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Regulation
Main article: Regulation of genetic engineering
The regulation of genetic engineering concerns the approaches taken by governments to assess and manage the risks associated with the development and release of GMOs. The development of a regulatory framework began in 1975, at Asilomar, California. The Asilomar meeting recommended a set of voluntary guidelines regarding the use of recombinant technology. As the technology improved the US established a committee at the Office of Science and Technology, which assigned regulatory approval of GM food to the USDA, FDA and EPA. The Cartagena Protocol on Biosafety, an international treaty that governs the transfer, handling, and use of GMOs, was adopted on 29 January 2000. One hundred and fifty-seven countries are members of the Protocol, and many use it as a reference point for their own regulations. # ISO Certification in India
The legal and regulatory status of GM foods varies by country, with some nations banning or restricting them, and others permitting them with widely differing degrees of regulation. Some countries allow the import of GM food with authorisation, but either do not allow its cultivation (Russia, Norway, Israel) or have provisions for cultivation even though no GM products are yet produced (Japan, South Korea). Most countries that do not allow GMO cultivation do permit research. Some of the most marked differences occur between the US and Europe. The US policy focuses on the product (not the process), only looks at verifiable scientific risks and uses the concept of substantial equivalence. The European Union by contrast has possibly the most stringent GMO regulations in the world. All GMOs, along with irradiated food, are considered “new food” and subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority. The criteria for authorisation fall in four broad categories: “safety”, “freedom of choice”, “labelling”, and “traceability”. The level of regulation in other countries that cultivate GMOs lie in between Europe and the United States. # ISO Certification in India
| Region | Regulators | Notes |
|---|---|---|
| US | USDA, FDA and EPA | |
| Europe | European Food Safety Authority | |
| Canada | Health Canada and the Canadian Food Inspection Agency | Regulated products with novel features regardless of method of origin |
| Africa | Common Market for Eastern and Southern Africa | Final decision lies with each individual country. |
| China | Office of Agricultural Genetic Engineering Biosafety Administration | |
| India | Institutional Biosafety Committee, Review Committee on Genetic Manipulation and Genetic Engineering Approval Committee | |
| Argentina | National Agricultural Biotechnology Advisory Committee (environmental impact), the National Service of Health and Agrifood Quality (food safety) and the National Agribusiness Direction (effect on trade) | Final decision made by the Secretariat of Agriculture, Livestock, Fishery and Food. |
| Brazil | National Biosafety Technical Commission (environmental and food safety) and the Council of Ministers (commercial and economical issues) | |
| Australia | Office of the Gene Technology Regulator (oversees all GM products), Therapeutic Goods Administration (GM medicines) and Food Standards Australia New Zealand (GM food). | The individual state governments can then assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products. |
One of the key issues concerning regulators is whether GM products should be labeled. The European Commission says that mandatory labeling and traceability are needed to allow for informed choice, avoid potential false advertising and facilitate the withdrawal of products if adverse effects on health or the environment are discovered. The American Medical Association and the American Association for the Advancement of Science say that absent scientific evidence of harm even voluntary labeling is misleading and will falsely alarm consumers. Labeling of GMO products in the marketplace is required in 64 countries. Labeling can be mandatory up to a threshold GM content level (which varies between countries) or voluntary. In Canada and the US labeling of GM food is voluntary, while in Europe all food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.# ISO Certification in India