The Risk Assessment determines whether there is a risk to workers’ health from using a plant or equipment in the workplace. In Canada, novel plant products derived through biotechnology must be kept in containment (such as in laboratories or greenhouses) during the research and development stage. Before these products are authorized for use as food, livestock feed, or for environmental release (for example, cultivation), they are required to undergo rigorous, pre-market science-based safety assessments. In addition to evaluating the safety of plant products that are proposed for use or release in Canada, the CFIA and Health Canada address cases where unauthorized plant products are found in the Canadian food or feed marketplace or in the environment.
If an unauthorized plant product is found, all available information regarding the nature of the product, and the scale and scope of the unauthorized occurrence, is gathered.
Basic biological information about the plant species in Canada is important when considering environmental risks.
It is important to note that risk assessment and management may occur simultaneously or one after another. The ultimate goal of the risk management steps taken by the CFIA is to address the risk to the environment and food or feed supply, while using the most appropriate level of regulatory intervention, so the situation is returned to compliance. They cannot be planted outside of containment unless they are in confined research field trials authorized and inspected by the CFIA. The environmental safety and livestock feed safety assessments are performed by the CFIA, while Health Canada is responsible for assessing food safety. The CFIA then determines which risk management and compliance actions are required to mitigate the risk.
The process of risk assessment is rigorous, yet flexible enough to adapt to the particulars of each case.
Safety assessments are aimed at considering products for regulatory authorization, while risk assessments address specific instances when unauthorized products are found in the Canadian environment or marketplace.
Similarly, if no hazards have been identified, the risk will be low regardless of the level of exposure. In the case of environmental safety, the CFIA's PBO asks the CFIA Plant and Biotechnology Risk Assessment (PBRA) Unit for an assessment. Less effective, or ineffective, against space- and overlook the prospective difficulties of heating boiler plant. The Risk Assessment determines whether there is a risk to employees’ health from using a plant or equipment in the workplace.


Under Canadian legislation, the presence of an unauthorized plant product in the marketplace or environment constitutes regulatory non-compliance.
The pertinent government departments responsible for risk assessment collaborate and share information. Risk management also includes follow-up activities confirming that the situation is returning to compliance. The CFIA develops the most appropriate risk management strategy to deal with the presence of unauthorized plant products of biotechnology, taking into consideration relevant information from other agencies and departments as deemed appropriate for the issue. For example, a food safety assessment considers the potential for a novel food to replace traditional counterparts and, therefore, requires nutritional data for a novel food to be authorized. In addition, its outcomes are considered when determining what risk management options are appropriate. It should also be noted that risk assessment, risk management and sometimes risk communication are often considered to be part of a broader overall framework called "risk analysis".
This fact sheet describes the current Canadian approach to managing cases of unauthorized presence of plants (and their products) derived through biotechnology in food, livestock feed, and the environment. The general approach taken when dealing with occurrences of unauthorized plant products, including those derived through biotechnology, is summarized in Figure 1. A key difference between "safety assessments" and "risk assessments" is determined by the situations where these processes are used. These occurrences are rare and, in cases to date, the CFIA and Health Canada's assessments have not identified health or environmental safety concerns associated with these incidents. In contrast, "risk assessment" is the term used for assessments of occurrences of unauthorized products.
A risk assessment would not typically consider nutritional content if the presence of an unauthorized product in the marketplace is deemed to be at a low level. The risk management actions used can be revisited and altered on the basis of new information. The fact sheet highlights the basic principles that are followed and the general steps that are taken during risk assessment and risk management of such occurrences.
3 If appropriate, the Consumer Protection Division will evaluate the risk of economic fraud. Because the questions asked in risk and safety assessments are different, the types of information required may be different.


For example, immediate control measures may be implemented before a risk assessment is completed. It should be noted that the term "risk assessment" may be used by Canadian agencies in other contexts beyond the scope of this document - for example, "risk assessment" may be applied to organisms that are not unauthorized products, and "risk assessment" may cover types of risks beyond health and safety risks (for example, trade risks).
These assessments are intended to determine the risk to the Canadian public, environment, and livestock. Note: In this document the term "safety assessment" is used to refer to assessments aimed at considering products for regulatory approval. The CFIA has a range of tools available to deal with non-compliance of unauthorized plant products. The general risk assessment framework applied to unauthorized plant products, including those derived through biotechnology, involves identifying potential hazards and potential routes of exposure. Risk management involves developing and implementing strategies to manage any potential risks identified. The decisions made by the CFIA are based on conclusions of risk assessments as well as on considerations of other legitimate factors, with the primary objective of protecting the safety of the Canadian food and feed supply and the environment. These two components determine the level of risk that the presence of an unauthorized product represents (that is, risk = hazard x exposure).
The CFIA also performs the inspection and enforcement activities related to environmental release as well as food and feed use of plant products derived through biotechnology.
The scope of regulatory action taken in response to an instance of non-compliance is based on the conclusions of the risk assessment(s) and is influenced by other legitimate factors (see Step 2 below, "Risk Management"). Although the focus of this document is on unauthorized plant products derived through biotechnology, it is important to keep in mind that the CFIA applies the same basic principles in dealing with the presence of all unauthorized products. In the case of food safety, the CFIA Food Safety Division will request the Health Canada carry out a health risk assessment.



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