Standard Operating Procedures Regarding Environmental Risk Assessment

March 2015

Japan imports a wide range of food and feed commodities at significant amounts from all over the world. Among them are those produced using genetic modification. Before they are permitted for import into Japan, conduct of risk assessment and deciding on risk management measures for these GM commodities are mandatory by the domestic law “Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms”. The competent authorities of the Japanese Government share responsibilities for ensuring food safety, feed safety, and safety to biodiversity concerning these GM commodities.

The Food Safety and Consumer Affairs Bureau of the Ministry of Agriculture, Forestry and Fisheries, Japan, developed the Standard Operating Procedures (SOP) for risk assessment and risk management on the safety to biodiversity of GM plants in December 2009 for ensuring consistency and increasing transparency. The objective of the SOP is to ensure consistent environmental risk assessment and management and to inform stakeholders about our regulatory framework and data requirements on GM plants. The SOP contains all necessary steps for risk assessment and risk management in chronological order. It clarifies for applicants when and on what condition additional data are required.

As most developers and exporters are located outside of Japan and we have been requested by developers, exporters and government administrators to provide information on our regulatory system and data requirements for application quite often, we decided to translate the SOP into English for those in the area of GM plants outside of Japan.

We hope the published English SOP will be of help to those who have interest in our regulatory system or who are planning to export GM food or feed commodities to Japan.

Link to TEXT （PDF：915KB）