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/ S. Hrg. 103-601 FEDERAL REGIMTION OF MEDICAL RADIATION USES Y 4, G 74/9: S. HRS. 103-601 Federal Regulations of lledical Radi. HEARING BEFORE THE COMMITTEE ON GOVERNMENTAL AFFAIRS UNITED STATES SENATE ONE HUNDRED TfflRD CONGRESS FIRST SESSION MAY 6, 1993 Printed for the use of the Committee on Governmental Affairs AUG 1 f 1954 U.S. GOVERNMENT PRINTING OFFICE 68-495cc WASHINGTON : 1994 ForsalebytheU.S.GovernmentPrintingOffice SuperintendentofDocuments,CongressionalSalesOffice,Washington,DC 20402 ISBN 0-16-0A4575-2 i / S. Hrg. 103-601 / \^ FEDERAL REGIMTION OF MEDICAL RADIATION USES Y 4. G 74/9: S. HRG. 103-601 Federal Regulations of lledical Radi.. HEARING BEFORE THE COMMITTEE ON GOVERNMENTAL AFFAIRS UNITED STATES SENATE ONE HUNDRED TfflRD CONGRESS FIRST SESSION MAY 6, 1993 Printed for the use of the Committee on Governmental Afffurs AUG 1 1 t994 U.S. GOVERNMENT PRINTING OFFICE 6&-495CC WASHINGTON : 1994 ForsalebytheU.S.GovernmentPrintingOffice SuperintendentofDocuments,CongressionalSalesOffice,Washington,DC 20402 ISBN 0-16-044575-2 ^H.,> COMMITTEE ON GOVER^fMENTAL AFFAIRS JOHN GLENN, Ohio, Chairman SAM NUNN, Georgia WILLIAM V. ROTH, Jr., Delaware CARL LEVIN, Michigan TED STEVENS, Alaska JIM SASSER, Tennessee WILLIAM S. COHEN, Maine DAVID PRYOR, Arkansas THAD COCHRAN, Mississippi JOSEPH I. LIEBERMAN, Connecticut JOHN McCAIN, Arizona DANIEL K. AKAKA Hawaii BYRON L. DORGAN, North Dakota Leonard Weiss, StaffDirector Robert Alvarez, Profeaaiorud StaffMember Christopher R. Kline,Professional StaffMember Franklin G. Polk, Minority StaffDirectorand ChiefCounsel Michal Sue Prosser, ChiefClerk (ID CONTENTS Opening statements: Page Senator Glenn 1 Senator Lieberman 4 Prepared statement: Senator Roth 59 WITNESSES Thursday, May 6, 1993 Ivan Selin, Chairman, Nuclear Regulatory Commission, accompanied by Ken- neth C. Rogers, James R. Curtiss, Forrest J. Remick, and E. Gail de Planque, Commissioners 7 Dr. D. Bruce Burlington, Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration, accompanied by Ronald M. Johnson, Director, Office of Compliance and Surveillance, Center for De- vices and Radiological Health, FDA; Marvin Rosenstein, Director, Office of Health Physics, Center for Devices and Radiological Health, FDA and Donald Hamilton, Radiation Policy Advisor, Office of Health Physics, Cen- ter for Devices and Radiological Health, FDA 33 Aubrey V. Godwin, Chairman, Conference for Radiation Control Program Directors 49 Alphabetical List of Witnesses Burlington, Dr. D. Bruce: Testimony 33 Prepared statement 65 Godwin, Aubrey V.: Testimony 49 Prepared statement 70 Selin, Ivan: Testimony 7 Prepared statement 59 APPENDDC Prepared statements ofwitnesses in order ofappearance 59 Criteria forAdequate Radiation Control Programs (Radioactive Materials) 75 Criteria forAdequate Radiation Control Programs (X-Ray) 96 Criteria for Adequate Radiation Control Programs (Environmental Monitoring and Surveillance) 110 COfrfiitceeriaoffoIrnAspdeecqtuoarteGeRnaedriaalt—ioInnvCeosnttirgoaltiPornogorfaNmsRC(NoSntiaofnfizAicntgi)ons Associated 142 with Oncology Services Co—rporation (OSC) — 177 Office of Inspector General Report of Investigation Inadequate Inspection and MishandlingofAllegations by Region I 203 Statement by theAmerican College ofMedical Physics 257 Resolutions submitted for the record by the American College of Medical Physics — 264 RecentAgreementState Reviews Regional Results 274 Explanatory Information on Recent Agreement State Reviews Regional Re- sults ChartAdequacy and Compatibility Findings 275 (III) FEDERAL REGULATION OF MEDICAL RADIATION USES THURSDAY, MAY 6, 1993 U.S. Senate, Committee on Governmental Affairs, Washington, DC. The Committee met, pursuant to notice, at 9:38 a.m., in room SD-342, Dirksen Senate Office Building. Hon. John Glenn, Chair- man ofthe Committee, presiding. Present: Senators Glenn and Lieberman. OPENING STATEMENT OF CHAIRMAN GLENN Chairman Glenn. The hearing will be in order. For a number of years, the Governmental Affairs Committee has maintained an interest in the subject of medical radiation. Our interest in this issue goes back a long way; and I am glad we are back on this subject again, because there is a strong need for con- tinued Congressional oversight. There is little question that medical uses ofradiation provide significant benefits and have led to important medical discoveries. Every year, many people lead better and more healthy lives because ofthis valuable medical tool. However, it has been known for decades that medical radiation misuse also poses risks ofinjury, latent disease and death, not only to the patient but to the health care and research professional as well as the community at large. A recent accident that took place at a clinic in Indiana, Penn- sylvania late last year is a case in point. A patient died £ifter a highly radioactive source was accidentally left inside her body. The source subsequently exposed unwitting workers and residents to radiation doses that significantly exceed the annual limit allowed for workers in the U.S. The radiation source also posed a potential environmental risk because it was almost disposed of in a private landfill. Over the past several years, the uses of ionizing radiation in medi—cine have exp—erienced major growth. Various studies now indicate or, estimate that over 170 million diagnostic radiation procedures and some 20 million radiation therapy procedures are given each year in the United States. The estimated annual cost for these procedures is about $12.3 billion. With the recent dramatic growth in medical radiation use over recent years, major questions have been raised as to whether Fed- eral and State regulation provides an adequate margin of protection of public health and the rights of those who may be put at (1) risk. It is abundantly clear that if people become ill, they or their families should not relinquish the basic right to know if unnecessary harm has been done to them. Unfortunately, the Nuclear Reg- ulatory Commission and the Food and Drug Administration have not taken action to assure that this basic right is guaranteed. The Committee has been reviewing the role of Federal and State agencies that regulate medical radiation uses for a long time, and this review goes way back; it goes back into the seventies. In the seventies, we had hearings, and I proposed legislation and a bill that would have coordinated some of these activities and brought a little more sense to them. At that time. President Carter sort of preempted us, which was fine with me, by issuing an Executive order, which did the same thing basically I was going to do with the bill. After the change of administration. President Reagan can- celled that Executive order. So that is where we now sit. We have had a Coordinating Council on Ionizing Radiation, but I think many would question whether their activities have been as forceful and effective as they should have been. So we have been reviewing these regulations for a long time. The review was initiated after several disturbing disclosures were made in the news media about patient deaths, injuries and overexposures. Particularly the hearing today was triggered by a series of articles beginning in December of last year, published by the Cleveland Plain Dealer. I think Plain Dealer reporters Ted Wendling and Dave Davis, I think have done an excellent job, and their pointing out some of these matters to us is why we are here today. We are glad to have Ted with us this morning over at the press table. I am pleased that the NRC has taken their reporting seriously and is starting to address some of the problems identified by the Plain Dealer. During this period, the Committee has been contacted by several people who have written about serious problems they experienced from radiation procedures. The Committee is in no position to determine the merits of these problems; however, I am submitting copies ofthese letters to the NRC and the Food and Drug Adminis- tration for their determination of whether any misadministrations took place. I expect the two agencies to report to the Committee about these disturbing letters. Assuring the safe and effective use of radiation in medicine involves a complicated web of relationships between the patient, medical professionals, equipment manufacturers, health care and research faciHties, and various State and Federal regulatory programs. With a few important exceptions, a great deal ofmedical radiation regulation relies on the voluntary reporting of problems. And as we know, not everybody is forthcoming enough to make that system work. Unfortunately, despite past scrutiny and recommendations by this Committee and others, medical radiation regulation is scattered, fragmented, and very inconsistent. Several Federal agencies in all 50 States have regulatory responsibiUty, but not the programs to follow up on that responsibiUty. States have varying and diff'erent programs which lack conformity with each other. One- third ofthe population ofthe United States Uves in States—includ- — ing my home State of Ohio, I am sorry to say that do not require people who operate radiation devices to be trained and certified. It was pointed out in the Plain Dealer articles that people with felony convictions for medical radiation violations in one State can move over to another State and serve as radiation protection officials in other States, because they are not likelv to be discovered. In the reporting, there were two cases exactly like that. Let me just give some short -examples to illustrate how complex this is. There are 27 States that license radiographers; 21 States license radiation therapy technologists; 14 States license nuclear medicine technologists; three additional States have legislation permitting regulation of radiographers; five States have legislation authorizing regulation of radiation therapy technologists; four States have enabling legislation authorizing regulation of nuclear medicine technologists. All States continue to license dental hygienists. Of the 50 States permitting dental assistants to perform radiographs, one State licenses, 29 States certify, and two States register dental assistants. Now, that indicates how complex it is and how the regulation goes all over the lot. I would like to acknowledge the efforts of Senator Lieberman, who is with us here this morning, in ensuring that the NRC fully and thoroughly in—vestigated allegations of safety and wrongdoing by NRC licensees for example. Senator Lieberman's diligence in oversight ofthe NRC and the work ofthe NRC's Office of Inspector General, which this Committee created. The OIG review resulted in a reinspection and validation of a number of allegations raised by Connecticut citizen Mr. Arnold Gunderson, which originally were missed by a faulty NRC inspection. After today's testimony, I will review the situation, and I may consider the need for legislation to address some ofthese problems, because obviously, something must be done. I don't know whether it will be the same legislation I introduced back in the Carter years, whether something new is necessary, or whether this administration will go ahead and t£ike action on their own, or whether NRC and FDA can in their testimony this morning give us some ideas about what direction we should go. They are the people who should be on the firing line, so I would welcome their suggestions, and we'll have some questions along that line after we hear testimony. A number of people have died from overuse of radiation. I think there were 28 deaths in my home State of Ohio back through the years that can be directly traced to some of these misadministration of radiation. So while we are interested in seeing what happened and why people were not notified, we are even more interested in seeing how we can prevent this in the future and how we can tighten up this system so that the people of this country are adequately protected, and that's the purpose of today's hearing. Prepared Statementof SenatorGlenn Over the past several years, the Governmental Affairs Committee has maintained an interest in the subject ofmedical radiation. There is little question that medical uses ofradiation provide significant benefits and have led to important medical discoveries. Every year, many people lead better and more healthy lives because ofthis valuable medical tool. However, it has been known for decades that medical radiation misuse also poses risks ofinjury, latent disease and death, not only to the patient, but to the health care and research professional as well as the community at large. A recent accident AthaptattioeonktpdliaecdeaafttearcalihniicghilnyIrnaddiiaonaac,tiPveennsosuyrlcveanwiaaslaatcecildaesnttlyyealreftisiansciadseehienrpbooidnyt.. The source subsequently exposed unwittingworkers and residents to radiation doses that significantly exceed the annual limit allowed for workers in the U.S. The radioactive source also posed a potential environmental risk because it was almost disposed ofin a private landfill. Over the past several years the uses ofionizingradiation in medicine have experienced major growth. Various studies indicate that over 170 million diagnostic radiation procedures and some 20 million radiation therapy procedures are given each year in the U.S. The estimated annual cost for these procedures is about $12.3 billion. With the recent dramatic growth in medical radiation use over recentyears, major questions have been raised as to whether Federal and state regulation provides an adequate margin of protection ofpublic health and the rights ofthose who may be put at risk. It's abundantly clear that if people become ill, they or their families should not relinquish the basic right to know if unnecessary harm has been done to them. Unfortunately, the Nuclear Regulatory Commission and the Food and Drug Administration have not assured thatthis basic right is guaranteed. The Committee on Governmental Affairs has been reviewing the role of Federal and state agencies that regulate medical radiation uses. This review was initiated after several disturbing disclosure—s were made in the news media about patient deaths, injuries and overexposures particularly a series ofarticles beginning in De- cember of last year published by the Cleveland Plain Dealer. The Plain Dealer reporters, Ted Wendling and Dave Davis, have done a commendablejob. I am pleased that the NRC has taken their reporting seriously and is starting to address some ofthe problems identified bythePlainDealer. During this period, the Committee has been contacted by several people who have written about serious problems they experienced from radiation procedures. The Committee is in no position to determine the merits of these problems. However, I am submitting copies ofthese letters to the Nuclear Regulatory Commission and the Food and Drug Administration for their determination if any misadministrations took place. I expect the two agencies to report to the Committee about these disturbingletters. Assuringthe safe and effective use ofradiation in medicine involves a complicated web of relationships between the patient, medical professionals, equipment manufacturers, health care and research facilities, and various state and Federal regulatory programs. With a few important exceptions, a great deal ofmedical radiation regulation relies on the voluntary reporting ofproblems. And as we know, not everybody is forthcoming. Unfortunately, despite past scrutiny and recommendations by this Committee and others, medical radiation regulation is scattered, fragmented and inconsistent. Sev- eral Federal agencies and all 50 states have regulatory responsibility. States have varying and different programs which lack conformity with each other. One third ofthe population ofthe U.S. lives in states, including my home state ofOhio, that do not require people who operate radiation devices to be trained and certified. Peo- ple with felony convictions for medical radiation violations in one state, can serve as radiation protection officials in other states. I would like to acknowledge the efforts of Senator Lieberman in ensuring that thatthe NRC fully and thoroughly investigated allegations ofsafety and wrongdoing by NRC licensees. For example, Senator Lieberman's diligence in oversight of the NRC and the work of the NnC's Office of Inspector General which this committee created. The OIG review resulted in a re-inspection and validation of a number of allegations raised by Mr. Arnold Gunderson which originally were missed due to a faulty NRC inspection. After hearing today's testimony, I will review this situation and I may consider the need for legislation to address some ofthese problems. I welcome today's witnesses and thank them for appearing for this important hearing. Senator Lieberman? OPENING STATEMENT OF SENATOR LIEBERMAN Senator LiEBERMAN. Thank you very much, Mr. Chairman.