ML20155H054
| ML20155H054 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/1998 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Diaz N, Shirley Ann Jackson, Mcgaffigan E, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20155H058 | List: |
| References | |
| NUDOCS 9811090321 | |
| Download: ML20155H054 (11) | |
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I UNITED STATES
, g' NUCLEAR REGULATORY COMMIS810N WAsHINeTON, D.C. SegeHOO1
.g October 21, 1998 MEMORANDUM TO: Chairman Jackson Commissioner Diaz Commissioner McGaffigan FROM:
William D. Travers
'AJb e
Executive Director for Operations
SUBJECT:
INTERNATIONAL REGULATIONS FOR THE SAFE TRANSPORT OF RADIOACTIVE MATERIAL The International Atomic Energy Agency's (IAEA's) Regulations for the Safe Transport of Radioactive Materialform the basis for the domestic transport regulations for most of the world's major industrial countries, including those of the United States (U.S.). As such, the U.S.
Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have a significant stake in the outcome of lAEA's regulatory process. This memorandum is to inform the Commission of an upcoming lAEA meeting on regulatory reform for transportation regulations and to report on the progress of NRC's and DOT's on-going initiatives to revise IAEA's regulatory process.
On October 19,1998, IAEA will convene a technical committee meeting (TCM) on improving the regulatory process for revising intemational transportation regulations. Among the items to be discussed at the TCM are proposed revisions to the regulatory process, including scheduling, administrative procedures, the roles of Member States and lAEA organizations, and the use of risk-informed decisions and cost-benefit analysis in the regulatory decision process.
As with previous meetings of this nature, DOT has requested, under its Memorandum of Understanding with NRC, that NRC provide technical assistance at the TCM. Accordingly, the U.S. Delegation will consist of: 1) Richard W. Boyle, Chief, Radioactive Materials Branch, l
Office of Hazardous Materials Technology, DOT; and 2) Earl P. Easton, Section Chief, Transportation and Storage Safety Section Transportation and Storage Directorate, Spent Fuel
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Project Office, Office of Nuclear Material Safety and Safeguards, NRC.
At the TCM, the U.S. Delegation will continue to press for further consideration of its two proposals to revise the IAEA regulatory process (Attachment 1). These proposals are aimed at fundamentally changing the IAEA regulatory process by: 1) establishing clear and precise guidelines, procedures, and schedules for submitting and considering regulatory changes; and
- 2) formalizing the use of risk-informed decisions and cost-benefit analysis in developing and adopting transportation regulations. The proposals from the U.S. are based on our view that the current IAEA revision process is too long (10 years); that risk and cost-benefits are not adequately considered in IAEA's regulatory process (Attachment 2); and that U.S. stakeholder CONTACT: Earl Easton, SFPO/NMSS (301) 415-8520
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e concerns are not adequately considered in the IAEA process. The U.S. partially addressed the latter concern in 1995 by adopting a policy of holding public stakeholder meetings before every j
IAEA TCM where proposed regulations were under consideration. However, we believe more i
could be done to assure stakeholder input at a much earlier stage in the international j
rulemaking process.
1 To date, international reaction to our proposals to revise the IAEA regulatory process has been mixed. Although substantial progress has been made toward developing guidelines, procedures, and schedules for submitting and considering regulatory changes, the use of risk-informed decisions, and cost benefit analysis as major components in the regulatory process have not been universally accepted. For example, at the June 1997 TCM on regulatory reform, a minority of Member States recommended that a group of experts be convened to e,tudy the use of safety goals and cost-benefit analysis for transportation regulations. The remaining Member States, although not opposed, were not convinced of the merits of adopting the proposed approach. However, most Member States have accepted the concept that additional guidelines are needed for developing, justifying, and adopting specific regulatory provisions.
The U.S. delegation also plans to use the October 1998 TCM to generate additional surport for its regulatory reform goals by meeting with individual Member States. In particular, we plan to discuss the implications of risk-informed decisions with the French, British, and German delegations, particularity in the context of recent spent fuel cask contamination incidents, and the proposed approval of large components, such as the Trojan Reactor Vessel, for shipment.
It should be noted'that the U.S. delegation does not intend to submit a specific proposal to revise cask contamination limits at this TCM. If, at some later time, the U.S. decides to submit such a proposal, it would be done in accordance with the current U.S. proposals for regulatory reform, (i.e., after completion of a cost-benefit analysis and risk study).
Staff would like to emphasize that changing the IAEA regulatory approach for transportation regulation is a long and complex process, and that it is important for representatives from NRC and DOT to consistently reiterate the U.S. position and seriousness of U.S. intent when dealing with our international counterparts. It is also important that NRC representatives on lAEA's Advisory Committee on Safety Standards and Transport Safety Standards Advisory Committee express strong support for U.S. proposals.
Finally, the staff will keep the Commission informed on the progress of current U.S. Initiatives on IAEA regulatory reform.
Attachments:
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DATE 10/02/98 10/02/98 10/02!98 10/ 06 /9g 10/19/98
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concerns are not adequately considered in the IAEA process. The U.S. partially addressed the latter concern in 1995 by adopting a policy of holding public stakeholder meetings before every lAEA TCM where proposed regulations were under consideration. However, we believe more could be done to assure stakeholder input at a much earlier stage in the international rulemaking process.
To date, intemational reaction to our proposals to revise the IAEA regulatory process has been mixed. Although substantial progress has been made toward developing guidelines, procedures, and schedules for submitting and considering regulatory changes, the use of risk-informed decisions, and cost benefit analysis as major components in the regulatory process have not been universally accepted. For example, at the June 1997 TCM on regulatory J
reform, a minority of Member States recommended that a group of experts be convened to study the use of safety goals and cost-benefit analysis for transportation regulations. The remaining Member States, although not opposed, were not convinced of the merits of adopting the proposed approach. However, most Member States have accepted the concept that additional guidelines are needed for developing, justifying, and adopting specific regulatory i
provisions.
The U.S. delegation also plans to use the October 1998 TCM to generate additional support for its regulatory reform goals by meeting with individual Member States. In particular, we plan to discuss the implications of risk-Informed decisions with the French, British, and German delegations, particularity in the context of recent spent fuel cask contamination Incidents, and the proposed approval of large components, such as the Trojan Reactor Vessel, for shipment, it should be noted that the U.S. delegation does not intend to submit a specific proposal to revise cask contamination limits at this TCM. If, at some later time, the U.S. decides to submit such a proposal, it would be done in accordance with the current U.S. proposals for regulatory reform, (i.e., after completion of a cost-benefit analysis and risk study).
Staff would like to emphasize that changing the IAEA regulatory approach for transportation regulation is a long and complex process, and that it is important for representatives from NRC and DOT to consistently reiterate the U.S. position and seriousness of U.S. Intent when dealing with our international counterparts. It is also important that NRC representatives on IAEA's Advisory Committee on Safety Standards and Transport Safety Standards Advisory Committee express strong support for U.S. proposals.
Finally, the staff will keep the Commission informed on the progress of current U.S. Initiatives on IAEA regulatory reform.
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Attachments:
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i Mr. Richard Rawl Head, Transport safety Unit Division of Radiation & Waste safety International Atomic Energy Agency Wagramerstrasse 5 P.O.. Box 100 A-1400 Vienna, Austria
Dear Mr. Rawls,
i Atthe-initiskmeetingoftheTransportationsafetyseries i
Advisory' Group (TRANS' SAC), the U.S. delegation recommended that the structure, operating procedures, and regulatory' review process used by both the transport safety program and TRANSSAC be reviewed.
After much discussion, TRANSSAC requested its members submit suggestions they believe' will
_ improve the efficiency of the transport division operations, increase the ' democratic accessibility" of all Member states, or improve the process and procedures used in formulating the transport regulations.
TRANSSAC requested these suggestions be sent to the Transportation Secretariat who would collate them and present them at the next meeting of TRANSSAC.
One method for' improving the efficiency and-accessibility of the transport program is to formalize the operations of TRANSSAC and its committees.
Adoption of " Rules of Procedure" would identify the members of the transport community, clarify the schedule of the transport program and the revision cycle, define when and how proposals and working papers are to be submitted, and explain how proposals are analyzed.
By standardizing its operations-and schedule, TRANSSAC and its committees will not only retain a better 4
i-focus at its meetings, but will make it easier for Member b
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i Stateo, moda~1 crganizctions, cnd tha nucloor industry to i
participate in the transport program, be included in the 1
agenda, and participate in its deliberations.
To assist TRANSSAC develop such rules, we have submitted draft
- Rules of Procedures", based on those used by the Board of Governors and the General Conference, as attachment (1).
Since TRANSSAC has recently completed the 1.996 revision of our transport regulations, the United States believes it is excellent time for them to review the regulatory revision process they use to develop revisions of the transport regulations.
In 1986, the transport program recommended a
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policy calling for the continuing review of the regulations and developed a standard format for submission of proposed regulatory changes.
During the recently completed revision cycle, the United States was concerned that this process was 3
not strictly adhered to and lacked a fair, technically and economically sound analysis process.
Therefore, before the TRANSSAC and the transport safety program embark on the next revision cycle, the United States requests TRANSSAC review and expand its' regulatory review process by defining what constitutes a need for a regulatory change, developing a formal regulatory analysis process, and defining the rationale used for approving a regulatory change.
To assist TRANSSAC develop such regulatory analysis procedures, we have submitted a draft regulatory review and analysis program as attachment (2).
Just as we have been an active participant in the past, the United States will continue to support the Transport Secretariat's efforts to develop the best possible transport regulations in the most efficient manner possible.
We appreciate the opportunity to submit our process improvement comments and would welcome the opportunity to discuss them with you.
As a TRANSSAC member, we also look forward to discussing these items at our next meeting.
Sincerely, Richard W. Boyle, Chief Radioactive Materials Branch office of Hazardous Materials i
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TC-XXX TRANSSAC-II Working Paper No. XX
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1 DrTERNATIONAL ATOMIC ENERGY AGENCY DIVISION OF RADIATION AND WASTE SAFE 1Y Second Meeting of The Transport Safety Standards Advisory Committee (TRANSSAC-II)
IAEA Headquarters, Vienna a Februa7-n March 1997 U.S. PROPOSAL TO IMPROVE THE REVISION PROCESS FOR AMENDING IAEA TRANSPORT REGULATIONS e
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low. This evaluationwould be
- tended to eliminate some proposed requirements frem further m
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I consideration independently of whether they could bejustified by a regulatory analysis on their net value-impact basisalone. To this end, IAEA member states should develop a clear quanti 6able safety goal for transportation activities.
This safety goal should not be developed with the intent of reassessing the total body of S Series No. 6, on which there is international consensus, but abould be used to assess the need for segulatory changes based on residust risk considerations, including probabilistic risk assessment
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FROPOSAL TO IMPROVE THE REVISION PROCESS
- Based on the experiences and insights gained during the recently completed revision cycle, t proposes the following changes to improve the revision process:
that speci6cguidelines be developed fbr use in demonstrating the need for a revision.
that standardized criteria for identifying and evaluating impacts ofproposed regulatory changes be developed.
that uniform We.shold" criteria (e.g., safety goals) be developed that could be used to
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assess the merits of an individual proposal, based on an overall evaluation of need, value-
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impacts, regulatory altematives and risk.
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Impacts that should be assessed include:
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Costs to shippers.
e Costs toimplement the regulation.
Adverse effects on health, safety or the natural environment.
Adverse effects on the ef5cient functioning of the economy and private markets.
The evaluation ofquantified estimates of the values and impacts associated with a proposed regulatory action generally involves expressing values and impacti on a common basis, (e.g constant US dollars from a reference year). Therefore, member states should develop and ag upon a set ofcriteria that could be used to convert measures ofvalues and impacts into a common monetary unit. Because the values and impacts need to be estimated for the entire period that members of society will be affected by the proposed regulatory action, a present worth basis should be used to allow meaningful comparisons.
An example of a conversion factor that would have to be developed is one that would be used to assess the monetary worth of a unit of radiation exposure. The conversion factor currently used by the U.S. Nuclear Regulatory Commission is $2000 per person rem avoided.' Since this is one
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of the more important conversion factors that is needed the IAEA should consider (ifvalue-impact analysis is adopted) developing a TEDOC explaining the buis for whatever conversion factor is chosen.
Additionally, there may be some values and impacts which cannot be assessed in a quantitativ manner. These need to be identified and guidance developed on how these impacts or values will}f be considered in an overall assessment.
DECISION RATIONALE FOR REGULATORY ACTION The regulatory analysis should explain why the proposed action is recommended over the other actions being conside ed. The decision criteria for the selection of the proposed action should be identified. The criteria should include, but are not limited to the following:
The net value and value impact computations.
The relative importance of attributes that are quantified in other than monetary terms.
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The relative importance ornonquantifiable attributes.
Consistency with safety goals.
A safety goal evaluation is desirable for determining when a regulatory requirement should not be generically imposed on transportation activities because the residual risk is already acceptab 5
NUREG 1530, Reassessment of NRC's Dollar Per Person-Rem Conversion Factor Policy, December 1995.
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V U.S. PROPOSAL TO IMPROVE THE REVISION PROCESS FOR AMENDING IAEA TRANSPORT REGULATIONS C
INTRODUCTION In 1986, SAGSTRAM recommended that the IAEA adopt a policy calling for the continuing review and revision of the Agency's Regulations for the Safe Transport ofRadioactive Matedals (Safety Series No. 6 ) on a ten year cycle. A set ofprocedures for proposing and implementing revisions to Safety Series No. 6 was presented in Working Paper No. 41, Rev.1, at TC-407.3, and subsequently adopted. These procedures require that proposed revisions be submitted through a Member State's competent authority, and that proposed revisions be submitted in accordance with a standard written' format. The standard format requires that a Member State's proposalinclude "an explanation ofthe need for a propose'd revision" and " justification for the proposed revision taking into account applicable impacts." In addition, the procedures recommended that the Agency submit any proposed revisions to other Member States for comment. It was felt that these procedures would allow all Member States the timely opportunity to independently evaluate the need and justification for new regulatory requirements.
The recent experience in updating Safety Series No. 6 has highlighted several important areas, in which either the procedures themselves, or the manner in which the procedures are implemented need to be improved. First, the process for submitting proposals, especially the requirements that proposals be submitted in a timely manner and in a standard fortnat, was not rigorously followed.
In particular, near the end of the revision cycle, revisions were most often proposed without the sponsor providing a clear written rationale for the proposal's need, or an adequate justification and evaluation ofimpacts. Substantive proposals were sometimes introduced at ongoing technical committee meetings.
Second, the procedures for submitting proposals in a standard format do not give adequate guidance on what criteria should be used injustifying the need for a proposed regulation. There is likewise a lack of specific guidance on what impacts need to be considered, and on how those impacts should be evaluated for each proposal. Finally, there is no stated criteria on which to base a final decision as to whether a regulation is justified considering defined safety goals, value-impact (i.e., cost-benefit) analysis and attemative methods of achieving the desired results.
In short, the failure to adhere to agreed upon procedures, and the lack of specific guidance in implementing those procedures, have limited a member state's ability to evaluate the need and impacts of proposed regulatory revisions in a consistent and timely manner. In particular, the lack of a common safety goal has resulted in numerous instances where it was necessary to include a provision requiring multilateral approval before a majority consensus for a revision could be
- developed. This has the effect ofcausing IAEA transport regulations to become less international in character, and increases the possibility for incompatibility between IAEA regulations and those ofindividual member states.
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- i OBJECTIVE The objectives of this paper are to propose that specific guidelines be developed for use in demonstrating the need for a revision, to propose standardized criteria for identifying and evaluating impacts ofproposed regulatory changes, and to recommend that uniform " threshold" criteria (e.g., aarety goals) be developed that could be used to assess the merits ofan individual proposal, based on an overall evaluation orneed, impacts, and regulatory ahernatives.
THE NEED FOR A REGULATORY REVISION The regulatory analysis process should begin when it becomes apparent that some type of action
~to address an identified problem may be needed. Initial efforts should be focused on the nature, extent, and magnitude of the problem being addressed; why regulatory action is needed, and identi6 cation ofshernative solutions. Detailed information gathering and analysis should be focused on the most promising alternatives.
In proposing a regulatory change, it should be shown that the proposed change is needed to achieve ans of the following regulatory objectives.
L The action is necess' ry to ensure that an activity provides adequate protection to the a
health sad safety ofthe public and occupational workers.
- 2. The action involves defining o'r redefining what level ofprotection to the health and safety of the public and occupational workers is regarded as necessary for adequate protection.
- 3. The action is required to bring an activity into compliance with the IAEA Safety Series No. 6.
Each proposed regulatory change (other than those made for editorial purposes) should be submitted to TRANSSAC with a written explanation of why the need for the revision in justified under one or more of the three criteria listed above. Additional guidance or criteria should be developed, as needed, to assist member states in interpreting the criteria in a quantitative manner where possible.
ELEMENTS OF A REGULATORY ANALYSIS Once the need for a regulatory amendment 1: identified and justified, a written regulatory analysis should be prepared and presented to member states (through the IAEA) for review and comment.
The regulatory analysis should, at a minimum, address each of the followirig clements:
- 1. A statement of the problem and objectives for the proposed regulatory action, i
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including a justi6 cation of why the proposal is needed.
- 2. Identification and preliminary analysis ofalternative approaches to the problem.
- 3. Estimation and evaluation of the values and impacts for the proposed regulatory amendment, as well as identi6ed alternatives.
- 4. Conclusions of the evaluation ofvalues and impacts and, iwhen appropriate, the safety goal evaluation.
- 5. The decision rationale for selection of the proposed regulatory action.
- 6. A tentative implementation schedule and method for the proposed action.
The appropriate level of detail to be included in a regulatory analysis can vary, depending on particular circumstances and the overall importance of the proposal. However, the analysis should contain sufficient detail to allow other member states to adequately assen the proposal, with the awpamtion that the analysis could be used as a basis for other member states to independently evaluate the value-impacts for their individual countries. The following factors abould be considered in determining the appropriate level of detail.
- 1. The complexity and policy significance of the panicular problem being addressed.
- 2. The magnitude and likelihood ofvalues and impacts.
- 3. The relative amount by which' projected values exceed impacts.
- 4. The immediate need for regulatory action.
VALUE-IMPACT ANALYSIS To enable member states to assess the value impacts implications for a proposalin a uniform and consistent manner, the IAEA should develop guidance on what impacts and values should be included in a proposal, and on how those values and impacts should be evaluated, either quantitatively or qualitatively.
Suggestions on some of the values that should be included in any assessment include:
Reductions in public and occupational exposure.
Reduction in accident risk.
i Enhancements to health, safety or the natural environment.
e Savings to shippers, competent authorities, carriers, etc.
Averted property damage.
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