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The Biosafety Protocol
by Luke Anderson August 2001

The Biosafety Protocol is an agreement which is designed to regulate the international trade, handling and uses of any genetically engineered organism ‘that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.’ (1)

A. History of the Biosafety Protocol

B. Key provisions of the Biosafety Protocol

C. Ratification of the Biosafety Protocol

D. Relationship between the Biosafety Protocol and the WTO

Conclusion

References

A. History of the Biosafety Protocol

The origins of the Biosafety Protocol are to be found in the UN Convention on Biological Diversity, which was signed by over 150 governments at the Rio "Earth Summit" in 1992, and which came into force in December 1993.

In the Convention on Biological Diversity (CBD), it was acknowledged that releases of genetically engineered organisms (referred to in the CBD as ‘Living Modified Organisms’) may have adverse effects on the conservation and sustainable use of biological diversity. All countries that signed up to the CBD were expected to:

a) "Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts…taking also into account the risks to human health." (2)

and

b) "Consider the need for and modalities of a protocol setting out appropriate procedures… in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity." (3)

To this end, the Executive Director of the United Nations Environment Programme set up an Expert Panel to consider the terms of reference, scope and elements of a possible ‘Biosafety Protocol’. The Panel concluded that a legally binding instrument was needed as no other effective international biosafety agreements were in existence, and in 1995, a formal working group was established to develop a draft protocol.

This working group met over the next four years, and then in February 1999, representatives from over 135 countries attended a meeting in Cartagena, Colombia, where it was expected that an agreement on a Biosafety Protocol would finally be reached. However, despite consensus among the vast majority of delegates present at the meeting, the negotiations collapsed because of a small group of grain-exporting countries, led by the US, and including Canada, Australia, Argentina, Chile and Uruguay.

The tortuous process of reaching agreement

These countries, which formed a powerful negotiating block called the Miami Group, feared that a strong protocol would disrupt their export markets. They tried, therefore, to force an agreement in which most genetically engineered organisms (including all those destined for use as food for humans and livestock) would actually be excluded from the protocol.

They also wanted any protocol to be subordinate to the rulings of the World Trade Organisation (WTO). This move was vigorously opposed, as a treaty specifically designed to protect biodiversity would become meaningless if it were subordinate to the WTO, which has consistently ruled against environmental protection in favour of ‘free trade’.

The US and its allies "came to the negotiations without any clear will to move forward" said the then EU Environment Commissioner Ritt Bjerregaard. "They wanted an agreement without any genuine environmental credibility. It would have excluded agricultural commodities, resulting in a liberalising of trade without proper protection of developing countries." (4)

In marked contrast to the position of the Miami Group, nearly all the countries of the ‘Third World’ called for a strong protocol, based on the precautionary principle, in which their right to say no to imports of genetically engineered organisms would be protected.

Because most Third World countries have tropical environments, which are rich in biological diversity, they are especially vulnerable to genetic pollution. Most of the plants we now grow as food crops originally came from the tropics – this means that when crops are grown in tropical countries they are much more likely to have related plants in the wild with which they can cross-pollinate. In Central and South America, for example, there are hundreds of indigenous varieties of tomato, and yet genetically engineered ‘FlavrSavr’ tomatoes were reportedly field-tested in countries there without the knowledge or consent of the authorities. (5)

Commenting on the urgent need for a protocol, Tewolde Berhan Gebre Egziabher (the head of the Ethiopian delegation who was also the spokesperson for the largest negotiating group of over 100 countries, called the ‘Like-Minded Group, which included most of the Third World and also China) had this to say: "All technologies involve risk. Since genetic engineering manipulates the basis of life, the risks involved are more frightening than any other developed so far. It is therefore essential for those of us who are the poorest of the world, and thus most vulnerable, to require a regime which assigns liability and ensures redress. We feel it is unjust of the richest of the world to expect us to bear the risks of their experimentation."(6)

Following the collapse of the biosafety negotiations in Colombia, consultations with delegates at a meeting of the Convention on Biological Diversity in July 1999 confirmed that there was still the political will among most countries to reach agreement on a protocol. Informal talks were then held in September, and preparations made for a new round of biosafety negotiations which would take place in Montreal in January 2000.

Attempts to subordinate biosafety to the WTO

One more obstacle presented itself, however, at the meeting of the World Trade Organisation in Seattle in November. Canada, the US and Japan attempted to set up a ‘biotechnology working group’ within the WTO. If this attempt had been successful, it could have seriously undermined a Biosafety Protocol by shifting the debate on genetically engineered organisms from the Convention on Biological Diversity, where biosafety is a priority, to the WTO, where ‘free trade’ considerations overshadow all else.

Fortunately, the biotechnology working group was opposed from the start. When, for example, it emerged that Commissioner Pascal Lamy (the lead trade negotiator for the EU) had voiced support for the working party without consulting EU member states, Environment Ministers from Denmark, the UK, Belgium, France and Italy immediately issued a press advisory strongly objecting to Lamy's position. (7)

In the end, the attempt to set up a biotechnology working group within the WTO had actually backfired – most countries left Seattle angry at this poorly disguised attempt to subvert nearly seven years of biosafety negotiations, and were strengthened in their resolve to reach agreement on a protocol.

Agreement finally reached in Montreal

Finally, at 4am on the 29^th of January 2000, after four days and nights of intense negotiations in Montreal, 133 countries reached agreement on a Biosafety Protocol. Under this Protocol, all countries are legally bound to ensure that any development, handling, transport, use, and release of genetically engineered organisms is undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health. (8)

The precautionary principle is at the heart of this agreement. This means that countries have the right to ban or restrict the import and use of genetically engineered organisms when there is a lack of scientific knowledge or consensus regarding their safety. Considering the power of those countries that had made every effort to weaken the Protocol, it is stronger than many people had expected. Many compromises were made, however, in order for an agreement to be reached. In the words of Rafe Pomerance, the deputy chief of the US delegation: "We were just too important, too big …to be ignored." (9)

January 2000 Biosafety Protocol Negotiations

B. Key provisions of the Biosafety Protocol

B.1 Advanced Informed Agreement

Under a procedure known as ‘advance informed agreement’ (AIA), before countries are allowed to export any genetically engineered organisms that are destined for ‘intentional introduction into the environment’, they must first obtain the importing country's explicit consent. Once the importing country has been informed of the proposed export, it has 270 days to decide whether or not to allow the shipment to proceed. (10)

Importing countries are required under the Biosafety Protocol to take all measures necessary to prevent genetically engineered organisms (GEOs) from causing any adverse effects on biological diversity, taking also into account risks to human health. (11) To this end, an importing country can demand that the exporter carry out, and bear the cost of, any further risk assessments that are needed to help the importing country to make a decision. (12)

In order to avoid or minimise any harm to biodiversity or human health, an importing country may place conditions on the import of a GEO, or refuse to allow it, if there is lack of scientific certainty regarding the extent of any potential adverse effects. (13) And, if an importing country decides to approve the import of a GEO, it may review and change this decision at any time in the light of new scientific information. (14)

Exclusions from AIA requirements

The ‘Like-minded Group’ of Third World countries wanted all genetically engineered organisms to be included under this AIA procedure. However, the Miami Group of exporting countries managed to force a compromise under which the AIA only applies to the first import of any GEO intended for direct release into the environment, and under which the majority of GEOs are actually excluded from the scope of the AIA. This includes:

a) All GEOs that are commodities (i.e. those intended for food, feed and processing). (15)

b) GEOs that are destined for ‘contained use’ (e.g. GEOs used in laboratories etc.). (16)

c) GEOs that are pharmaceuticals for humans, if the pharmaceuticals are addressed by other ‘relevant international agreements or organisations’. (17)

d) Exports of GEO’s that are ‘in transit’ (i.e. passing through a territory of a country on route to another). (18)

Commodities

The Miami Group had obvious reasons for wanting commodities to be excluded from the scope of the AIA procedure, as commodities currently comprise more than 90% of these countries’ exports of GEOs. Nearly all other countries, however, argued that any distinction made between a GEO destined for ‘intentional introduction into the environment’ and a GEO destined for ‘food, feed or for processing’ would be arbitrary and inconsistent with the objectives of the Protocol. In most countries of the world, such a distinction is clearly artificial as seed originally intended for use as food will often be planted, and surplus seed that is not needed for planting will often be eaten.

Even if GEOs intended for use as food did not end up being deliberately planted, accidental releases into the environment are commonplace (e.g. seed fed to free-range poultry, seed falling from open trucks during transport etc.).

"A seed is a seed," said Tewolde Berhan Gebre Egziabher, spokesperson for the Like-minded Group. "Whether it is for planting or processing, it will enter into the environment. It will also have health impacts." (19)

Although GEOs intended for food, feed and processing are covered by the Protocol, they are covered by a weaker procedure than the AIA. The procedure used for these commodities places the onus on importing countries to make the effort to find out about potential shipments of GEOs, rather than obliging the exporter to first obtain the importing country’s explicit consent.

Once a country has given final approval for the domestic use of a GEO intended for food, feed or processing, it is required to provide information about this GEO (if it is likely to be exported) to the Biosafety Clearing-House within 15 days of this approval. The Biosafety Clearinghouse is basically a website administered by the Secretariat to the Convention on Biological Diversity.

It is then up to importing countries to monitor these approvals, and to judge whether or not they think these GEOs could be exported to them. If they believe that this is possible, they can then contact the Biosafety Clearinghouse for further information about the GEO. The Biosafety Clearinghouse will not, however, be able to tell them whether, or when, the GEO could be exported to them.

Importing countries are then required to evaluate any potential harm to biological diversity, including human health, that could occur if this GEO were exported to them. This evaluation should be made in much the same way as with GEOs intended for direct release into the environment, with the emphasis on a precautionary approach. Importing countries may then inform the Biosafety Clearinghouse whether or not they will allow any shipments of this GEO to enter their countries. (20)

Contained Use

Genetically engineered organisms that are intended for ‘contained use’ are also excluded from the AIA procedure. This does not, however, exempt countries from their obligations under the Protocol to prevent GEOs intended for ‘contained use’ from harming biodiversity, including human health. Therefore, countries are still required to apply the precautionary principle when making any decisions with regards to any development, handling, trade, transport, and use of these GEOs. (21)

As defined in the Biosafety Protocol, ‘contained use’ includes "any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment." (22)

This definition is extremely broad, and examples of GEOs which could potentially fall under this definition include GE fish kept in land-based ponds or in cages in the sea, any GEO grown in a greenhouse or used in a laboratory, GE livestock kept in barns, or even GEOs that are released in field-trials which have some kind of barrier or fence around them.

However, the Protocol also states that it is up to each country to decide whether or not a GEO is regarded as being under ‘contained use,’ in accordance with its own standards. As many of the above examples are effectively releases into the environment, countries may decide that such GEOs should actually fall under the rules which apply to the intentional introduction of GEOs into the environment, and therefore subject to the full AIA procedure. (23)

Pharmaceuticals

The Biosafety Protocol does not apply to any GE pharmaceuticals for humans, if they are ‘addressed by other relevant international agreements or organisations’. It is thought that ‘international agreements or organisations’ is meant to refer to bodies such as the World Health Organisation. However, it remains to be seen whether these organisations will be regarded as ‘relevant’ to the objectives of the Protocol, as they do not actually address the potential of GE pharmaceuticals to have adverse effects on biological diversity (e.g. genetic pollution from GE crops or animals which produce pharmaceuticals and are released into the environment). (24)

Transit

GEOs which are ‘in transit’ are excluded from the AIA procedure. The Biosafety Protocol does not therefore require exporting countries to obtain the explicit consent of countries that lie on trading routes before transporting GEOs through their territories. However, exporting countries are still required to respect the domestic rules and regulations which apply to GEOs in transit through these countries. As with commodities, countries on trading routes also have the right to monitor new approvals of GEOs in other countries, and may inform the Biosafety Clearinghouse if they decide they need to ban or restrict the passage of certain GEOs through their territories. (25)

Products derived from GEOs

Another major compromise made to the Miami Group was the exclusion of all products derived from GEOs from the scope of the Protocol. As the Protocol only applies to genetically engineered organisms that can replicate or reproduce genetic material, products derived from them, such as paper from GE trees, or soy protein from GE soy beans, remain unregulated internationally. (26)

There are, however, products which are derived from GEOs, which would still fall within the scope of the protocol. This could include, for example, maize that has been ground up for use in animal feed, yet which still frequently contains pieces that are able to germinate.

B. 2 Labelling Requirements

1. GEOs intended for direct introduction into the environment

The Protocol requires exporters to ensure that all consignments of GEOs that are intended for direct introduction into the environment are clearly labelled. This label has to include:

Identification of the consignment as ‘living modified organisms’
Specific identity and relevant traits and/or characteristics
Any requirements for safe handling, storage, transport and use
The contact point for further information and, as appropriate, the name and address of the importer and exporter
A declaration that the movement is in conformity with the requirements of the Protocol (i.e. that the importing country has given permission for the consignment to enter its territory).

2. GEOs intended for contained use

The labels for GEOs intended for contained use do not have to include the specific identity, relevant traits and/or characteristics of the GEO. They must, however, include:

Identification of the consignment as ‘living modified organisms’
Any requirements for safe handling, storage, transport and use
A contact point for further information (including the name and address of the individual and institution to whom the GEO is being sent).

3. GE commodities

GE commodities, however, are not subject to the same labelling requirements. The Miami Group of exporting countries fought hard against the labelling of these GEOs, because they did not want to have to segregate their GE commodities from their non-GE commodities. For the moment, all that is required is that commodities be labelled as ‘may contain living modified organisms’. This label must also say that the commodities are not intended for introduction into the environment, as well as giving details of a contact point for further information. A final decision about more detailed labelling of GE commodities will be taken no later than two years after the Protocol comes into force. (27)

B. 3 Socio-Economic Concerns

Although socio-economic considerations are not an explicit requirement of the risk assessment procedures in the Protocol, countries are given the right to consider socio-economic impacts, when evaluating potential imports of GEOs. Countries may also take into account socio-economic considerations, such as the value of biological diversity to indigenous and local communities, when implementing domestic regulatory measures for GEOs. (28)

B.4 Liability

Despite the Miami Group’s confident assurances that GEOs are absolutely safe, this confidence was not matched in the biosafety negotiations by a willingness to accept demands for a strict system of liability and redress, under which exporters of GEOs would be held responsible for any damage caused by them. However, although agreement on this issue has not yet been reached, countries are required to finalise a liability regime within four years of the Protocol coming into force. (29)

B. 5 Public Consultation

Governments are required by the Protocol to:

consult the public in all decision-making processes regarding GEOs
provide access to information on GEOs that may be imported
publicise the results of any decisions made. (30)

B. 6 Unintentional movements of GEOs

Each country is required to take appropriate measures to prevent any unintentional movements of GEOs across borders from taking place. (31)

If countries become aware of any unintentional movements of GEOs originating within their jurisdiction, they must immediately notify affected or potentially affected countries in order to enable them to determine appropriate responses and initiate necessary action. This notification, which must also be passed on to the Biosafety Clearinghouse and other relevant international organisations, should include the following:

any relevant information about the GEO, such as its characteristics, traits and usage

estimated quantities of the GEO and on the circumstances and estimated date of its release

any available information about possible adverse effects of the GEO on the conservation and sustainable use of biological diversity, taking also into account risks to human health,

any available information about possible risk management measures, and a point of contact for further information. (32)

The Protocol gives affected countries the right to demand that the country from which the GEOs originated retrieve and/or destroy the GEO, at its own expense. (33)

C. Ratification of the Biosafety Protocol

The Biosafety Protocol was opened for signature on the 24 May 2000. By December 2000 it had been signed by 81 countries. (34)

When a country signs the Protocol, this indicates general support for its principles, as well as that country’s intention to become legally bound by it. However, the Protocol does not become legally binding for a country until:

it ratifies the agreement (i.e. deposits a letter of accession, acceptance or approval with the United Nations).

and

The Protocol comes into force as a legally binding international agreement, which will happen 90 days after 50 countries have ratified it. Once the Protocol has come into force, it will be subject to review at least every five years.

Providing that the pressure on countries to ratify the Protocol is kept up, it is likely to enter into force by 2002 or 2003. In the meantime, countries are expected to apply the spirit and objectives of the Protocol to which they have agreed. (35)

Note: Despite the pervasive influence of the US in the biosafety negotiations, it cannot actually ratify the Biosafety Protocol because it has failed to ratify the Convention on Biological Diversity. In order to ratify the Protocol, it must first ratify the CBD.

D. Relationship between the Biosafety Protocol and the WTO

The relationship between the Biosafety Protocol, an agreement concerned with the protection of biodiversity, and the WTO, which is concerned with the removal of barriers to trade, is of critical importance and certain to be controversial.

While the Biosafety Protocol emphasises that its rules should not be interpreted as implying a change in the ‘rights and obligations of other international agreements’ (such as the WTO), it goes on to say that this does not mean that the Protocol is subordinate to these other international agreements. The Protocol also maintains that trade and environment agreements should be mutually supportive. (36)

However, the differences between the WTO and the Biosafety Protocol are so significant that a mutually supportive relationship looks extremely unlikely. Under the WTO, for example, the onus is on the importing country to provide proof that a GEO is not safe if it wishes to block an import, and the importing country will be subject to punitive sanctions if it cannot provide this proof. Under the Biosafety Protocol, on the other hand, the onus is on exporting countries to provide the evidence that a GEO is safe, and importing countries are required to take all measures necessary to prevent a GEO from causing any adverse effects.

In case of disputes, countries can refer to the Vienna Convention on the Law of Treaties, which governs the interpretation of treaties under international law. The Vienna Convention rules that a later international agreement supersedes an earlier one, and an agreement on a specific subject prevails over a general one. (37)

It would be logical to assume, therefore, that the Biosafety Protocol should take precedence over the WTO in any dispute, as the Protocol deals specifically with biosafety issues which are not covered by the WTO, and because the Protocol is also the more recent of the two agreements.

However, a favourable interpretation such as this is far from certain, as a lot depends on the forum where any dispute is arbitrated. If disputes are brought in front of the WTO, where the dispute settlement panel usually rules in favour of the interests of big corporations and powerful countries, countries following their obligations under the Protocol could potentially find themselves in trouble.

But if a country were ruled against for taking measures to prevent GEOs from damaging biodiversity and human health, such a ruling could end up further undermining the legitimacy of the WTO. This is something that countries such as the US are keen to avoid at the moment. It is possible, therefore, that the continued public scrutiny and criticism of the WTO, together with growing opposition to genetic engineering, makes it less likely that countries will challenge a Protocol-based decision by appealing to the WTO. (38)

Note: The references to the relationship between the Biosafety Protocol and trade agreements are not included in the articles of the Protocol, but appear in the introductory text, which is called the ‘preamble’. In international agreements such as the Biosafety Protocol, while text in a preamble is relevant, it carries less weight than if it were included as a substantive provision, i.e. in the articles of the agreement.

Conclusion

Considering that industry, backed by powerful governments with vested interests to protect, had not wanted any meaningful agreement at all, the Biosafety Protocol is a historic achievement. For the first time under international law, there is an explicit requirement that countries take precautionary measures to prevent GEOs from causing harm to biodiversity and human health.

Many essential biosafety measures have clearly been compromised in the efforts to reach agreement, but the Biosafety Protocol is a step in the right direction. The Protocol as it stands lays down minimum standards that have to be adhered to, and it is for all those who care about the protection of our environment, food security and the preservation of our genetic resources, to demand a more rigorous protocol that truly serves its original objective.

References:
hyperlinks as of Sept. 2001

1. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Article 1 www.biodiv.org/biosafety/articles.asp

2. Convention on Biological Diversity, Article 8(g) www.biodiv.org/convention/articles.asp?lg=0&a=cbd-08

3. Convention on Biological Diversity, Article 19 (3) www.biodiv.org/convention/articles.asp?lg=0&a=cbd-19

4. "Biosafety: Economic Concerns Steered Cartagena Talks", UN Wire (United Nations Foundation News Briefing), 25 February 1999