**NRC INSPECTION MANUAL**NSIR

INSPECTION MANUAL CHAPTER 0609, APPENDIX B

EMERGENCY PREPAREDNESS

SIGNIFICANCE DETERMINATION PROCESS

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0609, App. B	B-16	Issue Date: 

Issue Date:   00/00/12  DRAFT	3	0609, App. B

1.0	INTRODUCTION	12.0	DEFINITIONS, ABBREVIATIONS, AND ACRONYMS	13.0	ENTRY CONDITIONS AND GENERAL INSTRUCTIONS	53.1	Entry Conditions	53.2	General Instructions	54.0	ACTUAL EVENT IMPLEMENTATION ISSUE (FAILURE TO IMPLEMENT)	64.1	Background	64.2	Criteria	64.3	Significance Determination	85.0	FAILURE TO COMPLY	95.0.1	Background	95.0.2	Criteria	105.0.3	Significance Determination	135.1	10 CFR 50.47(b)(1), Emergency Response Responsibility	145.2	10 CFR 50.47(b)(2), Onsite Emergency Organization	155.3	10 CFR 50.47(b)(3), Emergency Response Support and Resources	185.4	10 CFR 50.47(b)(4), Emergency Classification System	205.5	10 CFR 50.47(b)(5), Emergency Notifications	265.6	10 CFR 50.47(b)(6), Emergency Communications	305.7	10 CFR 50.47(b)(7), Emergency Public Information	325.8	10 CFR 50.47(b)(8), Emergency Facilities and Equipment	355.9	10 CFR 50.47(b)(9), Emergency Assessment Capability	385.10	10 CFR 50.47(b)(10), Emergency Protective Actions	405.11	10 CFR 50.47(b)(11), Emergency Radiological Exposure Control	455.12	10 CFR 50.47(b)(12), Emergency Medical Support	465.13	10 CFR 50.47(b)(13), Recovery and Reentry Planning	475.14	10 CFR 50.47(b)(14), Drill and Exercise Program	485.15	10 CFR 50.47(b)(15), Emergency Responder Training	545.16	10 CFR 50.47(b)(16), Emergency Plan Maintenance	556.0	GUIDANCE ON CORRECTIVE ACTIONS	566.1	Timeliness Guidelines	566.2	Considerations	566.3	Effectiveness of Corrective Actions	57

FIGURES

Figure 5.4-1	Significance Determination for Ineffective EALs and Overclassification25

Figure 5.14-1	Significance Determination for Critique Findings53

Figure 5.14-2	Significance Determination for Failure to Cireect a Weakness53

TABLES

Table 5.1-1   -- Significance Examples §50.47(b)(1)	15

Table 5.2-1   -- Significance Examples §50.47(b)(2)	17

Table 5.3-1   -- Significance Examples §50.47(b)(3)	19

Table 5.4-1   -- Significance Examples §50.47(b)(4)	23

Table 5.5-1   -- Significance Examples §50.47(b)(5)	28

Table 5.6-1   -- Significance Examples §50.47(b)(6)	31

Table 5.7-1   -- Significance Examples §50.47(b)(7)	33

Issue Date:   09/22/15	i	0609, Appendix B

Table 5.8-1   -- Significance Examples §50.47(b)(8)	36

Table 5.9-1   -- Significance Examples §50.47(b)(9)	39

Table 5.10-1 -- Significance Examples §50.47(b)(10)	42

Table 5.11-1 -- Significance Examples §50.47(b)(11)	45

Table 5.12-1 -- Significance Examples §50.47(b)(12)	46

Table 5.13-1 -- Significance Examples §50.47(b)(13)	47

Table 5.14-1 -- Significance Examples §50.47(b)(14)	51

Table 5.15-1 -- Significance Examples §50.47(b)(15)	54

Table 5.16-1 -- Significance Examples §50.47(b)(16)	55

ATTACHMENTS

Attachment 1 Failure to Implement (Actual Event) Significance Logic	Att1-1

Attachment 2 Failure to Comply Significance Logic	Att2-1

Attachment 3 Revision History for IMC 0609 Appednix B	Att3-1

# 1.0	INTRODUCTION	

The U.S. Nuclear Regulatory Commission’s (NRC’s) Emergency Preparedness Significance Determination Process (EP SDP) described in this appendix utilizes riskinformed qualitative analyses to estimate the risk significance of inspection findings related to licensee performance in meeting EP Cornerstone objectives and performance expectations.  Attachment 3, “Significance Determination Process Basis Document,” to Appendix B, “Technical Basis for Emergency Preparedness Significance Determination Process,” to Inspection Manual Chapter 0308, “Reactor Oversight Process (ROP) Basis Document,” provides the technical basis for the EP SDP.

# 2.0	DEFINITIONS, ABBREVIATIONS, AND ACRONYMS	[footnoteRef:1] [1:  	In this document, acronyms may be plural or singular and are to be read in the context of the statement in which they appear.] 

The following terms, which are capitalized throughout the remainder of this appendix, are defined for the purpose of the EP SDP only.  The individual section in which each term is primarily used provides additional clarification and guidance.  The terms are ordered such that each definition builds on the preceding definitions. 

a.	EMERGENCY PLAN (E–plan):  The document, or documents, that the licensee prepares and maintains that identifies and describes its methods for maintaining emergency preparedness (EP) and responding to emergencies.

b.	EMERGENCY RESPONSE ORGANIZATION (ERO):  The licensee’s organization identified in the E–plan for responding to emergencies at the licensee’s facility.  The ERO includes the on shift staff and the augmentation staff in the designated licensee emergency response facilities.

c.	PLANNING STANDARD[footnoteRef:2] (PS):  One of the 16 EP planning standards established in Title 10 of the Code of Federal Regulations (10 CFR) 50.47(b) that the E–plan must meet and which are supported by the corresponding sections of Appendix E, “Emergency Planning and Preparedness for Production and Utilization Facilities,” to 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities.” [2:  	As used in this appendix, “PLANNING STANDARD” includes RISK-SIGNIFICANT PLANNING STANDARDs, but “RISK-SIGNIFICANT PLANNING STANDARD” excludes non risk-significant PLANNING STANDARDs.] 

d.	EP REQUIREMENT:  Any requirement within the purview of the EP Cornerstone, including the PS, Appendix E to 10 CFR Part 50, 10 CFR 50.54(q), 10 CFR 50.54(t), the E–plan, Commission orders, other commitments, and licensee self-imposed requirements necessary for demonstrating compliance with the PS and Appendix E to 10 CFR Part 50, and commitments made under 10 CFR 50.47(c) and 

	10 CFR 50.54(s)(2)(ii).

Issue Date:  09/22/15	16	0609, Appendix B 

e.	RISK-SIGNIFICANT PLANNING STANDARD (RSPS):  A subset of the PS, which includes the following four PS:  10 CFR 50.47(b)(4) — emergency classification system, (b)(5) — emergency notifications, (b)(9) — emergency assessment capability, 	or (b)(10) — emergency protective actions, and supported by the corresponding sections of Appendix E to 10 CFR Part 50.  (Note that parts of 10 CFR 50.47(b)(10) are treated as not risk significant.  See Section 5.10 of this appendix for more information.)

f.	PLANNING STANDARD FUNCTION (PSF):  One or more functions that are considered essential to complying with a RSPS or PS.  PSF are identified for assessing the significance of a finding that involves noncompliance with a RSPS or PS.

g.	PROGRAM ELEMENTS (PE):  Items that comprise the implementation aspects of a PSF.  Such items correspond to the evaluation criteria (e.g., contained in            NUREG-0654/FEMA-REP-1, “Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants,” or the licensee’s E–plan) that provides specific acceptable methods for complying with a PS.  Note that the failure of a single PE does not always mean that a PSF cannot be accomplished.

h.	FAILURE TO COMPLY (FTC):  A finding that an EP program is noncompliant with a EP REQUIREMENT.  An FTC is associated with preparedness issues, whereas an FTI is associated with response issues.  Attachment 2 illustrates the significance determination logic for an FTC.

i	FAILURE TO IMPLEMENT (FTI):  A finding of an FTC during an actual radiological event that precluded effective implementation of a PE.  In this case, the PE complies with the PS, and the PSF would have been accomplished had it been implemented by the ERO.  An FTI is associated with response issues, whereas an FTC is associated with preparedness issues.  Attachment 1 depicts the significance determination logic for an FTI. 

j.	LOSS OF RSPS [PS] FUNCTION:  An FTC finding that one or more PE is not adequate, not compliant with the RSPS [PS], or otherwise not functional to such an extent that the RSPS [PS] FUNCTION would not be accomplished if an actual radiological emergency were to occur.  One or more of the following reasons may apply:

Certain E–plan commitments are not met.

The E–plan is less than adequate.

Implementing procedures are not effective.

ERO personnel are not capable of implementing the PE.

The EP program design is not fully adequate.

	Although licensees must comply with all EP REQUIREMENTS, a LOSS OF RSPS [PS] FUNCTION will likely have greater significance than a noncompliance with other EP REQUIREMENTS (e.g., 10 CFR 50.54(t)).

k.	DEGRADATION OF RSPS [PS] FUNCTION:  An FTC finding that one or more PE is not adequate or not compliant with the RSPS [PS], but reasonable assurance exists that the RSPS [PS] FUNCTION, although degraded, would be accomplished if an actual radiological emergency were to occur.  One or more of the following reasons may apply:  Certain E–plan commitments are not met.

The E–plan is less than adequate.

Implementing procedures are not effective.

The EP program design is not fully adequate.

	However, diverse or redundant PE, or other circumstances, would allow for the RSPS [PS] FUNCTION to still be accomplished, albeit in a degraded manner, if an actual radiological emergency had occurred.  

l.	WEAKNESS:  A level of ERO performance demonstrated during an exercise, drill, or training that provides performance opportunities to develop, maintain, or demonstrate key skills that would preclude effective implementation of the E–plan if it were to occur during an actual radiological emergency.

		1.	A WEAKNESS identified by the licensee in its CRITIQUE is not a performance deficiency (PD) and is, therefore, neither an FTC nor an FTI.

		2.	A deficient PE uncovered by the exercise and identified by the licensee in its CRITIQUE is a licensee-identified PD and is evaluated as an FTC.  If identified by the inspector, the deficient PE is an NRC-identified PD and is evaluated as an FTC. 

		3.	A licensee’s failure to identify a WEAKNESS in a CRITIQUE, or failure to take timely corrective actions, is a PD and is evaluated as an FTC with PS      

		10 CFR 50.47(b)(14).

m.	CRITIQUE:  A formal or documented licensee assessment of the ERO performance following an exercise, drill, or training that provides performance opportunities to develop, maintain, or demonstrate key skills.  In a CRITIQUE, which may occur in various venues and formats, WEAKNESSES are identified and subsequently entered into a corrective action system.

n.	FULL-SCALE DRILL OR EXERCISE:  An event that tests the integrated capability of the ERO to accomplish a major portion of the PSF(s).  A FULLSCALE DRILL OR EXERCISE is not limited to the evaluated biennial exercise, but does involve the following:

		1.	participation or simulation of multiple emergency response facilities (ERFs),

		2.	assessment by a team of evaluators, and,

		3.	a subset of a “full participation exercise,” as defined in Appendix E to 10 CFR Part 50.

o.	OFFSITE RESPONSE ORGANIZATIONS (OROs):  Those entities having responsibility for managing the implementation of measures to protect public health and safety within the plume exposure pathway, ingestion pathway, and emergency planning zones (EPZs) in the event of an emergency.  This would typically include State, county, municipal, or Tribal emergency management agencies, as applicable.  

p.	TIME OF DISCOVERY:  The point in time when the licensee “knew or should have known” of a condition.  See Section 5.0.2.f of this appendix for further discussion.

q.	MITIGATING FACTORS:  Considerations that an inspector may evaluate in determining whether or not a noncompliant PE is a LOST RSPS [PS] FUNCTION or a DEGRADED RSPS [PS] FUNCTION.  Such factors might include the existence of a redundant emergency action level (EAL), backup capabilities identified in the E–plan, or other capabilities that allow the inspector to conclude that the PSF could be completed despite the inadequate PE.  Generally, these factors must have been in place before the TIME OF DISCOVERY.  These factors are credited only in determining the significance of the noncompliance.  See Section5.0.2.b of this appendix for further clarification.

r.	COMPENSATORY MEASURES:  An interim action taken by a licensee after discovery of a noncompliant PE to compensate for an inadequate PE such that there is a reasonable expectation that the associated PSF would be accomplished, albeit in a degraded manner, should an actual radiological emergency occur before the completion of corrective actions to restore compliance.  COMPENSATORY MEASURES, which must be viable, are credited only in determining the significance of the noncompliance.  See Section5.0.2.h of this appendix for further clarification.

In addition to the abbreviations and acronyms identified above, this appendix uses the following acronyms and abbreviations:

ANS—alert and notification system

DEP PI—drill and exercise performance (DEP) performance indicator

EAL—emergency action level

EOF—emergency operations facility

EP—emergency preparedness/emergency planning

EP SDP—emergency preparedness significance determination process

EPIP—emergency plan implementing procedure

EPZ—emergency planning zone

ERF—emergency response facility

FEMA—Federal Emergency Management Agency

IC—initiating condition

JIC—joint information center

KI—potassium iodide

OSC—onsite/operations support center

PAR—protective action recommendation

PD—performance deficiency (See IMC0612 for definition)

ROP—reactor oversight process

SDP—significance determination process

TSC—technical support center

3.0	ENTRY CONDITIONS AND GENERAL INSTRUCTIONS	

## 3.1	Entry Conditions	

a.	An NRC inspector enters this EP SDP for findings related to EP REQUIREMENTS as directed by Appendix B, “Issue Screening,” of Inspection Manual Chapter 0612, “Power Reactor Inspection Reports.”  In performing this screening, the inspector should consider the guidance in Appendix G, “Emergency Planning Cornerstone-Specific Supplemental Guidance for Appendix B Screening Figures 1 and 2,” of IMC 0612.  The EP SDP is not used to assess the significance of a finding under the EP Cornerstone that is caused by a finding under a different cornerstone[footnoteRef:3] if the following is true: [3:  	This situation typically occurs when the E–plan relies upon equipment under the control of another cornerstone (e.g., an effluent radiation monitor used in the EAL scheme).] 

· the licensee’s performance would have been compliant if the finding in the other cornerstone had not occurred, and,

· if a finding is being issued under the other cornerstone, and the deficiency will be corrected.  

If either condition is not met, then the EP SDP is to be used to ensure that corrective action will be taken.  

## 3.2	General Instructions	

a.	Any finding related to an EP REQUIREMENT will be assessed for significance in accordance with this appendix, including findings associated with violations being treated under traditional enforcement (TE), if any.

b.	If the findings are related to EP REQUIREMENTS that are not associated with a PS (i.e., 10 CFR 50.54(t) and requirements in Appendix E to 10 CFR Part 50 that do not support a PS[footnoteRef:4]), then assign Green significance, and return to IMC 0612.  [4:   	Sections 5.1 through 5.16 of this SDP, where applicable, identify the requirements of Appendix E to 10 CFR Part 50 that support the PS of 10 CFR 50.47(b).] 

c.	Identify the PSF(s) affected by the finding and assess the significance of each finding.  

		1.	A finding may affect two or more PSF and each should be assessed for significance.

		2.	Include all associated issues in the inspection report to provide a complete record.  This can be particularly important when additional information from the licensee causes the staff to reconsider a preliminary finding. 

d.	Assess the significance of each issue of concern associated with a finding (e.g., multiple contributing issues).  

		1.	If the finding involved an actual radiological emergency (i.e., FTI), go to Section4.3 of this appendix to assess the significance of the finding.

		2.	If the finding was identified during a baseline or a program inspection, or identified by the licensee (i.e., FTC), go to Section 5.0.3 of this appendix to assess the significance of the finding.

# 4.0	ACTUAL EVENT IMPLEMENTATION ISSUE (FAILURE TO IMPLEMENT	)

## 4.1	Background	

This branch of the EP SDP is used to assess the significance of a finding that occurs during an actual radiological emergency (i.e., an FTI).  An FTI signifies that a licensee has failed to follow its E–plan, which is a noncompliance with 10 CFR 50.54(q)(2).  An FTI is associated with an emergency response issue, rather than an emergency preparedness issue.  

## 4.2	Criteria	

a.	The significance of an FTI is assessed based on (1) the declared emergency classification and (2) whether the affected PSF is risk significant or not, as shown in Attachment1.  

b.	An FTI typically results from a PD on the part of the ERO.  However, it is important to note that a PD that occurs during an actual radiological emergency may not rise to the level of an FTI, particularly if the deficiency is self-identified by the ERO and corrected in a timely manner such that the PSF is successfully accomplished.  In addition, the failure of the ERO to implement a single PE does not always mean that the associated PSF was not accomplished.  Examples include the following:

An operations support center (OSC) team was not fully briefed and had to return for tools but the assigned task was successfully completed.

Engineering efforts initially misdiagnosed the accident sequence, but the diagnosis was corrected by peer checking.

A notification form was not peer checked as required by emergency plan implementing procedures (EPIPs), but the information was found to be accurate.

c.	NRC EP regulations require licensees to have the capability of making classifications, declarations, notifications, and initial protective action recommendations (PARs) within specific periods of time.  Although explicit timeliness requirements are not provided in regulation for follow-up PARs or the notification of such PARs, the NRC expects that licensees will make follow-up PAR decisions as soon as possible after indications are 

	available that a PAR threshold has been exceeded and will notify OROs of such PARs as soon as possible.[footnoteRef:5]   [5:  	Section IV.D.3 of Appendix E to 10 CFR Part 50 requires the licensee to have the capability to notify State and local governmental agencies within 15 minutes after declaring an emergency.  PS 10 CFR 50.47(b)(5) requires that the content of initial and follow-up messages to the OROs and the public be established.  Evaluation Criterion II.E.3 in NUREG-0654/FEMA-REP-1 states that the initial notification should contain information as to whether offsite protective measures may be necessary.  Some licensees have included these criteria in their E–plans or implementing procedures.] 

		1.	Although a failure to meet these timeliness requirements may be a failed opportunity under the Drill and Exercise Performance (DEP) Performance Indicator (PI), there may be defensible reasons for a delay during an actual radiological emergency if the delay has a minimal impact on the EP Cornerstone objective.  Emergency classifications, declarations, notifications, and PARs that take longer than the specified time should be evaluated and a determination made as to whether the delay was justifiable.  Generally, if the delay was caused by the licensee actively performing necessary safety-related actions to protect the public health and safety, and the delays did not deny OROs the opportunity to implement actions to protect public health and safety, a FINDING would not be issued.  Return to IMC 0612 and reconsider the determination of a more than minor PD.  Each event response must be evaluated on a case-by-case basis.  

		2.	Delays in classification, declaration, notification, or PARs caused by factors that were reasonably within the licensee’s ability to foresee and prevent likely represent an FTC and should also be assessed in accordance with Section5.0.3 of this appendix.

d.	The NRC expects that licensees will make accurate emergency declarations, PAR decisions, and notifications.  The inspector should evaluate the effects of inaccurate declarations, PAR decisions, and notifications against the affected risk-significant PSF to determine whether the errors rise to the level of an FTI.  For example, although an error on a completed notification form (e.g., an erroneous time) may be a failed opportunity under the DEP PI, a similar error during an actual radiological emergency might have little or no impact on ORO response efforts and a finding may not be warranted. Return to IMC 0612 and reconsider the determination of a more than minor PD.

e.	A PD that occurs in another ROP cornerstone can cause an emergency declaration issue.  Consider the following examples:

Shift personnel concluded, based on an erroneous protection signal that a main steam line break had occurred when all other plant indications suggested otherwise.  Given this misdiagnosis, the shift manager declared an Alert based on an EAL threshold of “main steam line break,” when no such declaration was warranted.

Because of a misinterpretation of a technical specification action statement, a plant was not placed in the required mode until 6 hours after the specified 

completion time.  An EAL required a Notification of Unusual Event (NOUE) declaration (e.g., inability to reach required shutdown within technical specification limits).  In this case, no declaration was made, as the mistaken interpretation was not recognized until after the plant entered the required mode.  

	In both of these examples, the emergency classification would have likely been correct if the performance in the other cornerstone had been adequate.  As such, the issue of concern needs to be evaluated under that cornerstone, rather than the EP Cornerstone, if a finding will be issued under the other cornerstone.  Otherwise, the PD should be treated as an FTI and assessed for significance under Section4.3 of this appendix.

f.	Since the significance of a finding identified during actual radiological emergencies is based, in part, on the emergency classification level, an inaccurate declaration could affect the significance determination.  The appropriate emergency classification level is to be used in Attachment 1 for assessing the significance of the finding, including the 10 CFR 50.47(b)(4) finding for the misclassification itself.  

		1.	The missed or delayed declaration may have caused another ERO PD to occur (e.g., the declaration of an NOUE instead of an Alert would have prevented timely augmentation of the on shift staff.)  In these cases, the inspection report should identify the associated issues, but only the 10 CFR 50.47(b)(4) finding would be identified as an FTI and assessed for significance under Section4.3 of this appendix.

		2.	However, if the additional PD was caused or exacerbated by factors other than the delayed or missed classification, an additional finding may be appropriate (e.g., the licensee failed to notify the NRC of the missed declaration within 1 hour of identification.)  

# 4.3	Significance Determination

a.	Identify the EP REQUIREMENT affected by the finding.

b.	Determine whether the finding is an FTI.

		1.	If the finding did not involve a failure to implement a PS or RSPS, an FTI is not warranted.  Return to IMC 0612 and reconsider the determination of a more than minor PD. 

		2.	An FTI is analogous to a LOST RSPS [PS] FUNCTION, examples of which are provided in Section5.0 of this appendix.  Those examples, while applicable only to an FTC, may be useful in informing the FTI determination.

		3.	A finding that did not rise to the level of an FTI should be identified to the licensee as an opportunity for improvement.  Return to IMC 0612 and reconsider the determination of a more than minor PD.

	c.	Identify the emergency classification declared by the licensee and evaluate its appropriateness.  If the classification was appropriate or under classified, proceed to Step4.3.e below.

d.	If the licensee over classified the actual event, then assess the significance of the 10 CFR 50.47(b)(4) finding as follows and continue with Step4.3.f: 

	1.	The minimum significance level for a misclassification during an actual radiological emergency is Green.

		2.	If public officials implemented protective actions other than evacuation (e.g., sheltering, early closure of schools) for members of the public,[footnoteRef:6] then the significance level is White.   [6:   	If the ORO response was clearly inappropriate for the conditions present (e.g., ordering an evacuation of the EPZ upon receiving notification of an Alert emergency), assign Green significance.] 

		3.	If public officials implemented an evacuation of the general public,6 then the significance level is Yellow.

e.	Assess the significance of the FTI using Attachment 1 and the appropriate emergency classification level that was or should have been declared.

f.	If the cause of the finding was one or more noncompliant PE (e.g., procedure or training shortcomings), also evaluate the finding as an FTC under Section5.0.3 of this appendix.  If this results in a higher significance, treat the finding as an FTC.

g.	Return to IMC 0612 to document the basis for the significance determination in the inspection report.  

# 5.0	FAILURE TO COMPLY	

# 

## 5.0.1	Background	

a.	This branch of the EP SDP, illustrated in Attachment2, is used to assess the significance of an FTC.  An FTC signifies that an EP program is noncompliant with an EP REQUIREMENT.

		1.	An FTC is generally identified during normal program inspection activities and is related to an emergency preparedness issue, rather than an emergency response issue.  

		2.	However, a finding of an FTI during an actual emergency event may uncover an inadequate or noncompliant PE (e.g., procedure or training shortcomings), the significance of which should also be assessed under this branch of the EP SDP, with the higher significance finding cited.

b.	Sections 5.1 through 5.16 of the appendix correspond respectively to PS 10 CFR 50.47(b)(1) through (b)(16).  Each section does the following:

Identifies the PS and the associated PSF(s).Identifies references to supporting requirements in Appendix E to 10 CFR Part 50 and the informing criteria of NUREG-0654/FEMA-REP-1.

Provides examples of finding(s) corresponding to, as appropriate, LOSS OF RSPS [PS] FUNCTION, DEGRADED RSPS [PS] FUNCTION, and Green finding.

c.	The significance examples are neither all inclusive nor exclusive; instead, the examples are intended to inform significance determinations.  These examples may or may not fully envelop the finding being considered.  If no significance example envelops the finding being considered, it will be necessary to compare the finding against the definitions of LOSS OF RSPS [PS] FUNCTION, or DEGRADED RSPS [PS] FUNCTION in conjunction with Attachment 2.

# 5.0.2	Criteria

a.	Multiple PE may comprise the implementation aspects of each PS.  These PE are developed from the PS, the supporting requirements in Appendix E to 10 CFR Part 50, the evaluation criteria guidance in NUREG-0654/FEMA-REP-1, and commitments made in the approved E–plan.  PS functionality does not require compliance with every PE.  An FTC with one or even a few inadequate PE is not necessarily a LOSS OF RSPS [PS] FUNCTION.  Consequently, the inspector must determine whether the PSF could be accomplished in spite of the inadequate PE. 

b.	There may be circumstances in which the PE is found to be noncompliant but, because of mitigating factors, the inspector is able to determine that reasonable assurance exists that the PSF would be accomplished, albeit in a degraded manner, if an actual radiological emergency were to occur.  In such cases, the PSF would be degraded rather than lost.

		1.	For example, an initiating condition that addresses a radioactive release contains two EALs:  an indication on an effluent radiation monitor or a certain result from an analysis on a sample obtained from the effluent release stream.  The licensee determined that the radiation monitor indication was in error — a noncompliance.  Although the sample analysis results could provide a basis for an emergency declaration, there would be a delay in identifying and classifying an abnormal release.  In this case, the PSF may be found to be degraded rather than lost.

		2.	To be considered in significance determinations, mitigating factors must have already been in place before the TIME OF DISCOVERY.  Section 5.0.2.h. of this appendix addresses measures implemented by the licensee to compensate after identification of the noncompliance.

c.	Several significance examples address unavailability issues related to equipment and facilities.  These examples are intended to encompass equipment, systems, and 

	facilities specifically identified in the E–plan, or relied upon by the E–plan, as PE.  Some of these resources may serve other functions in the plant design or operations.  However, only the functions specifically identified in the E–plan should be considered when assessing the significance of the finding.  For example, an effluent radiation monitor skid may include several monitor channels of which only one is used in an EAL threshold.  Only a finding with that channel would be assessed significance under this EP SDP.

d.	Time limits and percentages are provided to inject objectivity and thus consistency to the assessment process.  These values should be used for any applicable finding in the absence of extenuating circumstances for which the predetermined criteria need to be reconsidered.  In those rare cases, a different characterization of the finding could be appropriate so long as the basis for the deviation is justified and agreed to by the SDP and Enforcement Review Panel.

e.	NRC EP regulations require licensees to have the capability of making classifications, declarations, notifications, and initial PARs within specific periods of time.  Licensees establish these capabilities by providing sufficient personnel, procedures, equipment, training, instrumentation, and other resources necessary to perform the functions in a timely and accurate manner.  A finding may exist if there is an issue of concern regarding the licensee’s capability to make timely declarations, notifications, or PARs, should an actual radiological emergency occur.  Consider the following examples:

The licensee no longer has the personnel on shift to evaluate a seismic reading used in the EAL scheme.

The licensee’s dose assessment capability no longer supports PAR development.

The licensee’s EAL scheme allows an indeterminate delay in classifying a fire to await verification of a fire alarm.

	Although explicit timeliness requirements are not provided in regulation for follow-up PARs or the notification of such PARs, the NRC expects that licensees will make follow-up PAR decisions as soon as possible after indications are available that a PAR threshold has been exceeded and will notify OROs of such PARs as soon as possible.[footnoteRef:7]  [7:   	Section IV.D.3 of Appendix E to 10 CFR Part 50 requires the licensee to have the capability to notify State and local governmental agencies within 15 minutes after declaring an emergency.  PS 10 CFR 50.47(b)(5) requires that the content of initial and follow up messages to the public be established.  Evaluation Criterion II.E.3 in NUREG-0654/FEMA-REP-1 provides that the initial notification contain information as to whether offsite protective measures may be necessary.  Some licensees have included these criteria in their E–plans or implementing procedures.] 

f.	Many of the significance examples incorporate the concept of TIME OF DISCOVERY.  It should be assumed that the condition occurred at this time including, as necessary, timely confirmation or analysis of raw indications (i.e., when the licensee “knew”).

		1.	If a condition existed before it was discovered and it can be shown that the licensee missed an earlier opportunity to recognize the condition, the TIME OF DISCOVERY is the first missed opportunity (i.e., when the licensee “should have known”).  A missed opportunity occurs when the activity failed to identify a condition or when corrective actions were not implemented upon identification.

		2.	Opportunities to identify conditions and initiate corrective actions may include normal surveillances, log reviews, self-assessments, audits, quality assurance activities, NRC generic communications, industry operating experience reports, condition reports, and inspection reports.

		3.	Consideration should be given to the opportunities for identification; the ease of discovery; specificity, relevance, and timing of a prior notification; and action(s) taken by the licensee.

g.	A finding related to licensee identification of a PD that occurred in the past (normally older than 3 years) in engineering, design, or installation that is not reasonably linked to the licensee’s present performance may be a candidate for enforcement discretion.  See IMC0305 11.05 for complete details.  Examples of such findings for the EP Cornerstone could be miscalculated EAL thresholds for installed radiation monitors or deficiencies in emergency response facility design.

h.	Some of the significance examples explicitly provide credit for viable measures that compensate for the inadequate PE.  Many of these significance examples also specify duration for the condition, for example**“...longer than 7 days from TIME OF DISCOVERY and no COMPENSATORY MEASURES were implemented.”[footnoteRef:8]** The following criteria should be considered before crediting a COMPENSATORY MEASURE in a significance determination: [8:  	If the licensee did implement COMPENSATORY MEASURES that met the guidance of this section, within the specified duration, the example threshold has not been exceeded.] 

		1.	The measure must be capable of accomplishing the affected PSF in a reasonably comparable manner.  For example, a company microwave link may be a viable COMPENSATORY MEASURE for a failure of a private telephone bridge if all OROs can still be notified without significant delay.  However, “comparable” does not require the COMPENSATORY MEASURES to meet the same performance requirements as the primary method.

		2.	The measure must be in place before the end of the specified duration.  If no duration is specified, the measure must have been implemented in a timely manner following discovery.

		3.	The specified duration is measured from the TIME OF DISCOVERY.  If the condition is first identified by the inspector, it will be necessary to assess when the licensee should have known of the condition in determining the COMPENSATORY MEASURE credit.

		4.	The inspector should determine the following:

The measure was addressed in procedures, night orders, or the like, and ERO members were made aware of the measure.

ERO personnel expected to implement the measure have received training (unless the measure reasonably falls within the definition of “skill of the craft”). 

The necessary equipment and personnel were readily available to implement the measure.

The licensee is placing an appropriate priority on completing corrective actions.

		5.	A COMPENSATORY MEASURE is used only in assessing significance; as such, a measure generally cannot be used to show compliance. 

		6.	See Section5.5 of this appendix for additional criteria for COMPENSATORY MEASURES for ANS outages.

		7.	The EP SDP allows COMPENSATORY MEASURES to continue to be used in certain situations in which the noncompliant PE was caused by major disruptive events (e.g., hurricanes, fires, explosions, loss of offsite power) or are the result of a planned outage of certain systems or facilities.  The EP SDP recognizes that there may be delays in implementing corrective actions that are not completely under the control of the licensee.  In these situations, such measures continue to be acceptable as long as the licensee implements the corrective actions with appropriate priority.  The significance examples to which this provision applies are annotated to this effect.

# 5.0.3	Significance Determination

a.	If the finding is related to EP REQUIREMENTS that are not associated with a PSF (e.g., 10 CFR 50.54(q),10 CFR 50.54(t), and requirements in Appendix E to 10 CFR Part 50 that do not support a PSF), assign Green significance.  Return to IMC 0612.

	b.	Identify the PSF(s) [footnoteRef:9] affected by the finding.  A finding may affect two or more PSF and each should be assessed for significance. [9:  	Sections 5.1 through 5.16, as applicable, of this EP SDP identify the requirements of Appendix E to 10 CFR Part 50 that support the PS of 10 CFR 50.47(b).] 

c.	Compare the identified finding to the examples tabulated in the appropriate section, and if needed, Attachment 2, to identify the significance.  The language of the PSF is generally broad and the determination of the significance of a finding may not always be obvious.

1. The examples provided for each PSF are not intended to be all-inclusive or all exclusive.

		2.	More than one PE may be associated with the PSF, and varied facilityspecific methods of implementation and a particular finding may not correspond directly to any particular example provided.

		3.	Extenuating circumstances may need to be considered.

		4.	In making the significance determination, the analyst will need to use judgment, informed by the examples that are provided.  The cited supporting requirements and informing criteria should be considered as necessary.  Reviewing previous inspection reports for a similar finding, where available, can provide additional insight. 

d.	Return to IMC 0612 to document the basis for the significance determination in the inspection report.

Table 5.1-1

Additional Guidance:	None

Additional Guidance:

EPPOS-3, “Emergency Preparedness Position (EPPOS) on Requirement for Onshift Dose Assessment Capability,” dated November 8, 1995 [ML023040473]

Nuclear Energy Institute (NEI) 99-02, “Regulatory Assessment Performance Indicator Guideline,” Revision 6, [ML092931123], identifies key ERO members.

NSIR/DPR-ISG-001, “Emergency Planning for Nuclear Power Plants” [ML113010523]

Information Notice (IN) 93-81, “Implementation of Engineering Expertise on Shift,” dated October 12, 1993, http://www.nrc.gov/reading-rm/doc-collections/#gen

Additional Guidance:	None

Issue Date:  09/22/15	18	0609, Appendix. B

Additional Guidance:	

NSIR/DPR-ISG-001, “Emergency Planning for Nuclear Power Plants” [ML113010523]

IN 1989-72, “Failure of Licensed Senior Operators to Classify Emergency Events Properly,” dated October 24, 1989, http://www.nrc.gov/reading-rm/doc-collections/#gen

IN 2005-19, “Effect of Plant Configuration Changes on the Emergency Plan,” dated July 18, 2005, http://www.nrc.gov/reading-rm/doc-collections/#gen

Regulatory Issue Summary (RIS) 2003-18, “Use of NEI 99-01, ‘Methodology for Development of Emergency Action Levels,’ Revision 4, Dated January 2003,” dated October 8, 2003, http://www.nrc.gov/reading-rm/doc-collections/#gen

0609, App. B	B-20	Issue Date: 

Issue Date:  09/22/15	21	0609, Appendix B

RIS 2003-18, Supplement 1, “Use of NEI 99-01, ‘Methodology for Development of Emergency Action Levels,’ Revision 4, Dated January 2003,” dated July 13, 2003, http://www.nrc.gov/reading-rm/doc-collections/#gen

EAL schemes typically have a series of initiating conditions (IC), which represent the condition being classified and, for each IC, one or more EALs, which represent indications that the IC may be exceeded.  As used herein, an EAL is ineffective when it no longer results in a timely and accurate declaration for the IC.  A particular EAL may be a single indication or may include a list of redundant instrument channels.  In either case, it is treated as a single EAL for significance purposes.

The significance examples differ by the licensee’s ability to make the proper emergency declaration even with the ineffective EAL.  An EAL may be rendered ineffective by changes to facility procedures, systems, or equipment; errors in numeric thresholds; or any other cause that could result in an IC, which should be declared, not being declared in a timely and accurate manner following the change(s).  These ineffective EAL examples do not apply to instruments that are temporarily out of service if timely corrective actions are being taken to restore the instrument(s).

EAL schemes often have either redundant or diverse indications for the same IC. Credit is to be given to these alternative EALs as MITIGATING FACTORS if they were part of the licensee’s approved emergency classification scheme before the ineffective EAL was identified.  Other ICs generally may not be credited as MITIGATING FACTORS.  One of the following two significance situations may exist:

(1) If the alternative EALs are such that an accurate declaration of the IC would still be made, but delayed beyond the 15-minute timeliness capability requirement, the classification function is degraded.  An example would be waiting on an analysis of a grab sample in lieu of observing a reading on a direct-indicating instrument.

(2) If the alternative EALs are such that an accurate and timely declaration of the IC would still be made, the classification function is neither lost nor degraded.  In this context, timely means within the 15-minute timeliness capability requirement.  For example, loss or potential loss of the fuel barrier IC may include EALs such as reactor pressure vessel (RPV) level and drywell radiation monitor.  A decreased RPV level is a precursor to core damage and can adequately compensate for an ineffective drywell radiation monitor threshold because the declaration will still be timely and accurate.  However, a classification based on drywell radiation monitor threshold rather than an ineffective RPV level would likely be delayed (as the core damage must first occur for the radiation monitor to indicate).

The NRC expects declarations to be timely and accurate (See Section 5.0.2 of this EP SDP).  Unnecessary public protective actions caused by an overclassification are a concern since the public could be placed at increased health risks without realizing the dose avoidance benefit of a necessary protective action.  The NRC encourages conservative decisionmaking in uncertain events.  However, the licensee’s emergency classification process should, to the extent possible, support timely and accurate declarations should an emergency occur.  A deficient emergency classification process that would result in an overclassification and cause the 

licensee to make a protective action recommendation, or cause OROs to implement protective actions (e.g., a nondiscretionary precautionary evacuation of schools on a Site Area Emergency) by procedure, should be identified as a DEGRADATION OF RSPS FUNCTION.  A deficient emergency classification process that would result in an overclassification, but would not result in unnecessary public protective measures, should be identified as a Green finding.

See NSIR/DPR-ISG-001 for guidance on the timeliness criteria, including when the “clock” starts and stops for classification and declaration.

Issue Date:  09/22/15	22	0609, Appendix B

Figure 5.4-1

Significance Determination for Ineffective EALs and Overclassification

1	Emergency condition would be declared because of unaffected redundant or diverse EAL thresholds.

2 	An EAL is ineffective when it, in of itself, no longer results in a timely and accurate declaration for the initiating condition.

3 	In making this determination, consider only those public protective actions that would be triggered by an ORO receiving notification of a particular emergency classification (e.g., an invalid General Emergency declaration).  This significance logic does not apply to over classifications during an actual event.

4.	Return to IMC 0612 and reconsider the more-than-minor determination.

0609, App. B	B-26	Issue Date:  

Issue Date:  09/22/15	25	0609, Appendix. B

# 

Additional Guidance:

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section5.0.2.h. of this appendix for additional guidance.

IN 2002-25, “Challenges to Licensee’s Ability to Provide Prompt Public Notification and Information During an Emergency Preparedness Event,” dated August 26, 2002, http://www.nrc.gov/reading-rm/doc-collections/#gen

Issue Date:  09/22/15	26	0609, Appendix. B

IN 2005-06, “Failure to Maintain Alert and Notification System Tone Alert Radio Capability,” dated March 30, 2005, http://www.nrc.gov/reading-rm/doc-collections/#gen

In the notification significance examples, the scope of OROs is limited to those agencies that the licensee must directly notify of an emergency as described in the E–plan.  This would typically include State, county, municipal, and Tribal emergency management agencies, but may include others that are notified by the licensee within 15-minutes of an emergency declaration.

Section IV.D.3 of Appendix E to 10 CFR Part 50 requires the licensee to demonstrate that the primary and backup ANS administrative and physical means of alerting the public have been established.  The NRC uses the FEMA-approved final ANS design report as evidence that the means have been established.  The following applies:

· Since the final ANS design report is approved by FEMA, licensee-proposed measures to compensate for ANS outages or failures must meet the criteria in Section5.0.2.h, and be reviewed by FEMA for acceptability, before being credited in determining significance*.*The Office of Nuclear Security and Incident Response/Division of Preparedness and Response (NSIR/DPR) staff will refer the issue to FEMA Headquarters for additional input.  

· FEMA must approve substantive changes to the ANS, hardware, testing, and maintenance under 44 CFR 350, “Review and Approval of State and Local Radiological Emergency Plans and Preparedness.”  A review under 10 CFR 50.54(q)(3) is not sufficient.

· FEMA evaluation of licensee deviations from the FEMA-approved final ANS design report (e.g., licensee fails to perform maintenance described in the design report) will be obtained before citing a finding related to these deviations.  The NSIR/DPR staff will refer the issue to FEMA Headquarters for its input.  Subsequent enforcement will depend on the input received from FEMA.

An approved prearranged backup method of notification, described in the FEMA approved ANS design report that meets the performance requirements described in Section IV.D.3 of Appendix E to 10 CFR Part 50 for the primary notification means may be credited for determining compliance.  Otherwise, the prearranged backup method can serve as a COMPENSATORY MEASURE only for determining significance. Primary ANS outages caused by planned maintenance and testing as identified in the FEMA-approved ANS Design Report are generally not FTCs.

There is an extensive record of case law related to intervener contentions regarding the requirements in 10 CFR 50.47(b)(5) or Section IV.D of Appendix E to 10 CFR Part 50 particularly, the “...about 15-minute...” performance criteria.  In general, such rulings have precedence only for the contested docket, but may be useful in informing staff decisions.  Assistance should be sought from NRC counsel.  Some significant rulings include the following:  Generic CLI-80-40, 12 NRC 636; Indian Point 18 NRC 811, 18 NRC 939 San Onofre 15 NRC 1163, 17 NRC 346, 17 NRC 528; Seabrook 29 NRC 527, 31 NRC 213, 32 NRC 57; Shearon Harris 23 NRC 294, 24 NRC 532; Shoreham 21 NRC 644, 27 NRC 85, 28 NRC 275, 28 NRC 603; Vermont Yankee CLI-74-40, 8 AEC 809

Issue Date:  09/22/15	27	0609, Appendix. B

# 

Additional Guidance:

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section5.0.2.h. of this appendix for additional guidance.

NEI 99-02, “Regulatory Assessment Performance Indicator Guideline,” [ML092931123], identifies key ERO members.

0609, App. B	B-24	Issue Date:  

Issue Date:  09/22/15	30	0609, Appendix B

Additional Guidance:	

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section5.0.2.h. of this appendix for additional guidance.

EPPOS-5, “Emergency Preparedness Position (EPPOS) on Emergency Planning Information Provided to the Public,” dated December 4, 2002, [ML023040492]

Issue Date:  	B-28	0609, App B

Issue Date:  09/22/15	32	0609, Appendix B

Additional Guidance:	

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section 5.0.2.h. of this appendix for additional guidance.

The principal functional areas of emergency response are, as established in 10 CFR Part 50, Appendix E, §IV.F.2.b: management and coordination of emergency response, accident assessment, event classification, notification of offsite authorities, assessment of the onsite and offsite impact of radiological releases, protective action recommendation development, protective action decision making, plant system repair, and mitigative action implementation.

IN 2004-19, “Problems Associated with Back-up Power Supplies to Emergency Response Facilities and Equipment,” dated November 4, 2004,

http://www.nrc.gov/reading-rm/doc-collections/#gen

The TSC, and the EOF in certain cases, have habitability requirements in NUREG-0696 that derive in part from the habitability requirements for the main control room.  Although neither document is explicitly applicable to TSCs or EOFs, the following additional guidance may be useful in informing issues related to TSC and EOF habitability.  

GL 2003-01, “Control Room Habitability,” dated June 12, 2003. http://www.nrc.gov/reading-rm/doc-collections/gen-letters/2003/gl03001.pdf

RIS 2006-04, “Experience With Implementation of Alternative Source Terms,” dated March 7, 2006, http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2006/ri200604.pdf

0609, App. B	B-32	Issue Date:  

Issue Date:  09/22/15	35	0609, Appendix. B

0609, App. B	B-34	Issue Date:  

Additional Guidance:

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section5.0.2.h of this appendix for additional guidance.

EPPOS-3, “Emergency Preparedness Position (EPPOS) on Requirement for Onshift Dose Assessment Capability,” dated November 8, 1995.  [ML023040473]

Some significance examples refer to an incapability of providing technically adequate estimates of projected releases and doses.  As with all significance examples, the focus is on a PD that is reasonably under the licensee’s control to identify and prevent.  Quantification of the magnitude of the error is not required.  These errors may be identified during exercise when licensee results are compared to those performed by other entities.  The following conditions are generally under the licensee’s control:

· Inadequate procedures and training may cause users to select processing options or make data entries that are not appropriate for the particular projections being performed.  

· Use of a dose projection model that does not account for site-specific and plant-specific meteorological regimes, terrain characteristics, release pathway configuration (e.g., elevated versus ground, building wake)

· Site- and unit-specific data files that adapt the modeling to a particular site (e.g., monitor efficiencies, terrain heights, stack heights, etc.) are inconsistent with the site configuration.

Conversely, the inherent uncertainties in the components of a dose projection — source term, meteorology, and dose calculation — are generally not under the control of the licensee, and therefore are not PDs. 

Issue Date:  09/22/15	38	0609, Appendix. B

Additional Guidance:

The significance examples provide for COMPENSATORY MEASURES as means of mitigating the significance of certain finding(s).  See Section5.0.2.h of this appendix for additional guidance.

0609, App. B	B-36	Issue Date: 

Issue Date:  09/22/15	41	0609, Appendix B

NUREG/CR-7002, “Criteria for Development of Evacuation Time Estimates Studies” [ML113010515]

NUREG-0654/FEMA-REP-1, Supplement 3, “Guidance for Protective Action Strategies” [ML113010596]

NSIR/DPR-ISG-001, “Emergency Planning for Nuclear Power Plants” [ML113010523]

(Remaining documents can be found at http://www.nrc.gov/reading-rm/doc-collections/#gen )

IN 1998-20, “Problems with Emergency Preparedness Respiratory Programs,” dated June 3, 1998 

RIS 2002-14, “Ensuring a Capability to Evacuate Individuals, Including Members of the Public, From the Owner-Controlled Area,” dated April 8, 2002

RIS 2002-21, “National Guard and Other Emergency Responders Located in Licensee’s Controlled Area,” dated November 8, 2002

RIS 2003-12, “Clarification of NRC Guidance for Modifying Protective Actions,” dated June 24, 2003 

RIS-2004-13, “Consideration of Sheltering in Licensee's Range of Protective Action Recommendations,” dated August 2, 2004, and Supplement 1, dated March 10, 2005

RIS-2005-08, “Endorsement of Nuclear Energy Institute (NEI) Guidance ‘Range of Protective Actions for Nuclear Power Plant Incidents,’” dated June 6, 2005

IN 2002-14, “Ensuring a Capability to Evacuate Individuals, Including Members of the Public, from the Owner-Controlled Area” dated April 8, 2002

Table 5.11-1

Additional Guidance:	None

0609, App. B	B-46	Issue Date: 

Issue Date:  09/22/15	50	0609, Appendix. B

Table 5.12-1

Additional Guidance:  None

Table 5.13-1

Additional Guidance:	

Because of the nonemergency nature of recovery efforts, no LOSS OF PS FUNCTION would be assigned for failures in this area (i.e., any FTC would not exceed a Green finding).

Additional Guidance:

See guidance in Section 6.0 regarding correction of WEAKNESSES.

Identification of WEAKNESSES

A WEAKNESS is defined as a level of ERO performance demonstrated during an exercise, drill, or training that provides performance opportunities to develop, maintain, or demonstrate key skills that would preclude effective implementation of the E–plan, if the weakness were to occur during an actual emergency.

A failure of a CRITIQUE to identify a WEAKNESS observed by NRC inspectors is a CRITIQUE finding and should be processed against 10 CFR 50.47(b)(14) and Section IV.F.2.g of Appendix E, if the WEAKNESS could preclude effective implementation of the E–plan in an actual emergency (i.e., FTI).  

Since a WEAKNESS is defined in the context of ERO performance, a PROGRAM ELEMENT issue related to the effectiveness and adequacy of the E–plan or its implementing procedures[footnoteRef:10] is not a WEAKNESS.  Accordingly: [10:  	The E–plan contains the licensee’s commitments to NRC regulations.  The implementing procedures are the licensee’s methods of implementing those commitments and may be used to judge effective, timely, and accurate implementation.  ] 

· A deficient PE uncovered by the exercise and identified by the licensee in its critique is a licensee-identified PD and is evaluated as a FTC.  

· If identified by the inspector, the deficient PE is an NRC-identified PD and is evaluated as a FTC.  

· Because of this dichotomy, inspectors will need to remain alert to the possibility that a WEAKNESS may have uncovered one or more inadequate PE.

A mistake or a misstep by ERO members that only detracts from the overall ERO performance should not be treated as a de facto WEAKNESS.  Mistakes are likely to happen in the course of an exercise and many are corrected by the ERO (e.g., peer-checking), which should be viewed as an organizational strength.  Failure to identify these mistakes as a WEAKNESS in the CRITIQUE is generally not a PD.  

Inspectors must remain alert to exercise controller actions (e.g., coaching, prompting) that have the effect of masking an ERO WEAKNESS such that corrective actions might not be implemented.  Failure of the licensee’s CRITIQUE to identify the ERO performance WEAKNESS masked by the controller action is a CRITIQUE finding.  (Even if identified in the CRITIQUE, the controller’s action could result in a DEP PI opportunity being considered as a failure.  See ROP FAQ No. 405 dated July 21, 2005.)

Classifications, PARs, and notifications could be accurate and timely (DEP PI opportunity successes) and there still be a WEAKNESS.  Such a WEAKNESS needs to be identified and corrected since, under different circumstances, it could affect activities necessary for protecting the health and safety of the public.  A failure to identify such a WEAKNESS in a CRITIQUE should be classified as a Green finding because of its lesser significance.  Examples include the following:

· An emergency classification is made as anticipated by the scenario, but the classification was based on misinformation, lack of information, invalid indicators, or reliance on emergency director judgment EALs when explicit EALs were applicable.

· A PAR is developed as anticipated by the scenario, but the PAR was based on a dose assessment performed using erroneous input parameters (e.g., improper release duration, credit for filtration when none available).

Licensees perform CRITIQUES in many different ways and the inspectors should be flexible in accepting mechanisms for WEAKNESS identification.  The critical feature of any CRITIQUE is 

that a WEAKNESS is captured and entered into a corrective action system with appropriate priority, regardless of whether the WEAKNESS was verbalized at a CRITIQUE meeting.  

If the inspector can be assured that all WEAKNESSES will be entered into a corrective action system, before disclosing the identified issues, the CRITIQUE should be considered acceptable.  

However, if the inspector does not have assurance that a WEAKNESS has or will be captured and entered into the corrective action system, the CRITIQUE was not acceptable and a CRITIQUE finding exists. 

The disposition of CRITIQUE observations also varies among sites.  In any given exercise, the licensee will evaluate numerous evaluator observations, identify which observations rise to the level of a WEAKNESS, and prioritize resources for correction.  Care should be taken to understand the logic underlying the suggested disposition before identifying it as a CRITIQUE finding.  If the inspector identifies that a wellfounded, evaluator-identified WEAKNESS was improperly dispositioned and was not entered into the corrective action system, a CRITIQUE finding exists since the NRC expects the licensee to enter identified WEAKNESSES and enter them into a corrective action system.

If the ERO performance during a biennial exercise is degraded to the extent that the inspector cannot find that reasonable assurance exists that adequate protective measures can be taken in the event of an actual radiological emergency or cannot find that the ERO has maintained key skills specific to emergency response, the NRC may require the conduct of a remedial exercise under Section IV.F.2.f of Appendix E to 10 CFR Part 50.

Figure 5.14-1

Significance Determination for CRITIQUE Findings

Figure 5.14-2

Significance Determination for Failure to Correct a****WEAKNESS

0609, App. B	B-60	Issue Date:  

Issue Date:  09/22/15	58	0609, Appendix B

Table 5.15-1

Additional Guidance:	

NEI 99-02, “Regulatory Assessment Performance Indicator Guideline,” Revision 6, [ML092931123], identifies key ERO members. 

Table 5.16-1

Additional Guidance:	

Because of the nonemergency nature of E–plan development efforts, no LOSS OF PS FUNCTION would be assigned for failures in this area (i.e., any FTC would not exceed a Green finding).

# 6.0	GUIDANCE ON CORRECTIVE ACTIONS	

# 6.1	Timeliness Guidelines

a.	The NRC expects that licensees will resolve an identified WEAKNESS in a timely manner consistent with its risk significance.  That said, it is important to note that the time it takes to correct a WEAKNESS may depend on various factors, not all of which may be under the licensee’s direct control.  The licensee determines the risk significance of a WEAKNESS and sets resolution priorities in accordance with its corrective action programs and other commitments.  Root cause and extent of cause analyses may take 60 days or longer to complete.  While immediate corrective actions, such as procedure changes, briefings, lessonslearned summaries, or COMPENSATORY MEASURES may be implemented rapidly, multiple longer term corrective actions may be necessary to fully resolve the WEAKNESS and prevent its reoccurrence.  

b.	This guidance, which should be interpreted as flexible guidelines, is intended to inform an inspector’s evaluation of the timeliness of the corrective actions for an identified WEAKNESS.  The following guidance is to be used when assessing timeliness of corrective actions:

		1.	An RSPSrelated WEAKNESS is typically corrected within 90 days of identification.

		2.	A PSrelated WEAKNESS is typically corrected within 180 days of identification.

		3.	Resolution of other WEAKNESSES is expected within the next evaluated biennial exercise cycle because of the lower risk significance of these efforts and expected lower priority of such efforts.

		4.	EP-related corrective action systems may track enhancement suggestions that result from the drill program.  These enhancement suggestions often add value to the EP program, but are not required and do not address WEAKNESSES.  There is no NRC timeliness expectation for resolution of enhancement suggestions.

# 6.2	Considerations

a.	If a WEAKNESS is corrected in less time than that suggested in Section 6.1.(b), above, further review of the timeliness of the corrective actions by the inspector is probably not necessary.  If a WEAKNESS is not corrected within the time periods suggested in Section 6.1.(b), the inspector should review:

		1.	the licensee’s schedule and prioritization rationale

		2.	reasons for the delay

		3.	any actions being taken to accelerate completion (if any) 

		4.	the effect of any immediate corrective actions that may have already been taken

b.	If the inspector finds that the licensee is not making a best effort to complete the corrective actions, or that the delay could potentially impact the effectiveness of the 

	E–plan to protect public health and safety, an FTC with PS 10 CFR 50.47(b)(14) finding should be pursued.

# 6.3	Effectiveness of Corrective Actions

a.	Although a licensee may have properly identified a WEAKNESS, entered it into the licensee’s corrective action program, and implemented necessary corrective actions to prevent reoccurrence, the associated ERO performance may recur in subsequent drills and exercises.  It is important to note that a single repetition of a WEAKNESS in a subsequent drill or exercise may not indicate a failure to correct a WEAKNESS.  Conversely, success in a drill or exercise (e.g., by one well-drilled team) might not be a valid demonstration that a WEAKNESS has been corrected.  

b.	When a previously identified WEAKNESS in a particular PS recurs in a subsequent drill or exercise, the inspector should do the following:

		1.	Review the specific corrective actions identified.

		2.	Verify that the corrective actions are complete.

		3.	Review associated root cause and extent of condition analyses, if performed.

		4.	Consider similar occurrences during responses to actual events, drills, exercises, and training evolutions.

		5.	Consider the status of relevant PIs; for the DEP PI, review the performance for the individual RSPS as well as that for the overall PI (good performance in two RSPS can mask poor performance in the third).

		6.	Review corrective actions, self-assessment, and inspection records for an entire inspection cycle with emphasis on similar performance deficiencies.

c.	Assessment of the effectiveness of the corrective actions should be based on the complete history of the issue.  The intent of the reviews suggested above is to uncover a pattern of recurring performance deficiencies in similar activities as a means to identify ineffective corrective actions.

d.	A specific root cause of a WEAKNESS in a particular RSPS may have been corrected, and yet another WEAKNESS in the same RSPS but with a different root cause may be observed in a subsequent drill or exercise.  A trend in such repetitive WEAKNESSES, even though each may have a different root cause, could indicate that the root cause and extent of cause analyses may have been ineffective such that an unidentified (and uncorrected) root cause still exists. Accordingly, the WEAKNESS is uncorrected and a

	failure to correct a WEAKNESS needs to be considered as provided for in this section.  In addition, a trend of repetitive WEAKNESSES may indicate the need to perform a root cause analysis of the trend.  

e.	If corrective actions are aggressive and appear to be complete but not yet fully effective, consideration may be given to allow more time for performance improvement (future drills should show such improvement).  

# Attachment 1 

FAILURE TO IMPLEMENT (ACTUAL EVENT) SIGNIFICANCE LOGIC

Issue Date:  09/22/15	Att1-1	0609, Appendix B

# Attachment 2 

FAILURE TO COMPLY SIGNIFICANCE LOGIC

Issue Date:  09/22/15	Att2-1	0609, Appendix B

Attachment 3

Revision History for IMC 0609, App B

Issue Date:  09/22/15		Att3-1                                                                                  0609, Appendix B

Issue Date:  09/22/15		Att3-2                                                                                  0609, Appendix B

Issue Date:  09/22/15		Att3-3                                                                                  0609, Appendix B

Issue Date:  09/22/15		Att3-4                                                                                 0609, Appendix B

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