Reflections on the safety regulation of commercialization of synthetic biology products

Abstract

With the rapid development of synthetic biology, lots of synthetic biology technology achievements in various application fields have been commercialized, generating broad market prospects. The commercialization of products employing synthetic biology technology (hereinafter referred as synthetic biology products) has brought benefits to human beings, but it has also produced potential safety risks. At present, relevant laws and standards for regulation of biotechnology or genetically modified organisms have been adopted to regulate the safety risks of commercialization of synthetic biology products (CSBP). However, due to the complexity and uncertainty of synthetic biology, the safety risks of CSBP cannot be comprehensively regulated by these laws and standards. Therefore, it is of great significance to formulate specific supervision and management measures for regulating the safety risks of CSBP. This paper summarized the situation of CSBP in the fields of food, medical care, agriculture, environment, energy and materials, analyzed the safety risks existing in the CSBP, and sorted out current supervision situation of its safety risks in European countries, United States, as well as in China. We further proposed suggestions on the safety supervision and management measures on the safety risks of CSBP, including classified examination and approval, classified identification of products, and strict screening and approval of market entities before entering the market, and strengthening safety supervision and emergency treatment as well as accident responsibility investigation after entering the market. This whole-process safety regulation might provide support for the safety of CSBP and promote the healthy and long-term development of synthetic biology industry.