Regulatory experiences in Canada with these products
In terms of systematically assessing any potential risks to human health and the environment from the use of such micro-organisms in cleaning products in Canada, only one legislative authority currently exists: the Canadian Environmental Protection Act, 1999 (CEPA1999; Department of Justice Canada, 2012a). Information and data required from manufacturers or importers of new micro-organisms subject to CEPA1999 that are contained in cleaning products are outlined in the New Substance Notification Regulations (Organisms) (NSNR(Organisms); Department of Justice Canada, 2012b). Screening assessments are also currently being conducted on “existing” microbial strains found on the Canadian Domestic Substances List (DSL) (Environment Canada, 2012).
Assessments of “new” micro-organisms in cleaning products in Canada
Since 2000, four new (i.e. not on the DSL) micro-organisms intended for use in various types of cleaning applications were notified and assessed for potential risks to human health and the environment under CEPA1999. These applications included drain cleaning, carpet cleaning, in grease traps and in odour control. All four notified micro-organisms were Bacillus species, including strains of B. subtilis, B. megaterium and B. pumilus. None of these strains were genetically modified. Three of these strains were obtained from or have been deposited into well-known culture collections such as the American Type Culture Collection (ATCC) (American Type Culture Collection, 2012) or that of the United States’ Department of Agriculture’s Agricultural Research Service, also known as the NRRL collection (United States Department of Agriculture, 2011). The fourth was an environmental isolate.
Information substantiating the taxonomic designation of the notified micro-organism is the cornerstone of these assessments. A “polyphasic” approach is usually recommended, which typically involves any combination of information/data on cell and colony morphology, nutrient requirements, biochemical/metabolic testing (e.g. substrate utilisation) and molecular and/or genotypic testing (e.g. fatty acid methyl ester - FAME, 16S rRNA, etc.). Typically, a taxonomic designation to the species level is expected. However, the primary goal of this approach for the purposes of conducting a CEPA1999 assessment would be to distinguish between potentially pathogenic and non-pathogenic strains. The assessment outcome in all four cases was “no suspicion of toxic” according to the definition of “toxic” found in Section 64 of CEPA1999.