合成生物学产品商业化安全监管思考

Reflections on the safety regulation of commercialization of synthetic biology products

摘要:

随着合成生物学技术的迅猛发展，很多合成生物学技术成果在多个应用领域已商业化且具有广阔市场前景。合成生物学技术制造产品(简称合成生物学产品)的商业化给人类带来了福祉，但也产生了潜在的安全风险。目前对合成生物学产品商业化(commercialization of synthetic biology products, CSBP)的风险大多采用生物技术或转基因生物相关法律规范进行监管，但是由于合成生物学具有复杂性和不确定性的特点，这些法律规范不能全面监管合成生物学产品商业化的安全风险，因此制定专门监管合成生物学产品商业化安全风险的管理办法具有重要意义。本文总结了合成生物学产品在食品、医疗、农业、环境、能源和材料领域商业化现状，分析了合成生物学产品商业化存在的安全风险，梳理了欧美国家和我国对合成生物学产品商业化安全风险监管现状，并进一步提出了针对合成生物学产品商业化安全监管办法的建议，包括入市前产品分类审批和分类标识及市场主体准入严格筛选审批、入市后加强安全监管及应急处理和事故责任追究的全过程监管办法，为合成生物学产品商业化的安全提供支撑，并促进合成生物学行业健康长远发展。

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.