ML20137A230
| ML20137A230 | |
| Person / Time | |
|---|---|
| Site: | Portsmouth Gaseous Diffusion Plant, 07007001 |
| Issue date: | 03/17/1997 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Halman E NRC OFFICE OF ADMINISTRATION (ADM) |
| Shared Package | |
| ML20137A235 | List: |
| References | |
| NUDOCS 9703200258 | |
| Download: ML20137A230 (29) | |
Text
.
March 17, 1997 MEMORANDUM T0:
Edward L. Halman. Director
. Office of Administration FROM: Carl J. Paperiello Director (0RIGINAL SIGNED BY J. GREEVES Office of Nuclear Material Safety FOR) and Safeguards
SUBJECT:
PUBLICATION OF NOTICE OF AVAILABILITY IN THE FEDERAL REGISTER On November 26, 1996, the U.S. Nuclear Regulatory Commission (NRC) issued the initial Certificates of Compliance to the United States Enrichment Corporation, authorizing the continuing operation of its Gaseous Diffusion Plants (GDPs). The certificates became effective on March 3.1997, and NRC assumed regulatory jurisdiction over the GDPs from the U.S. Department of Energy.
Section 76.76 of 10 CFR Part 76 contains a provision on "Backfitting."
Attachment 1 contains the Office of Nuclear Material Safety and Safeguards (NMSS) Policy and Procedures Letter 1-53 to implement this backfit requirement. Attachment 2 contains the Federal Reaister ( B ) Notice announcing the availability of this procedure. It is requested that the B Notice be published and the attached NMSS GDP backfit procedure be placed in the Public Document Room and the Local Public Document Rooms assigned to the Portsmouth and Paducah Gaseous Diffusion Plants.
Should you have any questions, please contact Dan Martin of my staff at (301) 415-7254.
Attachments:
- 1. NMSS Policy and Procedures Letter 1-53
- 2. O Notice of Availability Dockets 70-7001 & 70-7002 ggFilfECB W2E y
Distribution: with attachments SPB r/f PTing.FCOB WSchwink FCOB MKnapp.NMSS STreby.0GC KWinsberg 0GC KStablein.E00 MMalsch.0GC Dross.AE00 JConran.AE00 GShear.RIII RTriparti.AEOD WTroskoski.FCOB MHorn.SPB YFaraz.SPB MLesar.ADM Dockets 70-7001 & 70-7002 NRC File Center PUBLIC
- AVAILABLE.FR *See previous concurrence OFC *FCOB *SPB *SPB *SPB *RIII *0GC FCSSO NMSS f .
NAME JWang/ij DHoadley 0 Martin RPierson WBeach W0lmstead ETenhck Cfyper2el DATE J/2//97 J/ W/97 JP/97 J/M/97 J/#/97 _S//f/97 ff th/97 7 / I'7 /97 C = COVER E = COVER & ENCLOSURE b = NO COPY
,,,,_m 0FFICIAL RECORD COPY 9703200258 970317 PDR ADOCK 0700 1
N ORANDUM T0: Edward L. Halman, Director Office of Administration FROM: Carl J. Paperiello, Director Office of Nuclear Material Safety ,
and Safeguards '
SUBJECT:
PUBLICATION OF NOTICE OF AVAILABIL Y IN THE l FIDERAL REGISTER
]
l On November 26, 1996, th .S. Nuclear Regu tory Commission (NRC) issued the initial Certificates of Co ance to the nited States Enrichment Corporation, authorizing the ntinuing peration of its Gaseous Diffusion Plants (GDPs). The certificate illa ecome effective on March 3, 1997, when the NRC will assume regulatory ju diction over the GDPs from the U.S.
Department of Energy.
Section 76.76 of 10 CFR Part J contains a rovision on "Backfitting."
Attachment 1 contains the 0 fice of Nuclear aterial Safety and Safeguards (NMSS) Policy and Proced es Letter 1-53 to impleqent this backfit l requirement. Attachme 2 contains the Federal Ret ter (FR) Notice l announcing the avail lity of this procedure. It is quested that the FR Notice be publishe and the attached NMSS GDP backfit pr edure be placed in the Public Docume Room and the Local Public Document Room assigned to the Portsmouth and ducah Gaseous Diffusion Plants.
Should you ve any questions, please contact Dan Martin of my staf 9t (301) 415-7254.
Attap ments:
1./NMSS Policy and Procedures Letter 1-53 jh FR Notice of Availability x Distribution: with attachments SPB r/f PTing,FCOB WSchwink,FCOB MKnapp,NMSS STreby,0GC KWinsberg,0GC KStablein,ED0 MMalsch,0GC Dross,AE00 JConran,AE00 GShear,RIII RTriparti,AE00 WTroskoski,FCOB MHorn,SPB YFaraz,SPB MLesar,ADM
- AVAILABLE.FR /0 WY hft OFC FCOB , , SPB SPB SPB - RIII F c0SC , [ FCSS NMSS 1- >W ) Ti fc1 W g/ RP (; son Wl tead CPaperiello NAME g adley j n c fBeg'( ETenEyck DATE 2.Af/97 2/7(/97 h97 1/b 97/ S/7o/97 3 / f/9h / /97 / /97 C = COVER E = COVER & ENCLOSURE N = NO COPY OFFICIAL RECORD COPY
NMSS POLICY AND PROCEDURES LETTER l-53. GDP PLANT SPECIFIC AND GENERIC BACKFIT MANAGEMENT I. DEFINITIONS A. Certificatee: The term certificatee is used in these procedures to denote the entity that holds a Part 76 certificate of compliance to operate a gaseous diffusion plant (GDP).
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 o]erate a plant; any of which results from a new or amended provision in tie Commission rules, or the imposition of a regulatory staff Josition interpreting the Commission rules or a certificate commitment tlat is either new or different from a previous staff position. A backfit is " plant-specific" when it involves the imposition of a position that is unique to a particular plant and " generic" when it involves 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 certi ficatee.
Section 76.76 to Title 10 of the Code of Federal Regulations (CFR) refers to the backfitting requirement for GDPs and was effective at the time of the initial certification. In addition, a staff position may be a proposed backfit if it would cause a certificatee to modify or change the operation of a plant from that consistent with already existing requirements, commitments, and staff positions, as described in Section I.C.
C. Existino Reouirements. 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 framework and have been specifically imposed on a certificatee, or committed to by a certificatee, before a new requirement, commitment, or staff position is proposed which will result in a backfit. Existing requirements.
commitments, and staff positions include the following:
- 1. Legal requirements, as in explicit regulations, orders, and plant certificates (amendments, conditions, compliance plan, technical safety requirements). Some regulations might have update features built into them. In that case, such update features would be legal requirements.
- 2. Written commitments. as contained in the final safety analysis report, certificatee event reports. docketed correspondence, and confirmatory action letters. including responses to bulletins, generic letters. inspection reports. or notices of violation.
ATTACHMENT 1
the standard review plans (SRPs). branch technical positions (BTPs),
regulatory guides, generic letters and bulletins. and which a certificatee previously has committed to or relied on. However.
positions contained in these documents are not considered existing requirements, commitments, and staff Jositions with respect to a particular certificatee if the staff las, in a previous certification or inspection action, provided written exception to the certificatee from part or all of the position.
II. BASIC REQUIREMENTS A. Identifyina Backfits The NMSS staff is responsible for identifying proposed backfits. Staff at all levels should decide whether or not any proposed requirement.
commitment, or staff position (generic or plant-specific) should be considered as a backfit. A]pendix 1 gives examples of the mechanisms '
that the staff should and s1ould not use to establish or communicate l regulatory positions. All generic communications that require the i certificatee's response shall address backfit and be approved by the Director. NMSS before issuance. The staff shall follow the procedures given below:
- 1. Staff Identification
- a. When conducting a review concerning the plant (s), the staff should identify the existing requirements, commitments, and staff positions. defined in Section I.C. for the plant (s). For any proposed staff position. the staff must question whether it is directing, telling, or coercing rather than merely suggesting or asking that the certificatee consider an action. When making this distinction, the staff must, in fact, exercise judgement to conclude whether a staff position would cause a certificatee to modify. or change the operation or repair of. the plant (s),
- b. To identify the existing requirements, commitments, and positions applicable to the plant (s), the staff should consult the legal requirements, commitments written by the certificatee, and NRC staff positions. (see Section I.C).
- 2. Certificatee Claims A certificatee may claim that a proposed requirement. commitment, or staff position is a Jotential backfit although the staff did not identify it as a bac(fit. The certificatee should 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 Safeguards (FCSS) Division Director. The FCSS Division Director will inform the project manager (PM) of the claim. The PM should ensure that a copy of the claim has been forwarded to the Executive Director for Operations (EDO). For generic backfit claims, the PM is the cognizant staff member assigned to the generic issue.
B. Backfit Determinations Once either the certificatee or the staff has identified a proposed requirement. commitment. or staff position as a )otential backfit. the staff should promatly determine whether or not tie proposed item constitutes a bac(fit. The backfit determination is usually made before the regulatory analysis or documented evaluation is started. Appendix 4 provides guidance for backfit determination.
- 1. Backfits identified by the Staff When an issue is identified as a cotential 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.
(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 back fit.
(1) The technical staff should reference NRC rules.
certificatee commitments, guidance documents, and so forth, to provide the basis for the determination. (See Section II.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 revi w.
(3) A proposed requirement, commitment or staff position does not require a regulatory analysis if the proposal is needed to bring the facility (a) into compliance with a certificate or with the rules or orders of the Commission or (b) into conformance with written commitments made by the certificatee. A documented evaluation of the need for the proposed requirement, commitment, or staff position, described in Section II.C.1. is required.
(4) If the technical staff determines that the proposal is a backfit that is 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 i determination, described in Section II.C.I. is required. '
(5) If the technical staff determines that a regulatory analysis is required, the documented evaluation should be performed as described in Section III.
(6) The initial recommendation on whether the potential backfit 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 constitutes a backfit.
- e. If the FCSS Division Director determines that an issue constitutes a backfit issue. it should be resolved in accordance with Section II.C.1. The FCSS Division Director should also inform the NMSS Deputy Director of the backfit. l
- 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. Certificatee Backfit Claims If a certificatee 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 PM is responsible for coordinating staff action and l preparing correspondence concerning the potential backfit issue. ]
- c. The PM should contact the appropriate technical staff to review !
the issue. i
- 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 e/aluate the backfit claim and i recommend to the FCSS Division Director whether or not the proposed staff position constitutes a backfit. It should follow I the steps noted in Sections II.B.1.c(1) through II.B.1.c(5).
l l
< ~
'. 9 1
- f. The PM should arrange a meecing between the certificatee and the NMSS technical staff in order to resolve the issue. This meeting will be chaired by the FCSS Director, and will be open to the public. 1 1
- g. The PM should provide a written summary of the discussions in j the meeting for input into step II.B.1.c(6).
- h. Proceed with steps II.B.1.c(6) through II.B.1.e. l l i. The PM should prepare a letter, from the FCSS Division Director I to the certificatee, 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 l claim.
j (1) If the FCSS Division Director determines that the proposed staff position is not a backfit, the certificatee should be 4
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 j this procedure. If the certificatee's backfit claim is
- denied, the certificatee should be advised in the letter
' that if the certificatee decides to appeal the staff's I
- backfit determination, it should do so within 60 calendar
- days of the date of the letter. (Section IV.B provides i guidance for submitting appeals: this guidance should be l l included in the letter as appropriate.) i 1 1 4 (2) If the FCSS Division Director determines that the proposed 4 staff position is a backfit. the letter should document i agreement with the certificatee's claim and establish a j
proposed plan and schedule for resolution. The backfit
- should be resolved in accordance with Section II.C.
l j. The FCSS Division Director should inform the NMS$ Deputy Director of the backfit determination.
C. 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 4
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 II.B.1.c(3) that the proposed modification is necessary to bring the plant into compliance with the certificate Commission rules, or Orders, or into i
conformance with written commitments made by the ,
certificatee, the documented evaluation ]rovided in lieu of 1 the regulatory analysis should provide t1e following:
(a) A description of the objectives of, and reasons for, the modification:
(b) A basis for determining that the modifications are required to ensure compliance or conformance:
(c) A citation of 6ppropriate portions of the certificate (s). Commission rules, or written commitments.
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. k The PM should prepare a letter to the certificatee containing the resolution and the documented evaluation.
The letter should state that if the certificatee decides to I appeal 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 certificatee I with a copy to the EDO and the NMSS Deputy Director.
(2) If it is determined that a position pro]osed by the staff is l a backfit that is necessary to ensure tlat the ]lant 1 presents no undue risk to worker and/or public lealth and i safety / safeguards, as described in Section II.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 I
(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 i issue is a backfit and should forward it to the PM. The PM should prepare a letter to the certificatee containing the l
7 staff's resolution and the documented evaluation. The letter should state that if the certificatee 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 certificatee 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 II.C.I.a.
(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 III.
(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 or justification 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 document the backfit ,
disposition. l 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 staff's judgments, significantly reduce risk from plant operation. The NMSS Director should be consulted, in such cases. for resolution. l (c) The technical staff should forward the regulatory analysis to the PM.
1 (d) The PM should 3repare a letter, from the FCSS Division Director, to t1e certificatee, containing the staff's resolution and the regulatory analysis, with a copy to the EDO. Usually, the letter to the certificatee should be issued within 2 weeks of completing the regulatory analysis. The letter should state that if the certificatee decides to appeal the staff's backfit determination, it should do so within 60 calendar days from the date of the letter. (Sections IV.A.1 and 2
8 t
l provide guidance for submitting appeals: this guidance should be included in the letter as appropriate.)
l (2) The FCSS Division Director should inform the NMSS Deputy l Director of the results of the regulatory analysis and the l backfit determination.
- 2. Backfits Identified by the Certificatee
- 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 conformance with written commitments made by the certificatee, 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(1).
(2) If the backfit is needed for adequate protection (to ensure that the plant presents no undue risk to public health and safety / safeguards), the staff should ] rep 6re a documented evaluation supporting the backfit. T1is 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 II.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 III.
(b) The technical staff should forward the regulatory analysis to the PM.
(c) If the staff decides to modify its position so that no certificatee action is required, the PM should prepare a letter for the signature of the FCSS Division Director, advising the certificatee that it need not take the proposed action, with a copy to the EDO and the NMSS Deputy Director.
(d) If the backfit is to be implemented. the staff should prepare and seno a letter to the certificatee as instructed in Section II.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 staff's judgment. significantly reduce risk from plant l operation. The NMSS Director should be consulted. in such cases. for resolution.
g (2) The FCSS Division Director snould inform the NMSS Deputy Director of the results of the regulatory analysis and the backfit determination.
D. Information Reouests In reviewing applications for recertification or amendments or in conducting inspections of plant modifications. the staff does not need to prepare an analysis or justification if it asks for information that is routinely sought as part of the standard procedures applicable to the l review. including verification of compliance. However if staff requests information that is not part of a routine certification review, the staff must prepare a statement of its reasons and receive FCSS l Division Director approval before it issues the information request.
For example, the staff must prepare such a statement if it seeks to i gather information in developing a new staff position. Similarly, in 4 situations involving certification review or inspections of operating l plants, the staff is exempt from the need to prepare a statement of its reasons if the information request seeks to verify a certificatee's compliance with the current certification basis for the plant.
Moreover, requests for information, including fact-finding reviews, inspections, and investigations of accidents or incidents, to determine compliance with existing plant requirements are not considered within the scope of the backfit rule.
When the staff is preparing and approving information requests to the certificatee, 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.
- 2. A description of the actions required from the certificatee and of the cost incurred by the certificatee 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 certificatee.
III. 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 and documented analysis, whether (1) a substantial increase in the overall protection of the worker
1 I .
'. 10 and/or public health and safety or the ccmmon 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 l guidance of NUREG/BR-0058 " Regulatory Ardysis 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 governing documents l concerning 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 alternatives.
Simplicity, flexibility, and common sense should be emphasized, in terms of both the type of information supplied and the level of detail l 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.
- 2. Describe the activity that the certificatee would engage in to complete the backfit.
- 3. Determine the potential impact 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 installation and continuing costs associated with the backfit, including the cost of facility donntime or the cost of construction delay.
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- d. The estimated resource burden on the NRC associated with the l proposed backfit and the availability of these resources. !
Use information to the extent that it is reasonably available. Make a qualitative assessment of benefits in lieu of a quantitative analysis if it will provide more meaningful insights or will be the only analysis practicable.
- 6. Consider important qualitative factors bearing on the need for implementing the backfit at the particular plant such as, but not limited to, operational trends, significant plant events. management effectiveness, or the resuits of performance reports such as l inspection reports. l
- 7. Prepare a statement affirming interoffice (e.g. regions if needed) l coordination related to the proposed backfit and the plan for its I implementation.
- 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 j operators and other plant personnel. '
- 9. Establish a schedule for staff actions involved in implementing and verifying the implementation of the backfit.
- 10. Determine the -tance of the proposed backfit activities considered in . . of other safety / safeguards-related activities in progress at the specific plant.
IV. APPEAL PROCESS The EDO may review and revise any backfit decision, at his own initiative or at the request of a certificatee. However, the certificatee can a3 peal any proposed backfit or denied backfit claim to NMSS as discussed lerein. 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 certificatee: or Appeal to reverse a denial of a previous certificatee claim that a staff position, not identified by the NRC as a backfit requiring a regulatory analysis, is such a backfit. Also, an appeal that a backfit that the staff has determined to be a compliance or adequate-protection exception does not meet the exception.
. _ _ _ _ _ _ _ _ _ _ . _ _ _ . ~ . ~ _ _ _ _ . _ . ..._ _ . _ _ _ . .
P 12 l A. Aooeal To Modify or Withdraw a Backfit l Issues that NMSS has determined are backfits and for which the staff has prepared a regulatory analysis should be appealed as follows:
i 1. The PM should ensure that the appeal submitted by the certificatee presents the certificatee's arguments against the staff's 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 implemented by an alternative approach.
- 2. The certificatee 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.
- 3. Within 3 weeks after the staff receives the appeal request, the FCSS Division Director should res)ond to the certificatee informing them that the staff will review tie appeal, with a copy to the EDO and the NHSS Deputy Director.
The PM is responsible for develo)ing and managing the staff's plans regarding the appeal process. T1e PM should ensure that all relevant information is available for supporting the staff's position.
- 4. The information prepared by the PM on the staff's position with regard to the appeal will be submitted to the NMSS Deputy Director and Director, by the FCSS Division Director.
S. The PM should arrange a meeting at which the certificates can present its appeal to the NMSS Deputy Director and/or Director.
This meeting should take place within about 4 weeks of tha staff's 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 certificatee 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. !
- 7. The NMSS Director, with in>ut from the NMSS Deputy Director as appropriate. will decide w1 ether or not the backfit is to be imposed on the certificatee. The NMSS Director's decision should be ,
forwarded to the certificatee within about 4 weeks of the appeal ,
meeting. The PM should also prepare a letter to the certificatee '
for the signature of the NMSS Director, with a copy to the EDO.
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- 8. If. as a result of the meeting, the NMSS Director decides that the backfit is still warranted and the certificatee 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 certificatee continues to refuse to implement it, the certificatee may appeal the decision to the EDO. If the appeal to the EDO is not made, the backfit may be imposed by order of the NMSS Director.
B. Aooeal to Reverse Denial of a Previous Certificatee Backfit Claim or that a Comoliance or Adeouate Protection Exception Does Not Meet the Criteria When a certificatee has claimed that a staff position is a backfit and the NRC subsequently has determined that it is not, the certificatee may appeal the NRC decision regarding the backfit claim. Also, when the staff has determined that a backfit is a compliance or adequate-protection exception and the certificatee claims that it does not meet the exception the certificatee may apaeal the NRC decision. The certificatee may also appeal to NMSS tlese types of appeal even if the backfits were denied or decided by the region. The 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 certificatee's arguments against the staff's rationale for denying the backfit claim or determining the backfit to be a compliance or adequate-protection exception.
V. Imolementation of Backfits l A. Immediate
- 1. A backfit proposed by the staff may be imposed on the certificatee before any of these procedures have been completed when the NMSS i 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 if no PM has been assigned for a generic issue, of any backfits identified.
- b. The branch responsible for identifying the requirement should prepare a written description of the issue along with the basis for the prompt imposition 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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- d. The PM should prepare a memorandum, from the NMSS Director to the EDO. 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 I should be included with the backfit, if possible. Otherwise, it may be prepared later.
l B. Other
- 1. If immediate imposition is not necessary, a backfit pro)osed by the staff should not be imposed and plant (s) operation (s) s1ould not be interrupted until final action is completed by either the certificatee or by the NMSS Director or the EDO (if appealed to the EDO).
- 2. The certificatee may elect to implement the backfit requirement after receiving the backfit determination and the approved documented evaluation or regulatory analysis or after any level of appeal.
- 3. The backfit requirement may be imposed by order from the NHSS Director if the final appeal decision requires the certificatee to implement it and the certificatee chooses not to implement it. !
C. Schedule I
Backfits not requiring immediate implementation will usually be implemented on a schedule negotiated between the certificatee and the PM. To maintain high-cuality maintenance and operations, the staff. I when scheduling, shoulc. consider the priority of the requirement relative to other safety / safeguards-related activities in progress or other plant maintenance or modification.
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" Standard
- 4. Guidance for Backfit Determinations l
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-APPENDIX 1 1 1
PRINCIPAL MECHANISMS USED BY THE NRC STAFF TO ESTABLISH OR j COMMUNICATE LEGAL REQUIREMENTS !
AND STAFF l POSITIONS l Rulemakina )
Final Rules l Policy Statements 2 Other Formal Reouirements 3 Multi-plant orders, including show cause orders and confirmatory orders ]
Technical Safety Requirements Staff Positions 4 Bulletins Generic Letters l l
Regulatory Guides !
Standard Review Plans (including Branch Technical Positions)
Evaluations and resolutions of Unresolved Safety / Safeguards Issues (USI NUREGs)
While Rulemaking is an action of the Commission rather than the staff, most rules are proposed by or prepared by the staff. Often. final rules are
-preceded by advanced notices and proposed rules.
2 A Policy Statement does not impose a legal requirement, as does a rule, order, or license / certificate condition.
3 The document itself imposes a legal requirement: e.g., regulatory orders or license / certificate conditions
- Documents that 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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- MECHANISMS SOMETIMES USED TO INTERPRET LEGAL ;
4 REQUIREMENTS OR STAFF POSITIONS ,
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i Action on petitions for rulemaking Action on 10 CFR 2.206 requests I j Approval of topical reports Facility certificates / licenses ano amer an,o.us f'
i Safety / compliance evaluation reports l NUREG reports (other than USIs)
Single Plant Orders l l
! Staff positions on industry codes s
Unresolved issues resulting from inspections I 1
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Page 3 of 3 MECHANISMS THAT SHOULD NOT BE USED TO COMMUNICATE LEGAL REQUIREMENTS OR STAFF POSITIONS Administrative Letters Entry. Exit, and Management Meetings Information Notices Inspection Manual (Including Temporary Instructions)
Certificatee 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 Speeches to Local Groups or Industry Associations l
Telephone Calls and Meetings with Certificatees. Vendors, and Industry Representatives.
Testimony i
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Page 1 of 3 APPENDIX 2 BACKFIT IDENTIFICATION FORM Plant Name:
Project Manager:
Branch:
Office Responsible for Providing Backfit Determindtlon:
Identifier of Backfit or Potential Backfit (Certificatee, NMSS, cr RIII):
Identification of Backfit Document Listing (List documents pertaining to the backfit or backfit 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 certificatee and staff positions.):
Page 2 of 3 Predicted Backfit Determination Date:
Backfit Determination Date (forwarded to certificatee):
Backfit Determination Organization:
Backfit Determination Official (last name, initial):
Backfit Issue Substance (Describe the technical substance of the issue. 1 including licensee /certificatee and staff positions.): l l
l Predicted Appeal ~Date:
1 Predicted Closing Action Date:
l Aooeal by Certificatee Appeal Date:
Predicted Closing Action Date:
Appeal
Description:
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Date Reg Analysis Sent:
Closing Action Date:
! Closing Organization:
} Closing Official:
1 i Closing Action Description (Describe how technical aspects of issue were i resolved. See Section VI.B.1.): l 1
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APPENDIS 3 l GUIDANCE ON APPLICATION OF THE " SUBSTANTIAL INCREASE" STANDARD i j The GDP Backfit Rule states that, aside from exceptions for cases of adequate ;
protection or compliance, the Commission shall require the backfitting of a plant only when it determines, based on a backfit analysis. "that there is a i substantial increase in the overall protection of public health and safety or i the common defense and security to be derived from the backfit and that the j direct and indirect costs of implementation for that plant are justified in d
view of this increased protection." (10 CFR 76.76(a)(3)) 1 Although NUREG/BR-0058. Revision 2. dated November 1995. " Regulatory Analysis '
l Guidelines of the U.S. Nuclear Regulatory Commission." contains specific guidance for nuclear power reactors, this NUREG can be a source of guidance on i application of the " substantial increase" standard for non-reactor facilities. l
- The $2,000 per person-rem conversion factor, however, is not appropriate since j the risk associated with enriched uranium exposure is primarily chemical toxicity, not radiological .
For the interim. the staff wili use the net benefits" approach. discussed in NUREG/BR-0058. Rev. 2. when addressmg " substantial increase" under 10 CFR l 76.76. In making this determination, the staff will use a qualitative non- 1 monetary methodology to derive the safety / safeguards benefit, taking into
, consideration the specific facility hazards. The use of qualitative arguments ;
for benefits where quantification has not been available is established in other areas regulated by the Commission (see Attachment 3 of CRGR Charter.
Rev. 6. April 1996). As an example, the incorporation of industry standards (including revisions to existing codes and standards) into NRC rules or staff positions, as a prudent means of assuring continued performance with currently voluntary standards 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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2 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. Incorpo ation of advances in science and technology.
l 2. Greatre uniformity of practice.
Greater flexibility in practice /less prescriptive requirements.
3.
l 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 3rograms.
- 7. : ewer exemption requests and interpretative debates.
- 8. Better focusing of corrective actions towards the sources of problems.
- 9. Benefits that may accrue in the longer term, beyond the immediately apparent effect of the backfit.
The staff using these factors will assess the necessity of a potential "back fi t . "
J page 1 of 5 APPENDIX 4 GUIDANCE FOR BACKFIT DETERMINATInNS General 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 act inhibit the normal informal dialogue between the NRC staff and the certificatee. The intent of this process is to manage backfit imposition, not to quell it. The discussion in this Appendix is intended to aid in identifying backfits in accordance with the principles that should be 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 certificatee to change the operation, reaair. or modification of a plant or plants. In making this determination. t1e fundamental question is whether the staff's action is directing, telling. or coercing. or is merely suggesting or asking the certificatee to consider a staff proposed action.
Actions proposed by the certificatee are not backfits when the actions result from normal discussions between staff and certificatee concerning an issue, even though the change or additions may meet the definitions of a backfit.
Standard Review Plans (SRPs)
SRPs delineate the scope and depth of staff review of certificatee 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 certificatee 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 not considered a backfit.
On the other hand, using acceptance criteria more stringent than those contained explicitly in SRPs or proposing certificatee actions more stringent than or in addition to those saecified explicitly in SRPs are considered i backfits. During meetings wit 1 the certificatee, staff discussion or comments l regarding issues and certificatee actions volunteered which are in excess of I the criteria in SRPs generally do not 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 certificatee agrees to take such action. However, the staff should recognize that a ,
verbally implied or suggested action should not be accepted by a certificatee 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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page 2 of 5 Application of SRPs to an operating plant or plants after the certificate is i granted generally is considere 2a backfit unless the SRPs were approved l specifically for operating pl ~ implementation and are applicable to such l operating plant or plants A rc , guidance is applied in review of a j certificatee-proposed modificat- .. to its current certification basis.
I Reauktary Guides 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. Sucn in.plen.cntation has been addressed by the certificatee 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 public review and comment process before staf f implementation 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 certificatee 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 certificatee to take actions 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.
An order issued to confirm a certificatee commitment to take specific action even if that action is in excess of previously existing requirements.
commitments, or staff positions. is not a backfit provided the commitment was l 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. I whether in meetings or written reports, do not constitute backfits. l Definitive statements to the certificatee directing a specific action to I satisfy staff positions are backfits unless the action is an explicit existing requirement. Commitment, or staff position.
InsDettions NRC inspection procedures are to govern the scope and depth of staff inspections associated with certificatee activities such as operation, repair.
or modification. As such, they define those items the staff is to consider in l its determination of whether the certificatee is conducting its activities in l
a safe manner. The conduct of inspection establishes no new staff positions
! for the certificatee and is ngt a plant-specific backfit because as a matter of policy, inspection guidance is not to go beyond properly approved existing
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- requirements commitments, and staff positions.
. Staff suggestion to the certificatee that the contents of NRC inspection 1
- procedures are )ositions that must be met by the certificatee constitute a l
. plant-specific Jackfit unless the item is an existing requirement commitment. l
- or staff position. Discussion or comment by the NRC staff regarding i
- deficiencies observed in the certificatee 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 positions applicable to the certificatee are the only way to conform to i regulatory requirements. When communicating to the certificatee, the )
inspector should always categorize his or her comments as either compliance ;
matters or matters to be discussed with NRC management. In the normal course of inspecting to determine whether the certificatee's activities are being conducted safely, inspectors may examine and make findings in specific
- technical areas wherein prior NRC positions and certificatee commitments do not exist. Examination of such areas and the subsequent findings are not
! considered a backfit. Likewise, discussion of findings with the certificatee
- is not considered a backfit. If during such discussions, the certificatee agrees that it is appropriate to take action in response to the inspector's
- findings, such action is not a backfit provided the inspector does not
- indicate that the specific actions are the only way to satisfy the staff, and 1
the certificatee freely volunteers to take such action. On the other hand, if the inspector indicates that a specific action must be taken. such action is a i backfit unless it constitutes an existing requirement, commitment, or staff l
, position. The inspector should, in such discussions, communicate to the
. certificatee whether its comments are compliance matters.
l For example, if the certificatee commits to an American National Standards l i Institute (ANSI) standard in the SAR and the inspector finds the i
- certificatee's implementing procedures do not contain all the elements i required by the ANSI standard, telling the certificatee it must take action to include all the elements in its imalementing proceJures is not a backfit.
Likewise, if the inspector finds t1e certificatee has included all the required elements of the ANSI standard. but has not included certain of the o)tional elements in its implementing procedures, an inspector discussion with t1e certificatee regarding the merits of including the optional elements is
, not a backfit. On the other hand, if the inspector tells the certificatee 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 certificatee.
Notice of Violations (NOV)
A NOV requesting description of a certificatee's proposed corrective action is not a backfit. The certificatee's commitments in the description of corrective action are not backfits. A request by the staff for the certificatee to consider some specific action in res)onse to an NOV is not a backfit. However, if the staff is not satisfied wit 1 the certificatee's proposed corrective actions and requests that the certificatee take additional actions, those additional actions are a backfit unless they are an existing requirement. commitment, or staff position. This may involve a compliance
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backfit for which full backfit evaluation will not be needed.
Discussions during enforcement conferences and responses to the certificatees requests for advice regarding corrective actions are not backfits: however, i definitive statements to the certificatee directing a specific action to
- satisfy staff positions are backfits, unless the action is an explicit existing requirement, commitment. or staff position. This may involve a i compliance backfit for which full backfit evaluation will not be needed. i 1
Bulletins and Generic Letters 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 1 would have to be justified in accordance with ap31icable plant-specific l backfit procedures. (An exception would be if t1e expansion was to request I additional information to verify compliance with existing requirements.) All generic communications which require GDP certificatees to respond. such as Bulletins and Generic letters, must obtain the approval of the NMSS Director prior to issuance.
Reanalysis of Issues l Throughout plant lifetime many inspectors have an opportunity to review the l requirements and commitments incumbent upon a certificatee. Inevitably, there ,
will be occasions when an inspector concludes the previously NRC-approved )
certificatee's program in a specific area does not satisfy a regulation, certificate condition, compliance plan or commitment. In the case where the NRC staff previously accepted the certificatee's program as adecuate, any staff specified change in the program would likely be classifiec as a backfit.
For example, once the Compliance Evaluation Reaort (CER) is issued signifying staff acceptance of the program contained in tie application and Compliance Plan, including the SAR, the certificatee should be able to conclude that its I commitments in the application and Compliance Plan satisfy the NRC j requirements for a particular area. If the staff were to subsequently require that the certificatee commit to additional action other than that specified in the application and Compliance Plan for the particular area. such action would ,
constitute a backfit. If there was tacit acce]tance by staff, by being silent l on the issue for an extended period of time, tien 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 Certificatee in Issue 2 of the Compliance Plan, is a compliance issue and is not considered to be a backfit. l A somewhat different situation exists when the certificatee has made a submittal committing to a specific course of action to meet an existing requirement, commitment, or staff position, and 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.
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page 5 of 5 Subsequent staff action, which must be taken within a reasonable time not
- delaying the applicant's' implementation plans, to cause the certificatee to
! meet the existing requirement. commitment, or staff position is not a backfit.
If the certificatee has moved ahead in the intervening time to implement that which the certificatee proposed to do in its submittal and the staff has not responded in a reasonable amount of time, then the staff position may be considered a backfit. Thus, if a certificatee has implemented a technical resolution intended to meet an existing requirement, commitment, or staff position and the staff. for an extended period, simply allows the certificatee resolution to stand with tacit acceptance indicated by non-action on the part of NRC, then a subsequent action to change the certificatee's operation, repair, or modification or the plant is a backfit.
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