Judgment reserved in challenge to EPA's consent to beet trials

The High Court has reserved judgment on a case expected to have major implications for the biotechnology industry. Submissions concluded yesterday after 10 days of the hearing of a challenge taken by Ms Claire Watson, of Genetic Concern, to the decision of the Environmental Protection Agency on May 1st, 1997 to permit Monsanto conduct field trials of genetically-engineered sugar beet in Co Carlow.

Monsanto has become involved with another company, Novartis, in the development of a glyphosate-tolerant sugar beet plant. The trials, on Teagasc-owned lands at Oak Park, Co Carlow, aim to test the effect of Monsanto's weedkiller, Round Up, in which the active ingredient is glyphosate, on that sugar beet.

At the conclusion of yesterday's hearing, Mr Justice O'Sullivan reserved judgment in what he said was a "very important" case. The case has heard complex scientific evidence and the judge had asked both sides if they could agree a simplified guide to genetic engineering which he could refer to. He was told yesterday that this had not been possible.

They did agree that he could be given a chapter from a book entitled Genetics by Peter J. Russell and a glossary of terms.

In the case, Ms Watson argued the EPA failed to observe the correct procedures when granting permission to Monsanto for the field trials and submitted the EPA must be satisfied there is an "effectively zero" risk of adverse effects to human health and the environment from the deliberate release of genetically modified organisms (GMOs) into the environment.

The EPA and Monsanto argued that the agency adhered to the correct procedures. Mr James Macken, for the agency, said its decision was reasonable, in accordance with fair procedures and considered the views of more than 400 objectors. Ms Fidelma Macken, for Monsanto, submitted that Irish policy on the release of GMOs operates on the basis that this is an unknown area and not on the basis that all such organisms are dangerous.

During the hearing, Mr Justice O'Sullivan was asked to consider the legislative framework within which the EPA decision was taken, which involves a consideration of Irish and European law. The key provisions are a 1990 European Council Directive on the deliberate release into the environment of GMOs (the Directive), the Environmental Protection Agency Act 1992 (the EPA Act) and the Genetically Modified Regulations 1994 (the 1994 Regulations).

In concluding submissions yesterday, Mr Frank Clarke SC, with Mr John Gordon SC, for Ms Watson, accepted there was no obligation on the EPA, when issuing permission for a release of GMOs, to make any assessment on unforeseen risks to human health and the environment.

He was not saying the Directive required the EPA to be satisfied there was an "effectively zero" risk to human health and the environment before permitting a GMO release.

He submitted the relevant question was whether the Directive "permitted" such a test. The Directive allowed some latitude and Ireland was entitled to impose a higher test on the release of GMOs. The court should take the view there was nothing in the Directive which precluded the "effectively zero" test.

He said the court had essentially two questions to answer.

The first was whether the Irish laws purported to create an "effectively zero" test regarding the deliberate release of GMOs into the environment.

Section 111.4 of the EPA Act provided that a person proposing to release GMOs should use the best available technology for the prevention of danger to health, protection of property and preservation of amenities. The 1994 Regulations required the EPA to be satisfied that GMO release would not adversely affect health or the environment.

He submitted the Irish provisions established a test that there must be an "effectively zero" risk to health and the environment before a GMO release is permitted.

If the answer to the first question was Yes, the second question was whether that "effectively zero" test conflicted with the Directive. He submitted the answer to this second question must be No.

Assuming he was right on both questions, the court must then decide whether the EPA applied itself to the correct test - whether there was an "effectively zero" risk - in granting permission for the Monsanto field trials.

It was clear that, whatever test the agency applied, it was one which allowed permission to Monsanto on the basis of a "very low" risk and this was the wrong test, Mr Clarke argued.