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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION WASHINGTON, D.C. 20555 December 27, 1991 NRC INFORMATION NOTICE 91-86: NEW REPORTING REQUIREMENTS FOR CONTAMINATION EVENTS AT MEDICAL FACILITIES (10 CFR 30.50) Addressees All licensees authorized to use byproduct materials for human use. Purpose The purpose of this notice is to explain morefully the kinds of contamination events, involving byproduct material, as described in 10 CFR 30.50, that might be considered reportable to the U. S. Nuclear Regulatory Commission (NRC) by a medical facility performing procedures with byproduct material, particularly Iodine-131. It is expected that licensees will review this information, distribute this notice to responsible staff, and develop appropriate procedures for making the required notification and reports to NRC. Information contained in this notice does not constitute a new requirement, and no written response is required. Description of Circumstances On August 16, 1991 (56 FR 40757), NRC published a final rule (effective October 15, 1991) that amended the reporting requirements in 10 CFR 20.403 and in the new 10 CFR 20.2202, and added a new provision (10 CFR 30.50). The rule establishes new reporting requirements for "unplanned contamination" and other events. The new rule deletes the old reporting requirements based on loss of operation and cost of damage criteria, because NRC believes that these criteria do not adequately define events with significant implications for public health and safety. NRC believes that the new criteria established in 10 CFR 30.50 will more accurately define potentially significant events, affecting the public health and safety and the environment, that must be reported to NRC. NRC is very interested in contamination incidents at medical facilities, because of the proximity of the general public to areas where byproduct materials are used and stored. Fires, spills, and other unplanned incidents involving significant quantities of radiopharmaceuticals or involving sealed sources with significant radiation levels pose potential health and safety hazards that warrant prompt notification of NRC. 9112190328 . IN 91-86 December 27, 1991 Page 2 of 2 Discussion In the practice of nuclear medicine, particularly I-131 therapy procedures, contamination resulting from patient nausea, incontinence, etc., occurs with sufficient frequency as to be considered within the paramenters of normal operations. Routine decontamination procedures are established in advance of patient treatment and followed during the course of the patient treatment. Under these conditions, no report, to NRC of those contamination events that fall within pre-determined normal operations, would be required, under the reporting requirements of 30.50. However, any contamination events that fall outside normal operations may require either an immediate or 24 hour report to NRC, as enumerated in 10 CFR 30.50. All three of the conditions cited in 10 CFR 30.50(b)(1) must be met before a report is required. These could include any unanticipated event or some unanticipated deviation from a normal procedure, not covered by the preestablished decontamination procedures. In such cases, you should refer to requirements of 10 CFR 30.50, to determine if it is necessary to report the contamination event. This information notice requires no specific action or written response. If you have any questions about the requirements of 10 CFR 30.50, please contact the technical contact listed below, or the appropriate NRC regional office. A copy of the Federal Register Notice of the final rulemaking is attached. Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Technical contact: Robert L. Ayres, NMSS (301) 504-3423 Attachments: 1. 56 FRN 40757 2. List of Recently Issued NMSS Information Notices 3. List of Recently Issued NRC Information Notices .
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