1050 A.Konig et al.Food and Chemical Toxicology 42 (2004)1047-1088 Protection administers the review process.The Eur- The USDA regulates the import,interstate movement, opean Food Safety Authority reviews the risk assess- field trial release,and commercial release of GM crops ment submitted by applicants intending to place a under the Federal Plant Pest Act and the Plant Novel Food on the European market.It is up to the Quarantine Act,which are administered by the Animal administrators in the European Commission Directo- and Plant Health Inspection Service (APHIS).Prior to rate General for Health and Consumer Protection to approval for unrestricted release,as in commercialisa- draft proposals based on the risk assessment and other tion,the USDA/APHIS must determine that the GM broader considerations that may affect choice of policy crop is not a plant pest.There is no Federal regulation options.A regulatory committee of representatives of requiring the registration of new plant varieties.The Member States competent authorities then decides EPA has regulatory oversight for all GM crops that whether to accept the Commission proposal through a produce a plant pesticide.Plant-integrated pesticides are weighted voting system.If the regulatory committee's regulated according to the same procedures as other opinion is not in accordance with the proposed pesticides. measure or if no opinion is delivered,the question is The FDA has authority over human food and animal referred to the Council of Ministers.The Council of feed safety and the wholesomeness of all plant products, Ministers can approve or reject a Commission proposal including those produced via genetic modification, given a qualified majority of member States support under the Federal Food Drug and Cosmetic Act.The the position.If rejected,the European Commission has FDA has concluded that food and feed derived from to prepare a new proposal.If the Council of Ministers GM crops pose no unique safety concerns and,there- takes no decision within three months,or does not fore,that the food and feed products derived from these reach a qualified majority indicating that it opposes the plants should be regulated no differently than compar- proposal,the European Commission shall adopt the able products derived from traditional plant breeding or proposal. any other genetic modification approach (US FDA, In June 2003 the European Council of Ministers 1992).Labelling is only mandated for foods that present adopted two new Regulations specific for foods and a health risk to subgroups of the population,such as feeds derived from genetically modified organisms. allergenic foods:the FDA does not mandate process- Regulation (EC)No 1829/2003 on genetically modified based labelling informing consumers for instance on a food and feed provides the legal basis for the approval food's content of genetically modified organisms.Partly procedure for genetically modified organisms as speci- in response to demonstrations by activists against GM fied in the General Food Law.The safety of foods crops in Seattle,Washington in 1999,and to three pub- derived from genetically modified organisms is assessed lic hearings,the FDA decided to adopt measures to by the European Food Safety Authority's Scientific strengthen the scientific basis and transparency of its Panel on genetically modified organisms (European decision-making process.The FDA proposed to modify Commission,2003a).[The panel assesses the food its voluntary process so as to establish mandatory pre- safety,environmental and animal health aspects of market notification and to make its decision process genetically modified organisms ('one-door-one-key' more transparent.The agency also developed draft gui- principle.)]Regulation (EC)No 1830/2003 concerning dance for food manufacturers who wish to label their the traceability and labelling of genetically modified foods voluntarily. organisms and the traceability of food and feed pro- Other systems that present variations of either the US ducts produced from genetically modified organisms or the EU approach are Canada,Australia,and Japan. requires traceability and labelling of genetically mod- In Canada all plants with novel traits are regulated, ified organisms and derived products (European Com- regardless of whether a plant with novel traits was pro- mission,2003b);this regulation also provides a legal duced by conventional breeding,mutagenesis,or basis for case-by-case decisions on post market mon- recombinant DNA techniques (Health Canada,1994; itoring requirements where deemed necessary. CFIA,1998).Foods derived from GM crops are con- The US regulatory framework for GM crops was laid sidered novel foods under the Food and Drugs Act out in the 1986 'Coordinated Framework for Regula- (CFIA,1998).The Canadian Biotechnology Advisory tion of Biotechnology'(US OSTP,1986).Existing laws Committee recently reviewed the Canadian regulations for the regulation of plant pests,pesticides and foods of GM foods;its recommendations include that were amended,resulting in a vertical,product-based research be carried out in order to monitor for hypo- regulatory framework for GM crops and derived foods. thetical long-term health effects(CBAC,2002). Three principal regulatory agencies conduct science- In Japan,the Ministry of Agriculture,Food,and based assessments of risks to human health and the Fisheries (MAFF)and the Ministry of Health,Labour, environment:the United States Department of Agri- and Welfare (MHLW)administer the regulation of food culture (USDA),the Environmental Protection Agency safety of GMOs,including GM crops and other foods (EPA),and the Food and Drug Administration(FDA). and food additives that contain organisms or have beenProtection administers the review process. The Eur￾opean Food Safety Authority reviews the risk assess￾ment submitted by applicants intending to place a Novel Food on the European market. It is up to the administrators in the European Commission Directo￾rate General for Health and Consumer Protection to draft proposals based on the risk assessment and other broader considerations that may affect choice of policy options. A regulatory committee of representatives of Member States competent authorities then decides whether to accept the Commission proposal through a weighted voting system. If the regulatory committee’s opinion is not in accordance with the proposed measure or if no opinion is delivered, the question is referred to the Council of Ministers. The Council of Ministers can approve or reject a Commission proposal given a qualified majority of member States support the position. If rejected, the European Commission has to prepare a new proposal. If the Council of Ministers takes no decision within three months, or does not reach a qualified majority indicating that it opposes the proposal, the European Commission shall adopt the proposal. In June 2003 the European Council of Ministers adopted two new Regulations specific for foods and feeds derived from genetically modified organisms. Regulation (EC) No 1829/2003 on genetically modified food and feed provides the legal basis for the approval procedure for genetically modified organisms as speci- fied in the General Food Law. The safety of foods derived from genetically modified organisms is assessed by the European Food Safety Authority’s Scientific Panel on genetically modified organisms (European Commission, 2003a). [The panel assesses the food safety, environmental and animal health aspects of genetically modified organisms (‘one-door-one-key’ principle.)] Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed pro￾ducts produced from genetically modified organisms requires traceability and labelling of genetically mod￾ified organisms and derived products (European Com￾mission, 2003b); this regulation also provides a legal basis for case-by-case decisions on post market mon￾itoring requirements where deemed necessary. The US regulatory framework for GM crops was laid out in the 1986 ‘Coordinated Framework for Regula￾tion of Biotechnology’ (US OSTP, 1986). Existing laws for the regulation of plant pests, pesticides and foods were amended, resulting in a vertical, product-based regulatory framework for GM crops and derived foods. Three principal regulatory agencies conduct science￾based assessments of risks to human health and the environment: the United States Department of Agri￾culture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). The USDA regulates the import, interstate movement, field trial release, and commercial release of GM crops under the Federal Plant Pest Act and the Plant Quarantine Act, which are administered by the Animal and Plant Health Inspection Service (APHIS). Prior to approval for unrestricted release, as in commercialisa￾tion, the USDA/APHIS must determine that the GM crop is not a plant pest. There is no Federal regulation requiring the registration of new plant varieties. The EPA has regulatory oversight for all GM crops that produce a plant pesticide. Plant-integrated pesticides are regulated according to the same procedures as other pesticides. The FDA has authority over human food and animal feed safety and the wholesomeness of all plant products, including those produced via genetic modification, under the Federal Food Drug and Cosmetic Act. The FDA has concluded that food and feed derived from GM crops pose no unique safety concerns and, there￾fore, that the food and feed products derived from these plants should be regulated no differently than compar￾able products derived from traditional plant breeding or any other genetic modification approach (US FDA, 1992). Labelling is only mandated for foods that present a health risk to subgroups of the population, such as allergenic foods; the FDA does not mandate process￾based labelling informing consumers for instance on a food’s content of genetically modified organisms. Partly in response to demonstrations by activists against GM crops in Seattle, Washington in 1999, and to three pub￾lic hearings, the FDA decided to adopt measures to strengthen the scientific basis and transparency of its decision-making process. The FDA proposed to modify its voluntary process so as to establish mandatory pre￾market notification and to make its decision process more transparent. The agency also developed draft gui￾dance for food manufacturers who wish to label their foods voluntarily. Other systems that present variations of either the US or the EU approach are Canada, Australia, and Japan. In Canada all plants with novel traits are regulated, regardless of whether a plant with novel traits was pro￾duced by conventional breeding, mutagenesis, or recombinant DNA techniques (Health Canada, 1994; CFIA, 1998). Foods derived from GM crops are con￾sidered novel foods under the Food and Drugs Act (CFIA, 1998). The Canadian Biotechnology Advisory Committee recently reviewed the Canadian regulations of GM foods; its recommendations include that research be carried out in order to monitor for hypo￾thetical long-term health effects (CBAC, 2002). In Japan, the Ministry of Agriculture, Food, and Fisheries (MAFF) and the Ministry of Health, Labour, and Welfare (MHLW) administer the regulation of food safety of GMOs, including GM crops and other foods and food additives that contain organisms or have been 1050 A. Ko¨nig et al. / Food and Chemical Toxicology 42 (2004) 1047–1088