Cobalt-60 Source Protection and Security

The International Irradiation Association (iia) shall always support regulatory initiatives that protect any vulnerable radioactive source from malicious use. We believe these regulations need to be logical, balanced, harmonized and implemented in a manner that truly acts in the best interest of a global society. To obtain the best regulations and standards we advocate a collaborative approach that includes industry participation as related to the different radioactive source types and use. The iia does not support an approach that treats all radioactive sources the same, nor ignores almost 50 years of experience and benefits of radiation processing. The purpose of this paper is to create a better understanding of cobalt-60 radioactive sources and industrial gamma irradiators.

• The US Nuclear Regulatory Commission (NRC) under 10 CFR36 tightly regulates, tracks and monitors the use of industrial cobalt-60 sources in gamma irradiators. Regardless of the security or risk classification criteria used, we agree these sources necessitate the highest level of protection to prevent unauthorized access and acquisition. The iia welcomes and supports in principle the NRC initiative, Radiation Source Protection and Security Task Force; Request for Public Comment, announced in the Federal Register – Vol. 71, No. 7, January 11, 2006 Notice.

• Concerns about the security of radiation-related industries rose sharply following the destruction of the World Trade Center towers on September 11, 2001. The design of industrial irradiation facilities, stringent control over the shipping of source in massive containers, and the detailed safety and security plans irradiator owners have implemented ensure gamma irradiation continues to be safe and effective and make cobalt-60 virtually useless as a tool of terrorism. In addition to the inherent safety of gamma technology, the industry has consistently regarded security as a top priority throughout its 50-year history, and has fulfilled that priority with regulatory rigor.

• Since the 1950s the beneficial uses of cobalt-60 and gamma radiation has significantly grown in size, diversity and sophistication. Gamma radiation is an established technology that is extremely flexible, versatile and cost-effective method for sterilizing single-use medical devices. It destroys harmful bacteria on a wide range of consumer goods and items that pose a risk to either the population or agriculture. Radiation processing modifies materials to enhance their physical and chemical properties and produce lightweight, fire-retardant automotive parts, tubing and cables, among many other industrial products.

• At present gamma radiation sterilizes over 40% of the world’s single-use medical disposable products. By 2050, the number of the people in the world aged 80 or older will be six times greater than today. As the global population ages we can expect the demand for healthcare to intensify and a significant requirement for sterile and novel human healthcare products. Cobalt-60 will be essential to sterilize conventional medical devices and many new combination healthcare products.

• As required by the US Energy Policy Act of 2005, the NRC has entered into an arrangement with the National Academy of Sciences to conduct an analysis of alternative technologies by 2007. This assessment is totally unnecessary for cobalt-60 and industrial irradiators. The iia membership includes the leading suppliers of both isotope-based and machine-based sources of radiation and many members use the multiple modes of sterilization and irradiation technologies that are available today. We need all methods and all technologies that transfer ionizing energy into the product to achieve the desired effect. One cannot simply substitute one method or technology for another.

• Currently, the worldwide installed base of cobalt-60 is approximately 260 million curies, contained in more than 170 large-scale gamma facilities. Today the United States has just over 50% of the total cobalt-60 installed base, which is contained in 51 commercial irradiation facilities.

• Irradiators operate continuously 24 hours per day, everyday. These facilities need to replace energy loss due to decay of 12.3% per year and add more cobalt-60 as the volume processed grows –currently 5-10% per annum.

• Cobalt-60 has a half-life of 5.26 years and each source is typically in use at an irradiator site for at least 20 years. Agreements are in place where the suppliers of cobalt-60 sources accept the return of these low activity sources back for re-encapsulation, re-cycling or disposal at the end of their useful life.

• All commercial cobalt-60 gamma irradiation facilities operate a number of access controls and interlock systems designed to preclude inadvertent access to the irradiation chamber. In the United States and elsewhere, these same systems have been enhanced and supplemented to detect unauthorized intrusions with notification to the pertinent authorities. In addition, without the use of special tools and a transport container, the self-protective nature of the high-energy source significantly reduces the probability of a successful theft attempt.

• The industry uses only regulatory approved containers to transport cobalt-60. They weigh many tons and are designed to maintain their integrity through severe accident scenarios. Under strict regulations, only licensed companies with personnel trained in safety and security requirements can transport cobalt-60 over US highways. Security of cobalt-60 transportation, to minimize theft, loss of control or misuse of product, has received particular attention by international and national regulators around the world to address potential terrorist threats. Each shipment is tightly controlled and monitored from the supplier site until installed at the irradiator. Cobalt-60 source suppliers own and tightly manage these specially designed and unique containers.

• Cumulative over 800 million curies (approximately 80,000 sources) of cobalt-60 have been safely and securely shipped to irradiators, worldwide. There has never been an incident.

• The industry uses unique serial numbers to perform “cradle to grave” tracking of the cobalt-60 sources in service. As stated by the US NRC, plans include the implementation of a national tracking system by mid-2007. The iia believes we need international harmonization to facilitate trade between countries and states, reduce administrative burden, minimize errors and maintain the confidential information contained in any database.

• The US NRC has implemented certification and registration of cobalt-60 suppliers and users. There are strict import and export regulations and controls in place. Additional controls are not required.

• For many years cobalt-60 suppliers have been offering safe and effective disposal services for spent sources. Disposal is inherently easy for several reasons. The cobalt-60 is inert and in doubly encapsulated stainless steel capsules. It decays into stable nickel-60. Achieving background radiation levels takes roughly 200 years. The physical volume of the number of sources in service is small. Wherever possible users extend the use cobalt-60 sources because it makes environmental and business sense.

• US NRC, Agreement States and DOE have requirements concerning the decommissioning and proper disposal of radiation sources and financial assurances. The iia supports the concept of adequate funding to ensure that regulators and the public are not left with the financial burden of cobalt-60 disposal and irradiator decommissioning. However, we believe factoring in disposal costs for higher activity cobalt 60 sources, using licensed capacity and assuming a catastrophic industry wide doomsday, scenario creates an unnecessary financial burden on irradiator owners. This will significantly affect the billions of healthcare devices and products being treated by radiation processing.

• Companies always transfer cobalt-60 sources to other irradiator sites in the event of a facility shutdown or decommissioning. No cobalt-60 sources used in commercial industrial irradiators have ever been lost or abandoned. Cobalt-60 sources are simply too valuable.

The iia believes increasing security costs have the potential to make gamma processing uneconomical, increase healthcare costs and subsequently stop the use of this beneficial technology. Any additional security measures must offer real, tangible value-added protection against the threat of cobalt-60 sources being abandoned, lost or stolen.
2006, January 31