general, biosafety regulations are more common than those focused specifically on BSAT research.
A number of countries have tiers of regulations, requiring various levels of notification, authorization, record keeping, and so forth. Some countries require permission or licensing of facilities at a particular biosafety level, independent of the agents the facility may work with and store. Some form of registration or licensing of BSL-3 and -4 facilities is required in Germany, China, South Korea and Switzerland. There are also examples of stratification of the types of notifications and permissions required to work at various biosafety levels. In Switzerland, for example, the equivalent of BSL-2 research requires notifying the relevant authorities, while permission is required to work at the BSL-3 or -4 level. Japan has four tiers, ranging from internal record keeping at the lowest level to notification and then permission. Some activities are prohibited outright.
European countries have strict rules governing work with GMOs, which in many cases are more stringent than their rules governing pathogens. These rules tend to be focused on regulating facilities and setting standards for accounting for inventories. Since much of potential pathogen research would involve the use of recombinant DNA methods, however, the GMO regulations effectively cover a large portion of pathogen research as well.
Some countries regulate BSAT research via their regulations on biosafety risk levels. Germany, Canada, and Switzerland regulate personnel and/or facilities for all the agents designated as BSL-3 or BSL-4. Other countries regulate via lists of “select agents,” which vary in length and composition, and in what special requirements they impose upon listed agents. The lists range in size from Australia’s 22 to South Korea (32), France (37), Japan (51), and the UK (105).
This chapter has provided background information on the origins and current operation of the Select Agent Program, additional requirements for personnel reliability and physical security that many federal agencies have applied to their own and, in some cases, their grant and contract BSAT research, and how the regulation of BSAT research is handled outside the United States. The committee drew on this information, as well as its own knowledge and experience, to develop a set of principles to guide formulation of its recommendations. Those principles are presented in the next chapter.