My name is Wayne Conlan. I'm a research scientist with the National Research Council, but I am appearing today as an individual. I'm a microbiologist with 27 years' experience working in level two and level three containment labs in the United Kingdom, the United States, and Canada.
I was a member of the committee that compiled the current Health Canada laboratory biosafety guidelines. Currently, I run a small-animal level three biocontainment facility at the NRC with a focus on highly virulent biodefence pathogens that cause life-threatening infections when inhaled.
I've been the responsible official for the design and implementation of all the biocontainment, biosafety, and biosecurity policies associated with this facility and for training staff in all these areas. And the requisite paperwork occupies more of my file space than all my other activities combined.
Annually, for the past ten years, my facility has been certified for its purpose by the Public Health Agency of Canada and the Canadian Food Inspection Agency. I receive significant funding for this work from the U.S. National Institutes of Health, and therefore my lab must also comply with the U.S. select agent rule, on which Bill C-11 appears to be partially modelled. Consequently, our level three containment facility has been inspected by representatives from the U.S. Centers for Disease Control and Prevention, most recently in October 2008, to ensure that it is operating in conditions equivalent to those required by the select agent rule.
In complying with the select agent rule, our laboratory is already fully operating within the limits being proposed by Bill C-11. For instance, all of our staff with access to our level three biocontainment facility have secret level clearance. Likewise, we already quantitatively update our pathogen inventories every three months. So I don't anticipate that compliance with Bill C-11 will impose any undue additional hardship on the operations of current level three containment facilities in Canada.
It needs to be remembered, in this regard, that many thousands of U.S. researchers are having to comply with the select agent rule, since their federal funding depends on it.
Interestingly, the revelation that the anthrax attack conducted by the U.S. Postal Service was an inside job now calls for even greater restrictions on the U.S. research community, including recommendations that staff with access to select agents undergo mandatory psychological screening. But given the innate eccentricity of many scientists, this could lead to the complete dismantling of the entire U.S. research enterprise in this area. So I hope we choose not to go down this road in Canada.
For the Canadian research community, it's the proposed oversight of level two labs that seems to be the most contentious issue. To date, this has been exclusively managed by the host institutions themselves. However, all such labs ought to be complying with the current biosafety guidelines and should therefore be readily able to comply with the provisions of Bill C-11.
In this regard, prior to the anthrax attack, the worst deliberate case of bioterrorism in the U.S. involved a religious cult contaminating several restaurant salad bars with a level two salmonella species, causing over 700 cases of food poisoning. Indeed, under normal circumstances, level two pathogens kill far more Canadians than level three pathogens. So there is a realistic argument to be made for more formal regulation of these organisms. I guess, on the other hand, it could be argued that level two pathogens are so ubiquitous in our everyday lives that they deserve no special consideration simply because they're being used in research. An analogy with this can be drawn between laboratory rodents, the use of which in research is highly regulated, and wild rodents, which anybody is allowed to kill by any means.
Overall, given the level of compliance being sought by Bill C-11 with respect to level two pathogens, it is difficult to argue against their inclusion in the act. However, level two labs are far more numerous than level three and four labs, and the system for regulating these could be overwhelmed if all these facilities try to register at once to comply with the act. It is incumbent on the Public Health Agency of Canada to ensure that the process of online registration of level two labs is an essentially painless experience that does not delay research progress. Allowing organizations to register all their level two labs in a single application should help in this regard.
There are a few issues obviously addressed by the act on which clarification would be helpful for assessing likely impacts of the act on the research community. For example, many labs use crippled strains of risk group two and three pathogens that are completely harmless, but it's not clear that these will be exempted from the act.
Additionally, many labs not involved in pathogen research use certain toxins in small quantities. A lot of immunologists use cholera toxin or enterotoxin in their immunology research as vaccine adjuvants, for example. Will these labs need to register? My own belief is that they should be allowed to possess a threshold limit of such toxins before being expected to register their facilities.
I thank you for your time. I am willing to answer any questions you might have.