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. This Act established three regulatory authorities—an Executive Council, Registrar, and an Advisory Committee—for effective implementation of its objectives.
The GMO Act places various restrictions on the research, production, and marketing of GMOs. 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. 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 Act also requires the registration of all facilities where GMO-related activities take place. It further requires that safety to the environment be demonstrated before GMOs can be approved for release.
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.
In addition to the primary legislation and regulatory institutions, South Africa also has in place other laws and institutions regulating specific issues relating to GMOs. 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. Further labeling requirements are imposed by the Consumer Protection Act and its subsidiary legislation.
Relative to other African countries, South Africa embraced biotechnology early on. The first field trials of genetically modified crops in the country were conducted in 1989. South Africa first approved the commercial release of genetically modified, insect-resistant cotton and maize in 1997. Today, South Africa is the world’s eighth largest producer of GMO crops. The statistics for the 2011–12 maize production season illustrate the scale of GMO penetration in the country. 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.
South Africa has a fairly vigorous regulatory regime governing various aspects of GMO use, including contained use, trial release, commercial release, and transboundary movement. The primary legislation governing the issue is the Genetically Modified Organisms Act of 1997 (GMO Act) and its subsidiary legislation (GMO Regulations). 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. 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.
This report briefly discusses key aspects of the GMO regulatory regime, including relevant legislation, regulatory bodies, and available case law on the subject.
II. Public and Scholarly Opinion
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. 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.
However, various key organizations have shown interest in the process of overhauling the GMO regulatory regime. 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. 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). Similarly, one of the farmers unions called for the introduction of labeling requirements for foods containing GMOs.
Despite the recognition of the risks involved, GMO-related activities appear to enjoy support within scientific and academic circles, with supporters believing that the risks are manageable. Nevertheless, opposition and skepticism persists among various groups, including rights groups, trade unions, and religious organizations.
III. Structure of Pertinent Legislation
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. 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.
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 is limited to
- a) the genetic modification of organisms;
- b) the development, production, release, use and application of genetically modified organisms (including viruses and bacteriophages); and
- c) the use of gene therapy.
As noted above, the GMO Act established three regulatory bodies with specific functions: the EC, the Registrar, and the AC. The EC, a juristic person, has a number of key functions in the application and approval process for GMO-related activities. Some of its functions include
- advising the Minister of Agriculture, Forestry and Fisheries on GMO-related activities and monitoring these activities to ensure that they follow the rules and procedures set under the GMO Act;
- determining whether an applicant should submit an environmental assessment report; and
- approving applications for the use of facilities for conducting GMO-related activities in consultation with the AC.
The EC may have up to ten members, who are appointed by the Minister of Agriculture, Forestry and Fisheries. 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. All decisions of the EC require unanimous support of its members, and anything short of that amounts to rejection.
The Registrar is appointed by the Minister of Agriculture, Forestry and Fisheries in consultation with the EC. 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. Among the Registrar’s functions are
- examining applications for GMO-related activity;
- issuing permits or extensions;
- amending or withdrawing permits;
- ensuring that all users take the necessary measures to protect the environment as well as human and animal health; and
- addressing any matter related to GMO-related activities.
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). 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.
Inspections are conducted by inspectors appointed by the Registrar. 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. 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 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. It is also mandated to liaise with international bodies concerned with biosafety through relevant national departments. 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. Two of the members must be from the public sector. 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.
IV. Restrictions on Research, Production, and Marketing
A GMO-related activity may not be conducted in South Africa without a permit. 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.
A person interested in carrying out a GMO-related activity may make an application to the Registrar, and the application must include
- a scientifically-based risk assessment;
- proposed risk assessment measures;
- a copy of public notices as required under the GMO Regulations; and
- if the EC deems it appropriate, an environmental risk assessment.
There are strict rules on how a scientifically-based risk assessment is to be conducted. The assessment should take into account current national, regional, and international risk-assessment methods. The steps of the assessment should include the following:
- a) Identification of any potential adverse effect resulting from the novel genotypic and/or phenotypic characteristics of the genetically modified organism.
- 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.
- c) An evaluation of the consequences should these adverse effects be realized.
- 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.
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. If the EC approves an application, it must include all applicable terms and conditions that the Registrar may then attach to a permit.
All facilities (any place where contained use of a GMO takes place) must be registered with the Registrar. 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.
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.
V. Restrictions on Releasing Organisms into the Environment
There is a strict application and approval process for the release of GMOs, including a trial release and a general release. 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. 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. 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. 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. 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.
If there is an accident involving unintentional environmental release or transboundary movement of GMOs, the user must notify the Registrar both verbally and in writing by providing relevant information, including the estimated quantities, date of the release, and possible adverse effect on the environment and on human and animal health and safety.
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. 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.” (For information on cleanup costs and liability when damage occurs, see the Liability Regime section below.)
VI. Restrictions on GMOs in Foodstuffs
The task of ensuring food safety in South Africa is under the jurisdiction of the Department of Health (DoH), specifically the Food Control Section. 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.
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. 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. . . .”
A different law imposes additional, specific labeling requirements. 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.
VII. Liability Regime
The GMO Act imposes two forms of liability: civil and criminal liability. 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. When damage occurs, users are responsible for cleanup costs. 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 user fails to take any such measures, the EC may step in and take all the necessary actions at the user’s expense. 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 and its subsidiary legislation also impose criminal liability for certain actions. 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. 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. A person who impersonates any officer appointed under the GMO Act also commits a crime. In addition, a person who violates any of the GMO Regulations commits an offense. 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.
The Consumer Protection Act, which imposes labeling requirements on food items containing a certain level of GMOs, also criminalizes certain acts. It makes it an offense for anyone to “alter, obscure, falsify, remove or omit . . . labeling . . . without authority.” This offense is, on conviction, punishable by a fine and/or up to one year imprisonment. In addition, a violation under the Consumer Protection Act may result in a civil action and/or administrative fines.
VIII. Judicial Decisions / Prominent Cases
In 2005, questions regarding access to information on GMO-related activities were litigated in court. 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. 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. 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. 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. 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.
Matters pertaining to cost were litigated further on appeal and settled by the Constitutional Court.
Foreign Law Specialist*
* This report was prepared with the assistance of Law Library intern Antoinette Ofosu-Kwakye.
 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.
 Id. at 185.
 Department of Agriculture, Forestry and Fisheries, Trends in the Agricultural Sector – 2012 at 11 (2013), http://www.nda.agric.za/docs/statsinfo/Trends2012.pdf.
 Genetically Modified Organisms Act (GMO Act) No. 15 of 1997, as amended, 2 Butterworths Statutes of the Republic of South Africa [BSRSA] (rev. ed. 2012). The 1997 GMO Act is available on the Department of Agriculture, Forestry and Fisheries (DAFF) website, at http://www.daff.gov.za/doaDev/sideMenu/acts/15%20 GMOs%20No15%20% 281997%29.pdf. The Genetically Modified Organisms Amendment Act No. 23 of 2006 (Apr. 17, 2007) is available on the South Africa government portal, at http://www.info.gov.za/view/DownloadFileAction?id=67850.
 Genetically Modified Organisms Act, 1997, Regulations, 2010, Government Notices [GN] No. 32966 (Feb. 26, 2010), http://www.info.gov.za/view/117972; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2010, GN No. 33007 (Mar. 12, 2010), http://www.info.gov.za/view/123130; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. 34020 (Feb. 18, 2011), http://www.info.gov.za /view/142060; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. 35007 (Feb. 10, 2012), http://www.info.gov.za/view/159582; Genetically Modified Organisms Act, 1997, Regulations Amendments, 2011, GN No. 36124 (Feb. 8, 2013), http://www.info.gov.za/view/183647 (hereinafter collectively referred to as GMO Regulations, as amended).
 Genetically Modified Organisms Amendment Act No. 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).
 National Environmental Management: Biodiversity Act No. 10 of 2004 [NEMBA], 20 BSRSA (rev’d through 2012).
 Consumer Protection Act No. 68 of 2008, 526 Government Gazette [GG], No. 467 (Apr. 29, 2009), http://www .info.gov.za/view/DownloadFileAction?id=99961.
 Foodstuffs, Cosmetics and Disinfectants Act No. 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.
 Wolson, supra note 1, at 3.
 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.
 Id., Submission by African Centre for Biosafety; GMO Act § 17.
 PMG, Genetically Modified Organisms Amendments Bill: Hearings, Submission by Kwangwanase Farmers Union, supra note 12.
 Wolson, supra note 1, at 188.
 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.
 GMO Act § 1.
 Id. § 2. The GMO Act also provides a list of activities to which it does not apply, including techniques involving human gene therapy. Id.
 Id. §§ 3 & 5.
 Id. §§ 4 & 5.
 Id § 3.
 Id. § 7.
 Id. § 8.
 Id. § 9.
 Id. § 8.
 Id. § 15.
 Id. § 16.
 Id. § 11.
 Id. § 10.
 GMO Regulations § 2, as amended.
 GMO Act § 1.
 GMO Regulations § 2, as amended.
 Id. § 3.
 Id. § 4.
 Id. § 3.
 Id. § 8.
 GMO Act § 19; GMO Regulations § 11, as amended.
 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).
 NEMBA § 78. Release means “release into the environment and includes a trial release, conditional release and general release.” GMO Act § 1.
 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).
 GMO Regulations § 9, as amended.
 Id. § 9.
 Id. §10.
 NEMBA § 10.
 Id. § 11.
 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).
 Regulations Relating to the Labelling of Foodstuffs Obtained Through Certain Techniques of Genetic Modification, GG No. 25908 (Feb. 26, 2010), http://www.doh.gov.za/docs/foodcontrol/advertising/2004/fcr25.pdf.
 Id. § 2. 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.
 Consumer Protection Act No. 68 of 2008, § 24, 526 GG No. 467 (Apr. 29, 2009), http://www.info.gov.za/view/ DownloadFileAction?id=99961.
 The Consumer Protection Act Regulations, No. 293, § 7, GN No. 34180 (Apr. 1, 2011), http://www.info.gov.za/ view/DynamicAction?pageid=623&myID=292342.
 GMO Act § 17.
 Id. § 21.
 GMO Regulations § 13, as amended.
 GMO Act § 21.
 Consumer Protection Act No. 68 of 2008, § 110, 526 GG No. 467 (Apr. 29, 2009), http://www.info.gov.za/view/ DownloadFileAction?id=99961.
 Id. §§ 112 & 113.
 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.
 Id. at 113; About Us, Biowatch South Africa, http://www.biowatch.org.za/main.asp?include=about/about.html (last visited Oct. 30, 2013).
 Trustees, Biowatch v. Registrar: Genetic Resources, and Others, at 119–26. 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).
 Trustees, Biowatch v. Registrar: Genetic Resources, and Others at 137.
 Id. at 145–46.
Last Updated: 11/03/2014