Risk assessment summaries for living organisms
Background
Risk assessments of living organisms are conducted by Environment and Climate Change Canada and Health Canada. These assessments determine whether a substance is or may become harmful to human health or the environment as set out in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). When potential risks are identified, CEPA empowers the Minister of Environment to impose control measures.
To promote transparency of the New Substances program, Environment and Climate Change Canada and Health Canada publish summaries of environmental and human health risk assessment reports for living organisms. These summaries provide an overview of information examined during the assessment period, as well as the conclusions and regulatory decisions that were made. All experimental and calculated values are listed as ranges to protect confidential business information. The key elements found in the summaries include:
- the substance identity
- its use
- its hazard
- its exposure
- its environmental fate
- the assessment of its ecological risk
- the assessment of its human health risk
- the regulatory decisions
Risk assessment summaries are published on a regular basis for notifications representing a wide spectrum of organism types, methods of manufacture, uses and risk levels, including but not limited to notifications where control measures are applied.
For more information on the risk assessment summaries or to obtain a full copy of a summarized risk assessment report, please contact us.
For more information on how the New Substances program conducts risk assessment summaries of new living organisms, please consult the following resources:
- Microbial risk assessment framework (MRAF) under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act, 1999
- Risk assessment of living organisms subject to the Canadian Environmental Protection Act, 1999 and the New Substances Notification Regulations (Organisms)
Substance identification in summaries
Where the substance identity of a living organism is not considered to be confidential, it is identified by its explicit biological name in the summary.
Where a substance’s explicit biological name is considered to be confidential business information, CEPA allows for masked names to be published in their place. Masked names are regulated under the Masked Name Regulations, which permit the masking of one or more distinctive elements of the explicit name. The Department of the Environment and Climate Change assigns each confidential substance identity numbers, also referred to as a confidential accession number by the New Substances program.
Accessing risk assessment summaries for living organisms
All risk assessment summaries for new living organisms that have been published since 2010 can be obtained through the following steps:
- go to Substances Search
- select “New Substances Risk Assessment Summaries” in the drop-down menu
- click "Export to Excel"
In the Excel file, filter the results for "Organism" in the "Additional Information" column. The links to the organisms’ risk assessment summaries can be found in the “Recent Publication(s)” column.
The risk assessment summaries for new living organisms can also be found below. Use the A–Z index to navigate to summaries alphabetically by substance name.
A
- Ad26.Mos1.Env. (New Substances Notification 19445)
- Arcobacter sp. strain (New Substances Notification 17179)
- Aspergillus species strain (New Substances Notification 18740)
- Recombinant replication-defective chimpanzee adenovirus Ox1 expressing Spike protein (S protein) of SARS-CoV-2 (ChAdOx1-S) (New Substances Notification 20657)
- Recombinant replication-defective human adenovirus type 5 expressing Spike protein (S protein) of SARS-CoV-2 (Ad5-nCoV) (New Substances Notification 20417)
B
- Bacillus amyloliquefaciens strain J1 (New Substances Notification 18253)
- Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 (New Substances Notification 20598)
- Bacillus paralicheniformis CH00005 (New Substances Notification 21835)
- Bacillus species strains 01 and 02 (New Substances Notifications 16596 and 16597)
- Bacillus species strains 06 and 03 (New Substances Notifications 16908 and 16909)
C
- Anaerobic 1,1,1-Trichloroethane Degrading Consortium KB-1 Plus 1,1,1-TCA (New Substances Notification 21661)
- Anaerobic benzene degrading consortium DGG-B™ (New Substances Notification 20103)
- Carnobacterium maltaromaticum strain CB1 (New Substances Notification EAU-313)
- Consortia DGG-XTM, DGG-BTM, and DGG-TTM (New Substances Notifications 20941, 20942, and 20943)
- Coxsackivarius A21, Kuykendall strain (New Substances Notification 20497)
- CTX001 (New Substances Notification 19662)
- KB-1 Anaerobic Dechlorinating Consortium containing Dehalococcoides spp. (New Substances Notification 15050)
D
- EntoEngine fruit fly (Drosophila melanogaster) expressing bovine FGF2 (New Substances Notification 21233)
- EntoEngine fruit flies (Drosophila melanogaster) expressing human EPO, IL-12 and TGF-beta3 respectively (New Substances Notifications 22153, 22154 and 22155)
- EntoEngine fruit fly (Drosophila melanogaster) expressing human FGF2 (New Substances Notification 21561)
- EntoEngine fruit flies (Drosophila melanogaster) expressing human IL-10 and human FGF-7 respectively (New Substances Notifications 22022 and 22023)
- EntoEngine fruit flies (Drosophila melanogaster) expressing human prolactin, bovine activin, TGF-beta 1, or bovine albumin respectively (New Substances Notifications 21725, 21726, 21727, and 21728)
- DTX301 (New Substances Notification 18831)
E
- Eschericia coli BL21 ΔrhaB M1RI_pLMAR, BL21 ΔrhaB A1RI_pLMAR, BL21 ∆rhaB M2RI_pLMAR and BL21 ∆rhaB LacZ::Taq (New Substances Notifications 21737, 21738, 21739, and 21740)
- Escherichia coli strain C003 (New Substances Notification 19393)
- Escherichia coli CBS (New Substances Notification 19832)
- Escherichia coli strain SYBNB1934v1 (New Substances Notification 21300)
G
- Corydoras (Corydoras aeneus) known as the GloFish® Electric Green® Corydoras (GCA2021) (New Substances Notification 22084)
- Corydoras (Corydoras aeneus) known as the GloFish® Moonrise Pink® Corydoras (PiCA2021) (New Substances Notification 22085)
- Corydoras (Corydoras aeneus) known as the GloFish® Sunburst Orange® Corydoras (OCA2021) (New Substances Notification 22086)
- Rainbow Shark (Epalzeorhynchos frenatum) known as the GloFish® Cosmic Blue® Shark (BS2017) (New Substances Notification 21655)
- Rainbow Shark (Epalzeorhynchos frenatum) known as the GloFish® Electric Green® Shark (GS2017) (New Substances Notification 21656)
- Rainbow Shark (Epalzeorhynchos frenatum) known as the GloFish® Sunburst Orange® Shark (OS2016) (New Substances Notification 21657)
- Rainbow Shark (Epalzeorhynchos frenatum) known as the GloFish® Galactic Purple® Shark (PS2016) (New Substances Notification 21658)
- Tiger Barbs (Puntigrus tetrazona) known as the GloFish® Electric Green® Barb (GB2011), GloFish® Starfire Red® Barb (RB2015), GloFish® Galactic Purple® Barb (PB2019), and GloFish® Sunburst Orange® Barb (OB2019) (New Substances Notifications 21071, 21072, 21073, and 21074)
L
- Lactococcus lactis subsp. cremoris strain sAGX0037 (New Substances Notification EAU-439)
- Listeria monocytogenes strains CRS-207, JNJ-64041809 and JNJ-64041757 (New Substances Notifications EAU 829, 18525 and 18526)
N
P
- Phages QP-PSA-001, QP-PSA-002, QP-PSA-017 and QP-PSA-018 targeting Pseudomonas aeruginosa (New Substances Notifications 22354, 22355, 22356 and 22357)
- Phages QP-STA-003 and QP-STA-005 targeting Staphylococcus aureus (New Substances Notifications 22296 and 22297)
- Phlebiopsis gigantea strain FTK 897A (New Substances Notification 16373)
- Pichia species strain (New Substances Notification 17329)
- Prevotella histicola strain ES894 (New Substances Notification 21116)
- Pseudomonas migulae (New Substances Notification 19719)
- Pseudomonas putida CR30RNSLL(pADPTel) (New Substances Notification 10642)
- Rosenblumvirus phage CIP-212 targeting Staphylococcus aureus (New Substances Notification 22301)
- Unmodified Pseudomonas bacteriophage 1 and 2 (New Substances Notifications 22052 and 22053)
R
- Rhynchosporium secalis (New Substances Notification 16243)
- Rotavirus strain RIX4414 (New Substances Notification EAU-425)
- Rotavirus strains (New Substances Notifications EAU-308 to EAU-312)
S
- Saccharomyces cerevisiae expressing lactate dehydrogenase (LDH) from Rhizopus oryzae (New Substances Notification 21573)
- Saccharomyces cerevisiae strain containing a carboxy-lyase gene from a foreign organism, overexpressing a native transporter protein gene (New Substances Notification 22152)
- Saccharomyces cerevisiae strain ECMo01 (New Substances Notification EAU-288)
- Saccharomyces cerevisiae strain ML01 (New Substances Notification EAU-224)
- Saccharomyces species MBG5318 (New Substances Notification 21962)
- Saccharomyces species MeJi797 and yMHCT484 (New Substances Notifications 20433 and 20434)
- Saccharomyces species yMHCT484 (New Substances Notification 18967)
- Saccharomyces species YS219-A3, YS372-C8, YS392-F7, and YS344-D1 (New Substances Notifications 21838, 21840, 21841 and 21842)
- Genetically modified Atlantic salmon (Salmo salar L.) including the AquAdvantage® Salmon (New Substances Notification 19702)
- Cassie line of genetically modified Sus scrofa domestica (New Substances Notification 15676)
- Four lines of gene-edited Sus scrofa domesticus with deletion of the SRCR5 domain of the CD163 protein conferring resistance to porcine reproductive and respiratory virus (New Substances Notifications 22051, 22196, 22197 and 22198)
T
- Recombinant Human T-cells transduced with a non-replicative lentiviral vector expressing a chimeric antigen receptor binding the human B-cell cell surface proteins CD19 and CD22 (IMJ995) (New Substances Notification 21343)
- TG1050 (New Substances Notification 18146)
- Trichoderma longibrachiatum RM4-100 (New Substances Notification 6823)
- Trichoderma reesei 1391A (New Substances Notification 11017)
- Trichoderma reesei P210A (New Substances Notification 12961)
- Trichoderma reesei P345A (New Substances Notification 13912)
- Trichoderma reesei P59G (New Substances Notification 11909)
- Trichoderma strain P1640A (New Substances Notification 17140)
V
- Alphainfluenzavirus influenzae A/Croatia/10136RV/2023 X-425A (New Substances Notification 22279)
- Alphainfluenzavirus influenzae A/Victoria/4897/2022 IVR-238, A/California/122/2022 SAN-022, and B/Michigan/01/2021 (New Substances Notifications 22147, 22148 and 22149)
- Influenza virus cold-adapted B/Massachusetts/2/2012 (New Substances Notification EAU-760)
- Live Vaccinia Virus Acambis clone 2000 (New Substances Notification 21722)
- PROSTVAC-V (modified Vaccinia virus), PROSTAC-F (modified Fowlpox virus) and TBC-FPV (Fowlpox virus vector) (New Substances Notifications EAU-666, 667 and 668)
- Recombinant and replicative human Herpes Simplex Virus encoding human derived genes for FMS like tyrosine kinase 3 ligand, single chain interleukin-12, cluster of differentiation 40 agonist, and antibody to human cytotoxic T-lymphocyte associated protein 4 (JNJ-87704916) (New Substances Notification 22095)
- Recombinant, chimeric vesicular stomatitis virus (VSV) carrying the envelope glycoprotein of the visceral non-neurotropic WE-HPI strain of the lymphocytic choriomeningitis virus, and a codon optimized human CD80 gene fused to the Fc IgG1 heavy chain constant region (VSV-GP-CD80Fc) (New Substances Notification 21695)
