ML20082P422
| ML20082P422 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/1995 |
| From: | NRC |
| To: | |
| References | |
| NUREG-BR-0195, NUREG-BR-195, NUDOCS 9504260253 | |
| Download: ML20082P422 (63) | |
Text
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NUREG/BR-0195 CHANGE NOTICE NO. 2 Insert:
Remove:
Pane /EGMm Issue Date Pane /EGMm Issue Date
- 1. v 3/31/95 v
12/30/94
- 2. xi/xii, 3/31/95 xi/xii, 12/30/94 xv/xvi 3/31/95 xv/xvi 12/30/94
- 3. Chap.4:
3/4 3/31/95 Chap.4:
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- 4. Chap.5:
13/14 3/31/95 Chap.5:
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- 8. Chap.5:
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- 9. Chap.7:
9/10 3/31/95 Chap.7:
9/10 9/94 NOTE: To facilitate the Manual change process, remove current pages 9/10 thru 35 in Chapter 8 and replace with newly issued pages 9/10 thru 37 in Chapter 8.
Items 12 thru 16 indicate those pages where changes have been i
made.
- 10. Chap.8:
10, 11
- 11. Chap.8:
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- 13. Chap.8:
29/30
- 14. Chap.8:
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- 15. App.A:
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9504260253 950331 PDR NUREO BR-0195 R PDR
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- 20. App.B:133/134 3/31/95 App.B:133/134 12/30/94
- 21. App.B:177/178 3/31/95 App.B:177/178 12/30/94 181/182 3/31/95 181/182 12/30/94
- 22. App.B:185/186 3/31/95 App.B:185/186
- 23. App.B:187/188 3/31/95 App.B:187/188
- 24. App.B:189, 3/31/95 App.B:189, 191/192, 193/194 191/192, 193/194
- 25. App.B:195/196 3/31/95 App.B:195/196 197/198,199 3/31/95 197/198, 199
- 26. App.C:
15 3/31/95 App.C:
15 12/30/94
- 27. App.C:
17 3/31/95 App.C:
17 12/30/94
- 28. App.D:
7/8 3/31/95 App.D:
7/8 12/30/94
- 29. App.D: 43/44 3/31/95 App.D: 43/44 12/30/94 Remarks:
The following remarks correlate to the numbered page changes noted above.
Note that a page or group of pages can include more than one revision.
1.
Revised Change Notice Index to reflect the issuance of the second Change Notice, including temporary EGM 95-001(T).
2.
Revised Table of Contents to reflect the addition of new sections and the change in the location (page number) for other sections.
3.
Section 4.2.3.a:
included guidance to reflect that the Regional Administrator may redelegate to qualified inspectors, the authority to sign and issue NRC Form 591.
4.
Section 5.3.6:
added new guidance to ensure that Enforcement Conference Summaries are not published in NUREG-0940.
5.
Section 5.5.8.d:
added reference to Section 8.6.7 for distribution on cases involving VA facilities and radiographers..
n
,v 6.
Section 5.9.1.b:
added reference to new standard forms for Letters of Reprimand (Forms 38 and 39).
7.
Section 5.9.1.b.ll:
added an alternative provision of placing Letter of Reprimand (LOR) in the PDR within 45 days unless the individual can provide a sufficient basis to withdraw the LOR.
This provision should be used in those o s n where the individual has not been given an opportunity to dispt.te the :ction, such as during an enforcement conference or previously issued DFI.
8.
Section 5.9.4:
added new guidance to (1) specify that LORs be mailed by either Certified Mail or Express Mail, (2) specify that not all LORs be immediately placed in the PDR, (3) ensure that LORs are not published in
.1VREG-0940, and (4) specify that the licensee be shown on the "cc" on the LOR.
8.
Section 5.10:
added new section, " Settlement of Enforcement Actions,"
and included reference to new forms involving settlement agreements Forms 40 and 41.
9.
Section 7.3.4:
added additional guidance to clarify (1) that individual actions are normally issued after the NRC has conducted an enforcement cortference with the individual or after the NRC has issued a DFI, (2, that all individual actions should give the individual subject to O
the action an opportunity to dispute the action, including the Q
underlying facts, and include an NRC contact and telephone number, and (3) that staff should see the matrix in Appendix C for guidance on placing individual actions in the PDR.
9.
Section 7.3.4.e:
added additional guidance to emphasize that all DFIs should provide an opportunity for the individual to challenge the underlying facts, including any apparent violations.
10.
Section 8.1.5:
added new guidance regarding application of 10 CFR Part 50, Appendix B to health physice and safeguards areas.
11.
Section 8.3.6:
added new section to address application of 10 CFR Part 50, Appendix B to the safeguards area.
12.
Section 8.4.4:
added new section to address application of 10 CFR Part 50, Appendix B to the health physics area.
13.
Section 8.6.3.1:
added new section to address use of byproduct material in areas under exclusive Federal jurisdiction within Agreement Statee..
14.
Section 8.6.7:
renamed section, "Information Copies to Outside Organizations," and included guidance on providing copies to ASNT.
15.
Appendix A: Revised Temporary Enforcement Guidance Index to reflect the p
issuance of EGM 95-001(T).
16.
Appendix.A:
added EGM 95-001(T), " Severity Levels of Violations at Fuel Facilities.
17.
Modified Appendix B Standard Format Index to reflect addition of new Forms 38, 39, 40, and 41.
18.
Appendix B, Form 17: modified letter to reflect that orders do not require a licensee response.
19.
Appendix B, Form 29: modified letter to D0L to reflect NRC policy of reviewing all Section 211 complaints filed against NRC licensee, regardless of the DOL decision.
20.
Appendix B, Form 30: modified transmittal letter for an NOV to an individual to indicate that the action would be placed in the PDR within 45 days unless the individual provided sufficient justification to withdraw the NOV.
21.
Appendix B, Forms 36-1 and II:
included a sentence to allow the individual to provide any other information that they want the NRC to consider, including whether the statements made in Section II of the DFI are correct.
22.
Appendix B, Form 38:
added new form, " Letter of Reprimand to an Unlicensed Individual."
23.
Appendix B, Form 39:
added new form, " Letter of Reprimand to a Licensed Individual. "
24.
Appendix B, Form 40:
added new form, " Settlement Agreement."
25.
Appendix B, Form 41:
added new form, " Confirmatory Order Settling NRC Civil Penalty Imposed by Order."
26.
Appendix C: modified the distribution list for materials escalated enforcement actions to reflect the need to provide copies of actions involving medical licensees to the Chairman, Board of Trustees and actions involving radiographers to the ASNT.
27.
Appendix C: modified individual action matrix to specify that not all NOVs and LORs should be placed in the PDR when they are originally issued and that orders are published after they have been adjudicated or where hearing has not been requested within the time limit for requesting a hearing.
28.
Appendix D: modified standard citation 20-60 to reflect that the requirement applies to controlled areas as well as unrestricted areas.
29.
Appendix D: modified standard citation 35-121 to specify that the dose calibrator be checked for constancy with a dedicated check source at the l
beginning of each day of use.
l -
f i
i i
i 30.
Appendix D: modified standard citation 20-60 to reflect that the
'l requirement applies to controlled areas as well as unrestricted areas.
31.
Appendix D:. modified standard citation 35-121 to specify that the dose calibrator be checked for constancy with a dedicated check source at the beginning of each day of use.
l J
1 '
(d~3 CHANGE NOTICE
- INDEX -
l EGM SUBJECT DATE j
N/A 92-01(T)
Programmatic Maintenance Failures 01/02/92 N/A 94-Oll(T)
Violations Against 10 CFR 20.1301(a) Should Not be Cited in Misadministrations 07/26/94 N/A 94-013(T)
Revised Procedures for Conducting Open Enforcement Conferences During the Agency's Continuing Trial Program 08/15/94 1
N/A Various Subjects, Including Revision of The Enforcement Policy to Address Discrimination Issues 12/30/94 2
N/A Various Subjects, Including Information Involving Individual Actions and Settlement of Enforcement Actions 03/31/95 Q
2 95-001(T)
Severity Levels of Violations at Fuel Facilities 03/31/95 O
Rev. 03/31/95
Table of Conksds l
,m 5.5 Notice of Violation and Proposed Imposition of Civil Penalty (C.ivil Penalty) 23 5.5.1 Base Civil Penalty..................
24 f
5.5.1.1 Ability to Pay and Size of Operation.....
24 l
5.5.2 Civil Penalty Adjustment Factors...........
26 5.5.2.1 Identification................
26 5.5.2.2 Corrective Action
. 27 i
5.5.2.3 Licensee Performance.............
29 5.5.2.4 Prior Opportunity to Identify
. 31
~
5.5.2.5 Multiple Occurrences.............
33 l
5.5.2.6 Duration...................
33 i
I 5.5.3 Minimum Civil Penalties for Violations involving Overexposures, Release or Loss of Radioactive Material................
34 5.5.4 Civil Penalty Preparation
. 34 5.5.5 Civil Penalty Coordination and Review
. 38 5.5.6 Civil Penalty Enforcement Notification..
. 41 5.5.7 Civil Penalty Signature Authority
. 42 5.5.8 Licensee Notification, Mailing, & Distribution of Civil Penal ties.................
43 s
5.5.9 Press Releases for Civil Penalties..........
43 5.5.10 Licensee Response to Civil Penalty..........
44 5.6 Order imposing Civil Monetary Penalty (Imposition)
. 46 j
5.6.1 Imposition Preparation................
46 5.6.2 Imposition Coordination and Review..........
48 5.6.3 Imposition Enforcement Notification
. 49 5.6.4 Imposition Signature Authority............
50 5.6.5 Licensee Notification, Mailing, & Distribution of Impositions...................
50 5.6.6 Press Releases for Impositions............
51 5.6.7 Licensee Response to Imposition
. 51 5.7 Order Modifying, Suspending, or Revoking License
. 52 5.7.1 Immediately Effective Orders.............
53 5.7.2 Order Preparation 53 5.7.3 Order Coordination and Review
. 55 5.7.4 Enfm cement Notification for Orders
. 56 5.7.5 Order Signature Authority
. 57 5.7.6 Licensee Notification, Mailing, & Distribution of Orders 57 5.7.7 Press Release for Orders...............
58 5.7.8 Licensee Responses to Orders.............
58 5.7.9 Rel axation of Orders.................
59 i
NUREG/BR-0195 xi l
Table of Contents 5.8 Demand for Information (DFI) 59 5.8.1 DFI Preparation...................
59 5.8.2 DFI Coordination and Review 61 5.8.3 DFI Signature Authority 62 5.8.4 Licensee Notification, Mailing, & Distribution of DFIs
......................63 5.8.5 Licensee Respon<,e to DFI...............
63 5.9 Letter of Reprimand (LOR)..................
63 5.9.1 LOR Preparation
...................64 5.9.2 LOR Coordination and Review 66 5.9.3 LOR Signature Authority 67 5.9.4 Notification, Hailing, & Distribution of LORs
......................67 5.10 Settlement of Enforcement Proceedings and Actions......
67 6.
EXERCISE OF DISCRETION 1
6.1 Scope of Chapter 1
6.2 Escal ation of Sanctions....................
1 6.2.1 Nvil Penalties 1
6.2.2 0.iders......................... 3 6.2.3 Daily Civil Penalties 3
6.3 Mitigation of Sanctions.................... 3 6.3.1 Non-Cited Violations (NCVs) 3 6.3.1.1 Severity Level V Violations 5
6.3.1.2 Licensee-Identified Severity Level IV and V Violations...............
5 j
6.3.2 Violations Identified During Extended Shutdowns or Work Stoppages......... 6 6.3.3 Violations Involving Old Design Issues.........
7 1
6.3.4 Violations Identified Due to Previous Enforcement Action.................. 8 6.3.5 Violations Involving Special Circumstances 8
6.3.6 Violations Involving Discrimination 9
6.4 Notice of Enforcement Discretion (N0ED)...........
10 0
Rev. 03/31/95 xii NUREG/BR-0195
Table of Contents
-s i
i\\
7.11 Violations of Record-Keeping Requirements..........
44 7.12 Meetings With Licensees on NRC Enforcement Action......
44 7.13 Reopening Closed Enforcement Actions 45 7.14 Liability of Former and Successor Licensees.........
45 7.15 Enforcement Actions Involving Non-Power Reactor Licensees 46 8.
GUIDANCE ON ACTIVITY AREAS..............
1 8.0 Scope of Chapter I
8.1 Reactor Operations 1
8.1.1 Actions Invalving Inoperable Equipment.........
1 8.1.2 Actions Involving Degraded Equipment..........
5 8.1.3 Enforceability of FSAR Commitments........... 6 8.1.4 Citations Agairi:t 10 CFR Part 50, Appendix A, General Design Criteria (GDC) 9 8.1.5 Citations Against 10 CFR Part 50, Appendix B.....
10 8.1.6 Enforcement Actions in Conjunction With Pl ant Shutdowns................
11 O
8.1.7 Actions Involving Fire Protection 11 V
8.1.8 Actions Involving Loss of Decay Heat Removal (DHR)..
12 8.1.9 Actions Involving Service Water-Systems 15 8.2 Facility Construct hn....................
17 8.3 Safeguards 17 8.3.1 Compliance With the Security Plan Versus 10 CFR Part 73 17 8.3.2 Access Control....................
17 8.3.3 Searches.......................
19 8.3.4 Protection of Safeguards Information.........
20 8.3.5 Protection Ao; inst Vehicle Bomb Threats 20 8.3.6 Citations A';ainst 10 CFR Part 50, Appendix B.....
21 8.4 Health Physics 21 l
8.4.1 Acti:,ns Against Revised 10 CFR Part 20........
21 8.4.2 wbstantial Potential for Overexposure........
21 8.4.3 Enforcement Policy Regarding Occupational Doses From " Hot Particles".............
22 8.4.4 Citations Against 10 CFR Part 50, Appendix B.....
23 b
\\j NUREG/BR-0195 xv Rev. 03/31/95
Table of Contents 8.5 Transportation.......................
23 8.5.1 Memorandum of Understanding (M00) Between NRC and DOT....................
24 8.5.2 NRC Action in conjunction With State Action
. 24 8.5.3 Accessibility of Areas With Excessive Radi ation Level s..................
25 8.5.4 Exercise of Enforcement Discretion Involving Transportation Casks................
25 8.6 Fuel Cycle and Materials Operation
. 26 8.6.1 Activities of Unqualified Persons
. 26 8.6.2 Failure to Control or Account for Licensed Material and Unauthorized Disposal.........
27 8.6.2.1 General Licensees (10 CFR 31.5)
. 27 8.6.2.2 Unauthorized Disposal of Certain Transuranic Elements............
28 8.6.3 NRC Action Against Agreement State Licensee
. 28 8.6.3.1 Use of Material in Areas Under Exclusive Federal Jurisdiction Within Agreement State
. 29 8.6.4 Actions Involving Quality Management Programs
. 31 8.6.5 Failure to Perform an Adequate Survey of a Radiography Device
. 32 8.6.6 Actions Involving Radiation Safety Officers (RS0s)
. 33 8.6.7 Information Copies to Outside Organizations
. 34 8.6.8 Possession of Material Without a License.......
35 8.6.9 Severity Level For Failure to Report A Misadministration.............
35 8.7 Mi scell aneous Matters....................
36 8.8 Emergency Preparedness
...................36 8.8.1 10 CFR 50.54 Deficiency Grace Period.........
36 8.8.2 Actions. Involving Emergency Exercises
. 37 O
Rev. 03/31/95 xvi NUREG/BR-0195
t i
Non-Escalated Enforcesnent Actions Chapter 4 q
lV) c.
Caver letters that transmit inspection reports and non-escalated NOVs to licensees should be prepared by the region using the appropriate standard. format (Form 2) in Appendix B.
If an inspection report is not issued, as may be the case for certain mate rial licensees, then all references to the inspection report in Forn3 2 should be deleted.
The Special Inspection Branch, NRR and the Source Containment and Devices Branch, NMSS should use Form 10.
The letter should:
1.
Indicate why the violation is of concern (e.g., because it was a repetitive violation, it was a willful violation, the potential existed for a more significant impact, or it was identified by the NRC).
The explanation may be expanded, where warranted, to convey the appropriate message to the licensee in terms of those actions that require additional attention.
2.
Provide an explanation of why a citation is being issued if the enforcement action includes violations that meet the criteria for being addressed as non-cited violations, notwith-standing the guidance in the Enforcement Policy and in this Manual.
3.
Describe the response that is necessary from the licensee, including any area that deserves special emphasis.
4.
Address, if applicable, any apparent violations being consid-ered for escalated enforcement action and the scheduling of an enforcement conference.
4.2.2 NOV Coordination and Review Non-escalated NOVs should be coordinated and reviewed according to the following guidelines:
a.
Non-escalated NOVs are normally issued by the regions (or the Special Inspection Branch, NRR for vendor cases; the Source Containment and Devices Branch, Division of Industrial and Medical Nuclear Safety, NMSS for transportation shipping package cases; or the Operations Branch, Division of Fuel Cycle Safety and Safeguards, NMSS for MC&A cases at fuel cycle facilities) without 0E's prior review and approval.
b.
Regional Enforcement Coordinators should be available for consultation on non-escalated NOVs.
OV sp +
Chapter 4 Non-Escalated Enforcement Actions c.
Non-escalated enforcement actions that must be coordinated with OE prior to issuance include:
1.
Any actions based on willful violations or an 01 investigation.
2.
Any actions involving an individual (other than an individual licensed by 10 CFR Parts 30, 40, & 70).
3.
Any actions resulting from an Augmented Inspection Team (AIT),
Diagnostic Evaluation Team (DET), or Incident Investigation To m (IIT) inspection.
4.
Any actions related to currently proposed escalated enforcement actions.
5.
Any actions that are outside the boundaries of the Enforcement Policy or this Manual (e.g., severity level categorization beyond the supplements).
6.
Any actions involving the loss or failure to control or account for licensed material.
7.
Any actions resulting from the third or fourth instance of a repetitive violation where an enforcement conference is not held or a civil penalty proposed.
8.
Any actions the regions believe warrant headquarters' review.
9.
Any actions that the
- Director, OE believes warrant headquarters' review prior to issuance, such as Severity Level IV violations that were the subject of enforcement conferences where the Director, OE, requests OE review.
4.2.3 NOV Signature Authority Non-escalated NOVs should be signed and issued according to the following guidelines:
a.
The Regional Administrator, or designee, normally signs all nonescalated NOVs issued in the region. The Regional Administrator may redelegate to Section Chiefs and above, the authority to sign and issue non-escalated NOVs issued in the region. In addition, the Regional Administrator may redelegate to qualified inspectors, the authority to sign and issue NRC Form 591 (see Section 4.3 for additional guidance on the use of NRC Form 591).
b.
The Director, NRR may redelegate to Branch Chiefs and above, the authority to sign and issue non-escalated NOVs involving vendors.
c.
The Director, NMSS may redelegate to Branch Chiefs and above, the authority to sign and issue non-escalated NOVs for fuel facility MC&A violations and for shipping cask transportation violations.
d.
When an enforcement conference is held and does not result in an escalated action, the non-escalated action will normally be signed by the person conducting the enforcement conference.
O Rev. 03/31/94 4
Facalme d Enforcement Actions Chapter 5 fg handout.s, if used) will provide sufficient information to summarize the conference proceedings.
The summary should include the following information (if not already addressed in the licensee's handouts):
1, A brief description of the licensee's position (i.e.,
if the licensee agrees with the findings in the inspection report, or if i
the licensee takes issue with the apparent violation (s)).
i 2.
A brief description of significant additions or corrections to the factual information in the inspection report.
3.
A brief description of any significant additional information which affects the regulatory or safety significance of each violation.
4.
A brief description of the short-term and long-term corrective actions the licensee has implemented or has committed to implement.
(This description should be sufficient for the staff to apply the corrective action civil penalty adjustment factor.)
The region should keep in mind that a summary that is too detailed defeats the purpose of having a closed meeting.
The summary should not include predecisional, safeguards, or proprietary information.
The region should include the summary as part of the background material D
submitted with proposed escalated enforcement actions.
The Enforcement
(
Conference Summary should be sent to the licensee either before or when
\\
the enforcement action is issued.
If the summary is included as an enclosure to the escalated action, the following parenthetical should be included after listing the summary as an enclosure: "(not to be published in NUREG-0940)."
5.3.7 Enforcement Conference Outcome Depending on the information gathered during the enforcement conference, the staff will determine (a) that escalated action should be proposed, (b) that non-escalated action should be proposed, (c) that no violation occurred, or (d) that additional violations should be addressed.
a.
If the staff concludes that escalated enforcement action should be proposed (including Severity Level IV violations with proposed civil penalties), the region should prepare the appropriate escalated enforcement action and package.
b.
If the staff concludes that non-escalated enforcement action should be proposed, the regions may generally isste the non-escalated enforcement action after coordination (not prior review and approval) with OE.
In special cases, OE may request review and approval prior to issuing a Severity Level IV violation that was the subject of an enforcement conference. The region should include an explanation in the cover letter to the licensee of why non-escalated action was appropriate in the particular case.
The final action NUREG/BR-0195 13 Rev. 03/31/95
Chapter 5 Escalated Enforcement Actions should be signed by someone at least at the level of the presiding official at the enforcement conference and should be sent to OE to close out the EA number.
c.
If the staff concludes that no violation occurred, the region should inform the licensee that the NRC does not intend to issue enforce-ment action. The region may use the Enforcement Conference Summary to clarify why a citation wn not issued.
d.
If additional facts are d'esclosed or developed (at or after the enforcement conference) that could lead to additional violations, special efforts should be taken to substantiate these violations before they are included in the proposed enforcement action.
In addition, it may be appropriate to contact the cognizant licensee official, by at least a telephone enforcement conference call, to (1) discuss the apparent violation before it is formalized and (2) provide any additional information that may be relevant.
5.4 Escalated Notice of Violation (NOV)
Notices of Violation are addressed in Section VI.A of the Enforcement Policy, and 10 CFR 2.201 sets forth the procedures for issuing NOVs.
An NOV is a formal written citation setting forth one or more violations of a legally binding requirement.
An NOV including Severity Level I,
II, or III violations is considered escalated enforcement action. Civil penalties are normally proposed for violations at Severity Level I, II, or III. The staff may mitigate a civil penalty for a Severity Level I, II, or III violation by applying the civil penalty adjustment factors or exercising discretion as discussed in Section VII.B of the Enforcement Policy.
Escalated NOVs are normally issued subsequent to enforcement conferences.
The timeliness goal for the regional offices to submit proposed escalated NOVs to headquarters is 35 calendar days after the inspection has been completed. The timeliness goal for OE to issue escalated NOVs is 21 calendar days after receiving the regional recommendation.
The timeliness goal for the regional offices to issue delegated escalated NOVs involving materials licensees is 42 calendar days after the inspection has been completed.
(See the guidance in Section 2.4.1.d for complete details regarding this regional delegation.)
5.4.1 Escalated NOV Preparation The regions (or the Special Inspection Branch, NRR for vendor cases; the Source Containment and Devices Branch, Division of Industrial and Medical Nuclear Safety, NMSS for transportation shipping package cases; or the Operations Branch, Division of Fuel Cycle Safety and Safeguards, NMSS for MC&A cases at fuel cycle facilities) should prepare the enforcement package consisting of (a) the Enforcement Action Recommendation Worksheet, (b) the NOV citation, (c) the enforcement action transmittal letter, and (d) the Reference Document Checklist with the supporting documents.
Enforcement packages should also include a draft Commission paper, if applicable (see Section 2.11).
Rev. 03/31/95 14 NUREG/BR-0195
r P
Escalated Enforcement Actions Chapter 5 '
i f.
The Regional Administrator (or designee) normally signs and issues delegated civil penalty actions for Severity Level III violations involving medical institutions, physicians, nuclear pharmacies, academic institutions, radiographers, irradiators, well loggers, and gauge users, without prior review and approval-by the Director, OE.
5.5.8 L.icensee Notification, Mailing, & Distribution of Civil Penalties Licensee notification, mailing, and distribution should be made according to the following guidelines:
i a.
In most cases, the region will notify the licensee by telephone of
)
an enforcement action involving a civil monetary penalty. However, in certain cases (determined on a case-by-case basis), headquarters personnel will provide this notification.
In all cases, the licensee will be notified of the proposed civil penalty before the information is made public.
b.
Licensees are to be provided a written copy of escalated enforcement actions as expeditiously as possible.
Electronic transmission of escalated enforcement actions should be used to provide a written 1
copy to licensees having facsimile equipment.
Al ternal,17:ly, licensees in close geographic proximity to regional offices may j
choose to have a written copy picked up by courier from the regional office.
In addition, escalated enforcement packages are to be
~
mailed by either Certified Mail (Return Receipt Requested) or Express Mail.
If facsimile equipment is not available, escalated enforcement packages are to be mailed by Express Mail.
c.
The office in which the package is signed is responsible for its distribution.
Distribution lists for NRC are-included in Appendix C.
In addition, a copy should be sent to the appropriate State.
d.
For all escalated enforcement actions involving medical licensees, the distr.:;ution list should include the Chairman, Board of Trustees. See Section 8.6.7 for distribution on cases involving VA medical facilities or radiographers.
5.5.9 Press Releases for Civil Penalties Press releases are generally issued for proposed civil penalty actinns, i
Regional enforcement personnel will inform the regional Public Affairs Officer (RPA0) when these actions are about to be issued. The RPA0 will provide a pres ; release to the regional staff for concurrence.
OE may also review pross releases in some particularly significant cases. After the enforcemer t action has been signed, the RPA0 will verify that the licensee has been notified of the action and has received a copy.
The s
NUREG/BR-0195 43 Rev. 03/31/95
l Chapter 5 Escalated Enforcement Actions 1
press release is generally issued 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee receives a copy of the enfcrcement action.
If the licensee issues its own press release during the intervening period, the RPA0 may proceed to issue a press release.
All press releases should include information regarding the status of the facility's corrective actions (e.o.,
corrective actions have been initiated and appear acceptable; or, plant will remain shut down until completion of corrective actions), the facility's recent operating history, as appropriate, and a brief basis for escalating or mitigating the civil penalty to present a balanced account to the public.
5.5.10 Licensee Response to Civil Penalty The provisions of 10 CFR 2.201 require that a licensee submit a written response addressing the violations included within a civil penalty action within 20 days of the date of the civil penalty action or other specified time frame; however, normally 30 days should be used.
If a licensee does not respond to a civil penalty action within the allotted time and the region has made several unsuccessful attempts to contact the licensee, the region should contact OE within 45 days and consideration will be given to whether the case should be referred to the Attorney General or whether an order imposing the civil penalty should be issued or whether some other enforcement action is warranted.
Licensees may be granted response extensions where good cause is shown.
The region may grant extensions of up to 2 weeks without OE approval. OE should be promptly notified of any extensions the region grants.
OE approval is required for extensions beyond two weeks.
Generally, verbal requests for extensions should be promptly followed up with written confirmation of the length of the extension and the date a reply is due.
The confirmation may either be prepared by the NRC or the licensee.
A copy of this followup correspondence is to be sent to OE and the region.
Within 2 weeks, responses should be reviewed for completeness of information. If the response is missing information necessary to evaluate the licensee's action, OE should be promptly notified, and the region, after coordination with OE, should take action to obtain the necessary information without waiting for action under b or c below.
In its response, licensees may: (a) admit the violation and pay the civil penalty; (b) deny the violation, contest the sta ff's facts or conclusions, or request mitigation of the civil penalty and pay the civil penalty; or (c) deny the violation, contest the staff's facts or conclusions, or request mitigation of the civil penalty and not pay the civil penalty.
a.
If the licensee admits that the violation occurred as stated in the NOV and pays the civil penalty, the regional office is to review the licensee's corrective action. The region should notify OE, usually within 2 weeks of receiving the licensee's response, of the acceptability of the licensee's response.
Rev. 03/31/95 44 NUREG/BR-0195
l Escalated Enforcement Actions Chapter 5 1
5.8.4 Licensee Notification, Mailing, & Distribution of DFIs l
Licensee notification, mailing, and distribution for DFIs should be made l
l according to the following guidelines:
a.
In most cases, the regior. will notify the licensee by telephone of the issuance of a DFI. However, in certain cases (determined on a case-by-case basis), headquarters personnel will provide this notification, b.
Licensees are to be provided a written copy of the Demand as expeditiously as possible.
Electronic transmission should be used to provide a written copy to licensees having facsimile equipment.
Demands should be mailed by Express Mail.
c.
OE is responsible for distribution of the Demand.
Distribution lists for NRC are included in Appendix C.
(See Section 7.3.4.e for guidance on distribution to the PDR for DFIs involving individuals.)
5.8.5 Licensee Response to DFI The provisions of 10 CFR 2.204 require that a licensee submit a written L
response to a DFI under oath or affirmation within 20 days of the date of the DFI or other specified time frame (determined on a case-by-case i
basis).
(The provisions of 10 CFR 2.204 provide that an individual to i
whom the Commission has issued a DFI may submit a written response to a DFI under oath or affirmation within 20 days of the date of the DFI or other specified time frame; see Section 7.3 for guidance on enforcement actions involving individuals.)
If a licensee does not respond to a DFI within the required time, the NRC will consider issuing an order to modify, suspend, or revoke the licensee or consider taking such other action as necessary to compel a response.
After reviewing the licensee's response to the DFI, the NRC determines whether further action is necessary to ensure compliance with regulatory requirements.
5.9 Letter of Reprimand (LOR)
Letters of Reprimand are addressed in paragraph (4) of Section VI.D of the Enforcement Policy. An LOR is a letter addressed to an individual (licensed or l
unlicensed) subject to Commission jurisdiction identifying a significant deficiency in their performance of licensed activities. An LOR may be issued to an individual for a violation when the NRC determines that more formal enforce-ment action against the individual is not warranted. The letter should serve as a vehicle for notifying the individual that his or her actions are unacceptable g
and that if uncorrected or continued, they could lead to formal NRC enforcement action. LOR are normally issued after the NRC has held an enforcement conference j
l I
Chapter 5 Escalated Enforcement Actions with the individual or after the NRC has issued a DFI to the individual. An LOR may be issued in conjunction with an enforcement action against the licensee.
5.9.1 LOR Preparation The regions (or the Special Inspection Branch, NRR for vendor cases; the Source Containment and Devices Branch, Division of Industrial and Medical Nuclear Safety, NMSS for transportation shipping package cases; or the Operations Branch, Division of Fuel Cycle Safety and Safeguards, NHSS for MC&A case's at fuel cycle facilities) should prepare the LOR consisting of (a) a brief memorandum to the Director, OE, (b) the LOR, and (c) the Reference Document Checklist with the supporting documents.
To avoid the release of predecisional information, all documents included in LOR packages should be marked " Proposed Enforcement Action:
Not For Public Disclosure Without The Approval Of The Director, OE."
a.
A brief memorandum should be prepared to the Director, OE summarizing the basis for the LOR.
In particular, the memorandum should address the basis for issuing an LOR versus formal enforcement action for those cases where formal enforcement action could be issued (action against an operator's license or action in accordance with the Deliberate Misconduct Rule).
b.
The LOR should be prepared using the applicable standard format for the specific case (Form 38 or 39) and should, depending on the recipient and nature of the letter, include the following elements, as applicable:
1.
Docket and license numbers.
2.
A description of relevant events, facts, or circumstances that substantiate issuing the LOR.
This description should reference relevant inspection reports, 01 reports, previous correspondence, or enforcement conferences.
3.
A discussion of enforcement action, if any, that was taken against the facility licensee.
If an enforcement action was issued to the facility, a copy should be enclosed.
4.
A reminder of an NRC licensed Reactor Operator's responsibilities.
For example-
"You are reminded that you hold a license from the United States government that confers upon you the special trust and confidence of the American people in the safe operation of nuclear facilities and places you in the position where your performance is expected to be above reproach. This includes as an NRC Reactor Operator license holder. your resp <msibility to remain alert and attentive at all times to ensure protection of the public health and safety. Your actions (condition) on (date) did not meet those standards."
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Escalated Enforcanent Actions Chapter 5 O
V 5.
A discussion of how an NRC licensed Reactor Operator failed to meet their responsibilities.
l l
'6.
Notification of the NRC's authority to take action against individuals.
For example:
"You should be aware that the NRC's regulations allow enforcement actions to be issued directly to unlicensed persons who through their deliberate misconduct, cause a licensee to be in violation of NRC requirements. Similarly, an order may be issued to such an individual I
preventing him or her from engaging in licensed activities at all NRC licensed facilities."
7.
A statement that the Deliberate Misconduct Rule is included as an enclosure to the letter.
8.
The basis for not issuing formal enforcement action against the individual.
9.
A statement notifying the individual that his or her actions are unacceptable and that if uncorrected or continued, could lead to formal NRC enforcement action.
10.
A statement that the individual is not required to respond to the letter. However, if the individual wants to respond, the (O
response should be made to the originating office within i
V) 30 days of the date of the letter.
11.
A statement that the letter (and any enclosures), with the individual's home address deleted will be placed in the NRC Public Document Room (PDR) or will be placed in the PDR after 45 days unless they provide sufficient basis to withdraw the LOR. The latter provision should be used in those cases where the individual has not been given an opportunity to dispute the action, such as during an enforcement conference or previously issued DFI.
c.
The regions should compile the information that supports the rationale for the Letter of Reprimand and indicate the enclosed documents on the Reference Document Checkli st, including (as applicable):
1.
NRC Inspection Report ur other documentation of the facts of the case.
2.
Licensee report or other incident / event report.
3.
Applicable license conditions, including technical specifica-tions or FSAR sections.
O 4.
Applicable' licensee procedures or extracts from license application.
NUREGIBR-0195 65 Rev. 03/31/95
Chapter 5 Escalated Enforcement Actions 5.
Enforcement Conference Summary, including all handouts.
The Reference Document Checklist should indicate those documents that were previously sent to headquarters.
5.9.2 LOR Coordination and Review LORs are sent to headquarters for review and approval prior to issuance.
LORs should be submitted to headquarters according to the following guidelines.
The brief memorandum to the Director, OE, summarizing the basis for the proposed action and the proposed LOR should be electronically mailed to OE ("0EMAIL"), the Deputy Assistant General Counsel for Enforcement, and the Associate Director for Projects, NRR for reactor cases; or the Associate Director for Projects, NRR and the Chief, Operator Licensing Branch for licensed operator cases; or the Director, Division of Industrial and Medical Nuclear Safety, NMSS for materials cases.
Draft Commission papers should also be electronically mailed, if applicable.
These documents and the Reference Document Checklist and supporting background materials should be mailed (1-day-overnight delivery) to the same addressees.
All documents, including staff comments on escalated enforcement packages, should be marked " Proposed Enforcement Action: Not for Public Disclosure Without The Approval Of The Director, OE."
In addition, enforcement packages including safeguards information should be clearly marked:
" Safeguards Information - Handle in Accordance With 10 CFR 73.21."
Internal staff reviews and comments should not be sent to the PDR.
Notwithstanding the stated steps and timeliness goals for the coordination and review process, it is recognized that additional steps and/or review time may be necessary for unusually complex cases.
a.
Unless OE requests, 0GC will not normally provide comments for LORs.
b.
The applicable program office may be requested to review a particu-lar proposed LOR.
The Operator Licensing Branch in NRR should review all LORs to licensed operators.
Program office reviews should be performed with a focus on ensuring that the technical accuracy of the issues and the significance of the issues with respect to safety has been properly evaluated from an overall agency perspective.
Program offices should address the questions, as applicable, in the Program Office Review Checklist included in Appendix C.
Comments should be forwarded to OE within 5 working days.
c.
OE will consider timely program office comments (if applicable) and revise the LOR, as appropriate. The OE Enforcement Specialist will notify the program office Project Manager when substantive program office comments are not going to be incorporated into the final proposed enforcement action.
Rev. 03/31/95 66 NUREG/BR-0195
n h.he=I Enforcennent Actions Chapter 5.
cQ b
d.
OE will' forward the revised LOR to the region indicating where the action was revised (normally through the use of comparative text)-
and explaining _any significant changes.
e.
The region should review the revised LOR and, if possible, provide concurrence on headluarters' changes by the next day.
f.
OE will approve issuance of the action or, if. warranted, will consult with the DEDO, as appropriate.
5.9.3 LOR Signature Authority The Regional Administrator (or designee) normally signs and issues LORs, after review and approval by the Director, OE.
5.9.4 Notification, Mailing, & Distribution of LORs The region is responsible for mailing and distributing LORs. LORs should be mailed by either Certified Mail (Return Receipt Requested) or Express Mail. '0E should be on distribution for all LORs.
The region must ensure that the copies of LORs that are placed in the Public Document Room do not include individuals' home addresses.
Not all LORs should immediately be placed in the Public Document Room (POR).
In those cases where the individual has not been given an opportunity to dispute the action, such as during an enforcement conference or in response to-a previously issued DFI, the LOR should state that it will be placed in the PDR after 45 days unless they provide sufficient basis to withdraw the LOR.
LORs are not and should not be published in NUREG-0940. Because LORs may be issued in conjunction with escalated enforcement actions, the following l
guidance should be: followed to avoid publication of LORs in NUREG-0940.
First, the escalated enforcement action cover letter to the licensee should indicate that an LOR is being issued in separate correspondence.
Second, the LOR should not be shown as an enclosure to the action to the licensee.
Finally, the licensee should be shown on the "cc" on the LOR.
5.10 Settlement of Enforcement Proceedings and Actions 10 CFR 2.203 sets forth procedures for settlement of a proceeding to modify, suspend, or revoke a license or for other action and compromise of a civil i
penalty.
For those cases where a hearing has been requested, the staff (normally OGC has the lead) is responsible for preparing a settlement agreement. The settlement O
agreement should retain the same EA number as the original proposed enforcement action and should be signed by the signatory official for the licensee and a NUREG/BR-0195 67 Rev. 03/31/95 j
Chapter 5 Escalated Enforcement Actions hearings attorney for the NRC.
The stipulation or compromise is subject to enproval by the designated presiding officer, or if none has been designated, by the Chief Administrative Law Judge. If approved, the ASLB will issue a decision or order settling and discontinuing the proceeding that will include the terms of the settlement or compromise.
For those cases that do not involve a hearing, the staff (normally OE) is responsible for preparing a settlement agreement.
(See the sample standard format (Form 40) in Appendix B.) The settlement agreement should retain the same EA number as the original proposed enforcement action and should be signed by the signatory official for the licensee and the Director, OE for the NRC.
The settlement is subject to approval by the Director, OE after consultation, as warranted, with the DEDO.
If approved, the staff (normally OE) will prepare an order settling, modifying, or discontinuing the enforcement action that will include the terms of the settlement or compromise.
(See the sample standard format (Form 41) in Appendix B.
O O
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Miscellaneous Guidance Chapter 7
,m 8.
The degree of management responsibility or culpability.
9.
Who identified the misconduct.
7.3.4 Action Against the Individual The particular sanction to be issued to an individual should be determined on a case-by-case basis.
Examples of sanctions include:
(a) Letters of Reprimand (LORs),
(b) NOVs, (c)
- orders, (d) civil penalties, or (e) Demands for Information.
An enforcement conference with the individual should normally be conducted before taking enforcement action against an individual.
In some cases, a DFI may be appropriate.
In any event, if the person has not had an opportunity to dispute the NRC's proposal, the action should give the individual an opportunity to dispute the action, including the underlying facts, and include an NRC contact and telephone number.
See the matrix in Appendix C for guidance on placing individual actions in the PDR.
a.
LORs are addressed in paragraph (4) of Section VI.D of the Enforcement Policy and in Section 5.9 of this Manual.
A LOR is a letter addressed to an individual (licensed or unlicensed) subject to Commission jurisdiction, identifying a significant performance deficiency.
A b.
NOVs may be issued to licensed or unlicensed individuals.
c.
Orders to NRC-licensed reactor operators may involve suspension for a specified period, modification, or revocation of their individual licenses.
Orders to unlicensed individuals may include provisions that:
(1) prohibit involvement in NRC licensed activities for a specified period of time (normally the period of suspension would not exceed 5 years) or until certain conditions are satisfied (e.g.,
completing specified training or meeting certain qualifications),
(2) require notification to the NRC before resuming work in licensed activities, or (3) require the person to tell a prospective employer or customer engaged in licensed activities that the person has been subject to an NRC order.
d.
An NRC-licensed operator may be assessed a civil penalty; however, such cases are rare, and require Commission approval.
Section 234 of the Atomic Energy Act (AEA) gives the Commission authority to impose civil penalties on "any person." However, except for individuals subject to civil penalties under Section 206 of the Energy Reorganization Act of 1974 (see the Enforcement Policy,Section VIII, Footnote 8), the NRC will not normally impose a civil penalty against an individual.
e.
Demands for Information (DFIs) are addressed in paragraph (5) of Section VI.D of the Enforcement Policy, and 10 CFR 2.204 sets forth the procedures for issuing DFIs. Demands for Information are also m[d
\\
addressed in Section 5.8 of this Manual. A DFI is a formal request NUREG/BR-0195 9
Rev. 03/31/95
Chapter 7 Miscellaneous Guidance for information that can be made to an individual for the purpose of enabling the NRC to determine whether an order or other enforcement action should be issued. An individual to whom the NRC has issued a DFI may, in its discretion, respond to a DFI by filing a written response under oath or affirmation.
All DFIs should provide an opportunity for the individual to challenge the underlying facts, including any (apparent) violations.
Demands for Information issued to individuals should be placed in the PDR or LPDR as follows:
1 1.
The DFI should be placed in the PDR/LPDR when the DFI is l
originally issued if the NRC has concluded that a violation exists, the NRC has information regarding the individual's level of involvement in the violation, the individual has had an opportunity to contest the violation, and the DFI is requesting information as to why, given the information, the individual should remain in licensed activities.
The home address should be deleted.
2.
The DFI should not be placed in the PDR/LPDR when the DFI is originally issued if the NRC has concluded that a violation exists and the DFI is requesting information regarding the individual's level of involvement in the violation.
If the staff review of the individual's response concludes that the individual was personally involved in the violation, or if the individual has not replied within the requested response time, the DFI and any other enforcement action and the individual's response, should then be sent to the PDR or LPDR.
The home address should be deleted from all documents sent to the PDR/LPDR.
If the staff review of the individual's response concludes that the individual was not personally involved in the violation, then a letter should be sent to the individual after approval by OE and the DFI and the individual's response should not routinely be sent to the PDR/LPDR.
3.
The DFI should not be placed in the PDR when the DFI is originally issued if the NRC has not concluded that a viola-tion exists and the DFI is requesting information regarding the apparent violation and the individual's level of involve-ment in the apparent violation.
If the staff review of the individual's response concludes that a violation exists and the individual was personally involved in the violation, or if the individual has not replied within the requested response time, the DFI and any other enforcement action and the individual's response, should then be sent to the PDR or LPDR.
The home address should be deleted from all documents sent to the PDR/LPDR.
If the staff review of the individual's response concludes that a violation does not exist or if a violation exists but the individual was not personally O
Rev. 03/31/95 10 NUREG/BR-0195
Guidance on Activity Areas Chapter 8
)
tV In addition to the guidance provided regarding citations against 10 CFR 50.59, in cases where a licensee has never implemented a commitment made under oath in the FSAR or amended FSAR, a waterial failure to have the facility conform to the FSAR may also constitute a violation of 10 CFR 50.9 if it occurred after 10 CFR 50.9 became effective (Decem-ber 31, 1987), or constitute a material false statement (see Section 5.6).
As a final note, in determining which enforcement action to recommend for a failure to implement an FSAR commitment-(i.e., NOV against a specific requirement, Appendix B,10 CFR 50.59,10 CFR 50.9; or Notice of Deviation against the FSAR), the region should consider which enforcement action will convey the appropriate message to the licensee and which enforcement action will constitute the strongest citation (i.e., most defendable).
8.1.4 Citations Against 10 CFR Part 50, Appendix A, General Design Criteria (GDC)
The general design criteria (GDC) may be viewed as legally binding on a licensee in the absence of an approved alternative design basis.
- Thus, they can be cited in cases where the construction permit postdates the effective date of the GDC. In many cases, however, the apparent violation can be tied to a more explicitly applicable NRC requirement (i.e., the plant TSs, FSAR statement, or plant procedures that are implemented to p
satisfy a requirement in the TSs).
In those few cases where an explicit (v) requirement does not exist, consideration should be given to use of the GDC.
While some of the GDC establish minimum requirements for the principal design criteria in terms of broad performance standards, others are more prescriptive (i.e., specifying particular numerical standards that must be achieved or system configuration requirements). Generally, only those GDC that include specific criteria should be used in enforcement action citations.
The following is an example of an appropriate citation that uses a GDC:
10 CFR Part 50, Appendix A, General Design Criteria (GDC) 56 requires, in part, that each line that connects directly to the containment atmosphere and penetrates primary reactor containment shall be provided with containment isolation valves both inside and outside the primary containment, unless it can be demonstrated that the containment isolation provisions for a specific class of lines, such as instrument lines, are acceptable on some other defined basis.
J Contrary to the above, as of August 4,1993, the containment isolation configuration for the primary containment radiation monitoring (PCRM) system violated the requirements of GDC 56, in that containment isolation valves were not provided on the system lines both inside and outside the primary containment and this configuration was not accepted on some other defined basin.
O NUREG/BR-0195 9
Chapter 8 Guidance on Activity Areas Because of the nature of some GDC, OE is to be consulted when citations against the GDC are considered. OE will discuss the matter with NRR and OGC as appropriate.
8.1.5 Citations Against 10 CFR Part 50, Appendix B Citations for Quality Assurance (QA) issues that are violations of 10 CFR Part 50, Appendix B should be constructed with a clear statement of the applicable Appendix B criterion, followed by a statement of how that requirement was not met. (Note that 10 CFR Part 50, Appendix B applies to safety-related structures, systems, and components.) Normally, it is not necessary to include a reference to 10 CFR 50.54(a) or 50.55(f) as the underlying regulation when citing Appendix B.
It is also normally not necessary to reference that portion of the licensee's approved QA program which implements Appendix B, unless the licensee's approved QA program significantly differs from that of Appendix B.
In most circumstances, the licensee's QA program is consistent with and amplifies the provisions of Appendix B and, therefore, a reference to the licensee's QA program is not normally necessary.
If there is a conflict between an approved QA plan and Appendix B, the matter should be discussed with OE and NRR before issuing a violation.
In the case of operating reactors where the TS administrative requirements may encompass certain Appendix B requirements, such as procedures, the TS, if more specific, should be cited.
However, it may be appropriate in a particular case to utilize Appendix B for the citation if broader corrective action is appropriate.
The following is an example of a citation against 10 CFR Part 50 Appendix B for failure to take corrective action.
10 CFR Part 50 Appendix D, Criterion XVI, " Corrective Action," requires, in part, that measures shall be established to assure that conditions adverse to quality, such as failures, deficiencies, and deviations, are promptly identified and corrected.
Contrary to the above, from June 10,1994 to August 3,1994, the licensee failed to take prompt and adequate corrective action for a condition adverse to quality. Specifically, on June 10,1992, a quality assurance auditor identified that a longitudinal pipe weld on the low head safety injection system was not included in the licensee's In-Service Inspection program and the licensee failed to conduct sufficient additional reviews to identify and resolve similar problems with longitudinal pipe welds that were present in other safety-related piping.
Note in this particular example of an Appendix B citation, that the
" contrary to" paragraph indicates that the licensee failed to take corrective action for a condition adverse to cuality.
This element is essential for Criterion XVI citations.
As noted above, Appendix B applies to safety-related structures, systems, and components.
As such, the provisions of Appendix B do not generally apply to the radiation protection and safeguards areas.
There may be Rev. 03/31/95 10 NUREG/BR-0195
' Guidance on Activity Areas Chapter 8 j
,/^\\
l C) i cases, however, where procedures relating to security and radiation i
protection might be subject to Appendix B quality assurance criteria under some circumstances (where " quality assurance" as defined in Appendix B comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform l
satisfactorily in service.).
See Sections 8.3.6 and 8.4.4 for further j
guidance on citations against Appendix B in the safeguards and radiation protection areas, respectively.
8.1.6 Enforcement Actions in Conjunction With Plant Shutdowns i
Enforcement actions based on findings at plants with major shutdowns I
should be processed substantially before restart is contemplated. There-fore, cases should normally be submitted to OE at least two months before scheduled startup, if possible. This should permit the case to be issued and the licensee's corrective action to be assessed prior to startup and will avoid issuing sanctions at the same time or after startup is authorized. A similar logic should be followed for plants to be licensed.
8.1.7 Actions Involving Fire Protection Fire protection requirements are established by 10 CFR Part 50, Appen-dix A, GDC 3; 10 CFR 50.48; 10 CFR Part 50, Appendix R; facility license Q
conditions; facility TSs; and other legally binding requirements, as applicable.
Failures to ment regulatory requirements for protecting trains of equipment requi'ed for achieving and maintaining safe shutdown constitute serious violat hns. Fire protection violations may involve inoperable or inadequate fira barriers; separation, suppression, or detection systems; repair parts; procedures; or other conditions or items required to prevent fires, protect shutdown equipment during a fire, or restore safe shutdown equipment to service following an actual fire.
Violations specific to a given case should be reviewed individually and as a group to determine their root cause(s).
Numerous violations of fire protection requirements which individually may be classified at lower severity levels may cumulatively be classified at a higher severity level because the multiple violations indicate inadequate implementation of the fire protection program.
The following guidance provides examples of violations at various severity levels and should be used as a guide to determine the appropriate enforcement action.
For purposes of this guidance, required structures, systems, and components are those that are necessary to achieve and maintain safe shutdown and that require the application of fire protection features as described in the licensee's fire hazards analysis report and O
NRC's safety evaluation report.
NUREG/BR-0195 11 Rev. 03/31/95
r Chapter 8 Guidance on Activity Areas Severity Level I: Violations of fire protection requirements established to protect or enable operation of safe-shutdown equipment, for cases in which an actual fire damages that equipment to such a degree that safe shutdown could not be achieved or maintained.
Severity Level II: Violations of fire protection requirements established to protect or enable operation of safe-shutdown equipment, for cases in which a postulated fire in the area would so damage that equipment that safe shutdown would not be achieved and maintained.
Severity Level III: Violations of fire protection requirements established to protect or enable operation of safe-shutdown equipment, for cases in which a postulated fire in the area, in the absence of additional evaluation, could so damage that equipment that shutdown could not be achieved and maintained using the applicable equipment identified in the fire hazards analysis in accordance with applicable requirements.
Failure to have an adequate written evaluation available for an area in which Appendix R compliance is not apparent will be taken as an indication that the area does not comply with NRC requirements, and may result in enforcement action at this severity level. Note that licensees may exer-cise engineering judgement as to the threshold for documenting detailed analysis for spurious equipment actuations following a fire.
- Thus, potential spurious actuations judged by the licensee to not involve substantial risk to safe shutdown capability may not be covered by documented evaluations.
The NRC may judge differently the potential impact on safe shutdown capability, and may request the licensee to provide additional analysis.
A Level III violation is probably not warranted unless this additional analysis confirms a significant problem.
Severity Level IV: Failures to meet one or more fire protection require-ments that do not result in a Severity Level I, II, or III violation and which have more than minor safety or environmental significence.
Severity Level V:
Violations of fire protection requirements that have minor safety or environmental significance.
8.1.8 Actions Involving Loss of Decay IIcat Removal (DHR)
Because of the NRC staff's reassessment of the potential consequences of DHR events, actions in this area must be critically assessed to apply the appropriate severity level.
In some scenarios, the precursors to core damage (such as boiling in the core) may occur much sconer after a loss of DHR than previously thought, and the implications of such a loss may be more serious.
To ensure that these cases are handled uniformly and to better determine whether escalated action is appropriate, all actions (cited or non-cited) that result in a loss of decay heat removal or shutdown cooling require prior OE notification.
Rev. 03/31/95 12 NUREG/BR-0195
P Guidance on Activity Areas Chapter 8
(
)
'V TSs may not always be specific about the amount of time allowed to restore DHR after an interruption. Therefore, a citation against a TS Limiting Condition for Operation may not be available, except in a rare case where the licensee took little or no action to immediately correct the problem.
Such rare cases would clearly warrant consideration for escalated enforcement no matter what caused the DHR loss. However, the majority of DHR problems do not involve prolonged losses or losses for which the licensee does not take at least some action. Under current NRC require-ments, enforcement actions related to DHR events will generally consist of 10 CFR Part 50 Appendix B violations for lack of adequate procedures or not following procedures.
The NRC has reassessed the significance of this issue and has provided extensive prior notice to the industry on this subject (particularly events occurring during reduced reactor coolant system inventory operations) in the form of Generic Letters (87-12 and 88-17), Information Notices, meetings with various industry groups, and letters to licensed operators. Given the potential for core damage and the guidance provided by the NRC, failure of licensees to take aggressive action to assure i
appropriate procedures, proc; dure implementation, and training is of significant regulatory concera and, therefore, may be appropriately cate-gorized at Severity Level III. As stated above, much of the NRC guidance focuses on losses of DHR during reduced reactor coolant system (RCS) inventory operation.
However, other types of losses of DHR, such as one
/7 caused by an improper design change, can also be evaluated using some or all of the guidelines as appropriate.
The following guidelines, which have been coordinated with NRR, should be used to evaluate whether a particular loss of DHR should be considered a l
Severity Level III matter.
It must be re-emphasized that there is no exact formula for arriving at a severity level and the factors discussed below may be weighted differently or not applicable in any given case.
The factors to consider are:
a.
How similar was the root cause of the loss of DHR to the deficien-cies addressed in NRC generic guidance such as Generic Letters 87-12 and 88-177 b.
Given that a deficiency similar to that in NRC guidance occurred, how sensitive were the operators to the problem?
1.
How quickly did they respond? (Core decay heat level may not call for instantaneous response; however, the failure to correct such a situation quickly simply because the operator does not view it as particularly pressing may indicate a lack of sensitivity to this type of problem.)
j 2.
Did they respond using detailed procedural guidance, and if p
they did not, was their training sufficient of itself?
NUREG/BR-0195 13 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas 3.
Given that the operators procedurally treated the " symptoms,"
did they recognize the problem as a loss of DHR7 4.
Did they have other available indications not specified in the procedures that could have been consulted, and did they use them?
c.
Does the plant have a history of interruptions of DHR7 (This may indicate a continuing lack of sensitivity to this issue.)
d.
Were procedures in place to provide operator guidance for alterna-tive DHR options not normally employed? (In a number of instances licensees have made after-the-fact arguments about alternative sources of circulation and cooling. Because such sources were not defined by procedures, it was unclear if the operator in such cases could have aligned such sources quickly enough and whether the availability of such sources was only fortuitous.)
The scenarios provided in the two examples that follow illustrate certain key actions or inactions that, when considered under the guidance provided earlier, would result in the recommended severity level classifications.
It should be noted that in neither instance is DHR flow lost for an extended period, if it was ever fully lost.
Example 1:
For maintenance work on a reactor coolant pump seal, reactor vessel water level needs to be lowered to mid-loop.
In preparation for the draindown, an auxiliary operator performs a full inspection of the tygon tube level-indication system and then reports to the control room that he is standing by to monitor level during the draindown. Shortly before level reaches the mid-loop area, the control room secures the draindown to allow the level indicators to stabilize before draining the last few inches to water. Simultaneously, maintenance personnel arrive in the containment in preparation for the seal work and inadvertently place a large box on the tygon hose. Upon resuming the draindown, the control room operator notes a growing discrepancy between the level being reported from the containment and the control room indication. Just as the control room operator terminates the draindown to investigate the discrepancy, the operating DHR pump begins to cavitate. The operator quickly secures the pump, restores RCS inventory, and starts the standby pump. The auxiliary operator again performs a walkdown of the tygon hose, discovers the blockage, and removes it before resuming draindown.
Recommendation: The licensee should be assessed a Severity Level IV or V violation for inadequate work control. Although pump cavitation occurred after a loss of adequate level, due to erroneous level indication, proper preparation for the draindown was accomplished and the operators responded quickly and correctly to the event.
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Guidance on Activity Artes Chapter 8 s.
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Example 2:
Before the draindown to mid-loop, an auxiliary operator is stationed to monitor level without first having anyone walk down the tygon hose.
Earlier, maintenance personnel had entered the containment and inadvertently placed a large box on the tygon hose.
After the draindown begins, the control room operator notes a growing difference between control room level indication and that being reported from the contain-4 ment. He secures the draindown and then asks the auxiliary operator about i
the condition of his indicating hose. The auxiliary operator replies that the level seems to be decreasing more slowly than he anticipated but the decrease has been smooth and he doesn't see any air bubbles.
With that i
information, the control room operator decides to continue the draindown relying solely on the tygon hose rather than on the relatively new control room indicator with which there have been problems.
The control room operator makes this decision despite the fact that, at the time, the control room indicator is providing a level reading significantly lower than that of the tygon hose.
After recommencing the draindown, the operating DHR pump begins to cavitate. The control room operator gets a report from the containment that the level is still indicated to be well above mid-loop and, therefore, he starts the standby pump and secures the cavitating pump.
Almost immediately, the standby pump also begins to cavitate.
The operator, realizing that level must be too low, finally t '.es action to restore level and directs the auxiliary operator to walk down the tygon hose.
Recommendation: The licensee should be assessed a Severity Level III vio-y
(
1ation.
Proper preparations were not made, the operator made a noncon-servative judgment in choosing which level indicator to use, and when given an opportunity to recognize the mistake, chose to start a second pump rather than to learn why the first pump was cavitating.
The more a case appears similar to the circumstances of the generic guidance and the less responsive the operators are, the more likely the case should be considered at Severity Level III.
8.1.9 Actions Involving Service Water Systems Although the specific title of the system (s) may vary, as used in the context of this guidance, the term " service water system" (SWS) refers to the cooling water system that provides the ultimate heat sink for the plant's safety-related systems.
Determining the appropriate enforcement action for cases involving the SWS may be challenging because of the potential difficulty in determining whether or not the SWS can adequately perform its design function.
Deficiencies that can effect the operability of the SWS include problems such as:
inadequate heat removal capability as a result of bio-fouling, silting, erosion and corrosion; single failure concerns, and inadequate i
original design margin.
Therefore, the first decision in SWS cases, is whether the agency should O
cite against SWS operability. Licensee expenditures of time and resources i
NUREG/BR-0195 15 Rev. 03/31/95 i
Chapter 8 Guidance on Activity Areas to perform after-the-fact analyses supporting SWS operability do not obligate similar NRC expenditures to review the analysis to support enforcement action.
As discussed in Sections 8.1.1 and 8.1.2 of this Manual, it may be preferable to cite against the root cause of the deficiency rather than to expend resources to perform complex operability analyses.
If it is not prudent to cite against the SWS being unable to perform its intended function under certain circumstances (e.g., one train of SWS not available), then enforcement action citing the requirement that best reflects the root cause failure may base a Severity Level III categori-zation on the example in Supplement I for a degraded system (C.2.b). The following example illustrates this point.
10 CFR Part 50, Appendix B, Criterion XVI (Corrective Action). requires, in part, that measures shall be established to assure that conditions adverse to quality, such as failures, deficiencies and deviations, are promptly identified and corrected.
Contrary to the above, between June 15,1994 and August 31.1994, a condition adverse to quality at the ABC Nuclear Station was not promptly identified or corrected. Specifically, mussel clusters of enough volume to cause significant reductions in service water flow to vital components had accumulated along an 80 foot section of service water system piping. On at least nine occasions during that time period, actions taken by licensee personnel in reaction to indications of degraded service water flow were ineffective in identif'ying and correcting the full extent of the problem. These ineffective corrective actions resulted in significantly reduced service water flow to the "B" Diesel Generator heat exchanger which in turn resulted in a reduction in the diesel generator's electrical load carrying capability.
Additional examples of requirements that could be cited for the root cause failure include failure to perform a design change safety analysis (10 CFR 50.59), failure to follow procedures (administrative TS require-ment), failure to control design (Appendix B, Criterion III), or failure to control tests (Appendix B, Criterion XI).
For those enforcement actions that do not cite against operability, the cover letter should focus on the licensee's root cause failure as the basis for the action, rather than focusing on whether the SWS was or was not operable.
Additional information on SWSs is addressed in Generic Letter (GL) 89-13,
" Service Water System Problems Affecting Safety Related Equipment."
As discussed in Section 3.4.a of this Manual, failure to comply with a GL is not a violation unless the commitment is incorporated into the licensee's license or is addressed by a legal requirement. Generic Letter 89-13 may, however, constitute prior notice in assessing a civil penalty for a particular action.
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r Guidance on Activity Areas Chapter 8 Ci U
8.2 Facility Construction - Supplement II i
No detailed guidance is being issued for this activity area at this time.
Supplement II of the Enforcement Policy provides examples of violations in each of the five severity levels as guidance in this activity area.
8.3 Safeguards - Supplement III This section provides specific guidance concerning enforcement practices for safeguards issues. Supplement III of the Enforcement Policy provides examples of violations in each of the five severity levels as guidance in this activity area.
8.3.1 Compliance With the Security Plan Versus 10 CFR Part 73 Licensees subject to the requirements of 10 CFR Part 73.25, 73.26, 73.40, 73.45, 73.46, and 73.55 must submit security plans to the NRC for approval. Once these plans are approved, they are incorporated into the license by amendment and the licensee is required to meet the approved plans.
Citations for violations of these requirements must be made against the applicable section of the NRC-approved security plan and not against Part 73.
If there is a conflict between a plan and a regulation,
\\
NRR or NMSS (as appropriate) should be consulted.
d However, other general sections of Part 73 (e.g., those governing the reporting of safeguards events and the protection of Safeguards Informa-tion) remain in force even when licensees insert references to these requirements in their security plans.
8.3.2 Access Control The severity level of an access control violation is determined by:
(1) the ease of exploitation of the vulnerability including its predict-ability and the ease of passage created by that violation, (2) the intent of the intruder, and (3) the combined integrity of both protected area and vital area / material access area barriers.
In determining the vulnerability of the area, one must consider whether it could be seen easily by a potential intruder (e.g., height above the ground, intervening structures, and light and color characteristics).
The predictability of the vulnerability refers to the ease with which the intruder can anticipate the opportunity created by the opening.
For example, since the operational status of an alarm system is not usually apparent to a potential intruder, the fact that a particular alarm zone allows access will probably not be obvious, and therefore the vulnerabi-lity is less significant.
(\\
l NUREG/BR-0195 17 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas The ease of passage of a vulnerability refers to the type of opening and the environment in or surrounding the pathway.
For example, if the pathway is an underground tunnel that has many twists and turns, or one that has sudden vertical drops or cl1mbs, a simple 96-square-inch standard may not be appropriate, since the diameter of such a tunnel would be inadequate to allow the intruder to maneuver along the inside of it. Ease of passage also refers to whether the opening, for example a tunnel, has constant or periodic flushing or high temperatures, or is under water.
The intent of the intruder must also be considered.
Unauthorized intrusions by licensee employees without malicious intent are not by themselves of significant concern.
Lastly, the significance of a vital area barrier breach is less if the protected area barrier is fully operational and functioning as intended.
Similarly, a protected area barrier failure is less significant when all vital area doors are appropriately locked and alarmed and when vital area barriers are properly constructed and/or monitored.
When considering ease of exploitation, the following elements of barrier, monitoring, and response should be weighed.
a.
Bar rier Integrity:
The integrity of the barrier may be compromised by breaches in that barrier, but it may also be compromised by procedural errors.
Lost keys and/or lost keycards have the potential to allow unautho-rized and undetected access to controlled areas of the plant. The significance of such violations is a function of:
(1) whether the keys /keycards were truly lost, (2) whether they were marked as to what areas they allowed access, (3) whether and when they were recovered, and (4) whether there is any evidence of use before being recovered.
The significance of underground pathways allowing access to controlled areas is discussed in Information Notice 86-83 (Septem-ber 19, 1986).
b.
Compensatory Measures for Unlocked / Unalarmed Portals:
The significance of guards being inattentive while posted as compensato-ry measures is determined by what functions they are intended to provide.
If the guard is posted at an unalarmed and locked door, the guard represents only the monitoring function and, if the guard is inattentive, only one element of access control is inadequate.
If the guard is posted at an unlocked and unalarmed door, two elements are inadequate.
For guards not posted as compensatory measures (e.g., if the guard is posted inside a bullet-resistant I
structure to issue access badges), no elements would be inadequate (although there may be other bases for a violation).
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t Guidance on Activity Areas Chapter 8 -
c.
Authorization versus Clearance for Access:
Individuals are consid-ered cleared for access as soon as they have successfully completed l
all the screening steps committed to by the licensee. However, they are not authorized access at that point and may not have unescorted access until they are added to the licensee's authorized access list and issued a proper badge.
Actual entry of a cleared but as-yet unauthorized individual is a violation, but is not as significant as-actual entry of an uncleared, unauthorized individual.
d.
Improper Access by Authorized Persons:
Employees who have been properly cleared and authorized for access to the site must still enter the protected area and vital / material access areas properly.
Tailgating or using another employee's badge is a violation, though i
usually a Severity Level IV violation.
However, it is more significant if the system broke down in a way that permitted an unauthorized individual or a disgruntled employee to gain access who was recently terminated for cause.
]
e.
Vital Areas Within Vital Areas: As a general rule, when vital areas are contained within other vital areas, the barrier and access control requirements are not required at each barrier. The licensee is only required to have one vital area barrier to protect all vital areas, and access control functions must be operative at only the necessary vital area barrier. However, the inner barrier and access control functions must be fully operative. Therefore, if an inner t'
vital area barrier remains intact while the outer vital area barrier is discovered to have vulnerabilities, there isn't necessarily a violation unless the failed outer barrier allows access to vital equipment.
8.3.3 Searches Searches of individuals, vehicles, and packages are not considered adequate unless they are reasonably sufficient to detect the items for which they are conducted.
For example, a vehicle search must include an examination of the inside of the glove compartment and the area under the seats.
j When a vehicle that has entered the site is later found to have contained contraband (weapon, drugs, camera) in an accessible area, it is assumed that the search was inadequate.
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Chapter 8 Guidance on Activity Areas 8.3.4 Protection of Safeguards Information When safeguards information is not properly protected from compromise, the severity level of the violation is a function of: (1) the location of the material, (2) the significance of the material, and (3) the amount of time left unprotected.
Safeguards information left in an unlocked container within the locked and continuously-staffed primary access control point is less significant than safeguards information left unprotected outside the protected area.
If the material left unprotected is sufficiently extensive or descriptive of the security system as to significantly assist sn intruder in an act of radiological sabotage or theft of strategic special nuclear material (SSNM), the severity level would be greater than if the material would not have significantly assisted the intruder.
8.3.5 Protection Against Vehicle Bomb Threats 10 CFR 73.55(c)(7) requires licensees to establish vehicle control measures, including vehicle barrier systems, to protect against land vehicle intrusion. 10 CFR 73.55(c)(8)(i) requires licensees to confirm to the Commission that vehicle control measures established to protect against land vehicle intrusion meet the design goals and criteria specified for protection against a land vehicle bomb.
Under 10 CFR 73.55(c)(8)(ii), licensees may propose alternative measures for protection against a vehicle bomb that would then be subject to review and approval by the NRC.
10 CFR 73.55(c)(9) requires that licensees submit a summary description of the proposed vehicle control measures within 180 days of the effective date of the rule and fully implement the measures by within 18 months of the effective date.
By allowing the licensees to propose alternative measures for protection against a vehicle bomb, the Commission is allowing them to change the focus of compliance from the rule to the approved plans submitted by licensees.
This is common in the area of physical security and already exists in 10 CFR 73.55 itself.
Violations of 10 CFR 73.55(c)(8)(1) and (9)(1) should be treated in the same manner as any other incomplete and/or inaccurate statement, i.e.,
under 10 CFR 50.9 and Supplement VII, examples A.1, A.2, B.1, B.2, C.1, C.2, 0.1, and 0.2.
Violations of 10 CFR 73.55(c)(8)(ii) should also be treated as incomplete and/or inaccurate statements, to the extent that they do not accurately " describe the level of protection that these measures would provide".
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Giddaar* on Activity Areas Chapter 8 p)
(U 8.3.6 Citations Against 10 CFR Part 50, Appendix B Appendix B to Part 50 addresses quality assurance criteria for nuclear power plants and fuel reprocessing plants.
As discussed in the introduction, Appendix B applies to structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. As such, the provisions of Appendix B rfo not generally apply to the safeguards area.
If the region desires to use the Appendix B criteria as the basis for a citation in the safeguards area, it will have to include in the citation sufficient facts and discussion to support the position that the procedure in question is necessary to assure, in the event of an accident, " adequate confidence that a
structure,
- system, or component will perform satisfactorily in service."
Citations against 10 CFR Part 50, Appendix B in the safeguards area should be coordinated with OE prior to issuance.
8.4 Health Physics - Supplement IV This section provides specific guidance concerning enforcement practices for health physics issues. Supplement IV of the Enforcement Policy provides examples
[m of violations in each of the five severity levels as guidance in this activity area.
8.4.1 Actions Against Revised 10 CFR Part 20 The new 10 CFR Part 20 was published May 21, 1991 and becomes effective l
not later than January 1, 1994.
For those licensees who adopt the new i
rule prior to the required implementation date, the provisions of the Enforcement Policy, Supplement IV, Paragraphs F through J apply.
These paragraphs were published in the same rulemaking as the new Part 20.
8.4.2 Substantial Potential for Overexposure t
The Severity Level III example in H.8 of Supplement IV involves situations that present a " substantial potential for an exposure or release in excess of 10 CFR Part 20 whether or not such exposure or release occurs."
An event presents a substantial potential when it was fortuitous that the resulting exposure or release did not exceed the limits of 10 CFR Part 20.
The concern is not the significance of the resulting or,,atential exposure _
L (example H.1 of Supplement IV addresses exposures in excess of Part 20 limits), but whether the licensee provided adequate controls over the situation, as required, to prevent exceeding the Part 20 limits.
No j
credit is given for luck.
O i
N1TREG/BR-0195 21 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas When considering whether the circumstances of a particular case meet the threshold for escalated enforcement action for this example, the staff should attempt to construct a reasonable scenario in which a minor alteration of circumstances would have resulted in a violation of the Part 20 limits.
Circumstances such as (a) timing, (b) source strength, (c) distance, and (d) shielding should be considered.
- a. Timing: Could the exposure period have reasonably been longer?
Example:
An individual in the proximity of an unknown source of radiation receives an unplanned excessive exposure. Because of the duration of the exposure, no limits were exceeded; however, the individual could reasonably have stayed in proximity to the source long enough to be overexposed.
- b. Source Strength: Could the radiation source have reasonably been stronger?
Example:
An inadvertent release results from a worker venting the wrong waste gas decay tank.
Although the release did not exceed Part 20 limits, the same mistake could have as easily resulted in venting a decay tank with enough activity to exceed the limits.
- c. Distance:
Could the person have reasonably been closer to the source?
Example:
In the example in paragraph (a) above, the individual could have been overexposed by standing closer to the source of radiation.
- d. Shielding: Could some unintended shielding have reasonably been removed?
Example: Radioactive source was accidently left in an office area.
Shielding afforded by a desk prevented the overexposure of an individual worker in the office.
However, nothing prevented the source from being left in a area of the office that would not have been shielded by the desk, such that the individual would likely have been overexposed.
8.4.3 Enforcement Policy Regarding Occupational Doses From "IIot Particles" On July 30, 1990, the Commission published a policy statement presenting criteria for enforcement discretion (notwithstanding the provisions of Enforcement Policy in 10 CFR Part 2) for cases that involve occupational skin dose due to radiation exposure from a hot particle.
The policy statement is included as an appendix to this Manual and is applicable until a new limit applicable to such cases is established by revision of 10 CFR Part 20.
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Guidance on Activity Areas Chapter 8 pV 8.4.4 Citations Against 10 CFR Part 50, Appendix B Appendix B to Part 50 addresses quality assurance criteria for nuclear power plants and fuel reprocessing plants.
As discussed in the introduction, Appendix B applies to structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. As such, the provisions of Appendix B do not generally apply to the health physics area.
If the region desires to use the Appendix B criteria as the basis for a citation in the health physics area, it will have to include in the citation sufficient facts and discussion to support the position that the procedure in question is necessary to assure, in the event of an accident,
" adequate confidence that a structure, system, or component will perform satisfactorily in service."
Citations against 10 CFR Part 50, Appendix B in the safeguards area should be coordinated with OE prior to issuance.
8.5 Transportation - Supplement V This section provides specific guidance concerning enforcement practices for y
transportation issues. Supplement V of the Enforcement Policy provides examples of violations in each of the five severity levels as guidance in this activity area.
10 CFR Part 71 establishes requirements for packaging, preparation for shipment, and transportation of licensed material. Part 71 also establishes standards for NRC approval of packaging and shipping procedures for fissile material and for quantities of other licensed material in excess of Type A quantity.
The packaging and transport of licensed material are also subject to other parts of Title 10 (e.g., Parts 20, 21, 30, 39, 40, 70, and 73) and the regulations of other agencies (e.g., U.S. Department of Transportation (DOT) and the U.S. Postal Service (USPS)) or Agreement States having jurisdiction over means of transport.
In addition, individual States may take enforcement action for transportation incidents that also involve violations of NRC, Agreement State, or D0T requirements.
Section 8.5.1 of this Manual addresses the inter-agency agreement between the NRC and DOT on transportation issues.
Section 8.5.2 provides guidance on NRC enforcement action in conjunction with individual State enforcement action for transportation issues. In addition, Section 8.7.3 provides guidance on generic enforcement activities in conjunction with Agreement States.
(V
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NUREG/BR-0195 23 Rev. 03/31/95
I
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Chapter 8 Guidance on Activity Areas 8.5.1 Menwrandum of Understanding (MOU) Between NRC and DOT The MOU between the NRC and the Department of Transportation (00T) is included in Appendix G.
In accordance with the MOU, DOT is required to regulate safety in the transportation of hazardous materials, including radioactive materials; NRC is authorized to license and regulate the receipt, possession, use, and transfer of " byproduct material," " source material," and "special nuclear material."
Each agency has its own inspection and enforcement programs within its jurisdiction to assure compliance with its requirements. The NRC will assist DOT, as appropri-ate, in inspecting shippers of fissile materials and other radioactive materials exceeding Type A limits. The D0T and the NRC will consult with each other on the results of their respective inspections in the areas where the results are related to the other agency's requirements, and each will take enforcement action as it deems appropriate within the limits of its authority.
Formalized working arrangements based on the MOV between the DOT and the NRC are also includea in Appendix G.
In accordance with Section IV of this document, the NRC normally carries out enforcement actions for violations of the requirements of 10 CFR 71 and 49 CFR (except 49 CFR Parts 390 through 397) by NRC licensees.
00T normally carries out enforcement actions for violations of 49 CFR (including Parts 390 through 397) by carriers of redioactive materials and shippers of radioactive materials from Agreement States, or any other shippers otherwise not subject to NRC requirements (shippers of radium, for example).
8.5.2 NRC Action in Conjunction With State Action Individual States msv take enforcement action against shippers for transportation incidents that also involve violations of NRC, Agreement State, or DOT requirements The following guidance is provided to address the NRC's enforcement approach for those cases where a State takes action (be it the imposition of a civil penalty or suspension or revocation of the licensee's burial permit or both) against a licensee for activities that also represent violations of NRC requirements.
a.
Notwithstanding the severity level of a violation, the NRC will not normally propose a civil penalty in cases where a State issues a civil penalty.
However, even if a State has taken enforcement action for the violation, the NRC may consider enforcement action beyond an NOV, such as the issuance of a civil penalty or order, if the violation is repetitive.
If the region believes that a civil penalty should be assessed in a particular case, the region should submit a recommendation to the Director, OE.
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G=id-* on Activity Areas Chapter 8 C\\
b.
The region may issue NOVs with Severity Level III, IV, or V violations wishout prior review and approval by the Director, OE or i
the DEDO. Enforcement conferences need not be held if the region is i
satisfied with the corrective action and the licensee understands the significance of the violation.
NOVs including Severity Level III violations should have an EA number and be signed by the Regional Administrator and subsequently.sent to OE for information.
c.
The region should submit NOVs with Severity Level I or II violations to headquarters for review and approval prior to issuance.
d.
Regardless of the severity level, all NOVs and accompanying documents should require the licensee to submit to the sending office a description of the corrective action taken or planned to prevent similar future violations. This corrective action will be l
reviewed by the region and, if the region deems the corrective action unsatisfactory, further enforcement action to ensure compliance with NRC regulations should be considered.
Violations that are discovered by the NRC at the licensee's facility, or in other cases where the State has not taken action, will continue to be processed in accordance with normal policy and practice.
8.5.3 Accessibility of Areas With Excessive Radiation Levels If the area of the transport vehicle with excessive radiation levels is not easily accessible, consideration may be given to categorizing the violation at a lower severity level.
8.5.4 Exercise of Enforcement Discretion Involving j
Transportation CasksSection V. A of the Enforcement Policy provides that, "... licensees are not ordinarily cited for violations resulting from matters not within their control, such as equipment failures that were not avoidable by reasonable licensee quality assurance measures or management controls." Enforcement may not be warranted for certain cask contamination issues.
Enforcement j
of the removable contamination limits in 10 CFR 71.87(i)(2) may not be i
appropriate where the licensee had taken comprehensive steps to ensure compliance, i.e., the licensee had decontaminated the cask several times before providing it for transportation and the staff is not aware of any further reasonable actions that the licensee could have taken to prevent the violation (see EA 93-306).
Exercise of this discretion requires an EA number and should be coordinated with OE.
OV NUREG/BR-0195 25 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas 8.6 Fuel Cycle and Materials Operations - Supplement VI This section provides specific guidance concerning enforcement practices for fuel cycle and materials operations. Supplement VI of the Enforcement Policy provides examples of violations in each of the five severity levels as guidance in this activity area.
8.6.1 Activities of Unqualified Persons The Severity Level III example C.4 in Supplement VI of the Enforcement Policy involves " Conduct of licensed activities by a technically unquali-fied person."
The routine inspection program of materials licensees discloses many cases of unauthorized and potentially unqualified users, such as users of certain gauges and gas chromatographs.
In taking escalated enforcement action for this example, consideration should be given to whether the individual is in fact unqualified to use the materials.
The inspector may ask the materials licensee to explain whether or not the current unauthorized user is actually technically qualified.
a.
If the user is not qualified, a Severity Level III violation should be cited.
The licensee's corrective action should preclude the person from further licensed activity without appropriate supervi-sion.
b.
If the user is qualified, the violation may be categorized at a Severity Level IV.
OE concurrence is not required.
The licensee should take corrective action to preclude further unsupervised activity by the unauthorized user of licensed material until the license has been amended, c.
If the only user of licensed material is not qualified, an order suspending the license until an authorized, qualified user is obtained may be appropriate in cases involving more hazardous materials, such as in medical programs. Alternatively, if radiation hazards are minimal, as in the use of gas chromatographs, stationary liquid-level-measuring gauges or stationary thickness-measuring gauges, a Confirmatory Action Letter (CAL) suspending the user or preventing the user from using licensed material until becoming qualified may be appropriate.
The CAL could also state, at the licensee's option, that the licensee will suspend further activities until it finds another qualified user and amends its license to reflect this change. If the CAL is ineffective, an order suspending the license should be considered.
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Guidance on Activity Areas Chapter 8 U.
8.6.2 Failure to Control or Account for Licensed Material and Unauthorized Disposal In most cases, no excuse exists for nat accounting for licensed material, releasing it to unrestricted areas, or disposing of it in a non-radioac-tive waste disposal facility.
Violations of NRC requirements involving the failure to control or account for licensed material, especially if the failure results in inadvertent disposal, loss, or theft, will be considered for escalated enforcement action.
This is consistent with examples C.5, C.6, C.8, and C.11 in Supplement IV of the Enforcement Policy and C.1 of Supplement VI.
The Assistant Director for Materials, OE, should be consulted if escalated enforcement action is not deemed appropriate by the region.
If OE approves of the issuance of a Severity Level IV violation, then the cover letter should convey a strong message that any similar violation will carry Screased significance and may result in escalated enforcement action.
While example C.6 of Supplement IV provides that Severity Level III is the lowest severity level for improper disposal, exceptions have been made on a case-by-case basis after consultation with OE, taking into account the chemical and physical characteristics of the radioactive material that was disposed and the circumstances surrounding the disposal. For example, the single inadvertent disposal of a sealed Ni-63 source in a gas chromato-graph has been considered to be a Severity Level IV violation in a number of enforcement actions.
The isolated, inadvertent disposal of less than
-V the exempt quantity in 10 CFR Part 30, Schedule B clearly does not rise above Severity Level IV.
Normally, exceptions will be made only in cases where the safety and environmental significance are low and the disposal represents an isolated, rather than programmatic, weakness.
In order to provide a deterrent effect, exceptions are normally not appropriate in cases where the licensee has derived a significant economic benefit from the unauthorized disposal, whether or not a willful violation is involved.
Economic benefit should be considered whenever disposal options are limited or unavailable because of Waste Compact status, designation as greater-than-Class C waste, or other factors.
8.6.2.1 General Licensees (10 CFR 31.5)
A pending change to 10 CFR 31.5 will require certain reports from persons licensed pursuant to the general license in that section.
In order to remove any potential disincentive to report the loss or inadvertent disposal of licensed material, the NRC staff intends to exercise discretion and not take escalated enforcement action in I
certain defined situations.
A revised EGM will be issued at the time of publication. Until that time, violations involving loss or inadvertent disposal by persons licensed pursuant to 10 CFR 31.5 n
should be coordinated with OE.
NUREG/BR-0195 27 Rev. 03/31/95
gpter8 Guidance on Activity Areas 8.6.2.2 Unauthorized Disposal of Certain Transuranic Elements Exceptions normally will not be made to classify unauthorized disposal at less than Severity Level III if the case involves Am-241 or other nuclides in concentrations that would be classified as greater-than-Class C waste pursuant to the requirements in 10 CFR 61.55. A significant regulatory concern is justified because of the stringent disposal requirements to which these materials are subject. Therefore, even if the improper disposal is inadvertent, the licensee may still derive a significant economic benefit from having bypassed those requirements.
In most cases, no excuse exists for not accounting for licensed material or for releasing it to unrestricted areas.
Violations of NRC requirements involving the failure to control or account for licensed material, especially if the failure results in loss or theft, will be considered for escalated enforcement action. This is consistent with examples C.5, C.6, C.7, and C.ll in Supplement IV of the Enforcement Policy and C.1 of Supplement VI.
Therefore, OE should be consulted on all cases, regardless of severity level, that involve failure to control or account for licensed material. Since accountability and control of radioactive material are important and the area warrants a strong message to material licensees, OE should be provided with an explanation if escalated enforcement action is not deemed appropriate by the region.
8.6.3 NRC Action Against Agreement State Licensee Regulatory guidance concerning Agreement States is addressed in 10 CFR Part 150.
An Agreement State is defined as any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1974, as amended, by which those States have assumed regulatory responsibility over byproduct and source materials and small quantities of special nuclear material. A non-Agreement State is defined as any other State. Approxi-mately 30 Agreement States administer approximately 15,000 radioactive materials licenses (approximately 65 percent of all radioactive materials licensees issued in the U.S.).
Under reciprocity, the provisions of 10 CFR 150.20 establishes a general license authorizing any person who holds a specific license from an l
Agreement State to conduct the same activity in non-Agreement States provided, that the specific license does not limit the activity authorized by the general license to specified installations or locations.
Part of the provisions of this regulation require that the licensee submit an NRC Form-241 at least 3 days before engaging in the activities permitted under the general license.
Regulatory guidance concerning general licenses is addressed in 10 CFR 31.6.
O Rev. 03/31/95 28 NUREG/BR-0195
f l
Guidance on Activity Areas Chapter 8 m
The NRC can take enforcement action against an Agreement State licensee if:
(1) it is improperly conducting activities in a non-Agreement State in conjunction with the general license in 10 CFR 150.20, (2) it is improperly conducting activities in a non-Agreement State in conjunction with an NRC specific license, or (3) it failed to submit an NRC Form-241 in accordance with 10 CFR 150.20.
Example C.9 in Supplement VI of the Enforcement Policy provides an example of a Severity Level III violation involving a failure to submit an NRC Form-241.
The NRC considers this failure significant because it results in the NRC not being aware of licensed activities being conducted in NRC jurisdiction, such that the NRC is not in a position to inspect the activity and address public health and safety issues. The NRC also recognizes that some licensees may decide not i
to file an NRC Form-241 because of its associated license fee.
j i
For those cases where the NRC proposes enforcement action against an Agreement State licensee, the office proposing enforcement action should ensure that the Agreement State that issued the specific license receive copies of any enforcement correspondence including the meeting notice for an enforcement conference.
In addition, for proposed escalated enforce-ment actions, the office issuing the enforcement action should discuss the enforcement action with the Agreement State before the enforcement action is issued.
The office proposing the action should ensure that the Agreement State understands the NRC's rationale for issuing the action.
8.6.3.1 Use of Material in Areas Under Exclusive Federal V
Jurisdiction Within Agreement State Under the Atomic Energy Act and NRC regulations, in order to use byproduct material, a person must obtain a license either from the NRC (for those areas under NRC jurisdiction) or from an Agreement State (for those areas under Agreement State jurisdiction).
As discussed in Section 8.6.3, any person who holds a specific license from an Agreement State can conduct the same activity in non-Agreement States (i.e.,
NRC. jurisdiction), provided that the licensee submits an NRC Form-241 at least 3 days before engaging in the activities permitted under the general license or the licensee obtains an NRC license. A complication exists for those areas under exclusive Federal jurisdiction within an Agreement State, because notwithstanding the location within an Agreement State, these areas are not under the jurisdiction of the Agreement State; rather, these areas are under NRC jurisdiction.
Consequently, in order for an Agreement State licensee to use material in these areas of exclusive Federal jurisdiction within the Agreement State, they must either obtain a license from the NRC as required by 10 CFR 30.3 or file NRC Form-241 pursuant to 10 CFR 150.20.
O NUREGIBR-0195 29 Rev. 01/31/95
Chapter 8 Guidance on Activity Areas Because Agreement State licensees may not fully understand the requirements of working in areas under exclusive Federal jurisdiction within the same Agreement State, and because of the frequent difficulty in recognizing these areas, each case involving the failure to file an NRC Form-241 or obtain an NRC license will need to be reviewed based on its own merits to determine the appropriate enforcement action.
Any proposed enforcement action should be prepared using the standard citation in Appendix D for failure to comply with 10 CFR 30.3, " Activities requiring license." The violation should normally be categorized at Severity Level III (the same severity level for failure to file NRC Form-241, i.e.,
example C.9 in Supplement VI).
Exclusive Federal jurisdiction actions should be coordinated with OE prior to issuance. The region should ascertain whether the licensee was aware of the requirements associated with working in areas under exclusive Federal jurisdiction (e.g., the licensee previously filed NRC Form-241, the requirement to follow reciprocity procedures in areas where NRC or an Agreement State maintains jurisdiction was included as an Agreement State license condition, or the NRC had previously made the licensee aware of the requirements through written correspondence), and aware of the status of the Federal property. The cover letter transmitting the enforcement action should specifically state that the licensee conducted NRC-licensed activities in an area under exclusive Federal jurisdiction.
If additional violations of NRC requirements exist, the " contrary to" paragraph should also indicate that the location was an area under exclusive Federal jurisdiction.
If the region determines that an Agreement State licensee was not aware that it was operating within NRC jurisdiction, then enforcement action may not be warranted.
In these cases, enforcement discretion in accordance with Section VII.B(6) of the Enforcement Policy may be warranted.
If other violations of NRC requirements exist, the region should issue an NOV for these failures and the " contrary to" paragraph and cover letter should indicate that the location was an area under exclusive Federal jurisdiction.
If discretion is being exercised on the basis of unawareness of Federal jurisdiction requirements, enforcement action for other violations should only be taken for Agreement State imposed requirements. The cover letter for these cases should also include " enforcement discretion" in the subject title and include the same notice to the licensee regarding future activities in these areas.
O Rev. 03/31/95 30 NUREG/BR-0195
Guidance on Activity Areas Chapter 8 G()
8.6.4 Actions Involving Quality Management Programs On April 2,1993, Supplement VI of the Enforcement Policy was modified (58 FR 17321) to revise certain examples of severity levels for violations associated with the quality management programs (QMPs) required by 10 CFR 35.32. The basic thrust of the revision was to provide greater emphasis, and attach greater importance, to violations indicative of or flowing from programmatic deficiencies (i.e., Supplement VI, Example C.6 for a Severity Level III). Such deficiencies are preventable and are more likely to have a widespread or severe impact than are isolated mistakes involving human error made in the treatment of individual patients.
The revision also reflected a reduced severity level assignment for individual violations that represent isolated mistakes or errors but are not indicative of or due to any programmatic failure or weakness (i.e.,
Supplement VI, Example 0.3 for a Severity Level IV).
As modified, the examples categorize two types of violations at Severity Level III: (1) violations that involve a substantial failure to implement the QMP that do not result in a misadministration, and (2) programmatic weakness in the implementation of the QMP that results in a misadministra-tion. A substantial failure to implement the QMP applies in cases where the licensee fails to establish or effectively implement one or more of i
the QMP objectives in 10 CFR 35.32(a)(1) - (5).
The failure to meet the objective (s) could be due to an inadequate QMP, such as licensee omissions in the written QMP procedures, or deficiencies in training such that licensee employees are not instructed to follow I
procedures established to meet one or more QMP objectives.
This substantial failure could potentially result in a misadministration.
Programmatic violations are closely related or repetitive violations that represent a pattern or trend in a specific program area (QMP objective).
As.an example:
suppose that a given licensee's employees are trained to check dose calculations prior to the administration of a teletherapy dose and normally do so, but that there have been failures to meet this requirement on a number of occasions and one of those occasions results in a misadministration.
This example is representative of a programmatic weakness in meeting the objective that final plans of treatment and related calculations are in accordance with the respective written directive (10 CFR 35.32(a)(1)(3)).
A decision on whether to categorize a violation resulting in a misadminis-tration at Severity Level III or IV must consider both the consequences and the isolated or programmatic nature of the violation.
If the misad-ministration was caused by an isolated violation and there were only insubstantial or transient medical consequences, then the violation would be categorized at Severity Level IV (see the table below for examples of consequences).
For example, a misadministration of 50 microcuries of 1
sodium iodine I-131 caused by a one-time failure of an authorized user to O
prepare a written directive prior to the administration would be NUREG/BR-0195 31 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas considered an isolated error of limited consequences.
However, if the medical consequences were not limited, or if the violation appeared to be programmatic, then the violation would be categorized at Severity Level III.
EXAMPLES OF MISADMINISTRATION RESULTING IN:
Substantial Chronic Residual Consecuence Insubstantial or Transient Consecuence Chronic hypothyroid or athyroid function.
Transient hypothyroid function.
Small bowel adhesions with obstruction Small bowel irritability and diarrhea following radiation of abdomen.
that subsides without obstruction.
Chronic skin ulceration with severe Transient skin erythema.
disfiguring scarring.
Radiation pneumonitis with fibrosis and Transient pneumonitis with no residual dyspnea following radiation of lung.
ventilatory impairment.
Hypertension and/or chronic renal failure Transient reduction of renal function following radiation of kidney.
with full recovery within a few months after radiation of kidney.
Chronic suppression ofimmunological Transient decrease of platelets and response with increased susceptibility lymphocytes following acute whole to whole body radiation >2Gy.
body radiation >0.5Gy and < l.75Gy.
To further contrast " isolated" vs. " programmatic": an isolated failure to follow a QMP applies in cases where an isolated error, mistake, or omission occurs in following an established QMP procedure. To be "isolat-ed,"
the failure must represent a single occurrence as opposed to repetitive or multiple failures in the QMP procedure for that specific objective.
Enforcement actions categorized at Severity Level IV that involve an isolated failure to meet or implement a quality management objective and that result in a misadministration must be coordinated with the Assistant Director for Materials, OE.
8.6.5 Failure to Perform an Adequate Survey of a Radiography Device This section provides guidance for determining the safety significance and the appropriate Severity Level of violations of 10 CFR 34.43(b).
10 CFR 34.43(b) rt quires making a survey with a calibrated and operable radiation surve.9 instruis,t. after each radiographic exposure, to determine that the sealed sotree has returned to its shielded position. The entire circumference of the radiographic exposure device must be surveyed.
If the radiographic exposure device has a source guide tube, the survey must Rev. 03/31/95 32 NUREG/BR-0195
Guidamee on Activity Areas Chapter 8 ex include the guide tube.
In the past, this rule has been interpreted to require a full 360-degree survey of the radiographic exposure device and the entire length of the guide tube. As indicated in Supplement VII.C.8 of the En/orcement Policy, the failure to use radiation survey instruments as required by 10 CFR Part 34 is a Severity Level III violation.
The safety concern involves whether~ there is adequate assurance that the surveys can identify the location of the source.
A Severity Level IV violation may be appropriate where a survey. less rigorous than that required-by the rule was still sufficient to identify the location of the source.
If the survey performed was not adequate to determine, with a high degree of assurance, the location of the source, then a Severity Level III violation is warranted.
In order to correctly assess the significance of the violation, it is important to know what portions of the radiographic exposure device and guide tube were surveyed, the type of sealed source, the location and configuration of the radiographic operation, the training provided on how to do an appropriate survey, and the explanation as to why the required survey was not performed.
Based on this information, the regional inspection staff should be able to determine if the survey was adequate to determine the source location.
In addition, since the NRC's inspection effort consists of selective reviews and it is, at times, difficult to observe radiography in O~
operation, it is important to ascertain whether the survey failure was isolated.
If the improper survey appears to be the norm, even if the observed survey was adequate to identify the location of the source, the matter should be considered for escalated action based on a programmatic concern and an enforcement conference should be held.
8.6.6 Actions Involving Radiation Safety Officers (RSOs)
Example C.10 in Supplement VI of the Enforcement Policy provides an example of a Severity Level III violation involving "a failure to receive required NRC approval prior to the implementation of a change in licensed activities that has radiological or programmatic significance, such as, a change in ownership; lack of an RSO or replacement of an RS0 with an unqualified individual; a change in the location where licensed activities are being conducted, or where licensed material is being stored where the new facilities do not meet safety guidelines; or a change in the quantity i
or type of radioactive material being processed or used that has radio-logical significance."
The following guidance provides additional clarification on when it may be appropriate to consider the lack of an RS0 or replacement of an RS0 with an unqualified individual as a Severity Level III violation.
t O
NUREG/BR-0195 33 Rev. 03/31/95
i Chapter 8 Guidance on Activity Areas a.
For some small materials licensees, there are no special qualifica-tion requirements or duties for the RSO position because of the limited types and quantities of material authorized on the license.
At this type of licensee, a violation involving a change of RSO without receiving required NRC approval or an absent RSO is more appropriately categorized at Severity Level IV, unless other concurrent violations indicate the existence of a programmatic breakdown.
b.
For these types of failures at all other materials licensees, the following guidance applies:
1.
If the RSO leaves the facility and no RS0 is appointed, a Severity Level III violation is appropriate.
2.
If the RSO leaves the facility and the individual assigned as a replacement RSO is not qualified under applicable NRC criteria, a Severity Level III violation is appropriate.
3.
If the RSO leaves the facility and the individual assigned as a repl acement RSO is qualified under the applicable NRC criteria, but the license has not been amended to name the new RS0, a Severity Level IV violation is appropriate.
8.6.7 Information Copies to Outside Organizations In an effort to improve coordination between the NRC and the Department of Veterans Affairs (VA), and thereby improve the VA's management of nuclear medicine departments in its hospitals, the following individual is to be sent a copy of every inspection report, Confirmatory Action letter, Notice of Violation, or order that is issued concerning a VA facility:
Director, Nuclear Medicine Service (115)
Department of Veterans Affairs 810 Vermont Ave.
NW Washington, DC 20420 Similarly, the following individual is to be sent a copy of every inspection report, Confirmatory Action letter, Notice of Violation, or order that is issued concerning a radiographer:
American Society of Nondestructive Testing, Inc.
ATIN:
Technical Services Manager 1711 Arlingate Lane P.O. Box 28518 Columbus, OH 43228-0518 9
Rev. 03/31/95 34 NUREG/BR4195
Guidance on Activity Areas Chapter 8 l
OU 8.6.8 Possession of Material Without a License This section has been reserved for future guidance on the issue of possession of material without a license.
8.6.9 Severity Level For Failure To Report A Misadministration The Enforcement Policy, Example VI.C.6, indicates that failure to report a misadministration is normally categorized at Severity Level III.
a.
10 CFR 35.33 requires that misadministrations be reported to the NRC. When there is a failure to report a misadministration to the i
NRC, the following considerations apply:
1 1.
If no report has been made to NRC at the time that NRC becomes aware of the misadministration, the violation normally should i
be categorized at Severity Level III.
l 2.
If the report to NRC is late or incomplete, but is nonetheless the vehicle by which NRC becomes aware of the misadministration, the violation may be categorized at Severity Level IV provided that the late or incomplete nature of the report did not substantially diminish the NRC's ability to determine the significant facts of the misadministration O
once the NRC became aware of it.
b.
10 CFR 35.33 also requires that misadministrations be reported to:
(1) the referring physician and (2) either the patient, or the j
patient's responsible relative or guardian. An exception in 10 CFR 35.33(a)(3) provides that the patient need not be notified if the referring physician informs the licensee that, based on medical judgement, telling the patient would be harmful. Pursuant to 10 CFR 35.33(a)(2), the term " patient" means both the patient and the patient's responsible relative or guardian. Therefore, a report to the patient is required unless the referring physician informs the licensee that, based on medical judgement, telling the patient would be harmful; and, in that case, a report to the patient's responsible relative or guardian is required unless the referring physician also informs the licensee that, based on medical judgement, telling the patient's responsible relative or guardian would be harmful.
When there is a failure to report a misadministration to:
(1) the referring physician or (2) the patient or the patient's responsible relative or guardian, the following considerations apply:
1.
If no report has been made to the referring physician, the violation normally should be categorized at Severity Level III.
(The regulation does not specify that the report to the referring physician needs to be in writing; therefore, an oral report to the referring physician is sufficient.)
NUREG/BR-0195 35 Rev. 03/31/95
Chapter 8 Guidance on Activity Areas 2.
If neither an oral nor a written report has been made to the patient and the referring physician did not invoke the exception in 10 CFR 35.33(a)(3) as it applies to the patient, the violation normally should be categorized at Severity Level III.
3.
If neither an oral nor a written report has been made to the patient because the referring physician invoked the exception in 10 CFR 35.33(a)(3) as it applies to the patient, one next must consider whether an oral or a written report was made to the patient's responsible relative or guardian. If there was also neither an oral nor a written report to the patient's responsible relative or guardian and the referring physician did not invoke the exception in 10 CFR 35.33(a)(3) as it applies to the patient's responsible relative or guardian, the violation normally should be categorized at Severity Level III.
4.
If the licensee made an oral report to the patient or the patient's responsible relative or guardian (whichever is required pursuant to 10 CFR 35.33(a)(3)), but failed to make a written report as required, the violation may be categorized at Severity Level IV provided that the licensee promptly provides the written report once the matter is brought to the licensee's attention.
8.7 Miscellaneous Matters - Supplement VII Guidance on the miscellaneous issues addressed in Supplement VII of the Enforcement Policy is given in Chapter 7 of this Manual.
See Section 7.4 for guidance concerning fitness-for-duty issues, Section 7.7 for guidance concerning employee discrimination, Section 7.8 for guidance concerning material false statements and completeness and accuracy of information, and Section 7.9 for guidance concerning enforcement actions against non-licensees (10 CFR Part 21 notification failures).
8.8 Emergency Preparedness - Supplement VIII This section provides specific guidance concerning enforcement practices for emergency preparedness issues. Supplement VII of the Enforcement Policy provides examples of violations in each of the five severity levels as guidance in this activity area.
8.8.1 10 CFR 50.54 Deficiency Grace Period The significant provision of the Commission's regulations in this area is 10 CFR 50.54(s)(2)(ii), which provides a 4-month grace period for correction of deficiencies that rise to such a level that the Commission may make a finding that the state of emergency preparedness no longer provides reasonable assurance that adeciate protective measures can and Rev. 03/31/95 36 NUREG/BR-0195
Guidance on Activity Areas Chapter 8 p)
\\v will be taken in the event of a radiological emergency. The grace period represents a recognition by the Commission that many elements of emergency planning involve complex arrangements and interactions with local, State, and Federal entities, much of which is beyond a licensee's direct control.
It reflects an acknowledgement that the licensee's degree of control in the emergency planning area is significantly less than that in the areas of reactor health and safety.
Thus, e-where there are significant deficiencies in emergency plans and a al finding to that effect is made, a grace period should be allowet corrective action. See County of Rockland v. U.S. Nuclear Reaulatorv ommission, 709 F.2d 766, 770-771 (2nd Cir. 1983).
The policy underlying the grace period strongly suggests that it was intended to apply to emergency planning deficiencies which can be remedied only in cooperation with State and local officials.
If plans were in place and capable of implementation, but a licensee itself failed to implement the plans either during a drill or an actual emergency, no grace period should be necessary to remedy the deficiency.
In short, if the plans are adequate and capable of implementation, but there is a deficiency in the licensee's execution of the plan, then a grace period is not applicable. The Statement of Considerations supports this view.
In the Statement of Considerations supporting the initial rule (45 FR 55402, August 19, 1980), the Commission discussed how it would apply the grace period, and, in considering plan deficiencies, indicated that it would consider local, State, and licensee plans to see if the features in one plan could compensate for deficiencies in another plan.
If an emergency planning deficiency can be remedied only in cooperation with State and local nfficials, enforcement action should await the exl.iration of the grace period.
In addition, the ED0 is to be notified before establishing the grace period and should concur on the enforcement action. If the deficiency is of such a nature that cooperation with State and local officials is not necessary to remedy the deficiency, then the grace period does not apply and the matter may be pursued.
8.8.2 Actions Involving Emergency Exercises i
Enforcement action is not normally taken for emergency preparedness l
violations that occur during emergency exercises.
This is because NRC i
desires that licensees broadly exercise their staffs with realistic scenarios.
If the licensees do not have this exception, it may result in
(
licensees using only experienced individuals and conservative scenarios to avoid potential enforcement action.
Moreover, it is recognized that exercises are designed to identify weaknesses that need to be corrected.
However, enforcement action may be appropriate where exercises reveal (1) training, procedural, or repetitive failures for which corrective actions have not been taken, (2) an overall concern regarding the licensee's ability to implement its plan in a manner that adequately protects public health and safety, or (3) poor self critiques of the licensee's exercises.
O i
l 1
NUREG/BR-0195 37 Rev. 03/31/95 i
O APPENDIX A G
Temporary Enforcement Guidance Appendix A contains temporary Enforcement Guidance Memorandums (EGMs). The EG Enforcement Manual Change Notice Index, located in the front of the Manual, contains a complete chronological listing of Change Notices, including the issuance of temporary EGMs. Temporary EGMs should be filed chronologically in this Appendix.
EGM SUBJECT DATE 92-01(T)
Programmatic Maintenance Failures 01/02/92 A-3 94-011(T)
Violations Against 10 CFR 20.1301(a) Should Not be Cited in Misadministrations 07/26/94 A-5 94-013(T)
Revised Procedures for Conducting Open Enforcement Conferences During the Agency's Continuing Trial Program 08/15/94 A-7 95-001(T)
Severity Levels of Violations at Fuel Facilities 03/31/95
. A-27 O
NtTREG/BR-0195 A-1 Rev. 03/31/95
pareg k
UNITED STATES g
g j
NUCLEAR REGULATORY COMMISSION wASHINGTOli, D.C. 20666 4001 J
March 31, 1995 MEMORANDUM T0:
Thomas T. Martin, Regional Administrator Region I Stewart D. Ebneter, Regional Administrator Region II John B. Martin, Regional Administrator Region III L. Joe Callan, Regional Administrator Region IV Roy Zimmerman, Associate Director for Projects, NRR Ashok C. Thadani, Associate Director for Inspection and Technical Assessment, NRR Robert Burnett, Director, Division of Safeguards and Transportation, NMSS r
Donald A. Cool, Director, Division of
(
Industrial and Medical Nuclear Safety, NMSS FROM:
James Lieberman, Director Office of Enforcement
SUBJECT:
ENFORCEMENT GUIDANCE MEMORANDUM - SEVERITY LEVELS OF VIOLATIONS AT FUEL FACILITIES (ENFORCEMENT POLICY) j l
The purpose of this memorandum is to provide guidelines for the assignment of severity levels for violations involving fuel cycle activities. This guidance should be used pending a modification to the Enforcement Policy supplements which is expected to be undertaken pursuant to the recommendations of the Enforcement Policy Review Team.
Since 1990, the NRC has initiated fifteen escalated enforcement actions against fuel cycle licensees. Of these fifteen actions, nine resulted in civil penalties and six in Notices of Violation without a civil penalty.
For each action, the staff determined the severity level of the associated 1
violation (s) from the guidance provided in Supplement VI, Fuel Cycle and Materials Operations.
The violations ranged from problems in the control of Nuclear Criticality Safety (NCS) measures and parameters at fuel fabrication facilities to the offsite release of toxic material from licensed processes in excess of regulatory limits by an uranium conversion facility.
g As a result of experience gained through those enforcement actions, OE believes that it would be beneficial to further develop the guidance currently V
provided in Supplement VI. While the major regulatory concerns regarding NCS, I
NUREG/BR-0195 A.27 Rev. 03/31/95
safety system operability, releases of radiation and contamination, and programmatic controls for licensed activities are addressed, a clearer differentiation among the severity levels is desirable.
The guidance would accomplish this by relating the loss of a criticality safety control (s) to the availability (or likely availability) of a sufficient amount of fissile material for a nuclear criticality accident.
In addition, the guidance provides clearer examples for events that involve chemical processes integral to licensed activities, whether or not radioactive material is released.
This guidance is built upon the experience gained from the November 17, 1992 offsite release of nitrogen dioxide from the Sequoyah Fuels Corporation's facility in Gore, Oklahoma (EA 93-010), and the September 10, 1992 explosion and fire at the Nuclear Fuel Services' facility in Erwin, Tennessee (EA 92-231).
(1)
In considering the term " system" in Supplement VI, it should have the same meaning as in Supplement I (i.e., it includes administrative and managerial control systems, as well as physical systems).
(2)
Consider violations which involve the following as an example of a Severity Level I matter:
Significant injury or loss of life to site personnel or the general public due to a loss u control over licensed fuel cycle activities, including chemical processes that are integral to the licensed activity, whether radioactive material is released or not.
This guidance amplifies what is considered a very significant regulatory concern that involves actual impact to the public, including licensee employees and contractors.
In addition to the radiation, contamination and releases defined in VI.A.I. of the Supplement, the NRC is concerned about the actual impact of any occurrence from a portion of a licensed fuel cycle activity, including chemical processes, that has been reviewed and approved as part of the NRC licensing process.
(3)
Consider violations which involve the following as examples of a Severity Level II matter:
A failure to establish, maintain or implepent all criticality a.
controls (or criticality control systems) for a single nuclear criticality scenario when a critical mass of fissile material was present o; reasonably available, such that a nuclear criticality accident was possible.
I Example a. indicates that the absence of all the criticality safety l
controls for a single anticipated or unanticipated nuclear criticality scenario is a very significant safety concern when the availability of fissile material makes a nuclear criticality accident possible.
' See Information Notice 94-73 for the NCS definition of control, control system and double contingency.
Rev. 03/31/95 A-28 NUREG/BR-0195
l (O
b.
The potential for significant injury or loss of life to site personnel or the general public due to a significant loss of l
control over licensed fuel cycle activities, including chemical processes that are integral to the licensed activity, whether radioactive material is released or not.
Example b. indicates that events which do not involve actual significant i
injuries or loss of life, but reasonably could have, had circumstances been different, are considered very significant safety concerns that do not amount to a Severity Level I threshold specified in Example VI.A.S.
(4)
In considering Example VI.C.1, " radiation purposes" should mean
" radiation protection purposes."
(5)
As to Example VI.C.10 addressing changes of significance, consider also the " lack of a nuclear criticality specialist or replacement of a nuclear criticality specialist with an unqualified individual."
This highlights the importance that the NRC places on the nuclear I
criticality specialist's position in a licensee's organization because this key position is responsible for conducting NCS evaluations and final reviews of changes or modifications to licensed processes. The l
failure to staff this position with an individual meeting the qualifications specified in the license could result in inadequate A
safety evaluations.
(6)
In considering whether a violation should be viewed as a significant regulatory concern and categorized at Severity Level III, the following examples should be used as guidance.
a.
A failure to establish, maintain or implement all but one criticality control (or criticality control system) for a single nuclear criticality scenario when a critical mass of fissile material was present or reasonably available, such that a nuclear criticality accident was possible.
Example a. indicates that the absence of all but one criticality safety control for a single anticipated or unanticipated nuclear criticality scenario is a significant regulatory concern when a critical mass is l
present, or is reasonably expected to be present. Although a nuclear criticality accident was not possible, the loss of the remaining control could result in such a possibility.
O l
FUREG/BR-0195 A-29 Rev. 03/31/95 i
b.
A release from licensed fuel cycle processes of toxic material in excess of regulatory limits, caused by a failure to comply with NRC regulations.
The NRC considers a more than minor release of toxic material caused by the failure to comply with NRC regulations, including licensee procedures established to comply with license conditions, to be a significant regulatory concern because, if not adequately corrected, it could have serious consequences to the public and licensee employees.
c.
The failure to adequately implement a significant fuel cycle license requirement, that has the substantial potential for a release in excess of regulatory requirements.
An actual release of toxic or licensed material is not necessary for the NRC to consider a situation to be a significant regulatory concern.
Rather, if the circumstances had been or could reasonably be slightly different to create that release, and it is due to the failure to comply with a significant license condition, then it is a significant regulatory concern.
The licensee is expected to conduct its activities in accordance with the license conditions.
(7)
In considering whether a violation should be categorized at Severity Level IV, the following guidance should be considered:
A failure to establish, maintain or implement a criticality control (or criticality control system) for a single nuclear criticality scenario when the amount of fissile material available was not but could have been sufficient to result in a nuclear criticality.
Tiiis indicates that the absence of one or more criticality safety controls for a single anticipated or unanticipated nuclear criticality scenario is a regulatory concern of lesser significance when a critical mass is not but could have been present.
If you have any questions regarding this matter, please contact me.
cc:
H. Thompson, DEDS J. Milhoan, DEDR J. Goldberg, OGC O
Rev. 03/31/95 A-30 NUREG/BR4195
l l
Standard Formats - Index Appendix B
. p) -
\\'u FORM 30:
Cover Letter Transmitting NOV to Licensed Operator who has a Positive Drug or Alcohol Test...........
133 FORM 31:
Notice of Violation to Licensed Operator for Positive Drug or Alcohol Test.......................
135 FORM 32:
Letter With NOV and Expiration of License to Licensed Operator who has a Positive Drug'or Alcohol Test 137 l
FORM 33-I: Order Modifying License (Reactor Licensee) i (prohibiting involvement by individual employee in certain NRC-licensed activities) 139 FORM 33-11: Order Modifying License (Materials Licensee)
(prohibiting involvement by individual employee in certain NRC-licensed activities) 145 FORM 34-I: Order Prohibiting Involvement in NRC-Licensed Activities (Effective Immediately)
(Individual employed by Reactor Licensee)..........
151 FORM 34-11: Order Prohibiting Involvement in NRC-Licensed Activities
?
(Effective Immediately)
(Individual employed by Materials Licensee).........
157 i
py)
FORM 35-I: Order Prohibiting Involvement in NRC-Licensed Activities (Non-Immediately Effective)
(Individual employed by Reactor Licensee)..........
163 FORM 35-11: Order Prohibiting Involvement in NRC-Licensed Activities (Non-Immediately Effective)
(Individual employed by Materials Licensee).........
169 FORM 36-I:
Demand for Information (Individual employed by Reactor Licensee)..........
175 FORM 36-11: Demand for Information (Individual employed by Materials Licensee).........
179 FORM 37:
Notification to DED0 and Commission on Issuance c#
i Enforcement Actions Older Than 18 Months 183
]
FORM 38:
Letter of Reprimand to an Unlicensed Individual.......
185 1
FORM 39:
Letter of Reprimand to a Licensed Individual 187 FORM 40:
Settlement Agreement 189 FORM 41:
Confirmatory Order Settling Civil Penalty Imposed by Order 195 O
NUIGG/BR-0195 B.y Rev. 03/31/b
Appendix B FORM 17, Page 1
\\\\
FORM 17:
Cover Letter for Various Orders & Demand for Information tc Licensees EA (Name of Licensee)
+
(Address)
SUBJECT:
[ Insert title of order; Order Modifying License, Order Suspending License, etc.; or Demand for Information]
(Name of Facility)
(for power reactors)
==Dear
- ==
The enclosed Order (Demand for Information) is being issued (briefly state the reason (s) why the Order or Demand is beina issued.)
[The narrative in this section should also describe any actions that are required or prohibited based f'
on the issuance of the Order.]
Pursuant to section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section.
[ Substitute the following sentence for DFIs, " Failure to comply with the provisions of this Demand for Information may result in enforcement action."]
[The following paragraph should be included if an individual employee.is the subject of the order or DFI that is being issued to the licensee.
"A copy of this letter and its enclosure (s) is being sent to (name or title of individual)
The individual is not required to provide a response to the order (Demand for Information), but may do so if he/she desires within days under oath or affirmation."]
t Questions concerning this Order (Demand for Information) should be addressed to Director, Office of Enforcement, who can be reached at (301)
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure ((s) will be placed in the NRC Public Document Room (PDR).
l
[ Substitute the following paragraphs for DFIs, "In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure ((s), and your response will be placed in the NRC Public Document Room (PDR).
To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to incluie such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide NUREG/BR-0195 B-55 Rev. 03/31/95
i FORM 17, Page 2 Appendix B O
the legal bagis to support your request for withholding the information from the public."
"The responses directed by this letter and the enclosed Demand for Information are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L.
No. 96.511."]
Sincerely, Deputy Executive Director for Docket No.
License No.
Enclosure (s): As Stated cc:
(If applicable, include the name of the individual employee that is the subject of the action.)
" If there is a high probability that a licensee's response may include personal privacy or proprietary information, delete this sentence, "However, if you find it..." and add the following sentence:
If personal privacy or proprietary information is necessary to provide an acceptable response then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. if you request withholding of such material. you mug specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g.. explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response please provide the level of protection, described in 10 CFR 73.21.
Rev. 72/30/94 B-56 NUREG/BR-0195
Appendix B FORM 29, Page 1 t")
FORM 29: Request for Information Letter to D0L U.S. Department of Labor Wage and Hour Division (Local Address)
Dear Mr./Ms.
On
, the U.S. Department of Labor's (DOL's) Wage and Hour Division in (name of city)
, received a complaint from (name of complainant) a (former) employee of (name of emplover)
(name of complainant) alleged that (briefly state the nature of the discrimination, e.g., dismissal, denial of employment, reassignment, etc.) because he had raised safety concerns while performing his duties at (name of site)
In response to that complaint, the Wage and Hour Division conducted an investigation, and in a letter dated
, the Area Director of the Wage and Hour Division issued a decision.
l
)
l In order to stay abreast of the circumstances in each Section 211 complaint filed against a licensee of the Nuclear Regulatory Commission (NRC), NRC continually reviews relevant information in the DOL files concerning these i
cases.
The purpose of this letter is to request a copy of the narrative of the D0L Compliance Officer's Report for the subject case. Under the October 25, 1982 Memorandum of Understanding between DOL and NRC, DOL makes all case file j
material available to NRC officials.
In response to an NRC request for arrangements to facilitate obtaining copies of DOL Compliance Officers' Reports, the Assistant Administrator, Wage and Hour Division, agreed in January 1987 that DOL will provide a copy of the narrative of any Compliance Officer's Report requested by NRC.
If necessary, copies of exhibits, however, will be made by NRC personnel using DOL copying equipment at the DOL office where the exhibits are filed.
The material requested will be conspicuously marked as material obtained from the Department of Labor under a special arrangement with the NRC and that the information may not be disclosed outside the NRC without prior DOL approval.
a NUREGIBR-0195 B-131 Rev. 03/31/95
v FORM 29, Page 2 Appendix B If you have any questions regarding this request, please contact me at (XXX) XXX-XXXX.
Sincerely, cc:
Assistant Administrator Wage and Hour Division Department of Labor, Washington, D.C.
bec: Director, OE Deputy Assistant General Counsel for Enforcement, OGC O
O B-132 NUREG/BR-0195
Appendix B FORM 30, Page 1 O(h
~
FORM 30:
Cover Letter Transmitting NOV to Licensed Operator who has a Positive Drug or Alcohol Test IA (Name of Licensed Operator)
[HOME ADDRESS DELETED i
UNDER 10 CFR 2.790]
SUBJECT:
NOTICE OF VIOLATION Dear (Name of Licensed Operator)
The Nuclear Regulatory Commission (NRC) has received a letter dated (date) from (name of facility licensee (sil informing us of your confirmed positive test for alcohol (or name of illegal drug) (copy enclosed). We plan to place this letter in your 10 CFR Part 55 docket file.
l This confirmed positive test identified a violation of 10 CFR 55.53(j). The purpose of the Commission's Fitness-for-Duty requirements is to provide reasonable assurance that nuclear power plant personnel work in an environment that is free of drugs and alcohol and the effects of the use of these substances. The use of illegal drugs (use of alcohol such that the operator exceeds the cutoff limits specified in 10 CFR Part 55, Appendix A, or in the licensee's fitness-for-duty program) is a serious matter which undermines the i
p J
special trust and confidence placed in you as a licensed operator. The tG violation is categorized as a Severity Level III violation in accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions",
10 CFR Part 2, Appendix C, because the use of illegal drugs (use of alcohol such that the operator exceeds the cutoff limits specified in 10 CFR Part 55, Appendix A, or in the licensee's fitness-for-duty program) by licensed operators is a significant regulatory concern. This violation is described in the enclosed Notice of Violation.
Please note that, in accordance with 10 CFR 26.27(b), future similar violations will substantially affect your authori-i zation for unescorted access to the protected area of a licensed facility.
l The purpose of this letter is to make clear to you the consequences of your violation of NRC requirements governing fitness-for-duty as a licensed l
operator.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice of Violation (Notice) when preparing your response.
In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence in order to ensure your ability and willingness to carry out the special trust and confidence placed in you as a licensed operator of a nuclear power facility. After reviewing your response to this Notice, including your proposed corrective actions, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, f
Title 10, Code of Federal Regulations, enforcement actions are placed in the NRC Public Document Room (PDR). A copy of this letter and the enclosed Notice NUREG/BR-0195 B-133 l
FORM 30, Page 2 Appendix B of Violation with your address removed will be placed in the PDR pfter 45 days unless you provide a sufficient basis to withdraw this violation.
The response directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No.96-511.
Should you have any questions concerning this action, please contact of my staff.
(Name of reaional contact) can be reached at either the address listed above or telephone number (
)
Sincerely, Division Director Region Docket No. 55-License No.
Enclosures:
1.
Letter from Facility Licensee 2.
(name of facility licensee)
' Note that this letter and its enclosures should not be placed in the PDR or the LPDR when they are originally tasued. This letter and the NOV (not enclosure 1) should be placed in the PDR and LPDR if the licensed operator has not replied within 30 days or if the staff review of the licensed operator's response concludes that the licensed operator dal not provide a sufficient basis to withdraw the violation.
Rev. ti3/31/95 B-134 NUREG/BR-0195
Appendix B FORM 36-I Page 3 m
\\
I V
a: tion should be taken against you to ensure future compliance with NRC requirements:
[Specifically list the necessary information, e.g.-
A.
i B.
C.
]
You may provide any other information that you want the NRC to consider, f
including whether the statements made in Section II are correct.
The information is to be 'ubmitted to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555, within days of the date of this Demand for Information, in writing and under oath or o
affirmation.
You may respond to this Demand for Information by filing a written answer under oath or affirmation or by setting forth your reasons why this Demand for Information should not have been issued if the requested information is not being provided. Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address, and to the Regional Administrator, NRC Region (reaional address) j I
Upon review of your answer, or if no answer is filed, the Commission may institute a proceeding pursuant to 10 CFR 2.202 or take such other action as may be necessary to ensure compliance with regulatory requirements.
Your response to the Demand for Information will be considered before a decision is OG NUREG/BR-0195 B-177 Rev. 03/31/95
FORM 36-1, Page 4 Appendix B made in this matter. However, if no answer is filed. we will oroceed on the basis of available information.
FOR THE NUCLEAR REGULATORY COMMISSION Deputy Executive Director for Nuclear Reactor Regulation, Regional Operations and Research Dated at Rockville, Maryland this day of (Month)
,19 (M)
O O
Rev.12/30/94 B-178 NUREG/BR-0195
4 Appendix B FORM 36-H, Page 3 V) action should be taken against you to ensure future compliance with NRr
+
requirements:
[Specifically list the necessary information, e.g.:
r A.
B.
C.
]
You may provide any other information that you want the NRC to consider, including whether the statements made in Section II are correct.
The information is to ne submitted to the Director, Office of Enforcement, U.S.
l Nuclear Regulatory Commission, Washington, D.C. 20555, within days of the date of this Demand for Information, in writing and under oath or affirmation.
1 x.)
You may respond to this Demand for Information by filing a written answer i
under oath or affirmation or by setting forth your reasons why this Demand for Information should not have been issued if the requested information is not being provided.
Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address, and to the Regional Administrator, NRC Region (reaional address)
Upon review of your answer, or if no answer is filed, the Commission may institute a proceeding pursuant to 10 CFR 2.202 or take such other action as may be necessary to ensure compliance with regulatory requirements.
Your response to the Demand for Information will be considered before a decision is (O) v NUREG/BR-0195 B 181 Rev. 03/31M f
N
FORM 36-H, Page 4 Appendix B made in this matter.
However, if no answer is filed. we will proceed on the basis of available information.
FOR THE NUCLEAR REGULATORY COMMISSION Deputy Executive Director for Nuclear Materials Safety, Safeguards and Operations Support Dated at Rockville, Maryland this day of (Month)
, 19 (XX)
O O
Rev.12/30/94 B-182 NUREG/BR-0195
Appendix B FORM 38, Page 1 i
d FORM 38:
Letter of Reprimand to an Unlicensed Individual IA YY-XXX Mr./Ms.
(Name)
[HOME ADDRESS DELETED UNDER 10 CFR 2.790]
SUBJECT:
LETTER OF REPRIMAND (NRC Inspection Report No(s). XX-XXX/YY-NN)
(if applicable, add "and (Investigation Report No(s). X-XX-XXX)"]
Dear Mr./Ms.
(Name) :
This refers to the inspection (investigation) conducted on (date(s))
at the (plant name or company name) facility located in (City. State)
[At a minimum, the narrative that follows should include a description of relevant events, facts, or circumstances that substantiate issuing the LOR.
This description should reference relevant inspection reports, 01 reports, previous correspondence, or enforcement conferences.]
[This section should include a discussion of enforcement action, if any, that was taken against the facility licensee.
If an enforcement action was issued to the facility, a copy should be enclosed.]
You should be aware that the NRC's regulations allow the issuance of orders and other civil sanctions to be taken directly against unlicensed persons who, i
through their deliberate misconduct, cause a licensee to be in violation of NRC requirements. Deliberate misconduct includes an intentional act or omission that the person knows constitutes a violation of a requirement, procedure or training instruction. An order may also be issued to an individual to prevent his or her engaging in licensed activities at all NRC licensed facilities. A violation of this regulation as set forth in 10 CFR (e.a.
30.10. 50.5. 60.11)
" Deliberate Misconduct" (Enclosure _), may also lead to criminal prosecution. The NRC expects no less than full compliance with all applicable requirements and deliberate disregard of those requirements will not be tolerated.
[This section should include a discussion of the basis for not issuing formal enforcement action against the individual.
It should also include a statement notifying the individual that his or her actions are unacceptable and that if uncorrected or continued, could lead to formal NRC enforcement action.]
You are not required to respond to this letter.
However, if you choose to provide a response, please provide it to me within 30 days at U.S. Nuclear l
Regulatory Commission, Region (reaional address)
In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, records or documents compiled for enforcement purposes are placed in the NRC Public Document Room (PDR). A copy of this letter with your address removed, and your response, if you choose to NUREGIBR-0195 B 185 Rev. 03/31/95
FORM 38, Page 2 Appendix B submit one, will be placed in the PDR (aftpr 45 days unless you provide sufficient basis to withdraw this letter).
If you have any questions or comments, please contact (Name. title. and oraanization) at (XXX) XXX-XXXX.
Sincerely, Regional Administrator or Designee Enclosure (s):
- 1. Notice of Violation (if applicable)
- 2. Deliberate Misconduct Rule cc:
(Name of facility licensee)
O
' Note that this letter and its enclosures should not always be immediately placed in the PDR or the LPDR when they are originally issued. The alternative provision should be used in those cases where the individual has not been given an opportunity to dispute the action, such as during an enforcement conference or previously issued DFl. This letter and enclosures should be placed in the PDR and LPDR if the individual has not replied within 30 days or if the staff review of the individual's response concludes that the individual did not provide a sufficient basis to withdraw the LOR.
Rev. 03/31/95 B-186 NUREG/BR-0195
I Appendix B FORM 39, Page I p.
\\'
FORM 39:
Letter of Reprimand to a Licensed Individual IA YY-XXX Mr./Ms.
(Name)
[HOME ADDRESS DELETED UNDER 10 CFR 2.790]
l
SUBJECT:
LETTER OF REPRIMAND (NRC Inspection Report No(s). XX-XXX/YY-NN)
[if applicable, add 'and (Investigation Report No(s). X-XX-XXX)"]
Dear Mr./Ms.
(Name) :
J This refers to the inspection (investigation) conducted on (date(s))
at the (plant name or company name) facility located in (City. State)
[At a minimum, the narrative that follows should include a description of relevant events, facts, or circumstances that substantiate issuing the LOR.
This description should reference relevant inspection reports, 0I reports, previous correspondence, or enforcement conferences.]
]
[This section should include a discussion of enforcement action, if any, that l
was taken against the facility licensee.
If an enforcement action was issued to the facility, a copy should be enclosed.]
O
\\
[This section should include a reminder of an NRC licensed Reactor Operator's responsibilities.
For example, "You are reminded that you hold a license from the United States government that confers upon you the special trust and confidence of the American people in the safe operation of nuclear facilities and places you in the position where your performance is expected to be above reproach.
This includes, as an NRC Reactor Operator license holder, your J
responsibility to remain alert and attentive at all times to ensure protection of the public health and safety. Your actions (condition) on (date) did not meet those standards." This section should also include a discussion of how an NRC licensed Reactor Operator failed to meet their responsibilities.]
You should be aware that the NRC's regulations allow the issuance of orders and other civil sanctions to be taken directly against persons who, through their deliberate misconduct, cause a licensee to be in violation of NRC requirements. Deliberate misconduct includes an intentional act or omission that the person knows constitutes a violation of a requirement, procedure or training instruction. An order may also be issued to an individual to prevent his or her engaging in licensed activities at all NRC licensed facilities. A violation of this regulation as set forth in 10 CFR (e.a.
30.10. 50.5.
60.11)
" Deliberate Misconduct" (Enclosure _), may also lead to criminal prosecution. The NRC expects no less than full compliance with all applicable requirements and deliberate disregard of those requirements will not be tolerated.
l
[This section should include a discussion of the basis for not issuing formal x
.]
enforcement action against the individual.
It should also include a statement l
NUREG/BR-0195 B-187 Rev. 03/31/95 1
1
FORM 39 Page 2 Appendix B notifying the individual that his or her actions are unacceptable and that if uncorrected or continued, could lead to formal NRC enforcement action.]
You are not required to respond to this letter.
However, if you choose to provide a response, please provide it to me within 30 days at U.S. Nuclear Regulatory Commission, Region (reaional address)
In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, records or documents compiled for enforcement purposes are placed in the NRC Public Document Room (PDR). A copy of this letter with your address removed, and your response, if you choose to submit one, will be placed in the PDR (aft sufficient basis to withdraw this letter).pr 45 days unless you provide If you have any questions or comments, please contact (Name. title. and oroanization) at (XXX) XXX-XXXX.
Sincerely, Regional Administrator or Designee Docket No.
License No.
Enclosure (s):
- 1. Notice of Violation (if applicable)
- 2. Deliberate Misconduct Rule cc:
(Name of facility licensee)
' Note that this letter and its enclosures should not always be immediately placed in the PDR or the LPDR when th(y are originally issued. The alternative provision should be used in those ca.ws where the individual has not been given an opportunity to dispute the action. such as during an enforcement conference or previously issued DFl. This letter and enclosures should be placed in the PDR and LPDR if the individual has not replied within 30 days or if the staff review of the individual's response concludes that the individual did not provide a sufficient basis to withdraw the LOR.
Rev. 03/31/95 B-188 NUREG/BR-0195
5 Appendix B FORM 40, Page 1
?
i FORM 40:
Settlement Agreement EA r
(Name of Licensee)
(Address)
SUBJECT:
SETTLEMENT AGREEMENT Dear Mr./Ms.
This refers to (describe telephone conversation or correspondence) regarding settlement of the unpaid civil penalty in the amount of proposed (imposed) on (date) and the option of the attached Settlement Agreement, the terms of which would then be ordered by Confirmatory Order.
j Under the terms of the Settlement Agreement and Confirmatory Order, [briefly describe the terms of the settlement agreement, e.g., "the NRC withdraws the civil penalty and the matter will be considered settled. However, should you violate any of the terms of the Settlement Agreement as ordered by the Confiraatory Order, then the unpaid civil penalty amount would be due in full."]
You should sign the enclosed Settlement Agreement in duplicate, under oath or
/
V) affirmation, and submit it within 10 business days of the date of this letter to (name of current Director. OE)
, Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, One White Flint North,11555 Rockville Pike, Rockville, Maryland 20852-2378.
Following receipt, a Confirmatory Order ordering the terms of the Settlement Agreement will be issued to you. A copy of the signed Settlement Agreement will also be returned to you.
Sincerely, Director, Office of Enforcement i
Docket No.
License No.
Enclosure:
As Stated O
NUREG/BR-0195 B-189 Rev. 03/31/95
Appendix B FORM 40, Page 3 D~
UNITED STATES NUCLEAR REGULATORY COMMISSION BEFORE THE OFFICE OF ENFORCEMENT In the Matter of
)
)
Docket No.
(LICENSEE)
)
License No.
(City. State)
)
EA SETTLEMENT AGREEMENT 1.
[This section should specify the date and amount of the Notice of Violation and Proposed Imposition of Civil Penalty, and provide the number and a brief description of the nature of the violations for which the NOV was proposed. The following example is provided as a sample discussion for this section.]
[0n (date)
, a written Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $7,500 was issued to (name of licensee) for a violation involving failure to perform an adequate survey of the entire circumference of a radiography device in accordance with 10 CFR 34.43 while conducting activities on (date) at (location)
.]
2.
[This section should briefly describe the licensee's response to the NOV.
The following example is provided as a sample discussion for this section.]
[
(Name of licensee) responded to the Notice in a letter dated The Licensee denied the violation and requested remission of the civil penal ty. ]
NUREGIBR-0195 B-191 Rev. 03/31/95
FORM 40, Page 4 Appendix B 3.
[This section should briefly indicate the NRC's consideration of the licensee's response, the date and amount of the Order Imposing Civil Monetary Penalty, and the current status. The following example is provided as a sample discussion for this section.]
[After consideration of the Licensee's response, the NRC staff concluded that the violation occurred as stated in the Notice.
The NRC issued an Order Imposing a Civil Monetary Penalty on (date) in the amount of $7,500.
The Licensee has not paid the civil penalty and has indicated in a letter dated that it would agree to cease activities in NRC jurisdiction for a period of 3 years if the fine were abated.]
4.
(Name of licensee) and its [ President], Mr./Ms.
, and the NRC staff conclude that the following Settlement Agreement best serves the interests of the parties and the purposes of the Atomic Energy Act and the NRC's requirements:
[The terms of the settlement agreement should follow.
The following example is provided as a sample discussion for this section.]
a.
[The NRC withdraws the
($ amount) civil penalty imposed by Order dated
.]
O Rev. 03/31/95 B-192 NUREG/BR-0195
Appendix B FORM 40, Page 5 tO l
U b.
[Mr./Ms./orLicensee agrees that for a period of three years from the date (s)he signs this Settlement Agreement:
(1) neither (s)he, nor the Licensee, nor any successor entity wherein Mr./Ms.
is an authorized user, radiographer, radiographer's assistant, Radiation Safety Officer, Assistant Radiation Safety Officer, or an officer or controlling stockholder, shall apply to the NRC for a license; and (2) neither Mr./Ms.
, nor the Licensee, nor a successor entity at described in (1) above, shall engage in licensed activities within the jurisdiction of the NRC for that same period of time.]
c.
This agreement constitutes settlement without full payment of the civil penalty imposed by Order dated (EA
).
However, if Mr./Ms.
(name of licensee)
, or a successor entity violates paragraph 4.b. of this Settlement Agreement, then the civil penalty amount will be due and payable i
by Mr./Ms./or Licensee immediately and without further notice.
In this event, Mr./Ms./or Licensee further agrees to waive the right to request a hearing on this imposition or otherwise contest or seek review of this penalty action before the NRC or in any court.
O NUREGIBR-4195 B-193 Rev. 03/31/95
FORM 40, Page 6 Appen&x B d.
Mr./Ms.
(name of licensee)
, and any successor entity hereby agree to the issuance of a Confirmatory Order ordering the terms of this Settlement Agreement, and agree to waive any rights that may still be extant to seek a hearing on, or otherwise contest, the matters raised in the Order Imposing Civil Monetary Penalty dated
.)
FOR (License)
Dated:
BY:
(Name of sianatory Official)
FOR THE NUCLEAR REGULATORY COMMISSION Dated:
BY:
(Name of current Director. OE)
, Director Office of Enforcement O
Rev. 03/31/95 B 194 NUREG/BR-0195
7 Appendix B FORM 41, Page 1 V(D FORM 41:
Confirmatory Order 59ttling Civil Penalty Imposed by Order UNITED STATES NUCLEAR REGULATORY COMMISSION In the Matter of
)
)
Docket No.
(LICENSEE)
)
License No.
(City. State)
)
EA CONFIRMATORY ORDER MODIFYING ORDER IMPOSING CIVIL PENALTY i
I i
[This section should include the normal introductory discussion for an order.
r The following example is provided as a sample discussion for this section.]
[(Name of licensee) (Licensee) is the holder of a Byproduct Material License issued by (Aareement State) which authorizes the Licensee to use byproduct material for (authorized use(s))
Pursuant to 10 CFR 150.20, on (date) the Licensee was working at a field site in (soecify the location of the work that took olace in NRC.iurisdiction)
.]
II
[This section should indicate the date of the inspection, the violation (s),
the date and amount of the Notice of Violation and Proposed Imposition of Civil Penalty, a brief summary of the licensee's response, the date and amount i
of the Order Imposing Civil Monetary Penalty, and the general terms of the proposed settlement. The following example is provided as a sample discussion for this section]
l NUREG/BR-0195 B-195 Rev. 03/31/95 i
FORM 41, Page 2 Appendix B
[0n (date) a written Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the amount of $7,500 was served upon the Licensee for a violation involving failure to perform an adequate survey of the entire circumference of a radiography device in accordance with 10 CFR 34.43 while conducting activities on (date) in (location of NRC iurisdiction)
In its response dated the Licensee did not deny the violation, but requested remission of the civil penalty.
After consideration of the Licensee's response, the NRC issued an Order Imposing a Civil Monetary Penalty (Order) to the Licensee on (date) in the full amount proposed.
The Licensee has not paid the civil penalty and has indicated in a letter dated that it would agree to cease activities in NRC jurisdiction for a period of 3 years if the fine were abated.)
O Rev. 03/31/95 B-1%
NtJREG/BR-0195
Appendix B FORM 41, Page 3 m
III
[This section should discuss the terms of the settlement. The following is provided as a sample discussion for this section.]
[The Order dated imposed a civil penalty that is still outstanding.
As the parties desire to resolve all matters pending between them, the Licensee, through its President Mr./Ms.
has entered into a settlement agreement with NRC executed on (date)
Under the terms of the Settlement Agreement, NRC withdraws the civil penalty in the amount of $7,500 imposed by Order dated Under the terms of the Settlement Agreement, Mr./Ms./or Licensee agrees that for a period of three years from the date (s)he signs this Confirmatory Order:
(1) neither (s)he, nor the Licensee, nor any successor entity wherein Mr./Ms.
is an authorized user, radiographer, radiographer's assistant, Radiation Safety Officer, Assistant Radiation Safety Officer, or an officer or controlling stockholder, shall apply to the NRC for a license; and (2) neither Mr./Ms.
, nor the Licensee, nor a successor entity as described in (1) above, shall engage in licensed activities within the jurisdiction of the NRC for that same period of time.]
O NUREG/BR-0195 B-197 Rev. 03/31/95
FORM 41, Page 4 Appendix B IV Accordingly, pursuant to sections 81, 161b, 1611, 186, and 234 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202, 2.205, and 10 CFR Parts 30, 34, and 150, IT IS HEREBY ORDERED THAT:
1.
The NRC withdraws the civil penalty in the amount of
($ amount) imposed by Order dated 2.
For a period of three years from (date that Settlement Aareement was sianed)
(a) neither Mr./Ms.
, nor (name of licensee)
, nor any successor entity wherein Mr./Ms.
is an authorized user,
[ radiographer, radiographer's assistant], Radiation Safety Officer, Assistant Radiation Safety Officer, or an owner or controlling stockholder, shall apply to the NRC for a license; and (b) neither Mr./Ms.
(name of licensee) nor a successor entity as described in (a) above, shall engage in licensed activities or exercise any control over licensed activities within the jurisdiction of the NRC for that same period of time.
O Rev. 03/31/95 B-198 NUREG/BR-0195
. Appendix B FORM 41, Page 5 3.
If Mr./Ms.
(name of licensee)
, or a successor entity violates paragraph 2. of this section of the Confirmatory Order, then the remaining unpaid civil penalty amount shall be due and payable by Mr./Ms.
immediately and without further notice.
I FOR THE NUCLEAR REGULATORY COMMISSION s
Deputy Executive Director for Dated at Rockville, Maryland this day of (Month) 19(XX)
OU NUREGIBR-0195 B 199 Rev. 03/31/95 l
n DISTRIBUTION LIST FOR MATERIALS
v
ESCALATED ENFORCEMENT ACTIONS i
DISTRIBUTION:
PDR LPDR i
SECY CA Executive Director for Operations Deputy Executive Director for Nuclear Materials Safety, Safeguards, and Operations Support Director, Office of Enforcement i
Regional Administrator Assistant General Counsel for Hearings and Enforcement Deputy Assistant General Counsel for Enforcement Director, Office of Nuclear Material Safety and Safeguards Director, Division of Industrial and Medical Nuclear Safety (or, alternatively, Director, Division of Fuel Cycle Safety and Safeguards)
Enforcement Coordinators RI, RII, RIII, RIV Assistant to the Director of Public Affairs Inspector General, Office of the Inspector General Director, Office of Investigations Associate Director, State Agreement Program (o)
Director, Office of Analysis and Evaluation of Operational Data L/
Chief, License Fee & Debt Collection Branch, Office of the Controller OE:ES (Enforcement Specialist)
OE:EA (2)
NUDOCS (State)
NOTES:
1.
This distribution list reflects headquarters (HQ) distribution.
Each Region (RG) should modify it accordingly to include regional distribution.
2.
Include the Chairman, Board of Trustees for cases involving medical licensees and the individuals identified in Section 8.6.7 for cases involving VA facilities or radiographers.
3.
Include the Director, Division of Accounting and Finance, Office of the Controller on civil penalty impositions.
4.
For enforcement correspondence containing Safeguards information, the bec w/ encl list should be modified to bec w/1tr only (without Safe-auards information) with the following exceptions:
bec w/Safeauards info.:
(HQ) Director, OE Chief, RSGB, NRR Director, SGTR, NMSS (RG) as determined by each region Rev. 03/31/95 C 15 NUREG/BR 4195
A
/
l INDIVIDUAL ACTION MATRIX 8s 4
z h
?G (TRACKINGSNUMBERi PUBLISHED 0
- PUB _LISSEDJ
~
!INi 11 Nl i.....
.. MAINTAINED?
Review i 11ssuedi PLACED?
'FEDERALK..
- IN PDR'
- REGISTERS
-NUREG-09402 ON;LISTi~
ENFORCENENT5 ACTION--
Approval
- Actioni LOR to Individtial (Licensed or Unlicensed)
EA IA Yes' No No No NOV to Licensed Individual:
2 FFD Violation EA IA Yes No Yes No All Other Violations EA IA Yes' No Yes No NOV to Unlicensed Individual (SL III or higher)
EA IA Yes' No Yes No Order to Licensee Involving Individual EA EA Yes Yes Yes No Order to Individual 3
3 (Licensed or Unlicensed)
EA IA Yes Yes Yes Yes DFI to Individual EA IA Yes' No No No (Licensed or Unlicensed)
' Not all LORs and NOVs should be placed in the PDR/LPDR when they are originally issued. A 45-day grace period should be provided if the individual has not been given an opportunity to dispute the action, such as during an enforcement conference or previously issued DFl.
FFD NOVs should not be placed in PDR when they are originally issued. NOV should be placed in PDR if: (1) licensed operator has not replied within 30 days, or (2) after review of response, staff finds no basis withdraw the NOV.
M
- Orders are published after they have been adjudicated or where hearing has not been requested within the time limit for requesting a beanng sad are 8
republished in every quarterly NUREG-0940, as long as restrictions contained in the order remain in effect.
9 3
- Not all DFis should be placed in the PDR/LPDR when they are originally issued. See Section 7.3.4 for specific guidance on this issue.
f i
Appendix D Standard Citations - Part 20 j
O SECURITY I
20-60 10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas.
10.CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage.
As defined in 10 CFR 20.1003, contro11ad area means an area, outside i
of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor i
controlled by the licensee.
t Contrary to the above, on (date)
, the licensee did not secure from unauthorized removal or limit access to (specify the tvoe and amount of licensed material) located in (identify the area) which is (a controlled area) / (an unrestricted area), nor did the licensee control and maintain constant surveillance of this licensed material.
Th'.s is a Severity Level violation (Supplement IV).
20-65 10 CFR 20.1902(a) requires that the licensee post each radiation area with a conspicuous sign or signs bearing the radiation symbol C
and the words " CAUTION, RADIATION AREA."
Contrary to the above, as of (date)
, the (identify the area)
, a radiation area with a radiation dose rate of approximately.__
millirem in one hour at 30 centimeters from the (radiation source)
/ (surface that the radiation oenetrated) was not posted with a sign bearing the radiation symbol and the words " CAUTION, RADIATION AREA."
This is a Severity Level violation (Supplement IV).
20-70 10 CFR 20.1902(e) requires that the licensee post each area or room in which certain amounts of licensed material, specified in 120.1902(e), are used or stored, with a conspicuous sign or signs bearing the radiation symbol and the words " CAUTION, RADI0 ACTIVE MATERIAL (S)" or " DANGER, RADI0 ACTIVE MATERIAL (S)."
Contrary to the above, on (date)
, the (identify the room) an area or room in which (specify radionuclide and aooroximate cuantity) was (used) / (stored)
, was not posted with a conspicuous sign or signs bearing the radiation symbol and the words
" CAUTION, RADI0 ACTIVE MATERIAL (S)"
or
" DANGER, RADI0 ACTIVE MATERIAL (S)."
This is a Severity Level violation (Supplement IV).
/~
t NUREG/BR-0195 D-7 Rev. 03/31/95
Standard Citations - Nrt 20 Appendix D 20-75 W CFR 20.1904(a) requires the licensee to ensure that each container of licensed material bears a durable, clearly visible label bearing the words " CAUTION, RADIDACTIVE MATERIAL," or " DANGER, RADI0 ACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, etc.) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.
Contrary to the above, on (date)
, a container of (specify the licensed material) did not bear a label that identified the radionuclide(s) or the quantity of radioactivity, nor did it otherwise bear sufficient information to permit individuals handling or using the container, or working in the vicinity of the container, to take precautions to avoid or minimize exposure.
This is a Severity Level violation (Supplement IV).
20-76 10 CFR 20.1904(b) requires that, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive l
materials.
Contrary to the above, on (date), the licensee transferred empty uncontaminated containers labeled as containing (soecify the licensed material) to the non-radioactive trash without first removing or defacing the radioactive material label or otherwise indicating that the containers no longer contained radioactive material.
This is a Severity Level violation (Supplement IV).
O D-8 NUREG/BR-0195
Appendix D Standard Citations - Part 20 7
~
35-100 10 CFR 35.33(a) requires, in_part, that, for a misadministration, the licensee notify by telephone the NRC Operations Center not later i
than the next calendar day after discovery of the misadministration.
10 CFR 35.2 defines, in part, " misadministration," to mean (fill in applicable definition)
Contrary to the above, on (date), the licensee became aware that a misadministration occurred and the licensee did not notify the NRC until
, which was later than the next calendar day.
Specifically, the misadministration involved faive a brief descriDtion of the misadministration to show that it meets the aDDlicable definition used above)
This is a Severity Level violation (Supplement VI).35-110 10 CFR 35.49(a) requires, in part, that a licensee use for medical use only byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in 10 CFR Part 30 and Sections 32.72, 32.73, or 32.74, or the equivalent regulations of an Agreement State.
Contrary to the above, on (date)
, the lice r ee administered to a patient (byoroduct material) which was not manufactured, labeled, packaged, and distributed in accordance with a license O
issued pursuant to the regulations in 10 CFR Part 30 and Sections Q
32.72, 32.73, or 32.74, or the equivalent regulations of an Agreement State.
This is a Severity Level violation (Supplement VI).35-120 10 CFR 35.50(a) requires that a medical use licensee authorized to administer radiopharmaceuticals have in its possession a dose calibrator and use it to measure the amount of activity administered to each patient.
Contrary to the above, from (date) _ to (date)
, the licensee did not possess a dose calibrator to measure the activity of radio-pharmaceuticals that were administered to patients.
This is a Severity Level violation (Supplement VI).
NUREGIBR-0195 D-43 Rev. 03/31/95
Standard Citations - Part 20 Appendix D 35-121 10 CFR 35.50(b)(1) requires, in part, that a licensee check each dose calibrator for constancy with a dedicated check source at the beginr.ing of each day of use and that the check be done on a frequently used setting.
Contrary to the above, on (date), the licensee did not check the dose calibrator for constancy with a dedicated check source at the beginning of each day of use, and the dose calibrator was used to measure patient doses of radiopharmaceuticals on that day.
This is a Severity Level violation (Supplement VI).35-122 10 CFR 35.50(b)(2) requires, in part, that a licensee test the dose calibrator for accuracy at least annually.
Contrary to the above, the licensee did not test its dose calibrator for accuracy from (date) until (date)
This is a Severity Level violation (Supplement VI).35-123 10 CFR 35.50(b)(3) requires, in part, that a licensee test r.ach dose calibrator for linearity over the range of its use br.cween the highest dosage that will be administered to a patient and 10 microcuries.
Contrary to the above, the licensee's dose calibrator linearity test performed on (date(s))
covered only the range between millicuries and (millicuries) / (microcuries)
(and the highest dosage that the licensee administers to a patient is millicuries).
This is a Severity Level violation (Supplement VI).35-124 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at least quarterly.
Contrary to the above, the licensee did not test its dose calibrator for linearity from (date) until (date) a period in excess of a calendar quarter.
This is a Severity Level __ violation (Supplement VI).35-125 10 CFR 35.50(b)(4) requires, in part, that a licensee test each Gse calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used.
Contrary to the above, the licensee did not test its dose calibrator for geometry dependence at the time of installation, which occurred on (date)
This is a Severity Level violation (Supplement VI).
Rev. 03/31/95 D-44 NUREG/BR-0195