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 Nuclear Regulatory Commission [NRC-2015-0176]
 AGENCY: Nuclear Regulatory Commission.
 ACTION: Policy revision; issuance.
 SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to its policy statement on reporting abnormal occurrences (AOs) to Congress. The revised policy statement adds more specific criteria for determining those incidents and events that the Commission considers significant from the standpoint of public health or safety for reporting to Congress and the public, and makes the policy consistent with recent changes to NRC regulations. The revised AO criteria contain more discrete reporting thresholds, making them easier to implement and ensuring more consistent reporting.
 DATES: This revision to the policy statement is effective on October 2, 2017.
 ADDRESSES: Please refer to Docket ID NRC-2015-0176 when contacting the NRC about the availability of information regarding this action. You may obtain publicly-available information related to this action using any of the following methods: *Federal Rulemaking Web Site:*
                         Go to 
                        *http://www.regulations.gov*
                         and search for Docket ID NRC-2015-0176. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: 
                        *Carol.Gallagher@nrc.gov.*
                         For technical questions, contact the individual listed in the 
                        **FOR FURTHER INFORMATION CONTACT**
                         section of this document.
                    *NRC's Agencywide Documents Access and Management System (ADAMS):*
                         You may obtain publicly-available documents online in the ADAMS Public Documents collection at 
                        *http://www.nrc.gov/​reading-rm/​adams.html.*
                         To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to 
                        *pdr.resource@nrc.gov.*
                         The ADAMS accession number for each document referenced in this document (if that document is available in ADAMS) is provided the first time that a document is referenced. For the convenience of the reader, the ADAMS Accession numbers are provided in a 
                        ( print page 45908)
                        table in Section VIII, “Availability of Documents,” of this document.
                    *The NRC's PDR:*
                         You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
 FOR FURTHER INFORMATION CONTACT: Tanya Palmateer Oxenberg, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2437; email: 
                        *Tanya.Oxenberg@nrc.gov.*


SUPPLEMENTARY INFORMATION:  Table of Contents I. Background II. Opportunity for Public Participation III. Coordination With NRC Agreement States IV. Coordination With the Advisory Committee on the Medical Uses of Isotopes V. Congressional Review Act VI. Availability of Documents I. Background Section 208, “Abnormal Occurrence Reports,” of the Energy Reorganization Act of 1974, as amended (Pub. L. 93-438) (the Act), defines an AO as an unscheduled incident or event that the NRC determines to be significant from the standpoint of public health or safety. The Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 104-66) requires that AOs be reported to Congress annually. As required by Section 208, the discussion for each reported event includes the date and place, the nature and probable consequences, the cause or causes, and the action taken to prevent recurrence. The Commission must also widely disseminate the AO report to the public within 15 days of publishing the AO report to Congress. Abnormal Occurrence Reporting The Commission has developed the AO policy statement to comply with Section 208 of the Energy Reorganization Act. The intent of the Act is to keep Congress and the public informed of unscheduled incidents or events that the Commission considers significant from the standpoint of public health or safety. The policy reflects a range of health and safety concerns and applies both to incidents and events involving a single individual and to those having an overall impact on the general public. The AO criteria use a high reporting threshold so that only those events considered significant from the standpoint of public health or safety are reported to Congress. Licensee Reports The changes to the policy statement do not change the reporting requirements for NRC licensees in Commission regulations, license conditions, or technical specifications. The NRC licensees will continue to submit required reports on a wide range of events, including instrument malfunctions and deviations from normal operating procedures that may not be significant from the standpoint of public health or safety but that provide data useful to the Commission in monitoring the operating trends of licensed facilities and in comparing the actual performance of these facilities with their design and/or licensing basis. II. Opportunity for Public Participation To develop the revised AO criteria, the NRC staff evaluated several AO approaches and consulted with experts in the reactor and nuclear material areas, including the Advisory Committee on the Medical Uses of Isotopes (ACMUI), and coordinated with Agreement States. The NRC staff undertook this effort to ensure that it was properly identifying those events that have the potential for significant health or safety consequences are reported to Congress. After an evaluation, the NRC staff incorporated several comments provided by the States and ACMUI into the draft revision in SECY-15-0040, “Proposed Revisions to Policy Statement on Reporting Abnormal Occurrence Criteria,” dated March 19, 2015 (ADAMS Accession No. ML12166A091). The proposed AO policy statement that was published for comment included the Commission's subsequent direction in the staff requirements memorandum (SRM) for SECY-15-0040, dated June 30, 2015 (ADAMS Accession No. ML15181A030). The proposed AO criteria was published in the 
                    **Federal Register**
                     (FR) on August 17, 2015 (80 FR 49177), for a 90-day public comment period. The NRC received three comment letters on the proposed AO criteria published in the FR from the Organization of Agreement States (OAS) (ADAMS Accession No. ML16209A194), Washington State Department of Health (WDH) (ADAMS Accession No. ML16209A199), and the Commonwealth of Virginia Department of Health (VDH) (ADAMS Accession No. ML16209A196). Each letter contained multiple comments. In summary, the comments asked the NRC to (1) revise and/or remove the dose threshold for reporting AO events to Congress on unintended exposures to an adult and a minor or an embryo/fetus, (2) add “medical physicist” or revise “independent physician” in the requirement to obtain the determination of an independent physician, (3) remove the requirements for “irretrievable well logging sources,” (4) clarify the applicability of the “substantial breakdown” provision in Criterion I.C.4 to materials licensees, and (5) remove or modify Criterion III.C medical events. III. Coordination With NRC Agreement States The NRC coordinated with the Agreement States throughout the development of this final policy statement. In October 2013, the NRC provided a preliminary proposed policy statement to the Agreement States for their review and comment. The Agreement States provided comments on the preliminary proposed policy statement. Several comments resulted in revisions to the proposed AO criteria. A summary of the Agreement State comments and the NRC staff responses to those comments are available at ADAMS Accession No. ML14346A274. The NRC received comment letters on the proposed AO criteria, which was published in the FR on August 17, 2015 (80 FR 49177). The NRC received comments from OAS, WDH, and VDH. Each letter contained multiple comments. The NRC staff analyzed and categorized these comments according to the AO criterion to which they apply. A summary of the Agreement States' comments and the NRC staff responses to the comments are available in ADAMS under Accession No. ML16209A049. The staff did not make any changes in response to the comments. The AO criteria are designed to identify those events that could signal a potential public health or safety issue and evaluate events in a broad industrywide perspective. In response to comments regarding the requirement that an independent physician determine whether permanent functional damage occurred, the NRC staff did not agree to add “authorized medical physicist” because medical physicists are neither qualified nor credentialed to make a medical determination that unintended permanent functional damage to an organ or a physiological system has occurred. The criterion requires a determination by an independent physician “deemed qualified by the NRC or Agreement State,” which takes into account all pertinent credentialing aspects of the individual, including specialty in the relevant field.
                    ( print page 45909) The staff disagreed with removing or modifying requirements for “irretrievable well logging sources” and Criterion III.C medical events. The staff disagreed with modifying the criterion regarding “irretrievable well logging sources” as NRC and Agreement State regulations require the licensee to evaluate the potential threat to public health or safety from an abandoned irretrievable source. This evaluation and dose assessment would be used as a basis to evaluate these events as potential AOs for irretrievable well logging sources. The NRC previously added Criterion III.C for medical AO because the Commission considered misadministrations to be a concern. The current criteria are based on doses that would likely have a significant potential for resulting in permanent deterministic effects. In response to a comment that requested clarification of the applicability of the “substantial breakdown” provision in criterion l.C.4 to materials licensees, the staff explained that this criterion is principally for licensees that possess special nuclear material and whose activities are included in a security plan required by part 73 of title 10 of the 
                    *Code of Federal Regulations*
                     (10 CFR). Criterion I.C.1 is the principal criterion for security incidents involving materials subject to 10 CFR part 37 for NRC or Agreement State radioactive materials licensee events to determine if an AO has occurred. IV. Coordination With the Advisory Committee on the Medical Uses of Isotopes The ACMUI submitted comments on the proposed AO policy statement in a letter dated November 6, 2015 (ADAMS Accession No. ML15356A087). These comments concerned the reporting of incidents and events related to medical use that the ACMUI found may not be significant for public health or safety. The NRC prepared a response to the ACMUI recommendations (ADAMS Accession No. ML16209A061). Most of ACMUI's comments indicated agreement with the proposed revisions to the policy statement. However, ACMUI had three comments recommending changes to the AO criteria. The staff disagreed with two comments and partially agreed with one comment. The staff agreed to add “and human research subjects” to footnote 2 to Criterion 1, but it disagreed with excluding events reported under § 35.3047 from Criterion I.A.2. The staff also disagreed with adding § 35.3047 to the footnote text because this would establish two different thresholds for reporting an AO involving exposure to an embryo/fetus: one for an embryo/fetus unintentionally exposed due to a medical administration to a pregnant individual and one for an embryo/fetus exposed from all other sources of licensed material. V. Congressional Review Act This policy statement is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). VI. Availability of Documents The documents identified in the following table are available as indicated. Date
Document
ADAMS
                             Accession No./FR 
                             citation03/19/2015
SECY-15-0040, Proposed Revisions to Policy Statement on Reporting Abnormal Occurrence Criteria
ML12166A09106/30/2015
Staff Requirements—SECY-15-0040—Proposed Revisions to Policy Statement on Reporting Abnormal Occurrence Criteria
ML15181A03008/17/2015
Proposed revision to policy statement issued for a 90 day public comment period.
80 FR 4917711/16/2015
OAS letter to NRC, RE: Opportunity to Comment on Proposed Revision to Abnormal Occurrence Policy Statement
ML16209A19411/17/2015
State of Washington Comment for Docket ID NRC-2015-0176 Abnormal Occurrence Criteria Revision
ML16209A19911/12/2015
Virginia Comments on Abnormal Occurrence (AO) Reporting Revision
ML16209A19603/19/2015
Summary of Major Agreement State Comments
                             and Staff Response
ML14346A27407/08/2016
Summary of Organization of Agreement State (OAS), State of Washington, and Commonwealth of Virginia Comments and Staff Response
ML16209A04911/06/2015
Final ACMUI Comments on Proposed Revision of the NRC Policy Statement on Reporting Abnormal Occurrences to Congress
ML15356A08710/09/2015
Meeting Summary, ACMUI Meeting, 
                             October 8-9, 2015
ML15294A46108/08/2016
Staff's Response to the Advisory Committee on the Medical Uses of Isotopes' November 6, 2015, Recommendations to Final Comments on Proposed Revision of the NRC Policy Statement on Reporting Abnormal Occurrences to Congress
ML16209A06106/24/2014
Management Directive 8.3, “NRC Incident Investigation Program”
ML13175A29404/11/2014
Management Directive 8.9, “Accident Investigation”
ML13319A13310/03/2010
Management Directive 8.13, “Reactor Oversight Process,” DT-10-14
ML10140004512/23/2015
Inspection Manual Chapter (IMC) 0305, “Operating Reactor Assessment Program”
ML15317A14712/15/2006
IMC 350, “Oversight of Reactor Facilities in a Shutdown Condition Due to Significant Performance and/or Operational Concerns”
ML06340007606/30/2015
NUREG-1520 Rev. 2, “Standard Review Plan for Fuel Cycle Facilities License Applications,” Final Report
ML15176A258
 
 
 The final policy statement is attached. Dated at Rockville, Maryland, this 26th day of September 2017. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission.
 Statement of Policy General Statement of Policy on the Implementation of Section 208 of the Energy Reorganization Act of 1974, as Amended Applicability Implementation of Section 208, “Abnormal Occurrence Reports,” of the Energy Reorganization Act of 1974, as amended, involves the conduct of Commission business and does not impose requirements on licensees or certified facilities. The reports cover certain unscheduled incidents or events related to the manufacture, construction, or operation of a facility or the conduct of an activity subject to the requirements of parts 20, 30 through 37, 39, 40, 50, 61, 70, 71, 72, or 76 of title 10 of the 
                    *Code of Federal Regulations*
                     (10 CFR). Agreement States provide information to the U.S. Nuclear Regulatory Commission (NRC) on incidents and events involving nuclear materials in those States. Agreement States are those States that have entered into formal agreements with the NRC, pursuant to Section 274 of the Atomic Energy Act of 1954, as amended (AEA) (Pub. L. 83-703), to regulate certain quantities of AEA material at facilities located within their borders. Events reported by Agreement States that reach the threshold for reporting as abnormal occurrences (AOs) are also published in the “Report to Congress on Abnormal Occurrences.” Abnormal Occurrence General Statement of Policy The Commission will apply the following policy in determining whether an incident or event at a facility or involving an activity that is licensed or otherwise regulated by the Commission or an Agreement State is an AO.[1] An incident or event is considered an AO if it involves a major reduction in the protection of public health or safety. The incident or event has a moderate or severe impact on public health or safety and could include, but need not be limited to, the following: (1) Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission or Agreement States; (2) Major degradation of essential safety-related equipment; (3) Major deficiencies in design, construction, or use of, or management controls for, facilities or radioactive material licensed by or otherwise regulated by the Commission or Agreement States; or (4) Substantiated case of actual loss, theft, or diversion of risk-significant radioactive material licensed by or otherwise regulated by the Commission or Agreement States. Appendix A to this policy statement sets forth the criteria for determining whether an incident or event is as an AO. Commission Dissemination of Abnormal Occurrence Information The Commission widely disseminates AO reports to the public. The Commission submits an annual report to Congress on AOs at or associated with any facility or activity that is licensed or otherwise regulated by the NRC. This report provides the date, place, nature, and probable consequences of each AO; the cause or causes of each AO; and any action taken by the licensee to prevent recurrence. Appendix A: Abnormal Occurrence Criteria An incident or event is considered an abnormal occurrence (AO) if it involves a major reduction in the degree of protection of public health or safety. This type of incident or event has a moderate or severe impact on public health or safety and could include, but need not be limited to, the following: (1) Moderate exposure to, or release of, radioactive material licensed by or otherwise regulated by the Commission or Agreement States; (2) Major degradation of essential safety-related equipment; (3) Major deficiencies in design, construction, or use of, or management controls for facilities or radioactive material licensed by or otherwise regulated by the Commission or Agreement States; or (4) Substantiated case of actual loss, theft, or diversion of risk-significant radioactive material licensed by or otherwise regulated by the Commission or Agreement States. Abnormal Occurrence Criteria The following presents the criteria, by types of events, used to determine which events will be considered for reporting as AOs. I. All Licensees.2 A. Human Exposure to Radiation from Licensed Material. 1. Any unintended radiation exposure to an adult (any individual 18 years of age or older) resulting in: (a) An annual total effective dose equivalent (TEDE) of 250 millisieverts (mSv) (25 rem) or more; (b) An annual sum of the deep dose equivalent (external dose) and committed dose equivalent (intake of radioactive material) to any individual organ other than the lens of the eye, the bone marrow, and the gonads of 2,500 mSv (250 rem) or more; (c) An annual dose equivalent to the lens of the eye of 1 sievert (Sv) (100 rem) or more; (d) An annual sum of the deep dose equivalent and committed dose equivalent to the bone marrow of 1 Sv (100 rem) or more; (e) A committed dose equivalent to the gonads of 2,500 mSv (250 rem) or more; or (f) An annual shallow dose equivalent to the skin or extremities of 2,500 mSv (250 rem) or more. 2. Any unintended radiation exposure to any minor (an individual less than 18 years of age) resulting in an annual TEDE of 50 mSv (5 rem) or more, or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5 rem) or more. 3. Any radiation exposure that has resulted in unintended permanent functional damage to an organ or a physiological system as determined by an independent physician [3]
                        
                         deemed qualified by the U.S. Nuclear Regulatory Commission (NRC) or Agreement State. B. Discharge or Dispersal of Radioactive Material from Its Intended Place of Confinement. The release of radioactive material to an unrestricted area in concentrations that, if averaged over a period of 24 hours, exceed 5,000 times the values specified in Table 2 of Appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage,” to 10 CFR part 20, “Standards for protection against radiation,” unless the licensee has demonstrated compliance with § 20.1301, “Dose limits for individual members of the public,” using § 20.1302(b)(1) or § 20.1302(b)(2)(ii). This criterion does not apply to transportation events. C. Theft, Diversion, or Loss of Licensed Material; Sabotage; or Security Breach.*4 5 6* 1. Any stolen, diverted, abandoned, or unrecovered lost radioactive material that 
                        ( print page 45911)
                        meets or exceeds the thresholds listed in Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR part 37, “Physical protection of category 1 and category 2 quantities of radioactive material.” Excluded from reporting under this criterion are those events involving sources that are lost or abandoned under the following conditions: sources that have been lost and for which a reasonable attempt at recovery has been made without success, or irretrievable well logging sources as defined in § 39.2, “Definitions.” These sources are only excluded if there is reasonable assurance that the doses from these sources have not exceeded, and will not exceed, the reporting thresholds specified in AO Criteria I.A.1 and I.A.2 and the agency has determined that the risk of theft or diversion is acceptably low. 2. An act that results in radiological sabotage as defined in § 73.2. 3. Any substantiated [7]
                        
                         case of actual theft, diversion, or loss of a formula quantity of special nuclear material,[8]
                        
                         or an inventory discrepancy of a formula quantity of special nuclear material8
                         that is judged to be caused by theft or diversion. 4. Any substantial breakdown [9]
                        
                         of physical security, cyber security, or material control and accountability programs that significantly weakens the protection against loss, theft, diversion, or sabotage. 5. Any significant unauthorized disclosures (loss, theft, and/or deliberate disclosure) of classified information that harms national security or of Safeguards Information that threatens public health or safety. D. Initiation of High-Level NRC Team Inspection.*10* II. Commercial Nuclear Power Plant Licensees. A. Malfunction of Facility, Structures, or Equipment. 1. Exceeding a safety limit of a license technical specification (TS) (§ § 50.36(c)). 2. Serious degradation of fuel integrity, primary coolant pressure boundary, or primary containment boundary. 3. Loss of plant capability to perform essential safety functions so that a release of radioactive materials that could result in exceeding the dose limits of 10 CFR part 100, “Reactor site criteria,” or five times the dose limits of General Design Criteria (GDC) 19, “Control Room,” in Appendix A, “General Design Criteria for Nuclear Power Plants,” to 10 CFR part 50, “Domestic licensing of production and utilization facilities,” could occur from a postulated transient or accident (
                        *e.g.,*
                         loss of emergency core cooling system, loss of control rod system). B. Design or Safety Analysis Deficiency, Personnel Error, or Procedural or Administrative Inadequacy. 1. Discovery of a major condition not specifically considered in the safety analysis report or TS that requires immediate remedial action. 2. Personnel error or procedural deficiencies that result in the loss of plant capability to perform essential safety functions such that a release of radioactive materials exceeding the dose limits of 10 CFR part 100 or five times the dose limits of GDC 19 in Appendix A to 10 CFR part 50, could occur from a postulated transient or accident (
                        *e.g.,*
                         loss of emergency core cooling system, loss of control rod drive mechanism). C. Any operating reactor events or conditions evaluated by the NRC ROP to be the result of or associated with licensee performance issues of high safety significance.*11* D. Any operating reactor events or conditions evaluated by the NRC Accident Sequence Precursor (ASP) program to have a conditional core damage probability (CCDP) or change in core damage probability (ΔCDP) of greater than or equal to 1 × 10−*3*
                        .*12* E. Any operating reactor plants that are determined to have overall unacceptable performance or are in a shutdown condition as a result of significant performance problems and/or operational event(s).*13* III. Events at Facilities Other Than Nuclear Power Plants and All Transportation Events. A. Events Involving Design, Analysis, Construction, Testing, Operation, Transport, Use, or Disposal. 1. An accidental criticality. 2. A major deficiency in design, construction, control, or operation having significant safety implications that require immediate remedial action. 3. A serious safety-significant deficiency in management or procedural controls. 4. A series of events (in which the individual events are not of major importance), recurring incidents, or incidents with implications for similar facilities (generic incidents) that raise a major safety concern. B. Fuel Cycle Facilities.*14* 1. Absence or failure of all safety controls (engineered and human) such that conditions were present for the occurrence of a high-consequence event involving an 
                        ( print page 45912)
                        NRC-regulated hazard (radiological or chemical).[15] 2. An NRC-ordered safety-related or security-related immediate remedial action. C. Events Involving the Medical Use of Radioactive Materials in Patients or Human Research Subjects.[16] 1. A medical event, as defined in § 35.3045, which results in a dose that: (a) Is equal to or greater than 1 gray (Gy) (100 rad) to a major portion of the bone marrow or to the lens of the eye; or equal to or greater than 2.5 Gy (250 rad) to the gonads; or (b) Exceeds, by 10 Gy (1,000 rad), the expected dose to any other organ or tissue from the administration defined in the written directive; and 2. A medical event, as defined in § 35.3045, which involves: (a) A dose or dosage that is at least 50 percent greater than that prescribed, or (b) A prescribed dose or dosage that: (i) Uses the wrong radiopharmaceutical or unsealed byproduct material; or (ii) Is delivered by the wrong route of administration; or (iii) Is delivered to the wrong treatment site; or (iv) Is delivered by the wrong treatment mode; or (v) Is from a leaking source or sources; or (vi) Is delivered to the wrong individual or human research subject. Appendix B: Other Events of Interest This appendix discusses other events of interest that do not meet the criteria for abnormal occurrences (AOs) in Appendix A to this policy statement. The Commission may determine that events other than AOs may be of interest to Congress and the public and should be included in an appendix to the AO report as “Other Events of Interest.” Such events may include, but are not necessarily limited to, events that do not meet the AO criteria but that have been perceived by Congress or the public to be of high health or safety significance, have received significant media coverage, or have caused the U.S. Nuclear Regulatory Commission to increase its attention to or oversight of a program area, or a group of similar events that have resulted in licensed materials entering the public domain in an uncontrolled manner.


# Footnotes

1.
    
                         Events reported to the NRC by Agreement States that reach the threshold for reporting as AOs will be reported as such by the Commission. Back to Citation
 2.
    
                             Medical patients and human research subjects are excluded from consideration under these criteria, and these criteria do not apply to medical events defined in § 35.3045 of title 10 of the 
                            *Code of Federal Regulations*
                             (10 CFR), “Report and notification of a medical event,” which are considered in AO Criteria III.C. Back to Citation
 3.
    
                             “Independent physician” is defined as a physician not on the licensee's staff and who was not involved in the care of the patient involved. Back to Citation
 4.
    
                             Information pertaining to certain incidents may either be classified or under consideration for 
                            
                            classification because of national security implications. Classified information will be withheld when formally reporting these incidents in accordance with Executive Order 13526, “Classified National Security Information,” as amended (75 FR 707; January 5, 2010), or any predecessor or successor order to require protection against unauthorized disclosures. Any classified details about these incidents would be available to Congress upon request, under appropriate security arrangements. 5.
    
                             Information pertaining to certain incidents may be Safeguards Information as defined in § 73.2 because of safety and security implications. The AO report would withhold specific Safeguards Information in accordance with Section 147 of the Atomic Energy Act of 1954, as amended. Any safeguards details regarding these incidents would be available to Congress upon request, under appropriate security arrangements. 6.
    
                             Reporting lost or stolen material is based on the activity of the source at the time the radioactive material was known to be lost or stolen. If, by the time the AO report is due to Congress, the radioactive material has decayed below the thresholds listed in Appendix A to 10 CFR part 37, the report will clarify that the radioactive material has decayed below the thresholds. Back to Citation
 7.
    
                             “Substantiated” means a situation in which there is an indication of loss, theft, or unlawful diversion, such as an allegation of diversion, report of lost or stolen material, or other indication of loss of material control or accountability that cannot be refuted following an investigation, and requires further action on the part of the agency or other proper authorities. Back to Citation
 8.
    
                             “Formula quantity of special nuclear material” is defined in § 70.4, “Definitions.” Back to Citation
 9.
    
                             A substantial breakdown is defined as a red finding under the Reactor Oversight Process (ROP) in the physical security inspection program or any plant or facility determined to have overall unacceptable performance. Back to Citation
 10.
    
                             This item addresses the initiation of any incident investigation teams, as described in NRC Management Directive (MD) 8.3, “NRC Incident Investigation Program” (ADAMS Accession No. ML13175A294), or initiation of any accident review groups, as described in MD 8.9, “Accident Investigation” (ADAMS Accession No. ML13319A133). Back to Citation
 11.
    
                             The NRC ROP uses four colors to describe the safety significance of licensee performance. As defined in NRC MD 8.13, “Reactor Oversight Process” (ADAMS Accession No. ML101400045), green is used for very low safety significance, white is used for low to moderate safety significance, yellow is used for substantial safety significance, and red is used for high safety significance. Reactor conditions or performance indicators evaluated to be red are considered AOs. Back to Citation
 12.
    
                             Results from the NRC ASP program are used to monitor agency performance against the agency's strategic safety goal (e.g., ensure the safe use of radioactive materials) and objectives (e.g., prevent and mitigate accidents and ensure radiation safety). A precursor event with a CCDP or ΔCDP of greater than or equal to 1 × 10−3.
    
                             is used as a performance indicator for the strategic safety goal by determining that there have been no significant precursors of a nuclear reactor accident and that there have been no more than one significant adverse trend in industry safety performance. Back to Citation
 13.
    
                             Any plants assessed by the ROP to be in the unacceptable performance column, as described in NRC Inspection Manual Chapter (IMC) 0305, “Operating Reactor Assessment Program” (ADAMS Accession No. ML15317A147), or under NRC IMC 0350, “Oversight of Reactor Facilities in a Shutdown Condition Due to Significant Performance and/or Operational Concerns” (ADAMS Accession No. ML063400076). This assessment of safety performance is based on the number and significance of NRC inspection findings and licensee performance indicators. Back to Citation
 14.
    
                             Criterion III.A also applies to fuel cycle facilities. Back to Citation
 15.
    
                             High-consequence events for facilities licensed under 10 CFR part 70, “Domestic licensing of special nuclear material,” are those that could seriously harm the worker or a member of the public in accordance with § 70.61, “Performance requirements.” The integrated safety analysis conducted and maintained by the licensee or applicant of 10 CFR part 70 fuel cycle facilities identifies such hazards and the safety controls (§ 70.62(c)) applied to meet the performance requirements in accordance with § 70.61(b) through (d). Fuel cycle facilities licensed under 10 CFR part 40, “Domestic licensing of source material,” or certified under 10 CFR part 76, “Certification of gaseous diffusion plants,” have licensing basis documents that describe facility specific hazards, consequences, and those controls used to prevent or mitigate the consequences of such accidents. For these facilities, a high-consequence event would be a release that has the potential to cause acute radiological or chemical exposures to a worker or a member of the public similar to that defined in Appendix A to Chapter 3, Section A.2, of NUREG 1520, Revision 2, “Standard Review Plan for Fuel Cycle Facilities License Applications—Final Report,” issued June 2015, under “Consequence Category 3 (High Consequences)” (ADAMS Accession No. ML15176A258). Back to Citation
 16.
    
                             Criteria III.A.2, III.A.3, and III.A.4 also apply to medical licensees. Back to Citation


[FR Doc. 2017-21043 Filed 9-29-17; 8:45 am] BILLING CODE 7590-01-P