ML20155F382

Clarifies Guidance Under Existing Enforcement Policy for All Matl Licensees & Fuel Cycle Facilities,Excluding Part 76 Certificate Holders & Part 70 Licensees with Resident Inspectors

ML20155F382
Person / Time
Issue date:	09/15/1998
From:	Lieberman J NRC OFFICE OF ENFORCEMENT (OE)
To:	Caldwell J, Miller H, Reyes L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
References
EGM-98-008, EGM-98-8, NUDOCS 9811060019
Download: ML20155F382 (12)

Text

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O Cf y & UNITED STATES

[DQ g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20566-0001 o% *****/ September 15, 1998 EGM 98-008 MEMORANDUM TO: Hubert J. Miller, Regional Administrator Region I Luis A. Reyes, Regional Administrator Region 11 James L. Caldwell, Acting Regional Administrator Region 111 Ellis W. Merschoff, Regional Administrator Region IV Samuel J. Collins, Director Office of Nuclear Reactor Regulation Elizabeth O. Ten Eyck, Director, Division of Fuel Cycle Safet/ and Safeguards, NMSS Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, NMSS John T. Greeves, Director, Division of Waste Management, NMSS William F. Kane, Director, Spent Fuel Project Office, NMSS FROM: James Lieberman, Director Office of Enforcement ML

SUBJECT:

ENFORCEMENT GUIDANCE MEMORANDUM - INTERIM GUIDANCE FOR SEVERITY LEVEL IV VIOLATIONS -

MATERIALS LICENSEES

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BACKGROUND This EGM is being issued as a short term measure to clarify guidance under the existing Enforcement Policy for all materials licensees and fuel cycle facilities, excluding Part 76 certificate holders and Part 70 licensees with resident inspectors. Similar guidance for these licensees is contained in EGM 98-006, " Enforcement Guidance Memorandum - Interim Guidance for Severity Level IV Violations," issued July 27,1998. -

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The NRC Enforcement Policy encourages licensees to identify and correct violations of NRC .A l L-requirements. Incentives to encourage self-identification and corrective action provide for licensees to avoid civil penalties and notices of violation. The Enforcement Policy also allows the staff to a waive a formal response to a cited violation if the licensee's corrective actions are already known and documented on the docket.

Consistent with this philosophy, NRC enforcement decisions must consider licencee actions in identifying and correcting violations. When cited violations result, consideration should be given to the value, if any, to be gained from requiring a formal response from the licensee.

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1 The staff should not be focusing resources on licensee-identified and corrected violations; rather, inspectors should focus their attention on potential safety and risk significant issues.

When determining the appropriate enforcement action, the inspector should consider whether the associated violations will be cited or treated as Non-Cited Violations (NCVs). In general, licensee-identified Severity LevelIV violations still need to be documented; however an exception is discusced under Section 4, " Violations identified as Part of Licenseb Self-Assessments." Additionally, it is still essential to follow-up on significant issues that a licensee Identifies. NCVs should be described as such in official inspection records (formerly field notes), an inspection report, or on an NRC Form 591, " Safety and Compliance Inspection."

IMPLEMENTATION

, The purpose of this EGM is to: (1) amphasize axisting guidance to ensure that NRC and licensee resources are not used to develop, review, track, respond, and close out SL IV violations that do not warrant being formally cited; (2) emphasize existing guidance to ensure that licensees are not directed to provide responses when the necessary information is already docketed; and (3) clarify guidance regarding the handling of multiple violations vs multiple examples of the same violation.

In order to ensure that a consistent approach is achieved during the conduct of inspections, the following general guidance is provided:

1. Use NCVs for non-repetitive, non-willful SL IV violations that were licensee identified and are or will be corrected within a reasonable time, as per Section Vll.B.1 oI the i

Enforcement Policy. In considering whether the licensee's corrective action is prompt and comprehensive, the standard is reasonableness (l.e., the licensee's corrective i action should be commensurate with the safety significance of the issue). I

2. Use Enforcement Discretion per Sections Vll.B.2, Vll.B.3, Vll B.4, and Vll.B.6 of the Enforcement Policy where warranted for Severity Level IV violations.

3. Do not require responses to cited Severity Level IV violations if the licensee's corrective action is already on the docket in the inspection report describing the violation, a 30 day report,' or other correspondence.

4. Do not use radiation safety committee meeting minutes or program audit records to identify violations that the licensee is already aware of unless the corrective action for the violation is not prompt or comprehensive.

5. Group multiple examples of the same violation into a single citation when appropriate.

This guidance is more fully discussed belove These reports are submitted by licensees in accordance with 10 CFR Parts 20,30,34, 35,36,39,40,70, and 71, typically following the notification of NRC of reportable occurrences.

Note: Part 35 requires a 15 day report for misadministrations and, for the purpose of this EGM, is considered to be included in the term "30 day report."

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1. Use Non-Cited Violations for non-repetitiva, non-willful SL IV violations that were licensee identified and are or will be corrected within a reasonable time.

Section Vll.B.1 of the Enforcement Policy describes the enforcement discretion available for licensee-identified SL IV violations. Generally, non-repetitive, non willful SL IV violations that are or will be corrected within a reasonable time should be dispositioned as NCVs. This discretion specifically applies to licensee-identified issues that may be formally reported in 30 day reports, as well as issues identified through other means, such as annual audits of the radiation protection program or quality management program. Except as noted in Section 4 below, NCVs must be described as such in official inspection records (formerly field notes), an inspection report, or on an NRC Form 591, " Safety and Compliance inspection."

1.A identification Credit for Violations Revealed through Events:

Generally, for the purposes of determining NCV applicability to a violation, the Enforcement Policy, Section Vll.B.1 states:

Licensee identification credit is not warranted when a licensee identifies a violation as a result of an event where the root cause of the event is obvious or the licensee had prior opportunity to identify the problem but failed to take action that would have prevented the event.

In applying this provision, consideration should also be given to the policy discussion regarding civil penalty assessment in Section VI.B.2.b, " Credit for Actions Related to identification":

When a problem requiring corrective action is identified through an event, the decision on whether to give the licensee credit for actions related to identification normally should consider the ease of discovery, whether the event occurred as the result of a ilcensee self-monitoring effort (i.e., whether the licensee was "looking for the problem"), the degree of licensee initiative in identifying the problem or problems requiring corrective action, and whether prior opportunities existed to identify the problem.

Any of these considerations may be overriding if particularly noteworthy or particularly egregious. For example, if the event occurred as the result of conducting a surveillance or similar self monitoring effort (i.e., the licensee was looking for the problem), the licensee should normally be given credit for identification. As a secondinstance, even if the problem was easily discovered (e.g., revealed by a large spill ofliquid), the NRC may choose to give credit because noteworthylicensee effort was enrtedin ferreting out the root cause and associated violations, or simply beceuse no prior opportunities . . . existed to identify the problem. [ Emphasis added.]

The event itself may be a violation, or it mcy be ti'e result of an underlying violation.

Identification credit should be considered when licensee follow-up of the event demonstrates thoroughness in assessing contributing factors as well as any obvious, direct cause. The standard for the thoroughness of the licensee's acCons is reasonableness based on safety

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! significance. See diccussion under item C below.," Corrective Action Considerations for NCV i Status."

l Cases where identification credit is denied should be limited to superficial licensee i investigations, when the licensee's corrective actions or root causes default to " easy fixes"inid the inspectors can demonstrate that significant, credible, differing causes existed that were not identified by the licensee. Not all" easy fixes" are inappropriate. There are cases where an

] event: (a) is caused simply by an isolated human error with minimal opportunity for prevention;

! or (b) lacks contributing causes, such as inadequate procedures, labeling errors, lack of l resources or supervision, or prior opportunities to identify. In such cases, the most obvious cause turns out to be the correct one. Granting of identification credit should be considered for i

these cases when licensee efforts are thorough enough to rule out the potential for more subtle

}' contributing factors.

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! If the licensee has identified an issue and the NRC is following up on it, the licensee should not

be denied credit for identification if it is reasonably pursuing the issue that it identified, even

! though NRC may have identified the associated violation first. This assumes the licensee's

plans and intent were such that it is likely the licensee would have identified the violation within j a reasonable time.

j In sum, credit for identification is warranted for non-escalated violations associated with events unless the staff can show credible actions that clearly should have been taken by the licensee in identifying event causes, in all non-escalated cases involvina events where identification '

credit is beina denied. the Division Director must aaree with the denial after consultation with the Reaional or NMSS Enforcement Coordinator (as aoorooriate).

1.B Determichg Repetitiveness:

In order to treat a SL IV violation as an NCV, the Enforcement Policy states:

It was not a violation that could reasonably be expected to have been prevented by the licensee's corrective action for a previous violation or a previous licensee finding that occurred within the past 2 years of the insoection at issue, or the period within the last two inspections, whichever is longer; EGM 97-012, dated June 9,1997, contained guidance for the determination of repetitiveness.

This guidance is being modified as follows: In considerina orevious NRC violations or licensee findinas to determine repetitiveness. use only docketed information so that the licensee has been out on notice of the need to take corrective action for a violation. For determining repetitiveness, the use of: (a) licensee records, such as program audit records; or (b) inspection records (formerly field notes), is appropriate only to the extent that the issue is also described in previous inspection reports, NRC Form 591s, or other docketed information.

Generally, inspection reports and NRC Form 591s should serve as the reference for determining repetitiveness, as these documents provide clear notice to the licensee concerning NRC findings or violations. This guidance may result in the inspector not issuing an NOV for a licensee-identified recurring violation because it was not previously described in any docketed document. However, in this case, the violation should be docketed as an NCV so that if the licensee's corrective action fails again, a citation would be warranted at that point.

5 in determining repetitiveness, the fact that the violation repeats is not the only criteria that should be considered. If a violation recurs, it does not necessarily mean that past corrective action was not reasonable or effective. The key is: Did the licensee develop andimplement reasonable corrective actions for the previous violation, commensurate wth the safety significance, such that at the time the corrective actions were implemented, there was a reasonable expectation that the root causes of the violation would be corrected? See discussion under item 1.C., " Corrective Action Considerations for NCV Status."

1.C Corrective Action Considerations for NCV Status:

4 For a SL IV violation to warrant NCV status, the Enforcement Policy requires that:

It was or will be corrected within a reasonable time, by specific corrective action committed to by the licensee by the end of the inspection, including immediate corrective action and comprehensive corrective action to prevent recurrence.

In evaluating the scope and comprehensiveness of corrective actions, inspectors and their management should judge whether the licensee's response is commensurate with the significance of the issue. The standardis reasonableness. Unless the inspector, in consultation with his or her management, determines that there were significant, credible, differing causes that were not reasonably addressed in the corrective actions, the licensee's actions should be considered adequate. In addition, if the licensee's corrective actions are ongoing and the licensee, after input from the inspector or other NRC staff, agrees that additional actions are necessary and states that additional actions will be taken, the licensee should be given credit for corrective action. However, if the licensee has previously completed its corrective action end, after input from the inspector or other NRC staff, agrees that additional corrective actions are necessary, then credit for corrective action is not appropriate. If there is a dispute with the licensee on the reasonableness of its corrective actions. the Division Director must concur on any cited violation.

The NCV criteria in Section Vil.B.1 of the Enforcement Policy requires " corrective action committed to by the licensee by the end of the inspection." If a licensee identifies an issue that prompts a reactive inspection, or if a licensee identifies an issue while an inspection is open, the licensee's corrective action may not be fully formulated by the end of an inspection. This l can create an artificial constraint for assigning an NCV instead of a cited SL IV violation, i Judgement is required in these situations to reasonably accommodate the timing of events.  !

Denial of an NCV in favor of a cited SL IV violation should not be based solely on undeveloped '

l corrective actions due to the close proximity to the end of the inspection. If necessary, follow- ,

up discussions via phone with licensees should be made prior to completing the inspection I report (or inspection records for those inspections that do not require the issuance of an inspection report) to gain the information needed to make decisions regarding corrective action credit for licensee-identified violations. If the inspection report has to be issued and there has not been a reasonable time for the licensee to develop its corrective actions (but no longer than ,

30 days from licensee discovery), a potential violation that otherwise meets the criteria for an l NCV may be described in the inspection report as an Apparent Violation and still be converted i

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6 to NCV status once the corrective action becomes known. It is not necessary to designate the apparent violation as an escalated enforcement item (EEI) 8 8 In sum, NRC is interested in development of adequate corrective actions which reasonably may require more time after the inspection has been completed. An Enforcement Policy change is planned to remove the "by the end of the inspection" criteria for NCVs.

1.D. NCVs involving Programmatic lasues:

EGMs97-012 and 12A, dated June 9 and June 26,1997, respectively, previously provided guidance regarding NCVs, including guidance pertaining to programmatic' issues. That guidance stated that in the case of Severity Level IV programmatic issues, a formal citation is warranted for deterrence and to obtain a more detailed discussion on the docket of the licensee's comprehensive correction action rather than the brief discussion of corrective action typically included in the inspection report for an NCV. This EGM revises that guidance as follows: Notwithstandina that somewhat broader corrective action may be warranted for Severity Level IV oroarammatic issues. an NCV normally should be assianed for SL IV violations meetina the NCV criteria in Section Vll.B.1 of the Enforcement Poliev. includina non-recetitiveness, orovided that the documented descriotion of corrective actions taken or olanneo is sufficient to cover the oroarammatic nature of the issue. This is because of the safety significance of the SL IV issues and the lack of prior recurrence. If NCV treatment is not warranted. the Reaional or NMSS Enforcement Coordinator (as aoorooriate) should be consulted and the cover letter transmittina Seve ity Level IV citations involvina oroarammatic issues meetina NCV criteria must be sianed by the Reaional Administrator. or Office Director for cases orecared by NMSS. and must exclain the basis for the NRC concern. The same guidance applies if there are other reasons why a violation meeting the NCV guidance should be cited. The Enforcement Coordinator should consult with OE for consistency.

2. Use Enforcement Discretion per Sections Vll.B.2, Vll.B.3, Vll.B.4, and Vll.B.6 of the Enforcement Policy where warranted for Severity Level IV violations.

The enforcement discretion in Sections Vll.B.2, Vll.B.3, Vll.B.4, and Vll.B.6 of the Enforcement Policy may be applied at the SL IV level to not issue citations. These sections involve, respectively: violations identified during extended shutdowns or work stoppages, violations involving old design issues, violations identified due to previous enforcement action, and violations involving special circumstances. Regional or NMSS management should seek 2

NMSS expects to revise associated guidance in Inspection Manual Chapters 0610, 0303, and 2800 to reflect this practice.

As a means of following up on open items, inspectors should continue to review docket files, inspection reports and inspection records (field notes) during preparation for upcoming inspections.

Programmatic is used here to mean that broad corrective actions (e.g., substantial retraining, procedure revisions, or additional resources) are needed to address root cause, i.e.,

the issue is more than a failure of a person to implement a reasonable program requirement.

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guidance on specific cases from the Regional or NMSS enforcement staff (as appropriate) who will coordinate with OE for application of these discretion options and obtain an EA number.

Note: The term "NCV"is reserved for instances where the enforcement discretion in Sectign Vll.B.1 is used to not issue a citation for a Severity Level IV violation.

Violations not cited per Section Vll.B.2, Vll.B.3, Vll.B.4, or Vll.B.6 should be documented in inspection reports with a description as follows: "The NRC is exercising discretion in accordance with Section Vll.B.x of the Enforcement Policy and refraining from issuing a citation for this Severity Level IV violation." For those inspections that do not require the issuance of an inspection report, the inspector should include a statement similar to the above in the inspection record.

3. Do not require responses to cited Severity Level IV violations if the licensee's corrective action is already on the docket.

When a SL IV violation will be cited, the staff should consider whether a response to the NOV is necessary. A response is not necessary if the information that would be providad in the response is already on the docket, usually in the inspection report describing the violation or in a licensee's 30 day report. The Standard Forms for the cover letter and NOV in Appendix B of the Enforcement Manual include the appropriate text for situations where no response is required:

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed on the docket in (indicate correspondence, e.g.,

inspection Report No. XX-XXXXX/YY-NN, LER YY-NNN or letter from Licensee5 ] dated

. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position.

In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

When sufficient information about the licensee's corrective action is already on the docket. "no response reauired" should be the usual approach instead of the exceotion.

With respect to SL IV violations cited on NRC Form 591s, as indicated on the form, no response is required since the licensee commits, in writing, to complete the corrective actions discussed with the inspector. To reinforce the guidance in inspection Manual Chapter 0610, it is important that inspe:: tors document these violations and corrective actions in the inspection records so that inspectors can review their effectiveness during subsequent inspections.

In cases involving a potential SL IV violation where a 30 day report is required (reportable occurrence), the enforcement decision, I.e., issuance of either an NOV or NCV, should be  ;

deferred until the report is submitted, assuming it is provided within the required time frame.  !

The information in the 30 day report should confirm the existence of the violation and  !

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5 Reports from the licensee to NRC, such as 30 day reports, also may be used as the  !

source of docketed corrective actions.

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reasonably address the reason for the violation and the corrective actions taken and planned to

correct it and prevent recurrence. If so, NCVs can be issued if the discretion criteria is met or i

citations can be issued as "no response required," indicating the 30 day report as the source of i

the docketed correspondence. '

l It is appropriate to hold an item open until after receipt of a 30 day report in order for the issue i

to qualify as a "no response required" citation or an NCV. For a reactive inspection prompted by a reportable occurrence, it is possible that the inspection will have ended, the exit interview j will have occurred, and the inspection report will be in final preparation prior to receipt of the 30 day report, in such cases, the potential violation may be left open and documented in the i inspection report as an Apparent Violation, or the inspection report may be held so as to have l the final disposition of the violation included in the report and not have to issue subsequent j

correspondence. However, the inspection report shou ld not be held open past the limit in j Manual Chapter 0610.

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4. Do not use radiation safety committee meeting minutes or program audit records to j identify violations that the licensee is already aware of unless the corrective action j for the violation is not prompt or comprehensive.

l The Enforcement Policy places great emphasis and provides much incentive for licensees to j self identify and correct violations. The staff should not be focusing its enforcement attention

! on licensee-identified and corrected violations; rather inspectors should focus their attention on

} uncorrected potential safety issues and then determine whether associated violations should be j cited or treated as NCVs.

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[ Inspectors should not be revisiting licensee-identified and corrected issues documented in radiation safety committee meeting minutes or program audit reports solely for the purpose of identifying violations. This includes annual radiation protection program reviews and quality j management program reviews, and applies to after-the-fact reviews of records in which the

, corrective action process worked to correct deficiencies _or violations. It is acceptable, and j inspectors are encouraged, to review records to determine compliance with regulations and i license conditions that require licensees to perform audits (l.e., to determine whether the audits were performed, the adequacy of the audits, the timeliness of the program reviews, etc.) and to j identify circumstances where enforcement action is appropriate based on lack of corrective

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! Inspection Manual Chapter 0610 contains the following discussion on violations identified as l part of licensee self assessments :

I Violations identified as Part of Licensee Self Assessments. Under certain

)i circumstances, even a violation that could be classified as SL IV ("more-than-minor")

need not be documented. This is generally justified when the violation has been j identified and corrected as part of a licensee self-assessment effort. As a matter of policy, NRC enforcement seeks to encourage licensee self-assessment efforts, and seeks to avoid the negative impact that can result from a redundant NRC emphasis on problems which the licensee's responsible action has already identified and corrected.

9 Thus, in general, licensee radiation safety committee meeting minutes and program audit records should not be reviewed for the purpose of identifying violations on issues that licensees have already surfaced and corrected. In regard to issues identified by the licensee that NRC is following, the licensee should not be denied credit for identification if it is reasonably pursuing an issue it identified, even though NRC may have identified the associated violation first. This assumes the licensee's plans and intent were such that it is likely the licensee would have identified the violation within a reasonable time. During the corrective action process, inspectors should promptly inform the licensee of known pertinent safety significant information that the licensee may be unaware of.

This guidance should not be interpreted to prohibit challenges to licensee fixes to issues identified during program audits. Since licensees may arrive at incorrect or incomplete resolutions, inspectors should continue to review and question licensee conclusions, including 1 conducting reviews of program records. If the inspector can show that the licensee reached the wrong conclusion (s), enforcement action may be appropriate. l l

l Some large materials licensees, such as fuel facilities, may commit to implementing a corrective I action program to resolve significant escalated enforcement actions or following significant events. The guidance discussed above is also applicable to NRC reviews of these corrective action programs.

If SL IV violations are beina cited. and thev were identified bv reviewina radiation safety committee meetina minutes or oroaram audit records. the Division Director must aaree with the enforcement action after consultation with the Reaional or NMSS Enforcement Coordinator (as ,

anorooriate).

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5. Group multiple examples of the same violation into a single citation when appropriate.

The Enforcement Manual, Section 4.2.1, NOV Preparation, states:

As a general rule, multiple examples of the same violation during the period covered by an inspection should be included in one citation. However, if the violations were I committeo by different disciplines, on different systems, or in different areas of the  !

facility, it may be appropriate to issue separate citations, even if the same basic requirement was violated. . . Consider also whether different root causes are involved and different corrective actions are nuded for the different examples.

The test of whether or not multiple examples should be cited in a single violation is whether or not the corrective actions necessary to prevent recurrence for each example is similar to all the examples. If the corrective action is similar for multiple examples of violations of the same requirement (s), they should normally be cited in a single citation. For these situations, the following guidance is provided:

For circumstances in which one inspection report will follow another within a reasonable timeframe, an Unresolved item from a previous inspection report that is subsequently determined to be a violation may be included with additional examples in a subsequent inspection report if, in the judgement of the inspector and his or her management, the

1 10 similarities of the violations reasonably constitute " examples" of the same underlying violation.

Absent the multiple examples, each example must be able to stand alone as a separate SL IV violation, i.e., multiple minor violations must not be aggregated to justify a SL IV violation.

The number of examples cited should be limited to the number necessary to make the case for any corrective actions beyond the specific details of each example such that the scope and depth of needed corrective actions is illustrated. If numerous examples were identified during the inspection, the NOV should cite representative examples of the highest safety / regulatory significance.

l Details about individual examples in the inspection report or inspection record should be limited  ;

to that necessary to support the examples cited in the violation. It should not be necessary to discuss examples that are not being used in the cited violation. If the multiple examples stem from a common root cause, are easily corrected, and are not likely to recur due in part to the scope of the proposed corrective actions, the violation can be issued on a Form 591.

Otherwise, SL IV violations with multiple examples should be issued to the licensee in a formal l NOV. This does not require that an inspection report be issued; inspection records are acceptable.

l This guidance presumes that licensees will assess any needed corrective actions broadly l enough to encompass any broader issues illustrated by the multiple examples. As such, an I increased burden is placed on the inspection staff to ensure the comprehensiveness of {

corrective actions when performing follow-up inspection of the violation. I l

Other cases may arise in which additional examples of violations are identified that have  !

already been cited as NOVs or dispositioned as NCVs. In such cases, if corrective actions from the earlier issues have not been completed at the time of the violation and no broad additional corrective actions are warranted (i.e., the examples, if known at the time of the original inspection, would not have been included in the initial citation to establish the scope and depth of the needed corrective actions), the additional examples need not be cited. In these cases, if the additional examples are included in an inspection report, the text should include the following:

This violation constitutes an additional example of (identify the violation or NCV and where it was cited or noted. e.a.. Insoection Reoort YY-XX-XX. letter dated. . . Form 591 dated. . .. etc.) and is not being cited individually. No additional response is required regarding this violation. Further corrective actions for this additional example are expected to be taken in conjunction with corrective actions for the forevious NCV/oreviously cited violation)

When an inspection report is not required, additional examples should be documented in the inspection record with wording similar to that above.

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11 Administration This EGM is effective upon issuance. Enforcement actions issued 30 days after this EGM should reflect this guidance. Questions regarding implementation should be directed to the corresponding Regional or NMSS Enforcement Coordinator who will coordinate with OE as necessary.

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The Chairman The Commissioners L. Callan, EDO H. Thompson, DEDR W. Travers, DEDE C. Paperiello, NMSS J. Goldberg, OGC SECY

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Distribution J. Lieberman, OE Enforcement Coordinators RI, Ril, Rill, RIV, NMSS EGM File Day File WEB (2-week delay)

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