Brief overview of the New Substances Program for Aquatic Living Organisms

The 1993 Federal Biotechnology Regulatory Framework outlines how departments will regulate animate products of biotechnology within their area of expertise.  The Canadian Environmental Protection Act, 1999 (CEPA 1999), administered by Environment Canada and Health Canada, is the key authority for the government to ensure that all new products of biotechnology are assessed for their potential to harm the environment and human health prior to their import, manufacture or sale in Canada. The New Substances Notification Regulations (Organisms) [NSNR (Organisms)] under CEPA 1999 prescribe the information that must be provided to Environment Canada prior to the proposed import to or manufacture in Canada of a new organism that is an animate product of biotechnology.

The NSNR (Organisms) apply to new living organisms that are animate products of biotechnology, including aquatic organisms. The Departments of Fisheries and Oceans Canada (DFO), Environment Canada (EC) and Health Canada (HC) signed a Memorandum of Understanding in May 2004 respecting the implementation of the NSNR (Organisms) for certain aquatic living organisms. As such, DFO will assist in administering the NSNR (Organisms) and conduct risk assessments for these organisms.

Aquatic living organisms that are subject to the NSNR (Organisms) include living aquatic animals and plants that are “new” and that are products of “biotechnology”. The Domestic Substances List (DSL) is the sole basis for determining whether a substance, including an aquatic living organism, is “new” for the purposes of CEPA 1999. Aquatic living organisms not appearing on the DSL are considered to be new and are subject to notification under the New Substances Notification Regulations (Organisms). Aquatic living organisms on the DSL do not require notification unless they are proposed for a Significant New Activity (SNAc) as indicated on the DSL.

“Biotechnology” is defined in the CEPA 1999 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”. Examples of aquatic living organisms that are animate products of biotechnology that could be subject to the NSNR (Organisms) include:

• Genetically modified plants and animals (including vertebrates and invertebrates)
   
• Interspecies hybrids
   
• Naturally occurring, exotic plants and animals used in biotechnology applications such as bio-remediation and industrial enzyme production.

Aquatic animal strains that are indigenous to Canada including Canadian wildlife species and their progeny produced through traditional breeding, artificial insemination or surrogate hosting are not subject to the NSNR (Organisms). In addition, aquatic living organisms that are research and development organisms^[1] and that meet the containment criteria specified in subsection 2(4) of the NSNR (Organisms) are not subject to the NSNR (Organisms).

The information prescribed in Schedule 5 of the NSNR (Organisms) must be provided at least 120 days prior to the proposed import or manufacture of the aquatic living organism. This information is used in the conduct of a risk assessment to determine whether the organism is “toxic”^[2] as defined in CEPA 1999. Where it is suspected that an organism is toxic, Environment Canada and Health Canada may impose control measures to minimize risk to the environment or human health, including:

• controls on import and manufacture,
   
• the prohibition of import and manufacture, or
   
• prohibition pending submission and assessment of additional information determined to be required by the Departments.

When it is suspected that a significant new activity (SNAc) in relation to an aquatic living organism may result in the organism becoming toxic, a SNAc Notice may be issued for the organism to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import or use the organism for activities not specified by the notice. The additional information will allow for the assessment of potential environmental and human health risks associated with the new activities.

New substances for which control measures are taken or SNAc Notices are issued are published in the Canada Gazette.

[1] "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.

[2] In accordance with section 64 of CEPA 1999, a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

(a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

(b) constitute or may constitute a danger to the environment on which life depends; or

(c) constitute or may constitute a danger in Canada to human life or health.