AGENDA AND

BACKGROUND INFORMATION

 

 

 

 

 

 

 

THIRTIETH MEETING

 

 

 

 

 

 

 

TECHNICAL ELECTRONIC PRODUCT

RADIATION SAFETY STANDARDS COMMITTEE

 

 

 

 

 

Oct 1, 2003

 

 

 

 

 

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

 

 

FOOD AND DRUG ADMINISTRATION

HILTON WASHINGTON, D.C. NORTH

620 PERRY PARKWAY

GAITHERSBURG, MD 20877

 

 

 

 

 

TABLE OF CONTENTS

 

 

Meeting Agenda                                                                                                Tab 1

 

 

TEPRSSC Charter and Committee Members                                                          Tab 2

 

 

Summary of Performance Standards                                                                     Tab 3

 

 

Background Briefing on Sunlamp Products                                                           Tab 4

 

 

NCRP Report on Security Screening Systems                                                Tab 5

 


TEPRSSC COMMITTEE MEMBERS

 

General Public:

 

 

Lawrence Rothenberg, PhD, a medical physicist with Memorial Sloan-Kettering Cancer Ctr, Dr. Rothenberg has an extensive background in radiation protection and measurement relating to diagnostic radiological imaging.  He has worked extensively in mammography and CT, investigating equipment performance and patient dosimetry.  He has made many contributions on the subjects of equipment quality assurance, radiological health, and professional practice.  He is an Assistant Professor at Cornell Univ Medical Coll., and is a Fellow of the AAPM, ACR, and ACMP.

 

 

Robert Pleasure, JD,– Mr Pleasure has extensive experience in industrial labor law and labor relations, both in the academic field and as an attorney representing labor organizations.  Currently Executive Director and President of the AFL/ CIO Center for Working Capital, he is a member of the Labor & Industrial Relations Advisory Boards at both Cornell Univ and Rutgers Univ.  He also serves on the Environmental Mgmt Advisory Board of the Worker Health & Safety Committee, U.S. Dept. of.Energy, and is Principal Investigator for the National Cooperative Agreement (NIOSH-CPWR) on Intervention and Surveillance Research, Safety and Health in the Construction Industry.

 

 

Jane Benson, MD, currently practices medicine at Johns Hopkins, where she is also Assistant Professor of Radiology and Pediatrics.  Dr Benson did her internship at Children’s Hosp in Cleveland and is strongly interested in children’s health.  She has co-authored numerous papers on the subjects of both medical diagnostic imaging procedures and treatment of childhood disorders. 

 

 

Francis Gasparro, PhD, possesses extensive research experience in photobiology and photochemistry.  He has had faculty appointments in chemistry and dermatology at a variety of institutions, including Yale and Columbia.  Dr Gasparro’s interests include bioanalysis, drug delivery systems, photochemotherapy and psoralen-DNA photo-chemistry.  He currently is teaching high school chemistry and is an adjunct research professor at Thomas Jefferson Univ.

 

 

James W Platner, PhD, CIH, a radiation biologist, Dr Platner is Associate Director of the center to Protect Worker's Rights.  He provides technical oversight and coordination of  research and training relating to both internal and external occupational injury and disease prevention interevention.  He formerly was affiliated with the Cornell Univ Industrial & Labor Relations Extension, where he provided training and technical assistance in occupational safety and health and initiated programs related to labor union environmental initiatives.

Government:

 

 

Kiyohiko Mabuchi, MD, currently at the Division of Cancer Epidemiology and Genetics of the National Cancer Institute, Dr Mabuchi was formerly Chief of the Dept. of Epidemiology at the Radiation Effects Research Laboratory in Japan.  He is an experienced researcher who has published extensively on the etiology of cancer and the long term health effects of the atomic bombing of Japan.

 

 

Jill Lipoti, PhD, directs the Radiation Protection Program for the New Jersey Dept. Of Environmental Protection.  Dr. Lipoti has twenty years of experience working with the regulated community, researchers, govt. officials, and the public addressing issues such as the safe use of medical diagnostic x-rays,  radioactive materials licensing, nuclear power regulation, laser safety, and training for employees working in hazardous environments.

 

 

Maureen Murdoch Nelson, MD, MPH, currently at the Minneapolis VAMC, Dept of General & Internal Medicine, Dr Murdoch Nelson is currently Core Investigator at the Center for Chronic Disease Outcome Research and is an Asstistant Professor at the Univ of Minnesota School of Medicine.  She formerly was Asst Director of Primary Care Clinics at the Minneapolis VAMC.  Dr Murdoch Nelson has done research involving infectious diseases, outcomes related to immunization programs, post traumatic stress disorder in military veterans, and violence against women.

 

 

Michele Loscocco, MS, a member of the Medical Service Corps, U.S. Navy, Michele currently is Chief of the Imaging & Telemedicine Branch, Joint Readiness Clinical Advisory Board.  She also is an Assistant Prof of Radiology/ Nuclear medicine at the Uniformed Services University for the Health Sciences, and was formerly a staff physicist at the National Naval Medical Center, where she was responsible for the diagnostic radiology quality assurance program, including MRI, CT, Ultrasound, Radiographic, Fluoroscopic, and ACR accreditation for mammography units.

 

 

John Cardarelli, PhD, an experienced health physicist, is currently a senior research officer with NIOSH, concerned with conducting health hazard evaluations of  radiation, biological, and chemical hazards.  He was a member of the multi-agency review working group which developed re-occupancy criteria for Capitol Hill buildings contaminated with anthrax.  His past accomplishments include an evaluation and dose reconstruction on workers employed in the nuclear weapons complex during the cold war era.    

 

 

 

 

 

Industry:

 

 

David Lambeth, PhD, Dr Lambeth, of Lambeth Systems Design & Consulting Group, is principally engaged in the development of magnetic materials, thin film material structures, sensor devices & electronic circuits. He is also a Prof of Electrical & Computer Engineering and Matls Science & Engineering at Carnegie Mellon Univ., and was formerly Assoc Director of the Data Storage Systems Ctr at Carnegie Mellon.  Dr Lambeth is on the board of directors of Intevac, which is involved in the manufacture of hard disk media.  He formerly was head of the Magnetic Materials Laboratory at Eastman Kodak.

 

 

Michael Caswell, PhD, following receipt of his PhD in biochemistry, Dr Caswell did post-doctoral work at Yale.  He subsequently has worked for companies which manufacturer dermatological products, including Unilever and Schering-Plough, and is knowledgable about the effects of various products on the skin.  He has experience also studying the effects of untraviolet radiation on the skin and with the use of  both sunscreens and tanning accelerators. 

 

 

Kimberly Kantner, BSc, Radiation Safety Program Mgr for AT&T Corp. She is responsible for providing training and support on occupational safety matters involving radioactive materials/ x-ray systems, RF, laser, UV, and IR devices.  She is experienced with industrial radiation protection programs including compliance with the licensing requirements of state & federal regulations.  Ms Kantner began her career working as a public health physicist for the state of Florida and subsequently was with the health physics office of the Kennedy Space Ctr before joining AT&T.

 

 

George Kambic, PhD, Dr Kambic has an extensive background in the manufacture of electronic products and computer software management, and has a thorough familiarity with international manufacturing standards and government regulatory requirements.  He currently is director of quality and regulatory programs at Philips Medical Systems.  He recently was director of  product development, and clinical evaluation of computed tomography imaging systems.

 

 

Wayne Myrick, MS, with a background in electrical engineering and computer science, Mr Myrick was responsible at Underwriters Laboratories for assuring safe operation of televisions, including verifying compliance with 21 CFR.  He was also designated as a laser technical expert and liaison to FDA.  Since 1991, he has been the national manager of product safety at Sharp Electronics.  Mr Myrick recently worked with members of the CEA, WEAC, and FDA on a training video to assist manufacturers in complying with electronic product regulations.