Suggestions on how to apply international safety testing guidelines for genetically modified organisms
Summary of recommendations Recommendation 1: The regulatory review process should begin with the participation of all stakeholders, from industry (not just the applicant’s industry), civil society and government and seek a consensus endorsement in the scope and nature of the risk assessment. The stakeholder engagement should not begin with an evaluation of the outcome of a risk assessment. Recommendation 2: A scientific risk assessment should be based on scientific information that is available for review and verifiable (through independent testing) by qualified scientists who have reliable career independence from the commercial incentives pervading both public and private research. Recommendation 3: The regulatory review process should follow that outlined in the Flowchart to the Roadmap for risk assessment for the CPB, with particular emphasis on articulating and addressing uncertainty in the assessment and on an integrated approach that builds confidence in the assessment as it progresses. Recommendation Four: The regulator should reduce uncertainty in the industry about the standards required in the risk assessment process. The most straightforward approach is to establish the minimum expectation that the developer will conduct the risk assessment by addressing each step of the procedures in relevant international guidance documents. In establishing this standard, the regulator should expect a response to every paragraph of the CAC guidelines (and any other chosen risk assessment procedures) rather than picking and choosing post hoc which CAC recommendations to pursue. Recommendation Five: The regulator should review and address all data relevant to the outcome of the risk assessment, regardless of whether the data was obtained for the purpose of the risk assessment. Recommendation Six: Recommendations 1-5 should be completed before approving field trials or releases into the environment, or approval for use of the product as food.
SubjectsField of Research::06 - Biological Sciences::0604 - Genetics::060499 - Genetics not elsewhere classified
- Science: Reports