17-19 JANUARY 2006
RESPONSE FROM THE DEPARTMENT OF AGRICULTURE
The relevant submissions in which the concerns listed below are indicated in brackets behind the concern.
Paragraph 1 Clause 1 - Section 1 of the Bill - Definitions
"activity" (14)
To make provision for the inclusion of activities pertaining to the use of GMO’s we propose the following amendment to the definition of activity.
"’activity’ means any activity with genetically modified organisms but is not limited to the importation, exportation, transit, development, production, release, distribution, [contained] use, storage and application of genetically modified organisms only".
"biosafety" (1, 6, 14)
Proposed new definition of biosafety below –
"’biosafety’ means the level of safety whereby risk management measures are taken to avoid potential risk to human and animal health and safety and to the conservation of the environment, as a result of exposure to activities with genetically modified organisms, and ‘biological safety’ shall have a corresponding meaning"
"contained use" (1, 14)
Movement and storage must be read in its normal, dictionary meaning. The intention is to cover all possible activities that could take place within a laboratory.
Genetic constructs could be considered as genetic material, and would be covered under the definition of a GMO in the principal Act, which makes reference to genetic material. The definition of a GMO is as follow –
"’genetically modified organism’ means an 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, and ‘genetic modification’ shall have a corresponding meaning."
Guidance on how to determine the different levels of containment applicable during a specific GMO activity are incorporated within the relevant guideline documents available to the applicant. The applicable level of containment, which is based on a risk assessment conducted by the applicant, is taken into consideration when taking a decision on a particular application.
We further propose that the definition of contained use be amended to address the concern raised in respect of contact and impact of the GMO.
"’contained use’ means the development, production, cultivation, use, application, storage, movement, destruction or disposal of genetically modified organisms within a facility, installation or other physical structure, including a greenhouse, that are controlled by specific measures, including physical barriers, or a combination of physical barriers together with chemical or biological barriers or both, that effectively limit contact with humans, animals and the external environment and their impact on humans, animals and the external environment."
"commodity clearance" (5, 14)
Commodity clearance is an authorization to use a GMO as food, feed and processing. General release is authorization for the commercial planting and use as food, feed and processing. SA carefully monitors GMO events approved in countries where SA normally imports from to determine whether SA could still import from that country. Imports will not be allowed from a country if that exporting country has GMO events commercially available that have not been approved in SA yet.
The wording of external environment originates from the Protocol and means outside a facility.
We propose the following amendment to the definition of commodity clearance.
‘‘ ‘commodity clearance’ means the authorisation to use [a] genetically modified organisms as a food or feed, or for processing, but excludes the planting of a genetically modified organism as a [direct] release into the environment;
"environmental impact assessment" (1, 14)
Risks related to the GMO will be assessed during the risk assessment process. An environmental impact assessment is a function that is regulated under the National Environmental Management Act (NEMA). The definition provided for in NEMA also refers only to activities and not the GMO per se. An environmental impact assessment is not a requirement for all types of GMO activities, only those listed in terms of NEMA.
"extension permit" (12)
Please refer to the response provided for under Clause 6, Section 9.
"release" (14)
The convention is to draft in the singular, but considering that the remaining definitions of the Bill and the principal Act is already in the plural, we propose amending the definition of general release to be in the singular.
‘‘ ‘general release’ means the [deliberate introduction] release of a genetically modified organism into the environment by whatever means, where the organisms are no longer contained by any system of barriers [and are no longer under any person’s control, so that the organism is likely to survive and be disseminated];’’
"protocol"
We propose the following amendment to the definition of protocol.
‘‘‘Protocol’ means the Cartagena Protocol on Biosafety to the Convention [on Biological Diversity], that has been negotiated and adopted by the Parties to the Convention [on Biological Diversity], acceded to by the Republic on 14 August 2003; a copy of the Protocol is attached for information purposes in the Annexure;’’
"transboundary movement" (6)
The word "beyond" was included in the initial draft of the Bill, but changed to the word "across" in the current draft to accommodate for both imports into and exports from SA. The intention was not to accommodate for movements between different provinces within SA.
For clarity purposes, we propose the following amendment to the definition of transboundary movement.
‘‘ ‘transboundary movement’ means the movement of a genetically modified organism [across the boundaries of the Republic] from the Republic to another country or from another country into the Republic."
Note also the change from the plural to the singular.
Paragraph 2: Clause 2 - Section 3 of the Bill – Executive Council
No concerns raised on this clause.
Paragraph 3: Clause 3 - Section 4 of the Bill – Objectives of the Council
No concerns were raised on this clause.
Paragraph 4: Clause 4 - Section 5 of the Bill – Powers and duties of the Council
Self-regulation/risk management (1, 14)
Although the Act does rely to an extent on self-regulation, there are mechanisms in place to ensure compliance with the Act, i.e. The principal Act establishes an inspectorate in Section 15, with one of its functions to inspect, request information and seize any appliance, book, statement, document or GMO and take samples if required. These provisions therefore create the mechanism for monitoring activities and ensure compliance with the provisions of the Act and any permit issued in terms of the Act.
The Bill provides for the Registrar to arrange for an inspection, including routine inspections, of any activity or facility, as well where the Registrar has ascertained or suspects that an activity is conducted contrary to the provisions of this Act, to arrange for an inspection of the activity.
Further reliance is also placed on reports received from the public on irregular activities taking place.
Precautionary approach not explicitly indicated in the Bill (1, 14, 23, 24, 29)
Regulation 3(2) does not satisfactory to address the precautionary approach as defined in the Protocol.
This concern comes down to the question: Is the Bill really not giving effect to the precautionary approach?
The precautionary approach holds that uncertainty regarding serious potential harm to the environment is not a valid ground for refraining from taking a decision, which could include preventative measures. In practice this means that although there may be concerns on the potential long-term impact of GMO’s, this may not keep you from taking a decision. The precautionary approach is provided for in Articles 10(6) and 11(8) of the Protocol.
The chief characteristic of the precautionary approach is that it operates as an enabling action. It authorizes the action of taking preventative measures in circumstances of scientific uncertainty. This may mean that you impose specific conditions, which would act as your preventative measures, into a decision to approve the proposed activity as a precautionary measure in approving the activity. You can therefore apply the precautionary approach and still approve an activity.
Where decision is necessary, the following factors, based on the precautionary approach, are taken into account -
Proportional to risk
Non-discrimination
Consistent
Based on cost-benefit assessment
Subject to review
Capable of assigning responsibility for producing scientific evidence
We are therefore of the opinion that the precautionary approach is adopted in the decision-making procedures contained in the Bill and principal Act. The wording of the Protocol per se does not need to be included in the Bill, as it is already an implied procedure. In every application the precautionary approach is applied by doing a case-by-case assessment of each application and taking the necessary risk management measures for each activity.
Absence of provisions regarding the advance agreement procedure (14)
The Advanced Informed Agreement (AIA) procedure constitutes 4 actions – notification, acknowledgement of notification, decision-making and notification of the decision. These all form part of the administrative procedures that are applied in administration of the Act to meet the different provisions relating to decision-making. In practice this means an application for importation is submitted to the Registrar’s office, the Registrar will acknowledge receipt of the application, the application will be assessed by the Advisory Committee who will make a recommendation to the Council, the Executive Council will take a decision on the application and the decision is communicated to the applicant and where required, to the Biosafety Clearing House.
The legal requirement pertaining to the correctness of the information provided in an application is obtained by way of an affidavit to be submitted with the application. The information prescribed in the different Annexes to the Protocol is already included in the application forms.
Council approval required for use of facilities (6, 7, 30)
Does not provide for international research co-operation (30)
The purpose of the proposed amendment is two-fold. It informs the Council of the research conducted and secondly at which facility. It should be remembered that although the facility must be registered, not all activities conducted within the facility needs a contained use permit, as some low containment activities may conducted without a permit [Regulation 2(2) of the principal Act].
The Bill makes provision in Section 5(1)(d) for the Council to determine when a user will be required to re-apply for approval should there be any change in the use of the facilities, as this may result in a change in the required containment levels and hence the requirement for a specific permit to conduct the activity. At the moment, most of the activities (including research forming part of international co-operation) conducted at facilities are of the nature that they don’t require a contained use permit. Should there however be a change in the type of activity conducted, notification of such a change is required to determine whether this change would result in a change in the containment levels, which could necessitate the requirements for a specific permit, which would imply a re-approval from the Council.
The Bill emphasizes a scientific approach towards risk assessment and decision-making (12, 14, 23, 24, 30)
Risk assessments are a primary requirement of any application and also include an initial assessment of the potential impact of the GMO activity on the environment and socio-economic factors. Furthermore, in addition to the requirement for a risk assessment, the Bill also provides for consideration of environmental and potential socio-economic factors when decisions are taken. It should however be noted that environmental impact assessments and an assessment of the socio-economic factors will not be required for all types of activities provided for in the Act, with specific reference to contained use activities within a facility.
The Protocol requires consideration of environmental impact whenever there is a release into the environment (Articles 7 - 10). This is also provided for in the Bill. Although there are no criteria in the Bill on when an EIA is required, the Council will be directed by DEAT on what the requirements and stipulations are in the relevant environmental legislation, such as National Environmental Management Act (NEMA) and National Environmental Management Biodiversity Act (NEMBA). It is envisaged that the requirements on when an EIA will be required will be incorporated into the various application forms and guideline documents.
The content of the risk assessment is determined by the different questions asked in the different applications forms. The questions contained in the application forms emanate from the Protocol (Annexes I-III) and the different legislative requirements within the different sectors represented in the Executive Council. There are already guidelines available to assist the applicant in the type of information that must be contained in the application. The framework for an environmental impact assessment will be determined by the requirements of NEMA.
In terms of NEMA, an environmental impact assessment (EIA) is only required for listed activities. The release of a GMO into the environment is one such listed activity, hence an EIA would be required when an application for release into the environment is made. The exclusion of activities from the requirement of an EIA will therefore also be subject to an exclusion from the list provided by NEMA.
With reference to the concerns raised pertaining to parallel regulation under various legislation, with particular reference to NEMA, NEMBA and the GMO Act. This issue may best be dealt with in the following manner. That the relevant Ministers consult and come to an agreement with regard to interaction between GMO Act, NEMA and NEMBA. This would also be in line with cooperative governance as provided for in the Constitution.
Review of decisions (1)
The provision does not indicate what the origin must be of the new information. New information could therefore include the submission of new information from a member of the public. However, the Council still has the prerogative to determine whether the new scientific information requires a review of any decision taken.
Sections 5(g) to 5(j) – submissions (26, 7)
We interpreted the issue to mean that, in some instances SA could incur liability to deal with GMO’s in another country, as a result of an unintentional transboundary movement. However, the provisions here provides for the notification process as established by the Protocol.
This provision therefore requires that SA must, if it is realized that there has been an unintentional transboundary movement, provide the information as stipulated in the Protocol, to the country that received the unintended consignment of GMO’s. SA will also further have to consult with that country on how that country could deal with the GMO within their country.
However, an unintentional transboundary movement as provided for in this Bill would not include an illegal transboundary movement. It is proposed that illegal transboundary movements and the responsibilities of the Republic concerning the affected country are dealt with under clause 15, Section 21 of the Bill. We therefore propose amendment of Section 21(1)(a) as follow –
"any person who contravenes or fails to comply with the Act, any condition, restriction, prohibition, reservation or directive imposed or issued in terms of this Act;"
Section (j) also requires that the Council must satisfy themselves that there is no lower level of protection before entering into any agreements or arrangements.
Section 5(m) – submission (26, 7)
This provision could be interpreted to refer to an activity conducted contrary to this Act in SA.
However, it could also infer that this could include an illegal transboundary movement. Article 25(2) in the Protocol provision is made that the affected State may hold SA financially responsible for repatriation or destruction of a GMO. However, in addition to the possible financial implications for SA as a result of SA’s accession to the Protocol, clause 11 [Section 17(2)] provides that damage caused as a result of the contravention is to be borne by the user concerned.
Insufficient public input (1, 23)
There is a process by which public notification is required in the Bill [clause 4 Section 5(2)(a)(i)]. Regulation 6 of the principal Act provides for public input by way of public notification in 3 national newspapers. The Council must evaluate all inputs received when taking a decision on an application. This therefore gives effect to the right to fair administrative action and the provisions of the Promotion of Administrative Justice Act, 2000 (Act No. 3 of 2000).
Public input is not required for activities that are not a release into the environment, for example contained use activities that are conducted within a facility.
Transparency of the system - no interaction and feedback (1, 14)
Any member from the public can obtain information on activities pending or being conducted by means of the Promotion of Access to Information Act, 2000 (Act No. 2 of 2000). In addition to this, the department has also placed certain information such as permits issued on the website of the department. The department is also in the process of finalising the development of a South African Biosafety Clearing House which will be a portal to information on the regulation of GMO’s in SA.
Lack of guidance for the applicant to conduct a risk assessment, EIE and socio-economic impact assessment, although it allows for guidelines to be developed. Guidelines should be adapted to NEMA and NEMBA (23).
This concern is addressed in clause 14 [section 20(b)] where regulations should be developed pertaining to the procedures to be followed by the applicant for the drawing up of risk assessments, environmental impact assessments, socio-economic considerations and risk management measures. These procedures would be based on the relevant legislation, for example, the procedures on how to conduct an EIA and what information would be required, would originate from the guidance and provisions of NEMA. Guidance on how to conduct a risk assessment is already contained in the application forms through the different types of questions asked as well as a guideline document that was developed to assist the applicant in conducting a risk assessment.
Guidelines are not made available to the public (14)
The intention of this amendment was not to restrict access to the guideline document. Although the complete set of guidelines will not be published in the Government Gazette, it would be made available to the public through the website of the Department of Agriculture and in hard copies from the department. Considering the dynamic nature of this technology and that the guidelines would continuously change to accommodate for new developments in this industry, it would not be feasible to publish these guidelines with every change in the Government Gazette.
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Paragraph 5: Clause 5 - Section 7 of the Bill – Meetings of the Council
The general principle is that the decision-making process is based on consensus by way of a quorum. However, 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, is that the latter situation could result in a GMO be approved for commercial use without an indication that the GMO has been assessed and is considered as safe as conventional food or feed, or is safe for introduction into the environment.
Paragraph 6: Clause 6 - Section 9 of the Bill – Functions of the Registrar
Powers of the Registrar are provided for in Section 9(1) and (3) for the issuance of permits, including import and export permits. The concern raised that the Registrar would issue permits without any insight by the Council is incorrect, as the Council would lay down terms and conditions under which the Registrar may issue a permit or extension permit.
Although some of the functions of the Registrar are now no longer subjected to the instruction of the Council, these are mainly administrative functions such as keeping a register, arrangements of inspections, submission of applications to the Council, communication of Council decisions to the Biosafety Clearing House and to act on possible contraventions taking place. These are therefore administrative functions and not functions that would give the Registrar the power to authorise activities without the Council’s insight and direction.
However, the concern raised that the Registrar can act with regard to transgressions without consulting the Council refers. Considering that immediate action is normally required when there is a possible transgression and that the Council may not be immediately accessible to address the issue of concern, it is proposed that the Registrar should be able to at least cause the cessation of an activity until further instruction for the repatriation or disposal of the GMO can be obtained by the Council, either in a meeting or prior to a meeting. It is therefore proposed that the section talking to the repatriation or disposal of a GMO [9(2)(c)(ii)] is moved to the section where the functions of the Registrar is subject to the instructions of the Council [9(1)]. This would then also fit in with Section 5(10(m) of the Bill.
An extension permit is a permit issued on the basis of a previous permit issued for the specific activity. If the request for an extension permit contains new information that differs from the information that was submitted with the initial application for a permit, the application would be regarded as a new application and would an extension permit not be issued.
If an extension permit is issued to extent the time period in which an activity should be conducted, this permit would be, as any other permit issued in terms of the GMO Act, recorded on the permit list, which is currently available on the website.
Paragraph 7: Clause 7 - Section 10 of the Bill – Advisory Committee
The motivation for specifying an environmental expert and an expert on human and animal health was to ensure that although there are many fields of science applicable to the regulation of GMO’s, these two fields are also the main area of concern in the objective of the Protocol. We are therefore of the opinion that these two areas of expertise should be provided for in the main structure of the Advisory Committee.
The prescripts for an environmental and human/animal health expert does not imply that experts on socio-economic issues or ethical issues or any other are of science are not important to be represented on the Advisory Committee. The remaining areas of expertise that could not be accommodated on the Advisory Committee, are accommodated in clause 11 [section 8(b)] as well as in Section 11(2) of the principal Act, where provision is made for the Advisory Committee to co-opt knowledgeable persons and for the appointment of sub-committees to assist the Advisory Committee in performing their functions.
Members of the Advisory Committee are recommended by the Executive Council. The criteria for selecting the members of the Committee are provided for in the Bill and the principal Act. Although members of the Committee are appointed by the Minister, this does not impact on their independence as a scientist in a field related to GMO’s.
Prior to the appointment of any member of the Committee, a public invite is made in a national newspaper for individuals to submit their applications to serve on this Committee, to the department. All compliant applications are considered by the Executive Council when making a recommendation to the Minister. There is therefore no legal provision that prevents a representative from organizations such a Biowatch to be considered for appointment as a member of the Committee.
Information on the names of the members appointed on the Advisory Committee is, upon request, available to the public. This information would also be incorporated into the new South Africa Biosafety Clearing House.
Paragraph 8: Clause 8 - Section 11 of the Bill – Functions of the Committee
Risk assessments submitted by applicants are reviewed by the scientific experts that serve on the Advisory Committee to determine whether the data provided in the risk assessment is scientifically valid and reliable. This assessment by the Committee includes an assessment of the impact of the GMO on human health, with particular reference to the possibility of causing allergic reactions.
Paragraph 9: Clause 9 - Section 12 of the Bill – Funding
No concerns were raised on this clause.
Paragraph 10: Clause 10 - Section 15 of the Bill – Inspectors
The concerns raised on this clause are closely linked to the concerns raised pertaining to self-regulation. The Committee is therefore also referred to the response provided for in clause 4 [section 5].
Inspectors are officials within the Department of Agriculture and have qualifications required for their appointment in their specific positions, such as a plant and quality control officer. Inspectors regularly attend workshops on monitoring and have guidance documents to enable standardization with regard to inspections. New appointees also receive in-service training by experienced inspectors.
Paragraph 11: Clause 11 - Section 17 of the Bill – Determination of risks and liability
We recognize the concerns raised pertaining to the adoption of the outcome of the Protocol negotiations on this matter.
We further proposed an amendment of the definition of user to mean "User means any person who conducts an activity with genetically modified organisms". This amendment would cover all persons conducting activities with GMO’s, including the manufacturers, and bring the provisions of liability in line with the common law principle of fault-based liability. To be liable there must be proof of negligence.
To accommodate the concerns related to rehabilitation, we propose the inclusion of a clause that would provide for the recuperation of any costs incurred due to the measures taken by the Council to deal with the contravention – clause 4 [section 5(1)(m)].
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Paragraph 12: Clause 12 - Section 18 of the Bill – Confidentiality
Access to information and the disclosure of information contained in applications are guided by the provisions of the Promotion of Access to Information Act, 2000 (Act No. 2 of 2000). In terms of this Act an applicant can only withhold information as confidential information if this is based on a provision of the PAIA Act.
The concern regarding the provision that a "general description" of the GMO is to be made available to the public, refers. This wording originates from the wording of the Protocol. In the absence of international guidance on what is constituted as a description of a GMO and to what extent a description is sufficient, the recommendation is that we follow the wording of the protocol.
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Paragraph 13: Clause 13 - Section 19 of the Bill – Appeals
The concern raised on the consideration of different factors in making any other order, refers. The intention of this clause was to enable the Board to make interim provisions until the outcome of the appeal is known. The need for a provision to take interim measures come to mind in the latest appeal concluded under the GMO Act, where the Board had to take an interim decision on whether a permit authorizing general release in SA should be revoked, which could have immense financial consequences for not only the Department, but also the company in possession of the permit, prior to the outcome of the appeal. Any decision of this kind would be a case-by-case decision and take into consideration the precautionary approach.
In practice, the following factors must be taken into consideration when convening a meeting of the appeal board. There may be a time delay in receipt of the appointment letters by the Registrar’s office, making contact with the Board members and determining a mutual date on which all members are available to meet to consider the documentation. Bearing in mind that the Board members will be conducting this function in addition to their existing occupation, it could become problematic to find a suitable date for the first meeting within a specific period of time.
However, the concern raised to facilitate a meeting of the Board within a specific period of time after appointment of the Board is recognized. It is therefore proposed, taking into consideration the administrative challenges in convening the Board, a time period of not less than 60 days after appointment, are provided in which the Board must meet. We therefore propose an additional insertion into clause 13 [section 19] –
"(2)(d) the registrar must convene the meeting of the appeal board within 60 days of the appointment of the appeal board."
Paragraph 14: Clause 14 - Section 20 of the Bill – Regulations
Amplification of the procedures to be followed by the applicant would be addressed in the regulations.
Paragraph :15 Clause 15 - Section 21 of the Bill – Offences and Penalties
Refer back to clause 4, sections 5(g) to (j) and (m) of the Bill.
Paragraph 16: Clause 16 – Long title of Act 15 of 1997
We propose that specific reference is made to the Cartagena Protocol.
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