Document ID: EPA-HQ-ORD-2010-0919-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-01-05T05:00Z

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.

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. 

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-of-way. 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. 

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 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 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 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 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 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

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.

Attachments 

	

Attachment A 		HSRB Members

Attachment B 		Federal Register Notice Announcing Meeting 

Attachment C 		Meeting Agenda 

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

*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

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.

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

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; e-mail address:   HYPERLINK
"mailto:downing.jim@epa.gov"  downing.jim@epa.gov , or Lu-Ann Kleibacker
at telephone number: (202) 564-7189; fax: (202) 564-2070; e-mail
address:   HYPERLINK "mailto:kleibacker.lu-ann@epa.gov"
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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
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:   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov:" http://www.regulations.gov:
 Follow the on-line instructions for submitting comments.    

E-mail:   HYPERLINK "mailto:ORD.Docket@epa.gov" ORD.Docket@epa.gov .    

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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" 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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" http://www.regulations.gov 
or e-mail. The   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" 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 e-mail comment directly to EPA, without going through  
HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" 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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/fedrgstr/"
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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" 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.

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 October
27-28, 2010 HSRB meeting can be found at Federal Register 75 193, 61748
(October 6, 2010) and at the HSRB Web site   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
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   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov" http://www.regulations.gov 
Web site and the HSRB Internet home page at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/osa/hsrb/"
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

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? 

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?

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.

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