Courtesy of Laval University
For 20 years, I was the curator of the world's largest bacteriophage collection: the Felix d'Herelle Reference Center for Bacterial Viruses (HER 607). The collection, now transferred to another laboratory at Laval University, houses some 450 bacteriophages and a similar number of bacterial hosts. During my tenure, I shipped bacteria and bacteriophages around the world, and I received many complaints on shipping regulations. The recent publication of the US Select Agents and Toxin Regulations1 reminded me that it is time to revise shipment and import regulations for certain agents.
Some background: For handling and transportation, human pathogenic microorganisms are commonly divided into four risk groups (RG),2 also called biosafety or confinement levels. Organisms in RG1 are not known to consistently cause disease in healthy adults. RG2 organisms are associated with human disease that is rarely serious and for which preventive or therapeutic interventions are often available. RG3 agents have potential for aerosol transmission; they cause diseases with serious or lethal consequences. Those in RG4 are dangerous agents that pose a high risk of life-threatening disease and aerosol-transmitted lab infections. RG3 and RG4 include pathogenic bacteria, such as
While control of RG3 and RG4 is clearly necessary, control of RG2 is debatable. To my knowledge, not a single illness, outbreak, or epidemic has been prevented by RG2 shipment regulations. RG2 is extremely vast. Some members, such as the salmonella and shigellas species,
In comparing RG2 lists,3 one notes a number of gems. For example,
The present system of regulations is a source of headaches to individual scientists and culture collection curators, who have been forced to introduce significant fee increases. The biggest problem is the need to obtain importation permits, a cumbersome and time-consuming procedure, for relatively harmless microorganisms. These regulations impede the free exchange of cultures and slow or block research on the very diseases they are supposed to prevent. In international shipments, the present procedure is both complex and expensive. For example, the exporter must complete a training course for correct packaging, must use expensive carriers, and shipments are often halted at the airport instead of going to the addressee directly. My declarations required a 52-item Canadian Customs checklist.
Many of the problems have arisen because an amorphous, variable, and capricious worldwide system of regulations has developed. Within the same country, regulations may be issued by several partly overlapping agencies – three, for example, in Canada. Some countries accept importation and exportation of RG2 agents, others accept only importation, and some countries, such as Saudi Arabia, accept neither. A frequent complaint in the United Kingdom and France is that permission-issuing authorities cannot be located. Obtaining epidemiologically valuable bacteria from developing countries may be impossible because no willing carrier can be found. The Web is of little help because it lists undated, possibly outdated regulations. Sometimes, those regulations are not published at all.
Clearly, the RG system requires updating. Some change is on the horizon: It appears that in 2007, RG2 agents may be transported like diagnostic specimens, under simplified regulations.3 But, that's not enough. Risk assessment must make use of cost-benefit analysis, balancing the costs of regulation and actual public health benefits. There are two options: In one, RG2 agents are assessed individually. Ubiquitous agents already present in the importing country and agents of negligible pathogenicity should be removed from RG2 lists. Lyophilized RG2 agents, which do not present the same risk as growing cultures, should also be removed. The second option, eliminating RG2 altogether, is the best solution for its simplicity.
Hans-Wolfgang Ackermann (