12, 2010), http://www.info.gov.za/view/123130; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. . Finally, it provides for the punishment of administrative violations and criminal offenses. USA.gov. [49]  The notice must include, among other things, information about the applicant, the objective of the application, the general description of the GMOs, and the place of release. The report discusses the legislation of genetically modified organisms (GMOs) and genetically modified (GM) plants and foods in Argentina, Belgium, Brazil, Canada, China, Egypt, England and Wales, France, Germany, Israel, Italy, Japan, Lebanon, Mexico, the Netherlands, New Zealand, Norway, the Russian Federation, South Africa, South Korea, Sweden, and the United States. [69] Consumer Protection Act No. The statistics for the 2011–12 maize production season illustrate the scale of GMO penetration in the country. Criminal penalties and administrative sanctions may be applied to violations of licensing requirements. There are several EU-approved GMOs that are specifically illegal in Norway. A draft law on biosafety was not approved by the Egyptian Parliament. [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]. Read More The testing, production, and marketing of GMOs in China are subject to government approval. South African GMO Act implemented. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases. Such activities must be approved by the Environmental Protection Authority, which is required to take into account environmental, economic, social, cultural, and public health considerations. [61]  If the user fails to take any such measures, the EC may step in and take all the necessary actions at the user’s expense. [73] Id. 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. The GMO Act and applicable implementing regulations and biosafety framework govern the regulation of biotech crops in South Africa. As Norway is only part of the European Economic Area and not a full European Union Member it is not bound by EU Directives but generally implements EU Directives nonetheless. The second section has materials discussing the issue in particular jurisdictions and is divided into sections on Africa, the Americas, Asia, and Europe. 35007 (Feb. 10, 2012), http://www.info.gov.za/view/159582; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. The form of regulation varies depending on the type of GMO involved. GM techniques have been approved for use in research involving both plants and animals, subject to various controls. The regulation for mandatory GM labelling in South Africa does not make provision for the terms "GMO free", "non-GM" or "organic". 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. Why are GMOs regulated? 34020 (Feb. 18, 2011), http://www.info.gov.za /view/142060; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN 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. This report summarizes enacted laws on the cultivation and sale of GMOs, as well as public opinion on GM products. [16], The Act defines a GMO as “[a]n organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both. 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. Kenya passed laws in 2011, and Ghana and Nigeria passed laws in 2012 which allowed the production and importation of GM crops. Most of Belgium’s regulation of GMOs is directly or indirectly derived from European regulations. 293, § 7, GN No. RELATED: GMOs in South Africa: Facts at a Glance The first GM crops, yellow maize hybrids from Monsanto, were introduced in 1997. 467 (Apr. Inspector General | Press | [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. To date, legislation specifically regulating the labeling of GMO components in food does not appear to have been passed. Egyptian activists have voiced their rejection of this policy. [1] Rosemary A. Wolson, Assessing the Prospects for the Adoption of Biofortified Crops in South Africa, 10(3) AgBioForum 184 (2007), available at https://mospace.umsystem.edu/xmlui/bitstream/handle/10355/57/ Biofortified %20Crops%20in%20South%20Africa.pdf?sequence=1. 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. Following a recent regime shift in Norway it is yet unclear whether Norway’s position on GMOs might change. A person interested in carrying out a GMO-related activity may make … [57] Id. 23 of 2006 (Apr. [68], The Consumer Protection Act, which imposes labeling requirements on food items containing a certain level of GMOs, also criminalizes certain acts. [13]  Similarly, one of the farmers unions called for the introduction of labeling requirements for foods containing GMOs. . Although Lebanon ratified the Convention on Biological Diversity in 1994 and the Cartagena Protocol in 2008, it has not yet adopted policies dealing with GMOs. The GMO Act places various restrictions on the research, production, and marketing of GMOs. Argentina has not ratified the Cartagena Protocol on Biosafety. 32966 (Feb. 26, 2010), http://www.info.gov.za/view/117972; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2010, GN No. 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. 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. At a Glance. [8] Consumer Protection Act No. Germany imposes strict liability for accidental contamination with GMOs, and has tough and methodically enforced controls over the release of GMOs. 673) Genetically Modified Organisms Act … 68 of 2008, 526 Government Gazette [GG], 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. 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. 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. The Department of Agriculture houses the GMO Secretariat and all decision-making is managed by 25908 (Feb. 26, 2010), http://www.doh.gov.za/docs/foodcontrol/advertising/2004/fcr25.pdf. Foreign Law Specialist* [43], Any applicant aggrieved by a decision or action of the EC, the Registrar, or an inspector may appeal before the Minister of Agriculture, Forestry and Fisheries within thirty days of the issuance of the decision or action in question. GMO Policies by Country describes laws in different countries allowing or banning Genetically Modified Organisms (GMOs). About | a) Identification of any potential adverse effect resulting from the novel genotypic and/or phenotypic characteristics of the genetically modified organism. [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. [33], A GMO-related activity may not be conducted in South Africa without a permit. [24]  Among the Registrar’s functions are, The Registrar is required by law to keep a register of all facilities used for the contained use of GMOs, all trial release sites, and the names and addresses of all users (individuals involved in GMO-related activities). 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. The regulation for mandatory GM labelling in South Africa does not make provision for the terms “GMO free”, “non-GM” or “organic”. in South Africa. As the official representative body for the sector, AFMA positions and aligns itself by identifying the business environment that will benefit its members. [36], A person interested in carrying out a GMO-related activity may make an application to the Registrar, and the application must include. [73]  When the Registrar refused to release information on the grounds that the request was too broad and that part of the information sought was proprietary in nature, Biowatch instituted a legal action before the High Court against the Registrar, the EC, and others. Egypt takes a permissive approach to GMOs, and its public policy does not oppose growing, importing, and exporting genetically modified crops. 29, 2009), http://www.info.gov.za/view/ DownloadFileAction?id=99961. Currently, eighteen GM food lines and fourteen GM feed lines are approved and registered in Russia. 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. About | The assessment should take into account current national, regional, and international risk-assessment methods. [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. [51], Once released, the impact of GMOs on the environment is monitored by a separate institution, the South African National Biodiversity Institute, a juristic person established under NEMBA. [9] Foodstuffs, Cosmetics and Disinfectants Act No. [22]  All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection. You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. 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. The country also has no restrictions on releasing genetically modified organisms into the environment. .”[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. 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. § 2. The agricultural GMO regulations regulate not only crops, but also animals, microorganisms, and products derived from these sources. [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. The primary legislation governing the issue is the Genetically Modified Organisms Act of 1997 (GMO Act)[4] and its subsidiary legislation (GMO Regulations). 29, 2009), http://www .info.gov.za/view/DownloadFileAction?id=99961. Overall, regulation of GMOs in Belgium is mostly focused on authorization requirements prior to their production, use, or distribution; on mandatory technical requirements to limit the potential release of GMOs into non-GMO fields; and on information and transparency measures. 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). 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. This country report was updated June 2014. approving applications for the use of facilities for conducting GMO-related activities in consultation with the AC. The EC reviews all GE applications submitted in terms of the “GMO” Act and uses a case-by-case and precautionary approach to ensure sound decision-making in the There are strict rules on how a scientifically-based risk assessment is to be conducted. [45] Department of Agriculture, Application for Intentional Introduction (Conduct a Trial Release) of a Genetically Modified Organism into the Environment of South Africa, http://www.services.gov.za /services/webdav/Documents /Agriculture/trial_release.pdf (last visited Oct. 30, 2013). [18] Id. There are two major international protocols that address genetically modified organisms, the Cartagena Protocol of  2000 and the Nagoya-Kuala Lumpur Supplementary Protocol of 2010. 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. [2]  Today, South Africa is the world’s eighth largest producer of GMO crops. Over this period of time, hundreds of articles and reports have been published by academic journals, government regulatory agencies, and national science organizations on the safety aspects of biotechnology and GM crops. Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States. [56]  The law imposes this requirement if the composition, nutritional value, mode of storage, preparation, or cooking “of the foodstuff differs significantly from the characteristic composition of the corresponding existing foodstuff. [21]  Members must include representatives from various departments listed in the GMO Act, including the Department of Science and Technology and the Department of Environmental Affairs and Tourism, who are well versed on the impact of GMOs in their respective fields/sectors and applicable law and policy. Genetically modified crops are currently grown in 29 nations around the world, while dozens ban farmers from planting GMO crops. 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. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern. [i] The Act was aimed at regulating all South Africa’s genetically modified activities. 15 of 1997, as amended, 2 Butterworths Statutes of the Republic of South Africa [BSRSA] (rev. As a consequence, some regions have enacted slightly more permissive regimes than others. [13] Id., Submission by African Centre for Biosafety; GMO Act § 17. [41], All facilities (any place where contained use of a GMO takes place) must be registered with the Registrar. Most South Africans, without their knowledge or consent, are unknowingly consuming genetically modified food products every single day. 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. Argentina has not ratified the Cartagena Protocol on Biosafety. . 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