Regulation of genetic engineering
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. 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 USA 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.John Davison (2010)"GM plants: Science, politics and EC regulations" Plant Science 178(2):94–98 link There is a scientific consensusBut see also:And contrast:and 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.Some medical organizations, including the British Medical Association, advocate further caution based upon the precautionary principle: 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.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.
HistoryThe 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 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 OECD, the 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 link 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 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 fifty-seven 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.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 The European Union first introduced laws requiring GMO's to be labelled in 1997. In 2013, Connecticut became the first state to enact a labeling law in the USA, although it would not take effect until other states followed suit.
In the laboratoryInstitutions 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. Most countries have exempt dealings for genetically modified organisms (GMOs) 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.http://www.uow.edu.au/research/rso/ethics/UOW009392.html 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.
Europe and United StatesThe approaches taken by governments to assess and manage the risks associated with the use of genetic engineering technology and the development and release of GMOs vary from country to country, with some of the most marked differences occurring between the United States and Europe. The U.S. regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology United States Regulatory Agencies Unified Biotechnology Website The policy has three tenets: "(1) U.S. policy would focus on the product of genetic modification (GM) techniques, not the process itself, (2) only regulation grounded in verifiable scientific risks would be tolerated, and (3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C.L. Rev. 733 (2003) link European Union by contrast enacted regulatory laws in 2003 that provided 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 (EFSA). The criteria for authorization fall in four broad categories: "safety," "freedom of choice," "labelling," and "traceability." GMO Compass: The European Regulatory System. Retrieved 28 July 2012. The European Union has heavily contrasted its regulations and restrictions regarding genetic engineering compared to those of the United States. The European Parliament's Committee on the Environmental, Public Health, and Consumer Protection pushed forward and adopted a "safety first" principle regarding the case of GMOs, calling for any negative health consequences from GMOs to be held liable. On the other hand, the United States still takes on a less hands-on approach to the regulation of GMOs, with the FDA and USDA only looking over pesticide and plant health facets of GMOs. Despite the overall global increase in the production in GMOs, the European Union has still stalled GMOs fully integrating into its food supply. This has definitely affected various countries, including the United States, when trading with the EU. However, although the European Union has had relatively strict regulations regarding the genetically modified food, Europe is now allowing newer versions of modified maize and other agricultural produce. Also, the level of GMO acceptance in the European Union varies across its countries with Spain and Portugal being more permissive of GMOs than France and the Nordic population. One notable exception however is Sweden. In this country, the government has declared that the GMO definition (according to Directive 2001/18/EC Directive 2001/18/EC) stipulates that foreign DNA needs to be present in an organism for it to qualify as a genetically modified organisms. Organisms that thus have the foreign DNA removed (for example via selective breeding Europe’s genetically edited plants stuck in legal limbo) do not qualify as GMO's, even if gene editing has thus been used to make the organism. Gene editing in legal limbo in Europe For a genetically modified organism to be approved for release in the U.S., it must be assessed under the Plant Protection Act by the Animal and Plant Health Inspection Service (APHIS) agency within the USDA and may also be assessed by the FDA and the EPA, depending on the intended use of the organism. The USDA evaluate the plants potential to become weeds, the FDA reviews plants that could enter or alter the food supply, FDA page for GM Food and the EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues. In Europe the EFSA reports to the European Commission who then draft a proposal for granting or refusing the authorisation. This proposal is submitted to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health and if accepted it will be adopted by the EC or passed on to the Council of Agricultural Ministers. Once in the Council it has three months to reach a qualified majority for or against the proposal, if no majority is reached the proposal is passed back to the EC who will then adopt the proposal. However, even after authorization, individual EU member states can ban individual varieties under a 'safeguard clause' if there are "justifiable reasons" that the variety may cause harm to humans or the environment. The member state must then supply sufficient evidence that this is the case."Health and Consumers: Food and feed safety." (under "What are the National safeguard measures?") Link. Retrieved 28 July 2012. The Commission is obliged to investigate these cases and either overturn the original registrations or request the country to withdraw its temporary restriction.
Other countriesThe level of regulation in other countries lies in between Europe and the United States. Common Market for Eastern and Southern Africa (COMASA) is responsible for assessing the safety of GMOs in most of Africa, although the final decision lies with each individual country. Transgenic harvest Editorial, Nature 467, pages 633–634, 7 October 2010, . Retrieved 9 November 2010 India and China are the two largest producers of genetically modified products in Asia. The Office of Agricultural Genetic Engineering Biosafety Administration (OAGEBA) is responsible for regulation in China, while in India it is the Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC). Brazil and Argentina are the 2nd and 3rd largest producers of GM food. In Argentine assessment of GM products for release is provided by the 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), with the final decision made by the Secretariat of Agriculture, Livestock, Fishery and Food. BASF presentation In Brazil the National Biosafety Technical Commission is responsible for assessing environmental and food safety and prepares guidelines for transport, importation and field experiments involving GM products, while the Council of Ministers evaluates the commercial and economical issues with release. Health Canada and the Canadian Food Inspection Agency Canadian Food Inspection Agency - Regulating Agricultural Biotechnology are responsible for evaluating the safety and nutritional value of genetically modified foods released in Canada.http://www.thecanadianencyclopedia.com/articles/genetically-modified-foods. Genetically Modified Food. License applications for the release of all genetically modified organisms in Australia is overseen by the Office of the Gene Technology Regulator, while regulation is provided by the Therapeutic Goods Administration for GM medicines or Food Standards Australia New Zealand for 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. Agriculture - Department of Primary Industries
LabelingOne 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%. In Canada and the United States 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. Japan, Malaysia, New Zealand, and Australia require labeling so consumers can exercise choice between foods that have genetically modified, conventional or organic origins. Northwestern.edu Northwestern Journal of Technology and Intellectual Property Paper on: "Consumer Protection" Consumer Strategies and the European Market in Genetically Modified Foods
TradeThe Cartagena Protocol sets the requirements for the international trade of GMO's between countries that are signatories to it. Any shipments contain geneticially modified organisms that are intended to be used as feed, food or for processing must be identified and a list of the transgenic events be available.
Substantial equivalence"Substantial equivalence" is a starting point for the safety assessment for GM foods that is widely used by national and international agencies - including the Canadian Food Inspection Agency, Japan's Ministry of Health and Welfare and the U.S. Food and Drug Administration, the United Nation’s Food and Agriculture Organization, the World Health Organization and the OECD. Substantial Equivalence in Food Safety Assessment, Council for Biotechnology Information, March 11, 2001 A quote from FAO, one of the agencies that developed the concept, is useful for defining it: "Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e., the food or food component can be concluded to be as safe as the conventional food or food component)".Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety. Rome, Italy, 30 September to 4 October 1996 link p. 4 The concept of substantial equivalence also recognises the fact that existing foods often contain toxic components (usually called antinutrients) and are still able to be consumed safely - in practice there is some tolerable chemical risk taken with all foods, so a comparative method for assessing safety needs to be adopted. For instance, potatoes and tomatoes can contain toxic levels of respectively, solanine and alpha-tomatine alkaloids.Organisation for Economic Co-operation and Development. Report of the Task Force for the Safety of Novel Foods and Feeds C(2000)86/ADD1. May 17, 2000 link Quote: "Much experience has been gained in the safety assessment of the first generation of foods derived through modern biotechnology, and those countries that have conducted assessments are confident that those GM foods they have approved are as safe as other foods." To decide if a modified product is substantially equivalent, the product is tested by the manufacturer for unexpected changes in a limited set of components such as toxins, nutrients, or allergens that are present in the unmodified food. The manufacturer's data is then assessed by a regulatory agency, such as the U.S. Food and Drug Administration. That data, along with data on the genetic modification itself and resulting proteins (or lack of protein), is submitted to regulators. If regulators determine that the submitted data show no significant difference between the modified and unmodified products, then the regulators will generally not require further food safety testing. However, if the product has no natural equivalent, or shows significant differences from the unmodified food, or for other reasons that regulators may have (for instance, if a gene produces a protein that had not been a food component before), the regulators may require that further safety testing be carried out. A 2003 review in Trends in Biotechnology identified seven main parts of a standard safety test:
- Study of the introduced DNA and the new proteins or metabolites that it produces;
- Analysis of the chemical composition of the relevant plant parts, measuring nutrients, anti-nutrients as well as any natural toxins or known allergens;
- Assess the risk of gene transfer from the food to microorganisms in the human gut;
- Study the possibility that any new components in the food might be allergens;
- Estimate how much of a normal diet the food will make up;
- Estimate any toxicological or nutritional problems revealed by this data in light of data on equivalent foods;
- Additional animal toxicity tests if there is the possibility that the food might pose a risk.
Public knowledgePublic knowledge of genetic engineering can effect the regulation of it. There's information asymmetry in this field. Consumers who know more about bio engineering products are more susceptible to resisting whereas those that don't have as much information on this subject are more inclined to buy GM products. The Food Policy Institute surveyed consumers on their knowledge of genetically modified organisms (GMOs). Over 60% of surveyors reported that they know little to nothing about genetically modified (GM) products. Over 50% of these consumers had no knowledge that GM products are being sold to consumers in supermarkets. When surveying people with a stronger background in science(i.e nursing students), knowledge on GMOs were surprisingly low—about 30% correctly identified crops that were GM products.
Genetically modified animalsTransgenic animals have genetically modified DNA. Animals are different from plants in a variety of ways—biology, life cycles, or potential environmental impacts. GM plants and animals were being developed around the same time, but due to the complexity of their biology and inefficiency with laboratory equipment use, their appearance in the market was delayed. There are six categories that genetically engineered (GE) animals are approved for:
- Use for biomedical research. Smaller mammalians can be used as models in scientific research to represent other mammals.
- Used to develop innovative kinds of fish for environmental monitoring.
- Used to produce proteins that humans lack. This can be for therapeutic use, for example, treatment of diseases in other mammals.
- Use for investigating and finding cures for diseases. Can be used for introducing disease resistance in GM breeds.
- Used to create manufacturing products for industry use.
- Used for improving food quality.