Radiation in Medicine: A Need for Regulatory Reform

indicating that with respect to the specific incidents that prompted the establishment of our committee, we found no deficiencies in NRC rules or procedures that led to these regrettable occurrences. Practitioner error and aberrational circumstances caused the problems. Short of the draconian step of stationing NRC inspectors in the facilities involved, however, there really was no way that the NRC could have prevented them from happening or could have resolved them more effectively once they occurred.

As far as I can tell, I do not make this point in dissent. There seemed to be complete unanimity among committee members that the accusations of incompetence and timidity directed against the NRC are unfair and misplaced. To the contrary, my colleagues have concluded the exact opposite of these accusations. They insist that the NRC, if anything, is too aggressive and too intrusive in dealing with nuclear medicine. Not only do I disagree with this conclusion, I feel it important to emphasize how difficult it is for a regulatory agency like the NRC to calibrate its regulatory initiatives when it is simultaneously damned for doing too much and for doing too little.¹

RISKS OF IONIZING RADIATION IN MEDICINE

Ionizing radiation carries both risks and benefits. I have little doubt that ionizing radiation both in its diagnostic and therapeutic uses carries great benefits. Although I believe that the report describes the benefits associated with ionizing radiation, I remain concerned that the report does not detail the potential risks of radiation medicine as thoroughly as it might. I grant that we do not know with certainty the extent, if any, to which radiation medicine causes harm. However, I believe it critical not to dismiss the potential harm that inappropriate use or misuse of this technology presents. Not every concerned voice that is raised about radiation belongs to a cancerphobe, a Luddite, or an ideologue. Given the devastation that cancer causes in the United States—striking roughly 1 million persons and killing roughly 500,000 annually—it is critical that great care be taken with anything, such as radiation, that could potentially cause cancer. It may be that we overdo the regulation of medical radiation compared to other risks, but there are real concerns that need to be addressed.² Moreover, the solution to

A number of committee members work in settings regulated by the NRC. They have shared their frustrations about the NRC with me and I have found a number of their comments helpful. As one of the few members who has worked for a regulatory agency, I have tried with equal concern to explain why agencies like the NRC act as they do. In particular, I have pointed out that agencies must enforce rules uniformly, that is, they must ask for the same compliance behavior from responsible actors as they do from irresponsible actors lest they be accused of ''selective and unequal" enforcement. To say the least, this can be annoying to those who feel hassled for what they consider minor infractions when they believe that they are operating in a safe and effective manner.

One might ask, "Where are the bodies?" associated with misuse of medical radiation. The response is that there are lots of bodies afflicted with cancer. Unfortunately, we lack the scientific means to discover which, if any, of them result from the misuse of medical radiation.

Table of Contents

Front Matter R1-R13

Summary 1-22

1 Introduction 23-38

2 Clinical Applications of Ionizing Radiation 39-76

3 Regulation and Radiation Medicine 77-110

4 Risks of Ionizing Radiation in Medicine 111-140

5 Alternative Regulatory Systems 141-168

6 Findings, Conclusions, and Recommendations 169-180

Appendix A: Committee Biographies 181-188

Appendix B: Abbriviations and Acronyms 189-191

Appendix C: Glossary 192-200

Appendix D: Selected Sections of the Unites States Code of Federal Regulations 201-243

Appendix E: Nuclear Regulatory Commission Agreement States and Nonagreement States 244-245

Appendix F: Regulatory Chronology 246-248

Appendix G: History of Radiation Regulation in Medicine 249-258

Appendix H: Public Meeting Documents 259-280

Appendix I: Quality Management Technical Panel 281-282

Appendix J: Commissioned Papers 283-283

Appendix K: The Linear, No-Threshold Model 284-289

Appendix L: Separate Statement 290-298

Index 299-308

RISKS OF IONIZING RADIATION IN MEDICINE