Genetically Modified Organisms Amendment Bill: Department Response to submissions

Meeting report

AGRICULTURE PORTFOLIO COMMITTEE
31 January 2006
GENETICALLY MODIFIED ORGANISMS AMENDMENT BILL: DEPARTMENT RESPONSE TO SUBMISSIONS

Summary of comments/concerns
Response from the Department of Agriculture
Summary of concerns not related to the Bill
Response from the Department of Agriculture to concerns not related to the Bill

SUMMARY
The Department gave a detailed response to the public submissions on the Genetically Modified Organisms Amendment Bill. Some members of the Committee felt that the Bill did not provide for meaningful public participation in the process of issuing permits for GMO activities. They felt that there was not proper communication between the public and the Executive Council. Another concern was that the whole system of dealing with genetically modified organisms (GMOs) was self-regulatory and largely depended on information provided by applicants for permits. Some members did not understand the need for introducing GMOs especially in cases where there were enough organic products. It was also pointed out that the issue of labelling was addressed in other legislation and not in this Bill. It was felt that it was important to deal with it in this Bill.

MINUTES
Ms M Selematsela (Assistant Director: Chemical Safety Sub-directorate, Department of Health), Dr J Jaftha (Senior Manager: Genetic Resources Management, Department of Agriculture), Mr L Makhoshi (Legal Adviser, Department of Agriculture), Ms M Vosges and Ms C Booyse (Chief State Law Adviser) attended the meeting. Dr Jaftha made the presentation. He read through the department's responses to issues raised by the public during public hearings on the Genetically Modified Organisms (GMOs) Amendment Bill (see documents attached).

Discussion
Mr T Ramphele (ANC) said that he could not understand the distinction between "use" and "contained use". There was an attempt to make the distinction but it was still unclear. He asked if the definitions of 'activity' and 'biosafety' gave any indication of the extent to which measures were taken to prohibit adverse impact on the environment, human beings and other organisms. The presenter had said that some guideline document would containment levels. An applicant for GM activity would be required to follow the guidelines. He asked if the guidelines were defined in the Bill, current act or in the regulations. He said that only the GMOs that were listed in National Environment Management Act (NEMA) required environmental impact assessment (EIA). He was of the view that there should be impact assessment should there be an introduction of something that never existed before. One should investigate if such a thing should be listed. He asked how the listing in terms of NEMA was related to GMOs. Was there any provision that required listing to be done taking into account all the risks set out in the Cartegena Protocol?

Dr Jaftha replied that 'contained use' referred to a particular activity taking place within a facility where there would be different barriers. This would include work conducted in a laboratory or a greenhouse. There were specific measures designed to limit the contact between the GMO and the external environment. With regard to 'use', the word should be understood in terms of its ordinary dictionary meaning. The difference between 'use' and 'contained use' was that 'use' could be use in contained areas or outside a facility.

With regard to biosafety and measures to prevent adverse environmental impact, he said that the published Amendment Bill defined biosafety as the avoidance of risk to human and animal health and safety and to the conservation of the environment, as a result of exposure to activities with GMOs. He felt that the definition adequately addressed the member's concern.

Ms Vosges replied that the guidelines on containment levels were compiled in consultation with the Advisory Committee. Clause 4 of the Bill provided that the Council might compile and develop guidelines with the consent of the Minister.

Mr Ramphele said that one might have a GMO introduced into the environment in a particular country with no adverse consequence to human or animal health and the environment. The question would be what would have to happen before such a GMO was introduced in South Africa. What would inform the Advisory Council's decision to allow the introduction of the GMO in our country?

Dr Jaftha said that the question posed was different from the initial question around containment levels. He understood the previous question to refer to guidelines and containment level in a specific facility. The guidelines were meant to assist in determining the containment level in a particular facility. An applicant could not continue with an activity at a particular facility without having approval or registration of the facility. An applicant had to go through a certain process before the facility could be registered. The applicant should specify the kind of activity that would take place and then it would be up to the Council to approve the containment level for the facility. The containment levels differed in terms of the risk management measures that should be in place to contain the activity.

Mr Ramphele asked if the process outlined applied to 'contained use' or 'use'. He also asked what was meant by 'containment level'. Did this refer to the level to which a facility could contain the probable spill out of the GMO?

Ms Vosges replied that containment level was linked to contained use. There were four containment levels. Number one was lesser concerns (less dangerous) and number four was high potential for risk (high danger). With respect to containment level one, one would be dealing with a GMO that had an extremely low potential risk to the environment, human and animal health. One would be required to have less containment measures due to the extremely low potential for risks.

The Chairperson and Mr Ramphele asked the Department to give examples of activities that would fall under the different containment levels.

Ms Vosges could not give the examples requested. One had to go through a risk assessment process before determining the required containment level. The containment level would depend on the characteristics of the GMO and how the GMO would interact with the environment and affect human and animal health. The E. coli bacteria used in university during experiments by students would fall under containment level one.

Dr Jaftha replied that activities that involved highly infectious materials would normally fall under containment level four. Highly infectious materials that could be air borne would require a high level of containment.

Mr Ramphele said that the containment levels seemed to be more concerned with risk to human being. The truth was that the GMOs could lead to harm to plants and other organisms as well. The Department should give examples of issues considered when an application is made for the introduction of genetically modified seeds to the environment.

Dr Jaftha said that the issue of containment level was different from the introduction of the GM seeds into the environment. There would have to be an EIA conducted before the seeds were introduced. The Department of Environmental Affairs and Tourism (DEAT) had EIA regulations which required an EIA to be conducted before a general release of a GMO would be authorised. The Department had indicated how the EIA should be conducted during the public hearings of the Bill. The DEAT's EIA was a progressive process.

Mr A Anslie (ANC) noted that imports from an exporting country that had GMO events commercially available would not be allowed in to South Africa if the events had not yet been approved in South Africa. He asked if the Department was able to keep track of what came in and what was GMO or organic. Was the tracking done on a regular basis? He asked if any consignment had ever been turned back. He was of the view that EIA was discretionary in terms of the GMO Act. He asked if the EIA required for listed events under the NEMA were mandatory.

Ms Vosges replied that countries like the USA had a lot of GMO activities commercially approved than South Africa. As a result, any consignment, especially of maize, coming from the USA was more likely to contain unapproved GMO events. South Africa did not allow grain imports from the USA because they were likely to contain unapproved GMO events. Inspectors at our harbours knew that any consignment of grain coming from the USA could not be offloaded in our harbours unless it was accompanied by a GMO import permit. If the consignment was compliant and an import permit had been issued, the Inspectors would monitor it and make sure that they knew where it had ended up. One of the requirements for the importing of a commodity was that consignment should be milled so that no live grain was available for planting in South Africa.

Dr Jaftha replied EIA was not required for every activity. Regulations would normally specify the activities that would require an environmental impact assessment to be conducted.

Mr Anslie said that the situation was confusing if NEMA made EIAs mandatory and the Bill gave the discretion to decide if an impact assessment should be conducted.

Dr Jaftha replied that NEMA had a list that required a full EIA. A general release of a GMO was one of the activities. The Council was bound to require an EIA for a general release under the Bill because the Act that would come from the Bill would be required to comply with NEMA.

Mr Makhoshi replied that some GMO activities did not require an EIA. All applications for GM activities relating to activities listed under NEMA required an EIA.

Mr Ramphele said that the legislation should clearly state when an EIA would be required. There should be a clear link between the Bill and NEMA. Mr Anslie agreed with the member's view.

Mr D Dlali (ANC) said that the proposed definition of 'activity' was not limited to the listed activities only. He asked the presenter to expand on what the definition was intended to mean.

Dr Jaftha said that the words 'not limited to' were intended to cover any situation that might arise at a later stage.

Mr Anslie asked who was responsible for conducting EIAs. It seemed like the whole process was self-regulatory and the applicants conducted the EIAs. In essence there was no independence.

Dr Jaftha replied that NEMA provided for the process that had to be followed when conducting an IEA. Independent consultants conducted the EIAs and this ensured that there was independence in the process.

Mr Anslie said that it might be better to specifically provide that the EIA should be independently conducted.

Dr Jaftha did not think that there was any need to refer to the whole process in the Bill. A simple reference to NEMA should be able to address the concern.

Mr Ramphele asked if transboundary movement referred to movement across South African borders or if it also included movement across provincial borders. South Africa and Botswana only had a fence separating them and this made it easy for organisms to move from one country to the another.

Dr Jaftha replied that there were legal and illegal transboundary movements. Some movements were intentional and others were unintentional and the movements had different permutations. Unintentional transboundary movement could occur in cases where there was an accident. It would also include movement as a result of natural forces. Anything that was intentional and unauthorised was an illegal transboundary movement. The definition of transboundary movement did not include movement across the borders of the nine South African provinces.

Mr Anslie noted that a general release was defined as the deliberation introduction of a GMO into the environment by whatever means, where the organism was no longer contained by any system of barriers. This meant that the disposal of organisms in a container into the environment would not constitute a general release. He wondered if the words "where the organisms are no longer contained by any system of barriers" were necessary.

Dr Jaftha replied that a general release was defined in relation to other activities under the GMO Act. The definition referred to barriers due to the context of other activities covered in the Act. A person who had been authorised to generally release something was not required to have risks management measures in place.

Mr Ramphele said that the presenter had said that the precautionary approach was by implication covered in the Bill and that it was not necessary to expressly provide for it. The issue of weighing risks against benefits was not clearly set out in the Bill. He asked the presenter to indicate the provision that enjoined the Council to look at the weighing of risks against the benefits if such provision was contained in the Bill. It was important not to have a situation wherein a GMO was introduced while an organic product would have achieved the objectives of introducing the GMO. The issue of determining the case for or against introducing GMOs was not clear in the Bill.

He said that the legislation had copied the time periods provided for in the Cartegena Protocol. He asked if the Department had looked at the country's capacity when adopting those timeframes. What informed the timeframes? The issue of corporate governance was very interesting. He wondered if people who dealt with alien invasive plants were part of the process of drafting the Bill. The issue of transboundary movement of GMOs and the question of liability were very important. It had been said that the Council had no legal personality. He felt that the person who had introduced the GMOs should be liable for damages caused as a result of a transboundary movement. He asked if there were any enforcement measures between States. There were also issues of jurisdiction that had to be dealt with.

Dr Jaftha replied that the precautionary approach provided that in order to protect the environment the approach shall be widely applied. Where there were threats or serious or irreversible damage, lack of full scientific evidence would not be used a reason for postponing cost effective measures to prevent environmental degradation. The decision that had to be taken could be an approval or denial. The measures put in the Bill were proportional to the risks. The requirements for contained use activities were different from those of a field trial. A person conducting a field trial would be expected to have more containment measures than one engaged in a contained use activity. Similar activities were treated in a similar way. There was no element of discrimination. There was a procedure in place that ensured that there was consistency in the way applications were treated.

He said that some people had made applications that did not show any benefits to the country and such applications were not approved. There was a process to do cost-benefit analysis. There was a mechanism to review decisions taken.

With regard to the issue of liability following the transboundary movement of GMOs, Ms Vosges replied that the Council would look at whether to repatriate or destroy the particular GMO. The Council would then claim the costs involved in repatriating or destroying the GMO from the person responsible for the transboundary movement. The Department was looking at empowering the Director General to enforce the cost order against the person responsible for the damage. The Protocol adequately addressed the issue of enforcement between states.

Mr P Holomisa (ANC) asked if the question of labelling was addressed anywhere in the Bill. He thought that the issue should have been covered in the provisions that dealt with the functions of the registrar or Council. He felt that there should be an agreement that GMOs would be labelled before the issuing of the permit.

Dr Jaftha replied that labelling was covered under the regulations made in terms of the Foodstuffs, Cosmetics and Disinfectants Act. There were specific conditions under which labelling was mandatory. It might be preferable to have further information on this by the Department of Health. It was not appropriate to deal with the matter in this Bill because it was already covered elsewhere.

Mr Dlali noted that the general principle was that the decision-making process would be based on consensus. The reason for requiring a decision to be based on consensus by all members of the Council and not only those present at a meeting was that the latter situation could result in a GMO being approved for commercial use without an indication that the GMO had been assessed and was considered as safe as conventional food or feed, or that it was safe for introduction into the environment. The requirement that the decision should be based on consensus by all members of the Council might have the effect of delaying the decision making process. The Council would be forced to wait for all embers to be present before a decision could be taken.

Dr Jaftha replied that the requirement that decisions should be arrived at by way of consensus of all members of the Council had led to some delays. The office of the Registrar placed a facilitative role and interacted with Council members and applicants. Sometimes members would require further information before making a decision. The situation could become worse as a result of applicant not furnishing the required information. In some instances Government Departments required more time to evaluate the information. For instance, one could not proceed with the release of an organisms unless DEAT had approved the release.

Mr Anslie said that the Executive Council implemented the GMO Act in an almost self-regulatory manner. There was no independent risk assessment and risk assessment was done by the applicants. No reasons for granting a permit were given by the Council. It seemed liked there was no engagement between the Council and people who wanted to make objections. People who had objected to GMOs were rarely informed of the decision of the Council and this complicated the matter because they were entitled to an appeal in terms section 19 of the Act. They could not appeal if they were not informed of the Council's decision. Section 5(a) of the GMO Act gave the Executive Council the discretion to ask for EIAs. It was the applicant who made the application, conducted the risk assessment and offered responses to questions raised by objectors. He wondered what this was if it was not self-regulation.

He said that the Bill did not provide for public participation. Biowatch was taking the Council to court and there were constant threats for court action to ensure public participation. People had complained about the nature of adverts put in newspapers advertising an application for a permit. The adverts did not contain enough information that would make it easier for the public to participate in the whole process. The Council was expected to evaluate all inputs received. The question was how did the public know if the Council was making proper evaluations if decisions were not communicated to objectors and no reasons were given as to why a permit had been issued. He wondered if everything should be left to the experts. Affidavits were called for to verify the information provided in an application. An affidavit from a person who had spent huge sums of money developing a product would surely confirm the information in the application. What was required was an independent verification and not an affidavit by the applicant.

Dr Jaftha was of the view that the Advisory Committee conducted an independent risk assessment. The assessment would vouch for the information supplied by means of an affidavit. The Council appointed the Committee. This was the only independence built into the process but improvements might have to be made should the Committee feel that the process was inadequate.

He said that there had been interaction between objectors and Executive Council. The Council had always tried to ensure that the public got sufficient information to enable them to interact with it more meaningfully. Public input was always taken into consideration before arriving at decision. The information that had to be the advertisement was prescribed. The advertisement was expected to name the type of GMO involved, the activity to be conducted and the area where activity would take place. It should also indicate a place where further information could be obtained. The Council had always responded to people who had made objections and evaluated the information supplied to it by applicants taking the objections into account.

Mr Ramphele said that there would be discrimination if one would allow GMOs from one country and not the other. He asked if, in allowing GMOs, the Department took the country's biodiversity into account. One might damage what we have as a country by introducing something new into the environment. In doing a cost benefit analysis, one had to ask if there was any need for introducing a GMO. The Protocol provided that one could accept a product even though the risks associated with it were unknown. The question was whether it was necessary to introduce something that might have adverse impact on the environment if there was enough organic products in the country.

Dr Jaftha did not think that the Protocol provided that one could still accept a product if the risks associated with it were still unknown. He was of the view that it said that where there were still some uncertainties, one had to decide whether or not to accept the product. One could accept the product and put measures in place to address some of the potential risks. This was what the precautionary principle required. One could reject the product and say that there was no capacity to deal with it or put risk management strategies in place.

On whether there was a need for GMOs, he said that first GMO were based on certain agricultural challenges.

Mr Ramphele said one could not take precautionary measures against unknown risks. This meant that one could import even though the risks where not known.

Dr Jaftha said that there were examples of cases wherein the Council had done a case benefit analysis. There were documented benefits attached to the reduction in the use of insecticides. There was a reduction in the exposure of workers to the pesticides. There was an application for GM sugar cane. The Council considered that there was no market to introduce GM sugar cane and the application was not approved. The science behind the product was good but there was no market for it. Because of the low maize price and the need to establish the potential impact of commodity imports, the Council had stopped further approval of commodity clearance applications. The Council had applied its mind before making the decision.

On the issue of the potential impact of the introduction of GMOs to the environment, DEAT was represented in the Council. It would make sure that the potential impact on biodiversity was addressed. The Department of Labour would ensure that there was no unnecessary exposure of workers to unnecessary risks. The Department of Trade and Industry would deal with the impact of the GMO on the trade environment. Each Department involved would extensively consider the application and ensure that there was compliance with its legislation and policies.

In terms of time periods, he said that the periods were initially shorter. The Protocol allowed for longer periods. The Council was not bound by the time periods especially in cases where there was a need additional information. There was always question of capacity in dealing with some of the issues that came before the Council.

Mr Holomisa was not satisfied with the answer to his question on labelling. The Bill was about GMOs and it would make sense to incorporate labelling requirements of GMOs in it and not some other legislation.

Mr Anslie said that there were difficulties around labelling. The Committee had asked the Department of Health to indicate countries wherein labelling had been done. He hoped that the Committee would be furnished with the relevant information.

The Chairperson said that a document had been distributed to members.

Mr Holomisa said that the document given to members was about a study conducted in Australia on the cost implications of mandatory labelling of GM food. The issue was that people should know that the product they had bought was genetically modified. One way of ensuring this was to label the product. Some seeds contained clear GMO label. The seeds would be planted and then become food. It was important to label the food that would come from those seeds. If the case for GMOs was food security, it was in the interest of GMOs manufacturers to have them label so that they could one day clearly point to their products and say that they had saved the nation.

Dr Jaftha replied that labelling was inseparable from identity preservation system. The identity preservation system was still under development in consultation with the South African Bureau of Standards. The system would include the whole value chain. A product that would include even a very minute trace of GMOs would have to be labelled. One could not have an identity preservation system if there were no mechanisms to test a product for GMOs.

Ms C Nkuna said that there were regulation drafted under the current Act. She asked if there would be regulations flowing from this Bill.

Dr Jaftha replied that the regulations follow after the Bill had been approved.

Mr Abram said that some people had carried on smoking despite the warnings printed on the cigarette packs. If tobacco companies could label their products, it should be possible for other companies to label their products.

Mr Abram asked if the Department of Health had conducted any research of foodstuffs that were produced from GMOs.

Mr Holomisa said that there was nothing preventing the Committee from amending the Bill to cater for its concerns.

Mr Anslie said that the Bill made no mention of the issue of liability.

Dr van Niekerk (DA) said that the Bill dealt with issues that impacted on human health. He wondered if the Department of Health had the necessary legislation to deal with issues that might arise from the Bill. It would be prudent to address the impact of the Bill on human health in this legislation until such time the Department of Health had enacted the relevant legislation.

Dr Jaftha said that the representative from the Department of Health was only brought as a member of the support team. It would be unfair to put her on the spot and expect here to defend policy positions of the Department.

The meeting was adjourned.