Regulation of the release of genetic modified organisms
Governments have taken different approaches to assess and manage the risks associated with the use of genetic engineering technology and the development and release of genetically modified organisms (GMO), including genetically modified crops and genetically modified fish. There are differences in the regulation of GMOs between countries, with some of the most marked differences occurring between the USA and Europe. Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety.
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%. 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.
Although there is now broad scientific consensus that GE crops on the market are safe to eat, some scientists who work at institutions such as the University of Texas and Cornell University, and advocacy groups such as Greenpeace and World Wildlife Fund have called for additional and more rigorous testing for GM food. See genetically modified food controversies for discussion of these issues.
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 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. 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. 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,
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.
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)". 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.
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.
There has been discussion about applying new biochemical concepts and methods in evaluating substantial equivalence, such as metabolic profiling and protein profiling. These concepts refer, respectively, to the complete measured biochemical spectrum (total fingerprint) of compounds (metabolites) or of proteins present in a food or crop. The goal would be to compare overall the biochemical profile of a new food to an existing food to see if the new food's profile falls within the range of natural variation already exhibited by the profile of existing foods or crops. However, these techniques are not considered sufficiently evaluated, and standards have not yet been developed, to apply them.
There are controversies over the definition and application of substantial equivalence. See section in genetically modified food controversies.
By continent 
In 2010, after nine years of talks, the Common Market for Eastern and Southern Africa (COMESA) produced a draft policy on GM technology, which was sent to all 19 national governments for consultation in September 2010. Under the proposed policy, new GM crops would be scientifically assessed by COMESA. If the GM crop was deemed safe for the environmental and human health, permission would be granted for the crop to be grown in all 19 member countries, although the final decision would be left to each individual country. South Africa is the major grower of Genetically Modified crops in Africa, with smaller amounts grown in Burkina Faso and Egypt. The National Assembly of Burkina Faso passed a biosafety law in early 2006, which established a National Biosafety Agency that would regulate GM products with the advice of various governmental and non-governmental advisory committees. In Burkina Faso, the African Biosafety Network of Expertise school, set up by the African Union and funded by the Bill and Melinda Gates Foundation, opened in April 2010. Its aim is to train and develop African regulators to approve, monitor and track genetically modified crops. Kenya passed laws in 2011, and Ghana and Nigeria passed laws in 2012 which allowed the production and importation of GM crops. 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 2002, Zambia cut off the flow of genetically modified food (mostly maize) from UN's World Food Programme on the basis of the Cartagena Protocol. This left the population without food aid during a famine. In December 2005 the Zambian government changed its mind in the face of further famine and allowed the importation of GM maize. However, the Zambian Minister for Agriculture Mundia Sikatana has insisted that the ban on genetically modified maize remains, saying "We do not want GM (genetically modified) foods and our hope is that all of us can continue to produce non-GM foods."
India and China are the two largest producers of genetically modified products in Asia. India currently only grows GM cotton, while China produces GM varieties of cotton, poplar, petunia, tomato, papaya and sweet pepper. Cost of enforcement of regulations in India are generally higher, possibly due to the greater influence farmers and small seed firms have on policy makers, while the enforcement of regulations was more effective in China.
GM crops in China go through three phases of field trials (pilot field testing, environmental release testing, and preproduction testing) before they are submitted to the Office of Agricultural Genetic Engineering Biosafety Administration (OAGEBA) for assessment. Producers must apply to OAGEBA at each stage of the field tests. The Chinese Ministry of Science and Technology developed the first biosafety regulations for GM products in 1993 and they were updated in 2001. The 75 member National Biosafety Committee evaluates all applications, although OAGEBA has the final decision. Most of the National Biosafety Committee are involved in biotechnology leading to criticisms that they do not represent a wide enough range of public concerns.
The release of transgenic crops in India is governed by the Indian Environment Protection Act, which was enacted in 1986. The Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC) all review any genetically modified organism to be released, with transgenic crops also needing permission from the Ministry of Agriculture. India regulators cleared the Bt brinjal, a genetically modified eggplant, for commercialisation in October 2009. Following opposition from some scientists, farmers and environmental groups a moratorium was imposed on its release in February 2010.
Other Asian countries that grew GM crops in 2011 were Pakistan, the Philippines and Myanmar. Japan requires labeling so consumers can exercise choice between foods that have genetically modified, conventional or organic origins.
South America 
Brazil and Argentina are the 2nd and 3rd largest producers of GM food behind the USA.
The Argentine government was one of the first to accept GM food. 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. The government is looking to tighten the current law which allows farmers to keep seed without paying royalties in a bid to encourage more private investment.
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. The Council of Ministers evaluates the commercial and economical issues with release. The National Biosafety Technical Commission has 27 members and includes 12 scientists, 9 ministerial representatives and 6 other specialists.
Honduras, Costa Rica, Colombia, Bolivia, Paraguay, Chile, and Uruguay also allow GM crops to be grown.
Until the 1990s, Europe's regulation was less strict than in the United States, one turning point being cited as the export of the United States' first GM-containing soy harvest in 1996. The GM soy made up about 2% of the total harvest at the time, and EuroCommerce and European food retailers required that it be separated. In 1998, the use of MON810, a Bt expressing maize conferring resistance to the European corn borer, was approved for commercial cultivation in Europe. Shortly thereafter, the EU enacted a de facto moratorium on new approvals of GMOs pending new regulatory laws passed in 2003.
Those new laws provided the European Union (EU) with 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." 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. The Commission is obliged to investigate these cases and either overturn the original registrations or request the country to withdraw its temporary restriction. The laws of the EU also stipulated that member nations establish minimum distances between fields of GM crops and non-GM crops. The distances for GM maize from non-GM maize for the six largest biotechnology countries are; France: 50 meters, Britain: 110 meters for grain maize and 80 for silage maize, Netherlands: 25 meters in general and 250 for organic or GM-free fields, Sweden: 15–50 meters, Finland: data not available, and Germany: 150 meters and 300 from organic fields.
In 2006, the World Trade Organization concluded that the EU moratorium, which had been in effect from 1998 to 2004, had violated international trade rules. The moratorium had not affected previously approved crops. The only crop authorised for cultivation before the moratorium was Monsanto's MON 810. The next approval for cultivation was the Amflora potato for industrial applications in 2010 which was grown in Germany, Sweden and the Czech Republic that year.
The slow pace of approval has been criticized as endangering European food safety although as of 2012, the EU has authorized the use of 48 genetically modified organisms. Most of these were for use in animal feed (it was reported in 2012 that the EU imports about 30 million tons a year of GM crops for animal consumption.), food or food additives. 26 of these were varieties of maize. In July 2012 the EU gave approval for an Irish trial cultivation of potatoes resistant to the blight that caused the Great Irish Famine.
The safeguard clause mentioned above has been applied by many member states in various circumstances, and in April 2011 there were 22 active bans in place across six member states: Austria, France, Germany, Luxembourg, Greece, and Hungary. However, on review many of these have been considered scientifically unjustified.
- In January 2005, the Hungarian government announced a ban on importing and planting of genetic modified maize seeds, which was subsequently authorized by the EU.
- In February 2008 the French government used the safeguard clause to ban the cultivation of MON810 after Senator Jean-François Le Grand, chairman of a committee set up to evaluate biotechnology, said there were "serious doubts" about the safety of the product (although this ban was declared illegal in 2011 by the European Court of Justice and the French Conseil d'État). The French farm ministry reinstated the ban in 2012, but this was rejected by the EFSA.
- In 2009 German Federal Minister Ilse Aigner announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause.
- In March 2010, Bulgaria imposed a complete ban on genetically modified crop growing either commercially or for trials. The cabinet of Boyko Borisov initially imposed a 5-year moratorium, but later extended it to a permanent ban after widespread public protests against the introduction of genetically modified crops in the country. And in recent years, France and several other European countries banned cultivation of Monsanto's MON-810 corn and similar genetically modified food crops.
In 2012, the European Food Safety Authority (EFSA) Panel on Genetically Modified Organisms (GMO) released a "Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis" in a response to a request from the European Commission. The opinion was, that while "the frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case," "similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants." In other words, cisgenic genetic engineering approaches should be considered similar in risk to conventional breeding approaches, each of which are more risky than transgenic approaches.
Labeling and traceability 
The regulations concerning the import and sale of GMOs for human and animal consumption grown outside the EU involve providing freedom of choice to the farmers and consumers. All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled. Twice GMOs unapproved by the EC have arrived in the EU and been forced to return to their port of origin. The first was in 2006 when a shipment of rice from America containing an experimental GMO variety (LLRice601) not meant for commercialisation arrived at Rotterdam. The second in 2009 when trace amounts of a GMO maize approved in the US were found in a "non-GM" soy flour cargo.
The coexistence has raised significant concern in many European countries and so EU law also requires that all GM food be traceable to its origin, and that all food with GM content greater than 0.9% be labelled. Due to high demand from European consumers for freedom of choice between GM and non-GM foods. EU regulations require measures to avoid mixing of foods and feed produced from GM crops and conventional or organic crops, which can be done via isolation distances or biological containment strategies. (Unlike the US, European countries require labeling of GM food.) European research programs such as Co-Extra, Transcontainer, and SIGMEA are investigating appropriate tools and rules for traceability. The OECD has introduced a "unique identifier" which is given to any GMO when it is approved, which must be forwarded at every stage of processing. Such measures are generally not used in North America because they are very costly and the industry admits of no safety-related reasons to employ them. The EC has issued guidelines to allow the co-existence of GM and non-GM crops through buffer zones (where no GM crops are grown). These are regulated by individual countries and vary from 15 meters in Sweden to 800 meters in Luxembourg. All food (including processed food) or feed which contains greater than 0.9% of approved GMOs must be labelled.
A 5-digit Price Look-Up code beginning with the digit 8 indicates genetically modified food. However the absence of the "8" does not necessarily indicate the food is not genetically modified since no retailer to date has elected to use the digit in voluntarily labeling genetically modified foods.
North America 
The United States and Canada do not require labeling of genetically modified foods.
The USA is the largest commercial grower of genetically modified crops in the world.
United States regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology This regulatory policy framework that was developed under the Presidency of Ronald Reagan to ensure safety of the public and to ensure the continuing development of the fledgling biotechnology industry without overly burdensome regulation. The policy as it developed had 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."
For a genetically modified organism to be approved for release, it must be assessed by the Animal and Plant Health Inspection Service (APHIS) agency within the US Department of Agriculture (USDA) and may also be assessed by the Food and Drug Administration (FDA) and the Environmental protection agency (EPA), depending on the intended use of the organism. The USDA evaluates the plant's potential to become a weed, and the FDA reviews plants that could enter or alter the food supply, and the EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues. Most genetically modified plants are reviewed by at least two of the agencies, with many subject to all three. Within the organization are departments that regulate different areas of GM food including, the Center for Food Safety and Applied Nutrition (CFSAN,) and the Center for Biologics Evaluation and Research (CBER). Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, California became the first and only county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority.
Several laws govern the US regulatory agencies. These laws are statutes the agencies review when determining the safety of a particular GM food. These laws include:
- The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (EPA);
- The Toxic Substances Control Act (TSCA) (EPA);
- The Federal Food, Drug, and Cosmetic Act (FFDCA) (FDA and EPA);
- The Plant Protection Act (PPA) (USDA);
- The Virus-Serum-Toxin Act (VSTA) (USDA);
- The Public Health Service Act (PHSA)(FDA);
- The Dietary Supplement Health and Education Act (DSHEA) (FDA)
- The Meat Inspection Act (MIA)(USDA);
- The Poultry Products Inspection Act (PPIA) (USDA);
- The Egg Products Inspection Act (EPIA) (USDA); and
- The National Environmental Protection Act (NEPA).
Mainland Canada is one of the world's largest producers of GM canola and also grows GM maize, soybean and sugarbeet. Health Canada, under the Food and Drugs Act, and the Canadian Food Inspection Agency are responsible for evaluating the safety and nutritional value of genetically modified foods. The Canadian regulatory system is based on whether a product has novel features regardless of method of origin. In other words, a product is regulated as GM if it carries some trait not previously found in the species whether it was generated using traditional breeding methods (e.g. selective breeding, cell fusion, mutation breeding) or genetic engineering. Canadian law requires that manufacturers and importers submit detailed scientific data to Health Canada for safety assessments for approval. This data includes: information on how the GM plant was developed; nucleic acid data that characterizes the genetic change; composition and nutritional data of the novel food compared to the original non-modified food' potential for new toxins; and potential for being an allergen. A decision is then made whether to approve the product for release along with any restrictions or requirements. Labeling of foods as products of Genetic Engineering or not products of Genetic Engineering is voluntary. The Canadian regulations were reviewed by the Canadian Biotechnology Advisory Committee between 1999 and 2003, with the conclusion that the current level of regulation was satisfactory. The committee was accused by environmental and citizen groups of not representing the full spectrum of public interests by only having one member of the board of 20 representing non-governmental organisations and for being too closely aligned to industry groups.
On the 15 February 2005, after consulting the Mexican Academy of Sciences, Mexico's senate passed a law allowing planting and selling of genetically modified cotton and soybean. The law requires all genetically modified products to be labelled according to guidelines issued by the Mexican Ministry of Health. In 2009 the government enacted statutory provisions for the regulation of genetically modified maize. Mexico is the center of diversity for maize and concerns have been raised about the impact genetically modified maize could have on local strains.
Malaysia, New Zealand, and Australia require labeling so consumers can exercise choice between foods that have genetically modified, conventional or organic origins.
Food Standards Australia New Zealand must approve any food produced from GM crops, or made using genetically engineered enzymes, before it can be marketed in Australia or New Zealand. FSANZ makes a list of such approvals available on its website.
Genetic engineering in Australia was originally (since 1987) overseen by the Genetic Manipulation Advisory Committee, before the Office of the Gene Technology Regulator (OGTR) and Food Standards Australia New Zealand took over in 2001. The OTGR is a Commonwealth Government Authority within the Department of Health and Ageing and reports directly to Parliament through a Ministerial Council on Gene Technology and has legislative powers. It was established as part of the Gene Technology Act 2003 and operates according to the Gene Technology Regulations 2001. The OGTR reports directly to Parliament through a Ministerial Council on Gene Technology and has legislative powers. The OGTR decides on license applications for the release of all genetically modified organisms, 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 are then able to assess the impact of release on markets and trade and apply further legislation to control approved genetically modified products.
Genetically modified cotton, canola, and carnations are grown in Australia. Genetically modified cotton has been grown commercially in New South Wales and Queensland since 1996. GM canola was approved in 2003 and was first grown in 2008.
In 2011 genetically modified plants were grown in all states except South Australia and Tasmania, who have extended their moratoriums until 2019 and 2014. The Queensland and Northern Territory Governments have not implemented any further legislation beyond the national level, but several other states placed bans on planting certain GM crops. In 2007 the New South Wales government extended a blanket moratorium on GM food crops until 2011, but allowed groups to apply for exemptions. New South Wales approved GM Canola for commercial cultivation in 2008, while the Victorian government let the moratorium on GM Canola expire in 2007. Western Australia passed the Genetically Modified Crops Free Areas Act in 2003 and was declared a GM free area in 2004. In 2008 an exception was made for the commercial cultivation of GM cotton in the Ord River Irrigation Areas. Trials of GM canola were carried out in 2003 and in 2010 the Western Australian government allowed the commercialisation of GM canola.
In New Zealand, no genetically modified food is grown and no medicines containing live genetically modified organisms have been approved for use. However, medicines manufactured using genetically modified organisms that do not contain live organisms have been approved for sale, and imported foods with genetically modified components are sold. In 2000 the Government appointed a Royal Commission to report on issues relating to genetically modified organisms (GMOs). The Report of the Royal Commission on Genetic Modification, released in July 2001, concluded that New Zealand should keep its options open with regard to genetic engineering and to proceed carefully in order to minimise and manage any risks. Field trials have been carried out with GM pine trees and brassicas.
See also 
- Genetic engineering
- Genetically modified crops
- Genetically modified food
- Genetically modified food controversies
- Genetically modified organisms
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