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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.


EPA - 28234 - Human Studies Review Board - Statutory (Congress Created)
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameHuman Studies Review BoardAgency NameEnvironmental Protection Agency
Fiscal Year2020Committee Number28234
Original Establishment Date1/20/2006Committee StatusChartered
Actual Termination Date Committee URLhttps://www.epa.gov/osa/human-studies-review-board
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*12
Current Charter Date3/28/2020Designated Fed Officer Position Title*Acting DFO
Date Of Renewal Charter3/28/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Thomas
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*O'Farrell
Establishment Authority*Statutory (Congress Created)Designated Federal Officer Suffix
Specific Establishment Authority*Public Law 109-54 and 40 CFR 26.1603Designated Federal Officer Phone*202-564-8451
Effective Date Of Authority*2/21/2006Designated Federal Officer Fax*
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*ofarrell.thomas@epa.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNo
Legislation StatusNot 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. In FY 2020, the Committee met on six occasions (all virtual meetings). The HSRB submitted three reports to EPA’s Science Advisor 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 (4 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 face-to-face or virtual meeting when the HSRB has drafted their report. This meeting provides the HSRB the opportunity to finalize their draft report.
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 were no closed or partially closed meetings in FY 2020. The Human Studies Review Board always meets in public.
Recommendation RemarksAll members are Tier 1 (parent committee members). There are no Tier 2 (subcommittee) members serving.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*No
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryYesAction OtherNo
Outcome Increased Customer SatisfactionYesAction CommentNA
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherYesNumber Of Grants Reviewed0
Outcome CommentThe 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 Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentNAGrants Review CommentNA
Number Of Recommendations*314Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentDuring FY 2020, the EPA requested that the HSRB respond to ten (10) charge questions in various topic areas. The Board provided their responses to charge questions/recommendations to five topics: “Field Evaluation of Two Topically Applied Insect Repellent Products Containing IR3535 Against Mosquitoes in Florida”, “A Study for Measurement of Potential Dermal
and Inhalation Exposure During the Application of Paint Containing an
Antimicrobial using an Airless Sprayer”, Agricultural Handler Exposure Task Force (AHETF) Study Report and Monograph (AHE500 and AHE1022): Determination of Dermal and Inhalation Exposure to Workers during Closed System Loading of Liquids in Returnable and Non-Returnable Containers/Mechanical Transfer of Liquids, A Single Group Trial to Determine the Complete Protection Time of an Insect Repellent Formulation Containing 30% Citridiol ® (Oil of Lemon Eucalyptus) against three species of ticks, A Study for Measurement of Potential Dermal and Inhalation Exposure During Pressurized Hand-Wand Spraying of Antimicrobial Products along with
Study Addendum: Addition of Electrostatic Sprayers (AEA14). The Committee submitted final meeting reports to EPA’s Science Advisor summarizing their advice and recommendations to these and other interesting topics. The Committee provided approximately 48 recommendations to EPA.
Access Agency WebsiteYes
% of Recs Fully Implemented*0.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentPartial 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 WebsiteYes
% of Recs Partially Implemented*0.00%Access PublicationsYes
% of Recs Partially Implemented CommentSee previous response.Access OtherNo
Agency Feedback*YesAccess CommentN/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 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. In FY 2020, the Committee met on six occasions (all virtual meetings). The HSRB submitted two meeting reports to EPA’s Science Advisor summarizing their recommendations. While the Committee is charged to provide comment on the science and ethics of human subjects research conducted, supported, or regulated by EPA, similar to previous years, in FY 2020 the HSRB focused mainly on proposed and completed third party research involving non-pregnant, non-nursing human adults. This research was conducted for submission to the Agency under the pesticide laws and was used for making regulatory decisions.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$24,676.00Est Payments to Non-Fed Members Next FY*$30,000.00
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff*$44,823.00Estimated Payments to Federal Staff*$45,000.00
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs$10,794.00Est. Other Costs Next FY*$11,000.00
Total Costs$80,293.00Est. Total Next FY*$86,000.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

Category
Area
Environment
Environmental Issues
Medicine
Health and Health Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-035599Human Studies Review Board2019
 COM-032764Human Studies Review Board2018
 COM-001747Human Studies Review Board2017
 COM-002527Human Studies Review Board2016
 COM-003623Human Studies Review Board2015
 COM-004897Human Studies Review Board2014
 COM-005729Human Studies Review Board2013
 COM-006861Human Studies Review Board2012
 COM-008106Human Studies Review Board2011
 COM-009230Human Studies Review Board2010
 COM-010180Human Studies Review Board2009
 COM-010898Human Studies Review Board2008
 COM-011807Human Studies Review Board2007
 COM-012752Human Studies Review Board2006