[40]  If the EC approves an application, it must include all applicable terms and conditions that the Registrar may then attach to a permit. Belgium is considered to have an intermediate level of restrictions on GMOs, although public opinion tends to generally be hostile to GMOs. [12] Parliamentary Monitoring Group (PMG), Genetically Modified Organisms Amendments Bill: Hearings (Jan. 17, 2006), http://www.pmg.org.za/minutes/20060116-genetically-modified-organisms-gmo-amendment-bill-hearings. [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. Genetically modified crops are currently grown in 29 nations around the world, while dozens ban farmers from planting GMO crops. The testing, production, and marketing of GMOs in China are subject to government approval. 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. 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. A study investigating voluntary labeling in South Africa found that 31% of products labeled as … A person interested in carrying out a GMO-related activity may make … 23 of 2006 (Apr. § 2. Canada regulates products derived from biotechnology processes as part of its existing regulatory framework for “novel products.” The focus is on the traits expressed in the products and not on the method used to introduce those traits. 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. This bibliography lists selected, recent English-language works on restrictions on GMOs. 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. At an African Agriculture Conference in 2012, 24 African countries agreed to allow the use of genetically modified crops. [2]  Today, South Africa is the world’s eighth largest producer of GMO crops. External Link Disclaimer | 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. There are several EU-approved GMOs that are specifically illegal in Norway. [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. 29, 2009), http://www .info.gov.za/view/DownloadFileAction?id=99961. 17, 2007) is available on the South Africa government portal, at http://www.info.gov.za/view/DownloadFileAction?id=67850. [6] Genetically Modified Organisms Amendment Act No. [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. Donate The various permits allow the following activities: importation of GMOs into South Africa; exportation of GMOs from South Africa Prior risk assessment and subsequent monitoring and reporting are necessary for all GMO-related activities. 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 … [22]  All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection. 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. 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. [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. 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. Russia recently adopted an approval procedure for release of GMOs into the environment, which brings the country closer to possible cultivation of GM plants. Following a recent regime shift in Norway it is yet unclear whether Norway’s position on GMOs might change. Accessibility | 34180 (Apr. This includes research and development, import/export, production, consumption and other uses of … [33], A GMO-related activity may not be conducted in South Africa without a permit. Egypt takes a permissive approach to GMOs, and its public policy does not oppose growing, importing, and exporting genetically modified crops. The GMO Act also provides a list of activities to which it does not apply, including techniques involving human gene therapy. [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. How are GMOs regulated in South Africa? The first section contains discussions of aspects of the topic in general and in international law. The GMO Act and applicable implementing regulations and biosafety framework govern the regulation of biotech crops in South Africa. [74] Trustees, Biowatch v. Registrar: Genetic Resources, and Others, at 119–26. As the official representative body for the sector, AFMA positions and aligns itself by identifying the business environment that will benefit its members. if the EC deems it appropriate, an environmental risk assessment. 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. 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. Jobs | They apply only to transboundary actions; they do not apply to use or transit of GMOs within countries. [75] Trustees, Biowatch v. Registrar: Genetic Resources, and Others at 137. 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. labeling . Genetically modified (GM) crops have been produced in the initial adopting countries for 20 years. 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. Apply for a permit at the Registrar of Genetically Modified Organisms (GMOs). [8] Consumer Protection 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. [44], There is a strict application and approval process for the release of GMOs, including a trial release and a general release. . [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. Egyptian laws do not contain restrictions on researching, producing, or marketing genetically modified crops and food products. By 2013 Cameroon, Malawi and Uganda had approved trials of genetically altered crops. [65]  A person who impersonates any officer appointed under the GMO Act also commits a crime. Finally, it provides for the punishment of administrative violations and criminal offenses. [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. [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. Donate [30]  It is also mandated to liaise with international bodies concerned with biosafety through relevant national departments. Official blog from the Law Library of Congress, Back to Restrictions on Genetically Modified Organisms. A GMO-related activity may not be conducted in South Africa without a permit. This report summarizes enacted laws on the cultivation and sale of GMOs, as well as public opinion on GM products. The use of GMOs in food is a sensitive topic that generates strong public opinion. Importing, cultivating, researching, and developing GMOs are permitted, as long as applicable procedures are observed. [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. Africa include 5 Argentine canola, 10 cotton, 42 maize, 1 rice (for food), and 12 soybeans. [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. [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. a) Identification of any potential adverse effect resulting from the novel genotypic and/or phenotypic characteristics of the genetically modified organism. 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. 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. [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. [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. 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. Israeli law permits the development and growth of GMOs for research purposes in accordance with requirements established by subsidiary legislation. 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. [67]  A conviction for any of these crimes is punishable by a fine or up to two years imprisonment; a second or subsequent conviction may result in up to four years imprisonment. [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. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases. [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. Typically, the GMO events that have been commercialized in South Africa have therefore been subjected to the regulatory requirements and scrutiny of various other countries as well. This report briefly discusses key aspects of the GMO regulatory regime, including relevant legislation, regulatory bodies, and available case law on the subject. at 113; About Us, Biowatch South Africa, http://www.biowatch.org.za/main.asp?include=about/about.html (last visited Oct. 30, 2013). [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. 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. 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. 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 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. GMOs in food, drugs, and biological products are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. External Link Disclaimer | c)      An evaluation of the consequences should these adverse effects be realized. 68 of 2008, § 24, 526 GG No. 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 467 (Apr. At a Glance. About | You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. Norway is one of the most restrictive importers of GM products and does not produce GMOs. The statistics for the 2011–12 maize production season illustrate the scale of GMO penetration in the country. [14] PMG, Genetically Modified Organisms Amendments Bill: Hearings, Submission by Kwangwanase Farmers Union, supra note 12. [1]  South Africa first approved the commercial release of genetically modified, insect-resistant cotton and maize in 1997. The agricultural GMO regulations regulate not only crops, but also animals, microorganisms, and products derived from these sources. The primary legislation governing the issue is the Genetically Modified Organisms Act of 1997 (GMO Act)[4] and its subsidiary legislation (GMO Regulations). Even though more and more research on GMOs is being performed, people are still concerned. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern. [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. 68 of 2008, § 110, 526 GG No. . 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. . [13] Id., Submission by African Centre for Biosafety; GMO Act § 17. GM techniques have been approved for use in research involving both plants and animals, subject to various controls. Inspector General | ed. Germany discourages the cultivation of GM crops to the extent possible within the already stringent European Union legislation on GMOs. approving applications for the use of facilities for conducting GMO-related activities in consultation with the AC. 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. The importation, development, testing, and release of GMOs are strictly regulated in New Zealand. Legal | [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). [68], The Consumer Protection Act, which imposes labeling requirements on food items containing a certain level of GMOs, also criminalizes certain acts. Cultivation of transgenic plants for commercial use is not allowed in the Russian Federation. Germany imposes strict liability for accidental contamination with GMOs, and has tough and methodically enforced controls over the release of GMOs. 467 (Apr. Legal | Most legislation in England and Wales that applies to GMOs is implementing legislation for EU law. Biotechnology, genetic modi cation, genetic engineering and GMOs are terms for essentially the same process: breeding crops and livestock to have certain desirable traits. 54 of 1972 (May 19, 1972), available on the South African Department of Health website, at http://www.doh.gov.za/docs/legislation/acts/2011/Act-541972.pdf. 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. These include promoting responsible GMO-related activities; limiting harm to the environment as well as to human and animal health; and establishing standards for conducting risk assessments for GMO-related activities. [75]  However, the Court held that Biowatch was entitled to access some information and that the Registrar’s refusal to grant access to such information violated Biowatch’s constitutional rights. 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. Criminal penalties and administrative sanctions may be applied to violations of licensing requirements. [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). [63], The GMO Act and its subsidiary legislation also impose criminal liability for certain actions. [78], Hanibal Goitom [9] Foodstuffs, Cosmetics and Disinfectants Act No. Activities involving GMOs are for research purposes in laboratories or field trials, and are tightly regulated, in particular through EU Directives made applicable in the Netherlands. . [70]  In addition, a violation under the Consumer Protection Act may result in a civil action and/or administrative fines. Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The Department of Agriculture houses the GMO Secretariat and all decision-making is managed by [18] Id. Why are GMOs regulated? [i] The Act was aimed at regulating all South Africa’s genetically modified activities. [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. [11], However, various key organizations have shown interest in the process of overhauling the GMO regulatory regime. These differences have created sharp trade conflicts for some nations, while also opening up export opportunities for others that favor GMO technologies. 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. 2. Swedes, both consumers and producers, are very conscious of GMOs. Since 2001 the EU has had a de facto moratorium on GMO approvals, but a September 2013 decision of the General Court of the EU may put an end to the moratorium. [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. South African GMO Act implemented. All activities with GMOs in South Africa are primarily regulated under the GMO Act (Act 15 of 1997). 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. 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. One of these members must be knowledgeable on ecological matters and GMOs, while the other must be well versed on the effects of GMOs on human and animal health. Under South Africa’s “GMO” Act, an Executive Council (EC), consisting of representatives of seven government departments is established. 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. Kenya passed laws in 2011, and Ghana and Nigeria passed laws in 2012 which allowed the production and importation of GM crops. 10 of 2004 [NEMBA], 20 BSRSA (rev’d through 2012). [23], The Registrar is appointed by the Minister of Agriculture, Forestry and Fisheries in consultation with the EC. Ethiopia has also revised its biosafety laws and … 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. [72] Trustees, Biowatch v. Registrar: Genetic Resources, and Others 2005 (4) SA 111 (T), available on the Southern Africa Legal Information Institute (SAFLII) website, at http://www.saflii.org/za/cases/ZAGPHC/2005/135.html. The primary legislation in South Africa dealing with genetically modified organisms (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. Nevertheless, opposition and skepticism persists among various groups, including rights groups, trade unions, and religious organizations. ), The task of ensuring food safety in South Africa is under the jurisdiction of the Department of Health (DoH), specifically the Food Control Section. [13]  Similarly, one of the farmers unions called for the introduction of labeling requirements for foods containing GMOs. The form of regulation varies depending on the type of GMO involved. One GM potato for industrial use has been approved for cultivation in Sweden, but currently no GMOs are being produced. Inspector General | Despite the higher cost of GM seeds, adoption by many farmers was quick, steady, and widespread. [72]  Biowatch Trust, a nongovernmental organization engaged in monitoring and publicizing issues of genetic modification, made a number of requests for information regarding the use of GMOs in South Africa, including locations of GMO field trials and risk-assessment data. 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. GMOs are not legal in all countries around the world. 33007 (Mar. Center for Food Safety (CFS) has announced the release of its new, interactive Genetically Engineered (GE) Food Labeling Laws map detailing the powerful, growing presence of laws requiring information on GE content in consumer food products around the world. Release means “release into the environment and includes a trial release, conditional release and general release.”  GMO Act § 1. They are attached to the Convention on Biological Diversity of 1993. 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. 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