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. 97-014 FOR IMMEDIATE

RELEASE

(Wednesday, January 29,

1997)

NRC REVISES REGULATIONS ON RELEASE

OF PATIENTS ADMINISTERED BYPRODUCT MATERIAL

The Nuclear Regulatory Commission is amending its

regulations governing the release of patients from a hospital or

other licensed medical facility after they have received

radioactive material for treatment or diagnostic purposes. The

revisions respond to three petitions received on this subject.

Radioactive pharmaceuticals or radioactive implants are

administered to approximately 8 to 9 million patients in the

United States each year for diagnosis or treatment of disease.

These patients can expose other persons around them to radiation

until the radioactive material has been excreted from their

bodies or has become less intense due to radioactive decay.

Under the final rule, licensees may not authorize the

release of patients if the estimated dose, to anyone in contact

with the patient, would be greater than 500 millirems. (Typical

natural background radiation in the United States is

300 millirems per year.) The new criteria are consistent with

recommendations of the International Commission on Radiological

Protection and the National Council on Radiation Protection and

Measurements.

Under current NRC medical use regulations, licensees are not

permitted to authorize the release of patients to whom nuclear

material has been administered until either (1) the measured dose

rate from the patient is less than 5 millirems per hour at a

distance of 1 meter or (2) the radiopharmaceutical content of the

patient is less than 30 millicuries.

The final rule amends the NRC's general radiation protection

regulations to exclude doses to individuals exposed to released

patients. Release of patients containing radioactivity is

instead governed by the more explicit requirements of revised

medical use regulations, which include, in addition to the

500-millirem limit, a requirement that, if the dose to an

individual exposed to the patient is likely to exceed
100 millirems, the licensee must provide the patient with written

instructions on how to minimize exposures to others. If the

released individual may be breast-feeding an infant or child, the

instructions must also include guidance on the interruption or

discontinuation of breast-feeding and information on the

consequences of failure to follow the guidance.

The revisions partially grant three petitions for rulemaking

on criteria for release of patients who have been administered

radioactive material. On June 12, 1991, March 9, 1992, May 18,

1992, and July 26, 1994, the NRC published Federal Register

notices concerning receipt of the petitions from Dr. Carol S.

Marcus, the American College of Nuclear Medicine and the American

Medical Association.

A proposed rule on this subject was published in the Federal

Register on June 15, 1994. The final rule reflects public

comments received.

The rule will be effective May 29 (120 days after

publication of a Federal Register notice on January 29).

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