The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Radiation in Medicine: A Need for Regulatory Reform
$525.6 million budget—is spent regulating nuclear power plants. The overwhelming majority of the NRC's professional staff are not health professionals (the staff's expertise is oriented toward technical and engineering skills). The staff of the Nuclear Medicine Safety and Safeguards division of the NRC has no full-time physicians and presently but one medical consultant.
Until 1946, when Congress first enacted the AEA, virtually all regulation of radioactive material, none of which was reactor-generated, took place at the state level.8 The AEA provided the Atomic Energy Commission (AEC) authority to regulate possession and use of certain artificial materials for the first time. The AEC's jurisdiction covered radiation and radiation sources (nuclides) produced by nuclear reactors; it did not extend to naturally occurring and accelerator-produced material (NARM) or to machine-produced radiation. The AEA designated the AEC as the agency responsible for establishing a licensing and inspection program for radioactive materials produced in reactors and not used in nuclear weapons or production of electricity.
In 1974, the Energy Reorganization Act split the functions of the AEC in two. Congress determined that it was in the public interest for the AEC licensing and related regulatory functions to be separated from the performance of the other AEC functions, and it created the Nuclear Regulatory Commission to do that job. As part of that job, the NRC is responsible for regulating the medical (diagnostic and therapeutic) use of byproduct materials and protecting the public from undue risks attendant upon their use in health care applications.
Thus, the NRC regulates the medical use of reactor-generated radionuclides under the auspices of a long succession of legislation and regulatory rules that date back about a half century and that include the Agreement State Program established in 1959. Through this program, the NRC discharges its responsibility in two ways: (1) direct regulation of affected institutions (in the case of 21 NRC-regulated or Non-Agreement States), or (2) through formal agreements with state governors (in the case of the remaining 29 Agreement States).9 The NRC's Medical Use Program, which applies to both the 21 NRC-regulated states and the 29 Agreement States, involves the following responsibilities and activities: (a) registering facilities; (b) registering physicians; (c) annual reporting by each facility; (d) setting criteria for determining misadministration of byproduct materials in medical use; (e) reporting misadministrations promptly; (f) conducting
Public Law 79-585, 60 Stat. 755 (1946).
Federal Register (FR) announcement RIN 3150-AC65, on the Quality Management Program and Misadministrations of the NRC Final Rule, indicates that 28 (now 29) states have entered agreements to regulate the use of byproduct material and that they currently issue licenses and otherwise regulate about 4,000 institutions (clinics, hospitals, and physicians in private practice). The NRC directly regulates administration of byproduct material or radiation from such material in 22 (now 21) states, the District of Columbia, the Commonwealth of Puerto Rico, and various territories, for about 2,000 civilian and military hospitals and clinics. See 56 Fed. Reg. (July 25, 1991) at p. 34104.