NUREG/CR-6204, Informs CRGR of Proposed Change to Existing Guidance in NUREG/CR-6204 Re Compliance Backfit Issues
| ML20207L632 | |
| Person / Time | |
|---|---|
| Issue date: | 03/03/1998 |
| From: | Lieberman J NRC OFFICE OF ENFORCEMENT (OE) |
| To: | Martin T Committee To Review Generic Requirements |
| Shared Package | |
| ML20207L615 | List: |
| References | |
| RTR-NUREG-CR-6204 NUDOCS 9903180203 | |
| Download: ML20207L632 (25) | |
Text
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20eer4001 *
- / March 3, 1998 Memorandum To: Thomas T. Martin, Chairman ,
Committee to Review Generic Requirements FROM: James Lieberman, Director j j Office of Enforcement .
SUBJECT:
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- COMPLIANCE BACKFIT ISSUE This memor'andum informs the CRGR of a proposed change to the existing guidance in NUREG/CR-6204. The staff believes that this change is a minor matter that does not warrant CRGR review and that it constitutes a compliance backfit for the reasons set forth below: ,
Background:
l The regulations in 10 CFR 20.1801 and 1802 require that licensed material either be secured or under surveillance at all times. From the regulations and associated statements of consideration, it is clear that these requirements apply even when the quantities of material are very small. When 10 CFR 20.1801 and 1802 were promulgated, the Commission discussed the need to secure small quantities of licensed materials and the associated cost / benefit in the statements of consideration (56 FR 23360 at 23379, May 21,1991):
[Commenter): . . the requirement to secure small quantities of licensed )
radioactive materials when they are not in use would interfere with university research.
[ Commission Response] . . locking radiotracer laboratories when they are not being used is a small nuisance compared to the consequences of unauthorized access to, or theft of, radioactive materials, which could result in contamination of unrestricted areas or exposure to individuals, as well as having to report a loss of licensed material to the NRC.
As a result of these rulemakings, the staff considers it to be the Commission's intent that constant control be maintained over all licensed material, either by physically restricting access or maintaining surveillance. On the other hand, the staff modified this position somewhat in May 1994 when it published " Questions and Answers Based on Revised 10 CFR Part 20" (NUREG/CR-6204): '
Question 129: 10 CFR 20.1801 and 1802 do not specify the quantities of radioactive material below which unauthorized access to, unauthorized removal from, or the maintenance of constant surveillance over, are not required in
'The staff apparently was not focusing on the statements of consideration quoted above at the time that the staff published these Questions and Answers.
9903180203 990301 PDR REVQP MtOCRQR MEETINO318 PDR
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controlled areas. Will these requirements be imposed (a) on all quantities of l
, licensed material, however small and (b) on quantities that are exempt from ;
labeling by 10 CFR 20.1905(a) and (b)?
Answer: (a).No. The requirements cf 10 CFR 20.1801 and 20.1802 are not new;
- they are sasentially the same as the req,uirements of 10 CFR 20.207(a) and '
20.207(b) except that the revised Part 20 requirements apply to controlled areas -
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_ as well as unrestricted areas. NRC will continue to enforce these requirements i as it has in the past.
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(b) No. ;
1 Question 419 etsentially restates the same query. The answer refers back to Question 129. I i
10 CFR 20.1905 is based on the quantities of licensed material listed in appendix C to Part 20.
Since the Office of Enforcement (OE) became aware of the existence of these published Questions and Answers, it has not pursued enforcement action against licensees for failure to secure from unauthorized removal amounts less than the quantities listed in appendix C.: ,
Proposed Action:
The staff intends to withdraw the guidance in the two Os and As (numbers 129 and 419) in -
NUREG/CR-6204 which states that the requirements of 10 CFR 20.1801 and 1802 do not apply to amounts of licensed material less than the quantities listed in appendix C to 10 CFR Part 20.
The staff intends to withdraw this guidance because it conflicts with the regulations at 10 CFR 1801 and 1802 and with the associated statements of consideration. Licensees will be notified by Administrative Letter as further detailed in the attached draft memorandum to the Commission, which includes a proposed Enforcement Guidance Memorandum (EGM).
After the guidance is withdrawn, violations of 10 CFR 20.1801 or 1802 that involve quantities less than those in appendix C to Part 20 will be treated as minor (non cited) violations. Under the NRC Enforcement Policy, a minor violation may occur several times and still be of minor concem; however, if a license refuses to correct a minor violation within a reasonable time such that it willfully continues, the violation normally will be categorized at least at Severity Level IV.
OGC (Jack Goldberg) is of the opinion that this proposed action constitutes a compliance backfit.
The staff intends to proceed with the attached memorandum to the Commission without a formal CRGR review unless the CRGR informs me otherwise within two weeles of the date of this
'For example, enforcement action was not taken against Wright State University, Dayton, Ohio, EA 95-255, for failure to secure multiple vials of tritium (H-3), each of which contained less than the quantity listed for H-3 in 10 CFR Part 20, appendix C. The circumstances involving the quantities of material were only fortuitous and not the result of any conscious evaluation on the
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3 memorandum. The EGM and Administrative Letter will be issued following the Commission notification.
1 Attachments: As stated !
I cc: A. Thadani, DEDE ,
H. Thompson, DEDR L. Chandler, OGC J. Goldberg, OGC j
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I MdMORANDUM TO: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan FROM: L. Joseph Callan Executive Director for Operations
SUBJECT:
ISSUANCE OF ENFORCEMENT GUIDANCE CATEGORIZING THE SEVERITY LEVEL OF VIOLATIONS THAT INVOLVE SECURITY AND CONTROL OF LICENSED MATERIAL Previously, the staff informed the Commission that it had under review the issue of the levpl of security that should be required for NRC-licensed material and how security requirements ,
should be related to the potential risk or hazard of the materialinvolved (see SECY-97-094, Enforcement Action Against the Department of Health and Human Services, National Institutes l
i of Health (EA 96-027), April 30,1997, and memorandum from Carl J. Paperiello to L. Joseph Callan, " Staff Actions Update," dated November 4,1997, WITS 9500131). Although the original concern in 1995 centered around the " controlled area" definition in 10 CFR Part 20, the staff has determined that the regulations in this area do not need to be revised, but rather recommends that the enforcement guidance for the security and control violations of 10 CFR $f 20.1801 and 20.1802 be clarified.
in SECY-97-094, the staff stated that programmatic security issues and repetitive security violations are considered to be significant regulatory concems under the NRC Enforcement Policy, and that the staff wished to encourage licensees to undertake a program of detecting and correcting security violations. The attached Enforcement Guidance Memorandum (EGM), which will be issued to the NRC staff by the Office of Enforcement, assigns regulatory significance to violations that involve security and control of licensed material according to the quantities of material involved, and places a premium on licensee programs that include training, staff awareness, detection, and corrective action to detect and deter security violations. After gaining experience with this guidance, the staff plans to propose that it be incorporated into the NRC Enforcement Policy.
As noted in the EGM, the staff intends to withdraw previous guidance which states that NRC's requirements to secure and contrM licensed material are not applicable to quantities less than those listed in appendix C of 10 UR Part 20. The guidance consists of two questions and answers published in NUREG/CR. 6204. It is being withdrawn because it conflicts with the regulations in 10 CFR 20.1801 and 1802, as well as the supporting statements of consideration.
The Committee to Review Generic Requirements (CRGR) has been consulted on this issue as a compliance backfit and has determined that a formal CRGR review is not necessary. In the
' Contacts: James Lieberman, OE,415-2741 Carl J. Paperiello, NMSS,415-7800 1
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EGM, security violations invoising quantities equal to or less than ten times those listed in appendix C are treated as m!aor violations. Minor violations may occur several times and still be of minor concem; however, licensees still must take corrective action for minor violations.
An administrative letter will be issued to inform licensees about the new enforcement guidance in the EGM and the withdrawal of the previous guidance regarding quantities less than i appendix C 'of 10 CFR Part 20. The administrative letter will include the backfit analysis.
Attachment:
As stated l l
cc: SECY !
OGC ;
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SCollins, NRR JLieberman, OE CPaperiello, NMSS CJones, NMSS DCool, NMSS PTressler, EDO (WITS 9500131)
MSchroll, SECY CPoland, PMDA ARBlough, Rl DCollins, Ril CPederson, Rlli RScarano, RIV d
paY / VA OEh SS OGC- NRR O DEDE EDO lMedico CPaperiello LChandler SC ins rman AThadani LCallan JDp/98 2/7 2/j;(98 2@8 8 3/ 2j98 2/ /98 2/ /98 l G:\NRCCJD.WPD l
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EGM 98-XXX ;
MEMORANDUM TO: Hubert J. Miller, Regional Administrator Region I ,
Luis A. Reyes, Regional Administra' tor Region II A. Bill Beach, Regional Administrator '
Region ill Ellis W. Merschoff, Regional Administrator Region IV ,
Roy Zimmerman, Associate Director for -
Projects, NRR Brian W. Sheron, Acting Associate Director for Technical Review, NRR :
Elizabeth Q. Ten Eyck, Director, Division of Fuel Cycle Safety and Safeguards, NMSS Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, NMSS ;
John T. Greeves, Director, Division of Waste Management, NMSS FROM: James Lieberman, Director Office of Enforcement
SUBJECT:
ENFORCEMENT GUIDANCE MEMORANDUM CATEGORIZING THE SEVERITY LEVEL OF VIOLATIONS INVOLVING SECURITY AND CONTROL OF LICENSED MATERIAL This memorandum is being issued to provide further guidance on the severity level of violations involving 10 CFR 20.1801 and 1802, security and control of licensed material.' The Enforcement Policy, Example IV.C.12, indicates that a significant failure to control licenced material is a Severity Level lil violation [ emphasis added). Severity Level til also is assigned under Example VI.C.1 for failure to control access to licensed materials for radiation purposes as specified by NRC requirements.
The following guidance uses a more risk-informed, performance-based approach to determine j the types of security violations that should be considered significant, vs. those of less serious j "oncem and those of minor significance. This guidance is intended to focus licensees' attention on assuring a program of training, staff awareness, detection (auditing), and corrective action
'This guidance is not meant to imply that the release of an individual following "
decontamination conducted in accordance with the licensee's decontamination procedure is a
. violation of 10 CFR 20.1801 or 1802.
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i (including disciplinary action) to detect and deter secJrity violations. Such a program normally is )
not a specrfic regulatory requirement, but rather :: function that licensees need to perform as an l inherent part of their compliance program. Normally, security violations that occur despite such i
- a program will be considered isolated.
As with other examples in the policy, the severity level may be increased if the violation involves willfulness, and may be increased or decreased as other circumstances warrant. For example, l the severity lavels of some security violations that involve large amounts of very low concentration material, such as a breach of the fencing at an SDMP site, may be reduced if ;
warranted by the safety and regulatory significance of the specific violation.
This memorandum does nc. address loss, release, or disposal of licensed material, which is !
covered under separate examples in Supplement IV of.the Enforcement Policy. j After gaining experience with this guidance, the staff plans to propose that the following l l
guidance be incorporated as specific examples in the Enforcement Policy. At that time, the current examples IV.C.12 and VI.C.1 will be withdrawn.
Seventy Level 111 - Violations involving, for example:
(a) failure to secure, or maintain surveillance over, licensed material in any aggregate quantity greater than 1000 times the quantity specified in appendix C to Part 20, or that results in a substantial potential for exposures or releases in excess of the applicable limits in Part 20; or (b) failure to secure or maintain surveillance over licensed material ,
not characterized above and involving an aggregate quantity greater than 10 times the quantity specified in appendix C to Part 20, where such failure is accompanied by the absence of, or a breakdowrf in, a program to detect and deter security violations that includes training, staff awareness, detection (including auditing), and corrective action (including disciplinary action), i Severity . Level IV - Violations involving, for example: ;
Isolated failures to secure, or maintain surveillance over, licensed material not characterized above and involving an aggregate quantity greater than 10 times the quantity specified in appendix C to Part 20, provided that: (i) the materialis labeled as radioactive or located in an area posted as containing radioactive materials; and (ii) such I failure is non-programmatic in that the failure occurs despite a functional program to detect and deter security violations that includes training, staff awareness, detection (including auditing), and corrective action (including disciplinary action).*
'The term
- breakdown" as used herein has the same meaning as in Examples IV.C.13 and IV.C.7 of the Enforcement Policy.
'In accordance with the Enforcement Policy, Section Vll.B.1, enforcement discretion normally is exercised to utilize non-cited violations (NCVs) for licensee-identified violations that wnuld otherwise be categorized at Severity Level IV.
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3 Note: It is unlikely that licensees can eliminate allsecurity infractions within large, broad-licensed programs; therefore, licensees with vigilant progrems are likely to detect these violations periodically. The fact that security violations recur does not necessarily mean that they are repetitive as defined in the Enforcement Policy. The Policy requires a consideration of whether corrective action was taken that was reasonably calculated to prevent additional similar violations. If the licensee has taken reasonable corrective action to prevent recurrence such as adopting a program of identification, staff awareness, auditing, training, and correction of individual security violations, normally Severity Level IV security violations should not be considered repetitive unless they involve the same individual (s), the same immediate supervisor, or the same workspace (e.g., the same laboratory).
Minor Violations * - Violations involving, for example:
Failures to secure, or maintain surveillance over: (1) licensed material involving aggregate quantities equal to or less than 10 times the quantity specified in appendix C to Part 20 ar (2) properly labeled sealed sources or waste forms measuring less than 0.02 mSv/hr (2 mrem /hr) at 30 cm.
Nota: At the present time, guidance in NUREG/CR-6204 indicates that 10 CFR 20.1801 and 1802 do not apply to amounts less than the quantities listed in appendix C to Part
- 20. This guidance is being withdrawn by administrative letter. The administrative letter willinclude a backfit analysis.
Security violations categorized as minor or Severity Level IV may be dispositioned by the Regions. For a period of three months from the date of this EGM, security violations categorized at Severity Level lli should be coordinated with NMSS. After that date, actions that involve Severity Level lli violations may be treated as normal delegated cases provided that they meet the delegation criteria.
, 'By definition, a minor violation may occur several times and still be of minor concem; however, if a licensee refuses to correct a minor violation within a reasonable time such that it !
willfully continues, the violation should be categorized at least at Severity Level IV. Enforcement Policy,Section IV.C. l I
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Minutes of CRGR Meeting No. 318, April 17,1998 ;
PRESENTATION MATERIAL USED BY THE STAFF Attachment 2-B
United States
{' - } Nuclear Regulatory Commission COMPLIANCE BACKFIT ISSUES ASSOCIATED WITH SECLRITY AXD CONTROL PER 10 CFR se20.1801 AXD 1802 Presentation to the Committee to Review Generic Requirements Cynthia G. Jones , Q, Senior Level Advisorfor Health Physics ? EI Office of Nuclear Material Safety and Safeguards 4q 4
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BACKGROUND & HISTORY l
( 1957 -
%20.207 Storage oflicensed material.
Licensed materials stored in an unrestricted are shall be secured against unauthorized removal from the place of storage (22 FR 548) 1964 -
- 20.205 Exemptionsfor radioactive materials packagedfor shipment.
(iv) For containers when they are attended by an individual who takes the precautions necessary to prevent the exposure of any individual to radiation or radioactive materials in excess of the regulatory limits established by the regulations in [Part 20]
(29 FR 14756) t
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Nuclear Regulatory Commission
- BACKGROUND & HISTORY (Continued) 1975 -
An Immediately Effective Rule was issued to strengthen f20.207 to assure that proper controls were maintained over licensed material !
at all times (40 FR 26679)-
@20.207 Storage of Licensed Material.
(a) Licensed materials stored in an unrestricted area shall be secured from unauthorized removal from the place of storage.
(b) Licensed materials in an unrestricted area and not in storage shall be tended under the constant surveillance and immediate control of the licensee.
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.l CURRENT REQUIREMENTS 1991 - (Final Rule)
@20.1801 Security of stored material.
The licensee shall secure from unauthorized removal or licensed materials that are stored in controlled or u areas.
%20.1802 Control of material not in storage.
The licensee shall control and maintain constant sur of licensed material that is in a controlled or unrestr and that is not in storage.
United States
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-l 1991 - Statements of Consideration for @20.1801 and 1802 General Comment " Unnecessary restrictions on research." One commenter thought that the requirement to secure small quantities of radioactive materials when they are not in use would interfere with university research.
Commission response " Locking radiotracer laboratories when they are not being used is a small nuisance compared to the consequences of unauthorized access to, or theft of, radioactive materials..." j 1994
- NUREG/CR-6204 (Q&As based on 10 CFR Part 20) issued.
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l i i WHY ISSUE Q&As (NUREG/CR-6204)?
e e Technical questions arose from the 1986 version of proposed 10 CFR Part 20 from public workshops, licensee interactions with NRC staff,
, and from NRC technical training courses.
- e To ensure consistent responses to 10 CFR Part 20 questions between the NRC offices and regions, and to reflect staff practices on the l
revised regulations, nine sets of Q&As were jointly developed by NRR, NMSS, RES, and OSP (seven sets of these Q&As are contained in NUREG/CR-6204).
e Although all of the Q&As were reviewed by OGC, the abstract to NUREG/CR-6204 states that they "do not constitute official legal interpretations."
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1 United States Nuclear Regulatory Commission
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-l RECENT EVENTS t
Date Location Isotope Dose / Intake No. Of People I Contaminated. .
6/95 NIH, Bethesda, MD P-32 820-1300 Ci 28* l 8/95 MIT, Cambridge, MA P-32 579 Ci 1 l
- Only one Individual received a dose of between 8.0 to 12.7 rem (800-1300 Ci) i i
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Nuclear Regulatory Commission l
1 ACTION ITEMS: Evaluate existing regulations, guidance, and standard review plans for security and control of radioactive materials. Determine the need to develop new or revised standards, guidance, and I regulations, as appropriate.
l l FINDINGS: -
Current NRC regulatory guidance (Health Physics i
Q & As - NUREG/CR-6204) for security & control of byproduct material are inconsistent with current regulations.
Enforcement guidance regarding thresholds for security and control violation is needed.
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Nuclear Regulatory Commission ;
t CURRENT PRACTICE e Currently NMSS headquarters staff is coordinating all materials security & control violations from the regions on a case-by-case basis.
e A "one size fits all" approach to security and control issues has proven to not be best for all types of licensees.
e NRC has gathered information from 4 licensee workshops since 1996 and initially developed a Commission options paper for security and control. Further discussion between NMSS and OE determined that new enforcement guidance was the best approach. This guidance was
- sent to the Commission on April 9,1998.
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Nuclear Regulatory Commission WITHDRAWAL OF Q&As #129 & #419 e Inconsistent with 10 CFR Part 20 and conflicts with the 10 CFR Part 20 Statements of Consideration.
e After the Q&As are withdrawn, violations of 10 CFR sf20.1801 or j 1802 that involve less than 10x Appendix C quantities will be treated as minor (non-cited) violations.
e OGC Enforcement has advised that this proposed action constitutes a compliance backlit because the Q&As are inconsistent with Part 20.
e OGC has recommended that an Errata Sheet, rather than an Administrative Letter, be issued to all parties that previously received NUREG/CR-6204, to inform them of the withdrawal of two Q&As.
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(,g-), United States Nuclear Regulatory Commission l I
I April 1998 Report Number: NUREG/CR-6204 Report
Title:
Questions and Answers Based on Revised 10 CFR Part 20 Prepared By: Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Date Published: May 1994 Instructions: Questions 129 and 419, as well as its associated answers, are being withdrawn. The answers to these !
questions stated incorrectly that the requirements of 10 CFR Gf20.1801 and 1802 did not apply to amounts of licensed material less tnan the quantities listed in l Appendix C of 10 CFR Part 20. They are being l withdrawn because they conflict with the regulations at 10 CFR Part Qf20.1801 and 1802 and with the associated statements of considerations. Current !
guidance for security and control violations can be found I in NRC's Enforcement Guidance Memorandum EGM-98-XXX, issued April XX,1998.
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, e e nRCu g k UNITED STATES g j
, NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 6:546 0001
% % ,+ / March 1, 1999 1
MEMORANDUM TO: William D. Travers Executive Director for Operations FROM: Joseph A. Murphy, Chairman '
Committee To Review Generic eq ' e en
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 318 t The Committee To Review Generic Requirements (CRGR) met on Friday, April 17,1998, from 9:00 am to 11:30 am. Attachment 1 contains the list of attendees.
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D. Cool and C. Jones, both of NMSS, presented for CRGR review and endorsement the compliance backfit issues associated with security and control requirements under the provisions of 10 CFR 20.1801 and 20.1802. The staff intended to articulate the proposed revised staff position in NUREG/CR-6204," Questions and Answers Based on Revised 10 CFR Part 20." This issue was discussed in the March 3,1998, memorandum from J. Lieberman to T.
Martin on the subject (Attachment 2-A). The staff's presentation material is included as Attachment 2-B. The Committee noted that the NUREG in question had not been submitted for CRGR review and endorsement prior to issuance. With respect to the proposed revised staff position, the Committee specifically commented that although the staff's approach is an expeditious and cost-effective solution to the problem, in the long term this issue would most appropriately be addressed by rule change. The Committee further commented that instead of going through the rulemaking process, the staff has opted to issue an administrative letter, which would in fact impose unnecessary burden on licensees. This is a backfit; however, to identify it as a compliance backfit is stretching the intent of the compliance exception in CRGR's view. The Committee also remarked that an administrative letter is not an appropriate vehicle to l articulate the staff's revised expectations of the licensees, and Committee recommended that a l generic letter clearly stating the revised staff position, with justification, and expected licensee !
compliance with due process of oublic comment, would be more suitable. Subject to these comments and recommendations, the Committee endorsed the revised staff position for issuance. No revised proposal was submitted for CRGR endorsement. i R. Lee Spessard (NRR) presented for CRGR review and endorsement the revised proposed generic lettet " Year 2000 Readiness of Computer Systems and Nuclear Power Plants." No presentation material was used by the staff. The Committee endorsed the generic let'er without comments. Furthermore, the Committee asked CRGR's NMSS member to have NMSS l management consider developing and issuing a Year-2000 generic letter to the nuclear materials licensees. The Committee was later informed that such an action was taken.
In accordance with the EDO's July 18,1983 directive concerning " Feedback and Closure of l CRGR Review", a written response is required from the cognizant office to report agreement or disagreement with the CRGR recommendations in these minutes. The response is to be forwarded to the CRGR Chairman and if there is disagreement with the CRGR i
PDR 1
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William D. Travers recommendations, to the EDO for decision making.
Questions concoming these meeting minutes should be referred to Raji Tripathi (415-7584).
i Attachments: As stated cc: Commission (5) SECY M.Knapp,DEDE F. Miraglia, DEDO
. J. Lieberman, OE -
M. Springer, ADM H. - Bell, OlG K. Cyr, OGC -
J. Larkins, ACRS H. Miller, R-l L Reyes, R-ll J. Dyer, R-lli E.- Marschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR J. Lieberman, OE D. Cool, NMSS J. Strosnider, NRR .
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William D. Travers recommendations, to the EDO for decision making.
Questions concerning these meeting minutes should be referred to Raji Tripathi (415-7584).
Attachments: As stated cc: Commission (5) SECY M. Knapp, DEDE F. Miraglia, DEDO J. Lieberman, OE M. Springer, ADM H. Bell, OlG K. Cyr, OGC J. Larkins, ACRS H. Miller, R-l L. Reyes, R-Il J. Dyer, R-ill E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES S. Collins, NRR J. Lieberman, OE D. Cool, NMSS J. Strosnider, NRR Distribution: -
File Center (w/att.) PDR (NRC/CRGR) CRGR SF CRGR CF JMitchell JJohnson, OCM STreby BSheron DCool DDambly NDudley GPurdy JDelMedico Leamper SKlementowicz JShapaker ,
MChiramal Jwermiel AHansen CJones DISK / DOCUMENT NAME: S:\CRGR\MITS-318 To recewe e copy, indcote *C" = Copy wf) attachment / enclosure:"A" = Cop t with attachment / enclosure;"N" = No copy. NO MARK = NO COPY!
OFC CRGR , j C C CM , C NAME RTripathi
' DATE A 42 /99 / [ SB N i OPPICIAL RECORD COPY