* Agenda times are app roximate and subject to change depending upon the discussion. [All times shown are

Eastern time zone.] US ENVIRONMENTAL PROTECTION AGENCY



### HUMAN STUDIES REVIEW BOARD

January 12

- 13, 2016 PUBLIC MEETING AGENDA

Internet Virtual Meeting

T he meeting will be conducted at the following website:

https://epa.connectsolutions.com/hsrb



### And on the phone: 866

- 299

- 3188 (access code: 2025647189)

Tuesday

, January 12

, 2016

HSRB WEB SITE http://www.epa.gov/osa/human

- studies

- review

- board

Docket Telephone: (202) 566 1752

Docket Number: EPA

– HQ

– ORD

– 201 5

– 0588

12 : 50 P M HSRB members login online

1: 0 0 P M * Convene Public Meeting

– Jim Downing

, Designated Federal Officer, EPA Human

Studies Review Board, Office of the Science Advisor

Virtual Meeting operations

– Liza Dawson

, Ph.D

. , HSRB Chair

Introduction of Board Members

– Liza Dawson

, Ph.D., HSRB Chair

Opening Remarks

– Toby Schonfeld

, Ph.D., Human Subjects Research Review

Official

, OSA, EPA

1:15 PM Finalize the Draft Final Report from the HSRB October 2015 Meeting

Assessing intermittent pesticide exposure from flea control collars containing the

organophosphorus insecticide tetrachlorvinphos, authored by M. Keith Davis, J. Scott Boone,

John E. Moran, John W. Tyler, and Janice E. Chambers. Journal of Exposure Science and

Environmental Epidemiology (2008) 18, 564

- 570

1 : 30 PM EPA Science Review Highlights

– Wade Br itton ( Health Effects Division, OPP, EPA)

1 : 50 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair

, EPA staff

2 : 10 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

2:30 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair

, EPA staff

2 : 50 PM Public Comments

2:5 5 PM Board Discussion* Agenda times are app roximate and subject to change depending upon the discussion. [All times shown are

Eastern time zone.] Charge to the Board

- Science:

 Is this research scientifically sound, providing reliable pet fur transferable residue data for use in

evaluating potential exposures of adults and children from contact with pets treated with

tetrachlorvinphos containing pet collars?

Discussant s : Randy Maddalena, Ph.D. (George Fernandez, statistics)

Charge to the Board

- Ethics:

1. Does the HSRB have any comments on EPA’s determination that the samp lers were not

human subjects?

2. Does the HSRB have any comments on the ethical conduct of the research?

Discussant: Susanne M. Rivera, Ph.D., M.S.W.

Field Testing of SC Johnson Personal Mosquito Repellent Products to Support their Use of

the EPA Repellency Awareness Graphic, GLP Study Number 865E1, J. Palm, September 24,

2015. Test Substance: MARK

- 3 OFF! Deep Woods Sportsmen Insect Repellent I (Maximum

Strength Pump Spray Deep Woods OFF! EPA Reg. No. 4822

- 276)

3 :25 PM EPA Science Review Highlights

– Eric Bohnenblust, Ph.D. (Registration Division,

OPP, EPA)

3:5 5 PM Board Questions of Clarification

– Liza Dawson, Ph.D., HSRB Chair, EPA staff

4:10 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

4:40 PM Board Questions of Clarifica tion

– Liza Dawson, Ph.D., HSRB Chair, EPA staff

4:55 PM Public Comments

5:10 PM Board Discussion

Charge to the Board

- Science:

 Is the study sufficiently sound, from a scientific perspective, to be used to estimate the duration

of complete protection against mosquitoes provided by the tested repellent?

Discussant s : Kenneth Ramos , Ph.D. ( Jun Zhu, Ph.D. , statistics)

Charge to the Board

- Ethics:

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

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

Discussant: Jewel H. Halanych, M.D., M.Sc.

5 : 45 PM * Adjourn* Agenda times are app roximate and subject to change depending upon the discussion. [All times shown are

Eastern time zone.] US ENVIRONMENTAL PROTECTION AGENCY



### HUMAN STUDIES REVIEW BOARD

JANUARY 12

- 13, 2016 PUBLIC MEETING AGENDA

Internet Virtual Meeting

The meeting will be conducted at the following website:

https://epa.connectsolutions.com/hsrb



### And on the phone: 866

- 299

- 3188 (access code: 2025647189)

Wednesday

, January 13 , 201 6

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone: (202) 566 1752

Docket Number: EPA

– HQ

– ORD

– 201 5

– 0588

12 :50 P M HSRB members login online

1:00 PM * Convene Public Meeting

– Jim Downing

, Designated Federal Officer, EPA Human

Studies Review Board, Office of the Science Advisor

Virtual Meeting operations

– Liza Dawson

, Ph.D., HSRB Chair

Introduction of Board Members

– Liza Dawson

, Ph.D., HSRB Chair

Opening Remarks

– Toby Schonfeld

, Ph.D., Human Subjects Research Review

Official, Office of the Science Advisor

, EPA

Field Testing of SC Johnson Personal Mosquito Repellent Products to Support their Use of

the EPA Repellency Awareness Graphic, GLP Study Number 873E1, C. Talbert, October 21,

2015. Test Substance: MARK

- 8 OFF! Deep Woods Insect Repellent V (OFF! Ins ect

Repellent Formula, EPA Reg. No. 4822

- 167)

1 : 1 5 PM EPA Science Review Highlights

– Eric Bohnenblust, Ph.D. ( Registration Division,

OPP, EPA)

1 : 2 5 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair, EPA staff

1:3 5 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

1 : 4 5 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair , EPA staff

1 :5 5 PM Public Comments

2:00 PM Board Discussion

Charge to the Board

- Science:

 Is the study sufficiently sound, from a scientific perspective, to be used to estimate the duration

of complete protection against mosquitoes provided by the tested repellent?

Discussant s : Helen Suh, Sc.D. ( Ed Gbur , statistics)* Agenda times are app roximate and subject to change depending upon the discussion. [All times shown are

Eastern time zone.] Charge to the Board

- Ethics:

 Does the available information supp ort a determination that the research was conducted in

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

Discussant: Susanne M. Rivera, Ph.D., M.S.W.

Field Testing of SC Johnson Personal Mosquito Repellent Products to Support their Use of

the EPA Repellency Awareness Graphic, GLP Study Number 866E1, E. Laznicka, October

21, 2015. Test Substance: MARK

- 4 OFF! Active Insect Repellent I (Unscented OFF! In sect

Repellent, EPA Reg. No. 4822

- 380)

2:15 PM EPA Science Review Highlights

– Mr. Kevin Sweeney ( Registration Division, OPP,

EPA)

2 : 25 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair, EPA staff

2:35 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

2 : 45 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair , EPA staff

2 : 55 PM Public Comments

3:00 PM Board Discussion

Charge to the Board

- Science:

 Is the study sufficiently sound, from a scientific perspective, to be used to estimate the duration

of complete protection against mosquitoes provided by the tested repellent?

Discussant s : Helen Suh, Sc.D. ( Ed Gbur , statistics)

Charge to the Board

- Ethics:

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

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

Discussant: Kyle Galbraith, Ph.D.

Field Testing of SC Johnson Personal Mosquito Repellent Products to Support their Use of

the EPA Repellency Awareness Graphic, GLP Study Number 864E1, J. Palm, September 24,

2015. Test Substance: MARK

- 2 OFF! Deep Woods Sportsmen Insect Repellent II

(UNSCENTED DEEP WOODS OFF! EPA Reg. No. 4822

- 397)

3 : 20 PM EPA Science Review Highlights

– Mr. Kevin Sweeney ( Re gistration Division, OPP,

EPA)

3 : 30 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair, EPA staff

3 : 40 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

3 : 50 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair

, EPA staff

4:00 PM Public Comments

4 : 0 5 PM Board Discussion* Agenda times are app roximate and subject to change depending upon the discussion. [All times shown are

Eastern time zone.] Charge to the Board

- Science:

 Is the study sufficiently sound, from a scientific perspective, to be used to estimate the duration

of complete protection against mosquitoes provided by the teste d repellent?

Discussant s : Kenneth Ramos , Ph.D. ( Jun Zhu, Ph.D. , statistics)

Charge to the Board

- Ethics:

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

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

Discussant: Jewel H. Halanych, M.D., M.Sc.

Field Testing of SC Johnson Personal Mosquito Repellent Products to Support their Use of

the EPA Repellency Awareness Graphic, GLP Study Number 867E1, E. Laznicka, October

21, 2015. Test Substance: MARK

- 5 OFF! Family Care Insect Repellent IV (Unscented)

(UNSCENTED OFF! SKINTASTIC SPRAY INSECT REPELLENT, EPA Reg. No. 4822

- 395)

4:25 PM EPA Science Review Highlights

– Mr. Kevin Sweeney ( Registration Division, OPP,

EPA)

4:35 PM Board Questions of Clarific ation

– Liza Dawson

, Ph.D., HSRB Chair, EPA staff

4:45 PM EPA Ethics Review Highlights

- Maureen Lydon (OPP, EPA)

4:55 PM Board Questions of Clarification

– Liza Dawson

, Ph.D., HSRB Chair , EPA staff

5:05 PM Public Comments

5:10 PM Board Discussion

Charge to the Board

- Science:

 Is the study sufficiently sound, from a scientific perspective, to be used to estimate the duration

of complete protection against mosquitoes provided by the tested repellent?

Discussant s : Randy Maddalena, Ph.D. (George Fer nandez, statistics)

Charge to the Board

- Ethics:

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

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

Discussant: Gary L. Chadwick, Pharm.D., M.P.H., C.I.P.

5 : 30 PM * Adjourn