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Text of letter to European Commissioner Bjerregaard

Dated 7.12.98

From: Ken Collins, European Parliament Environment Committee


Dear Commissioner

Biosafety Protocol to the Convention on Biological Diversity (CBD)

As you will know, the Environment Committee held an exchange of views with your officials on this matter on 27 October and the Committee has asked me to write to you to express our thoughts on the forthcoming negotiations in the Biosafety Working Group (BSWG-6) in Cartagena, Columbia in February 1999 at which the Commission will represent the European Union. We understand that this will be the final round leading, if all goes well, to the adoption of a Protocol by the parties to the CBD. We also understand that many key issues have not so far been resolved and much of the draft text remains bracketed with various options still on the table. We should put on record at this point our clear view that the Protocol should be about Biosafety and not primarily about trade.

You will also know that at its plenary session on 20 October, the European Parliament adopted the Sjostedt Report (A4-0347/98) in response to your Communication COM(98)0042 on a European Community Biodiversity Strategy and I will refer to the relevant conclusions below. The ACP-EU Joint Assembly in adopting a Resolution on Biotechnology (24 September 1998, ACP-EU 2613/98) also visited this subject.

At the exchange of views with your officials, we heard that there is a large divergence between a bloc of developed (mainly grain-exporting) nations who seek a minimalist, low-obligation Protocol and developing nations who want to see a much more binding and comprehensive document. Our overall view is that we would expect the EU to press for an extensive agreement rather than one which represents only the lowest common denominator.

1. The Precautionary Principle

The Protocol should make it clear that this is a paramount principle. It should be clearly established that signatory states have the right to apply the precautionary principle as they interpret it in deciding whether to allow the import, introduction, transfer, handling or use of Living Modified Organisms (LMOs) or their products within their sovereign territories, based on their assessment of risks to human and animal health, to the environment, to biological diversity and to the socio-economic welfare of their societies. (Sjostedt Paragraph 45 “Takes the view that legislation concerning the introduction and implantation of extraneous species and genetically modified organisms must be based on the precautionary principle, and stresses that in the forthcoming negotiations for adoption of the Biosafety Protocol the starting-point must be a high level of protection of human health and biodiversity;”, Paragraph 47 “Calls on the Commission to commit itself to a binding Biosafety Protocol to the Convention which safeguards human and animal health, the environment and biological diversity and which protects the socio-economic welfare of societies;”)

2. Compatibility with EU Standards

The rules for transboundary movements should represent international standards based on a high level of protection for the environment and for human health. These should not be merely factors to be taken into account but primary objectives. It is self-evident that the EU should not accept lesser standards externally than those applicable internally, as required in Article 130r of the EU Treaty and exemplified in Directive 90/220 on the Deliberate Release of GMOs.

3. Scope

Your officials argued against extending the scope to include non-living products of LMOs. This is not consistent with the position of the EU internally, which has already moved towards recognition of the potential indirect and long-term hazards of genetically modified organisms. This is reflected in your proposed revision of criteria for risk assessment in Directive 90/220. The possible impact on the environment and on human health of non-viable material is as yet not well understood and for this reason the Protocol should extend to “LMOs and products thereof”.

4. Provisions for Derogation

As indicated in my letter to you of 16 October 1998, the Environment Committee is deeply concerned at the lack of consensus on risks from the release of GMOs and called for a moratorium. Additionally, Article 16 of the 90/220 Directive permits member states to restrict or prohibit releases within their territories where they consider that there is a risk to human health or the environment. The Protocol should contain equivalent provisions which allow signatory states to take such actions.

5. Advanced Informed Consent

We support the position being taken by the Commission which places the authority with the importer to give active consent. We consider that the rights of the importing party to accept or reject must be unambiguous and may not be over-ridden by any system of passive consent or third party intervention. We consider it important also to ensure that there are no exceptions to the AIA system, such as that under consideration for agricultural commodities.

(Sjostedt Paragraph 51 “Calls on the Commission to add the following rules for the export of genetically modified organisms (GMOs):

for the export of GMOs and/or products containing GMOs to non-Member States, the exporter or importer must be in possession of

·approval of the import from the country of destination

·an export permit from the authority in the competent Member State.

Import authorisation from the country of destination must be submitted for the authority in the competent Member State to grant approval;”)

6. Liability

As you know, the Parliament is most anxious to establish a clear liability regime for producers and users of LMOs/GMOs and we are aware that this is also a key issue of the Protocol for many of the developing countries -indeed some reports suggest that negotiations could founder over this issue. We would ask the Commission to press hard for the inclusion of strict liability and redress principles as an effective mechanism for ensuring that the proper degree of responsibility is attached to the exporter.

7. Labelling and Traceability

It is clearly fundamental to an international safety system that the products in question should be easily identifiable and traceable in the event of emergencies or unauthorised movements. Mixed shipments and uninformative labelling of the “may contain” variety will not provide the certainty which is required and we ask that the Commission presses strongly for appropriate and explicit procedures and documentation to achieve such certainty. (Sjostedt Paragraph 52. “Calls on the Commission to set up a clear and all-inclusive system for labelling products which are derived from or contain genetically modified organisms;”)

8. Non-Parties

As the US is not a party to the CBD and would therefore not be able to sign the Protocol, this raises serious questions about transboundary movements originating from non-parties. The international value of a Protocol becomes seriously diminished if there is a bloc capable of trading without agreed rules. We would ask the Commission to insist that the movement of LMOs from or to non-parties be prohibited.

9. Precedence over other International Agreements

As noted above, this is primarily a biosafety instrument, not a trade mechanism. We welcome, therefore, the statement by your officials that there should be no express subordination of the protocol to other international agreements, such as the WTO. However, we would like to see the Commission go further in this respect by pressing for the removal of any clauses dealing with non-discrimination or cross-relationships with other treaties which restrict or remove the primacy of decisions on biosafety grounds.

10. Parliamentary Involvement

Negotiations on the Protocol are clearly linked to the ongoing concerns of Parliament on issues relating to the proper regulation of genetic engineering. We consider it appropriate to be kept closely in touch with developments since we expect that any agreement on the Protocol will be submitted for Parliamentary scrutiny before signature.

Yours sincerely

Ken Collins