NUREG-1324, Informs Commission of Staff Action Plan & Provides Evaluation of Public Comments in Response to NUREG-1324, Proposed Method for Regulating Major Matls Licensees

Informs Commission of Staff Action Plan & Provides Evaluation of Public Comments in Response to NUREG-1324, Proposed Method for Regulating Major Matls Licensees

ML20127E315
Person / Time
Issue date:	10/05/1992
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
RTR-NUREG-1324 SECY-92-337, NUDOCS 9210150103
Download: ML20127E315 (70)

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POLICY ISSUE October 5, 1992 (Notation Vote) 3scy_,,_33, faC: The Cemmissioners 3 James M. Taylor k

n Froni: 1 E Executive Director for Operations -

Sub.iect : RESPONSE TO RECOMMENDATIONS OF THE MATERIALS REGULATORY REVIEW TASK FORCE

Purpose:

To inform the Commission of a staff action plan and to prMide an evaluation of public comments in response to NUREG-1324, " Proposed Method for Regulating Major Materials Licensees."

S.ymmary: NUREG-1324, the report of a Materials Regulatory Review Task Force appointed by the Director of the Office of Nuclear ,

Material Safety and Safeguards (NMSS), sets forth the task force's findings and recommendations concerning deficiencies and needed improvements in the licensing and regulation of major materials licensees. The staff has prepared and begun implementation of an action plan (Enclosure 1) that responds to the recommendations. The plan assigns priorities to the tasks, and provides resource and schedule estimates. A summary table of high, medium, and low priority actions is -

provided in Enclosure 2. In addition, a number of public comments were received on the task force report, and Enclosure 3 contains staff responses to the public-comments.

Backaround: In August 1991, in response to identified deficiencies in the staff's materials licensing and inspection processes following the potential criticality incident at the General Electric Nuclear Fuel and Component Manufacturing facility, the Director, NMSS, appointed a task force to review the NOTE: TO BE MADE PUBLICLY AVAILABLE Q3 WHEN THE FINAL SRM IS MADE ON AVAILABLE

Contact:

Frederick C. Combs, NMSS 7? [- / d' 301-504-3332 I

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The Commissioners 2 existing licensing and inspection programs for fuel cycle and major materials-facilities. This task force consisted _of-four individuals experienced in regulating fuel facilities-from safety and safeguards perspectives. Three were NMSS managers or supervisors: tio other was a senior fuel

_i facility inspector from Region I.

The task force took an indepth " fresh look" at the regulatory process, defined the components and subcomponents of an ideal regulatory evaluation system for these types of facilities, and presented findings and recommendations for improving the licensing, inspection, training, guidance, and regulatory base associated with fuel cycle facilities and major materials licensees. The task force was free to propose whatever actions it considered were appropriate for regulating. fuel cycle and major materials licensees, regardless of the likely impacts on NRC resources or existing regulations and guidance. The task force report, NUREG-1324, was published in February 1992.

The report included an open lettcr from the NMSS Director requesting public comments, especially with respect to which of the 29 recommendations should be adopted, which should be modified, and what priorities the staff should assign to each item. The letter also indicated that there had been no commitments to adopt any of the recommendations.

A separate analysis of the report by two NRC managers, which appeared as Appendix A of the NUREG, stated that "the report demonstrates considerable insight into the regulation of- fuel cycle and large material manufacturing facilities. It .

recommends a substantially increased effort in-almost all-aspects of the regulatory regime governing safety.... It-will require a very substantial increase in resources and take years to complete action on all- of the report's recommendations."

NMSS, the Office of Nuclear Regulatory Research (RES), the Office for Analysis and' Evaluation of Operational Data (AE00), and the regions agreed with most of the' task force's recommendations,.but' realized that a significant amount of effort and resources would be required to undertake each action. Therefore, the Staff Action Plan (Enclosure 1) was developed to establish ' appropriate priorities and realistic schedules and determine the need tc reallocate resources.. At the same time, the staff began to receive and review public .

comments (Enclosure 3) received on NUREG-1324.

The staff began the planning process in advance ~of receipt of public comments in recognition of the fact that, while the i

Q The Commissioners 3 recommendations and plans might be somewhat modified along the way as a result of such input, major adjustments in work plans and resources .would nevertheless be involved which required substantial lead times and budget planning. In order to be in a position to begin carrying out actions promptly, the staff developed the enclosed action plan.

Discussion: The action plan follows the. format of NUREG-1324 in that items are numbered according to the report's recommendations.

However, in some instances it was necessary to divide a recommendation into sut, tasks, assigning some of the subtasks higher priorities than others. The priorities were assigned based on an assessment of each action's importance to the safety of licensee operations. A high priority was assigned to actions that would contribute most to the improvement of safety for operating facilities within one to two years. A medium priority was assigned to actions that would contribute to safety improvement and strengthen the regulatory base, but-for which the safety need is less immediate. These medium priority actions would require two to three years to complete. A low priority was assigned to actions which provided less obvious safety improvement relative to the costs associated with implementing them. These actions are not currently scheduled, and it is questionable whether resources will become available to pursue them. A summary table of the actions grouped by high, medium, and low priority is provided in Enclosure 2.

Substance of the Plan

1. The plan assigns highest priority to the following actions:

revising the approach for performing operational safety team assessments and developing better methods of assessing fuel cycle licensee performance;

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initiating fuel cycle licensing-and regulatory reforms, including the updating of two major fuel cycle regulatory guides covering management control and process safety, the development of the technical

' bases for revi_ sing quality assurance provisions, criticality re' porting requirements, and new requirements for hazards analyses as a licensing basts; and developing a Fuel Cycle echnology course and a

! Criticality Safety course for fuel cycle license "eviewers and inspector..

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The Commissioners 4

2. The plan assigns medium priorities to the following actions:

• improving t[he guidance documents for fuel cycle and nuclear materials license reviewers and inspectors.

For example, this would include Inspection Manual Chapters 2600 and 2800, as well as an environmental regulatory guide for uranium hexafluoride facilities, and procedures for fuel cycle resident inspectors.

• developing additional training courses in areas such as fuel facility process safety, hazards analyses, and management effectiveness; and

• improving the National Program Review, the process by which NMSS assures the technical adequacy, consistency, and timeliness of its fuel cycle and materials licensing and inspection programs.

3. The plan assigns lower priorities to the development of other guides and standard review plans which deal primarily with nuclear materials or safeguards it.<ues.

Other recommendations, such as the establishment of a separate organization within NMSS to manage regulatory guide development, or the development of a prelicensino or preoperational inspection program, new safeguards int.pection procedures, etc., were not deemed to be cost-effective. ~

4. NMSS has assigned lead responsibility for implementation of the plan to John T. Greeves, Deputy Director, Division of Industrial and Medical Nuclear Safety, NMSS. The staff intends to provide updates to the Commission in March 1993 and September 1993. The March update will focus on the team assessment initiatives and the Regulatory Impact Survey. The September update will discuss progress toward the licensing and inspection program milestones listed in tiie action plan and staff recormendations on proposed rulemaking activities.

Public Particioation In response to NUREG-1324, the Nuclear Regulatory Commission  !

received over ninety comments from 10 respondents. The j respondents represented a public group, a State government,  !

two industry groups, and six licensees or applicants.  !

Comments are summarized in Enclosure 3. The industry members who provided comments generally agreed with most of the -

The Commissioners 5 NUREG's recommendations, although there were some concerns about implementation, particularly with regard to costs. The public group submitted a number of comments on the recommendations.

In addition to submission of comments, other opportunities are t.vailable for licensee and.public participation in the deveiopment and evolution of plans for responding to the Task Force recommendations. For example, NRC holds periodic Fuel Cycle licensee workshops, such as the une held in Bethesda, Maryland, in September 1992, to bring together NRC officials-and industry representatives to discuss various NRC programs and policies and to aid in the management and. implementation of safety programs at these facilities. The agenda for the September workshop included 1% days for a general discussion of NUREG-1324 and more detailed discussions related to two of its key recommendations (integrated safety analysis and criticality reporting requirements).

NRC also initiated Phase I of a Regulatory Impact Survey involving nine major NHSS licensees (SECY-92-166, May 7, 1992). The survey includes a structured interview protocol designed to obtain licensee views on the extent to which NRC regulations, licensing, inspection, enforcement, and fee st.hedule affect the safety of operations. This should help-NRC assess- the impact of its regulatory programs on safety at-licensed sites. The survey should also determine if there is an appropriate balance between the burden imposed by NRC requirements and the level' of safety achieved. The results of the survey.will be analyzed to determine whether any components of the regulatory program should be modified.

The development of the plan, the evaluation of the public comments on NUREG-1324, the initiation of the Regulatory Impact survey, and the conduct of the fuel cycle workshop have progressed along separate but parallel tracks. _The staff expects that the convergence of these actions as implementation continues will lead to a more integrated regulatory philosophy and approach. As. mentioned above, the culmination of these actions is scheduled to be presented to the Commission in September 1993.

The staff expects that these dialogues could influence the technical details of p1'an implementation and strategy, but does not anticipate that they would result.in significant-changes to the basic thrust and emphasis of the plan.

In addition, any proposed regulations and regulatory guides that may be developed pursuant to the plan would be published for public comment before final implementation.

The Commissioners 6 Resources: The plan includes a combination of one-time initiatives and ongoing projects. HMSS, RES, AE00, and the regions estimate that it requires a total cost for high and medium priority tasks of approximately 13 FTE and $400K in FY 1993, 10 FTE and $100K in FY94, and 6-7 FTE in FY95 and thereafter. These resources are currently included in the FY 1993-1997 Internal Program / Budget Review. Some activities related to team assessments, regulatory guide development, and participation in various rulemakings were budgeted before the Task Force report was issued. In other cases, reprogramming did occur, particularly from the regional nuclear materials inspection program to the fuel cycle program. No resources are currently budgeted for low priority items.

Although this reprogramming is reflected in the FY 1993-1997 Internal Program / Budget Review, a more meaningful shift must now occur in terms of personnel. There are likely to be competing activities and responsibilities for key staff currently in short supply such as fuel cycle license reviewers, inspectors, and rulemaking personnel with fuel-cycle experience. The affected organizations realize this problem and will reassign individuals with applicable technical skills to the maximum extent possible. However, achieving-optimal staffing for these key positions is likely to be one of the primary limiting factors in the success of the plan.

Coordination: The Office of the General Counsel has reviewed this paper and has no legal objection.

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aes H. T lor ecutive irector for Operations

Enclosures:

1. Staff Action Plan

2. Staff Action Plan Summary Table

3. NRC Response to Comments i

. 7 Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Thursday, October 22, 1992.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Thursday, October 15, 1992, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional review and comment,.

the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION:

Commissioners OGC OCAA OIG OCA OPA OPP REGIONAL OFFICES EDO ACNW l SECY

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e ENCLOSURE 1.

STAFF ACTION PLAN E

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STAFF ACTION PLAN The recommendations by the task force, and the resources needed to implement them, are substantial. Current staff resources that could be made available for work on the recommendations are severely limited, so it is necessary to assign priorities to the tasks. The task force's recommendations include actions to improve safety and actions to improve the procedural effectiveness of the regulatory process. While actions in both areas are important, improvement to safety was given the highest priority.

In establishing priorities for the action plan, the staff took into consideration the premises upon which the task force report was based..

The basic premise of the report was that NRC's regulatory approach to plant licensing and inspection should be based on the concept of material confinement within defined barriers, designed to restrict material and radiation to prescribed locations and quantities.

Flowing from this concept comes the proposition that the occurrence of materials and radiation beyond the barriers results from abnormal operation of the process within the barriers, i.e., process upsets, failure to follow procedures, poorly designed equipment, poorly maintained equipment, poorly trained operators, poor proceduras, and so on. Consequently, the task force recommended that the well-defined health-safety provisions. of 10 CFR Part 20 be augmented by requirements for process-safety evaluations, including hazards analyses. The task force concluded that the current regulatory process overemphasizes the health-safety aspects of regulation at the

! expense of process-safety considerations, Many of the task force recommendations flow logically from the above premise. For example,.

to assure well-designed equipment, a design review must be incorporated into the plant's quality assurance . program. To assure that equipment is not degraded, a change-control program and a-maintenance program are required. To assure that unanticipated process events do not result in the release'of material or radiation, a hazards analysis is needed. Other recommendations that flow from the task force approach _ deal with the need for management control systems to assure long-term stability for approved operations, and training for licensees to conduct process safety reviews and hazards analyses. Training is also needed for NRC staff who will- have to provide oversight of licensees' management control systems, process j safety-analyses, hazards analyses, and criticality analyses.

The task force emphasized its view that, :in order to implement the i

above concepts, a well-defined regulatory base should be provided in t the way of regulations, standard format and content guides, and i standard review plans for each type of licensed operation. The l inspection program should then be tailored to focus on both radiation l safety and process safety, using standard review plans and regulatory j guides as a basis for det elopment of the inspection program.

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The task force's preferred approach for implementation of its recommendations notwithstanding, it is necessary to consider the current status of the licensed community in developing a plan to correct deficiencies in the regulatory program for large materials processors, especially fuel cycle facilities. In Appendix A of the

- task force report, a separate analysis of the report by two NRC managers cogently nakes this point. Consequently, the staff has attempted to consider all of these factors, as well as the current availability of resources, in developing a plan to respond to the task force recommendations.

The staff has assigned priorities of high, medium, or low to actions resulting from the task force report based on an assessment of each action's importance to the safety of licensee operations. The priorities were then used in developing schedules. The action plan reflects, for high and medium priority actions, the staff's estimates of the time that completion of the action would require and the FTE and funding resources that would be needed to implement the action.

The staff has not attempted at this time to provide resource and schedule estimates for low priority actions.

A high priority is assigned to actions that would contribute most to the improvement of safety for operating facilities within one to two years. In some cases these actions required reprogramming of existing NMSS, regional, or RES staff resources, A medium priority is assigned to those actions that would contribute to safety improvement and would strengthen the regulatory base, but for which the safety need is less immediate. These actions require a longer period (two to three years) to complete and required reallocation of FTEs and/or technical assistance funding. A low priority is assigned to those actions which would serve to establish and maintain the underlying regulatory base for licensing and inspection activities but which would provide less obvious immediate safety improvement in contrast to the considerable resource costs that would be incurred. These actions would need to be scheduled over the longer term (three years and beyond).

This plan presents the task force's recommendations, followed by the actions that would be required to implement them, with resource and schedule estimates. In addition, some of the actions under this plan would subsume certain of the actions contained in the staff action plan which was prepared in response to the Incident Investigation Team report on the potential criticality incident at the General Electric Nuclear Fuel and Component Manufacturing facility on May 29, 1991 ("GE IIT report"). However, the task force report and the GE IIT report were developed for different purposes and had different focuses, so while there are a number of recommendations in each report that correspond, there are also a number in each plan that do not relate to the other plan. This task force action rian provides a reference to related actions from the GE IIT action plan. Those items in each action plan which have no corresponding action in the other plan are also noted for reference.

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RECOMMENDATIONS AND ACTIONS 5.1.1 Licensina Guidance Good regulatory policy dictates that licensing actions be based'on a standard review plan and supported with a standard-format.and content guide. In Appendix C to this report (NUREG-1324), the '

Task Force identified for each major _ materials operation the standard-format and content guides and standard review-plans that are missing or inadequate. It recommends that the NRC:

• develop those that are missing or revise those that are-inadequate to incorporate the topics listed in Section 3 of this report; reissue the two safeguards standard _ format and content NUREG reports (NURECs 1280 and 1065) as regulatory guides; e incorporate appropriate sections of branch technical positions on quality management controls / quality assurance, requirements for operations, chemical safety, and fire protection (53 FR 11590) into appropriate standard format _

and content guides and standard review plans;

• develop detailed information for a single document

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containing the standard format and content guide and standard review plan to serve as a basis _for evaluating managers and managerial controls. Include in this material details about plant management, including its organization and structure, safety functions, and internal controls,1plus the essential functions of management obtained from a systems analysis approach to management, such as the Management Oversight and Risk-Tree (MORT). _ Anticipate that, in many cases, technical assistance will be required to i

develop the detailed criteria associated with each topic; l-and

• subject the Accident Analysis Handbook (NUREG-1320) to a

formal, independent peer review. After completing that

- review, incorporate the analytical techniques described in the handbook directly or by reference in-the applicable.

sections of the standard review plans.

, Action Plan The staff will develop consistent guidance to11mprove managementi

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. control and process safety. Two standard format.andz content-guides for fuel facilities (RG'3.52, " Standard: Format and Content for.the Health and Safety Sections of License Renewal Applications for Uranium Processing and Fuel Fabrication" and RG 3.55,

" Standard Format;and Content for the Health and Safety-Sections of License Renewal Applications for Uranium Hexafluoride Production")

will be revised and published for comment. Provisions of branch

-technical positions on quality management controls / quality assurance,. requirements:for operations,fchemical process _ safety,

- and fire protection,-will~be_ incorporated. Analyticalstechniques-from the Accident Analysis Handbook (NUREG-1320)- Will be '

incorporated as-appropriate during the review of RG 3.52. The standard review plan for Type A Licenses of Broad Scope, which previously focused only on the Radiation-Safety Officer and did w

not sufficiently address issues such as management involvement,

• control systems, etc., will be expanded and an updated standard review plan will be issued.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 (publish for comment)

RESOURCES: Staff: 4.0 Contract: 9/94 (publish final)

LEAD: NMSS STATUS: On schedule. Broad Scopo draft done.

NMSS 1.0 RES 1.5 Rgns 0.2 each, except RII at 0.7 __

CE IIT Action No.: 1.B Safety operating specifit,ations for radiation

& nuclear instruments & controls Pris 2 Dues 9/93 FTE: 0.5 2.B Requirements / guidance for management controle Prit 2 Duet 9/93 FTEt 1.0 B. The standard format and content guide and standard review plan for environmental protection for UF 6 conversion and fuel fabrication plants, currently in draft form, will be rewritten and issued.

PRIORITY: M SCHED. COMPLETION DATE: 9/94 RESOURCES: Staff: 0.6 Contract: $100K LEAD: NMSS/RES STATUS: On schedule NMSS 0.3 RES 0.3 No corresponding GE IIT action C. Updating of standard review plans and standard format and content guides for the remainder of large materials licensees will be considered as part of a periodic review effort. See Recommendation 5.1.2 (" Maintenance of Regulatory Guides").

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD:

No corresponding GE IIT action-D. The staff will review and consolidate the information contained in the two safeguards standard format and content NUREG reports (NUREGs 1280 and 1065) into the format of regulatory guides.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD: . ,

No corresponding GE'IIT action CONTACTS:

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-5.1.2 Maintenance of Reculatory Guides-.

The NMSS-regulatory guide program requires resources to continually review, correct, and maintain the-fuel cycle, materials, and safeguards regulatory guides. We recommend _a five-year cycle of review and revision. In particular, the approximately 150 guides pertinent to fuel cycle and materials licensing, some of which are more than 10 to 15 years old, need redevelopment and reissuance. Develop a plan for continually updating and reissuing the guides. Similarly, review and update the safeguards regulatory guides.

Action Plan A. Radioloaical Safety. The staff will develop a plan to provide for regular review, correction, and updating of regulatory. guides.

The plan will include all NMSS regulatory guides. Contract resources will be budgeted to assure-technical assistance where needed. The plan will include those regulntory guides that are indicated as medium or low priority under Recommendation-5.1.1.B or 5.1.1.C (" Licensing Guidance").

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD: NMSS CE.IIT Action No.: -1.A Safety Analyses for criticality / process changes:

Pris 2 'Duas 9/93 FT* 0.75-(criticality only) l B. Eafeauards. The staff will review, rewrite and reissue each of the 36 safeguards-related regulatory guides over_a five-year period. This includes all safeguards-related regulatory guides applicable to Category I, II or III facilities. Approximately seven guides would be reissued each year for-the first' Mve years.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD: NMSS l-I No corresponding GE IIT action l

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CONTACTS:

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5.1.3 Proiect Manaaers' Handbook '

Develop, publish, and distribute a project managers' hana_iok, similar to that used by NRR's project managers, for NMSS' project managers. The Task Force has conducted an initial review of NRR's document and identified areas to be revised to make it useful for NMSS reviewers.

Action Plan The staff will develop and distribute an NMSS project manager's handbook similar to that used by NRR project managers.

PRIORITY: H SCHED. COMPLETION DATE: 3/93 RESOURCES: Staff: 0.5 Contract:

LEAD: NMSS STATUS: On schedule No corresponding GE IIT action CONTACTS:

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5;1.4 Desionated Proiect Manaaers

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Formally designate project managers for major materials' licensees,-

in order to provide for continuity of licensing actions.

-Action Plan A. The staff will formalize the designation of license project managers for fuel facilities (Part 40 & 70) in Headquarters and the regions. .

PRIORITY: H SCHED. COMPLETION DATE: 9/92 RESOURCES: Staff: 0.05 Contract:

LEAD: NMSS STATUS: Completed No corresponding GE IIT action B. The staff will evaluate the feasibility and value of establishing regional project managers for major Part 30 and non-fuel-cycle Part 40 licensees.

PRIORITY: M SCHED. COMPLETION DATE: 6/93 RESOURCES: Staff: 0.05 Contract:

LEAD: NMSS STATUS: On schedule No corresponding CE.IIT action-l CONTACTS:

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5.1.5 Safety Evaluation Reqqrla ,

f Analyze the costs and benefits of performing safety analyses and preparing safety evaluation reports for initial materials licensing, renewal, and major amendment actions for the large materials plants. Base management decisions about these issues on the results of that analysis.

Action Plan The staff will complete an analysis within three years to support a recommendation to management on these issues for Part 30 and non-fuel-cycle Part 40 licensees PRIORITY: M SCHED. COMPLETION DATE: 9/95 RESOURCES: Staff: 0.2 Contract:

LEAD: NMSS STATUS: On schedule No corresponding CE IIT action CONTACTS:

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5.1.6 Evaluation of Ooeratina Experience Develop a program for evaluation of operating experience at fuel cycle and large materials plante that includes a review and analysis of the reports provided by the licensee as required by 10 CFR Parts 30.50,-40.50, 70.50, and 70.52.

Action Plan AEOD will coordinate with NMSS to evaluate the capability for assessing operating experience at fuel cycle and large materials plants. The capability to analyze and provide feedback on operating experience will depend on the depth of reporting by licensees.

PRIORITY: M SCHED. COMPLETION DATE:- 9/94 RESOURCES: Staff: O.3 Contract:

LEAD: AEOD STATUS: On schedule

• e GE IIT Actic , No. : 4.B operating Experience review / feedback Pris 3 Dues 9/94 FTE: 0.5 4 . 'D Use and Evaluation of operating Experience Pris 3 Duas 9/94 FTE: No estimate CONTACTS: H. Karagiannis, AEOD 9

-5.2 Insnection 5.2.1 Update Insnection Manpal Chapters Revise Manual Chapters 2600 and 2800 and associated inspection procedures to incorporate explicit guidance concerning each of the topics listed in Section 3 of this report. Incorporate appropriate sections of branch technical positions on managerial controls / quality assurance, requirements for operations, chemical safety, and fire protection,(53 FR 11590) into appropriate MCs and associated inspection procedures. Develop materials for inspection guidance to serve as a basis for evalv3 ting managers and managerial controls. Include in these materials plant management, organization, and structure; safety functions; and internal controls, plus the essential functions of managers obtained from a systems analysis approach to management such as the MORT. The Task Force anticipates that, in many cases, technical assistance will be required to develop tee detailed criteria associated with these topics.

Action Plan A. Key personnel in regions and IMNS will be assigned to develop procedures for team inspections for fuel facilities, in coordination with the actions under Recommendation 5.4.3 (" Team Assessments").

PRIORITY: H SCHED. COMPLETION DATE: 12 92 RESOURCES: Staff: See 5.4.3.A Contract.:

LEAD: NMSS & Regions STATUS: On schedule GE IIT Action No.: 2.c Inspection of fuel facility safety performancu information (Commits to make study of the issue.)

See Task Force Action 5.1.1 Pris 3 Dues 9/94 FTEs 1.0 B. Revision of inspection guidance and procedures for Manual Chapters 2600 and 2800 will be assigned to the regions and coordinated through NMSS, with the lead for MC 2600 being Region II and the lead for MC 2800 being Region III. The regions will be instructed to include the topics discussed in the recommendation in the revised material. Development of procedures for inspection of

'5.2.1.B_(cont'd) large Part 30 and non-fuel-cycle'Part.40 licensees considering fuel cycle inspection concepts, pursuant _to Recommendation 5.2.2

(" Inspect Large_ Materials _ Processors with Fuel Cycle Procedures"),

-.will-be incorporated in this effort. See also Recommendation-S.2.4 (" Process Safety Evaluations").

PRIORITY: M SCHED. COMPLETION DATE: 9/94 RESOURCES: Staff: 2.1 Contract: NMSS 0.5 LEAD: NMSS, RGN II/III RI 0.2 STATUS On schedule RII 0.7-RIII 0.5

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RV -0.1 GE IIT Action No.: 1.D Inspect. ion / guidance for changes to criticality safety.

controls commito to evaluation of existing programs, for inspection of changes to criticality safety-controls, review of RG 3.52,.MC 2600, Inspection Procedures 88015, " Criticality Safety,"_and 88020,-

" operations Review." Documents to be revised.as.

appropriate after the evaluation is _ completed;

'Pris 2' Dues;9/93' FTE: 1.Ol 2.A Inspection guidance-for management controls -provides for upgrading inspection guidance.

Pris?3 Dues 9/94 FTE : -. 0. 7 5 CONTACTS:

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5.2.2 Inspect Larce Materials Processors With Fuel Cycle Procedures Because large materials processors are similar to fuel cycle-plants in operation, include large materials processors in the fuel cycle inspection program rather than the materials inspection program. This would allow inspectors to use MC-2600 procedures for inspecting these plants, rather than the less appropriate MC-2800 procedures. The latter are more health physics than process oriented.

Action Plan Action will be assigned to Region I, with coordination through NMSS, to develop a set of procedures for inspection of large materials processors and to coordinate that effort with Region III for the revision of MC 2800. See action under Recommendation 5.2.1.B (" Update Inspection Manual Chapters").

PRIORITY: M SCHED. COMPLETION DATE: See 5.2.1.B RESOURCES: Staff: See 5.2.1.B Contract:

LEAD: RGN I STATUS: On schedule CE IIT Action No.: 2.A Inspection guidance for management controls Pri 3 Duas 9/94 FTE: 0.75 CONTACTS:

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5.3.3 Proiect Insoectors for Maior Materials Licensees Create ~a system of project inspectors for major materials licensees and' fuel cycle facilities to provide continuity to the inspection activity.

Action Plan A. The staff will designate project inspectors in'the regions to perform inspection project management functions for_ fuel facilities (Part 40 & 70), such as:

Planning, coordination, conduct, and oversight offall inspection activities at assigned plants. Preparation of status and management reports, briefings, issue papers on plant problems, licensee event and report _ analysis _and preparation of resulting reports to NRC management. Review of all inspection reports to detect trends, common: findings, etc. Coordination and review of license amendment and renewal requests. Coordination of and participation in licensee meetings and enforcement conferences,_and reporting of results. Maintaining updated information for use by incident response organization. Coordination, review, and-comment on. proposed regulatory documents and standards-applicable to assigned facilities.

(See action under Recommendation 5.1.4, " Designated Project Managers"). Requires approximately 1.0 FTE per year (0.1 per-facility) to implement.

PRIORITY: H SCHED. COMPLETION DATE: 9/92 RESOURCES: Staff: 0.05 Contract:

LEAD: Regions STATUS: Completed i

_No-corresponding CE IIT action-l l

l B. The staff will evaluate the feasibility and value of designating project inspectors for major Part 30 and non-fuel-cycle-Part 40 licensees.

PRIORITY: M SCHED. COMPLETION DATE: 6/93 i RESOURCES: Staff: 0.05 Contract:

I LEAD: NMSS

! STATUS: On schedule j

No corresponding-GE=IIT. action i

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9 5.2.4 Process Safety Evaluations Revise MC-2800 to include process safety evaluations in this inspection program.

Action Plan This will be considered in the revisions of MC 2800 to be conducted under Recommendation 5.2.1.B (" Update Inspection Manual Chapters"), but with a low priority for addition of process safety evaluations for major Part 30 and non-fuel-cycle Part 40 licensees.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD: NMSS No corresponding CE IIT action

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CONTACTS:

- 14 -

5.2.5 Prelicensina Insoections Develop generic-guidance for prelicensing inspections of large materials _and fuel cycle plants.

Action Plan

-A. Procedures for conducting prelicensing (construction and preoperational) inspections of fuel cycle plants-will be developed as part of the effort under. Recommendation 5.2.1.B (" Update Inspection Manual Chapters"). Prelicensing inspection procedure development for enrichment plants will be assigned to Region IV.

Prelicensing inspection procedure development for fuel manufacture will be assigned to Region III. Prelicensing inspection procedure development for process scrap recovery will be assigned to Region II.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD:

No corresponding GE IIT action B. NMSS is not aware of any contemplated new large materials facilities. However, procedures for conducting prelicensing inspections of large non-fuel-cycle materials plants will be developed by the affected region on an as-needed basis.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

l LEAD: NMSS No corresponding CE IIT action t

. CONTACTS:

l-

l l 5.2.6 Update Safeauards Insoection MC I Revise MC-2681 to reference the use of current inspection procedures and update procedures for inspections of moderate and low SNM licensees to reflect current requirements.

Action Plau The staff will review and revise MC 2681 and each of the MC&A and physical security inspection procedures relLting to Sim of low and moderate strategic significance. To ensure program consistency, the procedures for high-enriched Sim will likewise be updated.-

This effort involves rewrite, headquarters and regional review, management oversight, and consolidation of comments prior to publication.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD: NMSS No cor*seponding GE IIT action CONTACTS: SGTR l

-- - .- -.. . _ _ . = . . .~. -

=5.2.'7 Resident InsDector Procedures

'? Revise the resident inspection procedures to' include actual

' inspector activities, for example,-performance of equipment and-process reviews rather than just the performance of records reviews. Prioritize equipment and process (systems) reviews commensurate to the potential safety risk involved with.their .

operation.

Action Plan Resident inspection procedures will be developed _as part of the effort under Recommendation 5.2.1.A (" Update Inspection Manual Chapters"). Feedback from team inspections will be factored into-the procedures. Region II will be assigned lead for development of resident /,nspection procedures.

PRIORITY: M SCHED. COMPLETION DATE: 1/94 RESOURCES: Staff: 0.3 Contract:

LEAD: RII STATUS: On schedule RII 0.2 NMSS 0.1 No corresponding GE IIT action L;

l l

l-CONTACTS:

l

5.2.8 Licensee Evaluations '

In lieu of the conduct of systematic assessments of licensee performance (SALP) evaluations, conduct periodic regional meetings with each licensee. Use the SALP criteria as the basis for developing the agenda for these meetings.

Action Plan The staff will develop a manual chapter which will call for a periodic regional meeting with each fuel cycle licensee. Guidance will be provided for conducting a periodic appraisal of licensee performance in a public meeting, with guidelines parallel to the SALP approach used for evaluation of reactor licensee performance.

Large materials licensees are inspected at least once a year.

Depending on the outcome of the inspection, NRC would meet with the licensee at a management level to discuss performance.

PRIORITY: H SCHED. COMPLETION DATE: 6/93 RESOURCES: Staff: 0.4 Contract:

LEAD: RII STATUS: On schedule RII 0.3 NMSS 0.1 NOTE: Will require continuing 1,0 FTE per year for conduct of five meetings annually (allocated approximately 0.2 FTE per fuel cycle facility meeting annually)

.. .i.

GE IIT Action No.* 2.c Systematic appraisal and feedback of fuel facility safety performance Prit 3 Dues 9/94 FTE: 1.0

, , ~ . .. ..,  ;..... . . , -.

CONTACTS:

- 18 -

.5.2.9 Informal Matrix Manacoment for Team Assessment Assial.3. ' M _.

Consider use of an informal matrix for team assessmelr ssignments to take advantage of skills and'expr.rience in manufar' ting processes,-process controls, and process safety, that exist across NRC organizations-and regional staff, Action Plan A core' group of diversely qualified individuals will be established for participation in fuel facility team inspections.

See action under Recommendation 5.4.3 (" Team Assessments").

PRIORITY: H SCHED. COMPLETION DATE: 9/92 RESOURCES: Staff: See 5.4.3 Contract:

LEAD: NMSS STATUS: Completed No corresponding GE IIT action asummsme

' CONTACTS:

5.? Reaulation2 ,

5.3.1 Hazard Analyses Revise the regulations in 10 CFR Parts 30, 40, and 70 to require that a hazards analysis be performed for each system and component within each process that contains radioactive material or that serves as a barrier to the release of radioactive material to an unauthorized location. Require that the plant engineering staff and the plant safety committee review and approve these analyses.

Likewise, analyze and review all changes to such systems and components before operation is authorized.

Action Plan The staff will develop guidance on performing hazards analysis for fuel cycle licensees under Parts 40 and 70 (See 5.1.1.A). Such guidance will not be developed for Part 30 licensees or for Part 40 non-fuel-cycle licensees. The result of this guidance development will serve as the basis for a recommendation for rulemaking.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 RESOURCES: Staff: 0.5 Contract: $200K LEAD: NMSS STATUS: On schedule CE IIT Action No.: 1.A Safety analyseo for criticality / process changes Pris 2 Dues 9/93 ETE: 0.75-CONTACTS:

l e 5.3.2 Hggi_ Lor.Dotalled Recuirements Provide specific technical and managerial requirements needed to strengthen licensee practices by revising 10 CFR Parts 30, 40, and 70 to ensure that prescriptive requirements are specified or by developing detailed standard review plan and standard format and content guides to define the technical criteria and management controls desired. For example, the prescriptive requirements for criticality alarm systems specified in 10 CFR Part 70.24 could be augmented with other sections containing similar detail on the topics listed in Section 3 of this report, or these details could be put in guidance documents that are based on the performance-oriented objectives contained in 10 CFR Part 70.22.

Evaluate the need for general design criteria (CDC) for major materials licensees. The GDC could provide a focus for the standard format and content guide and the standard review plan and help bound the scope of the licenuing review. To begin, consider using some or all of the GDC being used for the Louisiana Energy Services (LES) centrifuge enrichment for the major materials licensees (53 FR 13276). For the GDC, consider the issues of backfitting and grandfathering for existing plants.

Action Plan A recommendation in the form of a user need memo will be made to RES by NMSS on the level of detail needed in the rule changes after RG 3.52 and 3.55 are completed. See 5.1.1.A. This recommendation will address topics such as technical criteria, management controls, and criticality. The staff will also evaluate the need for development of general design critoria for specific types of plants.

PRIORITY: H SCHED. COMPTETION DATE: 9/93 g RESOURCES: Staff: 0.3 Contract:

LEAD: NMSS STATUS: Part of 5.1.1.A GE IIT Action No.: 1.A See Task Force Action 5.3.1 CONTACTS:

. . _ . __..___....____..___...___._-.__m - _ _ . _ _ _ . _ . _ _

5.3.3 Revisi^n of 10 CPR Part 70.22(f)

Revis3 10 CFR Part 70.22(f) to make it apply to all fuel cycle '

plants, rather than just plutonium processors. However, the extent to which plants should be required to provide protection against natural phenomena should be determined as part of the rule revision process. Insert a similar paragraph in the contents of applications sections of 10 CFR Parts 30 and 40 for large materials processors. Consider applying this provision to large t irradiation facilities. provide in the licensees' quality assurance and control programs developed pursuant to the revised 10 CFR Part 70.22(f) assurance that the uncertainty in sampling and measurements on processes that are important to safety is controlled commensurate with the ultimate use of the data.

Action Plan A. A recommendation will be made in the form of a user need memo from HMSS to RES. 10 CFR 70.22(f) requirements will be expanded to apply to all Part 70 and Part 40 fuel cycle plants, not just plutonium facilities. The revision would include, for example, requirements to establish QA/oC programs.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 RESOURCES: Staff 0.5 Contract:

LEAD: NMSS STATUS: On schedule No corresponding CE IIT action B. Consideration will be given in the long term to applying these requirements to Part 30 licensees and non-fuel-cycle Part 40 licensees, after part A of this action has been completed.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff Contract:

LEAD:

No corresponding GE IIT action 1

CONTACTS:

• -- P' y- we+- --v'y e

5.3.4 Rgstricted External Contamination Revise 10 CFR Parts 30, 40, and 70 to prohibit contamination of areas external to structures and engineered confinements and to require immediate decontamination of areas inadvertently contaminated with radioactive material.

Acti2D PIAD Fuel cycle licensees have experienced spills of liquido containing licensed material and other chemicals under a variety of circumstances. Scme licensoo remedial actions have taken or will take years tc "omplete, particularly when the licensee delays final action ontil license termination. The HMSS staff will develop draft soil and ground water remedial action procedures applicable to leaks and spills. These procedures will include consideration of whether the remediation chould occur promptly or, if delayed, what monitoring activities would be appropriate. NHSS will coordinate with NRR and the regions to assure consistency in approach to remedial action. The need for regulatory requirements for prompt remedial action will be considered as part of the review effort under Recommendation 5.3.1 (" Hazard Analyses").

An information notice has been prepared to inform licensees of the events that have been disclosed to date.

PRIORITY: H SCHED. COMPLETION DATE: 3/93 RESOURCES: Staff: 0.5 Contract:

LEAD: HMSS STATUS: On schedule No corresponding GE IIT action CONTAC13: J. parrott S. Duraiswamy 1

l 5.3.5 10 CPR Part 50.59-Tvoe Chances

• Revise 10 CFR Parts 30, 40, and 70 to allow licensees to make 10 CFR Part 50.59-type changes to procedures and the plant only after a hazards analysis of the affected area has been performed, documented, reviewed, and approved by the plant safety committee.

Otherwise, continue to require NRC approval for a'.1 changes to the plant as described in the license.

Af: tion Plan A recommendation will be made jn the form of a user need memo to RES from NMSS. This change will afford a basis for providing flexibility to licensees so that they don't have to obtain NRC approval of every plant change that affects the contents of the application, provided self-approved changes have boon based on a hazards analysis, and the change and the analysis are documented for NRC inspection.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 RESOURCES: Staff: 0.3 Contract:

LEAD: NMSS STATUS: On schedule No corresponding GE IIT action CONTACTS:

5.3.6 Criticality Reportina Revise 10 CFR Part 70.52 to clarify the requirements for reporting criticalities, potential criticalities, or loss of control of a potentially critical mass of material.

6ption Plan A recommendation will be made in the form of a user need memo from NMSS to RES which would address criticality reporting. The staff recently distributed a bullatin requiring licensees to report to the Commission concerning procedures for prompt reporting of the degradation of any controlled parameters used to prevent nuclear criticality. On next revision, the staff will incorporate reporting requirements into Part 70 based on the contents of the bulletin and on experience gained from the response to the bulletin.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 RESOURCES: Staff: 0.2 Contract:

LFAD: NMSS STATUS: On schedule s

N GE IIT Action No.: 4.A Event reporting: commits to completo evaluation of need for additional requirements and guidance Pris 1 Dues 9/92 FTE: 0.5 (RES O.3, IMSB O.2)

This task has been subsumed by staff action 5.3.6.

CONTACTS:

1 l

- ..~ . . - - . . - . . . . . - - - - _ . ~ . _ - . - . - - . - . - - . _ . - . . . . - - - ... -

5.3.7 License conditiori Process Revise 10 CFR Parts 30, 40, and 70, as appropriate, to require

• applicants to submit applications according to a standard format and to revise plans by submitting each changed page. '

Action Plan Requirements for development of standard. formats for applications will not have a near-term safety impact, hence do not aerit use of near-term resources. This recommendation will be considered >

within the framework of competing priorities in developing the "

five year plan.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Stafft Contract:

LEAD NMSS >

CE IIT Action No.: 1.C- License condition process-Pris'2 Duas 9/93- FTE : : 0. 75 J 1.F- Facility change request process Prit 2 Duet 3/93 PTEt 0.75-CONTACTS:

,-n. - , -.. . ., . , - . , .. ,- - - . - . . . - - , , .-., ..,n.-. , n .

5.4 Staffina 5.4.1 Establish an Oraanization for Inspection and Guidance Development Establish and staff an organization in NMSS and assign it direct responsibility and accountability for ensuring that actions pertaining to revision of MCs, procedures, and regulatory guidus, and for developing criteria for courses to train and qualify fuel cycle headquarters and regional staff, are completed.

Aption Plan The staff has established priorities for updating the most important regulatory guides pursuant to Recommendation 5.1.1

(" Licensing Guidance"). Ilowever, creation of a separate organization within HMSS dedicated to :taintaining regulatory guides and procedures is beyond current staffing capabilities.

PRIORITY: L SCHED. COMPLETION DATE:

RESOURCES: Staff: Contract:

LEAD:

No corresponding GE IIT action CONTACTS:

~ 27 -

_ . . _ _ _ __._-.______m._--_._... _ _ _ . _ _ _ . . . . _ _ _ . .

i 5.4.2 Resources i Roevaluate staffing and technical assistance _ funding levels

• l required to implement the Task Force approach to program  ;

direction, licensing, and inspection. Include in this evaluction '

a comprehensive review of the resources needed to revise  ;

regulations and to review, develop, reissue, or update the needed  ;

regulations and regulatory guidance for the major materials licensees. Reevaluate the allocation and use of available resources in the regions to, ensure that all inspection activities ,

at fuel cycle plants can be accommodated by the available +

resources. .,

Acnon PlaD  !

Resources to accommodate all of the high and medium priority tasks ,

have been reflected in the FY 1993-1997 Internal Program / Budget Review. No additional resources have been reprogrammed'to accommodato low priority items.

PRIORITY: H SCHED. COMPLETION DATE: 9/92 RESOURCES: Staff O Contract:  ;

LEAD: NMSS STATUS: NMSS: Completed No corresponding GE-IIT action-1

}

CONTACTS:

l 1

.}

.._-._-__.._._.___.u_____.. -. _ _ . _ _

a_ . - _ . - - _ _ _ . . ____._ _-

5.4.3 Team Assessments Establish and staff a special organization in NMSS, charged with the conduct of team assessments at fuel cycle and large materials plants. Restructure the makeup of assessment teams to assign permanent team Icaders in headquarters or the regions and cther individuals in assigned areas, so that assessments are uniformly conducted. Extend the duration of the assosaments from one to two wooks, doomphasize interacting with other agencios, and include on the teams region-based individuals who know the plant being assessed. Revise MC-2601 to ensure that the assessannts properly examino plant and managerial performanco.

2LGliGLrLElAD A. NMSS headquarters and regional DRSS Directors will reviso the structure for assessment teams to provido for designated team leaders in the regions. Soo action under Recommendations 5.2.1.A

("Updato Inspection Manual Chaptors") and 5.2.9 (" Matrix for Team Assignments"). Procedures will be revised through deletion of MC 2601 and, initially, development of a Temporary Instruction for team assessments, with revision of MC 2601 to follow. As part of that instruction, a specific charter will have to be prepared for each inspection, approved by lloadquarters and the involved region.

A contral core of people will be named to form a pool of candidatos for assessment teams. This may include contractor personnel.

PRIORITY: H SCllED. COMPLETION DATE: 12/92 RESOURCES: Staff: 1.0 Contract:

LEAD: NMSS STATUS: On schedulo GE IIT Action No.: 2.c uvaluate merits of team inspections: Provides resources and schedule to study need for and benefits of team inspections Pri: 3 Duas 9/94 FTE: 1.0 B. The staff will conduct team assessments at fuel cycle plants (approximately three por year). Teams will be comprised of regional, NMSS, and NRR personnel as appropriate. The first pilot effort will be completed by 12/92.

PRIORITY: H SCHED. COMPLETION DATE: 12/92 RESOURCES: Staff: 4.1 Contract:

LEAD: NMSS RI 0.4 [Rogional resources STATUS: On schedulo RII 1.2 may vary from year to RIII 0.6 year, depending on Rgns NMSS 3.0 1.1 RIV 0.4 facilities selected)

RV 0.4 See Task Force Action 5.4.3.A

5.4.3 (cont'd) ,

C. The staff will evaluate the results of the effort for-team

assessments for fuel cycle plants and, based on those results, will consider extending that effort to major Part 30 and non-fuel-cycle Part 40 plants.

PRIORITY: M SCHED. COMPLETION DATE: 12/93 RESOURCES: Staff 0.1 Contract:

LEAD: HMSS STATUS On schedule .

No corresponding GE IIT action k

I 1

t CONTACTS:

l l

5.5 Trainina j 5.5.1 IEpinina Proarsm Jovelopment Develop and offer formal training to the headquarters and regional staff, both initial and retrosher training, to provide the basis for inspecting and licensing process operations and performing the associated safety analyses. Include in this training fundamentals of criticality safety, understanding of plant processes and equipment, process design and operation, process safety considerations, and handling and storage of radioactivo and nonradioactive hazardous materials.

Action P14D A. The development of a general-level course on the nuclear fuel cycle and a journoyman-level course on criticality safaty are undstrway, with the pilot Fuel Cycle Technology courso s1 ready offered in June, 1992, and the criticality course to be presented next year. The fuel cycle course provides a broad overview of processen and equipment.

PRIORITY: H SCHED. COMPLETION DATE: 9/93 RESOURCES: Staff: 0.5 Contract: $200K (AEOD)

LEAD: AEOD/TTC STATUS: On schedule AEOD 0.3 NMSS 0.2 CE IIT Actioa No.: 1.E NRC training and qualification, states that the criticality course will be completed by 9/93 Prit 2 _ Dues 9/93 FTE: 0.33 contracts $110,00,0 .

B. Additional courso(s) will be developed by AEOD to address the other topics in the recommendation, namely: (1) plant processes that have nuclear safety implications; (2) how to conduct process safety evaluations, including hazards analyses; and (3) how to licenso, inspect, and evaluate licensee management for safety effectiveness.

PRIORITY: M SCHED. COMPLETION DATE: 9/95 RESOURCES: Staff: 0.7 Contract: $400K (NMSS)

LEAD: AEOD/TTC STATUS: On schedule AEOD 0.5 NMSS 0.2 OE IIT Action No.: 2.D Adequacy of training and qualification of inspectors Prit 2 Duet 9/93 FTE: Shown in GE Action ,1.E CONTACTS:

5.5.2 Trainina Prouram Content '

, Establish a special working group to consider the content of-the training coursos discussed in this report. Staff from the '

i Technical Training Center, HMSS, and the re represented on this special working grcup. gions should be Action Plan A working group will be established to determine the material training coarses needed and to formulate the contents of the courses. The working group will include individuals with the authorit.y to make training decisions on behalf of their-respective i organizations (NMSS, TTC, and the regions) and be given the responsibility to propose and present future materials training requirements.

PRIORITY: H SCHED. COMPLETION DATE: 12/92 RESOURCES: Staff O Contract:

LEAD HMSS-STATUS: On schedule No corresponding GE IIT action CONTACTS:

- , _ . _ , u .- - . . . _ . _ _ _ . _ , . - , - . _-_ _ _ . _ - _ _ _ _ . - - _ . _ . _ ,

5.6 Other Recommendationg 5.6.1 Hational Procram Review Revise the National Program Review of materials and fuel cycle licensing and inspection activities and programs to ensure that the NRC reviews program adequacy rather than implementation. This revision can be accomplished through an in-depth analysis of a selected portion of the program, rather than by conducting a broad, shallow review of the entire program. Perform an in-depth review of the basis used for allocating and using inspection rosnurces in all the regions during National Program Reviews.

Action Plan The FY 92 National Program Reviews (NPR) regional visits were ,

completed during February and March 1992. Some revisions were incorporated into the 1992 NPR in response to regional and headquarters concerns.

The staff intends to further revise the NPR to evaluate program adequacy and will factor this into the FY 93 NPR. The FY 93 NPR i

could be structured to accomplish a " vertical slice" evaluation in a critical area, e.g., licensing and inspecting broad scope licensees, to assess program effectiveness.

l PRIORITY: M SCHED. COMPLETION DATE: 3/93 RESOURCES: Staff 0.25 Contract:

l LEAD: NMSS I

STATUS: On schedule l

No corresponding CE IIT action l

l l

i CONTACTS:

1 1

l 5.6.2 Unarado Resource Utilization Trackinn System Reevaluate the computer programs and codos used to track

• inspection activities in the regions to ensure that useful data can be obtained when required.

Afdi2n Plan The staff believes a separato effort to be unnecessary in light of the current updating of agency tracking systems (e.g., resourco tracking for full-cost-recovery under fee rule) that are underway.

PRIORITY: NA SCllED. COMPLETION DATE RESOURCES: Stafft Contract LEAD:

No corresponding oE IIT action CONTACTS:

NOTE: The Task Force Report does not contain recommendations on the following GE IIT recommandations:

2.E GE's responso to IIT report 3.A Revision of regulatory guide on emergency plann 3.B Evaluation of adequacy of GE's emergency plan 4.C New inspection guidance for event reporting and roviews 4.E Evaluation of GE's root cause program

i Enclosure 2 staff Action Plan Summary Table

+ ---

w

l 4

HIGH PRIORITY ACTIONS

• i Due Data ' Action No. l 9 TEAM ASSESSMENTS OF FUEL FACluTIES i t

1

• Develop Team Assessment Program 12/92 5.4.3.A l I

• Develop Matrix for Team Assignments Completed 5.2.9 l i

• Develop Team Assessment Procedura 12/92 5.2.1.A ,

• Conduct Team Assessment Pilot Program 12/92 '5.4.3.B -i e LICENSING AND REGULATORY CHANGES i

• Update Two Major FC Reg Guides 9/93- 5.1.1.A

f. publish for comment

• Determine Heed for Reg. Changes 9/93 5.3.2 after Reg. Guide Development

• QA for Fuel Cycle Facilities (70.22(f)] 9/93 -5.3.3.A ,

• User Need Memo to RES on Adding 9/93 5.3.6 Criticality Reporting to Part 70

• Develop Regs Requiring Hazards Analysis 9/93 5.3.5 for Design Changes (50.59 concept)

• Develop Guidance on Performing Hazards Analyses 9/93 5.3.1

• Designate Proj. Mgra for Fuel Facilities ' Completed- 5.1.4.A

• Develop Project Manager Handbook 3/93 5.1.3

• Issue Draft Remedial-Action Procedures- 3/33 5.3.4 ,

for Site Contamination p.

9 NRC STAFF DEVELOPMENT

• - Establish Traininq Working Group 12/92 5. 5. 2 -

• Develop Fuel Cycle Technology and 9/93. 5.5.1.A Criticality _ Training Courses C

9 FUEL FACILITY LICENSEE ASSESSMENT <

• Develop Program for'Periddic_, 6/93 5. 2. 8 -

Licensee Evaluation (SALP. concept)

L- -- ;

l; * .

Designate Proj. Inspectors for FC Facil. Completed S.2.3.A-

,, g .- ,, -!

O\ . . - - . . ~ , . ,,a. .: - - -,J- L. A- 'l -- a-" - - + -l~'~~- '

MEDIUM PRIORITY ACTIONS 1

) -

t Due Dale ALC1l011_Nm 9 INSPECTION PROGRAM INITIATIVES

• Revise Inspection MCs 2600 (FC) 9/94 5.2.1.B

& 2800 (Mat'Is)

• Develop Procedures for Inspecting 9/94 5.2.2 Large Haterials Processorn

• Develop Fuel Facility 1/94 5.2.7 Resident Inspector Procedures

• Evaluate Results of Fuel Facility 12/93 5.4.3.C Team Assessments for Applicability to Major Materials Licensees

• Evaluate Need for Project Inspectors 6/93 5.2.3.3 for Large Materials Licensees

• Evaluate NRC Capability to Assess 9/94 5.1.6 Fuel cycle and Major Materials Licenseo Operating Experience e LICENSING PROGRAM INITIATIVES

• Upgrade UF6 Environmental Reg. Guide 9/94 5.1.1.B e Evaluate Need for Project Managers 6/93 5.1.4.B for Major Materials Licensees

• Evaluate Need for SERs for Major Materials 9/95 5.1.5 Licensing Actions 9 NRC STAFF DEVELOPMENT

• Develop courses Addressing Fuel Facility 9/95 5.5.1.B Process Safety, Hazards Analyses, and Licensing, Inspection, and Evaluation of Management Safety Effectiveness 8 NRC PROGRAM ASSESSMENT

• Improve National Program Review Process 3/93 5.6.1 i

LOW PRIORITY ACTIONS Action No.

9 LICENSING PROGRAM INITIATIVES e Updata Remaining Standard Format & Content Guides 5.1.1.C and Standard Review Plans )

e Update Remaining Materialu Reg. Guides 5.1.2.A e Update Safeguards Reg. Guides 5.1.1.D, 5.1.2.B o Revise License Application Process e

5.3.7- ,

o Establish Separate Organization in NHSS 5.4.1 to Manage Reg. Guides *

(Staff does not believe that this is cost-effective) 8 INSPECTION PROF 1 RAM INITIATIVES

.?

e Develop Prelicensing Inspection Procedures 5.2.5.A for Fuel Facilities e Revise Materials Inspection Program to Include 5.2.4 Process Safety Evaluations e Develop Preoperational Inspection Program for 5.2.5.B Major Materials Licensees e Update Safeguards Inspection Procedures 5.2.6-9 REGULATION REVISION INITIATIVES o Consider Need to Develop Regulations Requiring-_QA 5.3.3.B  ;

for Major Materials' Licensees (70.22(f) concspt) ,

J . . . _ - . . - . . - - . - - - .. - - . . --

ENCLOSURE 3 NRC RESPONSE TO COMMENTS 4

INTRQDUCTXQM f

. In February 1992, NUREG-1321, "

Proposed Method for Regulating Major -t Materials Licensees," was published and distributed with a request >

that members-of the public and industry comment on the report. In  ;

particular, comments were solicited in three areast j

1. Which of the recommendations should, or should not, be adopted and why? .

2. Which of the recommendations should be modified, and, if any  ;

should, how and why?

3. What priority should be assigned each recommendation to be i implemented and why?

Comments were received from one public group, one State, two industry -

groups, and six licensees or applicants. - This report categorizes into subject areas, summarizes, and paraphrases comments that-were received. The following table lists the categories into which comments were grouped and are discussed. The Nuclear Regulatory Commission (NRC) staff response is also provided. A copy of the '

comments that were received is available in the Public Document Room.-

Public Comment Cateaories

1. Performance-Based Regulations "

2. Need for Changes

3. Licensing l 4. Timely Renewal

5. Hazards Analysis

6. Regulatory Guides '

7. Management Controls

[

8. Team Inspections

9. Resident Inspectors ,

10. Inspection Program Improvements

11. Public Involvement

12. _ Dialogue with Industry j 13. Cost-Benefit Analysis.

l 14. Financial Impacts;-Fees

15. National Program Review

16. Other Comments -

1-

'Yt T r31F M +n ywwNmcy--@ y7yy-met- -

-i----? Te gir - ibew-,, * -.g-4-J p1++-- en -~-'Mb YYh n'rt- -e -**1--+- T T-5++-

1. PERFORMANCE-BASED REGULATIONS A number of comments urged the Commission to develop performance-based regulations rather than prescriptive regulations. The commenters noted that the former provide flexibility to licensees in meeting the regulations, whereas the latter allow only limited discretion in meeting the regulations. In this regard, one commenter noted that prescriptive regulation assumes that regulators are at least as knowledgeable about the details of conducting a safe operation as the licensee, an assumption that is not necessarily valid. Other commenters stated that prescriptive fixes through means other than rulemaking are good for short-term problems, but that regulations that deal with long-term problems should be performance-oriented. Another commenter suggested that licensees should be challenged by regulations that set high performance standards which provide licensees freedom to use their resources in an optimal fashion to meet those standards.

Resoonse:

The staff agrees, in principle, with these comments.

Performance-based regulations do allow for creativity and innovative solutions in meeting health and safety, as well as environmental, objectives. However, there are instances in which prescriptive regulation is the appropriate approach. one example of this latter case is reporting requirements: to meet NRC's objective in being promptly informed of incidents, the regulations need to establish clear and unambiguous criteria for reporting.

1 The staff has not yet taken a position on whether changes to the regulations as a result of the recommendations in NUREG-1324 would be performance or prescriptive in nature. The staff will consider these comments in any rulemaking efforts and, in any case, opportunity for public comment on the approach taken will be afforded at the proposed rule stage.

2. NEED FOR CHANGES 4

Several commenters questioned the need for consideration of revising the existing regulatory framework if-the objective of that revision is only standardization. Commentere'noted further-that the industry is largely a mature one,.not likely to expand' and therefore, the appropriateness of new regulations and license review plans should be critically examined. one commenter stated that NRC regulations are too complex and detailed, with too great a concentration on legally correct language, and consequently are difficult to understand. The commenter suggested'that NRC should.

develop its regulations in a: more integrated fashion and write them in clearer language. Another commenter went on-to identify several areas where existing regulations are unnecessary or redundant and could actually detract from safety. These areas include emergency preparedness plans, fitness for duty programs, i

nuclear medicine and nuclear pharmacy, and requirements for work permits.

Resoonse:  !

The objective of the regulatory changes recommended in NUREG-1324  !

and the staff's action plan is not standardization, por so,-but rather direct improvements in safety at fuel cycle and large materials facilities. The task force that prepared NUREG-1324 found that the absence of specific regulations or detailed guidance to the staff unavoidably led to licensing on an ad hoc basis. The staff shares the task force viaw that such an approach is not good regulatory policy, from the : standpoint of I resource utilization, public involvement, or consistency. l Although the industry may be a mature one, and new facilities may  !

not be likely to come about, licensees continue to request renewals of their licenses. The need for a comprehensive, consistent regulatory framework is as compelling for review of these renewal applications and making licensing decisions as it is for applications for new facilities.

The staff agrees that NRC regulations are sometimos complex and detailed. Although the requirements of legal r,'ficiency to some extont dictate the content of regulations, NIC as attempting to make its regulations more clear as they are r evisod, and has in place a Regulations Handbook (NUREG/BR-0053 to ansist in regulation writing. The rulemaking to revise 10 CFR Part 70, addressed in the staff action plan, will include efforts to write the regulation in clear and understandable language.

With respect to the comments on existing regulations that may have an adverse effect on safety, the staff notes that this subject will be examined in detail in Phase I of NMSS' regulatory impact survey. Dur!ng this phase, licensee personnel at nine fuel cycle and large materials facilities will be interviewed by a team of NRC managers. In these interviews, the team will explore the impacts of NRC's regulatory program on-these facilities and will make recommendations for modification of that program, as appropriate.

3. LICENSING l Several comments addressed recommendations for inproving the I

licensing process. One commenter. urged caution in revising the contents of licenses,-recommending that part of'the license should' continue to-be broad in scope, stating performance requirements that the licensee's safety program must meet. That gives the licensee flexibility to neet the safety requirements without having to submit burdensomeLapplications for amendments to the license for minor changes in its-operations. A second commenter supported the recommendation that "50.59" changes- -

should be allowed if the operator undertakes an internal, formal, reviewed and approved hazards analysis. Two connenters suggested ,

changes in the licensing process, one recommended.a-three-part

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license format, including license conditions (which could not be changed without amendment), safety analyses, and description of '

facilities. Another comment contained several proposals for changes or clarification in licensing guidance. And one commenter urged that NRC adopt formal adjudicatory procedures for material licenses.

Response

The provisions in 10 CFR 50.59 allow operators of nuclear power r reactors to make procedural and facility changes that satisfy criteria specified in the regulation without license amendment.

The NRC staff determined that similar requirements are appropriate for certain materials licenses, and in a recent renewal of a major material license, the NRC staff incorporated such a condition. The license condition permits the licensee to make facility, structural, process, equipment, and procedural changes without license amendment, provided that any proposed change does not involve (1) a modification-to the conditions of the license or part 1 of the renewal application; (ii) a significant increase in the annual individual or cumulative occupational radiation exposures; (iii) a significant change in the types or significant increase in the amounts of effluents released offsite; or (iv) an unroviewed safety question. The "50.59 type" condition was developed, in part, to better define when facility and procedural changes do not require prior NRC-approval. Licensees receiving renewed licenses with this condition incorporated will be required to submit annual or biennial updates to the safety demonstration section of the application. The "50.59 type" condition, safety demonstration updates, and updates provided with amendment applications, should expedite the license renewal and amendment process and provide a means to maintain the license documents current.

In 1990, NRC announced a policy of 10-year renewals for selected fuel facility licenses. The new policy included a requirement for periodic updates of the renewal application. This policy has-been implemented with the renewal of two fuel facility licenses.

This license renewal policy requires annual or biennial updates to the safety demonstration of the. renewal application. These-updates reflect current operations;and the results of safety evaluations performed in accordance with the licensen's ongoing safety analysis programs. '

L Guidance on the format for license applications for uranium i

processinn and fuel fabrication and uranium hexafluoride l production is found in Regulatory Guides 3.52, " Standard Format and Content for the Health:and Safety Sections of License Renewal Applications for Uranium processing and Fuel Fabrication," andL 3.55, "

Standard Format and content for the Health and Safety Sections of License Renewal Applications for Uranium Hexafluoride l

L Production," respectively.- These guidance-documents-specify a two-part format for applications, which the NRC staff' believes is appropriate. The first section of the application.shouldLprovide proposed license' conditions stating the performance requirements to which the licensee proposes to-commit. - This is the license l

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conditions section that is incorporated into the license by reference. The second section of the application contains detailed descriptive information such as safety analyses and facility descriptions that should be maintained in a separate safety demonstration, since safety analyses can be comprehensive and lengthy, licensees are expected to incorporate summaries of ,

analyses into the safety demonstration. ,

The other detailed suggestions.for changes or clarification in ,

licensing guidance will be considered during revision of the guidance documents. With regard to the comment concerning use of formal adjudicatory procedures for materials licenses, the commission has determined that, in most instances, if a hearing r request is granted, an informal hearing with an opportunity to present written views is sufficient. The regulations in 10 CFR 2.1209(k) give the presiding officer the power to recommend to the Commission that procedures other than those authorized in Subpart L be used for a particular proceeding.

4. TIMELY RENEWAL

Two comments were received concerning the " timely renewal" provision, 10 CFR 2.109, which states that if an application for renewal of a license has been filed at least 30 days before the expiration of an existing license, the existing license will not expire until a final determination has been made on the application for renewal. A licensee stated a concern that there was an unjustified implication in the Task Force report that licensees are primarily responsible for delays in obtaining a renewed license under timely renewal, and suggested that any corrective efforts not be directed at penalizing any-party, but rather use positive incentives for both the licensee and NRC to complete the action promptly. Another commenter stated that, under the timely renewal provisions, there is no incentive for ensuring that a proceeding for renewal of a license, with attendant opportunities for hearing, actually proceeds in a ,

timely fashion. This commenter recommended that NRC require that renewal applications must be acted on within one year of submission.

RESPONSE

NRC shares the concerns expressed by the task force and'by the comments about the length of time for license. renewal actions to be completed. A number of factors contribute-to this problem, including delays in licensee responses'to NRC requests for additional-information, and competing demands on -limited }UIC staff resources. The implementation-of the planned actions in response to the task force _ recommendations, such as: updating,of two major fuel cycle regulatory guides and revising 10 CFR Part 70, is expected to improve the effectiveness'of NRC's licensing operations and assist in reducing the backlog in license renewals. Therefore, the staff intends to establish a timeliness goal of one year for completing fuel cycle license renewals.

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5. IIAZARDS ANALYSIS commenters generally supported the recommendation that hazard analyses should be required where a failure could result in a significant incident involving release of materials, personnel exposures, and unsafe conditions. However, there were several comments addressed to the scope and implemente : ion of such a requirement. One commenter stated that the scope of such analysis should be limited to only those systems necessary for ,

radiological safety of the public, and that chemical safety should be included only if an event could jeopardize radiological safety of the public. Two commenters expressed concerns that the requirement as presented in the recommendation is too prescriptive. one stated that the recommendation assumes that a plant integrated safety committee is required to review hazard analyses, and urged that licensees be judged individually as to the acceptability of their method of performing safety analyses.

Another supported the general concept as sound, but stated that implementation of the concept requires more deliberate assessment as to what types of licensees should be required to perform such analyses, what methodologies make sense, and what specific hazards need to be analyzed. The commenter suggested that specific issues, discussions with licensees could help address those one commenter noted disagreement with the recommendation, stating that major manufacturing facilities should not be required to conduct orocess hazard analyses.

Resnonse: -

There is a significant advantage to a clear understanding by facility management of the general and specific hazards of the operations under their. responsibility. A hazard analysis is an important component of the information that should be available to facility management in order to intelligently manage the risk of operation. Competent management of-the risks of licensed operations is a necessary NRC concern.

Since the analysis of many hazards, such as radiological, chemical, or criticality, requires the same building blocks, it is reasonable to perform an integrated hazard (or safety) analysis which would include chemical hazards that could affect- i in-plant safety. A hazard analysis is inherently a multidisciplinary effort and requires a multidisciplinary review and approval. The NRC staff agrees that a plant safety committee is but one way of assuring such review.

The. comment suggesting more deliberate assessment of-the details of implementation appears to desire more specific guidance on hazard analyses which is,.nevertheless,-less prescriptive. NRC requirements on hazard analysis will certainly need to be developed deliberately and with input from industry and the public. The NRC; staff will discuss the concept of hazards '

analysis with fuel cycle licensees at the September 1992 Puel Cycle Workshop and at other future meetings.

The comment disagreeing with the recommendation refers to non-  !

fuel-cycle facilities. The staff has no immediate plans to pursue requirements for process hazards analyses for non-fuel-cycle facilities. If such a rulemaking is initiated in the l future, further opportunity for public comment will be provided.

6. REGULATORY GUIDES Commenters noted that regulatory guidos should be well-defined, timely, and non-contradictory, and allow licensees latitude in-meeting regulations. One commenter noted that there are few guides that pertain to radiopharmaceutical manufacturing facilities, and those guides that exist appear to have been written with little knowledge of the operations to which-they will apply. Other commenters noted that the guides that exist are in need of revision and updating and recommended that NRC

-adopt a five year cycle of revision and updating of its regulatory guides.

Resnonset Resource constraints forced the staff to place priorities on the recommendations contained in NUREG-1324. The staff is proposing as a high priority item in its action plan the revision-of Regulatory Guides 3.52, " Standard Format and Content for the-Health and Safety Sections of License Renewal Applications for Uranium Processing and Fuel Fabrication," and 3.55 " Standard Format and Content for the ilealth and Safety Sections of License Renewal for Uranium Hexaflouride Production." _These guides will be revised to incorporate branch technical positions cn1 quality management controls / quality assurance, requirements for operations, chemical process safety, and fire protection, and will be published for comment.

The staff considered routine revision of regulatory guides, ,

including those associated with large materials facilities, on a five year cycle. However, this recommendation was accorded a low priority because of the high resource requirements and the relatively long lead time with little or no significant improvement in safety.

7. MANAGEMENT CONTROLS 1

Comments on management controls came from two sourcess one stating that NRC's concern over the adequacy of-licensees' ,

management systems was " inappropriate," and the other supporting recommendations in this' area, with suggested additions and enhancements.

Resoonse:

NRC's position on the first comment is straightforward: a careful analysis of-events at the Oequoyah. Fuels Corporation / Facility'in 1986 (and continuing regulatory concerns at that site), and the

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e

potential criticality at the General Electric Nuclear Fuel and component Manufacturing Facility in 1991, strongly indicates that ,

a breakdown in management control systems was a root cause in both cases. Consequently the agency has no choice but to evaluate licensee manageme,nt control systems generically.

With respect to the second set of comments, the staff recognizes that both the licensing and the inspection programs for large materials processors need to be strengthened in the area of management control system oversight. It is also recognized that expertise in this area will have to be obtained to asuist in developing training curricula and in conducting training, in updating licensing and inspection procedures, and in evaluating licensee programs for adequacy. The suggestions made by public comment will be considered and, as appropriate, incorporated in such efforts when they are initiated.

l

8. TEAM ASSESSMENTS 1

One of the Task Force recommendations dealt with team '

assessments. Although many of the public comments discussed the recommendation in terms of team inspections, assessments are ,

different from inspections. Inspections are compliance-oriented.

Assessments are used to review existing operational conditions at each facility to. determine whether there are potential safety hazards that, when combined with site operations, could impact public health and safety. The assessments assist NRC in determining whether additional license conditions are needed to preclude such impact. The assessments are not inspections, but will provide feedback to both NRC and the licensee. During each assessment, the team determines whether the licensee ~has systems and procedures in place to identify and correct in-plant-industrial safety type problems which could result in radiological safety consequences, and will determine whether the licensee is adequately implementing those procedures that exist, j Four of the six commenters on the topic of team assessments

' focused on the large impact a multi-person inspection or assessment could have on licensee activities. These commenters amplified their remarks by expressing concern that large, five to ten person teams could engage key engineers and managers _or their staffs for several weeks, detracting from their abilities to perform assigned work, including important safety functions.

Included in these comments were objections to the high cost of inspection fees for major. team inspections as compared with'any obvious safety benefit that could result from these inspections.

L One commenter stated'that team _ inspections rarely disclosed safety issues not already known to licensees. Another objected to the use_of_ consultants as team members, since consultants might be used to make compliance-related-decisions. Another suggested the NRC use smaller teams composed of people highly familiar with the fuel cycle plant operations, and that these teams review the applicable license, regulatory guides,.and safety analyses, and then focus on methods the licensees could use to improve performance. Another commenter suggested that NRC E

\ ,. . _ _ . _ _ _ _ , , . _ _ .

define the term " properly," as used.in team assessments, to

" properly examine plant and managerial performance."

Banponses NRC understando and appreciates the concerns of many commenters a

who are fearful of the potentially disruptive impact of large team inspections or assessments. Developing NRC initiatives in the team inspection and assessment area were intended to, among other things, diminish those concerns by making the team inspections and assessments more offective. Such initiatives include the ure of some permanent team members, and central 141ng control and management of the teams. Methodical selection of team members can also serve to make the tot a highly professional group, which can obtain a degree of respect both from the conduct of the inspection or assessment and the nature of the findings.

NRC cannot abandon the team in+;pection/ assessment concept. Over the years, it has proven to be one of the more efficient means of discovering fundamental weaknesses in a licensee's organization.

However, the licensees' concern about the disruptive nature of a poorly conducted inspection or assessment is a pointed caution to the staff to ensure that future team inspections and assessments are of high calibre.

Where consultants are used on NRC team assessments or inspectiont, they are assigned to supplement the team and to provide specific technical expertise. Only NRC staff members, usually experienced regional inspectors and regional supervisors, develop compliance matters. These matters might include technical issues, identified by consultants, that NRC staff members determine to be potentially items of non-compliance.

One commenter cautioned that the staff not abandon the concept of

. conducting multi-agency team inspections with Federal or State Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) participation, since that initiative had specifically stemmed from the 1986 Sequoyah Fuels accident and a Memorandum of Understanding had been signed to establish that interrelationship. The staff does not intend to eliminate or abandon the interagency nature of its materials team inspections and assesements. However, the practical aspects of ensuring that the staff always achieves interagency participation have not been uniformly successful in the past. NRC will, however, continue to extend invitstions to these other agencies and encourage their participation.

The comment suggesting that NRC define the term " properly" as it relates to the staff's examination of plant and managerial performance is a worthy one and appears to relate to the issue of acceptance criteria. The task force did not set out to define a new set of acceptance criteria or revise existing guidance documents that may be affected by its recommendations. The issue of plant performance is complex and controversial. During team assessments and inspections, NRC considers many different 1

measurec of performance: the regulations and license, management ,

and standards that the plant internally or externally treats as commitments, professional judgment of the team as to whether safety is being achieved by plant activities, and a natural comparison of activities and initiatives at the plant to those at ocher facilities within the collective experience of the tet.m.

Ultimately, the team's assessment of whether a licensee's performances is proper rests with the collective judgment of the team, based on its observations. Significant weaknesses in performance may compel the team to recommend substantial regulatory actions. Less significant weaknesses may well be characterized as items needing improvement or may be suggested as areas for indepth examination by the licensee. Teams need to be properly selected, trained, and managed so that they can uncover any significant safety problems that may be present, to help avoid a repetition of the incidents of the past few years.

9. RESIDENT INSPECTORS Two comments were received on the resident inspection recommendation which involve revising the inspection p. aures available to the resident to include observation of in-plant activities such an equipment and "rocess performar.ce rather than just record reviewc. One commenter suggested that resident inspectors be placed at sites only as a relatively temporary action, to alleviate specific problems. The second commenter claimed that there was insufficient information available in the task forco report to determine if the recommendation should be adopted. This commenter went on to suggest that several tasks be added in addition to the resident inspector requirements. These additicnal tasks included nonthly review of performance indicator syatem reports, periodic review of varicus audit reports, and a sampling of corrective action plans that compare intention to actual accomplishments.

Resoonse:

The comment involving limiting the assignment of resident inspectors to sites with a particular problem is noteworthy.

Histor.ically, resident inspectors have been assigned only at-materials sites where problems may have been perceived or, more likely, where ongoing activities have been particularly complex.

NRC management probably can use both of these criteria for deciding on the future placement of resident inspectors.

Temporary assignments of resident inspectors can be accomplished, but depending on the duration of the assignment, may or may not involve permanent change of duty station and attendant moving expenser. The comment involving NRC's intention to revise the inspection procedures included two items that are already part of existing inspection proceduras and consist of records review in the QA audit and corrective action areas. The suggestion for looking at performance indicator systems could prove useful at a plant that has established its inn plant-specific set of

, oerformance indicators. At th>s time, however, there is no NRC-

.pecified set of performance indicators that applies to fuel

cycle licensees. Finally, the recommendation that inspectors observe activities rather than simply review records reflects-an acknowledgement of actual practice by resident inspectors. This recommendation also reflects the valuable amount of, safety information an experienced inspector can obtain by carefully observing plant activities. This can supplement information gleaned through review of records or interviews of plant personnel.

M. INSPECTION PROGRAM IMPROVEMENTS One commenter suggested that affected rules, regulatory guides, and inspection procedures be issued simultaneously, as opposed to the present practice of having them over a period of several years. The present practice makes it difficult for the inspection procedures to reflect industry and public comment and the NRC consensus associated with the rule change and corresponding guidance.

One commenter suggested that NRC "can't inspect safety into the licensees." A second commenter suggested that NRC go beyond its performance-based inspections to the concept of technical reviews. Then the staff could make better use of the NRC and industry experience to both find and solve problems in a non-threatening environment. Another commenter suggested that the staff require inspectors to spend more time at the plant to learn the plant-specific details and become more effective inspectors.

Another suggestion was that the inspectors only examine management controls if improper symptoms are found in other areas. A second observation agreed with assigning the same or

" project" inspectors and stated that this practice seems to be already in effect for most major materials licensees. A third comment suggested that NRC obtain inspectors with substantial manufacturing experience at major materials licensees. The fourth comment suggested that NRC train its inspectors more thoroughly on international standards. The fifth comment objected to NRC's compliance terminology, which tended to potentially alarm the public for minor severity violations. This commenter suggested the NRC carefully examine OSHA terminology to see if it could apply. The sixth comment suggested that some inspectors too often review tasks in isolation and have difficulty coming to grips with the integrated safety approach used by many major materials licensees.

Resconse:

The suggestion to simultaneously issue new rules, regulatory guides, and related inspection procedures doeb have merit and would accomplish the improvements suggested by the commenter.

Because of workload backlog, this comment may be difficult to achicve; however, since rule changes require a lengthy developing cycle, the suggestion is worth pursuing.

The suggestion to examine the concept of technical reviews could provide a valuable method to assure an independent safety review. '

However, NRC must be cautious in its participation with industry during reviews of regulated activities in order to maintain sufficient independence as a regulatory agency and to maintain the confidence of the public that it is seting in the public interest. Further examination of the intent of this comment appears worthwhile. The suggestion that inspectors spend more time at their plants to learn plant details is noteworthy.

However, there are practical and personal limits to the amount of time the inspectors can spend traveling. The notion that inspectors should learn the details of their plants is certainly correct and needs to be pursued.

The suggestion that management controls be examined only if other symptoms are found reflects the current practice used by NRC.

Since tre inspection program is sampling by nature, it's unlikely -

that the staff would inspect facility management unless such action were suggested by the identification of other problems.

The suggestion that the staff try to obtain inspectors with major materials manufacturing experience is appropriate. The staff is always looking for good, experieteed plant personnel and believes that such persons can make excellent inspectors and license reviewers. Unfortunately, such persons are not always available.

The staff will examine the need to better train its inspectors on appropriate international standards. The staff will ask its Office of Enfcrcement to examine the OSHA compliance terminology and to consider whether its use is more appropriate for NRC circumstances.

The comment that inspectors review tasks in isolation and have difficulty coming to grips with an integrated safety approach may be valia, but may reflect a few disturbing encounters with selected licensees. The inspectors are trained and cautioned to keep the overall safety impact of both their and licensees' ~

activities at Phe forefront of their efforts. Reemphasis of this concept is warranted and needs repetition on a continuing basis.

11. PUBLIC INVOLVEMENT Two commenters expressed concerns regarding public involvement in the materials regulatory process. An industry group urged caution in attempting to increase public participation in inspections, stating that for an inspection to be of benefit to a licensee, the participants must be highly qualified and experienced,'and that inspection results must be placed in the proper context for the public, lest the generally negative nature of the results be misconstrued to imply that there are big problems,-when in fact there are not. A public'commenter stated that the hearing opportunity provided in materials licensing.

cases is inadequate to allow for public ventilation of licensing issues, and also stated that the absence of a requirement for NRC to prepare a Safety Evaluation Report (SER) for materials e

L licensing decisions deprives the public of en accounting of tho 4 basis for NRC's licensing decisions.

Resoonse:

With respect to the first comment, NRC does not plan to involve members of the public directly in the-conduct of inspections.

However, it is important that the public have access to the results of NRC inspections in order to be informed about both the safety atatus of licensed operations and the fairness and effectiveness of the inspection process. To that end, all inspection reports and other documents concerning the results of an inspection are publicly available in the Public Document Room, except for information that may be proprietary or that may involve classified or safeguards information. NRC believes that its inspection reports describe deficiencies in a licensee's operations in a balanced context that should not engender undue public alarm.

The comment that the hearing opportunity in materials licensing cases is inadequate is similar to views that were expressed in opposition to the adoption of informal hearing procedures for materials licensing cases in 10 CFR Part 2, Subpart L. These views generally disapprove of the failure to provide for discovery or extensive cross examination. However, the Commission believes that the opportunity for a full and fair hearing is afforded by those procedures. Although there is no discovery, the NRC staff is required to create and update a hearing file consisting of the materials relevant to the licensing proceeding, including the application and any amendments to the application, any environmental assessment or impact statement, and any NRC report or correspondence between the NRC and the applicant relating to the application. In addition, if the presiding officer finds that an oral presentation would be useful in fact finding, the presiding officer may ask witnesses questions that have been suggested by the parties.

The comment recommending the preparation of SERs for materials licensing decisions supports Task Force Recommendation 5.1.5.

The staff agrees that this recommendation has merit, and.the staff plans to conduct an analysis to determine the costs and benefits of preparing such reports for Part 30 and non-fuel-cycle Part 40 licensees.

12. DIALOGUE WITH INDUSTRY Several commenters expressed concern that the recommendations in NUREG-1324 constitute a major regulatory initiative that could result in a su..'% 7tial imposition of new requirements'and programs. The wommenters suggested that NRC enter into an interactive dialogue, including workshops, with licensees and industry groups to discuss the assessments and recommendations before implementation.

1

Resnonse:

The scope of NUREG-1324 is broad, and the staff does not plan to pursue all of the issues raised with equal priority. It would not be practical to enter into broad discussions that would address all issues at the same time. Rather, the staff will pursue more limited discussions on various topies as appropriate.

For example, the staff discussed selected fuel cycle topics at a workshop in September 1992.

13. COST-BENEFIT ANATMSIS Five comments addressed the need for cost-benefit analyses to assess the impact of regulatory changes on the involved licensed community and to ensure that those changes result in a significant improvement in public safety. The comments also addressed concerns of licensees over changes in the regulatory process that might result in increased use of NRC resources and, subsequently, in increased fees, since NRC now operates on a 100 percent cost recovery basis. Alsc, one comment suggested that a backfit requirement, similar to the reactor backfit rule in 10 CFR 50.109, be developed for material regulations.

Es.snonse:

NRC's policy with respect to evaluating potential regulatory changes is to perform cost-benefit or value-impact analyses before imposition of new requirements. This policy will be applied with respect to the recommendations in NUREG-1324, insofar as they pertain to new requirements. There is an exception to the policy which will also_ continue to be observed; namely, that any change naeded to correct a practice that creates undue risk to public health and safety will be implemented immediately, without regard to cost.

This statement of NRC's policy does not completely respond to the comments, however. Because of NRC's newly adopted fee structure, changes to NRC's operational practices could impact licensees' costs. Such cost impacts notwithstanding, NRC is responsible for carrying out an effective licensing and inspection program to assure the safe use of nuclear material. A continuing process of self-evaluation of licensing and inspection programs by the NRC staff is essential in identifying, correcting, and upgrading parts of the regulatory process that are not effective. Such changes are necessary for program improvement and are not subject to the formal cost-benefit analysis process.- (A typical example of such a change is the implementation of team assessments).

Every effort will be made to minimize tne addition of unnecessary or ineffective changes to regulatory operations.

With respect to the need for a backfit rule for fuel cycle facilities and large materials processors, the staff believes that there is no foundation for such a request. Other than revisions of the regulations to keep them in accord with international standards, there has been little change to the

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requirements regulating fuel cycle facilities and large materials processors over the past twenty years. Perhaps this is why there is need for an overhaul of the regulatory base at this time.

t

14. FINANCIAL IMPACTS; FEES Licensees stated concerns about encountering additional costs to respond to regulatory changes resulting from the recommendations in NUREG-1324, as well as paying higher fees resulting from increased NRC use of resources for rulemaking, licensing, and inspection. Licensees thus could be impacted twice by the changes recommended in the report. In addition, several comments addressed the belief that there are no longer any budgetary checks and balances to control the level of resources NRC assigns to materials licensing and inspection, because licensees now pay 100 percent of the costs for NRC services. Other commenters stated that an increased regulatory burden not only increases costs to licensees, but also results in unproductive use of management time. A final comment suggested that regulatory changes could be made on a more cost-efficient basis by placing ccnditions in licenses, on a site-specific basis, thereby requiring modification of only those programs with identified weaknesses.

Resnonse:

The NRC budget review process has not changed in any significant respect as a result of implementation of the 100 percent fee rule. The same review process exists; the same resource controls are in place; tha name congressional and executive branch oversight pertain. The only difference in the badgetary process is that once an allocation is made to NRC, it must be reimbursed to the U.S. Treasury in the form cf user fees. All the processes that, in tha past, have controlled the level of material regulation will continue to do so. Consequently, any growth in the program will be made in a planned, reasonable manner, subject-to agency management and executive and congressional branch review, and will not result in spiraling, uncontrolled costs to licensees.

With respect to the direct cost impact of implementation of the report's recommendations, it is inevitable that improvements and correction of deficiencies in the materials regulatory program will be acccmpanied by increased costs. However, only those changes that are cost-effective will be implemented; so the cost impact will be minimized. Moreover, changes will be made over time, in a phased manner; so-cost impacts will be spread over a period of years. Also, those licensees that have well-managed, well-controlled programs which are operated with little or no risk to public health and safety should not be significantly impacted by the envisioned regulatory changes.

The suggestion that the license condition process be used to implement regulatory changes, in lieu of modification of regulations, is contrary to policy. Not only does it deprive the I

public of its right to participate in the regulatory process, but ,

it also fails to provide NRC with a regulatory base for its actions and to provide licensees with a regulatory base for their interactions with NRC.

15. HATIONAL PROGRAM REVIEW There was general support among the commenters who addressed this topic for a change in emphasis from program implementation to pr ogram adequacy. One commenter also noted that an in-depth analysis of a selected program area could produce useful results if: the objectives and purpose of the review are clear, the personnel are skilled in program review techniques, and there are sufficient time and resources for the job. Finally, this same commenter observed that an in-depth review of the basis for allocating and using inspection resources, as recommended in NUREG-1324, is a complex and time-consuming process that may better be undertaken as a separate study, outside the National Program Review.

Resnonse:

The staff is planning to incorporate the action plan recommendation to evaluate program adequacy into the FY93 National Program Review. One approach under consideration is to conduct a " vertical slice" evaluation in a critical area, such as licensing and inspecting broad scope licensees. At this time, the staff does not have plans for conducting an in-depth review of the inupection resources issue.

16. OTHER COMMFELS Current Procram Works Well One commenter suggested that the report was critically deficient and that it failed to describe how well current regulatory systems had met the objective of protecting public he.lth and safety and commented on the entire nuclear fuel plant safety performance of 200 operating years. A comment mentioned that ignoring the results of the current program and focusing on one incident can only result in over-reaction and over-regulation.

Response

The comment on the successful operating history of the fuel j plants is valid. However, the purpose of the task force was not to review the historical record of accomplishment of overall safety objectives by-the materials industry, That record is not in debate. Nevertheless, there were several recent plant incidents that came close to causing potential significant harm to plant personnel, as well as some unnecessary environmental insult, that would produce substantial unanticipated decommissioning cocts. Fcr those reasons, NRC decided to examine 1

its regulatory program to find if fundamental improvements could i

or should be made.

Systematic Assessment of Licensee Performance (GALP) Techniaues; agcident Analysis Handbook one commenter concurred in the task force recommendation.to incorporate appropriate sections of the Accident-Analysis Handbook (NUREG-1320) in the Standard Review Plan. Another commenter objected to the task force recommendation that the staff not use the SALP techniques to assess the performance of major materials licensees. One commenter objected to the substitution of periodic regional meetings with licensees to review performance as being too subjective. As an alternative to SALp the commenter recommended that the NRC develop other reliable performance review techniques.

Response

The task force's recommendation to not employ the SALP technique is based on its intrinsic development and relationship to reactor operation. The SALP technique has been used occasionally for specific reasons at selected fuel cycle plants, but always with significant difficulty for both staff and the licensee. The difficulty stems from;SALP's construction to suit another type of 4

facility, as well as the staff's lack of resources to smoothly conduct the SALP assessment. The comment that the periodic regional meetings may prove too subjective.to be useful is a valid warning. For the present, the staff will concentrate efforts on obtaining more meaningful inspection findings.

Meaningful findings can provided a better basis for an overall performance assessment of these plants.

Senior Licensge Nuclear Officer One comment referred to the appointment of a senior license nuclear officer to settle disputes between organizational groups at a facility. The commenter objected to creation of such a special position, pointing out that it is a licensee's responsibility to establish a process for resolving disputes i between organizations.

Response

NRC agrees that it is not necessary to create a special position of senior-nuclear officer. The senior nuclear officer is intended to be the senior corporate officer with sufficient knowledge, training, and experience to exercise reasoned judgment in resolving disputes between organizations. NRC agrees that it is a licensee's responsibility to establish a process for resolving such disputes.

r

d 10 CFR 7Q.22(f) Recuirementa ,

one commenter opposed the inclusion of the requirements of 10 CFR 70.22(f), proposed in Recommendation 5.3.3, for plants processing only low enriched uranium.

Response

The NRC staff believes that the recommendation to apply 10 CFR

70. 22 ( f) to uranium fuel facilities has merit. If such a rulemaking is proposed, there will be additional opportunity for public comment.

The provisions of 10 CFR 70.22(f) place certain requirements on applicants for a license to possess and use special nuclear material in a plutonium processing and fuel fabrication plant.

These requirements include, in part, the submittal of a description of the plant site, a description and safety assessment of the design bases of the principal structure, systcms, and components of the plant, and a description of the quality assurance (QA) program. The QA program is applied to the design, fabrication, construction, testing and operation of the structures, systems, and components.

In proposing rulemaking to apply 10 CFR 70.22(f) to all fuel cycle facilities, NRC would take into consideration that these facilitica have been in operation for many years. Descriptions of plant sitas are already found in facility licenses. However, the extent of documented safety analyces of facility processes, systems, and structures varies. Licensees processing special nuclear material, producing uranium hexafluoride or uranium tetrafluoride, or possessing large quantities of radioactive material that could potentially be released offsite, should perform integrated safety analyses for their authorized activities.

Chanaeji_in Fuel Cycle Industry One commenter noted that Appendix A of the Task Force report stated that it was unlikely that there would be significant new fuel cycle facility or major materials manufacturing construction or major process changes over the next five or ten years. The-commenter pointed out that an application has been submitted, and is currently pending, for construction of a uranium enrichment facility, and that an application for another uranium enrichment facility is anticipated in the mid-1990s, i

Resoongg:

The comment is correct. However, the observation in Appendix A was addressed to the need to undertake major revisions of the licensing and inspection guidance documents for fuel cycle facilities and major materials licensees, noting that the-industry is evpected to remain fairly static for.a number of years. The development of the new uranium enrichment facilities l

is'already being addressed and the licensing and inspection L

guidance documents for those facilities are currently being written.

Priority Tasks One industry commenter generally agreed with the Task Force recommendations and submitted a list of five recommendations that it regards as the highest priority for implementation:

(1) Designate Project Managers;. (2) 10 CFR 50.59-type changes; (3) Resident Inspector Procedures; (4) Inspect Large Materials Processors with Fuel Cycle Procedures; and (5) Prelicensing Inspections. The commenter noted that impleme; station of those recommendations will enhance NRC/ licensee communication, increase the efficiency of safety reviews for facility modifications, improve consistency of inspections, and improve inspections, by emphasizing process safety as well as health physics.

Resnonse:

NRC agrees that these recommendations have merit. However, the limited availability of NRC staff resources requires that priorities be assigned to-the tasks based on safety need. The first four of the recommendations listed in this comment are among those assigned a high or medium priority. The fifth recommendation was assigned a low priority.

Dunlicative Reculation An industry group commented that there are a number of areas in which the industry is subject to regulatin,ns which duplicate or conflict with NRC regulations, e.g., by r,ther Federal agencies such as EPA, the Department of Transportation, OSHA, and by States. The comment ruggested that NRC should take a lead role in raising and reso'. viny such duplication.

Resoonse:

NRC agrees that duplication of regulation can impose financial burdens on licensees and can be confusing.- However, a number.of-agencies do have responsibility.and authority that sometimes overlap in the radioactive materials area. In most cases where there.is such overlap, NRC has entered into a Memorandum of Understanding with the other agency, in which there is agreement as to which agency will take the regulatrryLlead to avoid any unnecessary duplication. Similarly, in ataas in which there is the opportunity for coordination with State officials, NRC will considsr entering into instruments of cooperation.

Eyglgation of Operatinq Exoerience A public' group commented on the recommendation that NRC develop a program for evaluation of operating experience at fuel cycle and large materials plants. The comment supported the

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recommendation, proposing that the term " program" be more clearly defined in terms of goal, activities included, and responsibility ,

for management and direction. The comment also suggested that the recommendation should be more descriptive in terms of operating experience analysis, including purpose, scope, analytic technique, and use of results. Further, the comment noted that incomplete or inaccurate licensee event reports could lead NRC reviewers to erroneous conclusions, and hence analysis of operating experience based only on such reports should not be the only means of evaluating plant and management performance, but rather should be one of a number of parformance indicators used.

Response

NRC agrees that analysis of operating experience is an important cool, and has had a program in place for the analysis of such data for a number of years. In response to this recommendation, the N1C staff intends to evaluate the analytical review and feedback capability for fuel cycle and large materials plants and make revisions to the program as needed for safety improvements.

Updatina Licensino and Insoection Guidance One group commented on the need to maintain and make available guidance for license reviewers and inspectors that is consistent in quantity and quality. A public group supported the recommendation that NRC establish and staff an organization which is assigned direct responsibility for revision of inspection procedures and guidance, and for developing criteria for training courses for the NRC staff.

Resoonse:

NRC agrees that guidance and procedures used for licensing and inspection should be current, and has established priorities for updating the more important regulatory guides for fuel cycle facilities pursuant to other recommendations of the Task Force.

However, creation of a separate organization dedicated to maintaining regulatory guides and procedures is beyond current Staffing Capabilities, given the demands of other work necessary to meet more immediate safety needs and the extremely limited resources that are likely to be available in the foreseeable future.

Adecuacy of Resources one comment was received related to the adequacy of program resources, specifically funi cycle and nuclear materials inspection program resources. The commenter agreed with Recommendation 5.4.2 that a re-evaluation of staffing and technical assistance funding was necessary, but disagreed with the implication that the program goals, objectives, and activities should be modified to " conform to the available resources."

Response

Each year, during the budget formulation process, NRC evaluates the adequacy of each program's resourceo. For the fuel _ cycle and nuclear materials inspection program, much of the evaluation is based on the past experience as to what has been necessary~to conduct complete programs in accordance with guidance provided in applicable chapters of the NRC Inspection Manual. Decisions are made to reprogram resources within the fuel cycle and_ nuclear materials program-areas, or to increase or decrease resources, as needed to meet the changing demands of the licensing and inspection programs. _These decisions by the agency's top managers, based on recommendations by the staff, are made only after thorough review of work priorities and the likely impacts of deferring or not conducting certain activities.

Chances to NRC Policies and Procedures One commenter stated that Agreement States should not be required to adopt policy and procedure changes but should be provided the changes for consideration.

Response

Agreement States are not required to adopt policy and procedure changes unless they are codified in the regulations and made an item of compatibility. Those which are determined to be items of compatibility must-be adopted by the Agreement States, to ensure consistency with NRC requirerents. We agree that policy and.

procedure changes should be provided to'the Agreement States for l review and consideration, so that the States may_be cognizant of j changes being considered by NRC and so that NRC might receive the benefit of their comments on the proposed changes. It is the-existing egency practice to provide proposed pelicy and_ procedure changes to the Agreement States before their adoption by NRC.

l Use of ADoropriate Inspection Proc.edures l

One commenter stated that it would not be appropriatesto use an inadequate manual chapter (MC 2600) to define inspection.

activities at11arge materials plants in lieu of whatEwas described in the Task Force report te be another inadequate i manual chapter (MC 2800). Another c)mmenter disagreed with the-L Task Force conclusion that-MC 2800 is inappropriate for-inspecting large materials licensees, because health physics is i still a major consideration in assuring the safety of those i

operations.

Response

Revision of both manual chapters is needed and is planned.

c Development of procedures for inspection of large-non-fuel-cycle:

l- materials plants using' fuel cycle inspection concepts-will be included in this effort. The manufacturing-operations at most of 4

1- '

the large materials plants have a number of features that have ,

more in common with the complexity of the fuel cycle facilities than with a-laboratory operation or a doctor's office. Manual-Chapter 2800 was written to cover a wide range of licensed activities, from doctors' offices to foundries. The NRC staff believes that the development of inspection procedures for large materials plants based on the concep:s used for inspection of fuel cycle plants would better serve the needs of both the liceneaes and NRC.

Dif ferina Ir.8Dection Practices One commenter stated that inspection practices differ between NRC regions and between NRC and Agreement States, resulting in unfairness to licensees.

Resoonse:

There are, and likely will continue to be, some differences in inspection practices between regions, between individual inspectors within regions, and between NRC and Agreement State inspectors. However, NRC hrs established inspection procedures to provide for consistency in practices between and within regions as much as possible. Methods used include inspection program reviews (National Program Reviews), inspector accompaniments by headquarters personnel, and cross training of regional inspectors through team inspections and counterpart meetings. Consistency between NRC and Agreement States is encouraged through State personnel accompaniments on NRC inspections and State program reviaws by NRC State Liaison Officers.

NRC-OSHA Memorandum of Understandina One commenter stated that since radiation protection falls under occupational safety, that aspect of licensee operations should be turned over to OSHA and NRC should consider rastricting its activities to safeguards and criticality safaty.

Response

It appears that the commenter misinterpreted the NRC-OSHA Memorandum of Understanding, which states that bork NRC and OSHA have jurisdiction over occupational safety and he _ch at NRC-licensed facilities. Because it is not always practical to sharply delineate boundaries between the nuclear and radiological safety that NRC regulates and the. industrial safety that OSHA i

regulates, a coordinated interagency effort can ensure against gaps in the protection of workers and, at the same time, avoid duplication of effort.

There are four kinds of hazards that may be associated with NRC-licensed nucl..ar facilities:

l a. Radiation risk produced by radioactive materials; 6

b. Chemical risk produced by radioactive materials;

c. Plant conditions that affect the safety of radioactive materials and thus present an increased radiation risk to workers. For example, these might produce a fire or an explosion, and thereby causo a release of radioactive materials or an unsafe condition; and .

d. Plant conditions that result in an occupational risk, but do not affect the safety of licensed radioactive materials. For example, there might be exposure to toxic nonradioactive materials and other industrial hazards in the workplace.

Generally, NRC covers the first three hazards listed above, and OSHA covers the fourth. However, OSHA standards also cover employee exposures from all radiation sources not regulated by NRC. Examples include x-ray equipment, accelerators, accelerator-produced materials, electron microscopes and betatrons, and naturally occurring radioactive materials such as radium. It may have been this aspect of OSHA responsibility that led the commenter to misinterpret the NRC-OSHA Memorandum of Understanding. That agreement has resulted in a productive working relationship that will continue to aid in the protection of worker safety at NRC-licensed facilities, i

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