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POLICY ISSUE SECY-04-0046 March 18, 2004
To obtain Commission approval to submit the report on abnormal occurrences (AOs) to Congress and revise the abnormal occurrence criteria to conform to changes to 10 CFR Part 35. This paper presents a draft of the "Report to Congress on Abnormal Occurrences,
Fiscal Year 2003" (NUREG-0090, Vol. 26) (Attachment
1 The report describes five medical events (previously called misadministrations) at facilities licensed by the NRC. Three events involved patients undergoing therapeutic brachytherapy treatments, one event involved an unintentional therapeutic dose of sodium iodide (I-131) to an embryo/fetus, and one event involved a diagnostic overexposure of a minor. The report also discusses nine AOs at facilities licensed by Agreement States. Seven events were medical events (five therapeutic and two diagnostic), one event involved overexposure to a radiographer, and one event involved overexposure to members of the public from a damaged gauge. All 14 events meet the criteria for AO categorization as defined in Appendix A. Appendix B, "Update of Previously Reported Abnormal Occurrences," gives updates of two events initially reported in the fiscal year (FY) 2002 annual report to Congress. The first update addresses the degradation of the reactor pressure vessel head at the Davis-Besse Nuclear Power Station. Davis-Besse has been shut down since the March 2002 discovery of the reactor vessel head degradation and will not be allowed to restart until the NRC has completed a thorough review to ensure that safety will be maintained. The second update describes inspection and enforcement actions undertaken after an unplanned radiological exposure of oil rig workers. These updates were not available before the FY 2002 report was published. Appendix C, "Other Events of Interest," discusses events that do not meet the AO criteria but may be of interest to Congress and the public. Appendix C describes three nuclear power reactor events and a materials event. On October 24, 2002, the final rule revising 10 CFR Part 35, "Medical Use of Byproduct Material," became effective. A change to Part 35 that will affect the categorization of medical events as AOs is the replacement of the term "misadministration" with the term "medical event." To maintain consistency with NRC's medical regulations, the staff is requesting that the Commission approve the name change to the AO criteria (Criterion IV, "For Medical Licensees") as documented in Appendix A of the AO report. Furthermore, staff is considering other changes to the AO criteria that may be suggested in the future. The Office of the General Counsel has reviewed the draft report and has no legal objection to its contents. The staff recommends that the Commission approve the contents of the proposed AO report to Congress for FY 2003, the proposed AO criteria, and the proposed letters forwarding the AO report to Congress. After receiving approval the staff will submit the letters to the President of the Senate and the Speaker of the House for the Chairman's signature. The Office of Congressional Affairs will then arrange for appropriate distribution to Congress. The NRC staff will issue a Federal Register notice describing the NRC and Agreement State licensee AOs and announcing publication of the report.
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