Prioritization of Micro-organisms on the Domestic Substances List prior to the Screening Assessment under paragraph 74(b) of CEPA 1999
Table of Contents
- Background
- Prioritization of living organisms currently on the DSL (as of September 2010)
- Prioritization of new additions to the DSL
- Steps after prioritization
- References
- Appendix 1: Priority level for the 68 micro-organisms on the DSL (as of September, 2010)
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:
- 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
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. - 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. - 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.
- 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 level | Criteria |
|---|---|
| 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
- Organisms listed on the DSL are prioritized in APPENDIX 1 of this document.
- 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):
| Species | Strain | Risk Group (Human)1 | Risk Group (Animal)2 | Plant pest/ invasive species3 | Evidence of path/tox for species in literature | Priority Level |
|---|---|---|---|---|---|---|
| Pseudomonas aeruginosa | ATCC 31480 | 2 | 2 | No | Several | A |
| Pseudomonas aeruginosa | ATCC 700370 | 2 | 2 | No | Several | A |
| Pseudomonas aeruginosa | ATCC 700371 | 2 | 2 | No | Several | A |
| Bacillus cereus | ATCC 14579 | 2 | 2 | No | Several | A |
| Pseudomonas fluorescens | ATCC 13525 | 1 | 1 | Yes4 | Several | A |
| Aspergillus brasiliensis (formerly A. niger) | ATCC 9642 | 2 | 2 | Yes4,5 | Several | A |
| Aspergillus oryzae | ATCC 11866 | 2 | 1 | Yes5 | Some | A |
| Bacillus licheniformis) | ATCC 12713 | 1 | 2 | No | Some | A |
| Bacillus subtilis subsp. Inaquosorum (formerly B. licheniformis) | ATCC 55406 | 1 | 2 | No | Some | A |
| Escherichia hermannii | ATCC 700368 | 2 | 1 | No | Some | A |
| Enterobacter aerogenes | ATCC 13048 | 2 | 2 | No | Some | A |
| Pseudomonas stutzeri | ATCC 17587 | 2 | 1 | No | Some | A |
| Enterobacter species | 18131-5 | 2 | 2 | No | Some | A |
| Pseudomonas species 6 | 18135-0 | 2 | 1 | No | Some | A |
| Complex microbial culture | 13637-2 | Unknown6 | Unknown6 | Unknown6 | Unknown | A |
| Bacillus species 4 | 18121-4 | 1 | 2 | No | Few | A |
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):
| Species | Strain | Risk Group (Human)1 | Risk Group (Animal)2 | Plant pest/ invasive species3 | Evidence of path/tox for species in literature | Priority Level |
|---|---|---|---|---|---|---|
| Aspergillus awamori | ATCC 22342 | 1 | 1 | No | Some | B |
| Bacillus amyloliquefaciens | strain 13563-0 | 1 | 1 | No | Some | B |
| Bacillus atrophaeus | 1 | 1 | No | Some | B | |
| Bacillus circulans | ATCC 9500 | 1 | 1 | No | Some | B |
| Bacillus megaterium | ATCC 14581 | 1 | 1 | No | Some | B |
| Bacillus subtilis | ATCC 6051A | 1 | 1 | No | Some | B |
| Bacillus subtilis | ATCC 55405 | 1 | 1 | No | Some | B |
| Bacillus subtilis | strain 11685-3 | 1 | 1 | No | Some | B |
| Bacillus subtilis subsp. subtilis | ATCC 6051 | 1 | 1 | No | Some | B |
| Bacillus thuringiensis | ATCC 13367 | 1 | 1 | No | Several4 | B |
| Bacillus species5 | 16970-5 | 1 | 1 | No | Some | B |
| Bacillus species 2 | 18118-1 | 1 | 1 | Yes6 | Several | B |
| Bacillus species 7 | 18129-3 | 1 | 1 | No | Some | B |
| Candida utilis | ATCC 9950 | 1 | 1 | No | Some | B |
| Chaetomium globosum | ATCC 6205 | 1 | 1 | No | Some | B |
| Flavobacterium species | 18124-7 | 1 | 1 | Yes7 | Some | B |
| Micrococcus luteus | ATCC 4698 | 1 | 1 | No | Some | B |
| Pseudomonas putida (formerly Pseudomonas fluorescens) | ATCC 31483 | 1 | 1 | Yes | Several | B |
| Pseudomonas putida | ATCC 12633 | 1 | 1 | No | Some | B |
| Pseudomonas putida | ATCC 31800 | 1 | 1 | No | Some | B |
| Pseudomonas putida | ATCC 700369 | 1 | 1 | No | Some | B |
| Pseudomonas sp. (formerly P. denitrificans) | ATCC 13867 | 1 | 1 | No | Some | B |
| Pseudomonas species 2 | 18123-6 | 1 | 1 | Yes8 | Some | B |
| Pseudomonas species 5 | 18134-8 | 1 | 1 | No | Some | B |
| Trichoderma reesei | ATCC 74252 | 1 | 1 | No | Some | B |
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):
| Species | Strain | Risk Group (Human)1 | Risk Group (Animal)2 | Plant pest/ invasive species3 | Evidence of path/tox for species in literature | Priority Level |
|---|---|---|---|---|---|---|
| Alcaligenes species | 18115-7 | 1 | 1 | No | None/ Few | C |
| Alteromonas species | 18116-8 | 1 | 1 | No | None | C |
| Arthrobacter globiformis | ATCC 8010 | 1 | 1 | No | None | C |
| Bacillus species 1 | 18120-3 | -4 | 1 | No | None | C |
| Bacillus species 3 | 18119-2 | 1 | 1 | No | None | C |
| Bacillus species 5 | 18122-5 | 1 | 1 | Yes | Few | C |
| Cellulomonas biazotea | ATCC 486 | 1 | 1 | No | None | C |
| Cellumonas species | 18130-4 | 1 | 1 | No | None | C |
| Micrococcus species | 18125-8 | 1 | 1 | No | None | C |
| Nitrobacter species | 16969-4 | 1 | 1 | No | None | C |
| Nitrobacter species | 18132-6 | 1 | 1 | No | None | C |
| Nitrobacter winogradskyi | ATCC 25391 | 1 | 1 | No | None | C |
| Nitrococcus species | 16972-7 | 1 | 1 | No | None | C |
| Nitrosococcus species | 16971-6 | 1 | 1 | No | None | C |
| Nitrosomonas europaea | ATCC 25978 | 1 | 1 | No | None | C |
| Nitrosomonas species | 16968-3 | 1 | 1 | No | None | C |
| Nitrosomonas species | 18133-7 | 1 | 1 | No | None | C |
| Paenibacillus polymyxa | ATCC 842 | 1 | 1 | Yes5 | None | C |
| Paenibacillus polymyxa | ATCC 55407 | 1 | 1 | Yes | None | C |
| Paenibacillus polymyxa | strain 13540-4 | 1 | 1 | Yes | None | C |
| Pseudomonas species 1 | 18117-0 | 1 | 1 | No | None | C |
| Pseudomonas species 3 | 18126-0 | 1 | 1 | No | None | C |
| Pseudomonas species 4 | 18127-1 | 1 | 1 | No | None | C |
| Rhodopseudomonas palustris | ATCC 17001 | 1 | 1 | No | None | C |
| Rhodopseudomonas species | 18136-1 | 1 | 1 | No | None | C |
| Saccharomyces cerevisiae | strain F53 | 1 | 1 | No | None | C |
| Thiobacillus species | 18128-2 | 1 | 1 | No | None | C |
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
- Date Modified: