ML20196B759

Rev 1 to Regional Office Policy Guide 0901, Plant-Specific Backfit Procedure. Related Info Encl

ML20196B759
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Issue date:	11/26/1986
From:	Martin R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
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ML20195G243	List: IA-87-714, Presents Composite Set of NRC & Industry Recommended Remedial Actions Based on 1985 AEOD Case Study Rept C503 Re DHR Problems for PWR Operation.Table 1 Presenting Chronology of 37 events,cost-benefit Analysis & Related Info Encl ML20195G238 ML20195G326 ML20195G369 ML20196B685 ML20196B759 ML20245B191
References
FOIA-87-714 0901, 901, NUDOCS 8802120119
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UNITED STATES NUCLEAR REGULATORY COMMISSION

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'E j REGION IV 8 811 RYAN PLAZA DRIVE. SUITE 1000 y,,. ARLINGTON. TEXAS 10011 NOV 2 61986 -

0901 Regional Office Policy Guide No. 9701, Revision 1 PLANT-SPECIFIC BACKFIT PROCEDURE A.

Purpose:

To prescribe procedures for implementation of MRC plant-specific backfit policy in accordance with NRC Manual Chapter 0514 dated February 1986.

Users of this Regional Office Policy Guide should familiarize themselves

, with MC 0514. Any apparent conflict between this Policy Guide and MC 0514 l should be brought to the attention of appropriate managers. Test and research reactors licensees are not covered by this guide or the provisions of MC 0514.

B. Objectives:

It is the ograll objective of this guide to assure the plant-specific backfitting- of nuclear power plants is justified and documented and the Regional senior management is responsible and accountable for adherence to the requirements and performance of the procedures set forth in this Policy Guide. The specific objective of the backfit program is to provide for improvements in the levels of protection of public health and safety while avoiding any unwarranted burdens on licensees in implementing these backfits. We should assure to the extent possible that backfits to be issued will in fact contribute effectively and significantly to the health i and safety of the public or the cononon defense and security.

Idefitified plant-specific backfits will be comununicated to the licensee ,

only after required regulatory analyses are completed and approved as  ;

described in Sections D.4 and 0.5 of this guide. The backfit and '

supporting regulatory analyses shall be approved by the Regional Administrator, or Deputy Regional Administrator before the backfit and supporting analysis are cosinunicated to the licensee.

This guide governs those plant-specific backfits connunicated to licensees or identified by licensees af ter May 1,1985.

l C. Discussion:

It should be clearly understood that backfits are expected to occur and are deemed an important part of the regulatory process to provide for the safety of nuclear power plants. However, it is important that backfitting be conducted in a controlled process in order to have effective and I

consistent regulation. The managernent of plant-specific backfitting as I described in this instruction in no way is meant to relieve licensees from BBj212g9880209 WEIBS87-714 PDR [O

j .

Regional Office Policy Guide No. 0701 -2 NOV 2 C 1986 Revision 1 complying with NRC requireinents. The provisions of this instruction are intended to provide for a cogent regional review of new or changed positions that we may desire to impose on licensees who have already implemented previously applicable requirements or positions which were considered by the NRC to have provided acceptable levels of safety. The plant-specific backfit process described in this guide will enhance both regulatory stability and safety by assuring that changes in staff positiv.t do in fact provide substantial additional safety protection that is warranted prior to igosing such changes on the licensee. This assurance will be provided through cor. duct of a regulatory analysis as described in Section D.4.

A plant-specific backfit is different from a generic backfit in that the former involves the imposition of a position unique to a particular plant, where as a generic backfit involves the imposition of the same or similar position on two or mere plants. Management of generic backfits is not governed by this guide, but by the CRGR process.

A backfit is an NRC staff position that would cause a licenseeb ot change the design, construction, or operation y a facility from that consistent with already applicable staff positions , if the time of issuance of the backfit position is such that certain design, construction, or operation milestones involving various NRC approvals have previously been achieved.

Licensee claims that NRC positions or actions are backfits should be sent to the Regional Administrator with a copy to the EDO.

Working level examples of staff positions which constitute backfits and those that do not corstitute backfits are discussed in Appendix A.

D. Action:

The overall backfit process should be condut.ted in accordance with the fol],owing instructices:

1. Regional Backfit Identification Any Regional staff member who identified the need for impositicn of a potential backfit will verbally identify this need for imposition to the Section Chief. If the issue is determined to be a backfit candidate by the Section Chief, in accordance with the guidance of Section C above, then a Backfit Identification Form (BIF) (see Appendix B) will be completed by the identifying staff me&rs, and forwarded by the staff member's Section Chief, through the Branch Chief, to the Division Director for disposition.

2. Licensee Claim of Backfit The NRC staff will prortptly consider a licensee claim of backfit to determine if the claimed backfit qualifies as such in accordance with Section 05 of the NRC Manual Chapter 0514 Licensees identifying such items should send a written claim of backtit (with appropriate

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Regional Office Policy Guide No. 0701 3 Fevision 1 supportingrationale)totheOfficeDirectororRegional Administrator of the NRC staff person who issued the position with a copy to the EDO. If the NRC staff determination is that the issue is '

a backfit, the appropriate staff office should proceed inmediately with the preparation of the regulatory analysis for approval in '

accordance with this Chapter. The final determination of whether an issue is a backfit is made by the NRC staff. ,

When a licensee is informed that a claim backfit is, in the judgement  :

of the NRC, not a backfit, the licensee may appeal this determination as described in Section 044 of NRC Manual Chapter 0514

3. Division Director Disposition l Each Division Director receiving a BIF will disposition the potential l backfit as follows:

a. If the Division Diractor considers that the position, if imposed, would constitute e backfit, and that imposition of the backfit on the licensee would pmvide substantial additional ,

safety protection, then the ba':. fit will be processed by the '

originating section in accordance with Sections D.4, 5, 7 and 8 below. If however, the Division Director believes that imediate imposition of the position is required to protect the public health and safety or the comon defense and security then the imposition procedure of Section D.6 below should be -

implemented. [

b. If the Division Director determines that the position, if .

imposed, would constitute a backfit, but that imposition on the  !

j licensee would not provide substantial additional safety protection or is otherwise not necessary, then no further action on the issue should be taken beyond documentation of this

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determination on the BIF and a copy of the BIF should be filed l in the facility docket file with copies given the normal cc and l bec distribution within the Region.

l c. If the Division Director determines that the position, if imposed, would not constitute a backfit, no further action under ,

this instruction is necessary. The determination should be i noted in the BIF and the BIF filed in the facility docket file along with documented evaluation that it will not be a backfit.

Appropriate copies will be given the normal cc and bec distribution within the Region. If the staff's position is determined not to be a backfit, then the Division Director will deal with the issue in accordance with office procedures other than this regional office policy guide. ,

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N3V 2 G 1386 Regional Office Policy bide No. 0701 Revision I

4. Regulatery Analysis (RA)

a. If the criginating staff's Division Director determines that the potential backfit constitutes backfitting, and it appears that impositic,n will provide substantial additional safety protection, then a Regulatory Analysis (RA) will be prepared.

Responsibility for preparation of the RA will be assigne<l by the Division Director whose staff identified the backfit issue.

b. The regulatory analysis shall generally conform to the directives and guidance of NUREG 0058 and NUREG CR 3568, which are the NRC's governing documents concerning the need for and preparation of regulatory analyses. In preparing regulatory -

analyses, the complexity and comprehensiveness of an analysis should be limited to that necessary to provide an adequate base -

for decision-making among the alternatives available.

NUREG 0058,Section III.A.2, Scepe of the Analysis indicates that "The emphasis is (doing the analysis) should be simplicity, flexibility, and cosmon sense, both in terms of the type of information supplied and in the level of detail provided."

Honver, as a minimum, the following information shall be included, as available and appropriate, in the regulatory analpis: -

(1) A statement of the specific objective that the proposed backfit is designed to achieve. This should also include a succfnct description of the backfit proposed, and how it provides a substantial increase in overall protection.

(2) A general description of the activity that would be reqvired by the licensee in ntder to complete the backfit.

J ; (3) The potential stiety impact of chinges in plant or [

operaticaal complexity, including the relationship to proposed and existing regulatory regstrements.

(4) Whether the proposed backfit is interim or final and, if interim, tha juctification for imposing the proposed backfit on an interim basisc (5) A statement that describes the benefits to be achieved and the cost to be incurred. Inforination should be used to the i extent that it is ressonably available, and a qualitative  :

assessment of benefits may be made is lieu of the quantitative analysis where it would provide ~ more meaningful insights, er is the only analysis practicable.

This statement should include consideration of at least the following listed factors.

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Regional Office Policy Guide No. 0701 5-O 2' T"e ,

Revision.1 (a) The potential change in risk to the public from the accidental offsite niease of radioactive siaterial.

(b) The potential impact on radiological exposure of facility employees. Also consider the effects on other onsite workers, due both to installation of  ;

procedural or hardware changes and to the effects of the changes, for the remaining lifetime of the plant.

(c) The installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay.

(d) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such ,

resources. '

(6) A consideration of important qualitative factors bearing on the need for the backfit at the particular facility, such as, but not limited to, operational trends, significant plant events, management effectiveness, or results of performance reports such as the Systematic Assessment of Licensee Performance.

l (7) A statement affirming appropriate interoffice coordination j

related to the preposed backfit and the plan for implementation.

l (8) The basis for requiring or permitting implementation on a f particular schedule, including sufficient information to demonstrate that the schedules are realistic and provide adequate time for in-depth engineering, evaluation, design, procurement, installation, testing, development of operating procedures, and training of onrators and other plant personnel, as appropriate. For tiose plants with y approved integrated schedules, the integrated scheduling process can be used for implementing this step and the following two procedural steps. ,

F (9) A schedule for staff actions involved in implementation and i verification of the backfit, as appropriate.

(10) Importance of the proposed backfit considered in light of other safety-related activities underway at the aff acted facility.  ;

c. The completed RA and updated BIF will be forwarded for review by the cognizant Division Director, and if approved, will be transmitted to the Director, DRSP, for concurrence (if RA and Bif completed by another Division) and then to the Regional Administrator for approval. Nomally the completed RA will be i

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. VV 2 L 'hY, i Regional Office Policy Guide No. 0701 ,

Revision 1 l provided to the Regional Administrator for a -

, maximum period of 4 weeks following either 1) (pproval staff identifi- within a '

cation of backfit or (2) determination that a licensee claim of l backfit is valid. If the cognizant Division Director determines  ;

further staff action is not warranted, the BIF and RA shall be filed in the facility docket file with cop ccandbecdistributionwithintheRegion.gsgiventhenormal l

5. Approval of Backfit Position  !

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a. The Division Director whose staff has initiated the backfit issue will forward the RA and BIF to the Director DRSP, for

, concurrence (ifRAandBIFcompletedbyanotherDivision)and then to the Regional Administrator for approval. At the same time, the comp.eted RA will be forwarded to the Division Director of tne appropriate headquarters office having program '

responsibilityforthebackfitissue(seeAppendixC). The Program Office will in this manner be fonnally kept apprised of any backfit issues and will be given the opportunity to connent on the issue prior to its imposition on the licensee. Five workdays should normally be sufficient. The secretary to the Director DRSP will confinn by telephone that the appropriate headquartersofficehasreceivedthecompletedRA.

b. The Regional Administrator, or the Deputy Regional Administrator t will either approve or reject the backfit depending on whether there is a substantial increase in the'overall protection of the 1 public health and safety or the connon defense and security to  :

be derived from the backfit, and that the direct and indirect i i costs of implementation for that facility are justified in view ,

of the increased protection. If approved, the BIF information  ;

will be provided to the Information Management Section for entry r into the Backfit Data Base (BDB). If not approved, the BIF and t

-:- .- RA will be filed in the facility docket file with copies given the nonnal cc and bec distribution within the Region. '

! c. If approved for issuance, the backfit position and RA will be

forwarded by the Regional Administrator to the EDO for information prior to transmitting the documents to the

.Ticensee. The Regional Administrator shall forward the backfit  ;

and su) porting RA to the licensee without awaiting feedback i

from tie EDO. The transmittal should clearly identify the i position as a backfit.

6. Imposition to Ensure No Undue Risk

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a. If the Division Director whose staff has originated the backfit

, position believes that impcsition of the position is necessary I to ensure that a facility poses no undue risk te public health

• i and safety, then no regulatory analysis is required. An evaluation to support the action taken will be performed.  ;

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NOV E6 m l

i Regional Office Policy Guide No. 0701  : Revision 1 j b. In this instance a backfit panel will convene, chaired by the

Regional Administrator or Deputy Regional Administrator, j attended by the Director, DRSP, or Deputy Director DR$P, and the Division Director and Branch Chief whose staff initiated the i backfit. A representative from the headquarters office having

. program responsibility for the backfit requirements should

] attend the backfit panel meeting or participate via telecon.

l The headquarters representative will be designated by the Office Director. The cognizant Section Chief will be responsible for i presenting the issue including the rationale for innediate j imposition.

j. c. If the backfit panel agrees with the need for imposition to

ensure no undue risk, the backfit will be forwarded, by the j Regional Administrator, to the Office Director of the i headquarters office having program responsibility for the

! backfit issue. The Office Director will be expected to act promptly on innediate issuance of the backfit position, and if immediate issuance is required, within two working days from receipt of the request.

d. If approval for imposition is given by the Office Director, then the backfit will normally be issued to the licensee by the cognizant Office Director. The ED0 will be infomed of such action by the Regional Administrator. A documented evalmation will be performed,

e. If approval for issuance to ensure no undue risk is not given by the Office Director, then the backfit will be processed in accordance with Sections D.4, 5, 7, and 8 above,

f. In either case (d. or e. above), the BDB will be updated by the originating Section Chief by the fonvarding of a completed BIF to the IMS.

7. Appeal Process When a licensee is informed that a claimed backfit is, in the judgement of the NRC, not a backfit, the licensee may appeal this determination to the Director of the program office having responsibility for the program area relevant to the staff position.

A copy of the appeal should be sent to the EDO.

a. For positions imposed by the Regional staff, licensees will nomally address appeals to the Regional Administrator and ull send a copy of the appeal to the EDO.

b. When an appeal is received in the Regional Office, it will be forwarded to the Director, DRSP, along with other docket related mail.

, NOV 2 61986 Reoional Office Policy Guide No 0701 '

Revision 1

c. When the DRSP technical staff recognizes that an appeal has been initiated by a licensee, the applicable DRSP Branch Chief will ensure that a copy of the appeal documentation has been forwarded by the licensee to the Director, ROGRS, and will forward the appeal through the Director, DRSP, to the Division Director whose staff initiated the backfit or staff action. The initiating Division Director will return the appeal to the initiating Branch Chief for action. If it is determined that the position is a backfit, a RA will be performed pursuant to Section D.4 above. The initiating Branch Chief will submit to IMS a BIF reflecting that the staff position has been appealed.

d. The initiating Branch Chief will arrange and issue appropriate documentation for a first level appeals meeting with the appealing licensee in order to attempt to resolve the issue.

This meeting will be chaired by the cognizant Division Director and be attended by the applicable DRSP Branch Chief and Section Chief, and the Branch Chief and Section Chief whose staff initiated the appealed backfit position or staff action. A copy of the RA (if appropriate) will also be provided to the licensee, by the initiating Branch Chief, in preparation for the appeals meeting. The first level meeting should normally occur within 3 weeks of receipt of the appeal,

c. The initiating Branch Chief will arrange for the drafting of a memorandum by which the Regional Administrator will inform the EDO of the planned disposition of the appeal. The Regional Administrator is required to notify the EDO of the planned disposition within 3 weeks of receipt of the appeal. The licensee should also be promptly informed in writing regarding i

the planned disposition. (The EDO could receive a copy of the l' 1etter to the licensee.) The ED0 may review and modify any

! plant-specific backfit decision, at EDO initiative or at the request of a licensee. A copy of this memorandum will be forwarded to the issuing Division Director, Director, DRSP, and the headquarters office having program responsibility for the backfit requirement or staff action and the BDB updated accordingly. This action should normally be completed within 3 working days.

! f. The preparation of a sumary of the appeals meeting will be the

! responsibility of the initiatino Branch Chief and will be forwarded by the Director, DRSP, to the licensee with copies to the initiating Division Director (if appropriate), RA, EDO, and the PDR. The result of the meeting with the licensee should take the form of one of the following:

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NOV 2 6 BBS l Regional Office Policy Guide No. 0701  !

Revision 1 (1) The licensee agrees with the NRC staff that the backfit  :

should be implemented as imposed. The appeal process in effect will be terminated pursuant to this instruction. ,

(2) The NRC agrees with the licensee that a backfit should be withdrawn or modified. If the backfit is to be modified, then the backfit should be reissued in accordance with Section D.S.c above.

(3) No agreement on final disposition will be reached. ,

g. If no agreement was reached at the meeting in Section 7.f above, then the applicable initiating Branch Chief will arrange for and issue appropriate documentation for a second level meeting with the appealing licensee in order to reattempt to resolve the issue. Normally, it should be attempted to hold this meeting on the same day as the initial meeting. This second meeting will be attended by the applicable DRSP Branch Chief and Section Chief whose staff initiated the appealed backfit er staff action and the Director, DRSP, or Deputy Director, DRSP. The meeting will be chaired by the Regional Administrator or Ceputy Regional Administrator.

h. The preparation of a sumary of this second appeals meeting will be the responsibility of the initiating Branch Chief and will be forwarded by the Director, DRSP, to the licenste with copies to

, the initiating Division Director (if appropriate), RA EDO, and ,

i PDR. The results of this second meeting with the licensee l

should take one of the forms specified in step D.5.f above and i the BDB will be updated accordingly. i

1. If no agreement was reached at the meeting in Section 7.g above, then the initiating Branch Chief will arrange for and issue

-:- .- appropriate documentation for a third meeting with the appealing licensee in order to again attempt to resolve the issue. This third meeting will be held in headouarters and coordinated with the office having program responsibility for the backfit or staff action. This third meeting will be attended by the applicable Prograp Office Director or Deputy Director, the Regional Ahtnistrator or Deputy. Regional Administrator, and other appropriate managers, whose staff initiated the ap>ealed  :

backfit position or staff action. The meeting will be ciaired l by the cognizant Program Office Director or Deputy Director.

The coonizant program offices are identified in Appendit C. The third level meeting should normally be conducted within 2 weeks of the second level meeting.

j. The preparation of a sumary of this third appeals meeting will .

be the re:ponsibility of the initiating Branch Chief and will be forwarded by the Director, DRSP, to the licensee with copies l to the initiating Division Director, RA EDO, and PDR. ,

1 Nov e 8 886 Regional Office Policy Guide No. 0701 i Revision 1

k. At the conclusion of this third meeting, the appeals process '

will be considered concluded, regardless of whether tte position of the licensee or NRC staff was modified. All information regarding the appeal process will be updated in a timely manner and the results of appeals process updated in the 808 by the initiating Section Chief usir.g revised BIFs.

7 Backfit Implementation t following approval of the backfit position b Administrator, and issuance to the licensee,y the the Regional licensee will either implement the backfit or appeal it. It should be noted that Orders must be implemented by the liceesee, and are not subject to the

! backfit appeal process since the licensee may request a hearing under 10 CFR Part 2. After an appeal and subsequent final decision by the NRC, the licensee may elect to implement a position resulting from ,

the decision. If the licensee does not elect to in)1ement the ~

position, the position may be imposed by Order of tie appropriate Program Office Director.

Implamentation of plant-specific backfit positions will be

, accomplished on a schedule negotiated between the licensee and the Director DRSP. Scheduling criteria should include the priority of the backfit relative to other safety-related activities underway, t

construction or maintenance planned for the facility, and schedules i i and reasonable constraints thereon to maintain high quality

! construction and operations. For plants that have integrated ,

j schedules, the integrated scheduling process can be used for this e purpose.

l A staff-proposed position may be imposed prior to completing any of I the procedures set forth in this Regional Office Instruction, provided the appropriate headquarters Office Director determines that prompt imposition is necessary to protect the health and safety or the comon defense and security. In this instance, the procedures of Section D.6 above will be followed. In such cases, the ED0 shall be notified promptly of the action.

If prompt imposition is not necessary, staff proposed positions shall not be imposed, and plant operation shall not be interrupted during the staff's initial evaluation ard transmittal process, or a subsequent appeal process, until a final action is completed by either the licensee or by the NRC staff.

E. Information Requests Pursuant to 10 CFR 50.54(f)

A revision to 10 CFR 50.54(f) was issued with the September 20, 1985, revision to 10 CFR 50.109 in the Federal Register (50 FR 38097). The l

revision generally requires that the U C prepare reasons for issuing infomation requests prior to issuance. Concerning the review of

NOV 2 61986 Regional Office Policy Guide No. 0701 Revision 1 applications for licenses or amendments, or the conduct of inspection activities for plants under construction, no analysis will be necessary if the staff seeks informatinn of a type routinely sought as a part of the standard procedures applicable to the review of applications. If the request is not part of routine licensing review, for example, it seeks to gather information pursuant to development of a new staff position, then a Staff analysis of the reasons for the request must be prepared and approved prior to issuance.

Concerning licensing review or inspection activities for operating plants, only information requests seeking to verify licensee compliance with the current licensing basis for the facility are exempt from the necessity to prepare the reason or reasons for the request. Requests for infonnation to determine compliance with existing facility requirements including fact-finding reviews, inspection and investigations of accidents or incidents, usually are not made pursuant to Section 50.54(f), nor are such requests normally considered within the scope of the backfit rule or Manual Chapter 0514 .

The request must be evaluated to determine whether the burden imposed by the information request is justified in view of the potential safety significance of the issue to be addressed. The information request and the staff evaluation must be approved by the cognizant Office Director or Regional Administrator prior to transmittal of the request for information to a licensee. NRC staff evaluations of the necessity for an information request shall include at least the following elements:

1. A problem statement that describes the need for the information in tenes of potential safety benefit.

2. The licensee actions required and the cost to develop a response to the information request.

3. ,,. An. anticipated schedule for NRC use of the information.

F. References

1. NRC Manual Chapter 0514, dated February 1986, "NRC Program for Management of Plant-Specific Backfitting of Nuclear Power Plants."

2. NUREG/BR-0058, Rev.1, May 1984, "Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Cornission."

3. NUREG/CR-3568, December 1983, "A Handbook for Value-Impact Assessment."

4 NUREG/CR-3971, October 1984, 'A Handbook for Cost Estimating."

5. Revision of Backfit Rule, Code of Federal Regulations, 50 FR 38097 (September 20,1985).

t 0M Ee a ffice Policy Guide No. 0701 G. Data and Recording Requirements:

The data identified in the Backfit Identification Form shall be entered into the Backfit Data Base within 3 working days After any ac. tion which requires u $ ting of the BIF. The cognizant Section Chief is responsib'te for providing the updated BlF to the IMS for BDB entry.

H.

Contact:

Questions or cossnents should be directed to the Chief Technical Support Staff.

I. Effective Date:

This Policy Guide is effective when issued and supersedes Policy Guide 0701, Rev. O, dated June M,1985.

J 3 M o$ert D. Martin Regional Admit istrator h

Enclosures:

Explanation of Footnotes Appendix A - Guidance for Backfit Determinations Appendix B - Backfit Identification Fonn Appendix C - Cognizant Headquarters Program Offices cc: DEDROGR (Copy of all future revisions)

Distribution B i

Il0V 2 8 806 i

i EXPLANATION OF FOOTNOTES M Backfitting is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility; any of which may ,

result from a new or amended provision in the Comission rules or the imposition of a regulatory staff position interpreting the Comission rules that is either new or different from a previous y applicable staff position after certain specified dates. Backfitting is "plant-specific" when it involves the imposition of a position that is unique to a particular plant.

E Except where defined otherwise, the word licensee, as used in this instruction, means that person that holds a license to operate a nuclear power plant, or a construction permit to build a nuclear power plant, or a Preliminary Design Approval or Final Design Approval for a Standardized Plant Design.

E Applicable regulatory staff posituns are those already specifically imposed upon or cossnitted to by a licensee at the time of the i identification of plant-specific backfit, and are of several different types and sources:

a.

Legal requirements licenses (amendments, such as in explicit regulations, orders}. plant conditions,technicalspecifications bote that some regulations have update features built in; as for example, 10 CFR 50.55a, Codes and Standards. Such update requirements are

, applicable as described in the regulation.

b. Written comitments such as contained in the FSAR, LERs, and docketed a correspondence, including responses to IE Bulletins, responses to Generic Letters, responses to Inspection Reports, or responses to l Notices of Violation, and Confirmatory Action Letters.

c. NRC staff positions that are documented, approved, explicit interpretations of the more general regulations, and are contained in

documents such as the SRP, Branch Technical Positions, Regulatory Guides, Generic Letters and IE Bulletins and to which a licensee or an applicant has previously comitted to or relied upon. Positions contained in these documents are not considered applicable staff positions to the extent that staff has, in a previous licensing or inspection action, tacitly or explicitly excepted the licensee from i part er all of the position. Irposition of a staff position from j which a licensee has previously been excepted is a backfit, i f'

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NOV 2 6 9986 l 2

N Those tines after which a staff position will be considered a backfit are as follows:

a. After the date of issuance of the construction permit for the facility (for facilities having construction permits issued after .

May 1, 1985); or

b. After 6 months before the date of docketing of the OL application for the facility (for facilities having construction pennits issued beforeMay1,1985);or

c. After the date of issuance of the operating license for the facility (for facilities having an operating license on May 1, 1985); or

, d. After the date of issuance of the design approval under 10 CFR 50, i Appendix M, N, or 0. (SeeNOTEbelow.)

N When (1) a staff proposed position is determined not to be a backfit .

because the proposed modification is necessary to bring a facility into compliance with a license or the rules or orders of the Comission or into j confoneance with written comitments by the licensee, or (2) the Director of NRR, RSS, or IE determines that imposition of a backfit is necessary to ensure that the facility poses no undue risk to public health and safety, no regulatory analysis is required. Instead, the a>propriate  ;

Director is to provide a documented evaluation to sup> ort tie action -

taken. The evaluation shall include a statement of tie objectives and reasons for the modification and the basis for involving the exception.

In the case of a backfit needed to assure that the facility >oses no undue risk to public health and safety the documented evaluation s.iall also include an analysis to document the safety significance and appropriateness of the action taken and consideration of how costs I contribute to selecting the solution among various acceptable l alternatives. Appendix A to Manual Chapter 0514 provides additional information to help in identifying backfits arising from selected staff i activities. When a staff proposed position is identified as a backfit and imposition of the backfit is not necessary to ensure that the facility

poses no endue risk to public health and safety, the appropriate staff

office should proceed promptly with the preparation of a regulatory i analysis (Section 043) for approval in accordance with this Chapter. The i

i 4

NOTE: 10 CFR 50.109 was revised and issued on Septerber 20, 1985 (50 FR 38097). MC-0514 was implemented on May 1, 1985. The current revision of the Backfit Rule 50.109 states that paragraph 50.109(a) of the rule does not apply -

to backfits isposed prior to the effective date of the rule. However, the EDO

directives esbedied in Manual Chapter 0514 have been effective and remain i

effective as of May 1,1985.

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. NOV 2 6 506 staff may, at any point in the development of the regulatory analysis, decide that further analysis is likely to show either that the proposed safety benefit is not likely to be substantial additional overall protection, or that the direct and indirect costs of implementation are not likely to be justified. In this case, the issue may be closed, with appropriate notice sent to all parties and recorded in the re:ordkeeping system described in Section 046 of MC 0514, i

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JUN 141995

I Appendix A GUIDANCE FOR BACKFIT DET*RVINATIONS  !

l General In this section selected regulatory activities or documents are discussed in  :

order to enable regional staff to better understand the conditions under which '

a plant-specific backfit may be recognised. It is important to understand that the necessity for making backfit deterrinations should not inhibit the normal informal dialcgue between the inspector and the licensee. The intent of this process is to manage backfit imposition, not to quell it. The discussion in this Aspendix is intended to aid in identifying backfits in accordance with the i

principles that shculd be implementad by all staff members. This Appendix is not intended to be an exhaustive, comprehensive workbook in which can be found a parallel example for each situation that may arise. There will be some

judgment necessary to determine whether a staff position would cause a licensee to change the design, construction or operation of a facility. In making this determination, the fundamental question is whether the staff's action is I

directing, telling, or coercing, or is merely suggesting or asking the licensee to consider a staff proposed action.

Actions proposed by the licensee are not backfits when the actions result from normal discussions between staff and TTeensee concerning an issue, even though the change or additions may meet the definitions of Section C of this instruction.

Standard Review Plan (SRP)  ;

The SRP delineates the scope and depth of staff review of licensee submittals l associated with various review activities. It is a definitive NRC staff I interpretation of measures which, if taken, will satisfy the requirements of the more generally stated, legally binding body of regulations, primarily found i in title ID'CFR. Since October 1981, changes to the SRP are to have been reviewed and approved through a generic review process involving the Committee to Review Generic Requirements (CRGR), and the extent to which the changes apply to classes of plants is defined. Consequently, application of a current SRP in a specific operating license (OL) revie. generally is not a plant-specific backfit, if the SRP was effective 6 months' prior to the start of the

OL review (i.e., 6 months prior to docketing of the OL application). Asking an ,

i applicant for an operating license questions tc clarify staff understanding of

proposed actions in order to determine whether the actions will meet the intent j of the SRP is not considered a backfit, i l On the other hand, using acceptance criteria mere stringent than 'those  !

! contained in the SRP or proposing licensee actions more stringent than or in addition to those specified in the SRP, whether in writing or orally, are '

, plant-specific backfits. During meeting with the licensee, staff discussion or

! comments regarding issues and licensee actions volunteered which are in excess *

! of the criteria in the SRP generally do not constitute plant-specific backfits; however, if the staff implies or suggests that a specific action in excess of

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JUN 14 585 41 easy applicab'.e staff Desitions is the only way for the staff to be sat sfied, the action is corsidered a plant-specific backfit whether or not the

'acensee agrees to take suto action. However, the staff should recognize that a ve da11y implied or suggested action should not be accepted by a licensee as ar. NRC position of any kinc, backfit or not; only written and authoritatively approved statements should be taken as NRC positions.

Application of an IRP to an operating plant after the license is granted generally is considered a backfit unless the SRP was approved specifically for operating plant implementation and is applicable to such operating plant.

Reeviatory Guides As part of the generic review process pursuant to the CRGR Charter, it is decided which plants or groups of plants should be affected by new or modified Regulatory Guide provisions. Such implementation is therefore not governed by the plant-specific backfit procedures. However, any staff proposed plant-specific implementation of a Regulatory Guide provision, whether orally or in l writing, for a plant not encompassed by the generic implementation determin-ation is considered a plant-specific backfit. A staff action with respect to a specific ' licensee that expands on, adds to, or modifies a generically approved regulatory guide, such that the position taken is more demanding than intended in the generic positions, is a plant-specific backfit.

l iant-Soecific Orders -

An order issued to cause a licensee to take actions which are not otherwise applicable regulatory staff positions is a plant-specific backfit. An order ef fecting prompt imposition of a backfit may be issued prior to completing any of the procedures set forth in this instruction provided that the appropriate Headquarters Office Director determines that prompt imposition is necessary.

An order issued to confirs a licensee conveitment to take specific action even if that action is in excess of previously applicable staff positions, is not a plant-specific backfit provided the commitment was not solicited by the sHTf with the expressed or implied emphasis that such a cossaiteent is necessary to gain acceptance in the staff review process. Discussion or comments by the NRC staff identifying ceficiencies observed, whether in meetings or written reports, do not constitute backfits. Definitive statements to the licensee directing a specific action to satisfy staff positions are backfits unless the

, action is an explicit already applicable regulatory staff position (s).

Inspections NRC inspection procedures are to govern the scope and depth of staff inspections associated with licensee activities such as design, construction and operation. As such, they define those items the staff is to consider in its determination of whether the licensee is conducting its activities in a NOV 2 6 586

~3~ M4 1478, sa'+ anner. The conduct of inspection establishes no new staff positions for tae ' :ensee and is not a plant-specific cackfit.

Sta" suggestions to the licensee that the contents of an NRC inspection oro:e: ares are positions that must be met by the licensee constitute a pla t-specific backfit unless the item is an applicable regulatory staff po s't 9 en. Discussion or comment by the NRC staff regarding deficiencies obstaved in the licensee conduct of activities, whether in meetings or in written inspection reports, do not constitute backfits, unless the staff suggests that specific corrective actions different from previous staff pos'ttons applicable to the licensee are the only way to satisfy the staff. In the nemal course of inspecting to determine whether the licensee's activities are being conducted safely, inspectors may examine and make findings in specific technical areas wherein prior NRC positions and licensee commitments do ect exist. Examination of such areas and making findings is not considered a bactfit. Likewise, discussion of findings with the licensee is not consicered a backfit. If during such discussions, the licensee agrees that it

' is ac:*opriate to take action in response to the inspector's findings, such actice is not a backfit provided the inspector does not indicate that the specific actions are the only way to satisfy the staFand the licensee freely i volunteers to take such action. On the other hand, if the inspector indicates that a specific action must be taken, such action is a backfit unless it constitutes an applicable regulatory staff position.

For eumple, if the licensee commits to ANSI-N18.7 in the SAR and the inspector finds the licensee's implementing procedures do not contain all the elements required by ANSI-N18.7, telling the licensee he must take action to include all the elements in its implementing procedures is not a backfit. Likewise, if the ,

insce tor finds the licensee has included all the required elements of ANSI-08.7, but has not included certain of the optional elements in its

! implementing procedures, inspector discussion with the licensee regarding the merits of including the optional elements is not a backfit. On the other hand,

if the inspector tells the licensee that the implementing procedures must include any or all of the optional elements in order to satisfy the staff,

inclusion of such elements is a backfit, whether or not agreed to by the .

licensee.

Notice of Violations (NOV) l i A NW requesting description of a licensee's proposed corrective action is not a ba:Lfit. The licensee's commitments in the description of corrective action i are not backfits. A request by the staff for the licensee to consider some spectfic action in response to an NOV is not a backfit. However, if the staff i is not satisfied with the lice 1see's proposed corrective actions and requests that the licensee take addition actions, those additional actions (whether requested orally or in writing) are a backfit unless they 're an applicable  ;

regulatory staff position, i

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-'- JUN 241995 h scussions during enforcement conferences and responses to the licensees reovests for advice regarding corrective actions are not ba.ekfits; however, cefin'tive statements tc the licensee cirecting a specific action to satisfy ,

staff oositions are backfits, unless the action is an explicit applicable regulatory staf f position.

Bulletins 8E Bulletins and resultant actions requested of licensees undergo the generic review process pursuant to the CRGR Charter. Therefore, in general, it is not necessary to apply the plant-specific backfit process to the actions requested in a Bulletin. However, if the staff expands the action requested by a Bulletin during its application to a specific licensee, such expansion is considered a plant-specific backfit.

Reanalysis of Issues Throughout plant lifetime, many inspectors have an opportunity to review the requirements and commitments incumbent upon a licensee. Undoubtedly, there will be occasions when an inspector concludes the previously NRC approved licensee's program in a specific ares does not satisfy a regulation, license condition or commitment. In the case where the staff previously accepted the

'icensee's program as adequate, any staff specified change in the program would e classified as a backfit. * '

For example, in the case of an NTOL, once the SER is issued signifying staff acceptance of the program contained in the SAR, the licensee should be able to conclude that his commitments in the SAR satisfy the NRC requirements for a I particular area. If the staff was to subsequently require that the licensee commit to additional action other than that specified in the SAR for the particular area, such action would constitute a backfit. If there was tacit acceptance by staff, by being silent on the issue for an extended period of '

time, then staff action to force change would be a backfit.

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JUN 14 G 5 Appendix B BACK~IT IDEN 1:ICATION FORM Se scr Authorizing Dan Ertry: Date:

EN !E BACKFIT IDENTIFIER BELOW:

BACKFIT IDENTIFIER -

123 45 Femat (Starting position):

1 Office resp. for initiating ba:kfit determination = R, S E, or I-5 2 Identifier of backfit = R, 5, E. L. or I-5 R=NRR, $=NMSS, E=IE, L= Licensee, != Regional . . 5= Region 5 3 Plant abbreviation (5 positions) 4 Year initiated (must be numeric, e positions) 5 Sequential number of backfit (must be numeric, 3 positions)

IDENTIFYING BACKFIT INFORMATION BACKFIT/ PETITION DOCUMENT DESCRIPTION (360 CHARACTER MAXIMUM):

BACKFIT ISSUE SUBSTANCE (660 CHARACTER MAXIMUM):

BACKFIT DETERMINATION DATE (PREDICTED): (YYMMDD) 1 BACKFIT DETERMINATION INFORMATION l BACKFIT DETERMINATION DATE (COMPLETED): (YYP9tDD) ,

WAS THIS DETERMINED TO BE A BACKFIT7 (Y=Yes,N=No)

• BACKFIT DETERMINATION SUBSTANCE (360 CMARACTERS nAXIMUM):

BACKFIT DETERMINATION ORGANIZATION (e.g. , NRR/DL):

BACKrIT DETERMINATION OFFICIAL (LAST NAME,1st INIT.):

• EGULATORY ANALYSIS COMPLETION DATE: (YYMMDD) i WEJ YJ

JUN 141935 Pe-son Authori:tn; Data Entry: Date: 1 APPEAL INFORMATION APPEAL DATE (PREDICTED): (YYMMDD)

ADPEAL DATE (COMPLETED): (YYMMDD)

APPEAL DESCRIPTION / STATUS (360 CHARACTERS MAXIMUM):

APPEAL ORGANIZATION (e.g., NRR/DL):

APPEAL OFFICIAL (LAST NAME,1st INIT.):

CLOSING ACTION INFORMATION wLOSING ACTION DATE (PREDICTED): (YYMMDD) i CLOSING ACTION DATE (CUMPLETED): (YYp94DD)

CLOSING ACTION DESCRIPTION (360 CHARACTER $ MAXIMUM):

CLOSING ACTION ORGANIZATION (e.g., NRR/DL):

CLOSING ACTION OFFICIAL (LAST NAME,1st INIT.):

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4 5 1415g5 Appendia C 003N!2 ANT HEA00'JARTERS PRO 3 RAM 0:FICES fr,seettien Related Backfit Positions - Office of Inspection and Enfo-cement EP.forcement Related Backfit Positions - Office of Inspection and Enforcement Licensing Related Backfit Positions - Office of Nuclear Reactor Regulation, except for:

o Safeguards Issues - NMSS o QA Issues - IE o EP Issues - IE O

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!z/[j' ,,s PURPOSE OF SEMINAR DISCUSS THE PHILOSOPHY OF BACKFITTING REVIEW THE HIGHLIGHTS OF REVISED MC-0514 DISCUSS THE BACKFITTING PROCESS DISCUSS EXAMPLES OF REGULATORY ACTIVITIES WHICH ARE AND ARE NOT BACKFITS REVIEW RECENT INITIATIVES AND FUTURE ACTIONS i

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• n 1 2-BACKGROUND 50.109 ON BOOKS SINCE 1970 PLANT SIZE RAPIDLY ADVANCED FROM 100 MWE TO 1,000 MWE TMI EVENTS ,

NUREG-0839 (1981), "A SURVEY BY SENIOR NRC MANAGEMENT TO

j. . OBTAIN VIEWPOINTS ON THE SAFETY IMPACTS OF REGULATORY ACTIVITIES FROM REPRESENTATIVE UTILITIES OPERATING AND

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CONSTRUCTING NUCLEAR POWER PLANTS CRGR (1981)  !

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• REGULATORY REFORM IASK FORCE-(1981) l ANPR PUBLISHED IN ER (1983) .

t COMMISSION RECOGNIZED NEED TO ADDPESS PLANT-SPECIFIC BACKFITS l DIRECTED PROCEDURES TO BE DEVELOPED, l

PUBLICATION OF DRAFT MC-0514 AND STAFF PROCEDURES IN ER (4/84)

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~3-BACKGROUND (CONTINUED)  !

REVISED 50.109 PUBLISHED IN @ FOR COMMENT (11/84)

CHAIRMAN PALLADINO MEMO TO EDO (12/84)

REPORT ON BACKFITTING AND LICENSING practices (3/85)

CRGR VISITS TO $1TES

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s t .4 OBJECTIVES OF REVISED MC-0514 i

CLAR!FY THAT BACKFITTING 13 A NECESSARY AND PROPER REGULATORY ACTIVITY.

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ESTABLISH ED0-LEVEL FRAMEWORK FOR THE BACKFITTING PROCESS.

IMPROVE MANAGEMENT OVERSIGHT OF BACKFITTING PROCESS.

EMPHAS:ZE THAT THE BACKFITTING PROCESS IN NO WAY RELIEVES THE  ;

LICENSEE OF ITS OBLIGATION TO COMPLY WITH NRC REQUIREMENTS.

t ARTICULATE THE BACKFITTING PROCESS TO NRC STAFF, INDUSTPY AND THE PUBLIC.  ;

ENHANCE PUBLIC HEALTH AND SAFETY. i i

1 IMPROVE REGULATORY STABILITY AND PREDICTABILITY.

PROMOTE NORMAL DIALOGUE BETWEEN REVIEWER / INSPECTOR AND j LICENSEE.  !

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5 MAJOR CHANGES TO PLANT-SPECIFIC BACKFITTING PROCESS APPLICABLE TO OPERATING PLANTS AND PLANTS UNDER CONSTRUCTION.

SIMPLIFIED THE REGULATORY ANALYSIS AND REQUIRED CONDUCT OF REGULATORY ANALYSIS PRIOR TO IMPOSING A BACKFIT.

REGULATORY ANALYSIS APPROVAL BY OFFICE DIRECTOP/ REGIONAL ADMINISTRATOR. (rt. 4/wr.a)

PROVIDE FOR AGENCY-WIDE RECORDKEEPING SYSTEM - REAL TIME ACCESS, ~ r//< < r 6 /cg/;s '

APPEAL PROCESS IN REGION AND HEADQUARTERS.

FINAL REGULATORY APPROVAL AUTHORITY IN OFFICE WITH PROGRAMMATIC RESPONSIBILITY.

MANAGEMENT ACCOUNTABILITY THROUGH SES CONTRACTS.

GENERAL TERMIN0 LOGY BACKFIT - A STAFF POSITION THAT CAUSES A LICENSEE TO CHANGE DESIGN, CONSTRUCTION OR OPERATION OF A FACILITY FROM THAT CONSISTENT WITH ALREADY APPLICABLE STAFF POSITIONS, AFTER CERTAIN REGULATORY MILESTONES ARE COMPLETED (052).

APPLICABLE REGULATORY STAFF POSITION - A POSITION ALREADY SPECIFICALLY IMPOSED UPON OP COMMITTED TO BY A LICENSEE AT THE TIME OF IDENTIFICATION OF A PLANT-SPECIFIC BACKFIT (053).

i l $ENERIC BACKFIT - APPLYING THE SAME NEW NRC STAFF POSITION ON l MORE THAN ONE LICENSEE. [ Er// y (b //h PLANT-SPECIFIC BACKFIT - APPLYING A NEW NRC GTAFF POSITION ON A SINGLE LICENSEE LICENSEE - CP HOLDER, OL HOLDER, PDA/FDA FOR STANDARDIZED l

PLANT.

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-7 BACKFIT  :

I A STAFF POSITION THAT WOULD CAUSE A LICENSEE TO CHANGE THE DESIGN, CONSTRUCTION, OR OPERATION FROM THAT CONSISTENT WITH ALREADY APPLICABLE REGULATORY STAFF POSITIONS, TAKEN AFTER CERTAIN DESIGN, CONSTRUCTION OR OPERATION MILESTONES, INVOLVING YARIOUS NRC APPPOVALS, HAVE PREVIOUSLY BEEN ACHIEVED.

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APPLICABLE REGULATORY STAFF POSITIONS (CONTINUED)

3. NRC STAFF POSITIONS THAT ARE DOCUMENTED, /PPROVED, EXPLICIT INTERPRETATIONS OF THE MORE GENERAL REGULATIONS, AND ARE CONTAINED IN DOCUMENTS SUCH AS THE SRP, BRANCH TECHNICAL POSITIONS, REGULATORY GUIDES, GENEPIC LETTEPS AND IE BULLETINS, SUcH POSITIONS AS THESE ARE NOT CONSIDERED APPLICABLE STAFF POSITIONS TO THE EXTENT THAT STAFF HAS, IN A PREVIOUS LICENSING OR INSPECTION ACTION, TACITLY OP EXPLICITLY EXCEPTED THE LICENSEE FROM PART OP ALL OF THE POSITION.

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TIME OF ISSUANCE THOSE TIMES AFTER WHICH A STAFF POSITION WILL BE CONSIDERED A BACKFIT.

1. AFT 2a THE DATE OF ISSUANCE OF THE CONSTRUCTION PERMIT FOR THE h CiLITY (FOR FACILITIES HAVING CONSTRUCTION PERMITS ISSUED AFTEP MAY 1, 1985); OR

2. AFTER 6 MONTHS BEFORE THE DATE OF DOCKETING OF THE OL 4 APPLICATION FOR THE FACILITY (FOR FACILITIES HAVING CONSTRUCTION PERMITS ISSUED BEFORE MAY 1,1985); OR I

i<wy r s g /. ,a .u k</{te?.')

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3. AFTER THE DATE OF ISSUANCE OF THE OPERATING LICENSE FOR THE FACILITY (FOR FACILITIES HAv!NG AN OPERATING LICENSE ON MAY 1, 1985).

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b REGULAf3FY AliALYSIS (O'42) f l

l SUBSTANTI AL ' INCREASE IN PROTECTION CF PUBLIC HEALTH AND SAFETY.

t COST OF IMPLEMENTATION IS JUSTIFIED.

l OFFICE DIRECTOR / REGIONAL ADMINISTRATOR APPROVAL.

l NUREG/E!R-0058, REV. 1, REGULATORY ANALYSIS GUIDELINES OF THE l

l U.S. NUCLEAR FIGULATORY COMMISSION 1

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NUREG/CR-3568, A HANDBOOK FOR VALUE-lMPACT ASSESSMENT ff gg NOT REQUIRED WHEN PROMPT IMPOSITION OF BACKFIT NECESSARY.

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CONTENT OF REGULATORY ANALYSIS (042)

BACKFIT DF. SCRIPT 10N AND HOW SAFETY IS SUBSTANTIALLY IMPROVED.

WHY PROPOSAL CLASSIFIED AS PLANT-SPECIFIC BACKFIT COST-BENEFIT ANALYSIS PUBLIC RISK IMPACT RELATIONSHIP TO OTHER PROPOSED AND EXISTING POSITIONS.

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IMPACT ON OCCUPATIONAL EXPOSURE l

l DOLLAR COST OF INITIAL AND CONTINUING IMPLEMENTATION.

RESOURCE COST TO NRC AND AVAILABILITY OF RESOURCES.

! QUALITATIVE FACTORS BEAPING ON NEED FOR BACKFIT (OPERATIONAL e

TRENDS, MANAGEMENT EFFECTIVENESS, SALP, ETC.)

IS BACKFTT INTERIM OR FINAL - JUSTIFICATION FOR INTERIM l

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CONTENT OF REGULATORY ANALYSIS (042) (CONTINUED)

AFFIRMATION OF INTEROFFICE COORDINATION SCHEDULE FOR LICENSEE IMPLEMENTATION AND BASIS SCHEDULE FOR STAFF ACTIONS PRIORITIZATION IN LIGHT OF OTHER SAFETY RELATED ACTIVITIES.

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APPEAL PROCESS (043)

ONLY PLANT-SPECIFIC BACKFITS APPEALABLE UNDER MC 0514 LICENSEE TO ADDRESS APPEALS TO 0FFICE DIRECTOR / REGIONAL ADMINISTPATOR (COPY TO DIRECTOR, ROGR STAFF)

M WITHIN3hEEKSOFFICEDIRECTOP/REGIONALADMINISTRATORREPORT TOED 0YLANFORRESOLUTION(PROMPTLYINF00MLICENSEE)

FINAL DECISION ON APPEALS WILL BE MADE BY OFFICE DIRECTOR RESPONSIBLE FOR PROGRAM AREA UNLESS RESOLV BY RA OR OTHER MANAGEMENT LEVEL g .g , ,s ,,

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-- LICENSING RELATED - NRR EXCEPT FOR SAFEGUARDS (NMSS), QA (IE), EP (IE)

ENFORCEMENT RELATED - IE INSPECTION RELATED - IE

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APPEAL PROCESS (043) (CONTINUED)

TWO APPEAL LEVELS (DIVISION DIRECTOR AND OFFICE DIRECTOR /

REGIONAL ADMINISTRATOR)

APPEAL PROCESS SHOULD FOCUS ON WHETHER OR NOT SAFETY IMPROVED SUBSTANTIALLY AT A REASONABLE COST AS DESCRIBED IN REGULATORY ANALYSIS.

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- . - 17 IMPLEMENTATION OF BACKFIT (044)

BACKFIT POSITIONS SHOULD BE TRANSMITTED TO LICENSEE IN WRITING AND IDENTIFIED AS A BACKFIT.

LICENSEE MAY EITHER APPEAL OR IMPLEMENT.

SCHEDULE FOR IMPLEMENTATION SHOULD BE DEVELOPED IN t

l CONSULTATION WITH LICENSEE.

l PROMPT IMPOSITION WITHOUT CONDUCT OF REGULATORY ANALYSIS MUST BE APPROVED BY PROGRAM 0FFICE DIRECTOR AND EDO NOTIFIED.

UNLESS PROMPT IMPOSITION NECESSARY, POSITIONS ARE NOT TO BE IMPOSED, PLANT OPERATIONS ARE NOT TO BE DISTURBED DURING l REGULATORY ANALYSIS AND APPEAL PROCESSES.

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RECORDKEEPING AND REPORTING (045)

SYSTEM BEING DEVELOPED BY RM EACH OFFICE ADMINISTRATIVELY MANAGES THE SYSTEM PROVIDES FOR PROMPT RETRIEVAL / CURRENT STATUS SYSTEM CONTENT t

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PLANT ID SUBSTANCE OF BACKFIT ISSUE STAFF / LICENSEE IDENTIFIED l

FOR EACH BACKFIT PROCESS ACTIVITY

RESPONSIBLE NRC PERSON PLANNED SCHEDULE ACCOMPLISHED SCHEDULE l REFERENCES l

FINAL DISPOSITION i

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FUNDAMENTAL CONCEPTS IN DETERMINING WHETHER A STAFF ACTION IS A BACKFIT IS THE POSITION A PREVIOUSLY APPLICABLE REGULATORY STAFF POSITION?

TIMING OF THE POSITION RELATIVE TO REGULATORY MILESTONES, HAS THE LICENSEE REALLY VOLUNTEERED TO TAKE ACTION?

ACTIONS PROPOSED BY LICENSEE RESULTING FROM NORMAL STAFF / LICENSEE DISCUSSIONS CONCERNING AN ISSUE ARE NOT

/ BACKFITS, WOULD THE STAFF POSITION CAUSE THE LICENSEE TO CHANGE DESIGN, CONSTRUCTION OR OPERATION?

IS THE STAFF ACTION DIRECTING, TELLING OR COERCING, OR MERELY SUGGESTING OR ASKING THE LICENSEE TO CONSIDEP THE STAFF PROPOSED ACTION?

IS THE LICENSEE IN NONCOMPLIANCE WITH AN NRC REQUIREMENT?

IS THE LICENSEE MEETING WRITTEN COMMITMENTS TO THE NRC?

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SPECIFIC APPLICATIONS INSPECTION INSPECTION OF ANY ITEM / ACTIVITY IS NOT BY ITSELF A BACKFIT.

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IDENTIFICATION OF DEFICIENCIES AND DISCUSSIONS WITH LICENSEES j REGARDING THE DEFICIENCIES ARE NOT BACKFITS.

l LICENSEE AGREEMENT TO TAKE ACTION IN PESPONSE TO INSPECTOR FINDINGS IS NOT A BACKFIT PROVIDED THE LICENSEE IS NOT FACED WITH AN ULTIMATUM.

IF THE STAFF INDICATES A CERTAIN ACTION IS THE ONLY WAY FOR THE STAFF TO BE SATISFIED, THAT ACTION IS A BACKFIT.

21 -

SPECIFIC APPLICATIONS INSPECTION (CONTINUED)

EXAMPLES

-- LICENSEE COMMITS TO ANSI-N18,7 IN SAR

-- IMPLEMENTING PROCEDURES DO NOT CONTAIN ALL N18,7 l

REQUIRED ELEMENTS TELLING LICENSEE HE MUST INCLUDE THEM IS NOT A BACKF1T.

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-- IMPLEMENTING PROCEDURES DO NOT CONTAIN CERTAIN N18,7 OPTIONAL ELEMENTS.

TELLING LICENSEE HE MUST INC' JDE THEM IS A BACKFIT.

DISCUSSION WITH THE LICENSEE REGARDING THE MERITS OF INCLUDING THE OPTIONAL ITEMS IS NOT A BACKFIT.

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, , - - - - - -. ----,--w, - -, - - - - ,, - -- -,

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ENFORCEMENT ENFORCEMENT OF NRC REQUIREMENTS IS NOT A BACKFIT.

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A MOV REQUESTING DESCRIPTION OF CORRECTIVE ACTION IS NOT A l

B AC KF IT .

LicEWSEE COMMITMENTS IN RESPONSE TO NOV ARE NOT BACKFITS.

DISCUSSIONS DURING ENFORCEMENT CONFERENCES AND RESPONSES TO REQUES1S FOR ADVICE ARE NOT BACKFITS.

A STATEMENT TO A LICENSEE DIRECTING A SPECIFIC ACTION TO i SATISFY THE STAFF IS A BACKFIT.

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REANALYSIS OF ISSUES OCCASIONALLY THE NRC STAFF MAY CONCLUDE THAT A PPEVIOUSLY NRC APPROVED LICENSEE PROGRAM DOES NOT SATISFY A REGULATION, LICENSE CONDITION OR COMMITMENT.

A SUBSEQUENT STAFF SPECIFIED CHANGE IS A BACKFIT.

A LICENSEE YOLUNTARY CHANGE IS NOT A BACKFIT.

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EXAMPLE LICENSEE IN THE SAR COMMITS TO A CARD 0X SYSTEM IN CABLE SPREADING ROOM.

STAFF PUBLISHES AN SER ACCEPTING SYSTEM AND LICENSEE INSTALLS THE SYSTEM.

l STAFF SUBSEQUENTLY REEVALUATES ORIGINAL POSITION AND DECIDES WATER SUPPRESSION SYSTEM IS NEEDED.

IF THE STAFF NOW REQUIRES A WATER SUPPRESSION SYSTEM IT IS A BACKFIT.

LICENSING - USE OF SRP SRP DELINEATES MANAGEMENT APPROVED SCOPE AND DEPTH OF REVIEW TO GIVE REASONABLE ASSURANCE THAT LICENSEE WILL SATISFY NRC REQUIREMENTS.

APPLICATION OF A CURRENT SRP IN AN OL REVIEW IS NOT A BACKFIT IF THE SRP WAS EFFECTIVE 6 MONTHS PRIOR TO START OF THE OL REVIEW (6 MONTHS PRIOR TO DOCKETING OL APPLICATION).

USING ACCEPTANCE CRITERIA MORE STRINGENT THAN OR IN ADDITION TO SRP CRITERIA IS A BACKFIT.

STAFF DISCUSSIONS WITH LICENSEES REGARDING THE MERITS OF ACTIONS WHICH ARE BEYOND SRP CRITERIA APE NOT BACKFITS UNLESS THE STAFF LEAVES THE LICENSEE NO OTHER REASONABLE ALTERNATIVE.

l APPLICATION OF SRP CRITEPIA TO AN OPERATING PLANT GENERALLY IS CONSIDERED A BACKFIT UNLESS THE SRP WAS SPECIFICALLY APPROVED FOP OPERATING PLANT IMPLEMENTATION.

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PLANT-SPECIFIC ORDERS AN ORDER ISSUED TO CAUSE A LICENSEE TO TAKE ACTIONS WHICH ARE NOT OTHERWISE APPLICABLE REGULATORY STAFF POSITIONS IS A BACKFIT.

AN ORDER ISSUED TO CONFIRM A LICENSEE COMMITMENT IS NOT A BACKFIT.

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SUMMARY

BACKFITTING IS AN EXPECTED STAFF ACTIVITY, BACKFITTING IS TO BE CONDUCTED IN A CONTROLLED MANNER.

BACKFITTING CONCEPTS ARE STRAIGHTFORWARD.

IS POSITION A PREVIOUSLY APPLICABLE STAFF POSITION?

STATUS OF LICENSEE IN REGULATORY PROCESS.

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IS LICENSEE BEING COERCED 7 IS COMPLIANCE /CONFORMANCE INVOLVED?

BACKFIT PROCESS IDENTIFY AND DETERMINE P

REGULATORY ANALYSIS MANAGEMENT APPROVAL

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SUMMARY

(CONTINUED)

TRANSMITTAL TO LICENSEE IMPLEMENT OR APPEAL FINAL DISPOSITION i

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ENCLOSURE C REGULATORY ANALYSIS l

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i REGULATORY ANALYSIS 10 CFR Part 21 and $50.55(e)

Criteria and Procedures for The Reporting of Defects

1. Statement of the Problee Existing Commission regulations contain several safety deficiency reporting requirements applicable to the construction and operation of nuclear power plants:

10 CFR Part 21 applies to all NRC licensees, as well as nonlicensees who supply components to these licensees, and requires the reporting of defects that could create a "substantial safety hazard," as defined in regulations. - -

10 CFR 50.55(e) applies solely to the holders of construction permits and currently requires the reporting of "significant deviations" or "significant deficiencies" which could adversely affect safety.

10 CFR 50.72 and 50.73, establish an event reporting system that applies uniformly to all operating nuclear power plants. These regulations require the licensee to submit a written report for each significant operating event.

Task II J.4 of the TMI Action Plan directed the staff to evaluate and j revise, if necessary, the existing requirements of 10 CFR Part 21 and 550.55(e) to ensure prompt and comprehensive reporting. Over several years, the need for revision of these regulations has become apparent.

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1 Enclosure C

-- .-- ,.- _ - - _ , . . . , . , , , . .-_,._-.__-..-,-,y _-,_-.._y_ , ,,,,--,,-----,-,,m ,- ,.-r-- - -e -n-r

l 1

l Approximately 12,000 organizations, licensees and nonlicensees, are under the scope of Part 21 reporting requirements.

Licenses are issued under the following parts: production and utilization facility licenses issued under 10 CFR Part 50, including nuclear power plants and research and test reactors at various stages in the licensing process; by product material licenses issued under Part 30, 31, 34, and 35; source material licenses issued under Part 40; high-level radioactive waste disposal licenses issued under Part 60; land disposal of radioactive waste issued under Part 61; special nuclear materials licenses issued under Part 70; the packaging l of radioactive materials for transport under Part 71; and spent fuel storage under Part 72.

The nonlicensee suppliers covered under Part 21 are fires of many different sizes, supplying many different types of basic components to NRC licensees.

Approximately 500 reports are currently submitted to NRC annually under Part 21. These reports of potential safety probless have resulted in 15tC bulletins, circulars, and information notices, and have contributed to the improved safety of the nuclear industry.

Section 50.55(e) of 10 CFR Part 50, originally published as a final rule on March 30,1972 (37 FR 6459), establishes requirements for reporting deficiencies occurring during the design and construction of nuclear power plants. The rule was designed to enable the NRC to receive prompt notiff-  ;

cation of deficiencies and to have timely infomation on which to base an evaluation of the potential safety consequences of the deficiency and l determine if further regulatory action is required. Therefore, the holder of a permit for the construction of a nuclear power plant is required to '

notify the Commission of each significant deficiency found in the j

' processes of design, manufacture, fabrication, installation, construction, quality assurance, testing, and inspection, which if it were to have remained uncorrected, could have adversely affected the safety of operations of the nuclear power plant at any time throughout the expected

! lifetime of the plant. '

2 Enclosure C l  :

l t 1

Approximately 1500 reports are currently submitted to the NRC annually under 550.55(e). As with Part 21, these $50.55(e) reports have formed the basis for NRC bulletins, circulars, and information notices and have also contributed to the improved safety of the nuclear industry.

Existing regulations have resulted in problems of d@licative evaluation and reporting of defects. The currently proposed amendments to Part 21 and $50.55(e) are intended to eliminate these problems.

Taking no action would continue the potential for duplicative reporting and evaluation and ignores the opportunity for establishing a more coherent regulatory framework that would reduce the burden for reporting on the regulated industry, without sacrificing safety effectiveness.

2. Objectives The staff previously submitted extensive proposed rule amendments in SECY-85-399. The Commission disapproved those proposed rule changes.

Based on Commission direction provided in NRC memorandum from Samuel J.

Chilk to Victor Stello, Jr. dated October 20, 1986, two, more modest proposed revisions have been provided. The first proposal, Alternate A, provides revisions to the rules which are entirely consistent with Consission direction given in response to SECY-85-399. Additionally, because of the staff's strong belief that timeliness of evaluation and reporting of defects is an essential aspect of the rules, that feature has been retained in proposed Alternate B.

Accordingly, based on the above direction and on current staff experience with Part 21 and $50.55(e), the proposed revision of the existing regulations focuses on the following four objectives:

1. Eliminating duplicative evaluation and reporting;

2. More clearly and uniformly defining the de'ects that need to be reported under $50.55(e);

3 Enclosure C

~

e 3.

Establishing a uniform content for reporting for $50.55(e) and Part 21; and 4.

Establishing time limits for evaluating, reporting, and notification (in Alternate B only).

3. Alternatives The regulatory alternatives considered for accomplishing each of the objectives in Section 2 of this Analysis were as follows:

3.1 Eliminating Duplicative Evaluation and Reporting Requirements As stated above, Commission regulations contain several safety deficiehcy reporting requirements.

Instances have occurred where the same deficiency in a component was evaluated and reported by two different organizations, one attempting to satisfy the criteria of Part 21, and the other attempting to meet the differently worded criteria of $50.55(e) or $50.73.

-The-original-intent was that reporting under any of these requirements would satisfy the other reporting requirements. In reality, this intended method of reporting has not occurred. Different reporting criteria for

$50.55(e) and Part 21 and the lack of any explicit framework in existing regulations addressing the duplicative reporting issue have led to significant duplication of licensee, construction permit holder, vendor, and NRC staff effort.

Proposed revisions explicitly relieve duplicate evaluation and reporting.

The proposed revisions to $21.2 would explicitly relieve the holders of construction pemits from the Part 21 evaluation and reporting requirements when previously unreported defects discovered by the holder of a construction parait are reported under $50.55(e). Similarly, proposed $21.2 would explicitly relieve the holders of operating licenses from the Part 21 evaluation and reporting requirements when defects discovered by a holder of an operating license are reported under $50.73 or $73.71. In addition, in Alternative 8, proposed revisions to $21.21 4 Enclosure C l l

I

would relieve vendors from reporting under Part 21 if a 50.55(e) or $50.73 report has been previously submitted for a particelar defect unless the vendor has additional required information not previously provided to the Commission. Under Alternative A, current $21.21 relieves vendors of this notification responsibility.

Section 50.55(e)(7) is being added to relieve the holders of construction permits under Part 50 from reporting a defect under $50.55(e) if a report has been previously submitted under Part 21 for that particular defect.

It should be noted that the contents of the reports under Part 21 and

$50.55(e) will be structured in such a way as to ensure that the Commission is notified of all pertinent information regarding any reported defect. The internal organizational evaluation requirement of $50.55(e) would still apply to holders of construction permits. '

3.1.1 Alternative - Maintain Continued Duplicative Reporting The alternative of continuing to require duplicate evaluation and

- reporting was rejected because it would not accomplish any regulatory relief and would continue duplicate effort estimated below to cost the industry approximately $1,934,400 annually.

3.1.2 Alternative - Incorporation of all Safety Defect Reporting Requirements Into One Regulation One alternative would be to incorporate all safety defect reporting by vendors, tha holders of construction persits, and the holders of operating i licenses into a single regulation to be codified in 10 CFR Part 50. This j alternative was rejected because Part 21, $50.55(e), and $50.73 are directed to different entities within the nuclear industry and as such incorporation would not result in any substantial improvement to the regulatory framework. It is further believed that one regulation might be overly cumbersome and difficult to implement by the reporting parties.

5 Enclosure C

3.2 Defining Defects to be Reported under $50.55(e)

Section 206 of the Energy Reorganization Act requires the reporting of "defects which could create a substantial safety hazard."

Existing $21.3(k) defines substantial safety hazard as "a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed, other than for export, pursuant to Parts 30, 40, 50, 60, 70, 71, or 72 . . . . " In addition, the supplementary information for the original Part 21 final rulemaking contained the following guidance on what constitutes a "substantial safety hazard":

Moderate exposure to, or release of, licensed material; Major degradation of essential safety-related equipment; and Major deficiencies involving design, construction, inspection, test, or use.

Section 50.55(e) requires the reporting of deficiencies in design and con-struction which could adversely affect the safety of operations of a nuclear power plant and which represents:

A significant breakdown in any portion of the quality assurance program; or A significant deficiency in a final design; or '

A significant deficiency in the construction of, or significant damage to a structure, systee, or component requiring corrective action involving extensive effort; or A significant deviation from performance specifications requiring corrective action involving extensive effort.

6 Enclosure C l

l

NRC experience with $50.55(e) reports has indicated that clarification of the type of deviation that is required to be reported would be helpful.

Accordingly, the reporting criteria in proposed $50.55(e)(1) are the same as those contained in Part 21.

3.2.1 Alternative - Maintaining Different Reporting Criteria One alternative to the criteria established in the proposed 50.55(e) revision would be to allow continued existence of differing criteria as discussed in section 3.2 above. Thisalternativewasrejectedbecauseit would allow continued differences in thresholds for reporting deficiencies and defects and attendant inconsistency in the regulatory framework.

Additionally, not changing the threshold allows the continued utilization of industry and NRC resources on deficiencies not truly representing safety significant items.

3.3 Unifons Reporting Content Section 50.55(e) revisions would require the information reported to the Comission to be consistent with Part 21. This revision will ensure that the' Commission obtains all the information necessary to evaluate and take corrective action in reference to a particular defect. Additionally, making $50.55(e) report content identical to that in Part 21 will provide  ;

uniform regulatory requirements.

l 3.3.1 Alternative - Maintaining Different Reporting Content The alternative of saintaining different contents for reporting was cor:sidered unacceptable because it would continue to create unnecessary -

burdens on the industry and the NRC staff with no offsetting benefits.

l l

7 Enclosure C

3.4 Extension of $50.55(e) Initial Notification Time limit.

The proposed $50.55(e) amendment would extend initial notification of the Commission from 24 to 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. This change provides the industry with additional flexibility and regulatory unifomity while providing the Commission with sufficient warning of safety problees.

3.4.1 Alternative - Maintaining Different Initial Reporting Time Limits The alternative of allowing different time limits for Part 21 and

$50.55(e) initial notifications was rejected on the basis of past experience as to what was a reasonable time period from the standpoint of licensee resourcre :rsus the potential impact on public health and safety. Further, arfferent time limits for the two different rules is not consistent with proposed $50.55(e) threshold under which the significance of defects reported under $50.55(e) would be the equal to that of Part 21.

3. 5 Establishing Time Limits for Evaluation (Included in Alternate B only)

Under existing $21.21(b)(2) the initial notification of a defect must be made to the NRC within two days of the time a director or responsible officer obtains information on the existence of a reportable defect.

However, the existing rule is silent concerning the time perior' between the discovery of a deviation and the time when an evaluation ol the deviation should be completed. Similarly, no deadline is established for when the director or responsible officer must be informed of a potentially reportable defect. Thus, the existing regulations allow the directors and responsible officers of a fire to remain uninformed concerning potentially reportable problems during the period free identification through l evaluation. The proposed revision to $21.21 would establish a 30 day time limit for evaluating deviations and informing directors or responsible corporate officers of defects determined to be reportable. As with the current regulation, the NRC sust be informed within the subsequent 5 days.

8 Enclosure C

Proposed $50.55(e) would also require CP holders to evaluate deficiencies within 30 days.

3.5.1 Alternative - Do Not Establish Evaluation Time Limits in Part 21 and

$50.55(e)

The absence of required time limits has sometimes resulted in long delays between the identification of a potential probles and the completion of a related evaluation. Furthermore, the existing regulations allow the directors and responsible officers of a fire to remain uninformed

oncerning potentially reportable problems during the period of evaluation.

Therefore, the person with the maximum responsibility, judgment, capability, and experience remains detached during the probles identification and evaluation process. As such, this alternative was

+

rejected.

3.6 Extension of Time Limit for Part 21 Written Followup Report Submittal '

(Included in Alternate B only)

In the current Part 21, submittal of the required written followup report within the 5 day time limit is viewed as extremely difficult to accomplish. Due to this time limit, adequacy of information is often questionable.

Significant NRC staff followup has usually been required to obtain additional information and verify previously supplied information.

Since the Commission is informed about the defect within two days of determination that a significant safety hazerd exists, the staff has adequate information to take appropriate action in a timely manner if the l

situation warrants. Also, the addition of time limits for evaluation of l

potential defects will further act to keep the staff informed regarding significant safety hazards. Thus, the proposed rule would change the time )

j limit for submission of the required followup Part 21 written report froe l 5 days to 30 days.

I 1

9 Enclosure C

3.6.1 Alternative - Maintain the 5 day Req' :t This alternative was rejected because it wou.o continue an unnecessary burden on the regulated industry with no attendant increase in safety.

Additionally, the alternative would create inconsistent written followup l report time limits for Part 21 and $50.55(e) respectively. The initial  !

NRC notification provides adequate information so that insediate action can be taken if the situation warrants.

3.7 Construction Permit llol.ier h'otification of Vendor (Included in Alternate B only)

The proposed amendment to $50.55(e) would require notification of the vendor of a product or service involved in the reported defect if the CP holder determines that the defect was caused by or wu related to a vendor process.

3.7.1 Alternative - Maintaining no Requirement in Section 50.55(e) to Infom Verers - the Status Quo - - --- -- - -

This alternative was rejected since one primary objective of the reporting system is to alert all affected parties as early as possible to problems with their products which could affect facilities licensed by the NRC and thereby enhance the protection afforded to the health and safety of the public.

j 3.7.2 Alternative - Have NRC Infore Vendors This alternative was rejected since the discoverer of the defect is most knowledgeable about the problem and NRC resources can better be utilized in other areas of the evaluation and notification process.

10 Enclosure C

3.8 Expansion of Part 21 to Construction of Part 60 Facilities (Included in Alternate A only)

In order to provide uniform coverage of all the activities and facilities licensed by the Commission, proposed Section 21.2 would extend the l coverage of Part 21 to organizations that construct a geologic repository  !

for the disposal of high-level radioactive waste under 10 CFR Part 60.

This proposed extension to geologic repositories would complete the Part 21 coverage by extending it to all the major activities or facilities licensed by the Commission.

3.8.1 Alternative - Do Not Extend Coverage This alternative was rejected because it would not extend Part 21 coverage uniformly to all the major activities or facilities licensed by the Commission.

4. Consequences 4.1 Costs and Benefits 4.1.1 Existing Benefits The reports of potential safety probless submitted under Part 21 and

$50.55(e) have contributed to improved saf9ty of nuclear power plants and have resulted in NRC bulletins, circulars, and information notices. A few notable examples follow:

POTENTIAL SEISNIC INTERACTION INWLVING THE MOVABLE IN-CORE FLUX MAPPIE SYSTEM USED IN WESTINGHOUSE DESIGNED PLANTS (Information Notice 85-45)

In June,1984, the licensee for Shearon Harris notified the NRC of a potential interaction between the non-safety portions of the flux sapping

' system and the safety related tubing / seal table during a seismic event.

The potential interactions existed because portions of the in-core flux 11 Enclosure C

/

mapping syste.e that were not seismically analyzed were located directly above the safety related in-core instrumentation tubing / seal table.

Failure,during a teismic event could possibly cause sultiple failures in the flux marping tubing or fittings that would produce a small break loss of coolant'accjdent (LOCA). It was subsequently deterninct that a sicilar situation;could exist at other plants. Multiple failures of flux sapping tubing and/cr fittings constitute an unanalyzed small break LOCA because the break flow would effectively be from the bottom of the reactor vessel.

Such an event wd beyond the licensing design basis for LOCA.

~

' POTENTIAL FCE tbs 5 OLMINIMUM F!.0W PATHS LEADING T A LOCA (Infomation Notice 85-9Q In July,1985, NRC was not,ified by the licer.see for Point Beach Units 1 and 2 of a potential defect,in the design of the control circuit for the safety injection (5I) pump recirculation flow path isolation valves. It was discovered that'ftihre of one power supply breaker could cause loss of both SI pumps.

This failura~could.cause valves in the recirculation line to close and cause both pumps to fail due-to-no-flow. -----

This event illustrated the difficulties associated with designing systems to meet multip,le criteria. The importance of minime flow recirculation

~

syste:ss.to ECCS punp operability may not have been fully reflected in design and operation because adequate attention may not have been focused on theifets of small break LOCA. sequences until re'atively recently.

FAILURE 0F SCRAM DISCHARGE YOLUME VEKI AND DRAIN VALVES (Information notice 8!-PM

.In February,1985, Geners) Electric Company (GE) notified NRC of a coupling failure of the valvg used as a Control Rod Drive (CRD) drain valve in the scram dischary voluee. The coupling connected the air actuator to the valve sten and its failure prevented the valve from fully opening or clasing. This failure occurred during equipment qualification in a laboratory and was due to automatic actuation while the manual hand 12 Enclosure C n -

wheel was partially engaged.

Subsequently, two additional operating plants experienced valve failures caused by partially engaged hardsheels.

Failure of this vent valve or either redundant drain valve represents a degradation of safety systems (CRD, primary containment, and primary containment isolation systes) and could result in unnecessary challenges to the reactor protection system.

_ POTENTIAL FAILURE OF REPLACEENT AC COILS SUPPLIED BY ELECTRIC CORPCRATION FOR USE IN CLASS 1E MOTOR STA (InformationNotice86-66)

In June,1986, Westinghouse Water Reactor Division notified NRC of a higher-than-normal failure rate for AC coils.

Failures had occurred during initial operation of the coils in non-nuclear applications. '

These coils were also used in certain motor starters and contactors in Class 1E (safety) applications in nuclear plants. These coils could have been subject to failure.

To correct the probles, Westinghouse made several manufacturing changes that included revised materials and processes.

The newly manufactured coils vere not subject to the same f ailures as those manufactured prior to the changes. It was also determined that if these coils operated satisfactorily for 5 days, then they could be expected to function correctly.

4.1.2. Existing Costs Approximately 500 nuclear power plant-related Part 21 reports are currently subeltted annually to the NRC by licensees and component suppliers. Approximately 80 percent of these Part 21 reports are submitted by a licensee, with the remainder coming froe nuclear steam systes suppliers, architect-engineers, and other nonlicensee vendors.

Approximately 1500 $50.55(e) reports, all from the M1ders of construction permits under Part 50, are currently submitted annually to the NRC, A substantial number of these reports (approximately 25 percent) are in the nature of interia or follow-up reports on the same deficiency. Therefore, in reality, a more representative number would be approximately 1100

! 13 Enclosure C i

i

a

$50.55(e) reports of individual deficiencies and 400 interia or follow-up reports. The following estimates are based on 1100550.55(e)reportsper year.

Based on estimates provided by utilities and vendors, wide variations (20 1

to 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br />) exist in the amount of effort expended in evalua* tion and reporting of Part 21 and $50.55(e) defects. The following analysis, is based on a value of 160 man-hours for evaluation and reporting of a single Part 21 report, and 80 san-hours for evaluation and reporting of a single 550.55(e) report. i These estimates represent our professional judgment in I a difficult crea to quantify. They include management review time, as l well as the time expended on the evaluation of defects which are ultimately determined to be nonreportable and submittal of interia reports. The annual industry time expended on Part 21 is approximately 80,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> x 500 reports), or $4,800,000 peryear(basedon

$60.00 per hour of professional staff time). The annual industry time expended on 550.55(e) reporting is approximately 88,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (1100 Reports x 80 san-hours) or $5,280,000 peryear(at$60.00perhour).

Additionally, current annual records retention costs-under-Part-21 and --

$50.55(e) are estimated to be $18,000 and $200,000 respectively. Thus, the combined total annual industry cost for both $50.55(e) and Part 21 reporting is $10.298 million.

i The annual NRC staff time expended on Part 21 evaluations is approximately 12,500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> (500 reports x 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />) or $750,000 annually (at$60,00per hour) and approximately 16,500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> (1100 reports x 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />) or $990,000 i

annually (at $60.00 per hour) for $50.55(e) evaluitions. The times expended to review both types of reports are average numbers based on previous experience with review of reports generated by these rules.

i Additionally, current NRC annual records review activities costs associated with Part 21 and $50.55(e) are estimated to be $126,000 and i $66,000 respectively. Thus, the combined annual total NRC cost for both I

$50.55(e) and Part 21 reporting is $1.93 million.

14 Enclosure C l

t

4.1.3 Proposed Benefits 4.1.3.1 Eliminating Duplicative Evaluation and Reporting Requirements The proposed revision would establish a systes of a single evaluation and reporting for any particular defect, submitted by the entity that discovers the defect. Discovery of a defect by a vendor would be reported under Part 21, by a holder of a construction permit under $50.55(e), and by the holder of an operating license under $50.73.

This change will accomplish:

1. A decrease in the burden on the industry by eliminating--

The dual evaluation and reporting process for the same defect because of the different reporting thresholds and requirements associated with Part 21 and S0.55(e).

The submission of two different reports by diffefe tini.itles on the same defect.

2. NRC staff effort currently expended on identifying and tracking duplicate reports will be redirected towards increased follow-up of safety concerns related to these reports thereby improving NRC's health and safety objectives.

4 4.1.3.2 Defining Defects to be Reported Under $50.55(e)

The proposed revision of 550.55(e) would establish a new reporting threshold, the same as to that contained in Part 21. This new threshold substantially raises the existing reporting ?hreshold for 550.55(e) providing more certainty for the determination of reportable defects, thereby reducing licensee time as well as providing more assurance that critical safety defects are reported. The new rt. < rting criteria will 15 Enclosure C

eliminate unnecessary reporting, thereby allowing industry and NRC to focus more closely on issues that are truly of safety sig.nificance.

4.1. 3. 3 Unifore Reporting Content Similar reporting content for both $50.55(e) and Part 21 defect reporting will reduce industry reporting costs. It will simplify the reporting process by establishing a unifore report content.

The unifore content for reporting will insure that all pertinent information is provided thus enhancing NRC's ability to assess the safety significance of the reported ites and ensure that all data pertinent to health and safety concerns are provided by the licensee.

4.1. 3. 4 Extension of $50.55(e) Initial Notification Time Limit.

This change provides the industry with additional flexibility while maintaining sufficient warning of safety problems.

4.1. 3. 5 Establishing Time Limits for Evaluation (Included in Alternate B only)

The proposed changes to Part 21 and $50.55(e) establish definite time frames for evaluation and reporting of defects. Although, difficult to

' quantify, establishing a reasonable schedule for the evaluation and reporting of potentially reportable defects will be beneficial in terns of safety, by ensuring that potential safety problems are brought to the NRC's attention as soon as possible after discovery.

4.1.3.6 Extension of Time Limit for Part 21 Written followup Report 1

Subsittal (Included in Alternate B only) f Ensuring more flexibility and additional quality of Part 21 written followup reports by allowing 30 days to establan information and prepare report (Alternate B only).

1 i

l 16 Enclosure C

)

4.1.3.7 Construction Permit 3 older Notification of Vendor (Included in Alternate B only)

Providing notification of reportable defects to vendors when the defects are determined by the licensee to be caused by or to be related to a vendor process, required by proposed $50.55(e) will be a minimal burden on the reporting parties with a significant increase in efficiency in the resolution of problems addressed by these reports.

4.1.3.8 Expansion of Part 21 to Part 60 Facility Constructio. (In Alternative 8only)

Expansion of Part 21 to those organizations that construct Part 60 facilities will allow uniforn coverage of all major activities licensed by the Commission with only modest increase in effort.

4.1. 4 Proposed Costs Estimates in this section indicate that savings to the nuclearindustry--~-

due to the proposed changes will be $1,934,400 annually. The present -

value of this annual savings is estimated to be approximately $18.24 million in savings to the nuclear industry over the next 30 years.

4.1.4.1 Eliminating Duplicative Evaluation and Reporting Requirements.

Changes proposed for elimination of duplicative evaluation and reporting are anticipated to decrease the industry reporting burden by 15 percent.

This is based on IRC staff judgment and staff's review of the reporting history under these rules. Based on the cost data presented in Section >

l 4.1.2, a 15 percent reduction in industry burden on Part 21 and Section 50.55(e) combined will result in an annual savings to the industry of

$1,512,000.

NRC costs will remain approximately the same as a result of the establishment of a system which generates a single report for a given 17 Enclosure C

defect. The staff assumes that savings in staff time froe not having ta identify and track duplicate reports will be offset by increased follow-up of safety concerns related to these reports.

4.1.4.2 DefiningDefectstobeReportedUnder$50.55(e)

The higher threshold contained in the proposed revision will reduce the number of $50.55(e) reports submitted to the NRC by approximately 10 percent. However, evaluations for reportability must still be performed..

Thus, the reduction in evaluation effort will not be as great as the reduction in the number of reports. Including both effects, it is anticipated that the industry burden due to raised threshold will decrease by approximately 8 percent without any resulting decrease in important safety information.

The annual decrease in industry burden resulting from the new $50.55(e) threshold will be approximately 7040 hours0.0815 days <br />1.956 hours <br />0.0116 weeks <br />0.00268 months <br /> (8 percent of 1100 reports x 90 hours0.00104 days <br />0.025 hours <br />1.488095e-4 weeks <br />3.4245e-5 months <br />) or $422,400 (at $60.00 per hour).

There will be no decrease in the amount of NRC evaluation time because the change in reporting threshold will simply eliminate reports of low --- -

threshold problems on which little effort is currently expended. Ihat effort will be applied to more safety significant issues.

4.1.4.3 Uniform Contents Uniform contents of Part 21 and $50.55(e) reports should reduce industry reporting costs and NRC review costs, but these savings are viewed as being insignificant compared to other costs and savings discussed above.

4.1.4.4 Extension of $50.55(e) Initial Notification Time Limit Extension of the time limit for initial reporting under $50.55(e) will provide additionally flexibility and say reduce required construction permit holder resources but the savings are judged to be insignificant compared to other costs and savings discussed here. There will be no decrease in important safety information.

18 Enclosure C

4.1. 4. 5 Establishing Time Limits for Evaluation (Included in Alternate 8 only)

Establishing time schedules for evaluation and reporting under Part 21 and

$50.55(e) any require the industry to devote more staff resources at a particular time to the evaluation of deviations. However, the existing regulations already require industry evaluation and reporting. It is estimated that this requirement will not increase industry burden.

Additionally, the existence of such a time limit would tend to limit industry time spent on defects prior to accomplishing the requirements of the regulations, e.g., the presence of a time limit for evaluation will cause the potential defect to be reported in a timely manner before the reporting entity expends excessive time and effort evaluating the deficiency.

i

'.1.4.6 4

Extension of Time limit for Part 21 Written Followup Report Submittal (Included in Alternate 8 only)

The extension of the time limit for the Part 21 written followup report --

has the potential to reduce industry burden by allowing the application of  ;

resources in a more efficient manner. However, the savings are judged to be insignificant compared to other costs and savings discussed here.

4.1.4.7.

Construction Permit Holder Notification of Vendor (Included in Alternate 8 only)

Additional costs to the construction holders, as a result of the requirement to notify vendors when a defect is determined to be caused by or to be related to a vendor process, are anticipated to be insignificant compared to other costs and savings discussed here.

4.1.4.8 Records Retention Changes Proposed records retention changes in Part 21 and $50.55(e) and are expected to increase industry costs because of the required retention of 19 Enclosure C l

--- ~~~' ~

1 550.55(e) evaluations and the definition of the period time for records retention. However, an overall reduction in the total number of records should also be achieved through the elimination of duplicative reports. '

This reduction should act to reduce the effect of increased records retention and, thus, the increase is estimated to be insignificant compared to other costs and savings discussed here.

4.1.4.9 Expansion of Part 21 to Construction of Part 60 Facilities (Included inAlternateBonly)

Extension of Part 21 to those entities who construct Part 60 facilities will necessitate development of procedures to ensure those entities are in compliance with Part 21. However, the population of those entities which are impacted by this extension is very small. Likewise, the potential number of such facilities is small (probably only one). Therefore, the cost of this effort is estimated to be insignificant when compared to other savings and costs discussed here.

4.1.4.10 Net cost (savings) to industry and NRC.

Based on the estimates above, net savings to industry reporting under Part 21 and 550.55(e) as a result of the proposed changes is anticipated to be

$1,934,400 annually.

Assuming a 10 percent real discount rate and a 30 year average remaining life for licensees impacted by Part 21 and Section 50.55(e), the 1987 present worth savings to industry is estimated to be approximately $18.24 million.

Due to the elimination of duplicate reporting and the use of unifom report content for Part 21 reports and $50.55(e) reports, a savings in NRC staff time will result. This time will be reallocated to staff followte actions regarding safety concerns arising from Part 21 and $50.55(e) reports. Therefore NRC costs are expected to remain the same.

20 Enclosure C

r 4.1.5 Costs and Benefits of Alternatives See discussion under heading 3 "Alternatives."

4.2 lapacts on Other Requirements '

As discussed above, a primary rationale for the proposed revision was to ensure coordination and consistency among NRC defect reporting requirements. Although the proposed revision focuses on nuclear power plants, implications for the nonreactor area were considered in the development of the proposed rule.

e 4.3 Constraints legal and institutional constraints, including issues related to enforceability, were discussed above under "Alternatives."

5. Decision Rationale An assessment of the costs and benefits of the proposed revisions leads to the conclusion that thert will be a substantial overall decrease in indus-try costs for either proposed revision (Alternative A or 8), a status quo ,

in NRC costs, and an important increase in the effectiveness of safety defect reporting. Therefore, proposed revision as described under l

. Alternative 8 is recommended because it would result in incremental improvements to safety over that provided by Alternative A with ,

inconsequential effect on the projected cost savings to industry. No alternatives other than those described in Alternative A or B were judged to be satisfactory. Our decision is supported by both the quantified cost i data and a reasoned judgment on improvements to safety.

1 1

1 21 Enclosure C .

6. Implementation ,

6.1 Schedule No implementation problees are anticipated. The framework for implementation is already well-established in both the industry and the NRC.

6.2 Relationship to Other Schedules No effect on other schedules is anticipated.

l i

L 22 Enclosure C

I -

& fAjop-A%c ENCLOSURE D BACKFIT ANALYSIS i t. occordance with (50.E.:g'f) l D-3

BACKFIT ANALYSIS ANALYSIS AND DETERMINATION THAT THE PROPOSED AMENDMENTS TO 10 CFR 21, "REPORTINGOFDEFECTSANDNCNCOMPLANCE"AND10CFR50.55(e),"REPORTINGOF DEFECTS IN DESIGN AND CONSTRUCTION" COMPLY WITH REQUIREMENTS OF FOR REQUIRED INFORMATION REPORTING AND RECORD KEEPING Existing Comission regulations contain several safety deficiency reporting requirements applicable to the construction and operation of nuclear power plants:

10 CFR Part 21 applies to all NRC licensees, as well as nonlicensees who construct facilities for or supply compbnents to these licensees, and requires the reporting of defects that could create a "substantial safety hazard," as defined in regulations.

10 CFR 50.55(e) applies solely to the holders of construction permits and curantly requires the reporting of "significant deviations" or "significant deficiencies" which could adversely aHect safety.

10 CFR 50.72 and 50.73 establish an event reporting system that applies uniformly to all operating nuclear power plants. These regulations require the licensee to make prompt telephone notification and to submit a written report for each significant operating event.

Existing regulations have frequently resulted in problems of duplicative evaluation and reporting of defects. The proposed amen &ents to Part 21 and

$50.55(e) would eliminate duplicative evaluation and reporting; more clearly and uniformly define the deviations that need to be reported under $50.55(e);

establish a unifors' content for reporting for Section 50.55(e) and Part 21; and, optionally in Alternative B, establish time limits for evaluation and reporting of defects.

Task II J.4 of the TMI Action Plan directed staff to evaluate anc revise, if necessary, the existing requirements of 10 CFR Part 21 and $50.55(e) to ensure 1 Enclosure 0

prompt and comprehensive reporting. Over several years, the need for revision of these regulations has become apparent.

Based on the Comission direction provided in NRC memorandum from Samuel J.

Chilk to Victor Stello, Jr., dated October 20, 1986; reconnendations in the TMI action plan; and on current staff experience with Part 21 and 550.55(e),

the proposed revision of the existing regulations has the following objectives:

o Eliminate duplicative evaluation and reporting; o More clearly and uniformly define the deviations that need to be reported under $50.55(e);

o Establish a uniform content for reporting for Section 50.55(e) and Part 21.

o Establish time limits for evaluation, reporting, and notification (In Alternative B only);

Ta. irg rc action woulc contiru the potertial for duplicative reporting and evaluation that now exists, and ignores the opportunity for establishing a more coherent regulatory framework that would reduce the burden for reporting on the regulated industry without sacrificing safety effectiveness. Consequently, the Commission is proposing amendments to 10 CFR 21 and 10 CFR 50.55(e) in order to clarify the criteria and procedures for reporting of safety defects by licensees and nonlicensees.

As described in NRC memorandum from Treby, OCG to Jordan, AE00, dated May 6, 1987, this proposed rule is subject to the backfit provision of 10 CFR 50.54(f).

The standard which is to be used in evaluating the imposition of this rule is "that the burden to be imposed on respondents is justified in view of the potential safety significance of the issues to be addressed in the requested infonnation."

The overall trurden on the regualted industry is reduced. However, although the overall burden is reduced, any additional burden due specifically to procedure l changes required under the proposed amendments is justified by the potential safety significance of the infonnation to be reported. As such, the proposed rule amendments meet the $50.54(f) standard. This detennination is discussed in detail below.

2 Enclosure D

prompt and comprehensive reporting. Over several years, the need for revision of these regulations has become apparent.

Based on the Comission direction provided in NRC memorandum from Samuel J.  !

Crilk to Victor Stello, Jr., dated October 20, 1986; reconsnendations in the TMI action plan; and on current staff experience with Part 21 and $50.55(e), l the proposed revision of the existing regulations has the following objectives:

o Eliminate duplicative evaluation and reporting; i

o More clearly and uniformly define the deviations that need to be '

reported under 150.55(e);

o Establish a uniform content for reporting for Section 50.55(e) and Part 21.

o Establish time limits for evaluation, reporting, and notification (In Alternative B only);

Tiring no action would certinue thi potential for duplicative reporting and e alu6 tion that now exists, and ignores the opportunity for establishing a more cc,herent regulatory framework that would reduce the burden for reporting on the regulated industry without sacrificing safety effectivens:s. Consequently, the Ccanission is proposing amendments to 10 CFR 21 and 10 CFR 50.55(e) in order to clarify the criteria and procedures for reporting of safety defects by licensees and nonlicensees.

The Comission has determined that these proposed rule amen &ents meet the standard under 10 CFR 50.54(f) necessary to require reporting of infonnation and attendant record keeping requirements. Specifically, although the overall burden is reduced, any additional burden due specifically to procedure changes required under the proposed amendments is justified by the potential safety significance of the information to be reported. As such, the proposed rule amendments meet the 550.54(f) standard. This determination is discussed in detail below.

2 Enclosure D

Analysis 10 CFR 50.54(f) Elements Element 1. Statement describing the need for the information required to be reported in terms of the potential safety benefit.

The reports of potential safety problems submitted under Part 21 and $50.55(e) have contributed to _ improved safety of nuclear power plants and have resulted in NRC bulletins, circulars, and information notices. These have substantially increased the overall safety of the nuclear industry.

Part 21 was intended to implement Section 206 of the Energy Reorganization Act of 1974 (42 U.S.C. 5846). The purpose of Section 206 was to ensure that the Commission has prompt inforsation concerning safety defects. In addition to ieposing obligations on the directors and responsible officers of NRC licensees, Section 206 also imposes obligations on the directors and responsible officers of nonlicensees that construct facilities for or supply components to licensed facilities or activities. Any individual officer or director who knowingly fails to comply with the notification requirements is subject to civil penalties.

raimately 12,000 organizations, licensees, and noniicensees, are under the scope of Part 21 reporting requirements. Licensees include those granted licenses under the following parts

production and utilization facility licen-ses issued under 10 CFR Part 50, including nuclear power plants and research and test reactors at various stages in the licensing process; by product matersal licenses issued under Parts 30 through 35; source saterial licenses issued under Part 40; high-level radioactive waste disposal issued under Part 60; land disposal of radioactive waste issued under Part 61; special nuclear materials licenses issued under Part 70; the packaging of radioactive materials for transport under Part 71; and spent fuel storage under Part 72.

Approximately 500 reports are submitted to the NRC annually under Part 21.

These reports of potential safety problems have resulted in NRC bulletins, circulars, and information notices, and have contributed to the overall improved safety of the nuclear industry. '

3 Enclosure 0

Section 50.55(e) of 10 CFR Part 50, originally published as a final rule on March 30,1972 (37 FR 6459), establishes requirements for reporting deficiencies occurring during the design and construction of nuclear power plants. The rule was designed to enable the NRC to receive prompt notification of deficiencies and to have timely information on which to base an evaluation of the potential safety consequences of the deficiency and determine if further regulatory action is required.

Approximately 1500 reports are submitted to the NRC annually under $50.55(e).

As with Part 21, these $50.55(e) reports have formed the basis for NRC bulletins, circulars, and information notices and have also contributed to the overall improved safety of the nuclear industry.

The proposed amenhents would augment and strengthen existing safety benefits discussed above as follows:

(i) Eliminating Duplicate Evaluation and Reporting i

The proposed revision would establish a framework within the regulations which would allow a single evaluation and reporting system for any particular defect.

' e entity discovering the defect would evaluate and rep:rt it. Thus, reporting would be accomplished as follows: discovery of a defect by a vendor would be report under Part 21; discovery by a construction permit holder would be reported under $50.55(e); and discovery by a operating license holder would be reported under 50.73.

a. A redistribution of the Part 21 reporting burden within the industry would be expected to take place. Holders of operating licenses would report under 50.73 instead of under Part 21. Also, Part 21 reports currently submitted by CP holders would be submitted under $50.55(e).

Vendors would submit under Part 21.

b. A decrease in the overall burden on the regulated industry due to elimination of the dual evaluation and reporting process for the same defect under Part 21 and $50.55(e) or $50.73.

4 Enclosure 0

~

(ii) New Reporting Criteria for 50.55(e) i The proposed revision of 150.55(e) would establish a new reporting threshold which is the same as that currently in Part 21. This new threshold would substantially raise the existing reporting threshold for 150.55(e), eliminating unnecessary reporting and allowing the industry to focus more effectively on issues that are trvly of safety concern. The higher threshold contained in proposed amendments to 50.55(e) is estimated to reduce the number of reports submitted under

$50.55(e) by approximately 10 percent. However, evaluation of deficiencies will still be required. Thus, the reduction in industry effort will not be as large as the estimated reduction in the volume of reports.

(iii) Unifom Content of Reporting Similar reporting content for all defect reporting under Part 21 and 150.55(e) will reduce industry reporting costs. However, the reduced costs are estimated to be negligible compared to other savings and costs considered. The uniform content will ensure all pertinent inforratien is provided thus enhar.cing NRC's ability te assess the safety significance of reported defects.

(iv) Extension of 150.55(e) Initial Notification Time limit.

Extension of the time limit for initial reporting of defects under

) 150.55(e) from 1 day to 2 days will allow more flexibility for construction pemit holders to make initial reports with no reduction in safety.

(v) Time Schedules for Evaluation, Reporting, and Notification of Vendors under Section 50.55(e) (AlternativeBonly)

The proposed changes to Part P1 and $50.55(e) estabitsh a definite time frame for evaluation of a defect. The proposed changes to 5 Enclosure 0

150.55(e) extend the time available for initial reporting of a defect and add a requirement to notify the vendor, if applicable. Although difficult to quantify, establishing a reasonable schedule for the evaluation of a potentially reportable defect will be beneficial in terms of safety by ensuring that safety probler.s are brought to the Consissions attention in a timely manner.

Providing notification of reportable defects to vendors, when the defects are determined by the CP holder to be related to a vendor, recuired by the proposed arnendments to $50.55(e) will be of minimal burden on the CP holder. There will be an attendant significant increase in efficiency in the resolution of problems addressed in these reports.

In sumary, the safety benefits of the existing 10 CFR Part 21 and ISO.55(e) are substantial. The rules ensure that the Comission is aware of defects in basic components used or intended to be used in licensed facilities which could cause a substantial safety hazard. These reporting requirements provided the Consnission with necessary infonnation to evaluate safety defects and take a;propriate act'cr;. The proposed a endrer.ts strerg; hen this process and ir. crease attendant safety of the nuclear industry with a reduction in overall burden.

Element 2. Licensee actions required and the cost to develop a response to the infonnation request.

The proposed amendments to 10 CFR 21 and 10 CFR 50.55(e) would only require changes in the procedures for reporting of safety defects by licensees and non11censees. No modifications of or additions to systems, structures, components, or design of a facility are required by the rule amendments.

Vendors of basic components, suppliers of services, construction pennit holders, and operating license holders would be required to modify procedures for safety defect reporting. Those modifications would accomplish the following:

6 Enclosure 0

c Eliminating Duplicative Evaluation and Reporting Reovirements. Comission regulations contain several safety deficiency reporting requirements. A number of instances have occurred where the same deficiency in a component was evaluated and reported by two different organizations, one attempting to satisfy the criteria of Part 21, and the other attempting to meet the differently worded criteria of $50.55(e). Reporting criteria are different for each requirement. There is no explicit framework in the regulations that addresses the duplicative reporting issue. The proposed revisions would explicitly relieve duplicative evaluation and reporting requirements. The proposed revision to $21.2 would relieve construction pemits holders from the Part 21 evaluation and reporting requirements because previously unreported defects discovered by the construction pemit holder will be reported under $50.55(e). Similarly, proposed 121.2-would explicitly relieve operating license holders from the Part 21 evaluation and reporting requirements because previously unreported defects may be reported by holders of operating licenses under 150.73 or

$73.71.

Proposed Section 50.55(e)(7) will relieve construction permit holders from t re,ertir.g a defect if it has previously been reported under Par: M. In addition, proposed revisions to 121.21 would relieve vendors from reporting under Part 21 if a defect has been previously reported under 550.55(e) or 550.73 unless the vendor has additional required information '

not previously provided to the Comission.

Thus, affected entities would be required to modify existing procedures to  !

accomplish the above reporting requirements changes, o Defining Defects To Be Reported under 550.55(e). Section 206 of the Energy Reorganization Act requires the reporting of "defects which could create a substantial safety hazard." Existing 121.3(k) defines substantial safety hazard as "a loss of safety function to the extent that I there is a major reduction in the degree of protecticn provided to public health and safety for any facility or activity licensed, other than for export, pursuant to Parts 30, 40, 50, 60, 61, 70, 71, or 72. . . . ' In  !

addition, the wpplementary information for the original Part 21 final  !

7 Enclosure D l

)

i rulemaking contained the following guidance on what constitutes a "substantial safety hazard":

Moderate exposure to, or release of, licensed material, or 1 Major degradation of essential safety-related equipment, or Major deficiencies involving design, construction, inspection, test, or use.

Existing Section 50.55(e) requires the reporting of deficiencies in design and construction which could adversely affect the safety of operations of a nuclear power plant and which represent:

A significant breakdown in any portion of the quality assurance program, or 1 A significant deficiency in a final design, or A significant deficiency in the construction of, or significant damage to a structure, system, or component requiring corrective action involving extensive effort, or A significant deviation frem perfomance specifications requiring corrective acticr. involvin; extensive effort.

NRC experience with 550.55(e) reports has indicated that clarification of the type of deviation that is required to be reported would be helpful.

Accordingly, the reporting criteria in proposed $50.55(e)(3) will be the same as those in Part 21.

Thus, construction permit holders would be required to modify existing procedures to accomplish the above reporting requirement change.

o Uniform Reporting Casteet. Proposed revisions to Section 50.55(e) would require that the costant of the information reported to be the same as that in the current Part 21. These revisions will ensure that the -

Ccenission obtains all the information necessary to evaluate and take corrective action la reference to a particular defect.

l 8 Enclosure D

1 Thus, construction permit holders will be required to modify existing procedures to raise the threshold of reporting to that of Part 21.

)

o Extension of $50.55(e) Initial Notification Time Limit. The proposed

$50.55(e) amendment would extend initial notification of the Connission from 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to two days. This change will provide the industry with additional flexibility while still providing the Commission with sufficient warning of safety problems. Constriction pennit holders will be required to revise procedures for reporting under 150.55(e) to extend the initial reporting time limit to 2 days, o Establishing Explicit Tire Limits for Evaluation, Reporting, and Notification of Vendors under $50.55(e). (In Alternative B only) Under existing 521.21(b)(2), the initial notification of a defect must be made to the NRC within two days of the time a director or responsible officer obtains infonnation on the existence of a reportable defect. However, the existing rule is silent concerning the time period between the discovery of a deviation and the time when an evaluation of the deviation should be completed. Similarly, no deadline is established for when the director or res;cnsibit officer rust h informeo of a potentia'ly reportat,le deviation. This 6bsence of required time limits has soretimes resulted in lono delays between the identification of a potential problem and the completion of an evaluation. Furthermore, the existing regulations allow the directors and responsible officers of a firm to remain uninformed concerning potentially reportable problems during the period from identification through evaluation. Therefore, the person with the maximum responsibility, judpent, capability, and experience remains detached during the problem identification and evaluation process. The proposed revision to 121.21 would establish required time limits for evaluating deviations, infonning directors or responsible corporate officers, and the NRC.

The props sed $50.55(e) would also require the holder of a construction permit to evaluate deviations within 30 days.

9 Enclosure D

o i We expect that the reduction in burden on industry cue to extended reportir.g time for $50.55(e) is insignificant with no decrease in important safety infomation. There will be no decrease in the amount of NRC effort.

The extension of the time limit for the Part 21 written followup report from 5 days to 30 days will allow the submitter to adequately gather infor1 nation and ensure correct facts are reported to NRC.

Providing notification of reportable defects to vendors when the defects are determined by the licensee to be caused by or to be related to a vendor product or process, required by proposed $50.55(e) will be a minimal burden on the reporting par. ties with a significant increase in efficiency in the resolut'on of problems addressed by these reports.

Thus, entities affected by these amenhnts would be required to change their respective procedures to comply with the new regulations.

c Records Retention. (Included in Alternative B only) It should also be noted that prcposed 150.55(e)(6) anc revisions to (?!.51 clarify the specific records that must be maintaired and their retention ceriod to ensure compliance with these rules, c Ex,isting Costs. Approximately 500 nuclear-power-plant-related Part 21 reports are currently submitted annually to the NRC by licensees and component suppliers. Approximately 80 percent of these Part 21 reports are submitted by a licensee, with the remainder ccsing from nuclear steam system suppliers, architect-engineers, and other nonlicensee vendors.

Approximately 1500 550.55(e) reports, all from the holders of construction permits under Part 50, are e,urrently submitted annually to the NPC. A substantial number of these reports (approximately 25 percent) are in the nature of interim or follow-up rs ets on the same deficiency. Therefore, in reality, a more representati ' wr would be approximately 1100 550.55(e) reports of individu' de+ 2ncies and 400 interim or follow-up reports. The following esti . 's a v based on 1100 550.55(e) reports per year.

10 Enclosure 0

Based on estir.ates provided by utilities and ver. dors, wide variations (20 to 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br />) exist in the amount of effort expended in evaluation and reporting of Part 21 and 150.55(e) defects. The folicwing analysis, is based on a value of 160 man-hours for evaluation and reporting of a single Part 21 report, and 80 man hours for evaluation and reporting of a single 150.55(e) report. These estimates represent our professional judgment in a difficult area to '

quantify. They include management review time, as well as the time expended on the evaluation of defects which are ultimately detennined to be nonreportable and submittal of interim reports. The annual industry time expended on Part 21 is approximately 80,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> x 500 reports), or $4,800,000 per year (based on $60.00 per hour of professional staff time). The annual industry time expended on 150.55(e) reporting is approximately 88,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> (1100 Reports x 80 man-hours) or $5,280,000 per year (at $60.00 per hour).

Additionally, current annual records retention costs under Part 21 and 150.55(e) are estimated to be $18,000 and $200,000 respectively.

Thus, the cos61ned annual total industry cost for both 150.55(e) and Part 21 reporting is $10.298 million. ,

o Proposec Costs (Savings).

(1) Eliminating Duplicative Evaluation and Reporting Requirements.

Changes proposed for elimination of duplicative evaluation and reporting are anticipated to decrease the industry reporting burden by 15 percent. This is based on NPC staff judg:aent and staff's review of the reporting history under these rules.

Based on the cost data presented in Section 4.1.2, a 15 percent reduction in industry burden on Part 21 and Section 50.55(e) combined will result in an annual savings to the industry of

$1,512,000.

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l l 1 11 Enclosure D

i (ii) New Peporting Criteria for 50.55(e).

The higher threshold contained in the propcsed revision will reduce the number of l!0.55(e) reports subritted to the NRC by approximately 10 percent. However, evaluations for reportability must still be performed. Thus, the reduction in evaluation effort will not be as great as the reduction in the number of reports. Including both effects, it is anticipated that the industry burden due to raised threshold will decrease by approximately 8 percent without any resulting decrease in important safety information. The annual decrease in industry burden resulting from the new $50.55(e) threshold will be a.pproximately 7040 hours0.0815 days <br />1.956 hours <br />0.0116 weeks <br />0.00268 months <br /> (8 percent of 1100 reports x 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />) or $422,400 (at $60.00 per hour).

(iii) Uniform content or Reporting.

Changing the required content of $50.55(e) to that required by the currer.: Fart Il W1 increase uniformit of replatcry fame work. However, any savings which might result for this change are considered to be insignificant compared with other costs and savings discussed here.

4 (iv) Extension of $50.55(e) initial Report Time Limit.

We expect that the reduction in burden on industry due to extended reporting time for $50.55(e) is insignificant with no decrease in important safety information.

(v) Establishing Time Limits for Reporting, Evaluation, and Notification of Vendors under Section 50.SS(e)

Establishing time schedules for evaluation and reporting under Part 21 may require the industry to devote more staff resources 1

12 Enclosure 0

at a particular time to the evaluation of deviations. However, the existing regulations already require industry evaluation and reporting, any substantial new total resource requirements on the industry. We estinate that this requirement will not increase industry burden. Additionally, the existence of such a time limit would tend to limit industry time spent on defects prior to accomplishing the requirements of the regulations, e.g., the presence of a time limit for evaluation will cause the potential defect to be reported in a timely manner before the reporting entity expends excessive time and effort evaluating the deficiency.

The extension of the time limit for the Part 21 written followup report will has the potential to reduce industry cost by allowing the application of resources in a more efficient manner. However, the savings are judged to be insignificant compared to other costs and Savings discussed here.

Additional costs on the construction klders, as a result of the requirtrent to notify vendors wher, a te4ct is deterHred to be causea by or to be related to a vendor process, are anticipated to be insignificant compared to other costs and savings discussed here.

(vi)RecordKeeping Record keeping costs are expected to increase because the proposed rule changes require specific retention periods for

, documents to be retained. This increase is viewed as an

insignificant additional cost to the industry compared to other

costs and savings discussed above.

1 o Net cost (savinos) to industry and NRC. Based en the estimates above, net sayings to industry reporting as a result of the proposed changes is anticipated to be $1,934,400 antwally.

13 Enclosure D

4 Assuming a 10 percent real discount rate and a 30 year average remaining life fcr licensees impacted-by Part 21 and Sectios 50.55(e), the present worth savings to the industry is estinated to be approximately $18.24 million.

NRC costs are expected to remain the same.

Element 3. The anticipated schedule for NRC use of the required informa tion.

All reports received are reviewed and evaluated promptly. The NRC use of information reported under 10 CFR Part 21 and 150.55(e) is expected to remain the same as that currently existing. A system currently is functioning to .

distribute and evaluate both Part 21 and $50.55(e) reports. Each individual report is distributed to headquarters and regional offices, The potential 1 generic nature and required regulatory actions due to the generic issues of the problem are evaluated by headquarters offices when reports are received. Plant specific defects end proposed plant specific corrective actions are evaluated by the applicable region. The tineframe by which regulatory ictions are taken

encs en the severit, of the reported defcct, the nurtte of licensett a'fected, ar.d. ultimately, the defect's impact on plant safety.

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14 Enclosure D I

, gg a 4 d* e #e *

" . Document Name:

BACKFIT W/50.54 Peauestor's 10:

J0hES Author's Name:

Occunent Coments:

9/19

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hf* YC,

-y e 8 ,

1)

ENCLOSURE F - DRAFT PUBLIC ANNOUNCEW NT P-s

N ORAFT PUBLIC ANNOUNCEMENT NRC PROPOSES TO CHANGE DEFECT REPORTING REQUIREMENTS IN 10 CFR Part 21 and 10 CFR 50.55(e) l The Nuclear Regulatory Commission is proposing to amend its regulations on the reporting of deficiencies found during the design, construction, and operation of nuclear power plants.

The proposed amendments would:

(1) eliminate duplicate reporting requirements for defects found in operating power plants or plants under construction; (2) redefine the kinds of defects and deficiencies which must be reported under 10 CFR 50.55(e); (3) establish a uniform format for reporting deficiencies and defects; and, [at the Commission's option, establish time limits for evaluation of deficiencies under 10 CFR 21 and Section 50.55(e).]

Presently, Part 50 of the NRC's regulations requires utilities building nuclear power plants to report significant deviations or deficiencies which could_ _ _ ..

adversely affect safety. Under the same part, utilities operating nuclear power plants are required to report all significant ope.ating events.

10 CFR Part 21 applies to both licensees and nonlicensees'. It requires directors and responsible officers of firms construction, owning, operating, or supplying components to any facility or activity licensed by the Commission to report the discovery of defects in basic components that could create a substantial safety hazard.

As prormed, the amendments to 10 CFR 21 and Section 50.55(e) would:

--Clarify reporting requirements under 10 CFR 21 and Section 50.55(e) to eliminate duplicative evaluation and reporting by licensees, construction permit holders, and nuclear industry vendors. The amendments would establish the use of one report for each separate defect found. The report would be made

either under 10 CFR Part 21,10 CFR 50.55(e),10 CFR 50.73, or 10 CFR 71.73 depending on the entity which discovers the defect.

--Define and make similar the kinds of deviations and deficiencies w be reported under the regulations.

--Require that the reporting c -tent of 10 CFR Part 21 and Section 50.55(e) be identical. This change will ensure that the Commission receives all information necessary to evaluate and act upon particular difects.

[at the Commission's option--Require, under 10 CFR 21 and 10 CFR 50.55(e) tha i deviations be evaluated for reportability within 30 days of discovery.] '

Comments on these proposed amendments should be received by [date). They s be directed to :The Secretary of the Comission, Nuclear Regulatory Commis Washington, DC 20555, Attention: Docketing and Service Branch.

- e _ =e

Vn 1, u, -

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ENCLOSURE E - DRAFT CONGRESSIONAL LETTER t

D'

ORAFT CONGRESSIONAL LETTER

Dear Mr. Chairman:

Enclosed for your information are copies of a notice of proposed rulemaking to be published in the Federal Register and a public announcement concerning that rulemaking.

The Commission is proposing to amend its regulations on the reporting of safety defects in 10 CFR 21 and 10 CFR 50.55(e). The proposed revisions are a result of Comission efforts to apply the experience gained at Three Mile Island and also to reflect Comission experience with existing regulations. The proposed amendments concentrate on the evaluation and reporting of significant safety defects in the construction and operation of nuclear power plants.

The revisions will eliminate duplicate reporting by different entities, establish consistency with other deficiency reporting requirements, clarify the criteria for reporting, and (at the Coamission's option, establish time limits for evaluation of defects.) --

Sincerely,

[0ffice Director)

i

/p'# *%,,

- UNITED STATES

'  % NUCLEAR REGULATORY COMMISSION s j

• i wAsmNoToN. o. c. ro655

%, p

..... May 13, 1966 MEMORANDUM FOR: All NRR Employees FROM: Harold R. Denton, Director Office of Nuclear Reactor Regulation

SUBJECT:

NRR OFFICE LETTER NO. 39, REVISION 3 - NRR PROCEDURES FOR MNTROL AND REVIEW OF GENERIC REQUIREMENTS This revised office letter supersedes the January 13, 1984 version (Revision

2) of NRC Office Letter No. 39. In this version the letter and enclosure have been generally updated and specific changes were made to:

(a) Accommodate the NRR reorganization (b) Incorporate the procedures for forwarding CRGR documents and decision making documents that are before the Commission to the Public Document Room (PDR) in accordance with a memorandum from the Executive Director for Operations (W. Dircks) dated March 29, 1984.

(c) Incorporate procedures for preparation for CRGR meetings when the subject being considered has not been originated in NRR and a NRR position is relevant to its disposition in accordance with a memorandum from the NRR Director (H. Denton) dated October 4,1985 (see Section B of the enclosure)

The Commission approved the Charter of the Committee to Review Generic Requirements (CRGR) on June 16, 1982. The CRGR has been constituted to review generic requirements proposed by the NRC. NRR will interface with CRGR to transmit new generic requirements proposed by NRR and to support generic requirements prepared by other NRC offices. This Office Letter sets forth the procedures to be followed by NRR personnel to control the communi-cation of generic requirements to the industry and obtsin CRGR review of new generic requirements and changes in existing generic requirements.

The lead Division within NRR for the particular prcposed generic requirement is responsible for ensuring that a complete CRGR submittal package has been prepared, including the proposed generic action as it would be sent out to licensees / applicants and associated regulatory analysis, and that sufficient time has been budgeted for a thorough internal review as called for in this procedure.

The lead Division Director is responsible for presenting the proposed require-ment and the supporting bases. Attendance at CRGR meetings will be established by the lead Division Director and coordinated with the Technical and Operations l Support Branch of PPAS.

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ENCLOSURE NRR PROCEDURES FOR PROCESSING PROPOSED GENERIC REQUIREMENTS A.

PROCEDURES FOR PROCESSING GENERIC REQUIREMENTS PROPOSED BY NRR I. INTRODUCTION AND SCOPE All significant actions proposed to'be implemented upon a class of nuclear power plants, licensees, or applicants are required to be reviewed by the Committee to Review Generic Requirements (CRGR).

Such actions are defined by this procedure as follows:

(1) All proposed generic requirements (Table I attached) shall be submitted for CRGR review.

(2) All documents, letters and communications that establish, reflect or interpret NRC staff positions or requirements (Table II attached) shall be submitted for review.by CRGR unless these documents refer only to requirements approved prior to November 12, 1981. In the latter case, the previ-ously approved requirement should be specifically cited and accurately stated. Divisions should be careful to review new or specific interpretations to assure that they are only case-specific. applications of existing requirements rather than initial applications having potential generic use.

(3) For all other communications with licensees (Table III, attached),

no statements shall be used that might suggest new or revised generic requirements, staff positions, guidance or recommen-dations (unless such statements have been approved by the E00 or the Commission).

(4) The above list is not meant to be all inclusive. These proce-dures apply to other circumstances in which the staff may wish to communicate changes in requirements indirectly to licensees (e.g., plant specific letters or Safety Evaluation Reports that contain actions that the staff intends to apply to other licensees.) The procedures apply regardless of whether the item represents a new requirement, removal of a requirement, an increase or a decrease in the nature or impact of a require-ment, or a change in prior understandings of the staff position.

(5) These procedures are not intended to apply to actions that solicit truly voluntary responses, such as requests for volun-tary industry review and/or input to value/ impact analyses for proposed new requirements. Also, CRGR review is not required i

Fifteen copies of the following will be attached to the memorandum:

1. The proposed Category 1 or Category 2 generic actions or the issued Emergency Actions. If not included as part of the action paper, the implementation schedule and method for each category of facilities (e.g. , PWR, BWR, operating reactors, OL or CP applicant, CP holder) or licensees t' ' .d be provided.

2. Draft staff papers or other underlying staff documents _ support-ing the requirements. (A copy of all materials referenced in the document shall be made available upon request to the DEDROGR staff. Any Committee member may request DEDROGR staff to obtain a copy of any referenced material for their use.)

3. A brief description of each of the anticipated steps that licensees must carry out in order to complete the requirements; e.g.,

3.1 Are there separate short-term and long-term requirements?

3.2 Is it the definitive, comprehensive position on the subject or is it the first of a series of requirements to be issued in the future?

3.3 How does this requirement affect other requirements?

Does this requirement mean that other items, systems, or prior analyses need to be reassessed?

3.4 Is it only computation? Or does it require or may it entail engineering design of a new system or modification of any existing systems?

3.5 What plant conditions are needed to install a new com-ponent or system, conduct preoperational tests and declare it operable?

3.6 Is plant shutdown necessary? How Long?

3.7 Does the design need NRC approval?

3.8 Does it require new equipment? Is it available for purchase in sufficient quantity by all affected or must such equipment be designed? What is the lead time for availability?

3.9 May it be used upon installation or does it need staff approval before use? Does it need tech. spec. changes before use?

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N, 5.2.1 The basis for requiring or permitting imple-mentation by a given date or a particular schedule.

5.2.2 Other acceptable implementation schedules and the basis therefore. This should include suffi-cient information to demorstrate that the schedules are realistic ard provide sufficient time for in-depth engineering, evaluation, design procurement, installation, testing, development of operating Vocedures, and train-ing of operators.

5.2.3 A schedule for staff actions involved in com-pletion of the requirement (based on hypothesized effective date of approval).

5.2.4 An implementation priority for the proposed item established by the sp:nsoring division (with OSR0 assistance if recessary) based on information developed in tne value-impact analysis and using a methodology consistent with that used in prioritizing generic issues (as HIGH, MEDIUM, LOW, or DROP).

5.2.5 For proposed requirements involving reports and/or record keeping, an assessment of whether such reporting or record keeping is the best means of implementation and the appropriate degree of formality and detail to be imposed.

6. The sponsoring Office's position, for eata proposed require-ment, as to whether the requirement implements existing regu-lations or goes beyond them.

7. The proposed method of implementation, developed in consulta-tion with OELD, along with the concurrence (and any comments) of OELD on the method proposed.

8. The OMB clearance package when required u-der the Paperwork Reduction Act, and a regulatory analysis sufficient to address the Regulatory Flexibility Act and Executive Order 12291.

a. OMB clearance is required whenever information collection from ten or more persons outside the Federal Government is involved, except where public comments on proposed rules, regulatory guides, standards, etc. are being requested. The OMB requirement applies to both voluntary and mandatory information collections. The applicability of the OMB clearance requirement, special provisions for

The lead division is responsible for insuring that this internal review process is completed. It will be responsible for the timely preparation of the generic requirements review package; the conduct of an internal l NRR review in accordance with this Office Letter; arranging that the l views of other appropriate NRC offices are presented to the Director, 1 NRR and the CRGR; and assuring the package is forwarded to CRGR in a  ;

timely manner. 1 Phase 3: CRGR Review In general, the Director of the lead Division is expected to present the proposed requirement before CRGR. NRR attendance at these meetings should be kept to a minimum and in general be limited to the presentor  !

and those technical experts whose knowledge is considered vital to the l meeting.

The Technical and Operations Support Branch of PPAS will coordinate attend- I ance at CRGR meetings to insure that only necessary NRR personnel are at meetings with CRGR. 1 Phase 4: Re-Review Af ter Public Comment (if applicable)

HRC has made it a practice to issue significant proposed new or changed requirements or guidance for public comment before promulgation in final form. This practice applies to significant informal standards (Regulatory Guides, SRP changes, etc.) as well as formal ruiemaking. 1 When solicitation of public comments is involved, CRGR review is required  ;

before issuance for public comments and a further submittal to CRGR for '

possible review will usually be required before issuance in final form. l l

The following procedures will apply when there has been a previous CRGR review prior to issuance for public comment and the Director, NRR, deter- I mines that a further CRGR submittal is required to be prepared in view l of the public comments: j

1. The lead division will prepare for the signature of the Director, I' NRR, a cover memorandum to CRGR which will contain the following:

a. Reference to the previous CRGR review. I

b. A concise characterization of the extent, nature, and significance of the public comments and of the changes, if any, made in the proposed requirement.

c. A statement, with reasons given, requesting CRGR re-review or expressing the view that there is no need for re review.

Re review should be requested when important changes have been made. It should also be requested when no major changes have been made but the public comments indicated

.g.

- assess the CRGR recommendation, identifying areas of potential disagreerent,

- identify office options vis-a-vis CRGR recommendations includ-ing the estimated resource and schedule impact of these options,

- consult with other affected NRR divisions (though no attempt need be made to obtain concurrences), and

- schedule and meet with the Director, NRR, (and other affected Division Directors) for a decision on the appropriate course of action on the generic issue.

3. Within four working days of receipt of the CRGR minutes, the lead Division Director will prepare a memorandum from the Director of NRR either to CRGR concurring in the CRGR coments or to the EDO (with opy to DEDROGR) indicating office disagreement with the CRGR decision and the rationale for the disagreement.

4. The lead division will follow through to assure completion of the appropriate regulatory action, such as processing a Standard Review Plan change in accordance with NRR Office Letter No. 2 or a Standard Technical Specif' cation change in accordance with NRR Office Letter No. 38.

5. The lead division will also assure that all documents related to the decision to issue proposed orders, generic letters, new or revised Standard Review Plan sections, Regulatory Guides or Stan-dard Technical Specifications or other proposed requirements or guidance by the Commission on a public forum are forwarded to the Public Document Room at the same time as the proposal is issued for public comment or in final form. These documents generally include (but are not limited to) the memorandum requesting CRGR review and any correspondence related to the review of the proposal, including the minutes of the CRGR meetings, and the NRR memorandum responding to the CRGR recommendations. Doctments related to rules and other matters that are to be addressed by the Commission in a public forum will be forwarded to the PDR by the DEDROGR staff, but the lead division should coordinate with them to assure that the appropriate documents are forwarded to the PDR when the matter is addressed in a public forum. Specifically, an advance copy of the appropriate documents should be sent to the Chief, Public Document Room for display, with an indication that the official copy will be forwarded via the Document Control System (DCS). At the same time, the official file copy should be sent to the Chief, Central Files for entry into the DCS.

B. PROCEDURES FOR NRR ACTIONS FOR GENERIC REQUIREMENTS PROPOSED BY OTHER NRC 0FFICES I. INTRODUCTION AND SCOPE Since NRR personnel are frequently involved with generic requirements proposed by other NRC offices, a procedure is necessary to assure NRR cognizance and approval of generic requirements proposed to CRGR by other NRC offices which will affect NRR licensing activities. The following procedures are to be used for NRR review of CRGR packages and the participation of NRR personnel in CRGR meetings for generic require-ments proposed by other offices.

II. REVIEW OF GlNERIC REQUIREMENTS CRGR PACKAGE Review of CRGR packages prepared by other NRC offices will be coordinated by the DSR0. DSR0 will rep;est the assistance of other appropriate NRR divisions as needed. The CiGR package will be reviewed for conformance with the content guidelines used for NRR development of Generic Require-ments Review Packages, with particular emphasis on the regulatory analysis section (see Section A.II of this procedure). DSR0 will coordinate the NRR response providing comments and/or approval to the originating office.

III. PARTICIPATION OF NRR PERSONNEL IN CRGR MEETINGS When NRR personnel are involved in the presentation and/or justification of generic requirements prccosed by other NRC offices to CRGR the follow-ing procedure will be followed.

Four weeks prior to the CRGR Meeting each division director with personnel involved will provide summa y information regarding the proposed generic requirements to the NRR CRG1 coordinator (presently R. Hernan/PPAS). The information to be provided is indicated in Table IV, attached.

The NRR CRGR Coordinator will prepare a summary for the Deputy Director, NRR using the information provided by the division directors. Two weeks prior to the CRGR Meeting the D/D NRR will meet with the affected NRR division director and appropriate staff members. The purpose of this meeting is to air the issue and any potential areas of controversy and to select the person (s) best suited to represent NRR's position.

TABLE I

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PRINCIPAL MECHANISMS USi.D BY NRC STAFF TO ESTABLISH OR COMMUNICATE GENERIC REOUIREMENTS Rulemaking I Advanced Notices Proposed Notices Final Rules Policy Statments Other Formal Requirements 2 Multiplant orders including show cause orders and confirmatory orders Staff Requirements Bulletins Circulars Generic Letters (including 50.54f and TMI Action Plan letters)

Regulatory Guides SRP (including Branch Technical Positions)

Standard Tech Spics USI NUREGs I

While Rulemaking is an action of the Comission rather than the staff, most rules are proposed or prepared by the staff.

2 The document itself imposes a legal requirement; e.g., regulatory orders license conditions.

3 Mechanisms which reflect staff positions which, unless complied with or a satisfactory alternative offered, the staff would impose or seek to have imposed by formal requirement. '

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TABLE III ADDITIONAL MECHANISMS SOPITIMES USED TO COMMUNICATE GENERIC REQUIREMENTS, DES, FES Entry Exit & Management Meetings NRC Operator Licensing People Contact with Licensees Phone Calls or Site Visits by NRC Staff or Connission to Obtain Infonnation (i.e., Corrective Actions, Schedules, ConductSurveys,etc.)

Pleadings Press Releast Proposed Findings Public Meetings, Workshops, Technical Discussions SALP Preports (NRR Input)

SECY Papers (some utilities apparently sent operators to college based on recent SECY paper on operator qualifications)

Special Reports Speeches to Local Groups or Industry Associations Technical Specifications Telephone calls and meetings with Licensees, vendors, industry representatives, owners groups Testimony n, -.,,,,,,-,------,--,-.--,-----,--,r-- r -.-----,--n-- . - - - ~---,s