ML20205L649
| ML20205L649 | |
| Person / Time | |
|---|---|
| Issue date: | 04/01/1999 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Inhofe J SENATE, ENVIRONMENT & PUBLIC WORKS |
| Shared Package | |
| ML20205L652 | List: |
| References | |
| NUDOCS 9904140232 | |
| Download: ML20205L649 (72) | |
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{ i wAsHlNGTON. D. C. 20655 (yi; April 1, 1999 g ..... p 3 CHAIRMAN The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wet! ands, Private Property, and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, D.C. 20510
Dear Mr. Chairman:
Thank you for the opportunity to appear before your Subcommittee on February 4,1999, to discuss the Nuclear Regulatory Commission's programs. I am enclosing the NRC responses to the post-hearing questions that were transmitted by your letter of February 26,1999. Please contact me if I can be of further assistance.
Sincerely
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?!l'QW.J y Shirley Ann Jackson
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Enclosure:
As Stated 1
cc: Senator Bob Graham i
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9904140232 990401 PDR COMMS NRCC CORRESPONDENCE PDR 4VV'5 J
A e
QUESTION 1 During the Hearing, Chaimian Jackson discussed a long range plan for reforming the agency. How does this plan relate to the Tasking Memo?
If they are different, please suppy a copy of the long-range plan, in addition, please explain the difference between the two plans or the two goals.
ANSWER.
The NRC's long-range plan for reforming the agency is embodied in an integrated Planning, Budgeting, and Pedormance Management (PSPM) process. This process, implemented with the P 2')00 budget cycle, sets the operational framework for the agency to manage its programs and operations. Key components are: the Strategic Plan, the Pedormance Plan, the Budget and Operating Plans. We are updating the agency's planning documents to reflect the new directions, goals and strategy for the agency. The PBPM approach will ensure that current changes wfl be institutionalized in a manner that ensures long-term organizational effectiveness. Our latest draft Strategic Plan will be shared with stakeholders, including Congress, for comment.
The August 7,1998 Tasking Memorandum to the NRC staff established an aggressive agenda for accelerating changes already underway at the NRC, and making immediate additional, significant changes and improvements in a number of key areas. The specific actions and schedules in the tasking memorandum are incorporated into program Operating Plans. The !
updated Strategic Plan and Performance Plan will capture the higher level performance measures, goals and strategies associated with thees and other initiatives. l Senator Inhofe l
i OUESTION 2. Can you provide a list of those regulatory activities that the NRC directly bills its licensees? How much of yourles income is derived from each activity? What percent of your fee income is derived from direct service fees?
ANSWER.
The NRC assesses two types of fees to its licensees: 10 CFR Part 170 fees for activities performed for a specific licensee or applicant (based on Independent Offices Appropriation Act) and 10 CFR Part 171 annual fees for the remainder of NRC's budget (based on the Omnibus Budget Reconciliation Act of 1990). Part 170 fees are assessed for inspections and licensing activities, including pre-application efforts and reviews of new license applications, renewal I applications, amendment requests, topical reports, standard plant designs, and decommissioning plans. The annual fee recovers NRC's other regulatory costs that are not recovered from Part 170 fees (e.g., research, rulemaking, and incident response). The Part 170 fees collected in FY 1998 by the two main classes of licensees are:
l CLASSES LICENSING INSPECTION TOTAL REACTORS $28.2M $59.6M $87.8M MATERIALS $7.5M $4.3M $11.8M l TOTAL $35.7M $63.9M $99.6M For FY 1998, of the total $459M collected in fees, $99.6M, or 22 percent was collected from Part 170 fees.
Senator Inhofe
QUESTION 2(A) Th3 NEl witn:ss, Mr. Colvin, stit:d thtt n: rly 80% of your f::s era not j directly tied to a particular service provided by the NRC. Do you agree l
with that figure? .
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l ANSWER.
No. The NRC mission to ensure the adequate protection of the public health and safety l
recognizes that the NRC serves a broader need than just providing a specific service to a ,
licensee or applicant. As stated in the response to the previous Question 2, approximately 20 i i
percent of our budgeted costs are recovered through fees for licensing and inspection activities '
performed by the NRC for specific licensees and applicants (10 CFR Part 170 fees). However, this does not mean that the remaining 80 percent does not benefit our licensees or the public or is not necessary for the NRC to provide regulatory oversight. For the NRC to carry out its mission, it must perform certain functions that are not requested by specific licensees or applicants, but which are, in fact, a service provided to categories or groups of licensees. For example, we must perform rulemaking, safety research and generic studies and maintain an incident respc,nse center. Such actions, either directly or indirectly, are of benefit to certain groups of licensees. The NRC does make an effort in assessing such fees to attribute these costs to the groups of licensees receiving the generic benefits of these regulatory activities.
Also some costs, such as for licensing and inspection services provided to Federal agencies and nonprofit educational institutions, are recovered through annual fees because we are precluded by law or policy from charging fees to those organizations.
Senator Inhofe L
OUESTION 2fB) Has the amount of general fees increased as a percent of total fees 1
charged to licensees over the past fiv6 years? If so, would the NRC provide an analysis explaining the change?
ANSWER.
l The percentage of fees collected through Part 171 annual fees (general fees) to total fees has j remained relatively constant over the past 5 years. Over the past two years, the Commission !
has made decisions which will result in an increase in Part 170 fee collections, shifting costs I l away from annual fees. These decisions recognize that, with few exceptions, agency work directly identifiable to a licensee should be billed to that licensee. As a result of this change, the !
NRC estimated Part 170 fee collection for FY 1999 will be approximately $10 million more than FY 1998. The Commission will be proposing rule changes which would result in further increased collection of Part 170 fees.
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Senator Inhofe
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- i QUESTION 2(C) Do you agree with the industry's position that your fees need to be more directly tied to services performed? does your current fee structure comply with the 1990 Omnibus Budget Reconciliation Act's requirement that fees be related to services performed?
ANSWER.
We agree, in general, that an identifiable licensee or applicant who receives agency services should be billed accordingly. This objective is not always attainable for legal and policy reasons. For example, current law precludes us from charging Federal agencies Part 170 fees, and public comments have supported continuing to recover costs for certain activities through Part 171 annual fees. As stated in the response to the previous question 2(B), over the past two years, the Commission has changed its policies so that more costs will be recovered directly from specific licensees and applicants. However, when NRC activitin have a generic l relationship to a group of licensees, NRC sees nothing inequitable about appo,tioning the costs of those activities to the appropriate group of licensees through Part 171 annual fees.
Our current fee structure complies with the provisions of the Independent Offices Appropriation Act and the Omnibus Budget Reconciliation Act of 1990. The inspector General has recently issued an audit report that concluded that one area, Part 170 hourly rates, needs to be reviewed to assure compliance with the full costs provisions of OMB Circu;ar A-25," User Charges." The CFO is initiating a study by a multi-office team to review this matter.
1 Senator Inhofe
l QUESTION 2(D) Doesn't it make sense, from both a safety and policy point of view, that those licensees that are necessitating the most regulatory action be assessedinore fees?
1 ANSWER.
l Yes. Iri general, licensees that require more licensing and inspection attention will be assessed l
more foes under 10 CFR Part 170. In developing the annual fees by category, we also take into consideration where the generic resources are being used and charge those categories of l
licensees accordingly. Therefore, in both Part 170 and Part 171 fee assessments, the charges l
/epresent either a directly identifiable benefit or a reasonable relationship to the NRC's cost of l
providing the regulatory service to the licensee. However, to meet the 100 percent fee recovery requirement, the NRC's annual fees include costs for activities that do not directly benefit l licensees. These activities are discussed in response to Chairman inhofe's Question 3.
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l Senator Inhofe t
QUESTION 2(E) Do you believe that your budget submissions as well as your annual rule regarding fee schedules provide adeq'uate information for the industry and others to analyze, understand, and critique those submissions?
a ANSWER.
The budget submissions and our annual fee rules provide sufficient information for our licensees and other interested parties to analyze, understand and critique our submissions.
Each year public comments are solicited on an annual proposed fee rule which describes the development of the proposed fees and outlines the Part 170 and Part 171 fee amounts. The final fee rule provides a response to those comments. Each year when a proposed rule is issued, a copy with a summary of the proposed changes is mailed to each licensee so that they may quickly assess the impact of the rule. A copy of all working papers providing backup data and other detailed information on the development of the fees is made available for public review in the NRC public document room. Additionally, the agency responds to maray inquires on its fee policies and practices and periodically meets with individual licensees to discuss particular issues.
Because the Commission has decided to rebaseline its fees in FY 1999, the Commission has directed the staff to ensure that the proposed fee rule provides sufficient information for allits licensees to analyze and understand. Rebaselining fees could result in significant changes to the anr ual fees for many NRC licensees.
Senator Inhofe
QUESTION 3 You have agreed in previous hearings that certain portions of your budget, such as the international programs, should not be included in the user fees. Please submit to the Subcommittee a list of those programs, and their budgets, that do not directly benefit licensees, for FY 1999 and FY 2000.
ANSWER.
1 The following chart lists programs and their budgets that do not directly benefit licensees.
These programs typically provide either a significant indirect benefit to our licensees or are essential for the NRC to effectively carry out its mission to protect public health and safety and common defense and ".ecurity. These estimates include direct costs as well as the overhead and agency general and administrative costs of providing these services. Estimates for direct costs reflect resource allocations developed for the FY 1999 enacted budget and for ths FY 2000 President's Budget. Estimates for overhead and administrative costs are based on hourly rates established by the 1998 fee rule and do not reflect changes that may result from the final 1999 fee rule.
i Senator Inhofe I
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2 ACTWITIES PROPOSED FOR FEE sure aamaON j (Dollars in Millions)
FY 1999 Bu6pt FY 2000 Budget e Activity Estimate Estimate Regulation of Federal Agencies 3.0 3.0 Regulation of NonproN Educahonal inattuhons 3.8 3.8 Regulation of Small Entities 5.2 5.2 Regulatory Support to Agreement States 12.4 11.0 Site C+:_. --0.si Management Program 5.7 7.4 Generic Decomnuessoning and Reclamaton AcJvities 10.7 10.7 Intemational Activities 4.2 5.0 Agreement State Ove;aight 5.5 5.3 TOTAL 50.5 51.4 I
i Senator Inhofe
QUESTION 4 At the hearing, Chairman Jackson indested Gutt the license renewal application for the Calvert Cliffs Plant would be, barring any glitches, completed in 25 months, well ahead of the proposed 30-36 month 1
schedule is the lack of intervention on the Calvert Cliffs application primarily responsible for the reduction in schedule? Are there improvements that can be made in the NRC review process to further reduce the schedule?
ANSWER.
The Commission denied the only petition for intervention in the Calvert Cliffs license renewal proceeding. Therefore, there will not be an adjudicatory hearing in this proceeding. This is the principal factor in the reduction in schedule to 25 months. There may be additional opportunities to improve the NRC renewal schedule for Calvert Cliffs and Oconee. After the NRC issues the renewal safety evaluation report, the staff will meet with the licensees for Calvert Cliffs and Oconee, Baltimore Gas and Electric (BGE) and Duke Energy, respectively, to discuss the scone of safety issues that need to be resolved and review ance revise, as appropriate, tile scope of the license renewal reviews and schedule milestones. It should be noted that the intervention petitioner has sought judicial review of the Commission's decision to deny intervention. That issue is currently before the D.C. Circuit Court of Appeals.
The NRC is developing experience from the review of the first two renewal applications, as well as the resolution of generic renewal issues and technical reports, which will achieve further efficiencies in the future.
Senator Inhofe
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l QUESTION 5 Aging of nuclear power plants is an ongoing process. Many existing licensee programs as well as enenfs of NRC's regulatory oversight s focus on ensuring that aging is not detrimental to the safe operation of the plants. In fact, the foundation for the license renewal regulation is that continuation of current licensing basis activities and regulatory oversight ensure the public health and safety as plants move beyond 40 years of operation.
Given this principle,is the focus of the NRC review of a renewal application on the aging that is not being managed under the current license? Is the Calvert Cliffs review being conducted in this manner? If it is not, can the proccss be made even more efficient without impacting safety?
ANSWER.
The focus of the NRC's review of the renewal applications is the adequacy of the aging management programs for specific passive structures and components needed to ensure safe plant operation for the period of extended operation. The renewal rule reflects a focused review because those parts of the existing licensing basis related to active components, system design, operating margins, emergency plans, security and other matters that do not involve aging are excluded from the scope of review under 10 CFR 54. Moreover, where a renewal applicant proposes to rely on existing maintenance and surveillance programs to manage aging effects for the structures and components within the renewal review scope, the NRC's review Senator Inhofe
r j QUESTION 5 2 l
l effort is limited to a determination of whether there is an aspect of aging that is not being adequately managed. The staff is currently examining this aspect of its reviews to determine whether changes to its review process are appropnate.
The NRC is developing experience from the review of the first two renewal applications, as well as the resolution of generic renewalissues and technical reports, which will achieve further efficiencies in the future. In particular, the NRC staff is developing a matrix of the common aging management elements for each of the major existing maintenance and surveillance programs. This effort is intended to improve the review guidance for the NRC staff so thEt their efforts will be focused even more than that provided by the 1995 amendment to the license -
4 renewal rule such that further efficiencies can be achieved.
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Senator Inhofe
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, QUESTION 6 When will the Commission reach a decision regarding the options that were presented to you by staff for risk-informing your regulations and i
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when do you believe you will complete the process of risk-informing all of your regulatkms?
ANSWER. i l
The options were presented to the Commission in SECY-98-300 for nuclear reactor regulations.
l The Office of the Secretary of the Commission anticipates that a decision on these options will be finalizecawithin the next several weeks. These estimates range from approximately 4 to 8 years depending on the option, or combination of options, the Commission chooses.
l Senator Inhofe l
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! OUESTION 7 What do you believe the impact of risk-informing your regulations will be on your budget submissions in the upcoming years? Should Congress
, expect those submissions to reflect increases or decreases once the process of risk-informing your regulations is complete? 1 ANSWER.
l l The process of reviewing risk-informed reactor licensee submittals (as allowed by current regulations) and the update of risk-informed guidance docaments is' ongoing, and these l activities are already reflected in the current NRC budget.
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With respect to the effort to modify reactor regulations, the budget impact will vary as the j project progresses. The NRC expects that resource expenditures to risk-inform our regulations l will be higher in the first few years, with lower expenditures in subsequent years due to the i benefits of a more efficient process in the areas of licensing reviews, inspection, and l t
enforcement. These lower expenditures in later years are expected to more than compensate ;
for the initial, higher expenditures.
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The NRC staff has presented preliminary estimates of resource expenditures in SECY 98-300 for risk-informing the NRC reactor regulations. The impact on the budget ovel the upcoming l years will be dependent on the option, or combinations of options, that the Commission decides i on over the next several weeks. These decisions will be integrated into the Planning, l
l Budgeting, and Performance Management Process which will identify the specific activities needed and the resource allocations to deliver the improvements.
Senator Inhofe
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QUESTION 7 2
' l For materials regulations, it is anticipated that, as with risk-informing reactor regulations, the resource expenditures for some materials areas will initially be higher in the first few years, and expenditures in the subsequent years may vary depending on the type of licensed activity and the outcome of the risk assessments.
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l Senator Inhofe
QUESTION 8 in promulgating rules, what is the Commission's policy on the timing and availability of implementation, inspection and enforcement guidance? Is
.s draft guidance available when a proposed rule is noticed for comment, or is guidance developed after a rule has been finalized?
ANSWER, The Commission policy is t ., when possible, the draft guidance on implementation, inspection, and enforcement should be available when the proposed rule is published. Some rules are sufficiently simple or clear so that additional guidance on compliance is not needed.
When industry standards are cited in a rule, NRC-specific guidance may not be nece ssary. In come instances guidance may be developed after publication of the final rule. Industry may take the initiative in developing guidance for implementing a rule and that guidanco may be endorsed by the NRC. In some instances, the effective implementation date of the rule may be linked to the publication date of the guidance document.
Senator Inhofe
QUESTION 9 The NRC paper (SECY-99-007) recommending changes to the oversight process (assessment, inspection, and enforcement) is about 500 pages
, long. Is that much detail necessary to improve the clarity, consistency, and objectivity of the process? Is the Commission satisfied with the direction and progress on reforming the NRC's oversight process?
ANSWER.
The level of detail provided in SECY-99-007 is necessary. SECY-99-007 proposes a substantially revised process for overseeing the performance of commercial operating reactors.
In addition to describing high level concepts related to the overall oversight framework and approach, it describes specific proposed changes to the agency's inspection, assessment, and enforcement processes. SECY-99-007 r 3rves as the primary vehicle for making !
recommendations available to stakeholders for review and comment. The level of detail included in the Commission paper is necessary to provide an understanding of the recommendations along with supporting rationale to enable respondents to provide meaningful commern. The NRC also has prepared a condensed summary of the proposed process.
Having said this, the Commission did direct the staff to ensure future papers associated with the new oversight process are prepared in accordance with Vice President Gore's " Plain English" initiative.
Although the Commission is generally satisfied with the direction taken by the staff in developing revisions to the reactor oversight process, the Commission is continuing its review of the proposed revisions and considering additional information provided by the NRC staff in Senator Inhofe
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QiSTION 9 2 i
March 1999. While many significant challenges remain for the NRC and the industry associated with completing process development and successfully ti ansitioning to full implementation, progress made to date has been good and will support timely completion of this important initiative.
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Senator Inhofe
l QUESTION 10(A) How are you ensuring that the principles embodied in the revised i
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' inspection, and enforcement? i i 1 ANSWF3 The NRC will ensure that the oversight process improvement initiative results in a consistent approach to assessment, inspection, and enforcement by: (1) developing an overarching hierarchical framework for the reactor oversight process along with high level principles regarding process design, (2) developing the inspection, assessment, and enforcement processes in accordance with the framework and principles, (3) incorporating outcome oriented criteria for assessing performance, (4) ensuring the transparency and scrutability of the process, and (5) routinely monitoring and evaluating the NRC performance against performance measures. This approach has been and will continue to be used by the NRC, working with various stakeholders, as the agency completes development and integration of the various p.ocesses. This need for consistency will be a principal focus of NRC headquarters systematic and ongoing review of regional operations.
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I OUESTION 10(B) What specific changes are you planning to make to the enforcement
! process to improve its safety focus?
I ANSWER.
Effective March 11,1999, the NRC changed the way it addresses relatively non risk significant violations (i.e., Severity Level IV violations) for operating reactors. The Commission recently approved revising the enforcement policy to change the treatment of Severity Level IV violations providing that except under limited, defined circumstances, individual Severity Level IV violations will normally result in Non-Cited violations. Additionally, closure of most Severity Level IV violations will be based on their having been entered into a licensee's corrective action program.
l Importantly, this change does not change the expectation of compliance with NRC i
requirements but it does recognize the relatively low risk significance of these violations and the fact that most licensees generally resolve these issues in their corrective action programs commensurate with their safety significance. The net effect we expect is that licensee and l NRC resources will be better utilized and available to focus on issues with greater risk i significance.
Additional changes in our Enforcement Policy for both escalated and non-escalated issues are being considered as part of our ongoing efforts to redefine inspection and performance assessment processes. These proposed changes are intended to integrate effectively the reactor oversight processes of inspection, assessment, enforcement and reporting and Senator Inhofe
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- l OUESTION 10(B) 2 contribute to a more risk-informed performance-based regulatory process. We will be prepared to discuss these changes during the September 1999 hearing.
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Senator Inhofe l
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V QUESTION 10fC) What have you decided regarding the term " regulatory significance"? If i
you are retaining the term, have you tiefined it? How is " regulatory significance" different from " safety significance *?
l ANSWER.
The concept of regulatory significance encompasses 1) aggregation of violations,2) willful violations including violations associated with discrimination issues, and 3) violations that impede the regulatory process such as reporting violations. Regulatory significance is a subset of safety significance. As used in aggregating violations, it addresses recurring or related violations for which, because of their programmatic nature and potential impact on safety, the ;
i root causes associated with the violations are more significant than their actual consequences. j l
l The staff is developing a proposal for the Commission concerning the use of " regulatory significance." The staff does not intend to continue the use of the term. The aggregation of violations will not need to be used for reactor violations considered under the assessment process. It may continue to be used for other violations but with a closer nexus to safety consistent with the current staff practice as described in Enforcement Guidance Memorandum 98-009 issued on November 25,1998. Violations involving willfulness and those that impede the regulatory process will be considered without the label of regulatory significance.
i Senator Inhofe
OUESTION 11(A) When does the NRC plan to systematically assess the risk basis for cask licensing to ensure current and new rdquirements are focused on those areas that can be demonstrated to have an impact on safety?
ANSWER.
The NRC's Spent Fuel Project Office (SFPO) staff continually uses available risk information and insights in assessing current and new regulations impacting storage and transportatioil cask safety.
The staff has continually used risk information to upgrade its regulatory framework to clarify and improve the current storage regulations and to ensure that the NRC regulatory program focuses on safety. For example, in preparing a conforming change to 10 CFR 72.48 (concerning a change process sirnitar to 10 CFR 50.59), the staff proposed to expand the scope of the regulation to include the certificate of compliance holders in addition to the current licensees.
After assessing comments from the industry, the staff decided to change this regulation further to ensure consistency and enhance usefulness, not only in the storage reculations, but in the transportation regulations as well.
Also, the staff made early efforts during the 1970's to apply risk assessment for the analysis of transportation risk, most notably, in the " Final Environmental Statement on the Transportation of Radioactive Material by Air and Other Modes"(NUREG-0170), and " Shipping Container Response to Severe Highway and Railway Accident Conditions" (NUREG/CR-4829, also known as the " Modal Study"). More recently, the staff has applied probabilistic risk assessment in 4
Senator Inhofe
I QUESTION 11(A) 2 deciding to approve the one-time shipment of the Trojan reactor pressure vessel, with internals, 1
i for disposal at the U.S. Ecology site in the State of Washington. Also, the staff has nearly completed its re-validation of NUREG-0170 in li@t of proposed shipments of spent fuel to a repository (vs. reprocessing). The rewalidation effort should be completed by the last quarter of FY99 and includes a computer evaluation of cask response to severe accidenta and probabilities, the use of current health effects models, and studies of population distributions along likely shipment routes. The staff intends to use the results of NUREG-0170 re-validation in its efforts to update the Modal Study for the new generation of dual-purpose cask designs.
The Modal Study update will focus on confirming severe accident probabilities and effects and will likely include partial or full-scale package tests. Moreover, the staff is encour:ging more risk informed decision-making with the U.S. Department of Transportation and the International Atomic Energy Agency. In addition, the staff intends to continue to use risk information in irnplementing its regulatory decisions.
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Senator Inhofe
u QUESTION 11(B) How and when does the Commission plan to address generic issues in cask licensing, e.g., higher burn-up fuels, better estimates of leakage rates and approval of innovative design approaches, that are impacting private fuel storage licensing, plans for licensing an interim storage facility, and decommissioning plants?
1 ANSWER.
The NRC's Spent Fuel Project Office (SFPO) staff is currently addressing a number of generic issues related to dry cask storage certification and licensing, as well as transportation package approvals. Last year, the staff began to augment its standard review plans with interim staff guidance documents (ISGs) to come to quick decisions about technical and regulatory issues without waiting for the standard review plan to be updated. This allowed the staff to continue its review with a sound technical or regulatory decision on a real-time basis. Currently, seven ;
ISGs are in place and cover a range of topics. This information is available to all members of the public on the NRC Internet site.
Other ISGs are currently being developed, in cooperation with industry representatives, related to various generic topics; e.g., high burn-up fuels, burn-up credit, contents, rod buckling, and codes and standards. These ISGs are expected to be completed within the next 3 to 6 months, long before the lack of such guidance would impact licensing of Private Fuel Storage, L.L.C.,
(PFS), the Central Interim Storage Facility, or plant decommissioning. These ISGs and future ones will enhance the technical and regulatory review for licensing independent spent fuel storage installations and certification of dry cask storage systems and transportation packages.
I Senator Inhofe
QUESTidN 11(B) 2 Prior to issuing an ISG, the staff typically discusses the ISG with industry representatives and other stakeholders at a widely attended publicly noticed gathering. For example, the ISGs in progress were discussed at a public industry workshop on March 2,1999, attended by approximately 150 persons. Moreover, at this meeting, SFPO staff repeated that it does not desire to stifle innovative design approaches that meet the current regulatory framework. The I
staff does stress, however, that any innovative designs must be openly discussed with the staff and must meet the regulatory requirements that ensure public health and safety. Finally, the industry itself must develop issue-specific criteria and provide supporting data to the NRC so that the staff can develop an enhanced regulatory approach.
l The staff will always consider an exemption to the regulations provided assurance of the public health and safety is maintained. Notably, the Department of Energy - Idaho Operations Office requested and was granted an exemption to the 10 CFR Part 72 seismic requirements which I
was based, in part, on probabilistic information provided by the Department. Additionally, to l preclude the need for further similar exemptions, the staff is working to modify its seismic and geologic requirements for siting an independent spent fuel storage installation.
i In a related matter, PFS was required to complete a thorough seismic study for its site characterization work which had not been completed at the time of the application. This is not a generic issue, but is related specifically to the information required to be in the PFS application concerning the site chosen by PFS.
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Senator Inhofe
QUESTION 11(C) How does the Commission plan to address these generic concerns without impacting the NRC's ambitious schedule for licensing new cask designs?
ANSWER. '
The NRC's Spent Fuel Project Office (SFPO) staff is working on a number of issues in parallel with its technical and regulatory activities. While SFPO staff considers safety-oriented casework to be its prime focus and highest priority, staff has been directed to develop resolution to those issues that may impact or impede reaching a technical or regulatory decision.
Where required, the SFPO staff has sought assistance from others. For example, NRC's Office 1
of Nuclear Regulatory Research is assisting in researching burn-up credit for final regulatory I action. As stated in the response to Question 11(B), the staff is developing interim staff guidance so that an interim, but safe, regulatory decision can be reached prior to the Office of Nuclear Regulatory Research completing its review.
Additionally, during FY 1998, the Department of Energy provided the NRC with $4 million for the purpose of licensing a multi-purpose canister (MPC) design. The DOE is now using a market-driven approach in which private entities will apply to NRC for approval of spent fuel storage and transportation designs, and therefore DOE has no further interest in obtaining NRC approval for the MPC design. The NRC is now working with the Appropriations Committees to allow use of these funds for review of applications from private industry for approval of dual Senator Inhofe l
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! OUESTION 11(C) 2 purpose canisters and other generic activities pertaining to 5anisters for the transportation, storage or disposal of high-level radioactive waste and spent nuclear fuel.
l Senator Inhofe l
QUESTION 12 (A) The backfit rule is a critical tool to assess the risk posed by permanently shut down plants. When will the NRC apply its backfit rule to all rules and guidance impacting decommissioning plants?
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! (B) When will the Commission provide guidance addressing the reduced risk posed by shutdown plants to ensure the critical Ie approvals needed to proceed with decommissioning can be in place 1-2 months after a plant shuts down?
ANSWER.
(A) The Commission has approved the development of a backfit rule (or modification to 10 CFR 50.109, as appropriate) specific to plants undergoing decommissioning consistent ,
l with other competing priorities. In the interim, the Commission has directed the staff to j continue to apply the current backfit rule to the extent practicable to plants undergoing decommissioning.
j (B) In March 1999, the NRC initiated a reevaluation of all ongoing decommissioning rulemaking activities to ensure that the reduced risk associated with permanently shutdown reactors was properly reflected in all decommissioning requirements. A public meeting with Nuclear Energy Institute representatives has been scheduled to solicit industry assistance in determining the level of risk posed by these plants and the associated time periods after which many regulatory requirements may be reduced. A new risk-informed framework and schedules for these rules are expected by mid-1999.
l Senator Inhofe
QUESTION 13(A) is the NRC currently contemplating any changes to the physical safety requirements placed on nuclear plants?
ANSWER.
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The staff has proposed, and the Commission is considering, changes in the safeguards performance assessment process to better utilize industry and NRC resources while at the same time assuring that plants maintain an appropriate level of readiness. Depending upon the approach chosen by the Commission, changes to regulations in this area may result. The Commission is also considering a rulemaking plan which would ultimately result in allowing !
licensees to revise security provisions during decommissioning commensurate with the risk presented by these facilities.
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OUESTION 13(B) What are the perceived threats to security that the current, and
! proposed, regulations intend to address?
ANSWER. I The NRC design basis threat (DBT) statements were first promulgated in the late 1970's.
Absent an historical basis of attacks on nuclear facilities or of thefts of strategic special nuclear material, the Commission concluded that the use of design basis threats were appropriate. The threat statements, one for radiological sabotage and one for theft and diversion, are hypothetical threats against which physical security systems are designed, and they provide a standard with which to measure changes in the real threat environment; are used to develop regulatory requirements; and provide a standard for evaluation of the periornance of implemented safeguards programs. The threat characteristics enumerated it; t'le DBT are based on extensive analyses of actual terrorist characteristics that were commonly demonstrated and could reasonably be expected in an adversary, on experienced analytical judgement, and on intelligence community assessments.
To ensure the continued adequacy of the DBTs, NRC staff continually review threat related intelligence, including information on vehicle bombings and other attacks worldwide. Staff also maintains an active liaison program with other Federal agencies concerned with terrorist threats and counterterrorism efforts, and performs DBT comparability reviews with the Department of Energy. The results of these efforts and staff conclusions are formally documented and Senator Inhofe
QUESTION 13(B) 2 provided to the Commission every 6 months, or as needed Based on current staff analyses, no modification of the DBT is warranted at this time. I 1
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Senator Inhofe
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- QUESTION 13(C) Has the list of threats changed over the past several years?
ANSWER.
Each of the design basis threat (DBT) statements used to design physical protection systems has been changed once. The DBT for theft of strategic special nuclear material (SSNM) was modified in 1987 to include the use of a vehicle for transporting personnel and equipment during an attempted theft. This change was made in order to maintain comparability with DOE's threat guidance regarding protection of SSNM. The design basis threat statement for l radiological sabotage was modified in 1994 to include: 1) use of a vehicle by an adversary to ,
I transport personnel and equipment to power reactor vital areas, and 2) the use of a vehicle bomb to attack the power reactor facility. These changes were made in response to two events that occurred in February 1993. In that month a vehicle intrusion occurred at the Three Mile Island nuclear facility and the World Trade Center was bombed. Subsequent to the Oklahoma )
City vehicle bomb attack on April 19,1995, and the twin vehicle bombing attacks on the U.S.
i Embassies in Kenya and Tanzania on August 7,1998, the NRC confirmed that the design basis l
. vehicle bomb remained valid.
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Senator Inhofe l
QUESTION 13(D) Over the past 10 years, how have the physical safety requirements of nuclear plants been changed?
- j ANSWER.
With respect to rulemaking, the following table summarizes rulemaking activities in the physical -
protection area from 1988 to the present. The " Title" column indicates both title and the type of facility to which the rule applies. The " Purpose" column gives a brief summary of the rule and
, indicates whether the amendments increase or decrease security requirements.
PHYSICAL PROTECTION RULEMAKINGS - 1988 TO PRESENT TITLE PURPOSE
)
" General Criteria for Security Personnel" (53 Amends medical examination scheduling.
FR 403),1/7/88 (power reactors and fuel Neither increases nor decreases security facilities) requirements.
" Licensing Requirements for the Independent Establishes licensing requirements for Storage of Spent Nuclear Fuel and High- independent spent fuel storage installations Level Radioactive Waste" (53 FR 31651), and high-level radioactNe waste, including 8/19/88 Independent Spent Fuel Storage physical protection requirements. Increases Installations (ISFSis) security requirements.
" Safeguards Requirements for Fuel Facilities Upgrades physical' protection measures to Possessing Formula Quantities of Strategic include tactical response force, vehicle Special Nuclear Material" (53 FR 45447), barriers, double perimeter fence, etc., for ;
11/10/88 (fuel facilities) NRC/U.S. Department of Energy (DOE) l comparability. Increases security :
requirements. l
" Access to Safeguards information (54 FR Implements Federallegislation. Increases 17703),4/25/89 (power reactors) security requirements.
" Fitness for Duty Program (FFD)" (54 FR Requires FFD programs at power reactors to 24468) 6/7/89 (power reactors) essure workforce is not under the influence or impaired for any cause. Drug-free workplace. Increases security requirements. )
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Senator Inhofe t
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QUESTION 13(D) 2
" Fingerprint Cards: Increase in Fee" (55 FR Administrative change to fee. Neither 3039,1/30/90 (power reactors) increases nor decreases security requirements.
" Fingerprint Cards: Increase in Fee" (55 FR Fee increase. Neitherincreases nor 35563) 8/31/90 (power reactors) decreases security requirements.
l " Access Authorization Program for Nuclear Establishes an access authorization Power Plants"(56 FR 18997),4/25/91 program, increases security requirements. !
(power reactors) 1
" Fitness for Duty Program" (56 FR 41922), Permits, under certain conditions, 8/26/91 (power reactors) employment actions based on prelim' nary test results. Decreases security requirements.
" Fingerprint Cards: Resubmittat Procedure Proceduralamendment. Neitherincreases Change"(57 FR 7645) 3/4/92 (power nor decreases security requirements.
reactors)
" Minor Amendments to the Physical Minor clarifying changes. Neither increases Protection Requirements"(57 FR 33426), nor decreases security requirements.
7/29/92 (power reactors and fuel facilities)
"FFD Programs: NRC Partial Withdrawal of Responds to the U.S. Office of Management NRC Information Collection Requirements" and Budget's finding that NRC failed to (57 FR 5543),11/25/92 (power reactors) demonstrate a compelling need for certain information. Neither increases nor decreases security requirements.
" Clarification of Physical Protection Clarifies Commission's regulatory intent.
Requirements at Fixed Sites"(58 FR 13699), Neither increases nor decreases security 3/15/93 (fuel facilities) requirements.
" Licensees' Announcements of Safeguards increases the effectiveness of unannounced inspections" (58 FR 29521), 5/21/93 (fuel safeguards inspections. Increases security facilities) requirements.
"FFD Requirements for Licensees Authorized Implements an FFD program at Category I to Possess, Use, or Transport Formula sites. Increases security requirements.
Quantities of Stretegic Special Nuclear Material (SSNM)" (58 FR 31467), 6/3/93 (fuel facilities)
Senator Inhofe
QUESTION 13fD) 3
" Day Firing Qualification Courses for Tactical Revises day-firing qualifc' ations to enhance Response Team Members, Armed Response skills. Increases security requirements.
Personnel, and Gunds at Cetegory i Facilities"(58 FR 45761),8/31/93 (fuel facilities)
- Modifications of FFD Program Reduces random testing rate. Decreases Requirements" (59 FR 502),1/5/94 (power security requirements.
reactors and fuel facilities)
" Fingerprint Carda: Change in User Fee" (59 Administrative change. Neither increases FR 661),1/6/94 (power reactors) nor decreases security requirementt,.
" Annual Physical Fitness Performance Provides increased assurance that the Testing for Tactica! Response Team licencee response force is able to perf :rm Members, Armed Response Personnel and duties under strenuous tactical Guards at Category I Licensees" (59 FR engagements. Increases security 38347),4/13/94 (fuel facilities) requirements.
" Temporary Access to Safeguards Minor procedural changes. Neither
, Information" (59 FR 38553),7/29/94 (power increases nor decreases security ,
reactors) requirements.
" Protection Against Malevolent Use of Requires vehicle bomb protection at Vehicles at Nuclear Power Plants"(59 FR operating power reactors. Increases security 38889) 8/1/94 (power reactors) requirements.
" Certification of Gaseous Diffusiois Plants" Applies physical protection requirements to (59 FR 48944),9/23/94 (fuel facilities) gaseous diffusion plants, increases security requirements.
" Reduction of Reporting Requireraents Reduces licensee burden. Decreases impos d on NRC Licensees" (60 FR 13615), security requirements. j 3/14/96 (power reactors)
" Changes to Nuclear Power Plant Security Deletes a requirement, to decrease licensee Requirements Associated witn Containment burden, without degradation of physicai ;
Access Control"(60 FR 46497) 9/7/95 protection. Decreases security j (power reactors) requirements. {
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" Changes to Nuclear Power Plant Security Deletes certain requirements associated with !
Requirements"(62 FR 63640),12/2/97 protection against an insider threat, to (power reactors) decrease licensee burden without compromising physical protection.
Decreases security requirements.
Senator Inhofe i
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I OUESTION 13fD) 4
" Physical Protection for Spent Nuclear Fuel Clarifies p"hysical protection requirements for arid High-Level Radioactive Waste" spent nuclear fuel and high-level radioactive
( 63 FR 26955 ), S/15/98 (ISFSI) waste stored at independent spent fuel storage installations.
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Senator Inhofe
QUESTION 1 Approximately one year ago, the NRC undertook several pilot projects to investigate the appropriateness of NFIC oversight of Department of Energy nuclear reactor programs. The NRC adopted limited programs at tF,e Savannah River, Lawrence Berkeley, and Oak Ridge facihties. How would you gauge the results so far?
ANSWER.
Although the pilot facilities selected by DOE represented only a small portion of the DOE I Complex, the results so far indicate that DOE's non-weaports related programs can be effectively regulated by NRC and continue to operate safely. Few changes in facilities, procedures, safety programs, and safety documentation (including Safety Analysis Reports) would be neCE:Ssary. DOE initiatives such as WorkSmart Standards and Integrated Safcty Management Systems could easily be incorporated into an NRC risk-informed, performance- !
based regulatory framework. Most technical, policy, and regulatory issues, including safety and i
safeguards and enforcement, encountered during the Pilot Program could be handled adequately within the existing NRC regulatory framework. However, to date the pilot program has concentrated on individual facilities located on a much larger DOS site. The next logical step in the pilot program would be to evaluate a pilot DOE s.te with all of its individual facilities.
NRC could develop a regulatory framework that would be risk-informed, .aking into account the age, material condition, and operating status of the DOE facilities. NRC brings a national perspective to the teguiation of DOE because NRC regulates a wide spectrum of activities including the public and private sector and facilities with a wide range of risks.
Senator Crapo
QUESTION 1 2 Based on the fact that the Pilot Program identified only a few needed changes in DCE facilities or proceduree, NRC anticipates the cost to DOE of making the transition to external regulation would be relatively small. However, the costs will vary depending on the degree to which DOE facilities are already in compliance with DOE's own requirements. For example, the costs for <
bringing the USEC gaseous diffusion plants into compliance with DOE and NRC requirements has proven to be significantly higher than what was inc1icated in the Pilot Prog aecause of the large costs required to bring the plants into compliance with long standing DOE safety and security requirements. DOE believes the costs to be much higher than the NRC believes. A program to place a few facilities like the Lawrence Berkeley National Laboratory under NRC regulation might clarify this issue. '
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Senator Crapo I
QUESTION 2 Given the limited nature of the programs, would the information uncovered from the studies give a go'od understanding of how NRC oversight of an entire facility would function?
ANSWER.
Yes. Within its scope, the Pilot Program has provided NRC with a very good understanding of how oversight of an entire site would function. Although the Pilot Program included only one entire site, Lawrence Berkeley National Laboratory (LBNL), and two facilities within large complex sites, the Receiving Basin for Offsite Fuel at Savannah River Site and the Radiochemical Engineering Development Center at Oak Ridge National Laboratory (ORNL),
the Pilot Projects and associated activities provided information on how NRC could oversee entire DOE sites. ,
At LBNL, the NRC found the radiation safety program adequate to protect public health and safety. NRC concluded that LBNL could be licensed by the NRC using a broad-scope materials license, similar to those issued at large universities.
During the Pilot Projects at the Savannah River Site and the ORNL, it became clear that it would be more efficient to regulate an entire site than a single facility within a complex site, because such facilities depend on the shared-site infrastructure for many of the key elements of sdie operation (0.g. Tadiation proteClion, waste management, emergency preparedness, safeguards and security). NRC did conduct a brief overview of the non-defense facilities at ORNL in order to better understand the shared site issues.
Senator Crapo
QUESTION 2 2 I
Licensing reviews of DOE facil! ties would be facilitated oy taking credit for the reviews already performed by DOE. It is evident from the Pilot Projects that DOE requirements, in general, nrovide a safety and security envelope that is comparable to that provided by NRC regulation.
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Senator Crapo
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QUESTION 3 What is your impression of external (NRC) regulation of DOE activities? '
Under what conditions would this be optimized?
ANSWER.
The NRC continues to believe that NRC regulation of DOE nuclear facilities would result in the key advantages identified by the DOE Working Group; i.e., that external regulation (1) would allow DOE to focus on its primary missions, (2) eliriinate the inherent conflict of interest arising from self-regulation, (3) enhancs safety and stability, (4) lead to a safety culture comparable to the commercial industry, (5) be consist 9nt with domestic and international safety management practices, (6) enhance DOE credibility by an open process, and (7) enhance public confidence in DOE. In particular, external oversight of DOE through an open process which allows involvement of State governments and other stakeholders will increase public confidence that DOE is taking the right action.
NRC is already regulating several DOE activities under existing law and could potentially regulate others. These activities are identified in the enclosed matrices, " Existing Regulatory Relationships between NRC and DOE and Privatized DOE Facilities / Activities Performed by Private Companies only for DOE" and " Potential Regulatory Relationships between NRC and DOE and Privatized DOE Facilities / Activities Performed by Private Companies only for DOE." It has been NRC's experience that the primary cost of external regulation has been the cost for DOE to modify its facilities to meet its own requirements prior to external regulation.
Legislation that clearly indicates responsibilities for NRC, DOE, and other Federal agencies may be the best approach to resolving many of the issues that have arisen in the Pilot Program.
Senator Crapo
r QUESTION 3 2 l -
l The NRC staff has prepared and submitted a white paper for Commission consideration on the l
l results of the Pilot Program and the technical, regulatory, and legal issues that have been explored by the Pilots.
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Enclosure:
I Existing and Potential Regulatory Relationships between NRC and DOE and Privatized DOE i l
Facilities / Activities Performed by Private Companies only for DOE i
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l Senator Crapo l
QUESTION 3 3 Enclosure. Existing Regulatory Relationships between NRC and DOE and Privatized DOE Facilities / Activities Performed by Private Companies only j for DOE i Facility / Activity Nature of Legal Basis issues Oversight Uranium Mill Tai!ings
- Title I site Review, concur on UMTRCA Law required completion of (Remedial action remedial action surface reclamation by sites) plan and license 9/30/98. All but 2 sites met DOE for long term date. l care
- Title 11 site After termination of UMTRCA none (Active sites) commerciallicense, DOE becomes the l Cenerallicensee High Level Waste prelicensing Energy Reorg. Resolution of key tech. 1 Repository consultation; Act 1974, Section issues at Yucca Mnt.
license 202, NWPA HLW standards for Yucca l Commission views on viability assessment Independent Spent Fuel Storage Facilities
- Fort St. Vrain License Energy Reorg. none Act 1974, Section 202
- TMI 2 Spent Fuel License Energy Reorg. none Debris Act 1974, Section 202 Naval Reactors
- Cores Review Economy Act none
- Transport / Packages Certify Economy Act none Fuel Fabrication
- Nuclear Fuels License AEA (AEC Awaiting NFS submittals for Service Regulatory NRC review and approval Decision)
- BWX Techrsbgies, License AEA (AEC inc. Regulatory Decision)
Senator Crapo
f QUESTION 3 4 Enclosure. Existing Regulatory Raiationships between NRC and DOE, continued Facility / Activity Nature of Legal Basis issues Oversight Gaseous Diffusion Certification AEA, Energy Backfit to meet seismic Plants (leased by Policy Act of design criteria USEC) 1992,USEC SAR upgrade Privatization Act )
of 1996 l Non-site-specific Review Energy report is non-site specific I i
centralinterim storage Reorganization facility topical report Act of 1974, (SNF) Section 202 DOE dry transfer Review Energy Part of the centralinterim system topical report Reorganization storage facility l Act of 1974, Section 202 DOE burnup credit Review Energy none topical report Reorganization Act of 1974, Section 202 l DOE Transportation Review, certify AEA, HMTSA none Packages (38)
West Valley Develop D&D WVDP Act,1980 Criteria for D&D Demonstration Project criteria, review, Reinstatement of license for consult State after completion WIPP Transportation Review and certify WIPP Land none packages Withdrawal Act of 1992 l Test of Tritium Review; lssue AEA Possible package review Production in conforming license Legislative framework Commercial Reactors amendments Senator Crapo r
QUESTION 3 5 Enclosure. Existing Regulatory Relationships between NRC and DOE, continued Facility / Activity Nature of Legal Basis issues Oversight Greater than Class C License Low-Level Rad Storage until disposal Waste Disposal Waste Policy Timely availability of Amendments Act disposal capacity of 1985 Cost of disposal Impact on reactor decommissioning Foreign Research Review AEA Public concern about Reactor Spent Fuel transportation Shipments / Package MOX Fuel Fabrication Prelicensing r ergy Reorg Need to update Part 51, S-3 and use Consultation, A:t of 1974 as License amended, AEA l
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Senator Crapo L.
OUESTION 3 6 Enclosure. Potential Regulatory Relationships between NRC and DOE and Privatized DOE Facilities / Activities Performed by Private Companies only for DOE Facility / Activity Nature of Legal Basis issues Oversight Hanford TWRS Technical 1997 Approp. Act Legislation needed to Assistance; authorize NRC regulation Potential License Savannah River Review; potential Economy Act Application of incidental Tanks (residues) license for HLW NWPA: Energy waste criteria to tank residues Reorg Act of waste 1974 Aluminum Based Review Economy Act Criteria for storage Spent Fuels dry NWPA; Energy Suitability for disposal storage Reorg Act of 1974 Brookhaven High Flux Review; technical Economy Act Review start date Beam Reactor assistance Extemal Regulation Simulated l Pilot Projects regulation 1999 Approp. Act Legislation needed Privatization Spent Potentiallicense Energy DOE must declare as Nuclear Fuel Projects Reorganization excess to R&D
- Peach Bottom Unit 1 Act of 1974 Cores I and ll
- Shippingport LWBR
- TRIGA Senator Crapo
QUESTION 4 What resources would the NRC need in order to regulate DOE?
How much more staff? How much more funding? How do these compare with DOE internal regulation?
ANSWER.
The Pilot Program included only three facilities, which do not represent the entire DOE complex. While the Pilot Program did not gather enough information to support an estimate of the resources, staff, or tending needed for NRC to regulate the entiro DOE complex, NRC did develop cost estimates for regulating the three facilities included in Pilot Programs. Precise resource estimates for NRC to regulate all or some of the DOE nuclear complex are difficult to develop without the completion of additional, more complex, pilot projects. These costs would be comparable to the costs for regulating commercial nuclear facilities and would be comparable for similar facilities with similar risks.
4 The following table provides the cost estimates for NRC to regulate Lawrence Berkeley National l Laboratory (LBNL), Oak Ridge National Laboratory, Radiochemical Engineering Development Center (REDC), and Savannah River Site, Receiving Basin for Offsite Fuel (RBOF):
Senator Crapo
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QUESTION 4 2 Pilot NRC transition NRC annual costs costs LBNL 1 FTE 0.2 FTE I REDC 2.8 FTE plus 0.1 FTE with an
$200K for technical additional 0.5 FTE for assistance first few years RBOF 2.5 FTE plus 0.3 FTE
$100K for technical i assistance l The NRC does not have sufficient informauon to compare its regulatory costs to those of DOE internal regulation. However, the cost to DOE could be minimized, potentially resulting in a net savings, by reducing the level of DOE oversight of the regulated activities to a level consistent with a corporate oversight model. If DOE does not decrease its oversight activities, costly, burdensome, dual regulation may well result. ,
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I Senator Crapo
u QUESTION 1 in your testimony you state that the Commission has aimed at completing the license renewal process for the Calvert Cliffs and Oconee Plants in 30 to 36 months.
You also state that lessons learned from the initial reviews will help to streamline later reviews even further.
Question: Therefore, in the interest of establishing a stable, predictable and timely license renewal process, will you be able to reduce the 30-36 month time period f < the later reviews for license renewal, and if so, what is your estimate for the length of time?
ANSWER.
As stated in the Chairman's testimony and discussed in the response to Senator Inhofe's Question 4, the NRC expects to improve the 30 month review schedule for Calvert Cliffs by at least five months, w;iich includes the time saved based on dismissal of the hearing requests in that case. Aside from time savings related to case specific hearing issues, the NRC expects that the 30 to 36 month review schedule can be improvea for future reviews, but those improvements are anticipated primarily from the later review stages that have not yet been performed for the Calvert Cliffs and Oconee reviews. When the first two renewal applications are completed, the NRC intends to reflect on the achievements and make additional improvements in the schedule for future renewal applications.
Senator Graham
O QUESTION 2 (A) In your testimony you state that the initial safety evaluation report and !
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, draft environmental impact statement for the Calvert Cliffs application should be completed on schedule next month.
Question: Do you have any preliminary results from these reports?
ANSWER.
The preliminary results of the safety review have been discussed during public meetings with Baltimore Gas and Electric and Duke Energy over the last few months, and are documented in associated meeting summaries. The NRC staff used those meetings to expand the public record relative to the NRC review of the scope and effectiveness of aging management programs for Calvv L.ifts and Oconee, beyond that described in the applications. That information is expected to provide the necessary technical basis to complete the safety evaluation and minimize the number of potential open items that would need to be resolved before a renewed license could be granted.
The supplement to the environmental impact statement for Calvert Cliffs was issued by letter dated February 24,1999. Comments on those findings are being sought during a public meeting on April 6,1999, and throughout the 75-day public comment period. The NRC staff issued the initial Safety Evaluation Report on renewal of the Calvert Cliffs license on March 19,1999.
Senator Graham
QUESTION 2 (B) Were there any "show stoppers?"
ANSWER.
No. The staff has not identified any safety issues thus far that cannot be resolved with appropriate license conditions or inspection requirements. The environmental review did not identify any significant environmental impacts associated with license renewal.
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I Senator Graham
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OUESTION 3(A) is there a way that the NRC can more closely link the fees levied against each licensee to the NRC resources expended on each licensee?
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ANSWER.
As discussed in Chairman inhofe's Question 2 (B), during the past two years NRC has taken l steps to improve the linkage of fees levied against specific licensees to the resources expended on each licensee. These decisions recognize that with few exceptions, agency work directly identifiable to a licensee should be billed to that licensee.
We will continue to link the generic regulatory costs, such as rulemaking and research efforts to the classes of licensees that cause us to incur the cost in accordance with the Omnibus Budget Reconciliation Act of 1990. These generic costs are assessed to licensees as Part 171 annual fees. It should be noted that the NRC has identified approximately 10% of its budget that would be more appropriately funded from the General Fund. If legislation was enacted to reduce the percentage amount the NRC must recover through fees, this would more closely align agency efforts for licensees with the fees assessed to those licensees. A listing of these programs and costs are found in the response to Chairman inhofe's Question 3.
Senator Graham l
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- t QUESTION 3fB) It seems that assessing licensees annual fees more consistently with the regulatory oversight required may pro' vide financial incentives for plants to improve their performance. Do you agree with this statement?
ANSWER.
t in general, licensees that require more licensing and inspection attention will be assessed more fees under 10 CFR Part 170. In developing the annual fees by category, we also take into consideration where the generic resources are being used and charge those categories of !
I licensees accordingly. Therefore, in both Part 170 and Part 171 fee assessments, the charges 1
represent either a directly identifiable benefit or a reasonable relationship to the NRC's cost of providing the regulatory service to the licensee. That having been said, we would point out that the NRC makes no deliberate attempt to use fees as an incentive or disincentive fo: plants to '
improve performance. The Commission believes that fees should not be a prima,y factor in l
I l determining the work to be performed in response to NRC's health and safety mission. NRC's i
safety related decisions cannot be driven by fees. The NRC must carry out its statutory mission which recognizes that the NRC serves a broader need than just providing a specific service to a licensee or applicant.
As the Congress is aware, the NRC is in the process of making a comprehensive revision to its reactor assessment, inspection, and enforcement programs. This will be built upon cornerstones of safe licensee performance that must be monitored to ensure no unacceptable public risks in reactor operations. As an outgrowth of that process, licensees requiring more oversight and for which we expend the greatest resources will continue to bear a proportionately higher share of the agency costs through Part 170 fees.
Senator Graham
QUESTION 4 A recent NRC Office of Inspector General report raised some questions about how the NRC handled concerns that two or more workers at the Millstone nuclear power plants in Connecticut may have been let go because they raised safety concerns.
The inspector General report concluded that the NRC staff at first found that such discrimination probably had occurred, but then reversed itself without providing the written documentation to support the changed conclusion.
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l What steps is the NRC taking to make sure the lack of accountable l
l documentation of decisions does not recur?
ANSWER.
In response to the findings of the inspector General, the Commission directed the NRC staff to review the findings, assess lessons learned, and recommend and take necessary corrective actions. The NRC staff completed this review in January 1999. The Office of Enforcement issued detailed enforcement guidance on January 14,1999, and February 26,1999, that l requires the staff to prepare and maintain an internal status summary for each significant enforcement action the agency considers. Although this administrative form is not an official i record of the agency decision, the staff has been directed to use it to record important information related to the enforcement decision-making process. The guidance also emphasizes the importance of updating the form based on subsequent changes to the agreed-upon enforcement strategy, including the rationale for the change.
Senator Graham
QUESTION 4
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2 The Commission has tiso directed an independent panel headed up by the Acting Chief Judge of the Atomic Safety and Licensing Panel to review the cases reviewed the by inspector General and the enforcement and investigation process and make recommendations for l
process improvements. This review was completed on March 12,1999, and is currently under*
Commission consideration in addition, the NRC staff has initiated a broader review of the agency's investigation and enforcement functions and will take appropriate actions.
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l Senator Graham j
QUESTION 5 in your testimony you state that you are revising the regulatorf programs from radioactive material to make them more risk-informed and to ensure that the regulatory burden is commensurate with the health and safety benefits of such regulations, including medical use regulations in 10 CFR Part 35.
When the proposed rule revising Part 35 was issued in early fall, many stakeholders stated that the proposed rule was not risk informed, that there was insuffici'ent time to offer meaningful comments, and that both the comment period and date to finalize the rule should be significantly extended. The Commission responded to these requests by extending the comment period by 30 days. A number of groups including the American College of Nuclear Physicians, Society of Nuclear Medicine, American College of Radiology, and others requested that the Commission extend the final rule date, which is now set for May 1999.
This request was also supported by the Organization of Agreement States, which represents state radiation officials.
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, in light of the strong suppoit by the regulated medical community for an I
extension of this May 1999 date, would the Cornmission consider extending the May 1999 date for finalizing the rule?
Senator Craham
l QUESTION 5 2 ANSWER.
In March 1997, in follow-up to several intemal and external reviews, the Commission directed -
that 10 CFR Part 35 be restructured into a risk-informed, more performance based regulation by June 1999. The Commission's intent is to focus the rule on those medical procedures that pose the highest risk, from a radiation safety aspect, while decreasing the oversight of low-risk activities. The Commission previously extended the public comment period by 30 days and reviewed a significant number of insightful public comments. The Commission is currently l
considering extending the schedule for the final rulemaking to more adequately incorporate the i
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significant number of public comments reviewed. '
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l Senator Graham
QUESTION 6 This next question is specifically addressed to Commissioner Diaz.
Commissioner Diaz, I am aware that fou met with some of the representatives of the nuclear medicine communities as well as some of my constituents. Could you please summarize the outcome of that meeting?
ANSWER (OF COMMISSIONER DIAZ).
As you may know, on January 28,1999, I met with Dr. Robert Carretta, President of The Society of Nuclear Medicine; David Nichols, Society of Nuclear Medicine; and l Mr. Roy Brown, Mallinckrodt Medical. We discussed their concerns about the proposed regulation of diagnostic nuclear medicine procedures in the new NRC Part 35. In particular, they believe that these low-risk procedures would be over regulated by the new rulemaking. In this regard, I expressed my belief that a risk-informed Part 35 would differentiate between diagnostic and therapeutic procedures; with the former (diagnostic procedures) having many fewer iequirements than the latter (therapeutic). In fact, I believe that in the diagnostic area the NRC could regulate by requiring that records be kept and made available to our inspectors.
However, I emphasized that in this and other issues regarding Part 35, I retain an open mind, look forward to reading the public comments and would make my decision based on the Part 35 rulemaking record.
Senator Graham
1 QUESTION 1 in response to inquiries by the Army Corps of Engineers, the NRC has recently indicated that it will not asseft regulatory authority over certain uranium and thoriurn processed wastes referred to as "11e(2) radioactive byproduct material." 10 : . nocarent change of position, NRC now contends that it does not have jurisdiction over byproduct material located at sites that were not licensed prior to 1978 when the Uranium Mill Tailings Radiation Control Act (UMTRCA) was enacted. The NRC interpretation is referenced in two pending RFP's in which the Army Corps indicates it will accept proposals for disposal of 11e(2) radioactive i
waste at ordinary landfills not regulated by the NRC. 1 i
I (A) What is the NRC's response to the pending RFP's by the Army Corps?
ANSWER.
As a general matter, the NRC has no regulatory responsibility regarding the Army Corps'
, management of radioactive material under the FUSRAP program.
In addition, the NRC does not consider its actions regarding FUSRAP as a change in position.
Earlier, the NRC said that it would not assert regulatory authority over this material. Later, the NRC said that it would not assert regulatory authority over this material because NRC does not have legislative authority to regulate this material. This later statement is not a change in position.
Senator Bennett
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l QUESTION 1 (B) What is the NRC's response to a 1998 resolution by the Conference of Radiation Control Program Directors which calls on l the Commission as a matter of public health'and safety to 1
l regulate the disposal of uranium and thorium mill tailings referred to as "11e(2)" radioactive byproduct material, even if it was generated prior to 19787
)
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ANSWER.
l The resolution of the Conference of Radiation Control Program Directors cannot, of course, confer jurisdiction on the NRC where jurisdiction does not exist under Federallaw. As discussed below in the answer to Question 1.E, the critical question regarding NRC jurisdiction is whether a site where this activity took place was licensed by the NRC on or after the date the l
Uranium Mill Tailings Radiation Control Act (UMTRCA) became effective, not when the material at the site was generated (Section 202; 42 USC 2111).
Senator Bennett
e OUESTION 1 (C) If pre-197811e(2) byproduct materialis not regulated by NRC, can this radioactive waste be disposed in ordinary solid wacts I )
landfills?
I l ANSWER.
NRC does not have jurisdiction over 11e(2) byproduct material generated before 1978 unless it ext.is at e site that was licensed by the NRC on or after November 8,1978, the effective date of new section 83 of the Atomic Energy Act. Pre-197811 e(2) byproduct material not regulated I
by the NRC is under the jurisdiction of other Federal and State agencies, including the Department of Transportation and the Environmental Protection Agency.
Senator Bennett i
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QUESTION 1 (D) If 11e(2) radioactive byproduct waste we.c disposed of in regular solid waste landfills, wouldn't this again raise the controversial specter of tne Below Regulatory Cc:.cern (BRC) issue that NRC confronted in 19907 ANSWER. '
l The Commission developed criteria and procedures to implement the concept of "Below Regulatory Concern" (BRC) in 1986 and 1990 consistent with Congressional directive in the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA). These actions '
and procedures were eventually withdrawn by the Commission in 1993 as directed by Congress in the 1992 Energy Policy Act. The LLRWPAA applies only to materials defined by that Act as low-level waste (LLW) and expressly excludes 11e (2) byproduct material from the definition of .
1 LLW (section 2(9)).
If NRC or an Agreement State authorized disposal of 11e (2) byproduct material waste in regular solid waste landfills, it could raise similar concerns to those expressed by the public in response to the NPC'r "Below Regulatory Concern" policy.
Senator Bennett
QUESTION 1 (E) How would the NRC's interpretation of 11e(2) jurisdiction affect the licensing of compartes such as the Atlas Corporation in Moab, Utah, where radioactive byproduct materials were created both before and after 19787 L
ANSWER.
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The language of section 83 of the Atomic Energy Act (42 U.S.C. 2113(a)) (AEA), was added to the AEA by UMTRCA. Section 83 a. provides that any NRC license for covered activities in effect on or after the effective date of section 83 (November 8,1978) must include the terms end conditions that the NRC determines are necessary to assure that the licensee can comply with the decontamination, decommissioning, and reclamation standards prescribed by the Commission. The Moab NRC license was in effect on and after the effective date of section 83 of the AEA. Therefore, all materials in the tailings impoundment at the site are subject to NRC jurisdiction, whether these were produced before or after 1978. The critical factor in determining jurisdiction over the wasts or tailings produced by the processing of ore for its source materia! content is whether a site where this activity took place was licensed by the NRC c", e after the date UMTRCA became effective, not when the material at the site was genciated.
Senator Bennett 1
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QUESTION 1 The NRC has collected data on medical misadministrations since 1980.
, This data includes misadministration's involving diagnostic Nuclear Medicine. On March 20, P?97, the Commission directed that the revision of Part 35 be risk-informed and performance-based. Please explain based on the data the NRC has collected since 1980 what risks were identified specifically for diagnostic Nuclear Medicine.
ANSWER.
Prior to initiating the revision of the regulations for diagnostic nuc!sar medicine, the Commission thoroughly reviewed several extensive assessments, including the external review conducted by the National Academy of Sciences-Institute of Medicine (NAS-lOM), a 1993 NRC internal senior management review, and the Commission's Strategic Assessment and Rebaselining Project.
Although the Commission decided not to adopt the NAS-lOM study recommendations, the Commission considered the risk assessment information, including information on comparative risks of ioniting radiation in medicine, in the NAS-!OM report. Both the NAS lOM Committee and the NRC Advisory Committee on the Medical Uses of Isotopes recognized that quantifying levels of risk in radiation medicine is problematic.
During the development of the overall revision of Part 35, NRC staff considered risk information provided by members of the public and professional societies, professional medical standards of practice, and event databases maintained by NRC, to determine where oversight of low risk activities could be decreased and where there needed to be continuation, or even broadening, of the regulations governing high-:isk activities.
Senator Bond
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l QUESTION 1 2 Additional information on risk that was considered by the staff included the National Council on .
Radiation Protection and Measurements Report No. 93,"lonizing Radiation Exposure of the Population of the United States," NCRP Report No.100," Exposure of the U.S. Population from Diagnostic Medical Radiation," and NCRP Report No.105, " Radiation Protection for Medical and Allied Health Personnel." These reports provide data on the exposure to a large number of medical patients and workers, and, consequently, the large collective doses, associated with this use of radioactive material.
The Commission proposed revisions to 10 CFR Part 35 and solicited comments during a 120-1 day period, which ended on December 16,1998. All the risk information received in writing l i
during the public comment period, as well as the information reccived at the three public meetings held during the public comment period, is being carefully considered to determine if l additional improvements should be made to achieve the goal of restructuring Part 35 into a risk-I informed regulation.
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l Senator Bond l
QUESTION 2 The regulated medical community has suggested that the NRC, based on data by leading experts, (National Academy of Sciences - Institute of Medicine, National Council on Radiation Protection and Measurements, and a 1993 NRC intemal management report), move to only enforce the radiation protecticn thresholds of 10 CFR Part 20 and the training and experier a recuirements of 10 CFR Part 35 for the regulation of low-risk diagnostic Nuclear Medicine. James Smith, the Technical Assistant to Chairman Jackson, first raised this proposal at a November 5,1998, meeting between representatives of the Nuclear Medicine community and the Commission staff as one possible way to address the concerns of the diagnostic Nuclear Medicine community while also meeting the directives of the Commission to strive for a " performance-based" regulation. Why has there been no further consideration of this proposal by the Commission or NRC staff working on the revision to 10 CFR Part 35?
Are 10 CFR Part 20 and the training and experience requirements of 10 CFR Part 35 not sufficient in meeting the NRC's requirements that the public, workers and patients be protected and the physicians and technologists be properly trained? Would this not be an example of true
" performance-based" regulation?
Senaior Bond
QUESTION 2 2 ANSWER.
The Commission has been considering this proposal. During the development of the proposed .
l rule the staff eliminated requirements in the currant Part 35 that are contained elsewhere in the Commission's regulations, such as the radiation protection requirements in Part 20. In 6 sme cases, where justified by risk, more specific requirements were maintained in Part 35. The majority of the requirements that were maintained apply to the high-risk therapeutic uses of radioactive material.
The proposed revisions to Part 35 include specific requirements, not included in Part 20, that are necessary to protect occupationally exposed individuals and the public, similar to requirements in Parts 31-39 for other materials licensees such as industrial radiography. For example, the Part 35 requirement to provide instructions to operators of therapeutic medical devices is not addressed in Part 20, but is necessary for the protection of the operators.
Another reason why there needs to be specific requirements for the medical use of byproduct material in Part 35 is that Part 20 does not apply to doses received as a result of exposure of patients to radiation for the purpose of medical diagnosis or therapy. The NRC does not regulate the physicians' determination as to the correct doses to be prescribed to patiernu.
However, minimal requirements are needed, for example, to ensure that the doses to patients are in accordance with the physician's directions. In other words, the primary focus of NRC regulation is providing that the correct patient receives the correct dose of byproduct material at the correct site and via the correct mode of administration.
Senator Bond 3 i
QUESTION 2 3 The Commission agrees that Part 35 could be more performance based and is considering the recommendations made by the diagnostic nuclear medicine community and the commenters.
NRC staff is in the process of analyzing many comments received on the proposed rule. Staff will consider the impact of maintaining the training and experience requirements in Part 35 and eliminating all other diagnostic nuclear medicine requirements. Some specific areas for consideration wili be deletion of requirements for: determining the activity of diagnostic dosages prior to administration; labeling syringes and shields containing byproduct material; and routinely calibrating survey meters and instruments used to determine the activity of a radioactive drug prior to administration.
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l Senator Bond
OUESTION 3 After having spent approximately 2 million dollars of user fee money the Commission rejected, with no explana' tion, the recommendations of the National Academy of Science -Institute of Medicine report (NAS-lOM).
This report found that for nuclear medicine, the risk and probability of harm occurring to a patient or a member of the public is extraordinarily low and recommended that the NRC reduce its focus in such low risk areas. What scientific or other information did the Commission base its i
rejection of the NAS lOM report?
ANSWER.
The NAS-lOM study was conducted because NRC sought an evaluation of whether the rules, policies, and procedures of the current regulatory framework for medical uses of byproduct material fulfilled the NRC's statutory responsibilities for protection of public health and safety.
Based on its review of the report and consultations with relevant agencies, the Commission was not persuaded by the NAS-lOM report's overall recommendation to Congress that NRC should not be the Federal agency involved in the regulation of Atomic Energy Act materials in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
The report was not rejected on the basis of its analysis of risks of ionizing radiation in medicine, in fact, the risk assessment information in the report, including the information on comparative risks of ionizing radiation in medicine, was considered during the rulemaking process in developing proposed revisions to 10 CFR Part 35. The NAS lOM report concluded that "no comprehensive raw data are available to make exact comparisons" between risks of medical Senator Bond 1
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OUESTIOfJ 3. 2 modalities (pg.124). In addition, both the NAS-lOM report and the NRC's Advisory Committee on the Medical Uses of isotopes (May 8,1997, Commission briefing) recognized that quantifying levels of risk in radiation medicine is problematic.
The Commission was not persuaded by the recommendations of the NAS-lOM report with regard to regulation of byproduct material for medical use. The Commission reached this decision, in part, based on comments received from some State and Federal agencies on the report. Some State and Federal agencies, such as the Department of Health and Human Services, Food and Drug Administration, to which additional responsibility would have fallen if the NRC adopted the recommendations, indicated that they did not support the recommendations in the report.
l Senator Bond L )