Micro-organisms are broadly defined as bacteria, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture, and any culture other than a pure culture. As with chemicals, new and existing micro-organisms must undergo a screening assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they can cause harm to human health or the environment.
As part of the Chemicals Management Plan, the 68 micro-organism strains on the Domestic Substances List (DSL) will be assessed. The Government of Canada used known hazard characteristics to rank the micro-organism strains into groups that determine their priority for assessment. The criteria used to rank the micro-organism strains are described in the Prioritization of Micro-organism Strains on the Domestic Substances List.
The systematic steps used to conduct science-based risk assessments of micro-organism strains on the DSL are described in the Framework for Science-Based Risk Assessment of Micro-organisms regulated under the Canadian Environmental Protection Act, 1999.
After the preparation of the screening assessment (informed by responses to the section 71 Notice), the screening assessment undergoes a scientific review by experts internal to Environment Canada and Health Canada followed by an external scientific review. The review process ensures that the screening assessments are scientifically sound, complete, and based on the most up-to-date information.
As a result of the screening assessment process, the Domestic Substances List (DSL) may be amended from time to time to indicate that the Significant New Activity (SNAc) provisions of CEPA 1999 apply to some existing micro-organism strains. For more details on the screening assessment process, please refer to the General Information on the Screening Assessments of Living Organisms on the Domestic Substances List.
Micro-organisms strains that are not listed on the DSL are considered 'new'. For more information on how new substances and new micro-organisms are assessed and managed, please visit Environment Canada's New Substances website.
To establish whether micro-organism strains on the DSL continue to be manufactured in or imported into Canada, an information-gathering Notice under section 71 of CEPA with respect to micro-organism strains on the DSL was published in the Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009 ( PDF Version - 1057 K). This section 71 Notice applied to all of the 45 micro-organisms on the list at that time, regardless of their priority ranking. Twenty three strains have since been added to the DSL. These were not subject to the section 71 Notice.
The following are examples of products that may contain new and existing micro-organisms that may be subject to the Canadian Environmental Protection Act, 1999 (CEPA 1999). Please note that these lists are not exhaustive.
Micro-organisms intended for use in:
Micro-organisms in products also subject to the Food and Drugs Act, including:
If you have questions or comments, please contact us. Indicate on the envelope or subject line "Screening Assessment of Existing Micro-organisms Inquiry".