ML20236H831

NMSS Policy & Procedures Ltr 1-53,GDP Plant Specific & Generic Backfit Mgt

ML20236H831
Person / Time
Issue date:	07/06/1998
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
1-53, NUDOCS 9807070377
Download: ML20236H831 (28)

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i NMSS POLICY AND PROCEDURES LETTER 1-53, GDP PLANT SPECIFIC AND GENERIC BACKFIT MANAGEMENT

l. DEFINITIONS' t g.

A: Certificate The term certificate is used in these procedures to denote the entity that Thdds a Part 76 certificate of compliance to operate a gaseous diffusion plant (GDP).-

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B Backfit .;The term."backfit"is used in .these procedures to denote modification of or-addition to systems, structures, or components'of a plant, or to the procedures or

organization required to operate a plant; any of which results from a new or amended-

,.' provision in the Commission rules,~ or the imposition of a regulatory staff position 1

, interpreting the' Commission rules or a certificate commitment, that is either new or different from a previous' staff positio'nf A backfit is " plant-specific" when it involves the imposition of a position that is unique to a particuiar plant and " generic"when it involves a ' the imposition of a position that applies to two or more plants. The backfitting

' determination does not apply to a modification or action proposed by a certifica!ee.

y> Section 76.76 to Title 10 of the Code of Federal Regulations (C8:R) refers to the b  : backfitting requirement for GDPs and was ef.';ctive at the time of the initial certification.

L In addition, a staff position may be'a proposed backfit if it would cause a certificate to

L " modify or change the operation of a plant from that consistent with alreaoy existing requirements, commitments, and staff positions, as described in Section 1.C.

l C. Existina Requirements. Commitments. and Staff Positions: The term " existing +

requirements,' commitments, and staff positions"is used in these procedures to denote those requirements, commitments, and positions that make up the existing regulatory -

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N framework and have been specifically imposed on a certificate, or committed to by a -

certificate, before a new requirement, commitment, or staff position is proposed which *

will result in a backfit.L Existing requirements, commitments, and staff positions include

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1. ' Legal requirements, as in explicit regulations, ordsrs, and plant certificates 1 P (amendments, conditions, compliance plan, technical safety requirements). Some I L . regulations might have update features built into them. In that case, such update L >

~ features would be legal requirements.

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2. Written commitments, as contained in the final safety analysis report, certificate 1 event reports, docketed correspondence, and confirmatory action letters, including /)/

f responses to bulletins,'ge 3ric letters, inspection reports, or notices of violation. -

l L 3. NRC staff positions that explicitly interpret the more general regulations and that

are approved and stated in such documents as the standard review plans (SRPs),

e branch technical positions (BTPs), regulatory guides, generic letters, and bulletins,

. and which a certificate previously has committed to or relied on. However, positions contained in these dor,uments are not considered existing requirements, j -fg ' commitments, and staff positions with respect to a particular certificate if the staff 9907070377 990706 R

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L has, in a previous certification or inspection action, provided written exception to Lthe certificate fiom part or all of the position.

L II, SMjC REQUIREMENTS A. . Identifvina Backfits -

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[ The NMSS staff is responsible f;r identifying proposed backfits.. Staff at all levels should decide whether or not any proposed requirement, commitment, or staff pcsition (generic or plant-specific) should be considered as a backfit. Appendix 1 gives y examples of the mechanisms that the staff should and should not use to establish or.

L communicate regulatory positions. All generic communications that require the l

certificate's response shall address backfit and be approved by the Director, NMSS, i before issuance. The staff shall follow the procedures given below; i

1. Sta# Identification I a. When conducting a review concerning the plant (s), the staff should identify the L

existing requirementsicommitments, and staff positions, defined in Section .

l.C. for the plant (s). For any proposed ttaff position, the staff must question l

. ' whether it is directing, telling, or coercing rather than merely suggesting or  !

asking that the certificate consider an action. When making this Ptinction, the staff must, in fact, exercise judgement to conclude whether a staff position l' would cause a certificate to modify, or change the operation or repair of, the plant (s).

. b. - To identify the existing requirements, commitments, and positions applicabic

- to the plant (s), the staff should consult the legal requirements, commitments.

wntten by the certificate, and NRC staff positions. (see Section I.C).

~ 2. Certificate Claims , i

'i A certificate may claim that a proposed requirement, commitment, or staff position_

is a potentsal backfit although the staff did not identify it as a backfit. The

certificate shculd send its written claim that an item is a backfit to the Director of  !

' NMSS.' The NMSS Director's office will refer the claim to the Fuel Cycle Safety and L . ,

Safeguards (FCSS) Division Director. The FCSS Division Director willinform the  !

project manager (PM) of the c' aim? The PM should ensure that a copy of the claim

- has been forwarded to the Executive Director for Operations (EDO). For generic .:

L backfit claims, the PM is the cognizant staff member assigned to the genene issue. 1 i

. B.? Backfit Determinations Once either the certificate or the staff has identified a proposed requirement,

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commitment, or staff position as a potential backfit, the staff should promptly determine

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E whether or not the proposed item constitutes a backfit. The backfit determination is usually made before the regulatory analysis or documented evaluation is started.

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3 Appendix 4 provides guidance for backfit determination.

.1. Backfits identified by the' Staff n

LWhen an issue is identified as a ootential backfit, the staff should use the following

- procedure to determine if it is or is not a backfit:

a -The staff that has identified a potential backfit should immediately notify line

' management and the PM. i L

L b. :The PM is responsible for coordinating staff action concerning the potential _

backfit.

L ~(1)' The PM should open a technical assignment control (TAC) number on

. the issue..

(2) The PM should ' ensure that the appropriate technical staff evaluates

' the potential backfit.

c. The technical staff should evaluate the potential backfit to determine whether or not the proposed item constitutes a backfit.

'(1) . The technical staff should reference NRC rules', certificate

' commitments, guidance documents, and so forth, to provide the basis for the determination. (See Section ll.A.1 for guidance.) The basis should not address the technical ramifications of the issue in the determination.

(2). .The technical staff performing the review should consult with FCSS Division management to ensure there is a common understanding of-the interpretation of the backfit rule for the issue under review.

r (3) A proposed requirement, commitment, or staff position does not'- ,

require a regulatory analysis if the proposal is needed to bring the - j facility (a) into compliance with a certificate or with the rules or orders . j j

L of the Comrriission or (b) into conformance with written commitments

- made by the certificate. A documented evaluation of the need for .j

the proposed requirement, commitment, or staff position, described in

Section ll.C.1, is required. I l

-(4). If the technical staff determines that the proposal is a backfit that is j l<

l required to ensure that the plant presents no undue risk to public <

' health and safety / safeguards, no regulatory analysis is required. A documented evaluation of the staff review and determination, described in Section ll.C.1, is required.,

i (5). If the techrical staff determines that a regulatory analysis is required, ,

the documented evaluation should be performed as described in 1 Section Ill. 1

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(6) The initial recommendation on whether the potential bacxfit is or is not a backfit should be provided to the FCSS Division Director in a memorandum from the originating branch chief. The memorandum should include concurrence from the PM..

d. The FCSS Division Director should determine whether or not the issue .j constitutes a backfit.

e. If the FCSS Division Director determines that an issue constitutes a backfit it should be resolved in accordance with Section ll.C.1. The FCSS Division Director should also inform the NMSS Deputy Director of the backfit.

f. ' If the FCSS Division Director determines that implementation of an issue originally identified by the staff is not justified, closure of the issue should be documented, and the staff need take no further action.

2. Certificate Backfit Claims if a certificate provides written documentation of a claim that a proposed staff position constitutes a backfit, the staff should promptly evaluate the claim using the following procedure:

a. The PTA is responsible for coordinating staff action and preparing correspondence conceming the potential beckfit issue.

I b.. The PM should open a TAC number for review of the issue. 1

c. The PM should contact the appropriate technical staff to review the issue.

d. The FCSS Division Director should inform the NMSS Deputy Director of the

~ backfit claim. Note that the NMSS Deputy Director should be informed of the -

backfit claim before the backfit determination is made.  ;

e. The technical staff should evaluate the backfit claim and recommene 4 the FCSS Division Director whether or not the proposed staff position constitutes a backfit. 'It should follow the steps r.oted in Sections ll.B.1.c(1) through II.B.1.c(5).

f. The PM should arrange a rr.eeting between the certificate and the NM60 technical staff in order to resolve the issue. This meeting will be chaired by the l l FCSS Director, and wW 'oe open to the public. l l

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g. The PM should provide a wiitten summary of the discussions in the meeting for  !

input into step fl.B.1.c(6).

h. Proceed with steps ll.B.1.c(6) through 11 B.1.e.

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i. The PM should prepare a letter, from the FCSS Division Director to the certificate, incorporating the report on the backfit determination, with a copy to the EDO. This letter should normally be sent within 4 weeks of receiving the written backfit claim.

(1) If the FCSS Division Director determines that the proposed staff position is not a backfit, the certificate should be advised in the letter that it can appeal the decision as discussed in Section IV.B or can provide a technical discussion of proposed alternative actions to meet the relevant regulatory requirements outside the provision of this procedure. If the certificate's backfit claim is denied. the certificate should be advised in the letter that if the certificate decides to appeal the staffs backfit determination, it should do so within 60 calendar days of the date of the letter. (Section IV.B provides guidance for submitting appeals; this guidance should be included in the letter as appropriate.)

(2) If the FCSS Division Director determines that the proposed staff position is a backfit, the letter should document agreement with the certificate's claim and establish a proposed plan and schedule for resolution. The backfit should be resolved in accordance with Section ll.C.

j. The FCSS Division Director should inform the NMSS Deputy Director of the backfit determination.

G. Resolution of Backfits Once a potential backfit has been determined to be a backfit, the staff should act to resolve the issue promptly, after deciding whether the baCKfit should be imposed immediately. (See Section V.A.)

1. Backfits identified by the Staff

a. When a Documented Evaluation is Used:

(1) If it is determined in Section ll.B.1.c(3) that the proposed modification is necessary to bring the plant into compliance with tne certificate, Commission rules, or Orders, or into conformance with written commitments made by the certificate, the documented evaluation provided in lieu of the regulatory ar,c!ysis should provide the following:

(a) A description of the objectives of, and reasons for, the modification; (b) A basis for determining that the modificaten are required to ensure l l

compliance or conformance, j i

(c) A citation of appropriate portior's of the certificate (s), Commission j rules, or written commitments. I L

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The technical staff should normally complete this documented evaluation within 3 weeks of the determination that the issue is a backfit and they

. should forward it to the PM. The PM should prepare a letter to the certificate containing the resolution and the documented evaluation.

The letter should state that if the certificate decides to appea! the staff's resolution, it.should do so within 60 calendar days from the date of the letter. (Section IV.B provides guidance for submitting appeals; this guidance should be included in the letter as appropriate.) Within 2 weeks of completing the documented evaluation, the FCSS Division Director should send the letter to the certificate vath a copy to the EDO and the NMSS Deputy Director.

(2) If it is determined that a position proposed by the staff is a backfit that is necessary to ensure that the plant presents no undue risk to worker and/or public health and safety / safeguards, as described in Section ll.B.1.c(4), the documented evaluation, in lieu of the regulatory analysis, should include:

(a) A description of the objectives of, and reasons for, the modification; (b) A basis for invoking the exception to the requirement to perform a regulatory analysis; (c) An analysis to document the safety / safeguards significance and appropriateness of the action; and (d) A description of how any consideration of costs contributed only to the extent of selecting the solution among various acceptable alternatives.

The technical staff should normally complete this documented evaluation  !

within 3 weeks of the determination that the issue is a backfit and should forward it to the PM. The PM should prepare a letter to the certificate containing the staff's resolution and the documented evaluation. The letter should state that if the certificate decides to appeal the staff resolution, it should do so within 60 calendar days from the date of the letter. (Section IV.B provides guidance for submitting appeals; this guidance should be included in the letter as appropriate.) Within 2 weeks of completing the documented evaluation, the FCSS Division Director should send the letter to the certificate with a copy to the EDO and the NMSS Deputy Director.

b. When a Regulatory Analysis is Used

'(1) If it is determined that a proposed requirement, commitment, or staff position constitutes a backfit and is not within the scope of Section L ll.C.1.a.

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(a) The technical staff should prepare, usually within 6 weeks of the time the backfit determination is made, a regulatory analysis in accordance with Section 111.

(b) If, at any time. the regulatory analysis shows that a backfit identified by the staff is not justified because of the lack of substantial additional overall protection orjustification of the direct and indirect costs of implementation, the issue may be closed. In this case, the technical-staff should notify the PM of the findings. The FCSS Division Director should then inform the NMSS Deputy Director of the backfit disposition in accordance with Section VI. The PM should complete .,

the Backfit identification Form (see Appendix 2) to allow the staff to j document the backfit disposition.

However, the staff may recommend specific plant and operational improvements that do not meet the 10 CFR 76.76 backfit test but, if implemented, will, in the staffs judgments, significantly reduce risk from plant operation. The NMSS Director should be consulted, in such cases, for resolution.

(c) The technical staff should forward the regulatory analysie to the PM.

(d) The PM should prepare a letter, from the FCSS Division Director, to

- the certificate, containing the staffs resolution and the regulatory analysis, with a copy to the EDO. Usually, the letter to the certificate should be issued within 2 weeks of completing the regulatory analysis. The letter should state that if the certificate decides to appeal the staffs backfit determination, it should do so within 60 calendar days from the date of the letter. (Sections IV.A.1 and 2 provide guidance for submitting appeals; this guidance should be included in the letter as appropriate.)

(2) The FCSS Division Director should inform the NMSS Deputy Director of the results of tne regulatory analysis and the backfit determination.

2. Backfits identified by the Certificate

a. When a Documented Evaluation is Used

-(1) If the backfit is needed to bring the plant (a) into compliance with a certificate or with the rules or orders of the Commission or (b) into I conformance with written commitments made by the certificate, the staff should prepare a documented evaluation sunporting the backfit. This evaluation should be prepared and sent as instructed in Section ll.C.1.a(1).

(2) If the backfit is needed for adequate protection (to ensure that the plant

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presents no undue risk to public health and safety / safeguards), the staff should prepare a documented evaluation supporting the backfit. This evaluation should be prepared and sent as instructed in Section II.C.1.a(2).

'b, When a Regulatory Analysis is Used (1) If the backfit is not within the scope of Section ll.C.2.a, (a) The technical staff should prepare, usually within 6 weeks of the time -

the backfit determination was made, a regulatory analysis in

~ accordance with Section 111.

-(b' ) The technical staff should forward the regulatory analysis to the PM.

(c) If the staff decides to modify its position so that no certificate action

~is required, the PM should prepare a letter for the signature of the .

FCSS Division Director, advising the certificate that it need not take

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the proposed action, with a copy to the EDO and the NMSS Deputy l

. Director.-

- (d) If the backfit is to be implemented, the staff should prepare and send

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a letter to the certificate as instructed in Section ll,C.1.b(1)(d).

(e) The staff may recommend specific plant and operational improvements that do not meet the 10 CFR 76.76 backfit test but, if -

implemented, will, in the staffs judgment, significantly reduce risk

from plant operation. The NMSS Director should be consulted, in

> such cases, for resolution.

, (2) The FCSS Division Director should inform the NMSS Deputy Director of the results of the regulatory analysis and the backfit determination.

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. D.' , information Requests j l

- In reviewing applications for decertification or amendments or in conducting inspections  !

of plant modifications, the staff does not need to prepare an analysis or justification if it j asks for information that_is routinely sought as part of the standard procedures l r applicable to the review, including verification of compliance. However, if staff requests l l information that is not part of a routine certification review lthe staff must prepare a  !

e & statement of its reasons and receive FCSS Division Director approval before it issues l the information request.; For example, the staff must prepare such a statement if it  !

seeks to gather information in developing a new staff position. Similarly, in situations l J involvirig certification review or inspections of operating plants, the staff is exempt from the need_to prepare a statement of its reasons if the information request seeks to venfy a certificate's compliance with the current certification basis for the plant. Moreover, j requests for information, including fact-finding reviews, inspections, and investigations of j

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9 accidents or incidents, to determine compliance with existing plant requirements are not I considered within the scope of the backfit rule.

When the staff is preparing and approving information requests to the certificate, it must take care to objectively determine into which of the above categories the request falls. If it determines that a statement of its reasons is required, then it must prepare a statement that contains at least the following elements:

1. A description of the need for the information in terms of potential safety benefit and any applicable regulatory requirements and references.

2. A description of the actions required from the certificate and of the cost incurred by the certificate in developing the response to the request, and

3. A schedule stating when the NRC will use the information.

If such a statement is required, the FCSS Division Director must approve the information request and the statement. After the FCSS Division Director concurs, the branch chief shall sign the information request letter to the certificate.

Ill. REGULATORY ANALYSIS The staff should prepare a regulatory analysis for backfits other than those necessary to ensure that the plant presents no undue risk to worker and/or public health and safety / safeguards or compliance to ascertain, on the basis of a systematic ard documented analysis, whether (1) a substantial increase in the overall protection of the worker and/or public health and safety or the common defense and security or property is to be derived from implementing the backfit and (2) the direct and indirect costs of implementing the backfit for that facility are justified in view of the increased protection.

A. The branch with the lead responsibility for reviewing the plant specific backfit should perform a regulatory analysis, in accordance with these procedures.

B. The regulatory analysis generally should conform to the directives and guidance of NUREG/BR-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission," Rev. 2, November 1995, and NUREG/BR-0184, January 1997, "A Regulatory Analysis Technical Evaluation Handbook, Final Report," which are the NRC's goveming documents conceming the need for and preparation of a regulatory analysis.

However, the complexity and comprehensiveness of the analysis should be only as involved as necessary to allow a choice among attematives. Simplicity, flexibility, and common sense should be emphasized, in terms of both the type of information supplied and the level of detail provided. The staff should do the following:

1. Determine the specific objective that the proposed backfit is designed to achieve.

. Describe the proposed backfit, and state how it substantially increases overall protection.

j 10 2( Desenbe the activity that the certificate would engage in to complete the backfit.

3. .-Determine the potentialimpact on safety / safeguards of changes in plant or operational complexity. Include the relationship of these changes to proposed and existing regulatory requirements.

4? : State whether the proposed backfit is interim or final and, if interim, justify imposing '

. the proposed backfit on an interim basis.

5.. Prepare a statement describing the benefit and the cost of implementing the backfit.

This statement should include consideration of at least the following four factors:

a,  ; The potential change in risk to the public from the accidental release of -

radioactive material.

b. The potential impact on radiological and/or. chemical exposure of plant employees. Also, consider the effects on other onsite workers due to procedural or hardware changes. Consider the effects of the changes for the

. remaining lifetime of the plant.-

- c. -The potential impact of differences in plant design on the relevancy and

.~practica:ity of the proposed backfit.

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

e. The estimated resource burden on the NRC associated with the proposed backfit and the availability of these resources.

'M  : Using complete information, to the extent that it is reasonably available, make a

'E - qualitative assessment of benefits in lieu of a quantitative analysis if it will provide more meaningful insights or will be the only analysis practicable.

6i = Consider important qualitative factors bearing on the need for implementing the

- betkfit at the particular plant, such as, but_ not limited to, operational trends, significant plant events, management effectiveness,' or the results of performance

+ reports 'such as inspection reports.-

7. - Prepare a statement affirming interoffice (e.g. regions if needed) coordination L related to the proposed backfit and the plan for its implementation.

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' 8. : State the basis for requiring or permitting implementation on a 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 operators and other plant personnel.

9e . Establish a schedule for staff actions involved in implementing and verifying the

• Implementation of the backfit.

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10. Determine the importance of the proposed backfit activities considered in light of other safety / safeguards-related activities in progress at the specific plant. J

' 11. Consider whether the proposed plant-specific backfit is a potential generic backfit.

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' IV. - APPEAL PROCESS The EDO may review and ' revise any backfit decision, at his own initiative or at the '

request of a certificate. However, the certificate can appeal any proposed backfit or denied backfit claim to NMSS as discussed herein. ,The appeal processes described in :

this section are of two types, applied to two distinctly different situations:

Appeal to modify or withdraw a backfit that has been identified and for which the staff has prepared a regulatory analysis and transmitted it to the certificate; or Appeal to reverse a denial of a previous certificate claim that a staff position, not identified by the.NRC as a backfit requiring a regulatory analysis, is such a backfit.

Appeal that a backfit that the staff has determined to be a compliance or adequate-protection exception does not meet the exception.

'A. Anoeal To Modifv or Withdraw a Backfit Issues th'at NMSS has determined are backfits and for which the staff has prepared a regulatory analysis should be appealed as follows:

1. ' The PM should ensure that the appeal submitted by the certificate presents the certificate's arguments against the staffs rationale for imposing the backfit..

Furthermore,' the appeal should be based on information that shows that the backfit would not provide a substantial increase in overall. protection, that its direct and indirect costs are not justified in comparison to the degree of increased protection, or that it may be effectively implemented by a less burdensome alternative approach.

2. The certificate should address appeals to the NMSS Director. The FCSS Division Director should notify the NMSS Deputy Director of the appeal in writing, and ensure that a copy has been forwarded to the EDO and the cognizant technical staff.

' ' L31 Within 3 weeks after the staff receives the appeal request, the FCSS Division

Director should respond to the certificate informing them that the staff will review the appeal, with' a copy to the EDO and the NMSS Deputy Director.

. The PM is responsible for developing and managing the staffs plans regarding the appeal process. - The PM should ensure that all relevant information is available for supporting the staffs position, i

4. The information prepared by the PM on the staffs position with regard to the appeal l l

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4. ' The information prepared by the PM on the staffs position with regard to the l appeal will be submitted to the NMSS Deputy Director and Director, by the FCSS l- Division Director.

5. The PM should arrange a meeting at which the certificate can present its appeal to the NMSS Deputy Director and/or Director. This meeting should take place within about 4 weeks of the staffs receipt of the backfit appeal.

6. No later than 2 weeks after the appeal meeting, the PM should issue a meeting summary; The PM should include on the distribution list: the certificalee, the EDO, the NMSS Director and Deputy Director, the FCSS Division Director, the lead NMSS branches, the' public document room, and the pertinent local public

- document rooms.

h -7 The'NMSS Director, with input from the NMSS Deputy Director as appropriate, will

, decide whether or not the backfit is to be imposed on the certificate. The NMSS l Director's decision should be forwarded to the certificate within about 4 weeks of the appeal meeting. The PM should also prepare a letter to the certificate for the signature of the NMSS Director, with a copy to the EDO.

8 If, as a result of the meeting, the NMSS Director decides that the backfit is still

, . warranted and the certificate agrees to implement it, the backfit should be implemented in accordance with Section V If the NMSS Director decides that the backfit is still warranted and the certificate

. continues to refuse to implement it, the certificate may appeal the decision to the EDO. t if the appeal to the EDO is not made, the backfit may be imposed by order -

-of the NMSS Director.

,= l B. Anneal to Reverse Denial of a Previous Cer+ificatee Backfit Claim or that a Comoliance j or Adeouate Protection Exc% tion Does Not Meet the Criteria :j When a certificate has claimed that a staff position is a backfit and the NRC subsequently has determined that it is not, the certificate may appeal the NRC decision regarding the backfit claim. Also, when the staff has determined that a backfit is a

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1 compliance or adequate-protection exception and the certificate claims that it does' not -

meet the exception, the certificate may appeal the NRC decision. The certificate may

, i also appeal to NMSS these types of appeal even if the backfits were denied or decided by the region.LThe decision should be appealed as instructed in Sections IV.A.2 through 8.' In following the procedure in Section IV.A.1, the PM should ensure that the appeal

presents the certificate's arguments against the staffs rationale for denying the backfit

. claim or determining the backfit to be a compliance or adequate-protection exception.-

V. - lmolementation of Backfits

A. Immediate i

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i 13 3 1. ' A backfit proposed by the staff may be imposed on the certificate before any of-these procedures have been completed when the NMSS Director decides that the

. plant (s) poses undue risk to public health and safety / safeguards.

a. . The staff identifying the requirement with the potential for prompt imposition should elevate it expeditiously through management levels to the NMSS .

Director. The staff should promptly notify the PM ' or line management af no t- PM has been assigned for a generic issue, of any backfits identified.;

1 b. The branch responsible for identifying the requirement should prepare a written description of the issue along with the basis for the prompt imposition u ' that could be used as technical substance for an order.

c. Prompt imposition will usually be done by issuing an order. The PM is responsible for preparing the order, assisted by the branch's technical staff..

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The PM should prepare a memorandum, from the NMSS Director to the EDO, a notifying the EDO 'of the prompt imposition. The memorandum should include a description of the requirement and the basis for the prompt imposition. The documented evaluation should be included with the backfit, if possible.

L Otherwise, it may be prepared later.

B. Other

1. If immediate imposition is not necessary, a backfit proposed by the staff should not

' be imposed and plant (s) operation (s) should not be interrupted until final action is completed by either the' certificate or by the NMSS Director or the EDO (if y n

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' appealed to the EDO).

2. The certificate may elect to implement the backfit requirement after receiving the q backfit determination and the approved documented evaluation or regulatory .j analysis or after any level of appeal.  !

L , 3. The backfit requirement may be imposed by order from the NMSS Director if th:

? final appeal decision requires the certificate to implement it and the certificate i' chooses not to implement it.

i C. Schedule l Backfits not requiring immediate implementation will usually be implemented on a schedule negotiated between the certificate and the PM. To maintain high-quality

, maintenance and operations, the staff, when scheduling, should consider the priority of the requirement relative to other safety / safeguards-related activities in progress or other plant maintenance or modification.

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July 6,1998 Please process the enclosed package through NUDOCS for public availability. I can be reached at 415-8103 should you have any questions.

Thank you, 1 -2.  :-- v(-r_i Rocio Castaneira h

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14 APPENDICES:

1. ' Principal Mechanisms Used by.NRC Staff to Establish or Communicate Generic Requirement or Staff Positions'

-2. Backfit Identification Form

3.. - Guidance on Application of the " Substantial increase" Standcrd i - Guidance for Backfit Determinations..

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Page 1 of 3 APPENDIX 1

' PRINCIPAL MECHANISMS USED BY THE NRC STAFF TO ESTABLISH OR COMMUNICATE LEGAL REQUIREMENTS AND STAFF POSITIONS Rulemakina' Final Rules Policy Statements 2 Other Formal Requirements' Multi-plant orders, including show cause orders and confirmatory orders y

Technical Safety Requirements Staff Positions' Bulletins

- Generic Letters Regulatory Guides

. Standard Review Plans (including Branch Technical Positions)

Evaluations and resolutions'of Unresolved Safety / Safeguards issues (USl NUREGs) r 1~-While Rulemaking 1s.an action of the Commission rather-than the-staff.

j. 1most. rules are proposed by orLprepared by the staff. Often, final . rules are

. preceded by advanced notices and proposed rules.

I izi A5 Policy. Statement does not impose.a legal-requirement, as does a rulet order. or.. license /c'ertificate condition.

'3 Theidocumen_ t itsel'f imposes a legal: requirement: e.g..' regulatory orders orilicense/ certificate conditions.

-4 Documents that reflect staff positions which. unless complied with or a satisfactory alternative offered. the staff would impose or. seek to have

!; imposed by;formalfrequirement. ,

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Page 2 of 3 MECHANISMS SOMETIMES USED TO INTERPRET LEGAL REQUIREMENTS OR STAFF POSITIONS L Action on petitions for rulemaking -

Action on 10 CFR 2.206 requests

. Approval of topical reports

. Facility certificates / licenses and amendments Safety / compliance evaluation reports NUREG reports (other than USIs)

- Single Plant Orders Staff positions on industry codes.

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Page 3 of 3 MECHANISMS THAT SHOULD NOT BE USED TO COMMUNICATE LEGAL REQUIREMENTS OR STAFF POSITIONS Administrative Letters l

l Entry, Exit, and Management Meetings l

l Information Notices inspection Manual (including Temporary instructions)

S Cedificatee Event Reports Telephone Calls or Site Visits by NRC staff or Commission to Obtain Information (i.e .

Corrective Actions, Schedules, Conduct Surveys, etc.)

Pleadings Preliminary Notifications Press Releases inspection Findings Public Meetings, Workshops, and Technical Discussions Resident inspector Day-to-Day Contact SECY Papers Special Reports Spaeches to Local Groups or Inductry Associations L phone Calls and Meetings with Certificates, Vendors, and Industry Representatives.

Testimony

4 Page 1 of 3 APPENDIX 2 l BACKFIT IDENTIFICATION FORM Plant Name:

Project Manager:

Branch:

Office Responsible for Providing Backfit Determination:

Identifier of Backfit or Potential Backfit (Certificate, NMSS, or Rlll):

Identification of Backfit Document Listing (List documents pertaining to the backfit or backtit claim. Description should only identify relationship to backfit.):

Date:

Description:

Date:

Description:

Date:

Description:

Backfit issue Substance (Describe the technical substance of the issue, including certificate and staff positions.):

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Page 2 of 3 Predicted Backfit Determination Date:

Backfit Determination Date (forwarded to certificate),

Backfit Determination Organization: l Backfit Determination Official (last name, initial):-

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Backfit issue Substance (Describe the technical substance of the issue, including licensee / certificate and staff positions.):

I Predicted Appeal Date: i Predicted Closing Action Date:

Acceal by Certif:catee Appeal Date:

Predicted Closing Action Date:

Appe'al

Description:

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l Page 3'of 3 Closing Action 1

Date Reg Analysis Sent

Closing Action Date:

Closing Organization:

' Closing Official:

- Closing Ac' tion Description (Describe how technical aspects of issue were resolved. . S' ee Section VI.B.t):- ., .]

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I' APPENDIX 3.

1 GUIDANCE ON APPLICATION OF THE SUBSTANTIAL INCREASE E AND JUSTIFIED COST STANDARDS The GDP Backfit Rule states that, aside from exceptions for cases of adequate protection or L: compliance, the Commission shall require the backfitting of a plant only when it determines,

' based on a backfit analysis;."that there is a substantial increase in the overall protection of public health and safety or the common defense and security to be derived from the backfit, i I

7 7 and that the direct and indirect costs of implementation for that plant are justified in view of this increased protection."

(10 CFR 76.76(a)(3)) .

_Although NUREG/BR-0058, Revision 2, dated November 1995, " Regulatory Analysis Guidelines of the U.S.l Nuclear Regulatory. Commission," contains specific guidance for nuclear-

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, l power reactors, this NUREG can be a source of guidance on application of the substantial

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t. increase and cost justification standards for non-reactor facilities.. The $2,000 per person-rem L

conversion factor, however, is not appropriate since the risk associated with enriched uranium -

D exposure is primarily chemical toxicity, not radiological.

E ^ ) For the interim, the staff will use.the " net benefits" approach, discussed in NUREG/BR-0058, Rev. 2, when addressing cost justification under 10 CFR 76.76. In making this determination; E ;the' staff will use a qualitative non-monetary methodology to derive the value of the safety / safeguards improvement, taking into consideration the specific facility hazards; The use

- _ :fof qualitative arguments for benefits where quantification has not been available is established in other areas regulated by the Commission (see Attachment 3 of CRGR Chapter, Rev. 6, April.

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, ,1996)f. As an example, the incorporation of industry standards (including revisions to existing .

h codes and standards) into NRC rules or staff positions, as a prudent means of assuring .

continued performance with currently voluntary standa-ds and practices that provide substantial:

safety benefit,'can provide the basis for a finding that a proposed backfit meets the " substantial increase" standard of 10 CFR 76.76.

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Page 2 of 2 Additional factors may be used to assess the " substantial increase"in safety / safeguards of a proposed modification or backfit. These include:

.1. Incorporation of advances in science and technology.

2.- . Greater uniformity of practice.

3. - Greater flexibility in practice /less prescriptive requirements.

4. Greater specificity in existing generally-stated requirements.

5. Correction of significant flaws in current requirements.

6; Greater confidence in the reliability and timeliness of information or programs, j

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7. Fewer exemption requests and interpretative debates.

8. Better focusing of corrective actions towards the sources of problems. 'l

9. . Benefits that may accrue in the longer term, beyond the immediately apparent effect of J the backfit.

The staff using these factors will assess the necessity of a potential"backfit."

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APPENDIX 4 ,

GUIDANCE FOR BACKFIT DETERMINATIONS General i

l in this section selected regulatory activities or documents are discussed in order to enable NRC staff to better understand the conditions under which a backfit may be recognized. It is important to understand that the necessity for making backfit determinations should not inhibit l

1 the normalinformal dialogue between the NRC staff and the certificate. The intent of this f

process is to manage backfit imposition, not to quell it. The discussion in this Appendix is j intended to aid in identifying backfits in accordance with the principles that should be I implemented 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 certificate to change the operation, repair, or modification of a plant or plants. In making this determination, the fundamental question is whether the staff's action is directing,

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

Actions proposed by the certificate are 11qt backfits when the actions result from normal '

' discussions between staff and certificate concerning an issue, even though the change or j additions may meet the definitions of a backfit.

Standard Review Plans (SRPs) j i

SRPs delineate the scope and depth of staff review of certificate submittals associated with various review activities. They are definitive NRC staff interpretations of measures which, if taken, will satisfy the requirements of the more generally stated, legally binding body of regulations, primarily found in Title 10 of the Code of Federal Regulations (CFR). Asking a certificate operational questions concerning the certificate / regulations to clarify staff understanding of proposed actions in order to determine whether the actions will meet the intent of SRPs is r&i ecnsidered a backfit.

On the other hand, using acceptance criteria more stringent than those contained explicitly in SRPs or proposing certificate actions more stringent than or in addition to those specified explicitly in SRPs are considered backfits. During meetings with the certificate, staff discussion or comments regarding issues and certificate actions volunteered which are in excess of the criteria in SRPs generally do nat constitute backfits; however, if the staff implies or suggests that a specific action in excess of existing requirements, commitments, or staff positions is the only way for the staff to be satisfied, the action is considered backfit whether or not the certificate agrees to take such action. However, the staff should recognize that a verbally implied or suggested action should not be accepted by a certificate as an NRC position of any kind, backfit or not; only written and authoritatively approved statements should be taken as NRC positions.

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! Application of SRPs to an operating plant or plants after the certificate is granted generally is considered a backfit unless the SRPs were approved specifically for operating plant

. implementation and are applicable to such operating plant or plants, or SRP guidance is applied in review of a certificate-proposed modification to its current certification basis.

Reoulatorv Guides l

Currently, there are no regulatory guides that have been specifically written for the GDPs.

However, there are existing regulatory guides that address generic issues, such as ALARA.

Such implementation has been addressed by the certificate in its application. Future regulatory guides which address areas where there may be no prior NRC position should be

discussed with management: they may not be backfits. These regulatory guides go through the NRC's puolic review and comment process before staff implemer:tation of these guides.

With respect to plant-specific backfit,. any staff proposed implementation of a regulatory guide provision for a plant not encompassed by the generic implementation determination is

' considered a plant-specific backfit. A staff action with respect to a specific plant that expands on, adds to, or modifies a generically approved regulatory guide, such that the position taken is more demanding than that in the generic guide, is a plant-specific backfit.

Orders An order issued to cause a certificate to take action's which are not otherwise existing requirements, commitments, and staff positions is considered to be a backfit. An order effecting prompt imposition of a backfit may be issued prior to completing any of the procedures set forth in this procedure provided that the Director, NMSS, determines that prompt imposition is necessary.

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' An order issued to confirm a certificate commitment to take specific action even if that action is in excess of previously existing requirements, commitments, or staff positions, is nat a backftt

.provided the commitment was not solicited by the staff with the expressed or implied emphasis that such a commitment is necessary to gain acceptance in the staff review process.

' Discussion or comments by the NRC staff identifying deficiencies observed, whether in meetings or written reports, do not constitute backfits. Definitive statements to the certificate 1 directing a specific action to satisfy staff positions are backfits unless the action is an explicit l existing requirement, commitment, or staff position.

Inspections NRC inspection procedures are to govern the scope and depth of staff inspections associated with certificate activities such as operation, repair, or modification. As such, they define those .a items the staff is to consider in its determination of whether the certificate is conducting its activities in a safe manner. The conduct of inspection establishes no new staff positions for the

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L certificate and is Dat a plant-specific backfit because as a matter of policy, inspection guidance j Lis not to go beyond properly approved existing requirements, commitments, and staff positions.

k 4 Staff suggestion to the certificate that the contents of NRC inspection procedures are positions

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that must be met by the certificate constitute a plant specific backfit unless the item is an iexisting requirement, commitment, or staff position.. Discussion or comment by the NRC staff

. . regarding deficiencies observed in the certificate conduct of activities, whether in meetings or in written inspection reports, do aqt constitute backfits, unless the staif suggests that specific

< corrective actions different from previous staff positions applicable to the certificate'are the L only way to conform to regulatory requirements; When communicating to the certificate, the j l z inspector should always categorize his or her comments as ih e t er compli ance matters or

. matters to be discussed with NRC management. In the normal course of inspecting to

!. l determine whether,the certificate's activities are being conducted safely, inspectors may L examine and make findings in specific technical areas wherein prior NRC positions and

' certificate commitments do not existi Examination of such areas and the subsequent findings h

[, are not considered a backfit Likewise, discussion of findings with the certificate is 001.

L considered a backfit. If during such discussions,' the certificate agrees that it is appropriate to take action in response to the inspector's findings, such action is GQt a backfit provided the

. inspector does not indicate that the specific actions are the only way to satisfy the staff, and the L certificate freely volunteers to take such action. On the other hand, if the inspector indicates  ;

L that a specific action'rnust be taken, such action is a backfit unless it constitutes an existing .

> requirement, commitment, or staff position. The inspector should, in such discussions,-

I, communicate to.the certificate whether its comments are compliance matters-For example, if the certificate commits to an American National Standards Institute (ANSI) 4

standard in the SAR and the inspector finds the certificate's implementing procedures do not ~

contain all the. elements required by the ANSI standard, telling the certificate it must take B ,

action to include all the elements in its implementing procedures is 0g1 a backfit. Likewise, if l' , the inspector finds the certificate has included all the required elements of the ANSI standard, .

! but has not included certain of the optional elements in its implementing procedures, an -

B ' inspector discussion with' the certificate regarding the merits of including the optional elements I is Dg1 a backfit.' On the other hand, if the inspector tells the certificate that the implementing j

' 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 certificate. i i

' Notice of Violations (NOV) i A NOV requesting description of a certificate's proposed corrective action is 001 a backfit. The certificate's commitments in the description of corrective action are Det backfits. A request by

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. the~ staff for the certificate to consider some specific action in response to an NOV is D91 a - .

i backfit However, if the staff is not satisfied with the certificate's proposed corrective actions - i

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q. - and requests that the certificates take additional actions, those additional actions are a backfit j Lunless they are an existing requirement, commitment, or staff position. This may involve a L compliance backfit for which full backfit evaluation will not be needed.

Discussions during enforcement conferences and responses to the certificates requests for 7

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advice regarding corrective actions are not backfits; however, definitive statements to the

' certificate directing a specific action to satisfy staff positions are backfits, unless the action is Lan . explicit existing requirement, commitment, or staff position. This may involve a compliance -

L . backfit for which full backfit evaluation will not be needed.

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' Bulletins and Generic Letten .

NRC Bulletins and Generic Letters are part of generic communications regarding materials and fuel cycle issues (See NRC Manual Chapter 0730). Therefore, in general, it is not necessary to '

apply the plant-specific backfit process to the actions requested in a Bulletin or Generic Letter.

However, if the staff expands the actions requested by a Bulletin or Generic Letter during its .

application to a specific plant, such expansion is considered backfit, and would have to be

' justified in accordance with applicable plant-specific backfit procedures. (An exception would

~ be if the expansion was to request additional _information to verify compliance with existing

- requirements.). All generic communications which require GDP certificates to respond, such p

as Bulletins and Generic letters, must obtain the approval of the NMSS Director prior to L issuance.  ;

l Reanalysis of Issues  !

. Throughout plant lifetime, many inspectors have an opportunity to review the requirements and (commitments incumbent upon a certificate. Inevitably, there will be occasions when an

. inspector concludes the previously' NRC-approved certificate's program in a specific area does

' not satisfy a regulation, certific ate condition, compliance plan, or commitment. In the case where the NRC staff previously accepted the certificate's program as adequate, any staff specified change in the program would likely be classified as a backfit. H

~ For example,f once the Compliance Evaluation Report (CER) is issued signifying staff

acceptance of the program contained in the application and Compliance Plan, including the SAR, the certificate should be able to conclude that its commitments in the application and Compliance Plan satisfy the NRC requirements for a particular area. If the staff were to

subsequently require that the certificate commit to additional action other than that specified in the application and Compliance Plan for the particular area, such action would constitute a

, backfit fif 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, in most cases, be a backfit. However, .

the staff's review and comments on the updated SAR, as committed to by the Certificate in ilasUe 2 of the Compliance Plan,'is a compliance issue and is 001 considered to be a backfit.

' "A somewhat different situation exists when the certificate has made a submittal committing to

? a specific course of action to meet an existing requirement, commitment, or staff position, and j

' the staff has not yet responded, and, therefore, has not indicated that the commitment is or is  :

~ not sufficient to meet the existing requirement, commitment, or staff position. Subsequent staff j

. action, which must be taken within a reasonable time not delaying the applicant's

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(implementation plans, to cause the certificate to meet the existing requirement, commitment,

' or staff position is not a backfit, if the certificate has moved ahead in the intervening time to o% . '

) implement that which the' certificate proposed to do in its submittal and the staff has not

' s Kresponded in a reasonable amount of time, then the staff position may be considered a backfit.

' Thus, if a certificate has implemented ~a technical resolution intended to meet an existing requirement,~ commitment, or staff position, and the staff, for an extended period, simply allows l

' the certificate resolution to stand with tacit acceptance indicated by non-action on the part of 1

. NRC, then a subsequent action to change the certificate's operation, repair, or modification of lthe plant is a backfit.

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. [7590-01)

NUCLEAR REGULATORY COMMISSION

[ DOCKET NOS. 70-7001; 70-7002)

PROCEDUREE COR MANAGING GASEOUS DIFFUSION PLANT BACKFIT REQUIREMENTS: NOTICE OF AVAILABILITY On March 26,1997, the U.S. Nuclear Regulatory Commission (NRC) published a notice of availability of the Office of Nuclear Material Safety and Safeguards (NMSS) Policy and Procec;ures Letter 1sJ, "GDP Plant Specific and Generic Backfit Management." This policy and procedures letter contains guidance and criteria for implementing the Gaseous Diffusion Plant backfit requirements of 10 CFR Part 76.76.

NRC received public comments on NMSS Policy and Procedures Letter 1-53, and has issued a revised version. This revised policy and procedures letter is available for inspection at the NRC Public Document Room,2120 L Street, NW (lower level), Washington, DC; the Paducah Public Library,555 Washington Street, Paducah, Kentucky 42003 (Docket No. 70-7001); and the Portsmouth Pablic Library,1220 Gallia Street, Portsmouth, Ohio 45662 (Docket No. 70-7002).

For further information, contact Tom Wenck, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC, 20555, telephone (301) 415-8088.

Dated at Rockville, Maryland this M/8 day of 80 n 6 1998.

For the Nuclear Regu!atory Commission.

M Malcolm R. Knapp, Acting Director l Office of Nuclear Matenal Safety l l

and Safeguards

• See Prevw)us Concurrence OP/PseOOPED/ JUNE 11.1998

• SPB SPB OGC Rlli FCSS NMSS OFC *SPB 'SPB TWenck:ij DHoadley DMartin RPiersen STreby ElenEyck NAME 5/15/98 gr20/98 5/19/98 5/27/98 6Ks4/98 6/10/98 6/10/98 6 //JPB DATE C = COVER E = COVER & ENCLOSURE N a NO COPY OFFICIAL RECORD COPY

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