High Court of Ireland Decisions

1. If the intricate balance of nature is capable of instilling respect not to say awe in a relatively untutored mind such as my own, it is small wonder that persons of elevated sensibility such as the Applicant express deep misgivings at what they perceive as experimental tampering at the heart of this delicate balance.

2. When the Applicant comes to Court seeking a judicial review of the trial consent granted by the first Respondent to the second, she knows that not only is she taking on a heavy onus of proof but that the battle ground has moved from the merits and weight of the strongly held opposing opinions in relation to genetic engineering to the legal technicalities governing the processing of the second Respondent's application for such consent and the Applicant's right to object, together with the interpretation of the legal provisions relating to them. Such a challenge is emphatically not a re-opening of the merits of the application itself which is rightly required by our law to be adjudicated upon by an expert tribunal having available to it appropriate scientific and engineering expertise and not by a High Court Judge whose expertise is in the field of law.

3. The Applicant ("Ms Watson") is 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. Ms Watson has herself become increasingly concerned about the development of genetically engineered plants and animals and in particular the deliberate release of GMOs into the environment. She brings these proceedings on her own behalf.

4. The first Respondent ("the EPA") was established by the Environmental Protection Agency Act, 1992 ("the Act") and is charged with general powers and duties for the protection of the environment which include a licensing function in relation to the deliberate release of GMOs into the environment conferred upon it by Regulations made by the Minister for the Environment under the Act.

5. The second Respondent ("Monsanto") has been engaged for many years in researching, developing, manufacturing and selling, inter alia, herbicides in this country and many other countries. The well-known product "Roundup" has been developed and manufactured by Monsanto. It is a non-selective herbicide which means it kills not only weeds but also the crop.

6. Monsanto, together with another company Novartis, has concerned itself with the development of a sugar beet plant which is tolerant of the main ingredient in Roundup, namely, glyphosate with the objective of producing a product which would permit farmers to apply a glyphosate-based product while the beet is actually growing thereby killing the weeds but not the crop.

7. In the context of developing such a product, Monsanto applied to the EPA for two licences to carry out limited field trials of the new product at the Oak Park Research Centre, Carlow owned and operated by Teagasc, the national Government organisation with responsibility for agricultural research, advice and education in Ireland.

8. The EPA issued consents for such field trials on the 1st May, 1997 and Ms Watson challenges those consents on a number of grounds which I will set out in a moment.

9. By Order of the 13th May, 1997 Moriarty J., granted Ms Watson leave to challenge the consents and to seek the several reliefs on the many separate grounds referred to in that Order. The legal issues are identical in relation to both consents and the trial proceeded on the basis that only one consent was being referred to. I will adopt the same regime from this point onwards.

10. Ms Watson requires the Court to quash the consent of the EPA, to declare that it failed to comply with the requirements of natural and/or constitutional justice in relation to her right to object and to send the matter back to the EPA to be determined in accordance with law. In addition she seeks a number of declarations to the effect that the EPA failed to apply the "effectively zero" test which she says is established in the Regulations, failed generally to abide by those Regulations and in her initial application sought, in addition, a declaration that the Regulations themselves offend against the principles of natural and constitutional justice. This particular relief was abandoned during the course of the proceedings before me upon the basis that the Minister was not a respondent in these proceedings. In its place a further ground was added by my direction after objection and argument by both Respondents, seeking a declaration that the EPA erred in law and acted ultra vires in imposing a condition attaching to the consent allowing a person other than the EPA to agree the matters referred to in that condition.

11. The issues which have to be determined on this application may be set out as follows:-

12. Monsanto challenges the locus standi of Ms Watson to bring these proceedings at all and secondly and on a slightly different basis her locus standi to seek an injunction against Monsanto. The issues in relation to the injunction and the injunction related locus standi argument were by agreement postponed until after the main judgment has been delivered.

13. Allied to this argument Ms Watson says that if she is correct that the standard is "effectively zero risk" , then the decision of the EPA was irrational in the legal sense because they accepted as their own conclusion that the risk was "extremely low" ; that is to say that the EPA granted consent notwithstanding that in their view the notification, as it is called, failed to meet the test.

14. A sub-issue in this context is whether the standard set by the relevant Regulations, the Act and the governing European Directive ("Council Directive of the 23rd April, 1990 on the Deliberate Release into the Environment of Genetically Modified Organisms") (90/220/EEC)) ("the Directive") is the same throughout, and if the Regulations or the Regulations and the Act set a higher standard than that set in the Directive, whether it is within the competence of the Irish legislative authorities so to do. Ms Watson claims that the Irish standard is higher and permissibly so; both the EPA and Monsanto claim that the standard is the same throughout and that it would be impermissible for the Irish authorities to set a higher standard.

15. Ms Watson contends that the Regulations should be construed so as to permit third party objectors such as herself to make further comment after the twenty-one days stipulated by the Regulations in relation to supplemental material furnished by Monsanto in response to a Notice requesting further information issued by the EPA. Both the EPA and Monsanto submit that the Regulations do not permit this. An allied issue is if the Regulations do not permit such further submissions, whether this lacuna as alleged by Ms Watson should be made good in practice by the EPA notwithstanding.

16. Linked, but not directly, to the above submission is the further submission by Ms Watson that the EPA should have referred the supplemental material furnished by Monsanto to its third party consultants in the circumstance that this supplemental material radically altered the notification itself. Furthermore, Ms Watson submits that the EPA failed to consider the issue relating to what is called "horizontal gene transfer" and these failures render their consent invalid. These arguments are contested by the Respondents.

17. By Condition 5(1) attaching to its consent, the EPA required Monsanto to submit a management protocol "in advance for agreement". Ms Watson says that the EPA had no power to postpone any part of the overall consent and, secondly, that it had no power to delegate this part of the decision to the Scientific Officer of the Environmental Management and Planning Division of the EPA (Dr. McLoughlin) who is the person who actually agreed the protocol and gave Monsanto the final go-ahead for the trial. A further subsidiary point made is that the EPA itself did not in fact delegate this agreement power to Dr. McLoughlin. In all the circumstances this failure of the EPA itself to determine this matter invalidated the consent.

18. Apart from the foregoing main issues, there were a number of subsidiary issues which can be shortly summarised as follows:-

19. It is necessary to set out in considerable detail portions of the Directive, the Act, and the Regulations (that is the Genetically Modified Organisms Regulations, 1994 (S.I. No. 345 of 1994)) ("the Regulations") made by the Minister for the Environment pursuant to powers contained in Sections 6 and 111 of the Act.

20. From the recitals the following should be noted in particular:

21. The following provisions should be noted in particular:-

22. The evidence has been set out in a number of Affidavits. There was no oral evidence and there was no cross-examination. I propose to set out the essential facts in two ways, firstly, by setting out in date order a series of key events and secondly, by elaborating on essential material extracted from the several Affidavits. Before I do this, however, I would like to make three general comments as follows:-

23. Catherine Webb and Sydney Reid of Monsanto.

24. Apart from legal submissions which I leave to her Counsel, Ms Watson makes the point that the notification by Monsanto was radically changed by the submission of further information and that accordingly her submissions were incomplete and inadequate. She says the EPA prohibited further submissions after the expiration of the twenty-one day period referred to in the corrected advertisement. She complains that the identity of the individuals responsible for carrying out and supervising the planting had not been disclosed and that the calibre, experience and type of person overseeing the trial were material considerations which third parties had a right to comment on. She says that there is a risk that pollen could escape from the trial site and complains that there is no fall back in the event of human error about the removal of flowering plants. She says that the trial plants will be too close to similar plants with which they could inter-breed in breach of minimum separation distances. She relies on a report from Dr. Steinbrecher. She says she received notification in relation to only one consent whereas in fact there had been two and she had objected to both: she asserts that the EPA did not address their minds separately and independently to each of the notifications.

25. She received notification of the consent about six days after the 1st May which she says was unfair given that Monsanto could commence planting within seven days of the giving of the notification. She says that the agreement required in relation to the trial protocol by Condition 5(1) was inherently unfair because it excluded her right to comment on this aspect which was fundamental to the assessment of the application. She says that on the 6th May she contacted the EPA in relation to the second notification and also to ask whether it would be possible for her to make submissions in relation to the trial protocol to be agreed under Condition 5(1). She was told that this information would be on the public file but it was not indicated whether she would be entitled to make submissions or representations relating thereto.

26. In accordance with my earlier comments, I will not have regard to opinion evidence or material advanced on an incorrect legal basis. An example of the latter is this witness's comment that the risk of dissemination of the plant had not been reduced to zero. An example of the former is a general complaint that the notification contained inadequate information to enable the EPA to reach a decision or Dr. Steinbrecher's critique of that decision including the criticism that it should have insisted on further information.

27. I adopt the same approach to the Affidavit of Dr. Webb filed on behalf of Monsanto and to all subsequent Affidavits. Dr. Webb refers to the two notifications and states that the sole difference between them lies in the genetic make up of the two types of line. She gives the dates of the submission of notification and receipt and so on which have been summarised at an earlier point in this judgment. She states, in addition, that on the 14th March, 1997 Mr. Sydney Reid and herself, on behalf of Monsanto, met Dr. Thomas McLoughlin and Ms Anne Butler from the EPA. She required to fully understand the EPA's questionnaire. On that occasion she was told that the EPA had considered more than 400 representations contained in 189 letters. The Monsanto representatives handed a copy of Monsanto's trial operations and maintenance guidelines to Dr. McLoughlin. Following receipt of the consent in accordance with the conditions, she sent copies of the trial operations and maintenance guidelines to the EPA on the 7th May, 1997 and further amended guidelines on the 9th May in response to a fax from the EPA on the 8th. By fax on the 13th May, 1997 the EPA indicated that Monsanto could proceed with the trials. In relation to the location of the tests, she said that it would not be possible for a farmer to identify the precise site for the tests at the time when the application is submitted and also it would be unwise to identify a precise location as this information might be used by activists to prevent or disrupt the tests. In relation to the duration of the tests she says that the EPA specifically requested Monsanto to amend the applications to indicate formally that the tests would take place over four years to allow for the fact that the test site must be monitored in the year following the three years planting. Planting would still only take place over three years, namely, 1997, 1998 and 1999. In the context of confidentiality, she says Monsanto abandoned its original plan to conduct tests in two other locations apart from the Teagasc facility in Carlow when the EPA insisted that the identity of the land owners involved would be made public.

28. In relation to the claim that there was a risk that pollen might "escape" from the test site, she stresses that sugar beet is a biennial plant meaning that in the first year of planting there is leaf growth only, that the plant has to experience a period of cold in order for it to flower and produce seed which therefore can only happen in the second year. Given that the test crop will be sown in Spring of one year and harvested before the end of the same year, there would simply be no possibility of the beet being allowed to flower in accordance with its natural growth with the only exception being the possibility of "bolting". The two week monitoring programme during the growing season was more than sufficient to ensure the removal of any "bolters" which were in any event extremely unlikely. This deponent dealt with the arguments and opinions of Dr. Steinbrecher but these responses are just as irrelevant to the subject matter of this judgment as were the original comments and I therefore equally ignore them.

29. His Affidavit deals with the number of consents and authorisations required before Monsanto could sell the genetically modified sugar beet in Ireland. In particular he emphasised that a marketing consent under Part C of the Directive would be required. In addition a plant variety approval is required for inclusion of the beet in a national catalogue. Furthermore, a plant protection product approval for the use of a glyphosate-based herbicide on the genetically modified beet would be required from the Department of Agriculture, Food and Forestry. The trial authorised by the present consent is for the purpose of generating information necessary for obtaining these several later approvals. This deponent refers to consents in other countries and also makes claims as to the environmental benefits of the eventual new product. On the same basis as before, I decline to have regard to this material filed on behalf of Monsanto.

30. James Burke swore an Affidavit on behalf of Monsanto. He is head of the Crop Science Department of Teagasc. The Oak Park Research Centre is a constituent research centre of Teagasc with over 300 hectares of land and a modern range of equipment and over 90 staff. He has received Monsanto's trial protocol and confirms that all conditions, including the conditions attaching to the EPA consent, will be fully complied with. He explains how this can be done using a special six row seeder. He says there are no cattle grazing in the area of the trial nor is there any rabbit infestation. If necessary a fence could be erected.

31. An Affidavit was filed on behalf of Ms Watson by Dr. Detlef Bartsch who works in the field of bio-safety research of genetically modified plants. He says that his experience with border control in field trials has led to the conclusion that a weekly control is absolutely necessary between June and August (as distinct from the two weekly control proposed by Monsanto). He adverts to the unwanted dispersal of beet seed through bird activity or of pollen through insect activity. A further affidavit was filed on behalf of Ms Watson by Dr. Paul Dowding of the Botany Department, Trinity College, Dublin. He again expresses concern that pollen could escape from the genetically modified plants which "bolt" in their first season. He also believes that the two week period for checking for bolting during the growing season is inadequate. Furthermore, it is not adequate as proposed by Monsanto simply to pull any bolting plants, break them in two and bury them under the soil at the test site as now suggested by Monsanto in contrast to their original submission which merely suggested pulling them and leaving them in the plots for material desiccation (wilting) and mechanical desiccation.

32. An Affidavit from Dr. Steinbrecher repeats much of the material in her report. She refers, in addition, to the response of Monsanto in relation to the NPT II GENE asserting that it is not present in the engineered plant. She questions the adequacy of this response and the lack of an experiment to demonstrate this conclusion. Again she is critical of the Environmental Protection Agency in failing to require further information and offers a general adverse critique of the submission of Monsanto and the response to it of the Environmental Protection Agency.

33. There is a further Affidavit from Dr. Webb replying to these affidavits filed on behalf of Monsanto but again it is not necessary to summarise its contents in this judgment. An Affidavit sworn by Dr. John McConnell who is Professor of Genetics and Head of the Department of Genetics at Trinity College, Dublin contains a stringent critique of the views and assertions of Dr. Steinbrecher and asserts his own conclusion that there is no risk to human health or the environment posed by these trials. Once again these are matters of opinion and debate between experts which may be appropriate for consideration by the Environmental Protection Agency in an application for a Consent but are not matters to which I am entitled to have regard on this application. The same has to be said generally of an Affidavit sworn by Michael J. Foxe on behalf of Monsanto and who is a bio-technologist and who engages in a detailed critique of Dr. Steinbrecher's report. He asserts, in addition, that the supplemental information provided by Monsanto in response to the Environmental Protection Agency's questionnaire did not in any way fundamentally or materially change the content of the original application.

34. Further affidavits were filed on behalf of Monsanto by Sydney Reid, their business manager, who gave details of notices published and the contents of the original notification by Monsanto. Dr. Steinbrecher in a supplemental Affidavit makes the point that the Environmental Protection Agency could not have been satisfied that an antibiotic resistant gene was not present in the genetically modified plants, that a trial crop in Holland got mixed up with an adjoining crop because it was not properly fenced off and that proper consideration was not given to the issue of horizontal gene flow. Dr. Mae-Wan Ho deals in particular with this latter topic of horizontal transfer of genes. She complains that the issue although raised in objections was not assessed in the final report to the Environmental Protection Agency and she exhibits abundant references to literature on this topic. This evidence is in turn countered by a supplemental Affidavit from Dr. John McConnell on behalf of Monsanto which deals with what he says are certain inaccuracies in the affidavits of both Dr. Steinbrecher and Dr. Mae-Wan Ho. He reasserts, forcibly, his view that the trial poses no conceivable dangers to man, plants, animals or the environment.

35. During the course of the trial I made the point that the merits of the debate were irrelevant to the determination of the legal issues before the Court and that I was prepared to consider the engineering and scientific evidence only in the context of assessing whether or not the supplemental material submitted by Monsanto in response to the Environmental Protection Agency's questionnaire (in respect of which third parties had not submitted observations) did or did not amount to a fundamental alteration of the original notification because this question was at issue between the parties. Counsel for Ms Watson in response to a direct question from me as to what was the relevance of the conflicting opinions accepted that they served only to demonstrate that there was controversy in relation to the subject of GMOs.

36. He is the programme manager of the Environmental Management and Planning Division of the Environmental Protection Agency and gives a detailed account of the receipt by the Environmental Protection Agency of the two notifications from Monsanto. He says that the Environmental Protection Agency was satisfied that both met all of the requirements under the Regulations save that further information was required before a decision was made. He then goes through the various Regulations one by one and specifies how they were complied with. He also refers to the confidentiality request by Monsanto and the refusal of the Environmental Protection Agency to allow the names of the landowners for the two trials which were subsequently abandoned to be kept confidential. He refers to the publication and republication of the advertisement (which I have already noted) and the request by the Environmental Protection Agency that it be published in a national newspaper. The Environmental Protection Agency was advised, notwithstanding, that an advertisement in a newspaper circulating in the area satisfied the Regulations and, therefore, went on to consider the notification. There were four hundred and twelve objections received in one hundred and eighty nine representations all of which were considered. There is no express provision for further representations to be made by the public outside the twenty-one day time limit in the event that the Environmental Protection Agency requests and receives further information. He says that Ms Watson did not seek to make further representations or submissions nor did she approach the Environmental Protection Agency at any stage in this regard.

37. The Environmental Protection Agency consulted the competent authorities in three other EU Member States, namely, France, Belgium and the United Kingdom but no written replies were received. A report was prepared by Dr. Tom McLoughlin which was before the Environmental Protection Agency Board at its meeting on the 22nd April, 1997 at which the notifications were considered and also a further meeting on the 29th April, 1997 when the decision to grant consents subject to conditions was reached. He says that Anne Butler of the Board of the Environmental Protection Agency dealt primarily with this matter and that she attended both meetings and presented reports on the notifications. He says that the Environmental Protection Agency was fully informed on all issues raised by the notifications. It received and considered representations by members of the public, it took great care in evaluating the potential risks posed to human health and to the environment and the agency was capable of being fully satisfied that the proposed releases, subject to the conditions imposed on the said consents, would not result in adverse effects to human health or the environment. He refers to a letter notifying the Applicant of the consent posted on the 2nd May and to the fact that the 4th May was a Bank Holiday and to the fact that the 1st May, the day of the making of the Consent, was a Thursday. He said that Ms Watson's Solicitor was notified of the decision by Fax dated 1st May and sent on the 2nd which she acknowledged by Fax on 6th May. There was also a press release on the 1st May and the news of the decision was carried in various national newspapers on the 2nd May. He says that the Environmental Protection Agency had access to the proposed trial operations and maintenance instructions which had been furnished to it by Monsanto and also to the fact that it was a fairly standard practice in granting a consent to require the recipient to furnish detailed information in relation to the management of the activity to allow for ongoing monitoring and assessment.

38. Ms Butler is a director of the Environmental Protection Agency and of the Environmental Management and Planning Division thereof which has responsibility for a range of issues including GMOs. She took overall responsibility for the notifications in this case. An advisory committee on GMOs had been established by the Environmental Protection Agency and she is a member of that committee. The committee was circulated with summaries of the notifications and after a discussion of approximately one and a half hours suggested that the Environmental Protection Agency consult with and seek the views of a plant molecular biologist on the potential environmental risks posed. Accordingly, summaries of the notifications were sent to Dr. Tony Kavanagh of the Genetics Department of Trinity College, Dublin on the 19th March, 1997 and he furnished a report on the 3rd April. She asked Dr. Tom McLoughlin who was employed by the Environmental Protection Agency as an expert on GMOs to prepare a report on the notifications based on all the information received by the Environmental Protection Agency and assess the potential risks to human health and the environment. This report was circulated to all the directors of the Environmental Protection Agency which met on the 22nd April, 1997 to consider the notifications, evaluate the risks and reach a decision. On that occasion the Environmental Protection Agency had before it the notifications of Monsanto together with all additional information supplied by Monsanto, all representations made by members of the public and other interested bodies and the reports of Drs. Kavanagh and McLoughlin. As director of the division of the agency dealing with notifications she presented the said reports to the meeting. After a lengthy discussion during which the potential risks were evaluated by the Environmental Protection Agency, the Agency reached a decision to grant consent for the trials subject to conditions which were then in draft form and which would be dealt with at a further meeting. At the further meeting on 29th April each condition was considered by the Environmental Protection Agency in the light of its statutory duty to ensure that the proposed releases would not result in adverse effects on human health or on the environment. The conditions were attached to the Environmental Protection Agency's decision and the Consents were issued on the 1st May.

39. In a second supplemental Affidavit in response to the Affidavit of

40. Dr. Mae-Wan Ho, Dr. McLoughlin asserts that Dr. Mae-Wan Ho has not put forward any basis or evidence for her contention that horizontal gene transfer can create new pathogens or plant viruses which could have adverse effects on human health or the environment and in a supplemental Affidavit Mr. Gerry Carty says that Dr. Mae-Wan Ho did not make any representation to the Environmental Protection Agency, but that an article written by her was submitted with the representation from another party and was duly considered by the Environmental Protection Agency. He says specifically that the Environmental Protection Agency evaluated all risks including those of horizontal gene transfer and in particular the transfer of genetic material from the genetically modified sugar beet plants to micro organisms. He says that the members of the Environmental Protection Agency are familiar with the published scientific literature on this topic including the literature referred to in

41. Dr. Mae-Wan Ho's Affidavit. He said that the experts consulted by the Environmental Protection Agency considered the risk of possible horizontal gene flow from genetically modified sugar beet to micro organisms to be so low as to be negligible and that this view is supported by the greater part of the available scientific literature and that the Environmental Protection Agency considered that any such risk was not such as to pose a real risk to the environment or to human health. He says that the Environmental Protection Agency strongly denies that it did not consider the issue of horizontal gene transfer in its determination of the notifications in this case.

42. Monsanto says that Ms Watson has no locus standi to challenge the EPA's consent. Ms Macken argues on their behalf that once Ms Watson's representations have been heard under the statutory scheme that is the end of her entitlement to be heard and thereafter the obligation to protect the common good is vested in the Environmental Protection Agency itself. This is not a case where her representation had been ignored: in such a case she would have had locus standi .

43. Mr. Clarke replied that once there is a scheme which involves Ms Watson she then has a right to challenge the process (which includes her representation) which leads to the consent.

44. Part of Ms Watson's case is that her entitlement to make representations should have included a right to respond to the further information supplied by Monsanto in response to the Environmental Protection Agency's questionnaire. These proceedings are brought by her on her own behalf and not on behalf of the public at large or of any particular group. I hold that she does have locus standi , in particular to make the argument on her own behalf to which I have just alluded.

45. As already noted Article 33(4) of the Regulations provides that:-

46. Both Mr. Gordon S.C. and Mr. Clarke S.C. for Ms Watson submit that this means that before a consent can be given by the Environmental Protection Agency the risk of adverse effects must be reduced to "effectively zero" . This in turn means that any identified risk must be effectively eliminated but it is accepted that there is no obligation on the Environmental Protection Agency to assess unforeseen risks.

47. They further submit that it can be demonstrated that the Environmental Protection Agency failed to eliminate all known risks. The documentation shows that the report prepared by Dr. McLoughlin and available to the Environmental Protection Agency when making its decision indicated that Dr. McLoughlin and Ms Butler agreed with the assessment of the reviewers of the notification to the effect that the risks posed to the environment and human health were very low. An issue arose between Mr. Clarke and

48. Ms Macken as to whether that risk (which was very low) was the risk of occurrence of the several items contained in the "risk assessment" portion of the submission by Monsanto (with which the reviewers agreed) or the risk of damage (to human health and the environment). I am satisfied after careful examination of the report that what is being referred to was risk of damage to the environment and human health.

49. Ms Watson's Counsel further submits that it is clear that the Board of the Environmental Protection Agency accepted this assessment. This follows as an inference to be reasonably drawn from the minutes of the Board's meeting held on the 15th April, 1997 which rejected the conclusion immediately following the conclusion on risk. Counsel submits, accordingly, that by inference the non-rejected conclusion was accepted. I think this is a fair reading of the minute and Mr. Macken S.C. for the Environmental Protection Agency did not quarrel with it.

50. That being the case Counsel for Ms Watson submits that it is demonstrable that the Environmental Protection Agency applied the wrong standard because in accepting the risks involved as "very low" they failed to eliminate them as required to do under the relevant Regulation.

51. This submission turns, therefore, on the true meaning of Article 33(4) of the Regulations to which I will turn in a moment.

52. In a supplemental submission Mr. Clarke S.C. for Ms Watson says that this paragraph does indeed establish a higher standard of environmental protection than is set by the directive, but he says that providing such a higher standard is not inconsistent with the objectives of the directive and that this is permissible. Mr. Macken for the Environmental Protection Agency and Ms Macken for Monsanto argued to the contrary: they say that the standard in the Directive is the same as the standard in the Act and in the Regulations and they further both submit that it is not within the competence of the Irish legislature to set a standard which is different to that set in the Directive.

53. Accordingly, it is necessary that I first determine what is the standard in the relevant instruments and whether they are the same, and if the Irish standard is higher whether it is or is not within the competence of the Irish legislature.

54. The main recital bearing on the point appears to me to be the following:-

55. Under Part A ("General Provisions") Article 4(1) provides:-

56. I would pause at this point simply to note that on a purely textual basis (as distinct from considering the purposes of the Directive) the foregoing recitals would not appear to be definitive as between the two interpretations.

57. I would comment that the words of Article 4(1) are strongly reminiscent of the phraseology of Article 33(4) of the Regulations. But what do they mean?

58. In Article 5(2) which is dealing specifically with notifications to the competent authority of Member States where field trial releases are concerned it is provided that the notification shall include:-

59. The latter appears to contemplate the possibility that risks would be posed to human health or the environment by GMO(s) in the specific context of notifications (that is applications for licences for a deliberate release). If this is so it must mean, in my view, that the reference in Article 4(1) to "Avoid adverse effects on human health and the environment" contemplates not an absolute elimination of all known risks but some less absolute form of control (to use the word in the recital) which would contemplate the possibility of risks posed by the deliberate release because, if this is not the true interpretation of the standard set in Article 4(1) then I cannot understand the reason for including Article 5(2)(b). The purpose of the Directive is to control risks, to establish a high level of protection throughout the community and to ensure that consent is given only for releases that are "safe" for human health and the environment.

60. This interpretation of the standard in the Directive is consistent with the "step by step" principle which governs applications for field trials. This ensures that a wider release which follows a prior narrower one is only permitted if evaluation of the earlier step (in terms of protection of human health and the environment) indicates that the next step can be taken. Clearly this phraseology (to be found in the recitals) contemplates the possibility that an earlier step could indicate that the later one should not be taken because the deliberate release involved has not proved "safe" within the meaning of yet a further recital.

61. Article 4(1), therefore, uses language which, when taken out of the overall context and interpreted by reference only to common law rules of interpretation, might well suggest a test of effectively reducing known risks to zero; however, such an interpretation appears to me to be contrary to the purpose of the Directive. Accordingly, when Article 4(1) refers to "... all appropriate measures (are) taken to avoid adverse effects ..." , the word "avoid" has to be read in the context to which I have referred and as requiring a high level of protection throughout the Community, as distinct from requiring such a level of risk elimination as would render pointless the step by step principle or the submission of risk evaluation in notifications for Part B Consents.

62. A difference arises between Ms Watson on the one hand and on the other, the two Respondents in what they say is the true meaning of the Irish legislation implementing this Directive. Mr. Clarke for Ms Watson says that Irish law establishes a higher standard than the Directive and that this is permissible: Counsel for the Respondents submit that Irish law establishes the same standard and that this is the only standard which is permissible.

63. I note in addition that Section 111(4) provides merely that a person in charge of any process or action involving a genetically modified organism shall use the best available technology not entailing excessive costs for the purposes of environmental protection, and so on, rather than a higher (and quite possibly excessively costly) degree of technology which one would have thought necessary if the standard contemplated by the Act is that all risks to health and the environment should be reduced to "effectively zero" as contended for by Counsel for Ms Watson.

64. I would conclude, therefore, that the standard indicated or contemplated by the Act is the same standard as that established by the Directive, and is not the "effectively zero" risk standard contended for by Ms Watson.

65. These are made by the Minister specifically pursuant to the power conferred on him by Sections 6 and 111 of the Act. I take it, therefore, that the purpose of these Regulations is to give full effect to the Directive.

66. It is clear that the Irish Courts when applying national law must interpret it as far as possible in light of the wording and purpose of the Directive where that law has been introduced in order to implement the Directive. As was stated by the Chief Justice in

67. Once again one finds in the Regulations references to risks that may be posed to human health or the environment in the context of consent applications relating to genetically modified organisms for example, Article 30(2)(a) requires a notification to include sufficient information to enable the EPA to .. ."evaluate the foreseeable risks ... which the deliberate release ... may pose to human health or the environment" ... and further to include a statement evaluating the impacts and risks posed. Equally, the agency itself is required to evaluate the risks posed by the deliberate release which would appear to be a pointless exercise if those risks were to be reduced to "effectively zero" . Instead of an evaluation of the risks posed one would have expected the Regulations to require the EPA to ascertain that any potential risks had been (effectively) eliminated.

68. Counsel for Ms Watson submit, however, that the evaluation of the risks posed is something which should be done and is necessary so that the EPA can satisfy itself that the risk of adverse effects is "effectively zero" . The EPA cannot be so satisfied unless it has first evaluated the risks, according to Ms Watson's Counsel.

69. Counsel for the Environmental Protection Agency submits that the test set out in Article 33(4) requires only that the agency be "reasonably" satisfied that there will be no adverse effects. The Environmental Protection Agency must be permitted to exercise a degree of discretion and Counsel points to the fact that even where a Court must be satisfied beyond a reasonable doubt this does not mean that there must be proof beyond a shadow of a doubt. Fanciful possibilities or even chances which can be dismissed with the sentence "Of course it is possible but not in the least probable" do not mean that the case has not been proved beyond a reasonable doubt. (see Miller -v- Minister of Pensions [1947]

70. Counsel for the Environmental Protection Agency submits that the test set out in Article 33(4) does not require the notifier to prove or the Environmental Protection Agency to be satisfied as a matter of absolute certainty. This would counter the very notion of "risk" which is inherent not only in the wording of the Regulations, Act and Directive but also in the very enterprise of a step by step licensing scheme in the case of GMOs, the knowledge of which is itself a young and developing science. Both Counsel for the Environmental Protection Agency and for Monsanto point to the several specific provisions requiring updating of information in the context of notifications, Consents and implementation thereof.

71. Having carefully considered the comprehensive submissions made I am satisfied that the standard set out in Article 33(4) of the Regulations does not require the Environmental Protection Agency to be satisfied that all risks have been reduced to an "effectively zero" level. Nor does it require the Environmental Protection Agency to be satisfied as a matter of certainty or even beyond all reasonable doubt. I think the Applicant's interpretation is based on a literal construction of Article 33(4) which places an exclusive and out of context burden of interpretation on this sub-article, which assigns minimalist or nugatory significance to other portions of the Regulations (for example those that refer to risk evaluation) and perhaps most importantly conflicts with the objective of the Directive to set up a scheme of Consents based on the step by step principle where field trial operations are concerned.

72. In my view the standard set out in the Regulations at Article 33(4) is the same as that contemplated (although not explicitly set out) in Section 111(1) of the Act and as established by the Directive.

73. That being the case it is unnecessary for me to deal with the various submissions made in the context of the national law establishing a standard which was different to that set in the Directive.

74. In light of this finding it is clear that Ms Watson cannot establish that the Environmental Protection Agency failed to implement the appropriate standard: I have held it to be a fair inference that the Environmental Protection Agency accepted the risks to the environment as very low and no question therefore arises of the Environmental Protection Agency applying the incorrect standard.

75. Closely allied to Ms Watson's submission in relation to the question of the standard, was her submission that the Environmental Protection Agency acted irrationally. This submission was clearly based upon the supposition that the standard was that all risks had to be effectively eliminated. Once this primary proposition is incorrect then the argument based on irrationality must fail because it is clear and I think accepted that there was material before the Environmental Protection Agency justifying their assessment that the risks were very low.

76. This arises because of the attachment of Condition 5(1) to the Consent. This sub-condition reads as follows:-

77. Counsel for Ms Watson submits that the management of the trial was central to the exercise of the Environmental Protection Agency's discretion. The qualification of the operatives, the exact protocol for dealing with the planting, monitoring, uprooting and protection of the beet crop and in particular the handling of "bolters" with their alleged potential for permitting the escape of pollen from the site of the trial was so central to the issue as to whether consent should be granted or not, that the subject matter of this sub-condition should not have been postponed until after the primary decision had been made, nor should it have been delegated, as it was in fact, to be the subject of agreement on behalf of the Environmental Protection Agency by Dr. McLouglin.

78. Counsel for the Environmental Protection Agency submits, on the contrary, that the subject matter to be agreed was no more than executive business and in particular when one looks at Conditions 5(2)-(8) it is clear that the matters for agreement and the only matters for agreement are those specifically identified in the remaining sub-conditions.

79. Ms Macken for Monsanto suggests that the true meaning of Condition 5(1) can more readily be apparent if it were regarded as the last sub-condition in Condition 5.

80. It is interesting to note that in the correspondence after the Consent was issued the Environmental Protection Agency sought to require Monsanto to erect a fence around the trial site. Monsanto insisted that this was not obligatory upon them because it was not referred to in Condition 5. The Environmental Protection Agency did not press the point.

81. In my view they were right not to press the point. I consider that Condition 5 is concerned with and only with the detailed specifics set out in the various sub-conditions. I think the condition should be construed in the light of the reason for the condition which specifies that it is imposed to make provision for the management of the trial on a planned basis having regard to the desirability of ongoing assessment, recording or reporting of matters affecting the environment or human health.

82. I consider that the condition would not be materially different if the last sentence of Condition 5(1) had read "A copy must be forwarded to the Environmental Protection Agency in advance to be checked". I think this wording is closer to the intention of the condition which is not the intention as contended for by Ms Watson which would assign to the sub-condition the possibility of reviewing a range of matters not set out in the Condition itself.

83. Given the precise limitations as I construe them to the ambit of the matters "for agreement" under Condition 5(1) I consider that the criterion established by Blayney J. in Raymond Boland -v- An Bord Pleanala (unreported Supreme Court: 21st March, 1996) would apply mutatis mutandis . I consider that having regard to the precise nature of the instructions on trial operations and maintenance requirements to be agreed in the staff manual under Condition 5(1) no member of the public could have reasonable grounds for objecting to the scope of this "agreement". This arises because the scope is already established in Conditions 5(2)-(8). No member of the public would have even the beginnings of a case for judicial review if the last sentence of Condition 5(1) had been omitted. I agree with Counsel for the Environmental Protection Agency that this is an executive matter in the nature of good housekeeping as it is clearly proper that the specific instructions which are detailed in the other sub-conditions should be committed to writing and agreed by the Environmental Protection Agency prior to the trial commencing.

84. Before I leave this point I should clarify that I fully accept that members of the public may well have a lot to say about the various matters detailed in Condition 5. Their opportunity for making submissions arises under Article 31(4) of the Regulations. In rejecting Ms Watson's application under this head I am simply saying that the issue arising in this context has been determined by the Environmental Protection Agency and the use of the phrase "for agreement" in Condition 5(1) does not indicate that the matter has been left over in any way involving discretionary assessment.

85. It was also submitted that it was not within the powers of the Environmental Protection Agency to delegate any part of their decision making function in the absence of a specific statutory provision such as Section 14(4) of the Local Government (Planning and Development) Act, 1976. I am not sure that this is a sound principle in general, but specifically with regard to Section 14(4) it seems to me that that Section is enacted upon the basis that a power to delegate already exists and the subsection is merely making provisions for the replacement of the Minister as appeals authority by An Bord Pleanala. The Section does not, it seems to me, create a power of sub-delegation, but rather makes provisions in relation to such a power upon the basis that it already exists.

86. This ground of challenge arises because after the twenty-one days within which members of the public were entitled to make representations to the Environmental Protection Agency (under Article 31(4) of the Regulations), which expired on the 6th February, 1997, Monsanto submitted further information in response to the questionnaire from the Environmental Protection Agency which was not available for comment by members of the public.

87. Counsel for Ms Watson says that the further information "changes radically the nature of the application made" and clarified issues concerning the deliberate release upon which Ms Watson "would have wished to make submissions" .

88. In response, Counsel for both the EPA and Monsanto submit that the regulations make no provision for additional submissions after the expiration of the original twenty-one day period. They also submit that the new material did not significantly alter the notification and they point specifically to Article 32(1) of the Regulations, which provides as follows:-

89. In the context of that regulation it is submitted on behalf of both Respondents that if there was any significant modification of the deliberate release of the type alleged by Ms Watson then the agency were required to oblige Monsanto to submit a fresh notification. Ms Watson does not make the case that this should have been done. But she does in her Affidavit claim that she would have wished to make comments on the new material and her Counsel submit that the processing of the notification was in breach of the principles of natural and constitutional justice in denying her that opportunity.

90. Counsel for the EPA point to the fact that Ms Watson did not specifically request an opportunity to make such a submission and she in turn replies that it was obvious from letters written by the EPA to other parties (including to one party with an address shared by Ms Watson herself) that the EPA regarded themselves as precluded by the Regulations from entertaining any further submissions after the expiration of the 21 day period.

91. In addition, Counsel for Monsanto submits that the original notification complied in every respect with the requirements of the Regulations and that the further material was volunteered by Monsanto in the knowledge that this was the first GMO notification being dealt with by the EPA and they wished to comply with requests which were strictly speaking above and beyond the requirements under the Regulations. Accordingly, it is submitted that members of the public and Ms Watson would have had no rights in regard to such volunteered information.

92. In my view it is clear that the Regulations themselves do not make any provision for further submissions from members of the public. It is pointed out by Counsel for Monsanto that Article 8 which deals with the contents of the official register, merely requires that the date of request for, and receipt of, any additional information be notified in the register as distinct from the contents thereof in contrast with other matters, for example, the date and nature of any recent objection by another Member state. This implies that those members of the public who consult the register would be entitled, so far as the Regulations go, only to the information that a request had been made on such and such a date and an answer given on such another date. Furthermore, it is quite true that the only provision for public involvement is as set out in Article 31(4). When these provisions are seen in light of the provision in Article 32 requiring a fresh notification where the original proposed deliberate release is modified subsequently in such a way as would have consequences for the risks to human health or the environment, then it is submitted that the Regulations when correctly construed do not require or even permit further submissions as contended for by Ms Watson.

93. I agree with this submission. I think this is the correct interpretation of the Regulations but I do not think the point ends there. I accept the principle that if Ms Watson should have been afforded a further opportunity to respond to the additional information as a matter of natural or constitutional justice then the processing of the notification should have been operated in such a way if that were possible or practicable.

94. Counsel for the EPA submits that it was not practicable given the large number of objectors. I am not prepared to dispose of the point on this basis because if natural or constitutional justice requires it then I think it would require a very strong argument before such a requirement would be set aside on the basis of administrative inconvenience.

95. But does natural or constitutional justice require it in this case?

96. Ms Watson's letter of objection deals primarily if not exclusively with general principles rather than the specifics of the particular notification. She is concerned with what she describes as the huge ethical and moral implications, the irreversibility of released GMOs, the lack of research, the prematurity of applications before a lengthy and public debate is held (indeed she says that "I feel that any response would, at this stage, be premature"), the impact on natural diversity, the lack of labelling laws, concerns about paving the way for 'patenting' and ownership of nature by large multinational companies and the fact that we seem to be blindly stumbling 'down a route that others have already rejected' (this last being a reference to an abandonment by a Dutch seed company of attempts to sow genetically engineered maize near Freiburg in Germany).

97. Even if - and I am not holding this - the EPA were obliged as a matter of procedural justice to inform third party objectors of the new material supplied by Monsanto and afford them an opportunity to comment, is it reasonable or fair to the EPA to suggest that they were in any way on notice of a wish by Ms Watson that she would like to comment on such material given the contents of her own two page letter? Clearly the EPA had no such notice and I hold that in this case there was no breach of the principles of procedural justice. Indeed I have doubts about Ms Watson's locus standi to make this specific argument given the contents of her own objection.

98. Furthermore, I do not think that she has established that the additional material radically changed the nature of the notification or that there was a modification of the proposed deliberate release which would have had consequences for risks to human health or the environment (if such had been the case the EPA would have been required to oblige Monsanto to make a fresh notification). As was pointed out by Ms Butler on behalf of the EPA the fresh material if anything allayed potential concerns indicated in the questionnaire from the EPA, specifically for example by assuring the EPA that an antibiotic resistant gene was not present in the genetically modified plant. In this context I think the following citation from the judgment of Murphy J. in The State (Haverty) -v- An Bord Pleanala [1988] ILRM 545 at page 552 is apposite:-

99. I think the reality in the present case is that Ms Watson did object but in general terms which were not related to the specific notification at all. It is not a failure of natural justice or of anything done or omitted by the EPA that the case which she now makes through Dr Steinbrecher, Dr Mae-Wan Ho and others in this Judicial Review application was not made by her to the EPA. The Regulations do not require third party objectors to be given a further opportunity to comment on additional material submitted by a notifier in response to a request for further particulars, but they do require the EPA to oblige such a notifier to present a fresh notification in the event that such additional material modifies the proposed deliberate release in a way which could have consequences for risks to human health or the environment. Even if, notwithstanding these provisions, a situation could arise that the requirements of natural or constitutional justice required the EPA to communicate further with a third party objector, I hold that this has not arisen in the present case. I think that the scheme established by the Regulations makes the circumstances in which such a requirement of procedural law would apply to be rare. In the present case, Ms Watson confined herself in her objection to making general objections to the whole principle of consenting to GMOs at this time in this country and cannot now blame the EPA or their application of the Regulations for the fact that the arguments which she now makes were not made at the time.

100. I decline, accordingly, to hold that the consent was granted in breach of the requirements either of natural or of constitutional justice.

101. It was further submitted on behalf of Ms Watson that the consideration by the EPA of the additional material was inadequate and their consent consequently invalid because they did not revert to the independent experts consulted by them in relation to such additional material. It appears that such consultation may have occurred otherwise than in writing, but in any event I consider that it is a matter for the expert judgment of the EPA itself to determine whether or not they need to consult independent experts and if so to what extent and that it is only in a case where it could be demonstrated that it was irrational on the part of the EPA either to fail to consult or re-consult such experts that a challenge upon this basis could be mounted. So far from such irrationality being demonstrated, it appears that in the present case in fact such queries or concerns as may have been expressed by independent consultants were in fact adequately dealt with to the satisfaction of the EPA.

102. There were nine additional points made either in the statement to ground the application for Judicial Review or in the submissions in Court. I will deal with each of them in turn as follows:-

103. The Regulations make it clear that the location referred to in the published notice is to be the same as the location given in the register. Article 8(1)(c) specifies that the register should contain "the location (including, where necessary, the name of the townland or townlands) of a deliberate release," .

104. This indicates, in my view, that what is intended by "location" in the regulations is a general indication - perhaps by reference to townland or townlands - of a deliberate release, rather than the identification of a specific site with pin-point accuracy. I hold that the notification gave the location in compliance with the Regulations and that a map was not necessary.

105. The consent issued on Thursday 1st May. A press release of that date was carried in the national newspapers on the 2nd May. The following Monday, the 5th May, was a Bank Holiday. Ms Watson's Solicitor was sent a fax dated 1st May confirming the notification which she acknowledged by fax dated Tuesday 6th May. Ms Watson in her Affidavit says that the notification was issued to her on the 6th May whereupon she contacted the EPA in relation to the second notification. She complains that notification to her was six days after notification to Monsanto.

106. In my view the EPA gave adequately prompt notice of the issuing of their consent to Ms Watson. Furthermore, an interim injunction prohibiting the commencement of the trial was granted on the 13th May, 1997 and has remained effective ever since.

107. What happened was this: The original notifications specified that the application was for a programme of work to be carried out over a three year period. In consultation with the EPA this was revised to specify a four year period (from 1997 to 2000 inclusive) for the specific purpose of ensuring that the monitoring of the results of the three year trial planting could take place in the fourth year. In response to the amended notification the consent does indeed state that "the duration of the experiment is for four (4) years from 1997-2000 (inclusive), subject to the consent conditions attached hereto."

108. Ms Macken on behalf of Monsanto submits that it is reasonably clear that when condition 7 is construed against the background which I have just outlined that the intention is that the first three years (1997, 1998 and 1999) will be planting years and that the last year is merely a reporting year for the trial planted in 1999. She accepts, however, that the matter could have been expressed more clearly.

109. It is clear from condition 7 that the first three of the four years in question are indeed treated differently from the fourth year. Furthermore, the report to be furnished at the end of the fourth year (the year 2000) is "for the trial planted in 1999". Unless Ms Macken's submission is incorrect, the condition dealing with monitoring and reporting would in fact be making no provisions for a report of planting in the year 2000. That is clearly contrary to the whole intention of the consent and would be construing it in a way which does even greater violence to that intention than is done to the language used by a construction allowing for a three year trial (each subject to its own monitoring and reporting regime) followed by a fourth year, at the end of which a report must be sent to the EPA covering the planting done in the previous year of 1999.

110. It is clearly within the power of the EPA to impose a condition requiring monitoring and reporting after the trials have ceased or indeed after a licence "expires" as is apparent from Section 111(2)(g)(iv) of the Act. Construed in this way, therefore, the consent is perfectly valid and it is not necessary for me to consider whether the EPA does in fact have power to grant a consent for a trial conducted over a longer period than that requested in the notification.

111. It is clear that the regulations contemplate the submission of additional information notwithstanding that the original notification complied with the regulations because Article 8 specifies that the register must include the date of any request for additional information and receipt thereof. Mr Carty goes on in his Affidavit to specify that the necessary information was provided with each notification and he deals with each sub-category separately in his Affidavit. He gives some details in relation to the EPA's response to Monsanto's request to have the names of landowners of two additional proposed trial sites kept confidential and the withdrawal by Monsanto of those applications rather than have the names of the landowners concerned published.

112. I do not accept that it has been demonstrated that the notifications themselves failed to comply with the regulations; rather I think that it has been demonstrated that they did so comply.

113. In these circumstances I hold that Ms Watson has failed to substantiate any of the grounds supporting her application for Judicial Review of the EPA's consents in this case and accordingly, I refuse to grant any of the reliefs sought.