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Policy Issue
Notation Vote

SECY-00-0070

March 23, 2000

• PURPOSE:
• SUMMARY:
• BACKGROUND:
• DISCUSSION:
• Stakeholder concerns and reactions
• Status of Technical Basis Development
• Other Factors Affecting Decision-making
• Recommendation
• RESOURCES
• COORDINATION:

PURPOSE:

To inform the Commission of results of public meetings (and written comments) on the Issues Paper on control of solid materials, the status of technical analyses supporting decision-making on this issue, and staff recommendations for proceeding.

SUMMARY:

This paper provides the Commission with information about alternatives for establishing control of solid materials and discusses issues and concerns related to the alternatives. Additionally, the paper provides a recommendation for proceeding to address control of solid materials by integrating recent Commission direction into the agency's approach.

BACKGROUND:

On June 30, 1999, the U.S. Nuclear Regulatory Commission (NRC) published, in the Federal Register (64 FR 35090), an Issues Paper indicating that the NRC was examining its approach for control of solid material. The purpose of the Issues Paper was to foster discussion about issues associated with alternative courses of action for control of solid materials at licensed facilities that have very low amounts of, or no, radioactivity. The Federal Register Notice (FRN) stated that publication of the Issues Paper was an initial step in an enhanced participatory process in which the NRC is seeking public input to its decision-making process through various forums, and invited written and electronic comment on the paper. To provide further opportunity for public input, the NRC held a series of public meetings during fall 1999 at four locations around the country, as announced in the FRN.

In a Staff Requirements Memorandum (SRM) dated September 20, 1999, the Commission directed the staff to prepare a paper, and brief the Commission, on: (a) stakeholder reactions and concerns with the Issues Paper expressed both at the public meetings and in written comment; (b) the status of technical analyses being done to support decision-making; and (c) recommendations on whether to proceed with rulemaking or other staff actions, regarding release of solid materials, and the schedule for future staff actions on this effort.

In an SRM dated March 8, 2000, the Commission provided further direction to the staff that it request the National Academy of Sciences (NAS) Board on Energy and Environmental Systems to conduct a study and provide recommendations on possible alternatives for release of slightly contaminated solid materials. The Commission also directed the staff to provide its recommendation on integrating the NAS study into the agency's approach for proceeding to address the control of solid materials

The staff has provided information to the public about current NRC efforts in this area. Specifically, a website dedicated to this effort was established at the following address: http://www.nrc.gov/NMSS/IMNS/controlsolids.html . The website includes the Issues Paper, other pertinent documents, and summaries of comments received to date. The website is continually updated to provide current news and information regarding upcoming meetings and other opportunities for public comment. In addition, the staff has developed a list server address through which it notifies subscribers of current activities and available documents.

The term "control of solid materials" is a general term that has been used in the Issues Paper and the public meetings on this subject; it should be noted that the international community uses the term "clearance" in referring to release of materials for unrestricted use.

DISCUSSION:

The staff has been examining process alternatives on whether criteria for control of solid materials should be established as well as technical approaches as to what the alternative might be. Both the process alternatives and technical approaches were initially discussed in the Issues Paper and much comment and additional insight about these alternatives and approaches has been obtained since the Issues Paper was published. Potential process alternatives indicated in the Issues Paper included: (a) not doing a rulemaking (either continue current practice or explore updating current guidance); or (b) proceeding to issue a proposed rule. Technical approaches would be decided upon during the conduct of a process alternative and could include: (a) permitting release of material for unrestricted use if it met certain criteria; (b) prohibiting release of material that had been in an area in a licensed facility where radioactive material was used or stored; (c) restricting release to only certain authorized uses; and (d) other approaches suggested in public comment. A discussion of the process alternatives and technical approaches is contained in Attachment 1.

In considering potential alternatives and approaches, the staff has reviewed: (a) stakeholder concerns with the Issues Paper; (b) the status of technical analyses needed to support decision-making; and (c) other important factors affecting alternatives and approaches, including ongoing international activities to develop standards and activities of other Federal agencies. Detailed discussion of public comments received, status of technical analyses, and international activities and issues, are contained in Attachments 2, 3, and 4, respectively. The following is a summary of those attachments.

Stakeholder concerns and reactions

After publication of the Issues Paper, four facilitated public meetings were held in fall 1999 in San Francisco, CA (September 15-16); Atlanta GA (October 5-6); Rockville, MD (November 1-2); and Chicago, IL (December 7-8). The agendas for the meetings consisted of sessions corresponding to the content of the Issues Paper. Attendance at the four meetings included representatives from scrap and recycling companies; steel and cement manufacturers; sanitary waste facilities; the U.S. Environmental Protection Agency (EPA); U.S. Department of Energy (DOE ); U.S. Department of State (DOS); State agencies; Tribal governments; NRC licensees and licensee organizations; and the Health Physics Society. Citizen groups had expressed opposition to this process and did not attend the San Francisco and Atlanta meetings. However, a letter, signed by citizen groups, explaining why they did not attend, was delivered at these two meetings by a representative of the groups, with copies provided to attendees. Certain citizen groups did attend the Rockville and Chicago meetings, although others continued to not attend.

In addition to the public meetings, the June 30, 1999, FRN invited written and electronic public comment on the Issues Paper. The comment period was originally scheduled to end on November 15, 1999, but was extended to December 22, 1999, to accommodate a change in the original workshop schedule and to better allow stakeholders to adequately prepare for the workshop discussions. Although a number of comment letters were received requesting that the comment period be extended beyond that date, it was decided not to extend the comment period further.

There were extensive and wide-ranging comments received at the four public meetings and in the written public comments. To date, over 800 comment letters have been received on the Issues Paper. Most of these comments focused on the specific technical approach or criteria that should be developed.

Many commenters stated that there should not be release of solid materials from licensed facilities even if the calculated dose or health risks were low. In particular, potential recipients of solid material, such as scrap, metals, and cement industry representatives, objected to release of solid materials. These commenters noted that there could be a severe economic impact on their industries if consumers refused to buy products because of concerns over the presence of radioactivity. Metal industry representatives indicated that they had installed detection systems at their facilities and might reject shipments of materials released from licensed nuclear facilities even if they meet an NRC standard. A metals industry representative suggested convening a group or panel of stakeholders to work out acceptable solutions. A large number of citizen groups and individuals also expressed concern about health effects of the potential presence of this material in consumer products and indicated that NRC should prohibit the release of this material and that it should be isolated from public use. An additional suggestion made was for the identification and recapture of material previously released from nuclear facilities.

Other commenters pointed out that there was a need for a national standard in this area because of lack of consistency in criteria and implementation. These commenters also noted that the levels discussed in the Issues Paper are in the range that scientific studies consider negligible and are a small fraction of the current NRC public health criteria in 10 CFR Part 20. With regard to an approach that would prohibit releases, nuclear industry representatives were concerned that a prohibition of this type had the potential for disrupting normal day-to-day operations and would be a significant waste of resources with no accompanying health benefit. Several commenters suggested NRC adopt the American National Standards Institute's (ANSI) N13.12 (see the discussion of other factors, below). There were comments suggesting that a broad spectrum of materials should be included in a rulemaking to cover the day-to-day decisions on materials that move into and out of licensee facilities and have either very low amounts of, or no, radioactivity.

While the Issues Paper suggested possibly restricting release of materials to only certain authorized uses as a way to keep the material out of consumer products, most commenters indicated that this approach would not work because such restrictions would be ineffective and burdensome to use. Also, it was noted that unrestricted use criteria would still be needed because restrictions would only last for the lifetime of the authorized use. The only restriction suggested as workable was to reuse or recycle the material to some other use within the nuclear industry, although some commenters suggested restricting the material to landfill sites.

Detailed discussion of stakeholder concerns and comments expressed at the public meetings and in the comment letters are presented in Attachment 2 of this paper.

Status of Technical Basis Development

The staff has continued with the development of the technical bases needed for decision-making for control of solid materials. The technical bases under development were initially described in SECY-99-028. Currently, the technical bases development includes: (a) evaluation of dose-conversion factors for individual doses; (b) estimation of collective doses, costs, and potential for multiple exposures for various alternatives; and (c) survey methods appropriate for surveying solid materials at the dose levels being considered. Complicating the technical development have been issues, raised in public comment, associated with a conflict of interest (COI) with NRC's contractor, SAIC. SAIC provided a significant portion of the technical support for this project over the past several years, including preparation of draft NUREG-1640, and was contracted to provide additional analyses to support the NRC in developing dose and cost estimates. On March 17, 2000, the staff entered into a no-cost termination settlement agreement and terminated the SAIC contract NRC-04-99-046. The staff is evaluating alternate plans for proceeding to develop technical bases. Detailed discussion of each aspect of the technical bases, including its current status, issues or problems, and future work plans, are presented in Attachment 3.

Other Factors Affecting Decision-making

There have been a variety of other activities and actions that should be considered in decision-making on control of solid materials.

Various activities are underway in the international community to set standards for control of solid material. The European Commission is proceeding to establish new radiation protection standards, including standards for clearance. Staff has been informed that these new regulations are expected to be in place by at least two European countries by May 13, 2000. In addition, the IAEA is establishing criteria for nuclide concentrations for its member states. Development of these guidelines and criteria will have an important effect on international trade and import standards.

The EPA has responsibility for setting generally applicable environmental standards under the Atomic Energy Act (AEA). Although EPA is not pursuing a rulemaking in this area at this time, they are continuing to develop a technical data basis for estimating potential doses resulting from release of solid materials. In addition, the EPA is working with the DOS regarding the international standards setting and its relationship to import issues. The DOE, which has a large inventory of stored solid material having low amounts of radioactivity from its various defense activities, has, as of January 12, 2000, instituted a moratorium on release of metals with volumetric residual radioactivity. DOE has also established a task force to review DOE policies on release of all materials for re-use and recycling which would include public participation.

In September 1999 the American National Standards Institute (ANSI) published ANSI N13.12, "Surface and Volume Radioactivity Standards for Clearance." This standard contains criteria for unrestricted release of solid materials from nuclear facilities. According to the National Technology Transfer and Advancement Act of 1995, Federal agencies are to use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such standards is inconsistent with applicable law or otherwise impractical.

Additional discussion of the ANSI standard and international activities, including their potential impact on NRC decision-making, are presented in Attachments 1 and 4, respectively.

Recommendation

The diversity of public views expressed on this issue, as well as the various actions being explored by private and public organizations, underscore the need to develop a national standard to provide a clear and uniform approach to the control of solid materials. However, the acceptability of criteria in a standard will depend on a variety of the factors described above. Thus, it is just as critical to consider the process used to move discussions forward as it is to clearly articulate the technical basis for any criteria that might be established.

Based on the above, it is the staff's recommendation that a final decision on whether to proceed with rulemaking be deferred at this time, and that the staff should take the following actions to integrate the March 8, 2000, SRM into the agency's approach for proceeding to address control of solid materials:

Conduct of the above items will allow NRC to gain further insights as to paths forward and further develop its information base. Together, they will place NRC in a better position to proceed with decisions on potential policy and technical approaches. It is planned that the staff would keep the Commission informed while the NAS study is underway and provide its recommendations as to next steps for proceeding approximately three months after completion of the NAS study.

RESOURCES

The proposed NAS study will be funded as part of the FY 2000 mid-year review. The resources for continuing to develop the information base are within current budget estimates. Resources to pursue the effort following completion of the NAS study and the Commission's decision on the alternatives to either not conduct a rulemaking or to develop a proposed rule will be considered during the FY 2002 budget formulation process.

COORDINATION:

This paper has been coordinated with the Office of the General Counsel, which has no legal objection. The Office of the Chief Financial Officer has reviewed this Commission Paper for resource impacts and has no objection. The Office of the Chief Information Officer has reviewed the paper for information technology and information management implications and concurs in it. A public announcement will be issued by the Office of Public Affairs.

ATTACHMENT 1

Analysis of Alternatives for Proceeding

• A. INTRODUCTION
• B. Listing of Alternatives
• C. Bases for Evaluation of Alternatives
• D. EVALUATION OF ALTERNATIVES
• E. Discussion of Technical Approaches
• F. Assessment of Technical Approaches

A.  INTRODUCTION

NRC is currently examining its approach for control of solid materials that have either no, or small amounts of, radioactivity at licensed facilities. This examination includes both process alternatives for establishing criteria for control of solid materials (i.e., conduct a rulemaking or not) and technical approaches for what the criteria should be (i.e., unrestricted use, prohibition, restricted use). Both the process alternatives and technical approaches were initially discussed in the Issues Paper and have been further developed to include public comment and other factors.

The analysis in this attachment is intended to provide information to facilitate decision-making regarding the process alternatives by discussing the input received at the public meetings and in written public comment, the technical bases available to support decision-making, and other important factors. The alternatives are listed and evaluated in Sections B, C, and D of this attachment.

During the course of carrying out the process alternatives, a technical approach for the actual criteria would be developed. Although it is not the intent of the analysis in this attachment to select a technical approach for control of solid material, it is instructive to discuss the approaches and describe the extensive and wide-ranging public comment received on them to date. This discussion is contained in Sections E and F of this attachment.

B. Listing of Alternatives

There are two broad process alternatives that the NRC could follow, i.e. to either not conduct a rulemaking, or to develop a proposed rule. These are discussed below:

C. Bases for Evaluation of Alternatives

The process alternatives are evaluated based on the following factors, which address the directions provided by the Commission in the September 20, 1999, SRM:

D.   EVALUATION OF ALTERNATIVES

1)  ALTERNATIVE 1: DO NOT CONDUCT A RULEMAKING. Under this alternative, NRC would not proceed with a rulemaking at this time. Instead it could take one of the following options: (a) continue with its current case-specific criteria or (b) explore options for updating existing guidance to improve consistency of criteria.

These alternatives were initially presented in the Issues Paper. However, based on the extensive discussions at the workshops and public comment received, if either Alternative 1a or 1b is selected, NRC could supplement those activities by maintaining an ongoing participation in various areas to evaluate major factors identified in the public comments to date that could affect its future decision-making in this area. This would include following other initiatives and addressing complicated issues including: (a) maintaining a dialogue with a broad spectrum of stakeholders, such as steel, scrap, and cement industry representatives, landfill representatives and public interest groups, to develop acceptable approaches for solid material usage; and (b) following international developments in setting standards and EPA actions taken in response to those developments, in particular with regard to its responsibilities in the area of import standards. In addition, the staff could continue its review of draft NUREG-1640 as discussed in Attachment 3 and conduct dose assessment studies and cost evaluations associated with control of solid material, as appropriate. Based on the outcome of these actions, NRC could further evaluate its alternatives for proceeding. A schedule is not established at this time for these activities.

The alternatives are discussed below.

ALTERNATIVE 1a: DO NOT CONDUCT A RULEMAKING AND CONTINUE CURRENT PRACTICE. Under this alternative, no NRC rule would be prepared and NRC would continue its use of existing guidance. Licensees would still continue to seek release of solid materials, and NRC would continue to evaluate these requests on a case-by case basis using existing guidance, license conditions, policies, etc.

ALTERNATIVE 1b: DO NOT CONDUCT A RULEMAKING AND EXPLORE OPTIONS FOR UPDATING EXISTING GUIDANCE TO IMPROVE CONSISTENCY OF CRITERIA. In this option, NRC would explore options for updating existing guidance under the existing regulatory structure of 10 CFR Part 20 to provide more uniformity in criteria. Potential updates might include defining detection limits for controlling solid materials or developing other more restrictive guidance. The extent to which guidance can be updated in the absence of a rule change may limit the extent of the guidance revision. An update to guidance would involve developing a value-impact analysis.

ALTERNATIVE 2: PROCEED AT THIS TIME TO DEVELOP A PROPOSED RULE. In this option, NRC would proceed towards issuance of a proposed rule in Part 20 establishing criteria for control of solid materials. There are technical approaches under this alternative that would have to be decided upon during the rulemaking process. These include those discussed in the Issues Paper and listed in Section E of this attachment. To support decision-making regarding these approaches, NRC would develop a GEIS and an analysis of costs and benefits in a RIA. To support these decision-making tools, NRC would develop a detailed technical analysis, including inventory of materials at licensed facilities, dose assessment (including evaluation of potential for multiple exposures), costs, and methods of implementation. These analyses are discussed further in Attachment 3. The staff would also need to maintain cognizance of other scientific studies being conducted and other major factors affecting decision-making. In addition, the rulemaking would also need to consider public comments made at the workshops and in written comment. This would likely involve significant staff efforts at resolving the comments and reconciling them.

E. Discussion of Technical Approaches

During the course of carrying out the process alternatives, a technical approach for the actual criteria would be developed. Potential technical approaches were initially described in the Issues Paper and have engendered significant public comment. Although it is not the intent of the analysis in this attachment to select a technical approach for control of solid material, it is instructive to discuss the approaches and describe the extensive and wide-ranging public comment received on them to date. The potential technical approaches are:

F. Assessment of Technical Approaches

The technical approaches noted in Section E would be decided upon during the conduct of a process alternative. Although it is not the intent of this attachment to select one of these technical approaches, the wide ranging concerns and issues raised in public comment regarding these technical approaches are important to consider when considering the process alternatives. A summary of the comments includes the following:

ATTACHMENT 2

Summary of Written and Public Meeting Comments

• A. Purpose
• B. Introduction
• C. Process Alternative - Continue Current Practice or Update Guidance
• D. Process Alternative - Should NRC Do a Rulemaking
• E. Technical Approach - Unrestricted Release of Solid Materials
• F. Technical Approach - Restrict Use of Materials to Only Certain Authorized Uses
• G. Technical Approach - Prohibition on Release of Material from Radioactive Areas
• H. Other Technical Approaches Suggested
• I. Issues with Development of NRC's Technical Bases
• J. Other Procedural Comments
• K. Comments Related to International Issues
• L. Comments on Additional Materials as Candidates for Rulemaking

A. Purpose

The purpose of this attachment is to provide a summary of the comments received both at the four public workshops and in written comments in response to the Issues Paper.

B. Introduction

As part of the Nuclear Regulatory Commission's (NRC's) examination of its approach for control of solid materials, the NRC sought early public input on the major issues associated with this effort, including conducting a scoping process related to associated environmental impacts. To aid in this process, the NRC prepared an Issues Paper that describes issues and alternatives related to release of solid materials. The purpose of the Issues Paper was to foster discussion about issues associated with alternative courses of action for control of solid materials at licensed facilities that have very low amounts of, or no, radioactivity.

This Issues Paper was published in the Federal Register on June 30, 1999. The closing period for public comments was originally November 15, 1999, but was extended until December 22, 1999. The Federal Register Notice (FRN) invited public comment on the paper and, to provide further opportunity for public input, the NRC held a series of public meetings during fall 1999 at the following four locations:

The Issues Paper described the following process alternatives:

• Continue current NRC practice of case-by case consideration of licensee requests for release of solid material or consider updating existing guidance;
  
  
• Conduct a rulemaking to establish criteria for control of solid materials.

The Issues Paper indicated that a rulemaking could have three technical approaches:

1. Permit release of solid materials for unrestricted use if the potential doses to the public from unrestricted use of the material were less than a specified level determined during the rulemaking process;
   
   
2. Restrict release of solid materials to only certain authorized uses;
   
   
3. Do not permit either unrestricted or restricted release of solid material that has been in an area where radioactive material has been used or stored, and instead require all such materials to go to a licensed low-level waste (LLW) disposal facility. This is referred to as prohibition.

Over 800 comments have been received on the Issues Paper. The majority of the comments focused on the specific technical approaches. With the assistance of contractors, the public meeting transcripts and the public comments received by the NRC staff were collected and organized into a database to facilitate NRC staff review of the public comment. The following provides a summary of the public comments and meetings, as well as major trends in the comments. It is anticipated that a more detailed characterization and summary of the comments will be published in a NUREG report and be available on the NRC's website on control of solid materials.

Sections C and D summarize comments received on the process alternatives for establishing criteria for control of solid material (Section C summarizes comments on whether to continue the current case-by-case approach or update that approach, and Section D summarizes comments on whether to conduct a rulemaking). Sections E, F, G, and H summarize comments on the technical approaches as to what the criteria should be. Sections I, J, K, and L summarize comments on development of NRC's technical information base, other procedural issues, international issues, and materials that should be considered, respectively.

C.  Process Alternative - Continue Current Practice or Update Guidance

Comments on the process alternative of continuing current approach or updating guidance included the following:

D.  Process Alternative - Should NRC Do a Rulemaking

Comments were received on the process alternative of whether NRC should do a rulemaking. These are summarized here. A number of comments focused on specific technical approaches and these are discussed in Sections E, F, G, and H of this attachment.

E.  Technical Approach - Unrestricted Release of Solid Materials

In general, comments in this area fell into distinct viewpoints by stakeholder grouping. Therefore for ease of following the nature of comments this section is arranged by stakeholder group. Specific stakeholder categories and comments include:

F.  Technical Approach - Restrict Use of Materials to Only Certain Authorized Uses

In a restricted use approach, material would be restricted to only certain authorized uses This could involve either limiting the material to: (i) some non-licensed use (e.g., bridge supports, public landfills); or (ii) within the nuclear industry (e.g., shipping casks). Comments treated both of these possibilities.

G.  Technical Approach - Prohibition on Release of Material from Radioactive Areas

As noted in Section B of this attachment, a prohibition approach would involve not permitting release of solid material that has been in an area where radioactive material has been used or stored, and instead require all such materials to go to a LLW disposal facility. Comments on this approach included:

H.  Other Technical Approaches Suggested

The issues paper indicated that other approaches besides those listed in the Issues Paper would also be considered. Comments on other approaches for control of solid materials included:

I.  Issues with Development of NRC's Technical Bases

There were a number of comments raised on NRC's development of a technical basis to support decision-making. The technical basis development is discussed in Attachment 3 of this paper. Comments included:

J.  Other Procedural Comments

Other comments were also received on various procedural issues regarding the establishment of criteria for control of solid materials. Comments included:

K.  Comments Related to International Issues

Comment was received on the relationship of this effort to international initiatives being considered (See Attachment 4 of this paper). Comments were divided on how to factor international initiatives into NRC decision-making. Comments included:

L.  Comments on Additional Materials as Candidates for Rulemaking

With regard to types of materials that should be covered in a rulemaking, it was noted that:

ATTACHMENT 3

Status of Technical Basis Development

• A. Purpose
• B. Introduction
• C. Individual Dose Assessments (Draft NUREG-1640)
• D. Additional Dose and Cost Analyses
• E. Soil Technical Basis Development
• F. Survey Analyses
• G. Technical Analysis Evaluation for Regulatory Development Analysis

A.  Purpose

The purpose of this attachment is to inform the Commission of the status of the technical basis work that is being performed by the staff and its contractors. This attachment discusses work that could be developed to support a rule or to update existing guidance, if the Commission selects this option. If the Commission decides not to pursue a rule at this time, some of this work could still be beneficial in assisting the Commission with other options discussed in Attachment 1 of this paper, such as updating existing guidance.

B.  Introduction

During the past several years, the staff has developed methods for assessment of doses to individuals as part of a technical basis to support decision-making on a regulatory standard for clearance of materials from nuclear facilities. This effort resulted in the establishment of material flow models and potential exposure scenarios for copper, aluminum, steel, and concrete. The dose assessment methodology was developed in consultation with other Federal agencies, namely, the EPA and DOE, as well as the IAEA. This effort culminated with the publication in March 1999, of a draft report entitled "Radiological Assessments for Clearance of Equipment and Materials From Nuclear Facilities" (NUREG-1640). The methods and results contained in the draft report may be used for translation of a hypothetical individual's dose from concentrations of radioactivity in or on metal and concrete.

In early 1999, the staff identified several areas that required additional technical assistance to support decision-making on the clearance of solid materials, including holding public meetings. NMSS and RES coordinated the award and management of six contracts to: (1) support public workshops (Meridian); (2) perform technical work on dose assessment and costs (Science Application International Corporation); (3) evaluate environmental impacts and cost-benefit analyses (ICF Consultants, Inc.); (4) search the literature for soils uses (U.S. Department of Agriculture); and (5) extend survey methods and estimates of survey costs for clearance(Oak Ridge Institute for Science and Education and the DOE's Environmental Measurements Laboratory).

Complicating the technical basis development have been issues, raised in public comment, associated with a conflict of interest (COI) with one of the contractors, SAIC. On March 17, 2000, the staff entered into a no-cost termination settlement agreement and terminated the SAIC contract NRC-04-99-046. As part of the settlement agreement, SAIC agreed not to seek reimbursement of invoiced costs in the amount of $120,000. The staff is evaluating alternate plans for proceeding to develop technical bases. Certain technical basis development work will be more impacted by the contract termination than others, as described in the following sections.

Descriptions of the technical basis work are divided into five interrelated sections, each with the following format: (1) a description of approach for technical assistance; (2) work to date; and (3) future work plans.

C.  Individual Dose Assessments (Draft NUREG-1640)

1. Approach for Technical Basis Development

In order to establish criteria for clearance of materials, it is necessary to estimate what hypothetical dose an individual might receive from residual radioactivity in solids. Draft NUREG-1640 describes the scenarios, models, calculation methods, and results of such analyses for individuals over a broad range of scenarios. The scenarios were designed to cover the probable fates of iron and steel, copper, aluminum, concrete and equipment for reuse if cleared to enter the general stream of U.S. commerce from a nuclear facility. These scenarios were also designed to identify the critical group, which is the group of individuals reasonably likely to receive the highest dose.

2. Work to Date

A substantial portion of the technical basis for this analysis decision-making was completed with the publication of the December 1998 draft, "Recycle/Reuse Literature Search Report," and draft NUREG-1640. The latter document was issued for public comment in March 1999 and the public comment period closed in December 1999. Currently, comments are being evaluated by the staff.

3. Future Work Plans

In response to the comments, draft NUREG-1640 needs to be revised and completed. However, during public comment period, issues were raised concerning a COI with the contractor, SAIC, that provided technical assistance on the draft NUREG-1640. In response, the staff obtained additional information on this matter and, based on its review, on March 17, 2000, the staff entered into a no-cost termination settlement agreement and terminated the SAIC contract. Currently, the staff is evaluating alternate plans for proceeding to develop technical bases.

In a memorandum from the Office of Research to the Deputy Executive Director for Materials, Research, and State Programs, dated February xx, 2000, the staff developed several options for resolving the COI allegations and completing NUREG-1640. In that memo, if the Commission decided not pursue rulemaking, Completion of draft NUREG-1640 may not be necessary for NRC technical basis development, but would be useful as a tool for estimating doses associated with surficial and volumetric clearance criteria that may be developed by other Federal, State, or international organizations.

D.  Additional Dose and Cost Analyses

1. Approach for Technical Basis Development

As described in Section A of this attachment, the technical analyses developed to date is limited to individual doses only. If an alternative involving rulemaking were to be pursued, a draft Generic Environmental Impact Statement (GEIS) and draft Regulatory Impact Analysis (RIA) would need to be prepared in support of decision-making on technical approaches, as discussed in Section G of this Attachment. Collective dose and cost impact estimates are required for the development of these documents. Because collective doses for copper, aluminum, steel, and concrete, which are the materials analyzed in draft NUREG-1640, have not been estimated yet, additional technical basis development on doses and costs is necessary. In addition to the scenarios already established in draft NUREG-1640, there may be potential population doses from additional scenarios that need to be examined.

Further, the amounts of materials and equipment and the kinds and amounts of radioactivity associated with scrap metal needs to be established in relationship to the potential regulatory alternatives for clearance. This information is required to calculate collective doses and to estimate the cost-benefit of regulatory alternatives. In addition, the Commission requested that the technical basis be comprehensively applicable to all materials; therefore, the assessment for clearance of other materials may be required. Soil is one of the materials the staff is assessing, based on direction from the Commission, which is described further in Section E of this Attachment.

Technical basis development would be needed in the following areas: (1) an assessment of the inventory of materials that would likely be available for release from various national and international sources; (2) an assessment of collective doses; and (3) an assessment of costs associated with clearance of materials using the attributes needed to support a regulatory analysis. Additional information on these areas is provided below:

2. Work to Date

SAIC had been contracted to develop this technical basis. The plan was to begin work on inventory of steel, copper, aluminum and concrete, followed by work on collective doses from these materials and draft NUREG-1640 scenarios, and then cost estimates for these materials and scenarios. The results of this work were to be provided to other contractors working on other aspects of the technical basis. Subsequent work on additional materials and scenarios was planned upon completion of the aforementioned tasks. Also, it may be useful to develop dose assessment methods and cost evaluations similar to those described above, as a tool in specific licensing reviews or in regulatory interactions with other Federal, State, or international organizations on clearance.

However, during public comment period, issues were raised concerning a COI with SAIC. In response, the staff obtained additional information on this matter and, based on its review, on March 17, 2000, the staff entered into a no-cost termination settlement agreement and terminated the SAIC contract.

3. Future Work Plans

Should the Commission decide to select the rulemaking alternative, this work would have to be completed. However, tThe original schedule was to complete the technical basis development by August 2001. However, this schedule is no longer valid due to termination of the SAIC contract. Currently, the staff is evaluating alternate plans for proceeding to develop technical bases.If the Commission decided not to pursue rulemaking, it would not be necessary to complete this work. However, i

E.  Soil Technical Basis Development

1. Approach for Technical Basis Development

In a SRM dated June 30, 1998, the Commission directed the staff to include soil in its overall technical basis development. In response to the SRM, the staff sent the Commission a paper (SECY-99-028) which stated that, both from its experience and from information received from licensee groups, it is important that soil is included in the technical basis development. However, soil was not one of the materials included in the draft NUREG-1640 analyses. Although draft NUREG-1640 does not include soil, work done previously for the license termination rule in draft NUREG-1496,"Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities," NUREG/CR-5512, "Residual Radioactive Contamination from Decommissioning," and NUREG-1549, "Decision Methods for Dose Assessment to Comply with Radiological Criteria for License Termination," provide baseline technical information on individual dose factors and cost-benefit analysis for soil which can be adapted for use in documents prepared to assist in decision-making.

Development of a technical basis for estimating hypothetical doses which could result from residual radioactivity in a soil matrix requires the establishment of individual and collective dose factors for use in a draft GEIS, RIA, and Regulatory Guide, if a rulemaking alternative were to be pursued. The work planned for developing these dose factors includes establishing scenarios and exposure pathways to the average member of the critical group. The same range of radionuclides analyzed in NUREG-1640 would be used for soils. In addition, staff plans to evaluate the differences, including their rationale, between the draft NUREG-1640 and license termination rule technical bases. Thus, the work conducted on soils is planned to be developed in a collaborative effort with other portions of the overall technical basis.

2. Work to Date

In May 1999, the staff began obtaining data on the use of soils in the United States so that exposure pathway modeling will reflect realistic exposure scenarios to radiologically contaminated soils. These soils could be excavated and transported offsite for use in commerce or by the general public once the soils were released from NRC-licensed facilities. The staff began its own literature search to obtain a reasonably complete characterization of such relevant soil usage. However, during the course of the staff's literature search, it became evident that additional technical assistance was needed from professional soil researchers to acquire the specific information needed by the staff.

In August 1999, the staff contracted with the U.S. Department of Agriculture's National Agricultural Library staff to conduct a comprehensive literature search on relevant soil-usage scenarios. The goal of this effort is to develop a database and the supporting references to provide NRC staff with current information on potential soil exposure scenarios and parameter values for dose assessment. Since soil as a commodity is not well characterized in the literature, a literature survey was undertaken of more than 500 databases covering science, technology, business, news and other categories, and the internet. From the more than two million records that were initially found in the databases searched, subsequent targeted search strategies recovered 77,877 titles for review. The staff screened these titles and selected a final listing of documents for review.

The results of this effort were documented in a letter report that was sent to the NRC Public Document Room on December 8, 1999. As a result of this effort, the staff has prepared a draft NUREG, "Human Interaction with Reused Soil: A Literature Survey." The report also describes the procedures and results of the extensive literature search. It will be issued in draft form to solicit public comments on the literature search findings and to actively seek additional documented information sources for developing soil reuse scenarios for use in dose assessments related to residual radioactivity.

3. Future Work Plans

This work would need to be completed if the Commission decides to select the rulemaking alternative. NUREG-xxxxThe draft NUREG would provide an important part of the technical basis development on soils. It lists about 70 references the staff will further evaluate for the purpose of developing exposure scenarios for the reuse of soils. The staff plans to review the references and extract useful information to establish the scenarios and estimate relevant parameters involved in soil reuse (e.g., contact time, soil type, number of people involved, volumes of soils, etc.) to supplement reviews already undertaken. To facilitate this task, a table has been developed to organize information regarding how soil may be reused and how people may come into contact with it. Column headings refer to potential soil reuse scenarios, rows list information important to describing parameters important for modeling exposure. Public comments are specifically requested to provide data that would complete and/or expand the soil reuse scenario framework.

Once a scenario is identified, more detailed information on human activities and behavior is needed to define the important exposure pathways. It should be noted that a complete scenario may have more than one set of exposure pathways, depending on the expected activities of the exposed individuals. As an example, for gardening activities within the suburban scenario, exposure pathways could include inhalation, ingestion of vegetables or fruits, inadvertent ingestion of soil, and external exposure. To evaluate the potential overall impact of soil reuse, several scenarios would need to be analyzed to determine the critical group. The critical group is the group of individuals reasonably expected to receive the greatest dose from residual radioactivity for any applicable set of circumstances. The dose to the average member of the critical group is then calculated.

Upon completion of the development of supporting information on scenarios, exposure pathways, and critical groups, the staff plans to document its findings in a separate draft NUREG and publish it for public comment. The draft NUREG would also address analyses used by other Federal agencies in regulating soil or soil-like material, such as the EPA's approach to regulating coal ash. Following the review of public comments on the soil exposure scenarios, exposure pathways, critical groups, and dose factors, the staff plans to complete its analysis and prepare a final NUREG incorporating public comments, which would complete the development of individual dose factors for soil.

The next step in the technical basis development on soil to support decision-making would be the assessment of collective dose and costs. Although the staff would be collecting supporting information during the development of the other NUREGs related to the soil technical basis, the analyses required under this portion will likely be more complex because of the diverse uses of soil in commerce in different locations throughout the United States.

It would not be necessary to complete this work if the Commission decides not to pursue rulemaking, However, it may be useful to develop soils information for use in other areas, such as the evaluation of 10 CFR 20.2002 disposals, during decommissioning, and for use as an aid in regulatory interactions with other Federal, State, or international organizations on clearance.

F.  Survey Analyses

1. Approach for Technical Basis Development

Measurement and analysis of residual radioactivity at or near background concentrations, either on the surface or when radioactivity is contained within the materials itself, has been a technical challenge. Previously, staff developed technical information in this area to support the license termination rule, which was issued in July 1997, and development of the draft Regulatory Guide for the license termination rule. The supporting technical basis was contained in NUREG-1505, "Nonparametrical Statistical Methodology for the Design and Analysis of Final Status Decommissioning Surveys," NUREG-1506, "Measurement Methods for Radiological Surveys in Support of New Decommissioning Criteria," NUREG-1507, "Minimum Detectable Concentrations with Typical Radiation Survey Instruments for Various Contaminants and Field Conditions," and NUREG-1575, "Multiagency Radiation Survey and Site Investigation Manual" (MARSSIM).

Although these documents provide baseline technical information on survey methods for lands and structures with residual surface radioactivity, they do not include survey methods that are applicable to materials and equipment with low levels of residual radioactivity on their surfaces and distributed throughout a volume. Therefore, these documents need to be updated to support decision-making regarding solid materials, either as part of a rulemaking or the development of a draft Regulatory Guide. It is essential that work conducted on the draft Regulatory Guide be developed in a collaborative effort with other portions of the technical basis.

As discussed previously in this attachment, the staff is evaluating technical information to support decision-making, including environmental impacts and the cost-benefit of alternatives. As part of the cost-benefit analysis, the staff is developing costs for conducting surveys at various dose levels and evaluating the corresponding regulatory guidance to provide licensees with information on how to demonstrate compliance with radiological criteria. Guidance would be provided on, for example, measurement methods for low concentrations of volumetrically contaminated materials that exist in various equipment and materials types, shapes, and sizes that are anticipated to be available for release. The analyses would include the cost of measurement and would also be used to evaluate the practicality of measurement options available to licensees. The primary approach the staff is taking involves the application of nuclide-specific measurements for increased detection sensitivity as well as alternative statistical methods.

Currently, staff is working with two different contractors to develop a technical basis on survey methods. ORISE is the lead NRC contractor supporting the NRC staff in developing survey cost estimates and technical support on survey methods using "off-the-shelf" instrumentation. ORISE and the EML would assist the staff in evaluating implementation issues, developing subsurface analysis methods for both soil and clearance materials, and expanding the statistical tests for subsurface measurements.

The technical approach for developing survey method information may entail the application of more sophisticated survey instruments than are currently used in practice. Continuing development of new statistical methodologies to plan, conduct and interpret the results of the survey is also necessary. The statistical methodology must also be coupled to the measurement technique to account for effects of certain factors, such as instrument response, the radionuclide chemical and physical form, the size and complexity of the material, and the residual radioactivity level relative to the background radiation level to assure that the appropriate criteria have been met. The contractors would assist the staff in addressing these challenging technical issues.

2. Work to Date

The staff and its contractors are conducting literature searches on the state-of-the art in surveying to take into account advances in instrumentation and measurement methods. However, some of the information on developing measurement and analytical techniques are proprietary to commercial companies and, in some cases, related to nuclear non-proliferation activities. The staff is currently working with vendors and radiation detection and measurement experts to obtain comprehensive information on the commercial availability of such instrumentation.

ORISE and EML began work on this portion of the technical basis in August 1999. The staff has expanded research on the simplification of survey methodologies of surface measurements to include subsurface contamination, which is a contamination configuration that is expected in materials potentially available for clearance. This research is expected to reduce or optimize the effort required to provide statistically meaningful results using a minimum number of samples. This work is applicable to all solid materials that require sampling below the visible surface or any other radiation survey that requires collecting radiological knowledge below a surface.

To date, the contractors have provided information on the following: (1) identification of facilities for survey estimates; (2) radionuclides of concern at the facilities; (3) preliminary information on the scope of survey effort at one facility; and (4) preliminary results of a literature review on survey instrumentation. There will be schedule impacts due to the termination of the contract with SAIC (see Section D of this attachment).

3. Future Work Plans

Independent of whether a rulemaking alternative is pursued, this work could be used by the NRC staff and by other Federal agencies to resolve existing and potential inconsistencies in the approaches and procedures for measuring low levels of radioactivity in or on contaminated equipment and material. In support of developing implementation guidance for the rulemaking on radiological criteria for licence termination (Subpart E of 10 CFR Part 20), the staff worked with other federal agencies to develop the MARSSIM (NUREG-1575). MARSSIM was developed to deal with the concerns and problems associated with making radiological measurements at low levels, but was limited to surface contamination in buildings and land areas. Although MARSSIM has been adopted nationally and is being used internationally for survey guidance, a limitation of MARSSIM is that it does not address subsurface contamination measurements and volumetric contamination in soils, materials and equipment. The staff considers MARSSIM the appropriate document to establish consist federal guidance for the control of solid materials.

The NRC staff participated fully in the development of MARSSIM and contributed significantly to its technical basis by developing the supporting analyses in NUREG-1505, NUREG-1506, and NUREG-1507. Currently, similar supporting documents for the clearance of solid materials are not available for incorporation into MARSSIM. Additional time and effort will be needed to expand or append MARSSIM and its technical basis to include subsurface measurement guidance. However, a draft Regulatory Guide developed independent of MARSSIM could be developed by the staff and its contractors separately, which may expedite completion of the guidance.

Plans for future work by the staff and its contractors include survey cost estimates and the development of a technical approach for conducting surveys. The staff expects to obtain general information on instrumentation and measurement and more specific information on difficult geometry sampling and analysis using advanced methods and a final report on survey methods. Regarding the development of survey costs, the staff expects estimates for various facilities and measurement methods using "off-the-shelf" instrumentation and plans to develop additional estimates using advanced survey techniques once they have been studied further.

G.  Technical Analysis Evaluation for Regulatory Development Analysis

1. Approach to Technical Basis Development

The staff is working with a contractor, ICF Consulting Inc. (ICF), to document public comments on the Issues Paper, which is discussed in greater detail in Attachment 2. Should the Commission elect to pursue rulemaking in this area Should the rulemaking alternative be pursued, the staff and its contractor would develop prepare the regulatory analyses of options consistent with required by NEPA and Executive Order 15992. A draft GEIS and RIA would be prepared to address the affected environment, environmental consequences, radiological and non-radiological risks, socioeconomic factors, such as environmental justice and expected land use, and the cost and industry impacts associated with implementation of newdiverse radiological criteria for clearance. If another alternative is pursued, such as updating guidance, work of this nature to support value-impact assessment for the guidance would still be needed.

Development of a GEIS and RIA are dependent on products from other staff and contractor analyses, such as those discussed in previous sections of this attachment. In particular, information on inventory, dose assessment and costs are essential to calculate collective doses and estimate the cost impacts of regulatory alternatives. Additional analyses for individual and collective doses may be needed to cover other materials, such as soil, and implementation consideration, which have not been analyzed yet.

2. Work to Date

As discussed in Attachment 2 of this paper, the staff held a series of workshops on the Issues Paper in fall 1999. During the workshops, the staff began the early stages of scoping under NEPA by discussing the regulatory approach for conducting the required analyses and, with assistance from its contractor, summarized public comments on different options for the control of solid materials. A database was utilized to prepare the summary of public comments contained in Attachment 2 of this paper.

A standard format and guidance document was prepared that could be used by the staff and its contractors to more efficiently prepare and analyze cost-benefit data, should a rulemaking be pursued. In addition, the feasibility of materials and inventory acquisition for NRC-licensed and non-NRC licensed generators has also been evaluated.

3. Future Work Plans

As discussed in Sections B, C, and D of this attachment, complicating this effort is the termination of the SAIC contract for development of the technical bases. The results of the SAIC contract were to provide input to the ICF work on the GEIS and RIA. However, the SAIC contract was terminated on March 17, 2000 and currently the staff is evaluating alternate plans for proceeding to develop technical bases. The staff will be considering the effect of that evaluation on this effort.

If a rulemaking alternative is pursued, an assessment of rulemaking alternatives would be made. This would be followed a preliminary draft GEIS and RIA, and a revised draft GEIS and RIA, and public interaction in development of the documents. The staff would then prepare an FRN proposing a rule, a draft Statement of Consideration, and supporting documentation. This would entail the analysis of and response to public comments related to the scoping process.

ATTACHMENT 4

International Aspects of Clearance

• A. Purpose
• B. Introduction
• C. International Status of Clearance Levels
• D. Relationships of an NRC Clearance Rulemaking to U.S. Agencies in the International Arena
• E. Overlapping International Issues
• F. Recent and Future IAEA Meetings on Clearance Levels

A.  Purpose

Provide information to the Commission on: the status of clearance regulatory efforts internationally; relationships of an NRC clearance rulemaking to U.S. agencies in the international arena; and to distinguish clearance from regulatory issues on import of orphan sources and illicit trafficking of nuclear materials.

B.  Introduction

The importance of clearance regulations internationally is the legal acceptance of imports and exports. Differences in clearance criteria among countries could adversely affect international trade. International acceptability of cleared materials and equipment is based on what is referred to in the international scientific community as "established trivial doses and risks"⁽¹⁾ (see "Principles for the Exemption of Radiation Sources and Practices from Regulatory Control," IAEA Safety Series No. 89, 1988). The National Council on Radiation Protection and Measurements (NCRP) refers to these levels as a "negligible individual dose." Regulatory issues concerning orphan sources and illicit trafficking of radioactive materials are distinct, but overlap with clearance issues, because they involve the detection of radioactivity associated with materials and equipment moved across national boundaries. Clearance is distinguished from orphan sources and illicit trafficking because the release from regulatory control for clearance is intentional and is based on a trivial dose.⁽²⁾ International aspects of clearance and these overlapping issues are briefly addressed below.

C.  International Status of Clearance Levels

A number of countries have adopted and implemented clearance levels. The concentrations of radionuclides and conditions for clearance vary among countries. However, there are two important international activities that will tend to harmonize clearance internationally. They are the activities of the International Atomic Energy Agency (IAEA) and the European Commission (EC). Many of the countries that have clearance levels are in the EC, and those countries have been directed to conform with EC recommendations by May 13, 2000. Staff is aware of at least two countries, Germany and the U.K., that are expected to be in full or virtually full compliance by that date. Other countries likely will apply for extensions of the deadline before their full compliance. Principal countries outside the EC that could clear materials and equipment generally may be expected to follow the EC. Significant amounts of cleared materials and equipment might be expected in the form of products imported from Canada, Japan, and former-Soviet-Union countries. The background and status of the activities of the IAEA and the EC are briefly described below in relationship to the NRC efforts in the area of clearance.

The concept of clearance was established by the IAEA in its Basic Safety Standards (BSS). Although the IAEA BSS does not clarify the implementation of clearance, there has been progress internationally by the IAEA and the EC and nationally in a number of countries. The consistent threads among these efforts are that "on the order of 10 µSv/a⁽³⁾ for a practice" is a trivial dose, 1 man-Sv⁽⁴⁾ per year of practice or less requires no further analysis for optimization (ALARA), and "clearance" means the total cessation of radiological control.

The IAEA has already published an interim report for the implementation of clearance. It used the 10 µSv/a criterion and pathway analyses from a number of countries to translate the dose criterion to concentrations of radioactivity distributed on surfaces (Bq/cm²) and throughout volumes (Bq/g). These clearance levels, in units of Bq/cm² and Bq/g, for each radionuclide, are the measurable quantities required for the implementation of the clearance criterion (10 µSv/a). The clearance levels were presented in ranges because of the associated uncertainties, and the values are intended to apply to all materials or equipment. The report was issued in 1996 as an interim, TECDOC-855,⁽⁵⁾ at the request of some member states, including the U.S. Both the EPA and the NRC wanted to complete their respective, independent pathway analyses so the U.S. could have substantive technical input. Now, the IAEA wants to finalize the clearance levels as a result of a number of technical meetings, getting input from the U.S. and other countries, refinements in methods of modeling, and comments on the interim IAEA report. Publication of the IAEA clearance levels is unlikely before 2001.

The progress of the EC in the area of clearance appears to be a significant driver for the IAEA. The EC published exemption values in 1993,⁽⁶⁾ and established clearance criteria, among other things, in a May 13, 1996, Euratom Council Directive.⁽⁷⁾ This Directive establishes as a basis for clearance 10 µSv/a to individuals and an automatic (no further consideration required) optimization level ("floor" to ALARA) of 1 man-Sv per year of practice, and requires Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before May 13, 2000.

The EC has published or has in press implementation recommendations that translate the 10 µSv/a trivial dose level to concentrations of radionuclides. Based on pathway analyses of steel, copper, and aluminum, Radiation Protection 89, "Recommended radiological protection criteria for the recycling of metals from the dismantling of nuclear installations," provides clearance levels for recycling of all metals. Radiation Protection 113, "Recommended radiological protection criteria for the clearance of buildings and building rubble arising from the dismantling of nuclear installations," is in press, and EC clearance of buildings is based on the trivial dose level, namely, 10 µSv/a. "Practical Use of the Concepts of Clearance and Exemptions-Part 1, Guidance on General Clearance Levels for Practices," (in draft) provides general clearance levels that are applicable to all materials and equipment. Part 2 of this document will address clearance of materials and equipment with associated radioactivity from natural sources (NORM), since the EC Directive also addressed significant increase in exposure due to natural radiation sources.

The EC approach for deriving clearance levels differs significantly from the NRC and EPA approaches. The NRC and EPA both analyze external exposure, inhalation, and ingestion pathways and generally sum them to get the values that enable translation from dose to radionuclide concentration. The American agencies use Federal Guidance Report Nos. 11 and 12, which are based on ICRP 26 and 30 for dose conversion. The EC uses ICRP 60 (1990) dose conversions, analyzes the same pathways plus skin exposure and separately analyzes doses to children. However, the EC does not sum the pathways to derive the clearance level, since the models are already conservative and analysis reveals that nearly all the dose comes from only one pathway in virtually all scenarios. Thus, the EC uses the most restrictive of the pathways examined. The IAEA has adopted the EC approach for the finalization of their clearance levels.

D.  Relationships of an NRC Clearance Rulemaking to U.S. Agencies in the International Arena

At least four other Federal agencies would likely be impacted by an NRC rulemaking: the Department of Defense (DOD); the Department of Energy (DOE); the Department of Transportation (DOT); and the Department of the Treasury (Customs Service). The Environmental Protection Agency (EPA) has responsibility for setting generally applicable environmental standards under the Atomic Energy Act. Although EPA is not pursuing a rulemaking in this area at this time, they are continuing to develop a technical data basis for estimating potential doses resulting from release of solid materials. In addition, the EPA is working with the U.S. Department of State regarding the international standards setting. The military services control radioactive materials in many foreign countries. Harmonization of the local clearance levels and U.S. clearance levels would simplify the management. The DOE has, as of January 12, 2000, instituted a moratorium on release of metals with volumetric residual radioactivity. Historically, the DOE has established its orders and regulations in conformance with NRC regulations. If the precedent were to continue, an NRC regulation would indirectly impact, among other things, the ability to export DOE materials. Transportation regulations are well established internationally. Clearance levels would need to comply with those regulations or the international regulations would require modification. Finally, the Customs Service would be impacted in their decisions to allow or reject imports with detected radioactivity.

E.  Overlapping International Issues

In the context of import and export, potential failures of adequate radiological protection can occur in a variety of ways. Intact orphan sources, shielded or unshielded, can be mixed in shipments of, for example, scrap and salvaged materials from industry. Another way is through the import or export of materials or equipment with concentrations of radioactivity ranging from hundreds of times that of clearance levels to very high concentrations. This situation can arise from several circumstances, for instance: incorporation of orphan sources by processing, including melting; activation products in materials and equipment; NORM at natural levels, concentration of NORM or other radionuclides by natural or man-made processes. Finally, there is a concern for the illicit trafficking of fissile materials.

The regulatory mechanisms to provide an adequate level of protection from relatively high concentrations of radionuclides in imports has yet to be developed.⁽⁸⁾ The regulatory emphasis may be best spent on international requirements that control the potential for exposures above the public dose limit. In a Memorandum of Understanding, "Establishment of Radiological Screening Guidelines for the Free Release of Metal Products for Export to the United States," signed September 2, 1998, and October 29, 1998, respectively, the EPA and the Department of State initiated efforts to address this issue internationally.

Other Federal Agencies, including the NRC and DOE, and industry were then invited to participate in a committee-the International Radioactive Source Management Committee (IRSM). The initiative had four mission objectives: 1) protect sources from becoming lost (tracking management); 2) identify primary location where sources have been lost (stopping future losses); 3) locate lost sources (monitor and retrieve); and 4) educate and train (deploy knowledge and technology). This would involve domestic and international partnerships among various entities including the IAEA, Western Europe, and the Americas. Along these same lines the IAEA has formulated an action plan to control radioactivity, and on October 1, 1999, the General Conference adopted the action plan. In addition, the European Commission recently decided to elaborate a directive to prevent orphan sources. The first preliminary draft defines responsibilities of holders of sources, users, manufacturers, and describes financial provisions for disposition of orphan sources.

On December 1, 1999, each subcommittee of the IRSM made presentations to Mr. Abel Gonzales of the IAEA, and Mr. Gonzales identified how the U.S. could assist in international efforts to control orphan sources. The IAEA has scheduled an "International Seminar on Implementation of Systems to Prevent and Detect Unauthorized Uses of Nuclear and Radioactive Materials," in Vienna, Austria on November 13-17, 2000.

The Department of State has focused its resources on the Non-Proliferation Treaty Review Conference. After the conference ends on May 20, 2000, the Department of State will re-direct attention to the IRSM and the U.S. support of international efforts in this area.

F.  Recent and Future IAEA Meetings on Clearance Levels

1. The economic and societal acceptability of cleared materials and equipment are somewhat related through cost/benefit and optimization analyses, but they are not central to the regulatory establishment of a trivial dose from materials and equipment.

2. Six major international organizations defined clearance as, "Removal of radioactive materials or radioactive objects within authorized practices from any further control by the Regulatory Authority." They are the: Food and Agriculture Organization of the United Nations (FAO); International Atomic Energy Agency (IAEA); International Labor Organization (ILO); Nuclear Energy Agency of the Organisation for Economic Co-operation and Development (OECD/NEA); Pan American Health Organization (PAHO); and World Health Organization (WHO), (International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, Safety Series No. 115, IAEA, Vienna, 1996; (BSS)).

3. 10 µSv/a is equivalent to 1 mrem/y.

4. 1 man-Sv is equivalent to 100 man-rem.

5. Clearance levels for radionuclides in solid materials: Application of exemption principles; Interim report for comment, IAEA-TECDOC-855, IAEA, Vienna, January 1996.

6. These exemption values were also adopted by the IAEA. Principles and Methods for Establishing Concentrations and Quantities (Exemption Values) below Which Reporting Is Not Required, European Directive, Radiation Protection 65, Doc. XI-028/93, CEC, Brussels, 1993.

7. Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. Official Journal of the European Communities L 159 of 29.6.1996.

8. By definition, cleared materials and equipment are not controlled, and for radiation protection purposes, they need not be controlled, because the potential doses are a small fraction of the public dose limit that, in turn, defines an adequate level of protection.