Risk assessment will take place at many different points in the development pathway, and will be conducted by:
Product developers: The World Health Organization has recommended that developers of a gene drive technologies should conduct a risk assessment before each new testing phase or expansion of test releases, with the aim of gathering the most informative data in support of creating a safe and effective product. Developers might conduct risk assessment themselves, or may commission an external risk assessment to be conducted by experts with no vested interest in the success of the product. The results of these risk assessments will help developers understand what data they need to collect, and what management plans they need to put in place to reduce any risks to an acceptable level. This information will be helpful in preparing applications to regulatory authorities.
Regulators: National regulatory authorities will conduct a risk assessment as part of their review of applications submitted by developers. For regulators, the types of risks that are considered are circumscribed by the legal mandates and authorities granted to the agencies charged with the risk assessment. The scope of jurisdiction for these agencies is defined by national laws, and their enabling regulations and policies. Therefore, the scope of the risk analysis for regulators is not open-ended, and is also under legally prescribed timeframes for completion.
For more information: https://www.who.int/publications/i/item/9789240025233 https://www.ajtmh.org/view/journals/tpmd/98/6_Suppl/article-p1.xml