Experts who have previously served the Organization for Economic Cooperation and Development (OECD) are proposing to update the Recommendation on Recombinant DNA Safety Considerations of 1986 to make it more suitable for the modern era of biotechnology.
In an article published by Trends in Biotechnology, the experts presented their suggestions on how to update the Recommendation to take into account the accomplishments made by modern biotechnology since 1986. They emphasized that there is a need for mutual understanding among nations and their respective regulatory approaches towards genome editing. They also stated that the Recommendation remains an important legal instrument and should be more widely known, especially to aspiring OECD candidates who intend to be compliant with the organization’s standards.
To begin with, the experts recommended that the Recommendation be renamed as Safety Considerations for Protocols of Modern Biotechnology: Applications in the Environment, Agriculture, and Food/Feed Production. Its Section I will focus on sharing experiences with rDNA organisms to harmonize approaches to rDNA techniques with biosafety regulations while still allowing the biotechnological developments to expand. Section II will highlight the validity of the principle of good industrial large-scale practice used for handling industrial microbial strains derived from modern biotechnology. Section III, which deals on agricultural and environmental applications, recommends that risk/safety assessment should take into account the knowledge gained over the years about the environmental and human health effects of living organisms. Lastly, the authors recognize that a regular review and updating of the Recommendation can help give rise to innovative safety assessment methodologies to possibly address challenges of synthetic biology products in terms of the application of familiarity and comparative safety assessment approach.
The revisions, according to the authors, could look forward to the likelihood and range of experience of modern biotechnology while still reflecting current discussions similar to the original Recommendation.
Read the full list with details of the suggested amendments in Trends in Biotechnology.