Preface

In Canada and the United States (U.S.), the regulation of genetically modified (GM) crops, livestock feeds and human foods, shares many similarities: both countries have a coordinated approach whereby regulatory responsibility is shared by several agencies; risk assessments are based on sound science; and each regulated product is assessed on a case-by-case basis.

At the heart of the risk assessment process is the principle that GM foods or plants can be compared with traditional counterparts that have an established history of safe use, and that this comparison can be based on an examination of the same types of risk factors for both (e.g., toxins, potential allergens, weediness, pest potential, etc). The objective is to determine if the novel plant or food presents any new or greater risks in comparison with its traditional counterpart, or whether it can be used interchangeably with its traditional counterpart without affecting the health or nutritional status of consumers, or the environment is which it is grown. The goal is not to establish an absolute level of safety, but rather the relative safety of the new product such that there is a reasonable certainty that no harm will result from intended uses under the anticipated conditions of production, processing and consumption. For example, a transgenic insect- and/or virus-resistant potato is first and foremost a potato, and the goal is to evaluate what, if any, additional risks to human health or impacts on the agro-ecosystem may result from the incorporation of these new traits. This comparative principle, whereby the plant or food being assessed is compared with one that has an accepted level of safety, is often expressed in the concept of "substantial equivalence".

The objective of this module is to provide basic information on the regulatory approaches taken by both Canada and the U.S., the roles and responsibilities of the different regulatory agencies, and access to specific regulatory guidelines and policy documents.