[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. 467 (Apr. They are required to take a number of actions, including ceasing the act causing the damage, containing/minimizing the spread of the GMOs, eliminating the source of the damage, and remedying the damage caused. 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. [54] Food Control, Department of Health, http://www.doh.gov.za/healthtopics .php?t=FoodControl (click on “Food Control” under “Health Topics”) (last visited Oct. 30, 2013). How are GMOs regulated in South Africa? A person interested in carrying out a GMO-related activity may make … 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. [ii] The GMO Act created a forum for cultivators, farmers … [48] Where there are no newspapers circulating in the immediate area in which the proposed trial release will take place, the applicant has to inform the public through other means of effective communication, document the means of communication employed, and submit it to the Registrar as proof. [11], However, various key organizations have shown interest in the process of overhauling the GMO regulatory regime. if the EC deems it appropriate, an environmental risk assessment. 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. [70] In addition, a violation under the Consumer Protection Act may result in a civil action and/or administrative fines. RELATED: GMOs in South Africa: Facts at a Glance The first GM crops, yellow maize hybrids from Monsanto, were introduced in 1997. The statistics for the 2011–12 maize production season illustrate the scale of GMO penetration in the country. 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. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases. 1 December 1999. The GMO Act places various restrictions on the research, production, and marketing of GMOs. .”[57], A different law imposes additional, specific labeling requirements. [42] The application for registration must include the name of the person taking responsibility for the facility; a map of the facility showing the different units within the facility; a locality map that includes geographic coordinates; a science-based risk assessment of the activity within the facility; and the proposed risk-management mechanism, measures, and strategies. [i] The Act was aimed at regulating all South Africa’s genetically modified activities. As of 2012, GMO planting had expanded to the following nations: USA: Corn, soybean, … 1, 2011), http://www.info.gov.za/ view/DynamicAction?pageid=623&myID=292342. The GMO Law provides that violations of its provisions or its regulations are punishable with civil penalties. § 2. 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 regulation for mandatory GM labelling in South Africa does not make provision for the terms "GMO free", "non-GM" or "organic". The GMO Act authorizes the inspectors to investigate and, among other things, seek and obtain warrants to search for and seize various items, including GMOs and documents, whenever the inspectors have reason to believe that the GMO Act has been violated. The second section has materials discussing the issue in particular jurisdictions and is divided into sections on Africa, the Americas, Asia, and Europe. [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. Sellers of GM food must follow labeling requirements. GMOs are safe. Press | 68 of 2008, § 24, 526 GG No. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern. Press | [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). 81 2 Summary of the challenges facing protected areas in South Africa 2.1 Poor conservation planning Prior to 2000, planning was wholly inadequate within South Africa’s conservation sector and the country’s protected areas network accordingly arose in a largely ad hoc manner. . [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. [77], Matters pertaining to cost were litigated further on appeal and settled by the Constitutional Court. 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. GMOs are not legal in all countries around the world. About | Egyptian laws do not contain restrictions on researching, producing, or marketing genetically modified crops and food products. Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. 467 (Apr. [71], In 2005, questions regarding access to information on GMO-related activities were litigated in court. 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. [9] Foodstuffs, Cosmetics and Disinfectants Act No. Although it is legal to plant GM crops in Japan if certain procedures are followed, no commercial planting of GM crops (aside from ornamental flowers) is occurring in Japan at this time, mainly because the general public is skeptical about the safety of GM crops. Donate USA.gov. [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. 32966 (Feb. 26, 2010), http://www.info.gov.za/view/117972; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2010, GN No. [44], There is a strict application and approval process for the release of GMOs, including a trial release and a general release. Genetically modified (GM) crops have been produced in the initial adopting countries for 20 years. Despite the higher cost of GM seeds, adoption by many farmers was quick, steady, and widespread. Developing countrie… Relative to other African countries, South Africa embraced biotechnology early on. Ethiopia has also revised its biosafety laws and … Foreign Law Specialist* [76] The Court also found unacceptable the Registrar’s claim that Biowatch’s request was too broad, noting that the Registrar had a legal obligation to work with Biowatch to identify the relevant information sought. Prior risk assessment and subsequent monitoring and reporting are necessary for all GMO-related activities. For instance, it requires a permit for conducting most GMO-related activities, and conducting such activities entails putting in place scientifically-based risk assessment measures and notifying the public before the release of GMOs into the environment. 12, 2010), http://www.info.gov.za/view/123130; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. [66] In addition, a person who violates any of the GMO Regulations commits an offense. 36124 (Feb. 8, 2013), http://www.info.gov.za/view/183647 (hereinafter collectively referred to as GMO Regulations, as amended). [40] If the EC approves an application, it must include all applicable terms and conditions that the Registrar may then attach to a permit. Biotechnology, genetic modi cation, genetic engineering and GMOs are terms for essentially the same process: breeding crops and livestock to have certain desirable traits. [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. Genetically Modified Organisms in Food focuses on scientific evaluation of published research relating to GMO food products to assert their safety as well as potential health risks. South Africa permits the production of genetically modified crops through the Genetically Modified Organisms Act of 1997 (Click here to download the Act). 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. [2] Today, South Africa is the world’s eighth largest producer of GMO crops. The EC, a juristic person, has a number of key functions in the application and approval process for GMO-related activities. [75] Trustees, Biowatch v. Registrar: Genetic Resources, and Others at 137. 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. 2. [47] Understanding Genetically Modified Organisms: What Are the Issues of Concern for the Environment?, DAFF, http://www.nda.agric.za/doaDev/sideMenu/biosafety/doc/understandingGMOs.pdf (last visited Oct. 30, 2013). In addition, this enables the country to collect information on the impact and implications of deliberate release of a particular GMO. [65] A person who impersonates any officer appointed under the GMO Act also commits a crime. 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.”However, a permit is not required for organisms under conditions of contained use at containment level 1 or 2 in a registered facility. [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. 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 . Legal | The European Union (EU) has in place a comprehensive and strict legal regime for GMOs, food and feed made from GMOs, and food/feed consisting or containing GMOs. Dr. Hennie Groenewald, executive manager at Biosafety South Africa, which is a national biosafety service platform within the nation’s technology innovation agency, said the country immediately knew what to do when the first genetically modified (GM) crop … 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. Accessibility | [18] Id. This bibliography lists selected, recent English-language works on restrictions on GMOs. External Link Disclaimer | [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. 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. . GMOs and food or feed made from GMOs can be marketed in or imported into the EU, provided that they are authorized after passing strict evaluation and safety assessment requirements that are imposed on a case-by-case basis. South African Government www.gov.za Let's grow South Africa together at 113; About Us, Biowatch South Africa, http://www.biowatch.org.za/main.asp?include=about/about.html (last visited Oct. 30, 2013). Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States. [59] The Consumer Protection Act Regulations, No. 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. An applicant who seeks to undertake a general or commodity release must publish a notice in at least three national newspapers; a proposed trial release requires publication of a notice in at least two local newspapers and one national newspaper. [33], A GMO-related activity may not be conducted in South Africa without a permit. § 2. Kenya passed laws in 2011, and Ghana and Nigeria passed laws in 2012 which allowed the production and importation of GM crops. Argentina has not ratified the Cartagena Protocol on Biosafety. However, several types of GM food and feed lines that have passed the procedure of state registration and control are allowed to be imported, processed, and used for food or feed production. [28] In addition, inspectors have the power to conduct routine, unannounced, and warrantless inspections of facilities registered for conducting GMO-related activities, and take samples of GMOs. d) An estimate of the overall risk proposed by the genetically modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized. A majority of Swedes consider it important that their milk is GMO free, and dairy farmers therefore avoid GMOs in their fodder. 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. Donate Apply for a permit at the Registrar of Genetically Modified Organisms (GMOs). 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. [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. All activities with GMOs in South Africa are primarily regulated under the GMO Act (Act 15 of 1997). GM techniques have been approved for use in research involving both plants and animals, subject to various controls. [23], The Registrar is appointed by the Minister of Agriculture, Forestry and Fisheries in consultation with the EC. [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. ), The task of ensuring food safety in South Africa is under the jurisdiction of the Department of Health (DoH), specifically the Food Control Section. It makes it an offense for anyone to “alter, obscure, falsify, remove or omit . [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. [62] In addition, users are subject to liability for damage caused by GMO-related activity, unless the GMO was in the possession of an inspector and the user could not have foreseen or prevented the damage. 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. in South Africa. The various permits allow the following activities: importation of GMOs into South Africa; exportation of GMOs from South Africa The GMO Act also provides a list of activities to which it does not apply, including techniques involving human gene therapy. approving applications for the use of facilities for conducting GMO-related activities in consultation with the AC. 25908 (Feb. 26, 2010), http://www.doh.gov.za/docs/foodcontrol/advertising/2004/fcr25.pdf. [13] Id., Submission by African Centre for Biosafety; GMO Act § 17. Legal | [27], Inspections are conducted by inspectors appointed by the Registrar. 29, 2009), http://www.info.gov.za/view/ DownloadFileAction?id=99961. South Africa– Blue Sky Publications (Pty) Ltd T/A TheSouthAfrican Number: 2005/028472/07. [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. [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. 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). Argentina is the third largest grower of biotech crops in the world, after the United States and Brazil. You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. [74] Trustees, Biowatch v. Registrar: Genetic Resources, and Others, at 119–26. [63], The GMO Act and its subsidiary legislation also impose criminal liability for certain actions. Labeling of GMO products in the marketplace is required in 64 countries. [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. labeling . 33007 (Mar. ed. [78] Biowatch Trust v Registrar Genetic Resources and Others 2009 (6) SA 232 (CC), available at http://www.saflii .org/za/cases/ZACC/2009/14.pdf. [69] Consumer Protection Act No. [32] Two of the members must be from the public sector. Argentina is the third largest grower of biotech crops in the world, after the United States and Brazil. 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). Genetically modified crops are currently grown in 29 nations around the world, while dozens ban farmers from planting GMO crops. 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. Most South Africans, without their knowledge or consent, are unknowingly consuming genetically modified food products every single day. 34180 (Apr. 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. 17, 2007) is available on the South Africa government portal, at http://www.info.gov.za/view/DownloadFileAction?id=67850. Germany discourages the cultivation of GM crops to the extent possible within the already stringent European Union legislation on GMOs. [7] National Environmental Management: Biodiversity Act No. The GMO Act and applicable implementing regulations and biosafety framework govern the regulation of biotech crops in South Africa. The regulation for mandatory GM labelling in South Africa does not make provision for the terms “GMO free”, “non-GM” or “organic”. 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. [30] It is also mandated to liaise with international bodies concerned with biosafety through relevant national departments. Genetically Modified Organisms (GMOs) Approach At Mars, we not only ensure the safety of all raw materials in our products, we also are committed to being transparent with our consumers so they can understand what is in the products they love. 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. [52] One of the functions of this institution is to “monitor and report regularly” to the Minister of Water and Environmental Affairs on the effects of any released GMO, including the impact on “non-target organisms and ecological processes, indigenous biological resources and biological diversity of species used for agriculture.”[53] (For information on cleanup costs and liability when damage occurs, see the Liability Regime section below. A number of national and international regulations govern the use of genetically modified organisms (GMOs) in South Africa. 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. [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. * This report was prepared with the assistance of Law Library intern Antoinette Ofosu-Kwakye. Russia recently adopted an approval procedure for release of GMOs into the environment, which brings the country closer to possible cultivation of GM plants. [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). [5] Genetically Modified Organisms Act, 1997, Regulations, 2010, Government Notices [GN] No. [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. [45] If the release of a GMO “may pose a threat to an indigenous species or the environment no permit for such a release may be issued unless an environmental impact assessment has been conducted” under the terms of the relevant law. [58] Consumer Protection Act No. Why are GMOs regulated? [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. [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. [22] All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection. [1] South Africa first approved the commercial release of genetically modified, insect-resistant cotton and maize in 1997. 23 of 2006 (Apr. 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. 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. 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