NRC NEWS

 U.S. NUCLEAR REGULATORY COMMISSION 

 Office of Public Affairs Telephone: 301/415-8200

 Washington, DC 20555-0001 E-mail: opa@nrc.gov 

 Web Site: www.nrc.gov

No. 02-048 April 17, 2002

NRC REVISES REGULATIONS ON MEDICAL USES 

OF RADIOACTIVE MATERIAL

The Nuclear Regulatory Commission has revised its regulations on the medical uses of

radioactive material. The regulations also respond to a petition for rulemaking filed by the University

of Cincinnati. 

The agency currently regulates the use of certain radioactive materials in medical diagnosis and

treatment, as well as research, for about eleven million patients a year.

The revisions, designed to be both risk-informed and more performance-based, focus the

regulations on the medical procedures that pose higher risks to workers, patients and the public from a

radiation safety aspect. The regulations also eliminate some of the previous detailed requirements of

those who perform lower risk diagnostic medical procedures such as bone or thyroid scans.

 Licensees have six months to implement the new requirements. 

Highlights of the revised rule are:

(1) Patient notification/reportable events -- Under the revised regulations, the term “medical

event,” referring to the administration of radioactive materials in a manner that differs substantially

from the physician’s direction, replaces the previous term “misadministration.” The regulations

continue to require that, when a medical event occurs, the licensee 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. Previously, the licensee was required to provide a written description of the medical event

regardless of whether it was requested. Under the revision, the patient must be informed that such a

description can be obtained from the licensee. Also, under the revision, if the physician is not the

licensee, the licensee must provide a copy of the medical event record to the referring physician. 

(2) Radiation Safety Committee -- Under the revised regulations, the Radiation Safety

Committee is responsible for broad oversight of the uses of certain radioactive materials. However, the

current specific responsibilities of the Radiation Safety Committee have been transferred from the

Committee to licensee management. A Committee is still required for certain medical licensees
performing two or more higher risk activities such as those used in the treatment of cancer. The

regulations specify radiation safety goals or objectives for the Committee, but allow licensee

management flexibility in implementing those goals. 

(3) Physician’s written directions -- Detailed requirements for a medical licensee to have a

quality management program have been deleted. Instead, the revised regulations require that licensees

have written procedures for those activities involving higher risk. Licensees must develop 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 instructions.

(4) Training and experience -- Some of the training requirements for individuals performing

diagnostic procedures using radioactive materials in unsealed form have been reduced, consistent with

the lower risk associated with these procedures. However, the revised regulations retain the current

training requirements for individuals using sealed sources of radioactive material for therapeutic

administrations because of the higher risk associated with using these types of material. The training

and experience requirements contained in Subpart J of the current regulation are also being retained for

a two-year period from the effective date of the revised rule. Training and experience were the primary

concerns expressed by commenters during development of the final rule. 

In addition, the revised rule adds a requirement for reporting unintended medical radiation

exposure of an embryo, fetus, or nursing child. 

The revised rule also addresses a petition for rulemaking filed by the University of Cincinnati. 

The petition requested 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 physical or emotional support. The

response to the petition, incorporated into the rule, allows physicians the discretion to permit visitors to

receive up to 500 millirem from exposure to a hospitalized patient. A millirem is a unit of

measurement used to determine the effect of radiation on the body (for instance, a round-trip, crosscountry flight is equal to about 5 millirem). The current limit of 100 millirem per year for visitors is the

same as for members of the public under other circumstances. The agency believes the emotional

benefit to the patient and the visitor outweighs any small increase in radiation risk to the visitor, and,

accordingly, physicians should be provided the flexibility to make decisions regarding patients’ visitors.

A proposed rule on the medical uses of radioactive material was published in the Federal

Register for comment on August 13, 1998. The NRC staff held meetings and workshops since then in

San Francisco, Kansas City and Washington, D.C., that included participation by the general public,

state regulators, medical professional societies, and medical boards. Also, the Commission was briefed

by the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and various stakeholders during

public meetings. Issues regarding the rule were also discussed with the ACMUI at public meetings.

Over 600 comments were received during development of the rule, which were considered in

development of the final version.

The agency has also revised its medical policy statement on the medical uses of radioactive

material. Highlights of the policy statement were announced separately. 

This regulation becomes effective six months after publication of a Federal Register Notice on

this subject, expected shortly. 
Documents related to this rulemaking may be examined at the NRC Public Document Room,

One White Flint North, 11555 Rockville Pike, Room O-1 F23, Rockville, MD 20852. Documents will

also be available through the NRC’s Agencywide Document Access and Management System

(ADAMS). Help in using ADAMS is available by contacting NRC’s Public Document Room staff at 1-

800-397-4209, 301-415-4737 or by sending an email message to pdr@nrc.gov. 

For more information on the final rule, contact Roger W. Broseus at 301-415-7608, or by email

at RWB@nrc.gov.

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