Key Issues and Key Elements Needed in the Biosafety Protocol

TWN position paper for the sixth and final Biosafety Protocol negotiations in Cartagena, 14-19 February 1999


Third World Network has been participating in all the meetings of the Open-ended Ad Hoc Working Group on Biosafety which started negotiations on a biosafety protocol in 1996. The final meeting will be from 14 to 19 February, 1999 in Cartagena, Colombia. This will be followed by an Extra-ordinary Meeting of the Conference of the Parties to the Convention on Biological Diversity, scheduled for 22-23 February.

The negotiations are in danger of being turned from a biosafety focus to producing an agreement which will facilitate international trade in potentially hazardous modified organisms (GMOs) and related products.

Hundreds of environmental, consumer, development and farmers' organisations have been calling for a global moratorium on commercial releases. Scientists independent of industry have joined the moratorium call, and a World Scientists' Statement has just been launched. The outlook for Cartagena appears grim if the pro-industry governments succeed in preventing a strong and comprehensive biosafety protocol. In that event, a global moratorium will gain more urgency. Some organisations such as Greenpeace go further to call for a ban. The phase-out of antibiotic resistance marker genes by the year 2002 has been proposed as part of risk management under the protocol. Given the established hazard of this use, it would be at least one concrete achievement of the negotiations if it survives the Cartagena meeting.

Intense pressure on developing countries

Although a significant number of developing countries have held on to a strong position, there is tremendous pressure on them to compromise and even surrender on key aspects of the protocol.

The outcome of the protocol, being the first international effort to set legal standards and norms for GMOs and products derived from or containing GMOs (collectively referred to as "products thereof" in the negotiations), will determine whether safety or profit wins the day.

The term "living modified organisms" (LMOs) is used in the draft protocol, the result of US-led opposition to the term GMOs during the negotiations of the Convention on Biological Diversity under which the protocol is being developed. This was part of the overall effort to deny that genetic engineering is a technology that is a new departure from conventional biotechnology, and that it brings with it new environmental and health problems.

As scientific evidence mounts on the environmental and health hazards of GMOs and products thereof, industry and those governments which put commercial interests above safety priorities have increased their pressures on developing countries. Information on hazards are being downplayed, ignored and even suppressed.

At the same time, those developing countries that are working for a strong biosafety agreement are accused of blocking international trade, and even keeping their countries in poverty by rejecting the new technology. Threats include warnings at the negotiations that a strong biosafety protocol would run counter to WTO rules and official letters before each meeting addressed to developing country governments to the effect that biosafety proponents are over-reacting and that they will not benefit from the technology if there is a strong protocol.

Communications from the US State Department and Australian government have been made public over the past months. In a number of cases, these were directed to the commerce and industry officials in developing countries, "warning" them that their environment colleagues may be "over-enthusiastic" and implying that those negotiators are not presenting a truly national position. Such actions are both shocking and reprehensible.

Over the last few weeks, pressure on developing countries, particularly those that are active in the negotiations have increased further. Former US Ambassador to the UN, Andrew Young, led an industry dominated delegation to visit the Prime Minister of Ethiopia. The Ethiopian delegation is one of the forefront biosafety proponents, and leads the African regional group in coordinating joint positions.

Attempts by industry to undermine the negotiations have aggressively escalated in the past 18 months. Industry forces have vehemently rejected a legally binding international biosafety protocol right from the beginning. When the majority of the world's governments, predominantly from developing countries, pressed for a biosafety protocol, almost all industrialised country governments opposed it. The United States, Australia, Japan, Germany, the UK and the Netherlands were particularly outspoken against such a development. NGO observers and independent scientists from those countries who attend the negotiations are appalled at the blatant manner in which their government representatives are protecting industry interests.

As countries, including non-Parties such as the US - the biggest developer and exporter of LMOs and products thereof - enter the final phase of the negotiations, there are divergent, even conflicting, positions among the groupings of countries on key and fundamental issues.

On liability, industrialised countries are categorically opposed to any substantive inclusion. A weak compromise to consider a liability regime after the protocol is adopted would be meaningless. These countries have made it clear that they oppose any international law on liability for hazards relayed to LMOs and products thereof. The Basel Convention with its more than 10 years of negotiations has no results, showing that there is no political will on the part of industrialised countries to attach international legal responsibility and liability on industry. Given the total rejection of the biotechnology industry of any regulation at all, it is unlikely that a liability agreement post-protocol will emerge.

The test is therefore in Cartagena. If the battle for a liability regime is lost, industrialised countries that kept this out of the protocol must hold themselves responsible for the grave consequences of hazards to biodiversity, environment and human health that are likely to occur.

On socio-economic considerations, again industrialised countries as a block refuse to include any substantive provision, except perhaps for a weak paragraph in the Preamble and a call for more studies. Conservation and sustainable use of biodiversity, especially in the case of domesticated plants and animals, is dependent on the socio-economic conditions of the people who hare been maintaining it. Any threat to their socio-economic well-being through the introduction of genetic engineering technologies, LMOs and products thereof is therefore properly the concern of a biosafety protocol, especially in the context of the Convention.

In any event, it is of utmost importance that every Party has the sovereign right to decide on any introduction of genetic engineering technologies, LMOs and products thereof by applying a comprehensive set of criteria. This would apply in relation to Advance Informed Agreement (AIA), risk assessment and risk management. The right to prohibit the entry of an LMO or product thereof or any activity related to them must be clear. The right to take necessary actions and measures that are more stringent than those provided by the protocol should also be ensured.

The push by most industrialised countries to carve out or exclude large areas from the biosafety protocol is also alarming. All of these countries reject the inclusion of products derived from or containing LMOs (products thereof). There is, even a move to exclude agricultural commodities even though genetically engineered seeds targeted for processing, not cultivation, can and will find their way to the environment.

In the provisions on general scope and the application of Advance Informed Agreement, the collective result of the positions of industrialised countries would allow for extensive categories of LMOs to be excluded on a unilateral basis while human health and socio-economic considerations will not be allowed for consideration.

Even worse, many countries are insisting on the right to make "side-agreements" at multilateral, regional and bilateral level. This would completely undermine the protocol, and particularly allow non-Parties to benefit from trade without any corresponding obligations under the protocol. Allowing this would also be a disincentive for countries to join the protocol.

The move by some countries to include a provision subjecting the protocol to other international agreements, particularly WTO agreements cannot be accepted. The Convention on Biological Diversity itself is an international agreement, and we are here concerned about biosafety. That objective should not be undermined or compromised and where disputes arise, those should be dealt with accordingly in the future.


TWN calls for a global moratorium on all commercial releases, and a comprehensive, independent public enquiry into genetic engineering and its application in agriculture and health.

We support an immediate ban on all antibiotic resistant marker genes since the health hazards are known and acknowledged.

There should be a total ban on the export of LMOs and products thereof and any activity in relation to them (research in, shifting of production to another country) when

  • these are banned in the country of export;

  • these are banned by the laws of the importing country;

  • although safe in the exporting country, these would be hazardous if introduced to the environment of the importing country.


1. The Precautionary Principle must be the basis of the Protocol, and the objective is to operationalise this principle. The Convention obliges Parties to apply this principle. Adverse effects are already being documented, and scientific data on real and potential hazards are growing. The long-term impact of LMOs and products thereof has yet to manifest themselves since these are new organisms and products. It would be logical and responsible for Parties to ensure that the precautionary principle be applied. Related to that is the case-by-case and step-by-step approach to risk assessment.

2. The Scope of the protocol, in line with the mandate of the Working Group, has to be the transfer, handling and use of LMOs. This covers research, contained use, field trials and commercial releases/uses.

"Use" itself also logically covers products derived or containing LMOs or parts of LMOs, i.e. products thereof. There should not be any exclusion of agricultural commodities.

Human health must be included.

3. Advance Informed Agreement (AIA)

For decisions by Parties of import to be genuinely protective of biodiversity and human health, and for risk assessment and risk management to be effective, there must be truly advanced and informed consent given by such Parties.

There should be explicit written consent from the Party of import and transit before any transboundary movement. States of transit should also be informed of any potential transboundary movement.

The prescribed time limits for the AIA procedure are unrealistic. Approval of transgenic maize in Europe took two years. Since different ecosystems in different countries require a case-by-case risk assessment, the protocol should not have fixed time periods for a full and effective AIA. Flexibility as necessary and appropriate should be the option, taking into account the special needs and concerns of developing countries.

Full disclosure of information and effective public participation in decision-making are necessary provisions. The proposed provisions on confidential information are broad and exclusionary. There should be no provision on this matter, and industrial secrets and confidential business information can be adequately protected under existing obligations at the international and national levels.

4. Liability and redress should be substantively provided in the protocol. Without such a regime, the protocol would at best be meaningless, and at worst be irresponsible.

5. Socio-economic considerations form part of risk assessment and management as well as having impact on the ability of communities to conserve and sustainable use of biodiversity.

6. Direct and indirect, short, medium and long-term effects of LMOs and products thereof on the conservation and sustainable use of biodiversity and/or human health should be included in risk assessment and management. Detailed monitoring after commercial releases should also be part of risk management.

7. Identification, segregation and labelling of LMOs and products thereof is a necessary component of the protocol.

First, the full impact of these organisms and products is unknown but there is already evidence of hazards. Segregation and labelling would enable proper tracking and monitoring in the post-release phase.

Secondly, labelling is fully in line with the consumer right to choose.

8. There should be no provision allowing for side agreements to be developed as this would undermine the protocol and endow more privileges to non-Parties with no corresponding obligations.

9. The biosafety protocol must maintain its independence as an international agreement and not be prematurely subject to other international agreements.