The Research Of Applicability Of The Principle Of Substantial Equivalence In The U.S. Genetically Modified Food Regulation

In the regulation of genetically modified food of the U.S.,substantial equivalence is a scientific concept of safety evaluation.But it distinguishes itself from other evaluation methods,not only as an evaluation tool to provide standards but also a regulatory tool to provide a regulatory thinking to authorities.Authorities can determine the regulatory status based on the establishment of substantial equivalence.In practice,the use of the principle of substantial equivalence is effective and flexible.Authorities can design different regulatory systems according to the targets and risks.It's not an accident that the U.S.adopts the principle of substantial equivalence as regulatory tools in its regulation of genetically modified food.As an evaluation tool,substantial equivalence,on the basis of scientific principles,has been used to determine the safety status of newly introduced food;as a regulatory tool,it originated from the interpretation of the principle of science and thus adopts a no different attitude towards genetically modified food.The reason behind such policy choice lies in the regulatory systems from farm to table: rich experience is accumulated over decades in safety approval,risk management,tolerance standards and labeling systems;authorities balance and cooperate with each other in an highly effective way;severe after-event supervision lower the possibility of illegal activities.In China,a genetically modified objects regulatory system is built on the Regulations on Administration of Agricultural Genetically Modified Organisms Safety issued by the State Council and other regulations issued by the Ministry of Agriculture and General Administration of Quality Supervision.However,it's designed to adopt danger grading principles combined with approvals in different stages.Genetically modified food regulatory system is not yet established.It's not enough to develop the genetically modified food market without transparent and specific regulations.Therefore,the paper brings out suggestions to integrate current approval stages and introduce substantial equivalence into the regulation of genetically modified food safety and not to lower the risk management ability: to strengthen the cooperation between authorities and integrate current approval procedures,and introduce the principle of substantial equivalence as a safety evaluation tool as well as a regulatory tool according to the difference of targets and risks.