EPA Human Studies Review Board (HSRB)

June 16, 2022 Meeting Minutes

June 16, 2022 EPA Human Studies Review Board Meeting Minutes

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

Date and Time: Thursday, June 16, 2022, 2:00 to 2:20 pm EDT.

Location: Via Zoom Meeting

Purpose: The HSRB provides advice, information and recommendations on issues related to scientific

and ethical aspects of human subjects research.

HSRB Website: https://www.epa.gov/osa/human-studies-review-board
Table of Contents

Thursday, June 16, 2022:	1

A.	Convene Public Meeting and Identification of Board Members	1

B.	Meeting Administrative Procedures	2

C.	Meeting Process	2

D.	Public Comments	2

E.	Board Discussion and Decision on April 27, 2022, Meeting Final Report and Minutes	3

F.	Summary and Next Steps	3

G.	Adjournment	3

Attachment A: HSRB Current Committee Membership	A-l

Attachment B: Federal Registers Notice Announcing Meetings	B-l

Thursday, June 16, 2022:

A. Convene Public Meeting and Identification of Board Members

Tom Tracy, Designated Federal Officer, EPA Human Studies Review Board (HSRB), Office of the
Science Advisor, Policy and Engagement (OSAPE)

Mr. Tom Tracy, Designated Federal Official (DFO) for the Human Studies Review Board (HSRB),
called the meeting to order at 2:00 pm, EST. He noted upcoming membership changes effective August
31st. He introduced the meeting, outlined the Federal Advisory Committee Act (FACA) procedures, and
performed a roll call of the meeting participants. The following members and observers were present:

HSRB members

Jennifer Cavallari, Sc.D., University of Connecticut (Chair)



Alesia Ferguson, Ph.D., North Carolina A&T State University (Vice Chair)



Mark Aulisio, Ph.D., Case Western University



Philip Day, Ph.D., UMass Chan Medical School



George Milliken, Ph.D., Milliken Consultants



Julia Sharp, Ph.D., Colorado State University



Albert J. Allen, M.D., Ph.D., Eli Lilly



Eun Um, Ed.D., AMSTAT Consulting



Lisa Corey, Ph.D., Intertox, Inc.



Thomas Lewandowski, Ph.D., Gradient

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EPA Human Studies Review Board (HSRB)
June 16, 2022 Meeting Minutes

EPA staff members

Michelle Arling, EPA, Office of Pesticide Programs (OPP)

Tom Tracy, EPA, Office of Science Advisor, Policy and Engagement

(OSAPE)

Taylor Lass, EPA, OSAPE

Monique Tadeo, EPA, Program in Human Research Ethics and Oversight
(PHREO)

Alexander Kliminsky, EPA, Office of Chemical Safety and Pollution
Prevention (OCSPP)

Timothy Dole, EPA, OPP

Members of the public,
representatives of
research sponsor and
research team:

Afroditi Katsigiannakis, ICF, Contractor Support
Julia Finver, ICF, Contractor Support

R Meeting Administrative Procedures

Tom Tracy, Designated Federal Officer, EPA Human Studies Review Board (HSRB), Office of the
Science Advisor, Policy and Engagement (OSAPE)

Mr. Tom Tracy reviewed Zoom Meeting platform tools and features and stated the purpose of the
meeting was to review the paper by L. Rosenheck et al.1 He noted minutes of the meeting and a report
will be prepared, certified, and posted on the website within 90 days of June 16, 2022.

C.	Meeting Process

Jennifer Cavallari, Sc.D., HSRB Chair

Dr. Jennifer Cavallari welcomed everyone to the EPA HSRB meeting and stated the purpose of the
meeting was to confirm the meeting report from the April 27th HSRB meeting. Dr. Cavallari explained
she would provide a high-level overview of changes in the report and then open the floor to comments
from participants. She noted she would share her screen during the Board discussion to allow for review
of the final draft of the report. HSRB members would vote on their agreement with the proposed
responses to the charge questions through the "agree" and "disagree" functionalities
within the Zoom Meeting platform.

D.	Public Comments

Dr. Cavallari asked whether any members of the public had comments. There were none.

1 Rosenheck, L. (2021) A Study for Measurement of Potential Dermal and Inhalation Exposure During Pressurized Hand-
Wand Spraying of Antimicrobial Products; Scenario 2b: Measurement of Potential Dermal and Inhalation Exposure During
Indoor Electrostatic Spraying of Sanitizers and Disinfectants. Sponsored by the Antimicrobial Exposure Assessment Task
Force II. Study Number AEA14(2b), 645 pages. September 20, 2021. MRID 51707701.

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EPA Human Studies Review Board (HSRB)
June 16, 2022 Meeting Minutes

R Board Discussion and Decision on April 27. 2022. Meeting Final Report and Minutes
Jennifer Cavallari, Sc.D., HSRB Chair

Dr. Cavallari shared her screen and identified the six changes suggested by EPA. The first suggestion
changed the microbial formulations text on page six from, "e.g., liquid concentrates, ready-to-use
powders, etc." to "e.g., soluble concentrates, ready-to-use solutions, etc." A change on page seven added
the clarifying sentence, "The surrogate chemical was one of the four quats, quat
Didecyldimethylammonium chloride (DDAC), had respective concentrations from 36.3 to 145 ppm."
The next suggestion added to page eight the sentence, "Lab spike recoveries were also used to adjust the
residue concentration measured for the subjects." An edit to page nine changed the text from, "the
highest residues were found on the hands (75% of dermal exposure)," to "80% of dermal exposure."
After explaining each of these changes, Dr. Cavallari asked whether anyone had comments about the
edits. There were no comments.

Dr. Cavallari next discussed proposed changes to page ten involving the sentence, "Use of the 12-inch
wand extension that can be used on Victory Electrostatic Spray Study (ESS) seemed to reduce both
dermal and inhalation exposures (creating more distance between the subject and the target compound),
but there was not enough data to conclude a reduction of exposure with use of the wand extension." She
asked whether there were any comments. Dr. Alesia Ferguson noted the language was contradictory. Dr.
Cavallari clarified the text, changing, "but there was not enough data to conclude a reduction of
exposure with use of the wand" to "but there was not enough data to conclude a statistically significant
reduction of exposure with use of the wand extension."

She then reviewed the final editorial change, which resulted in the sentence, "If a specific estimate has a
k-factor of three or less, the sample statistic will be accurate to within 3-fold the population estimate 95
percent of the time." Dr. Lisa Corey asked whether the sentence should read, "3 -fold of the population
estimate...." Dr. Julia Sharp replied, noting the addition of the word "of' after "3 -fold" was correct. Dr.
Cavallari changed the sentence to, "If a specific estimate has a k-factor of three or less, the sample
statistic will be accurate to within 3-fold of the population estimate 95 percent of the time."

Dr. Cavallari asked whether anyone had final comments or concerns about the final report. There were
none. She motioned that the Board accept the April 27th, 2022, HSRB meeting final report, and the
members unanimously agreed. She noted she would accept all the changes, finalize the report, and
forward it to Mr. Tracy to review and upload onto the HSRB website.

R Summary and Next Steps

Tom Tracy, Designated Federal Officer, EPA HSRB, OSAPE
Jennifer Cavallari, Sc.D., HSRB Chair

Dr. Cavallari asked Ms. Michelle Arling to share the July meeting date. Ms. Arling stated the HSRB
would review the science and ethics of a patch test with an isothyazolinote at the next meeting on July
21st, 2022. She thanked Ms. Arling and asked whether Mr. Tracy had anything else to add. He reiterated
there would be a change in Board membership after the meeting in July. Dr. George Milliken asked
when participants would receive more information about the July meeting. Ms. Arling responded, stating
information would be available by the end of the week or next Tuesday, June 21st, 2022.

G. Adjournment

The meeting adjourned at 2:18 pm, EST.

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EPA Human Studies Review Board (HSRB)
June 16, 2022 Meeting Minutes

Attachment A: HSRB Current Committee Membership

Name

Title

Affiliation

Jennifer Cavallari, ScD,
CIH, Chair

Associate
Professor

Division of Occupational and Environmental Medicine
University of Connecticut
Storrs, CT

Alesia Ferguson, Ph.D.,
Vice Chair

Associate
Professor

Department of Built Environment
North Carolina A&T State University
Greensboro, NC

Janice Britt, Ph.D.

Managing
Scientist

ToxStrategies
Tallahassee, FL

George Milliken, Ph.D.

Statistical
Consultant

Milliken Consultants
Manhattan, KS

Mark Aulisio, Ph.D.

Professor

Case Western Research University
Cleveland, OH

Thomas Lewandowski,
Ph.D.

Principal

Gradient
Seattle, WA

Julia Sharp, Ph.D.

Associate
Professor

Colorado State University
Fort Collins, CO

Albert J. Allen, M.D.,
Ph.D.

Senior Medical
Fellow

Eli Lilly
Indianapolis, IN

Lisa Corey, Ph.D.

Toxicol ogi st

Intertox, Inc.
Seattle, WA

Lindsay McNair, M.D.

Chief Medical
Officer

WIRB-Copernicus
Princeton, NJ

Eun Um, Ed.D.

President and
CEO

AMSTAT Consulting
San Jose, CA

Philip Day, Ph.D.

Assistant
Professor

University of Massachusetts Chan Medical School
Worcester, MA

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EPA Human Studies Review Board (HSRB)

June 16, 2022 Meeting Minutes

Attachment B: Federal Registers Notice Announcing Meetings
ENVIRONMENTAL PROTECTION AGENCY
[FRL-10017-40-ORD]

Human Studies Review Board; Notification of Public Meetings
AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

SUMMARY: The Environmental Protection Agency (EPA), Office of Research and Development
(ORD), gives notice of the 2022 public meetings of the Human Studies Review Board (HSRB). The
HSRB provides advice, information, and recommendations on issues related to scientific and ethical
aspects of third-party human subjects' research that are submitted to the Office of Pesticide Programs
(OPP) to be used for regulatory purposes.

DATES: Four three-day virtual public meetings will be held on:

1.	January 25-27, 2022;

2.	April 26-28, 2022;

3.	July 19-21, 2022; and

4.	October 25-27, 2022.

Meetings will be held each day from 1 p.m. to 5:00 p.m. Eastern Time. For each meeting, separate
subsequent follow-up meetings are planned for the HSRB to finalize reports from the three-day
meetings. These meetings will be held from 2 p.m. to 4 p.m. Eastern time on the following dates:
March 17, 2022; June 16, 2022; September 14, 2022; and December 14, 2022.

ADDRESSES: These meetings are open to the public and will be conducted entirely virtually and by
telephone. For detailed access information and meeting materials please visit the HSRB
Website: https://www.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to receive
further information should contact the HSRB Designated Federal Official (DFO), Tom Tracy, via
phone/voicemail at: 919-541-4334; or via email at: tracv.tom@epa.gov.

SUPPLEMENTARY INFORMATION:

Background

The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory
Committee Act 5 U.S.C. App.2 section 9. The HSRB provides advice, information, and
recommendations on issues related to scientific and ethical aspects of third-party
human subjects research that are submitted to the Office of Pesticide Programs (OPP) to be used for
regulatory purposes.

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EPA Human Studies Review Board (HSRB)
June 16, 2022 Meeting Minutes

Meeting access: These meetings will be open to the public. The full agenda with access information and
meeting materials will be available seven calendar days prior to the start of each meeting at the HSRB
Website: https://www.epa.gov/osa/human-studies-review-board.

For questions on document availability, or if you do not have access to the Internet, consult with the
DFO, Tom Tracy, listed under FOR FURTHER INFORMATION CONTACT.

Special Accommodations. For information on access or services for individuals with disabilities, or to
request accommodation of a disability, please contact the DFO listed under FOR FURTHER
INFORMATION CONTACT at least 10 days prior to each meeting to give EPA as much time as
possible to process your request.

How May I Participate in this Meeting?

The HSRB encourages the public's input. You may participate in these meetings by following the
instructions in this section.

1.	Oral comments. To pre-register to make oral comments, please contact the DFO, Tom Tracy,
listed under FOR FURTHER INFORMATION CONTACT. Requests to present oral comments
during the meetings will be accepted up to Noon Eastern Time, seven calendar days prior to each
meeting date. To the extent that time permits, interested persons who have not pre-registered may be
permitted by the HSRB Chair to present oral comments during the meetings at the designated time on
the agenda. Oral comments before the HSRB are generally limited to five minutes per individual or
organization. If additional time is available, further public comments may be possible.

2.	Written comments. For the Board to have the best opportunity to review and consider your
comments as it deliberates, you should submit your comments prior to the meetings via email by Noon
Eastern Time, seven calendar days prior to each meeting date. If you submit comments after these dates,
those comments will be provided to the HSRB members, but you should recognize that the HSRB
members may not have adequate time to consider your comments prior to their discussion. You should
submit your comments to the DFO, Tom Tracy listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for consideration by the HSRB.

Topics for discussion. The agenda and meeting materials will be available seven calendar days in
advance of each meeting at https://www.epa.gov/osa/human-studies-review-board.

Meeting minutes and final reports. Minutes of these meetings, summarizing the topics discussed and
recommendations made by the HSRB, will be released within 90 calendar days of each meeting. These
minutes will be available at https://www.epa.gov/osa/human-studies-review-board. In addition,
information regarding the HSRB's Final Reports, will be found at https://www.epa.gov/osa/human-
studies-review-board or can be requested from Tom Tracy listed under FOR FURTHER
INFORMATION CONTACT

Dated:

Mary Ross, Director, Office of Science Advisor, Policy and Engagement.

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