General Information on the Screening Assessments of Micro-organisms

Table of Contents

Background

Micro-organisms are broadly defined as bacteria, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture, and any culture other than a pure culture.

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 RVholding 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

Screening assessments are a requirement under CEPA 1999. Under paragraph 74(b), the Minister of the Environment and the Minister of Health are required to conduct screening assessments of the mico-organism strains on the Domestic Substances List (DSL) in order to determine whether they are “toxic” or capable of becoming “toxic” as defined under the Act.

Section 64 of the Act states that a substance is “toxic” if it is entering or may enter the environment in a quantity or concentration or under conditions that

  1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity; or
  2. constitute or may constitute a danger to the environment on which life depends; or
  3. constitute or may constitute a danger in Canada to human life or health.

The DSL is a compilation of all reported substances (chemicals, polymers and micro-organisms) that were:

  • in Canadian commerce between January 1, 1984, and December 31, 1986; or
  • added to the list following notification and risk assessment, in accordance with CEPA 1999.

The Minister of the Environment is responsible for amendments to the DSL. The list currently contains about 23,000 chemicals, 67 microbial strains and 2 complex microbial cultures. Sixty eight micro-organisms currently on the list were nominated because of the commerce provisions described above and one complex microbial culture was added to the DSL following notification and risk assessment, in accordance with the New Substances Notifications Regulations (Organisms). The DSL of micro-organisms can be viewed on the Environment Canada Web site.

Micro-organism strains currently on the DSL that have the potential to cause harm to human health or the environment must undergo a screening assessment under paragraph 74(b) of CEPA 1999.

To establish whether micro-organisms on the DSL continue to be manufactured in or imported into Canada, a Notice with respect to animate substances (micro-organisms) on the Domestic Substances List pursuant to paragraph 71(1)(a) of CEPA 1999 was published in Part I of the Canada Gazette on October 3, 2009 for the 45 micro-organisms that were on the list in October 2009, Since then, 23 strains were added to the DSL and these were not subject to this notice.

Top of Page

Assessment Approach for Higher Hazard (Priority A) and Moderate Hazard (Priority B) Micro-organisms

The following diagram gives a summary of the screening assessment process.

Figure 1 –The Screening Assessment Process This flow chart outlines seven important steps in the screening assessment process for existing micro-organisms. The first step is Prioritization. The second step under the screening assessment process is the preparation of a joint Environment Canada and Health Canada screening assessment report. The various information sources used at this step to inform the assessment are shown as input from the left hand side of the flow chart. The sources listed are in-depth literature review, experimental data, section 71 notice, decisions from other jurisdictions and others. The third step under the screening assessment process is the internal scientific review. The fourth step is the external scientific review process. On the right hand side of the flow chart, the contribution of the Technical Expert Group to the screening assessment process is shown as inputs to steps one through four. That is the Technical Expert Group provides recommendations to the Government on prioritization, preparation of the joint draft screening assessment report, and the internal and external scientific review. The fifth step is the finalization of the draft screening assessment report. The sixth step under the screening assessment process is the publication of the draft screening assessment report in Canada Gazette Part 1 for a 60-day public comment period, along with the proposed risk management scope (as needed). The 60-day public comment period is shown as input from the right hand side of the sixth step. The seventh step is the publication of the final screening assessment report and the final risk management approach in Canada Gazette Part 1.

The micro-organism strains on the DSL will be assessed in order of priority. The criteria used to rank the priority of micro-organisms are described in the Prioritization of Micro-organism Strains on the Domestic Substances List List prior to the Screening Assessment under paragraph 74(b) of CEPA 1999.

The systematic steps used to conduct science-based risk assessments of micro-organisms is 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 draft screening assessment report, the report will 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 assessment reports are scientifically sound, complete, and based on the most up-to-date information.

The Technical Expert Group (TEG)  is a multi-stakeholder group that contributed to the implementation of the screening assessment of micro-organisms since 2007 and provides advice to the government on scientific and technical issues pertaining to the screening assessment. Members represent environment non-government organizations, health non-government organizations, other government departments, industry and academia. The TEG progress reports are available on request.

Proposed Measures

Environment Canada and Health Canada publish a summary of the screening assessment report in the Canada Gazette, Part I, along with the proposed measure. The proposed measure could take the form of one of the following recommendations:

  • No further action under CEPA 1999. This measure is typically recommended for organisms found not to be “toxic” under the Act. No further action under CEPA 1999 may also be proposed for organisms found to be “toxic” under the Act, but for which actions being taken or about to be taken under other federal acts or by provincial, territorial or Aboriginal governments are sufficient to manage the risks effectively and in a timely manners; or
  • A recommendation that the Governor in Council (the federal Cabinet) add the organism in question to the List of Toxic Substances (Schedule 1). The organism would be added to Schedule 1 if it is determined that it meets the criteria for “toxic” substance under the Act and that regulatory or pollution prevention measures, or environmental emergency planning risk-management measures should be taken under CEPA 1999.

The public is invited to comment on the proposed conclusion for a 60-day period, after which the public’s comments is reviewed and addressed.

Environment Canada and Health Canada then publish the final assessment conclusion and final measure in the Canada Gazette, Part I.

Even though a micro-organism strain on the DSL can be found to be “not toxic” under CEPA 1999, a Significant New Activity (SNAc) notice can still be issued for the living organism by Environment Canada and Health Canada. A notice can be issued when the use of a substance or other activity will result or may result in:

  • A significantly greater quantity or concentration of the substance in the environment; or
  • A significant change in the manner or conditions of exposure to the substance.

SNAc notices are published when there is a suspicion that an alternative use of the living organism may result in the organism becoming toxic. The Notice communicates the criteria under which the government must be re-notified. The government assesses the new information on the substance to determine if it is toxic in relation to the SNAc.

Publication in Canada Gazette Part I

The official Canada Gazette Part I Notices for Priority A and Priority B are published to announce the Government’s proposed conclusions, followed by a 60-day public comment period.  Public comments will be addressed before notice of the final conclusion is published in Canada Gazette Part I. For more information, please visit the Government of Canada’s Chemical Substances Micro-organisms Webpage.

Top of Page

Assessment Approach for Lower-Hazard (Priority C) Micro-Organisms on the Domestic Substances List (DSL)

Introduction

Under paragraph 74(b) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health are required to conduct screening assessments of the List of Organisms on the Domestic Substances List (DSL) to determine whether they present or may present a risk to the environment or human health. For more details on the screening assessment process, please refer to the General Information on the Screening Assessments of Micro-organisms or to the Micro-organisms Webpage.

Lower-hazard (Priority C) DSL microorganisms were identified for expedited assessment because of a lack of evidence of pathogenicity or toxicity to species including humans or of adverse ecological effects. The following diagram gives a summary of the screening assessment process for lower-hazard (Priority C) micro-organisms.

This flow chart outlines six important steps in the screening assessment process for existing micro-organisms that have been deemed low concern for human health and the environment. The first step is Prioritization. The second step under the screening assessment process is the grouping of the Priority C micro-organisms into batches for assessment. The third step under the screening assessment process is the preparation of the draft screening assessment report. The various information sources used at this step to inform the assessment are shown as input from the left hand side of the flow chart. The sources listed are in-depth literature review and the section 71 notice (also referred to as the Survey). The fourth step is the scientific peer review process. The fifth step under the screening assessment process is the publication of the summary of the draft screening assessment report in Canada Gazette, Part 1 for a 60-day public comment period, along with the proposed conclusion. The 60-day public comment period is shown as input from the right hand side of the fifth step. The sixth step is the publication of the summary of the final screening assessment report and the final conclusion in Canada Gazette, Part I.

Prioritization

There are 68 organisms currently on the Domestic Substances List (DSL). As described in the document Prioritization of Micro-organisms on the Domestic Substances List prior to the Screening Assessment under paragraph 74(b) of CEPA 1999, these organisms were prioritized into three groups (Priority A, B, C) based on a review of pathogen lists and the scientific literature against the following criteria:

i. Pathogenicity or toxicity for humans
ii. Pathogenicity or toxicity to non-human species
iii. Potential for adverse ecological effects

Twenty-seven micro-organisms were considered to be of lower hazard (Priority C) because there was a scarcity of evidence of pathogenicity or toxicity for humans or non-human species or of potential for adverse ecological effects, and therefore, these were identified for expedited assessment.

Lots

Within the lower-hazard (Priority C) group, micro-organisms were further sub-divided into ‘Lots’ for assessment according to their taxonomic classification (genus or species) and known and potential uses related to their biological properties (Table 1). All the lower-hazard (Priority C) micro-organisms that were confirmed to be in Canadian commerce by the Notice [under section 71 of Canadian Environmental Protection Act, 1999 (CEPA 1999)] with respect to animate substances (micro-organisms) on the DSL, published in the Canada Gazette, Part I: Vol. 143, No. 40 - October 3, 2009 (PDF Version - 1057 K) were grouped in Lots 1 and 2 to be assessed before those in Lots 3 and 4, which appear no longer to be in commerce (Table 1).

Table 1: Priority C Lots

Lot #OrganismStrain/Accession Number
1Nitrobacter winogradskyiATCC 25391
Nitrobacter species18132-6[*]
Nitrobacter species16969-4[*]
Nitrosomonas europaeaATCC 25978
Nitrosomonas species16968-3[*]
Nitrosomonas species18133-7[*]
Rhodopseudomonas palustrisATCC 17001
Rhodopseudomonas species18136-1[*]
2Paenibacillus polymyxaATCC 842
Paenibacillus polymyxaATCC 55407
Paenibacillus polymyxa13540-4[*]
Nitrococcus species16972-7[*]
Nitrosococcus species16971-6[*]
Alteromonas species18116-8[*]
3Cellulomonas biazoteaATCC 486
Cellumonas species18130-4[*]
Arthrobacter globiformisATCC 8010
Alcaligenes  species18115-7[*]
Micrococcus species18125-8[*]
Thiobacillus species18128-2[*]
4Bacillus species 118120-3[*]
Bacillus species 318119-2[*]
Bacillus species 518122-5[*]
Pseudomonas denitrificansATCC 13867
Pseudomonas species 118117-0[*]
Pseudomonas species 318126-0[*]
Pseudomonas species 418127-1[*]
[*] At the request of the nominating party, these strains have been listed by a confidential substance identity in place of the explicit biological name and strain number under the Masked Name Regulations pursuant to section 113 of CEPA 1999


Preparation of Draft Screening Assessment Report (DSAR)

The Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999outlines the elements considered in the risk assessment of micro-organisms, regardless of assigned priority. Features that are particular to the assessment of lower-hazard (Priority C) micro-organisms are described below.

Hazard Assessment

A review of the biological and ecological properties of the micro-organism is performed to confirm its low hazard potential (i.e. identification of potential virulence factors or characteristics that could permit the organism to adversely affect human health or the environment). If evidence of significant hazard is identified, the micro-organism is removed from the Lot and appropriately reprioritized for further assessment.

Exposure Assessment

The exposure assessment considers exposure from the deliberate addition of the micro-organism to consumer or commercial products or its use in industrial processes in Canada, using conservative assumptions that are protective of the environment and human health. Sources of exposure are identified from known uses, including uses identified through any section 71 Notice under Canadian Environmental Protection Act, 1999 (CEPA 1999), and uses predicted from industry information, the scientific literature, patent searches and the biological characteristics of the micro-organism. Exposure to the environment is characterized through consideration of probable sites of release, characteristics of the receiving environments, and the ability of the micro-organisms to survive, reproduce, persist or disperse in ecological niches available there. Human exposure is characterized through consideration of routes of direct exposure through known and predicted uses and indirect exposure resulting from release of the micro-organism into the environment.

Risk Characterization

Risks are characterized as low when no adverse effects attributable to the micro-organism from known and probable exposure scenarios are likely.

Considerations

This approach is consistent with the principles of the Framework mentioned above, including the use of weight of evidence in assessing hazard and the use of conservative assumptions that are protective of the environment and human health in assessing exposure to lower-hazard (Priority C) micro-organisms. Uncertainties always exist and if new information becomes available it will be considered. Such information may be identified from a number of different sources, including:

  • published scientific literature;
  • direct submission of information by stakeholders;
  • research and DSL update activities;
  • other assessment or regulatory activities in Canada or in foreign or international fora.

Scientific Peer Review

The draft screening assessment reports undergo a scientific peer review. The review process ensures that the screening assessment reports are scientifically sound, complete, and based on the most up-to-date information.

Publication in Canada Gazette Part I

An official Canada Gazette Part I Notice for each lower-hazard (Priority C) Lot will be published to announce the Government’s proposed conclusions, followed by a 60-day public comment period.  Public comments will be addressed before notice of the final conclusion is published in Canada Gazette Part I. A Draft Screening Assessment Report and Public Summary for Lot 1 were published on the Government of Canada’s Chemical Substances web site.

Top of Page

Contact Information

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