South Africa ranks among the top 10 in the world for the introduction of GM crops. (File photo: Rajesh JANTILAL/AFP via Getty Images)
After nine years of bitter legal battles, the full bench of the Supreme Court of Appeal (SCA) has suspended commercial approval of drought-tolerant genetically modified (GM) varieties of corn.
In a landmark ruling, five SCA judges set aside several steps of decision-making regarding the approval of Monsanto's (now Bayer) application for the public release of GM corn MON87460.
The case was launched by the non-profit African Center for Biodiversity (ACB), represented by South African Legal Aid. The SCA also set aside Judge Ronel Gertruida Tolmey's June 2023 High Court judgment, which had rejected the ACB's application but granted a stay of appeal to the SCA.
The respondent was the Minister of Agriculture, Forestry and Fisheries. Director of the Agriculture, Forestry and Fisheries Bureau. Executive Council on Genetically Modified Organisms (GMOs). Board of Appeal against GMO and Monsanto South Africa.
This is the first judicial decision on GMO decision-making in South Africa and “sets a precedent in its own right,” the ACB said, particularly as it sets aside the three tiers of decision-making: the board, the appeals committee and the minister. said. , Tolmey's judgment is similar.
ACB Director-General Mariam Mayet said the discovery was very important because it “highlights the rubber-stamp nature of South Africa's decision-making on GMOs. “This is what we have witnessed and resisted for the past 21 years.”
This is a “failure to adequately assess the risks posed by GMOs, particularly in order to protect our constitutional right to an environment that does not adversely affect our health and well-being.” It was vindicated and made the years of struggle so worth it. ”
GMO regulations in South Africa
South Africa ranks among the top 10 in the world for the introduction of GM crops.
The use of GMOs is regulated by the Genetically Modified Organisms Act, under which GMO regulations are established. The purpose of this law and regulation is to promote the responsible development, production, use and application of GMOs within the framework of the Constitution and the National Environmental Management Act (Nema).
This law establishes an executive council and advisory board for GMOs. A permit is required for the release of GMOs. Whether a permit is granted is determined by the Board of Directors in consultation with the Advisory Committee.
“The envisaged process is a fact-based and science-based investigation into whether there are risks posed by the release of particular GMOs into the environment and whether those risks can be effectively managed.” The SCA pointed out in its judgment.
The advisory committee evaluates the scientific elements of the permit application and reports to the Board, which makes the final decision whether to approve the application and issue the permit.
Origin of litigation
On July 14, 2014, Monsanto applied to the Executive Committee for approval to make MON87460 available to the public. MON87460 has been genetically modified to reduce yield losses under water-limited conditions.
According to Monsanto, “Reduced yield loss in corn containing MON87460 is achieved through expression of an inserted Bacillus subtilis cold shock protein B (CSPB).” It is known to promote adaptation to environmental stress (such as water scarcity) by binding to structures and help maintain normal cell function. ”
Maize containing MON87460 also expresses neomycin phosphotransferase II (NPTII) protein from E. coli. The NPTII protein in MON87460 confers resistance to the kanamycin antibiotic.
Monsanto said the purpose of inserting the gene encoding the NPT II protein was to provide a way to select plant cells containing the CSPB gene during early product development.
The SCA's ruling noted that Monsanto submitted both confidential and non-confidential versions of the application, which included assessments of human and animal health, toxicology, allergenicity, and nutritional risks. was advertised in rapport, business days and Bild From March to April 2014.
No comments or objections to the ad were accepted.
approval
The Advisory Committee considered the application and issued a recommendation approving the application on December 17, 2014. Following that recommendation, the Executive Council authorized Monsanto for public release of MON87460 on June 12, 2015.
On August 7, 2015, ACB appealed the approval. Monsanto filed a response to ACB's appeal on July 13, 2016.
The Appeal Board dismissed the appeal on 1 September 2016 by a majority, and the Minister confirmed the Appeal Board's decision on 2 December 2016. In June last year, the High Court dismissed ACB's application.
The crux of ACB's case is that the state defendants accepted Monsanto's claims at face value and used Monsanto's application independently to satisfy them that the health and safety risks associated with the public release of MON87460 were adequately addressed. This means that they did not evaluate it objectively and critically. It has been dealt with.
It argued that the expert evidence given to the state defendants should have triggered the application of the precautionary principle enshrined in Nema. First, there was a lack of scientific data to draw conclusions about the safety of MON87460. Second, the data that became available supported concerns about health risks arising from the use of MON87460.
The appellants argued that these were the very circumstances that should have given rise to the application of the precautionary principle by the Executive Board, the Appeal Board and the Minister.
“Instead of requiring Monsanto to adopt a routine and prudent approach and address the identified safety concerns, state respondents accepted Monsanto’s version without further consideration of the safety risks. I started.”
According to the judgment, the experts highlighted several fundamental concerns, all of which were clearly stated in the appeal documents submitted to the Appeals Committee. These included that Monsanto's risk assessments were insufficient to identify possible hazards. Claims of non-allergenic properties are unsubstantiated. Monsanto itself has identified that a fragment of the protein used in MON87460 (CSPB) is resistant to pepsin digestion. This “means it is not completely digested by gastric juices.” Therefore, further experiments were required to evaluate the potential allergenicity.
There was no evidence in the records submitted to the Executive Council, the Appeal Board or the Minister regarding the effects of food processing and the safety of human exposure through MON87460 cooked in South African diets.
The only data included was a summary of a chicken feeding study in which chickens were fed raw corn. Acute toxicity studies on the effects of isolated proteins of bacterial origin on mice. This has “limited applicability to human exposure and in any case does not study all proteins associated with MON87460.” Rat feeding studies. And the broiler chicken studies concerned food quality standards, not adverse health effects.
precautionary principle
The ACB welcomed the SCA's findings on the applicability of the precautionary principle. The SCA reviewed Judge Tolmey's findings, considering the precautionary principle to be central to the issue. He called the ACB's claims of procedural fairness fair and refused to refer the matter back to the board to reconsider its decision.
The ACB bases its arguments on the precautionary principle, which states that when an activity has the potential to have a significant impact on the environment, decision makers must consider the limits of current knowledge about the consequences of their decisions and actions. It is necessary to apply a risk-averse and prudent approach that takes into account the
The SCA said the precautionary principle is deeply rooted in almost all recent international environmental agreements. “The High Court's rejection of the appellant's reliance on the precautionary principle was based on its finding that the precautionary principle is not directly applicable in review proceedings.
“However, such an approach ignores the fundamental role that the precautionary principle plays in forcing decision makers to exercise their discretion. Current knowledge and uncertainty, serious or irreversible harm , and the adoption of a prudent approach is clearly consistent with the subject matter, scope and purpose of the Act.”
a terrible failure
The SCA unanimously found that the Executive Board complies with the mandatory provisions contained in section 5(1)(a) of the GMO Act, which determines whether Monsanto is required to submit an environmental impact assessment by Nema. It was found that there was a gross failure to do so.
The SCA found that this evidence strongly suggests that the Board was unable to consider or determine whether an environmental impact study was required for Nema at the time it reviewed the permit application for public release of MON87460.
The SCA said the state had failed to provide any evidence that the decision had been made, which would have been a relatively simple matter.
Mr Justice Tolmey of the SCA confused the “duty” arising from Article 5(1)(a) with the applicability of the precautionary principle, wrongly finding that environmental impact studies are only necessary where the precautionary principle applies. I decided that I did. caused. The SCA ruled that the precautionary principle should have been invoked and applied.
Second, whether the Board complied with section 5(1)(a) by considering the need for an environmental impact study to ascertain the environmental impact of the proposed commercial release of MON87460. is a separate and distinct inquiry from whether the precautionary principle has been applied. should have been triggered and applied.
The SCA ruled that Bayer's application for commercial release of MON87460 must be referred back to the Board for reconsideration.
'That was disappointing'
The court ordered that the state, along with Monsanto/Bayer, pay ACB's costs, including the fees of two attorneys.
Bayer said it was disappointed by the ruling, but “our next steps will be determined after full consultation with our legal team and relevant government and industry bodies.”
“Bayer's mission is to help create a world where everyone has good health and no one goes hungry.
We do this through innovative products and services that help farmers meet challenges such as a changing climate, pests, diseases and economic pressures. Developing biotech solutions and breeding climate-resilient crops like corn are also part of its mission. ”
Although the appeal by the ACB, which focused on the regulator and its approval process regarding MON87460, was successful, it is important to note that “none of the other GMO traits currently available on the market are implicated in this issue. be.”
“We are confident that all commercially available trait technologies and seeds can be used safely and effectively, as has been done in South Africa and around the world for over 20 years.”
Bayer is committed to complying with all national and international regulatory standards and conducting business ethically in accordance with these protocols. “The efficacy and safety of our commercially available GMO traits are consistent with positive reviews from international professional regulatory authorities and have improved sustainable agricultural production around the world. ”
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