Risk Assessment
Risk assessment is a safety check that is carried out before a new product is used. It looks for possible hazards and determines whether these are ‘likely’ to occur, or ‘very unlikely’ to occur. If the benefits of the new product are large enough to warrant some risk, then the risk assessors look for ways to manage the risk, so that it will be less likely to happen. If, after careful assessment, the risk is considered to be too great, then the new product is not approved for use. If the risk is ‘unlikely’ and can be managed, then the product is approved so that people can enjoy the benefits it offers.
Separate assessments and decisions are made for each new organism, because the potential hazards can be different. For this reason it is not possible for regulators or scientists to say that all genetically modified organisms are safe. A risk assessment enables a safety decision to be made on each new organism and the products it produces.
Risk assessments are carried out by the developers of new products. For some products, like genetically modified crops, governments carry out an independent assessment and give approvals for the use of new GM products. For living organisms that will be planted, grazed or released into the environment, an environmental risk assessment is carried out. If the product will enter the food or feed chain, then a food safety assessment is also carried out. These risk assessments inform decisions on whether or not to proceed with the release and use of modified plants, animals and microbes.
Resources
- Aspects considered in environmental safety assessments, GMO Compass
Outline: Are genetically modified plants a threat to the environment? Up until now, genetically modified crops have not caused environmental problems. But each new genetically modified plant needs to be closely examined to find out if negative impacts on the environment could be possible down the road. What is taken into consideration? This site presents the most important areas of research. Click here
- Example of an environmental risk assessment
Outline: This teaching module was developed as a tool for providing regulators with practical training in the safety assessment of transgenic plants. The concepts of risk assessment discussed in the text do not reflect any one country's regulatory approach, but are modelled after international consensus documents such as those produced by the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations. In order to provide some indication of the type of data usually presented in support of a safety evaluation, a case study using genetically engineered maize (Zea mays) event MON 810 and its progeny is used. Click here
- Aspects considered in human health assessments, GMO Compass
Outline: Foods made from genetically modified plants must be considered safe – otherwise they would not have been authorised. All GM products are tested to see if they could trigger allergies or contain other substances that could possibly be dangerous to human health. This site reviews important components of human safety reviews. Click here
- Example of a food safety risk assessment
Outline: In order to provide some insight into the type of data usually presented in support of a novel food evaluation, a case study of genetically engineered soybean (Glycine max) event GTS 40-3-2 and its progeny has been developed. The content of the study includes excerpts from applications for food safety assessment submitted to regulatory authorities in Canada, the United Kingdom (UK), and the United States (U.S.). Click here
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