Judicial Review - Applicant a member of an unincorporated organisation called Genetic Concern - Second respondent given consent by first respondent for limited trials of genetically modified organisms - Applicant applied to have consent quashed - Standard by reference to which first respondent is to decide to grant licences - Whether risk should be reduced to effectively zero before consent can be given - Whether third party objectors should be allowed to respond to supplemental material - Whether first respondent engaged in unlawful delegation of power - Whether first respondent was in fact postponing overall con- sent - Whether first respondent had power to postpone consent Environmental Protection Agency Act 1992 (No 7), section 111 - Genetically Modified Organisms Regulations 1994 (SI 345 of 1994) - Council Directive 90/220/EEC.
The High Court (before Mr Justice O'Sullivan); judgment delivered 6 October 1998.
The Environmental Protection Agency, in deciding whether to consent to a deliberate release of a genetically modified organism into the environment, is not required to be satisfied beyond reasonable doubt that the risk of adverse effects has been reduced to an effectively zero level. The standard to be applied is set out in the 1994 regulations and is the same as that contemplated by the 1992 Act and as established by the 1990 directive and requires the agency to ensure that all appropriate measures are taken to avoid adverse effects and in the light of that finding it is not necessary to decide whether the Irish legislature is competent to set a higher standard than the directive. It is only proper that the agency should as an executive matter require that specific instructions should be committed to writing and agreed by the agency prior to the trial commencing and this does not amount to postponing the decision on consent. The principles of natural justice do not entitle the applicant to make further submissions after the 21 day period for the making of submissions had elapsed as her original submissions were general and principled in nature rather than technical and it was not established that the further material furnished by the second respondent to the first respondent radically changed the nature of the notification.
The High Court so held in refusing the reliefs sought.
John Gordon SC, Frank Clarke SC, Michael O'Donnell BL and Patrick O'Callaghan BL for the applicant; James Mackin SC and Nuala Butler BL for the first respondent; Fidelma Macken SC and Brian Creegan BL for the second respondent.
Mr Justice O'Sullivan said that the applicant was a member of an unincorporated association called Genetic Concern which seeks to raise public awareness of the dangers of the release of genetically modified organisms (GMOs) into the environment. The first respondent (the EPA) was established by the Environmental Protection Agency Act 1992 and on 1 May 1997 issued consents to the second respondent, a company concerned in the development of a sugar beet plant tolerant of herbicide, to carry out field trials of their new product. The applicant was given leave on 13 May 1997 to challenge these consents and sought to have them quashed. The applicant argued that the standard by reference to which the EPA must decide whether to issue consents is that risks to the environment have been reduced to an "effectively zero" level. She further argued that the decision of the EPA to grant the consents was irrational because they were granted on the basis that the risk was "extremely low" and therefore the EPA had not applied the correct test. The applicant also contended that in a situation where, as here, supplemental material was provided to the EPA by Monsanto in response to a questionnaire from the EPA then she, as a third party objector, should have been given extra time to make further submissions. The applicant also argued that the EPA was postponing part of its consent, which it had no power to do, because it required Monsanto to submit a management protocol in advance for agreement. Allied to this submission the applicant argued that the EPA had no power to delegate this part of its decision to the scientific officer of the Environmental Management and Planning Division of the EPA, one Dr McLoughlin.
Mr Justice O'Sullivan set out a number of affidavits filed on behalf of both sides and said that a considerable amount of this opinion evidence would have to be ignored as it was the function of the EPA rather than the court to assess the scientific material put before it and the merits of the debate were irrelevant to the determination of the legal issues. However, the engineering and scientific evidence would have to be considered in order to assess whether the supplemental information submitted by Monsanto, in respect of which the applicant could not make submissions, was such as to significantly alter Monsanto's original notification. The original notification was acknowledged by the EPA on 16 December 1996 and on 23 December the EPA informed Monsanto of its obligation, under the regulations, to place an advertisement in a national newspaper. On 10 January 1997 Monsanto caused an advertisement to be published in a local newspaper which the EPA was advised was acceptable but the advertisement contained an incorrect response period for submissions. On 17 January Monsanto caused to be published in a local newspaper an advertisement with the correct response period. On 21 February the EPA sent Monsanto a detailed request for particulars and a meeting in relation thereto was held on 14 March. Written responses to queries continued throughout March and consents were issued subject to conditions on 1 May and notifying letters were sent to all those who had made representations. The applicant's solicitor also received a faxed notification on 2 May and on 6 May the applicant inquired as to whether she could make submissions in relation to the trial protocol to be agreed. On 8 May the EPA sent Monsanto queries in relation to the trial protocol and an amended protocol was submitted on 9 May. On 13 May the EPA faxed confirmation to Monsanto authorising commencement of the trials.
Article 33(4) of the 1994 Regulations in relation to the release of GMOs provides that "the agency shall not consent to a deliberate release unless it is satisfied that the deliberate release will not result in adverse effects on human health or the environment." The applicant submitted that this meant that prior to any consent being given the EPA had to be satisfied that the risk of adverse effects had been reduced to effectively zero but the EPA could not have been so satisfied because its own conclusion on the Monsanto proposal stated that the risks involved were "very low". Mr Justice O'Sullivan was of the view that a determination as to what standard was to be applied could only be made by having regard to the 1994 Regulations, the 1992 Act and also the 1990 directive on GMOs. It would have to be decided what standard was required by these instruments, whether the standard was the same in all the instruments and if the Irish standard was higher than that contained in the directive whether this was within the competence of the Irish Legislature.
Article 5(2)(b) of the directive which deals with notifications to the competent authority of member states where field trials are concerned provides that the notification shall include "a statement evaluating the impact and risks posed by the GMOs to human health or the environment from the uses as envisaged." This must be read in conjunction with Article 4(1) of Part A of the directive which provides that "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".
Mr Justice O'Sullivan was of the view that when Article 4(1) was read in the light of Article 5(2)(b) it must be taken to contemplate the possibility of risks posed by the deliberate release of GMOs as that is the only reason why Article 5(2)(b) would have been included. This is consistent with the general "step by step" principle which governs applications for field trials whereby permission for a further step is only given when the full effects of a prior step have been evaluated. To interpret the word "avoid" in Article 4(1) so as to require an effective elimination of all risks before a consent is given would be to render pointless the step by step principle and also the submission of risk evaluation in notifications under Article 5(2)(b). Mr Justice O'Sullivan said that the position in Irish law is that section 111(1) of the 1992 Act specifies that the Minister for the Environment may for the purpose of giving full effect to the directive make regulations for the control, management, regulation or prohibition of any process or action or class of processes or actions involving GMOs. The closest the Act comes to setting a standard in relation to the risks posed by the release of GMOs is the use of the phrase "prevention of danger to health or damage to property or for the preservation of amenities" in section 111(1). However, section 111(2) provides that the Minister shall have the power to provide for studies and assessments of "possible risks to the environment from the organism or the process or action involving the organism and the potential effects of a release of such organism whether planned or accidental." Mr Justice O'Sullivan was of the view that when read together it was clear that the Act allowed for the possibility of risks to the environment because if the possibility of risk was to be totally eliminated then it was unlikely that the Act would make provision for the assessment and study of such risk. Therefore, the standard laid down in the Act is the same as that established by the directive and is not the "effectively zero" standard contended for by the applicant.
Similarly the regulations, which must be interpreted as far as possible in light of the wording and purpose of the directive, provide that the EPA must evaluate the risks posed by the deliberate release of GMOs which would be a pointless exercise if those risks were to be reduced to "effectively zero". Mr Justice O'Sullivan said he was satisfied that the EPA were of the view that the risks were very low and this view could not be regarded as irrational as there was material before the EPA justifying this assessment. Given that the standard set out in the regulations was the same as that contemplated by the Act and as established by the Directive it was unnecessary to determine whether it was within the competence of the Irish legislature to set a standard different to that set out in the Directive.
The applicant submitted that the management of the trial had been improperly delegated to Dr McLoughlin by condition 5(1) which was attached to the consent and which also stated that a copy of the detailed instructions on trial operations and maintenance had to be "forwarded to the EPA in advance for agreement" which, the applicant contended, amounted to an improper postponement of a consideration of trial operations until after the primary decision had been made. Mr Justice O'Sullivan said that this condition was imposed to make provision for the management of the trial on a planned basis and the intention behind the condition was not to provide for the possibility of reviewing a wide range of matters not set out in the condition itself. The scope of the "agreement" is established by the other sub-conditions in condition 5 and the EPA was correct in saying that this was an executive matter and that it was proper that the specific instructions which were detailed in the other sub-conditions should be committed to writing and agreed by the EPA prior to the trial commencing. Further, there was no improper delegation of the EPA's decision making function and it was not a sound principle in general to say that no part of a decision making function could be delegated in the absence of a specific statutory provision.
Mr Justice O'Sullivan said that it was clear that the 1994 regulations did not provide for further representations from members of the public after the 21-day period provided for in article 31(4) of the regulations had expired even where further material has been tendered to the EPA by the party seeking the consent. However, article 32 requires a fresh notification where the original proposal is modified in such a way as to have consequences for the risks to human health or the environment. While this was the correct interpretation of the regulations, if the position was that the applicant should have been given the opportunity of responding to the additional material provided by the second respondent as a matter of constitutional justice then this should have been done if possible or practicable. However, constitutional justice did not require such a procedure in the present case because the applicant's objections were of a general and principled nature rather than of a specific technical nature and it could not be said that the EPA were on notice, from the applicant's two page letter to the EPA, of the applicant's desire to comment on any further material submitted. Further, it had not been established that the additional material radically changed the nature of the proposal or that there was a modification of the proposed release which would have consequences for risks to human health or the environment.
Mr Justice O'Sullivan dealt with a number of subsidiary issues at the end of his judgment. He said that article 31(1) of the regulations states that a newspaper notice must be published within 14 days of the date of receipt of a notification. The second and correct notice here was published outside this time on 17 January but the applicant could not be heard to say that this notice was invalid as her own representations, made on 4 February, would have been out of time if the only notice published was the original one on 10 January. Similarly, the applicant could not be allowed to succeed in her argument that the EPA had no power to require the re-publication of the incorrect first notice as she actually gained an advantage by relying on it to make her representations. Further, the regulations only require publication in a local newspaper as was the case here. Mr Justice O'Sullivan said that while the notification was not accompanied by a map giving the precise location of the trials he was satisfied that the regulations only required a general indication of the site of the release and that the notification in this case complied with that requirement. He also said that the applicant had been given adequate notice that the trial of the GMOs was to take place and that in any event an interim injunction prohibiting the commencement of the trial was granted and has remained effective ever since.
Mr Justice O'Sullivan said that the original notification was for a programme of work to be carried out over a period of three years whereas the EPA varied this to four years to include a one-year monitoring period at the end of the trial. He accepted that the fourth year was, however, not to be a planting year but was, rather, to be a reporting year and it was clearly within the power of the EPA to impose a condition requiring monitoring and reporting after trials have ceased and therefore it was not necessary to decide whether the EPA does in fact have power to grant a consent for a trial for a period longer than that requested in the notification. He was also of the view that he could not accept the argument of the applicant that the use of the word "Spring", which was the planting season in the notification, excluded planting in May.
Finally, Mr Justice O'Sullivan said that he was satisfied that the notifications themselves complied with the regulations and he accordingly refused to grant any of the reliefs sought.
Solicitors: Cawkhill and Associates (Dublin) for the appellants; T.T.L. Overend, McCarron & Gibbons (Dublin) for the first respondent; Eugene F. Collins (Dublin) for the second respondent.
