Prioritization of Micro-organisms
on the Domestic Substances List prior to the Screening
Assessment under paragraph 74(b) of CEPA 1999
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 the Public 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) EC/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. 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), found at
http://www.inspection.gc.ca/english/sci/bio/anima/disemala/disemalae.shtml
b) The list of plant pests regulated by Canada, found at
http://www.inspection.gc.ca/english/plaveg/protect/listpespare.shtml
c) The lists of pests regulated by member countries of the International Plant
Protection Convention, as found on the International Phytosanitary Portal (IPP) at
http://www.ippc.int
d) The Global Invasive Species Database focuses on invasive alien species that
threaten native biodiversity and covers all taxonomic groups from microorganisms to animals and plants in all ecosystems. Species information is either
supplied by or reviewed by expert contributors from around the world. This
database is found at http://www.issg.org/database/welcome/.
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 microorganisms 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 some evidence 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 little evidence 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
Criteria
level
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: http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index.html
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:
http://www.ec.gc.ca/Publications/default.asp?lang=En&xml=6D1111F3-FB7D-4432B20F-6ACCB59A0FE9
APPENDIX 1: Priority level for the 68 micro-organisms on the DSL as of
September, 2010.
PRIORITY A (16 micro-organisms):
Strain
Risk
Group
1
(Human)
Risk
Group
2
(Animal)
Pseudomonas
aeruginosa
Pseudomonas
aeruginosa
Pseudomonas
aeruginosa
Bacillus cereus
ATCC 31480
2
2
ATCC 700370
2
ATCC 700371
2
ATCC 14579
2
2
No
Pseudomonas
fluorescens
Aspergillus brasiliensis
(formerly A. niger)
Aspergillus oryzae
ATCC 13525
1
1
Yes
4
ATCC 9642
2
2
Yes
4, 5
Several
A
ATCC 11866
2
1
Yes
5
Some
A
Bacillus licheniformis)
ATCC 12713
1
2
No
Some
A
Bacillus subtilis subsp.
Inaquosorum (formerly
B. licheniformis)
Escherichia hermannii
ATCC 55406
1
2
No
Some
A
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
Bacillus species 4
13637-2
Unknown
Unknown
A
18121-4
1
Few
A
1
6
No
Evidence of
path/tox for
species in
literature
Several
A
2
No
Several
A
2
No
Several
A
Several
A
Several
A
Unknown
2
6
Plant pest/
invasive
3
species
Priority
Level
Species
Unknown
No
6
Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
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
2
Tab 4.2
PRIORITY B (25 micro-organisms):
Species
Strain
Risk
Group
1
(Human)
Risk
Group
2
(Animal)
Aspergillus awamori
ATCC 22342
1
1
Bacillus
amyloliquefaciens
Bacillus atrophaeus
strain 13563-0
1
Bacillus circulans
Bacillus megaterium
Priority
Level
No
Evidence of
path/tox for
species in
literature
Some
B
1
No
Some
B
1
1
No
Some
B
ATCC 9500
1
1
No
Some
B
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
Bacillus thuringiensis
ATCC 6051
1
1
No
Some
B
ATCC 13367
1
1
No
Several
Bacillus species
5
Plant pest/
invasive
3
species
16970-5
1
1
No
Bacillus species 2
18118-1
1
1
Yes
Bacillus species 7
18129-3
1
1
Candida utilis
ATCC 9950
1
Chaetomium globosum
ATCC 6205
1
4
B
Some
B
Several
B
No
Some
B
1
No
Some
B
1
No
Some
B
Some
B
6
7
Flavobacterium species
18124-7
1
1
Yes
Micrococcus luteus
ATCC 4698
1
1
No
Some
B
Pseudomonas putida
(formerly
Pseudomonas
fluorescens)
Pseudomonas putida
ATCC 31483
1
1
Yes
Several
B
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)
Pseudomonas species
2
Pseudomonas species
5
Trichoderma reesei
ATCC 13867
1
1
No
Some
B
18123-6
1
1
Yes
Some
B
18134-8
1
1
No
Some
B
ATCC 74252
1
1
No
Some
B
8
1
Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
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
2
7
Tab 4.2
Priority C (27 micro-organisms):
Species
Strain
Risk
Group
1
(Human)
Risk
Group
2
(Animal)
Alcaligenes species
18115-7
1
1
Alteromonas species
18116-8
1
Arthrobacter
globiformis
Bacillus species 1
ATCC 8010
Priority
Level
No
Evidence of
path/tox for
species in
literature
None/ Few
C
1
No
None
C
1
1
No
None
C
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
Nitrococcus species
ATCC 25391
1
1
No
None
C
16972-7
1
1
No
None
C
Nitrosococcus
species
Nitrosomonas
europaea
Nitrosomonas species
16971-6
1
1
No
None
C
ATCC 25978
1
1
No
None
C
16968-3
1
1
No
None
C
Nitrosomonas species
18133-7
1
1
No
None
C
None
C
Paenibacillus
polymyxa
Paenibacillus
polymyxa
Paenibacillus
polymyxa
Pseudomonas species
1
Pseudomonas species
3
Pseudomonas species
4
Rhodopseudomonas
palustris
Rhodopseudomonas
species
Saccharomyces
cerevisiae
Thiobacillus species
Plant pest/
invasive
3
species
5
ATCC 842
1
1
Yes
ATCC 55407
1
1
Yes
None
C
strain 13540-4
1
1
Yes
None
C
18117-0
1
1
No
None
C
18126-0
1
1
No
None
C
18127-1
1
1
No
None
C
ATCC 17001
1
1
No
None
C
18136-1
1
1
No
None
C
strain F53
1
1
No
None
C
18128-2
1
1
No
None
C
1
Risk level designation based on the Public Health Agency of Canada’s Laboratory Biosafety Guidelines.
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
2
8