A Brief Overview of the Cartagena Protocol on Biosafety

By Tewolde Berhan G'~hre ffgzia'bher Chief Alegotiator in the Blo safety Protocol for the Ah'can Group and the Like-Minded Group

11 September 2003

1 Context

The United States of America is now subjecting the European Union to the dispute settlement mechanism of the WTO. The EU has been trying to put measures in place necessary for the protedion of human life, agricultural systems and the environment against possible harm from the introdudion of genetically engineered (GE) crops, also known as Genetically Modified Organisms (GMOs). The United States believes that its GE crops are harmless and the EU is only protecting its own market from imported commodities.

The USA starts from the premise of "Substantial Equivalence", which states that GE crops are as safe as non-GE crops unless they are proved to be harmful The EU has ratified the Cartagena Protocol on biosafety, which starts from the "Precautionary Principle" embodied in the Protocol. The "Precautionary Principle" states that a GE crop is to be considered possibly risky unless it is proved to be safe. The perceived differences are, therefore, serious in nature.

"How does the Cartagena Protocol operationalize the Precautionary Principle?" is a question we shall try to answer now.

 

2. The Advance Informed Agreement (AlA) Procedure

The Cartagena Protocol on Biosafety requires a country to allow the importation of a GE organism (referred to as a Living Modified Organism or LMO), only after it has obtained all the necessary information about it and carried out a risk assessment to evaluate the likelihood of harm to human health, to agricultural systems and to the environment as well as to its socioeconomic conditions. The AlA procedure is aimed at making this possible. The putative country of import is first informed by the exporter or by the country of export of the intention to export the GMO.

The country of import, after a risk assessment, then informs the exporter or the country of export in writing as to whether or not it will allow the importation of the GMO into its territory. If it disallows the import, it is expeded to give the reasons in writing.

In the case of GE commodities intended for food, feed or for processing, the intention to export is notified to all countries in one go through a computerised data base system called the clearing-house.

In the AlA procedure, failure to communicate decision to the country of export or to the clearinghouse cannot be taken as an agreement to import. The failure might happen through lack of

capacity and the Precautionary Pnnciple wou~d then imp~y that no exportation takes place.

3. Exceptions to the AlA Procedure

A GMO that is merely transiting through a country is not subjected to the AlA procedure. However, if a country considers any GMO as too dangerous to be allowed transit, it has the right to register this fact at the clearing-house and prohibit its transiting.

A GMO that is destined for contained use, i.e. for use under conditions from which it cannot escape into the open environment and it cannot come into contact with people or other forms of life, need not go through the AlA procedure before importation. Each country, therefore, considers its own environment and defines what it accepts as contained use.

A GMO for use as a pharmaceutical for humans is subjected to the AlA procedure unless there is another international law or a specified international organisation to govern its import and export authorisation.

At the moment there is no international law other than the Protocol to govern the environmental impacts of GMOs whether meant for pharmaceuticals or otherwise. The World Health Organisation is a UN body that is responsible for the safety to human health of pharmaceuticals, be they GMOs or otherwise, and not for their environmental impacts. Therefore, owing to their possible environmental impacts, GMOs meant to be used as pharmaceuticals also have to be subjected to the AlA procedure for import and export.

 

4. Co-operation Amongst Countries

The Protocol expects a close co-operation among all countries in dealing with accidental releases of GMOs and in preventing their illegal movement across countries' borders.

It also expects the developed countries to fund capacity building to enable developing countries to acquire the technical competence to implement the Protocol.

 

5. Relationship With Non-Parties

The United States of America, the biggest maker of GMOs, will not be a party to the Protocol because it is not a party to the Convention on Biological Diversity. It is, therefore, important to note that the Protocol requires parties to adhere to its objectives when dealing with non-parties.

 

6.Unfinished Business

The Protocol has left some difficult decisions for future negotiations among parties. The main ones include the establishment of a liability and redress regime, the labelling of GMOs and their products, as well as the development of a compliance procedure.

ØØ¥! The Special Vulnerability of the Developing Countries to Genetically Modified Organisms

By Tewolde Berhan Gebre Egziabhei; Chief Negotiator in the Biosafety Protocol for the Africa Group and the Uke-A4inded Grou'p 11 September 2003

 

1. Introduction

The Cancun meeung on trade and the coming into force of the Cartagena Protocol on Biosafety take place within the same week, The Cancun meeting, which is expected to try to reconcile conflicts between environmental and trade agreements, will directly or indirectly deal with the disagreement between the USA and the EU on genetically engineered (GE) commodities. This obviously fortuitous coincidence is uncanny because trade considerations caused the greatest complications during the negotia~ons of the Cartagena Protocol, and will, no doubt, continue to cause on its implementation.

The central focus of the Cartagena Protocol on Biosafety is ensuring the safety of the movement between -and subsequent use within - countries of organisms changed through the artificial (or in vitro) modification of nucleic acids, e.g. recombinant DNA technology and chimeraplasty, or through cell fusion. The Protocol refers to these genetically engineered organisms (GEOs) or genetically modified organisms (GMOs) as living modified organisms (LM Os).

Such artificial modifications, by w'rtue of being new to nature, may create equally new promises of usefulness to humans or hazards to humans or the environment. Their potential usefulness makes them appealing for development. But their poten~al harm makes regulating their development absolutely essential.

Both the development of and trade in GMOs, and therefore their regula~on, present developing countries with difficulties that must be overcome if they are to be protected from serious environmental and socio-economic crises. It is even possible that some of them could be targetted with GMOs designed to affect or kill specific ethnic groups. They need to also maintain a level of economic growth so as not to be left behind developed countries. Let us look at these difficulties,

 

2. Poverty

Developing countries, especially the least developed among them, have very limited financial resources. Therefore the money they can allocate for biosafety is bound to be inadequate. Even more worrying is the tact that, should a risk materialize, combating it requires financial and technical capacity that the countries do not have. The Protocol recognizes this fact in its Preambular Paragraph 8.

 

3. Information

Information is essential for effective management. It would, therefore, seem logical that the Protocol would make the ~vailability of information about GMOs and their products a central issue. That is why it has an article (Art 21) on the distribution of information through a clearing-house mechanism. But, the United States of America and five other countries allied to ii: opposed the labelling of GMOs and their products. Therefore, attempts to make labelling a requirement failed during the nego~ations of the Protocol, thus limiting the usefulness of the information distributed through the clearing-house mechanism. However, the Protocol does intend to have a labelling regime to be negotiated as soon as possible (Article 18.2(a)).

 

4. Socio-economic Considerations

One would have thought that, given this situation, socio-economic considerations would constitute a very important component when deciding whether to import a GMO or not. But the relevant provision of the Protocol, Article 26, is very weak owing to pressure by industrialized countries to protect their structural advantages in trade and development. However, neither this weakness nor any other intemational law prevents a poor country from adhering to the precautionary principle and making a rigorous soclo-economic assessment before importing a GMO.

5. Complex Environment

A microorganism under contained use functions opUmally at high temperatures. If it escapes into the open environment it is unlikely to survive the winter cold of industrialized countries. In the hotter tropical and subtropical environments of developing countnes, it may survive and flourish indefinitely. Other aspects of risk assessment in developing countries also become complicated because of the complex tropical and subtropical environments.

And yet, the Protocol fails to subject GMOs destined for contained use to the Advance Informed Agreement (Al A) procedure. However, it does allow a country to determine what it accepts as contained use. Developing countries should, therefon~, put in place biosafety systems that restrict the term "contained use" only to laboratory conditions from which escape of GMOs is impossible.

 

6. Richer Biodiversity

It is a well recognized fact that biodiversity increases towards the equatorwards and decreases polewards.

The environmental risk GMOs pose is one of passing their transgenes (and possibly other genes) to wild species. Therefore, the larger the biodiversity is, the more com~ex and uncertain becomes the evaluation of risks posed by GM Os.

And yet, owing to the low technical capacity of developing countries, specific knowledge on their biodiversity is very poor. This makes the evaluation of risks posed by GMOs to their environments time consuming, difficult and unreliable. Howeve pressure on them to accept many GMOs without adequate risk assessment is growing. They have to resort to caution. But even Europe is now under pressure from America through the WTO because it had to have time to put in place the measures necessary to protect human life and the environment. That is why Europe1s fight in this is the fight of the Developing countries as well

 

7. Cent~es of Origin and Genetic Diversity of Crops

Crops were domesticated and diversifled in certain regions of the worid, but not equally everywhere. Most centres of origin and diversity of crops are in developing countries. It is, therefore, obvious that a mistaken release of a GMO crop variety is more likely to introduce the unwanted gene or genes into the crop1s gene pool for good in a developing than in a developed country. This would jeopardize future prospects for food production in the world.

That is why in its Preambular Paragraph 7, the Protocol recognizes this fact, and the information requirements (Annex I & 11) as well as the risk assessment (Annex III) all include the centres of origin or genetic diversity. Refraining from the introduction of crop GMOs into countries of crop genetic diversity therefore should be in the interest of industrialized countries, even though. at present, the reverse seems to be the norm.

 

8. Greater Diversity of Environment-related Health Problems

There are more agents that cause or transmit diseases in humans in the tropics and subtropics, where developing countries are found, than in the temperate areas, where industrialized countries are found.

This makes evaluating the risks to human health posed by OMOs (Art. 1 & 15.1) in a developing country much morn complex than evaluating them in an industrialized country. Of course, the lower financial, technical and scientific capacity in the developing country makes the task onerous, and thus also greater caution essential.

 

9. Trade and Environment

Trade mies favour industrialized countries. The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPs) is especially problematic for developing counties in the context of modern biotechnology and CMOs.

Article 27.3 (b) of TRIPs makes the patenting of microorganisms and microbiological processes compulsory, and the patenting ot other life forms optional. Industrialized countries are allowtng the patenting of CMOs and their subcellular components based on this article. The celluiar parts essential for modern biotechnology are already patented. This means that any en~oc1enous moder~

biotechnology development and use will become bureaucratic and expensive, having to negotiate access to the'~e patented parts from tens of patent holders as well as having to pay royalties on them. It also means that GMOs, even when developed in a developing country, are controlled by these foreign patent owners of subcellular parts, infringing on their use for sovereignty in food production, medical applica~on etc.

Article 34 of TRIPs puts the burden of proof of innocence on the person accused of the infringement of a process patent. This means that when a GMO cross pollinates with the unmodified crop of a smallholder farmer, his crop becomes contaminated by genes from the GMO. Most absurdly, he is assumed to be a process patent infringer. The culprits, the winds anc the insects, cannot be summoned to court as witnesses. A developing country that wants food sovereignty and its farmers to remain innocent of crime can refuse the planting of GMOs of crops in its territories. But if WTO rules are used to force countries to import the seeds of GE crops albeit as food, feed or for processing, it would not take more than the accidental or uninformed spilling or planting of one or two of these seeds to wrest control of agricultural production from the local farmers' hands to El distant corporation in a foreign land.

 

10. Liability and Redress

It would seem logical that if a GMO causes damage, its owner~ developer should become liable to pay compensation for that damage. The industrialized countries do not want to rectify damage their GMOs might cause. But at the insistence of developing countries, there is now a commitment to negotiate a liability and redress regime under the Protocol (Art 27).

11. Concluding Remarks

Given these disadvantages, are developing countries going to benefit from modern biotechnology in their attempts to develop? I wonder. But they have no choice but to stay safe. They have no choice but to combat possible ethnic target~ng through GMO1s. Therefore, they have to put in place biosafety systems firmly based on the precautionary principle, which is allowed by the Protocol (Preambular Paragraph 4; Art. 1, 10.6,11.8; Paragraph 4 of Annex Ill and Article 2.4) and to develop a commensorate genetic engineering capacity (Arfole 22.1).

_"POINT OF VIEW OF THE DIRECTORATE

 

The opinion of the Directorate with regard to some of these suggested amendments will be given below with reference to the sections given in the text of Biowatch:

(i) Only the definition of ~'contained nse", ~release~' and ~~geneticall~v modified organism'~ given in the GMO Act is relevant

(ii) The term modern biotechnology' need no definition since it not used else\\~here in the text of the Biodiversity Bill.

(iii) Section 11: page 2

The proposed amendment is acceptahle~ (iv) Chapter 5: page 2

The proposed amendment of the heading for this Chapter is referred to DEAT for revision.

(v) Part 3, Genetically modified Organisms: page 3

We note that there is no difference between point 76A (1) and the ~iven ~ltemative.

The wording of Point 76A (1) to be changed to include a reference to the GNIO Act 1997 (Act 15 of 1997). Chapter 7 (of the Biodiversity Bill) Should then also refer to permits issued under the G~tO Act.

Point (2) is co~~ered under the GMO Act.

76B to read as follows: 'The Ai~~ISrc'i' ~ h3' ,'ioiice I/i i/ic' Gazeuc' eUc~z[[fi'oIJi [/70 /)~O ~'/SioU Oj'Sc'C[iOii 76A a1ij' aci/~i/es i~0'gaidiiig i/ic' ~'e/ease of ge/i e[!caMt' /?io(I~/c'i[' orgaii/si~i 1/iLO [he eiivirou,'ic'iii aspI-escrihe(I I))' ihe GAfO ACA

Subsections (a) to (c) not supported

(Vi) Restricted acti~'ities involving certain genetically modified organisms and prodLicts totally prohibited. Page 3

All discussion under this section not supported (Vii) Amendment of notices page 4

Point 76D should refer to section 76B and not 76A. (Viii) Section 86 page 4 5

Points 1,3, 4 (including subsections) and 6 are already addressed bv the GMO Act. Point 2: not supported.

Point 5: not clearly stated.

Point 7: Included in the Biodiversity Bill

(ix) Part 3: General provisions page 5-6

Points a, b, d and f covered under the GMO Act

Points C: Can be included in the proposed amendments to the GlvIO Act which is still under review

Point e: Unclear

(x)

 

 

 

 

(xi)

The following statement on page 5 is not supported: "The giving ofsecLIrir)) in Mespect of on)' ohilgation that 'nay anse from carrying o£'t [a restricted] an acavitj' aitihonsed h)' a permit and the form ofsi£ch secl£nt)'"

The following statement on page 5 is covered under the GMO Act:

"Insert a new paragraph (f) before the current paragraph (f) to read as follow~:

(0 the prohibition or restriction of the release of any genetically modified that poses unacceptable risks to human health or the environment.

o A Sign-on Statement for Africa:

Our Commitment to a Rigorous Biosafety Protocol

lewo/de Berhan Gebre Egziabher, ChiejNegotiatoi' in the Biosafert) Pro taco/for the African Group and

the Like-Ajinded Group.

 

The Cartagena Protocol on Biosafe~ came into force on II September 2()O.~. Those of us who have

Africa's interests at heart do so because we are Africans, because we love Africa, and live and work in it.

Even if we do not live in it, we love Africa and we work on issues of importance to it.

We see this day as special. Africa took the negotiations of the Protocol ver~' seriously because its sur,'ival and prosperi~ are intimately linked to the health of its people, its agricultural systems and its em'ironrnent.

 

We take this da~ to renew our resolve to continue to pursue what is important for Africa and the worhi. We will pursue that which was left ururesolved by the Protocol. We will use our unity of purpose to make up for what has been left wanting, and we will continue to cohfront the forces which selfishly pursue the exercise of power and the capture of trade advantages. We do this because we want a healthier and more equitable world for all humans together with all other forms of life on Earth that have always lived together.

 

To this effed:

I. We urge the African Group on Biosafetv to continue negotiating for an effective system of liabilii~' and redress with regard to GMOs and their products. We also urge them to negotiate for a fi~lly info~ative system of labelling and traceabili~ of GMOs and their products. and for a reassuring system of couLpuance that will protect Africa not only from aberrant parties. but also from non-parties.

2. We call on the African states that have yet to ratii~~' the Protocol to do so as soon as possible, and on all

African states to make their biosafety laws based on the African Union1s Model Law on Safety in

Biotec~olog,,'. This must be done to bring in a uniform biosafety system that protects the whole of the

African continent. This is essential because GMOs recognise no borders. A mistaken release in one

countr,; may reach the whole continent just as a fire reaches an entire di~ grassland.

3. In particular, we want to point out to all African countries that they need to apply the precaution~ principle (a) in regulatitig the transit of GMOs through their territories and refiise such transit to dangerous GMOs. 1 (0) in restricting GMOs for contained use to stringent laborato~ conditions from which accidental escape of GMOs is impossible[2] and: (c) in subjecting all GMOs intended for use as pharmaceuticals to the Advance Informed Agreement (AlA) procedure until there is an intemational law to govern them. or an intemational orgarusation to be held responsible for their environmental impactsl3l. We would like to point out that the World Health Organisation is not entnisted with overseeint,' the en\~ironmental impacts of GMOs that are meant to be used as pha~aceuticals.

4. We call upon African countries to make their biosafety as protective as their natural, social and economic environments require. noting the fact the Protocol empowers them to do so~4J.

 

5. We call upon all African countries to apply the AlA procedure to all other GMOs. In the case of G;\4os used for food. feed or processing. notification is to be done through the Biosafet,; Clearing Rousef5~.

6. We call upon all African countries not to be intimidated into making decisions upon notification as part of the AlA Procedure when their capacities do not allow a competent iinplementation~6j. Thev are able to

ask for as long a time as they need for a hilly considered response complete with appropriate risk assessment~7J.

7. We call upon the United Nations Em4ro~ent Programme and the African Union as well as each African count~~ to take capacity building seriously to implement this highly teclinical Protocol effectively.

8. As co-residents of the same biosphere but concerned with different and diverse natural environnients in Africa we beg of the United States of America to let African countries implement the Protocol without pressure that disregards the Biosafety Protocol. Such pressure has already been shown by the pusbing of GM food aid upon African countries, even though it was clear that these countries did not have biosafety systems in place to deal with the imports as required by the Protocol.

9. We also call upon the United States of America to keep its trade fight with the European Union out of Africa. We find it a distortion of facts to blame Europe for Africa1s caution in handling GM crops. including those coming as food aid. It must be noted that Africa's awareness of its poverty, low level of techaical capacity and enviromnental complexity moved the African Group on Biosafety to come up with the first proposed draft Biosafety Protocol in 1996. long before any European count~' did so. This was because Africa is aware of its vulnerability and is thus afraid of adventurism in GMOs. We find it unfair and repulsive to use Europe's guilty feeling for Africa's weakness to blackmail Europe into accepting

American GE crops in the name of Africa. We would prefer the elephants that are Anierica and Europe to fight elsewhere and let the grass that is Africa be.

10. We also note. therefore. the diversion of biosafet,' issues into the World Trade Organisation in this fight between America andthe EU. remembering that such a diversion was attempted in Seartle ml 999. and we call upon the world to reject it at Cancun as happened in Seattle. We hope that all auempts to kill the enVironment to foster trade died in Johannesburg a 5~ar ago. and will remain buried there.

11. We congratulate the African Group in the WTO negotiations for their insistence on the recognition of Community Pights and for their rejection of the patenting of living things and life processes. Such patenting, coupled with 3the reversal of the burden of prool' on the patent infringer[8~ will othenvise introduce patented genes into the crops of small-holder African farmers. crinunalise them, and force them into becoming users of seeds patented by foreign based transnational corporations. Africa's food

sovereignty will be lost and the sur"~ival of all Africans will be subjected to the whims of patent-tiling transnational corporations. We wish the African negotiators strength in the fo~coming negotiations in Cancun.

 

111 See Article 6.1 See Article 6.2

[3j Sec Article 5

~4j Article 2.4

~51 Article 11

16j Article 9.1. 9.5.11.7

17J Article ]().3 (c)

181 Article 34 of TIllPs

TO SIGN ON TO THIS STAmMENT. PLEASE SEND YOUR NAME. ORGANISATION. EMAIL ADDPESS AND COUNTRY TO:

 

- abionet.;a~e.tec..o.tu...n..e.~..t (Yonas Yohaunes. Africa Biodiversit, Network. Ethiopia)

-e p5 p in tel,on~. ~ ~lfrieda Pschorn-Strauss. Biowatch. South Africa)

e_ ~\

"bioprospecting," in relation to indigenous biological resources or traditional uses of such resources by an indigenous community, means research on or development or application of such resources for commercial or industrial exploitation, including the systematic search , collection or gathering of such resources or making extractions from such resources