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EPA - 28234 - Human Studies Review Board - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Human Studies Review Board	Agency Name	Environmental Protection Agency
Fiscal Year	2025	Committee Number	28234
Original Establishment Date	1/20/2006	Committee Status	Chartered
Actual Termination Date		Committee URL	https://www.epa.gov/osa/human-studies-review-board
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	20
Terminated This FY	No	Designated Fed Officer Position Title*	DFO
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	3/8/2024	Designated Federal Officer First Name*	Thomas
Date Of Renewal Charter	3/8/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Tracy
Exempt From Renewal*	No	Designated Federal Officer Suffix
Specific Termination Authority		Designated Federal Officer Phone*	919-541-4334
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*
Specific Establishment Authority*	Public Law 109-54 and 40 CFR 26.1603	Designated Federal Officer Email*	tracy.tom@epa.gov
Effective Date Of Authority*	2/21/2006
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	No
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The purpose of the Human Studies Review Board (HSRB) is to provide 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. So far in FY 2025, the committee has met on two occasions (all virtual meetings) - October 10-11, 2024, and November 6, 2024. The HSRB submitted one report to EPA’s Human Subjects Research Review Official summarizing their recommendations.
How is membership balanced?*	Balanced membership is driven by a number of considerations characterized by: inclusion of the necessary areas of technical expertise, different perspectives within each technical discipline, and the collective breadth of experience needed to address the Agency’s charge. HSRB members are selected on the basis of their qualifications addressing the scientific and ethical aspects of research with human subjects. The HSRB membership includes experts in relevant scientific or technical disciplines in bioethics, biostatistics, human health risk assessment and human toxicology.
How frequent & relevant are cmte mtgs?*	The committee meetings are scheduled approximately every quarter (four times a year, typically January, April, July and October) with the committee providing comments on matters related to scientific and ethical aspects of research involving human subjects. Teleconference meetings typically occur after each in-person or virtual meeting when the HSRB has drafted their report. This meeting provides the HSRB the opportunity to finalize their draft report. Though meetings are scheduled for every quarter, if no topics or charge questions are presented to the Board at the time, a meeting may be cancelled.
Why advice can't be obtained elsewhere?*	EPA was directed by Congress to establish a Human Studies Review Board pursuant to the 2006 EPA Appropriations Act, and included the establishment of such a board in its final rule for the protection of subjects in human research. (See: “Department of Interior, Environment, and Related Agencies Appropriations Act, 2006”, Pub. L. No. 109-54 and “Protections for Subjects in Human Research: Final Rule,” 40 CFR 26). Additionally, in a report requested by the Agency, the National Academy of Sciences recommended that EPA establish such a board. (See: NRC 2004, Intentional Human Dosing Studies for EPA Regulatory Purposes. Washington, D.C.: National Academy Press). There are no other existing EPA advisory committees that have the breadth of technical and ethical expertise that is needed for the scientific and ethical review of research with human subjects. Further, review of proposed and completed human studies for time-critical regulatory decisions requires procedures for focused, expert, and rapid review not presently available.
Why close or partially close meetings?	There have not been any closed or partially closed meetings in FY 2025. The Human Studies Review Board always meets in public.
Recommendation Remarks	All members are Tier 1 (parent committee members). There are no Tier 2 (subcommittee) members serving.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	No
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	Yes	Action Other	No
Outcome Increased Customer Satisfaction	Yes	Action Comment	NA
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	Yes	Number Of Grants Reviewed	0
Outcome Comment	The HSRB’s role as adviser to EPA on the ethical and scientific issues arising from studies using human subjects in research has strengthened the Agency's capabilities to support the ethical conduct and regulatory compliance of human subjects research conducted, supported, or regulated by EPA.	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	NA	Grants Review Comment	NA
Number Of Recommendations*	347	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	So far in FY 2025, the EPA has requested that the HSRB respond to three (3) charge questions in various topic areas. The board has provided their responses to charge questions/recommendations to on topic: "Operator dermal exposure and individual protection provided by personal protective equipment during application using a backpack sprayer in vineyards". The committee submitted final meeting report to EPA’s Human Subjects Research Review Official summarizing their advice and recommendations on these and other interesting topics. The committee has provided approximately 2 recommendations to EPA.	Access Agency Website	Yes
% of Recs Fully Implemented*	0.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Partial versus full implementation of HSRB recommendations could not be assessed due to the nature of the charge questions/responses and the way the HSRB recommendations were presented. The following is an example of how HSRB recommendations were used by the Agency: EPA decided to rely on the results of a study to support a pesticide registration decision based on HSRB recommendations.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	0.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	See previous response.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	The Agency sets aside time at each HSRB public meeting to provide an update on EPA follow-up to HSRB recommendations.	Narrative Description*	The Human Studies Review Board addresses the EPA's Goal of Assessing and reducing risks posed by chemicals and promote the use of safer chemicals in commerce. The HSRB provides advice, information, and recommendations on issues related to scientific and ethical aspects of research with human subjects. So far in FY 2025, the committee has met on two occasions (all virtual meetings). The HSRB submitted one meeting report to EPA’s Human Subjects Research Review Official summarizing their recommendations.

COSTS

1. Payments to Non-Federal Members*	$6,925.38	1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*	$67,614.00	3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs	$21,676.00	10. Est. Other Costs Next FY*
11. Total Costs	$96,215.38	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	9/25/2025 8:50 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*	0.30	Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Environment Environmental Issues Medicine Health and Health Research

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