Food Trade and the Biosafety Protocol

It remains to be seen whether the outcome in Montreal on January 28 - 29 is a landmark achievement in international biotechnology cooperation. The final draft text raises questions likely to precipitate significant debate in the months and years ahead. At first blush, the Protocol complicates rather than clarifies both the debate on trade and environment, and food safety.

The purpose of the negotiation was defined in a 1995 decision of the Parties to the Convention on Biological Diversity. The decision provided that the Parties develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement.

The text addresses these issues, and introduces consideration of human health, as well as the entire realm of transboundary movement of LMOs intended for direct use as food, feed, or for processing. New documentation requirements combined with recognition of the precautionary principle, suggest the prospect of extensive product labeling requirements is real. Moreover, the Protocol adds fuel to the case for establishing PPM regimes inasmuch as LMOs invite a distinction on the basis of production methods.

To the extent that there is an inconsistency between the Protocol and any other international agreement, there is room for debate on precedence. The preambular text notes that, "this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements." Thus, the Protocol does not presume to alter rights and obligations under any WTO agreements, such as TBT or SPS. However, the preamble concludes by saying, "the above recital is not intended to subordinate this Protocol to other international agreements" In other words, there is no intention to subordinate the Protocol to the WTO.

Article 14 speaks directly to bilateral, regional, and multilateral agreements and arrangements. This is an important article, and bears repeating in full:

1. Parties may enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of living modified organisms, consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.
2. The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilateral agreements and arrangements that they have entered into before or after entry into force of this Protocol.
3. The provisions of this Protocol shall not affect intentional transboundary movements that take place pursuant to such agreements and arrangements as between the parties to those agreements or arrangements.
4. Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision.

Paragraph 1 has clear prospective application, and sets a floor on the objectives of such other agreements to which Parties are members. The larger issue, however, is with the proviso that such other agreements "do not result in a lower level of protection than that provided for by the Protocol." Were it not for the inclusion of the precautionary principle, this phrasing might be interpreted as meaning a rigourous science-based standard no lower than set out in the Protocol.

However, given the flexibility allowed the Parties to make a determination not to allow entry of an LMO in situations where the science is ambiguous, the level of protection afforded by the Protocol is extremely high. There is therefore some doubt that, for example, the SPS Agreement meets this test in relation to LMOs that could have "potential adverse effects on biological diversity, taking also into account risks to human health." At a minimum, there are some trade-related issues here that need to be examined in more detail.

One might consider this a moot point in the light of paragraph 3, which seeks not to tread on transboundary shipments made pursuant to other agreements to which the involved Parties are members. The significance of paragraph 3 is diminished, however, by virtue of paragraph 4, which clearly envisions parties identifying specific imports for which domestic regulations will apply. The Protocol itself defines "import" as meaning the "intentional transboundary movement into one Party from another Party." Since the purpose of the Protocol is to ensure minimal adverse effects from transboundary movement, this provision may lead to specific LMOs being treated as within the ambit of the Protocol, and not within the operational jurisdiction of any other international agreement. If countries are enabled to shift unilaterally specific LMOs to the jurisdiction of the Protocol, other agreements -- the purpose of which is trade enhancement -- could be drained of significance. This is relevant in relation to LMOs directly used in food, feed, or processing because Article 11 specifically repeats the same domestic regulatory language, indicating that food is a specific import that can be constrained by the domestic regulatory process. Moreover, the lack of scientific certainty does not preclude action to avoid potential adverse effects.

There are other aspects of the agreement that raise questions. The notification provisions call upon the importing country to inform the exporter of their decision within a set period. However, the importing country is not obliged to do so, and the absence of a response is explicitly stated not to constitute acceptance. However, the Protocol does not clearly address how an exporter secures a response from the import country in such a situation. This appears to be left to the domestic regulatory regime, which could frustrate exporters indefinitely.

In addition, there appears to be a difference between the decision process for LMOS under Article 10, and the procedure for LMOs intended for direct use as food, feed, or for processing under Article 11. For example, Article 11 does not reference paragraphs two and three of the general decision procedure, suggesting that the importing country is not bound even by the extended timeframes for decision on other LMOs.

If these interpretations are accepted in practice, LMOs in the food trade could be faced with significant barriers to entry. The EC has moved rapidly in recent months to elaborate further its systematic approach based on the precautionary principle. In January, the EC issued the Biosafety White Paper on Food Safety, which includes recommendations to further regulate in the area of food labeling before the end of calendar 2000. On February 2, the EC adopted a statement on the use of the precautionary principle. The statement deems its application to cover protection of environment, human, animal and plant health. EU Commissioner David Byrne (Health and Consumer Protection) will visit Washington February 8 - 11 to sell the white paper, the precautionary principle, and the proposed European Food Authority.

North American farmers and food processors are reacting with considerable interest to the Protocol. A week ago, participants at an agriculture conference in New Brunswick, Canada expressed an appreciation for segregating organic and GMO products before they reach the marketplace. In the US, the National Food Processors' Association has called for labeling at the farm gate. In due course, these concerns will reach the fisheries sector, starting with the NAFO/Fisheries Commission meeting in Brussels February 29.