T11-607  Special Local Regulation; Lake Havasu City Christmas
Boat Parade of Lights; Colorado River; Lake Havasu, AZ.

    (a) Location. The following area is a special local regulation: The
waters in the northern portion of Thompson Bay, the Bridgewater
Channel, and waters off Windsor Beach.
    (b) Enforcement Period. This section will be enforced from 5 p.m.
to 9 p.m. on December 6, 7, and 14, 2013.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  100.35 of this part, entry into this area is prohibited unless
authorized by the Captain of the Port of San Diego or his designated
on-scene representative.
    (2) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (3) Upon being hailed by U.S. Coast Guard patrol personnel or
designated law enforcement representatives by siren, radio, flashing
light or other means, the operator of a vessel shall proceed as
directed.
    (4) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: November 6, 2013.
S. M. Mahoney,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2013-28583 Filed 11-27-13; 8:45 am]
BILLING CODE 9110-04-P