Scientists continually push the frontiers of nuclear medicine. Positron Emission Tomography (PET) now allows researchers to metabolically image the brain while under the influence of various drugs.

The Department of Energy's (DOE) Isotope Program oversees the production and sale of radioactive and stable isotopes, associated byproducts, surplus materials, and related isotope services. These services include irradiation services, target preparation and processing, source encapsulation and other special preparations, analyses, chemical separations, and the lease of stable isotopes for research purposes. The Department's high energy accelerators, high flux reactors and associated hot cells produce unique isotope products and related services that are not available from other sources.

To enable these services to continue, the Department's Isotope Program mission is to maintain the infrastructure required to support this national need for a reliable supply of isotope products, services, and related technology used in medicine, industry, and research.

For the future, the goal of Isotope Program is to upgrade and enhance its isotope production and processing facilities to support year-round availability of short-lived isotopes by 2012, thus avoiding isotope shortages and stimulating biomedical and scientific research.

In addition to supporting medical applications and scientific research, Isotope Program also supports homeland defense and energy security initiatives by producing isotopes that are uniquely applicable for oil exploration, monitoring commercial and military nuclear fuel, as isotope tracers for climate change research, isotopic detection of weapons of mass destruction, and countering biological weapons by irradiation.

Planning for the Future

To ensure the goals of the program are met, Isotope Program must plan for current and future isotope needs. These goals are achieved by:

• Upgrading facilities as required to maintain operational readiness, safety, and environmental compliance.
• Investing in new facilities and equipment to support anticipated increases in isotope demand for medical applications, homeland security, and scientific research.
• Ensuring that products and services provided meet customer specifications and are delivered when scheduled.
• Continuing implementation of the Nuclear Energy Protocol for Research Isotopes for the selection of research isotopes for production and distribution.
• Collaborating with other Federal agencies and advisory committees to promote development of isotope-based applications using such mechanisms as Cooperative Research and Development Agreements, industrial partnering, and other contractual arrangements.
• Improving reliability of isotope supply by maintaining and establishing cooperative isotope supply agreements and understandings with other isotope suppliers.

DOE supports the peaceful production and distribution of stable and radioactive isotopes under the authority of the Atomic Energy Act of 1954. The sale of these isotopes encourages research and provides a reasonable return to the Government.

The Fiscal Year 1990 Energy and Water Appropriations Act (Public Law 101-101) consolidated all isotope production and distribution activities under one DOE program and established a revolving fund for Isotope Program. The Fiscal Year 1995 Energy and Water Appropriations Act (Public Law 103-316) modified earlier Energy and Water Appropriation Acts and thereby gave authority to set prices for isotope products and services with regard to production costs, market value, U.S. research needs, and other factors.

Who buys our services and products?

Research organizations, as well as commercial entities, purchase DOE products or services. DOE sorts its products into two groups, research and commercial. Commercial isotope products and services are used in established, routine applications. They are sold on a cost-recovery basis. In many cases they are resold by DOE's customers to hospitals and other commercial entities. A second group is composed of research radioisotopes. Research isotope products and services are often used in basic or applied research, usually in small quantities in an effort to develop new or improved applications. They are generally not resold by the customer and are sold to our customers at discounted prices.

As shown in Figure 1 below, most DOE isotope sales are to domestic customers, followed by foreign sales and intergovernmental sales.

Isotope Customer Categories Figure 1

Figure 2 illustrates that each year DOE serves about 170 different customers with approximately 500 deliveries.

Isotope Customers Served Figure 2

Policy on Privatization

DOE's policy is to produce isotopes only where there is no U.S. private sector capability or when there is insufficient production capacity to meet U.S. need. The Department encourages private sector investment in new isotope production ventures.

Security and Regulation of Isotopes

The safekeeping and security of materials produced at and stored in DOE sites are in accordance with DOE orders, specifically United States Code 10 CFR 835, Radiation Protection, which includes requirements for control of radiological sources. Typically, isotopes produced or stored for distribution under DOE's Isotope Program are kept inside vaults in secured, fenced-in areas.

The U.S. Nuclear Regulatory Commission (NRC) and/or Agreement States regulate the safety and security of special nuclear, by-product, and source materials, whether they are in storage or in transit. While the NRC is currently considering to govern accelerator-produced isotopes, some, but not all, Agreement States include these materials in their scope.

Before DOE ships a radioactive isotope to a domestic, private sector customer, DOE verifies that the customer has a valid NRC or Agreement State license for that isotope. If the isotope is exempt from licensing, DOE requires verification from the customer that they have a health and safety program that can adequately protect public health and safety.

Sales and exports of radioactive isotopes fall under the regulatory purview of a number of Federal agencies and international entities. Special nuclear, by-product, and source material sales and exports may require the approval of NRC, State Department, the National Nuclear Security Administration, the European Community (EURATOM) and/or the International Atomic Energy Agency (IAEA). In addition, the packaging and shipment for these materials is governed by NRC, IAEA, U.S. Department of Transportation, and the International Civil Aviation Organization. These regulations provide for the safe packaging and protection of public health when transporting these materials.

Program Outreach

The program maintains a proactive policy to inform business and the general public about ongoing and new program initiatives. Community involvement, where appropriate, is encouraged through periodic meetings with local, national, and international stakeholders. Through its operations offices and production sites, the program communicates its mission and capabilities to other DOE organizations that process, use, or develop isotopes. The program solicits other DOE elements and operations offices to obtain their commitment to integrate the program goals into their planning processes. This enables the program to work synergistically with other programs to achieve cost-effective production of isotopes on a schedule that serves customers' needs.

Isotope Program Collaborations

In order to improve isotope availability and reliability, the Department has entered into cooperative isotope supply agreements with other foreign supplies, such as, the Institute for Nuclear Research (INR) in Troitsk, Russia, and iThemba LABS in Faure, South Africa. These collaborations with other production facilities around the world to irradiate targets will continue as needed for the foreseeable future.