The CFIA Assessment Process and What is Expected from Industry

This information also applies to the use of biotechnology in feeds, fertilizers and veterinary biologics

How are biotechnology-derived products assessed?

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).

Before being approved, biotechnology-derived plants must go through a series of assessment steps:

• an environmental review for field trials
• a second environmental review prior to commercialization
• a livestock feed safety review
• a food safety review
• variety registration (for most field crops)

Companies submitting a novel plant for approval must provide CFIA scientists with detailed information about the trait that has been introduced into the plant, the method used to introduce that trait, and any risks of adverse environmental effects that could result from the release of the plant into the environment. These risks include:

• the potential for the plant to become a weed
• the potential for gene flow to wild relatives
• the potential for the plant to become a plant pest
• the potential to affect non-target organisms
• the potential impact on biodiversity.

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.

Do CFIA scientists deal directly with industry applicants?

CFIA scientists are often contacted by industry representatives for information and explanations of assessment requirements. As part of the assessment process, the CFIA will discuss the reasons why company data might be rejected or need to be clarified.

For more detailed information on environmental assessments, please refer to the CFIA's Plant Biosafety Office. The CFIA's Feeds Section is responsible for safety assessments of livestock feeds and Health Canada is responsible for food safety assessments.

What qualifies CFIA scientists to conduct these assessments?

There is a wide range of expertise available within the CFIA to evaluate new biotechnology-derived products. CFIA personnel, many with post graduate degrees, include animal nutritionists, ecologists, entomologists, toxicologists, veterinarians, and molecular and plant biologists. With a combination of expertise like this, the CFIA is in a position to rigorously review these new products.

We are committed to maintaining the highest scientific standards at the CFIA. We strive to ensure that our assessments keep pace with new scientific discoveries. The CFIA also participates in international organizations such as the WHO, FAO and OECD. By participating in these groups, we share expertise in developing ways to assess new products of biotechnology, and we assure that Canada's science capacity is among the best in the world.