1 March 28, 2012

2

3 EPA-HSRB-12-01

4

5 Lek Kadeli, Acting Assistant Administrator

6 Office of Research and Development

7 U.S. Environmental Protection Agency

8 1200 Pennsylvania Avenue, NW

9 Washington, DC 20460 

10

11 Subject: January 26, 2012 EPA Human Studies Review Board Meeting Report

12

13 Dear Mr. Kadeli,

14

15 The United States Environmental Protection Agency (EPA or Agency) requested that the 

16 Human Studies Review Board (HSRB) provide scientific and ethics reviews of one new protocol 

17 for a study involving intentional exposure of human subjects to pesticides: a proposed 

18 Agricultural Handler Exposure Task Force, LLC (AHETF) scenario measuring dermal and 

19 inhalation exposure of workers who perform mixing, loading and application of pesticides using 

20 powered (gasoline or electric) handgun/hand wand equipment in greenhouses and nurseries 

21 (AHE-600).

22

23 The Agency also requested that the HSRB review a completed study of dermal and 

24 inhalation exposure of professional janitorial workers who clean indoor surfaces with an 

25 antimicrobial pesticide product using hand-held pressurized aerosol canisters, conducted by the 

26 Antimicrobial Exposure Assessment Task Force II (AEATF II). This study (AEA-04) was 

27 conducted after publication of the EPA’s expanded final rule for protection of subjects in human 

28 research. The data will be posted to the Biocide Handlers Exposure Database (BHED®), and 

29 used generically to estimate daily dermal and inhalation exposures of those who wipe indoor 

30 surfaces with antimicrobial pesticides.

31

32 The enclosed report provides the Board’s response to EPA charge questions presented at 

33 the January 26, 2012 meeting.

34

35 Assessment of Proposed AHETF Research Study AHE-600: Mixing, Loading, and Applying 

36 Liquid Pesticides in Managed Horticultural Facilities Using Powered Handgun Equipment.

37

38 Science

39

40 • The Board concluded that the protocol submitted for review, if modified in accordance 

41 with EPA (Evans, Sarkar and Sherman 2011) and HSRB recommendations, is likely to 

42 generate high quality, reliable and useful data for assessing worker’s pesticide exposures in 

43 horticultural settings. 

44

45 • The Board provided several additional comments or suggestions with respect to the use of 

46 personal protective equipment (PPE), the potential effect of unanticipated incidental 
47 exposures and other variables on proportionality, and the utility of existing European Crop 

48 Protection Association (ECPA) data.

49

50 Ethics

51

52 • The Board concluded that the protocol submitted for review, if modified in accordance 

53 with EPA and HSRB recommendations, is likely to meet the applicable requirements of 40 

54 CFR 26, subparts K and L.

55

56 Assessment of Completed AEATF II Research Study AEA-04: Measurement of Potential 

57 Dermal and Inhalation Exposure During Application of a Liquid Antimicrobial Pesticide 

58 Product Using a Pressurized Aerosol Can for Indoor Surface Disinfecting.

59

60 Science

61

62 • The Board concurred with the Agency’s assessment that this study provides scientifically

63 valid results for estimating the dermal and inhalation exposure of those who apply liquid 

64 antimicrobial pesticide products for indoor surface disinfecting using a pressurized aerosol 

65 can, but noted several issues, limitations and concerns with the data and proposed analyses.

66

67 Ethics

68

69 • The Board concurred with the Agency’s assessment that the study submitted for review 

70 was conducted in substantial compliance with subparts K and L of 40 CFR 26.

71

72

73 Sincerely,

74

75

76

77 Sean Philpott, PhD, MSBioethics

78 Chair

79 EPA Human Studies Review Board
80 NOTICE

81

82 This report has been written as part of the activities of the EPA Human Studies Review 

83 Board, a Federal advisory committee providing advice, information and recommendations on 

84 issues related to scientific and ethical aspects of human subjects research. This report has not 

85 been reviewed for approval by the Agency and, hence, the contents of this report do not

86 necessarily represent the view and policies of the Environmental Protection Agency, nor of other 

87 agencies in the Executive Branch of the Federal government, nor does the mention of trade 

88 names or commercial products constitute a recommendation for use. You may obtain further 

89 information about the EPA Human Studies Review Board from its website at 

90 http://www.epa.gov/osa/hsrb. You may also contact the HSRB Designated Federal Officer, via e91 mail at ord-osa-hsrb@epa.gov

92

93 In preparing this document, the Board carefully considered all information provided and 

94 presented by the Agency presenters, as well as information presented by public commenters. 

95 This document addresses the information provided and presented within the structure of the 

96 charge by the Agency.
97 US ENVIRONMENTAL PROTECTION AGENCY

98 HUMAN STUDIES REVIEW BOARD

99

100 Chair

101

102 Sean Philpott, PhD, MSBioethics, Director for Research Ethics, The Bioethics Program of Union 

103 Graduate College and the Mount Sinai School of Medicine, Schenectady, NY

104

105 Vice Chair

106

107 Rebecca Parkin, PhD, MPH, Professorial Lecturer (EOH), School of Public Health and Human 

108 Services, The George Washington University, Washington, DC

109

110 Members

111

112 Janice Chambers, PhD, DABT, Fellow ATS, William L. Giles Distinguished Professor, Director, 

113 Center for Environmental Health Sciences, College of Veterinary Medicine, Mississippi State 

114 University, Mississippi State, MS

115

116 George Fernandez, PhD, Professor of Applied Statistics, Director of the University of Nevada117 Reno Center for Research Design and Analysis, University of Nevada-Reno, Reno, NV

118

Vanessa Northington Gamble*119 , MD, PhD, University Professor of Medical Humanities, Professor 

120 of Health Policy and American Studies, The George Washington University, Washington, DC

121

122 Sidney Green, Jr., PhD, Fellow of the ATS, Professor, Department of Pharmacology, Howard 

123 University College of Medicine, Washington, DC

124

125 Jewell H. Halanych, MD, Assistant Professor, Department of Preventative Medicine, University 

126 of Alabama at Birmingham, Birmingham, AL

127

128 Dallas E. Johnson, PhD, Professor Emeritus, Department of Statistics, Kansas State University, 

129 Manhattan, KS

130

Michael D. Lebowitz†131 , PhD, FCCP, Retired Professor of Public Health & Medicine, University 

132 of Arizona, Tucson, AZ 

133

José E. Manautou*134 , PhD, Associate Professor of Toxicology, Department of Pharmaceutical 

135 Science, University of Connecticut School of Pharmacy, Storrs, CT

136

137 Jerry A. Menikoff, MD, JD, Director, Office for Human Subjects Research, Office of the

138 Secretary, Department of Health and Human Services, Rockville, MD

139

140 William Popendorf, PhD, MPH, Professor Emeritus, Department of Biology, Utah State 

141 University, Logan, UT

142
Leonard Ritter*

143 , PhD, Professor Emeritus, School of Environmental Sciences, University of 

144 Guelph, Guelph, ON, Canada

145

146 Virginia Ashby Sharpe, PhD, Medical Ethicist, National Center for Ethics in Health Care, 

147 Veterans Health Administration, Washington, DC

148

Bernard A. Schwetz*149 , DVM, PhD, Director (Retired), Office of Human Research Protections, 

150 Department of Health and Human Services, Cadott, WI

151

152 Linda J. Young, PhD, Professor, Department of Statistics, Institute of Food and Agricultural 

153 Sciences, University of Florida, Gainesville, FL

154

155 Human Studies Review Board Staff

156

157 Jim Downing, Executive Director, Human Studies Review Board Staff, Office of the Science 

158 Advisor, United States Environmental Protection Agency, Washington, DC

159

160

* 161 Not present on January 26, 2012.

† 162 Participated in the January 26, 2012 meeting via telepresence.
163 INTRODUCTION 

164

165 On January 26, 2012, the United States Environmental Protection Agency’s (EPA or 

166 Agency) Human Studies Review Board (HSRB) met to address scientific and ethical issues 

167 concerning one new protocol for research involving human participants: a study measuring 

168 dermal and inhalation exposures associated with the mixing, loading and application of 

169 pesticides using powered (gasoline or electric) handgun/hand wand equipment in greenhouses 

170 and nurseries. In accordance with 40 CFR 26.1601, EPA sought HSRB review of this proposed 

171 study. This study is discussed more fully below.

172

173 In addition, the Agency has data from one completed study measuring dermal and 

174 inhalation exposure of professional janitorial workers who clean indoor surfaces with an 

175 antimicrobial pesticide product using hand-held pressurized aerosol canisters. In accordance with 

176 40 CFR 26.1602, EPA sought HSRB review of this completed study. This study is discussed 

177 more fully below.

178

179

180 REVIEW PROCESS

181

182 On January 26, 2012, the Board conducted a public face-to-face meeting in Arlington, 

183 Virginia. Advance notice of the meeting was published in the Federal Register as “Human 

184 Studies Review Board; Notice of Public Meeting” (76 Federal Register 248, 80938).

185

186 Following welcoming remarks from Agency officials, the Board heard presentations from 

187 EPA on the following topics: one new study protocol to measure dermal and inhalation exposures 

188 associated with the mixing, loading and application of pesticides using powered (gasoline or 

189 electric) handgun/hand wand equipment in greenhouses and nurseries, and one completed study

190 measuring dermal and inhalation exposure of professional janitorial workers who clean indoor 

191 surfaces with an antimicrobial pesticide product using hand-held pressurized aerosol canisters. 

192

193 The Board also asked clarifying questions of several study sponsors and/or research 

194 investigators, including:

195

196 Ms. Megan Boatwright, Analytical Coordinator, Golden Pacific Laboratories.

197 Dr. Victor Cañez, Technical Chair, Agricultural Handler Exposure Task Force.

198 Dr. Richard Collier, Administrative Committee Chair, Agricultural Handler Exposure 

199 Task Force.

200 Mr. William McCormick III, Clorox, on behalf of the Antimicrobial Exposure 

201 Assessment Task Force II.

202 Mr. Robert Testman, Vice-President, Golden Pacific Laboratories.

203

204

205 Public oral comments were provided by:

206

207 Dr. Victor Cañez, Technical Chair, Agricultural Handler Exposure Task Force
208 Dr. Richard Collier, Administrative Committee Chair, Agricultural Handler Exposure 

209 Task Force.

210 Mr. Robert Testman, Vice-President, Golden Pacific Laboratories.

211

212 One written public comment from a New Jersey resident was submitted, but the substance 

213 of that comment was not directly related to the two studies under review by the HSRB at the 

214 January 26, 2012 meeting. 

215

216 For their deliberations, the Board considered the materials presented at the meeting, oral 

217 comments, and Agency background documents (e.g., published literature, sponsor and 

218 investigator research reports, study protocols, data evaluation records, and Agency science and 

219 ethics reviews of proposed protocols and completed studies). A comprehensive list of 

220 background documents is available online at http://www.regulations.gov. 

221

222

223 CHARGE TO THE BOARD AND BOARD RESPONSE

224

225 Assessment of Proposed AHETF Research Study AHE-600: Mixing, Loading, and Applying 

226 Liquid Pesticides in Managed Horticultural Facilities Using Powered Handgun Equipment.

227

228 Overview of the Study

229

230 This proposal presents an agricultural handler exposure scenario involving mixing, 

231 loading and application of pesticides using powered (gasoline or electric) handgun/hand wand 

232 equipment in greenhouses and nurseries. Pesticides can be formulated as either liquids or as 

233 wettable powders.

234

235 A total of 30 participants (described in the protocol as “Monitoring Units” [MUs]) will be 

236 observed; three volunteers from each of ten geographically distinct growing regions will be 

237 enrolled using a purposive sampling method (with some elements of random selection). For each 

238 scenario, volunteers will be randomized to mix and load a defined amount of active ingredient 

239 within one of three strata: 0.5 to 1.6 pounds, 1.6 to 4.8 pounds of active ingredient, or 4.8 to 15 

240 pounds of active ingredient. After mixing and loading the pesticide, participants will use 

241 powered equipment to treat ornamentals and nonbearing fruit trees in nurseries, or ornamentals 

242 and vegetables grown in greenhouses, using spray patterns that include downward, outward and 

243 upward directions.

244

245 For this protocol, all participants will wear long sleeved shirts, long pants, and shoes plus 

246 socks. In addition, all participants will wear chemical resistant gloves. Additional personal 

247 protective equipment (PPE) may be required depending on product labeling directions, including 

248 the use of chemical-resistant aprons when mixing and loading the pesticide, and chemical249 resistant headgear when making overhead applications. 

250

251 Dermal exposure will be measured by a whole body dosimeter worn beneath the subject’s 

252 outer clothing. Hand wash and face/neck wipe samples will also be collected prior to, during, and 

253 after completion of pesticide loading and mixing procedures. For study participants wearing 
254 chemical-resistant headgear, patches placed inside and outside of the headgear will be employed 

255 to estimate dermal exposure of the protected portions of the body covered by these garments. 

256

257 Airborne concentrations of the surrogate will be monitored in the participant’s breathing 

258 zone using an OSHA Versatile Sampler (OVS) tube connected to a personal sampling pump. 

259 Additional measures will also record environmental conditions at the time of monitoring, and 

260 observers will make field notes, photographs and videos of participant activity throughout the 

261 monitoring event. 

262

263 The results of sample analysis under the powered handgun scenario will be posted to the 

264 Agricultural Handlers Exposure Database (AHED®), where they will be available to the EPA 

265 and other regulatory agencies for statistical analysis. The proposed documentation will report a 

266 confidence interval-based approach to determine the relative accuracy for the arithmetic mean 

267 and 95th percentile of unit exposures. The Agency proposes to use these data to estimate daily

268 dermal and inhalation exposures of agricultural handlers who mix, load and apply pesticides 

269 using powered handgun equipment.

270

271 Science

272

273 Charge to the Board

274

275 If the AHETF proposal is revised as suggested in EPA’s review and if the research is 

276 performed as described, is the research likely to generate scientifically reliable data, useful for 

277 assessing the exposure of workers mixing, loading and applying pesticides in managed 

278 horticultural facilities using powered handgun equipment?

279

280 Board Response to the Charge

281

282 HSRB Recommendation

283

284 The Board concluded that the protocol submitted for review, if modified in accordance 

285 with EPA (Evans, Sarkar and Sherman 2011) and HSRB recommendations, is likely to generate 

286 high quality, reliable and useful data for assessing worker’s pesticide exposures in horticultural 

287 settings. 

288

289 Several comments or suggestions were made by the Board with respect to the use of PPE, 

290 the potential effect of unanticipated incidental exposures and other variables on proportionality, 

291 and the utility of existing European Crop Protection Association (ECPA) data.

292

293 HSRB Detailed Recommendations and Rationale

294

295 This protocol, a study designed to measure dermal and inhalation exposure of agricultural 

296 workers who mix, load and apply pesticides in nurseries or greenhouses using a hand-held 

297 sprayer or gun, was well thought out and well designed. The study sponsors (Collier 2011) 

298 found no suitable existing information that could constitute some of the MUs for this particular 

299 scenario; consequently, the entire scenario has to be conducted. The design requires ten (10) 
300 regions with three (3) MUs per region, for a total of 30 MUs. The rationale for this design is that 

301 there are relatively few nurseries and greenhouses that would be suitable for this scenario in 

302 most, if not all, regions of the United States. Similarity restrictions will be imposed to assure 

303 diversity. The investigators consulted several information sources to identify locations with 

304 suitable nurseries or greenhouses that could be venues for the conduct of this scenario. The areas 

305 of the country selected represent a variety of climatic and geographic conditions, likely providing 

306 the representativeness and diversity sought for the scenario. Given these factors and 

307 considerations, the Board determined that the proposed study design is reasonable. 

308

309 The scenario will include several tasks: mixing/loading of the pesticide product, open 

310 pouring of the formulated product, application of the product to the plants, and potentially some 

311 cleaning. The objective is to demonstrate proportionality between the amount of active ingredient 

312 handled (AaiH) and exposure level. One concern that was raised by the Board was that 

313 proportionality may not be observed due to the high variability of unanticipated incidental 

314 exposures (e.g., accidentally touching a treated plant or contaminated part of spray equipment in 

315 some settings but not others), and these sources may contribute substantially to participants’

316 exposure levels. Because workers may be close to some of the sprayed plants in a setting such as 

317 a nursery, it seems likely that unintended contact of workers with these plants might easily occur. 

318 In scenarios where unanticipated incidental exposures are likely to occur, it will be important for 

319 researchers to observe and document all unintentional contacts with treated plants or other events 

320 that might contribute to the exposure levels. However, even if proportionality is not seen --

321 particularly if the results are attributable to observed unanticipated exposures -- this scenario will 

322 still provide valid information about worker exposure when using a powered handgun or hand 

323 wand in a horticultural setting.

324

325 The Board provided additional recommendations and advice to the Agency about 

326 personal protective equipment (e.g., chemical-resistant headgear), respirators, the many sources 

327 of diversity, and analysis of data. For example, the Agency was reminded that, should chemical328 resistant headgear be worn, the use of patches inside the headgear should yield valid estimates of 

329 exposure for those participants wearing such a hat (an issue previously raised at the April 2011 

330 HSRB meeting [EPA HSRB 2011]). However, this method may underestimate exposures if 

331 attempts were made to extrapolate these data to those not wearing such headgear. Such 

332 extrapolation may not be an explicit intent, but the Agency states its plans to use the head 

333 exposure data to develop mitigation strategies (e.g. Evans, Sarkar and Sherman 2011, 11). The 

334 effect of the protection afforded by the brim of the chemical-resistant headgear would negatively 

335 affect that use. Thus, the Board suggested that the sponsors consider: 1) having study participants 

336 use chemical-resistant headgear without a brim (but only if this is allowed by the Worker 

337 Protection Standards); or 2) add a third patch dosimeter against the head below the brim, as the 

density of deposition (μg/cm2338 ) onto this patch could be compared to the deposition onto the rest 

339 of the face to estimate the magnitude of protection afforded by such a brim.

340

341 The Board also discussed the use of respirators and half-masks in the scenario, and how 

342 to handle the impact that use of such PPE might have on dermal exposure levels. For example, 

343 the Board raised concerns about whether the measured skin exposure to the face would be 

344 adjusted upward in proportion to the area of the face/neck covered by a respirator. Although the 
345 Agency responded affirmatively, this adjustment was not stated in the protocol or the Agency’s

346 review of the protocol. 

347

348 Several Board members noted that there are many sources of diversity in this scenario. 

349 As a result, it may be difficult to test the numerous variables to the degree the Agency intends for 

350 identifying statistically significant differences. Variables that may influence the proposed 

351 exposure data include:

352

353 1. The predominant direction of spray (downward, outward, or upward); 

354 2. Whether or not the MU does “minor clean-up”; 

355 3. Whether the MU uses a handgun or a hand wand;

356 4. Whether the MU applies the pesticide indoors or outdoors; 

357 5. The width of the path through which the applicator must pass, as determined by

358 facility type (i.e., ornamental greenhouse, vegetable greenhouse, nursery), which may

359 or may not be a surrogate for the proximity of foliage;

360 6. The formulation type mixed (liquid or solid/wettable powder); and 

361 7. The mixing sequence (pre-mix or tank mix). 

362

363 The Board also considered issues related to the Agency’s recommendation to include 

364 wettable powder by at least one participant in each cluster (Evans, Sarkar and Sherman 2011, 4). 

365 In particular, concerns were raised about the use of two formulation types (wettable powder and 

366 liquid) in the scenario; this could be seen as akin to conducting two studies. The lack of clarity as 

367 to how many participants would use the wettable powder in each cluster is problematic for 

368 assessing the recommended study design and field conduct. The number of MUs who would 

369 handle the powder versus liquid formation is critical for statistical and analytical questions to be 

370 fully answered. If both formulations are to be used, the Board recommended that the Agency

371 conduct a separate analysis of each type before combining all of the data for analysis. If the 

372 intent is to maximize the power of detecting a difference attributable to this variable, then the 

373 sponsor could have 15 MUs use the powder formulation and 15 MUs use the liquid formulation. 

374 Alternatively, all MUs could use the wettable powder, as that formulation type is more likely to 

375 generate more conservative exposure data. 

376

377 Finally, the Board cautioned the Agency and the sponsors that the justification for the 

378 study may be weak. In particular, the Board raised a question about the utility of ECPA data. 

379 The Agency’s rationale for not using those data was that the proposed AHETF scenario involves 

380 individual workers performing both mixing/loading and application activities, whereas the ECPA 

381 exposure data was collected from agricultural handlers involved only in the application of 

382 pesticides. The Board was not convinced, however, that this difference precludes the use of 

383 existing ECPA data. While there may be other scenario or data quality issues with the ECPA 

384 data, the Board recommended that the Agency consider the viability of combining the ECPA 

385 application-only exposure data with the Task Force’s mixing/loading-only exposure data to 

386 satisfy the Agency’s registration needs without further human exposure studies. Despite this, the 

387 Board noted that the amount of active ingredient handled might be very different for the 

388 proposed scenario and the existing ECPA data set; if true, then the existing data sets might not be 

389 useful in assessing worker exposure in this horticultural scenario.

390
391 Ethics

392

393 Charge to the Board

394

395 If the AHETF proposal is revised as suggested in EPA’s review and if the research is 

396 performed as described, is the research likely to meet the applicable requirements of 40 CFR part 

397 26, subparts K and L?

398

399 Board Response to the Charge

400

401 HSRB Recommendation

402

403 The Board concluded that the protocol submitted for review, if modified in accordance 

404 with EPA (Evans, Sarkar and Sherman 2011) and HSRB recommendations, is likely to meet the

405 applicable requirements of 40 CFR 26, subparts K and L.

406

407 HSRB Detailed Recommendations and Rationale

408

409 The submitted documents assert that the study will be conducted in accordance with the 

410 ethical and regulatory standards of 40 CFR 26, Subparts K and L, as well as the requirements of 

411 the US EPA’s Good Laboratory Practice (GLP) Standards described at 40 CFR 160, and, for 

412 research conducted in California, the California State EPA Department of Pesticide Regulation 

413 study monitoring (California Code of Regulations Title 3, Section 6710) (Collier 2011). 

414 Requirements of FIFRA §12(a)(2)(P) also apply. Researchers who participate in the study and 

415 interact with study participants will be required to undergo ethics training. The training will 

416 include the successful completion of the course from the National Institutes of Health (Protecting 

417 Human Research Participants) and/or the Basic Collaborative IRB Training Initiative Course. 

418

419 The protocol was reviewed and approved by an independent human subjects review 

420 committee, IIRB, Inc. of Plantation, FL, prior to submission. IIRB, Inc. is fully accredited by the 

421 Association for the Accreditation of Human Research Protection Programs (AAHRPP). IIRB, 

422 Inc. is also listed as an active Institutional Review Board (IRB) on the Office of Human 

423 Research Protection (OHRP) website (Reg. #IORG0002954). Copies of all correspondence with 

424 IIRB, Inc. (Collier 2011) and a copy of IIRB, Inc. policies and membership roster were provided 

425 (IIRB, Inc. 2010; 2011). These documents indicate that IIRB, Inc. reviewed this protocol 

426 pursuant to the standards of the Common Rule (45 CFR Part 46, Subpart A). 

427

428 1. The Board concurred with the conclusions and factual observations of the ethical strengths 

429 and weaknesses of the study, as detailed in the EPA’s Ethics Review (Evans, Sarkar and 

430 Sherman 2011). The proposed study is likely to meet the applicable ethical requirements for 

431 research involving human subjects, in accordance with the following criteria: 

432

433 a. Societal value of the proposed research. The clearly stated purpose of the proposed 

434 monitoring study is to develop data to determine the potential exposure for workers who 

435 mix, load, and apply liquid pesticides using powered handgun equipment in managed 

436 horticultural facilities in the United States. This mixing/loading/applying method is 
437 applicable to a large variety of commercially important crops associated with the nursery

438 and greenhouse industry across the US and Canada, and the existing exposure data are 

439 likely inadequate. This study will provide a partial answer to the question of what dermal 

440 and inhalation exposures are likely for workers who mix/load and apply pesticide 

441 products using handguns and hand wands in nurseries and greenhouses. EPA will use the 

442 results of this study to estimate the dermal and inhalation exposure likely for a wide 

443 range of agricultural pesticides mixed, loaded, and applied under this exposure scenario.

444

445 b. Subject selection and informed consent. The inclusion/exclusion criteria are complete 

446 and appropriate. Pregnant or nursing women are excluded from participation. Pesticide 

447 company employees and contractors to the AHETF are also excluded from participation. 

448 Protections are adequate even if a subject were from a vulnerable population. Informed 

449 consent will be obtained from each prospective subject and appropriately documented in 

450 the language (Spanish or English) preferred by the subject. Recruitment materials and 

451 interactions with potential subjects will be conducted in English or Spanish, depending 

452 on subject preference. The Board agrees with EPA’s suggestion that it is preferable for 

453 recruitment discussions to take place away from the work site, to minimize the potential 

454 for coercion and that the protocol should describe the types of locations where 

455 recruitment discussions between researchers and potential subjects will take place, 

456 clarifying whether these discussions will take place at the work site or at locations that 

457 are away from the work site. The proposed monetary compensation is not so high as to 

458 unduly influence participation. Candidates and subjects will be repeatedly informed that 

459 they are free to decline to participate or to withdraw at any time for any reason, without 

460 penalty.

461

462 Depending on the number of employees and size of the grower’s facility, the Study

463 Director or researcher may contact employees using an informational recruitment flyer 

464 posted in a common work area. Alternatively, or subsequent to the use of a flyer, the 

465 Study Director or researcher will arrange a meeting with the grower’s employees who

466 express interest in participation. Such recruitment meetings will always occur without 

467 supervisors being present. The Study Director or researcher will describe the AHETF 

468 Exposure Monitoring Program, the goals of this specific study, the procedures to be used 

469 in exposure monitoring, and the risks and benefits to participants. The subject eligibility

470 factors listed in the consent form and SOP AHETF-11.B.6 are appropriate. Candidates 

471 who attend an individual interview will be paid $20 whether or not they agree to 

472 participate; enrolled subjects who put on the whole-body dosimeter will be paid $80 in 

473 addition to their usual pay, whether or not they complete participation.

474

475 c. Risks to subjects. The proposed test materials are EPA-registered products registered for 

476 nursery and/or greenhouse use and the specific application planned by the grower, and 

477 will be used in full compliance with the approved labels. All identified risks are 

478 characterized as of low probability, and risks are further minimized by exclusion of 

479 candidates who self-report that they are in less than “good” health; alerting subjects to 

480 signs and symptoms of heat stress; monitoring heat index with associated stopping rules; 

481 close observation of subjects; training of experienced technicians to minimize 

482 embarrassment; incorporation of procedures to keep results of pregnancy testing private 
483 and to permit discrete withdrawal; provision of appropriate work clothing and PPE. 

484 Provision is made for discrete handling of the pregnancy testing that is required of female 

485 subjects on the day of testing.

486

487 Five kinds of risks to subjects are discussed in the protocol, along with specific steps 

488 proposed to minimize them: the risk of heat-related illness; the risk associated with 

489 scripting of field activities; psychological risk; the risk of exposure to surfactants, and; 

490 the risk of exposure to surrogate chemicals. In this study, risks to subjects are classified 

491 as ‘greater than minimal’ since the likelihood of harm or discomfort is greater than what 

492 is encountered in ordinary daily life. In particular, the risk of heat-related illness 

493 (resulting from wearing an extra layer of clothing to trap the chemical) will be increased 

494 due to study participation. AHETF has adopted an extensive program to minimize these 

495 risks. Appropriate provision is made for safety and medical monitoring. The protocol also 

496 incorporates procedures to keep results of pregnancy testing private and to permit discrete 

497 withdrawal of a study subject. Finally, the protocol incorporates procedures to ensure 

498 that no photographs or videos will be taken in which a worker can be readily identified. 

499

500 d. Benefits to participants. This research offers no direct benefits to the subjects. The 

501 principal benefit of this research is likely to be reliable data about the dermal and 

502 inhalation exposure of people mixing, loading and application of pesticides using

503 powered handgun equipment. These data are intended to be used by EPA and other 

504 regulatory agencies to support exposure assessments for a wide variety of antimicrobial 

505 products and their uses. 

506

507 e. Risk/benefit balance. Risks to subjects have been thoughtfully and thoroughly minimized 

508 in the design of the research. The low residual risk is reasonable, in light of the likely

509 benefits to society from new data supporting more accurate exposure assessments for 

510 antimicrobial products. 

511

512 2. In addition to this analysis, the Board recommended a few edits to improve the clarity of the 

513 Informed Consent Form. These are listed below, organized according to the section within 

514 the Informed Consent Form in which they appear. In particular, in the past the Agency and 

515 the Board have suggested that protocols and consent forms clarify the steps that participants 

516 should take if participants have an adverse reaction within 24 hours. This was not included in 

517 the materials provided by the AHETF, and the Board recommends that such information be 

518 included on the consent form.

519

520 • Introduction and Purpose: 

521

522 “If you do In order to take part in this study, you must read and sign this consent form” 

523 (Line 4).

524

525 • Procedures Before the Start of the Study:

526

527 Modify the language per the protocol (p. 248/SOP II.D.2) to clarify that the pregnancy test 

528 will be taken prior to the start of the study:
529

530 8. If you are female, within 24 hours of prior to starting the study you will perform an

531 over-the-counter pregnancy test. If there is a delay in the start of the study of more than 24 

532 hours, another pregnancy test may be needed. The negative results of your pregnancy test 

533 will be verified by a female member of the study.

534

535 • Injury to Participants:

536

537 Add a line indicating the name and contact information of the Study Director or other 

538 individual to be contacted if the participant experiences an adverse event within 24 hours.

539

540 3. The Board agreed with the Agency that information about potential psychological and social 

541 harms related to unwanted disclosure of test results and breach of confidentiality associated 

542 with photographs or video may be included in the protocol (Evans, Sarkar and Sherman 

543 2011). However, the Board recommended that this information not be included in the 

544 informed consent form as it might give participants the erroneous impression that these risks 

545 are particularly significant or that appropriate steps have not been taken to mitigate them. 

546

547

548 Assessment of Completed AEATF II Research Study AEA-04: Measurement of Potential 

549 Dermal and Inhalation Exposure During Application of a Liquid Antimicrobial Pesticide 

550 Product Using a Pressurized Aerosol Can for Indoor Surface Disinfecting.

551

552 Overview of the Study

553

554 AEATF II aerosol spraying scenario was designed to measure a typical occupational 

555 handler’s daily exposure to an antimicrobial spray (containing C14 alkyl dimethyl benzyl

556 ammonium chloride [ADBAC]) packaged in a commercially-available pressurized aerosol spray

557 can. 

558

559 Eighteen (18) professional janitors were enrolled in the study, and applied (but did not 

560 wipe) the product on surfaces at one of three motels in the Fresno, CA area. Study participants 

561 were randomized to apply different amounts of product, from one (1) to four (4) cans of product 

562 in 1/2-can increments (i.e., 1 to 1.5 cans, 1.5 to 2 cans, and so on up to 3.5 to 4 cans).

563

564 Participants wore a variety of clothing combinations, ranging from short pants and short 

565 sleeved shirts with shoes plus socks, to long pants and long sleeved shirts with shoes plus socks. 

566 No participant wore gloves, but participants were given the option of wearing a respirator during 

567 product application; all 18 subjects elected to wear respirators during monitoring. All 

568 participants wore inner and outer sets of whole-body dosimeters that were sectioned and 

569 analyzed separately.

570

571 Dermal exposures were measured using whole-body dosimeters (inner and outer), and 

572 hand and face washes. Dermal unit exposures (reported in mg/lb AaiH) were calculated by 

573 dividing the summed total exposure by AaiH. The study sponsor report normalized the dermal 
574 exposures by milligrams (mg) of active ingredient applied, but these exposure data were 

575 recalculated by the Agency and expressed as mg/lb of active ingredient applied.

576

577 Inhalation exposures were measured using a personal air sampling pump and OVS tubes 

578 plus a separate pump used to run a RespiConTM Particle Sampler. This allows for collection and 

579 analysis of inhalation exposure monitoring results as total particles, as inhalable particles (<100 

580 μm), as thoracic particles (<10 μm), and as respirable particles (<2.5 μm). Inhalation unit 

exposures (reported in mg/m3581 /lb AaiH) were calculated by dividing the air concentrations by

582 AaiH.

583

The data will be posted to the Biocide Handlers Exposure Database (BHED®584 ). The 

585 Agency plans to use these data generically to estimate dermal and inhalation exposures and risks 

586 for other antimicrobial ingredients where the applied product is packaged in a pressurized 

587 aerosol spray can. Although the scenario as performed did not include the subsequent wiping of 

588 the aerosol spray solution, the Agency believes that dermal and inhalation exposure that results 

589 from the subsequent wiping of sprayed antimicrobial solutions can be determined by combining 

590 the results of this study with the results of the previously AEATF II conducted ready-to-use 

591 (RTU) wipe study (favorably reviewed at the April 2011 HSRB meeting; EPA HSRB 2011).

592

593 Science

594

595 Charges to the Board

596

597 Was the research reported in the AEATF II completed aerosol study report faithful to the 

598 design and objectives of the protocol and governing documents of the AEATF? 

599

600 Has EPA adequately characterized, from a scientific perspective, the limitations on these 

601 data that should be considered when using the data in estimating the exposure of professional 

602 janitorial workers who apply liquid antimicrobial pesticide products to indoor surfaces using 

603 pressurized aerosol cans? 

604

605 Board Response to the Charge

606

607 HSRB Recommendation

608

609 The Board concluded that the research reported in the completed monograph, associated 

610 field study reports, and associated supplemental documents was conducted in a manner that was 

611 reasonably faithful to the design and objectives of the protocol and governing documents of the 

612 AEATF. 

613

614 The Board also concluded that the Agency has adequately, but not completely, 

615 considered the limitations in this study when using the data in estimating the dermal and 

616 inhalation exposure of those who apply liquid antimicrobial pesticide products for indoor surface 

617 disinfecting using a pressurized aerosol can. In particular, the Board noted several issues, 

618 limitations and concerns with the data and analyses. These are described in greater detail below.

619
620 HSRB Detailed Recommendations and Rationale

621

622 The Board concluded that the study (Testman and Boatwright 2011) was done 

623 thoroughly, yielding detailed and helpful data that appear to be reliable. Some data trends were 

624 not explained in the accompanying Agency analysis, but overall the diversity of subjects and 

625 settings were strengths of the study. 

626

627 The Board agreed with the Agency that the number of participants was adequate to 

628 achieve the primary benchmark accuracy goal. The Board also agreed that the modest diversity

629 of application settings was a reasonable attempt to offset the practical limitation of recruiting and 

630 assessing all exposures within one geographic area. The documented diversity in application 

631 behaviors indicates the robust nature of the resulting exposure data. 

632

633 The Agency's analyses of protocol deviations and of the blank, fortified field, and lab 

634 samples were acceptable. In addition to the deviations noted in the final report (Testman and 

635 Boatwright 2011, 1033-104) or by the Agency (Leighton 2012, 9), however, the Board identified 

636 a few more. For example, subject AE4 was apparently observed to be applying the product to 

637 surfaces at much heavier rates than usual. About 20% of the way into the sampling time, the 

638 study director instructed this subject to “lighten up” in their application (Testman and Boatwright 

639 2011, 488). This intervention comprises an unknown limitation that may have had a large effect 

640 on reducing a potentially high exposure. Alternatively, it may have had no significant effect and 

641 was unjustified in terms of protecting the subject. Although no specific prohibition against such 

642 interventions was found in the protocol, such instructions regarding applicator behavior were 

643 counter to the intent of the protocol (i.e., that the study participants “spray surfaces as they would 

644 normally do” [Testman and Boatwright 2011, 18]). Thus, it is unclear whether this event actually

645 qualifies as a protocol deviation. However, the lack of an explicit prohibition of study director 

646 intervention raised issues in this study’s analysis and interpretation. Guidance about how to 

647 handle interventions should be incorporated into future protocols and standard operating 

648 procedures (SOPs). 

649

650 Subject AE18 (in cluster #1) was a borderline outlier without any indication in the field 

651 notes of intervention by the researchers. The Board did not disagree completely with the 

652 Agency’s conclusion that AE18’s data was not an outlier (Leighton 2012, 15), but believed that 

653 one particular combination of these data -- application rate -- reflects the characteristics of an 

654 outlier. However, the Board did not advocate excluding this data point from subsequent 

655 analyses. Rather, these sometimes substantial differences provide additional support for the 

656 diverse and therefore broadly representative nature of the subjects and the qualitatively robust 

657 nature of the study results. 

658

659 The Board also discussed outliers in laboratory recovery data. These data were not used 

660 by the Agency to correct field samples; the Board agreed with the EPA’s approach. However, 

661 the lack of explicit procedures for handling outliers raised questions among Board members. 

662 Explicit discussions about when data should or should not be excluded should be incorporated 

663 into future protocols and SOPs.

664
665 The Board raised concerns that the 20% higher flow rates (or discharge rates) from the 

666 batch of aerosol cans used in the first four MEs, as compared with the flow rates from those cans 

667 used in the last 14 MEs, could cause an appreciable difference in exposure (Leighton 2012, 9). 

668 Typically, a faster discharge rate through a given nebulizer produces smaller droplets. An 

669 analysis of variance for data in this study found a statistically significant difference between the 

670 average fraction of the a.i. <10 μm in the first four RespiConTM samples and the last 14 samples 

671 (44% versus 55%, respectively; p < 0.00001). This difference is consistent with the expectation 

672 that the first batch of canisters may have produced particles with a mass median aerodynamic 

673 diameter just over 10 μm and the last batch particles with a mass median aerodynamic diameter 

674 just under 10 μm. The difference in particle size is more likely to have been due to the reported 

675 difference between flow rates than the difference in ADBAC concentration in the product. 

676 Notably, the impact of this probable shift to slightly smaller droplets is small in comparison to 

677 the much wider variation in flow rates and particle sizes among the many other products these 

678 studies are intended to represent.

679

680 The Board also raised concerns that the ventilation data presented were unclear, 

681 inadequately recorded, and inadequately interpreted (Testman and Boatwright 2011, 119-20). 

682 For example, “fresh air” was presented using different metrics (e.g., %, total fan cubic feet per 

683 minute [CFM], and CFM fresh air). Furthermore, the reported air changes per hour seem to 

684 differ from separately calculated values by factors of 1.5- to 3-fold. Analyses by one Board 

685 member suggest that the overall effect of the deficiencies may have been small; the amount of 

686 time that participants spent in each room was so short that airborne ABDAC was just beginning 

687 to accumulate by the time the subjects left the space, limiting the effect of ventilation on overall 

688 rates of exposure. However, the Board recommended that the Agency consider the potential 

689 limitations associated with the heating, ventilation and air conditioning systems in the test 

690 facilities.

691

692 The Agency requested the Board’s advice on the use of RespiConTM versus OVS results. 

693 The major advantage of the RespiConTM air samples is their ability to look at the data by size 

694 ranges. A disadvantage of collecting RespiConTM samples is the challenge of confronting the 

695 difference inherent in the entrance losses of any two air samplers. Such losses are a 

696 characteristic primarily of entrance diameters and flow rates, but also of the shape of those 

697 entrances and their orientation, and the air velocity and particle diameters in any given setting. 

698 These characteristics affect both the RespiConTM and OVS samples. Unfortunately, it appears 

699 that no tests could be found in the literature comparing the OVS with the RespiConTM sampler 

700 (e.g., Leighton 2012, 35-7). Thus, there is no reliable basis upon which to correct the 

701 RespiConTM to the OVS data. For the purposes of calculating dose via inhalation, however, the 

702 Board recommends that the <10 micron-size results from RespiConTM monitors be used because 

703 this size range represents the fraction that enters the respiratory tract and thus provides a more 

704 conservative estimate of inhalation exposure. 

705

706 The Board suggested that the dermal and inhalation exposure data be combined to obtain 

707 total exposure results. The Board also questioned whether a slope of 1.5, with a confidence 

708 interval (CI) including one (1), should be considered as evidence of proportionality. 

709 Furthermore, a CI that does not include one may not provide adequate protection. The Board 

710 thus recommended that the Agency always clarify coefficients over one. Finally, the Board 
711 recommended that the Agency and the Task Force refrain from using the word ‘proportional’ 

712 without preceding it by an adjective such as 1:1 proportional or 1:2 proportional. 

713

714 Ethics

715

716 Charge to the Board

717

718 Does available information support a determination that the study was conducted in 

719 substantial compliance with subparts K and L of 40 CFR Part 26?

720

721 Board Response to the Charge

722

723 HSRB Recommendation

724

725 The Board concurred with the Agency’s assessment (Sherman 2012) that the study

726 submitted for review was conducted in substantial compliance with subparts K and L of 40 CFR 

727 Part 26. 

728

729 HSRB Detailed Recommendation and Rationale

730

731 The documents prepared by Golden Pacific Laboratories, LLC, and submitted by

732 American Chemistry Council Antimicrobial Exposure Assessment Task Force II under Project 

733 No. AEA-04, state that the study was conducted in compliance with the requirements of the 

734 EPA’s Good Laboratory Practice (GLP) Standards; FIFRA §12(a)(2)(P); and the applicable 

735 subparts of 40 CFR 26 (Testman and Boatwright 2011). 

736

737 The protocol was reviewed and approved by an independent human subjects review 

738 committee, IIRB, Inc. of Plantation, FL prior to submission. Minutes of IIRB, Inc. meetings and 

739 a copy of IIRB, Inc. policies and procedures were provided. This IRB is fully accredited by 

740 AAHRPP and registered with OHRP (see details above). Documentation provided to the EPA 

741 indicated that IIRB, Inc. reviewed this study pursuant to the standards of the Common Rule (45 

742 CFR Part 46, Subpart A) and found it in compliance (IIRB, Inc. 2010; 2011).

743

744 1. The Board concurred with the conclusions and factual observations relating to the study, as 

745 detailed in the EPA’s Ethics Review (Sherman 2012). Specifically:

746

747 a. Prior HSRB and Agency Review. The requirements of 40 CFR §26.1125 for prior 

748 submission of the protocol to EPA and of §26.1601 for HSRB review of the protocol 

749 were satisfied. The study (Testman and Boatwright 2011) was conducted in accordance 

750 with the protocol previously reviewed by the Agency (Leighton, Walls and Sherman 

751 2009) and by the HSRB (EPA HSRB 2009). Neither the Agency’s nor the HSRB’s ethics 

752 reviews identified any significant deficiencies requiring correction relative to 40 CFR 26, 

753 subparts K and L, or to FIFRA § 12(a)(2)(P) (Leighton, Walls and Sherman 2009). 

754 Because the study was conducted in California, the approval of the California 

755 Department of Pesticide Regulation (CDPR) was also required before the study could be 
756 initiated. CDPR granted final approval of the amended protocol and supporting 

757 documents on April 19, 2010.

758

759 b. Responsiveness to HSRB and Agency Reviews. Following HSRB review, the protocol and 

760 consent form were modified to incorporate changes responsive to the all of the comments 

761 of EPA (Leighton, Walls and Sherman 2009) and the HSRB (EPA HSRB 2009). 

762 Additional corrections and amendments were also requested by CDPR. IIRB, Inc. granted 

763 approval to the amended protocol and supporting documents on April 6 and April 7-9, 

764 2010, respectively (Testman and Boatwright 2011; Sherman 2012). 

765

766 c. Substantial Compliance with Reporting Requirements (40 CFR Part 26 subpart M). The 

767 AEATF II’s submission (Testman and Boatwright 2011), along with the separately 

768 submitted documents describing the procedures and roster of the IRB (IIRB, Inc. 2010; 

769 2011), fully meet the requirements of 40 CFR §26.1303 to document the ethical conduct 

770 of the research.

771

772 2. The Board concluded that this study, as conducted, met all applicable ethical requirements 

773 for research involving human participants, in accordance with the following criteria that had 

774 been stated in the Board’s prior review of this study protocol (EPA HSRB 2009):

775

776 a. Acceptable risk-benefit ratio. The risks to study participants were minimized 

777 appropriately and were justified by the potential societal benefits, particularly data on the 

778 dermal and inhalation exposure of professional janitorial workers to antimicrobial 

779 compounds as they sprayed indoor surfaces with aerosolized pesticides. These data could 

780 be used to develop mechanisms to protect future users of these antimicrobial pesticides.

781

782 • Minors and pregnant or lactating women were excluded from participation, with 

783 pregnancy confirmed by over-the-counter pregnancy testing on the day of study or by 

784 opt-out. The potential of stigma resulting from study exclusion was also appropriately 

785 minimized. 

786

787 • Clear stopping rules and medical management procedures were in place, and no adverse 

788 events or other incidents of concern related to product exposure were reported.

789

790 • The study was designed to minimize the risks of exposure to the test compounds.

791

792 b. Voluntary and informed consent of all participants.

793

794 • The study protocol included several mechanisms designed to minimize coercive 

795 recruitment and enrollment. 

796

797 • Monetary compensation was not so high as to unduly influence participation. Minors 

798 and pregnant or lactating women were excluded from participation, with pregnancy

799 confirmed by over-the-counter pregnancy testing on the day of study or by opt-out. The 

800 potential of stigma resulting from study exclusion was also appropriately minimized. 

801
802 3. Although the first study participants were enrolled in April 2010 and monitoring began in 

803 June 2010, shortly thereafter the study was placed on ‘hold’ as the result of an issue raised 

804 by CDPR. In response to a request from some participants to wear a respirator while 

805 engaged in study related tasks, the AEATF II decided to offer all study subjects the option 

806 of wearing a half-mask respirator fitted with organic vapor cartridges. This decision was 

807 made after consulting with the Agency and with the IRB, and the amended protocol and 

808 informed consent forms were reviewed and approved by the IRB. Upon receipt of the 

809 approved protocol amendment, CDPR requested that the study be halted temporarily until 

810 Golden Pacific Laboratories could conduct an additional review of its procedures for 

811 respirator use. CDPR granted approval for the amended protocol on May 11, 2011.

812

813 This hold is unlikely to have affected the integrity of the research or the safety of 

814 participants. In fact, by allowing subjects to wear a respirator, the researchers further 

815 minimized potential risks to study participants. All 18 monitored subjects used a respirator, 

816 which was fitted by a trained study investigator and worn under the supervision of a 

817 registered study nurse.

818

819 4. Several minor deviations from GLP were reported by the study sponsors (Testman and 

820 Boatwright 2011, 3), but these were unlikely to have affected the integrity of the research 

821 or the safety of participants. Only one of these deviations bears further discussion, namely

822 the enrollment of a participant who self-reported that his health was only “fair,” despite the 

823 requirement that all participants be in “good health” (Testman and Boatwright 2011, 227). 

824 This same issue was discussed by the HSRB during its October 2010 and April 2011 

825 meetings (EPA HSRB 2010; 2011), at which time the Board recommended that the study

826 sponsors clarify the criteria used to establish participants’ health status prior to enrollment. 

827 Enrollment of this particular participant, however, happened prior to those two Board 

828 meetings. Furthermore, although formally enrolled in the study, this participant was not 

829 one of the 18 subjects monitored. Thus, the Board concluded that this deviation did not put 

830 the participant at increased risk.
831 REFERENCES

832

833 Collier, R. for the Agricultural Handler Exposure Task Force (AHETF). 2011. Mixing, Loading 

834 and Application of Pesticides in Managed Horticultural Facilities using Powered Handgun 

835 Equipment (AHETF Study No. AHE600). Dated October 24, 2011. Unpublished document 

836 prepared for the AHETF, 474 p.

837

838 EPA Human Studies Review Board. 2009. October 21-22, 2009 Human Studies Review Board 

839 Meeting Report. 26p.

840

841 EPA Human Studies Review Board. 2010. October 27-28, 2010 Human Studies Review Board 

842 Meeting Report. 31p.

843

844 EPA Human Studies Review Board. 2011. April 13-14, 2011 Human Studies Review Board 

845 Meeting Report. 31p.

846

847 Evans, J., B. Sarkar, and K. Sherman. 2011. Science and Ethics Review of AHETF Scenario 

848 Design and Protocol AHE600 for Exposure Monitoring of Workers during Mixing, Loading and 

849 Application of Pesticides in Managed Horticultural Facilities using Powered Handgun 

850 Equipment. Dated December 30, 2011. Unpublished document prepared by the Office of 

851 Pesticide Programs, United States Environmental Protection Agency. 57p. 

852

853 Independent Institutional Review Board, Inc. (IIRB, Inc.). 2010. Human Research Protection 

854 Program Plan (HRPP Plan). Dated November 3, 2010. Unpublished document prepared by IIRB, 

855 Inc. 131p.

856

857 IIRB, Inc., 2011. IRB Membership Roster. Dated September 12, 2011. Unpublished document 

858 prepared by IIRB, Inc. 1p.

859

860 Leighton, T., C. Walls and K. Sherman. 2009. Science and Ethics Review of AEATF II Aerosol 

861 Scenario Design and Protocol for Exposure Monitoring. Dated September 21, 2009. 

862 Unpublished document prepared by Office of Pesticide Programs, United States Environmental 

863 Protection Agency. 52p.

864

865 Leighton, T. 2012. Science Review of the AEATF II Aerosol Human Exposure Monitoring 

866 Study. Dated January 3, 2012. Unpublished document prepared by Office of Pesticide Programs, 

867 United States Environmental Protection Agency. 38p.

868

869 Sherman, K. 2012. Ethics Review of Completed AEATF II Aerosol Scenario Worker Exposure

870 Monitoring Study. Dated January 4, 2012. Unpublished document prepared by the Office of the 

871 Director, Office of Pesticide Programs, United States Environmental Protection Agency. 20p.

872

873 Testman, R.J. and M.T. Boatwright, for the AEATF II. 2011. A Study for Measurement of 

874 Potential Dermal and Inhalation Exposure During Application of a Liquid Antimicrobial 

875 Pesticide Product Using a Pressurized Aerosol Can for Indoor Surface Disinfecting. Dated 
876 November 14, 2011. Unpublished document prepared by the Golden Pacific Laboratories, LLC, 

877 for the AEATF II. 1851p. MRID 48659001.