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Regulation of the release of genetically modified organisms
One of the key issues concerning regulators is whether GM products should be labeled. Labeling can be mandatory up to a threshold GM content level (which varies between countries) or voluntary. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%.〔Gerda M. Botha and Christopher D. Viljoen (2009) "South Africa: A case study for voluntary GM labelling" Food Chemistry 112(4):1060–1064 ()〕 In Canada and the USA labeling of GM food is voluntary,〔(The Regulation of Genetically Modified Foods )〕 while in Europe all food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.〔John Davison (2010)"GM plants: Science, politics and EC regulations" Plant Science 178(2):94–98 ()〕
There is general scientific agreement that food on the market derived from GM crops poses no greater risk than conventional food.〔American Association for the Advancement of Science (AAAS), Board of Directors (2012). (Legally Mandating GM Food Labels Could Mislead and Falsely Alarm Consumers )〕 There is no evidence to support the idea that the consumption of approved GM food has a detrimental effect on human health.〔American Medical Association (2012). (Report 2 of the Council on Science and Public Health: Labeling of Bioengineered Foods )〕〔United States Institute of Medicine and National Research Council (2004). Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. National Academies Press. (Free full-text ). National Academies Press. See pp11ff on need for better standards and tools to evaluate GM food.〕 Some scientists and advocacy groups, such as Greenpeace and World Wildlife Fund, have however called for additional and more rigorous testing for GM food.〔NRC.
==History==
The development of a regulatory framework concerning genetic engineering began in 1975, at Asilomar, California. The first use of Recombinant DNA (rDNA) technology had just been successfully accomplished by Stanley Cohen and Herbert Boyer two years previously and the scientific community recognized that as well as benefits this technology could also pose some risks. The Asilomar meeting recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology. The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health (NIH) formed a rDNA advisory committee. This was followed by other regulatory offices (the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA)), effectively making all rDNA research tightly regulated in the USA. In 1982 the Organization for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms into the environment as the first transgenic plants were being developed. As the technology improved and genetically modified organisms moved from model organisms to potential commercial products the USA established a committee at the Office of Science and Technology (OSTP) to develop mechanisms to regulate the developing technology.〔 In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.
The basic concepts for the safety assessment of foods derived from GMOs have been developed in close collaboration under the auspices of the Organisation for Economic Co-operation and Development (OECD) and the United Nations' World Health Organisation (WHO) and Food and Agricultural Organisation (FAO). A first joint FAO/WHO consultation in 1990 resulted in the publication of the report ‘Strategies for Assessing the Safety of Foods Produced by Biotechnology’ in 1991.〔(FAO/WHO Report 1991 )〕 Building on that, an international consensus was reached by the OECD’s Group of National Experts on Safety in Biotechnology, for assessing biotechnology in general, including field testing GM crops.〔(OECD(1992) Safety Considerations for Biotechnology )〕 That Group met again in Bergen, Norway in 1992 and reached consensus on principles for evaluating the safety of GM food; its report, ‘The safety evaluation of foods derived by modern technology – concepts and principles’ was published in 1993.〔OECD(1993) Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles ()〕 That report recommends conducting the safety assessment of a GM food on a case-by-case basis through comparison to an existing food with a long history of safe use. This basic concept has been refined in subsequent workshops and consultations organized by the OECD, WHO, and FAO, and the OECD in particular has taken the lead in acquiring data and developing standards for conventional foods to be used in assessing substantial equivalence.〔OECD (2010) (Consensus Document on Molecular Characterisation of Plants Derived from Modern Biotechnology )〕〔(OECD harmonization webpage )〕 In 2003 the Codex Alimentarius Commission of the FAO/WHO adopted a set of "Principles and Guidelines on foods derived from biotechnology" to help countries coordinate and standardize regulation of GM food to help ensure public safety and facilitate international trade.〔Codex Alimentarius Commission, 2003 (Principles and Guidelines on foods derived from biotechnology )〕 and updated its guidelines for import and export of food in 2004,〔Codex Alimentarius Commission, 2004 (Food Import & Export )〕
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