1

Minutes of the

United States Environmental Protection Agency (EPA)

Human Studies Review Board (HSRB) 

December 13, 2010 Public Teleconference Meeting

Docket Number: EPA–HQ–ORD–2010–0919

HSRB Web Site: http://www.epa.gov/osa/hsrb

Committee Members: (See EPA HSRB Members list – Attachment A) 

Date and Time: Monday, December 13, 2010, 3:00 p.m. – 4:30 p.m.

(See Federal Register Notice – Attachment B) 

Location: Via teleconference

Purpose: The EPA Human Studies Review Board provides advice, information, and 

recommendations on issues related to the scientific and ethical aspects of 

human subjects research. 

Attendees: Chair: Sean Philpott, Ph.D., M.S. Bioethics

Vice Chair: Janice Chambers, Ph.D., D.A.B.T.

Board Members: George C.J. Fernandez, Ph.D.

Vanessa Northington Gamble, M.D., Ph.D.

Sidney Green, Jr., Ph.D., Fellow ATS

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP

José E. Manautou, Ph.D.

Rebecca T. Parkin, Ph.D., M.P.H.

William J. Popendorf, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Meeting Summary: Meeting discussions generally followed the issues and general timing as 

presented in the meeting Agenda (Attachment C), unless noted otherwise 

in these minutes. 

INTRODUCTORY REMARKS

Mr. Jim Downing (Designated Federal Officer [DFO], Human Studies Review Board 

(HSRB), Office of the Science Advisor [OSA], U.S. Environmental Protection Agency [EPA or 

Agency]) opened the teleconference meeting and welcomed Board members on behalf of the 

EPA Science Advisor Dr. Paul Anastas and the Program in Human Research Ethics. He noted 

that the Agency appreciates the Board members’ time and work in preparing for the meeting and 

deliberations. He also welcomed EPA colleagues and members of the public. The purpose of this 

teleconference meeting was to review the decisions made by the Board at the October 27-28, 

2010 HSRB meeting and to finalize the Board report from that meeting.
2

MEETING ADMINISTRATIVE PROCEDURES

As DFO, Mr. Downing serves as the liaison between the HSRB and EPA and ensures that 

Federal Advisory Committee Act (FACA) requirements are met. As DFO, he also works with the 

appropriate officials to ensure that all applicable ethics regulations are satisfied. Each Board 

member has been briefed on the provisions of the federal conflict of interest laws and has filed a 

standard government financial disclosure form that has been reviewed to ensure that all ethics 

disclosure requirements have been met. Mr. Downing reminded participants that meeting times 

listed on the agenda would be approximate, and that Board members should introduce 

themselves before speaking. At the appropriate time, members of the public may provide public 

comments; these must be limited to 5 minutes.

Copies of the meeting materials are available on regulations.gov under the docket number 

EPA-HQ-ORD-2010-0919. According to FACA requirements, meeting minutes, including 

descriptions of the discussions and conclusions reached by the Board will be prepared. These 

minutes will be certified by the Chair within 90 days of the meeting and posted at 

www.regulations.gov and on the HSRB Web site. 

MEETING PROCESS

Dr. Sean Philpott explained that the Board would discuss the final draft Board report, 

focusing on the charge questions presented to the Board at the October 2010 meeting and 

summarizing the Board’s response. The report is intended to be a summary of the HSRB’s 

consensus recommendations and not a detailed technical document. The Agency and study 

sponsors have access to detailed meeting minutes for additional information. 

For each charge question, Board members would have an opportunity to raise concerns 

they may have about Board conclusions and rationales. Dr. Philpott requested that the HSRB 

focus on substantive changes to the report that directly affect the Board’s recommendations. 

Board members should submit typographical and grammatical corrections to Dr. Philpott and 

Mr. Downing via e-mail and they will be incorporated into the final report.

PUBLIC COMMENTS

Dr. Philpott invited public comment on the draft October 2010 HSRB meeting report. No 

public comments were presented. Dr. Philpott stated that one public comment was received via 

e-mail in response to the Federal Register announcement of the Board’s teleconference meeting, 

but this comment focuses on the question of whether or not compounds such as the pesticides 

that the HSRB reviews should be tested on animals or humans. Because the comment does not 

relate directly to any of the issues discussed at the October 2010 meeting, he did not read it into 

the record. 
3

BOARD DISCUSSION AND DECISION ON FINAL REPORT

Carroll-Loye Biological Research, Inc. Protocol No Mas-003: Field Efficacy Test of 16% 

Para-menthane-3,8-diol (PMD) and 2% Lemongrass Oil-based Repellent “No Mas” 

Against Mosquitoes

Dr. Philpott reviewed the Board’s conclusions regarding Carroll-Loye Biological 

Research, Inc. protocol No Mas-003, which describes a study to test the repellent efficacy of a 

lotion formulation containing 16% PMD and 2% lemongrass oil (“No Mas”) against three 

species of mosquitoes in the field. The Board was asked whether the proposed No Mas-003 field 

repellency study, if revised as suggested in EPA’s review and if the research is performed as 

described, will likely generate scientifically reliable data useful for assessing the efficacy of the 

tested material in repelling mosquitoes (page 8, line 273). The Board concluded by concurring 

with the Agency’s assessment that the proposed field repellency study protocol is likely to 

generate such scientifically reliable data. Dr. Philpott inquired if the Board members had 

comments on the Board’s response to the charge question. The Board members did not have 

comments on the recommendation or rationale. 

The ethics charge question for this protocol asked whether the research is likely to meet 

the applicable requirements of 40 Code of Federal Regulations (CFR) Part 26, subparts K and L, 

if the proposed field repellency study protocol No Mas-003 is revised as suggested in EPA’s 

review and if the research is performed as described (page 9, line 309). The Board concluded that 

the protocol, if modified in accordance with EPA and HSRB recommendations, is likely to meet 

the applicable requirements. No Board members had comments on the recommendation or 

detailed rationale in the report. 

Several Board members had recommended, during the report-writing process, that the 

HSRB develop a template for writing the scientific recommendations and rationale similar to the 

template for responses to ethics questions. This topic will be included on the administrative 

agenda for the January 2011 Board meeting.

Proposed Agricultural Handler Exposure Task Force (AHETF) Scenario and Protocol 

AHE-400: Backpack and Handgun Application of Liquid Sprays in Utility Rights-of-Way

Dr. Philpott explained that AHETF’s proposal presents an agricultural handler exposure 

scenario involving backpack and handgun application of liquid pesticides along utility rights-ofway. Study participants would be asked to apply and potentially load one of four surrogate 

pesticides, with a total of 21 participants (three volunteers each from seven geographically

distinct regions) enrolled using a purposive sampling method. During the October 2010 HSRB 

meeting, the Board was asked to address whether the proposed AHETF Right-of-Way

application scenario and field study proposal AHE-400, if revised as suggested in EPA’s review, 

and if the research is performed as described, is likely to generate scientifically reliable data 

useful for assessing the exposure of workers who apply pesticides in utility rights-of-way using 

backpack or handgun sprayers (page 13, line 475). The Board concurred with EPA’s assessment 

that the proposed scenario and protocol AHE-400 is likely to generate scientifically reliable data. 
4

Dr. Michael Lebowitz noted that the Board’s recommendation did not describe 

adequately the Board’s concerns in its discussions at the October 2010 HSRB meeting. At that 

time, the HSRB concluded that the protocol would provide useful data, but the issue of 

variability was raised a number of times in comments, both at the meeting and during preparation 

of the draft meeting report. There are only 21 sample points and the variability is high. If the 

study was replicated, results also could vary significantly, and concluding that the data would be 

“reliable” would be inappropriate. Dr. Philpott noted that Dr. Lebowitz had submitted comments 

during preparation of the report, and he had made a change in the detailed recommendations and 

rationale to remove the phrase “scientifically reliable” so that line 493 (page 13) reads “this 

protocol will likely generate data that may be useful for assessing the exposure” of pesticide 

handlers. Dr. Philpott suggest that a similar change be made at lines 486 and 487 (page 13) if the 

Board approved. 

Dr. Janice Chambers cautioned that by removing the phrase “scientifically reliable,” the 

Board would not be addressing the charge question. Dr. Philpott asked Board members and the 

Agency staff on the call for input on whether describing the data only as potentially useful 

adequately addresses EPA’s charge. Mr. John Carley (Office of Pesticide Programs [OPP], EPA) 

believed that EPA would prefer the HSRB to address the charge question using the term 

“scientifically reliable data.” He noted that although the concerns that the scenario could result in 

highly variable data were not without basis, the Board has not had the same concern about the 

term “reliable” with similar scenarios it has reviewed previously. The sample size, with seven 

clusters of three, is not statistically less reliable than a five-by-five sample, and the variability of 

individual behavior is not greater than in other scenarios. Dr. Chambers commented that the 

proposed locations are more variable than an orchard or row crop field, but she did not have a 

problem with the use of the term “reliable” because this does not mean that every situation would 

be the same. Dr. Lebowitz stated that the question concerned EPA’s definition of “reliable” in 

the charge question; if trustworthy is meant rather than reproducible, the response would be 

different. He did not recall EPA instructing that the Board use the same words in its responses as 

in the charge question. 

Dr. Philpott stated that there seemed to be Board consensus that the study would yield 

data that is trustworthy and useful for analysis, but the fundamental concern is that the variability

inherent in the different proposed study environments calls into question the reproducibility of 

those data, should this design be replicated. Dr. William Popendorf suggested that the problem of 

variability should have been put into the model that determined the 3X factor, and he was unsure 

whether the same expected variability within the data was present in many other scenarios. If the 

3X value is valid, then the mean value of those data should be as reliable as in any other 

scenario. Dr. Johnson responded that the data would be useful, but until the study is conducted 

the HSRB will not know whether the data are likely to be reproducible. 

Dr. José Manautou stated that a clear definition of “scientifically reliable data” was 

needed. Dr. Chambers responded that the Board previously had not considered reproducibility

when discussing reliability. Dr. Philpott noted that this case highlights a need for the Board to 

define its interpretation of some of the terms in the charge questions; the Board did not speak to a 

specific definition of “scientifically reliable” during the October 2010 HSRB meeting and 

therefore it should not be addressed within the meeting report. The Board’s concerns have been 
5

noted by the Agency and will be captured in the meeting minutes. He proposed that the Board 

come to consensus on how to phrase its response to the charge question so that the meeting 

report may be finalized. During the next HSRB meeting in January 2011, he will ask the lead 

discussants to be explicit about their definitions or interpretations of the phrase “scientifically 

reliable data.” 

Dr. Lebowitz suggested that the statements in question be reworded to read “is likely to 

generate scientific data, reliable in the sense that it is trustworthy.” Dr. Philpott suggested that 

the Board not use a value-laden term like “trustworthy.” Dr. Popendorf suggested that the 

statements should be kept as written. Dr. Philpott noted general consensus that in this case, an 

acceptable definition of scientific reliability would be data that are accurate within the context of 

the study, but that may not be reproducible should the scenarios be repeated. He would like to 

capture this idea in the report so that the Agency and the sponsors have an accurate assessment 

of the Board’s interpretation. Dr. Lebowitz suggested leaving the recommendation as written, but 

adding Dr. Philpott’s statement in the detailed recommendations. Dr. Philpott noted that the 

report states, on line 507 (page 14): “However, the Board noted a few weaknesses in the 

proposed study design. In particular, the variability in individual dermal and inhalation exposure 

levels may be extremely high because of the diversity of terrains and locations selected for the 

study and the opportunity for large (but potentially categorical) personal differences in 

application practices.” Dr. Lebowitz suggested adding the following text after this sentence, “As 

such, results may not be reproducible should the study be repeated.” Dr. Johnson added that the 

term “reliable” might be appropriate and that will be assessed when the Board reviews the data 

after the study is conducted. Once the data are received, it will be clear how accurately exposure 

can be assessed. 

Dr. Philpott suggested that the HSRB recommendation (line 486, page 13) be changed 

from “is likely to generate scientifically reliable data” to “may generate scientifically reliable 

data.” Drs. Rebecca Parkin, Chambers, and Manautou agreed. Dr. Philpott stated that with this 

change and the addition of the sentence Dr. Lebowitz suggested (above), the Board achieved 

consensus that the study may generate scientifically reliable data, but recognized that a high level 

of variability that may result from the diversity of terrain, location, and personal differences in 

application practices may call into question the data’s reproducibility. 

The ethics charge question asked whether the proposed scenario and protocol, if revised 

as suggested in EPA’s review and if the research is performed as described, is likely to meet the 

applicable requirements of 40 CFR Part 26, subparts K and L (page 14, line 524). The Board 

concluded that the protocol, if modified in accordance with EPA and HSRB recommendations, is 

likely to meet the applicable requirements. Dr. Philpott noted that the primary concern raised by

the Board was the task force conclusion that the risk of toxicity from pesticide-handling was not 

considered and the risk of surrogate toxicity would not be listed in the consent forms or the 

protocol. The HSRB strongly recommended that, given the scripted nature of the study, the risk 

of exposure to pesticides should be categorized as a risk due to study participation, albeit one 

that is appropriately minimized. The Board further made minor suggestions on how the study

protocol should be modified, such as addressing some of the discrepancies noted in the exclusion 

criteria, and suggesting that study participants undergo handwashing prior to eating or smoking 
6

to reduce the risk of accidental ingestion of the surrogate compound. Board members had no 

further comments or questions on the recommendation. 

Completed Scenario Monograph and Study Report from the Antimicrobial Exposure 

Assessment Task Force II (AEATF–II): Dermal and Inhalation Exposure of Professional 

Janitorial Workers Applying Liquid Antimicrobial Products to Indoor Floors Using 

Bucket and Mop (AEA-03)

Dr. Philpott commented that during the report writing process, Dr. Popendorf noticed 

some data entry errors in the presentation of results from the mop study; these have been 

adequately resolved. The corrections did not affect the conclusions nor are they likely to affect 

the Board’s recommendation, but there will be changes to EPA’s presentation on the docket. 

The Board was asked to address two scientific charge questions: (1) was the research 

reported in the AEATF–II completed study report AEA-03 and associated supplemental reports 

faithful to the design and objectives of the protocol and governing documents of the AEATF-II 

(page 17, line 674); and (2) has the Agency adequately characterized, from a scientific 

perspective, the limitations that should be considered when using these data in estimating 

exposure of those who apply antimicrobial floor-cleaning products with mop and bucket (page 

18, line 678). 

Dr. Popendorf will submit a separate report to the Agency with recommendations 

regarding some of the data limitations for the development of exposure models that he noted at 

the meeting, but that the HSRB did not have time to discuss in detail. These are mentioned in the 

report as being included in an appendix, but they will be sent to the Agency separately. The 

report has been modified accordingly. Line 779 (page 20) has been changed to read “Although 

not discussed in detail by the Board at the October 2010 meeting, several of these factors are 

discussed in a separate report submitted independently by HSRB member Dr. William Popendorf 

to the Agency.” Dr. Chambers suggested that Dr. Popendorf not be mentioned by name, and 

Dr. Philpott agreed to remove his name from the sentence. All Board members will receive a 

copy of these recommendations. 

In response to the charge questions, the Board concurred with the Agency’s assessment 

that the research was conducted in a manner that was reasonably faithful to the design and 

objectives of the protocol and governing documents of the AEATF-II. The Board also concluded 

that the Agency had adequately, but not completely, characterized the limitations on those data 

that should be considered when using the data in estimating exposure of those who apply 

antimicrobial floor-cleaning products with mop and bucket. Those concerns about factors that 

may have been overlooked or underestimated are summarized in the Board’s detailed 

recommendations and rationale (page 18, line 694). 

Dr. Parkin pointed out that line 737 (page 19), which reads: “However, although the 

presumption of proportionality was demonstrated for dermal exposure and the amount of AI 

handled, the rationale supporting the presumption of proportionality for inhalation exposure 

needs to be recalculated but based on current data may not be as clear and consistent as for the 

dermal exposure,” is unclear. Dr. Popendorf responded that the need to recalculate arose because 
7

the correlation was based on concentration versus dose, so it did not include time. The current 

data do not correlate with the amount of active ingredient handled (AaiH); based on that, the 

recalculated data may not correlate either. He suggested adding “to include duration of exposure” 

after the word “recalculated” on line 740 (page 19) and ending the sentence at that point. Dr. 

Popendorf suggested that the phrase “but based on current data may not be as clear and 

consistent as for the dermal exposure” be deleted because it is speculation. 

Dr. Manautou called the Board’s attention to the sentence on line 713 (page 18) that 

reads: “While this lack of information places potentially important limitations on how the 

inhalation data should be interpreted, in the professional opinion of at least one Board member 

the impact of differences among the test sites are likely to be within a factor of about two and 

thus not substantively change the overall mean exposure levels.” He asked whether it was 

necessary to stress that this comment was the opinion of one member. Dr. Philpott responded 

that this was an opinion that was not discussed at the meeting and was not part of the HSRB’s 

consensus recommendation. Dr. Chambers questioned whether the Board had phrased anything 

like that in the past, and Dr. Philpott replied that it had used this phrasing when there had been 

disagreements in response to ethics questions when reviewing pre-rule studies. Mr. Downing 

commented that the phrase “in the professional opinion” had not been used previously by the 

Board. Dr. Philpott noted that “in the professional opinion of at least one Board member” could 

be changed to state “some Board members felt that...” Several Board members agreed to this 

change. However, Dr. Lebowitz questioned inclusion of the sentence. Dr. Lebowitz stated that 

most indoor environment studies show a factor of at least five in difference in air exchange due 

to ventilation. Dr. Popendorf asked whether this was in buildings like those being discussed in 

this study. Dr. Lebowitz responded that it was, and that the data were in the EPA Building 

Assessment Survey and Evaluation (BASE) database derived from a discussion of the Integrated 

Human Exposure Committee of the EPA Science Advisory Board. It is also included in a 1981 

National Academy of Sciences (NAS) report on indoor pollutants. Dr. Chambers noted that this 

should be cross-referenced to add substance to the sentence. Dr. Lebowitz recommended 

removing the sentence because the Board has not had sufficient discussion on the topic. Dr. 

Philpott noted that if there were no objections, he would remove the sentence, but suggested that 

a reference to the NAS report be included. Dr. Popendorf suggested that a 1981 reference would 

not be applicable to the buildings under discussion. Dr. Lebowitz suggested the Integrated 

Human Exposure Committee of EPA’s Science Advisory Board and the EPA BASE database be 

referenced instead, but he did not have the specific reference. Dr. Philpott asked Mr. Carley if the 

Agency would like additional guidance or references for consideration of the impact of heating, 

ventilating, and air conditioning (HVAC) systems on inhalation exposures. Mr. Carley responded 

the statement that the topic should be addressed with greater care is sufficient. Dr. Philpott will 

delete the sentence, but asked that Mr. Downing look for the reference that Dr. Lebowitz 

mentioned and send it to the HSRB members. Mr. Downing agreed to do so.

On line 753 (page 19), Dr. Lebowitz suggested removing the phrase “One Board member 

observed, however, that” and stating instead that “The Agency’s reliance on hand wash data 

should be examined more closely to ensure that it has not overcorrected face and neck residue 

estimates.” Dr. Popendorf questioned the sentence on line 755 that states “Another Board 

member questioned whether the model actually supports the conclusion of proportionality for 

some of the dermal configurations.” Dr. Sidney Green, Jr. stated that this sentence may relate to a 
8

question he raised at the meeting regarding a statement made by an EPA presenter to the effect 

that the data that would be generated may not be broadly applicable, but were being used in risk 

assessment. His concern was that if not broadly applicable, the data should not be used for risk 

assessment. Dr. Parkin commented that her notes indicated that the Board member who raised 

the issue was not in attendance. Dr. Philpott noted that the first sentence under discussion (line 

753) could be changed to “The Agency should carefully examine the hand wash data, however, 

to ensure that it does not over-correct for face and neck residue estimates.” Mr. Carley

mentioned that in reviewing the draft, Mr. Timothy Leighton (OPP, EPA) and he had discussed 

the sentence, and Mr. Leighton agrees that the hand wash data may have over-corrected for face 

and neck residues. With respect to the sentence on line 755, Mr. Leighton noted that the 

Agency’s conclusion was that the data do not support proportionality for some of the clothing 

configurations. He added that the Board and the Agency are in basic agreement about these 

points. Dr. Philpott then suggested that the sentence on line 753 be changed to state that the 

Agency has already recognized that the hand wash data may over-correct for face and neck 

residue estimates. Dr. Parkin recommended that the sentence on line 755 be simplified to state 

that “additionally, the model may not always support the conclusion of proportionality for all 

clothing configurations.” The Board members agreed to these two changes. 

The ethics charge question asked whether available information supports a determination 

that the study was conducted in substantial compliance with 40 CFR Part 26, subparts K and L 

(page 20, line 785). The Board concurred with the Agency’s assessment that the study was 

conducted in substantial compliance with the applicable requirements. The Board’s detailed 

response notes that there were three minor protocol deviations, but that they were unlikely to 

have affected the integrity of the research or the safety of the study participants. For future 

reference, the HSRB recommended that the sponsors clarify the criteria used to establish 

participants’ health status prior to study enrollment. Dr. Vanessa Northington Gamble noted that 

number 1(b) was listed twice, on lines 817 and 832 (page 21). Dr. Philpott had found this error 

and corrected it. Board members did not have further comments on the recommendation or 

rationale. 

Revised Scenario Design and Associated Protocol from the Agricultural Handler Exposure 

Task Force (AHETF) Describing Proposed Research to Monitor Exposure of Workers 

Who Mix and Load Pesticides Formulated as Wettable Powders in Water-Soluble 

Packaging (AHE-120)

Dr. Philpott noted that this was a revised proposal that had originally been reviewed 

favorably by the Board at the June 2009 HSRB meeting, but one of the surrogate pesticides was 

no longer available in water-soluble packaging, and the AHETF proposed to substitute three 

additional surrogate compounds. The AHETF proposed to change some of the study sites 

because of the use patterns of those compounds. 

The scientific charge question asked whether the revised task force protocol and field 

study proposal, if revised as suggested in EPA’s review and performed as described, was likely

to generate scientifically reliable data useful for assessing the exposure of handlers who mix and 

load pesticides in water-soluble packaging (page 23, line 943). The Board concluded that it 

concurred with the Agency’s assessment that the protocol will generate such scientifically 
9

reliable data. The Board cautioned, however, that these data may not be useful for creating 

distributions of worker exposure that are scientifically accurate or precise. No Board members 

had comments on the recommendation or rationale. 

The ethics charge question asked if the revised AHETF scenario and field study proposal 

AHE-120 is revised as suggested in EPA’s review, and if it is performed as described, whether 

the research is likely to meet the applicable requirements of 40 CFR Part 26, subparts K and L 

(page 25, line 1006). The Board concluded that the protocol is likely to meet the applicable 

requirements. The HSRB noted that exposure to the surrogate chemicals should be considered a 

risk of study participation because of the scripted nature of the study, and should be listed as 

such in the protocol and the informed consent documents. The Board noted that the risk, 

however, is appropriately minimized. In addition, the Board raised concerns about the 

Institutional Review Board (IRB) review of the protocol using an expedited procedure and 

recommended that future protocol revisions that involve such major changes should be reviewed 

under full IRB procedures. Dr. Philpott noted that Dr. Virginia Ashby Sharpe is leading a small 

working group to address task force questions and concerns about how to release individual 

study exposure data to study participants; the findings of this group will hopefully be presented 

to the HSRB at the January 2011 HSRB meeting or the subsequent March 2011 teleconference. 

There were no Board comments on the recommendation or rationale. 

SUMMARY AND NEXT STEPS

Mr. Downing noted that the next face-to-face HSRB meeting would be held on January

26, 2011. The meeting will be held in Arlington, Virginia, at EPA’s Potomac Yard conference 

center. 

Dr. Philpott asked whether there were any Board member concerns or questions about the 

final October 2010 HSRB meeting report. All members present at the teleconference meeting 

agreed to accept the report if amended as discussed. 

Dr. Philpott thanked Board members for their participation. The teleconference meeting 

was adjourned by the Chair at 4:30 p.m.

Respectfully submitted:

Jim Downing

Designated Federal Officer

Human Studies Review Board

United States Environmental Protection Agency
1

Certified to be true by:

Sean Philpott, Ph.D., M.S. Bioethics 

Chair

Human Studies Review Board

United States Environmental Protection Agency

NOTE AND DISCLAIMER: The minutes of this public teleconference meeting reflect diverse 

ideas and suggestions offered by Board members during the course of deliberations within the 

meeting. Such ideas, suggestions, and deliberations do not necessarily reflect definitive 

consensus advice from the Board members. The reader is cautioned to not rely on the minutes to 

represent final, approved, consensus advice and recommendations offered to the Agency. Such 

advice and recommendations may be found in the final report prepared and transmitted to the 

EPA Science Advisor following the public meeting.
1

Attachments 

Attachment A HSRB Members

Attachment B Federal Register Notice Announcing Meeting 

Attachment C Meeting Agenda 
1

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*Sean Philpott, Ph.D., M.S. Bioethics Term: 3/27/2006-10/31/2011

Director, Research Ethics

The Bioethics Program

Union Graduate College-Mt. Sinai School of Medicine

Schenectady, NY

Vice Chair

*Janice Chambers, Ph.D., D.A.B.T. Term: 3/27/2006-10/31/2011

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine 

Mississippi State University

Mississippi State, MS 

Members

*George C.J. Fernandez, Ph.D. Term: 5/1/2010-8/31/2013

Director, Center for Research Design and Analysis 

University of Nevada – Reno

Reno, NV

*Vanessa Northington Gamble, M.D., Ph.D. Term: 10/19/2009-10/31/2012

University Professor of Medical Humanities

Gelman Library

The George Washington University

Washington, DC

*Sidney Green, Jr., Ph.D., Fellow ATS Term: 10/19/2009-10/31/2012

Department of Pharmacology

Howard University College of Medicine

Howard University

Washington, DC

*Dallas E. Johnson, Ph.D. Term: 8/31/2007-8/31/2013

Professor Emeritus

Department of Statistics

Kansas State University

Manhattan, KS
1

*Michael D. Lebowitz, Ph.D., FCCP Term: 3/27/2006-8/31/2012

Retired Professor of Public Health

(Epidemiology) & Medicine & Research Professor of Medicine

University of Arizona

Tucson, AZ

*José E. Manautou, Ph.D. Term: 5/1/2010-8/31/2013

Associate Professor of Toxicology

Department of Pharmaceutical Sciences

School of Pharmacy, University of Connecticut

Storrs, CT

^Jerry A. Menikoff, M.D. Term: 3/27/2006-8/31/2012

Director, Office for Human Research Protections

Department of Health and Human Services 

Rockville, MD 

*Rebecca T. Parkin, Ph.D., M.P.H Term: 10/1/2007-8/31/2013

Professorial Lecturer (EOH)

School of Public Health and Health Services

The George Washington University

Washington, DC

*William J. Popendorf, Ph.D. Term: 10/19/2009-10/31/2012

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

Virginia Ashby Sharpe, Ph.D. Term: 5/1/2010-8/31/2013

National Center for Ethics in Health Care

Veterans Health Administration

Department of Veterans Affairs 

Washington, DC

*^Linda J. Young, Ph.D. Term: 3/28/2008-8/31/2012

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL 

*Special Government Employee (SGE)

^Not in attendance at the December 13, 2010 teleconference
1

Attachment B

FEDERAL REGISTER NOTICE ANNOUNCING MEETING

[Federal Register: November 29, 2010 (Volume 75, Number 228)]

[Notices] 

[Page 73078-73080]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr29no10-82] 

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0919; FRL-9232-5]

Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft 

Report From the October 27-28, 2010 HSRB Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Human Studies Review Board (HSRB) announces a public teleconference 

meeting to discuss its draft report from the October 27-28, 2010 HSRB meeting.

DATES: The teleconference will be held on Monday, December 13, 2010 from 3-5 p.m. (Eastern Time). 

Location: The meeting will take place via telephone only. 

Meeting Access: For information on access or services for individuals with disabilities, please contact 

Lu-Ann Kleibacker at least ten business days prior to the meeting using the information under FOR 

FURTHER INFORMATION CONTACT, so that appropriate arrangements can be made. 

Procedures for Providing Public Input: Interested members of the public may submit relevant written 

or oral comments for the HSRB to consider during the advisory process. Additional information 

concerning submission of relevant written or oral comments is provided in section I, under subsection D, 

of this notice.

FOR FURTHER INFORMATION CONTACT: Members of the public who wish to receive further 

information should contact Jim Downing at telephone number: (202) 564-2468; fax: (202) 564-2070; email address: downing.jim@epa.gov, or Lu-Ann Kleibacker at telephone number: (202) 564-7189; fax: 

(202) 564-2070; e-mail address: kleibacker.lu-ann@epa.gov; mailing address: U.S. Environmental 

Protection Agency, Office of the Science Advisor, Mail Code 8105R, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460. General information concerning the EPA HSRB can be found on the EPA Web 

site at http://www.epa.gov/osa/hsrb/.

ADDRESSES: Submit your written comments, identified by Docket ID No. EPA-HQ-ORD-2010-0919, 

by one of the following methods: http://www.regulations.gov: Follow the on-line instructions for submitting 

comments. 

E-mail: ORD.Docket@epa.gov. 
1

Mail: ORD Docket, U.S. Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460.

[[Page 73079]]

Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room, Infoterra Room (Room Number 

3334), EPA West Building, 1301 Constitution Ave., NW., Washington, DC 20460, Attention Docket ID 

No. EPA-ORD-2010-0919. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed 

information. 

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2010-0919. EPA's policy is that 

all comments received will be included in the public docket without change and may be made available 

online at http://www.regulations.gov, including any personal information provided, unless the comments 

includes information claimed to be Confidential Business Information (CBI) or other information whose 

disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise 

protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an 

“anonymous access” system, which means EPA will not know your identity or contact information unless 

you provide it in the body of your comment. If you submit an electronic comment, EPA recommends that 

you include your name and other contact information in the body of your comment and with any disk or 

CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact 

you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the 

use of special characters, any form of encryption, and be free of any defects or viruses. If you send an email comment directly to EPA, without going through http://www.regulations.gov, your e-mail address will 

be automatically captured and included as part of the comment that is placed in the public docket and 

made available on the Internet.

I. General Information

A. Does this action apply to me?

 This action is directed to the public in general. This action may, however, be of interest to persons who 

conduct or assess human studies on substances regulated by EPA or to persons who are or may be 

required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act 

(FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may 

also be interested, the Agency has not attempted to describe all the specific entities that may be affected 

by this notice. If you have any questions regarding the applicability of this notice to a particular entity, 

consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other related information?

 In addition to using regulations.gov, you may access this Federal Register document electronically 

through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/. 

Docket: All documents in the docket are listed in the index under the docket number. Even though it 

will be listed by title in the index, some information is not publicly available, e.g., CBI or other 

information whose disclosure is restricted by statute. Copyright material will be publicly available only in 

hard copy. Publicly available docket materials are electronically available either through 

http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, Public Reading Room, Infoterra 

Room (Room Number 3334), 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 

number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket 

is (202) 566-1752.
1

C. What should I consider as I prepare my comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you use that support your views.

4. Provide specific examples to illustrate your concerns and suggest alternatives.

5. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in 

the subject line on the first page of your response. You may also provide the name, date and Federal 

Register citation.

D. How may I participate in this meeting?

 You may participate in this meeting by following the instructions in this section. To ensure proper 

receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-2010-0919 in the 

subject line on the first page of your request.

1. Oral comments. Requests to present oral comments will be accepted up to December 6, 2010. To the 

extent that time permits, interested persons who have not pre-registered may be permitted by the HSRB 

Chair to present oral comments at the meeting. Each individual or group wishing to make brief oral 

comments to the HSRB is strongly advised to submit their request (preferably via e-mail) to Lu-Ann 

Kleibacker listed under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern 

Time, December 6, 2010 in order to be included on the meeting agenda and to provide sufficient time for 

the HSRB Chair and HSRB Designated Federal Official to review the meeting agenda to provide an 

appropriate public comment period. The request should identify the name of the individual making the 

presentation and the organization (if any) the individual will represent. Oral comments before the HSRB 

are limited to five minutes per individual or organization. Please note that this includes all individuals 

appearing either as part of, or on behalf of, an organization. While it is our intent to hear a full range of 

oral comments on the science and ethics issues under discussion, it is not our intent to permit 

organizations to expand the time limitations by having numerous individuals sign up separately to speak 

on their behalf. If additional time is available, public comments may be possible.

2. Written comments. Although you may submit written comments at any time, for the HSRB to have 

the best opportunity to review and consider your comments as it deliberates on its report, you should 

submit your comments at least five business days prior to the beginning of this teleconference. If you 

submit comments after this date, those comments will be provided to the Board members, but you should 

recognize that the Board members may not have adequate time to consider those comments prior to 

making a decision. Thus, if you plan to submit written comments, the Agency strongly encourages you to 

submit such comments no later than noon, Eastern Time, December 6, 2010. You should submit your 

comments using the instructions in section I, under subsection C, of this notice. In addition, the Agency 

also requests that persons submitting comments directly to the docket also provide a copy of their 

comments to Lu-Ann Kleibacker or Jim Downing listed under FOR FURTHER INFORMATION 

CONTACT. There is no limit

[[Page 73080]]

on the length of written comments for consideration by the HSRB.

E. Background

 The EPA Human Studies Review Board will be reviewing its draft report from the October 27-28, 2010 

HSRB meeting. The Board may also discuss planning for future HSRB meetings. Background on the 
1

October 27-28, 2010 HSRB meeting can be found at Federal Register 75 193, 61748 (October 6, 2010) 

and at the HSRB Web site http://www.epa.gov/osa/hsrb/. The October 27-28, 2010 meeting draft report is 

now available. You may obtain electronic copies of this document and certain other related documents 

that might be available electronically from the http://www.regulations.gov Web site and the HSRB Internet 

home page at http://www.epa.gov/osa/hsrb/. For questions on document availability or if you do not have 

access to the Internet, consult the person listed under FOR FURTHER INFORMATION CONTACT.

Dated: November 19, 2010.

Paul T. Anastas,

EPA Science Advisor.

[FR Doc. 2010-29814 Filed 11-26-10; 8:45 am]

BILLING CODE 6560-50-P
1

Attachment C

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (EPA)

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

Monday, December 13, 2010

3:00 p.m. - 5:00 p.m. (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT OCTOBER 27-28, 2010 HSRB MEETING REPORT

HSRB Web Site: http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566-1752

Docket Number: EPA–HQ–ORD–2010–0919

Meeting location via telephone only

3:00 PM Convene Meeting and Identification of Board Members – Jim Downing 

(Designated Federal Officer [DFO], HSRB, Office of the Science Advisor [OSA], 

EPA)

3:10 PM* Meeting Administrative Procedures – Jim Downing (HSRB DFO)

3:15 PM Meeting Process – Sean Philpott, Ph.D. (HSRB Chair)

3:20 PM Public Comments

3:30 PM Board Discussion and Decision on Final Report – Sean Philpott, Ph.D. (HSRB 

Chair)

The Board’s response to EPA charge questions presented at the October 27-28, 2010 meeting.

Carroll-Loye Biological Research, Inc. Protocol No Mas 003, a Field Efficacy Test of PMD 

and Lemongrass Oil-based Repellent “No Mas” Against Mosquitoes

Charge to the Board:

If the proposed field repellency study protocol No Mas 003 is revised as suggested in EPA’s 

review and if the research is performed as described: 

 Is the research likely to generate scientifically reliable data, useful for assessing 

the efficacy of the tested material in repelling mosquitoes?

Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L? 
1

A new scenario design and associated protocol from the Agricultural Handler Exposure 

Task Force (AHETF) to measure dermal and inhalation exposure to applicators who use 

backpack sprayers or hand gun sprayers to apply pesticides in utility rights-of-way

Charge to the Board:

If the proposed AHETF Right-of-Way application scenario and field study protocol AHE400 is 

revised as suggested in EPA’s review and if it is performed as described:

 Is the research likely to generate scientifically reliable data, useful for assessing the 

exposure of workers who apply pesticides in utility rights-of-way with backpack or hand 

gun sprayers? 

 Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K 

and L?

Completed scenario monograph and study report from the Antimicrobial Exposure 

Assessment Task Force II (AEATF–II): Dermal and Inhalation Exposure of Professional 

Janitorial Workers Applying Liquid Antimicrobial Products to Indoor Floors Using 

Bucket and Mop

Charge to the Board:

In the completed scenario monograph and study report AEA03 from the AEATF–II:

 Was the research reported in the AEATF–II completed study report AEA03 and 

associated supplemental reports faithful to the design and objectives of the protocol and 

governing documents of AEATF-II?

 Has the Agency adequately characterized, from a scientific perspective, the limitations on 

these data that should be considered when using the data in estimating exposure of those 

who apply antimicrobial floor-cleaning products with mop and bucket? 

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

substantial compliance with 40 CFR 26, subparts K and L?

Revised scenario design and associated protocol from the Agricultural Handler Exposure 

Task Force (AHETF) describing proposed research to monitor exposure of workers who 

mix and load pesticides formulated as wettable powders in water-soluble packaging

Charge to the Board:

If the revised AHETF scenario and field study proposal AHE120 is revised as suggested in 

EPA’s review, and if it is performed as described:

 Is the research likely to generate scientifically reliable data, useful for assessing the 

exposure of handlers who mix and load pesticides in water-soluble packaging?

 Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K 

and L?
2

4:55 PM Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and Jim 

Downing (HSRB DFO)

5:00 PM Adjournment

* Please be advised that agenda times are approximate. For further information, please contact 

the Designated Federal Officer for this meeting, Jim Downing via telephone: (202) 564-2468 or 

email: downing.jim@epa.gov.