BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER

An International Biosafety Protocol:

The fight is still on

As the following account of the negotiations for a biosafety protocol reveals, the fight for an international agreement to guard against the environmental and health hazards of genetic engineering continues in the face of opposition from industry.

by Chee Yoke Ling

OFFICIALS from about 100 countries worked from 5 to 13 February in Montreal to produce a draft biosafety agreement. This was the fourth meeting since the inter-government working group on biosafety was set up in December 1996 by governments party to the Convention on Biological Diversity (CBD). The group was directed to negotiate a biosafety protocol on 'the safe transfer, handling, and use of living modified organisms (LMOs), ...specifically focusing on trans-boundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity'. The negotiators were also mandated to take into account human health.

It was clear from the meeting that industry opposition to a strong biosafety agreement had been building up.

Biotechnology industry representatives turned up in large numbers to persuade governments, especially those from developing countries, against a strong agreement. In a meeting with European Union delegates, it was observed by some participants that the industry representatives were openly voicing their opposition against the way the protocol discussions, were proceeding. According to one European delegate, on a number of occasions during the discussions some of the representatives of the industry were downright rude.

Daily lunchtime briefings targeted at Southern delegates extolled the perceived benefits of biotechnology and often did not distinguish genetic manipulation techniques from other types of biotechnology. According to a number of independent scientists at the meeting, industry clearly sought to confuse and mislead the government delegates.

Dr Terje Traavik, a Norwegian molecular biologist who was part of the government panel that recommended a ban on two rabies vaccines, was struck by the lack of sound scientific basis in the industry statements. In his view, the precautionary principle must be applied in every commercialisation of a genetically modified organism or product simply because the technology is not safe. There is a need to go back to the laboratories first, he stressed. It was the precautionary approach that had led the Norwegian government to ban the vaccines and four genetically modified crops.

WTO rules

Industry representatives also alluded to the disruptive impact of a biosafety protocol on international trade, a development which would be undesirable for developing countries.

Predicably, this industry concern was conveyed through some Northern governments which often invoke World Trade Organisation (WTO) rules as a Sword of Damocles, to threaten the biosafety proposals of Southern countries by claiming that such protocols would violate WTO rules. Such arguments were refuted by Southern governments, such as Brazil, Ethiopia and India. They argued that the biosafety protocol is primarily about biodiversity conservation, environmental safety and public health and that trade issues should be dealt with in trade fora and should not supersede the biosafety working group's goal.

In a statement made towards the end of the meeting, an industry spokesperson claimed that it was not appropriate for the protocol to address socio-economic impacts and questions of liability. Such issues, the spokesman argued, should be covered by other mechanisms. Such arguments have been echoed at every biosafety meeting by Northern governments, especially the United States, the EU, Japan, Switzerland, Canada and Australia.

These issues are the most contentious, with the Group of 77 and China still maintaining the demand to include them (though a few countries in that group have some reservations) in the protocol.

Norway proposed a compromise at the February meeting, suggesting that a liability protocol be negotiated after the main protocol is concluded. Informally, it supported the inclusion of a deadline for completion as part of a provision in the biosafety protocol. Opponents of the inclusion of a liability regime argued that it was not necessary to have a liability provision, or that the general liability discussion under Article 14 of the CBD should first take place at the Conference of the Parties (COP) level. Some countries warned that insistence on this point would derail the entire protocol because liability was a complex issue. Proponents, on the other hand, strongly argue that without liability and compensation, the biosafety protocol would have no teeth and would be no more than a non-legally binding code of conduct.

Public-interest non-governmental organisations (NGOs), led by Third World Network, The Edmonds Institute and ECOROPA, widely circulated a badge proclaiming 'No liability, no protocol' and this became a visible call throughout the meeting. Many government delegates also wore the badge.

In a statement on behalf of 18 public-interest organisations at the meeting, Third World Network stressed that the commercialisation of LMOs, including illegal trans-boundary movements, had already started. At the same time, there was growing evidence of hazards and failures of a number of LMOs and products derived from them, with consequent effects on the environment, biodiversity and animal and human health. The Basel Convention on regulating transboundary movements of hazardous wastes was cited as an example to alert delegates. In that case, a separate agreement on liability was initiated but almost 10 years later, there was still no conclusion to the issue. Meanwhile, illegal dumping was raising problems of responsibility.

A large number of Southern delegates spoke strongly on the subject, with Ethiopia leading the fight. (Ethiopia is the spokesman for the African group at the biosafety meetings.) It was clear to observers that the issue was not one of complexity (as asserted by opposing Northern delegates) or the lack of a precedent in international law; rather, it was the fact that Northern countries were attempting to protect the interests of industry.

Though government delegates continued their exchanges of views (as in previous meetings) till the end, there were no major shifts in position. However, the point is there are at least a number of options on the table for negotiation at the next meeting in August. (see box below)

OPTIONS

ON the question of liability and compensation, apart from a no-provision option, there are five options in various degrees of detail regarding a liability and compensation regime. A compromise option proposes that Parties to the protocol shall, at their first meeting, examine how to establish a liability and compensation regime for damage to biodiversity resulting from LMOs. Some countries wish to include an examination of the need for such a regime.

For socio-economic considerations, one option is for no reference in the protocol, with some countries favouring a reference to the COP and others for a reference to other more relevant fora. Two options follow, a general and a more detailed one.

One proposal requires that socio-economic impacts specific and unique to the use of LMOs that may manifest adverse consequences, be considered during the assessment and management of risks. In particular, the importing country should take into account genetic erosion and associated loss of income and dislocation of traditional farmers and farm products. This is based on concerns that genetically modified organisms and products derived from them could soon be substitutes for commodities that are the main exports of developing countries.

The proposal of the African region goes further, by requiring a minimum of seven years' advance notification of product substitution, a form of early-warning system.

The African proposal also requires the user of an LMO and products thereof to take due account of the long observation period that these socio-economic impacts may require to manifest adverse effects. Risk management steps shall also incorporate strategies and measures that prevent or mitigate the potential adverse socio-economic impacts.

Ethiopia introduced an additional issue: each Party to the protocol shall develop or maintain appropriate policy and legislation that protect the general public from a monopolistic manipulation of the biotechnological, seed, chemical and related individuals by private-sector entities.

Interestingly, a number of scientists who are regulators voiced their support for the inclusion of socio-economic considerations just before the Montreal meeting, in a letter to the scientific journal, Nature. They were John Barret (University of Cambridge), Chris Giddon (University of Wales) and Julian Kinderlerer (University of Sheffield) who, together with two UN Industrial Development Organisation (UNIDO) officials, wrote that the assessment of any new technology demands a balanced consideration of both the possible associated risks and the perceived benefits. All too often, the regulatory apparatus provides only for the scientific assessment of risk, thus concealing the corresponding consideration of wider issues.

As individuals involved in either the development or implementation of risk assessment frameworks for biotechnology, they called for the biosafety protocol to permit the overt consideration of socio-economic issues before the environmental release or transboundary movement of genetically modified organisms.

It is significant that they concluded that the inclusion of these issues would at least allow open discussion of issues that many regulators are currently obliged to consider implicitly.

Battle over scope

The EU and Canada are adamant that the biosafety protocol should not cover human-health impacts. They argue that Article 19(3) of the CBD restricts the scope to adverse impacts on the conservation of biodiversity only. Southern delegates and NGOs argue that the Jakarta mandate (negotiated at the second meeting of the COP in Jakarta in 1995) allows for the inclusion of human health. Moreover, in the light of new scientific evidence, especially on horizontal gene transfers (where engineered genes can cross species barriers which were unintended), it is imperative that human health be included.

The issue of scope also arose in the debate on the definition of an LMO, with a large number of Southern delegations wanting to include products derived from LMOs as well. A few delegations from Africa stressed the importance of naked DNA. Not surprisingly, Northern delegations support a narrow definition, even those few countries that privately acknowledge that, from a scientific viewpoint, a wide definition is logical.

Observers remarked on the irony of many Northern countries having more rigorous standards and wider scope at the national level than what they are proposing in the international agreement.

Some countries wish to restrict the scope to transboundary movements, specifically import and export. Others wish to include use and handling, an option for the South.

Similar issues related to scope were also central in the debate on Advanced Informed Agreement (AIA) for movements of LMOs and their products.

Agreed, reviewed and considered

Two sub-Working Groups open to all delegates were established in October 1997 to work on two clusters of issues until the completion of the protocol at the end of 1998 (the prescribed deadline when the biosafety working group was first established). In addition, two Contact Groups had been set up. These are supposed to be informal small group discussions to work out the complicated points in a negotiation.

The first Contact Group was authorised to deal with Definitions and Annexes (D+A), which comprise some of the most difficult and controversial components of the protocol. At the February meeting, this group was made a sub-group of sub-Working Group I and required to report to the latter. Shorn of diplomatic language, this means that delegates wanted to ensure that the D+A group was made formally accountable. Although the work of contact groups is theoretically not negotiation and subject to review and change, in reality, the results are part of the negotiation process. Given the small size of Southern delegations, with the majority being one- person delegations, it is common for contact groups to comprise a majority of Northern delegates.

The second group is essentially a legal drafting group advising the parent Working Group on institutional and financial matters, as well as final clauses. In February, CG 2 was asked to also consider the title and preamble, and recommendations to the COP 4 in May.

At the February meeting, they proceeded on the basis of the consolidated text that was produced after the October discussions, on the understanding that any government could still make changes and introduce new proposals on legal text by 1 July. The result was a scaled-down draft with content and various options of countries and/or groupings of countries. The annexe on risk assessment and management was expanded to two options.

Throughout the meeting, there was continuing tension between countries which wanted a strong protocol based on the precautionary principle, and the few countries with a powerful biotechnology-industry interest that wanted a minimal framework. This was typical of the history of the biosafety battle.

Among the former group are the African countries, key Asian countries including India, Indonesia and Malaysia, as well as Colombia. The African region had submitted a detailed protocol as early as 1996, while the other countries also submitted specific provisions on the major elements of the protocol which were on the table at the recent February meeting.

Although Malaysia had submitted detailed proposals (among the strongest, according to independent scientists and public-interest lawyers at the meeting), it was unfortunate that it was not present to defend its proposals. Indonesia, which was active in the October meeting, was able to participate only for a few days in the beginning of this last meeting. India took over the chairing of the G77 and China.

The thrust of the government delegations' work in February was to respond to the numerous submissions from countries which had been compiled into one document, and to streamline the document into a consolidated text for further negotiations. The majority were in the form of legal proposals for specific items of the protocol, such as the procedure for Advanced-Informed Agreement (AIA) in the transboundary movement of LMOs and related products, with Southern contributions on information-sharing and capacity-building, liability and compensation. Other submissions comprised elements and views of the governments concerned.

While the majority of Northern industrialised countries sought to delete options and reduce details, the majority of the South insisted that the protocol be as specific as possible. African countries, in particular, pressed for an international agreement that could protect weaker and more vulnerable countries because the lack of capacity to assess risk and monitor transboundary movements of LMOs (including transit countries' welfare) demands that the exporting countries be more vigilant and bear the burden of ensuring safety.

This was reflected in the options laid out for AIA, where the North wants the primary responsibility to rest with importing countries, with the South pressing for the exporting country instead. General/simplified notification, implicit agreement, and whether every export needs a new AIA, remain unresolved. On notification of transit, some Northern countries opt for no provision while the South insists on detailed provisions on explicit agreement by the state in transit.

On risk assessment and management, some Northern countries opt for no provision in the main protocol text, on the ground that an annexe will be sufficient. While the CBD provides that annexes form part of the protocol, there were worries among some delegates and NGOs that this could be a move to have an annexe that lists a set of criteria that does not bind each and every situation, leaving it to Parties to pick and choose what they will apply.

Unintentional releases and emergency measures were two separate provisions which have now been merged and diluted.

UNEP makes questionable moves

Meanwhile, the UN Environment Programme (UNEP) announced at the opening of the meeting that it had obtained US$2.744 million from the Global Environment Facility to launch a UNEP/GEF pilot biosafety enabling project. The aim of the project is to assist developing countries and countries with economies in transition in formulating national biosafety frameworks for the implementation of the UNEP International Technical Guide- lines for Safety in Biotechnology. UNEP claims that this exercise is in the context of Article 8(g) of the CBD and any future implementation of any agreements on biosafety, including the one currently under negotiation.

NGOs and some government delegates were concerned over this move. The UNEP Guidelines were first promoted by the Netherlands and the UK in 1994 as a voluntary framework. Since they were informally circulated at the height of the debate on the need for a legally-binding agreement, the fear of many Southern delegates and NGOs was that these Guidelines were designed to deflect work commencing on a protocol. Independent scientists working with Third World Network had reviewed these Guidelines and concluded that they were scientifically flawed and highly inadequate.

Despite the criticisms over content and process, UNEP went ahead to adopt the Guidelines and convened a series of regional consultations to promote them. Many government participants voiced concerns over the inadequacies of the Guidelines but they remain essentially the same in their final form. To placate concerned CBD parties, the proponents of the Guidelines, with support from some Southern countries, agreed that any move on the Guidelines should not prejudice the outcome of the biosafety protocol negotiations.

The reality is the opposite, said a Third World Network representative at the Montreal meeting. Like a hydra, the UNEP Guidelines emerged again and again at every meeting. The new scientific knowledge gained over the past four years reinforces the fatal flaws of those Guidelines and yet, they are the main international model being promoted in developing countries.

According to Dan Leskien of Friends of the Earth International, the Guidelines are not strictly technical either; they prescribe policy and now, with the GEF funding, countries will be guided by a framework that certainly prejudges the biosafety protocol.

Though UNEP asserts that the project will be useful in helping governments undertake an initial assessment of the state of play of biosafety in their countries, it is undeniable that the Guidelines will be further promoted as the scientific basis for national biosafety policy and law.

Scientist Dr Mae-Wan Ho, who has been attending the biosafety meetings and advising some delegations, was extremely worried that at the same time, the UNEP Guidelines risk assessment and management criteria kept appearing as the proposed criteria for the biosafety protocol.

Until the recent February meeting, the only formal submission for risk assessment and management criteria was one from the African regional group which formed an annexe to the consolidated draft being discussed by governments. Yet, the UNEP Guidelines were introduced again by the co-Chair of the informal group that met on this subject. This informal group is chaired by Piet van der Meer of the Netherlands (the co-author of the Guidelines subsequently adopted by UNEP) and Dr Gert Willemse of South Africa. When Dr Willemse re-introduced the UNEP Guidelines during the discussion, without any apparent formal request from any country, delegates from Zambia and Ethiopia objected. After some intense discussions, it was agreed that two drafts would be prepared - one based on the UNEP Guidelines and another on the existing annexe proposed by the African group. These are now presented as two options in the consolidated text.

Lack of finances

The shortage of funds for the working group continues to be a problem. In his opening statement at the beginning of the meeting, Calestous Juma (Executive Secretary of the CBD Secretariat) appealed again for financial support. Because of the urgency and significance of the biosafety protocol, the February meeting had been held on the basis of pledges from some governments and not on the basis of cash in hand. Juma stressed that the secretariat could not continue to do so at the expense of curtailing activities in other programme areas of the CBD.

The lack of funding has meant that developing country participation has been undermined. As only the participation of least developed countries can be supported, and given that some of the other developing countries are among the key negotiators, the integrity of the process is at stake. At the last meeting, the Asian financial crisis also made its mark as the participation of South-East Asian countries was at its lowest since the CBD was negotiated and implemented.

On the other hand, the US, a non-Party, sends a team of more than 10 persons to each biosafety meeting to prevent a strong protocol from emerging. According to a number of Southern delegates, this situation is totally unacceptable.

The next meeting of the working group will be from 17-28 August. Given the extremely busy schedule of international meetings, it was agreed that the original deadline of end 1998 for completion and adoption of the protocol may not be feasible. The working group thus agreed to recommend to the COP at its fourth meeting in May 1998, that the final meeting be held no later than February 1999. (Third World Resurgence No. 93, May 1998)

Chee Yoke Ling, a former university law lecturer, is an environment representative of Third World Network.

 

BACK TO MAIN  |  ONLINE BOOKSTORE  |  HOW TO ORDER