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Micro-organisms

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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 an assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they can cause harm to human health or the environment. For more information on how new substances are assessed and managed, please visit Environment Canada's New Substances website.

Micro-organisms currently on the Domestic Substances List (Micro-organisms) that have the potential to cause harm to human health or the environment must undergo a screening assessment. As part of the Chemicals Management Plan, 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 substances.

• Applying Significant New Activity (SNAc) Provisions
• Draft Screening Assessment Report
• Screening Assessment Process
• Background

Applying Significant New Activity (SNAc) Provisions

One Notice of intent has been published for a 60-day public comment period (July 2, 2011 to August 31, 2011).

• Notice of intent to amend the Domestic Substances List that applies to three strains of Pseudomonas aeruginosa:  Canada Gazette, Part I: Vol. 145, No. 27 - July 2, 2011 ( PDF Version - 2280 K)

Draft Screening Assessment Report

Strain/Accession Number	Micro-organism	Canada Gazette Notice	Draft Screening Assessment Report
1 These substances have been evaluated together in a single Screening Assessment.
ATCC 314801 ATCC 7003701 ATCC 7003711	Pseudomonas aeruginosa	HTML PDF	HTML

There is a 60-day public comment period (July 2, 2011 to August 31, 2011) associated with these publications. Details on how to submit public comments can be found within the Canada Gazette.

Screening Assessment Process

The micro-organisms on the Domestic Substances List (DSL) will be assessed in order of priority. The criteria used to rank the priority of micro-organisms are described in the prioritization guidelines.

The systematic steps used to conduct science-based risk assessments of micro-organisms 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 report (informed by the section 71 survey responses), the report will undergo 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 assessment reports are scientifically sound, complete, and based on the most up-to-date information.

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.

Background

To establish whether micro-organisms on the DSL continue to be manufactured in or imported into Canada, information gathering was done for the 45 micro-organisms.  A  Notice with respect to animate substances (micro-organisms) on the DSL was published in the Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009 ( PDF Version - 1057 K).  In March 2010, 22 strains were 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:

• Adhesives
• Biofiltration
• Biofuel production
• Biological waste treatment
• Biomass conversion
• Bioremediation
• Biosensing
• Catalysts
• Cleaners/Detergents
• Compost starter
• Enhanced oil recovery
• Enzyme Production
• Fermentation
• Fossil fuel or natural gas desulfuration
• Microbial biomass/feedstock
• Microbial degreasing
• Microbial drain cleaning
• Odour control products
• Products for RV holding tanks
• Pulp and paper
• Septic tank starter
• Solubilizing hemicellulose
• Wax separation

Micro-organisms in products also subject to the Food and Drugs Act, including:

• Biologics
• Cosmetics
• Food additives
• Food packaging
• Medical devices
• Natural health products
• Novel foods
• Personal care products
• Pharmaceuticals
• Production organisms
• Veterinary drugs

If you have questions or comments, please contact us. Indicate on the envelope or subject line "Screening Assessment of Existing Micro-organisms Inquiry".