Regulation of the release of genetically modified organisms

History

The development of a regulatory framework concerning genetic engineering began in 1975, at Asilomar, California. The first use of Recombinant DNA (rDNA) technology had just been successfully accomplished by Stanley Cohen and Herbert Boyer two years previously and the scientific community recognized that as well as benefits this technology could also pose some risks. The Asilomar meeting recommended a set of guidelines regarding the cautious use of recombinant technology and any products resulting from that technology. The Asilomar recommendations were voluntary, but in 1976 the US National Institute of Health (NIH) formed a rDNA advisory committee. This was followed by other regulatory offices (the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA)), effectively making all rDNA research tightly regulated in the USA. In 1982 the Organization for Economic Co-operation and Development (OECD) released a report into the potential hazards of releasing genetically modified organisms into the environment as the first transgenic plants were being developed. As the technology improved and genetically modified organisms moved from model organisms to potential commercial products the USA established a committee at the Office of Science and Technology (OSTP) to develop mechanisms to regulate the developing technology. In 1986 the OSTP assigned regulatory approval of genetically modified plants in the US to the USDA, FDA and EPA.

The basic concepts for the safety assessment of foods derived from GMOs have been developed in close collaboration under the auspices of the Organisation for Economic Co-operation and Development (OECD) and the United Nations' World Health Organisation (WHO) and Food and Agricultural Organisation (FAO). A first joint FAO/WHO consultation in 1990 resulted in the publication of the report ‘Strategies for Assessing the Safety of Foods Produced by Biotechnology’ in 1991. 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:

1. Study of the introduced DNA and the new proteins or metabolites that it produces;
2. Analysis of the chemical composition of the relevant plant parts, measuring nutrients, anti-nutrients as well as any natural toxins or known allergens;
3. Assess the risk of gene transfer from the food to microorganisms in the human gut;
4. Study the possibility that any new components in the food might be allergens;
5. Estimate how much of a normal diet the food will make up;
6. Estimate any toxicological or nutritional problems revealed by this data in light of data on equivalent foods;
7. 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.

Africa

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.

In 2012, South Africa was the major commercial grower of genetically modified crops in Africa, with smaller amounts grown in Burkina Faso (maize), Egypt (cotton) and Sudan (cotton).Kenya passed laws in 2011, and Ghana and Nigeria passed laws in 2012 which allowed the production and importation of GM crops. By 2013 Cameroon, Malawi and Uganda had approved trials of genetically altered crops. A study investigating voluntary labeling in South Africa found that 31% of products labeled GMO-free had a GM content above 1.0%. 2011 studies for Uganda showed that transgenic bananas had a high potential to reduce rural poverty but that urban consumers with a relatively higher income might reject the introduction.

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 insisted in 2006, that the ban on genetically modified maize remained, saying "We do not want GM (genetically modified) foods and our hope is that all of us can continue to produce non-GM foods."

Asia

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. Other Asian countries that grew GM crops in 2011 were Pakistan, the Philippines and Myanmar. GM crops were approved for commercialisation in Bangladesh in 2013 and in Vietnam and Indonesia in 2014.

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.

India

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.

Official Reports on GMO

There have been four official reports on GMO in India till August 2013 :

1. The ‘Jairam Ramesh Report’ - February 2010, imposing an indefinite moratorium on Bt Brinjal
2. The Sopory Committee Report - August 2012
3. The Parliamentary Standing Committee (PSC) Report on GM crops - August 2012
4. Final Report of The Technical Expert Committee established by Supreme Court - July 2013

Japan

Two laws regulate food safety and food quality in Japan, the Food Sanitation Law passed in 1947 and the Law Concerning Standardization and Proper Labeling of Agricultural and Forestry Products passed in 1950. The Food Sanitation Law has been amended and updated many times; an amendment dealing with pre-market approval and labeling of GMOs was passed in 2000 and came into effect in 2001. Japan passed laws to implement the Cartagena Protocol on Biosafety in September 2003 which came into effect in February 2004 - the Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Law No. 97 of 2003).

Authority for approvals for various uses of genetically modified organisms is divided in Japan. The Ministry of the Environment has final approval for all uses of GMOs, but crops for commercial use and live vaccines for animals first go through the Ministry of Agriculture, Forestry and Fisheries; viruses for gene therapy and other medical applications first go through the Ministry of Health, Labor and Welfare; field trials of GM crops and recominant DNA used in biotechnology research first goes through the Ministry of Education, Culture, Sports, Science and Technology; and uses in the process of production of industrial enzymes, etc. goes through the Ministry of Economy, Trade and Industry.

Japan has not approved any commodity GM crops to be grown in Japan, but does allow import of agricultural products made from GM crops and food made of imported GM ingredients. Japan does however allow cultivation of GM flowers (e.g. Blue roses).

GM foods must undergo a safety assessment prior to being awarded certification for distribution to the domestic market. The Food Safety Commission (FSC) performs food and feed safety risk assessments.

Certain GM food must be labeled, but this is limited to designated genetically modified agricultural products, which are soybean, corn, potato, rapeseed, cottonseed, alfalfa and beet, and is limited to 32 processed foods which contain soybean, corn and potato, alfalfa and beet, in which recombinant DNA or the resulting protein still exists even after processing. However, processed food in which recombinant DNA or protein is dissolved in or removed during processing, such as soy sauce, soybean oil, corn flakes, millet jelly, corn oil, rapeseed oil, cottonseed oil, and others, do not have to be labeled.

Japan does not require traceability, and allows negative labeling ("GMO-free" and the like).

Philippines

The Philippines bans all GMOs recently overturning existing Department of Agriculture regulations. A petition filed on May 17, 2013 by environmental group Greenpeace Southeast Asia and farmer-scientist coalition Masipag (Magsasaka at Siyentipiko sa Pagpapaunlad ng Agrikultura) asked the appellate court to stop the planting of Bt eggplant in test fields, saying the impacts of such an undertaking to the environment, native crops and human health are still unknown. The Court of Appeals granted the petition, citing the precautionary principle stating "when human activities may lead to threats of serious and irreversible damage to the environment that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish the threat." Respondents filed a motion for reconsideration in June 2013 and on September 20, 2013 the Court of Appeals chose to uphold their May decision saying the bt talong field trials violate the people’s constitutional right to a "balanced and healthful ecology." The Supreme Court on Tuesday, December 8, 2015 permanently stopped the field testing for Bt (Bacillus thuringiensis) talong (eggplant), upholding the decision of the Court of Appeals which stopped the field trials for the genetically modified eggplant. The Philippines Supreme Court also took the unprecedented step and invalidated the Department of Agriculture administrative order allowing the field testing, propagation and commercialization, and importation of GMOs.

Europe

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 coexistence regulations. In many cases national coexistence regulations include 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. Larger minimum distance requirements discriminate against adoption of GM crops by smaller farms.

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 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 less risky than transgenic approaches.

In 2014 a panel of experts set up by the UK Biotechnology and Biological Sciences Research Council argued that "A regulatory system based on the characteristics of a novel crop, by whatever method it has been produced, would provide a more effective and robust regulation than current EU processes , which consider new crop varieties differently depending on the method used to produce them." They said that new forms of "genome editing" allow targeting specific sites and making precise changes in the DNA of crops. In the future it would become increasingly difficult if not impossible to tell which method has been used (conventional breeding or genetic engineering) to produce a novel crop. They proposed that existing EU regulatory system should be replaced with a more logical system like that used for new medicines.

In 2015 Germany, Poland, France, Scotland and several other member states opted out of cultivating GMO crops in their territory.

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

As of 2002 the United States, Canada, and Mexico did not require labeling of genetically modified foods.

Canada

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. Environmental assessments of biotechnology-derived plants are carried out by the CFIA's Plant Biosafety Office (PBO). 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.

Mexico

In February 2005, after consulting the Mexican Academy of Sciences, Mexico's senate passed a law allowing to plant and sell 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 had been raised about the impact genetically modified maize could have on local strains. In 2013, a federal judge ordered Mexico’s SAGARPA (Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca, y Alimentación), which is Mexico’s Secretary of Agriculture, and SEMARNAT (Secretaría de Medio Ambiente y Recursos Naturales), equivalent of the EPA, to temporarily halt any new GMO corn permits, accepting a lawsuit brought by opponents of the crop.

United States

Federal regulation

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." In 2015 the Obama administration announced that it would update the way the government regulated genetically modified crops.

For a genetically modified organism to be approved for release, it must be assessed under the Plant Protection Act 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. The FDA has a voluntary consultation process with the developers of genetically engineered plants. The Federal Food, Drug, and Cosmetic Act, which outlines FDA's responsibilities, does not require pre-market clearance of food, including genetically modified food plants. 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). As of 2008, all developers of genetically modified crops in the US had made use of the voluntary process. Final approval can still be denied by individual counties within each state. In 2004, Mendocino County, California became the first county to impose a ban on the "Propagation, Cultivation, Raising, and Growing of Genetically Modified Organisms", the measure passing with a 57% majority. In May, 2014 Jackson and Josephine Counties in Southern Oregon passed initiatives similar to that passed by Mendocino County; both passing by 2 to 1 margins.

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:

State regulation

Several states have passed regulations concerning labelling of GM food; Connecticut passed a GMO labeling bill in May 2013, but the bill will only be triggered after four other states enact similar legislation. On January 9, 2014, Maine’s governor signed a bill requiring labeling for foods made with GMO's, with a similar triggering mechanism as Connecticut's bill. In May 2014 Vermont passed a law requiring labeling of food containing ingredients derived from genetically modified organisms. A federal judge ruled Maui's GMO ban invalid.

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.

Venezuela banned genetically modified seeds in 2004, in 2008, Ecuador prohibited genetically engineered crops and seeds in its 2008 Constitution, approved by 64% of the population in a referendum (although Ecuadorian President Rafael Correa said in 2012 that this was "a mistake". Peru has banned transgenic crops.

Oceania

Malaysia, New Zealand, and Australia require labeling so consumers can exercise choice between foods that have genetically modified, conventional or organic origins.

Australia

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 and was first approved in Western Australia in 2010.

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.

New Zealand

As of 2004 no genetically modified food was grown in New Zealand, 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. Food Standards Australia New Zealand (FSANZ) 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.