International Regulation of Microorganisms for Biofuel or Chemical Production: Europe, Asia and Australia

by David Glass (DGlassAssociates.com) In two blog entries in 2010, I described the possible regulatory regimes that might affect the use of genetically modified microorganisms or plants in the production of biofuels or bio-based chemicals, focusing on Canada and Europe. In a post last week, I briefly summarized several countries in North America, South America and Africa having explicit biotechnology laws with reasonably clear applicability to uses of GMO microbes in contained manufacturing ( “contained use” or “confined use”). In today’s entry, I’ll describe regulatory regimes for contained uses of modified microorganisms in Europe and Australia, and in selected countries in Asia.

The European Union has adopted a directive governing the “contained uses” of GMOs (Directive 2009/41/EC). Briefly, this directive would require applicants to assign a risk level to its organisms, to adopt containment measures appropriate for that risk level, and to notify a designated national agency before beginning operations. However, specific requirements in any given EU nation would be governed by national legislation or regulation adopted in conformance with the EU directive, so that national requirements in any given country may differ from, and may even exceed, the requirements of the EU directive. ...

Indonesia has ratified the Cartagena Protocol, and adopted Law Number 21 of 2004, followed by Government Regulation Number 21 of 2005 to implement its responsibilities under the Protocol. These regulations, although largely focusing on agricultural uses of GMOs, appear to require an environmental risk assessment for the importation of any GMO, even for contained use. The gist of the regulations is that any GMO either created in the country or imported into Indonesia must undergo a risk assessment to ascertain environmental safety, food safety, or animal feed safety. ...

It appears that importation of a GMO into Indonesia, even for a contained use, requires government review. ...

Japan is a signatory to the Cartagena Protocol, and it has adopted Law 97 of 2003, entitled “Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms,” to place Japanese law in conformance with the Protocol. (Note: this law and other documents referenced here can be downloaded in English from the Japan Biosafety Clearing House website). Law 97 forms the basis for Japan’s biotechnology regulatory regime. Among the defined terms of Law 97 are definitions of two categories of use of Living Modified Organisms (LMOs). ...

India has an existing regulatory framework, although it is based on a 27-year-old law that the government has been trying to update. This law is the Environmental Protection Act of 1986, whose provisions are implemented by the 1989 “Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms and Cells” (both the law and the rules can be downloaded from the government’s biotechnology website. The two primary regulatory bodies under this regime are the Department of Biotechnology (DBT) within the Ministry of Science and Technology and the Genetic Engineering Approval Committee (GEAC) within the Ministry of Environment and Forestry. The DBT has developed recombinant DNA guidelines, and the GEAC has developed guidelines for field testing and food use of GMOs. Under the Act and the Rules, all uses of genetically engineered organisms, including “production in which genetically engineered organisms or cells or micro-organisms are generated or used” require advance approval of the GEAC (although the final section of the Rules gives the Environment Ministry the power to grant exemptions from this requirement). In relying on a single regulatory committee with representatives from various government agencies, the Indian system embodies a regulatory regime that is better suited for R&D applications than for commercial uses, but which reflects the prevailing practice at the time the law was adopted. ...

Australia has a Gene Technology Act of 2000, implemented by the Gene Technology Regulations of 2011, which would dictate whether the use of modified microorganisms for biofuel production would require a license. The Act and regulations established the Gene Technology Regulator (GTR) as the central office that administers the Act. The GTR plays the key role in assessing, regulating and licensing GMOs and enforcing license conditions. The Gene Technology Act defines gene technology as any technique for the modification of genes or other genetic material, although there is an exception for “homologous recombination” that appears quite narrow. READ MORE