Testimony of William E. Kennedy, Jr.
Member of the Board of Directors
Presidential Representative
Health Physics Society
March 9, 2000

Introduction

Mr. Chairman, Ranking Member Graham, and distinguished members of the subcommittee, my name is William E. Kennedy, Jr. I am a member of the Board of Directors of the Health Physics Society, an independent non-profit scientific organization of professionals who specialize in radiation safety. Health Physics Society President, Raymond H. Johnson, Jr., has asked that I represent the Society today and wishes to thank the Committee for providing this opportunity for the Society to serve as a resource on this matter. I am pleased to testify today on the efforts of the Health Physics Society and the American National Standards Institute (ANSI) to develop a formal consensus standard on the release of contaminated materials, including metals, and to comment on the current U.S. Nuclear Regulatory Commission's (NRC) rulemaking in this area. In addition to being on the Board of Directors of the Health Physics Society, I am past chairman of an ANSI Writing Group chartered to develop a National Consensus Standard on Clearance, or the release of materials from radiological controls. The final standard, titled "Surface and Volume Radioactivity Standards for Clearance" ANSI/HPS N13.12-1999, was published in January of this year. Since 1986, I have also served as a consultant to the International Atomic Energy Agency (IAEA), an agency of the United Nations, to develop scientifically based release criteria that will be applied to international commerce.

The Health Physics Society includes over 6,000 members in over 40 countries that are currently engaged in the practice, science, or technology of radiation safety. Society activities include encouraging research in radiation science, developing standards, and disseminating radiation safety information. As a non-profit scientific organization, we are not affiliated with any government, industrial, or private entity. The Society is affiliated with the International Radiation Protection Association, the American Academy of Health Physics, the American Board of Health Physics, the National Academy of Sciences, the National Council on Radiation Protection and Measurements, and other Scientific and Professional Societies and Institutions. The Society is in a unique position to provide informative, scientific positions that are independent of both government and industry.

Health Physics Society Position

The Health Physics Society has taken a formal position on the release of contaminated materials, including metals, in response to the NRC's recent rulemaking process. I have included a copy of this position statement at the end of my testimony for your information.

Based on this position statement it is my testimony to you today that the Health Physics Society believes:

-- establishing uniform standard criteria for the clearance or release of radioactively contaminated materials is a necessary and important part of protecting the public and the environment from radiation exposure

-- regulations for radiation protection should be based on consensus standards. including those issued by ANSI and the Health Physics Society. the primary radiation protection criterion should be a dose standard and should consider all radiation pathways

-- the primary dose criterion should be related to screening levels that can be used to establish radiation survey programs that will ensure the dose level will be met. and

-- the ANSI Standard N13.12 should be adopted by U.S. Federal Agencies for application to the clearance or release of materials from radiological controls.

Clearance Criteria Will Increase Radiation Protection

The motive for establishing clearance criteria is not to produce unnecessary sources of radiation, but rather to increase protection of the public by establishing strict standards and guidelines to ensure that harmful sources are controlled, while conserving our natural resources.

Background Information

The development and use of release criteria is not unique to radiation and radioactive materials. For example, the Food and Drug Administration sets acceptable levels of pesticides in foods and the U.S. Environmental Protection Agency (EPA) sets contamination levels in water and soil in the cleanup of land contaminated with hazardous materials.

Comprehensive, unconditional release criteria for materials, equipment, and facilities with low levels of radioactive contamination have been needed in the United States for several decades. In addition to invoking radiation protection requirements during facility operation, release criteria would serve as the basis for deciding what materials require disposal as radioactive waste.

In 1964, the Health Physics Society, under the auspices of ANSI, began the technical evaluation of clearance, resulting in early drafts of ANSI N13.12. These early drafts of the clearance standard were based primarily on detection levels that could be achieved using field instruments, with secondary concerns about the potential individual doses that may result. An early draft version of ANSI N13.12 was consistent with the surface contamination limits that were published by the U.S. Atomic Energy Commission in the 1974 version of Regulatory Guide 1.86, Termination of Operating Licenses for Nuclear Reactors, which is still in use by the NRC today.

However, the criteria in Regulatory Guide 1.86 are not risk based, and are not consistently applied across all situations. The current rulemaking under consideration by the NRC addresses updating these existing release criteria and the process used to make release decisions.

ANSI Standard N13.12

The decision to continue efforts to develop an ANSI standard was driven by the continuing need for comprehensive release criteria, changing national and international guidance, and risk or dose based regulations. In 1993, the Health Physics Society Standards Committee, in agreement with ANSI Committee N13, established a technical writing group to develop the final N13.12 clearance standard. The final clearance standard was approved in August 1999 as N13.12, Surface and Volume Radioactivity Standards for Clearance and was published in January 2000.

The purpose of ANSI Standard N13.12 is to provide guidance for protecting the public and the environment from radiation exposure. It does this by specifying a primary radiation dose criterion and derived screening levels for the clearance of items that could contain radioactive materials. The standard sets a primary radiation dose criterion of 1 millirem per year (mrem/y), and provides derived screening levels that define the allowable amount of radioactivity per unit surface area or per unit mass.

Perspective on the ANSI N13.12 Primary Dose Criterion

In our deliberations, the ANSI writing group considered international dose criteria for release of materials. These dose criteria have been defined by the IAEA and have been adopted by most nations. They state that the dose rate to an individual in the population expected to receive the highest dose from the released material should not exceed 1 mrem/y, i.e., exactly the same criterion contained in ANSI N13.12.

This primary dose criterion is a very low dose rate. Part of the reason for selecting a dose rate so small was to ensure that members of the public that may be exposed to multiple sources of radiation would receive only a small fraction of the doses permitted by Federal regulations. The 1 mrem/y dose rate is an even smaller fraction of the doses they receive from background sources. For example, Americans typically receive about 300 mrem/y from natural background sources, including radon in their homes. The dose standard defined in ANSI N13.12 is only 0.3% of the dose Americans normally receive from these natural background sources. For perspective on the yearly dose in this criterion, I would like to point out 1 mrem is about 20% of the dose I will have received from cosmic rays at an altitude of about 35,000 feet while flying to attend this hearing and returning home.

This 1 mrem/y dose rate is also considered to be a "Negligible Individual Dose" by the Congressionally Chartered National Council on Radiation Protection and Measurements. Materials that meet the ANSI Standard N13.12 criteria are only slightly contaminated and should not be confused with low-level radioactive waste.

Thus, there is a solid scientific basis and a good regulatory rational associated with the dose criteria defined in ANSI N13. 12.

Current Issues Regarding the NRC Rulemaking

The focus of the current debate associated with the NRC rulemaking is the recycle of contaminated metals, and fears that consumer products will become contaminated to unacceptable levels. However, the subject of clearance covers much more, including establishing uniform, dose-based, radiation survey criteria. Currently, nuclear facilities regulated by the NRC, States, or the DOE can release materials, on a case-by-case basis, if no radiation can be detected using field instruments. This practice does not imply that radioactive contamination does not exist, only that none is "detected." The determination of what can be detected can vary from facility to facility. By establishing clearance standards in the NRC regulations, there will finally be uniform guidance in the United States on acceptable detection levels that are, hopefully, consistent with those recommended by the IAEA and accepted by the international community. The existence and application of uniform monitoring and survey criteria should reduce the potential for the unintentional release of radioactive materials.

Recycling cleared metals would not mean the dilution of highly contaminated metal with other metal in the industry. Rather, it would mean the careful sorting of metals, using standard criteria, such that no metals above the 1 mrem/y clearance criterion would find their way into commerce. Metals containing levels above the standard could be further decontaminated or sent for low-level radioactive waste disposal if decontamination to the clearance criteria could not be achieved. The credibility of the United States' radiation protection framework is at stake since many other countries have already adopted uniform clearance criteria that the U.S. currently does not have.

Industry standards, such as ANSI Standard N13.12, can play an important role in the regulatory process. In fact, the White House Office of Management and Budget (OMB) issued proposed revisions to Circular A-119, Federal Participation in the Development and Use of Voluntary Standards. These revisions are the outcome of the National Technology Transfer Act of 1995 (Public Law 104-113) signed by the President in March 1996. The law now requires federal agencies to use voluntary, industry standards developed by the private sector whenever possible. The purpose of this requirement is to eliminate excessive costs to the government by developing its own standards. As a recognized standards institute, standards developed under ANSI must be considered. Agencies who choose not to use private-sector standards are required to document their actions to the Secretary of Commerce. Thus, ANSI Standard N13. 12 should play a key role in the development of Federal regulations and policy regarding clearance.

Closing Comments

Mr. Chairman, as I have outlined, the Health Physics Society believes that it is important that clearance or release criteria for low levels of radioactive materials be established to provide consistency in radiation protection requirements, thereby increasing protection of the public. The establishment of strict standards and guidelines will ensure that potentially harmful sources are controlled, while conserving our natural resources. We strongly support the continuation of the NRC rulemaking in this area, and we encourage the NRC to adopt the criteria outlined in ANSI Standard N13. 12.


CLEARANCE OF MATERIALS HAVING SURFACE OR INTERNAL RADIOACTIVITY POSITION STATEMENT OF THE HEALTH PHYSICS SOCIETY Adopted: September 1999
Richard J. Burk, Jr.
Executive Secretary
Health Physics Society

* The Health Physics Society is a non-profit scientific professional organization whose mission is to promote the practice of radiation safety. Since its formation in 1956, the Society has grown to approximately 6,000 scientists, physicians, engineers, lawyers and other professionals representing academia, industry, government, national laboratories, the department of defense, and other organizations. Society activities include encouraging research in radiation science, developing standards, and disseminating radiation safety information. Society members are involved in understanding, evaluating, and controlling the potential risks from radiation relative to the benefits. Official position statements are prepared and adopted in accordance with standard policies and procedures of the Society.

The Health Physics Society welcomes the opportunity to participate in the process initiated by the Nuclear Regulatory Commission for development of standards for the clearance of materials having surface or internal radioactivity. The Society believes that the definition of clearance levels is an important part of the standards that provide for the safe handling, use, and disposal of radioactive materials.

The position of the Society relative to radiation protection regulations and standards for the general public have been established in previous Position Statements of the Society. Portions of these positions relative to the clearance of materials having surface or internal radioactivity are:

(1) we support regulations for radiation protection that are based on the National Council of Radiation Protection and Measurements' (NCRP) recommendations for dose limits for individual members of the public;

(2) we recommend that constraints\1\ be applied to all regulated, non-medical, non-occupational sources of radiation exposure to the general public, excluding indoor radon, such that no individual member of the public will receive in any one year a total effective dose equivalent (TEDE)\2\ exceeding 100 mrem (1 mSv)\3\ from all such sources combined; and,

\1\ "Constraints" refer to restrictions placed on sources or practices in order to achieve the dose limits that apply to an individual.

\2\ The total effective dose equivalent (TEDE) is the sum of the absorbed doses that will be delivered to the separate organs or tissues during the lifetime of an individual from one year's intake of radionuclides plus irradiation by external sources, with each organ or tissue dose weighted for the type of radiation producing the dose and with an estimate of the risk that the organ or tissue will develop a radiation induced cancer or result in a genetic effect.

\3\ The Sievert (Sv) is the international (SI) unit of dose equivalent or of effective dose equivalent; 100 mrem = 1 millisievert (mSv). The Society endorses the use of SI units; however, because U.S. regulatory agencies continue to use traditional units in regulations, this position statement uses the traditional unit for dose equivalent, i.e., mrem, throughout the document.

(3) we recommend that dose limits be applied only to individual members of the public, not to the collective dose to population groups.

Expansion and clarification of these recommendations specific to clearance of materials having surface or internal radioactivity further leads the Society to take the position that:

(4) we recommend that regulations for radiation protection be based on consensus standards of the American National Standards Institute (ANSI) issued by the Health Physics Society Standards Committee in keeping with the intent of Public Law 104-113 "National Technology and Transfer Act of 1995" and OMB Circular A-119 "Federal Participation in the Development and Use of Voluntary Consensus Standards";

(5) we recommend that primary radiation protection standards be all pathway TEDE standards with screening levels related to quantities that can be measured such that compliance with these levels will result in the primary dose standards being met for reasonable and likely scenarios;

(6) we recommend that these screening levels be derived with consideration of the principle of as low as reasonably achievable (ALARA); and,

(7) we support the adoption of ANSI Standard N13.12 (1999), "Surface and Volume Radioactivity Standards for Clearance", which is consistent with positions (1) through (6) above.

ANSI Standard N13.12

Clearance is the removal from further control, of any kind, of items or materials that may contain residual levels of radioactivity. In 1964, the Health Physics Society, under the auspices of ANSI, began the technical evaluation of clearance, resulting in early drafts of ANSI N13.12. These early drafts of the clearance standard were based primarily on detection levels that could be achieved using field instruments, with secondary concerns about the potential individual doses that may result. An early draft version of ANSI N13.12 was consistent with the surface contamination limits that were published by the U.S. Atomic Energy Commission in the 1974 version of Regulatory Guide 1.86, Termination of Operating Licenses for Nuclear Reactors, which is still in use today.

In 1993, the Health Physics Society Standards Committee, in agreement with ANSI Committee N13, established a technical writing group to develop the final N13.12 clearance standard. The charter of the writing group was to develop a consensus clearance standard that would be protective of public health based on the recommendations of the International Commission on Radiological Protection (ICRP). Recommendations of the NCRP that have been adopted as the regulatory basis in this country are consistent with those of the ICRP. The standard was also chartered to consider both surface and volume radioactive contamination, consider radiation detection issues, and consider international issues such as the clearance principles outlined by the International Atomic Energy Agency and international trade implications for recycled or reused items or materials.

The final clearance standard was approved in August 1999 as N13. 12, Surface and Volume Radioactivity Standards for Clearance. This standard provides both the individual dose criterion of I mrem per year for clearance and derived screening levels for groups of similar radionuclides. The standard also allows for clearance, when justified on a case-by-case basis, at higher dose levels when it can be assured that exposures to multiple sources (including those not covered by the standard) will be maintained ALARA and will provide an adequate margin of safety below the public dose limit of 100 mrem/y (TEDE). It was recognized that there were several complex issues that would make it difficult to fully implement the clearance standard. As a result, some of these issues were defined to be beyond the scope of the standard, including: naturally occurring radioactive materials, radioactive materials in or on persons, release of a licensed or regulated site or facility for unrestricted use, radioactive materials on or in foodstuffs, release of land or soil intended for agricultural purposes, materials related to national security, and process gases or liquids.