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South Africa apex court reverses GMO approval
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After an arduous nine-year legal battle, a full bench of the supreme court of appeal (SCA) has set aside the commercial approval of a drought-tolerant genetically modified (GM) variety of maize.
In a groundbreaking judgement, five judges of the SCA set aside several layers of decision-making regarding the approval of an application by Monsanto, now Bayer, for general release of its GM maize, MON87460.
The litigation was launched by the non-profit African Centre for Biodiversity (ACB), represented by Legal Aid South Africa. The SCA, too, set aside the June 2023 high court judgement of Judge Ronel Gertruida Tolmay, who dismissed the ACB's application, but granted it leave to appeal to the SCA.
The respondents cited were the minister of agriculture, forestry and fisheries; director-general of the department of agriculture, forestry and fisheries; the executive council for genetically modified organisms (GMOs); the appeal board for GMOs and Monsanto South Africa.
This is the first judicial decision concerning GMO decision-making in South Africa and "as such is precedent-setting", the ACB said, particularly since it sets aside three layers of decision making Â- by the executive council, the appeal board and the minister, as well as Tolmay's judgement.
The finding is extremely significant, said the ACB's director Mariam Mayet "because it brings into sharp relief the rubber-stamping nature of decision-making in South Africa concerning GMOs - something we have witnessed and resisted over the last 21 years".
This is "especially the failure to make a proper determination of the risk posed by GMOs to safeguard the constitutional right to an environment that is not detrimental to our health and well-being. This judgement has vindicated us and made these long years of struggle very worthwhile".
GMO regulation in South Africa
South Africa ranks among the top 10 countries globally for the adoption of GM crops.
The use of GMOs is regulated by the Genetically Modified Organisms Act and the GMO regulations are framed thereunder. The purpose of the Act and the regulations 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).
The Act establishes an executive council for GMOs and an advisory committee. A permit is required for the release of GMOs. Whether a permit is granted falls to be determined by the executive council in consultation with the advisory committee.
"The process envisaged is a fact and science-based investigation into whether there are any risks posed by the release of a particular GMO into the environment and whether these risks can be effectively managed," the SCA noted in its judgement.
The advisory committee evaluates the scientific components of applications for permits and reports to the executive council, which ultimately decides whether to approve the application and issue a permit.
Origins of the lawsuit
On 14 July 2014, Monsanto applied to the executive council for a permit for the general release of MON87460, which it said has been genetically modified to reduce yield loss in water-limited conditions.
According to Monsanto, "the reduced yield loss of maize containing MON87460 is achieved by the expression of the inserted Bacillus subtilis cold shock protein B (CSPB). This protein has been extensively studied and is known to facilitate adaptation to environmental stress (such as water scarcity) by binding secondary RNA structures thus helping to preserve normal cellular function."
Maize containing MON87460 also expresses the neomycin phosphotransferase II (NPTII) protein derived from Escherichia coli. The NPTII protein in MON87460 confers resistance to Kanamycin antibiotic.
Monsanto said the purpose of inserting the gene encoding for the NPTII protein was so that there was a way of selecting plant cells, which contain the CSPB gene during early product development.
The SCA's judgement noted that Monsanto submitted both confidential and non-confidential versions of the application, which included an assessment of the risks relating to human and animal health, toxicology, allergenicity and nutrition. It was advertised in the Rapport, Business Day and Beeld during March and April 2014.
No comments or objections were received in response to the ads.
Approval
The advisory committee, having considered the application, issued a recommendation on 17 December 2014 that the application be approved. On the strength of its recommendation, the executive council granted a permit to Monsanto on 12 June 2015 for the general release of MON87460.
On 7 August 2015, the ACB appealed the approval. Monsanto submitted a response to ACB's appeal on 13 July 2016.
The appeal board, by a majority, dismissed the appeal on 1 September 2016, and the minister confirmed the appeal board's decision on 2 December 2016. In June last year, the high court dismissed the ACB's application.
The thrust of the ACB's case is that the state respondents accepted, at face value, the claims made by Monsanto and failed to independently and critically evaluate Monsanto's application to satisfy themselves that the health and safety risks associated with the general release of MON87460 had been properly addressed.
It argued that the expert evidence that was served before the state respondents ought to have triggered the application of the precautionary principle enshrined in Nema. First, there was a lack of scientific data from which conclusions about the safety of MON87460 could be drawn; and second, the data that had been made available supported concerns about health risks arising from the use of MON87460.
These are the precise circumstances, the appellants contended, that ought to have triggered the application of the precautionary principle by the executive council, the appeal board and the minister.
"Instead of adopting the prescribed cautious approach and requiring Monsanto to address the safety concerns that had been identified, each of the state respondents proceeded to accept the say-so of Monsanto without any further consideration of safety risks."
According to the judgement, the experts highlighted several fundamental concerns, all of which were articulated in the appeal document served before the appeal board. These included that Monsanto's risk assessment was inadequate in identifying plausible hazards; its claims of lack of allergenicity are unsubstantiated; Monsanto itself identified a fragment of the protein used in MON87460 (CSPB) that was resistant to pepsin digestion, "meaning that it is not fully digestible by gastric juices", and further experimentation was thus required to assess potential allergenicity.
There was no evidence in the record before the executive council, the appeal board and the minister on the effects of food processing and the safety of human exposure via cooked MON87460 in South African diets.
The only data included was summaries of a chicken feeding study in which raw maize was fed to chickens; an acute toxicity study on the effects on mice of a bacterially derived isolated protein, which has "limited application to human exposure and is in any event not a study of all proteins associated with MON87460"; a rat feeding study; and a broiler chicken study, which was concerned with food quality standards and not with any adverse impacts on health.
Precautionary principle
The ACB welcomed the findings of the SCA regarding the applicability of the precautionary principle. The SCA scrutinised Judge Tolmay's findings as it viewed the precautionary principle as being central to the matter before it. She rejected the ACB's arguments regarding procedural fairness in the process, as claimed that it was fair and refused to refer the matter back to the executive council to reconsider its decision.
The ACB based its argument on the precautionary principle, which requires that where an activity may significantly affect the environment, decision-makers must apply a risk-averse and cautious approach that considers the limits of current knowledge about the consequences of decisions and actions.
The SCA said the precautionary principle is deeply rooted in almost every recent international environmental agreement. "The high court's rejection of the appellant's reliance on the precautionary principle was based on its finding that the precautionary principle does not find direct application in review proceedings.
"However, such an approach disregards the fundamental role that the precautionary principle plays in directing decision-makers in the exercise of their discretion. The current state of knowledge and uncertainty, the potential for serious or irreversible harm and the adoption of a cautious approach is clearly consistent with the subject-matter, scope and purpose of the Act."
Abject failure
Unanimously, the SCA found that there was an abject failure by the executive council to comply with a mandatory prescript contained in section 5(1)(a) of the GMO Act to determine whether Monsanto was required to submit an environmental impact assessment by Nema.
The SCA found that the evidence strongly suggested that, at the time that the executive council assessed the application for a permit for the general release of MON87460, it failed to consider or determine whether an environmental impact study in terms of Nema was necessary.
The SCA said that it was a relatively straightforward matter for the state to have adduced evidence that a determination was made one way or the other, but it had failed to do so.
Judge Tolmay, the SCA held, had "conflated the obligation" arising from section 5(1)(a) with the applicability of the precautionary principle, finding erroneously that an environmental impact study would only be required in the event of the precautionary principle being triggered. The SCA ruled that the precautionary principle was triggered and ought to have been applied.
Secondly, whether the executive council complied with section 5(1)(a) by considering the necessity of an environmental impact study to ascertain the impact on the environment of the proposed commercial release of MON87460 was a separate and distinct inquiry from whether the precautionary principle was triggered and should have been applied.
The SCA ruled that the application for commercial release of Bayer's MON87460 must be sent back to the executive council for reconsideration.
‘Disappointed'
The court ordered that the state together with Monsanto/Bayer must pay the ACB's costs, including the costs of its two counsels.
Bayer said that although it is disappointed in the verdict, "our next steps will be determined after thorough consultation with our legal team and the relevant government and industry entities.
"Bayer's mission is to help shape a world where there is health for all and hunger for none.
We do this through innovative products and services that equip farmers against the challenges of a changing climate, pests, disease, and economic pressure. Developing biotechnology solutions and breeding more climate-resilient crops like maize, is part of that mission."
Despite the setback of the successful appeal by the ACB, focusing on the regulator and its approval process regarding MON87460, "it is important to note that none of the other GMO traits that are currently available in the market are implicated in this matter.
"We are confident that all our commercially available trait technology and seed can be used safely and effectively like it has been for over two decades in South Africa and around the world."
Bayer is committed to complying with all local and international regulatory standards and to ethically conduct our business according to these protocols. "The efficacy and safety of our commercially available GMO traits are consistent with the positive assessments of expert regulators internationally and it has elevated sustainable agricultural production around the world."
The department did not respond to the Mail & Guardian's enquiries.
In a groundbreaking judgement, five judges of the SCA set aside several layers of decision-making regarding the approval of an application by Monsanto, now Bayer, for general release of its GM maize, MON87460.
The litigation was launched by the non-profit African Centre for Biodiversity (ACB), represented by Legal Aid South Africa. The SCA, too, set aside the June 2023 high court judgement of Judge Ronel Gertruida Tolmay, who dismissed the ACB's application, but granted it leave to appeal to the SCA.
The respondents cited were the minister of agriculture, forestry and fisheries; director-general of the department of agriculture, forestry and fisheries; the executive council for genetically modified organisms (GMOs); the appeal board for GMOs and Monsanto South Africa.
This is the first judicial decision concerning GMO decision-making in South Africa and "as such is precedent-setting", the ACB said, particularly since it sets aside three layers of decision making Â- by the executive council, the appeal board and the minister, as well as Tolmay's judgement.
The finding is extremely significant, said the ACB's director Mariam Mayet "because it brings into sharp relief the rubber-stamping nature of decision-making in South Africa concerning GMOs - something we have witnessed and resisted over the last 21 years".
This is "especially the failure to make a proper determination of the risk posed by GMOs to safeguard the constitutional right to an environment that is not detrimental to our health and well-being. This judgement has vindicated us and made these long years of struggle very worthwhile".
GMO regulation in South Africa
South Africa ranks among the top 10 countries globally for the adoption of GM crops.
The use of GMOs is regulated by the Genetically Modified Organisms Act and the GMO regulations are framed thereunder. The purpose of the Act and the regulations 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).
The Act establishes an executive council for GMOs and an advisory committee. A permit is required for the release of GMOs. Whether a permit is granted falls to be determined by the executive council in consultation with the advisory committee.
"The process envisaged is a fact and science-based investigation into whether there are any risks posed by the release of a particular GMO into the environment and whether these risks can be effectively managed," the SCA noted in its judgement.
The advisory committee evaluates the scientific components of applications for permits and reports to the executive council, which ultimately decides whether to approve the application and issue a permit.
Origins of the lawsuit
On 14 July 2014, Monsanto applied to the executive council for a permit for the general release of MON87460, which it said has been genetically modified to reduce yield loss in water-limited conditions.
According to Monsanto, "the reduced yield loss of maize containing MON87460 is achieved by the expression of the inserted Bacillus subtilis cold shock protein B (CSPB). This protein has been extensively studied and is known to facilitate adaptation to environmental stress (such as water scarcity) by binding secondary RNA structures thus helping to preserve normal cellular function."
Maize containing MON87460 also expresses the neomycin phosphotransferase II (NPTII) protein derived from Escherichia coli. The NPTII protein in MON87460 confers resistance to Kanamycin antibiotic.
Monsanto said the purpose of inserting the gene encoding for the NPTII protein was so that there was a way of selecting plant cells, which contain the CSPB gene during early product development.
The SCA's judgement noted that Monsanto submitted both confidential and non-confidential versions of the application, which included an assessment of the risks relating to human and animal health, toxicology, allergenicity and nutrition. It was advertised in the Rapport, Business Day and Beeld during March and April 2014.
No comments or objections were received in response to the ads.
Approval
The advisory committee, having considered the application, issued a recommendation on 17 December 2014 that the application be approved. On the strength of its recommendation, the executive council granted a permit to Monsanto on 12 June 2015 for the general release of MON87460.
On 7 August 2015, the ACB appealed the approval. Monsanto submitted a response to ACB's appeal on 13 July 2016.
The appeal board, by a majority, dismissed the appeal on 1 September 2016, and the minister confirmed the appeal board's decision on 2 December 2016. In June last year, the high court dismissed the ACB's application.
The thrust of the ACB's case is that the state respondents accepted, at face value, the claims made by Monsanto and failed to independently and critically evaluate Monsanto's application to satisfy themselves that the health and safety risks associated with the general release of MON87460 had been properly addressed.
It argued that the expert evidence that was served before the state respondents ought to have triggered the application of the precautionary principle enshrined in Nema. First, there was a lack of scientific data from which conclusions about the safety of MON87460 could be drawn; and second, the data that had been made available supported concerns about health risks arising from the use of MON87460.
"Instead of adopting the prescribed cautious approach and requiring Monsanto to address the safety concerns that had been identified, each of the state respondents proceeded to accept the say-so of Monsanto without any further consideration of safety risks."
According to the judgement, the experts highlighted several fundamental concerns, all of which were articulated in the appeal document served before the appeal board. These included that Monsanto's risk assessment was inadequate in identifying plausible hazards; its claims of lack of allergenicity are unsubstantiated; Monsanto itself identified a fragment of the protein used in MON87460 (CSPB) that was resistant to pepsin digestion, "meaning that it is not fully digestible by gastric juices", and further experimentation was thus required to assess potential allergenicity.
There was no evidence in the record before the executive council, the appeal board and the minister on the effects of food processing and the safety of human exposure via cooked MON87460 in South African diets.
The only data included was summaries of a chicken feeding study in which raw maize was fed to chickens; an acute toxicity study on the effects on mice of a bacterially derived isolated protein, which has "limited application to human exposure and is in any event not a study of all proteins associated with MON87460"; a rat feeding study; and a broiler chicken study, which was concerned with food quality standards and not with any adverse impacts on health.
Precautionary principle
The ACB welcomed the findings of the SCA regarding the applicability of the precautionary principle. The SCA scrutinised Judge Tolmay's findings as it viewed the precautionary principle as being central to the matter before it. She rejected the ACB's arguments regarding procedural fairness in the process, as claimed that it was fair and refused to refer the matter back to the executive council to reconsider its decision.
The ACB based its argument on the precautionary principle, which requires that where an activity may significantly affect the environment, decision-makers must apply a risk-averse and cautious approach that considers the limits of current knowledge about the consequences of decisions and actions.
The SCA said the precautionary principle is deeply rooted in almost every recent international environmental agreement. "The high court's rejection of the appellant's reliance on the precautionary principle was based on its finding that the precautionary principle does not find direct application in review proceedings.
"However, such an approach disregards the fundamental role that the precautionary principle plays in directing decision-makers in the exercise of their discretion. The current state of knowledge and uncertainty, the potential for serious or irreversible harm and the adoption of a cautious approach is clearly consistent with the subject-matter, scope and purpose of the Act."
Abject failure
Unanimously, the SCA found that there was an abject failure by the executive council to comply with a mandatory prescript contained in section 5(1)(a) of the GMO Act to determine whether Monsanto was required to submit an environmental impact assessment by Nema.
The SCA found that the evidence strongly suggested that, at the time that the executive council assessed the application for a permit for the general release of MON87460, it failed to consider or determine whether an environmental impact study in terms of Nema was necessary.
The SCA said that it was a relatively straightforward matter for the state to have adduced evidence that a determination was made one way or the other, but it had failed to do so.
Judge Tolmay, the SCA held, had "conflated the obligation" arising from section 5(1)(a) with the applicability of the precautionary principle, finding erroneously that an environmental impact study would only be required in the event of the precautionary principle being triggered. The SCA ruled that the precautionary principle was triggered and ought to have been applied.
Secondly, whether the executive council complied with section 5(1)(a) by considering the necessity of an environmental impact study to ascertain the impact on the environment of the proposed commercial release of MON87460 was a separate and distinct inquiry from whether the precautionary principle was triggered and should have been applied.
The SCA ruled that the application for commercial release of Bayer's MON87460 must be sent back to the executive council for reconsideration.
‘Disappointed'
The court ordered that the state together with Monsanto/Bayer must pay the ACB's costs, including the costs of its two counsels.
Bayer said that although it is disappointed in the verdict, "our next steps will be determined after thorough consultation with our legal team and the relevant government and industry entities.
"Bayer's mission is to help shape a world where there is health for all and hunger for none.
We do this through innovative products and services that equip farmers against the challenges of a changing climate, pests, disease, and economic pressure. Developing biotechnology solutions and breeding more climate-resilient crops like maize, is part of that mission."
Despite the setback of the successful appeal by the ACB, focusing on the regulator and its approval process regarding MON87460, "it is important to note that none of the other GMO traits that are currently available in the market are implicated in this matter.
"We are confident that all our commercially available trait technology and seed can be used safely and effectively like it has been for over two decades in South Africa and around the world."
Bayer is committed to complying with all local and international regulatory standards and to ethically conduct our business according to these protocols. "The efficacy and safety of our commercially available GMO traits are consistent with the positive assessments of expert regulators internationally and it has elevated sustainable agricultural production around the world."
The department did not respond to the Mail & Guardian's enquiries.
Source - The Mail & Guardian
