United States Nuclear Regulatory Commission

Office of Public Affairs

Washington, DC 20555

Phone 301-415-8200 Fax 301-415-2234

Internet:opa@nrc.gov

No. 98-138 FOR IMMEDIATE RELEASE

(Friday, August 7, 1998)

NRC PROPOSES TO REISSUE POLICY STATEMENT

ON MEDICAL USES OF RADIOACTIVE MATERIALS

The Nuclear Regulatory Commission is proposing to revise its 1979 policy statement on

the medical uses of radioactive material. The agency intends to focus regulation on medical

procedures that pose the highest risk to workers, patients and the public and to structure its

regulations to be risk-informed and more performance-based.

The proposed policy statement stresses the Commission’s determination to continue to

regulate the use of radioactive materials in medicine, with the goal of protecting the radiation

safety of occupational workers, the public and patients, without intruding into medical judgments

affecting patients except as necessary to ensure adequate protection. When justified by the

risk, the NRC will regulate the radiation safety of patients by ensuring that the physician’s

directions for administration of the radioactive material or radiation are followed.

The proposed statement and associated proposed revisions to the agency’s regulations,

which are expected to be published soon for public comment, result from the NRC’s detailed

examination of issues regarding its medical use program during the last five years. This

process started with a 1993 internal senior management review of the medical program. It

continued with the NRC-requested 1996 independent external review by the National Academy

of Sciences, Institute of Medicine; and culminated in NRC’s strategic assessment and

rebaselining initiative. In September 1997, the Commission issued its strategic plan, which

included the subject of medical oversight and stated that its goal in regulating nuclear materials

safety is “to prevent radiation-related deaths or illnesses due to civilian use of...nuclear

materials.”

In its March 20, 1997, direction to its staff, the Commission stated that it supported

continuation of the ongoing medical use regulatory program with improvements, decreased

oversight of low-risk activities, and continued emphasis on high-risk activities. The Commission

expressed its support for the continued use of its Advisory Committee on the Medical Use of

Isotopes (ACMUI), professional medical organizations and societies, and members of the public

in the revision of the regulations and the medical policy statement, if necessary.

In developing the proposed policy statement revision, the Commission established a

working group and a steering group, made up of members of the NRC staff and state

organizations, which held a series of public meetings and workshops in the fall of 1997 and the

spring of 1998 to obtain public and stakeholder suggestions. To ensure that a wide crosssection of interests were represented, invited workshop participants included physicians,

radiopharmacists, medical physicists, radiation safety officers, educators, patient rights

advocates, nurses, medical technologists, hospital administrators, representatives of state and
federal governments, and radiopharmaceutical manufacturers.

The NRC has received comments on the proposed revision of the medical policy (which

was posted on the NRC web site), through meetings of the ACMUI, professional medical

organization meetings and state regulators. It also has solicited written and electronic

comments.

Under the proposed new policy statement:

“(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.” This

portion restates the first part of the current policy statement, issued in 1979, but substitutes the

phrase “uses of radionuclides in medicine” for the phrase “medical uses of radioisotopes.” As

noted in an August 6, 1997, Federal Register notice requesting public comments on

development of revised regulations on medical uses, the Commission “was not persuaded by

the National Academy of Sciences, Institute of Medicine report that recommends that the NRC

should not be the Federal agency involved in the regulation of ionizing radiation in medicine.”

“(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

portion is based on the third portion of the current statement. It substitutes the phrase “will not

intrude” for the current “will minimize intrusion,” as suggested by the ACMUI.

“(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 portion is based on the second part of the current statement,

but makes clear that the focus of this regulation is primarily on ensuring that physician’s

directions are followed. This part of the statement also reflects the Commission strategy of

decreasing oversight of materials that pose the lowest radiological risk to the public and

continuing emphasis on high-risk activities.

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

and professional standards that define acceptable approaches of achieving radiation

safety.” This portion is also based on the second part of the current policy statement, which

states that “The NRC will regulate the radiation safety of patients...where voluntary standards,

or compliance with these standards, are inadequate.” The proposed revision indicates that

NRC will consider industry standards in regulating medical uses of nuclear material, as part of

its strategy to increase the involvement of licensees and others in its regulatory development

process.

The proposed new policy statement will be published in the Federal Register shortly.

Interested persons are invited to submit written comments to the Secretary, U.S. Nuclear

Regulatory Commission, Washington, DC 20555, Attention: Rulemakings and Adjudications

Staff, within 90 days of publication of the Federal Register notice. Comments may also be

submitted electronically through the NRC’s interactive rulemaking website at

http://www.nrc.gov/NRC/rule.html.

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