International Regulation of Industrial Biotechnology David J. Glass, Ph.D., D. Glass Associates, Inc.

European Union Oversight under national laws adopted by EU member states based on binding EU Directives. Contained manufacturing: Contained uses of LMO microorganisms require national government notification under EU “Contained Use” Directive 2009/41/EC. Open Ponds and Transgenic Plants: Uses of LMOs in the open environment would be covered by EU Directive 2001/18/EC on “Environmental Release”.

International regulations may cover the use of genetically modified microorganisms or plants to produce fuels or chemicals. Such regulations will be described for several important countries or regions.

Japan Contained manufacturing: Under the biotechnology laws, contained uses of LMOs are regulated as “Type 2” uses: the Ministry having jurisdiction may vary. Open Ponds and Transgenic Plants: are regulated more stringently by the Agriculture Ministry as “Type 1” uses.

China Contained manufacturing and open ponds: Open-pond use of LMO microorganisms would likely require approval from the Agriculture Ministry. Jurisdiction over contained uses is less certain, although approval would be needed to import LMOs into China for any purpose. Novel Plant Feedstocks: Approval for field tests and commercial uses are needed from the Agriculture Ministry.

Australia Under the Gene Technology Act and its regulations, both contained and non-contained uses of LMOs would require a license from the government. Contained uses (“Dealings not involving release”) would face a shorter, easier approval process. Numerous transgenic plant field tests have been approved.

David Glass is an independent consultant with over thirty years experience in industrial biotechnology regulation. D. Glass Associates, Inc. (617) 653-9945 124 Bird Street dglass@dglassassociates.com Needham, MA 02492 www.dglassassociates.com

Canada Contained or Open Pond uses of modified microorganisms may require Environment Canada approval under the New Substances Notification regulations under the Canadian Environmental Protection Act. Novel Plant Feedstocks: The Canadian Food Inspection Agency regulates “confined” and “unconfined” releases of plants with novel traits.

United States Contained manufacturing: Most contained uses of modified microorganisms would be regulated by EPA under TSCA (40 CFR Part 725) and would require MCAN filings. Open Pond uses of GM algae would require TERA approval and later MCAN filings under the TSCA regulations. Novel Plant Feedstocks: Field testing and use of transgenic plants as biofuel feedstocks would be subject to USDA biotechnology regulations (7 CFR Part 340).

Brazil Under the National Biosafety Law, all proposed uses of LMOs would require approval from the Biosafety National Technical Committee (CTNBio) and the applicable Ministry. There have been previous approvals for contained industrial uses of LMOs and transgenic plant field testing.

Canada

U.S.A.

Brazil

Europe Japan China

Australia South Africa

Indonesia Contained manufacturing: Under Government Law 21, government notification and a risk assessment are needed. Open Ponds and Transgenic Plants: Outdoor uses of LMOs require approval by the National Biosafety Commission on Genetically Engineered Products (KKH).

Mexico CIBIOGEM, an Inter-Ministerial commission, coordinates oversight activities under Mexico’s Biosafety Law. Contained manufacturing: Uses of LMO microorganisms require review and approval, likely by the Environment Ministry SEMARNAT. Open Ponds and Transgenic Plants: Outdoor uses of LMOs must be approved by the Agriculture Ministry SEGARPA.

Regulatory regimes are described for three industrial approaches: contained use of microorganisms in fuel or chemical manufacture; open-pond use of algae or photosynthetic bacteria to produce fuels or chemicals; and the field testing and commercial cultivation of transgenic plants as feedstocks. Other areas of regulation not discussed here are the requirements for certification of renewable fuels and the regulations governing the use of spent microbial biomass in animal feed (e.g., in dried distillers grains).

Malaysia Contained manufacturing: Under the Biosafety Law, the National Biosafety Board must be notified before using or importing LMOs in contained manufacturing. Open Ponds and Transgenic Plants: The Biosafety Board’s Genetic Modification Advisory Committee must approve releases of LMO plants and microorganisms into the environment.

Malaysia Indonesia

Mexico

Many national laws are based on the principles of the Cartagena Protocol on Biosafety, part of the Convention on Biological Diversity, which was adopted in January 2000. Under such laws, government approvals are generally needed for importation of Living Modified Organisms (LMOs) into countries, and for many industrial activities including “contained uses” or “environmental uses”. Such approvals may often require a risk assessment of the LMO and its proposed use.

South Africa Under the Genetically Modified Organisms Act, permits are needed from the Agriculture Ministry for importation, contained use, and environmental use of LMOs. An Advisory Committee conducts risk assessments, and an Executive Council makes final decisions.

Please visit the Advanced Biotechnology for Biofuels blog for a more detailed discussion of these and other international regulations. (http://wp.me/pKTxe-a4)