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.98-139 FOR IMMEDIATE RELEASE

(Friday, August 7, 1998)

NRC PROPOSES EXTENSIVE REVISIONS TO REGULATIONS

ON MEDICAL USES OF RADIOACTIVE MATERIAL

The Nuclear Regulatory Commission is proposing extensive revisions to its

regulations on medical uses of radioactive material. The revisions, designed to be riskinformed and more performance-based, focus regulation on the medical procedures

that pose the highest risk to workers, patients and the public from a radiation safety

aspect.

The NRC regulates the use of byproduct material and radiation from byproduct

material in medical diagnosis and treatment, as well as research, for about eleven

million patients a year.

In developing the proposed changes to the regulations, the NRC provided

extensive opportunities for public input beyond the normal rulemaking process. Publicly

announced meetings and workshops were held last year and this year where

rulemaking alternatives for significant “cross-cutting issues” were discussed. The

alternatives for the cross-cutting issues were discussed with the NRC’s Advisory

Committee on the Medical Uses of Isotopes, as well as with state regulators, medical

professional societies, and the public at meetings in Philadelphia and Chicago. In

addition, the rulemaking alternatives and an early “strawman” version of the NRC staff’s

proposed revisions to the regulations were made available for comment on the Internet

and in the NRC’s Public Document Room in Washington, DC, as early as January of

this year.

In general, the proposed changes to the regulations reflect an overall change in

regulatory philosophy to make the regulations more performance based and to delete

some of the more detailed requirements. An applicant for an NRC medical-use license

would have to develop and implement procedures, but would no longer be required to

submit those procedures as part of the license application. Further, licensees would

have maximum flexibility in developing their procedures, because most of the

requirements in the proposed changes to the regulations are stated in terms of the

objectives to be achieved, rather than stated with a list of prescriptive details.

The significant cross-cutting issues that were identified, and their resolutions in

the proposed revisions to the regulations, are:
(1) Patient notification/reportable events -- The requirements in the current

regulations for notifying individuals following a misadministration would remain

unchanged, with the exception of substituting the term “medical event’ for

“misadministration.” The term, defined in detail in the proposed revisions to the

regulations, generally refers to the administration of radioactive materials or radiation in

a manner that differs substantially from the physician’s direction. Using “medical event”

responds to objections that the term “misadministration” has possible connotations of

carelessness and harm, which is not always the case. In addition, “medical event” is

consistent with terms used to characterize events in non-medical activities regulated by

the NRC. The proposed regulations would continue to require that, when a medical

event occurs, licensees must notify the NRC, the referring physician and the affected

patient -- unless the referring physician personally informs the licensee either that he

will inform the individual or that, based on medical judgment, telling the individual would

be harmful. If the patient is a minor, or is unconscious and incapable of comprehending

the information, it is expected that the licensee would report to the patient’s responsible

relative or guardian rather than to the patient.

(2) Radiation safety committee -- The proposed revisions to the regulations

delete the requirement for a medical institution licensee to have a radiation safety

committee, with specified membership and duties, to oversee the use of radioactive

material. The key functions of the committee would be transferred to licensee

management. The proposed regulations specify the responsibilities for and functions to

be accomplished by the radiation safety program, including some of the functions

previously listed as those of the radiation safety committee.

(3) Quality management program -- Provisions in this area have been revised to

focus more on patient safety. Detailed requirements for a medical licensee to have a

quality management program have been deleted. Instead, the proposed revisions to

the regulations require licensees to have written directives for procedures involving

greater risk. Licensees would also have to develop, implement and maintain

procedures to provide high confidence that the right patient receives the correct dose at

the correct treatment site, consistent with the physician’s written directive. This

proposed revision not only eliminates unnecessary details, but is more consistent with a

proposed revision to the agency’s NRC’s medical policy statement, which states that

“NRC will, when justified by the risk to patients, regulate the radiation safety of patients

primarily to assure the use of radionuclides in accordance with the physician’s

directions.”

(4) Training and experience -- Requirements in both the current regulations and

the proposed revisions differ for diagnostic versus therapeutic uses of nuclear material.

The proposed regulations basically retain the current training requirements for

therapeutic uses of sealed sources of radioactive material because of the high risk

associated with the types of material in such uses. However, the proposed revisions

would reduce some of the training requirements for diagnostic procedures using

radioactive materials in unsealed form, because of the lower risk associated with these

procedures. Training and experience were the primary concerns expressed by the
public comments during development of the proposed changes to the regulations. Most

of the commenters thought the current requirements should be retained. Under the

proposed revisions, the current training requirements would stay in effect for two years

to allow licensees time to implement the new requirements. During the intervening

period, licensees would have the option of meeting either the current or the revised

requirements.

(5) Precursor events -- The Commission considered, but is not proposing,

changes that would have required licensees to notify the NRC after identifying certain

types of defects in equipment, radioactive material or procedures supplied by a

manufacturer or vendor. Instead, the agency will issue an information notice to alert

licensees to existing requirements and will reinforce the need for compliance with these

requirements in its inspection and enforcement activities.

The proposed changes to the regulations also address a petition for rulemaking

filed by the University of Cincinnati. The petition requests a 500-millirem radiation dose

limit for certain individuals visiting patients who are required to be confined to the

hospital while receiving radiation treatment, where the visitors are determined by the

physician to be necessary for the patient’s emotional or physical support. The current

limit of 100 millirem for visitors is the same as for members of the public under other

circumstances. The proposed regulations would respond to this petition by allowing

licensees the discretion to permit visitors to receive up to 500 millirem from exposure to

a patient who could not be released under Section 35.75 of the Commission’s

regulations.

In addition, the proposed changes add a requirement for reporting unintended

radiation exposure of an embryo, fetus, or nursing child, and add specific requirements

for medical uses of radiation by a licensee at temporary job sites and for specific

technologies that are not currently addressed in the regulations. They also add a

section to allow easier licensing of new medical procedures that use radioactive

material or radiation.

Details of these and other aspects of the proposed changes to the regulations

are contained in a Federal Register notice to be published shortly. Interested persons

are invited to submit comments within 90 days of publication of the Federal Register

notice to the Secretary, U.S. Nuclear Regulatory Commission, Attention: Rulemakings

and Adjudications Staff.

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