Plants > Biotechnology / PNTs  

The Scope of CFIA Safety Assessments for
Biotechnology-Derived Products:  What’s In and What’s Out?

What is the primary focus of the CFIA’s safety assessments of biotechnology-derived products?

The Canadian Food Inspection Agency (CFIA) is mandated to evaluate the safety of novel agricultural products, including those derived through biotechnology. The word "safety" applies here to the product’s impact on human health, animal health, or the environment. The primary methodology used to assess this is the use of the natural sciences.

Depending on its intended use, CFIA evaluators must determine the following for each novel agricultural product:

• potential impact on human health (i.e. via consumption of animal products or occupational or bystander exposure)
• potential impact on animal health
• potential impact on the environment

An agricultural product may be considered "novel" if it has:

• a new trait(s) or characteristic(s), or
• a changed trait(s) or characteristic(s), or
• a new use

In the case of plant and soil supplements, products that have not yet been registered in Canada are also considered "novel".

The criteria for novelty are specific to the product. For example, novel livestock feeds, novel plant and soil supplements, and plants with novel traits are all defined in the appropriate acts and regulations.

The CFIA applies the word "novelty" or "novel trait" to some of the products it regulates, such as plants, livestock feeds, and plant and soil supplements. This includes the more well-known genetically engineered plants. This focus on novelty and novel traits, as opposed to selected novel methods of production, leads the CFIA to assess the safety of a broader array of products than other countries. For more information, see the factsheet called, "Biotechnology? Modern Biotechnology? GM? GMO? GE? PNTs? What do these terms mean?" and "Novelty and Plants with Novel Traits".

What kinds of risk does the CFIA consider?

Plants

For plants, a CFIA environmental safety assessment examines five broad categories of possible impacts of a plant with a novel trait (PNT). These are:

• the potential of the plant to become a weed or to be invasive of natural habitats
• the potential for gene flow to wild relatives
• the potential for a plant to become a plant pest
• the potential impact of a plant or its gene products on non-target species
• the potential impact on biodiversity

In other words, the assessment looks at the effects of the PNT, both in its agricultural and natural environments, as well as the effects of the possible transfer of the novel trait into another organism. Whether or not foods produced using plants with novel traits are safe for human health is determined by Health Canada, in close partnership with the CFIA. The CFIA‘s safety assessments match or exceed the requirements under the Cartagena Protocol on Biosafety.

For more information on these assessments, see the factsheet "Regulating Agricultural Biotechnology in Canada: Environmental Questions".

Livestock Feed

A livestock feed safety assessment considers the safety of a novel feed to:

• livestock
• humans, through exposure to the feed (for example, to workers or by-standers) or consumption of animal products
• the environment

For more information, please refer to the factsheet, "Genetically Engineered Livestock Feeds Derived from Plants: Assessment and Safety".

Veterinary Biologics

Before they can be licensed, veterinary biologics (such as animal vaccines, toxoids, antisera, and diagnostic kits) are assessed for safety. The assessments are based on laboratory safety testing and limited field trials on the target animal species.

In addition, a novel vaccine undergoes an environmental assessment. This includes the following:

• characterization of the vaccine
• documentation of animal, human, and environmental safety considerations
• assessment of risks
• proposed strategies for monitoring field use of the vaccine

After licensing, the CFIA reviews results of safety tests that the manufacturer conducts on every serial or batch of a veterinary biologic. See the Veterinary Biologics section of the CFIA web site for more details.

Plant and Soil Supplements

Novel plant and soil supplements are reviewed by the CFIA’s Fertilizer Section. Most of the biotechnology-derived novel supplements are microorganisms. The CFIA does safety assessments on domestic and imported products in terms of their safety to human health, plants, animals and the environment. These assessments examine the following possible impacts of novel supplements:

• the potential of the microorganism to become invasive
• the potential for gene flow to other organisms
• the potential for the microorganism to become a pest or a pathogen
• the potential impact of the microorganism or its gene products on non-target species
• the potential impact on biodiversity

In addition to safety assessments, novel agricultural products are evaluated for their performance and quality, according to prescribed standards.

Why are CFIA product safety assessments "science-based"?

The key feature of a good safety assessment is that it is reproducible—conclusions should follow from evidence and should not depend on who is doing the assessment. The methods used in the natural sciences provide three features serving this goal.

First, the most basic evidence in the natural sciences is empirical, which means that scientists gather important information by directly observing nature.

Second, it is a custom in the natural sciences to standardize judgments and, thus, render these decisions reproducible.

Third, it is common in the sciences for data to be reviewed by scientists other than those who produced the data. This is done so that quality standards are followed and to allow for shared judgments of difficult issues—this co-operative approach also serves the goal of the reproducibility of regulatory decisions.

What is excluded from CFIA product safety assessments?

Safety assessments at the CFIA do not target any non-physical risks, for example, risks to specific markets, the economy at large, or the social and ethical fabric of Canadian communities. Because these risks are of interest to Canadians, the Canadian Biotechnology Advisory Committee (CBAC) was established in September 1999 by the Government of Canada as part of its Canadian Biotechnology Strategy. The CBAC was formed to provide expert advice to the federal government on ethical, social, regulatory, economic, scientific, environmental and health aspects of biotechnology.

Similarly, the CFIA’s safety assessments do not consider issues such as the risks of new products to the reputation of the CFIA or the risk of being sued.

What is the reason behind the choice of this scope?

There are at least three reasons why the CFIA’s scope is defined this way within the broader regulatory framework implemented by the Government of Canada. The first two reasons relate to the approach of using a science-based assessment process; the third has to do with an approach to regulation more broadly.

The first reason lies in the strength of the natural sciences to yield reproducible results. It is in everybody’s interest that safety assessments are determined by evidence rather than partisan interests.

The second reason lies in the reality of modern trade agreements. Within these agreements, products may be rejected based on a unacceptable risk to humans or the environment, but a rejection based on socio-economic risks may be interpreted by trade partners to represent protectionism.

The third reason is the benefit of clearly separating the regulation and promotion of a new product or technology. Regulatory agencies that assess biotechnology-derived products need to maintain an objective position. The Canadian Food Inspection Agency Act separated the CFIA from any part of the Government involved in research and development of biotechnology products. In addition, the CFIA is separated from other arms of the Government that are responsible for trade promotion, market information, and policy-related issues such as farm income and rural development.

What about the products that fall outside the CFIA scope?

Under the Canadian Environmental Protection Act, 1999 Environment Canada can take action if a product falls outside of the CFIA’s scope, and is not covered under other federal legislation.

What about social aspects?

The 1993 Federal Regulatory Framework for Biotechnology requires departments and agencies to consider "the prosperity and well being of Canadians" in the development of regulations, including provisions for public input into the development of these regulations. As a result, social and economic impacts are considered when decisions to establish regulations are made; this includes an analysis of immediate and long-term impacts. More information on this can be found in the document Response of the Federal Departments and Agencies to the Petition Filed May 9, 2000 by the Sierra Legal Defence Fund under the Auditor General Act: Review of Federal Laws, Regulations and Policies on Genetically Modified Organisms.

Industry Canada,  Agriculture and Agri-Food Canada (AAFC), and Natural Resources Canada (NRCan) provide broad advice regarding biotechnology regulatory policy development. For example, AAFC may evaluate the socio-economic impacts of novel agricultural products and technologies, and develop policies in this sphere regarding the need for regulations. These policies in turn influence regulations that are being developed, but not individual product decisions.