June 30, 2015 

MEMORANDUM TO: Mark A. Satorius 

 Executive Director for Operations 

FROM: Rochelle C. Bavol, Acting Secretary /RA/ 

SUBJECT: STAFF REQUIREMENTS – SECY-15-0040 – PROPOSED 

REVISIONS TO POLICY STATEMENT ON REPORTING 

ABNORMAL OCCURRENCES CRITERIA 

The Commission has approved the staff's recommendation to publish for public comment in the 

Federal Register a proposed revision to the Commission's Policy Statement for reporting 

Abnormal Occurrences to Congress, subject to the enclosed edits. 

In the Federal Register Notice the staff should specifically seek public comment on screening all 

reports for exposures to embryo/fetus or nursing child as an Abnormal Occurrence under l.A-2., 

unintended radiation exposure, versus screening reports required by 10 CFR 35.3047 for 

exposures to embryo/fetus or nursing child resulting from treatment to a patient as an Abnormal 

Occurrence under III.C, Medical Use criteria. 

The staff should consider revising the structure of the annual report to more readily distinguish 

those medical abnormal occurrences with expected health consequences from those that do not 

have such consequences. 

Enclosure: 

Revised Federal Register Notice 

cc: Chairman Burns 

 Commissioner Svinicki 

 Commissioner Ostendorff 

 Commissioner Baran 

 OGC 

 CFO 

 OCA 

 OPA 

 Office Directors, Regions, ACRS, ASLBP (via E-Mail) 

 PDR 
DRAFT

[7590-01-P] 

NUCLEAR REGULATORY COMMISION 

[NRC-20142015-0XXX] 

Abnormal Occurrence Reports 

AGENCY: Nuclear Regulatory Commission. 

ACTION: Proposed revision to policy statement; request for comments. 

 

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing revisions to its 

policy statement on reporting abnormal occurrences (AO) to Congress. The proposed revisions 

would amend and restructure the criteria used by the NRC and Agreement States for 

determining whether to consider an incident or event as an AO. The proposed amendments to 

the policy statement would ensure consistency with current NRC guidance and regulations. The 

NRC is requesting public comments on this policy statement at this time. 

DATES: Submit comments by [INSERT DATE 90 DAYS FROM DATE OF PUBLICATION IN 

THE FEDERAL REGISTER]. Comments received after this date will be considered if it is 

practical to do so, but the Commission is able to assure consideration only for comments 

received on or before this date. 

ADDRESSES: You may submit comments by any of the following methods: 

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for 

Docket ID <INSERT: NRC-20YY-XXXX>. Address questions about NRC dockets to Carol 

Gallagher; telephone: 301-287-3422; e-mail: Carol.Gallagher@nrc.gov. For technical 
2 

questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT 

section of this document. 

• Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: 

3WFN-06-A44M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 

 For additional direction on obtaining information and submitting comments, see 

“Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION 

section of this document. 

FOR FURTHER INFORMATION CONTACT: Katie Tapp, Office of Nuclear Regulatory 

Research, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 

301-251-7520; e-mail: Katherine.Tapp@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments. 

A. Obtaining Information. 

Please refer to Docket ID <INSERT: NRC-20YY-XXXX> when contacting the NRC 

about the availability of information for this action. You may obtain publicly-available information 

related to this action by any of the following methods: 

• Federal rulemaking Web Site: Go to http://www.regulations.gov and search for 

Docket ID <INSERT: NRC-20YY-XXXX>. 

• 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, 
3 

please contact the NRC’s Public Document Room (PDR) reference staff at 1-800-397-4209, 

301-415-4737, or by e-mail to pdr.resource@nrc.gov. 

• 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. 

B. Submitting Comments. 

Please include Docket ID <INSERT: NRC-20YY-XXXX> in the subject line of your 

comment submission. 

The NRC cautions you not to include identifying or contact information that you do not 

want to be publicly disclosed in your comment submission. The NRC will post all comment 

submissions at http://www.regulations.gov as well as enter the comment submissions into 

ADAMS. The NRC does not routinely edit comment submissions to remove identifying or 

contact information. 

If you are requesting or aggregating comments from other persons for submission to the 

NRC, then you should inform those persons not to include identifying or contact information that 

they do not want to be publicly disclosed in their comment submission. Your request should 

state that the NRC does not routinely edit comment submissions to remove such information 

before making the comment submissions available to the public or entering the comment into 

ADAMS. 

II. Background. 

Section 208 of the Energy Reorganization Act of 1974, as amended (Public Law 93-438) 

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 (Public Law 104-66) requires that AOs be reported to Congress annually. As required 
4 

by Section 208, the discussion for each 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 of 1974, as amended. 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 and safety. The policy reflects a range of health 

and safety concerns and applies to incidents and events involving a single individual, as well as 

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 

and safety are reported to Congress. 

Licensee Reports

This general policy statement will not change the reporting requirements for NRC 

licensees in Commission regulations, license conditions, or technical specifications (TS). NRC 

licensees will continue to submit required reports on a wide range of events, including 

instrument malfunctions and deviations from normal operating procedures that are not 

significant from the standpoint of the public health and safety but provide data useful to the 

Commission in monitoring operating trends of licensed facilities and in comparing the actual 

performance of these facilities with their design and/or licensing basis. 

Applicability 
5 

 Implementation of Section 208 of the Energy Reorganization Act of 1974, as amended, 

“Abnormal Occurrence Reports,” 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 conduct 

of an activity subject to the requirements of parts 20, 30 through 37, 39, 40, 50, 61, 70, 71, 72 or 

76 of Chapter I, Title 10, Code of Federal Regulations (10 CFR). 

 Agreement States provide information to the NRC on incidents and events involving 

applicable nuclear materials in their 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 (AEA) (Public Law 83 703), to regulate certain quantities of AEA material at facilities 

located within their borders. Events reported by Agreements States that reach the threshold for 

reporting as AOs are also published in the ‘‘Report to Congress on Abnormal Occurrences.’’ 

Proposed Revisions 

The NRC is proposing revisions to the AO criteria to clarify reporting the criteria 

regarding which for determining events that are significant from the standpoint of public health 

and safety and should therefore be considered AOs. In addition, tThe proposed revisions is

would also make the criteria consistent with the NRC’s “Strategic Plan for Fiscal Year (FY) 

2014–2018” (NUREG-1614, Volume 6, issued August 2014) and new NRC requirements in 10 

CFR Part 37, “Physical protection of category 1 and category 2 quantities of radioactive 

material.” Additionally, extensive revision to the criterion for reporting medical events as AOs is 

being proposed. Further, the NRC proposes to amend the AO criteria to separate “Other 

Events of Interest” from the AO criteria to clearly delineate that events considered “Other Events 

of Interest” are not AOs, but do represent significant events that the Commission deems 
6 

appropriate to report to Congress. Finally, restructuring and minor editorial changes are 

proposed to some sections for clarity. 

 The NRC is requesting public comments on this policy statement at this time. 

Licensee Reports 

 The proposed changes to the general policy statement would not change the reporting 

requirements for NRC licensees in Commission regulations, license conditions, or technical 

specifications. 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 the public health and safety but provide data useful 

to the Commission in monitoring operating trends of licensed facilities and in comparing the 

actual performance of these facilities with their design and/or licensing basis. 

III. Paperwork Reduction Act. 

 This policy statement does not contain information collection requirements that are 

subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 

Public Protection Notification 

 The NRC may not conduct or sponsor, and a person is not required to respond to, a 

request for information or an information collection requirement unless the requesting 

documents displays a currently valid Office of Management and Budget control number. 
7 

IV. Abnormal Occurrence 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 AO1. 

 An incident or event will be is considered an AO if it involves a major reduction in the 

protection of public health or safety. The incident or event would have 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, 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 

{double space}

licensed by or otherwise regulated by the Commission or Agreement States. 

 The criteria for determining whether to consider an incident or event for reporting as an 

AO are set forth in Appendix A of this policy statement. 

Commission Dissemination of Abnormal Occurrence Information 

 The Commission widely disseminates the AO reports to the public. The Commission will 

submit an annual report to Congress on AOs that occur at or are associated with any facility or 

activity that is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as 

 

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. 
8 

amended, or the Energy Reorganization Act of 1974, as amended. This report gives the date, 

place, nature, and probable consequences of each AO,; the cause or causes of each AO,; and 

any action taken to prevent recurrence. 

Appendix A: Abnormal Occurrence Criteria 

 An accident or event will be 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 would have 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, 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. 

 
9 

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 Licensees2

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 adult (any individual 18 years of age or older) resulting in an annual total 

effective dose equivalent (TEDE) of 250 millisievert (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 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

 Medical patients are excluded from consideration under this criterion. T and these criteria do not apply to medical events defined 

in 10 CFR 35.3045, which are considered in AO Criteria III.C. “Events involving the Medical Use of Radioactive Materials in Patients 

or Human Research Subjects.” 
10 

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 physician3

 deemed 

qualified by the NRC or Agreement State. 

 4. These criteria do not apply to medical events defined in 10 CFR 35.3045 and 

included in AO Criteria III.C. “Events Involving the Medical Use of Radioactive Materials in 

Patients or Human Research Subjects.” 

 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, exceeds 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 Title 10 of the Code of Federal Regulations (10 CFR) part 20, “Standards for 

protection against radiation,” unless the licensee has demonstrated compliance with 

10 CFR 20.1301, “Dose limits for individual members of the public,” using 10 CFR 20.1302(b)(1) 

or 10 CFR 20.1302(b)(2)(ii). This criterion does not apply to transportation events. 

C. Theft, Diversion, or Loss of Licensed Material; Sabotage; or Security Breach4,5,6

 

3 Independent physician is defined to be a physician not on the licensee’s staff and who was not involved in the care of the patient 

involved.

4

 Information pertaining to certain incidents may be either classified or under consideration for classification because of national 

security implications. Classified information will be withheld when formally reporting these incidents in accordance with Section 208 
11 

 1. Any stolen, diverted, abandoned, or unrecovered lost radioactive material that meets 

or exceeds the thresholds listed in Appendix A of 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 10 CFR 39.2, 

“Definitions.” These sources are only excluded if there is reasonable assurance that the doses 

from these sources do 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 10 CFR 73.2, “Definitions.” 

 3. Any substantiated7

 case of actual theft, diversion, or loss of a formula quantity of 

special nuclear material8

 or an inventory discrepancy of a formula quantity of special nuclear 

material7

 that is judged to be caused by theft or diversion. 

 4. Any substantial breakdown9

 of physical security, cyber security, or material control 

and accountability programs that significantly weakens the protection against loss, theft, 

diversion, or sabotage. 

 of the Energy Reorganization Act of 1974, as amended E.O. 13526, as amended, or any predecessor or successor order to require 

protection against unauthorized disclosures. Any classified details about these incidents would be available to the Congress, upon 

request, under appropriate security arrangements. 

5

 Because of increased terrorist activities worldwide, Information pertaining to certain incidents may be Safeguards Information as 

defined in 10 CFR 73.2 because of safety and security implications. tThe AO report would withhold specific safeguards information 

in accordance with Section 147 of the Atomic Energy Act of 1954, as amended. Safeguards information is defined in 10 CFR 73.2. 

Any safeguards details regarding these incidents would be available to the 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 to below the thresholds listed in 

Appendix A of 10 CFR Part 37, the report will clarify that the radioactive material has decayed below the thresholds. 

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. 

8 Formula quantity of special nuclear material is defined in 10 CFR 70.4, “Definitions.”

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.
12 

 5. Any significant unauthorized disclosures (loss, theft, and/or deliberate) of classified 

information that harms national security or safeguards information that threatens public health 

and 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 license technical specification (TS) (10 CFR 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, which could result in exceeding the dose limits of 10 CFR Part 100, 

“Reactor Site Criteria,” or 5 times the dose limits of General Design Criteria (GDC) 19 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 loss of plant capability to 

perform essential safety functions so that a release of radioactive materials, which could result 

 

10 This item addresses initiation of any incident investigation teams, as described in NRC Management Directive (MD) 8.3, “NRC 

Incident Investigation Program,” or initiation of any accident review groups, as described in MD 8.9, “Accident Investigation.”
13 

in exceeding the dose limits of 10 CFR Part 100 or 5 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 Reactor Oversight 

Process (ROP) to be the result of or associated with licensee performance issues of high safety 

significance of licensee performance.

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 1x10-3.

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, or Operation, Transport, 

Use, or Disposal of Licensed Facilities or Regulated Materials 

 

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,” 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.

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 1x10-3 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. 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” or under the NRC IMC 0305, “Oversight of Reactor Facilities in a 

Shutdown Condition Due to Significant Performance and/or Operational Concerns.” This assessment of safety performance is 

based on the number and significance of NRC inspection findings and licensee performance indicators.
14 

 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 Facilities14

 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 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 Subjects16

 1. A medical event, as defined in 10 CFR 35.3045, which and 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 or greater than 2.5 Gy (250 rad) to the gonads; 

or 

 

14 Criterion III.A also applies to Fuel Cycle Facilities. 

15 High-consequence events for facilities licensed under 10 CFR Part 70 are those that could seriously harm the worker or a 

member of the public in accordance with 10 CFR 70.61. The integrated safety analysis (ISA) conducted and maintained by the 

licensee or applicant of 10 CFR Part 70 fuel cycle facilities identifies such hazards and the safety controls (10 CFR 70.62(c)) applied 

to meet the performance requirements in accordance with 10 CFR 70.61 (b) to (d). Safety controls may include items relied on for 

safety designated in accordance with 10 CFR 70.61 (e) as well as other controls available to prevent or mitigate the consequences 

of an event. High-consequence events should be considered as those that could seriously harm the worker or a member of the 

public in accordance with 10 CFR 70.61. Fuel cycle facilities licensed under 10 CFR Part 40 or certified under 10 CFR Part 40 or

under 10 CFR Part 76 have licensing basis documents which that describe facility specific hazards, consequences, and those 

controls utilized to prevent or mitigate the consequences of such accidents. For these facilities, an AO 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 a high-consequence event, as that defined in NUREG-1520, Revision 1, Appendix A to Chapter 3, Section A.2, under 

“Consequence Category 3 (High Consequences).”

16 Criteria III.A.2, III.A.3, and III.A.4 also apply to medical licensees.
15 

(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 10 CFR 35.3045, which involves Represents either:

(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.; and 

3. Results in one or more of the following, as determined by an independent 

physician(s)2 deemed qualified by NRC or an Agreement State:

(a) unintended or unexpected permanent functional damage to an organ or 

physiological system; 

(b) a significant unexpected adverse health effect; or 

(c) death. 

Appendix B: Other Events of Interest

 This appendix discusses other events of interest that do not meet the AO criteria in 

Appendix A. 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 
16 

health and safety significance, have received significant media coverage, or have caused the 

NRC 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. 

Dated at Rockville, Maryland, this day of 2015 

 For the Nuclear Regulatory Commission 

 Annette Vietti-Cook, 

 Secretary of the Commission.