美国SECURE规则评析及其对中国的启示

An Analysis of the U.S.SECURE Rule and Its Enlightenment to China

美国农业部动植物卫生检疫局在最近一次生物技术法规的修订中,将原有的关于监管利用基因工程开发的生物体的进口、州际移动和环境释放一章的规定进行了较大幅度的修改,并将之命名为SECURE规则。这一规则采用了新的安全评价方法,将评价的重心从原来的生产方法转移到了产品的特性上。此外,新的规则还通过豁免程序和监管状态审查等程序的设立,进一步简化了监管方式。但SECURE规则也存在着部门立法之间的协调不足、配套机制建设不完善等问题,可能给新规则的实施带来一定的挑战。我国作为转基因技术大国,在农业生物技术及其产品监管的立法上可以批判性地借鉴美国最新的立法实践,为我国生物技术产业的发展提供法治保障。

In the latest revision of biotechnology regulations,the Animal and Plant Health Inspection Service(APHIS)of the United States Department of Agriculture revised the original regulations on the import,interstate movement and environmental release of organisms developed by genetic engineering to a greater extent.APHIS names it SECURE rule.This rule adopts a new safety evaluation method,shifting the focus of evaluation from the original production method to the characteristics of the product.In addition,the new rules further simplify the supervision method through procedures such as exemption procedures and supervision status review.However,the SECURE rule also has problems such as insufficient coordination between departmental legislation and imperfect construction of supporting mechanisms,which may bring certain challenges to the implementation of the new rules.As a major country of genetically modified technology,China can critically learn from the latest U.S.legislative practice in the legislation of agricultural biotechnology and its product supervision to provide legal protection for the development of the Chinese biotechnology industry.