The regulation of genetic engineering varies widely by country. Countries such as the United States, Canada, Lebanon and Egypt use substantial equivalence as the starting point when assessing safety, while many countries such as those in the European Union, Brazil and China authorize GMO cultivation on a case-by-case basis. Many countries allow the import of GM food with authorization, but either do not allow its cultivation (Russia, Norway, Israel) or have provisions for cultivation, but no GM products are yet produced (Japan, South Korea). Most countries that do not allow for GMO cultivation do permit research.Restrictions on Genetically Modified Organisms. Library of Congress, March 2014 (LL File No. 2013-009894). Summary about a number of countries. via Most (85%) of the world's GMO crops are grown in the Americas (North and South). One of the key issues concerning regulators is whether GM products should be labeled. 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. A study investigating voluntary labeling in South Africa found that 31% of products labeled as GMO-free had a GM content above 1.0%. 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.
There is a scientific consensus that currently available food derived from GM crops poses no greater risk to human health than conventional food, but that each GM food needs to be tested on a case-by-case basis before introduction. Nonetheless, members of the public are much less likely than scientists to perceive GM foods as safe. 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.
There is no evidence to support the idea that the consumption of approved GM food has a detrimental effect on human health. 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.
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 US.
In 1982 the Organisation for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms (GMOs) into the environment as the first transgenic plants were being developed. As the technology improved and genetically organisms moved from model organisms to potential commercial products the US 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 OECD, the World Health Organization (WHO) and Food and Agriculture Organization (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. 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. 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. 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.
The Cartagena Protocol on Biosafety was adopted on 29 January 2000 and entered into force on 11 September 2003. It is an international treaty that governs the transfer, handling, and use of genetically modified (GM) organisms. It is focused on movement of GMOs between countries and has been called a de facto trade agreement. One hundred and seventy-two countries are members of the Protocol and many use it as a reference point for their own regulations. Also 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. and updated its guidelines for import and export of food in 2004,
The European Union first introduced laws requiring GMOs to be labelled in 1997. In 2013, Connecticut became the first state to enact a labeling law in the US, although it would not take effect until other states followed suit.
In the laboratory Institutions that conduct certain types of scientific research must obtain permission from government authorities and ethical committees before they conduct any experiments. Universities and research institutes generally have a special committee that is responsible for approving any experiments that involve genetic engineering. Many experiments also need permission from a national regulatory group or legislation. All staff must be trained in the use of GMOs and in some laboratories a biological control safety officer is appointed. All laboratories must gain approval from their regulatory agency to work with GMOs and all experiments must be documented. As of 2008 there have been no major accidents with GMOs in the lab.
The legislation covering GMOs was initially covered by adapting existing regulations in place for chemicals or other purposes, with many countries later developing specific policies aimed at genetic engineering. These are often derived from regulations and guidelines in place for the non-GMO version of the organism, although they are more severe. In many countries now the regulations are diverging, even though many of the risks and procedures are similar. Sometimes even different agencies are responsible, notably in the Netherlands where the Ministry of the Environment covers GMOs and the Ministry of Social Affairs covers the human pathogens they are derived from.
There is a near universal system for assessing the relative risks associated with GMOs and other agents to laboratory staff and the community. They are then assigned to one of four risk categories based on their virulence, the severity of disease, the mode of transmission, and the availability of preventive measures or treatments. There are some differences in how these categories are defined, such as the World Health Organization (WHO) including dangers to animals and the environment in their assessments. When there are varying levels of virulence the regulators base their classification on the highest. Accordingly, there are four biosafety levels that a laboratory can fall into, ranging from level 1 (which is suitable for working with agents not associated with disease) to level 4 (working with life-threatening agents). Different countries use different nomenclature to describe the levels and can have different requirements for what can be done at each level.
In Europe the use of living GMOs are regulated by the European Directive on the contained use of genetically modified microorganisms (GMMs). The regulations require risk assessments before use of any contained GMOs is started and assurances that the correct controls are in place. It provides the minimal standards for using GMMs, with individual countries allowed to enforce stronger controls. In the UK the Genetically Modified Organisms (Contained Use) Regulations 2014 (SI 2014/1663) provides the framework researchers must follow when using GMOs. Other legislation may be applicable depending on what research is carried out. For workplace safety these include the Health and Safety at Work etc. Act 1974, the Management of Health and Safety at Work Regulations 1999 (SI 1999/3242), the Carriage of Dangerous Goods legislation and the Control of Substances Hazardous to Health Regulations 2002 (SI 2002/2677). Environmental risks are covered by section 108(1) of the Environmental Protection Act 1990 and the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996 (SI 1996/1106).
In the US the National Institute of Health (NIH) classifies GMOs into four risk groups. Risk group one is not associated with any diseases, risk group 2 is associated with diseases that are not serious, risk group 3 is associated with serious diseases where treatments are available and risk group 4 is for serious diseases with no known treatments. In 1992 the Occupational Safety and Health Administration determined that its current legislation already adequately covers the safety of laboratory workers using GMOs.
Australia has an exempt dealing for genetically modified organisms that only pose a low risk. These include systems using standard laboratory strains as the hosts, recombinant DNA that does not code for a vertebrate toxin or is not derived from a micro-organism that can cause disease in humans. Exempt dealings usually do not require approval from the national regulator. GMOs that pose a low risk if certain management practices are complied with are classified as notifiable low risk dealings. The final classification is for any uses of GMOs that do not meet the previous criteria. These are known as licensed dealings and include cloning any genes that code for vertebrate toxins or using hosts that are capable of causing disease in humans. Licensed dealings require the approval of the national regulator.
Work with exempt GMOs do not need to be carried out in certified laboratories. All others must be contained in a Physical Containment level 1 (PC1) or Physical Containment level 2 (PC2) laboratories. Laboratory work with GMOs classified as low risk, which include knockout mice, are carried out in PC1 lab. This is the case for modifications that do not confer an advantage to the animal or doesn't secrete any infectious agents. If a laboratory strain that is used isn't covered by exempt dealings or the inserted DNA could code for a pathogenic gene, it must be carried out in a PC2 laboratory.
Release