Advisory Committee on Medical Uses of Isotopes 

NRC Medical Uses Policy Statement Final Report 

May 08, 2014 

Subcommittee members: 

Philip Alderson, M.D. 

Milton Guiberteau, M.D. 

Chris Palestro, M.D. 

John Suh, M.D. 

James Welsh, M.D. 

Bruce Thomadsen, Ph.D., Chair 

Subcommittee charge: 

To consider if the Nuclear Regulatory Commission’s policy statement on medical 

uses of byproduct materials should be revised. 

Background 

The NRC has the responsibility to ensure that the use of radioactive materials under 

its control is safe for all persons involved with that use as well as the general public. 

At the same time, the regulations should not be so onerous as to discourage 

beneficial medical uses. To help balance these potentially conflicting goals, the NRC 

has established a guidance policy on medical uses of radionuclides. The earliest 

official policy available to this subcommittee which was developed in 1979, had 

three principles: 

1. The NRC will continue to regulate the medical uses of radioisotopes as 

necessary to provide for the radiation safety of workers and the general 

public. 

2. The NRC will regulate the radiation safety of patients where justified by the 

risk to patients and where voluntary standards, or compliance with these 

standards, are inadequate. 

3. The NRC will minimize intrusion into medical judgments affecting patients 

and into other areas traditionally considered to be a part of the practice of 

medicine. 

In 2000, the revised policy included four principles: 

1. The NRC will continue to regulate the uses of radioisotopes in medicine as 

necessary to provide for the radiation safety of workers and the general 

public. 

2. NRC will not intrude into medical judgments affecting patients, except as 

necessary to provide for the radiation safety of workers and the general 

public. 
3. NRC will, when justified by the risk to patients, regulate the radiation safety 

of patients primarily to assure the use of radionuclides is in accordance with 

the physician's directions. 

4. NRC, in developing a specific regulatory approach, will consider industry and 

professional standards that define acceptable approaches of achieving 

radiation safety. 

The changes in 2000 clarified that regulations were designed to ensure that a 

physician’s directions are executed correctly and safely and that the development of 

regulations takes into account professional and industrial standards. 

In the middle the past decade it became clear that some aspects of the regulations in 

10 CFR 35 were causing problems with medical practice. One example was the 

definition of a medical event. The definition worked well for external-beam 

treatment and temporary brachytherapy but was ambiguous and difficult to apply 

to permanent implants, leading to some conflict between clinicians and regulators. 

Another problem was the attestation related to preceptor statements, which led 

some preceptors to refuse to sign the forms required for their trainees to obtain 

authorization (authorized user status). 

This background led to the question of whether the policy on medical uses should be 

revised. 

Subcommittee conclusion 

The subcommittee studied the policies from 1979 and 2000 along with the 

discussions leading to those policies and other proposed policy items. The 

subcommittee also considered whether or not the current policy fails in either 

protecting persons or preventing infringement on medical practice. 

The subcommittee concluded that the problems encountered with 10 CFR 35 were 

due to a failure of the regulations to follow the policy, and that the revision of Part 

35 brings the regulations into compliance with the policy and eliminates the 

problems the conflict with policy created. The subcommittee felt that the current 

policy on medical uses of radionuclides provides effective guidance. 

Subcommittee recommendation 

The ACMUI feels that the current policy statement provides for the safe medical use 

of radionuclides for patients, subjects, staff and the general public while avoiding 

intrusion into the practice of medicine, and no therefore revision is warranted at 

this time.