The High Court yesterday cleared the way for field trials of genetically-modified crops in the State when it upheld the Environmental Protection Agency's decision to permit controversial trials of genetically-engineered sugar beet in Co Carlow.
In a decision expected to have major implications for the biotechnology industry in the State and internationally, Mr Justice O'Sullivan rejected all grounds of a challenge by Ms Clare Watson, of Genetic Concern, to the field trials being conducted by Monsanto plc.
He stressed he was not dealing with the merits or otherwise of genetic engineering but rather with legal matters about the processing of Monsanto's application by the EPA and Ms Watson's right to object to it.
The Co Carlow trials were the first such permitted in the State. Earlier this year, the EPA also granted consent for four more crop trials in Cos Cork, Meath and Wexford. A challenge to these is dependent on the outcome of Ms Watson's action.
Ms Watson, of Foster Avenue, Mount Merrion, Dublin, had argued that the EPA failed to observe the correct procedures when granting permission on May 1st, 1997, to Monsanto, with an address at High Wycombe, Buckinghamshire, England, for the field trials on lands owned by Teagasc at Oak Park, Co Carlow.
The court heard Monsanto had developed a sugar beet plant which is tolerant of glyphosate, the main ingredient in Monsanto's weedkiller Roundup. The field trials are being conducted to assess the effect of Roundup on that glyphosate-tolerant sugar beet.
Ms Watson had challenged the EPA's permission for the field trials before Mr Justice O'Sullivan over 10 days in July.
Delivering his 58-page judgment yesterday, the judge noted that Ms Watson was not only taking on a heavy onus of proof in the action but "the battle ground" had also moved from the merits and weight of the "strongly-held opposing opinions" on genetic engineering to the legal technicalities governing the processing of Monsanto's application for consent for the field trials and Ms Watson's right to object, together with the interpretation of the legal provisions relating to them.
The judge said there were three main issues. The first related to the correct standard which the EPA must apply before granting consent for field trials.
Ms Watson argued the correct standard was that risks to the environment and health must be "effectively zero", while the EPA and Monsanto both said the standard was not as high or absolute as that, although they did not say precisely what the standard was.
A sub-issue was whether the standard set by the 1994 Genetically Modified Regulations, the EPA Act 1992 and the 1990 European Directive on the Deliberate Release into the Environment of Genetically-Modified Organisms, was the same throughout.
There was a further sub-issue regarding whether the 1994 regulations and the EPA Act set a higher standard than the directive and, if they did, whether they were competent to do so.
The judge found that the standard indicated or contemplated by the EPA Act was the same as that established by the directive and was not the "effectively zero" risk standard contended for by Ms Watson.
It was his view that both the Act and directive contemplated the possibility that risks would be posed to human health and the environment by GMOs in the specific context of applications for a deliberate release of these and that both legal instruments contemplated not an absolute elimination of all known risks but some less absolute form of control.
He said the purpose of the GMO regulations (1994) was to give full effect to the directive. He was satisfied the standard set out in Article 33.4 of the regulations did not require the EPA to be satisfied all risks had been reduced to an effectively zero level.
He said it was clear that Ms Watson could not establish the EPA failed to implement the appropriate standard when granting consent to Monsanto. He held it to be "a fair inference" that the EPA accepted the risks to the environment as "very low" and no question arose, therefore, of the agency applying the incorrect standard or of acting irrationally.
On the second main issue - whether the 1994 regulations should be construed to permit objectors like Ms Watson to make further comment outside the 21-day period specified by the regulations in relation to additional material supplied by Monsanto in response to an EPA Notice for Particulars - the judge also found against Ms Watson.
He accepted the regulations do not make any provision for further public submissions and found there was no breach of the principles of procedural justice.
The judge also found against Ms Watson on the third main issue. This related to the EPA by a condition attached to the consent granted to Monsanto for the trials, requiring Monsanto to submit a field trial management protocol in advance for agreement.
Ms Watson argued the EPA had no power to postpone any part of its overall consent or to delegate part of its decision to an EPA official, Dr Thomas McLoughlin, who was the person who agreed the protocol with Monsanto and gave the company the final go-ahead for the trial.
The judge said he agreed with the EPA that this was a matter of "good housekeeping".
Several other points raised by Ms Watson were also rejected. The judge found the consent granted to Monsanto was not in breach of the requirements of natural or constitutional justice; that a newspaper notice acknowledging receipt of Monsanto's application was valid; that it was sufficient to publish this notice in a local newspaper; that a second newspaper notice was not irregular; that it was not necessary to include a map in the notification of the trials; that the notifications complied with the 1994 regulations; and that the EPA gave adequately prompt notice of the issuing of its consent to Ms Watson.
After the judgment, Mr John Gordon SC, for Ms Watson, asked for an adjournment to allow all sides to consider the decision. Mr Justice O'Sullivan adjourned the matter until Tuesday.