Achieving bottom-up ethical, legal, and societal implications and responsible research and innovation in the synthetic biology research community from the Japanese context.

Biomanufacturing and synthetic biology are increasingly seen as essential to realizing a global bioeconomy. Within the broader trends in science and technology policy, the emphasis on foresight and addressing societal challenges has been growing. Addressing ethical, legal, and social implications/issues (ELSI) has become a prerequisite for responding to these trends in several countries, including Japan. This paper focuses on a specific aspect of ELSI, rulemaking, which is attracting increasing attention in the policy context. It highlights the lack of sufficient bottom-up initiatives from the academic research and development (R&D) community in this area and identifies three key areas for action that should be considered: (1) Advancing R&D informed by technological trends as well as policy and societal developments, (2) engaging in proactive deliberation to ensure safety and security, and (3) contributing to discussions on standardization. Moving forward, these recommendations must be elaborated on through discussions with universities, academic societies, the government, funding agencies, industries, and other stakeholders.