United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 91-86: New Reporting Requirements for Contamination Events at Medical Facilities (10 CFR 30.50)

                                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 

.
Page Last Reviewed/Updated Tuesday, November 12, 2013