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Prioritization of Micro-organisms on the Domestic Substances List prior to the Screening Assessment under paragraph 74(b) of CEPA 1999


(PDF Version - 132 KB)

Table of Contents

Background

The objective for the prioritization of living organisms on the Domestic Substances List (DSL) is to identify the organisms of higher concern early in the screening assessment process.

The Environment Canada (EC) and Health Canada (HC) reached consensus on the criteria to be used for prioritization and the strategy to be implemented.

Criteria that are considered are:

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

Pathogenicity refers to the ability of an organism to cause harm or disease to the host. This ability is a property of the pathogen and the extent of damage done to the host depends on host-pathogen interactions.

Toxicity: refers to the degree to which a substance (toxin) or an organism can cause harm to living organism as a whole, its tissue or its cells. Live microorganisms need not necessarily be present for a toxic effect to occur (e.g., in toxin-mediated food poisoning or for toxic products of micro-organisms used in industrial applications).

Adverse ecological effects: refers to the ability of the micro-organism to adversely alter biotic and abiotic components of the ecosystem (e.g. loss of biodiversity, loss of habitat).


Prioritization of living organisms currently on the DSL (as of September 2010)

As of September 2010, there are 68 micro-organisms on the DSL that are subject to screening assessment: 67 microbial strains and 1 complex microbial culture (i.e. consortium).  They are prioritized as follows:

  1. Laboratory Biosafety Guidelines from the Public Health Agency of Canada (PHAC) are used to identify micro-organisms of higher concern for human and environmental health.  These Guidelines provide lists of organisms falling in Risk group 1 to 4 categories.  For the EC/HC guidelines for the prioritization of living organisms on the DSL, micro-organisms listed by the PHAC as Risk Group 2 or higher are given Priority Level A.

    Background information on the Risk Groups from thePublic Health Agency of Canada:

    The factors used by the Public Health Agency of Canada to determine which risk group an organism falls into is based upon the particular characteristics of the organism, such as

    • pathogenicity
    • infectious dose
    • mode of transmission
    • host range
    • availability of effective preventive measures
    • availability of effective treatment

    These classifications presume ordinary circumstances in the research laboratory or growth in small volumes for diagnostic and experimental purposes, which may be different than the circumstances of use for the micro-organisms on the DSL. Four levels of risk have been defined by the Public Health Agency of Canada, as follows:

    Risk Group 1 (low individual and community risk)
    Any biological agent that is unlikely to cause disease in healthy workers or animals.

    Risk Group 2 (moderate individual risk, low community risk)
    Any pathogen that can cause human disease but, under normal circumstances, is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available, and the risk of spread is limited.

    Risk Group 3 (high individual risk, low community risk)
    Any pathogen that usually causes serious human disease or can result in serious economic consequences but does not ordinarily spread by casual contact from one individual to another, or that causes diseases treatable by antimicrobial or antiparasitic agents.

    Risk Group 4 (high individual risk, high community risk)
    Any pathogen that usually produces very serious human disease, often untreatable, and may be readily transmitted from one individual to another, or from animal to human or vice-versa, directly or indirectly, or by casual contact.

  2. C/HC uses additional tools to identify micro-organisms of special concern for the environment which may not be captured by the classification scheme used by the PHAC and the CFIA.  Some of these tools are:

    a) The list of reportable animal diseases used as priority list of animal pathogens by Canadian Food Inspection Agency (CFIA).
    b) The list of plant pests regulated by Canada.
    c) The lists of pests regulated by member countries of the International Plant Protection Convention, as found on the International Phytosanitary Portal (IPP).
    d) The Global Invasive Species Database focuses on invasive alien species that threaten native biodiversity and covers all taxonomic groups from micro-organisms to animals and plants in all ecosystems. Species information is either supplied by or reviewed by expert contributors from around the world.

    Micro-organisms on the DSL, found on these lists/database, are also given a Priority Level A, regardless of the Risk Group designation given by the PHAC or the CFIA.

  3. Consortia are given the Priority Level A because of the high scientific uncertainty associated with the identification and hazard characterization of all component micro-organisms in a consortium.

  4. A preliminary search of the scientific literature and databases on potential hazards for human and environmental health is performed by Health Canada and Environment Canada.   

Risk Group 1 micro-organisms for which someevidence of pathogenicity or toxicity toward human or animal or plant species or potential for adverse ecological effects, was reported in the scientific literature are given a Priority Level B. 

Risk Group 1 micro-organisms for which littleevidence of pathogenicity or toxicity toward human or animals or plant species or potential for adverse ecological effects, was reported in the scientific literature are given a Priority Level C. 

Summary of criteria used to assign the priority for screening assessment of micro-organisms currently on the DSL

Priority levelCriteria
A

Micro-organisms belonging to Risk Group 2 (moderate individual risk, low community risk for humans and the environment) or above, according to the PHAC

or

Micro-organisms belonging to Risk Group 2 (moderate individual risk, low risk to community, livestock or the environment) or above, according to Office of Biohazard Containment & Safety, Canadian Food Inspection Agency (CFIA).

or

Micro-organisms found on a List of regulated plant pests of Canada or one of the member countries of the International Plant Protection Convention.

or

All Consortia

B

Risk Group 1 micro-organisms (low individual and community risk for humans and the environment) according to the PHAC with some evidence of pathogenicity or toxicity in the scientific literature

or

Risk Group 1 micro-organisms (low individual and community risk, and unlikely to cause disease in healthy people or animals), according to Office of Biohazard Containment & Safety, CFIA, with some evidence of pathogenicity or toxicity or potential for adverse ecological effect in the scientific literature

C

Risk Group 1 micro-organisms (low individual and community risk for humans and the environment) according to the PHAC with little evidence of pathogenicity or toxicity in the scientific literature.

or

Risk Group 1 micro-organisms (low individual risk, low community risk, and unlikely to cause disease in healthy people or animals), according to Office of Biohazard Containment & Safety, CFIA, with little evidence of pathogenicity or toxicity or potential for adverse ecological effect in the scientific literature


Prioritization of new additions to the DSL

  1. Organisms listed on the DSL are prioritized in APPENDIX 1 of this document.

  2. New microbial strains and complex microbial cultures (i.e. consortia) nominated to the DSL will be prioritized following the rationale outlined above.

Steps after prioritization

Screening assessment under paragraph 74(b) of CEPA 1999 is conducted by Environment Canada and Health Canada for all micro-organisms that are nominated to listing on the DSL.

The prioritized list is dynamic and may change upon addition of new micro-organisms, or when Health Canada or Environment Canada finds additional information that changes the priority level for a given micro-organism.


References

The Laboratory Biosafety Guidelines 3rd Edition, 2004. Publication N° 4252.  Minister of Health, Population and Public Health Branch, Centre for Emergency Preparedness and Response.

Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms. March 2004. Environment Canada. Report EPS 1/RM/44.


Appendix 1:Priority level for the 68 micro-organisms on the DSL (as of September, 2010)

Priority (16 micro-organisms):

SpeciesStrainRisk Group
(Human)1
Risk Group
(Animal)2
Plant pest/ invasive species3Evidence of path/tox for species in literaturePriority Level
Pseudomonas aeruginosaATCC 3148022NoSeveralA
Pseudomonas aeruginosaATCC 70037022NoSeveralA
Pseudomonas aeruginosaATCC 70037122NoSeveralA
Bacillus cereusATCC 1457922NoSeveralA
Pseudomonas fluorescensATCC 1352511Yes4SeveralA
Aspergillus brasiliensis (formerly A. niger)ATCC 964222Yes4,5SeveralA
Aspergillus oryzaeATCC 1186621Yes5SomeA
Bacillus licheniformis)ATCC 1271312NoSomeA
Bacillus subtilis subsp. Inaquosorum (formerly B. licheniformis)ATCC 5540612NoSomeA
Escherichia hermanniiATCC 70036821NoSomeA
Enterobacter aerogenesATCC 1304822NoSomeA
Pseudomonas stutzeriATCC 1758721NoSomeA
Enterobacter species18131-522NoSomeA
Pseudomonas species 618135-021NoSomeA
Complex microbial culture13637-2Unknown6Unknown6Unknown6UnknownA
Bacillus species 418121-412NoFewA
1 Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
2 Risk level designation based on priority list used by Animal Pathogen Import Program, Office of Biohazard Containment & Safety, Canadian Food Inspection Agency (CFIA)
3 Risk level designation based on Regulated Pests of Canada list (Office of Biohazard Containment & Safety, CFIA), and/or Regulated Pests of member countries of  International Plant Protection Convention (IPPC) and/or  Invasive species list of Global Invasive Species Programme (GISP).
4 P. fluorescens and A. niger (strain not specified) are considered as a plant pest of quarantine importance in the Commonwealth of Dominica (Pest list of the Commonwealth of Dominica, 17 November 2005).
5 A. niger and A. oryzae (strains not specified) are considered as endemic (not regulated) pests of rice in Cambodia (Cambodian Endemic and quarantine pest of rice, 06 May 2005).
6 According to the identity information supplied by the applicant, all 9 strains considered as principal members of the consortium belong to Risk Group 1.  Based on the precautionary principle, the consortium has therefore been designated Priority A so as to expedite its screening assessment

 

Priority (25 micro-organisms):

SpeciesStrainRisk Group
(Human)1
Risk Group
(Animal)2
Plant pest/ invasive species3Evidence of path/tox for species in literaturePriority Level
Aspergillus awamoriATCC 2234211NoSomeB
Bacillus amyloliquefaciensstrain 13563-011NoSomeB
Bacillus atrophaeus 11NoSomeB
Bacillus circulansATCC 950011NoSomeB
Bacillus megateriumATCC 1458111NoSomeB
Bacillus subtilisATCC 6051A11NoSomeB
Bacillus subtilisATCC 5540511NoSomeB
Bacillus subtilisstrain 11685-311NoSomeB
Bacillus subtilis subsp. subtilisATCC 605111NoSomeB
Bacillus thuringiensisATCC 1336711NoSeveral4B
Bacillus species516970-511NoSomeB
Bacillus species 218118-111Yes6SeveralB
Bacillus species 718129-311NoSomeB
Candida utilisATCC 995011NoSomeB
Chaetomium globosumATCC 620511NoSomeB
Flavobacterium species18124-711Yes7SomeB
Micrococcus luteusATCC 469811NoSomeB
Pseudomonas putida (formerly
Pseudomonas fluorescens)
ATCC 3148311YesSeveralB
Pseudomonas putidaATCC 1263311NoSomeB
Pseudomonas putidaATCC 3180011NoSomeB
Pseudomonas putida ATCC 70036911NoSomeB
Pseudomonas sp. (formerly P. denitrificans)ATCC 1386711NoSomeB
Pseudomonas species 218123-611Yes8SomeB
Pseudomonas species 518134-811NoSomeB
Trichoderma reeseiATCC 7425211NoSomeB
1 Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
2 Risk level designation based on priority list used by Animal Pathogen Import Program, Office of Biohazard Containment & Safety, Canadian Food Inspection Agency (CFIA)
3 Risk level designation based on Regulated Pests of Canada list (Office of Biohazard Containment & Safety, CFIA), and/or Regulated Pests of member countries of  International Plant Protection Convention (IPPC) and/or  Invasive species list of Global Invasive Species Programme (GISP).
4 Toxicity toward specific insect taxa
5 The species and strain identification for this species is masked.  The species belongs to Risk Group 1 and is not known to be pathogenic to animals or plants, or considered invasive or plant pests.
6 Non-regulated Plant Pest New Zealand
7 Plant Pest Pacific Islands (Cook)
8 Regulated Pest New Zealand

 

Priority C (27 micro-organisms):

SpeciesStrainRisk Group
(Human)1
Risk Group
(Animal)2
Plant pest/ invasive species3Evidence of path/tox for species in literaturePriority Level
Alcaligenes species18115-711NoNone/ FewC
Alteromonas species18116-811NoNoneC
Arthrobacter globiformisATCC 801011NoNoneC
Bacillus species 118120-3-41NoNoneC
Bacillus species 318119-211NoNoneC
Bacillus species 518122-511YesFewC
Cellulomonas biazoteaATCC 48611NoNoneC
Cellumonas species18130-411NoNoneC
Micrococcus species18125-811NoNoneC
Nitrobacter species16969-411NoNoneC
Nitrobacter species18132-611NoNoneC
Nitrobacter winogradskyiATCC 2539111NoNoneC
Nitrococcus species16972-711NoNoneC
Nitrosococcus  species16971-611NoNoneC
Nitrosomonas europaeaATCC 2597811NoNoneC
Nitrosomonas species16968-311NoNoneC
Nitrosomonas species18133-711NoNoneC
Paenibacillus polymyxaATCC 84211Yes5NoneC
Paenibacillus polymyxaATCC 5540711YesNoneC
Paenibacillus polymyxastrain 13540-411YesNoneC
Pseudomonas species 118117-011NoNoneC
Pseudomonas species 318126-011NoNoneC
Pseudomonas species 418127-111NoNoneC
Rhodopseudomonas palustrisATCC 1700111NoNoneC
Rhodopseudomonas species18136-111NoNoneC
Saccharomyces cerevisiaestrain F5311NoNoneC
Thiobacillus species18128-211NoNoneC
1 Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
2 Risk level designation based on priority list used by Animal Pathogen Import Program, Office of Biohazard Containment & Safety, Canadian Food Inspection Agency (CFIA)
3 Risk level designation based on Regulated Pests of Canada list (Office of Biohazard Containment & Safety, CFIA), and/or Regulated Pests of member countries of  International Plant Protection Convention (IPPC) and/or  Invasive species list of Global Invasive Species Programme (GISP).
4 Not included in PHAC  designated risk group database
5 Regulated Pest New Zealand