DUBLIN, Ireland - An environmentalist's court challenge to the Irish EPA's decision to grant Monsanto Co. consent to carry out field trials of genetically modified sugar beets is expected to finish in the High Court in Dublin today.

Clare Watson, a member of the campaign group Genetic Concern, is seeking to overturn the EPA's decision on the grounds the agency failed to meet requirements under Irish law in granting the consent.

Monsanto, of St. Louis, has been named as the second respondent in the case, which suffered numerous delays before finally commencing on June 30. (See BioWorld International, Jan. 7, 1998, p. 1.)

The case hinges on what constitutes an acceptable level of risk. Watson's legal team is attempting to demonstrate the Irish legislation that gives effect to the European Union (EU) directive on the deliberate release of genetically modified organisms (GMOs) imposes a stricter safety test than that implied by the EU regulation.

Watson's legal counsel argued last week the directive, known as 90/220, makes provision for national authorities to apply their own discretion in setting a safety threshold in Article 4.1, which states: “Member states shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or placing on the market of GMOs.“

The corresponding passage in the Irish regulations states: “The agency shall not consent to a deliberate release unless it is satisfied that the release will not have any adverse effect on human health or the environment.“

Genetic Concern has argued Monsanto's field trial constituted an efficacy test only and failed to guarantee it would have no adverse environmental impact.

Monsanto has countered that Genetic Concern's interpretation of the legislation is overly restrictive and is tantamount to a requirement that all GMO trials should carry zero risk, which, it says, is impossible to guarantee. The company also has argued 25,000 GMO trials have been performed worldwide without any adverse consequences.

Genetic Concern has also argued the Monsanto dossier that formed the basis of the EPA's decision was incomplete and the consent is therefore invalid.

The judge, Justice Philip O'Sullivan, who declared himself to be a part-time organic farmer at the outset of the case, is not expected to give his ruling until late September, although according to a Monsanto spokesman, a decision could come earlier if he decides to rule in favor of Genetic Concern.

Whichever organization loses the case is likely to appeal, he said. Genetic Concern spokesman Quentin Gargan said his organization will appeal if it feels it has a strong point of law.

The current case concerns Monsanto's license to carry out field trials at a state agricultural research station in County Carlow. Its outcome could affect four other trials the company is conducting at other sites in Ireland. One of these, at Arthurstown, County Wexford, was sabotaged by environmental protesters last month.

The case also could have international implications for Monsanto. In a court affidavit originally submitted in May, Monsanto stated: “If it becomes apparent that approvals have been suspended by the courts in Ireland, this may affect the approach adopted by regulatory authorities in other [EU] member states. . . there might be a snowball effect throughout Europe with serious consequences for Monsanto in terms of the loss of advantage of the patent life.“ *