ML20207M753
| ML20207M753 | |
| Person / Time | |
|---|---|
| Issue date: | 03/01/1999 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-99-062, SECY-99-062-01, SECY-99-062-R, SECY-99-62, SECY-99-62-1, SECY-99-62-R, NUDOCS 9903190176 | |
| Download: ML20207M753 (50) | |
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REl. EASED TO THE PDR l
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a s e e e e e e e e e e e e e s e e e e e e POLICY ISSUE March 1.1999 (lnfOrmation)
SECY-99-062 FOR:
The Commissioners FROM:
William D. Travers Executive Director for Operations
SUBJECT:
NUCLEAR BYPRODUCT MATERIAL RISK REVIEW PURPOSE:
To inform the Commission of the staff's approach for identifying and documenting a methodology for determining a technical basis for risk-informed decisions on the regulation of nuclear byproduct material (i.e., risk assessment) and for developing plans for a graded approach to nuclear byproduct material regulation based on risk information (i.e., risk management). The nuclear byproduct material risk assessment is one piece of the overall approach described in a separate Commission paper, " Framework for Risk-Informed Regulation in the Office of Nuclear Material Safety and Safeguards."
SUMMARY
This paper addresses Commission direction transmitted by an April 15,1997, Staff Requirements Memorandum (SRM) related to Direction Setting issue 12 (DSI-12): " Risk-Informed, Performance-Based Regulation"(see Attachment 1) and Commission direction j
transmitted by an April 13,1998, SRM related to " improving NRC's Control Over, and Licensees' Accountability for, Generally and Specifically Licensed Devices"(see Attachment 2),
in response to those SRM's, the staff has initiated a process for development and implementation of a risk analysis methodology appropriate to the systems regulated under 10 CFR Parts 30-36 and 39. Pursuant to the Commission's request, this paper provides information about the current status and products of that effort. This paper also describes l
r'ONTACTS: Patricia K. Holahan, NMSS/IMNS (301) 415-8125 Betsy Ullrich, Rl/DNMS (610) 337-5040 Q 31 Q 6 990301 y y-jp 30 o
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The Commissioners 2
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4 those steps necessary to assure a firm foundation for application of the risk assessment methodology to materials systems, use of the iisk assessment methodology to explore the impacts of various regulatory options, and integration of the results of the risk assessment activities into the Office of Nuclear Material Safety and Safeguards (NMSS) ongoing effort to establish a framework for risk management.
BACKGROUND:
In an April 15,1997,SRM the Commission indicated that, in the future, the regulatory focus should be on those licensee activities that pose the greatest risk to the public. It further indicated that accomplishment of that focus would depend on increased use of probabilistic risk assessment concepts or other approaches that would allow a graded approach for determining high-and low-risk activities. The staff was directed to identify and prioritize areas of nuclear material regulation that were, or could be made amenable to, risk-informed, performance-based, l
or risk-informed, less-prescriptive, approaches, with minimal additional staff effort / resources.
Subsequent to initiation of staff activities in response to the SRM on DSI-12, the Commission further directed that the staff use the results of its activities to restructure current licensing and materials programs and, in particular, to consider the findings when determining whether additional sources / devices should be subject to registration and follow-up.
Part of the staff's response to the SRM on DSI-12 was the establishment of a Nuclear Regulatory Commission (NRC)/ Agreement State Working Group, referred to as the Nuclear Byproduct Material Risk Review Group (hereafter called NBMRRG). The scope of NBMRRG's activities was to encompass byproduct materials as defined in Section 11.e(1) of the Atomic Energy Act of 1954 and regulated under Title 10 of the U.S. Code of Federal Reaulations, j
Parts 30-36 and 39. NBMRRG's goals were to identify and document a technical basis for a risk-informed approach to regulation of materials within its scope and to develop plans for a graded approach to regulation of that material using risk information. NBMRRG's approach was to obtain systematic eva!uations of the " nuclear byproduct material systems" that fell within the scope of its efforts. Each system was to be characterized in terms of risk to workers and the public under normal and off-normal conditions. Existing and potential approaches and regulatory positions for addressing the risk associated with the nuclear byproduct material systems were to be identified and evaluated, and a model for a graded approach to regulation, including licensing and inspection, was to be developed. The evaluation was to include cost-benefit analyses comparing the model for a graded approach with the existing approaches.
The April 15,.1997 SRM also directed the staff to develop a framework for applying probabilistic risk assessment (PRA) to all nuclear material uses, including byproduct materials in review by NBMRRG, similar to the framework developed for application of PRA to reactor regulation. The staff concluded that the reactor framework using PRA was not directly applicable to all of the activities regulated by the Office of Nuclear Materials Safety and Safeguards (NMSS). The staff also concluded that the tasks of NBMRRG could not be fully addressed until such a framework was developed. A separate task group was assembled to (1) develop an appropriate framework j
of risk assessment methods for regulation of NMSS materials, and (2) make a preliminary identification of how the association risk assessment method could be used in a risk-informed e
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regulatory framework for nuclear materials regulation. The work of this task group is contained 1-in the Commission paper, " Framework for Risk-informed Regulation in the Office of Nuclear I
Material Safety and Safeguards."
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l DISCUSSION:
I At the outset of its task, NBMRRG recognized the challenge presented by the diverrity of 1
materials, activities, and uses of the byproduct materials within its scope. NBMRRG also recognized the challenge presented by the variability in the way that use of nuclear byproduct
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material was regulated. In response to those challenges, NBMRRG chose to organize the risk assessment and development of regulatory options on the basis of systems. That approach sttempted to categorize similar uses, types, forrns, and quantities of materials, together, regardless of the current regulatory basis. A preliminary list of such systems was developed at the outset of the risk assessment and has continued to be refined as the assessment progressed (see Attachment 3).
Major efforts after developing the preliminary list of systems, included:
1.
Obtaining the services of a contractor to assist the review group; 2.
Directing the contractor's efforts to develop and implement an approach to risk assessment that was appropriate for material systems; 3.
Documenting the bases (e.g., regulations, guidance, good practices) for existing barriers and administrative controls that work to limit worker and public exposure j
to radiation from nuclear byproduct material systems; and 4.
Surveying materials licensing and inspection personnel on typical worker doses; typ! cal events and frequencies; perceptions of safety; materials and quantities 4
typical of various systems; the existence and value of various barriers to dose; and the value of particular regulatory options.
l Risk assessment methodoloav. A working draft of the contractor's report on development and implementation of a risk assessment methodology for nuclear byproduct material systems is provided as Appendix 1 to a report by NBMRRG (see Attachment 4). After review of the working Craft, NBMRRG concluded that the approach developed by the contractor had a i
number o. potential strengths. Among the more important of the potential strengths were its 4
provision of a structured and repeatable risk methodology, its ability to provide risk metrics for workers and.the public under normal and off-normal conditions, its provision of a risk metric for lost sources, and its ability to focus on the highest-priority safety functions and regulatory options in managing the risk associated with each system. Additional potential strengths of the risk assessment methodology are listed in the aforementioned Attachment 4.
NBMRRG also identified a number of concems with the risk assessment developed and implemented by the contractor. One major concem was whether the risk methodology developed by the contractor was appropriate (i.e., was capable of providing reasonable and i
useful estimates of the radiologit..isk of materials systems). To confirm its appropriateness,
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The Commissioners 4
NBMRRG arranged for a peer review of the methodology by Dr. Charles Meinhold of the National Council on Radiation Protection and Measurements. Dr. Meinhold's comments on the contractor's risk assessment methodology are provided as Attachment 5. Those comments support a conclusion that the risk assessment methodology is appropriate for materials systems.
Other major concems involved: the completeness and accuracy of the system descriptions; the assumptions about system operation that were used as input to the individual risk assessments; the fact that only 26 of the approximately 40 nuclear byproduct material systems were analyzed using the contractor's quantitative (i.e., probabilistic) methodology; the extent of the uncertainty associated with the risk assessment of some systems; and the possibility that the current definitions of some systems are too broad to allow development of appropriate regulatory options across their full range. Additional concems about the risk assessment methodology are listed in Attachment 4.
The majority of the concems with the risk assessment methodology appeared to be the result of the limited time, resources and information available. In most cases, results for a given system are reported with an uncertainty of at least an order of magnitude, usually due to lack of data or completeness of detail; overall, the systems risks range over six orders of magnitude. [To date, the effort has resulted in: (1) development of a sophisticated risk assessment methodology that can be applied to a wide range of systems; (2) the collection of information that describes the majority of the nuclear byproduct material systems and their operation in those terrns required as input to the risk assessment; (3) implementation of the full risk assessment methodology for 26 of those systems; (4) implementation of a less complete risk assessment for the remaining systems; (5) prioritization of safety functions, in terms of risk, for 26 systems; and (6) development of regulatory options directed toward management of the risk associated with those 26 systems.] Resolution of the major concems with the risk assessment can be addressed in part by completing quantitative analyses of all systems - includiro subdividing several systems that, as currently defined, are too broad for results to be useful - and by a combination of in-house technical and public review to assure that input to the risk assessment methodology is adequate. Attachment 6 provides a schedule for completion of those activities.
This schedule does not address information collection to improve the uncertainties due to the limitation of data available.
Bases for barriers. Beginning with sets of contractor-identified barriers (i.e., engineering and administrative controls) that work to limit worker and public exposure to radiation from the nuclear byproduct material systems, NBMRRG identified the existing bases for those barriers (e.g., good practices, license conditions, and regulations intended to assure that barriers are in place). That information was documented in a draft report provided as Appendix 2 to AMachment 4. When finalized, the information in that document can serve as a basis for comparing current barriers and their bases with those barriers identified at important by the contractor. NBMRRG is concemed about the completeness of the draft listing of barriers and their bases. Resolution of that concem willinvolve peer and public review of the draft report on barriers. The schedule for those activities is included in Attachment 6 to this paper.
Survey of materials licensina and inspection personnel. NBMRRG conducted a survey of NRC and Agreement State licensing and inapection personnel. The survey asked about typical worker doses, typical events and frequencies, perceptions of safety, materials and quantities typical of various systems, the existence and value of various barriers to dose, and the value of
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particular regubtory options. A draft summary of the results of that survey are provided as 3
i Appendix 3 to Attacnment 4. The survey was system-based and linked to the systems assessed by the contractor. Survey results conceming annual worker dose and events associated with individual systems will be available for comparison with similar data developed
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for the contractor's risk assessment. Marked differences for any system may indicate the need for improving knowledge of that system. Results conceming the safety of the various systems are expected to provide a broader perspective about what is required to manage the risk associated with the various systems. Other survey resu!!s can also be compared with the j
results of the contractor's risk assessment. The staff has committed to the Organization of Agreement States to make draft results of the survey available for public review and comment.
The schedule for those activities is included in Attachment 6 to this paper.
Next Steos. To date the activities of the staff have focused on development and in.plementation of a methodology for assessing the risks associated with nuclear byproduct material systems.
Although there are concems, the risk methodology that has been developed has the potential to provide very useful information about the risks associated with byproduct materials systems as they exist under current regulations. The staff plans to resolve identified concems with the risk methodology through the process outlined in Attachment 6. The staff then plans to use the risk methodology to evaluate various regulatory options in terms of risk and burden to licensees and regulatory bodies.
Finally, the staff plans to integrate the results of the risk assessments of materials systems as they currently exist, and as those systems might exist if various regulatory options were exercised, with ongoing NMSS activities to establish a framework fer risk management. The byproduct materials activities reviewed by NBMRRG are the same as the " Group 4" regulated uses of nuclear materials defined by the framework task group. The work of this task group is contained in the Commission paper " Framework for Risk-informed Regulation in the Office of Nuclear Material Safety and Safeguards". For the Group 4 uses, the nuclear materials byproduct risk assessment will provide: development and application of a modified 4
hazard / barrier risk assessment method, risk assessment results using annual whole body dose as the risk metric, recommendations for regulatory approaches for several categories of accident consequences, and peer review of these issues. This information supports, in part, Step 1 (identification of specific regulatory applications that would be amenable to risk-informed regulatory approaches), Step 2 (modification of current regulatory approaches), and Step 5 (development of needed tools for risk assessment) of the implementation of the proposed framework for nuclear materials uses and disposal.
RESOURCES:
The staff estimates that continuation of the nuclear byproduct material risk review, as discussed above, will require additional resources of $500,000 and approximately 1 full-time equivalent position each year in FY 1999 and FY2000, which are not currently budgeted. The necessary resources will be accommodated within the budget by reprogramming funds from currently planned activities.
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l COORDINATION:
The Office of the General Counsel has reviewed this paper and has no legal objection. The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no objection. There is no information technology impact that would result directly from this paper.
D h_A %
William D. Tr' vers a
Executive Director for Operations Attachments:
- 1. SRM Dated 4/15/97
- 2. SRM Dated 4/13/98
- 3. List of Byproduct Systems
- 4. Dec.1998 RRG Report (Appendices 1, 2 & 4 to Comissioners and SECY only)
- 5. Letter from Charles Meinhold dated 12/15/98
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ATTACHMENT 1 i
SRM Dated 4/15/97 4
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APRIL 15,1997, STAFF REQUIREMENTS - COMSECY-96-061 - RISK-INFORMED, PERFORMANCE-BASED REGULATION (DSI-12) e y
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4 UNITED STATES a
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2056 5 0001 d
April 15, 1997
(*****,o MEMORANDUM TO:
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Joseph Callan Executive Director for Operations Karen D.
Cyr i
l General Counsel FROM:
Annette L. Vietti-Cook, Acting Secretary
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SUBJECT:
STAFF REQUIREMENTS - COMSECY-96-061 - RISK-INFORMED, PERFORMANCE-BASED REGULATION (DSI 12)
The Commission recognizes that, in order to accomplish the l
principal mission of the NRC in an efficient and cost-effective manner, it will in the future have a regulatory focus on those licensee activities that pose the greatest risk to the public.
This can be accomplished by building upon probabilistic risk assessment (PRA) concepts, where applicable, or other approaches that would allow a risk-graded approach for determining high-and low-risk activities.
In general, those activities that are of a higher risk should be the primary focus of the agency's efforts and resources.
The level of staff activity associated with lower i
risk activities should be determined based on a consideration of the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on agency and licensee efficiency.
The Commission continues to believe that the use of PRA technology should be increased in all regulatory matters to the extent supported by the state-of-the-art in PRA methods and data and in a manner that complements the NRC's deterministic approach and supports the NRC's traditional defense-in-depth philosophy.
The risk insights could be used to reduce unnecessary regulatory burdens as well as to identify areas where requirements should be increased.
The staff should continue with the current efforts, in cooperation with the industry (Option 1), including pilot The objective of this initiative is to obtain programs.
additional information regarding the appropriateness of a risk-informed, performance-based approach for the subject activities.
These activities and their schedule, are presently captured in the agency's PRA Implementation Plan.
As data from performance j
monitoring of structures, systems and components are accumulated, I
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l-should evaluate and clarify any technical and/or administrative issues associated with performance-based approaches to regulation l
(e.g., inspection activities, enforcement, etc.). Also, OGC's analysis of litigative risks requested in the Staff Requirements Memorandum on SECY-96-218 should be factored into future determinations and guidance on the extent to which the NRC i
implements risk-informed performance-based regulation.
(EDO/OGC)
(SECY Suspense:
8/29/97)
The staff should proceed in the direction of enhancing the PRA Implementation Plan (i.e., moving towards implementation of e'.ements of option 3) by building on the Regulatory Review G oup's (RRG) results, which were initially focused on reducing l
t i regulatory burden, with a more focused assessment of those r lations which are amenable to a risk-informed, performance-r ba...< or a risk-informed less prescriptive approach.
In determining the priority and scope of regulatory activities to be included in moving in the direction of partial implementation of Option 3, the staff should consider the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on NRC and licensee efficiency.
To minimize use of resources in any fresh look at the RRG results, such a review should be simply incorporated into the semiannual updates of the Commission's Rulemaking Activity Plan.
(EDO)
(SECY Suspense:
8/1/97)
The staff should also reexamine the applicability of its risk-informed, performance-based or risk-informed less prescriptive approaches with regard to nuclear material licensees and to high level waste issues, to ensure that the needs of those licensees and those areas receive adequate consideration.
The staff should perform a review of the basis for nuclear materials regulations and processes, and should identify and prioritize those areas that are either now, or could be made, amenable to risk-informed, performance-based or risk-informed less prescriptive approaches with minimal additional staff effort / resources.
This assessment
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should eventually lead to the development of a framework for applying PRA to nuclear material uses, similar to the one developed for reactor regulation (SECY-95-280), where appropriate.
(EDO)
(SECY Suspense:
10/1/97)
The staff should develop objective standard (s) for the application of risk-informed, performance-based and risk-informed less prescriptive approaches to regulations on an expedited
- basis, such standard (s) could be in the form of individual plant safety goals and subsidiary objective performance criteria as The staff should also describe how discussed in the issue paper.
f any relevant knowledge developed in the implementation of the maiatenance rule will be utilized in the development of risk-informed, performance-based regulation.
(SECY Suspense:
8/29/97)
-(EDO)
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j This Direction Setting Issue is closely related to DSI-11, Operating Reactor Program Oversight, and DSI-13, Role of Industry.
The staff should ensure that implementation plans developed for these' issues are mutually compatible and do not create duplicate activities.
1 cc:
Chairman Jackson Commissioner Rogers 3
Commissioner Dicus Commissioner Diaz j
Commissioner McGaffigan 1
s OCA OIG CIO CFO Office Directors, Regions, ACRS, ACNW, ASLBP E. Jordan (SARSC)
J. Silber (SARSC)
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APRIL 13,1998, STAFF REQUIREMENTS - SECY-97-273 - STAFF REQUIREMENTS - SECY-96-221 "lMPROVING NRC'S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR GENERALLY AND SPECIFICALLY LICENSED DEVICES" l
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UNITED STATES o
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April 13, 1998 Thadani Thompson i
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OFFICE OF THE Blaha SECRETARY Martin, AE0D Knapp, RES Lubinski, NMSS MEMORANDUM TO:
L. Joseph Callan i
Executive Director for Operations Jesse L. Funches Chief Financial Officer William M. Beecher, Director Office of Public Affairs i m.ArTT,
- 3.,, h;d FROM
'Annette L. Vietti-Cook, Acting Secretary I
SUBJECT:
STAFF REQUIREMENTS - SECY-97-273 - STAFF REQUIREMENTS - SECY-96-221
" IMPROVING NRC'S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR, I
GENERALLY AND SPECIFICALLY LICENSED DEVICES" The Commission had disapproved the staff's recommendation and directs the staff take the following actions:
- 8900090 and 9000192 (NMSS) 1.
Terminate the rulemaking on 10 CFR Part 31.5$ hat was initiated in 1991 except those provisions that will enable NRC to request information from certain general licensees to provide the regulatory basis for initiation of a registration program in advance of the rulemaking described below. Those portions of the 1991 proposed rule should be renoticed for public comment.
(200) (NMSS)
(SECY Suspense:
8/2W98) 9800070 8/14/98 2.
Provide a set of milestones to the Commission for information for implementing the rulemaking described below. The milestones should be in lieu of the standard rulemaking plan required by Management Directive 6.3, but should meet the requirement for coordination with Agreement States.
(500) (NMSS)
(SECY Suspense:
8/G4/98) 9800071 8/14/98 SECY NOTE: SECY-97-273 WAS RELEASED TO THE PUBLIC ON DECEMBER 2,1997.
THIS SRM AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
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Oraft a proposed rule to implement a registration and follow up program for the generally-licensed sources / devices identified by the NRC Agreement State Working Group, apply fees to these general licensees, and incorporate requirements for permanent tabeling of sourcesidevices. The proposed rule should include the staff's i
preferred approach - Attachment item 11, Option 3 - to apply a registration fee, per licensee, at the time of initial registration and annual re-registration of sources / devices.
The staff should explore the possibilities, advantages, and disadvantages of other fee approaches such as pro-rating the fees, e.g., per device (fixed or sliding scale) or per license and provide recommendations to the Commission. Determine the extent to which application of the small business rule will affect the fees.
(EDO/CFO)
(SECY Suspense:
42/31/08) 9800071 NMSS 12/24/98 4.
Use the results of the materials risk assessment study to restructure the current licensing and materials programs. Consider the findings when determining whether additional sourcer/ devices should be subject to registration and follow up, and for performing the risk ranking necessary if a phase-in approach is used to reduce the initial resource surge associated with an increased regulatory program. Review the basis of the generallicenses for adequacy with respect to consideration of the consequences of off-site accidents, such as loss of shielding or melting in metal making furnaces. The sta'f should provide the technical basis document for the risk assessment together with recommendations on how to proceed.
(SECY Suspense:
42/31/98) 9800090 12/24/98 5.
Include provisions in the registration program for follow up of cases where there are no j
l responses or where discrepancies are found between responses and NRC records.
Explore with vendors their willingness to voluntarily assist the NRC (and Agreement States) in the follow up effort. Develop follow up procedures which integrate the following fundamental concepts:
the extent of follow up should consider the risk to public health and safety that a.
the source or device in question poses as well as the likelihood of finding the device; b.
considering the associated level of risk, there should be a point at which the follow up of certain low risk sources and devices is terminated; allinformation about lost sources should be made public in a timely manner.
c.
(SECY Suspense:
concurrent with effective date 9800070 for final rufe)
Implement an enforcement program that includes a short amnesty program for general l
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licensees and increased civil penalties for both general and specific licensees for " lost" sources. The increased civil penalties should be significantly greater than the costs of proper disposal or transfer of a source or device. Work with Agreement States in
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- i implementing enforcement programs such that their policies, practices, and procedures have the same impact as NRC's enforcement program.
tE90) (NMSS/0E/SP)
(SECY Suspense:
cmcurrent with effective date 9800071 for final rule) l 7.
Provide an estimate of the resources needed to fully support this program. Preparation
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of this estimate should include:
Estimating resource needs for the various phases of the registration program o
including, in particular, the substantial" spike" of resources needed to carry out the follow up program.
Reviewing registratbn programs for general licensees that have been o
implemented by Agreement States for apficability of concepts, and exploring the possibility of utilizing other Federal agency registration programs and off-the-shelf commercial programs to minimize development and operatiag costs.
Exploring the possibility of contracting with the States to carry out this part of the o
progrnm under authority of Section 274i of the Atomic Energy Act, as amended.
identifying, through the Executive Council, resources to support the expanded o
program, and inform the Commission if other program areas need to be reduced.
The Executive Council should consider program areas outside of NMSS. The Executive Council should a!so evaluate and inform the Commission of the impact of this change on the Strategic Plan, Strategic Goals, and specific programs.
HiiGO) (NMSS/CFO)
(SECY Suspense:
42/91196) 9800091 12/24/98 8.
Continue efforts to further address the orphan sources. A guiding principle is that non-licensees who find themselves to be la possession of radiosctive sources that they did not seek to possess should not be expected or asked to assume rosponsibility and cost for exercising control or arranging for their disposal. These efforts should include:
Consulting with DOE, EPA, FEMA'and the States to define jurisdictions and o
regulatory responsibilities for addressing the orphan source problem, and cor tinued close coordination with the Conference of Radiation Control Program Directors to ensure that a similar regulatory framework is applied to source / devices containing Atomic Energy Act (AEA) material and sources / devices containing naturally-occurring or accelerator-produced radioactive material.
The staff should aggressively pursue finalizing the MOU with DOE.
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. Consider the pros and cons of establishing a contract program that would enable o
licensees or DOE to take possession of and arrange for proper transfer or dispt,al of orphan sources and provide an estimate of the costs of such a program.
(SECY Suspense:
12/3148) 9800092 12/24/98 if NRC funding is necessary for an orphan source recovery program, the staff o
should provide recommendations for funding the program including, as directed by the Commission in its December 1996 SRM, " exploring with Congress the possibility of removing specific program cocts from the NRC's user fee base (e.g., orphan source recovery fund)."
(CFO)
(SECY Suspense:
12/31/98)
The Office of Public Affairs should issue a press release concerning the Commission's decision.
(OPA)
(SECY Suspense:
4/15/98) 1 Chairman Jackson Commissioner Dieus i
Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OlG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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ATTACHMENT 3 4
List of Byproduct Systems i
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LIST OF SYSTEMS AS USED IN THE SURVEY OF NUCLEAR REGULATORY COMMISSION AND AGREEMENT STATE MATERIALS LICENSING AND INSPECTION PERSONNEL l
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LIST OF SYSTEMS AS USED IN THE SURVEY OF NUCLEAR REGULATORY COMMISSION AND AGREEMENT STATE MATERIALS LICENSING AND INSPECTION PERSONNEL
- 1.
Research and development synthesis laboratories 2.
Research and development laboratories using carbon, hydrogen, iodine, phosphorous, and sulfur 3.
In-vitro laboratory testing 4.
10 CFR 35.100 - nuclear medicine and human use research 5.
10 CFR 35.200 - nuclear medicine with generator (s) 6.
10 CFR 35.200 - nuclear medicine without a generator 7.
10 CFR 35.300 - nuclear medicine B.
Brachytherapy using seeds 9.
Brachytherapy - manual afterloading 10.
Brachytherapy -low dose rate remote afterloading 11.
Brachytherapy - high dose rate remote afterloading 12.
Brachytherapy - eye applicator 13.
10 CFR 35.500 - diagnostic devices 14.
Teletherapy devices 15.
Gamma stereotactic surgery 16.
Nuclear pharmacies 17.
Veterinary use 18.
R&D on animals 19.
Well logging - tracers and field flood studies 20.
Well logging - using sealed sources 21.
Radiography - permanent installation 22.
Radiography - field use 23.
Pool irradiators 24.
Self-shielded irradiators 25.
Fixed gauges - gamma emitters 26.
Fixed gauges - beta emitters 27.
Portable gauges 28.
X-ray fluorescence devices 29.
Gas chromatographs
' Currently there are minor variations in the lists of systems in the contractor's working draft report, the staff's documentation of barriers, and the survey of materials licensing and inspection personnel. The system lists in the contractor's final report and the staff's final report on barriers will be reconciled before completion of the risk review. Survey results will be interpreted with respect to that reconciled list of systems.
2 30.
Other measuring devices 31.
Small sealed sources or devices (e.g., those used under a general license) 32.
Very small sealed sources or devices (e.g., those used under an exemption) 33.
Manufacturing or distribution of devices containing sealed sources 34.
Manufacturing of sources containing solids 35.
Manufacturing of sources containing liquids 36.
Manufacturing of sources containing gases 37.
Incineration of waste 38.
Compacting of waste 39.
Packaging of waste 40.
Solidification of waste l
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ATTACHMENT 4 December 1998 RRG Report l
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ATTACHMENT 4:
DECEMBER 1998 REPORT OF THE NUCLEAR BYPRODUCT MATERIAL RISK REVIEW GROUP i
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DECEMBER 1998 REPORT OF THE NUCLEAR BYPRODUCT MATERIAL RISK REVIEW GROUP
- 1. BACKGROUND One of the Direction Setting issues (DSis)in the Commission's Strategic Assessment and Rebaselining initiative was " Risk-informed, Performance-Based Regulation"(DSI-12). The Commission transmitted its views on the matters discussed in DSI-12 to the staff in an April 15,1997, Staff Requirements Memorandum (SRM). The SRM expressed the Commission's general view that:
1.
To accomplish the principal mission of the Nuclear Regulatory Commission (NRC) in an efficier 2 and cost-effective manner, it will, in the future, have a regulatory focus on those licenue activities that pose the greatest risk to the public; 2.
This focus can be accomplished by building upon probabilistic risk assessment (PRA) concepts, where applicable, or other approaches that would allow a risk-graded approach for determining high-and low-risk activities; and 3.
The use of PRA technology should be increased in all regulatory matters to the extent supported by the state-of-the-art in PRA methods and data and in a manner that complements the NRC's deterministic approach and supports NRC's traditional defense-in-depth philosophy.
With respect to activities within the purview of the Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, the April 15,1997, SRM related to DSI-12 stated:
The staff should... reexamine the applicability of its risk-informed, performance-based or risk-informed less prescriptive approaches with regard to nuclear material licensees..., to ensure that the needs of those licensees... receive adequate consideration. The staff should perform a review of the basis for the nuclear materials regulations and processes, and should identify and prioritize those areas that are either now, or could be made, amenable to risk-informed, performance-based or risk-informed less prescriptive approaches with minimal additional staff effort / resources. This assessment should eventuaiiy lead to the development of a framework for applying PRA to nuclear material uses, similar to the one developed for reactor regulation (SECY-95-280), where appropriate.
Subsequent to the SRM related to DSI-12 and to initiation of staff activities to respond to that SRM, the Commission issued an SRM related to *lmproving NRC's Control Over, and Licensee's Accountability for Generally and Specifically Licensed Devices " That SRM implicitly acknowledged initiation of staff actions in response to the SRM related to DSI-12 and stated:
Use the results of the materials risk assessment study to restructure the current licensing and materials programs. Consider the findings when determining whether additional sources / devices should be subject to registration and follow-up, and for performing the risk ranking necessary if a phase-in approach is used to reduce the initial resource surge associated with an increased regulatory program. Review the basis of the generallicenses for adequacy with respect to consideration of the consequences of off site accidents, such as loss of shielding or melting in metal making furnaces. The staff should provide the technical basis document for the risk assessment together with recommendations on how to proceed.
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Among the staff's responses to the SRM related to risk-informed, performance-based regulation, was establishment of an NRC/ Agreement State Working Group. This was known as the Nuclear Byproduct Material Risk Review Group (hereafter the Group), and included John Lubinski, John Randall, and Dennis Serig from NRC Headquarters, Elizabeth Ullrich from NRC Region I, and Nancy Daugherty from the Agreement State of Colorado. The Group's expertise encompassed health physics, mechanical l'
engineering, risk and reliability engineering, byproduct material licensing and inspection, and human l-
' factors.
The scope of the Group's efforts was to encompass by,3roduct materials as defined in Section 11.e(1) of I
the Atomic Energy Act of 1954, and Title 10 of the U.S. Code of Federal Reoulations (CFR) Section l
30.4, and addressed by 10 CFR Parts 30-36 and 39. The Group's goals with respect to those materials were to:
1.
Identify and document a technical basis for a risk-informed approach to the regulation of nuclear byproduct material; and l
2.
Develop plans for a graded approach to nuclear byproduct material regulation, based on j
riskinformation.
1 The Group's approach was to obtain systematic evaluations of the " nuclear byproduct matenal systems' that fell within the scope of its efforts. The nuclear byproduct material systems were to be defined as broadly as necessary, to identify the real-world risks associated with them. The approach was to be an iterative process and wks intendec to include:
1.
A multi-dimensional characterization of risk associated with nuclear byproduct material l
systems in the form of a matrix that would allow ranking of those systems in terms of low, medium, and high risk. This would include consideration of risk f actors to be taken into account when regulating byproduct material such as doses to occupational workers and the public and the likelihood (probability) and potential severity (consequence) of events (including contamination cleanup).
2.
Use of qualitative and, to the extent possible and reasonable, quantitative tools to identify and evaluate risks associated with nuclear byproduct material systems and l
development of an analytical risk-ranking model by applying the criteria developed in 1, above, to categorize each system.
3.
Identification and evaluation of existing and potential technical approaches and regalatory positions for addressing the risk associated with nuclear byproduct material systems.
4.
Integration of the analytical risk ranking model with the identified technical and regulatory positions into a model for a graded approach to regulation, including licensing and inspection.
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Cost-benefit analyses comparing the model for a graded approach to regulation with the l
existing approach to regulation.
The 3roup initiated a number of actions intended to provide the information necessary to meet its goals.
I The first was to evaluate the scope of Section 11.e(1) (of the Atomic Energy Act of 1954) activities encompassed by the effort and to develop a preliminary list of approximately 40 " systems" (see l
subsequent discussion). The second action was to develop a statemen; of work and request for proposals and to select a contractor to refine the preliminary list of systems and to develop and j
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implement an appropriate risk assessment methodology. The third action was to monitor the progress of the contractor in development and implementation of a risk assessment of the approximately 40 systems determined to fall within the scope of 11.e(1) activities. Monitoring of the contractor's efforts identified the neeGI for the staff to provide substantial assistance regarding 11.e(1) activities. That assistance included identification and documentation of current means for supporting barriers intended to limit worker and public exposure to radation from nuclear byproduct material systems (e.g., regulations, license conditions, guidance, goM oractices, etc.). The f ourth action was to develop, implement, summarize, and evaluate the raponses to a survey of NRC and Agreement State materials licensing and inspection personnel regarding the safety of the nuclear byproduct material systems. A working draft of the contractor's report on development and implementation of the risk assessment methodology for nuclear byproduct material systems is provided as Appendix 1 to this report. Drafts of the Group's identification of current barriers intended to limit worker and public exposure to radiation from nuclear byproduct material systems and the Group's summary of responses to its survey of NRC and Agreement State materials licensing and inspection personnal are provided as Appendices 2 and 3 to this report.
- 2. DISCUSSION At the outset of its activities, the Group recognized the diversity of types, forms, and quantities of nuclear byproduct materials encompassed by Section 11.e(1) of the Atomic Energy Act of 1954. For example, unsealed materials are typically used in microcurie or millicurie quantities in laboratories and in nuclear medicine. Sealed sources may be found in microcurie or smaller quantities as calibration sources and in products such as wrist watches and smoke detectors, in millburie quantities in devices such as gas chromatographs and portable gauges, and in curie quantities in devices such as tritium exit signs, fixed i
gauges, radiography devices, and medical devices. The Group also recognized the diversity of approaches to regulation of nuclear byproduct materials. All specific licensees regulated by NRC must comply with the requirements of 10 CFR Part 19 (notices, instructions, and reports to workers); 10 CFR Part 20 (standards f or protection against radiation); and 10 CFR Part 30 (rules of geaeral applicability... ). Manufacturing, radiography, medical uses, panoramic irradiators, and well-logging are also addressed by dedicated parts of 10 CFR (Parts 32,34,35,36, and 39, respectively). Those chapters describe regulations for specific ticensing of the subject's uses of nuclear byproduct materials.
In addition, Part 32 requires that the design for all devices and sealed sources be reviewed and registered before distribution.
The Group also recognized that some devices incorporating nuclear byproduct materials, usually as sealed sources, are exempt from the regulatory requirements of 10 CFR. Other devices incorporating nuclear byproduct materials, again, usually as sealed sources, are generally-licensed and are subject to only limited requirements under certain sections of 10 CFR Part 31 and, for some uses, referenced sections of Parts 19,20, or 30. Some States require registration of some types of generally licensed devices. The issue of differing approaches to regulation is further confused by the f act that some devices incorporating nuclear byproduct materials, such as gas chromatographs, fixed gauges, and in-vitro kits, may, depending on minor vatiations in design or who the user is assumed to be, be either specifically-or generally-licensed.
Given the diverse uses, quantities, and approaches to regulation, the Group chose, as noted above, to organize the risk assessment on the basis of systems. That approach attempted to categorize similar uses, types, forms, and quantities together, regardless of the current regulatory basis. Those systems were not bounded by the way nuclear byproduct materials are currently regulated not by what various
- types" of licensees do with the nuclear byproduct materials that they possess. Any licensee may use nuclear byproduct materials from one or more systems. For example, medicallicensees may use unsealed materials for diagnostic scans (Systems 4 and 5 in the contractor's report; Systems 5 and 6 in the Group's survey of NRC and Agreement State materials licensing and inspection personnel), and may simultaneously have self-shielded irradiators (System 21 in the contractor's report; System 24 in the
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Group's survey of NRC and Agreement State materials licensing and inspection personnel) for sterilization of blood, small sealed sources for calibration of instruments (System 29 in the contractor's report; System 31 in the Group's survey of NRC and Agreement State materials licensing and inspection personnel), and a laboratory where in-vitro testing is performed (System 3 in both the contractor's report and the Group's survey of NRC and Agreement State materials licensing and inspection personnel).
The risk assessment required description of each of the r'uclear byproduct material systems. It was recognized that, as implemented, those systems reflected past and current regulatory positions and practices (e.g., rules, license conditions, guidance) as well as good practices developed by users over i
the years. Thus, it was inevitable that accurate descriptions of the systems would also reflect current and past regulations and good practices, it was also recognized that there was variability in the way that some of the nuclear byproduct material systems were regulated. For example, the nickel-63 sealed source in an electron capture detector used in a gas chromatograph (System 27 in the contractor's report; System 29 in the Group's survey of NRC and Agreement State materials licensing and inspection personnel) may be generally-or specifically-licensed, depending on variations in design. However, i
because the basic designs of the generally-and specifically-licensed devices, as well as the use of the material, are similar, many of the barriers intended to limit radiation exposure from the devices, regardless of how they are licensed, are similar. The risk assessment approach for such systems was intended to be free of consideration of variations in the ways that they were regulated. Thus, regardless of any variations in the way a system was regulated, the description and risk analysis of that system were to include consideration of all the barriers typical to that system. Similarly, the exploration of regulatory options for a system was tc identify those barriers necessary and sufficient to maintain doses at specified levels without regard to the current approach or approaches to regulation of that system.
i Contract efforts. Scientech, Inc., was awarded a contract to assist the Group on December 31,1997.
Scientech's tasks included:
1.
Developing a risk assessment methodology that could be applied to each of the systems; included within the scope of the review; 2.
Acquiring information about each system in order to understand and describe its hazard (s), potential dose receptors, and the barriers that work to limit exposure of the receptors to the hazard (s), as well as other information naeded to exercise the risk assessment methodology that was developed; and 3.
Using information from the system descriptions and risk assessments to identify important barriers for each system and to identify regulatory options that would work to control risk by supporting those barriers.
A working draft report of the results of Scientech's efforts is provided as Appendix 1. "lho report describes the approach to risk evaluation developed by Scientech; provides a summary of the risk evaluation results for each sysmi, including development of regulatory options; and summarizes results across all systems.
The Group has completed preliminary review of Scientech's working draft and has concluded that the approach developed for risk assessment of materials systems has a number of potential strengths.
Among the potential strengths are:
1.
Provision of a structured and repeatable risk methodology.
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Provision of risk metrics for both worker and public under normal (i.e., all barriers and controls intact) and off-normal (i.e., one or more barrier breached) conditions; 3.
Provision of a risk metric for lost sources; 4.
Linkage of dose and risk information system to safety functions and to the barriers and administrative controls needed to support those functions; 5.
Prioritization of safety functions (i.e., source strength, shielding, confinement, and access) with respect to Csk; 6.
Identification and prioritization of regulatory options that support the barriers and administrative controls necessary to manage risk; 7.
Development of a structured, repeatable risk evaluation methodology; 8.
Ability to perform sensitivity analyses; 9.
Ability (given sufficient data) to perform uncertainty analyses; 10.
Ability to define, evaluate, and develop regulatory options for subsystems of the current systems or of entirely new systems; 11.
The possibility of identifying and evaluating the performance-based regulatory options.
12.
A peer review of the methodology by Dr. Charles Meinhold of the National Council on Radiation Protection anc' Measurements, whose comments support a conclusion that the risk assessment methodology is appropriate for materials systems.
Despite the potential strengths of the risk evaluation methodology developed and implemented by Scientech, review of the draft report identified a number of concems about the current status of that effort. Among those concems are:
1.
The level of understanding of the scope of the activities (i.e., the system description) for a number of systems does not yet appear adequate and the completeness and accuracy of the system descriptions may be questioned; 2.
The impact of the limited quantity of available data relevant to the operation and risk of materials systems, and the impact of limited access to those data that do exist; 3.
The impact of inconsistencies in, and the, questionable quality of the data on, materials systems that are available; 4.
Confidence in assumptions about the systems and scenarios describing their operation; 5.
Largii unquantified and/or unsupported uncertainties; 6.
Linkage between the dose and risk metrics and the approach for identifying and prioritizing regulatory options; and
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The possibility that, as currently defined, some of the nuclear byproduct material systems are so broad (e.g., encompass a range of material activities from microcuries to hundreds of curies) that consideration of multiple regulatory options would be appropriate; and 8.
Lack of evaluation of whether current variations in the regulation of particular systems are appropriate.
9.
Only 26 nuclear byproduct material systems were evak.Ved quantitatively, whereas the others were evaluated qualitatively or evaluation was det ned, awaiting the results of a t
separate study.
Given the idercified concems with the status of the contractor's efforts, the Group concludes that, although the potential of the approach has been demonstrated, that potential has not yet been realized to an extent sufficient to support regulatory decision-making. Several actions are needed to facilitate implementation of the methodology such that it can serve its intended function. The actions include:
1.
Confirmation of the appropriateness and adequacy of the methodologies for risk evaluation and development of regulatory options through peer and public review (peer review completed December 17,1998).
2.
Confirmation and improvement of the data and assumptions about each system that are critical to the risk evaluation and development of regulatory options.
3.
Quantitative evaluation of those systems currently evaluated qualitatively.
4.
Improvement of the methodology and upgrade of the information and assumptions about the systems based on the review processes and quantitative evaluation of additional systems.
5.
Evaluation of whether con 't.t variations in the regulation of particular systems are appropriate.
Basis for barriers. Beginning with sets of cc... actor identified barriers (i.e., engineered and administrative controls) that work to limit worker and public exposure to radiation from the nuclear byproduct material systems, the Group identified the existing basis for barriers (e.g., good practices, license conditions, and regulations intended tc assure that barriers are in place). Appendix 2 reports the results of that effort. The strengths of the current identification of support for barriers are:
1.
- The basis for cum-Jit barriers in each system are identified; and 2.
The current barriers and their current basis can be compared with the barriers identified by the contractor report.
Those strengths are balanced by several concems. They ace:
1.
The completeness of the current listing of barriers; and 2.
The completeness of the current listing of bases for barriers, in the case of the basis for barriers, resolution of the concerns requires peer and public review of the current document for accuracy and completeness of identification.
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i Survev of materials licensina and insoection oersennel. The Group conducted a survey of NRC and Agreement State materials licensing and inspection personnel. The survey was developed to confirm and augment information gathered by the contractor and to assist in development of plans for a graded approach to nuclear byproduct material regulation informed by risk. The survey asked about typical
- worker doses; typical events and frequencies; perceptions of safety; materials and quantities typical of various systems; the existence and value of various barriers to dose; and the value of particular regulatory options. The final contractor report will address most of those same areas, thus allowing comparison of results. The Group received 41 responses to its survey of licensing and inspection personnel. Twenty-two were from Agreement State personnel and 19 were from NRC personnel. Data from the responses were entered into a spread sheet for analysis. The spread sheet was modified, as data entry progressed, to accommodate the fullest possible range of responses (e.g., to expand coding of data to include responses that were not consistent with instructions, but that appeared to be useful).
Comments that could not be entered into the spread sheet, but that could affect the data analysis, were noted.
The strengths of the survey were:
1.
System-based, linked to systems assessed by the contractor and in the documentation of the basis for barriers intended to limit exposure; 2.
Tapped professional opinions of NRC and Agreement State materials licensing and inspection personnel; 3.
Asked about distribution of doses received by workers within a system; 4.
Asked about perceived safety of systems; 5.
Asked about basis for safety perceptions; 6.
Permitted analysis of the respondents' views of safety; 7.
Asked specifically about the types and quantities of radionuclides used in selected j
systems; 8.
Asked about the perceived value of various regulatory options for selected systems; 9.
Asked about opinions conceming issues related to the actions of regulatory agencies in decision-making; 10.
Permitted respondents to indicate where they lacked sufficient knowledge to respond to a question; and 11.
Accommodated responses beyond those anticipated by the design of the survey.
The weaknesses of the survey were:
1.
Limited to professional opinions rather than to responses based on reference to documented sources of information; 2.
Some questions asked respondents to imagine the effects of conditions that they could not have experienced (e.g., the safety of material systems in the absence of current regulations),
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Several survey questions asked respondents to state their opinions about the " safety" of nuclear byproduct material systems without defining safety or providing a link between safety and risk; and 4.
Variations in respondents' interpretations of " safe."
Results of the survey indicate consistency in the respondents' opinions about the distribution of annual doses to workers in the various nuclear byproduct material systems and their opinions about the safety of those systems. However, for the respondents, safety appears to include a number of dimensions beyond those that formally define risk (i.e., likelihood and consequence). With a few notable exceptions, ranking of systems based on an annual dose estimate for individual workers c'erived from the contractor's working draft report, and a ranking of the same systems, based on dose information obtained from the survey of NRC and Agreement State materials licensing and inspection personnel were fairly similar (see Appendix 3 for results of a preliminary comparison). A more complete discussion of the results of the survey is found in Appendix 4.
- 3. CONCLUSION Consistent with the Commission's direction in the April 15,1998, SRM related to DSI 12, the staff has initiated a process intended to place appropriate regulatory focus on the activities of materials licensees that pose the greatest risk to the public. That initiative includes development and implementation of a risk assessment methodology appropriate to materials systems and review of the basis for nuclear materials regulations. In the staff's judgment, the initiative has tne potential for identification of those areas that are either now, or could be made, amenable to risk informed, performance-based, or risk-informed, less-prescriptive approaches to regulation.
Consistent with the Group's charter, draft documents identify the basis for current regulation of nuclear byproduct material systems and document a technical basis for a risk informed approach to the regulation of nuclear byproduct material. The group did not develop plans for a graded approach to nuclear byproduct material regulation, but the results of the quantitative risk assessments of nuclear byproduct materials activities can be used for this purpose when appropriate context is provided by NMSS's risk management efforts associated with DSI-12. Additional actions that are required in order to provide risk information that is adequate for use in the risk management effort include technical review of the systems for completeness and accuracy, review of the data and assumptions on which the risk assessments are based for an understanding of the certainty of the evaluation and to identify if additional data is needed, and completion of quantitative risk assessments for nuclear byproduct materials systems that have nnt been evaluated.
In the review Group's judgment, ti,e next phase of the risk review activities should focus on resolution of identified concems with the risk methodology and its implementation. Upon completion of those activities, the risk review should proceed to exploration of the impacts of various regulatory options on risk and on the burdens to licensees and regulators. Finally, the risk review should integrate the results of the risk as'sessments of systems, both as those systems currently exist and as they might exist if various regulatory options were exercised, with ongoing NMSS activities designed to establish a framework for risk management.
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l APPENDIX 1 TO ATTACHMENT 4: CONTRACTOR'S 12/98 WORKING DRAFT - RISK ANALYSIS AND EVALUATION OF REGULATORY OPTIONS FOR NUCLEAR BYPRODUCT MATERIAL SYSTEMS (under separate cover) j I
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i APPENDIX 2 TO ATTACHMENT 4: BASIS FOR BARRIERS (under separate cover) 1 r
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APPENDIX 3 TO ATTACHMENT 4: PRELIMINARY COMPARISON OF SYSTEM RANKINGS WITH RESPECT TO RISK DEVELOPED FROM THE CONTRACTOR WORKING DRAFT REPORT AND THE RESULTS OF THE SURVEY OF NRC AND AGREEMENT STATE MATERIALS LICENSING AND INSPECTION PERSONNEL l
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Componeon of System Ranks Somed on Survey and CanWessor Annual Does Esnmeses to workera l.
System System lewnbar Syomm feems tes pose en survey)
Reung-Rank Rank" l
(survey)
(survey)
(Scionesch)
Number (Scientsch)
(Survey) 785 41b 882 i
I 22 40 8W""8d ""'*** """""8 '#8 362 34 32 auC888'Ph*""*C"'
355 2
14 16 15 10 CFR 36.300. nucteer messine with generatorts) 5 4
,294 3
5 ose graphy. pen enent enstatesuon 262 4
9 r
21 19
""8
" " ****"""""8 236 35 33 prochytherapy.menuel et.J :mg 231 5
3 9
8 1
manutecturing of sources contamme games 223 y
to CFR 36.300. nuclear enessano 211 0
12 i
7 6
I nucteer leunenes 210 wellleggm9.essers one Aete Race stumese 171 7
6 99 p
manufactunne or L
- of e consommg essase sources 167 5
19 j
10 CFR 36.300. nucteer meemme without e -- -
155 0
4 GBrechytherapy uomg esses 154 q
g 7
- H 18998a0 M**9 ***888 * "'5**
135 10 8
20 18
'**"*8*8 # "**"
128 il I
j 30 37 l
W88 125 i
17 16 i
schelRcemen of wtom j11 12 26 g
3g 10 CFR 36.100. nucteer enemme one human i. e resserch 102 4
y D'*ChVth*'*PV I *88 ** '888 '** ** *#*'8 d*9 91 13 13 10 9
compecene of weste se 14 10 38 36 sonene ou.
m se j
15 13 erschytherapy high some row semon.Lume 76 15 18 11 10
=Doyrhes. =. _
N 1
27 65 17 N
23 20 MD on om 63 18 25 Pon*De pus **
56 18 H
27 24 erschyinerapy. eye opphcoto' 56 12 M
56 14 12 encemen W
44 2
23 37 35 10 CFR 36.400.seegnests oevsee 42 g
3, II N
N 28 26 MD le6...n unang corson, hydrogen, comme, pnosphorus, and outtur N
21 22 2
2 10 CFR 36.500. enognostic ew g3, 3g ernau eseM sources w eences (e.e, m W under a generse-m 2,
31 29 20 22 I'
25 22
- *h"88'd 8"88'***'*
13 23 2
l 24 21 seat g uges e is e st*'*
11 24 15 26 23 Poes 1
_ ~ _ _..
_______.m.
I Companoon ct System Ranks Based on Survey and Conversar Annual Dose E semates to worters
h*'****"""8d*"***
11 M
28 M
9 25 24 3
3 1
988 Chr m88 9'8Ph*
6 26 25 29 27 very oman seated sourses of devges (e.g.,those used under en esempuon) 5
' Survey reung is bened on the mean eeumated annual dose fee indrvidual workers for each l
system calculated from peopwndents opinions.
The rev6ew group recognized that, in caculaung thow means uomg the unequal class intervais prov6ded to the respondents, tow done estwnstos received less we6ght than h6gh t
does setsnates.
WhHe this wee recoghtged as reducing the value of the mean se an endcator of annual dose to workers,it wee judged to be "close enough" to developing a rank 6ng of systems for a "ballpark" comparson of survey results with contractor resuhs.
- The "Scientsch" rank wee dertved from, but is not the same as the rank shown in the contractors soport.
The rank here is the annual worker dose estNnate fortved by Scaentech dMded by the smaller number of persone in the range of people over which Sc6entsch 6nd6cated that the dose might be detributed.
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APPENDIX 4 TO ATTACHMENT 4: PRELIMINARY RESULTS OF SURVEY OF NRC AND AGREEMENT STATE MATERIALS LICENSING AND INSPECTION PERSONNEL (under separate cover) i i
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i ATTACHMENT 5 Letter from Charles Meinhold Dated 12/15/98 l
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i ATTACHMENT 5:
DECEMBER 15,1998, LETTER FROM CHARLES B. MEINHOLD, NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENT, TO DENNIS SERIG, U.S. NUCLEAR REGULATORY COMMISSION, SUBJECT PEER REVIEW OF THE METHODOLOGY AND ITS APPLICATION AS DESCRIBED IN THE 9-18-98 DRAFT NUREG ENTITLED," RISK ANALYSIS AND EVALUATION OF REGULATORY OPTIONS FOR NUCLEAR BY-PRODUCT MATERIAL SYSTEMS,";....
N C R R National Council on Radiation Protection and Measurements President: Charies B. Meinhold, Vlce President: S James Adelstein, Executive Director: William M Beckner 7A10 Woodmort Avenue, Sune 800, Bethesda, Maryland 208143095 Vece- (301) 657 2652 Fax: (301) 907 8768 e-tr. ail nerp@ncrp com http]/www nerp com scnentmc Vke etee60 erne BaseCnterna Esud.moobey Ramonology and Rrsk 5 T""" '
5' n a' "'
December 15,1998 ewonm.n nian a
Corpomen C"a.io, ca 5" Dr. Dennis I. Serig Technical Monitor Senior Human Factors Analyst
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Office of Nuclear Material Safety LwaceResp msyResearch y;=g and Safeguards gu,,= u=
U.S. Nuclear Regulatory Commission TWFN Mail Stop 8 F5 won emon ZlI',,'d".'l"t m.
Washington, DC 20555 0001 E.flI"u'""'
fMB) 343738
Subject:
Peer Review of The Methodology and Its Application As Described in the 9-18-98 draft NUREG entitled, " Risk Analysis and oy,,. m w, g,a A.
Evaluation of Regulatory Options for Nuclear By Product ga,",y g gp==
Material Systems,"; Contract No. NRC-02-98-001, " Nuclear 7l,ga=
Byproduct Material Risk Review," JCN J5215 euwe e*y w R.* conn,.ca.on N"O'a
Dear Dr. Serig:
m n.a As part of Modification 4 of the subject contract, I have reviewed in detail
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the 9-18-98 draft NUREG entitled, " Risk Analysis and Evaluation of Regulatory Options for Nuclear By-Product Material Systems," which was prepared for the "fl 7 " """""
I"1".".l"s",.m m rg Nuclear Regulatory Commission by Scientech, Inc.
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For many years the nuclear related industries have questioned the how Vosh NY 10014 efficacy of the regulatory burden placed on licensees by the Nuclear Regulatory Commission. At the same time any licensing authority is responsible to the n,,. p
,,,,c,n, lga^ 7,,, Q nation for ensuring that their licensees act responsibly in protecting workers, gg members of the public and the environment. The objective of reconciling these l
= = s
two apparent differences is the objective of this study.
%"CL The approach taken in this document exceeds admirably in developing naoomanewee wase an engineering based approach to evaluating the appropriate level of regulatory
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oversite based primarily on the radionuclides used, the quantities involved, together with all of the radiological engineering and radiological protection elements used to limit exposure to these materials. The database which A nonoovemmen.
supports this effort is extensive. For each task (receipt, f;torage use) within a cong
- med,
- o,,_,n
. - _.. _ _ _ _.__ _. _ _ _ _.__ -._ _._ m -. _
Page 2 - Serig 12/15/98 licensing category (or " system," as used in the report) i.e., laboratory use (R&D, unsealed, i
J synthesis quantities) through irradiators (pool) the potential exposure is calculated for the full family of sequences involving the loss of protection functions (shielding, containment, failure of the radiation protection program, etc.). This database forms the cornerstone of the effort.
Given the potential exposure, the authors are able to develop levels of exposure as they relate to the nature and extent of the required regulatory response. These range from highly prescriptive regulatory requirements to the implied reliance on the licensee need to provide a safe and healthful workplace when the potential exposures are below those of regulatory
)
concern.
This overall approach has enormous potential. Clearly there are policy issues involved in the selection of the doses used for the various classifications of regulatory requirements.
j The authors have suggested quite reasonable values which should promote helpful discussion.
The methodology and assumptions needed to calculate the miriad scenarios are given j
1 in general terms in the main body of the report but the effected communities (the regulators, the licensees, the workers and members of the public) need to have access to the detailed information on these topics as given in the database. Whilo a few of the input values were i
i spehily reviewed and appeared to be reasonable, people familiar with each specific category should carefully review the assumption used in calculating the potential doses. Although the assumptions are technically defensible and carefully referenced when the information is available, having these reviewed by experts in each category is a necessary extension of this work. -
The draft provides an important step in developing the data and an approach to reducing the regulatory burden while ensuring the safety of the worker and the public are ensured. One additional point is that the need to address perceived risks is mentioned in the draft but not included in the final analysis. The implication which I believe is implied is to expect the licensee to provide the level of protection they need to reduce the potential for pub concern and potentiallitigation.
In summary, an excellent approach and a report which provides the detail necessary for the Commission to begin a process of extending this work in a manner that will ensure the overall objectives of reducing the burden and still ensuring the health of the worker and the public.
Sincerely yours,
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M Charles B. Meinhold President D. Umbel, PO, NRC T-8-A-23 ec:
R. Mann, NRC T-7-12 J. Meyer, SCIENTECH, Inc.
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ATTACHMENT 6 Preliminary Schedule
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ATTACHMENT 6:
PRELIMINARY SCHECULE FOR COMPLETION OF THE NUCLEAR BYPRODUCT MATERIAL RISK REVIEW S
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PRELIMINARY SCMEDULE FOR COMPLETION OF THE NUCLEAR BYPRODUCT MATERIAL RISK REVIEW s
March 1999 Complete in-house technical review of the working draft of the contractor's risk assessment.
1 Complete in-house review of draft document on basis for barriers.
April 1999 Complete quantitative analyses of systems not yet analyzed quantitatively and of severa! subsystems of systems that are currently defined too broadly (defer quantitative analyses of systems addressed by Oak Ridge project on exempt devices and quantities until publication of draft report on that project in May 1999).
Complete draft summary of results of survey of materials licensing and inspection personnel.
1 May 1999 Complete final draft of contractor report for public co-nent.
Complete final draft of document on basis for barriers, or public comment.
June 1999 Publish draft contractor report, for public comment.
Publish draft doument on basis for barriers, for public cnnmer,t.
Publish draft summary of results of survey of materials licensing and inspection personnel, for public comment.
Septemoer 1999 Complete finalization of draft contractor's report, document on basis of barriers, and results of survey, based en public comments.
October 1999 Complete nuclear byproduct material risk review report, integrating results of the contractor effort, document on basis for barriers, and survey results into a consolidated risk assessment of nuclear byproduct material systems for incorporation into the Nuclear Materials Safety and Safeguards wide risk management effort associated with risk informed and performance-based regulation.
Put'lish final contractor's report as NUREG/CR.
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