Micro-organisms

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 (CMP), 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.

  • Priority A- Micro-organism strains on the DSL given a high priority for assessment because they are considered human, plant or animal pathogens by recognized authorities or (in the case of microbial consortia) because the hazard level is uncertain.
  • Priority B- Micro-organism strains on the DSL given a medium priority for assessment because, while they are not specifically identified as pathogens, there is significant evidence in the scientific literature of potential to cause harm to human health or the environment.
  • Priority C- Micro-organism strains on the DSL identified for expedited assessment based on their lower potential to cause harm to human health or the environment.

Work plan

A Two-year Rolling Risk Assessment Publication Plan for the Remaining Existing Living Organisms to be Assessed under CEPA (2017-2019) is available. This plan outlines proposed publication dates for both draft and final screening assessments of existing micro-organisms. It will be updated yearly.

Screening assessment process

The 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.

Once complete, screening assessments undergo scientific review by both governmental and non-governmental experts. This 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 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 micro-organisms on the Domestic Substances List.

Micro-organisms strains that are not listed on the DSL are considered 'new'. Read about how new substances and new micro-organisms are assessed and managed.

Background

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 1999 with respect to micro-organism strains on the DSL was published in the Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009. 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 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
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