By the Ministers of Agriculture and Environmental Affairs and Tourism
18 November 1999 in Cape Town
Introduction
Since the early 1970s recombinant DNA technology has enabled scientists to genetically modify plants, animals and microbes rapidly.
The term modern biotechnology has evolved to encompass three basically different technologies:
To date biotechnology has led to advances in medicine with new biopharmaceuticals and diagnostics that offer possibilities in the treatment of incurable and disabling diseases. This capacity to analyse and manipulate genes has been extended to other field s and holds the possibility of improving agricultural products as well as industrial processes.
Although modern biotechnology has demonstrated its utility, there are concerns in its application to agriculture about the potential risks to the environment and biodiversity.
For the most, a potential problem is that the transgene may escape into wild and weedy relatives and affect the biodiversity by replacing indigenous flora because once an organism is released, it cannot be recalled. As it reproduces, the genetic informati on it carries is replicated and can be dispersed into the surrounding environment through natural processes (pollen transfer and horizontal gene transfer).
In other words the source of a hazard is rarely the organism itself when modified forms of familiar organisms are being reintroduced into environments in which they were already present. While some traits are recommended as safe (e.g. á-glucuronidase) oth ers may be associated with certain hazards (for instance, a gene conferring a selective advantage to its host).
Depending on the nature of the novel trait, harm may occur if the genetic information transferred and expressed crosses geographical boundaries and taxonomic classes. Gene transfer frequencies are dependent on such factors as sexual compatibility between t he donor and recipient species, flowering synchrony, sharing a common insect pollinator and distance.
During field trials of transgenic plants, biosafety regulators often enforce the use of containment measures such as fencing, netting or barrier rows to maintain reproductive isolation. This strategy for dealing with pollen flow is not much different from the isolation distances used in traditional breeding for maintaining genetic purity in cultivated crops.
The application of containment measures to commercial releases of transgenic crops may not be feasible. Some interpollination between cultivated species and wild or weedy relatives is to be expected. Since pollen flow is a natural process, gene dispersal is not the risk but rather the consequences of the possible plant-gene combinations that might be created.
Ultimately, under an effective biosafety regime genetically modified crops should not be given blanket approvals because of the intricate nature of gene expression. The biology of individual genes in individual crops in individual locations has to be asse ssed. The risks posed by genetically modified organisms (GMOs) to the environment and biodiversity should routinely be addressed on a case by case basis.
The GMO Act (Act No 15 of 1997), introduced by the Department of Agriculture, will come into effect early next year addresses environmental and human safety with regard to the application of biotechnology. The Act applies to all viable entities whose gene tic material has been altered in some way.
[Related legislation: Environmental Conservation Act (DEAT), Agricultural Pest Act (Agriculture), National Environmental Management Act (DEAT) and the Foodstuffs and Cosmetic Act (Health)]
The Genetically Modified Organisms Act promulgated in 1997 makes provisions for:
Many countries, particularly developed countries, have legislation regulating various aspects of genetically modified organisms. However, there is no binding international agreement that regulates movement of GMOs across national borders.
The Biosafety Protocol that is being negotiated under the auspices of the Convention on Biological Diversity is aimed at regulating the transboundary movement, handling and use of GMOs derived from modern biotechnology that may have an impact on conservati on and the sustainable use of biodiversity.
The development of a Biosafety Protocol is driven by the recognition that biotechnology, although potentially beneficial, raises concern that the new genetic combinations derived from modern biotechnology could manifest themselves in ways that could be ris ky to the environment.
South Africa has been an active participant in these negotiations, which are due to be concluded from 20 - 28 January 2000 in Montreal. The Department of Environmental Affairs and Tourism is the lead department in these negotiations. The negotiation of the Biosafety Protocol has several issues of contention, mainly the tension between trade and environment. Of the 39 articles in the draft Protocol, nine have yet to be resolved.
The South African position on the outstanding articles, which were forwarded to the Informal Consultations between governments in September Biodiversity (attached to this document). South Africa's position seeks to balance trade and environment concerns on biosafety.
The article on the Scope of the protocol: The draft text of the Protocol excludes living modified organism (LMOs - a GMO that given the right conditions would be able to replicate) that "will not adversely affect biodiversity"; as well as pharmaceuticals for humans; those in transit; and those destined for research. Developed countries favour a scope as in the draft text whereas the developing world favours an inclusive scope covering all LMOs.
The article on the application of the Advance Informed Agreement (AIA) procedure defines applicability and non-applicability of AIA procedures. The draft text excludes LMOs that are for food, feed and processing (termed as commodities in the negotiations). Developed countries favour this article as in the chair's text. Developing countries, specifically the Africa Group, recently shifted their position from requiring application of AIA on all transboundary movements of all LMOs to requiring it on only first transboundary movements.
Developing countries in the proposal tabled recently, suggested that any exclusions (eg pharmaceutical for humans, LMOs in transit and LMOs destined for research) in the protocol should be dealt with under this article and flexibility should there for coun tries to require AIA on some LMOs. South Africa is largely in line with the developing countries position.
The article on Relationship with International Agreements has trade issues underlying it, and it is a widely known "secret" that it seeks to link the biosafety protocol to the World Trade Organisation, which is perceived to have structured dispute resoluti on mechanism arising from trade. The draft text states that the Protocol shall not affect rights and obligations of parties under existing agreements except if these would "cause serious damage or threat to biological diversity". There is a disagreement w ithin the developed world on this, with some wanting it included and some wanting it deleted. Many developing countries wanted it out of the protocol. South Africa's has always maintained that its inclusion or exclusion is acceptable.
The negotiations of the Biosafety Protocol will be resumed in January 2000 and the goal is to finalise the Protocol. If South Africa signs and ratifies a Protocol on Biosafety, the infrastructure provided by the GMO Act will be the mechanism to effect obli gations of the Protocol.
Members of the public are expected to participate through representation on the Advisory Committee of the GMO Act. The Registrar keeps a register of all applications submitted which is accessible to the public. In addition, the regulations require applic ants to notify the general public of planned trials and general releases by publishing such notifications in at least three local newspapers.
1. Background
The last session of the Biosafety negotiations, which took place in February 1999 in Cartegena, Colombia, ended with no consensus being reached on the Protocol. The 1st Extraordinary Meeting of the Conference of Parties (1st ExCOP) which met to adopt the P rotocol decided to suspend itself. It also made a decision to resume itself on a date before the fifth Conference of Parties, which is to take place in May 2000. The Bureau of the Conference of Parties at a meeting held in May 1999 decided that informal co nsultations between negotiation groups be held so as to decide on the process for the continuation of the negotiations. This meeting which was chaired by Minister Juan Mayr of Colombia, in his capacity as the Chair of the 1st ExCOP, was held on the 1st Jul y 1999. The meeting of the 1st July 1999 decided that Informal Consultation between governments be held in preparation for the resumed ExCOP. The Informal Consultation was held on the 15 -19 September 1999 in Vienna, Austria.
This document is the South African position to be forwarded at upcoming Informal Consultation. Members of the delegation that participated in the negotiation session in Cartegena, contributed to this document. The National Consultation Workshop on Biosafet y Protocol held on the 23rd August 1999, and the special Ministerial Meeting on the negotiations of the Biosafety Protocol which took place on the 8th of August 1999, have also provided guidance on positions.
It should be stated that the positions taken in Cartegena are still preferred, and therefore to a large extent this document draws from the position document prepared for the negotiations at that session. However, the ground covered at the Cartegena meetin g, as well as the political climate existing at these negotiations cannot be ignored in preparation for the Informal Consultation.
A point of note, is the fact that the Chair's Text - a text submitted by the Chair of the now defunct Open - ended Ad Hoc Working Group on Biosafety or BSWG (UNEP / CBD/BSWG/6/L.2/REV.1) is now the point of reference for the negotiations. Some articles in the text are not open for negotiation, and consequently the document focuses only on the outstanding articles (which are noted in the Report of the ExCOP). The second point of note relates to the political climate that prevailed at the Cartesian meeting. As at the end of the Cartegena meeting a, chasm between environmental and trade concerns still existed. If middle ground between the two is not found, it is likely that no consensus on the Biosafety Protocol will be reached. South Africa would like to see the Protocol contentious issues resolved. It is in this light that in revising the South African position a more middle position accommodating both concerns on the contentious articles is suggested.
2. South Africa's Position on the Chair's Text.
As indicated earlier, the focus is on those articles noted in the Report of the 1st ExCOP, as outstanding.
2.1. Article 4 - Scope
(Please Note: The proposal on this article should be considered together with Article 5)
The scope establishes areas of applicability and non- -applicability of the Protocol.
The Chair's Text excludes living modified organisms (LMOs) that are " not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health". This category of LMOs will be specifi ed in an annex. Further LMOs that are pharmaceuticals for humans are excluded. LMO's that are in transit and those that are destined for contained use are only covered in certain provision in some articles.
South Africa's position is that all LMO's should be covered in the scope, and that any exclusions should be relating to application of AIA procedure.
2.2. Article 5 - The Application of the Advance Informed Agreement (AIA) Procedure
This article specifies what is and what is not subject to AIA procedure. Articles 6, 7,8 and 9 cover the mechanism of AIA procedure.
The Chair's Text provides for application of AIA only " to the first intentional trans-boundary movements of living modified organisms for intentional introduction into the environment of the Party of import". LMOs that are intended for food, feed and fo r processing (~ commodities) are excluded from the AIA. An allowance is made for Parties to require AIA type procedures for some LMOs, under domestic legislation.
The South Africa position on this article is that first trans-boundary movement of an LMOs, excluding LMOs in transit except with regards to Article 6, those destined for contained use, and pharmaceuticals for humans, should be subjected to AIA procedure. Countries may decide at national level to exclude some LMOs application of AIA procedures.
2.3. Article 6 - Notification
Notification of the intended trans-boundary movement of LMOs covered by Article 5, is the first step of the AIA procedure.
The Chair's Text puts the onus on the Party of export to ensure notification in writing to the competent national authority of the Party of import prior to the intentional trans-boundary movement of LMOs, and that information provided is accurate. Minimum information required for notification is specified in an annex.
The article as formulated in the Chair's text is acceptable but reference is made to Article 5.1 and this article may need revision depending on the outcome of Article 5.
2.4. Article 15 - Handling, Transport, Packaging and Identification.
The idea of this article is to ensure that LMOs en-route are handled, transported, packaged under conditions of safety. Further, it seeks to ensure that LMOs en-route are clearly identified.
The Chair's text in an attempt to compromise, makes reference to identification rather than labelling.
The article as in the Chair's text is largely acceptable. Wording in paragraph 1b (iv) -"except that the Party of import may..." and paragraph 2 - "shall consider the need for", however, needs re - working.
2.5. Article 21 - Non - Parties.
This article specifies the relationship between Parties and non- - Parties.
In principle, the formulation - which provides for trade with non- -Parties - in the Chair's Text is acceptable as is.
2.6. Article 22 - Non - discrimination.
The article states that Parties will not discriminate among foreign and domestic LMOs in implementing the Protocol.
South Africa takes a position that this article is not necessary.
2.7. Article23 - Illegal transboundary movements.
This article obliges Parties to adopt measures to prevent and penalise illegal transboundary movements of LMOs.
The point of disagreement is whether the measures should be domestic or international. The Chair's text proposes domestic measures.
South Africa supports the article as formulated in the Chair's text.
2.8. Article 24 - Socio -economic considerations.
This article is intended to ensure that socio - economic impacts of introducing LMOs.
The formulation in the Chair's text is acceptable.
2.9. Article 31 - Relationship with other international agreements
The Chair's text states that the Protocol shall not affect rights and obligations of Parties under existing agreements except if these would "cause serious damage or threat to biological diversity.
South Africa's position on this is that, the Chair's text is acceptable but if this article is excluded, it will also be acceptable.
Inquiries: Department of Agriculture:
Bongi Njobe: (012) 319 6069
Department of Environmental Affairs and Tourism:
Khungeka Njobe: (012) 310 3549
Issued by Didi Moyle: Ministry of Environmental Affairs and Tourism