Time for a New EU Regulatory Framework for GM Crops?

In this section, based on what has been proposed in the GMO regulation literature to date, we identify a non-exhaustive set of legal principles and criteria of relevance that we believe any reformed EU GM regulatory system would have to meet. By “legal principles” we mean rules or standards of a general kind that, whether codified or not, have to be followed by legislators and decision-makers in one way or another. They are of various kinds; some principles have substantive effects, others guide procedures; some aim at protecting individual rights, others at protecting common values. However, what unites them is that they are usually of great importance as legal sources and that it is common to use them as a point of departure when analyzing law interpretations and applications in practice (Marcusson 2012). In this paper, they will primarily be used to analyze the design of the present EU GM legislation (i.e., the legal acts themselves), rather than interpretations and applications of the legislation, for example in the form of legal rulings.

As the terms “at least” and “inter alia” reveal, the Release Directive allows for additional techniques to the ones mentioned in the present section to be considered resulting in a GMO. The general scope of the directive can thus be said to be wide and non-exhaustively defined. At the same time, the directive allows for a number of precisely formulated exceptions. Annex I A, part 2 explicitly excludes in vitro fertilisation, natural processes (such as conjugation, transduction and transformation), and polyploidy induction, on condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques methods other than those excluded in Annex I B. Annex I B explicitly excludes mutagenesis and cell fusion, including protoplast fusion, of plant cells of organisms which can exchange genetic material through traditional breeding methods.

A number of new breeding techniques (NBTs) have been developed since the enactment of the EU legislation in the early 2000s. Site-directed nuclease (SDN), cisgenesis, and RNA-dependent DNA methylation are three examples. At present, these techniques are stuck in a legal limbo within the EU system, since it is uncertain whether they should fall within the general scope of the legislation (which a literal reading of the Release Directive appears to support) or be part of the list of techniques explicitly excluded from oversight (Hartung and Schiemann 2014; Abbott 2015). Pending a policy decision by the EU Commission on the NBTs some Member States have unilaterally decided to exempt some varieties developed by the use of some NBTs from oversight. For example, in spring 2016 the Swedish Agricultural Board decided that a new variety that had been developed by using CRISPR-Cas9 should not count as a genetically modified organism.⁸ Because of the uncertain legal status of CRISPR/Cas9 and other breeding techniques the EU GM legislation does not meet the principle of legal certainty at present. This is unsatisfactory, not only because it threatens to stifle innovation and investment within the EU (Jones 2015); it could in addition lead to loss of valuable knowledge and resources, as plant breeding specialists increasingly look to go abroad to continue their research. It could of course be objected that, once a decision has been reached by the Commission concerning the status of the NBTs currently under investigation, everybody will know which techniques fall within the scope of the directive and legal certainty will, thus, be restored. However, other NBTs will likely be developed in the future in which case the problem of legal uncertainty re-surfaces. There is, in other words, an inherent vulnerability in a legal construction that regulates risk based on the use of a specific technology and where the boundaries of the technology are in need of continuous re-definition due to rapid advancement in science. This point will be further elaborated on in “Scientific Adaptability” section.

It could be argued that one way of avoiding this problem is to adopt a product-based legislation that is based on the notion of substantial equivalence. In Canada, only “plants with novel traits” (PNTs) are subject to regulatory scrutiny (Smyth and McHughen 2008). PNTs are plants that contain traits that are new to the Canadian environment and have the potential to significantly impact on the environment or human health. To enter the market, PNTs must undergo stringent assessment, which aims to ensure that the plant is as safe as the conventional plants already in use (Marchant and Stevens 2015). Since the legislation applies to all varieties with novel traits, regardless of breeding method, it can be said to provide greater legal certainty than the present EU legislation.

In the United States, the rules cover introductions of so-called “regulated articles”. Regulated articles are organisms or products altered or produced through genetic engineering, which are plant pests or at least there is reason to suspect that they are.⁹ Genetic engineering is defined as genetic modification of organisms by recombinant DNA techniques. The U.S. legislation on plant pests aims to determine the extent to which an organism can harm plants, or parts thereof, directly or indirectly; the aim is not to protect ecosystems. Furthermore, there is a risk that the U.S. product based legislation, consisting of many different legal acts, will not be comprehensive and that some GM varieties will remain unregulated (Czarnezki and Montgomery 2013). To take one example, if a GM crop is not classified as a “plant pest” according to the US GM legislation, there is no other piece of legislation that enters into force and the crop will remain unregulated (Kimbrell 2013).¹⁰

A second major point of criticism against the EU GM legislation is that it violates the principle of non-discrimination, since it puts severe restrictions on (GM) varieties that fall under the directive but fails to regulate (conventional, non-GM) varieties that involve similar or in some cases even more serious risks (McHughen 2007; Morris 2007; Morris and Spillane 2010; Podevin et al. 2012; ACRE 2013a).¹¹ Batista et al. (2008) mention the example of plant mutagenesis, which does not fall under the present legislation but which could induce much more transcriptomic changes than transgene insertion. Arguably, if the health and environmental risks associated with GM crop introductions are the same in kind as those associated with conventional varieties, there are no good reasons for maintaining separate legislations for GM and conventional varieties from the viewpoint of health and environmental risk prevention (NIH 1992; Miller 2010).

From the viewpoint of “risk consistency” a product-based legislation is preferable. Since the legislation uses an organism’s phenotype instead of a particular technology as a trigger for regulatory oversight, it can be applied more consistently to the real risks of GM introductions (McHughen 2007; Heap 2013). It can of course be objected that the product-based legislations presently in force have a too limited view on what risks should be taken into account in the approval process. For example, in the United States where the U.S. Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases the scope of the risk assessment in the U.S. APHIS notification procedure is limited to include only direct and immediate effects.¹² On the other hand, in the APHIS authorization procedure, an Environmental assessment (EA) may be required when a release of a GM organism or product “involves new species or organisms or novel modifications that raise new issues”.¹³ If a Threatened and Endangered Species or NEPA analysis will be required, the analysis must consider both the direct (immediate) and indirect (later in time, but reasonably certain to occur) effects.¹⁴ However, the large majority of applications involving plant species are for notifications and not permits and, thus, do not include assessment of indirect and delayed effects (Kimbrell 2013).

This is to be contrasted with the Release Directive according to which a case-by-case risk analysis shall describe direct, indirect, immediate, and delayed effects. The applicant’s obligation is comprehensive, since also analysis of cumulative long-term effects is to be carried out.¹⁵ It could be argued that by refraining from assessing indirect and delayed effects, the U.S. GM risk assessment process is incomplete and does not adequately protect human health or the environment. However, whether the scope of the risk assessment process is wide enough to provide sufficient protection against harm to human health or the environment is a separate question to whether or not the risks of GM and non-GM introductions are consistently regulated. The risks of GM and non-GM introductions can be consistently regulated, in which case the legislation would satisfy the criterion of non-discrimination; however, the argument can still be made that the scope of the risk assessment protocol used is too narrow to protect human health or the environment to a sufficient degree.

The proportionality principle requires that the legal measures specified in the GM legislation are suitable and necessary to achieve the objectives of the legislation. As noted above, the primary objectives of the Release Directive are, in accordance with the precautionary principle, to protect human health and the environment as well as to approximate the laws.¹⁶ The directive includes references to other values, such as “respect for ethical principles recognized in a Member State” (recital 9) and “socioeconomic advantages and disadvantages” (recital 62); however, they are not expressed as objectives in Article 1 of the directive.¹⁷ The precautionary measures specified in the directive include conducting an environmental risk assessment before any experimental release of a genetically modified variety takes place, taking safety measures once a genetically modified variety has been released, and various notification and labelling requirements. One of the central arguments against the present EU legislation is that the required measures do not meet the requirement of proportionality, since they do not constitute an effective, necessary or balanced means of protecting human health and the environment (Podevin et al. 2012; Riviere and Buckley 2012). Below, each of the preconditions of the proportionality principle will be used to analyse the Release Directive in greater detail. For the sake of the argument it will be assumed that the objectives pursued through the directive are justifiable, and that the first precondition of the proportionality principle is thus met.

First of all, the proportionality principle requires that the precautionary measures specified in the directive are effective in the sense that they are capable of serving the public interest (in this case protection of human health and the environment). Arguably, by subjecting new GM varieties to extensive risk assessment and other safety measures the probability of harm to the environment and human health caused by such introductions is indeed significantly reduced. However, it could be disputed whether the precautionary measures prescribed by the directive reduce the overall risks to human health and the environment. It could be argued that the present legislation fails to satisfy the criterion of effectiveness, since there is reason to believe that (at least some) GM crops, because of their genetically modified traits, could have a much less negative impact on the adopted objectives than their conventional counterparts. To the extent that this holds, the precautionary measures required by the directive in order to safeguard human health or the environment do not meet the criterion of effectiveness.

Second, the proportionality principle requires that the precautionary measures are necessary in the sense that they cannot be replaced by alternatives that are equally effective but less intrusive on individual rights. Here, at least two lines of argumentation are possible. First, it could be argued that since the risks associated with GM introductions are close to zero, virtually no precautionary measures can ever qualify as necessary in the sense that they cannot be replaced by alternatives that are less intrusive on individual rights. Consequently, the precautionary measures required by the present legislation do not satisfy the proportionality principle. Furthermore, even if one agrees that the risks of GM introductions are much larger, one can still question whether there is a need for the precautionary measures prescribed, for example, by the Release Directive. Perhaps an equal level of protection could be achieved through a different legislative technique, say a product-based legislation.

Let us look deeper into this argument. There are good reasons to believe that a product-based regulatory framework, such as the Canadian, is less intrusive on the freedom of cultivation/trade than the EU legislation, since it only regulates introductions of varieties with “novel traits”. As long as the variety does not contain any such traits, farmers are free to cultivate it without any further safety measures having to be taken. If the Canadian legislation is, in addition, equally effective in preventing harm to human health and the environment as the EU legislation, it satisfies the proportionality principle to a greater degree than its European counterpart. However, the key question is whether the legislation does in fact provide equal protection. That question is very difficult to answer, not only because a meaningful comparison would require empirical investigations into the policy-outcome relationship in the two jurisdictions under consideration; it also depends on how the objectives of the legislations under consideration are interpreted. Both the Canadian and the EU legislation aim at protecting human health and the environment. However, since the EU, but not the Canadian, legislation is based on the precautionary principle, the acceptable level of risk may differ between the two, which in turn affects the proportionality assessment.¹⁸

Finally, the proportionality principle requires that the precautionary measures are balanced in the sense that they do not intrude on individual rights to a greater degree than what is justified given the importance of the objectives pursued. This involves balancing the public interest (protection of human health and the environment) against a private interest (freedom of cultivation and trade). Since such a balancing would require a much more developed argumentation than can be offered in this paper, it will not be dealt with further here.

Since the provisions do not explicitly cover situations in which new scientific evidence has emerged to the effect that an assessed GMO is less risky than previously thought, the EU regulation could be criticized for failing to meet the criterion of scientific adaptability.²⁰

Arguably, there is greater room for accommodating the value of scientific adaptability in a product-based system. The U.S. legislation has certain flexibility in that a GM variety can be listed as a plant pest, and thus be more stringently regulated, as well as removed from the list as new information comes to light.²¹ Furthermore, any person may submit a petition to APHIS to seek a determination that a regulated article should have a “non-regulated status”.²² If the authority determines that the regulated article does not present a risk of introduction or dissemination of a plant pest, the petition will be granted, thereby allowing unrestricted introduction of the article. Before the assessment, the applicant must provide information on, inter alia, deleterious effects on non-target organisms and environment from field releases.²³ Depending on the risk picture the decision will be preceded by various investigations, such as an Environmental Assessment declaring a “Finding of no significant impacts”²⁴ or the more ambitious Environmental Impact Statement (EIS). APHIS may also extend a determination of non-regulated status to additional regulated articles, upon finding that those articles do not pose a plant pest risk, and should therefore not be regulated (a similarity test).²⁵ Thus, there is much greater room in the U.S. than in Europe for adjusting the GM legislation to new scientific findings.

As noted above, the primary objective of the Release Directive is to protect human health and the environment. There is no explicit requirement that a Member State take non-safety considerations into account in its approval process, although recital 9 of the directive allows for such aspects to be part of the approval process. It is, however, uncertain to what extent the Member States can in fact take ethical, religious or socioeconomic aspects into consideration in their national approval processes. The directive is market-based and contains a free trade clause, which all Member States have to follow. Moreover, the right to take ethical, religious or socioeconomic aspects into account is not clearly reflected as substantive standards in the operative articles, but merely mentioned in relation to the Commission’s duty to seek advice on the ethical implications of biotechnology and submit reports to the European Parliament and Council.

From a legal point of view, it is not entirely clear-cut what should count as an ethical aspect in the context of GM crop introductions. Ethical aspects are not defined in the Release Directive, nor have they been clearly delineated by the European Court of Justice (ECJ). Some guidance can be found in the decisions made by the authorities involved in assessment of GM varieties at the national level. For example, the Swedish Gene Technology Advisory Board, which is responsible for carrying out ethical assessment of GM varieties before they can be released in Sweden, have identified a number of aspects considered to be ethical, including animal welfare, consumer autonomy, and justice in a national and global context.²⁶

Ethical aspects have been the subject of a case in the ECJ (Case C-165/08). Poland had in its seeds legislation provisions stating “genetically modified varieties shall not be included in the national catalogue” and “the seeds of genetically modified varieties cannot be accepted on the market in the territory of the Republic of Poland”. Anyone who placed a GM seed on the Polish market would be imposed an economic sanction. The central question was whether the national provisions were contrary to the free trade clauses in the Release Directive and the Seeds Directive (2002/53/EC).²⁷ Poland claimed ethical reasons of Christian and humanistic character, which were alleged to be shared by the majority of the Polish population. According to the ECJ, Poland, which had the burden of proof, was unable to show that the national provisions were based on religious and ethical grounds.

However, the possibilities for taking non-safety considerations into account have recently increased. As of 2015, through the insertion of Article 26b into the Release Directive, the EU Member States have been given a right to adopt measures restricting or prohibiting the cultivation of GMOs within their territories based on environmental or socioeconomic considerations that have not been dealt with in the environmental risk assessment process.²⁸ The Member States are given two options: They can either demand restriction of the geographic area during the authorization procedure, or in cases where a GMO has already been approved, they may adopt measures restricting or prohibiting the cultivation of the GMO in all or part of its territory. In the former case, the Member State do not need to justify why the want it that way, although a giving reason is recommended (Winter 2015). The latter requires that certain grounds are in place. The grounds have to be in conformity with Union law, reasoned, proportional and non-discriminatory as well as compelling. The directive has a non-exhaustive list of compelling grounds in article 26b(3), among them those related to environmental policy objectives, town and country planning, socio-economic impacts, and agricultural policy objectives. The grounds must not in any case conflict with the environmental risk assessment carried out pursuant to the Release Directive or the Food and Feed Regulation, but could nevertheless be based on new scientific evidence concerning aspects not dealt with in the environmental risk assessment process, such as socioeconomic impacts, organic production, or “maintenance of local biodiversity, including certain habitats and ecosystems, or certain types of natural and landscape features, as well as specific ecosystem functions and services”.²⁹ The list of compelling grounds is non-exhaustive and may include ethical or religious grounds, such as respect for nature, “recognition of a plant’s genuine character”, and “reverence for the Creation” (Winter 2016, p. 130). According to Winter (2016), and in the light of the above-mentioned ECJ case, there are indications that in case of a renewed referral of the question of ethical grounds to the ECJ, the court would grant them an appropriate role.

In the U.S. product-based legislation and praxis, there are no inclusions of non-safety considerations. None of the eligibility criteria mentioned above or performance standards require that socioeconomic or ethical considerations be taken into account in the approval process.

From our analysis above it seems that the present EU legislation does not meet the criteria of legal certainty, non-discrimination, and scientific adaptability. Further analysis is needed in order to answer to what extent it satisfies the criterion of proportionality. In what ways, then, could the present EU framework for GM varieties be reformed so that it better satisfies the principles and criteria of legal certainty, non-discrimination, and scientific adaptability, while at the same time taking non-safety considerations into account? Below, we briefly discuss two ways of reforming the present EU framework toward greater accommodation of the values expressed through these principles and criteria. They both, in different ways, constitute a regulatory shift for GM varieties within the union.