TECHNICAL ELECTRONIC PRODUCT RADIATION SAFETY STANDARDS COMMITTEE MEETING

May 17, 2001

In accordance with the Radiation Control for Health and Safety Act of 1968, Public Law 90-602 (21 USC §360kk), the Secretary, DHHS, has established the Technical Electronic Product Safety Standards Committee (TEPRSSC) for consultation on matters relating to technical electronic product radiation safety. As specified by Public Law 90-602, the Committee consists of fifteen members, including the chairman, who are appointed by the Commissioner of Food and Drugs for overlapping terms of four years of less. Five members are selected from governmental Agencies, including State and Federal governments, five members from the affected industries, and five members from the general public, of which at least one shall be a representative for organized labor. Members must be technically qualified by training and experience in one or more fields of science or engineering applicable to electronic product radiation and safety standards.

The primary function of TEPRSSC is to provide advice and consultation to the Commissioner of Food and Drugs on the technical feasibility and reasonableness of performance standards for electronic products, to control the emission of electronic product radiation from such products, and to review amendments to such standards before being prescribed by the Commissioner. The Committee is not requested to review individual applications or particular products of specific firms.

Public Law 90-602, and its legislative history, clearly indicated that the TEPRSSC members are expected to represent a very wide range of interests with at least one third of the Committee nominated by the regulated industry itself and appointed on the basis of their being able to represent industry-wide concerns. Section 534 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §360kk) specifies that TEPRSSC members are not to be considered officers or employees of the United States for any purpose including conflict of interest determinations. However, to be consistent with FDA’s general policies regarding advisory committees, the Agency believes a public disclosure memorandum should be made a part of the public record which identifies each member and provides their employment affiliation. Approved on September 15 and 23, 1998, August 30, 1999, and June 9, 2000, by delegated authority of the Commissioner of Food and Drugs, the members of the Technical Electronic Product Radiation Safety Standards Committee are:

GENERAL PUBLIC: AFFILIATION:

John Cardella, M.D. SUNY Syracuse Health Science Center

Mary Marx, M.D. University of Michigan Medical Center

Robert Pleasure, J.D. The Center to Protect Workers’ Rights

William Rice, M.D. American Radiology

Lawrence Rothenberg, Ph.D. Memorial Sloan-Kettering Cancer Center

GOVERNMENT: AFFILIATION:

Kathleen Kaufman, B.S. Los Angeles County, Dept. of Health Services

Michele Loscocco, LCDR, MSC Joint Readiness Clinical Advisory Board

W. Gregory Lotz, Ph.D. Nat’l Inst. for Occupational Health and Safety

Maureen Murdoch-Nelson, M.D. Veterans Administration Medical Center

Jerry Thomas, M.S. Uniformed Services Univ. of Health Sciences

INDUSTRY: AFFILIATION:

Quirino Balzano, Ph.D. Motorola Florida Laboratories

Alice Fahy-Elwood Lucent Technologies

David Lambeth, Ph.D. Lambeth Systems

John Sandrik, Ph.D. General Electric Medical Systems

Stephen Szeglin, M.S. PTW New York Corporation