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Minutes of the

United States Environmental Protection Agency (EPA) 

Human Studies Review Board (HSRB)

January 26, 2012 Public Meeting

Docket Number: EPA-HQ-ORD-2011-0954

HSRB Website: http://www.epa.gov/osa/hsrb

Committee Members: (See EPA HSRB Members List—Attachment A) 

Date and Time: Thursday, January 26, 2012, 9:45 AM – 4:30 PM

(See Federal Register Notice—Attachment B) 

Location: EPA, One Potomac Yard (South Building), 2777 S. Crystal Drive, 

Arlington, VA 22202

Purpose: The EPA HSRB 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: Rebecca T. Parkin, Ph.D., M.P.H. 

Board Members: Janice Chambers, Ph.D., D.A.B.T.

George C.J. Fernandez, Ph.D.

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

Jewell H. Halanych, M.D.

Dallas E. Johnson, Ph.D.

Michael D. Lebowitz, Ph.D., FCCP (via telephone)

Jerry A. Menikoff, M.D. 

William J. Popendorf, Ph.D.

Virginia Ashby Sharpe, Ph.D.

Linda J. Young, Ph.D.

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

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

Commencement of Public Meeting and Review of Administrative Procedures

Mr. Jim Downing (Designated Federal Officer [DFO], HSRB [or Board], Office of the 

Science Advisor [OSA], EPA [or Agency]) convened the meeting at 9:45 a.m. and welcomed

Board members, EPA colleagues and members of the public. He thanked the Board members for

their work in preparing for the meeting deliberations.

Mr. Downing noted that in his role as the DFO under the Federal Advisory Committee 

Act (FACA), he serves as liaison between the Board and EPA and is responsible for ensuring that 

all FACA requirements are met. The DFO must work with appropriate Agency officials to ensure 

that all appropriate ethics regulations are satisfied regarding conflicts of interest; HSRB members 

have been briefed on federal conflict of interest laws and have completed a standard government 

financial disclosure report. In consultation with the deputy ethics officer for OSA and the Office 
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of the General Counsel, Mr. Downing has reviewed the reports to ensure that all ethics 

requirements are met.

Mr. Downing informed members that there were two interesting and challenging topics on

the agenda for the meeting. He noted that agenda times are approximate, with the exception that 

the afternoon session will start at 1:30 p.m. due to the availability of a Board member. Following

the presentations, time has been scheduled for questions of clarification to EPA staff and the

principal investigator and sponsors of the studies discussed. This time is to be used for points of

clarification rather than Board discussion. A public comment period will be maintained, and

remarks must be limited to 5 minutes. No members of the public had pre-registered to make a 

public comment for the two topics under consideration. All speakers, including Board 

members and members of the public, should use their microphone and identify themselves 

before speaking, as the meeting is being recorded and broadcast on the Internet. During Board

discussions, if members require clarification from the public, they may request such information

through the Chair or DFO. Copies of the meeting materials, supporting documents and public 

comments will be available at http://www.regulations.gov under docket number EPA-HQ-ORD2011-0954 and most are available on the HSRB website at http://www.epa.gov/osa/hsrb. Meeting

minutes, including a description of the matters discussed and conclusions reached by the Board,

will be prepared and must be certified by the meeting Chair within 90 days. The HSRB also will

prepare a final report in response to questions posed by the Agency that will include the Board’s 

review and analysis of materials presented. EPA will announce the Board review and subsequent

approval of the report in the Federal Register. Mr. Downing turned the meeting over to the

HSRB Chair, Dr. Sean Philpott.

Introduction and Identification of Board Members

Dr. Philpott noted that the Board worked on a consensus model, and that consensus 

opinions of the Board would be included in the final report. He asked Board members to

introduce themselves, and members completed their introductions. Dr. Philpott invited Dr. 

Warren Lux (Director, Program in Human Research Ethics, OSA, EPA) to offer welcoming

remarks.

Welcoming Remarks

Dr. Lux welcomed all in attendance to the first face-to-face HSRB meeting of 2012. He 

extended a special welcome to the four original Board members whose terms are nearing 

completion, Dr. Philpott, Dr. Janice Chambers, Dr. Michael Lebowitz and Dr. Jerry Menikoff. 

Dr. Lux explained that those four members have helped to shape the Board into the thriving 

institution it is recognized as now since its inception as an untested entity in 2006. The Board 

has acquired credibility and stature that complement its success, to the benefit of the Agency, 

stakeholders and research colleagues. The projected agenda for 2012 raises the possibility that 

there will be no new agenda topics for the Board to review until October. If that is the case, 

Drs. Philpott, Chambers, Lebowitz and Menikoff will have completed their HSRB tenure. With 

the prospect of this meeting being their final meeting on the HSRB, Dr. Lux thanked the 

departing Board members for their service personally and on behalf of the Agency.
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Office of Pesticide Programs (OPP) Follow-Up on Previous HSRB Recommendations

Dr. Philpott welcomed Mr. William Jordan (OPP, EPA) to give the follow-up of the 

previous recommendations. Mr. Jordan proffered greetings and expressed appreciation for the 

efforts of the Board on behalf of Dr. Steven Bradbury (Director, OPP, EPA). Mr. Jordan 

reiterated Dr. Lux’s appreciation for the four departing Board members and commended their 

extraordinary amount of work and commitment throughout all 22 HSRB meetings. He thanked 

Drs. Philpott, Chambers, Lebowitz and Menikoff for their thorough and thoughtful reviews, and 

noted that they have made a real difference in the quality of research in terms of science and 

ethics. Mr. Jordan thanked all of the Board members for their public service. 

Mr. Jordan discussed four topics reviewed by the Board at the previous HSRB meeting. 

The Antimicrobial Exposure Assessment Task Force (AEATF) protocol discussed previously 

was designed to evaluate the dermal and inhalation exposure resulting from pouring liquid 

antimicrobial products from conventional or reduced-splash containers for mixing or application 

purposes. The AEATF had revised the liquid pour protocol and consensus documents to address 

comments from EPA and the HSRB. The revised documents were submitted to Independent 

Investigational Review Board, Inc. (IIRB) and have been approved. Study recruitment is 

expected to begin during the week of February 6, 2012, and in-field monitoring is targeted to 

begin the week of February 12, 2012, and be completed by the end of February. The goal is to 

submit the report to EPA so that it can be reviewed in advance of the October 2012 meeting.

The Agricultural Handler Exposure Task Force (AHETF) has modified the protocol and 

supporting documents in response to Agency and HSRB review for the closed system liquid 

loading scenario that evaluates the dermal and inhalation exposure to workers who load liquid 

pesticides with closed-system equipment. The AHETF plans to submit the revised materials to 

IIRB in February 2012. Work has begun on compiling names for the Grower Universe List so 

that recruitment and monitoring can begin in southeastern states immediately after final 

approval. This protocol is dependent on seasonal timing of application using these closed 

systems, which occurs in the spring and summer. The AHETF anticipates finishing data 

collection in 2013 and submitting a completed report for review in 2014. 

The completed No Mas-003 mosquito repellent study performed by Carroll-Loye

Biological Research, Inc., was reviewed favorably by EPA and the HSRB. EPA is prepared to 

accept the registration application after it is submitted. The study is regarded as adequate to 

satisfy efficacy data requirements and evaluate label claims. 

The Moiemen et al. study received favorable reviews from the Agency and the HSRB. 

This study was conducted with burn patients treated with dressings that included nanosilver. The 

purpose of the study was to evaluate the extent of dermal absorption of nanosilver. The HSRB 

concluded that the study can be used to support the Agency’s conclusion that the dermal 

absorption of silver from nanosilver is less than 0.1 percent. EPA used the 0.1 percent dermal 

absorption factor in the risk assessment that supported the registration of HeiQ AGS-20, a textile 

preservative containing nanosilver. The conditional registration, issued in December 2011, is 

notable because it provides the first example of a quantitative risk assessment of a nanomaterial, 

and is the first pesticide product containing nanomaterials that EPA has registered knowingly. 

Mr. Jordan noted that HSRB efforts were very helpful with regard to this study.
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Mr. Jordan discussed the status of the regulation promulgated by EPA in 2006 that has 

been the subject of litigation. EPA proposed a settlement of litigation to amend the regulation 

with minor modifications. The proposal was published for public comment in January 2011. Of 

the 10 public comments received, only two or three were relevant to the merits of the proposal. 

The Office of Management and Budget is in the process of completing an interagency review to

provide an opportunity for other federal agencies (e.g., the Department of Health and Human 

Services and the Veterans Administration) to offer comments and express concerns. This 

proposal is expected to be finalized in the near future. If the modifications are finalized as 

proposed, these changes will not alter the work at EPA or the HSRB standards applied to studies.

Session 1: A new scenario design and associated protocol from the AHETF describing 

proposed research to measure dermal and inhalation exposure to workers, who mix, load 

and apply liquid pesticides with powered handgun equipment

Background

Ms. Kelly Sherman (OPP, EPA) noted that the Board would be discussing a new 

scenario design and associated protocol from the AHETF describing proposed research to 

measure dermal and inhalation exposure to professional agricultural workers who mix, load and 

apply liquid and solid pesticides with powered handgun equipment in managed horticultural 

facilities. The study will measure exposure to fungicides and insecticides used to treat foliage in 

open, enclosed or partially enclosed greenhouse and nursery settings. Existing exposure data do 

not meet the AHETF’s requirements for inclusion in the Agricultural Handlers Exposure 

Database (AHED). The scenario consists of new data points, which are expected to be highly

variable due to the diversity of application sites. The study will employ a 10 x 3 design 

consisting of three monitoring units (MUs) at each of 10 sites. Ms. Sherman noted that the 

protocol proposal, design objectives, rationale and procedures related to ethical conduct are 

very similar to previous studies reviewed by the HSRB.

EPA Science Assessment

Mr. Jeff Evans (OPP, EPA) noted that this is the first scenario to measure the exposure 

of workers, who mix, load and apply pesticides, which is common in small-scale operations. 

Workers will mix and load liquid and solid formulations and then apply the pesticides using 

powered handgun or hand wand equipment that is connected to tanks by hoses. The varied 

scenario will include treatments in greenhouses and open and partially enclosed nursery

settings. 

The baseline attire includes long-sleeved shirts, long pants, shoes and socks. Personal 

protective equipment (PPE) consisting of chemical resistant gloves will be worn by all workers. 

Additional PPE may include chemical resistant headgear in the event of overhead sprays; the 

AHETF will be informed ahead of time of overhead spraying, and patches will be used to 

estimate exposure to the subject’s head. A chemical resistant apron may be worn for mixing and 

loading of some products, but this is expected to have minimal impact on exposure. The 

majority of the exposure is likely to come from mixing, spraying and incidental brushing 

against treated foliage. Protective eyewear may be worn, which also is expected to have 

minimal impact on exposure; a standard operating procedure (SOP) will be used to extrapolate 

exposure data.
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Agricultural workers will be managing a hose connected to a sprayer to treat plants 

organized in a uniform manner in benches and hanging pots. Plants with similar sizes and 

growing characteristics are often grouped together. The capacity of the portable tanks will range 

from 25 to 150 gallons, and some will be carried on small carts or powered vehicles. Some 

hoses are managed by reels to connect the tank to the handgun or hand wand. The use of 

handguns results in pesticide application closer to the hand than the use of a hand wand, which 

has a longer barrel. Greenhouses will require an upward or downward spray pattern or an 

outward spray pattern if the plants are grown on benches. Nurseries will vary in the degree of 

openness, providing diversity of growing conditions. Partially open sites that contain structures 

to provide shade will be included in the scenario. The AHETF identified clusters of exposure 

sites across the United States, ranging from lower New England to Washington. Groups of 

counties delimiting a cluster location may include more than one state. This provides a wide 

range of climactic differences that may affect exposure. 

Similarity restrictions for each cluster include provisions that MUs cannot be identical. 

Diversity exists in the facility type (e.g., nursery or greenhouse); mixing procedure 

(e.g., directly into the tank or premix and then transfer); hose attachment (e.g., hand wand or 

handgun); formulation type (e.g., liquid or solid); predominant spray type (e.g., downwards, 

outwards, or upwards); and whether equipment cleanup is performed. MUs within a cluster 

cannot be the same worker, have the same employer, or be based on the same degree of 

structural openness. Preferably, MUs will not use the same formulation type or be within the 

same amount of active ingredient handled (AaiH) stratum (e.g., 0.5 to 1.6 pounds, more than 1.6 

up to 4.8 pounds, and more than 4.8 up to 15 pounds). Pesticides will be selected from a 

predetermined surrogate product list that includes a variety of insecticides and fungicides. All 

pesticides can be used safely under the conditions of the proposed studies. Analytical methods 

for dosimetry have been evaluated (methods for permethrin and azoxystrobin are in 

development). Dosimetry will consist of six sections of whole body dosimeters, patches, socks, 

hand rinses, face and neck wipes, and Occupational Safety and Health Administration (OSHA) 

Versatile Sampler (OVS) tubes. 

Mr. Evans emphasized that this is a highly varied scenario in regards to structures, spray

patterns and the type of plants treated. Mixing, loading and application of pesticides by the 

same person is the industry standard. The study includes provisions for liquid and dry

formulations, and subjects will handle small amounts of active ingredient (AI). Application of 

the pesticide is expected to be the predominant contribution to exposure. However, EPA 

requests that the Board address the recommendation to include a wettable powder formulation 

in at least one MU per cluster due to the potential for higher inhalation exposure that is not 

mitigated by aprons or other PPE.

In conclusion, EPA found the study to be scientifically acceptable. The scenario is well 

defined, and the study is likely to produce reliable mixer and loader applicator data to assess the 

potential exposure of handlers using powered handgun or hand wand equipment. 

Board Questions of Clarification—Science

Dr. Chambers asked why the wettable powders might lead to higher exposures. 

Mr. Evans responded that previous studies from the Pesticide Handler Exposure Database 

(PHED) have found inhalation levels to be much higher for powder formulations because they
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are dustier than liquids. An analogy would be to compare the dust that arises from pouring flour 

into a bowl versus pouring liquid into a bowl. This AHETF study provides an opportunity to 

determine whether the physical process of wetting a powder formulation affects exposure. 

Mr. Evans clarified for Dr. William Popendorf that the previous PHED studies indicated an 

increase in exposure of two orders of magnitude for mixing, loading and applying a powder 

formulation. Dr. Linda Young asked whether the data on wettable powders would be used 

separately when making recommendations. Mr. Evans responded that if the data are different 

between wettable powder and liquid formulations, they may add the powder component to the 

scenario to assess exposures.

Dr. Dallas Johnson cautioned that the inclusion of liquid and solid formulations might 

result in two studies, one with 10 clusters of one MU and the other with 10 clusters of two MUs. 

He questioned whether the risk assessment would be adequate with those data. Dr. Philpott 

remarked that he was unsure if the Agency has considered that issue and thus could respond as to 

whether or not the risk assessment would be adequate. Rather, Dr. Philpott believed, this may be 

one of the Board’s recommendations to the Agency . Mr. Evans welcomed remarks from the 

Board and noted that the risk assessment would rely on all 30 data points for a conservative 

estimate. The topic was tabled for later discussion.

Dr. Rebecca Parkin requested clarification as to whether all participants will use 

headgear, including a face shield, and if there would be variation in the type of headgear. 

Mr. Evans replied that headgear would be varied. There are many types of chemical resistant 

purifying respirators. Some headgear contains chemical resistant fabric and some cover the head 

with a flap on the back. Air purifying respirators are common and may have a cooling effect. Mr. 

Evans was unsure whether respirators would be used because the pesticide products may not 

require use of a respirator. Dr. Parkin asked Mr. Evans if he was satisfied that there was 

sufficient documentation of the variety of headgear in the study, and Mr. Evans affirmed that 

documenting headgear would be important. Dr. Popendorf questioned if adjustments would be 

made for subjects wearing half-mask respirators. Dr. Evans responded affirmatively that there is 

a provision within the protocol to adjust for that situation. 

Dr. Popendorf questioned whether the European Crop Protection Association (ECPA) 

data regarding pesticide application exposure levels could be combined with the separate 

mixer/loader data to meet the data requirements of EPA. Mr. Evans thought that it would be 

useful to compare the data within the ECPA database.

Dr. Sidney Green requested clarification regarding the asterisk that appeared slide 19 of 

EPA’s Science Assessment presentation detailing the outward, downward and upward directions 

of spray. Mr. Evans stated that the asterisk likely indicated that an upward spray pattern would 

require the use of chemical resistant headgear.

Dr. Green mentioned that the proposal objectives applied to dermal toxicity and he 

questioned the rationale for why inhalation toxicity was treated differently from dermal toxicity. 

Mr. Evans clarified that the study was not measuring toxicity, just exposure through the dermal 

or inhalation route. The AHETF will perform proportionality and relative fold accuracy tests for 

inhalation to evaluate whether those data can be used, but Mr. Evans noted that dermal contact is 

the primary route of exposure for most studies of this nature. The relative fold accuracy

requirements may be larger for inhalation exposure. 
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Dr. Jewell Halanych noticed that the protocol included the option of pesticide application 

by walking or riding in a vehicle. She questioned whether differential exposure may occur in the 

two situations. Mr. Evans explained that EPA was satisfied that the protocol captures all 

variability limited to handgun equipment in regards to spray direction and so forth, but although 

it would be interesting to assess, evaluating the option of walking or riding is beyond the limits 

of the scenario. 

Dr. Philpott noted that one picture from Mr. Evans’ presentation depicted two workers 

applying product simultaneously and wondered whether the presence of multiple applicators may

affect the data in this monitoring scenario. Mr. Evans replied that worker protection standards in 

the United States require that workers apply product alone, with distance requirements existing 

for others within the spray vicinity. The picture referred to by Dr. Philpott was taken in Mexico 

where requirements are different. 

EPA Ethics Assessment

Ms. Sherman stated that additional data are needed to improve EPA’s ability to assess 

safety and risk associated with these application scenarios, and this scenario will consist of all 

new data to better estimate dermal and inhalation exposure for a wide range of pesticides. The 

data will be used to populate the AHED database, in which similar data do not exist. There is a 

broad applicability due to the diversity of test sites and application scenarios and the study will 

provide value to society. 

Subjects will be selected by identifying eligible commercial growers and contacting 

them by telephone to discuss potential interest in the study. The growers will be required to sign 

a non-coercion statement. Subjects will be recruited among employees who have experience 

within the past year with mixing, loading and applying pesticides using powered handgun 

equipment. The subjects also must meet the other eligibility criteria specified in the protocol. 

Permission will be sought to approach employees of eligible growers, at which point 

prospective subjects will be contacted directly and flyers will be posted. A recruitment meeting 

with interested employees will be held on site in the absence of supervisors to explain the basic 

principles, procedures, risks and benefits of the research. If prospective subjects choose to 

continue, a private consent interview will be conducted between the employee and the 

investigators in the employee’s preferred language of English or Spanish. Similar to procedures 

followed by the AHETF in other protocols, the consent form containing all elements required 

by 40 Code of Federal Regulations (CFR) §26.1116 will be explained to each subject. 

Ms. Sherman noted that the organization and presentation of risk information contained 

in the consent forms is thorough and acceptable. Five categories of risk are outlined in the 

protocol, and measures to protect against these risks are sufficient. Heat-related illness is a 

concern because the extra layer of clothing worn by the subjects might raise body temperature. 

An SOP for monitoring the heat index will be followed, and the monitoring will be stopped if 

the temperature rises above a 105 degrees Fahrenheit (°F) heat index. A medical professional 

will be on site to provide care. The second and third risk categories detail exposure to pesticides 

and surfactants. Protections against those risks consist of excluding subjects with sensitivity to 

these substances, selecting handlers in good health, and requiring that subjects be experienced 

with the equipment. The fourth risk category involves scripting of field activities. The workers 

will be performing their normal task of employment, but they might be changing their behavior 

slightly by applying more or less product than usual to establish the variability needed for the 
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study. EPA decided that this was a small additional risk. The fifth risk described psychological 

hazards, including the possibility of breach of privacy or unwanted disclosure of pregnancy

results. The protocol details methods to mitigate these risks and protect subject privacy by

handling test results discretely and ensuring that identifiable characteristics of the subject are 

obscured in photographs. Ms. Sherman reiterated that the risks of this study are adequately

explained and appropriately minimized.

Although there are no direct benefits to the subjects of the study, sponsors will benefit 

from improved risk assessments that accurately reflect actual exposure. The likely societal 

benefit includes higher quality exposure and risk assessments for pesticides that are mixed, 

loaded and applied using handheld equipment in greenhouses and nurseries. Regarding riskbenefit balance, the risk to subjects is low and can be considered reasonable given the potential 

societal benefits. Subjects will be paid a reasonable amount of $20 to participate in the consent 

interview and $80 to participate in the study, and will be informed that they can withdraw at any

time without loss of payment providing that they suit up with the dosimeter. The protocol 

indicates that medical care for research-related injuries will be provided at no cost to the 

subjects. 

The protocol was reviewed and approved by IIRB, which is an accredited ethics 

committee independent of the study sponsors and investigators. IIRB’s “Human Research 

Protection Program Plan” and the current membership roster have been provided to the HSRB 

along with background materials. This proposal is for third-party research involving intentional 

exposure of human subjects to a pesticide, with the intention of submitting the resulting data to 

EPA under the pesticide laws; therefore, the primary ethical standards applicable to the conduct 

of this research are 40 CFR part 26, subparts K and L, and the Federal Insecticide, Fungicide 

and Rodenticide Act (FIRFA) 12(a)(2)(P).

EPA requested that future protocols be revised in three ways. First, the protocol should 

clarify the discussion of “psychological risks.” Breach of confidentiality should be added to the 

discussion of psychological risk, and the protocol needs to clarify what is meant by risk of 

pregnancy testing. The wording should be crafted differently to indicate that psychological risk 

in regards to pregnancy testing refers to unwanted disclosure of pregnancy test results rather 

than risk of embarrassment. Second, the protocol should specify where the recruitment 

discussions between researchers and potential subjects will occur; ideally, the site will be 

separate from the work site so that influence from employers is minimized. Finally, criteria 

should be developed for medical professionals to determine if a subject is too sick to refuse 

medical treatment, and the criteria should be documented in an SOP. Ms. Sherman noted that 

none of these provisions will prevent approval of the current protocol, but should be included in 

future protocols. 

In conclusion, Ms. Sherman indicated that EPA has adequate information to conclude 

that the protocol meets substantial compliance with subparts K and L for 40 CFR part 26. 
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Board Questions of Clarification—Ethics

Dr. Virginia Ashby Sharpe noted that the risk mitigation detailed in the proposal 

addressed the problems that would have been associated with the psychological risk of unwanted 

exposure by the fact that identifying features would be obscured in photographs and pregnancy 

test results would be handled discretely. Ms. Sherman agreed that the protections are in place; 

however, the details of the risks are not described adequately and the description in the protocol 

needs to be modified. Dr. Philpott noted that an additional psychological risk would be 

embarrassment associated with disrobing in front of an observer to collect the dosimeter. He 

agreed that there was confusion in the protocol section describing psychological risk and this 

topic would be revisited in the Board discussion.

Dr. Sharpe requested confirmation that “open pour” will be the method used for mixing 

and loading, and Mr. Evans verified that was correct.

Questions for Researchers

Dr. Philpott invited the study sponsors Drs. Victor Cañez and Richard Collier to the table 

to answer Board questions regarding study design and ethics. Drs. Cañez and Collier introduced 

themselves, noting that they were speaking on behalf of the AHETF. 

Dr. Chambers asked how easy it was to recruit subjects for this scenario. Dr. Cañez 

replied that it was no easier than for other studies, but they had an advantage of a finite and 

easily obtained list of growers. He noted that if the growers meet the criteria for the surrogates 

and are willing to participate, difficulties in recruiting should be minimial.

Dr. Popendorf asked if Drs. Cañez and Collier were knowlegdeable about the ECPA 

database, and if they have identified restrictions with use of the European data. Dr. Cañez 

explained that they evaluated the data available in the ECPA database. After surveying 

greenhouse and nursery practices, they realized that the person who mixes and loads also does 

the applying. They determined that separating the mixing/loading exposure monitoring from the 

application exposure monitoring may create artificial situations. Additionally, interference with 

workers will be reduced by monitoring one person performing all tasks rather than monitoring 

two people (i.e., one who is mixing/loading and the other who is applying pesticide). Dr. 

Popendorf clarified that he was suggesting that the AHETF and the Agency use the ECPA 

applicator data in conjunction with the existing AHETF mixer/loader data to measure exposure 

for these scenarios, thus precluding the need to collect new data. He questioned whether there 

were any factors that would preclude the use of combining databases for this purpose. Dr. Cañez 

replied that there were variations in the PPE used in the other studies, causing confounding 

issues in addition to the artificial separation of tasks. This point was tabled for Board discussion.

Dr. Philpott questioned the reasonability of applying a 105°F heat index cutoff if the 

workers are operating within greenhouses where high temperatures are likely. Dr. Cañez agreed 

that high humidity levels may restrict the application time to morning, evening or night.

Public Comments

Dr. Cañez noted that he enjoys the HSRB meetings and has learned a lot through his 

interactions with the Board. He will miss the four Board members who are departing. Dr. Collier 
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repeated Dr. Cañez’s sentiments and expressed gratitude to all of the Board members. He noted 

that the protocols are substantial and complex, and he appreciates the Board’s effort to give good 

advice to the sponsors and the Agency.

Dr. Philpott asked if anyone else present would like to comment on the AHETF study. No 

additional public comments were made. Dr. Philpott noted that one written public comment was 

received, but the substance of the content was not directly related to the two protocols under 

review by the HSRB. The comment is available on the docket.

Charge Questions

Ms. Sherman read the charge questions into the record:

If the proposed research is revised as suggested in EPA’s review and the research is 

performed as described:

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

exposure of workers mixing, loading and applying pesticides in managed horticultural 

facilities using powered handgun equipment?

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

and L? 

Board Science Review

Dr. Philpott asked Dr. Chambers, as Lead Science Discussant, to address the first charge 

question. Dr. Chambers began the discussion by indicating that she has appreciated the privilege 

to serve on the Board, and values the friendship of the Agency, sponsors and Board members. 

She will miss them when her term is complete. 

Dr. Chambers asserted that the answer to the first charge question was affirmative. The 

protocol was well planned and well designed, reflecting iterations in protocols over the past few 

years. Noting that the investigators found no suitable existing information that could constitute 

the monitoring units for this scenario, the entire scenario has to be conducted. The design 

provides for three MUs across 10 different regions for a total of 30 MUs. She rationalized that 

this was because few nurseries and greenhouses would be suitable for the study. Due to the 

diverse types of scenarios, she expects that exposure numbers will be widely varied. The design 

is similar to other protocols in the objective to demonstrate proportionality between exposure and 

AaiH. Dr. Chambers noted that incidental exposures, not unlike those seen with roadside 

spraying as in an AHEFT protocol previously reviewed by the Board, may be important to 

consider in the analysis. Unintended contact with foliage needs to be observed, documented and 

evaluated to determine if it can explain some of the diversity in the exposure values. Another 

consideration is the added exposure resulting from equipment cleanup. She noted that the AaiH 

limit of 15 pounds seems smaller than what would be required for many outdoor situations, and 

merging high-level mixing/loading exposure data in the ECPA with low-level nursery

application exposure data for risk assessment may not be viable due to the different scales of 

magnitude. In conclusion, Dr. Chambers assessed that the protocol was well designed, well 

written and will yield valuable information. 
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Dr. Philpott asked if Dr. Green, as Associate Discussant on this protocol, if he had any

additional comments or recommendations for the Agency. Dr. Green agreed with the scope of 

Dr. Chambers’ discussion.

In discussing statistics, Dr. Young returned to the question of whether wettable powders 

differ substantially from liquids. She noted that this was an important question regarding the 

study design. Dr. Young presented a few slides to illustrate her point regarding the separation of 

data. She demonstrated that the wettable powder has a different intercept than the liquid 

formulation with standard deviation on a log-based scale. If data like these are generated in the 

current study, it would be useful to differentiate the two formulations. However, she noted that 

changing the standard deviation of the data by one unit of log exposure was enough to obscure 

any differences between wettable powders and liquids. Additional observation of wettable 

powder MUs may be needed to decrease the standard deviation enough to observe a measurable 

difference given the diversity of exposure scenarios. EPA should consider the importance of 

measuring differences in formulation type and whether the differences may be obscured due to 

the scenario’s diversity.

Dr. Young added that a common question raised by the HSRB is whether there is enough 

power to estimate exposure with a certain level of precision. However, this study is not 

evaluating power. She suggested broadening the sample size to include adequate precision or 

power, whichever is applicable. 

Dr. Johnson applauded the study for its relatively broad decision to monitor 10 clusters of 

three MUs apiece. He echoed Dr. Young’s concern about whether there would be a big 

difference between the powder and liquid formulations. He noted that the Agency is 

recommending that every cluster include one powdered formulation. Dr. Johnson questioned 

whether it would be better to have 15 solid and 15 liquid MUs. If it is likely that powder will 

cause higher levels of exposure than liquid, perhaps all of the MUs should use powder 

formulations to generate a conservative estimate. Another option would be to have two separate 

studies, one involving powder and one involving liquid formulations. It may not be possible to 

make that decision now; perhaps a second study will be initiated based on the results of the first. 

Mr. Evans replied that they have evaluated all of those considerations and they are confident that 

many aerosolized particles will be captured by the OVS tubes. He asserted that product 

application is the largest proportion of exposure. 

Dr. Philpott noted this was a fundamental question, and summarized the 

recommendations of Drs. Johnson and Young. He noted that the Board is raising concerns about 

the assumption that greater inhalation exposure will result from mixing and loading powder 

versus liquid formulations, and the impact of this difference is as yet unknown. A simple change 

in standard deviation may mask any effects of wettable powders. Dr. Johnson responded that it 

appears that EPA has considered these implications and realizes that additional data might be 

needed. Dr. Philpott noted that the Board’s report will provide careful consideration to this issue 

and the potential impact on the Agency’s analysis of the data.

Dr. Popendorf suggested that the solid or liquid formulation variable in the study is just 

one example of how the diversity of variables in the scenario might complicate data analysis. He 

considers the biggest variables to be the direction of application and whether the subject cleans 

the equipment afterward. The proximity of the hand to the spray and the degree of enclosure are 

other important variables. Dr. Popendorf considers the liquid or solid powder to be less 
12

important, albeit relevant. He questioned whether the study design is intended to maximize 

variability or if the intent was to separate variables. Dr. Young requested that EPA clarify if the 

intent was indeed to separate the variables. Mr. Evans responded that the data will be used for 

decision making and, to that effect, wettable powder may be important and regulatable. There is 

less control over regulation of variety in handguns. Mr. Evans agreed that with the diversity of 

scenarios, it might not be possible to see separate effects. He noted that any comments from the 

Board about how to approach the data analysis are appreciated. Dr. Young responded that EPA 

should analyze the data separately and then together. Combining the data will increase variability

to the extent that it may be obscured in the analysis.

Dr. Popendorf revisited the issue related to the use of data within the ECPA database. He 

agreed with Dr. Chambers that the use of mixer/loader data will not have a large impact on the 

data generated, and he recommended that EPA consider combining the European applicator data 

and AHETF mixer/loader data, thus precluding the need for this study. 

Dr. Popendorf addressed the use of protective hats in the study. He noted that the topic 

was reviewed in October 2010 when the Board discussed limitations to estimating the exposure 

of people with and without hats. If hats are worn in monitoring scenarios, exposure to people not 

wearing hats will be underestimated. Dr. Popendorf recommended that this issue be addressed in 

the protocol under discussion. He noted that subjects could use a chemical resistant hat without a 

brim, or the exposure of the area of the head beneath the shadow of the brim could be monitored 

with a patch to better quantify exposure without a hat.

Dr. Chambers asserted that because of the diversity and possibility of incidental 

exposures, proportionality may not be observed. Nevertheless, she reiterated that the study is 

well designed and will generate high quality and useful data for EPA to use in risk assessments.

Dr. Lebowitz initiated a discussion about what should be considered “incidental” 

exposures. Brushing against equipment while mixing, loading and touching treated plants may be 

critical in determining excesses of exposure and defining differences between individuals. He 

questioned whether recording incidental events would be sufficient to detect the contribution of 

each source of variability. Mr. Evans reiterated that the biggest driver of exposure is the AaiH. 

He affirmed that good observations are critical for informing conclusions in this type of study. 

Dr. Philpott summarized the Board’s opinion, noting that the answer to the charge 

question is that the study will generate reliable and useful data, but there are caveats for the 

Agency and sponsors to consider. The first caveat considers potential sources of diversity in 

exposure. The Board recognizes that the Agency is operating on the assumption that AaiH is the 

predominant driver of exposure, but other variables might obscure the results and prevent the 

observation of proportionality. The Board recommended that the Agency and sponsors observe 

and record all cases of incidental exposures as uniformly as possible. Dr. Philpott continued, 

noting that the statisticians are concerned about the use of powder and liquid formulations. He 

repeated Dr. Young’s request that the data be analyzed separately first and then together. The 

Board suggested standardizing the use of hats without a brim if in compliance with worker’s 

regulations, or adding another patch below the brim and shadow of the brim. The data within the 

ECPA database has been discussed in regards to whether justification exists for the study given 

the data available. The Board’s recommendation is for the study sponsor and EPA to revisit those 

data to ensure that they do not answer the questions asked by the study before proceeding. The 
13

broader issue will be how to incorporate results from this study with the ECPA evidence in 

regards to the overall weight of evidence.

Dr. Popendorf added that the Board should clarify the terminology of incidental 

exposure. This could mean exposure to a chemical unrelated to the amount used, including 

exposure to residues on equipment surfaces. The amount of exposure from brushing against 

recently treated foliage could be related to the amount of product applied. Dr. Chambers clarified 

that brushing against a treated plant would be considered an incidental exposure because that 

behavior is meant to be avoided. Dr. Lebowitz emphasized that the incidental exposures might be 

critical to the outcome of the study and may preclude the observation of proportionality. 

Dr. Philpott asserted that the Board discussants and Chair will work together to craft a mutually 

agreeable definition for incidental versus other types of exposures.

Dr. Parkin questioned if Dr. Popendorf was suggesting that the Board should require 

additional written justification from EPA regarding the use of ECPA data. Dr. Philpott replied 

that he did not believe that the Board was not going to require further justification from EPA. Dr. 

Popendorf had suggested a formal review of the data available and to document the impact on 

the study, but the Board will not require additional written rationale. Rather, the Board will defer 

to the Agency and sponsors in their expert opinions that the study is justified. Dr. Sharpe noted 

that the question of whether the study was necessary given the ECPA data was a difficult 

question. She is confident that the Agency and sponsors will address the concern. Dr. Philpott 

concluded that the consensus position of the Board that no further justification or approval by the 

HSRB was necessary to move forward with the study. 

Board Ethics Review

Dr. Philpott asked Dr. Sharpe, as Lead Ethics Discussant, to address the charge question 

that asked whether the research was likely to meet the applicable requirements of 40 CFR part 26, 

subparts K and L. Dr. Sharpe stated that it is likely that the research will meet ethical requirements. 

She opened a discussion about suggested modifications to the informed consent form, noting that 

the consent form does not contain information about adverse reactions. Dr. Sharpe suggested that 

the Board consider whether language should be included about the name and contact information of 

the study director if the subject experiences adverse effects within 24 hours. Dr. Sharpe and Ms. 

Sherman discussed whether the information about adverse reactions was present in the consent 

form. Dr. Philpott concurred that the language regarding adverse reactions should be on the consent 

form and, if it is not there, it should be added. The Board agreed with this recommendation. 

Dr. Sharpe noted that the language in the protocol relevant to the timing of the pregnancy 

test prior to the start of the study is adequate, but language in the consent form is unclear. The 

consent form states that pregnancy tests should be conducted within 24 hours of the study, but this 

could be interpreted in such a way to allow testing to occur following completion of the study. and 

Dr. Sharpe recommended that it should be modified to say 24 hours prior to starting the study. She 

also noted that the language on the consent form should say “In order to take part in the study...” 

rather than “If you do take part in the study...” With the exception of these minor modifications, 

Dr. Sharpe was satisfied with the consent form.

Dr. Sharpe agreed with EPA recommendations that the protocol should define the offwork site at which consent takes place and the SOP should include the criteria for determining if a 
14

subject is too sick to refuse medical treatment. She disagreed that the Agency’s concern that the 

language in the protocol describing psychological risk is inadequate. Dr. Sharpe noted that sufficient 

risk mitigation procedures were detailed in the protocol, and describing them further might cause 

undue anxiety to participants. Many steps have been taken to ensure confidentiality, so emphasizing 

the parameters in place for dealing with breach of confidentiality may be superfluous. Dr. Philpott 

concurred that adding language to the consent form clarifying risks could overly emphasize the risks 

of study participation and thus make subjects anxious. Ms. Sherman clarified that the suggestion 

was to improve the language in the protocol, not the consent form. The comment had resulted from 

a discussion with Dr. Lux regarding true psychological risk. Ms. Sherman agreed that too much 

detail in the consent form is unnecessary. Dr. Philpott asked if the Board agreed that the information 

in the consent form regarding risk was adequate. Dr. Sharpe and the other Board members 

concurred. Dr. Halanych also voiced her approval of the information in the consent form being 

sufficient in regards to the description of risk.

Dr. Philpott reiterated that the Board’s response to the ethic charge question is affirmative; 

if the study is amended as discussed and conducted as designed, it will likely be in agreement with 

40 CFR part 26, subparts K and L. He noted general agreement that the sponsors should clarify

where informed consent will take place and develop clear criteria for assessing the capacity for a 

subject to refuse medical treatment by a medical officer. The consent form is sufficient, with minor 

suggestions, to ensure informed consent by participants. The protocol, but not the consent form, will 

be clarified in the discussion of risk. 

Session 2: A completed scenario monograph and study report from the AEATF II in which 

the dermal and inhalation exposure of professional janitorial workers was monitored as 

they applied a liquid antimicrobial pesticide product for indoor surface disinfecting using a 

pressurized aerosol can

Background and EPA Science Assessment

Mr. Timothy Leighton (OPP, EPA) noted that the Board will review a completed study

from the AEATF that monitored exposure of workers spraying various indoor surfaces with aerosol 

cans. The HSRB had reviewed the initial proposal for this study, monitoring exposure of workers 

spraying aerosolized disinfectants, in October 2009. He introduced Dr. Jonathan Cohen, who served 

as the statistician for the review and who was available via telephone. Dr. Leighton acknowledged 

the Joint Regulatory Committee, with participants from Health Canada, California Department of 

Pesticide Regulation (CDPR) and EPA, for their work on the aerosol study. 

Mr. Leighton noted that this completed aerosol scenario was one of 17 AEATF exposure 

scenarios. He noted that the AEATF has acted on recommendations proffered by the HSRB for 

the liquid pour study reviewed in October 2011 and that study will begin in 2 weeks. The 

AEATF is working hard to get studies moving forward. The current scenario monitored spraying 

indoor surfaces (e.g., showers, sinks, countertops and so forth) with an aerosol spray can but 

excluded the wiping of sprayed surfaces, which was monitored as a different scenario. 

Mr. Leighton asserted that the lack of wiping was an important consideration because some 

products sprayed with an aerosol can do not need to be wiped. Workers might be accustomed to 

wiping after product application; however, special attention was paid to the recorded 

observations, which noted that no workers wiped surfaces after they were sprayed.
15

The aerosol study was conducted at three randomly selected hotels in Fresno County, 

California, including a Marriott hotel, a Piccadilly Inn and a Hilton hotel. The study was 

stratified by six independent monitoring events (MEs) at each of three sites. To ensure diversity

of individual exposures, at each site one enrolled subject was assigned to one of six MEs defined 

by the number of cans sprayed, ranging from one can to four cans. Some cans were emptied 

halfway and weighed prior to the start of the ME to account for slight differences in the amount 

of product applied. The dermal and inhalation exposure to Clorox disinfecting spray (n-alkyl 

dimethyl benzyl ammonium chloride [ADBAC]) was monitored using six inner/outer whole 

body dosimeters. Other clothing requirements included long pants, long-sleeved shirt and no 

gloves. Subjects wore two breathing zone air samplers, OVS tubes and RespiCon Particle 

Samplers (RPSs). Notably, the OVS tubes process 2 liters per minute while RPSs process 3 liters 

per minute.

The aerosol protocol’s study objective was to have sample estimates of the arithmetic 

mean and 95th percentile of normalized exposure accurate to within three-fold 95 percent of the 

time. The AEATF discussed the SOP with the HSRB early in the process and responded to EPA 

comments. EPA recommended that the AEATF indicate the course of action if the benchmark 

accuracy goals (i.e., a K-factor of 3) are not achieved. The AEATF responded that they will work 

with EPA to determine the course of action, including collecting additional data, if the accuracy

goals were not met. 

In its original review of the protocol, the HSRB had noted that many variables might 

affect exposure and the Board wanted to know if results could be generalized for consumers. Mr. 

Leighton noted that, ideally, the two populations would be monitored in parallel. However, the 

EPA accepts the data for consumers because the spray behavior for a consumer is not expected to 

deviate from that of a janitorial worker due to aerosol spray cans being easy to use. The AEATF 

assessed the observation data to determine that no behaviors were performed by workers that 

would be inconsistent with the behavior of a consumer. Workers experienced incidental 

exposures from leaning on surfaces and brushing against shower curtains similar to what 

consumers would experience. Additionally, labels on the aerosol cans do not distinguish workers 

from consumers, so monitoring the exposure of janitorial service workers who apply multiple 

cans at a time will ensure that product labels are appropriate for both cohorts and will provide a 

more conservative estimate of exposure for consumers. 

The HSRB also had noted in its prior review that they could not judge the sample size 

adequacy without a statistical analysis plan. The AEATF responded that they will use the base 

set of data to determine the sample size, and acknowledge that additional data collection might 

be required. The HSRB also requested clarification of the details regarding spray application, 

which was provided by the AEATF in the revised protocol and in two letters that are appended to 

the EPA Science Review. Clarifications resulting from HSRB comments included the 

designation of hotels as study sites, the limit of two MEs per day, and the specification of the 

number of cans sprayed at a time. 

Regarding quality assurance improvements, the AEATF increased the minimum 

fortification levels from two-fold to four-fold limitation of quantitation (LOQ), ensured that 

surfaces were dry prior to application, and recorded careful observations. Mr. Leighton noted 

that additional improvements resulting from HSRB comments could be read in the study report. 
16

The completed aerosol study reported 18 deviations in protocol, methods and SOP, none 

of which affected scientific validity. The order in which the number of cans sprayed was 

reversed in one of the clusters to ensure there were enough MEs. Hand wash and wipe removal 

efficiency studies were modified to address the EPA Science Review. Hand washes were 

performed with a 30-minute drying time. Solubility of the quaternary ammonia products was a 

concern, but the AEATF responded that they are all soluble up to 2 percent in an isopropyl 

alcohol (IPA)/water solution. Products of less than 2 percent were used in the scenario. The two 

wipe efficiency studies, didecyl dimethyl ammonium chloride (DDAC) and alkyl dimethyl 

benzyl ammonium salt (ADBAS), show conflicting results. The difference may have resulted 

from the fact that the ADBAS study measured the wipe removal efficiency directly from the 

skin, as opposed to the DDAC wipe portion of the study that measured wipe efficiency after 

fortified hands were dried for 30 minutes and then washed, resulting in a 10 percent residue of 

the initial fortification remaining on the hands. When that amount was wiped off, a 60 percent 

recovery was calculated for the wipe. In the ADBAS study, hands were fortified, dried for 30 

minutes, and wiped directly to remove 90 percent of the fortification. Finally, the drying time in 

removal efficiency studies came under consideration, but according to literature, a range of 

drying time from 30 minutes to 2 hours should not significantly affect removal efficiencies 

because DDAC dermal penetration is less than 1 percent.

Study participants wore whole body dosimeters under and on top of long pants, longsleeved shirts and no gloves. The dermal unit exposures (UEs) can be estimated for three 

clothing configurations due to the placement of the whole body dosimeters: long pants with a 

long-sleeved shirt, long pants with a short-sleeved shirt, and short pants with a short-sleeved 

shirt. The mean AaiH was 0.0031 pounds, with a range from 0.0013 to 0.0053 pounds. The mean 

ME duration was 70 minutes, with a range from 25 to 128 minutes. The mean surface area 

sprayed was 1,282 square feet, with a range from 417 to 2,419 square feet. Rather than using 

nominal concentrations, the investigators measured the percent AI and the weight in the cans to 

calculate AaiH of ADBAC accurately. 

Mr. Leighton noted that all laboratory and field controls were less than the LOQ. The 

samples had satisfactory LOQs, indicating that non-detects were not a problem. Laboratory

recovery rates ranged from 90 to 100 percent with a few outliers. Field recoveries were collected 

and processed in parallel with samples to correct dosimetry samples. The mean recovery for all 

samples was 90 percent, similar to previous studies. Two outliers were discarded from the 

analysis. 

Regarding statistical evidence, three methods were used to estimate UEs: empirical 

estimates, simple random sample and mixed model methods. Empirical estimates were used to 

look at individual data points, which is useful to ensure data transparency. Mr. Leighton noted 

that the public may be looking at the data in addition to statisticians. If the mixed model is 

drastically different from the empirical estimate, the public will want to know why. Similar 

values between models facilitate transparency. The mixed model was selected to best represent 

the UE results. 

Of the 108 sections analyzed for dermal exposure, 87 percent had detectable values, 

indicating that the study was designed adequately to detect residues. The LOQ was adequate for 

the study. One of the monitoring clusters had exposure levels much higher than the rest, but the 

data were included in the analysis because none of the behavior observations were considered 

negligent. The potential impact of this one cluster is 10 percent. 
17

Inhalation exposure was measured using values for spray time instead of sampling time 

to correct for variations in spray speed between subjects. Because the monitor ran the entire time, 

it was more appropriate to use sampling time for the calculations. The calculated arithmetic 

mean for inhalation using sampling time was 60.3 milligram per cubic meter per pound 

(mg/m3/lb) AI. 

Mr. Leighton discussed whether the sample size was large enough based on the data. He 

noted that the benchmark objective of three-fold relative accuracy (K-factor is less than or equal 

to 3) was met for the mixed-model results using the study design of three clusters each with six 

MEs. Because the relative accuracy was less than three, there was no need for additional data 

collection. 

The aerosol data are not inconsistent with the assumption of proportionality. 

Proportionality between exposure and AaiH is used by EPA to extrapolate the data to other 

chemical exposure assessments. Results of the aerosol study support this assumption. The 

relationship between dermal exposure and AaiH shows evidence of proportionality with a slope 

of approximately one. The Board had suggested looking at inhalation as a dose, not in terms of 

air concentration. There is a suggested proportional relationship between inhalation dose 

(measured in mg) and AaiH, although the slope is 1.5 with a confidence interval (CI) from 1.05 

to 1.84. There is no evidence for proportionality between air concentration (measured in mg/m3) 

and AaiH, although the CI included zero. Time weighting those averages, however, generates a 

slope similar to that of the inhalation dose because time has been factored into the equation.

Data generalization from this study has limitations. For example, the aerosol study

population is not a random sample due to the assumption that exposure is independent of 

location. Notably, statistical inference from these results to all people who spray with an aerosol 

can is not justifiable and was not a goal of the study. The study assumes that the location of 

Fresno, California, is not much different than any other city, and the sprayable surfaces within 

buildings are not going to be significantly different.

EPA plans to use the UE data from the aerosol study to estimate potential exposure to 

low- or moderate-volatility pesticides use in aerosol scenarios. The data will not be used to 

assess fumigants. Dermal UE values are available for various clothing configurations. Inhalation 

exposure is still being evaluated by EPA, but preliminary results suggest that a factor of 1.25 

separates the OVS and RPS values. The two air samplers agree fairly well in the measurement of 

100 micrometer (μm) particles. The AEATF is uncertain whether the data should be corrected by 

that factor and welcomes advice from the Board. EPA plans to use UEs normalized by pounds 

AI values in collaboration with chemical-specific hazard and dermal absorption values to 

estimate the internal dose and risk from these data.

In conclusion, EPA determined that the study results are sufficiently sound to support 

estimates of dermal and inhalation UEs. An adequate number of samples were collected, thus 

precluding the collection of additional aerosol MEs and certifying the use of the data now. 

Mr. Leighton acknowledged the data limitations. 
18

Board Questions of Clarification—Science

Dr. Philpott noted that Dr. Menikoff had joined the Board, and then opened the floor for 

questions of clarification.

Dr. Young requested clarification regarding whether the proportionality between exposure 

and AaiH was on a log scale in Figure 9 within the EPA Science Review. Dr. Cohen responded 

affirmatively: the straight purple line is the log of exposure regressed using a mixed model against 

the log of AaiH normalized such that the slope of log exposure is one. The curved green line in the 

same graph indicates an arbitrary slope and intercept for log of exposure related to log of AaiH. 

Dr. Young asked if the curved green line indicated a quadratic fit on the log-log scale. Dr. Cohen 

responded that was not correct. Dr. Cohen explained the equations for the models representing the 

two different lines in the graph. The models are included in Appendix A of the EPA Science 

Review. The point of the purple line is that exposure and AaiH are assumed to be normally

distributed. The green line does not assume a slope of one, but is based upon a model where the 

exposure is equal to some constant times AaiH is raised to the power of the slope of the line. The 

data are proportional in the log-log scale. Dr. Johnson clarified that the purple line does not depend 

on data other than the intercept, and Dr. Cohen said that was correct. He explained that after the 

mean of exposure and AaiH is calculated and the constant K is defined, then AaiH multiplied by K 

can be used to estimate exposure. Dr. Johnson clarified that the green line resulted from the actual 

data. He explained that he had trouble determining if the figure was labeled correctly because the 

line would be straight unless plotted on a log scale.

Dr. Young raised concern with the slope of the relationship between inhalation dose and 

AaiH not being equal to one with a wide CI. Mr. Leighton responded that was the cause of using the 

terminology of “suggested” rather than “evidence” of a proportional relationship.

Dr. Popendorf asked if the workers had to be experienced. Mr. Leighton responded that the 

subjects were recruited from janitorial maintenance services. Dr. Popendorf noted that there was a 

fair amount of diversity in the subjects. 

Dr. Popendorf stated that the number of non-detected values was small, and because all of 

the non-detects in the inner dosimeter were 10-fold lower than the unusually high inner dosimeter 

values for subject AE19, the effect of the non-detected values was negligible. Mr. Leighton replied 

that application of three methods of statistical analysis did not make a difference in the overall 

evaluation. Only 13 percent of the inner dosimeters did not function; the results were driven by the 

higher exposure values.

Dr. Popendorf noticed that the average time taken to treat each room was significantly

different at one of the sites. Two of the sites had an average of 8.5 minutes per room, but the last site 

had an average of 6 minutes per room. He questioned whether that was because one of the sites had 

a different layout than the other two. Mr. Leighton noted that the hotel with faster times was the 

Hilton hotel. He suggested that they revisit the question during the public comment period.

Dr. Johnson asked Mr. Leighton to elaborate on Figures 6 and 7 of the EPA Science 

Review. Mr. Leighton referred the query to Dr. Cohen, who explained that Figure 6 represented the 

log of dermal exposure plotted against the log of AaiH. The line in the figure indicates the fitted 

regression line in log-log scale. Notably, the fitted lines from the simple linear regression model and 

the mixed model are the same, indicating that there is no cluster effect. Dr. Johnson thanked him for 
19

the clarification. Dr. Johnson asked about the models within Appendix A of the EPA Science 

Review. Dr. Cohen clarified that the results of the spray duration are not within statistical review 

because the inhalation dose was corrected by multiplying by sampling time rather than spray

duration. Dr. Young questioned the genesis of the “half” value that is multiplied by variance within 

the models. Dr. Cohen answered that is done to calculate the arithmetic mean of the ratio of the 

exposure divided by the AaiH. If the variance of the log of exposure is V, then the expected value of 

the UE is given by E to the intercept times E to the half of the variance. This equation results from 

log-normal distribution models.

Dr. Lebowitz asked how the EPA analysis accounted for the sample outliers of laboratory

recovery values. Mr. Leighton explained that the laboratory recovery outliers were included in the 

analysis, and were not used to correct field samples because the field recovery samples were used to 

cover both the laboratory and the field samples. Dr. Lebowitz confirmed that the two very high field 

recoveries were not included in the analysis, and Mr. Leighton concurred. Dr. Lebowitz asked how 

the samples are used to correct the data. Mr. Leighton explained that each sampling matrix, 

including the whole body dosimeters, the hand wash, the wipes, and the air, had their own set of 

fortifications for the field recoveries. Each one was used as an average to correct samples 

themselves. If the field recoveries came back at 100 percent, then no correction was applied.

EPA Ethics Assessment

Ms. Sherman reviewed the timeline of the AEATF study, which began with a protocol 

review by the HSRB in October 2009. Recruitment and subject enrollment began in April 2010 and 

field monitoring began in June 2010. The study was then stopped for 1 year before resuming subject 

monitoring in May 2011. Data analysis and reporting was completed in 2011, and the completed 

report was submitted to EPA in November 2011. 

The subjects for this study were recruited by posting flyers at janitorial service providers 

identified through telephone directories and Chambers of Commerce. Of the 228 companies 

contacted, 34 agreed to post flyers. Advertisements also were placed in three Fresno County

newspapers. Subjects obtained through both methods were interviewed by telephone to ascertain if 

they met the inclusion criteria, in which case they were scheduled for an informed consent meeting 

in person at Golden Pacific Laboratories. Ms. Sherman noted that the consent process was 

consistent with the protocol, equitable and free of coercion. No deviations were reported. During the 

consent meeting, potential subjects met with the study director or a Spanish-speaking researcher 

who explained the procedures, evaluated exclusion criteria, and gave the subjects consent 

documents with instructions to take the forms home to discuss with friends and family. After 

signing the consent form, the subject was enrolled in the study. Of the 42 people who came for 

consent interviews, 34 subjects were enrolled, and of those enrolled, 18 subjects were monitored. 

Regarding demographics, the study included 11 male and 7 female subjects, and 16 preferred that 

the process be conducted in English. The mean age was 46 years old and all had previous janitorial 

experience with a mean of 7.5 years. 

Ms. Sherman explained that the study was put on hold after initial monitoring of four 

subjects in June 2010, some of whom expressed the desire to wear a respirator. The AEATF 

contacted EPA and IIRB and amended the protocol and consent form to offer subjects the option to 

wear a half-mask respirator. The protocol amendment and revised consent documents were 

approved by IIRB in May 2010 and four subjects, all of whom decided to use the respirator, were 

monitored in June 2010. Shortly thereafter, the CDPR asked for an additional review of the 
20

respirator. The AEATF put the study on hold pending the outcome of the review. In a meeting in 

August 2010, EPA, sponsors and the study director decided to proceed with the study, giving 

subjects the option of wearing a respirator. CDPR approved the respirator documents and supported 

study resumption. Ultimately, all 18 monitored subjects chose to wear a respirator. During that hold, 

the original study director resigned and a new study director was named. The study resumed in 

spring 2011.

Monitoring was conducted with no incidents. Subjects were offered rest breaks, and six of 

the 18 subjects availed themselves of the opportunity. Some subjects asked for assistance with 

adjusting their respirator. No instances of sickness or injury were reported. 

Ms. Sherman lauded the AEATF’s responsiveness to EPA and HSRB protocol reviews, 

noting that all suggestions were taken into account. She explained that the investigators also 

complied with IIRB procedures and requirements. The initial protocol was reviewed by IIRB in 

August 2009. Four amendments, two of which were related to ethics, were approved by IIRB 

throughout the course of the study. The first amendment gave subjects the choice of wearing a 

respirator. The second amendment resulted in a revised procedure for removing subjects’ socks 

during sample collection. The investigators revised the protocol to respect the subjects’ preference 

to not remove their socks prior to removing the dosimeter. Ms. Sherman was pleased that the 

AEATF responded to the desires of the subject and modified the protocol accordingly.

Ethical deviations from the protocol include the enrollment of one subject who reported 

“fair health,” but that subject was not monitored. Previous HSRB discussions about self-reported 

health as an study inclusion, initiated after the period of enrollment for this study, have led to 

development of an SOP that clarifies health status reporting, so this issue likely will not arise again. 

The ethics training certificate renewals of the original field study director and field coordinator were 

overdue when monitoring first began in 2010, but were current by the time monitoring resumed in 

2011. Ms. Sherman noted no unreported deviations.

Ms. Sherman stated that the report and IIRB records were complete and well indexed, 

satisfying the requirements of 40 CFR §26.1303. The study also satisfied the following acceptance 

standards: 40 CFR §26.1703, which prohibits reliance on data involving intentional exposure of 

pregnant or nursing women or of children; 40 CFR §26.1705, which prohibits reliance on data 

unless EPA has adequate information to determine substantial compliance with subparts A 

through L for 40 CFR part 26; and FIRFA §12(a)(2)(P), which makes it unlawful to use a 

pesticide in human tests without fully informed and voluntary consent. 

Ms. Sherman reported that all subjects were at least 18 years old, all females were 

tested for pregnancy, and pregnant or nursing women were excluded. Subjects were fully

informed and their consent was fully voluntary without coercion. The protocol was faithfully

executed and amended when needed; minor deviations did not compromise the safety or 

consent of the subjects. There were no noteworthy deficiencies in the ethical conduct of the 

research.

Ms. Sherman stated that the available information indicates the AEATF aerosol study was 

conducted in substantial compliance with 40 CFR part 26, subparts K and L.
21

Board Questions of Clarification—Ethics

Dr. Menikoff requested additional explanation about the nature of the CDPR concerns. 

Mr. Leighton deferred to the researchers and study sponsors to answer that question. Dr. Philpott 

invited Mr. William McCormick III, Mr. Robert Testman, and Ms. Megan Boatwright to respond to 

the questions. Mr. Testman replied that the primary concern of the CDPR was that although a 

procedure was in place to ensure that the subjects were qualified to wear a respirator, the CDPR 

wanted a respiratory protection plan document that included the subjects. The AEATF had one 

document that included researchers and staff and a separate procedure for the subjects. After the 

procedure was modified into a single document, the CDPR was satisfied because they wanted to 

ensure that subjects completely understood the procedure and compliance. The CDPR did not ask 

for protocol changes but rather clearly written documentation in one plan. Dr. Menikoff asked if the 

CDPR was worried about the respirator harming subjects or affecting the scientific results of the 

study. Mr. Testman stated that the CDPR did not have enough information at first to judge whether 

sufficient protections were in place, and they were not concerned about anything aside from better 

documentation. Ms. Sherman added that the CDPR asked for a review of the procedures in June 

2010 and approval was granted in August 2010. Additional factors also influenced the 1 year study

delay.

Dr. Popendorf asked if there was a minimum requirement for janitorial experience of the 

study subjects. Mr. Testman replied that there was a 1-year requirement and that all subjects were 

screened based on professional janitorial experience.

Dr. Popendorf asked for clarification about the sequence of the hotels monitored. 

Mr. Testman replied that the sites included kitchens and kitchenettes. The one site with the shorter 

average spray duration referred to earlier by Dr. Popendorf was a Hilton hotel with a kitchenette 

design. The application likely went faster because it was a bigger layout with a full shower and no 

bathtub, so the subjects were able to cover more square footage much quicker. Additionally, the 

rooms were closer together at the Hilton hotel. Subjects took longer to move from room to room at 

the Piccadilly hotel site. Another possible explanation is that the researchers improved over time 

and did not impede the progress of the subjects at the later sites. 

Dr. Popendorf noted that it appeared that all of the subjects were covered by the OSHA 

respiratory protection plan along with the researchers and staff. Mr. Testman said that the CPDR 

had wanted everyone addressed in the same written plan and the AEATF had to comply with 

OSHA guidelines, although it was unclear why voluntary subjects would be covered under the 

OSHA plan because OSHA only regulates employees.

Dr. Philpott summarized that it sounded like CPDR wanted to ensure that subjects were 

adequately informed and knew how to use the respirator, noting that the use of a respirator was not 

otherwise required for use of this disinfecting product.

Dr. George Fernandez asked how the hotels were selected. Mr. Testman explained that the 

original list was selected from the telephone book and other sources. The hotels were then 

categorized by the presence of a kitchen into groups of “hotel only,” “kitchenette,” or “kitchen.” 

The investigators chose one hotel from each category through use of a randomization program. The 

hotel was then asked if they would like to participate in the study. Mr. Testman noted that there 

were more potential hotels without kitchens than ones with full kitchens. Dr. Fernandez asked 

whether these hotels were treated as random and thus could be used to make inferences about 
22

similar establishments. Mr. Testman affirmed that the study protocol was designed specifically for 

hotels. Mr. Leighton noted that they had originally considered using unoccupied buildings, but they

settled on using hotels because of the large number of available rooms to treat.

Dr. Fernandez questioned whether the findings would be limited to a hotel environment, 

noting that households may have open windows and more air circulation. He commented that 

environmental conditions can influence the study approach. Mr. Leighton explained that the study

measured 0.6 to 2 air exchanges in the hotels and noted that it would be better to have low air 

exchanges to make a conservative estimate of exposure.

Dr. Johnson commented that the study design had been discussed in detail, including what 

results can be concluded based on these data. He noted that the statisticians are responsible for 

helping EPA realize that some of the inferences are not based on statistical conjecture but rather 

expertise and knowledge of the situation. Dr. Johnson accepted the limits of the data. 

Mr. McCormick clarified that the commercial Clorox solutions are supplied in 19-ounce 

cans compared to the 13-ounce consumer can. Dr. Popendorf noticed that the reported averages of 

the flow rates of two batches of cans differed by 20 percent. He questioned if that difference was 

statistically significant and if there was any information regarding how variable flow rates are 

between cans. Mr. Testman replied that there was no information on the variability of flow rates, but 

noted that the test was designed by the AEATF and was not using an SOP supplied by Clorox. The 

AEATF performed that calculation to understand how fast the product discharges to ensure it 

occurred at a reasonable rate. Mr. Leighton referred the HSRB to the original protocol rationale for 

the study, which described a test of the spray characteristics for 18 different products. There was no 

protocol for that test. Rather, it was used to inform the product selection criteria. 

Dr. Philpott asked the study sponsors to explain why the subject who self-reported “fair 

health” was enrolled despite the fact that he did not meet the inclusion criteria. Mr. Testman 

speculated that the original study director may have been looking at multiple criteria of health, the 

self-reported value being only part of the decision. He noted that another individual who selfreported “good health” was excluded for other health reasons. Dr. Philpott asserted that it would be 

useful to clarify the exact method of determining health in future protocols. 

Dr. Popendorf asked whether the first four subjects were monitored by the same field 

personnel, and Mr. Testman assured him that they were. 

Mr. Testman thanked the Board for their remarks and expressed appreciation for their time 

and effort in reviewing the studies.

Public Comments

Dr. Philpott called for public comments on the AEATF II completed study; no public 

comments were presented.

Charge Questions

Ms. Sherman read the charge questions into the record:
23

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

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

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

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

professional janitorial workers who apply liquid antimicrobial pesticide products to indoor 

surfaces using pressurized aerosol cans? 

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

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

Board Science Review

Dr. Philpott asked Dr. Popendorf, as Lead Science Discussant, to address the first two 

charge questions. Dr. Popendorf first disclosed that he had stayed at one of the hotels in the study. 

He began his analysis by stating that the study was done thoroughly, the information provided was 

helpful and detailed, and the individual data appear reliable. When he looked for patterns within the 

data, he found some trends that were not explained. Dr. Popendorf noted that the diversity of 

subjects and study settings makes the study strong. He mentioned a few limitations of the study. 

Although the field notes were very thorough, he noticed that subject AE4 had been given 

instructions to “lighten up” his application. This reflects two points of relevance. First, the protocols 

stated that subjects were to apply the product as they normally do, but in this case the researcher 

intervened. This may have been a worthwhile activity to prevent harm, but the situation was not 

documented as a deviation. Dr. Popendorf remarked that there were some interesting outliers, one of 

which was subject AE18. Dr. Popendorf outlined reasons to consider that data point an outlier, but 

he emphasized that he was not suggesting that be done. Dr. Popendorf recommended that the data 

be kept in the analysis for the sake of robustness, although that subject had exposure levels much 

higher than the average subject. He also mentioned that future protocols should define more 

precisely when intervention is appropriate and when a subject should be considered an outlier. For 

example, if someone was very meticulous, they could have no exposure. 

Dr. Popendorf questioned how the values were calculated for ventilation in air changes per 

hour. He had attempted to replicate the results using various calculations of room volume and flow 

rates but could not duplicate the reported values. The second cluster had reported 100 percent 

recirculated air, and Dr. Popendorf would like to see that clarified. He noted that the ventilation 

calculation could be viewed from a different perspective of the time for one air exchange. If subjects 

spend a few minutes in each room, the air exchange rate will not make much of a difference. 

Dr. Popendorf summarized that although there may be problems with the way ventilation has been 

calculated and recorded, he does not think those calculations will significantly affect the results. 

Dr. Popendorf’s final comment was related to differences between the first four subjects 

and the remaining 14 that were monitored after the study interruption. He noted that the discharge 

rates on the cans were different between the two sets, and the percentage of product also was 

different. The measurement of total aerosols versus particles less than 10 μm were dissimilar 

between the two sets, as were RPS and OVS measurements. In his pattern analysis, Dr. Popendorf 

noted that an increase in the flow rate of the nebulizer would result in a smaller particle size that is 

inhaled less. The RPS contained a fraction of 50 percent in the 10 μm range, which was higher in 

the first four subjects. He noted the possibility that the flow rate differences were real and may not 

constitute a limitation, but rather increase the variability of the data. Dr. Popendorf suggested that 
24

the aerosol flow rate deserves consideration because of the 20 percent difference between sets. He 

noted that his comments did not indicate major problems and were designed to make the study more 

robust, more useful and more reliably extrapolated to other settings. 

Dr. Lebowitz, Associate Discussant for this protocol, stated that he agreed with Dr. 

Popendorf on many of the comments. He suggested combining dermal and inhalation exposures to 

determine the actual exposure levels. Dr. Lebowitz was pleased to see that the EPA analysis 

adjusted for fortified samples. However, he noted that some questions of clarification were not 

answered, including whether a slope of 1.5 indicates true proportionality. This needs to be evaluated 

by EPA to improve upon future study protocols. Dr. Lebowitz concluded by thanking the Board and 

EPA for his 6 years of service.

Dr. Johnson suggested that the HSRB discuss the term “proportional.” He noted that a 

deviation from a slope of 1, such as 1.2 or 1.3, is still proportional although the term is not applied 

unless the slope approximates exactly 1. Mr. Leighton agreed that the term proportional would be 

excluded from future reports. 

Dr. Johnson reiterated that the earlier questions regarding the EPA Science Review figures 

could have been prevented by maintaining one scale or the other, either log-log or exposure versus 

AaiH. He suggested additional discussion about the figures and what can be interpreted from them, 

not for the purposes of asking EPA to rewrite the review, but to clarify the impact on other reviews. 

Dr. Johnson suggested including the models in the body of the EPA Science Review rather than the 

appendix. Dr. Johnson responded affirmatively to both charge questions.

Dr. Philpott solicited further discussion on a topic raised by Mr. Leighton in the Agency’s 

Science Review. Specifically, was it was proper to correct the data from the RPS back to OVS, or 

should the two data sets should be considered separately? Mr. Leighton clarified that they have not 

yet applied the correction and welcome the Board’s input. Dr. Lebowitz responded that because 10 

μm particles were more important than 100 μm particles, he thought that the RPS results would be 

more useful in terms of inhaled dose than the OVS results. Dr. Popendorf agreed with Dr. Lebowitz, 

noting that literature suggests a correction of 1.5 to 1.8 for respiration. The 10 μm particle 

differences were not large in the RPS measurements, especially within the first four replicates, 

which were nearly identical. Comparisons between RPS and OVS were very similar in the first four 

samples, but the other 14 varied substantially up to 76 percent. He would not recommend applying a 

large correction to the first four subjects; at most, a correction factor of 1.3 is needed.

Dr. Young expressed appreciation for the effort that went into the analyses and noted that 

each review gets better. She pointed out that Dr. Johnson is fine-tuning the analyses rather than 

suggesting the existence of major issues. In Dr. Young’s opinion, the CI of the slope of 1.5 covers 1, 

so she is not concerned with calling the relationship between inhalation exposure and AaiH 

proportional. If a CI does not cover 1, the analysis may need to be handled differently. 

Dr. Philpott summarized the Board’s consensus opinion. He stated that the research 

reported is faithful to the design, and EPA has characterized many of the limitations on using the 

data to estimate exposure of professional workers. He noted a few caveats, such as the issue of 

variability introduced by Dr. Johnson. Dr. Philpott emphasized the importance of being cognizant of 

the limitations to general applicability of a janitorial worker to a consumer. He repeated 

Dr. Popendorf’s observation of differences between the first set of four subjects and the rest, which 

were attributed to the study’s delay. In particular, differences in the discharge rate of the aerosol 
25

cans could affect inhalation data. Dr. Philpott entreated EPA and the sponsors to consider 

differences between these two groups in the analysis. The Board considers the RPS data to be more 

useful than the OVS data and should be treated as a more representative value of the amount of 

product inhaled. 

Dr. Young emphasized that coefficients larger than 1 require clarification. In particular, 

slopes of 1.5 where the CI does not cover 1 are of concern and proportionality should not be 

assumed. Dr. Popendorf requested that the report also include clarification that possible ventilation 

calculation errors might not affect the results, to which Dr. Philpott noted that EPA is now aware of 

that limitation and the HSRB will clearly detail the rationale for this recommendation in its report. 

Board Ethics Review

Dr. Philpott noted that Dr. Popendorf had left the meeting but the Board was still had 

quorum. Dr. Philpott asked Dr. Menikoff, as Ethics Lead Discussant, to discuss whether the 

available information supports a determination that the study was conducted in substantial 

compliance with subparts K and L of 40 CFR part 26. 

Dr. Menikoff agreed that the study was conducted with substantial compliance. He thanked 

Ms. Sherman for the thorough analysis and noted that EPA researchers continue to refine their 

studies according to HSRB review. Dr. Menikoff commended the good study design and noted that 

the minimal deviations were largely inconsequential. Recruitment lacked coercion, and pregnant 

and nursing women were excluded from the study. Regarding the voluntary use of respirators, he 

commended the researchers for making the effort to add an additional element of protection that was 

not required. Dr. Menikoff agreed that the self-reported condition of “fair health” was not the best 

estimate for excluding an individual from the study. He noted that those criteria have been 

redesigned and will be applied to future studies. 

Dr. Philpott, Associate Discussant for this protocol, also commended Ms. Sherman for her 

ethics review given the challenges of the study interruption, amendments and reported deviations. 

Her thorough analysis facilitated the Board’s review. He agreed with Dr. Menikoff that the sponsor 

and investigator could not be faulted for enrolling a person with reported “fair health” because the 

subject was enrolled prior to HSRB review of the issue. Although not relevant to the charge 

question, the issue of self-reported health will need to be clarified in the future. 

Dr. Johnson had one more remark regarding the science of the study. He expressed 

surprise at the consistency of the quantile plots given the amount of scripting in the studies. Even 

with all of the variables, the results still look like random sampling and are statistically robust. 

Dr. Philpott stated that the general Board consensus was that the answer to the ethics 

charge question is “yes” and that the Board is in agreement that the available information supports 

the determination that the study was conducted in substantial compliance with subparts K through L 

of 40 CFR part 26. With that determination, the Board review of the two agenda items was 

concluded.
26

An Update from the Work Group on Return of Individual Research Results

Dr. Philpott noted that there was no update regarding the working group’s analysis of the 

return of individual research results. Dr. Lux mentioned that his office is available to provide 

guidance on areas such as the reporting of results, and the Agency is welcome to contact him.

Adjournment

Dr. Philpott stated that it has been a privilege to have worked with the Board, and he 

acknowledged Mr. Downing’s efforts as DFO. Dr. Philpott also stated that it has been a pleasure to 

work with all of the Board members, and he is grateful for the opportunity to have become 

colleagues. He acknowledged the efforts of Drs. Chambers and Parkin, who served as his vicechairs during the past 3 years. He thanked Ms. Susan Podziba, an EPA contractor, for providing 

support in facilitating the HSRB meetings. Dr. Philpott thanked the EPA staff of Drs. Lux and 

Cohen, Ms. Sherman, and Mr. Evans, Mr. Jordan and Mr. Leighton. He also expressed gratitude to 

the sponsors for being responsive to the Board’s concerns. Dr. Philpott concluded that the change 

seen over the past 6 years of the Board’s existence in terms of quality of research has been 

remarkable.

Mr. Downing announced that the April 2012 meeting was cancelled due to a lack of 

discussion topics. The date and times of the next meeting will be announced in the Federal Register 

and posted on the HSRB website. Mr. Downing adjourned the meeting at 3:51 PM.

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
27

NOTE AND DISCLAIMER: The minutes of this public 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.
28

Attachments

Attachment A HSRB Members

Attachment B Federal Register Notice Announcing Meeting

Attachment C Meeting Agenda
29

Attachment A

EPA HUMAN STUDIES REVIEW BOARD MEMBERS

Chair

*+Sean Philpott, Ph.D., M.Bioethics Term: 3/27/2006–8/31/2012

Director, Research Ethics

The Bioethics Program

Union Graduate College–Mt. Sinai School of Medicine

Schenectady, NY 

Vice Chair

*+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

Lake Frederick, VA

Members

*+Janice Chambers, Ph.D., D.A.B.T. Term: 3/27/2006–8/31/2012

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, MS

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

Statistical Training Specialist

SAS Institute, Statistical Training and Technical Services

Sparks, 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
30

*+Jewell H. Halanych, M.D. Term: 11/14/2011–8/31/2014

Assistant Professor

Department of Medicine

Division of Preventative Medicine

University of Alabama at Birmingham

Birmingham, AL

*+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) and 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

Office of the Secretary

Department of Health and Human Services

Rockville, MD

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

Professor Emeritus

Department of Biology

Utah State University

Logan, UT

*Leonard Ritter, Ph.D. Term: 11/14/2011–8/31/2014

Professor Emeritus (Toxicology)

School of Environmental Sciences

University of Guelph

Guelph, Ontario, Canada
31

*Bernard A. Schwetz, D.V.M., Ph.D. Term: 11/14/2011–8/31/2014

Retired Director

Office of Human Research Protections

Department of Health and Human Services

Cadott, WI

+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

Professor and Associate Chair

Department of Statistics

Institute of Food and Agricultural Sciences

University of Florida

Gainesville, FL

*Special Government Employee (SGE)

^ Present via telephone January 26, 2012

+ Present on January 26, 2012

# Present for Session 2 on January 26, 2012
32

Attachment B

Federal Register Notice Announcing Meeting

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)] 

[Notices]

[Pages 80938-80940]

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

[FR Doc No: 2011-33156]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0954; FRL-9611-6]

Human Studies Review Board (HSRB); Notification of a Public Meeting

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the Science Advisor 

(OSA) announces a public meeting of the Human Studies Review Board (HSRB) to advise the 

Agency on EPA’s scientific and ethical reviews of research with human subjects.

DATES: This public meeting will be held on January 26, 2012, from approximately 9 a.m. to 

approximately 5:30 p.m. Eastern Time. Comments may

[[Page 80939]]

be submitted on or before Thursday, January 19, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No. EPA-HQ-ORD2011-0954, by one of the following methods:

 Internet: http://www.regulations.gov: Follow the on-line instructions for submitting comments.

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

 Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), ORD Docket, 

Mailcode: 28221T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460. 

 Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, 

Room Number 3334 in the EPA West Building, located at 1301 Constitution Avenue, NW, 

Washington, DC 20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday

through Friday, excluding Federal holidays. Please call (202) 566-1744 or e-mail the ORD Docket 

at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on 

the Web site (http://www.epa.gov/epahome/dockets.htm).

 Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD- 2011-0954. EPA’s 

policy is that all comments received will be included in the public docket without change and may
33

be made available online at http://www.regulations.gov, including any personal information 

provided, unless the comment includes information claimed to be Confidential Business 

Information (CBI) or other information the disclosure of which 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 send an e-mail 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. 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 electronic storage media 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.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 

receive further information should contact Jim Downing at telephone number: (202) 564-2468; 

fax: (202) 564-2070; e-mail 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: Environmental Protection Agency, Office of the Science Advisor (8105R), 1200 

Pennsylvania Avenue, 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/.

SUPPLEMENTARY INFORMATION:

 Location: The meeting will be held at the Environmental Protection Agency, Conference 

Center--Lobby Level, One Potomac Yard (South Building.) 2777 S. Crystal Drive, Arlington, VA 

22202. 

 Meeting access: Seating at the meeting will be on a first-come basis. To request accommodation 

of a disability, please contact the persons listed under FOR FURTHER INFORMATION 

CONTACT 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, 

“Public Meeting,” under subsection D. “How May I Participate in this Meeting?'” of this notice.

I. Public Meeting

A. Does this action apply to me?

 This action is directed to the public in general. This action may, however, be of particular 

interest to persons who conduct or assess human studies, especially 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). This notice might also be of special interest to participants of studies 

involving human subjects, or representatives of study participants or experts on community

engagement. Since many entities may also be interested, the Agency has not attempted to describe 

all the specific entities that may be affected by this action. If you have any questions regarding the 
34

applicability of this action to a particular entity, consult Jim Downing or Lu-Ann Kleibacker 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 http://www.regulations.gov index. 

Although listed in the index, some information is not publicly available, e.g., CBI or other 

information whose disclosure is restricted by statute. Certain other material, such as copyrighted 

material, will be publicly available only in hard copy. Publicly available docket materials are 

available either electronically in http://www.regulations.gov or in hard copy at the ORD Docket, 

EPA/ DC, Public Reading Room. The EPA/DC Public Reading Room is located in the EPA 

Headquarters Library, Room Number 3334 in the EPA West Building, located at 1301 

Constitution Avenue, NW, Washington, DC 20460. The hours of operation are 8:30 am to 4:30 

p.m. Eastern Time, Monday through Friday, excluding Federal holidays. Please call (202) 566-

1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading 

Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm). 

 EPA’s position paper(s), charge/questions to the HSRB, and the meeting agenda will be 

available by the first of January 2012. In addition, the Agency may provide additional background 

documents as the materials become available. You may obtain electronic copies of these 

documents, and certain other related documents that might be available electronically, from the 

regulations.gov Web site and the EPA HSRB Web site at http://www.epa.gov/osa/hsrb/. For 

questions on document availability, or if you do not have access to the Internet, consult either Jim 

Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.

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. 

[[Page 80940]]

 2. Describe any assumptions that you used.

 3. Provide copies of any technical information and/or data that you used to 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-2011-

0954 in the subject line on the first page of your request. 

 1. Oral comments. Requests to present oral comments will be accepted up to Thursday, January

19, 2012. To the extent that time permits, interested persons who have not pre-registered may be 

permitted by the Chair of the HSRB to present oral comments at the meeting. Each individual or 
35

group wishing to make brief oral comments to the HSRB is strongly advised to submit their 

request (preferably via e-mail) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER 

INFORMATION CONTACT, no later than noon, Eastern Time, Thursday, January 19, 2012, in 

order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and 

HSRB Designated Federal Official (DFO) 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 generally 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, further public 

comments may be possible.

 2. Written comments. Submit your written comments prior to the meeting. 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 meeting. 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, Thursday, 

January 19, 2012. You should submit your comments using the instructions in Section I., under 

subsection C., “What should I consider as I prepare my comments for EPA?” In addition, the 

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

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

INFORMATION CONTACT. There is no limit on the length of written comments for 

consideration by the HSRB.

E. Background

 The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory

Committee Act (FACA) 5 U.S.C. App.2 Sec.9. The HSRB provides advice, information, and 

recommendations to EPA on issues related to scientific and ethical aspects of human subjects 

research. The major objectives of the HSRB are to provide advice and recommendations on: (1) 

Research proposals and protocols; (2) reports of completed research with human subjects; and (3) 

how to strengthen EPA’s programs for protection of human subjects of research. The HSRB 

reports to the EPA Administrator through EPA’s Science Advisor. 

 1. Topics for discussion. At its meeting on January 26, 2012, EPA’s Human Studies Review 

Board will consider scientific and ethical issues surrounding these topics:

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

Force (AHETF) describing proposed research to measure dermal and inhalation exposure to 

workers who mix, load and apply liquid pesticides with powered handgun equipment. EPA 

requests the advice of the HSRB concerning whether, if it is revised as suggested in EPA’s review 

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

useful for assessing the exposure of those who mix, load and apply liquid pesticides with powered 

handgun equipment, and to meet the applicable requirements of 40 CFR part 26, subparts K and L.

 b. The report of a completed scenario monograph and study report from the Antimicrobial 

Exposure Assessment Task Force II (AEATF) in which the dermal and inhalation exposure of 

professional janitorial workers was monitored as they applied a liquid antimicrobial pesticide 
36

product for indoor surface disinfecting using a pressurized aerosol can. The EPA seeks the advice 

of the HSRB on the scientific soundness of this completed research and on its appropriateness for 

use in estimating the exposure of professional janitorial workers who apply liquid antimicrobial 

pesticide products to indoor surfaces using pressurized aerosol cans, and on whether available 

information supports a determination that the study was conducted in substantial compliance with 

subparts K and L of 40 CFR part 26.

 2. Meeting minutes and reports. Minutes of the meeting, summarizing the matters discussed and 

recommendations, if any, made by the advisory committee regarding such matters, will be released 

within 90 calendar days of the meeting. Such minutes will be available at 

http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, information regarding 

the Board’s Final meeting report, will be found at http://www.epa.gov/osa/hsrb/ or from the person 

listed under FOR FURTHER INFORMATION CONTACT.

 Dated: December 19, 2011. 

Paul T. Anastas

EPA Science Advisor

[FR Doc. 2011-33156 Filed 12-23-11; 8:45 am] 

BILLING CODE 6560-50-P
37

Attachment C

U.S. ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

JANUARY 2012 PUBLIC MEETING AGENDA

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive, Arlington, VA 22202 

Thursday, January 26, 2012

HSRB Website: http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566-1752

Docket Number: EPA–HQ–ORD–2011–0954

9:45 AM* Convene Public Meeting – Jim Downing (Designated Federal Officer, EPA Human 

Studies Review Board, Office of the Science Advisor)

Introduction of Board Members – Sean Philpott, Ph.D. (HSRB Chair)

Welcome – Warren Lux, M.D. (Director, Program in Human Research Ethics, 

Office of the Science Advisor, EPA)

Follow-up on Previous HSRB Recommendations – Mr. William Jordan (Office of 

Pesticide Programs [OPP], Office of Chemical Safety and Pollution Prevention, 

EPA)

Session 1: A new scenario design and associated protocol from the Agricultural Handler 

Exposure Task Force (AHETF) describing proposed research to measure 

dermal and inhalation exposure to workers who mix, load and apply liquid 

pesticides with powered handgun equipment.

10:00 AM EPA Science Review – Mr. Jeff Evans (OPP, EPA) 

10:25 AM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor

10:55 AM EPA Ethics Assessment – Ms. Kelly Sherman (OPP, EPA)

11:15 AM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor

11:35 AM Public Comments 

11:50 AM Board Discussion 

Charge to the Board – Science: 

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

exposure of workers mixing, loading and applying pesticides in managed horticultural 

facilities using powered handgun equipment?
38

Charge to the Board – Ethics: 

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

and L?

12:30 PM* Lunch

Session 2: A completed scenario monograph and study report from the Antimicrobial 

Exposure Assessment Task Force II (AEATF) in which the dermal and 

inhalation exposure of professional janitorial workers was monitored as they 

applied a liquid antimicrobial pesticide product for indoor surface disinfecting 

using a pressurized aerosol can.

 

1:30 PM* EPA Science Review – Mr. Tim Leighton (OPP, EPA) and Jonathan Cohen, Ph.D. 

(ICF International)

1:55 PM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor

2:20 PM EPA Ethics Assessment – Ms. Kelly Sherman (OPP, EPA)

2:45 PM Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB Chair), EPA, 

Principal Investigator/Sponsor

3:10 PM Public Comments

3:25 PM Board Discussion

Charge to the Board – Science:

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

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

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

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

professional janitorial workers who apply liquid antimicrobial pesticide products to indoor 

surfaces using pressurized aerosol cans?

Charge to the Board – Ethics:

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

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

4:20 PM An update from the Work Group on Return of Individual Research Results

4:30 PM Adjournment

* Agenda times are approximate and subject to change depending upon the discussion.