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New Substances Notification Advisory Note 2010-02

Research and Development Exemption for Organisms other than Micro-organisms

Guidance concerning the application of subsection 2(4) of the New Substances Notification Regulations (Organisms)


(PDF Version - 26 KB)

Preamble

This note assumes the reader is quite familiar with the New Substances Notification Regulations (Organisms) [the Regulations] and in particular with the exemption from notification for ‘higher’ organisms used in research.  As such, it is directed to research institutions using, typically but not exclusively, genetic modification or genetic engineering on organisms such as insects, mice, fish or livestock.  The note has been prepared to assist persons who intend to import or manufacture a living organism[1] that is (i) a new substance; (ii) an organism other than a microorganism; and (iii) a research and development substance, to meet their obligations under s 2(4) of the New Substances Notification Regulations (Organisms) [Regulations] of the Canadian Environmental Protection Act, 1999 (the Act).

If the requirements of s 2(4) cannot be satisfied, importers or manufacturers of research and development (R&D) organisms[2] other than microorganisms, are required to notify Environment Canada and provide the information set out in Schedule 5 of the Regulations at least 120 days before importing into or manufacturing in Canada.

Purpose

This note replaces Advisory Note 2002-01.  It has been prepared to assist importers and manufacturers of living organisms that are not micro-organisms to meet their obligations under the Regulations, including being aware of and in compliance with the exemption criteria for contained R&D organisms specified in subsection 2(4) of the Regulations. This advisory note provides administrative and technical guidance on this matter.

Adherence to the requirements of the Regulations is subject to the Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999.

Background

The Regulations came into force on August 31, 2005; these regulations replaced those originating in 1997. The Regulations prescribe the information that must be provided to the Minister of the Environment by persons intending to import or manufacture a “new” living organism. This information is used by Environment Canada and Health Canada to assess the living organism before it is imported into or manufactured in Canada to ensure that the environment, including biological diversity, and human life and health, are protected.

The Regulations implement certain provisions of Part 6 of the Act for new living organisms that are animate products of biotechnology.  “Biotechnology” is defined in section 3 of the Act as "the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms". The Domestic Substances List (DSL) is the sole basis for determining whether an organism is “new” for the purposes of the Law. For more information see the Guidelines for the Notification and Testing of New Substances: Organisms.

Note that these regulations are not limited in application to ‘genetically engineered’ animals; animals modified through other ‘science and engineering’ means (e.g. directed mutation), and those unmodified organisms used for applications involving science and engineering, may also be included.

Guidance concerning the application of subsection 2(4) of the Regulations

The Regulations prescribes conditions and circumstances under which the import or manufacture of a living organism is exempt from notification. Subsection 2(4) of the Regulations specifies the exemption criteria for organisms other than micro-organisms. A person intending to import or manufacture a R&D organism other than a micro-organism, is required to notify Environment Canada with the information set out in Schedule 5 of the Regulations at least 120 days prior to the import or manufacture unless the exemption criteria specified in subsection 2(4) of the Regulations are met.

Subsection 2(4) of the Regulations states:

“The regulations do not apply in respect of an organism, other than a micro-organism, that is a research and development organism and is imported to or manufactured in a facility from which there is no release into the environment of:

(a) the organism;
(b) the genetic material of the organism; or
(c) material from the organism involved in toxicity”.

The following provides guidance regarding the elements referred to in the above paragraph:

A “facility” refers to a structure (examples: fixed structure or building) in which the research and development organism is housed and may include a container (examples: cage, tank, box) in which the organism is transported or transferred from one facility to another for the purpose of disposal or for additional experimentation, provided the criteria in paragraphs 2(4) (a), (b) and (c) of the Regulations continue to be met.

(a) “the organism” refers to a living organism that is not a micro-organism (examples: a livestock animal, a fish, a propagule, a fertilized egg or embryo).

(b) “the genetic material of the organism”refers to nucleic acids that:

i) are contained within living cells capable of surviving long enough in the environment to come into contact with a sexually compatible cell that may result in the reproduction or propagation of the organism or a hybrid (examples: wind- or water-dispersed gametes such as pollen or those from bivalves);

ii) whether contained within living or dead cells, may autonomously increase the mobilization of a novel combination of genetic material or that have been genetically engineered to increase their potential for mobilization (example: use of viral vectors that have not been attenuated, or the incorporation of a construct that includes transposons which contain their associated functional transposase gene); or

iii) whether contained within living or dead cells, are of unknown function and that are associated with a micro-organism strain known to be pathogenic[3], including a virus.

The exemption criterion for no release of genetic material from the organism into the environment can be met by effectively degrading the nucleic acids referred to above to levels below detection prior to release. An effective nucleic acid degradation treatment should result in reducing target genes, such as transgenes, to below detectable levels when using validated detection techniques[4] such as polymerase chain reaction with transgene specific or other diagnostic primers. These nucleic acids may be found in tissues derived from the organism, carcasses and wastes (including manure). Such treatment could be physical, chemical, biological or any combination of treatments.

Proponents should be using established and tested protocols to achieve effective nucleic acid degradation. Proponents should be able to demonstrate the efficacy and the consistency of use of these protocols to ensure successful containment. Efficacy may be demonstrated through periodic testing of wastes while consistency of use may be demonstrated through accurate record keeping of waste management practices.

All other nucleic acids that do not meet the criteria described under b(i), (ii) and (iii) do not require full containment and may be disposed of in compliance with municipal waste disposal standards and practices.

(c) “material from the organism involved in toxicity” refers to a substance that is produced by the organism at a concentration or in a quantity that is greater than that known to be produced naturally by the organism where the substance is:

i) released in an amount capable of causing death or harm when introduced into or absorbed by another organism (examples: prion, botulinum toxin, ricin); or

ii) released in an amount capable of interfering with biological processes when introduced into or absorbed by other organisms and capable of causing ecological effects at the population level (example: production of pheromone-like compounds in a genetically engineered organism that if released in sufficient concentration could interfere with the natural breeding behaviour of insects).

The exemption criterion for no release into the environment of material from the organism involved in toxicity can be met by the effective treatment of effluents or waste such that the entry or release of the material into the environment and its subsequent adverse effects are controlled. The concentration and/or quantity released should not result in acute or chronic toxicity above that which is naturally being introduced into the environment. Such treatment could be physical, chemical, biological or any combination of treatments.

Proponents should be using established or tested protocols to achieve effective treatment of effluents and wastes. Proponents should also be able to demonstrate the efficacy and the consistency of use of these protocols to ensure successful containment. Efficacy may be demonstrated through periodic testing of wastes while consistency of use may be demonstrated through accurate record keeping of waste management practices.

Although a given disposal measure of a R&D organism may meet the exemption criterion under the NSNR (Organisms), all disposal should be in compliance with all relevant Acts and Regulations. For example, disposal of carcasses of R&D animals via the food and/or feed chains is not permitted unless proper authorizations have been issued under the Food and Drugs Act and/or the Feeds Act.

Contact Information

Substances Management Information Line
Program Development and Engagement Division
Environment Canada
Fontaine Building, 8th Floor
Gatineau QC K1A 0H3

Telephone: (800) 567-1999 (Toll Free in Canada); (819) 953-7156 (Outside of Canada)
Facsimile: (819) 953-7155
E-mail: substances@ec.gc.ca

For further information or documentation regarding the Regulations, please visit the New Substances Website.

Original signed by

Mark Burgham
A/Executive Director
Program Development and Engagement Division
Envrionment Canada

Signed on:  April 26, 2010


Footnotes

[1] As defined in section 104 of the Act,"living organism" means a substance that is an animate product of biotechnology.
[2] As defined in subsection 1(1) of the Regulations, “Research and development organism” means an organism that is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following:

(a) to create or improve a product or process;
(b) to determine the technical viability or performance characteristics of a product or process; or
(c)to evaluate the organism prior to its commercialization, by pilot plant trials, production trials, including scale-up, or customer plant trials so that technical specifications can be modified in response to the performance requirements of potential customers.

As defined in subsection 1(1) of the Regulations, “Test marketing”, in respect of a product, means the exploration of its market capability in a competitive situation in which the creation or improvement of the product is not the primary objective.
[3] These include, but are not limited to, those micro-organisms that are listed on various pathogen lists such as the Disease Agent Information - PHAC: Pathogen Safety Data Sheets and Risk Assessment.
[4] It remains the proponent’s responsibility to demonstrate the efficacy and appropriateness of the detection methods used in relation to potential risks associated with the target genetic material.