New substances notification of assessment: trichoderma strain P1640A
What is it?
- Trichoderma strain P1640A is a genetically modified strain that was engineered to produce increased levels of cellulase/hemicellulase with xylanase enzymes.
- Trichoderma species are common soil saprophytic fungi that can be found in many climatic zones, and are used industrially in the production of cellulases and hemicellulases.
How is it used?
- The notified strain of Trichoderma strain P1640A will be used for the production of cellulase/hemicellulase enzyme mixture consisting xylanases and will be produced in a contained facility.
Why did the Government of Canada assess it?
- A micro-organism that is not on the Domestic Substances List (DSL) and is not subject to federal legislation listed in Schedule 4 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), is considered "new" and before it is manufactured in or imported into Canada, the Government must assess its potential to harm human health and the environment under the New Substances Notifications Regulations (Organisms), as required by Section 106 of CEPA 1999. Trichoderma strain P1640A is not on the DSL.
- The Government of Canada conducted an assessment of Trichoderma strain P1640A because Novozymes Canadasubmitted a notification in order to manufacture this new micro-organism into Canada for use in the production of cellulase/hemicellulase enzyme mixture.
How is it released to the environment?
- Trichoderma strain P1640A will be used only within one contained facility that meets the standards for Good Large Scale Practice (GLSP) as defined in Appendix K of the US NIH Guidelines for Research Involving Recombinant DNA Molecules for large scale operations, April 2002. Environmental release of the notified strain of Trichoderma strain P1640A is therefore not expected.
How are Canadians exposed to it?
- Based on the intended use in a contained facility, the general population in Canada is not expected to be exposed to Trichoderma strain P1640A.
What are the results of the assessment?
- The Government of Canada has conducted a science-based risk assessment of Trichoderma strain P1640A.
- Risk assessments address potential for harm to the general population in Canada (not including workplace exposures) and the environment.
- Trichoderma strain P1640A does not cause disease in healthy plants, animals or humans.
- Containment measures are in place to prevent the dispersal and unintentional spread of the micro-organisms.
- Trichoderma strain P1640A is therefore not considered to be harmful to human health or the environment based on the intended use, and the Government of Canada has concluded that Trichoderma strain P1640A is not entering the environment in a quantity or under conditions that constitute a danger to the environment or humans.
What is the Government of Canada doing?
- Based on the conclusion of the risk assessment, the Government of Canada will take no further action on the production of Trichoderma strain P1640A in the contained facility.
