In the United States over 50 large scale cobalt-60 irradiators annually sterilize approximately 200 million cubic feet of medical items composed of thousands of different devices including disposable or single-use and implantable healthcare products — representing 45 to 50% of all sterile medical devices produced in the US. Several irradiators are annually processing over 79,000 metric tons (175 million pounds) of spices, and there is a trend towards irradiating specifically labelled food items that include ground beef, poultry, fruits, vegetables, and pet treats to eliminate harmful microbes and enhance food safety. Other current applications of gamma processing include the treatment of tropical fruits, combination (drug/device) products, rattan furniture, carpets and other quarantine items to prevent insects from being imported and harming agriculture.
Concerns about the security of radiation-related industries rose sharply around the world, and particularly in the United States, following the destruction of the World Trade Center towers on September 11, 2001. Some people suggested that the cobalt sources required for gamma irradiation might be stolen and used to create so-called ‘radiological dispersion devices” or “dirty bombs” – weapons of terrorism.
The design of industrial irradiation facilities, stringent control over the shipping of sources in massive licenced containers, and the detailed safety and security plans shippers and irradiator owners have implemented, ensure gamma irradiation continues to be safe and effective, which together with the nature of cobalt-60 , make it 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.
GIPA agrees with the need to be ever vigilant to protect any vulnerable radioactive source from malicious use. We shall always support and advocate any legislative and regulatory initiatives that fulfill this objective. However it is important to note that the gamma radiation industry and irradiator owners are strictly regulated and follow security measures that meet International Atomic Energy Agency (IAEA) guidelines, stringent U.S., Canadian, U.K. and E.U. nuclear regulations , plus countless country, state and local requirements.
The development of new regulations needs to be logical, fair, harmonized and implemented in a manner to maximize tangible security benefits and to avoid adding complexity, increased administrative difficulties and escalating costs. This balance is essential. Medical device manufacturers have spent many years and billions of dollars to take advantage of the unique penetrating properties of gamma radiation which has proven itself over many years to be a primary means of providing effective, reliable sterilization capability. The fact remains that gamma radiation is an established technology that’s extremely flexible, versatile and cost-effective for treating a vast range of medical, consumer and industrial products that benefit society as a whole.