Trustees, Biowatch v. Registrar: Genetic Resources, and Others at 137. 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).  South Africa first approved the commercial release of genetically modified, insect-resistant cotton and maize in 1997. 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. It makes it an offense for anyone to “alter, obscure, falsify, remove or omit . 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. To date, legislation specifically regulating the labeling of GMO components in food does not appear to have been passed. . This includes research and development, import/export, production, consumption, and other uses of GMOs … 2012). Argentina has not ratified the Cartagena Protocol on Biosafety. 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 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. Further labeling requirements are imposed by the Consumer Protection Act and its subsidiary legislation. Inspector General | 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. 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. 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.  When damage occurs, users are responsible for cleanup costs. .  Today, South Africa is the world’s eighth largest producer of GMO crops. 34020 (Feb. 18, 2011), http://www.info.gov.za /view/142060; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. In general, the EU espouses the principle that the polluter pays. at 113; About Us, Biowatch South Africa, http://www.biowatch.org.za/main.asp?include=about/about.html (last visited Oct. 30, 2013). 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. 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.  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.  Two of the members must be from the public sector. 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.  Similarly, one of the farmers unions called for the introduction of labeling requirements for foods containing GMOs. 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.  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). A majority of Swedes consider it important that their milk is GMO free, and dairy farmers therefore avoid GMOs in their fodder. The use of GMOs in food is a sensitive topic that generates strong public opinion. Swedes, both consumers and producers, are very conscious of GMOs. 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.  A person who impersonates any officer appointed under the GMO Act also commits a crime. Most of Belgium’s regulation of GMOs is directly or indirectly derived from European regulations.  Consumer Protection Act No. A study investigating voluntary labeling in South Africa found that 31% of products labeled as …  In effect, a GMO would not be approved for any form of release if “safety to the environment cannot be demonstrated.”, The law also imposes a public notification requirement for the release of 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 imposes two forms of liability: civil and criminal liability. 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.  If the EC approves an application, it must include all applicable terms and conditions that the Registrar may then attach to a permit. USA.gov. 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 study found that eighty percent of those surveyed had limited understanding of biotechnology, and more than two-thirds had never heard of GMOs before. The GMO Act places various restrictions on the research, production, and marketing of GMOs.  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. 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. , 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 Consumer Protection Act, which imposes labeling requirements on food items containing a certain level of GMOs, also criminalizes certain acts. 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. Africa include 5 Argentine canola, 10 cotton, 42 maize, 1 rice (for food), and 12 soybeans. 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. Legal | He or she is in charge of administering the GMO Act and exercises the powers delegated and duties assigned to the position by the GMO Act or the EC.  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).  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. 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. There are strict rules on how a scientifically-based risk assessment is to be conducted. Release means “release into the environment and includes a trial release, conditional release and general release.” GMO Act § 1. 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.  PMG, Genetically Modified Organisms Amendments Bill: Hearings, Submission by Kwangwanase Farmers Union, supra note 12. 10 of 2004 [NEMBA], 20 BSRSA (rev’d through 2012). Restrictions on GMO food include a safety assessment in addition to a risk assessment and approval procedure. Germany discourages the cultivation of GM crops to the extent possible within the already stringent European Union legislation on GMOs. Legal |  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). You need a permit if you want to participate in activities relating to genetically modified organisms in South Africa. By 2009, 98 percent of c… 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.” Goods covered by this requirement are all goods approved for consumption by the EC and containing at least 5% GMOs. 12, 2010), http://www.info.gov.za/view/123130; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. Ethiopia has also revised its biosafety laws and … , Hanibal Goitom
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 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. South Africa Patent Act (No. The GMO Act and applicable implementing regulations and biosafety framework govern the regulation of biotech crops in South Africa. Accessibility | The form of regulation varies depending on the type of GMO involved. They are attached to the Convention on Biological Diversity of 1993.  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. Plant GMOs are regulated by the US Department of Agriculture’s Animal and Plant Health Inspection Service under the Plant Protection Act.  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. All activities with GMOs in South Africa are primarily regulated under the GMO Act (Act 15 of 1997). In addition, this enables the country to collect information on the impact and implications of deliberate release of a particular GMO.  Id., Submission by African Centre for Biosafety; GMO Act § 17. 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.  Genetically Modified Organisms Amendment Act No. South Africa IUCN-EPLP No. The statistics for the 2011–12 maize production season illustrate the scale of GMO penetration in the country. Sellers of GM food must follow labeling requirements. Jobs | Most legislation in England and Wales that applies to GMOs is implementing legislation for EU law. The regulation for mandatory GM labelling in South Africa does not make provision for the terms “GMO free”, “non-GM” or “organic”.  There are also a number of other laws imposing additional rules on GMO-related activities, including the National Environmental Management: Biodiversity Act (NEMBA), the Consumer Protection Act, and the Foodstuffs, Cosmetics and Disinfectants Act.. About | ), The task of ensuring food safety in South Africa is under the jurisdiction of the Department of Health (DoH), specifically the Food Control Section. 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. The importation, development, testing, and release of GMOs are strictly regulated in New Zealand. The second section has materials discussing the issue in particular jurisdictions and is divided into sections on Africa, the Americas, Asia, and Europe. Inspector General | . 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. Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States. They apply only to transboundary actions; they do not apply to use or transit of GMOs within countries. The agricultural GMO regulations regulate not only crops, but also animals, microorganisms, and products derived from these sources. The GMO Act also provides a list of activities to which it does not apply, including techniques involving human gene therapy. 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 . 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.  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. 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. GMO pesticides and microorganisms are regulated by the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act.  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. A person interested in carrying out a GMO-related activity may make …  Foodstuffs, Cosmetics and Disinfectants Act No. , All facilities (any place where contained use of a GMO takes place) must be registered with the Registrar. 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. , However, various key organizations have shown interest in the process of overhauling the GMO regulatory regime. Under South Africa’s “GMO” Act, an Executive Council (EC), consisting of representatives of seven government departments is established. Egypt takes a permissive approach to GMOs, and its public policy does not oppose growing, importing, and exporting genetically modified crops. in South Africa. 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. Accessibility | § 2. The production and sale of certain GMOs are legal in France, but are subject to very restrictive rules. This bibliography lists selected, recent English-language works on restrictions on GMOs. Belgium is considered to have an intermediate level of restrictions on GMOs, although public opinion tends to generally be hostile to GMOs.  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.  All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection. [i] The Act was aimed at regulating all South Africa’s genetically modified activities. Argentina is the third largest grower of biotech crops in the world, after the United States and Brazil.  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. No general conservation strategy Apply for a permit at the Registrar of Genetically Modified Organisms (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. External Link Disclaimer |  It is also mandated to liaise with international bodies concerned with biosafety through relevant national departments. if the EC deems it appropriate, an environmental risk assessment. 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.  In addition, a violation under the Consumer Protection Act may result in a civil action and/or administrative fines. . March 2014. Foreign Law Specialist*
 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. There are several EU-approved GMOs that are specifically illegal in Norway. Donate 68 of 2008, § 24, 526 GG No. A draft law on biosafety was not approved by the Egyptian Parliament.  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. , 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. Nevertheless, opposition and skepticism persists among various groups, including rights groups, trade unions, and religious organizations. 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. This country report was updated June 2014. The Genetically Modified Act 15 of 1997 was implemented by the Department of Agriculture on 1 December 1999. c) An evaluation of the consequences should these adverse effects be realized.  Department of Agriculture, Forestry and Fisheries, Trends in the Agricultural Sector – 2012 at 11 (2013), http://www.nda.agric.za/docs/statsinfo/Trends2012.pdf. 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 … Relative to other African countries, South Africa embraced biotechnology early on. Despite the higher cost of GM seeds, adoption by many farmers was quick, steady, and widespread.  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. The primary legislation governing the issue is the Genetically Modified Organisms Act of 1997 (GMO Act) and its subsidiary legislation (GMO Regulations). 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. As a consequence, some regions have enacted slightly more permissive regimes than others. 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. 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. The Animal Feed Manufacturers Association of South Africa (AFMA), is the official industry representative body of the South African feed industry in the livestock feed sector and larger agricultural environment. The Act also requires the registration of all facilities where GMO-related activities take place.  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. 1 December 1999. a) Identification of any potential adverse effect resulting from the novel genotypic and/or phenotypic characteristics of the genetically modified organism. This Act established three regulatory authorities—an Executive Council, Registrar, and an Advisory Committee—for effective implementation of its objectives. 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. 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. Jobs | External Link Disclaimer | Genetically modified (GM) crops have been produced in the initial adopting countries for 20 years.  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. Developing countrie… 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.  Consumer Protection Act No. * This report was prepared with the assistance of Law Library intern Antoinette Ofosu-Kwakye. About | South Africa– Blue Sky Publications (Pty) Ltd T/A TheSouthAfrican Number: 2005/028472/07. Press |  GMO Act § 19; GMO Regulations § 11, as amended. 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. As the official representative body for the sector, AFMA positions and aligns itself by identifying the business environment that will benefit its members. GMO use is limited and almost exclusively used in animal fodder products. 35007 (Feb. 10, 2012), http://www.info.gov.za/view/159582; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Russia recently adopted an approval procedure for release of GMOs into the environment, which brings the country closer to possible cultivation of GM plants. 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. 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. .  Genetically Modified Organisms Act, 1997, Regulations, 2010, Government Notices [GN] No. 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. These differences have created sharp trade conflicts for some nations, while also opening up export opportunities for others that favor GMO technologies.  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