General risk assessment/risk management framework for unauthorized plant products derived through biotechnology

This flowchart shows the steps for general risk assessment/risk management framework for unauthorized plant products derived through biotechnology.

1. The CFIA is informed of occurrence, or potential occurrences, of an unauthorized product1

2. Appropriate group(s) within the CFIA contacted: Plant Biosafety Office (PBO), Animal Feed Division, Food Safety Division and Consumer Protection Division - information gathering2

3. Risk assessments (RA) commissioned as necessary. In the case of food safety, the CFIA Food Safety Division will request the Health Canada carry out a health risk assessment. In the case of environmental safety, the CFIA's PBO asks the CFIA Plant and Biotechnology Risk Assessment (PBRA) Unit for an assessment. In the case of feed safety, the CFIA Animal Feed Division does the assessment - information gathering.3

4. RA: Identification and characterization of potential hazards (to the environment, food or feed) - Additional information gathered or made available as appropriate

5. RA: Characterization of potential exposure (potential routes, likelihood of exposure and amounts) - Additional information gathered or made available as appropriate

6. RA: Determination of potential risk (hazard x exposure) - Additional information gathered or made available as appropriate

7. Risk management (decision making and implementation) - Evaluation of effectiveness of risk management decisions

8. The situation is brought to compliance - Evaluation of effectiveness of risk management decision

1 The originator of the information may vary:  the CFIA, provincial governments, Health Canada, governments of other countries, developers, or other stakeholders.

2 Other relevant government departments may also be contacted depending on the case.

3 If appropriate, the Consumer Protection Division will evaluate the risk of economic fraud.