ML20205Q684
| ML20205Q684 | |
| Person / Time | |
|---|---|
| Issue date: | 04/01/1999 |
| From: | Jerome Murphy Committee To Review Generic Requirements |
| To: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9904220020 | |
| Download: ML20205Q684 (22) | |
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.,' g UNITED STATE 3 s
j NUCLEAR REHULATORY COMMISSION g
WASHINGTON, D.C. 20066-4001 N+,.
5
,o April 1, 1999 MEMORANDUM TO:
William D. Travers Executive Director for Operations FROM:
Joseph A. Murphy, Chairman Committee To Review Generic R uir nts
SUBJECT:
MINUTES OF THE CRGR MEETING NUMBER 315 The Committee To Review Generic Requirements (CRGR) met on Friday, February 13,1998, from 9:00 a.m. to 12:00 p.m. Attachment 1 contains a list of attendees.
J. Roe and L. Bush, both of NRR, briefed the Committee on the historic perspectives and backfit aspects of the proposed final amendments to the Fitness For Duty Rule (10 CFR Part 26).
Attachments 2-A and 2-B contains the material distributed by the staff at the meeting. The Committee made various comments and expressed an interest in a formal review at a later date.
R. Lee Spessard and M. Bugg, both of NRR, presented for CRGR review and endorsement the proposed generic letter on guidance on the storage, preservation, and safekeeping of quality assurance records in electronic media. Attachment 3 contains the presentation material used by the staff. The Committee endorsed the proposed generic letter subject to minor comments.
R. Lee Spessard, S. Black and R. Correia, all of NRR, briefed the CRGR on the proposed amendments to 10 CFR 50.65, " Requirements for Monitoring the Effectiveness of Maintenance at Nuclear Power Plants." Attachment 4 contains the presentation material used by the staff.
The Committee offered various comments and recommendations, and to support the expedited schedule, accepted the staffs request to review the proposed amendments at the final ruelmaking stage.
in accordance with the EDO's July 18,1983 directive conceming " Feedback and Closure of 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 recommendations, to the EDO for decision making.
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MEETING 315
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William D. Travers Obestions conceming 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 H. Bell, OlG K. Cyr, OGC J. Larkins, ACRS H. Miller, R-1 L. Reyes, R-il J. Dyer, R-Ill E. Merschoff, R-IV C. Paperiello, NMSS A. Thadani, RES i
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i William D. Travers April 1, 1999 Questions conceming these meeting minutes should be referred to Raji Tripathi (415-7584).
Attachments: As stated ec:
Commission (5)
SECY M. Knapp, DEDE F. Miraglia, DEDO J. Lieberman, OE 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 W. Kane, NRR Attachments: As stated Distribution:
File Center (w/atts.) PDR (NRC/CRGR) (w/o atts.) '
CRGR SF CRGR CF STreby Distribution (via e-mai' :
RCorreia MBugg JPeralta JShapaker DDambly DISKIDOCUMENT NAME: C:\\CRGR98\\ MINUTES \\ MINUTE.315.WPD To roc-iva a copy of this document, indicate in the box: "C" = Copy w/o attachment. *E' = Copy w/ attachment. 'N" = No copy OFC CRGR C
C;Gf99R,
NAME RTripathi DATE 3///99
[///99 OFFICIAL RECORD COPY l
I
Minutes of CRGR Meeting No. 315, dated February 13,1998
)
1 CRGR Meeting No. 315
- Attendance List February 13,1998 CRGR MEMBERS NRC STAFF T. T. Martin (Chairman)
R. L. Spessard, NRR F. J. Miraglia J. Roe, NRR D. F. Ross L. Bush, NRR W. F. Kane for M. Knapp J. Shapaker, NRR D. C. Dambly M. Bugg, NRR S. Black, NRR R. Correia. NRR J. Peralta, NRR CRGR STAFF l
t R. Tripathi l
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Minutes of CRGR Meeting No. 315, February 13,1998 PRESENTATION MATERIAL USED BY THE STAFF I
i i
ATTACHMENT 2-A
Chronology ofInterfaces Between FFD and Backfit 1.
August 5,1982 - Proposed FFD Rule 2.
August 4,1986 - Policy Stitement 3,
December 16,1987 - SRM directed staff to prepare a propo' sed rule after NUMARC and staff briefed the Commission on implementation experience with the Policy Statement. Key problems were:
a.
not all licensees random testing, some due to union intervention or State laws b.
cutoff levels varied significantly, some inedequate c.
sanctions impo sed varied due to local tolerances d.
training and awareness programs needed improvement.
4.
September 22,1988 - Proposed FFD rule, over 3,000 comments j
S.
March 22,1989 - SRM approved final rule and specifically directed the staff to; I
I a.
make it clear that the rule may be amended in the future in response to advances in technology, additional experience, or other factors as identified by HHS or the NRC (SRM item 4);
b.
assure adequate data collection so that licensees programs can be analyzed, the j
effectiveness of the rule can be assessed, and, if necessary, make appropriate j
improvements or changes (SRM item 7),
c.
revisit the need for changes to the final rule by July 91 (SRM item 12).
6.
June 7,1989 - Final FFD rule with implementation date of January 3,1990.
7.
March 7,1991 - Commission briefed on implementation of rule.
8.
March 27,1991 - SRM directed the staff to further investigate potential changes to the rule in regard to:
a.
extrapolation of test results b,
requiring FFD program personnel be tested c,
specifying individuals be providej copies of drug test records, and d.
being more explicit in follonp testing requirements.
9.
September 17,1991 - SF.CY 91-293 reported the staff's assessment of the implementation of the rule and need for changes to the rule.
- 10. November 7,1991 - SRM directs the staff to:
4 2
a.
prepare proposed amendments as proposed by SECY-91-293 b.
continue to consider further experience with implementation of the rule to identify possible areas where amendments may be needed.
adhere to the HHS Guidelines absent a compelling reason why a departure is c.
necessary to address a unique situation in the nuclear industry, Specifically, the stafff should not reduce the required specimen quantity, reduce the marijuana screening cutoff levels, and eliminate batch reporting, because they go beyond what the HHS Guidelines currently endorse. NOTE: HHS changed those requirements, and many others, on June 9,1994, and DOT adopted those changes a few weeks later.
- 11. September 2,1992 - SECY-92-308 proposed amendments to the FFD rule.
- 12. September 30,1992 - Commissioner Remick asked questions about the application of the Backfit Rule to the proposed amendments to Part 26.
- 13. October 29,1992 - SRM requested that the staff develop recommendations concerning possible changes to 50.109.
14 November 19,1992 - Memo from Taylor and Parler to Commissioner Remick makes the following points:
The changes proposed in SECY-92-308 were to achieve the intent of the original a.
rulemaking in that testing results are accurate, the testing process is valid, and the licensees can meet the general performance objectives of the rule.
b.
The Commission recognized that the rule might need to be updated and instructed the staff to inform it of any changes that may be needed, which the staff has done through a series of briefings and Commission papers.
c.
The Commission directed the staff to proceed with rulemaking and to continue monitoring implementation experience to find other areas where amendments may be needed.
d.
The rule changes proposed are only relatively minor modifications, clarifications, or adjustments to existing provisions. While the proposed changes are important and would improve the program in a manner consistent with the rule's original performance objectives, none of the changes satisfy a rigoroas application of the backfit standards of a substantialincrease in safety.
- 15. February 19,1993 - EDO withdraws SECY-92-308 because changes do not meet the
" substantial increase" standard.
- 16. March 1,1993 - SRM instructs the staff to resubmit the proposed FFD rule changes when the backfit issues in response to the SRM of 10/29/92 are resolved.
- 17. April 1,1993 - SECY-93-086 provided the staff's evaluation of the backfit rule and its recommendations.
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- 18. June 30,1993 - SRM provided the staff with flexibility in implementing the backfit rule and provided for promulgation of rules for nonsafety reasons where the rules do not meet a flexible application of the " substantial increase" standard. Reasonable, well justified changes will be considered on a case-by-case basis as exceptions to the backfit rule.
19.
October 31,1995 - SECY-95-262 provided the staff's recommended changes. (This was updated version of SECY-92-308).
- 20. March 18,1996 - SRM approves publication of proposed amendments.
- 21. May 9,1996 - Proposed amendments published. Nearly 1100 comments received.
4 Minutes of CRGR Meeting No. 315, February 13,1998 PRESENTATION MATERIAL USED BY THE STAFF f
ATTACHMENT 2-B
I FEB 05-1998 13:19 FROM iATTELI 5%eBRC4 i0
,o-.24 E 30141522*?9 P.003. 00-.
ANALYSIS OF THE APPLICATION OF THE BACKFrr RULE may be TO THE REVISIONS TQ THE FITNESS-FOR DUTY RULE
'odard (10 CFR PART 26)
' is This paper presents the staff's analysis of the application of the NRC's Backfit Rule (10 CFR 50.109) to the proposed revisions to the Fitness-for-Duty rule (10 CFR Part 26). In publishing the proposed revisions to Part 26 on May 9,1996 (61 FR 21105), the NRC listed the revisions in three groups to facilitate the public's consideration. Group Iincluded revisions that would conform Part 26 requirements to other national standards, including the Department of Health and Human Services' Mandatory Guidelinesfor Federal Workplace Drug Testing Programs. Group H included revisions that would reduce licensee burden and Group III revisions included revisions that would be worthwhile for other reasons. Minor edits that make no substantive change are not included in this analysis. This paper describes each of the proposed Part 26 revisions in the order that they were listed in these three groups.
It should be noted that the staff is now recommending, based on public comments or new information, some modifications to the rule revisions that were published in the NRC's May 9,1996 Federal Register notice. For the revisions that have been modified, the description of the revision notes the nature and reason for the modification and the application of the Backfit Rule to the modification.
BACKGROUND The Backfit Rule,10 CFR 50.109, defines backfitting as "... the modification of or addition to... the procedures or organization required to... operate a facility....".Backfitting can result from "a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position...." The rule also requires that a backfit analysis be conducted, including consideration of associated implementation costs, for all proposed
~
backfits except when backfits fit within one or more of three specific exceptions. One of these, the " compliance exception," exempts modifications that are "necessary to bring a facility into compliance with a license or the mies or orders of the Commission, or into conformance with written commitments by the licensee...." According to'the NRC's BacAfitting Guidelines (NUREG-1409, July 1990), the Backfit Rule applies to actions that impose positions or requirements on licensees; it does not apply to requested actions that are optional or voluntary. Also, the rule generally does not apply to relaxations in requirements.
A Staff Requirements Memorandum (SRM) dated June 30,1993 (SECY-93-086) contains additional guidance regarding Backfit Rule implementation. In that SRM the Commission stated that it expects the Backfit Rule's " substantial increase" criterion to be flexibly administered. Accordingly, qualitative as well as quantitative arguments can be made to demonstrate that a given proposed rule would substantially increase safety. The Commission also noted that this approach is flexible enough to allow for arguments that proposed rules that would make NRC requirements consistent with national and international standards, or would incorporate widespread industry practices, can either directly or indirectly 1
Febmary 5.1998,1:14pm
4 FEB-05-1998 13:19 FR0t1 BATTELLE 5FRINGBP00x TO
- 15645691~014 22275 P.001 00 create a substantial increase in safety. The Commission also recogmzed that there may be proposed rules which, in the staff's opinion, do not meet the " substantial increase" standard but should be promulgated mainly for non-safety reasons. The Commission stated that it is willing to consider, on an case-by-case basis, whether such proposed rules should be promulgated as exceptions to the Backfit Rule as long as the proposal not to apply the Backfit Rule has been the subject of public notice and comment.
Based on the guidance provided by these two documents, the staff has concluded that none of the rule revisions is subject to further backfit analysis becsuse each revision fits into at least one of the following classifications:
1)
Clarifications. Several revisions would clarify current requirements to assure consistent understanding and implementation of the Commission's original intent for these requirements. Inquiries from licensees, attorneys, and NRC inspectors during the past eight years about the specific meaning of certain rule sections indicate that the current wording of those sections does not clearly convey the Commission's original intent. The staff has responded to these inquiries by providing verbal guidance as to the Commission's intent and the staff is confident that most or all licensees are now properly implementing these requirements. However, since the inquiries continue, clarifications are deemed necessary Further, the staff is aware that some licensee FFD 4
programs do not cunently fully comply with certain Pan 26 requirements, because of differences in interpretation of ambiguous language in the regulations. Therefore, the purpose of some of the proposed revisions is to clarify the requirements so that these licensees' FFD programs may be brought into compliance with those panicular requirements. Without changing the underlying requirements stated in these sections, these revisions would instead remove the ambiguities that produced the licensees' uncertainty. The revisions would minimize the possibility for any future confusion, uncenainty, and misperception. According to an OGC memo interpreting the Backfit Rule, the rule applies to revisions or changed staff positions that create more stringent requirements. It does not apply to rule revisions that leave current requirements unchanged, as these ele y :g revisions would do (memo from M. G. Malsch to Comm. Asselstine, ~
.ary 23,1986). Because they do not change current requirements, the staff concludes that these particular revisions are not covered by the Backfit Rule.
2)
_ Relaxations. These revisions are not subject to the Backfit Rule's requirements because they are pennissive relaxations of current requirements. Several revisions will provide licensees with the opportunity to reduce costs but do not require licensees to edopt a change. As the Backfitting Guidelines notes, the Backfit Rule does not apply to optional relaxations of regulatory burden.
3)
Administrative matters. These revisions are administrative matters which, as the Backfitting Guidelines notes, are not subject to Backfit Rule requirements.
2 February 5.1998,114pm
FEE-CI '.998 13:IL FRO 11 BATTELLE SFTilbGL k TO 46456456M 3014151179 P.;3a,0Cu I'
4)
Comoliance exceptions. These revisions fit under the Backfit Rule's
. compliance exception. This exception encompasses rule revisions that are necessary to bring licensees into compliance with the Commission's original intent in promulgating the requirement. In addition, some of the proposed revisions modify current requirements where there is evidence that the current version of the standards is not achieving the purpose that the Commission had when it originally promulgated the rule. In both these cases, some licensees will have to change some of their current FFD practices / procedures to bring their FFD programs into compliance with the Commission's rules.
5)
Information collection and reoorting reauirements. Information collection and reporting requirements are not considered to be backfits per the CRGR charter.
6)
"Non-safety" exceptions. The staff recommends that the Commission consider a relatively few revisions for promulgation as non-safety exceptions to the Backfit Rule. In the June 30,1993 SRM, the Commission reiterated that it will consider, on a case-by-case bar.s, whether rule revisions that do not meet the Backfit Rule's " substantial increase" standard should be promulgated for non-safety reasons as exceptions to the Backfit Rule. A relatively few of the proposed rule revisions will,in the staff's view, substantially enhance the effectiveness of licensee's FFD programs without increasing licensee burden.
For example, some of these revisions will make certain Part 26 requirements consistent with the HHS Mandatory Guidelines or other national standards or otherwise conform the rule to current industry practice. These revisions do not readily fit within any of the five previous classifications and, instead, should be promulgated as exceptions to the Backfit rule for non-safety reasons.
For each of the changes listed the following is provided:
- Revision: A brief description of the rule change.
Purpose:
A discussion of why the rule change is necessary.
Licensee Cost Reduction /Increaset An estimate of the cost impact on licensees.
Backfit Rule Considerations: A discussion of how the Backfit Rule applies to the revision, sometimes including public comments on the Backfit Rule implications'.
Staf
Conclusion:
The staff's conclusion as to the application of the Backfit Rule to the proposed revision.
'It should be noted that NEI prefaced some of its suggested changes and objections to panicular rule revisions as requiring backfit analyses if its recommended change was not adopted. Hence, many of NEI's recommended substantive nde revisions that are actually unrelated to backfit inues are included as public comments on backfit issues.
3 February 5,1998.1:14pm
Minutes of CRGR Meeting No. 315, February 13,1998 PRESENTATION MATERIAL USED BY THE STAFF ATTACHMENT 3
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..........~........
. -..... i
, MAINTENANCE RULE AMENDMEST RULEMAKING ACTIVITY TIME TO TOTAL i
(NORMAL)
COMPLETE ELAPSED (MONTHS)
TIME (MONTHS)
Receipt of SRM from Commission 0
0 Prepare rulemaking package 5
5 Proposed rule to NRR Office Director 1
6 Proposed rule to Office Directors 1
7 Proposed rule to CRGR and ACRS 2
9 Proposed rule EDO 1
10 Proposed rule to Commission 1
11 Proposed rule issued for public comment 2
13 (60 days)
Resolution ofpublic comments 2
15 Final rule to Division Director (s) 2 17 Final rule to NRR Office Director 1
18 Final rule to Office Directors 1
19 Final rule to CRGR and ACRS 2
21 Final rule to EDO 1
22 Final rule to Commission 1
23 Final rule to Federal Register 1
24
RULEMAKING ACTIVITY TIME TO TOTAL (Per SRM)
COMPLETE ELAPSED (MONTHS)
TIME (MONTHS)
Receipt of SRM from Commission 0
0 Prepare rulemaking package 2
2 Proposed rule to NRR Office Director 2%
Proposed ruic to Officc Dirccicrs n/a n/a Propcscd ruic to CRCR and ACRS n/a n/a Proposed rule EDO 3
Proposed rule to 4
Commission /ACRS/CRGR i
Proposed rule issued for public comment 1%
5%
(45 days) i Resolution ofpublic comments 1
6%
Final rule to Division Director (s) 1 7%
Final rule to NRR Office Director 8
Final rule to Office Directors 8%
9%
Final rule to EDO 10 Final rule to Commission 10 %
Final rule to Federal Register 1
11 %
,o
,