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Safety Assessment Process for Novel Foods and Agricultural Products of Biotechnology

How are biotechnology-derived products assessed?

Both Health Canada and the CFIA share responsibility for the safety assessments and final approval of new products of biotechnology. Under the Food and Drugs Act, Health Canada conducts a thorough assessment for human health of each new product before it can be sold in Canada. The Canadian Food Inspection Agency also has responsibility for the regulation of products derive from biotechnology including plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics.

Before a new agricultural or food product can be produced and marketed, it is subjected to thorough safety assessments to protect humans, animals, and the environment. The Canadian Food Inspection Agency (CFIA) is responsible for the regulation of agricultural products derived through biotechnology, including plants, animal feeds, fertilizers, and veterinary biologics. The Agency also authorizes and oversees import permits, confined trials, unconfined release and variety registration.

For crops developed through biotechnology, CFIA scientists examine the scientific data submitted by developers who are hoping to have their product approved. There are strict regulations that dictate what data has to be submitted, and how CFIA scientists must examine the data. The Government based these regulations on principles developed through technical and broad-based consultations with a wide range of Canadians. They also based them on consultations carried out by the United Nations World Health Organization (WHO) and Food and Agriculture Organization (FAO), and the Organisation for Economic Co-operation and Development (OECD).

What kinds of risk does the CFIA consider?


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 "Novelty" and Plants with Novel Traits".

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 "Novel Feeds - Frequently Asked Questions",

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.

Like other government regulators, CFIA scientists use data submitted by the companies seeking approval of their products. This data must be of the same high quality that is required by scientific journals for publication and peer review. The data are thoroughly analysed, as are the rules used to ensure the validity of results. If the data is not scientifically sound, if it is incomplete, or if it is inadequate, government regulators require that the product developer address these problems before the assessment can continue.

Canada is not unique in using this method to examine industry data. These "paper reviews" are considered to be a standard scientific method of evaluation, and are used by regulators around the world. The CFIA can also contract studies or convene groups of experts to gain further advice about specific types of products including research about their potential interaction with the environment. For example, the CFIA has had studies done about corn products derived through biotechnology.

In addition to the information provided by applicants, government regulators use available peer-reviewed scientific literature and expert advice from the scientific community. This expert advice can be obtained in a number of ways, including:

  • establishing advisory panels with a specific focus or mandate from the CFIA;
  • the Agency's commission of regulatory research studies by academia or scientists in government research institutions; or
  • CFIA technical workshops involving a diverse range of stakeholders including academia, industry, agricultural or agronomic experts from Canada or other countries.

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. 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 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.