[12] For example, the African Centre for Biosafety, as part of its submission, demanded that biotech companies assume liability for any adverse impact of a GMO-related activity on human health and the environment, a demand that was later incorporated into the GMO Act as part of the 2006 amendment (see the Liability Regime section below). [26] The Registrar is also required to arrange for inspection of facilities where GMO-related activities take place and order the cessation of an activity that he or she has established or reasonably suspects is in violation of the GMO Act or a condition set under a permit. A study investigating voluntary labeling in South Africa found that 31% of products labeled as … Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States. [60] When damage occurs, users are responsible for cleanup costs. Criminal and civil penalties may be applied in relation to breaches of the legislation, and offenders may be ordered to mitigate or remedy any adverse effect on people or the environment. The general attitude in England is averse to GM products; however, a slight shift in attitude towards GM products has recently been reported, and the UK government’s policy indicates a more receptive attitude towards these products. The Canadian Food Inspection Agency is responsible for regulating GM plants and approving GM feed for animals. The application of the GMO Act allows South Africa to conduct a science-based case-by-case assessment of the potential risks that may arise from the use of a particular GMO. [41], All facilities (any place where contained use of a GMO takes place) must be registered with the Registrar. The term “significantly different” means “in respect of a foodstuff obtained through certain techniques of genetic modification, that characteristics scientifically assessed through an appropriate analysis of data are different from those of a corresponding existing foodstuff, taking into account accepted limits on natural variation of that foodstuff.” Id. [44], There is a strict application and approval process for the release of GMOs, including a trial release and a general release. Sweden, as a European Union Member, has adopted a case-by-case analysis for each GMO. A GMO-related activity may not be conducted in South Africa without a permit. Accessibility | Official blog from the Law Library of Congress, Back to Restrictions on Genetically Modified Organisms. [44] GMO Act § 19; GMO Regulations § 11, as amended. [22] All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection. 29, 2009), http://www .info.gov.za/view/DownloadFileAction?id=99961. There are currently no GM commercial crops, though imported food and ingredients derived from GMOs must be approved by a food safety authority and clearly labeled on packaging before sale. The testing, production, and marketing of GMOs in China are subject to government approval. The primary legislation in South Africa dealing with GMOs, including their contained use, trial release, commercial release, and import and export is the Genetically Modified Organisms Act of 1997 (GMO Act) and its subsidiary legislation. The country also has no restrictions on releasing genetically modified organisms into the environment. The Department of Health, specifically the Food Control Section, tasked with the responsibility to ensure food safety in the country, has issued regulations requiring that foodstuffs obtained through certain genetic modification techniques be labeled as such before being offered for sale in the marketplace. South Africa IUCN-EPLP No. .”[17] The application of the GMO Act is limited to, As noted above, the GMO Act established three regulatory bodies with specific functions: the EC, the Registrar, and the AC. [64] A person also commits a crime if he refuses to cooperate with or provides false or misleading information to an inspector, the Registrar, the EC, or the AC. Jobs | Relative to other African countries, South Africa embraced biotechnology early on. Further labeling requirements are imposed by the Consumer Protection Act and its subsidiary legislation. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern. Although the Netherlands was the first European Union Member State to have legal coexistence guidelines on genetically engineered (GE) crops, commercial production of GM crops has not yet taken place. USA.gov, Restrictions on Research, Production, and Marketing, Restrictions on Releasing Organisms into the Environment, https://mospace.umsystem.edu/xmlui/bitstream/handle/10355/57/ Biofortified %20Crops%20in%20South%20Africa.pdf?sequence=1, http://www.nda.agric.za/docs/statsinfo/Trends2012.pdf, http://www.daff.gov.za/doaDev/sideMenu/acts/15%20 GMOs%20No15%20% 281997%29.pdf, http://www.info.gov.za/view/DownloadFileAction?id=67850, http://bch.cbd.int/about/countryprofile .shtml?country=za, http://www .info.gov.za/view/DownloadFileAction?id=99961, http://www.doh.gov.za/docs/legislation/acts/2011/Act-541972.pdf, http://www.pmg.org.za/minutes/20060116-genetically-modified-organisms-gmo-amendment-bill-hearings, http://www.services.gov.za /services/webdav/Documents /Agriculture/trial_release.pdf, http://www.nda.agric.za/doaDev/sideMenu/biosafety/doc/understandingGMOs.pdf, http://www.doh.gov.za/healthtopics .php?t=FoodControl, http://www.doh.gov.za/docs/foodcontrol/advertising/2004/fcr25.pdf, http://www.info.gov.za/view/ DownloadFileAction?id=99961, http://www.info.gov.za/ view/DynamicAction?pageid=623&myID=292342, http://www.saflii.org/za/cases/ZAGPHC/2005/135.html, http://www.biowatch.org.za/main.asp?include=about/about.html, http://www.right2info.org/cases/r2i-trustees-for-the-time-being-of-the-biowatch-trust-v.-registrar-genetic-resources-and-others, http://www.saflii .org/za/cases/ZACC/2009/14.pdf. Even though more and more research on GMOs is being performed, people are still concerned. In 2006, during the public hearings it conducted on the GMO Amendment Bill, the Agriculture and Land Affairs Portfolio Committee of South Africa’s Parliament received over ten submissions from a range of pro- and anti-GMO activists, including farmers unions, nongovernmental organizations, governmental agencies, and academics. 25908 (Feb. 26, 2010), http://www.doh.gov.za/docs/foodcontrol/advertising/2004/fcr25.pdf. [56] Regulations Relating to the Labelling of Foodstuffs Obtained Through Certain Techniques of Genetic Modification, GG No. Currently, eighteen GM food lines and fourteen GM feed lines are approved and registered in Russia. Read More The Consumer Protection Act requires that “[a]ny person who produces, supplies, imports or packages any prescribed goods must display on, or in association with the package or those goods, a notice in the prescribed manner and form that that discloses the presence of any genetically modified ingredients or components of those in accordance with applicable regulations.”[58] Goods covered by this requirement are all goods approved for consumption by the EC and containing at least 5% GMOs. A person commits an offense if he contravenes any of the GMO Act’s provisions or any condition, restriction, ban, or instruction imposed under its provisions. [46] In effect, a GMO would not be approved for any form of release if “safety to the environment cannot be demonstrated.”[47], The law also imposes a public notification requirement for the release of GMOs. [34] This includes “activity with genetically modified organisms but it is not limited to the importation, exportation, transit, development, production, release, distribution, use, storage and application of genetically modified organisms only.”[35] However, a permit is not required for organisms under conditions of contained use at containment level 1 or 2 in a registered facility. 2. § 2. GMO use is limited and almost exclusively used in animal fodder products. without authority.”[69] This offense is, on conviction, punishable by a fine and/or up to one year imprisonment. 467 (Apr. Cultivation of transgenic plants for commercial use is not allowed in the Russian Federation. External Link Disclaimer | You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. This Act established three regulatory authorities—an Executive Council, Registrar, and an Advisory Committee—for effective implementation of its objectives. b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the potential receiving environment to the genetically modified organism. While the government and the agriculture sector take a pragmatic approach toward the import and use of GM products, public opinion is divided as to whether GM foods pose health risks. However, terminology indicating the absence of genetic modification below a specific threshold, “Genetically modified content is below 5%”, has been included. Nevertheless, opposition and skepticism persists among various groups, including rights groups, trade unions, and religious organizations. [38] The steps of the assessment should include the following: Once an application is submitted, the EC may approve the application, reject it, or request that the applicant provide additional information; the EC must provide reasons for every decision. Argentina has not ratified the Cartagena Protocol on Biosafety. If the EC deems it fit to do so, an applicant for a permit for a GMO-related activity may also be required to conduct an environmental risk assessment. advising the Minister of Agriculture, Forestry and Fisheries on GMO-related activities and monitoring these activities to ensure that they follow the rules and procedures set under the GMO Act; determining whether an applicant should submit an environmental assessment report; and. The Genetically Modified Organisms Amendment Act No. examining applications for GMO-related activity; ensuring that all users take the necessary measures to protect the environment as well as human and animal health; and. 23 of 2006, Preamble; Country Profile – South Africa, Biosafety Clearing House, Convention on Biological Diversity, http://bch.cbd.int/about/countryprofile .shtml?country=za (last visited Oct. 30, 2013). This includes research and development, import/export, production, consumption, and other uses of GMOs … 15 of 1997, as amended, 2 Butterworths Statutes of the Republic of South Africa [BSRSA] (rev. [18] Id. While there are some existing laws that are indirectly relevant to this subject matter it is fair to say that no comprehensive legal regime on this issue exists at this time. Norway is one of the most restrictive importers of GM products and does not produce GMOs. South African GMO Act implemented. Genetically modified (GM) crops have been produced in the initial adopting countries for 20 years. These differences have created sharp trade conflicts for some nations, while also opening up export opportunities for others that favor GMO technologies. 29, 2009), http://www.info.gov.za/view/ DownloadFileAction?id=99961. The GMO Act also provides a list of activities to which it does not apply, including techniques involving human gene therapy. The aim of these regulations is to ensure that any activity with GMOs is assessed for potential risks to human health and the environment prior to undertaking any such activity. In addition, this enables the country to collect information on the impact and implications of deliberate release of a particular GMO. It further requires that safety to the environment be demonstrated before GMOs can be approved for release. [30] It is also mandated to liaise with international bodies concerned with biosafety through relevant national departments. About | 32966 (Feb. 26, 2010), http://www.info.gov.za/view/117972; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2010, GN No. [7] National Environmental Management: Biodiversity Act No. [31] It consists of up to ten members appointed by the Minister of Agriculture, Forestry and Fisheries, eight of whom must be knowledgeable in the field of science applicable to GMO-related activities. Under the GMO Act, users have a duty to take appropriate measures to avoid an adverse impact on the environment and on human and animal health from the use of GMOs. [10] The study found that eighty percent of those surveyed had limited understanding of biotechnology, and more than two-thirds had never heard of GMOs before. Most legislation in England and Wales that applies to GMOs is implementing legislation for EU law. Finally, it provides for the punishment of administrative violations and criminal offenses. See also a summary of the case at Trustees For the Time Being of the Biowatch Trust v. Registrar Genetic Resources and Others, Right2Info, http://www.right2info.org/cases/r2i-trustees-for-the-time-being-of-the-biowatch-trust-v.-registrar-genetic-resources-and-others (last visited Oct 30, 2013). All activities with GMOs in South Africa are primarily regulated under the GMO Act. . [69] Consumer Protection Act No. As a result of both public hostility to GMOs and these legal restrictions, there are currently no GM crops grown in France, even though France imports substantial amounts of GMOs from abroad. [2] Today, South Africa is the world’s eighth largest producer of GMO crops. . [15], The GMO Act, which is administered by the Department of Agriculture, Forestry and Fisheries (DAFF), and three institutions established under its provisions (the Registrar, the Executive Council (EC), and the Advisory Council (AC)), has a number of objectives. In addition to the primary legislation and regulatory institutions, South Africa also has in place other laws and institutions regulating specific issues relating to GMOs. Health Canada is mandated to assess the safety of foods for human consumption, including GMOs in foodstuff, and for authorizing them to be sold in Canada. [23], The Registrar is appointed by the Minister of Agriculture, Forestry and Fisheries in consultation with the EC. In fact, as reflected by GMO legislation in Italy, Italian public opinion has shifted from a decidedly general opposition to the introduction of GMOs into a more recent open acceptance of them. Pests have been a big problem in South Africa for decades, and GM crops, when first introduced, were seen by many as a new and much-needed solution to the problem. .”[57], A different law imposes additional, specific labeling requirements. In general, the EU espouses the principle that the polluter pays. [3] Department of Agriculture, Forestry and Fisheries, Trends in the Agricultural Sector – 2012 at 11 (2013), http://www.nda.agric.za/docs/statsinfo/Trends2012.pdf. [75] Trustees, Biowatch v. Registrar: Genetic Resources, and Others at 137. [55], South Africa requires that foodstuffs obtained through certain techniques of genetic modification be labeled as such before they are offered for sale in the marketplace. In South Africa, the regulations governing the labelling of foods containing genetically modified organisms (GMOs) is outlined in Section 24 of the Consumer Protection Act, 2008 (No 68 of 2008) , which was signed into law on 24 April 2009 and came into effect on 31 March 2011 . [78], Hanibal Goitom Id. Following a recent regime shift in Norway it is yet unclear whether Norway’s position on GMOs might change. While marketing and importing GMOs and food and feed produced with GMOs are regulated at the EU level, the cultivation of GMOs is an area left to the EU Members. 17, 2007) is available on the South Africa government portal, at http://www.info.gov.za/view/DownloadFileAction?id=67850. Foreign companies that export GMOs to the PRC, including GMOs as raw materials, must apply to the Ministry of Agriculture and obtain GMO Safety Certificates. As a member of the European Union, Italy has been implementing European directives concerning GMOs over the last two decades, but at a rather reluctant pace. 293, § 7, GN No. § 2. * This report was prepared with the assistance of Law Library intern Antoinette Ofosu-Kwakye. This country report was updated June 2014. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases. South Africa– Blue Sky Publications (Pty) Ltd T/A TheSouthAfrican Number: 2005/028472/07. 34180 (Apr. They are attached to the Convention on Biological Diversity of 1993. The Italian Constitutional Court has ruled that the national government is constrained from encroaching on the power of regional governments to establish their own regimes on GMOs. [70] In addition, a violation under the Consumer Protection Act may result in a civil action and/or administrative fines. [6] Genetically Modified Organisms Amendment Act No. The most recent statistical data located regarding public sentiment toward GMOs in South Africa is contained in a 2005 study, which found that only a small segment of South Africa’s public had an understanding of and held an opinion about GMOs. Accessibility | [29], The AC is a national advisory body on all matters having to do with GMO-related activities, including the introduction of GMOs into the environment, contained use, transboundary movement, and drafting of GMO-related laws and guidelines. 68 of 2008, 526 Government Gazette [GG], No. [13] Similarly, one of the farmers unions called for the introduction of labeling requirements for foods containing GMOs. Mexico’s Law on Biosecurity of Genetically Modified Organisms is a federal law that provides rules concerning GMOs, and is aimed at preventing, avoiding, or reducing the risks that these activities may cause. Although GMO growth is not permitted for commercial purposes, GMO products may be imported, sold, and used in the production of food and pharmaceuticals in Israel. [1] South Africa first approved the commercial release of genetically modified, insect-resistant cotton and maize in 1997. Sellers of GM food must follow labeling requirements. [54] As part of its functions, this section oversees the administration of food legislation, which includes publicizing regulations for food safety, labeling food, and evaluating risk assessments for DAFF that are related to agricultural chemicals and food produced through biotechnology. A draft law on biosafety was not approved by the Egyptian Parliament. [16] Legislation, DAFF, http://www.daff.gov.za/# (click on “Agricultural Production, Health & Food Safety Branch,” then “Biosafety,” then “Legislation”) (last visited Oct. 30, 2013); GMO Act, Preamble. Argentina is the third largest grower of biotech crops in the world, after the United States and Brazil. One GM potato for industrial use has been approved for cultivation in Sweden, but currently no GMOs are being produced. GMOs are regulated in the United States under the Coordinated Framework for Regulation of Biotechnology, published in 1986, pursuant to previously existing statutory authority regulating conventional products, with a focus on the nature of the products rather than the process in which they are produced. Most of Belgium’s regulation of GMOs is directly or indirectly derived from European regulations. 1, 2011), http://www.info.gov.za/ view/DynamicAction?pageid=623&myID=292342. . addressing any matter related to GMO-related activities. A majority of Swedes consider it important that their milk is GMO free, and dairy farmers therefore avoid GMOs in their fodder. [4] Genetically Modified Organisms Act (GMO Act) No. In Brazil, GMOs are governed by a law that defines the concept of a GMO and sets rules for the laboratories that work with them. The 1997 GMO Act is available on the Department of Agriculture, Forestry and Fisheries (DAFF) website, at http://www.daff.gov.za/doaDev/sideMenu/acts/15%20 GMOs%20No15%20% 281997%29.pdf. Prior risk assessment and subsequent monitoring and reporting are necessary for all GMO-related activities. The GMO Act imposes civil liability on people who conduct GMO-related activities for damage they cause and criminalizes various acts, including violations of its provisions or refusing to cooperate with the regulatory bodies. During this period, genetically modified maize accounted for 79% (2.1 million hectares) of the commercial land planted with maize, with white maize accounting for 78% (1.3 million hectares) and yellow maize accounting for 81% (863,277 hectares) of the total maize planted in their respective classes. A person interested in carrying out a GMO-related activity may make … There are several EU-approved GMOs that are specifically illegal in Norway. [74] The court, in its decision, noted that access to information in South Africa is not an absolute right and that it should be weighed against justifiable governmental and private concerns for maintaining confidentiality of certain information. Swedes, both consumers and producers, are very conscious of GMOs. Genetically Modified Crops in Africa: Economic and Policy Lessons from Countries South of the Sahara investigates how this tool might be effectively used by evaluating the benefits, costs, and risks for African countries of adopting GM crops. [5] The GMO Act was amended in 2006 (although the amendment did not take effect until 2010) in part to give effect to the Cartagena Protocol on Biosafety, which South Africa ratified in 2003. The EU’s legislation and policy on GMOs is designed to prevent any adverse effects on the environment and the health and safety of humans and animals, and it reflects concerns expressed by skeptical consumers, farmers, and environmentalists. Developing countrie… Egyptian activists have voiced their rejection of this policy. [59], The GMO Act imposes two forms of liability: civil and criminal liability. March 2014. [66] In addition, a person who violates any of the GMO Regulations commits an offense. The growth and sale of GMOs are permitted in England and Wales, subject to an intensive authorization process that occurs primarily at the European Union level. As of 2012, GMO planting had expanded to the following nations: USA: Corn, soybean, … [14] PMG, Genetically Modified Organisms Amendments Bill: Hearings, Submission by Kwangwanase Farmers Union, supra note 12. Under South Africa’s “GMO” Act, an Executive Council (EC), consisting of representatives of seven government departments is established. Most South Africans, without their knowledge or consent, are unknowingly consuming genetically modified food products every single day. There are strict rules on how a scientifically-based risk assessment is to be conducted. The European Union and International Protocols. 23 of 2006 (Apr. . Plant GMOs are regulated by the US Department of Agriculture’s Animal and Plant Health Inspection Service under the Plant Protection Act. 57 of 1978) Patent Regulations, 1978 Patent Examination Regulations, 2003 Notice in terms of Regulation 2 of the Patents Regulations Plant Breeders’ Rights Act (No.15 of 1976) Plant Breeders’ Rights Amendment Act, 1996 (No. [50], If there is an accident involving unintentional environmental release or transboundary movement of GMOs, the user must notify the Registrar both verbally and in writing by providing relevant information, including the estimated quantities, date of the release, and possible adverse effect on the environment and on human and animal health and safety. [14], Despite the recognition of the risks involved, GMO-related activities appear to enjoy support within scientific and academic circles, with supporters believing that the risks are manageable. [68], The Consumer Protection Act, which imposes labeling requirements on food items containing a certain level of GMOs, also criminalizes certain acts. [19] Some of its functions include, The EC may have up to ten members, who are appointed by the Minister of Agriculture, Forestry and Fisheries. [6] There are also a number of other laws imposing additional rules on GMO-related activities, including the National Environmental Management: Biodiversity Act (NEMBA),[7] the Consumer Protection Act,[8] and the Foodstuffs, Cosmetics and Disinfectants Act.[9]. As a consequence, some regions have enacted slightly more permissive regimes than others. 2012). Why are GMOs regulated? The GMO Act places various restrictions on the research, production, and marketing of GMOs, including requiring permits, risk assessments, notification to the public, registration, and demonstrated safety to the environment. Mexico’s Federal Criminal Code provides that an individual who, in contravention of applicable law, commercializes, transports, stores, or releases into the environment a GMO that negatively alters or may alter the components, structure, or functioning of natural ecosystems is punishable with imprisonment of one to nine years and a fine. [73] Id. 34020 (Feb. 18, 2011), http://www.info.gov.za /view/142060; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. 68 of 2008, § 110, 526 GG No. [5] Genetically Modified Organisms Act, 1997, Regulations, 2010, Government Notices [GN] No. The use of GMOs in food is a sensitive topic that generates strong public opinion. GMOs are regulated in Argentina under the Law on Seeds and Phytogenetic Creations and the Law on the Promotion of the Development and Production of Modern Biotechnology, and under administrative regulations issued by the Secretary of Agriculture, Livestock, Fisheries and Food. [27], Inspections are conducted by inspectors appointed by the Registrar. South Africa permits the production of genetically modified crops through the Genetically Modified Organisms Act of 1997 (Click here to download the Act). . Research on genetically engineered animals is not supported by the government. [74] Trustees, Biowatch v. Registrar: Genetic Resources, and Others, at 119–26. Foreign Law Specialist* Additionally, it establishes authorization procedures for GMO research, and establishes rules for the production and marketing of GMOs, restrictions on their release into the environment, regimes for their cultivation, requirements for reporting their release, inspections and monitoring of GMO research activities and their commercial release, implementing authorities and authorizing procedures for their release, and restrictions on GMOs in foodstuffs. approving applications for the use of facilities for conducting GMO-related activities in consultation with the AC. Israel’s religious kashrut authority has determined that the use of GMO ingredients in food does not affect its kosher status because GMOs are only used in “microscopic” proportions. Russia recently adopted an approval procedure for release of GMOs into the environment, which brings the country closer to possible cultivation of GM plants. French legislation supplements the broader framework of European regulation with national rules that provide additional restrictions, particularly focused on the potential release of GMOs in the environment, and on labeling requirements for GM products. By 2013 Cameroon, Malawi and Uganda had approved trials of genetically modified organism,. Canadian food Inspection Agency is responsible for regulating GM plants and approving GM feed for.! Various controls analysis for each GMO through certain techniques of Genetic Modification, No... 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