Regulation of genetic engineering
|Part of a series on|
|Genetically modified organisms|
|History and regulation|
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.
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. Some scientists and advocacy groups, such as Greenpeace and World Wildlife Fund, have however called for additional and more rigorous testing for GM food.
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 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 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 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 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. and updated its guidelines for import and export of food in 2004,
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 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 Organisation (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 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 Act 1974, the Management of Health and Safety at Work Regulations 1999, the Carriage of Dangerous Goods legislation and the Control of Substances Hazardous to Health Regulations 2002. 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.
In the USA 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.
The 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 United States takes on a less hands-on approach to the regulation of GMOs than in Europe, 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.
European Union 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."
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.
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) 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) do not qualify as GMO's, even if gene editing has thus been used to make the organism.
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. The Commission is obliged to investigate these cases and either overturn the original registrations or request the country to withdraw its temporary restriction.
The U.S. regulatory policy is governed by the Coordinated Framework for Regulation of Biotechnology 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."
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, and the EPA regulates genetically modified plants with pesticide properties, as well as agrochemical residues.
The level of regulation in other countries lies in between Europe and the United States.
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. 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.
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.
|USA||USDA, FDA and EPA|
|Continental Europe||European Food Safety Authority|
|England||Department for Environment Food and Rural Affairs||The Scotland and Welsh governments are responsible for release in their respective countries.|
|Canada||Health Canada and the Canadian Food Inspection Agency||Based on whether a product has 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 (overseas all), 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. 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. In the US state of Oregon., voters rejected Measure 27, which would have required labeling of all genetically modified foods. Japan, Malaysia, New Zealand, and Australia require labeling so consumers can exercise choice between foods that have genetically modified, conventional or organic origins.
The 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" 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.
Genetically modified animals
Transgenic 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.
- "Restrictions on Genetically Modified Organisms". Law Library of Congress. 22 January 2017.
- Hallenbeck T (2014-04-27). "How GMO labeling came to pass in Vermont". Burlington Free Press. Retrieved 2014-05-28.
- Botha GM, Viljoen CD (2009). "South Africa: A case study for voluntary GM labelling". Food Chemistry. 112 (4): 1060–64. doi:10.1016/j.foodchem.2008.06.050.
- "The Regulation of Genetically Modified Foods". Office of Biotechnology and Science. Government of Canada. 12 December 2012.
- Davison J (2010). "GM plants: Science, politics and EC regulations". Plant Science. 178 (2): 94–98. doi:10.1016/j.plantsci.2009.12.005.
- Nicolia, Alessandro; Manzo, Alberto; Veronesi, Fabio; Rosellini, Daniele (2013). "An overview of the last 10 years of genetically engineered crop safety research" (PDF). Critical Reviews in Biotechnology. 34 (1): 1–12. doi:10.3109/07388551.2013.823595. PMID 24041244.
We have reviewed the scientific literature on GE crop safety for the last 10 years that catches the scientific consensus matured since GE plants became widely cultivated worldwide, and we can conclude that the scientific research conducted so far has not detected any significant hazard directly connected with the use of GM crops.
The literature about Biodiversity and the GE food/feed consumption has sometimes resulted in animated debate regarding the suitability of the experimental designs, the choice of the statistical methods or the public accessibility of data. Such debate, even if positive and part of the natural process of review by the scientific community, has frequently been distorted by the media and often used politically and inappropriately in anti-GE crops campaigns.
- "State of Food and Agriculture 2003–2004. Agricultural Biotechnology: Meeting the Needs of the Poor. Health and environmental impacts of transgenic crops". Food and Agriculture Organization of the United Nations. Retrieved February 8, 2016.
Currently available transgenic crops and foods derived from them have been judged safe to eat and the methods used to test their safety have been deemed appropriate. These conclusions represent the consensus of the scientific evidence surveyed by the ICSU (2003) and they are consistent with the views of the World Health Organization (WHO, 2002). These foods have been assessed for increased risks to human health by several national regulatory authorities (inter alia, Argentina, Brazil, Canada, China, the United Kingdom and the United States) using their national food safety procedures (ICSU). To date no verifiable untoward toxic or nutritionally deleterious effects resulting from the consumption of foods derived from genetically modified crops have been discovered anywhere in the world (GM Science Review Panel). Many millions of people have consumed foods derived from GM plants—mainly maize, soybean and oilseed rape—without any observed adverse effects (ICSU).
- Ronald, Pamela (May 5, 2011). "Plant Genetics, Sustainable Agriculture and Global Food Security". Genetics. 188 (1): 11–20. doi:10.1534/genetics.111.128553. PMC 3120150. PMID 21546547.
There is broad scientific consensus that genetically engineered crops currently on the market are safe to eat. After 14 years of cultivation and a cumulative total of 2 billion acres planted, no adverse health or environmental effects have resulted from commercialization of genetically engineered crops (Board on Agriculture and Natural Resources, Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants, National Research Council and Division on Earth and Life Studies 2002). Both the U.S. National Research Council and the Joint Research Centre (the European Union's scientific and technical research laboratory and an integral part of the European Commission) have concluded that there is a comprehensive body of knowledge that adequately addresses the food safety issue of genetically engineered crops (Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health and National Research Council 2004; European Commission Joint Research Centre 2008). These and other recent reports conclude that the processes of genetic engineering and conventional breeding are no different in terms of unintended consequences to human health and the environment (European Commission Directorate-General for Research and Innovation 2010).
- But see also:
Domingo, José L.; Bordonaba, Jordi Giné (2011). "A literature review on the safety assessment of genetically modified plants" (PDF). Environment International. 37 (4): 734–742. doi:10.1016/j.envint.2011.01.003. PMID 21296423.
In spite of this, the number of studies specifically focused on safety assessment of GM plants is still limited. However, it is important to remark that for the first time, a certain equilibrium in the number of research groups suggesting, on the basis of their studies, that a number of varieties of GM products (mainly maize and soybeans) are as safe and nutritious as the respective conventional non-GM plant, and those raising still serious concerns, was observed. Moreover, it is worth mentioning that most of the studies demonstrating that GM foods are as nutritional and safe as those obtained by conventional breeding, have been performed by biotechnology companies or associates, which are also responsible of commercializing these GM plants. Anyhow, this represents a notable advance in comparison with the lack of studies published in recent years in scientific journals by those companies.
Krimsky, Sheldon (2015). "An Illusory Consensus behind GMO Health Assessment" (PDF). Science, Technology, & Human Values. 40 (6): 1–32. doi:10.1177/0162243915598381.
I began this article with the testimonials from respected scientists that there is literally no scientific controversy over the health effects of GMOs. My investigation into the scientific literature tells another story.
Panchin, Alexander Y.; Tuzhikov, Alexander I. (January 14, 2016). "Published GMO studies find no evidence of harm when corrected for multiple comparisons". Critical Reviews in Biotechnology. 37 (2): 1–5. doi:10.3109/07388551.2015.1130684. ISSN 0738-8551. PMID 26767435.
Here, we show that a number of articles some of which have strongly and negatively influenced the public opinion on GM crops and even provoked political actions, such as GMO embargo, share common flaws in the statistical evaluation of the data. Having accounted for these flaws, we conclude that the data presented in these articles does not provide any substantial evidence of GMO harm.
The presented articles suggesting possible harm of GMOs received high public attention. However, despite their claims, they actually weaken the evidence for the harm and lack of substantial equivalency of studied GMOs. We emphasize that with over 1783 published articles on GMOs over the last 10 years it is expected that some of them should have reported undesired differences between GMOs and conventional crops even if no such differences exist in reality.
Yang, Y.T.; Chen, B. (2016). "Governing GMOs in the USA: science, law and public health". Journal of the Science of Food and Agriculture. 96 (6): 1851–55. doi:10.1002/jsfa.7523. PMID 26536836.
It is therefore not surprising that efforts to require labeling and to ban GMOs have been a growing political issue in the USA (citing Domingo and Bordonaba, 2011).
Overall, a broad scientific consensus holds that currently marketed GM food poses no greater risk than conventional food... Major national and international science and medical associations have stated that no adverse human health effects related to GMO food have been reported or substantiated in peer-reviewed literature to date.
Despite various concerns, today, the American Association for the Advancement of Science, the World Health Organization, and many independent international science organizations agree that GMOs are just as safe as other foods. Compared with conventional breeding techniques, genetic engineering is far more precise and, in most cases, less likely to create an unexpected outcome.
- "Statement by the AAAS Board of Directors On Labeling of Genetically Modified Foods" (PDF). American Association for the Advancement of Science. October 20, 2012. Retrieved February 8, 2016.
The EU, for example, has invested more than €300 million in research on the biosafety of GMOs. Its recent report states: "The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of more than 25 years of research and involving more than 500 independent research groups, is that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies." The World Health Organization, the American Medical Association, the U.S. National Academy of Sciences, the British Royal Society, and every other respected organization that has examined the evidence has come to the same conclusion: consuming foods containing ingredients derived from GM crops is no riskier than consuming the same foods containing ingredients from crop plants modified by conventional plant improvement techniques.
Pinholster, Ginger (October 25, 2012). "AAAS Board of Directors: Legally Mandating GM Food Labels Could "Mislead and Falsely Alarm Consumers"". American Association for the Advancement of Science. Retrieved February 8, 2016.
- "A decade of EU-funded GMO research (2001–2010)" (PDF). Directorate-General for Research and Innovation. Biotechnologies, Agriculture, Food. European Commission, European Union. 2010. doi:10.2777/97784. ISBN 978-92-79-16344-9. Retrieved February 8, 2016.
- "AMA Report on Genetically Modified Crops and Foods (online summary)". American Medical Association. January 2001. Retrieved March 19, 2016.
A report issued by the scientific council of the American Medical Association (AMA) says that no long-term health effects have been detected from the use of transgenic crops and genetically modified foods, and that these foods are substantially equivalent to their conventional counterparts. (from online summary prepared by ISAAA)" "Crops and foods produced using recombinant DNA techniques have been available for fewer than 10 years and no long-term effects have been detected to date. These foods are substantially equivalent to their conventional counterparts. (from original report by AMA: )
"REPORT 2 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (A-12): Labeling of Bioengineered Foods" (PDF). American Medical Association. 2012. Archived from the original (PDF) on 7 September 2012. Retrieved March 21, 2017.
Bioengineered foods have been consumed for close to 20 years, and during that time, no overt consequences on human health have been reported and/or substantiated in the peer-reviewed literature.
- "Restrictions on Genetically Modified Organisms: United States. Public and Scholarly Opinion". Library of Congress. June 9, 2015. Retrieved February 8, 2016.
Several scientific organizations in the US have issued studies or statements regarding the safety of GMOs indicating that there is no evidence that GMOs present unique safety risks compared to conventionally bred products. These include the National Research Council, the American Association for the Advancement of Science, and the American Medical Association. Groups in the US opposed to GMOs include some environmental organizations, organic farming organizations, and consumer organizations. A substantial number of legal academics have criticized the US's approach to regulating GMOs.
- "Genetically Engineered Crops: Experiences and Prospects". The National Academies of Sciences, Engineering, and Medicine (US). 2016. p. 149. Retrieved May 19, 2016.
Overall finding on purported adverse effects on human health of foods derived from GE crops: On the basis of detailed examination of comparisons of currently commercialized GE with non-GE foods in compositional analysis, acute and chronic animal toxicity tests, long-term data on health of livestock fed GE foods, and human epidemiological data, the committee found no differences that implicate a higher risk to human health from GE foods than from their non-GE counterparts.
- "Frequently asked questions on genetically modified foods". World Health Organization. Retrieved February 8, 2016.
Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.
GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post market monitoring, should form the basis for ensuring the safety of GM foods.
- Haslberger, Alexander G. (2003). "Codex guidelines for GM foods include the analysis of unintended effects". Nature Biotechnology. 21 (7): 739–41. doi:10.1038/nbt0703-739. PMID 12833088.
These principles dictate a case-by-case premarket assessment that includes an evaluation of both direct and unintended effects.
- Some medical organizations, including the British Medical Association, advocate further caution based upon the precautionary principle:
"Genetically modified foods and health: a second interim statement" (PDF). British Medical Association. March 2004. Retrieved March 21, 2016.
In our view, the potential for GM foods to cause harmful health effects is very small and many of the concerns expressed apply with equal vigour to conventionally derived foods. However, safety concerns cannot, as yet, be dismissed completely on the basis of information currently available.
When seeking to optimise the balance between benefits and risks, it is prudent to err on the side of caution and, above all, learn from accumulating knowledge and experience. Any new technology such as genetic modification must be examined for possible benefits and risks to human health and the environment. As with all novel foods, safety assessments in relation to GM foods must be made on a case-by-case basis.
Members of the GM jury project were briefed on various aspects of genetic modification by a diverse group of acknowledged experts in the relevant subjects. The GM jury reached the conclusion that the sale of GM foods currently available should be halted and the moratorium on commercial growth of GM crops should be continued. These conclusions were based on the precautionary principle and lack of evidence of any benefit. The Jury expressed concern over the impact of GM crops on farming, the environment, food safety and other potential health effects.
The Royal Society review (2002) concluded that the risks to human health associated with the use of specific viral DNA sequences in GM plants are negligible, and while calling for caution in the introduction of potential allergens into food crops, stressed the absence of evidence that commercially available GM foods cause clinical allergic manifestations. The BMA shares the view that that there is no robust evidence to prove that GM foods are unsafe but we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit.
- Funk, Cary; Rainie, Lee (January 29, 2015). "Public and Scientists' Views on Science and Society". Pew Research Center. Retrieved February 24, 2016.
The largest differences between the public and the AAAS scientists are found in beliefs about the safety of eating genetically modified (GM) foods. Nearly nine-in-ten (88%) scientists say it is generally safe to eat GM foods compared with 37% of the general public, a difference of 51 percentage points.
- Marris, Claire (2001). "Public views on GMOs: deconstructing the myths". EMBO Reports. 2 (7): 545–48. doi:10.1093/embo-reports/kve142. PMC 1083956. PMID 11463731.
- Final Report of the PABE research project (December 2001). "Public Perceptions of Agricultural Biotechnologies in Europe". Commission of European Communities. Retrieved February 24, 2016.
- Scott, Sydney E.; Inbar, Yoel; Rozin, Paul (2016). "Evidence for Absolute Moral Opposition to Genetically Modified Food in the United States" (PDF). Perspectives on Psychological Science. 11 (3): 315–24. doi:10.1177/1745691615621275. PMID 27217243.
- "Restrictions on Genetically Modified Organisms". Library of Congress. June 9, 2015. Retrieved February 24, 2016.
- Bashshur, Ramona (February 2013). "FDA and Regulation of GMOs". American Bar Association. Retrieved February 24, 2016.
- Sifferlin, Alexandra (October 3, 2015). "Over Half of E.U. Countries Are Opting Out of GMOs". Time.
- Lynch, Diahanna; Vogel, David (April 5, 2001). "The Regulation of GMOs in Europe and the United States: A Case-Study of Contemporary European Regulatory Politics". Council on Foreign Relations. Retrieved February 24, 2016.
- "Report 2 of the Council on Science and Public Health: Labeling of Bioengineered Foods" (PDF). American Medical Association. 2012. Archived from the original (PDF) on 7 September 2012. Retrieved 21 March 2017.
- United States Institute of Medicine and National Research Council (2004). Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects. National Academies Press. ISBN 978-0-309-09209-8. See pp11ff on need for better standards and tools to evaluate GM food.
- Key S, Ma JK, Drake PM (June 2008). "Genetically modified plants and human health". Journal of the Royal Society of Medicine. 101 (6): 290–8. doi:10.1258/jrsm.2008.070372. PMC 2408621. PMID 18515776.
- Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D, Roblin R, Watson JD, Weissman S, Zinder ND (July 1974). "Letter: Potential biohazards of recombinant DNA molecules" (PDF). Science. 185 (4148): 303. Bibcode:1974Sci...185..303B. doi:10.1126/science.185.4148.303. PMC 388511. PMID 4600381.
- Berg P, Baltimore D, Brenner S, Roblin RO, Singer MF (June 1975). "Summary statement of the Asilomar conference on recombinant DNA molecules". Proceedings of the National Academy of Sciences of the United States of America. 72 (6): 1981–4. Bibcode:1975PNAS...72.1981B. doi:10.1073/pnas.72.6.1981. PMC 432675. PMID 806076.
- Hutt PB (September 1978). "Research on recombinant DNA molecules: the regulatory issues". Southern California Law Review. 51 (6): 1435–50. PMID 11661661.
- McHughen A, Smyth S (January 2008). "US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars". Plant Biotechnology Journal. 6 (1): 2–12. doi:10.1111/j.1467-7652.2007.00300.x. PMID 17956539.
- Bull AT, Holt G, Lilly MD (1982). Biotechnology: international trends and perspectives (PDF). Paris: Organisation for Economic Co-operation and Development.
- U.S. Office of Science and Technology Policy (June 1986). "Coordinated framework for regulation of biotechnology; announcement of policy; notice for public comment" (PDF). Federal Register. 51 (123): 23302–50. PMID 11655807. Archived from the original (PDF) on 2011-05-16.
- "Strategies for assessing the safety of foods produced by biotechnology" (PDF). Report of Joint FAO/WHO Consultation. Geneva: World Health Organization. 1991.
- "Safety Considerations for Biotechnology" (PDF). Organisation for Economic Co-Operation and Development (OECD). 1992.
- "Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles" (PDF). Organisation for Economic Co-Operation and Development (OECD). 1993.
- "Consensus Document on Molecular Characterisation of Plants Derived from Modern Biotechnology" (PDF). Organisation for Economic Co-Operation and Development (OECD). 2010.
- "Consensus documents: work on harmonisation of regulatory oversight in biotechnology". Organisation for Economic Co-Operation and Development (OECD).
- "About the Protocol". The Biosafety Clearing-House (BCH).
- Redick TP (2007). "The Cartagena Protocol on biosafety: Precautionary priority in biotech crop approvals and containment of commodities shipments, 2007". Colorado Journal of International Environmental Law and Policy. 18: 51–116.
- Kimani V, Gruère GP. "Implications of import regulations and information requirements under the Cartagena Protocol on biosafety for GM commodities in Kenya". AgBioForum. 13 (3): article 2.
- Codex Alimentarius Commission (2003). "Principles and Guidelines on foods derived from biotechnology" (PDF).
- Codex Alimentarius Commission (2004). "Food Import & Export" (PDF).
- Carter CA, Gruère GP (2003-12-15). "Mandatory Labeling of Genetically Modified Foods: Does it Really Provide Consumer Choice?". AgBioForum. Retrieved 2016-01-21.
- Strom S (2013-06-03). "Connecticut Approves Qualified Genetic Labeling". The New York Times. ISSN 0362-4331. Retrieved 2016-01-21.
- Schmid RD, Schmidt-Dannert C (2016-05-31). Biotechnology: An Illustrated Primer. John Wiley & Sons. p. 332. ISBN 9783527335152.
- Kimman TG, Smit E, Klein MR (July 2008). "Evidence-based biosafety: a review of the principles and effectiveness of microbiological containment measures". Clinical Microbiology Reviews. 21 (3): 403–25. doi:10.1128/CMR.00014-08. PMC 2493080. PMID 18625678.
- Biotechnology in a Global Economy. DIANE Publishing Company. 1992. pp. 173–178. ISBN 978-0-941375-60-3.
- "Contained use of genetically modified microorganisms". Directive 2009/41/EC. European Parliament. Retrieved 2019-02-11.
- "GMOs and the law". Health and Safety Executive. Retrieved 2019-02-09.
- "How to Apply for Approval to Conduct Research with GMOs - Research & Innovation". University of Wollongong. Archived from the original on March 10, 2011. Retrieved 2018-12-23.
- Endres AB (1999). "GMO: Genetically Modified Organism or Gigantic Monetary Obligation-The Liability Schemes for GMO Damage in the United States and the European Union". Loyola of Los Angeles International and Comparative Law Journal. 22: 453.
- Jensen H, Jensen H, Gylling M (15 September 2009). "Adoption of GM Food Crop Varieties in the European Union" (PDF). Institute of Food and Resource Economics, University of Copenhagen. Retrieved 15 November 2016.
- Mahgoub S (2015). Genetically Modified Foods: Basics, Applications, and Controversy. Taylor & Francis Group. p. 9. ISBN 9781482242812.
- "GMO Compass: The European Regulatory System". Archived from the original on 14 August 2012. Retrieved 28 July 2012.
- Costa-Font M, Gil JM, Traill WB (2008-04-01). "Consumer acceptance, valuation of and attitudes towards genetically modified food: Review and implications for food policy". Food Policy. 33 (2): 99–111. doi:10.1016/j.foodpol.2007.07.002.
- "Directive 2001/18/EC". European Parliament and of the Council.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration
- Abbott A (December 2015). "Europe's genetically edited plants stuck in legal limbo". Nature. 528 (7582): 319–20. doi:10.1038/528319a. PMID 26672535.
- "Gene editing in legal limbo in Europe". Nature. 542 (7642): 392. February 2017. doi:10.1038/542392a. PMID 28230148.
- "Health and Consumers: Food and feed safety". European Commission. Archived from the original on 3 November 2012. Retrieved 28 July 2012.
What are the National safeguard measures?
- "United States Regulatory Agencies Unified Biotechnology Website". Archived from the original on 2012-11-17.
- Marden E (May 2003). "Risk and regulation: US regulatory policy on genetically modified food and agriculture". Boston College Law Review. 44 (3): Article 2.
- "Plant Biotechnology for Food and Feed: FDA's Biotechnology Policy". U.S. Food and Drug Administration. Archived from the original on 5 January 2012.
- "Guide to U.S. Regulation of Genetically Modified Food and Agricultural Biotechnology Products" (PDF). The Pew Initiative on Food and Biotechnology. Washington, DC: The Pew Charitable Trusts. 2001. Retrieved 2012-06-02.
- "Transgenic harvest". Nature. 467 (7316): 633–4. October 2010. doi:10.1038/467633b. PMID 20930796.
- "ISAAA Brief 37-2007 – Slides & Tables". International Service for the Acquisition of Agri-biotech Applications (ISAAA).
- Huang J, Wang Q. "Agricultural biotechnology development and policy in China". AgBioForum. 5 (4).
- "Bio Technology: GM Regulation". TNAU Agritech Portal :: Bio Technology.
- "Global Status of Commercialized Biotech/GM Crops: 2010". ISAAA Brief 42-2010. International Service for the Acquisition of Agri-biotech Applications (ISAAA).
- Contri D (23 February 2007). "BASF presentation" (PDF). Archived from the original (PDF) on 2011-09-28.
- "Plants with novel traits: Information for the general public". Canadian Food Inspection Agency – Regulating Agricultural Biotechnology.
- "Genetically Modified Foods". The Canadian Encyclopedia. Archived from the original on 18 August 2013.
- "Commonwealth and State Responsibilities (for growing genetically modified crops commercially)". Agriculture – Department of Primary Industries. Victoria State, Australia. Archived from the original on 2011-03-29.
- "Welcome to the Office of the Gene Technology Regulator Website". Office of the Gene Technology Regulator. Retrieved 25 March 2011.
- U.S. Office of Science and Technology Policy (June 1986). "Coordinated framework for regulation of biotechnology; announcement of policy; notice for public comment" (PDF). Federal Register. 51 (123): 23302–50. PMID 11655807. Archived from the original (PDF) on 16 May 2011.
- Evans B, Lupescu M (15 July 2012). "Canada – Agricultural Biotechnology Annual – 2012" (PDF). GAIN (Global Agricultural Information Network) report CA12029. United States Department of Agriculture, Foreifn Agricultural Service. Retrieved 5 November 2012.
- McHugen A (14 September 2000). "Chapter 1: Hors-d'oeuvres and entrees/What is genetic modification? What are GMOs?". Pandora's Picnic Basket. Oxford University Press. ISBN 978-0198506744.
- "Transgenic harvest". Nature. 467 (7316): 633–4. October 2010. doi:10.1038/467633b. PMID 20930796.
- Grobe D, Raab C (2004). "Voters' Response to Labeling Genetically Engineered Foods: Oregon's Experience". Journal of Consumer Affairs. 38: 320–331.
- Gibson J (Fall 2006). "Consumer Protection: Consumer Strategies and the European Market in Genetically Modified Foods". Northwestern Journal of Technology and Intellectual Property. 5 (1): Article 5.
- "Substantial Equivalence in Food Safety Assessment". Council for Biotechnology Information. 11 March 2001.
- "Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety" (PDF). Rome, Italy. 30 September 1996. p. 4. Archived from the original (PDF) on 18 May 2017.
- "Report of the Task Force for the Safety of Novel Foods and Feeds C(2000)86/ADD1" (PDF). Organisation for Economic Co-operation and Development. 17 May 2000.
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.
- Novak WK, Haslberger AG (June 2000). "Substantial equivalence of antinutrients and inherent plant toxins in genetically modified novel foods". Food and Chemical Toxicology. 38 (6): 473–83. PMID 10828499.
- Kok EJ, Kuiper HA (October 2003). "Comparative safety assessment for biotech crops". Trends in Biotechnology. 21 (10): 439–44. doi:10.1016/j.tibtech.2003.08.003. PMID 14512230.
- "Safety aspects of genetically modified foods of plant origin". Consultations 4. Approaches to the Nutritional and Food Safety Evaluation of Genetically Modified Foods. Food and Agricultural Organization (FAO).
- Murray JD, Maga EA (March 2016). "Opinion: A new paradigm for regulating genetically engineered animals that are used as food". Proceedings of the National Academy of Sciences of the United States of America. 113 (13): 3410–3. Bibcode:2016PNAS..113.3410M. doi:10.1073/pnas.1602474113. PMC 4822638. PMID 27035930.
- Vàzquez-Salat N (2013). "Are good ideas enough? The impact of socio-economic and regulatory factors on GMO commercialisation". Biological Research. 46 (4): 317–22. doi:10.4067/S0716-97602013000400002. PMID 24510133.
- Jagadeesan P, Bin Salem S (November 2015). "Transgenic and cloned animals in the food chain--are we prepared to tackle it?". Journal of the Science of Food and Agriculture. 95 (14): 2779–82. doi:10.1002/jsfa.7205. PMID 25857482.