NRC INSPECTION MANUAL FCSE

INSPECTION MANUAL CHAPTER 2601

REACTIVE INSPECTION DECISION MAKING PROCESS FOR FUEL FACILITIES
Issue Date: 09/20/16 i 2601

Table of Contents

2601-01 PURPOSE .............................................................................................................. 1

2601-02 BACKGROUND ...................................................................................................... 1

2601-03 RESPONSIBILITIES ............................................................................................... 1

03.01 Region II, Regional Adminstrator (RA).................................................................... 1

03.02 Region II, Division of Fuel Facility Inspection (DFFI) ................................................1

03.03 Programmatic Oversight and Regional Support Branch (PORSB) .......................... 2

03.04 Division of Fuel Cycle Safety, Safeguards, and Environmental Review (FCSE)...... 2

03.05 Office of Nuclear Security and Incident Response, Division of Preparedness and 

Response (DPR)..................................................................................................... 2

2601-04 REQUIREMENTS ................................................................................................... 2

04.01 Initial Event Norification and Follow-up ................................................................... 2

04.02 Deterministic Criteria................................................................................................2

04.03 Consideration of Risk Insights................................................................................. 5

04.04 Event Management Screening................................................................................ 5

04.05 Recommendation to Management .......................................................................... 5

04.06 Communications with Internal and External Stakeholders on Event Response and 

Assessment............................................................................................................ 6

2601-05 REFERENCES........................................................................................................ 6

Enclosure 1 – Decision Documentation for Reactive Inspection (Deterministic and Risk Insights)

Enclosure 2 – Reserved

Attachment 1 – Revision History for IMC 2601
Issue Date: 09/20/16 1 2601

2601-01 PURPOSE

01.01 Provide guidance to the Division of Fuel Cycle Safety, Safeguards, and Environmental 

Review (FCSE) in the Office of Nuclear Material Safety and Safeguards (NMSS) and the 

Division of Fuel Facility Inspection (DFFI) in the Region II Office staff for implementing the 

requirements prescribed in Management Directive (MD) 8.3, “NRC Incident Investigation 

Program.”

01.02 Provide detailed guidance consisting of both deterministic criteria and risk-informed

insights that can be used as a decision basis for implementing Incident Investigation Teams 

(IITs), Augmented Inspection Teams (AITs), and Special Inspection Teams (SITs).

01.03 Provide the availability of various tools to communicate with internal and external 

stakeholders on event response and assessment.

01.04 Provide a sample format to use when documenting reactive inspection decisions.

2601-02 BACKGROUND

MD 8.3 is the Agency-level governing document for this Inspection Manual Chapter (IMC) that

includes deterministic and risk-informed criteria for determining the agency’s appropriate event 

response and delineates organizational responsibilities for event response. A significant 

operational event is any radiological, safeguards, or other safety-related operational event at an 

NRC-licensed facility that poses an actual or potential hazard to public health and safety, 

property, or the environment. In this IMC, a significant operational event may also be referred to 

as “an event.” This manual chapter provides specific roles and responsibilities for the staff 

involved in the reactive inspection decision-making process as well as guidance for developing 

cooperative staff-level relationships among the participating offices. Furthermore, it provides 

guidance on the use of both deterministic and risk insights to assess the significance of an 

event. Inspection Procedure (IP) 88075, “Event Follow-up,” provides inspection guidance for 

evaluating licensee events and communicating event information to management, risk analysts,

and staff in both Region II and headquarters as input to the reactive inspection decision-making 

process. IP 88003, “Reactive Inspections,” provides implementing guidance for AIT and SIT

responses. NUREG-1303 provides guidance for conducting an IIT.

2601-03 RESPONSIBILITIES

03.01 Region II, Regional Administrator (RA)

1. Decide the appropriate level of reactive inspection given the available information and 

the need to make a timely regulatory response to the operational event. 

2. Coordinate with the Office Directors of NMSS and NSIR, as appropriate.

03.02 Region II, Division of Fuel Facility Inspection (DFFI). 

1. Responsible for the initial follow-up of a significant operational event at a fuel facility.
Issue Date: 09/20/16 2 2601

2. Formulate the recommendation to the Regional Administrator (RA) regarding the 

appropriate response in the form of an SIT, AIT, or IIT with support from PORS and 

other FCSE staff as needed. 

3. Provide the basis for a reactive inspection decision in the inspection charter, to include

a description of the specific deterministic criteria and other risk insights, as applicable, 

that served as a basis for deciding on the particular reactive inspection. 

4. Coordinate with staff in NMSS and NSIR as appropriate for technical support and 

assistance in the decision-making process. 

03.03 Programmatic Oversight and Regional Support Branch (PORSB).

1. Identify appropriate technical staff in FCSE to address relevant technical and regulatory 

issues and coordinate their support.

2. Support DFFI in evaluating the risk associated with significant operational events at fuel 

facilities. 

03.04 Division of Fuel Cycle Safety, Safeguards, and Environmental Review (FCSE).

1. Provide technical support and expertise for resolving issues identified during the followup of significant operational events.

2. Coordinate support for DFFI and other FCSE staff during the short-term event response

to ensure that all the appropriate technical and management staff are involved in the 

process.

03.05 Office of Nuclear Security and Incident Response, Division of Preparedness and 

Response (NSIR/DPR).

1. Participate in the reactive inspection decision-making process when headquarters 

involvement is needed to support the reactive inspection effort.

2601-04 REQUIREMENTS

04.01 Initial Event Notification and Follow-up. DFFI receives the initial event notification and 

performs the initial follow-up communications with the licensee and implements the inspection 

guidance in IP 88075, “Event Follow-up”. If the event meets applicable reporting requirements, 

headquarters receives a formal notification via the Operations Center staff. DFFI requests 

technical and logistical support from FCSE, as needed, by contacting PORS staff and the 

Project Manager (PM). The PM is kept informed of the event and coordinates appropriate event 

follow-up activities on behalf of FCSE. 

04.02 Deterministic Criteria. The following list of deterministic criteria is used as the initial 

screening criteria to evaluate the appropriate level of response for a significant event. The IIT 
Issue Date: 09/20/16 3 2601

and AIT deterministic criteria below is a combination of criteria from MD 8.3 and additional 

criteria applicable to fuel cycle facilities.

1. An IIT should be considered for a significant event with one or more of the following 

characteristics:

a. Led to a significant radiological release (levels of radiation or concentrations of 

radioactive material in excess of 10 times any applicable limit in the license or 10 

times the concentrations specified in 10 CFR Part 20, Appendix B, Table 2, 

“Effluent Concentrations,” when averaged over a year) of byproduct, source, or

special nuclear material to unrestricted areas.

b. Involved an inadvertent criticality.

c. Led to a high consequence event as defined by 10 CFR 70.61(b).

d. Led to a significant occupational exposure or significant exposure to a member of 

the public. In both cases, “significant” is defined as five times the applicable 

regulatory limit (except for shallow-dose equivalent to the skin or extremities from 

discrete radioactive particles).

e. Led to a site area emergency.

f. Involved the commercial use of source or special nuclear material and resulted in 

the potential exposure of a significant number of individuals above occupational 

or public dose limits.

g. Involved the deliberate misuse of source or special nuclear material from its 

intended or authorized use, which resulted in the exposure of a significant 

number of individuals.

h. Involved source or special nuclear material, which may have resulted in a fatality.

i. Involved circumstances sufficiently complex, unique, or not well enough 

understood, or involved safeguards concerns, or involved characteristics the 

investigation of which would best serve the needs and interests of the 

Commission.

j. Actual intrusion into the protected area or controlled access area or the 

established first-line physical barrier for controlling personnel access to the 

facility.

k. Involved a willful disclosure of classified information with potential damage to 

national security.

2. An AIT should be considered for a significant event with one or more of the following 

characteristics:

a. Led to a radiological release of source or special nuclear material to unrestricted 

areas that resulted in occupational exposure or exposure to a member of the 

public in excess of the applicable regulatory limit (except for shallow-dose 

equivalent to the skin or extremities from discrete radioactive particles).

b. Led to an intermediate consequence event as defined by 10 CFR 70.61(c).

c. Involved a high consequence event that was not unlikely or a very substantial 

increase in its likelihood.

d. Involved a fire or explosion involving licensed material or hazardous chemicals 

produced from licensed materials.
Issue Date: 09/20/16 4 2601

e. Involved the deliberate misuse of source or special nuclear material from its 

intended or authorized use and had the potential to cause an exposure of greater 

than 5 rem to an individual or 500 mrem to an embryo or fetus.

f. Involved a significant infraction or repeated instances of safeguards infractions 

that demonstrate the ineffectiveness of facility security provisions.

g. Involved repeated instances of inadequate nuclear material control and 

accounting provisions to protect against theft or diversions of nuclear material.

h. Involved the failure of radioactive material packaging that resulted in external 

radiation levels exceeding 10 rads/hr or contamination of the packaging 

exceeding 1000 times the applicable limits specified in 10 CFR 71.87, “Routine 

Determinations.”

i. Involved a loss of classified or safeguards information with potential disclosure to 

unauthorized individuals affecting national security or the common defense and

security.

j. Involved an a failure to control unauthorized disclosure of other classified 

information or safeguards information that results in the removal of material from 

a controlled area and disclosure to an unauthorized individual.

3. An SIT should be considered for a significant event with one or more of the following 

characteristics:

a. Involved safety function(s) that have been lost or significantly degraded such that 

the performance requirements of 70.61(b), (c), or (d) are not being met.

b. Involved repetitive failures or events involving items relied on for safety (IROFS) 

or deficiencies in operations.

c. Involved a high consequence event that was unlikely or a substantial increase in 

its likelihood.

d. Involved an intermediate consequence event that was not unlikely or a significant 

increase in its likelihood.

e. Led to a radiological release of source or special nuclear material or a chemical 

release that had a reasonable potential in exceeding an occupational or public 

radiation regulatory limit.

f. Led to an Alert in accordance with the facility Emergency Plan.

g. Involved a significant instance of inadequate nuclear material control and 

accounting provisions to protect against theft or diversions of nuclear material.

h. Involved a safeguards infraction that significantly weakens the effectiveness of 

the facility security provisions.

i. Involved a major deficiency in design, construction, or operation having potential 

generic safety or safeguards implications.

j. Involved an unanalyzed condition or unexpected system interactions that could 

reasonably lead to a significant safety or safeguards concern.

k. Involved a significant failure to obtain NRC approval to implement a facility 

change or change process in accordance with 10 CFR 70.72.

l. Involved a failure to control safeguards information with substantial potential for 

disclosure to unauthorized individuals.
Issue Date: 09/20/16 5 2601

04.03 Consideration of Risk Insights. Fuel facility events meeting one or more of the 

deterministic criteria associated with the safety operations performance area are further 

evaluated based on additional risk insights, as applicable. DFFI staff, with the support of staff in 

FCSE, will promptly consider risk insights associated with the event based on the best available 

information (e.g., the facility ISA, realistic assumptions regarding IROFS, other safety controls, 

operator actions, etc.) Given the relatively short time frame to decide whether or not to initiate a 

reactive inspection, some event information will most likely be missing or incomplete, which can 

inevitably add an appreciable level of uncertainty to be addressed in the decision-making 

process. This lack of complete event information focuses attention on the uncertainty of 

influential assumptions and their effect on the risk significance. Overall, the consideration of risk 

insights should be as realistic as possible given all of the information available at the time while 

balancing the need to make a timely decision. Inspection Procedure 88075, “Event Follow-up,”

discusses inspector inputs to can support the consideration of risk insights. 

04.04 Event Management Screening. An event is additionally evaluated on how well it is 

understood by the NRC and how it is being managed by the fuel facility. The staff shall 

determine if the event is terminated and if the applicable facility processes and/or systems are in 

a safe condition. The staff shall assess if the licensee is exercising conservative operational 

decision making, has implemented effective immediate corrective actions, is conducting an 

appropriately scaled event investigation, and evaluating the extent of condition and generic 

implications. Based upon the results of this evaluation the option exists to reduce the level of 

inspection.

04.05 Recommendation to Management. Based on the initial event notification and follow-up, 

the deterministic criteria screening, the consideration of risk insights (for the safety operations 

performance area), and the event management screening, the staff will propose a reactive 

inspection recommendation to the DFFI Division Director using Enclosure 1 as a guide. The 

recommendation should be considered a risk-informed and integrated assessment that 

incorporates all of the relevant information into a recommendation to support a management 

decision. 

If the initial review of the event significance, based on the information from sections 04.02, 

04.03, and 04.04, suggests at most the consideration of a SIT, the RA will make the decision 

whether or not to initiate the SIT. In this case, regional management may consult with NRR and 

NSIR, but is not required to do so.

If the initial review of the event significance, based on the information from sections 04.02, 

04.03, and 04.04, suggests more resources and effort beyond a SIT, regional management 

should promptly coordinate with FCSE and NSIR/DPR to discuss whether a SIT or AIT is more 

appropriate. In such cases, the RA, in consultation with the NMSS Office Director, makes the 

final decision on whether to proceed with an AIT or SIT.

For events that may warrant an IIT, the Directors of NMSS and NSIR will consult with the RA 

and provide a recommendation to the EDO. In such cases, the EDO, in consultation with the 

RA, will make the ultimate decision on whether to proceed with an IIT.
Issue Date: 09/20/16 6 2601

04.06 Communications with Internal and External Stakeholders on Event Response and 

Assessment. For significant operational events, the staff should be cognizant of the 

communication tools that are available to enhance the effectiveness and efficiency of the 

agency’s communications with its stakeholders. The NRC has developed the Event Response 

and Assessment Communications Plan. The plan is available in the ADAMS Main Library 

internal folder entitled “Communication Plans,” and should be consulted following a significant 

operational event or discovery of a significant degraded plant condition.

The communication tools available for event response and assessment include:

 a communications team

 central tracking of controlled correspondence

 a notification sequence for significant regulatory documents

 formalized questions and answers (Q&A) for common and expected significant 

events for use by the Office of Public Affairs (OPA) during initial event response

 a dedicated Web page for each event

If it is determined that a communications team is warranted, the FCSE PM typically plays the 

key headquarters role in developing and coordinating the communications team and 

subsequent communications activities. Specific communication activity assignments are 

determined by the communications team. Communication activities typically continue beyond 

the initial phase of investigative response until their goals have been accomplished.

Reactive inspections may generate high public interest. The RA in consultation with the OPA 

may elect to open a reactive inspection exit meeting to the public. Alternately, the RA may 

decide it is more appropriate to have a separate public meeting and/or press conference in lieu 

of a public meeting with the licensee.

2601-05 REFERENCES

1. Management Directive 8.2, “NRC Incident Response Program”

2. Management Directive 8.3, “NRC Incident Investigation Program”

3. NUREG 1303, “Incident Investigation Manual”

4. Inspection Procedure 88075, “Event Follow-up”

5. Inspection Procedure 88003, “Reactive Inspections”

6. Inspection Manual Chapter 2606,”Risk for Potential Non-compliances”

7. Event Response and Assessment Communications Plan, dated 10/3/2000 

(ML003774969)

END

Enclosures:

1. Decision Documentation for Reactive Inspection (Deterministic and Risk Criteria 

Analyzed)

2. Reserved
Issue Date: 09/20/16 E1-1 2601

Enclosure 1 – Decision Documentation for Reactive Inspection

(Deterministic and Risk Criteria Analyzed)

Decision Documentation for Reactive Inspection

(Deterministic and Risk Insights)

FACILITY: EVENT DATE: EVALUATION DATE:

Brief Description of the Significant Operational Event:

Type DETERMINISTIC CRITERIA

List the screening criteria that were met

Remarks:

List the screening criteria that were met

Remarks:

List the screening criteria that were met

Remarks:

List the screening criteria that were met

Remarks:

List screening criteria that were met

Remarks:
Issue Date: 09/20/16 E1-2 2601

RISK INSIGHTS

Brief description of the additional Risk Insights to consider (may include influential 

assumptions, uncertainties, calculations, complexities, areas with lack of information, 

references, and any risk insights provided by the licensee):

RESPONSE DECISION

USING THE ABOVE INFORMATION AND OTHER KEY ELEMENTS OF CONSIDERATION 

AS APPROPRIATE, DOCUMENT THE RESPONSE DECISION TO THE EVENT AND THE 

BASIS FOR THAT DECISION.

DECISION AND DETAILS OF THE BASIS FOR THE DECISION:

BRANCH CHIEF REVIEW: DATE:

DIVISION DIRECTOR REVIEW: DATE:

ADAMS ACCESSION NUMBER:

EVENT NOTIFICATION REPORT NUMBER (as applicable):

Note: The above tables are provided as examples only. The regions have discretion to 

modify these tables in their implementing procedures or office instructions.
Issue Date: 09/20/16 E2-1 2601

Enclosure 2 – Reserved
Issue Date: 09/20/16 Att1-1 2601

Attachment 1 – Revision History for IMC 2601

Commitment 

Tracking 

Number

Accession 

Number

Issue Date

Change Notice

Description of Change Description of 

Training Required 

and Completion Date

Comment and 

Feedback Resolution 

Accession Number

(Pre-Decisional, NonPublic Information)

N/A ML16160A407

09/20/16

CN 16-023

Initial Issue. Provides guidance for 

implementing Management Directive 8.3, 

"NRC Incident Investigation Program," at 

fuel cycle facilities and describes the 

reactive inspection decision-making 

process. 

None ML16232A188