The outcomes of a risk assessment are often presented in the form of a written report prepared by the risk assessor(s).
The report is primarily intended to assist the decision makers in making informed decisions regarding the safe use of an LMO. Presenting the results of a risk assessment could be categorized as a form of risk communication. As in any form of communication, risk assessors should be mindful of the intended recipients, which in addition to decision makers may also include regulators, risk managers, other risk assessors and the general public amongst others.
It is important that the report is presented in a well-structured form, which not only facilitates the deliberations of decision makers, but also allows for an easier exchange of information and experience. The context and scope of the risk assessment should be clearly explained as other institutions (e.g. in the same or in different countries) may have an interest in understanding how the risk of a particular LMO was assessed.
With regard to sharing of information, a Party to the Protocol is required to submit to the Biosafety-Clearing House (BCH) all “summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology” (Article 20). This will include all risk assessments generated to support decisions regarding LMOs for intentional introduction into the environment (Articles 8, 10 and 13) or for direct use as food or feed, or for processing (Article 11) whether they are triggered by a transboundary movement or by an internal request.
The required contents and format of a risk assessment report are generally defined by the Competent National Authority(ies) that have the responsibility to make decisions on the LMO(s) in the context of the national biosafety framework.
