NRC NEWS

U.S. NUCLEAR REGULATORY COMMISSION

Office of Public Affairs Telephone: 301/415-8200

Washington, DC 20555-001 E-mail: opa@nrc.gov

Web Site: http://www.nrc.gov/OPA

No. 00-115 July 26, 2000

NRC REVISES POLICY STATEMENT ON MEDICAL USES

OF CERTAIN RADIOACTIVE MATERIALS

The Nuclear Regulatory Commission has revised its 1979 policy statement on the medical uses

of NRC-regulated radioactive material to put greater emphasis on higher risk procedures, and

correspondingly less emphasis on procedures posing lower risk to the patient, workers and the public.

The policy statement affirms the Commission’s determination to continue its role in regulating

the use of certain radioactive material in medicine with the goal of providing adequate radiation

protection for workers, the public, and patients. The policy statement focuses the Commission’s

direction on radiation safety issues and furthers the objective of utilizing industry and professional

standards that define acceptable levels of radiation safety.

The policy statement and amended regulations on the medical use of certain radioactive

material, which will be announced separately, result from the NRC’s detailed examination of its

medical use program during the last several years.

One purpose of NRC regulation of the medical use of certain radioactive material is to reduce

unnecessary radiation exposure to patients, workers, and the public. The focus of NRC regulation to

protect the patient’s health and safety is primarily to ensure that the physician’s directions are followed

as they pertain to the administration of radiation or of NRC-regulated radioactive material, rather than

to non-radiation aspects of the administration. Although the Commission recognizes that physicians

have primary responsibility for the protection of their patients, NRC also has a necessary role in the

radiation safety of patients. NRC regulations are based on the assumption that properly trained and

adequately informed physicians will make decisions that are in the best interest of their patients.

NRC established a working group of agency staff and state organization representatives to

develop the revised policy statement. The group held a series of workshops and meetings over a twoyear period. To ensure that a wide variety of interests were represented, invited workshop participants

included physicians, radiopharmacists, medical physicists, radiation safety officers, educators, patients

rights advocates, nurses, medical technologists, hospital administrators, representatives of state and

federal governments, and radiopharmaceutical manufacturers. The revised policy statement takes into

account written comments on the statement as proposed in the Federal Register, and those obtained

during the workshops and meetings.
The revised medical policy contains the following statements:

“(1) NRC will continue to regulate the uses of radionuclides in medicine as necessary to

provide for the radiation safety of workers and the general public.” Retention of this portion of

the previous policy statement affirms the Commission determination that it will continue its role of

regulating the use of certain radioactive material in medicine, with the goal of providing radiation

safety for workers, the public, and patients.

“(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.” This sentence is based on

the third statement of the previous medical policy statement. It substitutes the phrase “will not intrude”

for the previous “will minimize intrusion.”

“(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.” This statement makes clear that the focus of NRC regulation is primarily on ensuring that

physician’s directions, as they pertain to the administration of radiation or of NRC-regulated

radioactive material, are followed. It also reflects the Commission’s strategy of decreasing oversight of

those uses of certain nuclear materials that pose the lowest radiological risks and strengthens emphasis

on those posing higher risks.

“(4) NRC, in developing a specific regulatory approach, will consider industry and

professional standards that define acceptable approaches of achieving radiation safety.” The

revision incorporates NRC’s intention to consider industry and professional standards in developing

regulations and guidance for the medical use program.

The policy statement will be published shortly in the Federal Register, and will be available at

the agency’s Public Document Room in Washington, D.C., telephone 202-634-3273.

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