Mr. Chairman, Members of the Committee, my name is Ronald Coene, I am the Deputy Director for Washington Operations, National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA or Agency). I serve as the Executive Secretary to the Advisory Committee on Special Studies Relating to the Possible Long-term Health Effects of Phenoxy Herbicides and Contaminants, better known as the Ranch Hand Advisory Committee. I am pleased to be here today to discuss my role with the Ranch Hand Advisory Committee.
As you may know, this Advisory Committee is the result of an inter-agency workgroup established by the Assistant to the President for Domestic Affairs and Policy in December 1979. In December 1980, this group recommended that the Air Force conduct epidemiological studies of the Ranch Hand personnel and that an independent monitoring committee oversees the study. Accordingly, in January 1981, the Secretary of Health and Human Services (HHS or the Department) established the Ranch Hand Advisory Committee (the Committee). The Committee operates under the authority of the Public Health Service Act and is guided by Title XII of Public Law 100-687 as it relates to the make up of the Committee. Specifically, Public Law 100-687 requires that one-third of the membership be made up of members nominated from veterans' organizations.
The Committee, as chartered, advises the Secretary and Assistant Secretary for Health, concerning its oversight of the Ranch Hand Study being conducted by the Air Force, as well as providing oversight of the Department of Veterans Affairs Army Chemical Corps Vietnam Veterans Health Study. The Committee is made up of nine members, including the Chair. Members are appointed to serve overlapping four-year terms.
FDA's Role as Executive Secretary
During the late 1980's, NCTR was involved in a Department-wide Committee on Agent Orange. Dr. Louis Sullivan, former Secretary, HHS, asked the Director of NCTR, FDA to support the Ranch Hand Committee. As the Deputy Director for NCTR, I was asked to assume the Executive Secretariat function for the Committee, and have served in that role since 1989.
In this role, I am responsible for administrative and logistical support of all meetings and the appointment of all members to the Committee. The Air Force Project Officer for the Ranch Hand Study and the Department of Veterans Affairs Project Officer for the Army Chemical Corps Vietnam Veterans Health Study provide agenda items for consideration by the Committee. Then the Committee Chairperson and I set the agenda for the meeting. My office is responsible for publishing that agenda in the Federal Register 30 days prior to the meeting. My staff and I develop minutes of the meetings which are available in the FDA dockets room. Starting with the August 1999 meeting we began having complete meeting transcripts recorded and these are also available in the FDA dockets room. Since 1989 we have supported twelve meetings of the Ranch Hand Advisory Committee. Two of these meetings were site visits to Brooks Air Force Base, San Antonio, Texas, where the Air Force project is based, and one was a site visit to the Scripps Clinic in La Jolla, California, the Air Force's contractor that performs the physical examinations of the study participants.
Over the last ten years I have worked through the Secretary's Office of Veterans Affairs and more recently its successor organization, the Office of Veterans Affairs and Military Liaison, in the Office of the Assistant Secretary for Health, in maintaining contacts with veterans groups and obtaining recommendations for nominations of members to the Committee. The Office of Veterans Affairs and Military Liaison maintains direct contact with veterans groups.
On an annual basis I prepare a report of the Committee's activities, membership, and actions taken during the previous year. This report ultimately becomes a part of the "President's Report on Federal Advisory Committees" sent to Congress.
General Accounting Office Report
The General Accounting Office (GAO) report on Agent Orange, that examined the Ranch Hand Study recommended that improvements be made in communications between the Advisory Committee and veterans' organizations.
In managing the Committee we utilized the Federal Register, the legal requirement, to notify the public, including veterans' organizations of its activities, namely meeting times, dates and places, and a preliminary agenda. In maintaining and assuring the proper mix of committee appointments among veterans' organizations we utilized the Secretary's Office of Veterans Affairs to obtain nominations of qualified veterans to fill vacancies on the Committee. We acknowledge that these informal practices could possibly lead to the perception that the Committee was not fulfilling its role as an independent, unbiased oversight body.
I would like to discuss the steps that the Department has taken to ensure that both in perception and practice veterans' organizations are being involved in the conduct of the advisory committee's activities. While the GAO investigation was underway, this past summer, and these issues became known to us, we took steps to use the Department's Office of Veterans Affairs and Military Liaison to intensify outreach and to contact veterans organizations concerning the Committee's planned meeting in October of this past year. In January of this year, that office began sending letters requesting nominations for vacancies that currently exist on the Committee. To date, thirteen veterans' service organizations have been contacted, and six organizations have expressed a desire to participate in the nomination process. The Department has received two nominations each from the American Veterans Committee and the Ranch Hand Vietnam Association, one nomination from the American Legion, and three draft nominations from the Vietnam Veterans of America. The Veterans of Foreign Wars also has indicated the intention to submit nominations. Additionally, the Disabled American Veterans have expressed the desire to participate by reviewing the list of nominees and providing endorsements. The Vietnam Era Veterans Association did not make a nomination, but indicated that they plan to send observers to Advisory Committee meetings. Finally, the American Ex-Prisoners of War also responded to our outreach, but did not make a nomination. The Department is continuing to follow up with the remaining organizations seeking their input to this process. Once again I would like to reiterate that FDA, in carrying out its executive secretariat functions, will work closely with the Department's Office of Veterans Affairs and Military Liaison to ensure that veterans' organizations are notified in a timely manner regarding Committee meetings and Committee vacancies.
We look forward to a more proactive relationship with veterans' organizations in carrying out the oversight function of the Secretary for these studies.
Mr. Chairman, thank you for the opportunity to discuss my role as the Executive Secretary to the Ranch Hand Advisory Committee. I would be happy to answer any questions the Committee may have.
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