BIOTECHNOLOGY, PROPERTY RIGHTS ANDTHEENVIRONMENT BIOTECHNOLOG Y PROPERTY RIGHTS AND THE ENVIRONMENT TOWARDS A NEW LEGAL ORDER? Gerard M F Snijders II D Differences of opinion will be the final blow for Avebe transgenic potato, so reads the heading of a detailed background article in the Agrarisch Dagblad of Saturday 4 August 2001. This article describes the demise, after ten years, of a project by the Avebe potato group which aimed to achieve large-scale cultivation of a potato developed in 1989 as the result of genetic modification. This potato no longer conta ined amylose starch, only amy lose pectin starch. This was to simplify the processing of the potato considerably, resulting in a substantal reduction of costs Init ally cultivation was perm itted-after just a few years about 200 Dutch farmers were growing a total of some 1200 hectares a year- but, after the scientific committee of the European Union had called the safety of the potato into question in 1998, cultivation of the potato was banned in the year 2000. There was the fear that because of the genetic modification used, the potato, once released into the environment, could lead to resistance to kanamycine, an essential antibiotic in the health care industry, and the chemical amy kacie derived from it. Both these products play an important role, particularly in the treatment of serious pulmonary disorders and blood poisoning. There is considerable debate among scientists about the legitimacy of this fear. Stopping the project resulted in(direct) loss to Avebe of more than 8.000. 000 Euro. The med a often on problems to do with genetic modification. In the Agrarisch Dagblad of 26 June 2001, for instance, we can read that the Dutch action group De Razende had destroyed two experimental plots growing genetically modified sugar beet. It concerned the variety Roundup-Ready, cultivated a field trial by the multinational Monsanto. On 29 June 2001, the magazine Oogst, the mouthpiece of the Confederation of Agriculture and Horticulture LTO-Nederland, reported that the Minister of Housing, Spatial Planning and the Environment had rejected all 2 1 Dutch requests for field trials with genetically modified crops, since the plots of and on which the trials were to take plce had not been sufficiently identified. The industries concemed considered appea ling against the decision in court. They objected to giving precise details of the plots of and where the field trials were to take place, fearing that this would lead to the destruction of the cultivated Genetic modif ication arouses strong emotions, but also leads to measures in the fom of legislation. This legislation may concen food safety, the la belling of roducts produced with the aid of genetic modification, the protection of the environment in general, and private property in particular This report takes the protection of the environment as the central theme. It contains a summary of prevailing Dutch law in this area, whereby a dist inction is made between public and private law. Public law contains regulations for the University of Nijmegen, Attomey at Wijn Stael, Utrecht
BIOTECHNOLOGY, PROPERTY RIGHTS AND THE ENVIRONMENT BIOTECHNOLOGY, PROPERTY RIGHTS AND THE ENVIRONMENT: TOWARDS A NEW LEGAL ORDER? Gerard M.F. Snijders* II D 1 Introduction Differences of opinion will be the final blow for Avebe transgenic potato , so reads the heading of a detailed background article in the Agrarisch Dagblad of Saturday 4 August 2001. This article describes the demise, after ten years, of a project by the Avebe potato group which aimed to achieve large-scale cultivation of a potato developed in 1989 as the result of genetic modification. This potato no longer contained amylose starch, only amylose pectin starch. This was to simplify the processing of the potato considerably, resulting in a substantial reduction of costs. Initially cultivation was permitted - after just a few years about 200 Dutch farmers were growing a total of some 1200 hectares a year - but, after the scientific committee of the European Union had called the safety of the potato into question in 1998, cultivation of the potato was banned in the year 2000. There was the fear that because of the genetic modification used, the potato, once released into the environment, could lead to resistance to kanamycine, an essential antibiotic in the health care industry, and the chemical amykacine derived from it. Both these products play an important role, particularly in the treatment of serious pulmonary disorders and blood poisoning. There is considerable debate among scientists about the legitimacy of this fear. Stopping the project resulted in (direct) loss to Avebe of more than 8,000,000 Euro. The media often report on problems to do with genetic modification. In the Agrarisch Dagblad of 26 June 2001, for instance, we can read that the Dutch action group De Razende Hazen had destroyed two experimental plots growing genetically modified sugar beet. It concerned the variety Roundup-Ready, cultivated in a field trial by the multinational Monsanto. On 29 June 2001, the magazine Oogst, the mouthpiece of the Confederation of Agriculture and Horticulture LTO-Nederland, reported that the Minister of Housing, Spatial Planning and the Environment had rejected all 21 Dutch requests for field trials with genetically modified crops, since the plots of land on which the trials were to take place had not been sufficiently identified. The industries concerned considered appealing against the decision in court. They objected to giving precise details of the plots of land where the field trials were to take place, fearing that this would lead to the destruction of the cultivated crops. Genetic modification arouses strong emotions, but also leads to measures in the form of legislation. This legislation may concern food safety, the labelling of products produced with the aid of genetic modification, the protection of the environment in general, and private property in particular. This report takes the protection of the environment as the central theme. It contains a summary of prevailing Dutch law in this area, whereby a distinction is made between public and private law. Public law contains regulations for the * University of Nijmegen, Attorney at Wijn & Stael, Utrecht
SNIDEI protection of the general interest in a clean and liveable environment. Private law protects the property rights of individualcitizens Public la 2.1 Legislation The central legislation under public law in this context is formed by the genetically Modified Organisms Decree (Besluit genetisch gemodificeerde organismen) hereafter referred to as the bogo. which is based on section 24 of the hazardous Substances Act. The decree includes, among other things, the implementation of the Council Directive 90/219/EEC of 23 April 1990 on the conta ined use of genetically modified micro-organisms(OJ 1990, L 117, p 1) and the Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(OJ 1990, L 117, p. 15). Sections 2 to 22 inclusive concern the conta ined use, the introduction of genetically modified rganisms into the environment is provided for in Sections 23 to 35 Under the terms of Section 23 of the bOGo, in principle the production, use, ransport, possession, making available to others, or disposing of genetically modified organisms is prohibited without a permit from the Minister of Housing, Spatial Planning and the Environment. Apart from conta ined use, there is an exception to this basic rule where the minister, accord ing to an announcement in the Government Gazette, on the grounds of a risk analysis as referred to in Section 24 subsection 2 of the bogo. has esta blished that the act iv it ies concemed cannot have any undesirable effects on man and the environment. In so far as aspects concerning the potection of the env ironment are at issue, for which the Minister of Agriculture, Nature Management and Fisheries is responsible, the latter must also have agree with this assessment. Furthermore, an exception is made for activ ities with genetically modified organisms which, after a specific risk assessment has been carried out as stipulated in accordance with part C of Council Directive 90/220/EEC conceming conta ned use, ha ve been marketed within a member state of the uropean Union or another state that is party to the European Economic Area Agreement, or with products that must undergo a specif ic risk assessment under the terms of community legislation as referred to in Section 10 subsection 1 of the directive A perm it must be applied for from the minister of Housing, Spatal Planning and the environment Under the tems of section 24 subsection 2 of the bggo. a risk analysis must be submitted with the application conceming the proposed activities. This analysis must conta in the following information at any rate-as summarized in Appendix 3 A. Concerning the mechanisms involved a. A description of the organism or organisms, with information on: the harmfulness to otherorganisms the formation of toxic compounds and the formation of surviv ingstructures
SNIJDERS 2 protection of the general interest in a clean and liveable environment. Private law protects the property rights of individual citizens. 2 Public law 2.1 Legislation The central legislation under public law in this context is formed by the Genetically Modified Organisms Decree (Besluit genetisch gemodificeerde organismen), hereafter referred to as the BGGO, which is based on Section 24 of the Hazardous Substances Act. The decree includes, among other things, the implementation of the Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (OJ 1990, L 117, p. 1) and the Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (OJ 1990, L 117, p. 15). Sections 2 to 22 inclusive concern the contained use; the introduction of genetically modified organisms into the environment is provided for in Sections 23 to 35. Under the terms of Section 23 of the BGGO, in principle the production, use, transport, possession, making available to others, or disposing of genetically modified organisms is prohibited without a permit from the Minister of Housing, Spatial Planning and the Environment. Apart from contained use, there is an exception to this basic rule where the Minister, according to an announcement in the Government Gazette, on the grounds of a risk analysis as referred to in Section 24 subsection 2 of the BGGO, has established that the activities concerned cannot have any undesirable effects on man and the environment. In so far as aspects concerning the protection of the environment are at issue, for which the Minister of Agriculture, Nature Management and Fisheries is responsible, the latter must also have agreed with this assessment. Furthermore, an exception is made for activities with genetically modified organisms which, after a specific risk assessment has been carried out as stipulated in accordance with part C of Council Directive 90/220/EEC concerning contained use, have been marketed within a member state of the European Union or another state that is party to the European Economic Area Agreement, or with products that must undergo a specific risk assessment under the terms of community legislation as referred to in Section 10 subsection 1 of the directive. A permit must be applied for from the Minister of Housing, Spatial Planning and the Environment. Under the terms of Section 24 subsection 2 of the BGGO, a risk analysis must be submitted with the application concerning the proposed activities. This analysis must contain the following information at any rate - as summarized in Appendix 3: A. Concerning the mechanisms involved: a. A description of the organism or organisms, with information on: - the harmfulness to other organisms, - the epidemiology, - the formation of toxic compounds and - the formation of surviving structures;
BIOTECHNOLOGY. PROPERTY RIGHTS ANDTHE ENVIRONMENT b. the method of construction of the organism ororganisms c. the origin of the DNA and RNA introduced, with a description of the function and characterization of that dna and rna d. the genetic sta bility of the organism and the possibility for transfer of genetic materialto other organisms e. information on organisms that are the ultimate target of the process, and the ffects of the host on these target organisms f. a description of the a biotic factors relevant to the survival of the organism or organisms. g. a description of the biotic factors that are important for the growth and surviva of the organism or organisms, and the anticipated effect of the modified dNA on this h. information concerning any changes that are aimed at affecting the survival of the organism or organisms or the transfer of genetic material B Concerning the activity a. a description of the location where activity is carried out, with details concerning the situation and access for persons and animals b. a description of relevant changes that can be expected in the near future in the c vicinity of the location where the activity is takingplace, a description of the dispersal route of the organism or organisms; d. a description of the ecosystem in which the activ ity is carried out, and the anticipatedeffects on that ecosystem e. the method and duration of the activ ity f. the way in which the growth and survival of the organism or organisms and the information referred to under ld and 2d can be monitored over time. the way in which emergency measures can be taken, should hamful effects of the activ ity arise in the environment Minister believes that, in order to obta in insight into the potental dangers for and the environment, certa in information may be required, he may order the ant to supply such infomation as specified by him conceming the proposed ent framework is formed by that which is laid down in Section 26 lbsection 2 of the hazardous substances protect the interests of man and the environment. The bOGo does not elborate further on this criterion, so that the Minister has to make decisions on a case -by-cas Under the terms of Section 26 subsection 3 of the hazardous Substances act subsections 3.5.2 to 35.5 inclusive of the General Adm inistrative law Act and Section 13.2 of the Environmental Mana gement Act apply to the preparation of the decision on the application. Briefly, the relevant provisions of the Genera Adm inistrative Law Act stipulate that the draft decision must be sent to the applicant and the administrative bodies concerned within twelve weeks of the application, after H.J. Bronkhorst en W.J.E. van der Werf, Genetische modificative in de landbouw( Genetic modification in agriculture Land-en Tuinbouw Bulletin, 200 1/0 1, p 19
BIOTECHNOLOGY, PROPERTY RIGHTS AND THE ENVIRONMENT 3 b. the method of construction of the organism or organisms; c. the origin of the DNA and RNA introduced, with a description of the function and characterization of that DNA and RNA; d. the genetic stability of the organism and the possibility for transfer of genetic material to other organisms; e. information on organisms that are the ultimate target of the process, and the effects of the host on these target organisms; f. a description of the abiotic factors relevant to the survival of the organism or organisms; g. a description of the biotic factors that are important for the growth and survival of the organism or organisms, and the anticipated effect of the modified DNA on this; h. information concerning any changes that are aimed at affecting the survival of the organism or organisms or the transfer of genetic material. B Concerning the activity: a. a description of the location where activity is carried out, with details concerning the situation and access for persons and animals; b. a description of relevant changes that can be expected in the near future in the vicinity of the location where the activity is taking place; c. a description of the dispersal route of the organism or organisms; d. a description of the ecosystem in which the activity is carried out, and the anticipated effects on that ecosystem; e. the method and duration of the activity; f. the way in which the growth and survival of the organism or organisms and the information referred to under 1d and 2d can be monitored over time; g. the way in which emergency measures can be taken, should harmful effects of the activity arise in the environment. If the Minister believes that, in order to obtain insight into the potential dangers for man and the environment, certain information may be required, he may order the applicant to supply such information as specified by him concerning the proposed activity. The assessment framework is formed by that which is laid down in Section 26 subsection 2 of the Hazardous Substances Act: The permit maybe refused only to protect the interests of man and the environment . The BGGO does not elaborate further on this criterion, so that the Minister has to make decisions on a case-by-case basis.1 Under the terms of Section 26 subsection 3 of the Hazardous Substances Act, subsections 3.5.2 to 3.5.5 inclusive of the General Administrative Law Act and Section 13.2 of the Environmental Management Act apply to the preparation of the decision on the application. Briefly, the relevant provisions of the General Administrative Law Act stipulate that the draft decision must be sent to the applicant and the administrative bodies concerned within twelve weeks of the application, after 1. H.J. Bronkhorst en W.J.E. van der Werf, Genetische modificatie in de landbouw (Genetic modification in agriculture), Land- en Tuinbouw Bulletin, 2001/0 1, p. 19
SNIDEI which it must be made available for general inspection within two weeks. This will involve publishing it in one or more national daily newspapers, free local papers, and in the State Gazette, after which the administrative bodies concerned may give their recommendations in relation to the decision to be taken, while any one may lodge their objections to the draft decision in writing within four weeks of its publication During this period, everyone has the opportunity to exchange views on the draft and express their objections verbally upon request. If this opportunity is taken up, the applicant must also be invited. Then the decision is taken-in principle within six months of the application- whereby the Minister is also required to state his considerations regarding the objections raised Restrictions and other types of regulations may be attached to the issue of a permit(Section 26 subsection 4 of the Hazardous Substances Act). Acting of his own accord or at the request of the pemit holder or other interested parties, the minister may amend, add to or revoke restrictions and regulations, im pose additional restrictions or attach regulations to the permit at a later date, or revoke the pemit as ch(Section 24 subsection 4 BGGO) If such a decision is not made at the request of the permit holder himself, the Minister will only proceed with such a decision in the interests of protectingman and the environment. If the a pplicant or perm it holder leams of new infomation concerning risks that the genetically modified organisms or their treatment may cause for man and the environment, he must inform the Minister immediately. In addition, he must also take measures straight away that are necessary to protect man and the environment (Section 25 BGGO) Section 26 of the BGGO obliges the permit holder to inform the Minister of the isks to man and the environment once the activ ity has been completed There is a Committee for Genetic Modification(COGEM), which advises the Minister on the risks associated with the manufacture of and activities with genetically modified organisms, as well as on the ethical or socil aspects relating to activ ities with such organisms. The Dutch govemment considered submitting a proposal to the States-General in the pring of 1992 for a specific Act to deal with all legally relevant aspects of genetically modified organisms. The wish for this was largely the result of the im portance of proper harmonization of the legislation concerning this as a subject considered important. However, based on an extensive analysis carried out by the ministries involved, this was decided against. Ultimately the government felt it better to acquire experience first with the legislative frameworks already in place and those in preparation in the area of genetic modification. Meanwhile the plan for separate gral legislation would appear to have be The above shows that the introduction of genetically modified organisms and crops See here the Explanatory Memorandum to the Decree for the amendment of the BGGOdated 3 July 1992, Bulletin of Acts and Decrees 1992, 376. For the results of the analysis, see the SJ.R Bostyn& oo, Mbdeme biotechnologieen recht, ( Modem biotechnology and law, Recht
SNIJDERS 4 which it must be made available for general inspection within two weeks. This will involve publishing it in one or more national daily newspapers, free local papers, and in the State Gazette, after which the administrative bodies concerned may give their recommendations in relation to the decision to be taken, while anyone may lodge their objections to the draft decision in writing within four weeks of its publication. During this period, everyone has the opportunity to exchange views on the draft and express their objections verbally upon request. If this opportunity is taken up, the applicant must also be invited. Then the decision is taken - in principle within six months of the application - whereby the Minister is also required to state his considerations regarding the objections raised. Restrictions and other types of regulations may be attached to the issue of a permit (Section 26 subsection 4 of the Hazardous Substances Act). Acting of his own accord or at the request of the permit holder or other interested parties, the Minister may amend, add to or revoke restrictions and regulations, impose additional restrictions or attach regulations to the permit at a later date, or revoke the permit as such (Section 24 subsection 4 BGGO). If such a decision is not made at the request of the permit holder himself, the Minister will only proceed with such a decision in the interests of protecting man and the environment. If the applicant or permit holder learns of new information concerning risks that the genetically modified organisms or their treatment may cause for man and the environment, he must inform the Minister immediately. In addition, he must also take measures straight away that are necessary to protect man and the environment (Section 25 BGGO). Section 26 of the BGGO obliges the permit holder to inform the Minister of the risks to man and the environment once the activity has been completed. There is a Committee for Genetic Modification (COGEM), which advises the Minister on the risks associated with the manufacture of and activities with genetically modified organisms, as well as on the ethical or social aspects relating to activities with such organisms. The Dutch government considered submitting a proposal to the States-General in the spring of 1992 for a specific Act to deal with all legally relevant aspects of genetically modified organisms. The wish for this was largely the result of the importance of proper harmonization of the legislation concerning this as a subject considered important. However, based on an extensive analysis carried out by the ministries involved, this was decided against. Ultimately the government felt it better to acquire experience first with the legislative frameworks already in place and those in preparation in the area of genetic modification.2 Meanwhile the plan for separate, integral legislation would appear to have been abandoned.3 The above shows that the introduction of genetically modified organisms and crops 2. See here the Explanatory Memorandum to the Decree for the amendment of the BGGO dated 3 July 1992, Bulletin of Acts and Decrees 1992, 376. For the results of the analysis, see the Parliamentary Documents II 1991/1992, 22300 XI, no. 11. 3. S.J.R. Bostyn & co., Moderne biotechnologie en recht, (Modem biotechnology and law), Recht en Praktijk 85, Kluwer, Deventer, 2001, p. 22-23
BIOTECHNOLOGY. PROPERTY RIGHTS ANDTHE ENVIRONMENT in the Netherlands is regarded as a problem in terms of env ironmental law, for which a solution is being sought-whether justified or not-based on legislation conceming hazardous substances. The law concerning spatal planning does not play a role within this framework 2.2 Case law Case law as a result of sections 23 to 35 of the bOGo is scarce. In a decision of 13 January 2000, the Administrative Law Division of the Council of State gave a lim ited interpretation of the scope of the BGGO, to the extent that products such as o ik and meat -originating from animals fed on genetically modified maize plants not fall under the BGGO since these products in them selves are not genetically odified organisms. The damaging consequences to man resulting from the consumption of products originating from animals fed with genetically modified maize, as feared by the plaintiffs, could not be regarded as detrimental to manand the environment because of the release into the environment of genetically modified organisms, so that these consequences could not lead to an overruling of the decision gral Private law 3.1 Legislation Dutch legislation has no specific regulations relating to the recognition and protection of private property interests e.g. those of neighbouring property owners where gMO technology is introduced on a farm. This means that as far as this ubject is concerned, we have to resort to(mutually coherent)general rules regarding statutory property rights between adjoining properties on the one hand, and unla wful acts on the other hand. 6 In his note to the decision of the chairman of the adm inistrative law divs ion of the coun cil of Sate of 22 March 1994, AB 1994, 446, Drupsteen put the question whether the Hazardous Substances Act indeed prov ides an adequat basis for the bOGo, since organ isms(as part of the animate world)cannot be regarded as belonging t the substances and preparations(as part of the inanimate world )for whichrules may be setunder the terms of Section 24 of the Act Seealso H.E.J. van der Meulen, Biotechnobgie en het Beshuit genetisch gemodificeende organismen Biotechnology and the Genetically Modifed Organisms Decree), Milieu en Recht 1997, p 127-128 Published inAB 2000. 95 In theory, other bases for a claim are conceiable. In particular, reference can be made in ths ontext to the regulations of product lability n Sec. 6: 185 b 6: 193 ndusive of the Duth Civil Code, whereby Council Directive 85/374EEC (OJ 1985 L 210, p. 29)was mplemented. However, generally speaking these regulations will not provide much consolation, since genetically modifed organisms that have given rse to damage as discussed here have not usually been put into circulaton withn the meaning of the directive, while there need not be defective products, nor a form of damage against which the directive aims to offer protection. Moreover, a clam has a substantal chance of failing against the plea of state of the art permitted under Dutch law. For a
BIOTECHNOLOGY, PROPERTY RIGHTS AND THE ENVIRONMENT 5 in the Netherlands is regarded as a problem in terms of environmental law, for which a solution is being sought - whether justified or not4 - based on legislation concerning hazardous substances. The law concerning spatial planning does not play a role within this framework. 2.2 Case law Case law as a result of Sections 23 to 35 of the BGGO is scarce. In a decision of 13 January 2000,5 the Administrative Law Division of the Council of State gave a limited interpretation of the scope of the BGGO, to the extent that products such as milk and meat - originating from animals fed on genetically modified maize plants do not fall under the BGGO since these products in themselves are not genetically modified organisms. The damaging consequences to man resulting from the consumption of products originating from animals fed with genetically modified maize, as feared by the plaintiffs, could not be regarded as detrimental to man and the environment because of the release into the environment of genetically modified organisms, so that these consequences could not lead to an overruling of the decision to grant the disputed permit. 3 Private law 3.1 Legislation Dutch legislation has no specific regulations relating to the recognition and protection of private property interests e.g. those of neighbouring property owners where GMO technology is introduced on a farm. This means that as far as this subject is concerned, we have to resort to (mutually coherent) general rules regarding statutory property rights between adjoining properties on the one hand, and unlawful acts on the other hand.6 4. In his note to the decision of the Chairman of the Administrative Law Division of the Council of Sate of 22 March 1994, AB 1994, 446, Drupsteen put the question whether the Hazardous Substances Act indeed provides an adequate basis for the BGGO, since organisms (as part of the animate world) cannot be regarded as belonging to the substances and preparations (as part of the inanimate world) for which rules may be set under the terms of Section 24 of the Act. See also H.E.J. van der Meulen, Biotechnologie en het Besluit genetisch gemodificeerde organismen (Biotechnology and the Genetically Modified Organisms Decree), Milieu en Recht, 1997, p. 127-128. 5. Published in AB 2000, 95. 6. In theory, other bases for a claim are conceivable. In particular, reference can be made in this context to the regulations of product liability in Sec. 6:185 to 6:193 inclusive of the Dutch Civil Code, whereby Council Directive 85/374/EEC (OJ 1985 L 210, p. 29) was implemented. However, generally speaking these regulations will not provide much consolation, since genetically modified organisms that have given rise to damage as discussed here have not usually been put into circulation within the meaning of the directive, while there need not be defective products, nor a form of damage against which the directive aims to offer protection. Moreover, a claim has a substantial chance of failing against the plea of state of the art permitted under Dutch law. For a