Genetically modified organisms and precaution in Norway

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    Genetically Modified Organisms and Precaution in Norway

    Associate professor dr. juris Ole Kristian Fauchald

    The precautionary principle has, together with requirements concerning sustainable

    development and usefulness to the society, been core elements in the regulation of

    deliberate release of genetically modified organisms (hereafter GMOs) in Norway. The

    Norwegian legislation on GMOs was adopted in 1993 (the Act relating to the Production

    and Use of Genetically Modified Organisms, no. 38 of 1993, hereafter the GMO Act),

    and has essentially remained unchanged since it was adopted. However, the link

    established in 1992 between Norway and the European Union (hereafter the EU) through

    the Agreement on the European Economic Area (hereafter the EEA Agreement) means

    that the framework within which the legislation has been applied to a large extent has

    been dominated by issues concerning the relationship between the criteria set out in the

    law and legislation adopted by the EU.

    Despite the close relationship between Norway and the EU through the EEA Agreement,

    which inter alia means that Norway is part of the internal market for trade in goods,

    Norwegian authorities have so far pursued a policy on marketing of GMOs that differs

    significantly from that of the EU. Given the fact that Norway is depending on the

    political will of the EU in order to continue its cooperation with the EU through the EEA

    Agreement, which gives Norway, Iceland and Liechtenstein a unique possibility to

    participate in political processes within the EU, it is remarkable that Norway has been

    willing to deviate from the policy of the EU on such a politically important issue as the

    marketing of GMOs. This indicates the extent to which Norwegian politicians have

    considered GMOs to be a major political issue.

    This article will not address all aspects of GMOs. It will focus on deliberate release of

    GMOs into the environment. In addition to use of GMOs for agricultural or aquacultural

    purposes, it will cover use of living GMOs for food and feed. Issues concerning use of

    GMOs in processed food or feed, contained use of GMOs and transborder movement of

    GMOs from Norway to other countries will not be specifically addressed.[1]

    In the following, we shall first address the international legal framework within which

    Norwegian authorities are making decisions concerning marketing and labeling of

    GMOs. Thereafter follows an overview of the status for GMOs in Norway and the

    framework for decision-making (sections 2-5). The latter part of this article (sections 6-

    11) will address the way in which the precautionary principle has been and may be

    applied in individual cases.

    1 The international framework for the Norwegian legislation

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    Norway is party to a number of treaties of relevance to decisions concerning release of

    GMOs. First, there are environmental treaties, in particular the Cartagena Protocol on

    Biosafety (2001, hereafter the Cartagena Protocol) and the Aarhus Convention on Access

    to Information, Public Participation in Decision-Making and Access to Justice in

    Environmental Matters (1998, hereafter the Aarhus Convention). While the Cartagena

    Protocol is primarily of relevance to decisions concerning export of GMOs, it is also of

    relevance as a justification of domestic policies in view of obligations under international

    trade law. In particular, the Cartagena Protocol is of relevance to the use of the

    precautionary principle when making decisions on marketing and labeling of GMOs and

    when determining the burden of providing information and evidence concerning the

    impacts of GMOs on human, animal or plant health and the environment.

    The Aarhus Convention is primarily of relevance when setting out rules concerning the

    decision making procedure to be applied when determining whether to allow marketing

    of GMOs. In particular, the Aarhus Convention is relevant for public access to

    information on the properties of GMOs and their effects on health and the environment,

    and for participation in decision-making and access to justice in cases concerning

    decisions on deliberate release of GMOs.[2] In relation to Norway, the Aarhus

    Convention has been important for the establishment of separate procedures for impact

    assessment of GMOs.

    Except from the points noted above, the above mentioned treaties have been insignificant

    for the design and application of the Norwegian legislation on GMOs. Their main role

    has so far been to justify maintenance of current regulation of GMOs in view of

    challenges it may face with a view to facilitate international trade and internal marketing

    of GMOs. Against this background, there will not be any separate analysis of the

    relationship between the Norwegian regulation of GMOs and the treaties in the

    following.

    Secondly, there are treaties of relevance that aim at reducing trade barriers. This is

    particularly the case for the following treaties under the Agreement Establishing the

    World Trade Organization; the General Agreement on Tariffs and Trade (hereafter the

    GATT), the Agreement on Technical Barriers to Trade (hereafter the TBT Agreement),

    and the Agreement on the Application of Sanitary and Phytosanitary Measures (hereafter

    the SPS Agreement). These Agreements set out rules that have the potential to be of great

    significance to the design and application of measures to prevent negative health and

    environmental effects from the release of GMOs. Nevertheless, they were not considered

    when Norwegian authorities designed the basic system for regulation of GMOs. One did

    not point to any potential problem in relation to the GATT, and the system was designed

    before the TBT and SPS Agreements were adopted. Moreover, the relationship to the

    GMO legislation was not considered when Norway ratified the WTO Agreements.[3]

    Finally, in relation to the application of the legislation in individual cases, issues

    concerning the relationship to the trade agreements have not been part of the formal

    justification for the decisions taken, and do not seem to have been any main concern in

    relation to the design and application of measures to GMOs.[4] Against this background,

    I do not intend to carry out any independent analysis of the WTO rules in this article.

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    Thirdly, there are international regimes aiming at international harmonization of the use

    of measures related to the contained use and deliberate release of GMOs. Such regimes

    can be found in the form of development of international standards under international

    institutions, such as under the International Plant Protection Convention (1997), in the

    form of obligations to base measures on international standards, such as in the SPS

    Agreement, and in the form of rules setting out a more or less closely defined framework

    for decision making, such as in the legislation adopted by the EU. As the first two forms

    of regimes have had limited effect on the design and use of Norwegian regulation, this

    will not be addressed in the following.

    Of the international framework in the area of GMOs, it is thus the legislation of the EU

    that has had significant impact on Norwegian measures. The EU legislation of primary

    interest in the context of this article are Directive 90/220/EC on the deliberate release into

    the environment of genetically modified organisms (hereafter the 90/220 Directive),

    which has subsequently been replaced by Directive 2001/18/EEC on the deliberate

    release into the environment of genetically modified organisms (hereafter the 2001/18

    Directive). Norway has actively participated in the preparation of the 2001/18 Directive,

    but this Directive has not yet been included in the EEA Agreement.[5] The 90/220

    Directive, which is still the only instrument on GMOs applicable under the EEA

    Agreement, has in general not been significant for the design of the GMO Act, but it has

    played an essential role for the way in which the Act has been applied through adoption

    of regulations and through decisions in individual cases. Moreover, Norwegian

    participation in the development of Directive 2001/18 and other new secondary

    legislation on GMOs in the EU has been of importance to the design of Norwegian policy

    in the area of GMOs. For these reasons, and also because the way in which the 90/220

    Directive has been applied in Norway differs from the way in which the Directive has

    been applied in the EU, this Directive will be an essential part of the analysis to be

    carried out in the following. Directive 2001/18 will be referred to wherever it may be of

    relevance.

    2 Status for GMOs in Norway There is some biotechnological research in Norway, and some of this research aims at

    producing GMOs that may at a later stage be subject to deliberate release. Examples

    often cited are the production of a genetically modified winter-flowering begonia

    (juleglede), tobacco and aspen (osp).[6] However, so far none of this research has

    resulted in the application for deliberate release of any product based on GMOs, and

    Norwegian biotechnological industry is in general insignificant.

    So far only one application for deliberate release of genetically modified tobacco and

    three applications for deliberate release of carnation have been approved by Norwegian

    authorities. Norway is requested to make decisions concerning marketing of all GMOs

    for which there are applications for marketing within the EU.[7] A number of these

    applications are under consideration in the Norwegian decision making bodies. Norway

    has refused marketing of eight GMOs that have been accepted by the EU, namely two

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    applications for marketing of vaccines, five applications for plants and one application

    for microorganisms.[8]

    In the following, it will be of interest to analyse why Norway has rejected applications for

    marketing of these products and the role that the precautionary principle has played in

    this context, in view of the fact that Norway has allowed other GMOs to be marketed.

    Moreover, the status of the application processes for those GMOs that have not yet been

    subject to any decision does also need to be addressed in order to identify the role of the

    precautionary principle for the procedures followed during the application process. But

    before addressing these issues, we need to take a closer look at the general conceptual

    and regulatory framework for the decision-making procedure.

    3 General conceptual framework It may be useful to distinguish between three general approaches that are essential to the

    design of decision-making procedures. One approach, which is generally regarded as the

    approach to be used unless there are specific and convincing arguments for other

    approaches, is to take decisions on the basis of cost benefit analyses. Here, the task of

    decision-makers is to identify relevant costs and benefits of alternative decisions, and to

    make the decision that gives the highest net benefit. This is generally the approach to be

    chosen where decision-makers have a broad margin of appreciation.

    A second approach, which is most common where decision-makers margin of

    appreciation is significantly limited through legislation, is to base the decision on cost

    effectiveness. Here, the legislator has limited the options available and the factors that

    can be taken into account when making the decision, and a main task for decision-makers

    is to design the decision in such a way that costs of the decision are kept to a minimum.

    There is no clear distinction between decision-making based on cost benefit analyses and

    on cost effectiveness. Both approaches may be of relevance in the context of a given

    decision.

    A third approach is to base decisions on precaution. Such an approach is of relevance in

    cases where the available information on the effects of decisions is such that it is not

    possible to make a decision based on a cost benefit analysis. Such cases occur primarily

    where there is uncertainty related to the costs of the decision. Hence, there is a

    fundamental difference between decisions based on a cost benefit analysis and decisions

    based on a precautionary approach, as a cost benefit approach will per definition not be

    available in cases where a precautionary approach is called for. Nevertheless, a decision-

    maker will in many cases be expected to take into account cost effectiveness when

    designing decisions based on a precautionary approach.[9] Moreover, it can be argued

    that a cost benefit analysis could be replaced by a proportionality test in cases where the

    precautionary principle is applicable.[10] In the opinion of this author, it cannot in this

    context be distinguished between a proportionality test and an approach based on

    ensuring cost effectiveness.

    4 General legislative framework

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    It can be argued that the environmental clause in Section 110 b of the Norwegian

    Constitution[11] is a general starting point for the application of the precautionary

    principle in the Norwegian legal system in the sense that it implicitly presupposes its

    existence. However, the provision does neither explicitly refer to the principle, nor

    address issues concerning decision-making in cases of uncertainty. There is thus no

    reason to emphasize Section 110 b when addressing the use of the precautionary principle

    in relation to GMOs.

    Decisions concerning deliberate release of GMOs in Norway are regulated in Section 10

    of the GMO Act (no. 38 of 1993):

    1. Deliberate release of genetically modified organisms may only occur subject to

    approval by the [Government]. A product may not be approved for placing on the

    market until it has been satisfactorily tested in natural environments that will be affected

    by the intended use.

    2. Deliberate release of genetically modified organisms may only be approved when

    there is no risk of harmful effects on health or the environment. Moreover, when deciding

    whether or not to grant the application significant emphasis shall be placed on whether

    the deliberate release represents a benefit to the community and a contribution to

    sustainable development.

    6. Approval is not required for the placing on the market of a product that is

    approved for placing on the market in another EEA country pursuant to the rules laid

    down in Annex XX, Entry 25, of the EEA Agreement (Council Directive 90/220/EEC).

    The authorities responsible under the present Act, however, may still prohibit or limit

    such placing on the market if in their opinion it involves a risk to health or the

    environment or if the placing on the market is otherwise in conflict with the purpose of

    this Act.

    Since almost all GMOs for which approval is sought in Norway have been app...

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