IMPACT OF THE RADIATION PROTECTION PROGRAM REQUIREMENT OF ST-1 ON THE UNITED STATES RADIOPHARMACEUTICAL INDUSTRY

The 1996 Edition of IAEA ST -1 contains a requirement that the transport of radioactive materials be covered by a Radiation Protection Program (RPP). The U.S. radiopharmaceutical industry makes more than 3 million shipments of radioactive materials each year. These shipments originate from manufacturing facilities and nuclear pharmacies. Although some shipments are made by the manufacturer's personnel, many of these shipments are transported by small carriers that do not operate fixed facilities and do not have radiation protection professionals on staff. Consequently, requiring a small carrier to write and implement a Radiation Protection Program is a costly and difficult requirement. Until the changes brought on by the RPP requirement in ST-1, the radiation exposures and protection of transport workers were managed by passive controls built into the IAEA and local competent authority regulations. Examples of these passive controls include maximum transport indices (Tl) on packages, maximum number of transport indices in vehicles, and separation distances. All of these passive controls were designed to limit radiation exposure to transport workers. In the United States, most of the radiopharmaceutical shipments are handled by independent carriers and not by the manufacturers. In other parts of the world, the manufacturer employs transport workers to deliver the radiopharrnaceuticals. Those transport workers employed by the manufacturer are usually included in the fixed facilities' RPP. It is not obvious that all transport workers who handle radioactive materials need to be covered under a Radiation Protection Program, as long as passive controls are in place. Most would agree that transport workers that handle large numbers of packages or packages with higher potential for exposure could benefit from a RPP. Some method of exempting certain smaller carriers is needed and would result in a more cost effective solution, without any reduction in their level of protection. No such exception currently exists in ST -1. Passive controls that have been in place for many years have proven effective in controlling the radiation doses received by transport workers. Adoption of an RPP requirement that does not recognize smaller transport operations is unduly restrictive and unnecessary